Text of S. 3187 (112th): Food and Drug Administration Safety and Innovation Act (Passed Congress version)

One Hundred Twelfth Congress of the United States of America

2d Session

Begun and held at the City of Washington on Tuesday, the third day of January, two thousand and twelve

S. 3187

IN THE SENATE OF THE UNITED STATES

AN ACT

To amend the Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee programs for prescription drugs and medical devices, to establish user-fee programs for generic drugs and biosimilars, and for other purposes.

This Act may be cited as the Food and Drug Administration Safety and Innovation Act.

(a)

The table of contents of this Act is as follows:

Sec. 1. Short title.

Sec. 2. Table of contents; references in Act.

Title I—Fees relating to drugs

Sec. 101. Short title; finding.

Sec. 102. Definitions.

Sec. 103. Authority to assess and use drug fees.

Sec. 104. Reauthorization; reporting requirements.

Sec. 105. Sunset dates.

Sec. 106. Effective date.

Sec. 107. Savings clause.

Title II—Fees relating to devices

Sec. 201. Short title; findings.

Sec. 202. Definitions.

Sec. 203. Authority to assess and use device fees.

Sec. 204. Reauthorization; reporting requirements.

Sec. 205. Savings clause.

Sec. 206. Effective date.

Sec. 207. Sunset clause.

Sec. 208. Streamlined hiring authority to support activities related to the process for the review of device applications.

Title III—Fees relating to generic drugs

Sec. 301. Short title.

Sec. 302. Authority to assess and use human generic drug fees.

Sec. 303. Reauthorization; reporting requirements.

Sec. 304. Sunset dates.

Sec. 305. Effective date.

Sec. 306. Amendment with respect to misbranding.

Sec. 307. Streamlined hiring authority to support activities related to human generic drugs.

Sec. 308. Additional reporting requirements.

Title IV—Fees relating to biosimilar biological products

Sec. 401. Short title; finding.

Sec. 402. Fees relating to biosimilar biological products.

Sec. 403. Reauthorization; reporting requirements.

Sec. 404. Sunset dates.

Sec. 405. Effective date.

Sec. 406. Savings clause.

Sec. 407. Conforming amendment.

Sec. 408. Additional reporting requirements.

Title V—Pediatric drugs and devices

Sec. 501. Permanence.

Sec. 502. Written requests.

Sec. 503. Communication with Pediatric Review Committee.

Sec. 504. Access to data.

Sec. 505. Ensuring the completion of pediatric studies.

Sec. 506. Pediatric study plans.

Sec. 507. Reauthorizations.

Sec. 508. Report.

Sec. 509. Technical amendments.

Sec. 510. Pediatric rare diseases.

Sec. 511. Staff of Office of Pediatric Therapeutics.

Title VI—Medical device regulatory improvements

Sec. 601. Investigational device exemptions.

Sec. 602. Clarification of least burdensome standard.

Sec. 603. Agency documentation and review of significant decisions.

Sec. 604. Device modifications requiring premarket notification prior to marketing.

Sec. 605. Program to improve the device recall system.

Sec. 606. Clinical holds on investigational device exemptions.

Sec. 607. Modification of de novo application process.

Sec. 608. Reclassification procedures.

Sec. 609. Harmonization of device premarket review, inspection, and labeling symbols.

Sec. 610. Participation in international fora.

Sec. 611. Reauthorization of third-party review.

Sec. 612. Reauthorization of third-party inspection.

Sec. 613. Humanitarian device exemptions.

Sec. 614. Unique device identifier.

Sec. 615. Sentinel.

Sec. 616. Postmarket surveillance.

Sec. 617. Custom devices.

Sec. 618. Health information technology.

Sec. 619. Good guidance practices relating to devices.

Sec. 620. Pediatric device consortia.

Title VII—Drug supply chain

Sec. 701. Registration of domestic drug establishments.

Sec. 702. Registration of foreign establishments.

Sec. 703. Identification of drug excipient information with product listing.

Sec. 704. Electronic system for registration and listing.

Sec. 705. Risk-based inspection frequency.

Sec. 706. Records for inspection.

Sec. 707. Prohibition against delaying, denying, limiting, or refusing inspection.

Sec. 708. Destruction of adulterated, misbranded, or counterfeit drugs offered for import.

Sec. 709. Administrative detention.

Sec. 710. Exchange of information.

Sec. 711. Enhancing the safety and quality of the drug supply.

Sec. 712. Recognition of foreign government inspections.

Sec. 713. Standards for admission of imported drugs.

Sec. 714. Registration of commercial importers.

Sec. 715. Notification.

Sec. 716. Protection against intentional adulteration.

Sec. 717. Penalties for counterfeiting drugs.

Sec. 718. Extraterritorial jurisdiction.

Title VIII—Generating Antibiotic Incentives Now

Sec. 801. Extension of exclusivity period for drugs.

Sec. 802. Priority review.

Sec. 803. Fast track product.

Sec. 804. Clinical trials.

Sec. 805. Reassessment of qualified infectious disease product incentives in 5 years.

Sec. 806. Guidance on pathogen-focused antibacterial drug development.

Title IX—Drug approval and patient access

Sec. 901. Enhancement of accelerated patient access to new medical treatments.

Sec. 902. Breakthrough therapies.

Sec. 903. Consultation with external experts on rare diseases, targeted therapies, and genetic targeting of treatments.

Sec. 904. Accessibility of information on prescription drug container labels by visually impaired and blind consumers.

Sec. 905. Risk-benefit framework.

Sec. 906. Grants and Contracts for the Development of Orphan Drugs.

Sec. 907. Reporting of inclusion of demographic subgroups in clinical trials and data analysis in applications for drugs, biologics, and devices.

Sec. 908. Rare pediatric disease priority review voucher incentive program.

Title X—Drug shortages

Sec. 1001. Discontinuance or interruption in the production of life-saving drugs.

Sec. 1002. Annual reporting on drug shortages.

Sec. 1003. Coordination; task force and strategic plan.

Sec. 1004. Drug shortage list.

Sec. 1005. Quotas applicable to drugs in shortage.

Sec. 1006. Attorney General report on drug shortages.

Sec. 1007. Hospital repackaging of drugs in shortage.

Sec. 1008. Study on drug shortages.

Title XI—Other provisions

Subtitle A—Reauthorizations

Sec. 1101. Reauthorization of provision relating to exclusivity of certain drugs containing single enantiomers.

Sec. 1102. Reauthorization of the critical path public-private partnerships.

Subtitle B—Medical gas product regulation

Sec. 1111. Regulation of medical gases.

Sec. 1112. Changes to regulations.

Sec. 1113. Rules of construction.

Subtitle C—Miscellaneous provisions

Sec. 1121. Guidance document regarding product promotion using the Internet.

Sec. 1122. Combating prescription drug abuse.

Sec. 1123. Optimizing global clinical trials.

Sec. 1124. Advancing regulatory science to promote public health innovation.

Sec. 1125. Information technology.

Sec. 1126. Nanotechnology.

Sec. 1127. Online pharmacy report to Congress.

Sec. 1128. Report on small businesses.

Sec. 1129. Protections for the commissioned corps of the public health service act.

Sec. 1130. Compliance date for rule relating to sunscreen drug products for over-the-counter human use.

Sec. 1131. Strategic integrated management plan.

Sec. 1132. Assessment and modification of REMS.

Sec. 1133. Extension of period for first applicant to obtain tentative approval without forfeiting 180-day-exclusivity period.

Sec. 1134. Deadline for determination on certain petitions.

Sec. 1135. Final agency action relating to petitions and civil actions.

Sec. 1136. Electronic submission of applications.

Sec. 1137. Patient participation in medical product discussions.

Sec. 1138. Ensuring adequate information regarding pharmaceuticals for all populations, particularly underrepresented subpopulations, including racial subgroups.

Sec. 1139. Scheduling of hydrocodone.

Sec. 1140. Study on Drug Labeling by Electronic Means.

Sec. 1141. Recommendations on interoperability standards.

Sec. 1142. Conflicts of interest.

Sec. 1143. Notification of FDA intent to regulate laboratory-developed tests.

Subtitle D—Synthetic drugs

Sec. 1151. Short title.

Sec. 1152. Addition of synthetic drugs to schedule I of the Controlled Substances Act.

Sec. 1153. Temporary scheduling to avoid imminent hazards to public safety expansion.

(b)

Except as otherwise specified, amendments made by this Act to a section or other provision of law are amendments to such section or other provision of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.).

101.

(a)

This title may be cited as the Prescription Drug User Fee Amendments of 2012.

(b)

The Congress finds that the fees authorized by the amendments made in this title will be dedicated toward expediting the drug development process and the process for the review of human drug applications, including postmarket drug safety activities, as set forth in the goals identified for purposes of part 2 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act, in the letters from the Secretary of Health and Human Services to the Chairman of the Committee on Health, Education, Labor, and Pensions of the Senate and the Chairman of the Committee on Energy and Commerce of the House of Representatives, as set forth in the Congressional Record.

102.

Section 735(7) (21 U.S.C. 379g) is amended by striking expenses incurred in connection with and inserting expenses in connection with.

103.

Section 736 (21 U.S.C. 379h) is amended—

(1)

in subsection (a)—

(A)

in the matter preceding paragraph (1), by striking fiscal year 2008 and inserting fiscal year 2013;

(B)

in paragraph (1)(A)—

(i)

in clause (i), by striking (c)(5) and inserting (c)(4); and

(ii)

in clause (ii), by striking (c)(5) and inserting (c)(4);

(C)

in the matter following clause (ii) in paragraph (2)(A)—

(i)

by striking (c)(5) and inserting (c)(4); and

(ii)

by striking payable on or before October 1 of each year and inserting due on the later of the first business day on or after October 1 of each fiscal year or the first business day after the enactment of an appropriations Act providing for the collection and obligation of fees for such fiscal year under this section;

(D)

in paragraph (3)—

(i)

in subparagraph (A)—

(I)

by striking subsection (c)(5) and inserting subsection (c)(4); and

(II)

by striking payable on or before October 1 of each year. and inserting due on the later of the first business day on or after October 1 of each fiscal year or the first business day after the enactment of an appropriations Act providing for the collection and obligation of fees for such fiscal year under this section.; and

(ii)

by amending subparagraph (B) to read as follows:

(B)

A prescription drug product shall not be assessed a fee under subparagraph (A) if such product is—

(i)

identified on the list compiled under section 505(j)(7) with a potency described in terms of per 100 mL;

(ii)

the same product as another product that—

(I)

was approved under an application filed under section 505(b) or 505(j); and

(II)

is not in the list of discontinued products compiled under section 505(j)(7);

(iii)

the same product as another product that was approved under an abbreviated application filed under section 507 (as in effect on the day before the date of enactment of the Food and Drug Administration Modernization Act of 1997); or

(iv)

the same product as another product that was approved under an abbreviated new drug application pursuant to regulations in effect prior to the implementation of the Drug Price Competition and Patent Term Restoration Act of 1984.

;

(2)

in subsection (b)—

(A)

in paragraph (1)—

(i)

in the matter preceding subparagraph (A), by striking fiscal years 2008 through 2012 and inserting fiscal years 2013 through 2017;

(ii)

in subparagraph (A), by striking $392,783,000; and and inserting $693,099,000;; and

(iii)

by striking subparagraph (B) and inserting the following:

(B)

the dollar amount equal to the inflation adjustment for fiscal year 2013 (as determined under paragraph (3)(A)); and

(C)

the dollar amount equal to the workload adjustment for fiscal year 2013 (as determined under paragraph (3)(B)).

; and

(B)

by striking paragraphs (3) and (4) and inserting the following:

(3)

For purposes of paragraph (1), the dollar amount of the inflation and workload adjustments for fiscal year 2013 shall be determined as follows:

(A)

The inflation adjustment for fiscal year 2013 shall be the sum of—

(i)

$652,709,000 multiplied by the result of an inflation adjustment calculation determined using the methodology described in subsection (c)(1)(B); and

(ii)

$652,709,000 multiplied by the result of an inflation adjustment calculation determined using the methodology described in subsection (c)(1)(C).

(B)

Subject to subparagraph (C), the workload adjustment for fiscal 2013 shall be—

(i)

$652,709,000 plus the amount of the inflation adjustment calculated under subparagraph (A); multiplied by

(ii)

the amount (if any) by which a percentage workload adjustment for fiscal year 2013, as determined using the methodology described in subsection (c)(2)(A), would exceed the percentage workload adjustment (as so determined) for fiscal year 2012, if both such adjustment percentages were calculated using the 5-year base period consisting of fiscal years 2003 through 2007.

(C)

Under no circumstances shall the adjustment under subparagraph (B) result in fee revenues for fiscal year 2013 that are less than the sum of the amount under paragraph (1)(A) and the amount under paragraph (1)(B).

;

(3)

by striking subsection (c) and inserting the following:

(c)

(1)

For fiscal year 2014 and subsequent fiscal years, the revenues established in subsection (b) shall be adjusted by the Secretary by notice, published in the Federal Register, for a fiscal year by the amount equal to the sum of—

(A)

one;

(B)

the average annual percent change in the cost, per full-time equivalent position of the Food and Drug Administration, of all personnel compensation and benefits paid with respect to such positions for the first 3 years of the preceding 4 fiscal years, multiplied by the proportion of personnel compensation and benefits costs to total costs of the process for the review of human drug applications (as defined in section 735(6)) for the first 3 years of the preceding 4 fiscal years, and

(C)

the average annual percent change that occurred in the Consumer Price Index for urban consumers (Washington-Baltimore, DC–MD–VA–WV; Not Seasonally Adjusted; All items; Annual Index) for the first 3 years of the preceding 4 years of available data multiplied by the proportion of all costs other than personnel compensation and benefits costs to total costs of the process for the review of human drug applications (as defined in section 735(6)) for the first 3 years of the preceding 4 fiscal years.

The adjustment made each fiscal year under this paragraph shall be added on a compounded basis to the sum of all adjustments made each fiscal year after fiscal year 2013 under this paragraph.

(2)

For fiscal year 2014 and subsequent fiscal years, after the fee revenues established in subsection (b) are adjusted for a fiscal year for inflation in accordance with paragraph (1), the fee revenues shall be adjusted further for such fiscal year to reflect changes in the workload of the Secretary for the process for the review of human drug applications. With respect to such adjustment:

(A)

The adjustment shall be determined by the Secretary based on a weighted average of the change in the total number of human drug applications (adjusted for changes in review activities, as described in the notice that the Secretary is required to publish in the Federal Register under this subparagraph), efficacy supplements, and manufacturing supplements submitted to the Secretary, and the change in the total number of active commercial investigational new drug applications (adjusted for changes in review activities, as so described) during the most recent 12-month period for which data on such submissions is available. The Secretary shall publish in the Federal Register the fee revenues and fees resulting from the adjustment and the supporting methodologies.

(B)

Under no circumstances shall the adjustment result in fee revenues for a fiscal year that are less than the sum of the amount under subsection (b)(1)(A) and the amount under subsection (b)(1)(B), as adjusted for inflation under paragraph (1).

(C)

The Secretary shall contract with an independent accounting or consulting firm to periodically review the adequacy of the adjustment and publish the results of those reviews. The first review shall be conducted and published by the end of fiscal year 2013 (to examine the performance of the adjustment since fiscal year 2009), and the second review shall be conducted and published by the end of fiscal year 2015 (to examine the continued performance of the adjustment). The reports shall evaluate whether the adjustment reasonably represents actual changes in workload volume and complexity and present options to discontinue, retain, or modify any elements of the adjustment. The reports shall be published for public comment. After review of the reports and receipt of public comments, the Secretary shall, if warranted, adopt appropriate changes to the methodology. If the Secretary adopts changes to the methodology based on the first report, the changes shall be effective for the first fiscal year for which fees are set after the Secretary adopts such changes and each subsequent fiscal year.

(3)

For fiscal year 2017, the Secretary may, in addition to adjustments under this paragraph and paragraphs (1) and (2), further increase the fee revenues and fees established in subsection (b) if such an adjustment is necessary to provide for not more than 3 months of operating reserves of carryover user fees for the process for the review of human drug applications for the first 3 months of fiscal year 2018. If such an adjustment is necessary, the rationale for the amount of the increase shall be contained in the annual notice establishing fee revenues and fees for fiscal year 2017. If the Secretary has carryover balances for such process in excess of 3 months of such operating reserves, the adjustment under this paragraph shall not be made.

(4)

The Secretary shall, not later than 60 days before the start of each fiscal year that begins after September 30, 2012, establish, for the next fiscal year, application, product, and establishment fees under subsection (a), based on the revenue amounts established under subsection (b) and the adjustments provided under this subsection.

(5)

The total amount of fees charged, as adjusted under this subsection, for a fiscal year may not exceed the total costs for such fiscal year for the resources allocated for the process for the review of human drug applications.

; and

(4)

in subsection (g)—

(A)

in paragraph (1), by striking Fees authorized and inserting Subject to paragraph (2)(C), fees authorized;

(B)

in paragraph (2)—

(i)

in subparagraph (A)(i), by striking shall be retained and inserting subject to subparagraph (C), shall be collected and available;

(ii)

in subparagraph (A)(ii), by striking shall only be collected and available and inserting shall be available; and

(iii)

by adding at the end the following new subparagraph:

(C)

Payment of fees authorized under this section for a fiscal year, prior to the due date for such fees, may be accepted by the Secretary in accordance with authority provided in advance in a prior year appropriations Act.

;

(C)

in paragraph (3), by striking fiscal years 2008 through 2012 and inserting fiscal years 2013 through 2017; and

(D)

in paragraph (4)—

(i)

by striking fiscal years 2008 through 2010 and inserting fiscal years 2013 through 2015;

(ii)

by striking fiscal year 2011 and inserting fiscal year 2016;

(iii)

by striking fiscal years 2008 through 2011 and inserting fiscal years 2013 through 2016; and

(iv)

by striking fiscal year 2012 and inserting fiscal year 2017.

104.

Section 736B (21 U.S.C. 379h–2) is amended—

(1)

by amending subsection (a) to read as follows:

(a)

(1)

(A)

the progress of the Food and Drug Administration in achieving the goals identified in the letters described in section 101(b) of the Prescription Drug User Fee Amendments of 2012 during such fiscal year and the future plans of the Food and Drug Administration for meeting the goals, including the status of the independent assessment described in such letters; and

(B)

the progress of the Center for Drug Evaluation and Research and the Center for Biologics Evaluation and Research in achieving the goals, and future plans for meeting the goals, including, for each review division—

(i)

the number of original standard new drug applications and biologics license applications filed per fiscal year for each review division;

(ii)

the number of original priority new drug applications and biologics license applications filed per fiscal year for each review division;

(iii)

the number of standard efficacy supplements filed per fiscal year for each review division;

(iv)

the number of priority efficacy supplements filed per fiscal year for each review division;

(v)

the number of applications filed for review under accelerated approval per fiscal year for each review division;

(vi)

the number of applications filed for review as fast track products per fiscal year for each review division;

(vii)

the number of applications filed for orphan-designated products per fiscal year for each review division; and

(viii)

the number of breakthrough designations for a fiscal year for each review division.

(2)

The report under this subsection for a fiscal year shall include information on all previous cohorts for which the Secretary has not given a complete response on all human drug applications and supplements in the cohort.

(2)

in subsection (b), by striking 2008 and inserting 2013; and

(3)

in subsection (d), by striking 2012 each place it appears and inserting 2017.

105.

(a)

Sections 735 and 736 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379g; 379h) shall cease to be effective October 1, 2017.

(b)

Section 736B of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379h–2) shall cease to be effective January 31, 2018.

(c)

(1)

Section 106 of the Food and Drug Administration Amendments Act of 2007 (Public Law 110–85) is repealed.

(2)

The Food and Drug Administration Amendments Act of 2007 (Public Law 110–85) is amended in the table of contents in section 2, by striking the item relating to section 106.

(d)

(1)

Effective September 30, 2007—

(A)

section 509 of the Prescription Drug User Fee Amendments Act of 2002 (Title V of Public Law 107–188) is repealed; and

(B)

the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (Public Law 107–188) is amended in the table of contents in section 1(b), by striking the item relating to section 509.

(2)

Effective September 30, 2002—

(A)

section 107 of the Food and Drug Administration Modernization Act of 1997 (Public Law 105–115) is repealed; and

(B)

the table of contents in section 1(c) of such Act is amended by striking the item related to section 107.

(3)

Effective September 30, 1997, section 105 of the Prescription Drug User Fee Act of 1992 (Public Law 102–571) is repealed.

106.

The amendments made by this title shall take effect on October 1, 2012, or the date of the enactment of this Act, whichever is later, except that fees under part 2 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act shall be assessed for all human drug applications received on or after October 1, 2012, regardless of the date of the enactment of this Act.

107.

Notwithstanding the amendments made by this title, part 2 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act, as in effect on the day before the date of the enactment of this title, shall continue to be in effect with respect to human drug applications and supplements (as defined in such part as of such day) that on or after October 1, 2007, but before October 1, 2012, were accepted by the Food and Drug Administration for filing with respect to assessing and collecting any fee required by such part for a fiscal year prior to fiscal year 2012.

201.

(a)

This title may be cited as the Medical Device User Fee Amendments of 2012.

(b)

The Congress finds that the fees authorized under the amendments made by this title will be dedicated toward expediting the process for the review of device applications and for assuring the safety and effectiveness of devices, as set forth in the goals identified for purposes of part 3 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act in the letters from the Secretary of Health and Human Services to the Chairman of the Committee on Health, Education, Labor, and Pensions of the Senate and the Chairman of the Committee on Energy and Commerce of the House of Representatives, as set forth in the Congressional Record.

202.

Section 737 (21 U.S.C. 379i) is amended—

(1)

in paragraph (9), by striking incurred after expenses;

(2)

in paragraph (10), by striking October 2001 and inserting October 2011; and

(3)

in paragraph (13), by striking is required to register and all that follows through the end of paragraph (13) and inserting the following: is registered (or is required to register) with the Secretary under section 510 because such establishment is engaged in the manufacture, preparation, propagation, compounding, or processing of a device..

203.

(a)

Section 738(a) (21 U.S.C. 379j(a)) is amended—

(1)

in paragraph (1), by striking fiscal year 2008 and inserting fiscal year 2013;

(2)

in paragraph (2)(A)—

(A)

in the matter preceding clause (i)—

(i)

by striking subsections (d) and (e) and inserting subsections (d), (e), and (f);

(ii)

by striking October 1, 2002 and inserting October 1, 2012; and

(iii)

by striking subsection (c)(1) and inserting subsection (c); and

(B)

in clause (viii), by striking 1.84 and inserting 2; and

(3)

in paragraph (3)—

(A)

in subparagraph (A), by inserting and subsection (f) after subparagraph (B); and

(B)

in subparagraph (C), by striking initial registration and all that follows through section 510. and inserting

later of—

(i)

the initial or annual registration (as applicable) of the establishment under section 510; or

(ii)

the first business day after the date of enactment of an appropriations Act providing for the collection and obligation of fees for such year under this section.

(b)

Section 738(b) (21 U.S.C. 379j(b)) is amended to read as follows:

(b)

(1)

Subject to subsections (c), (d), (e), (f), and (i), for each of fiscal years 2013 through 2017, fees under subsection (a) shall be derived from the base fee amounts specified in paragraph (2), to generate the total revenue amounts specified in paragraph (3).

(2)

For purposes of paragraph (1), the base fee amounts specified in this paragraph are as follows:

Fee Type	Fiscal Year 2013	Fiscal Year 2014	Fiscal Year 2015	Fiscal Year 2016	Fiscal Year 2017
Premarket Application	$248,000	$252,960	$258,019	$263,180	$268,443
Establishment Registration	$2,575	$3,200	$3,750	$3,872	$3,872

(3)

For purposes of paragraph (1), the total revenue amounts specified in this paragraph are as follows:

(A)

$97,722,301 for fiscal year 2013.

(B)

$112,580,497 for fiscal year 2014.

(C)

$125,767,107 for fiscal year 2015.

(D)

$129,339,949 for fiscal year 2016.

(E)

$130,184,348 for fiscal year 2017.

(c)

Section 738(c) (21 U.S.C. 379j(c)) is amended—

(1)

in the subsection heading, by inserting ; Adjustments after Setting;

(2)

by striking paragraphs (1) and (2);

(3)

by redesignating paragraphs (3) and (4) as paragraphs (4) and (5), respectively; and

(4)

by inserting before paragraph (4), as so redesignated, the following:

(1)

The Secretary shall, 60 days before the start of each fiscal year after September 30, 2012, establish fees under subsection (a), based on amounts specified under subsection (b) and the adjustments provided under this subsection, and publish such fees, and the rationale for any adjustments to such fees, in the Federal Register.

(2)

(A)

For fiscal year 2014 and each subsequent fiscal year, the Secretary shall adjust the total revenue amount specified in subsection (b)(3) for such fiscal year by multiplying such amount by the applicable inflation adjustment under subparagraph (B) for such year.

(B)

The applicable inflation adjustment for a fiscal year is—

(i)

for fiscal year 2014, the base inflation adjustment under subparagraph (C) for such fiscal year; and

(ii)

for fiscal year 2015 and each subsequent fiscal year, the product of—

(I)

the base inflation adjustment under subparagraph (C) for such fiscal year; and

(II)

the product of the base inflation adjustment under subparagraph (C) for each of the fiscal years preceding such fiscal year, beginning with fiscal year 2014.

(C)

(i)

Subject to further adjustment under clause (ii), the base inflation adjustment for a fiscal year is the sum of one plus—

(I)

(II)

(ii)

For purposes of subparagraph (B), if the base inflation adjustment for a fiscal year under clause (i)—

(I)

is less than 1, such adjustment shall be considered to be equal to 1; or

(II)

is greater than 1.04, such adjustment shall be considered to be equal to 1.04.

(D)

For each of fiscal years 2014 through 2017, the base fee amounts specified in subsection (b)(2) shall be adjusted as needed, on a uniform proportionate basis, to generate the total revenue amounts under subsection (b)(3), as adjusted for inflation under subparagraph (A).

(3)

For each of fiscal years 2014 through 2017, after the base fee amounts specified in subsection (b)(2) are adjusted under paragraph (2)(D), the base establishment registration fee amounts specified in such subsection shall be further adjusted, as the Secretary estimates is necessary in order for total fee collections for such fiscal year to generate the total revenue amounts, as adjusted under paragraph (2).

(d)

Section 738 (21 U.S.C. 379j) is amended by—

(1)

redesignating subsections (f) through (k) as subsections (g) through (l), respectively; and

(2)

by inserting after subsection (e) the following new subsection:

(f)

(1)

The Secretary may, at the Secretary’s sole discretion, grant a waiver or reduction of fees under subsection (a)(2) or (a)(3) if the Secretary finds that such waiver or reduction is in the interest of public health.

(2)

The sum of all fee waivers or reductions granted by the Secretary in any fiscal year under paragraph (1) shall not exceed 2 percent of the total fee revenue amounts established for such year under subsection (c).

(3)

The authority provided by this subsection terminates October 1, 2017.

(e)

Section 738(h)(1)(A) (21 U.S.C. 379j(h)(1)(A)), as redesignated by subsection (d)(1), is amended by striking $205,720,000 and inserting $280,587,000.

(f)

Section 738(i) (21 U.S.C. 379j(i)), as redesignated by subsection (d)(1), is amended—

(1)

in paragraph (1), by striking Fees authorized and inserting Subject to paragraph (2)(C), fees authorized;

(2)

in paragraph (2)—

(A)

in subparagraph (A)—

(i)

in clause (i), by striking shall be retained and inserting subject to subparagraph (C), shall be collected and available; and

(ii)

in clause (ii)—

(I)

by striking collected and after shall only be; and

(II)

by striking fiscal year 2002 and inserting fiscal year 2009; and

(B)

by adding at the end, the following:

(C)

;

(3)

by amending paragraph (3) to read as follows:

(3)

For each of the fiscal years 2013 through 2017, there is authorized to be appropriated for fees under this section an amount equal to the total revenue amount specified under subsection (b)(3) for the fiscal year, as adjusted under subsection (c) and, for fiscal year 2017 only, as further adjusted under paragraph (4).

; and

(4)

in paragraph (4)—

(A)

by striking fiscal years 2008, 2009, and 2010 and inserting fiscal years 2013, 2014, and 2015;

(B)

by striking fiscal year 2011 and inserting fiscal year 2016;

(C)

by striking June 30, 2011 and inserting June 30, 2016;

(D)

by striking the amount of fees specified in aggregate in and inserting the cumulative amount appropriated pursuant to;

(E)

by striking aggregate amount in before excess shall be credited; and

(F)

by striking fiscal year 2012 and inserting fiscal year 2017.

(g)

Section 515(c)(4)(A) (21 U.S.C. 360e(c)(4)(A)) is amended by striking 738(g) and inserting 738(h).

204.

(a)

Section 738A(b) (21 U.S.C. 379j–1(b)) is amended—

(1)

in paragraph (1), by striking 2012 and inserting 2017; and

(2)

in paragraph (5), by striking 2012 and inserting 2017.

(b)

Section 738A(a) (21 U.S.C. 379j–1(a)) is amended—

(1)

by striking paragraph (1) and inserting the following:

(1)

(A)

Beginning with fiscal year 2013, for each fiscal year for which fees are collected under this part, the Secretary shall prepare and submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives annual reports concerning the progress of the Food and Drug Administration in achieving the goals identified in the letters described in section 201(b) of the Medical Device User Fee Amendments of 2012 during such fiscal year and the future plans of the Food and Drug Administration for meeting the goals.

(B)

With regard to information to be reported by the Food and Drug Administration to industry on a quarterly and annual basis pursuant to the letters described in section 201(b) of the Medical Device User Fee Amendments Act of 2012, the Secretary shall make such information publicly available on the Internet Web site of the Food and Drug Administration not later than 60 days after the end of each quarter or 120 days after the end of each fiscal year, respectively, to which such information applies. This information shall include the status of the independent assessment identified in the letters described in such section 201(b).

(C)

The Secretary shall include in each report under subparagraph (A) information on all previous cohorts for which the Secretary has not given a complete response on all device premarket applications and reports, supplements, and premarket notifications in the cohort.

; and

(2)

in paragraph (2), by striking 2008 through 2012 and inserting 2013 through 2017.

205.

Notwithstanding the amendments made by this title, part 3 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379i et seq.), as in effect on the day before the date of the enactment of this title, shall continue to be in effect with respect to the submissions listed in section 738(a)(2)(A) of such Act (in effect as of such day) that on or after October 1, 2007, but before October 1, 2012, were accepted by the Food and Drug Administration for filing with respect to assessing and collecting any fee required by such part for a fiscal year prior to fiscal year 2013.

206.

The amendments made by this title shall take effect on October 1, 2012, or the date of the enactment of this Act, whichever is later, except that fees under part 3 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act shall be assessed for all submissions listed in section 738(a)(2)(A) of such Act received on or after October 1, 2012, regardless of the date of the enactment of this Act.

207.

(a)

Sections 737 and 738 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 739i; 739j) shall cease to be effective October 1, 2017. Section 738A (21 U.S.C. 739j–1) of the Federal Food, Drug, and Cosmetic Act (regarding reauthorization and reporting requirements) shall cease to be effective January 31, 2018.

(b)

(1)

Section 217 of the Food and Drug Administration Amendments Act of 2007 (Title II of Public Law 110–85) is repealed.

(2)

The Food and Drug Administration Amendments Act of 2007 (Public Law 110–85) is amended in the table of contents in section 2, by striking the item relating to section 217.

(c)

Effective September 30, 2007—

(1)

section 107 of the Medical Device User Fee and Modernization Act of 2002 (Public Law 107–250) is repealed; and

(2)

the table of contents in section 1(b) of such Act is amended by striking the item related to section 107.

208.

Subchapter A of chapter VII (21 U.S.C. 371 et seq.) is amended by inserting after section 713 the following new section:

714.

(a)

In addition to any other personnel authorities under other provisions of law, the Secretary may, without regard to the provisions of title 5, United States Code, governing appointments in the competitive service, appoint employees to positions in the Food and Drug Administration to perform, administer, or support activities described in subsection (b), if the Secretary determines that such appointments are needed to achieve the objectives specified in subsection (c).

(b)

The activities described in this subsection are activities under this Act related to the process for the review of device applications (as defined in section 737(8)).

(c)

The objectives specified in this subsection are with respect to the activities under subsection (b), the goals referred to in section 738A(a)(1).

(d)

The Secretary shall institute appropriate internal controls for appointments under this section.

(e)

The authority to appoint employees under this section shall terminate on the date that is 3 years after the date of enactment of this section.

III

301.

(a)

This title may be cited as the Generic Drug User Fee Amendments of 2012.

(b)

The Congress finds that the fees authorized by the amendments made in this title will be dedicated to human generic drug activities, as set forth in the goals identified for purposes of part 7 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act, in the letters from the Secretary of Health and Human Services to the Chairman of the Committee on Health, Education, Labor, and Pensions of the Senate and the Chairman of the Committee on Energy and Commerce of the House of Representatives, as set forth in the Congressional Record.

302.

Subchapter C of chapter VII (21 U.S.C. 379f et seq.) is amended by adding at the end the following:

744A.

For purposes of this part:

(1)

The term abbreviated new drug application—

(A)

means an application submitted under section 505(j), an abbreviated application submitted under section 507 (as in effect on the day before the date of enactment of the Food and Drug Administration Modernization Act of 1997), or an abbreviated new drug application submitted pursuant to regulations in effect prior to the implementation of the Drug Price Competition and Patent Term Restoration Act of 1984; and

(B)

does not include an application for a positron emission tomography drug.

(2)

The term active pharmaceutical ingredient means—

(A)

a substance, or a mixture when the substance is unstable or cannot be transported on its own, intended—

(i)

to be used as a component of a drug; and

(ii)

to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the human body; or

(B)

a substance intended for final crystallization, purification, or salt formation, or any combination of those activities, to become a substance or mixture described in subparagraph (A).

(3)

The term adjustment factor means a factor applicable to a fiscal year that is the Consumer Price Index for all urban consumers (all items; United States city average) for October of the preceding fiscal year divided by such Index for October 2011.

(4)

The term affiliate means a business entity that has a relationship with a second business entity if, directly or indirectly—

(A)

one business entity controls, or has the power to control, the other business entity; or

(B)

a third party controls, or has power to control, both of the business entities.

(5)

(A)

The term facility—

(i)

means a business or other entity—

(I)

under one management, either direct or indirect; and

(II)

at one geographic location or address engaged in manufacturing or processing an active pharmaceutical ingredient or a finished dosage form; and

(ii)

does not include a business or other entity whose only manufacturing or processing activities are one or more of the following: repackaging, relabeling, or testing.

(B)

For purposes of subparagraph (A), separate buildings within close proximity are considered to be at one geographic location or address if the activities in them are—

(i)

closely related to the same business enterprise;

(ii)

under the supervision of the same local management; and

(iii)

capable of being inspected by the Food and Drug Administration during a single inspection.

(C)

If a business or other entity would meet the definition of a facility under this paragraph but for being under multiple management, the business or other entity is deemed to constitute multiple facilities, one per management entity, for purposes of this paragraph.

(6)

The term finished dosage form means—

(A)

a drug product in the form in which it will be administered to a patient, such as a tablet, capsule, solution, or topical application;

(B)

a drug product in a form in which reconstitution is necessary prior to administration to a patient, such as oral suspensions or lyophilized powders; or

(C)

any combination of an active pharmaceutical ingredient with another component of a drug product for purposes of production of a drug product described in subparagraph (A) or (B).

(7)

The term generic drug submission means an abbreviated new drug application, an amendment to an abbreviated new drug application, or a prior approval supplement to an abbreviated new drug application.

(8)

The term human generic drug activities means the following activities of the Secretary associated with generic drugs and inspection of facilities associated with generic drugs:

(A)

The activities necessary for the review of generic drug submissions, including review of drug master files referenced in such submissions.

(B)

The issuance of—

(i)

approval letters which approve abbreviated new drug applications or supplements to such applications; or

(ii)

complete response letters which set forth in detail the specific deficiencies in such applications and, where appropriate, the actions necessary to place such applications in condition for approval.

(C)

The issuance of letters related to Type II active pharmaceutical drug master files which—

(i)

set forth in detail the specific deficiencies in such submissions, and where appropriate, the actions necessary to resolve those deficiencies; or

(ii)

document that no deficiencies need to be addressed.

(D)

Inspections related to generic drugs.

(E)

Monitoring of research conducted in connection with the review of generic drug submissions and drug master files.

(F)

Postmarket safety activities with respect to drugs approved under abbreviated new drug applications or supplements, including the following activities:

(i)

Collecting, developing, and reviewing safety information on approved drugs, including adverse event reports.

(ii)

Developing and using improved adverse-event data-collection systems, including information technology systems.

(iii)

Developing and using improved analytical tools to assess potential safety problems, including access to external data bases.

(iv)

Implementing and enforcing section 505(o) (relating to postapproval studies and clinical trials and labeling changes) and section 505(p) (relating to risk evaluation and mitigation strategies) insofar as those activities relate to abbreviated new drug applications.

(v)

Carrying out section 505(k)(5) (relating to adverse-event reports and postmarket safety activities).

(G)

Regulatory science activities related to generic drugs.

(9)

The term positron emission tomography drug has the meaning given to the term compounded positron emission tomography drug in section 201(ii), except that paragraph (1)(B) of such section shall not apply.

(10)

The term prior approval supplement means a request to the Secretary to approve a change in the drug substance, drug product, production process, quality controls, equipment, or facilities covered by an approved abbreviated new drug application when that change has a substantial potential to have an adverse effect on the identity, strength, quality, purity, or potency of the drug product as these factors may relate to the safety or effectiveness of the drug product.

(11)

The term resources allocated for human generic drug activities means the expenses for—

(A)

officers and employees of the Food and Drug Administration, contractors of the Food and Drug Administration, advisory committees, and costs related to such officers and employees and to contracts with such contractors;

(B)

management of information, and the acquisition, maintenance, and repair of computer resources;

(C)

leasing, maintenance, renovation, and repair of facilities and acquisition, maintenance, and repair of fixtures, furniture, scientific equipment, and other necessary materials and supplies; and

(D)

collecting fees under subsection (a) and accounting for resources allocated for the review of abbreviated new drug applications and supplements and inspection related to generic drugs.

(12)

The term Type II active pharmaceutical ingredient drug master file means a submission of information to the Secretary by a person that intends to authorize the Food and Drug Administration to reference the information to support approval of a generic drug submission without the submitter having to disclose the information to the generic drug submission applicant.

744B.

(a)

Beginning in fiscal year 2013, the Secretary shall assess and collect fees in accordance with this section as follows:

(1)

(A)

Each person that owns an abbreviated new drug application that is pending on October 1, 2012, and that has not received a tentative approval prior to that date, shall be subject to a fee for each such application, as calculated under subparagraph (B).

(B)

The amount of each one-time backlog fee shall be calculated by dividing $50,000,000 by the total number of abbreviated new drug applications pending on October 1, 2012, that have not received a tentative approval as of that date.

(C)

Not later than October 31, 2012, the Secretary shall publish in the Federal Register a notice announcing the amount of the fee required by subparagraph (A).

(D)

The fee required by subparagraph (A) shall be due no later than 30 calendar days after the date of the publication of the notice specified in subparagraph (C).

(2)

(A)

Each person that owns a Type II active pharmaceutical ingredient drug master file that is referenced on or after October 1, 2012, in a generic drug submission by any initial letter of authorization shall be subject to a drug master file fee.

(B)

If a person has paid a drug master file fee for a Type II active pharmaceutical ingredient drug master file, the person shall not be required to pay a subsequent drug master file fee when that Type II active pharmaceutical ingredient drug master file is subsequently referenced in generic drug submissions.

(C)

(i)

Not later than October 31, 2012, the Secretary shall publish in the Federal Register a notice announcing the amount of the drug master file fee for fiscal year 2013.

(ii)

Not later than 60 days before the start of each of fiscal years 2014 through 2017, the Secretary shall publish in the Federal Register the amount of the drug master file fee established by this paragraph for such fiscal year.

(D)

(i)

Subject to subsection (g)(2)(C), for a generic drug submission to reference a Type II active pharmaceutical ingredient drug master file, the drug master file must be deemed available for reference by the Secretary.

(ii)

A drug master file shall be deemed available for reference by the Secretary if—

(I)

the person that owns a Type II active pharmaceutical ingredient drug master file has paid the fee required under subparagraph (A) within 20 calendar days after the applicable due date under subparagraph (E); and

(II)

the drug master file has not failed an initial completeness assessment by the Secretary, in accordance with criteria to be published by the Secretary.

(iii)

The Secretary shall make publicly available on the Internet Web site of the Food and Drug Administration a list of the drug master file numbers that correspond to drug master files that have successfully undergone an initial completeness assessment, in accordance with criteria to be published by the Secretary, and are available for reference.

(E)

(i)

Subject to clause (ii), a drug master file fee shall be due no later than the date on which the first generic drug submission is submitted that references the associated Type II active pharmaceutical ingredient drug master file.

(ii)

No fee shall be due under subparagraph (A) for a fiscal year until the later of—

(I)

30 calendar days after publication of the notice provided for in clause (i) or (ii) of subparagraph (C), as applicable; or

(II)

30 calendar days after the date of enactment of an appropriations Act providing for the collection and obligation of fees under this section.

(3)

(A)

Each applicant that submits, on or after October 1, 2012, an abbreviated new drug application or a prior approval supplement to an abbreviated new drug application shall be subject to a fee for each such submission in the amount established under subsection (d).

(B)

(i)

Not later than October 31, 2012, the Secretary shall publish in the Federal Register a notice announcing the amount of the fees under subparagraph (A) for fiscal year 2013.

(ii)

Not later than 60 days before the start of each of fiscal years 2014 through 2017, the Secretary shall publish in the Federal Register the amount of the fees under subparagraph (A) for such fiscal year.

(C)

(i)

Except as provided in clause (ii), the fees required by subparagraphs (A) and (F) shall be due no later than the date of submission of the abbreviated new drug application or prior approval supplement for which such fee applies.

(ii)

For fiscal year 2013, such fees shall be due on the later of—

(I)

the date on which the fee is due under clause (i);

(II)

30 calendar days after publication of the notice referred to in subparagraph (B)(i); or

(III)

if an appropriations Act is not enacted providing for the collection and obligation of fees under this section by the date of submission of the application or prior approval supplement for which the fees under subparagraphs (A) and (F) apply, 30 calendar days after the date that such an appropriations Act is enacted.

(D)

The Secretary shall refund 75 percent of the fee paid under subparagraph (A) for any abbreviated new drug application or prior approval supplement to an abbreviated new drug application that the Secretary considers not to have been received within the meaning of section 505(j)(5)(A) for a cause other than failure to pay fees.

(E)

An abbreviated new drug application or prior approval supplement that was submitted on or after October 1, 2012, and that the Secretary considers not to have been received, or that has been withdrawn, shall, upon resubmission of the application or a subsequent new submission following the applicant’s withdrawal of the application, be subject to a full fee under subparagraph (A).

(F)

An applicant that submits a generic drug submission on or after October 1, 2012, shall pay a fee, in the amount determined under subsection (d)(3), in addition to the fee required under subparagraph (A), if—

(i)

such submission contains information concerning the manufacture of an active pharmaceutical ingredient at a facility by means other than reference by a letter of authorization to a Type II active pharmaceutical drug master file; and

(ii)

a fee in the amount equal to the drug master file fee established in paragraph (2) has not been previously paid with respect to such information.

(4)

(A)

Facilities identified, or intended to be identified, in at least one generic drug submission that is pending or approved to produce a finished dosage form of a human generic drug or an active pharmaceutical ingredient contained in a human generic drug shall be subject to fees as follows:

(i)

Each person that owns a facility which is identified or intended to be identified in at least one generic drug submission that is pending or approved to produce one or more finished dosage forms of a human generic drug shall be assessed an annual fee for each such facility.

(ii)

Each person that owns a facility which produces, or which is pending review to produce, one or more active pharmaceutical ingredients identified, or intended to be identified, in at least one generic drug submission that is pending or approved or in a Type II active pharmaceutical ingredient drug master file referenced in such a generic drug submission, shall be assessed an annual fee for each such facility.

(iii)

Each person that owns a facility identified, or intended to be identified, in at least one generic drug submission that is pending or approved to produce both one or more finished dosage forms subject to clause (i) and one or more active pharmaceutical ingredients subject to clause (ii) shall be subject to fees under both such clauses for that facility.

(B)

The amount of fees established under subparagraph (A) shall be established under subsection (d).

(C)

(i)

For fiscal year 2013, the Secretary shall publish in the Federal Register a notice announcing the amount of the fees provided for in subparagraph (A) within the timeframe specified in subsection (d)(1)(B).

(ii)

Within the timeframe specified in subsection (d)(2), the Secretary shall publish in the Federal Register the amount of the fees under subparagraph (A) for such fiscal year.

(D)

(i)

For fiscal year 2013, the fees under subparagraph (A) shall be due on the later of—

(I)

not later than 45 days after the publication of the notice under subparagraph (B); or

(II)

if an appropriations Act is not enacted providing for the collection and obligation of fees under this section by the date of the publication of such notice, 30 days after the date that such an appropriations Act is enacted.

(ii)

For each of fiscal years 2014 through 2017, the fees under subparagraph (A) for such fiscal year shall be due on the later of—

(I)

the first business day on or after October 1 of each such year; or

(II)

the first business day after the enactment of an appropriations Act providing for the collection and obligation of fees under this section for such year.

(5)

For purposes of this Act, a generic drug submission or Type II pharmaceutical master file is deemed to be submitted to the Food and Drug Administration—

(A)

if it is submitted via a Food and Drug Administration electronic gateway, on the day when transmission to that electronic gateway is completed, except that a submission or master file that arrives on a weekend, Federal holiday, or day when the Food and Drug Administration office that will review that submission is not otherwise open for business shall be deemed to be submitted on the next day when that office is open for business; or

(B)

if it is submitted in physical media form, on the day it arrives at the appropriate designated document room of the Food and Drug Administration.

(b)

(1)

(A)

For fiscal year 2013, fees under subsection (a) shall be established to generate a total estimated revenue amount under such subsection of $299,000,000. Of that amount—

(i)

$50,000,000 shall be generated by the one-time backlog fee for generic drug applications pending on October 1, 2012, established in subsection (a)(1); and

(ii)

$249,000,000 shall be generated by the fees under paragraphs (2) through (4) of subsection (a).

(B)

For each of the fiscal years 2014 through 2017, fees under paragraphs (2) through (4) of subsection (a) shall be established to generate a total estimated revenue amount under such subsection that is equal to $299,000,000, as adjusted pursuant to subsection (c).

(2)

In establishing fees under paragraph (1) to generate the revenue amounts specified in paragraph (1)(A)(ii) for fiscal year 2013 and paragraph (1)(B) for each of fiscal years 2014 through 2017, such fees shall be derived from the fees under paragraphs (2) through (4) of subsection (a) as follows:

(A)

Six percent shall be derived from fees under subsection (a)(2) (relating to drug master files).

(B)

Twenty-four percent shall be derived from fees under subsection (a)(3) (relating to abbreviated new drug applications and supplements). The amount of a fee for a prior approval supplement shall be half the amount of the fee for an abbreviated new drug application.

(C)

Fifty-six percent shall be derived from fees under subsection (a)(4)(A)(i) (relating to generic drug facilities). The amount of the fee for a facility located outside the United States and its territories and possessions shall be not less than $15,000 and not more than $30,000 higher than the amount of the fee for a facility located in the United States and its territories and possessions, as determined by the Secretary on the basis of data concerning the difference in cost between inspections of facilities located in the United States, including its territories and possessions, and those located outside of the United States and its territories and possessions.

(D)

Fourteen percent shall be derived from fees under subsection (a)(4)(A)(ii) (relating to active pharmaceutical ingredient facilities). The amount of the fee for a facility located outside the United States and its territories and possessions shall be not less than $15,000 and not more than $30,000 higher than the amount of the fee for a facility located in the United States, including its territories and possessions, as determined by the Secretary on the basis of data concerning the difference in cost between inspections of facilities located in the United States and its territories and possessions and those located outside of the United States and its territories and possessions.

(c)

(1)

(A)

one;

(B)

the average annual percent change in the cost, per full-time equivalent position of the Food and Drug Administration, of all personnel compensation and benefits paid with respect to such positions for the first 3 years of the preceding 4 fiscal years multiplied by the proportion of personnel compensation and benefits costs to total costs of human generic drug activities for the first 3 years of the preceding 4 fiscal years; and

(C)

the average annual percent change that occurred in the Consumer Price Index for urban consumers (Washington-Baltimore, DC–MD–VA–WV; Not Seasonally Adjusted; All items; Annual Index) for the first 3 years of the preceding 4 years of available data multiplied by the proportion of all costs other than personnel compensation and benefits costs to total costs of human generic drug activities for the first 3 years of the preceding 4 fiscal years.

The adjustment made each fiscal year under this subsection shall be added on a compounded basis to the sum of all adjustments made each fiscal year after fiscal year 2013 under this subsection.

(2)

For fiscal year 2017, the Secretary may, in addition to adjustments under paragraph (1), further increase the fee revenues and fees established in subsection (b) if such an adjustment is necessary to provide for not more than 3 months of operating reserves of carryover user fees for human generic drug activities for the first 3 months of fiscal year 2018. Such fees may only be used in fiscal year 2018. If such an adjustment is necessary, the rationale for the amount of the increase shall be contained in the annual notice establishing fee revenues and fees for fiscal year 2017. If the Secretary has carryover balances for such activities in excess of 3 months of such operating reserves, the adjustment under this subparagraph shall not be made.

(d)

(1)

For fiscal year 2013—

(A)

the Secretary shall establish, by October 31, 2012, the one-time generic drug backlog fee for generic drug applications pending on October 1, 2012, the drug master file fee, the abbreviated new drug application fee, and the prior approval supplement fee under subsection (a), based on the revenue amounts established under subsection (b); and

(B)

the Secretary shall establish, not later than 45 days after the date to comply with the requirement for identification of facilities in subsection (f)(2), the generic drug facility fee and active pharmaceutical ingredient facility fee under subsection (a) based on the revenue amounts established under subsection (b).

(2)

Not more than 60 days before the first day of each of fiscal years 2014 through 2017, the Secretary shall establish the drug master file fee, the abbreviated new drug application fee, the prior approval supplement fee, the generic drug facility fee, and the active pharmaceutical ingredient facility fee under subsection (a) for such fiscal year, based on the revenue amounts established under subsection (b) and the adjustments provided under subsection (c).

(3)

In establishing the fees under paragraphs (1) and (2), the amount of the fee under subsection (a)(3)(F) shall be determined by multiplying—

(A)

the sum of—

(i)

the total number of such active pharmaceutical ingredients in such submission; and

(ii)

for each such ingredient that is manufactured at more than one such facility, the total number of such additional facilities; and

(B)

the amount equal to the drug master file fee established in subsection (a)(2) for such submission.

(e)

The total amount of fees charged, as adjusted under subsection (c), for a fiscal year may not exceed the total costs for such fiscal year for the resources allocated for human generic drug activities.

(f)

(1)

Not later than October 1, 2012, the Secretary shall publish in the Federal Register a notice requiring each person that owns a facility described in subsection (a)(4)(A), or a site or organization required to be identified by paragraph (4), to submit to the Secretary information on the identity of each such facility, site, or organization. The notice required by this paragraph shall specify the type of information to be submitted and the means and format for submission of such information.

(2)

Each person that owns a facility described in subsection (a)(4)(A) or a site or organization required to be identified by paragraph (4) shall submit to the Secretary the information required under this subsection each year. Such information shall—

(A)

for fiscal year 2013, be submitted not later than 60 days after the publication of the notice under paragraph (1); and

(B)

for each subsequent fiscal year, be submitted, updated, or reconfirmed on or before June 1 of the previous year.

(3)

At a minimum, the submission required by paragraph (2) shall include for each such facility—

(A)

identification of a facility identified or intended to be identified in an approved or pending generic drug submission;

(B)

whether the facility manufactures active pharmaceutical ingredients or finished dosage forms, or both;

(C)

whether or not the facility is located within the United States and its territories and possessions;

(D)

whether the facility manufactures positron emission tomography drugs solely, or in addition to other drugs; and

(E)

whether the facility manufactures drugs that are not generic drugs.

(4)

(A)

Any person that owns or operates a site or organization described in subparagraph (B) shall submit to the Secretary information concerning the ownership, name, and address of the site or organization.

(B)

A site or organization is described in this subparagraph if it is identified in a generic drug submission and is—

(i)

a site in which a bioanalytical study is conducted;

(ii)

a clinical research organization;

(iii)

a contract analytical testing site; or

(iv)

a contract repackager site.

(C)

The Secretary may, by notice published in the Federal Register, specify the means and format for submission of the information under subparagraph (A) and may specify, as necessary for purposes of this section, any additional information to be submitted.

(D)

The Secretary’s inspection authority under section 704(a)(1) shall extend to all such sites and organizations.

(g)

(1)

Failure to pay the fee under subsection (a)(1) shall result in the Secretary placing the person that owns the abbreviated new drug application subject to that fee on a publicly available arrears list, such that no new abbreviated new drug applications or supplement submitted on or after October 1, 2012, from that person, or any affiliate of that person, will be received within the meaning of section 505(j)(5)(A) until such outstanding fee is paid.

(2)

(A)

Failure to pay the fee under subsection (a)(2) within 20 calendar days after the applicable due date under subparagraph (E) of such subsection (as described in subsection (a)(2)(D)(ii)(I)) shall result in the Type II active pharmaceutical ingredient drug master file not being deemed available for reference.

(B)

(i)

Any generic drug submission submitted on or after October 1, 2012, that references, by a letter of authorization, a Type II active pharmaceutical ingredient drug master file that has not been deemed available for reference shall not be received within the meaning of section 505(j)(5)(A) unless the condition specified in clause (ii) is met.

(ii)

The condition specified in this clause is that the fee established under subsection (a)(2) has been paid within 20 calendar days of the Secretary providing the notification to the sponsor of the abbreviated new drug application or supplement of the failure of the owner of the Type II active pharmaceutical ingredient drug master file to pay the drug master file fee as specified in subparagraph (C).

(C)

(i)

If an abbreviated new drug application or supplement to an abbreviated new drug application references a Type II active pharmaceutical ingredient drug master file for which a fee under subsection (a)(2)(A) has not been paid by the applicable date under subsection (a)(2)(E), the Secretary shall notify the sponsor of the abbreviated new drug application or supplement of the failure of the owner of the Type II active pharmaceutical ingredient drug master file to pay the applicable fee.

(ii)

If such fee is not paid within 20 calendar days of the Secretary providing the notification, the abbreviated new drug application or supplement to an abbreviated new drug application shall not be received within the meaning of 505(j)(5)(A).

(3)

Failure to pay a fee under subparagraph (A) or (F) of subsection (a)(3) within 20 calendar days of the applicable due date under subparagraph (C) of such subsection shall result in the abbreviated new drug application or the prior approval supplement to an abbreviated new drug application not being received within the meaning of section 505(j)(5)(A) until such outstanding fee is paid.

(4)

(A)

Failure to pay the fee under subsection (a)(4) within 20 calendar days of the due date as specified in subparagraph (D) of such subsection shall result in the following:

(i)

The Secretary shall place the facility on a publicly available arrears list, such that no new abbreviated new drug application or supplement submitted on or after October 1, 2012, from the person that is responsible for paying such fee, or any affiliate of that person, will be received within the meaning of section 505(j)(5)(A).

(ii)

Any new generic drug submission submitted on or after October 1, 2012, that references such a facility shall not be received, within the meaning of section 505(j)(5)(A) if the outstanding facility fee is not paid within 20 calendar days of the Secretary providing the notification to the sponsor of the failure of the owner of the facility to pay the facility fee under subsection (a)(4)(C).

(iii)

All drugs or active pharmaceutical ingredients manufactured in such a facility or containing an ingredient manufactured in such a facility shall be deemed misbranded under section 502(aa).

(B)

The penalties under this paragraph shall apply until the fee established by subsection (a)(4) is paid or the facility is removed from all generic drug submissions that refer to the facility.

(C)

(i)

If an abbreviated new drug application or supplement to an abbreviated new drug application submitted on or after October 1, 2012, references a facility for which a facility fee has not been paid by the applicable date under subsection (a)(4)(C), the Secretary shall notify the sponsor of the generic drug submission of the failure of the owner of the facility to pay the facility fee.

(ii)

If the facility fee is not paid within 20 calendar days of the Secretary providing the notification under clause (i), the abbreviated new drug application or supplement to an abbreviated new drug application shall not be received within the meaning of section 505(j)(5)(A).

(h)

(1)

Fees under subsection (a) shall be refunded for a fiscal year beginning after fiscal year 2012, unless appropriations for salaries and expenses of the Food and Drug Administration for such fiscal year (excluding the amount of fees appropriated for such fiscal year) are equal to or greater than the amount of appropriations for the salaries and expenses of the Food and Drug Administration for fiscal year 2009 (excluding the amount of fees appropriated for such fiscal year) multiplied by the adjustment factor (as defined in section 744A) applicable to the fiscal year involved.

(2)

If the Secretary does not assess fees under subsection (a) during any portion of a fiscal year and if at a later date in such fiscal year the Secretary may assess such fees, the Secretary may assess and collect such fees, without any modification in the rate, for Type II active pharmaceutical ingredient drug master files, abbreviated new drug applications and prior approval supplements, and generic drug facilities and active pharmaceutical ingredient facilities at any time in such fiscal year notwithstanding the provisions of subsection (a) relating to the date fees are to be paid.

(i)

(1)

Fees authorized under subsection (a) shall be collected and available for obligation only to the extent and in the amount provided in advance in appropriations Acts, subject to paragraph (2). Such fees are authorized to remain available until expended. Such sums as may be necessary may be transferred from the Food and Drug Administration salaries and expenses appropriation account without fiscal year limitation to such appropriation account for salaries and expenses with such fiscal year limitation. The sums transferred shall be available solely for human generic drug activities.

(2)

(A)

The fees authorized by this section—

(i)

subject to subparagraphs (C) and (D), shall be collected and available in each fiscal year in an amount not to exceed the amount specified in appropriation Acts, or otherwise made available for obligation for such fiscal year; and

(ii)

shall be available for a fiscal year beginning after fiscal year 2012 to defray the costs of human generic drug activities (including such costs for an additional number of full-time equivalent positions in the Department of Health and Human Services to be engaged in such activities), only if the Secretary allocates for such purpose an amount for such fiscal year (excluding amounts from fees collected under this section) no less than $97,000,000 multiplied by the adjustment factor defined in section 744A(3) applicable to the fiscal year involved.

(B)

The Secretary shall be considered to have met the requirements of subparagraph (A)(ii) in any fiscal year if the costs funded by appropriations and allocated for human generic activities are not more than 10 percent below the level specified in such subparagraph.

(C)

Until the date of enactment of an Act making appropriations through September 30, 2013 for the salaries and expenses account of the Food and Drug Administration, fees authorized by this section for fiscal year 2013, may be collected and shall be credited to such account and remain available until expended.

(D)

Payment of fees authorized under this section for a fiscal year (after fiscal year 2013), prior to the due date for such fees, may be accepted by the Secretary in accordance with authority provided in advance in a prior year appropriations Act.

(3)

For each of the fiscal years 2013 through 2017, there is authorized to be appropriated for fees under this section an amount equivalent to the total revenue amount determined under subsection (b) for the fiscal year, as adjusted under subsection (c), if applicable, or as otherwise affected under paragraph (2) of this subsection.

(j)

In any case where the Secretary does not receive payment of a fee assessed under subsection (a) within 30 calendar days after it is due, such fee shall be treated as a claim of the United States Government subject to subchapter II of chapter 37 of title 31, United States Code.

(k)

This section may not be construed to require that the number of full-time equivalent positions in the Department of Health and Human Services, for officers, employees, and advisory committees not engaged in human generic drug activities, be reduced to offset the number of officers, employees, and advisory committees so engaged.

(l)

(1)

Submission of an application for a positron emission tomography drug or active pharmaceutical ingredient for a positron emission tomography drug shall not require the payment of any fee under this section. Facilities that solely produce positron emission tomography drugs shall not be required to pay a facility fee as established in subsection (a)(4).

(2)

Facilities that produce positron emission tomography drugs or active pharmaceutical ingredients of such drugs are required to be identified pursuant to subsection (f).

(m)

To qualify for the return of a fee claimed to have been paid in error under this section, a person shall submit to the Secretary a written request justifying such return within 180 calendar days after such fee was paid.

(n)

An abbreviated new drug application that is not considered to be received within the meaning of section 505(j)(5)(A) because of failure to pay an applicable fee under this provision within the time period specified in subsection (g) shall be deemed not to have been substantially complete on the date of its submission within the meaning of section 505(j)(5)(B)(iv)(II)(cc). An abbreviated new drug application that is not substantially complete on the date of its submission solely because of failure to pay an applicable fee under the preceding sentence shall be deemed substantially complete and received within the meaning of section 505(j)(5)(A) as of the date such applicable fee is received.

303.

Part 7 of subchapter C of chapter VII, as added by section 302 of this Act, is amended by inserting after section 744B the following:

744C.

(a)

Beginning with fiscal year 2013, not later than 120 days after the end of each fiscal year for which fees are collected under this part, the Secretary shall prepare and submit to the Committee on Energy and Commerce of the House of Representatives and the Committee on Health, Education, Labor, and Pensions of the Senate a report concerning the progress of the Food and Drug Administration in achieving the goals identified in the letters described in section 301(b) of the Generic Drug User Fee Amendments of 2012 during such fiscal year and the future plans of the Food and Drug Administration for meeting the goals.

(b)

(c)

The Secretary shall make the reports required under subsections (a) and (b) available to the public on the Internet Web site of the Food and Drug Administration.

(d)

(1)

In developing recommendations to present to the Congress with respect to the goals, and plans for meeting the goals, for human generic drug activities for the first 5 fiscal years after fiscal year 2017, and for the reauthorization of this part for such fiscal years, the Secretary shall consult with—

(A)

the Committee on Energy and Commerce of the House of Representatives;

(B)

the Committee on Health, Education, Labor, and Pensions of the Senate;

(C)

scientific and academic experts;

(D)

health care professionals;

(E)

representatives of patient and consumer advocacy groups; and

(F)

the generic drug industry.

(2)

Prior to beginning negotiations with the generic drug industry on the reauthorization of this part, the Secretary shall—

(A)

publish a notice in the Federal Register requesting public input on the reauthorization;

(B)

hold a public meeting at which the public may present its views on the reauthorization, including specific suggestions for changes to the goals referred to in subsection (a);

(C)

provide a period of 30 days after the public meeting to obtain written comments from the public suggesting changes to this part; and

(D)

publish the comments on the Food and Drug Administration’s Internet Web site.

(3)

Not less frequently than once every month during negotiations with the generic drug industry, the Secretary shall hold discussions with representatives of patient and consumer advocacy groups to continue discussions of their views on the reauthorization and their suggestions for changes to this part as expressed under paragraph (2).

(4)

After negotiations with the generic drug industry, the Secretary shall—

(A)

present the recommendations developed under paragraph (1) to the congressional committees specified in such paragraph;

(B)

publish such recommendations in the Federal Register;

(C)

provide for a period of 30 days for the public to provide written comments on such recommendations;

(D)

hold a meeting at which the public may present its views on such recommendations; and

(E)

after consideration of such public views and comments, revise such recommendations as necessary.

(5)

Not later than January 15, 2017, the Secretary shall transmit to the Congress the revised recommendations under paragraph (4), a summary of the views and comments received under such paragraph, and any changes made to the recommendations in response to such views and comments.

(6)

(A)

Before presenting the recommendations developed under paragraphs (1) through (5) to the Congress, the Secretary shall make publicly available, on the Internet Web site of the Food and Drug Administration, minutes of all negotiation meetings conducted under this subsection between the Food and Drug Administration and the generic drug industry.

(B)

The minutes described under subparagraph (A) shall summarize any substantive proposal made by any party to the negotiations as well as significant controversies or differences of opinion during the negotiations and their resolution.

304.

(a)

Sections 744A and 744B of the Federal Food, Drug, and Cosmetic Act, as added by section 302 of this Act, shall cease to be effective October 1, 2017.

(b)

Section 744C of the Federal Food, Drug, and Cosmetic Act, as added by section 303 of this Act, shall cease to be effective January 31, 2018.

305.

The amendments made by this title shall take effect on October 1, 2012, or the date of the enactment of this title, whichever is later, except that fees under section 302 shall be assessed for all human generic drug submissions and Type II active pharmaceutical drug master files received on or after October 1, 2012, regardless of the date of enactment of this title.

306.

Section 502 (21 U.S.C. 352) is amended by adding at the end the following:

(aa)

If it is a drug, or an active pharmaceutical ingredient, and it was manufactured, prepared, propagated, compounded, or processed in a facility for which fees have not been paid as required by section 744A(a)(4) or for which identifying information required by section 744B(f) has not been submitted, or it contains an active pharmaceutical ingredient that was manufactured, prepared, propagated, compounded, or processed in such a facility.

307.

Section 714, as added by section 208 of this Act, is amended—

(1)

by amending subsection (b) to read as follows:

(b)

The activities described in this subsection are—

(1)

activities under this Act related to the process for the review of device applications (as defined in section 737(8)); and

(2)

activities under this Act related to human generic drug activities (as defined in section 744A).

; and

(2)

by amending subsection (c) to read as follows:

(c)

The objectives specified in this subsection are—

(1)

with respect to the activities under subsection (b)(1), the goals referred to in section 738A(a)(1); and

(2)

with respect to the activities under subsection (b)(2), the goals referred to in section 744C(a).

308.

Subchapter A of chapter VII (21 U.S.C. 371 et seq.), as amended by section 208, is further amended by adding at the end the following:

715.

(a)

Beginning with fiscal year 2013 and ending after fiscal year 2017, not later than 120 days after the end of each fiscal year for which fees are collected under part 7 of subchapter C, the Secretary shall prepare and submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives a report concerning, for all applications for approval of a generic drug under section 505(j), amendments to such applications, and prior approval supplements with respect to such applications filed in the previous fiscal year—

(1)

the number of such applications that met the goals identified for purposes of part 7 of subchapter C, in the letters from the Secretary of Health and Human Services to the Chairman of the Committee on Health, Education, Labor, and Pensions of the Senate and the Chairman of the Committee on Energy and Commerce of the House of Representatives, as set forth in the Congressional Record;

(2)

the average total time to decision by the Secretary for applications for approval of a generic drug under section 505(j), amendments to such applications, and prior approval supplements with respect to such applications filed in the previous fiscal year, including the number of calendar days spent during the review by the Food and Drug Administration and the number of calendar days spent by the sponsor responding to a complete response letter;

(3)

the total number of applications under section 505(j), amendments to such applications, and prior approval supplements with respect to such applications that were pending with the Secretary for more than 10 months on the date of enactment of the Food and Drug Administration Safety and Innovation Act; and

(4)

the number of applications described in paragraph (3) on which the Food and Drug Administration took final regulatory action in the previous fiscal year.

401.

(a)

This title may be cited as the Biosimilar User Fee Act of 2012.

(b)

The Congress finds that the fees authorized by the amendments made in this title will be dedicated to expediting the process for the review of biosimilar biological product applications, including postmarket safety activities, as set forth in the goals identified for purposes of part 8 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act, in the letters from the Secretary of Health and Human Services to the Chairman of the Committee on Health, Education, Labor, and Pensions of the Senate and the Chairman of the Committee on Energy and Commerce of the House of Representatives, as set forth in the Congressional Record.

402.

Subchapter C of chapter VII (21 U.S.C. 379f et seq.) is amended by inserting after part 7, as added by title III of this Act, the following:

744G.

For purposes of this part:

(1)

The term adjustment factor applicable to a fiscal year that is the Consumer Price Index for all urban consumers (Washington-Baltimore, DC–MD–VA–WV; Not Seasonally Adjusted; All items) of the preceding fiscal year divided by such Index for September 2011.

(2)

The term affiliate means a business entity that has a relationship with a second business entity if, directly or indirectly—

(A)

one business entity controls, or has the power to control, the other business entity; or

(B)

a third party controls, or has power to control, both of the business entities.

(3)

The term biosimilar biological product means a product for which a biosimilar biological product application has been approved.

(4)

(A)

Subject to subparagraph (B), the term biosimilar biological product application means an application for licensure of a biological product under section 351(k) of the Public Health Service Act.

(B)

Such term does not include—

(i)

a supplement to such an application;

(ii)

an application filed under section 351(k) of the Public Health Service Act that cites as the reference product a bovine blood product for topical application licensed before September 1, 1992, or a large volume parenteral drug product approved before such date;

(iii)

an application filed under section 351(k) of the Public Health Service Act with respect to—

(I)

whole blood or a blood component for transfusion;

(II)

an allergenic extract product;

(III)

an in vitro diagnostic biological product; or

(IV)

a biological product for further manufacturing use only; or

(iv)

an application for licensure under section 351(k) of the Public Health Service Act that is submitted by a State or Federal Government entity for a product that is not distributed commercially.

(5)

The term biosimilar biological product development meeting means any meeting, other than a biosimilar initial advisory meeting, regarding the content of a development program, including a proposed design for, or data from, a study intended to support a biosimilar biological product application.

(6)

The term biosimilar biological product development program means the program under this part for expediting the process for the review of submissions in connection with biosimilar biological product development.

(7)

(A)

The term biosimilar biological product establishment means a foreign or domestic place of business—

(i)

that is at one general physical location consisting of one or more buildings, all of which are within 5 miles of each other; and

(ii)

at which one or more biosimilar biological products are manufactured in final dosage form.

(B)

For purposes of subparagraph (A)(ii), the term manufactured does not include packaging.

(8)

The term biosimilar initial advisory meeting—

(A)

means a meeting, if requested, that is limited to—

(i)

a general discussion regarding whether licensure under section 351(k) of the Public Health Service Act may be feasible for a particular product; and

(ii)

if so, general advice on the expected content of the development program; and

(B)

does not include any meeting that involves substantive review of summary data or full study reports.

(9)

The term costs of resources allocated for the process for the review of biosimilar biological product applications means the expenses in connection with the process for the review of biosimilar biological product applications for—

(A)

officers and employees of the Food and Drug Administration, contractors of the Food and Drug Administration, advisory committees, and costs related to such officers employees and committees and to contracts with such contractors;

(B)

management of information, and the acquisition, maintenance, and repair of computer resources;

(C)

leasing, maintenance, renovation, and repair of facilities and acquisition, maintenance, and repair of fixtures, furniture, scientific equipment, and other necessary materials and supplies; and

(D)

collecting fees under section 744H and accounting for resources allocated for the review of submissions in connection with biosimilar biological product development, biosimilar biological product applications, and supplements.

(10)

The term final dosage form means, with respect to a biosimilar biological product, a finished dosage form which is approved for administration to a patient without substantial further manufacturing (such as lyophilized products before reconstitution).

(11)

The term financial hold—

(A)

means an order issued by the Secretary to prohibit the sponsor of a clinical investigation from continuing the investigation if the Secretary determines that the investigation is intended to support a biosimilar biological product application and the sponsor has failed to pay any fee for the product required under subparagraph (A), (B), or (D) of section 744H(a)(1); and

(B)

does not mean that any of the bases for a clinical hold under section 505(i)(3) have been determined by the Secretary to exist concerning the investigation.

(12)

The term person includes an affiliate of such person.

(13)

The term process for the review of biosimilar biological product applications means the following activities of the Secretary with respect to the review of submissions in connection with biosimilar biological product development, biosimilar biological product applications, and supplements:

(A)

The activities necessary for the review of submissions in connection with biosimilar biological product development, biosimilar biological product applications, and supplements.

(B)

Actions related to submissions in connection with biosimilar biological product development, the issuance of action letters which approve biosimilar biological product applications or which set forth in detail the specific deficiencies in such applications, and where appropriate, the actions necessary to place such applications in condition for approval.

(C)

The inspection of biosimilar biological product establishments and other facilities undertaken as part of the Secretary’s review of pending biosimilar biological product applications and supplements.

(D)

Activities necessary for the release of lots of biosimilar biological products under section 351(k) of the Public Health Service Act.

(E)

Monitoring of research conducted in connection with the review of biosimilar biological product applications.

(F)

Postmarket safety activities with respect to biologics approved under biosimilar biological product applications or supplements, including the following activities:

(i)

Collecting, developing, and reviewing safety information on biosimilar biological products, including adverse-event reports.

(ii)

Developing and using improved adverse-event data-collection systems, including information technology systems.

(iii)

Developing and using improved analytical tools to assess potential safety problems, including access to external data bases.

(iv)

Implementing and enforcing section 505(o) (relating to postapproval studies and clinical trials and labeling changes) and section 505(p) (relating to risk evaluation and mitigation strategies).

(v)

Carrying out section 505(k)(5) (relating to adverse-event reports and postmarket safety activities).

(14)

The term supplement means a request to the Secretary to approve a change in a biosimilar biological product application which has been approved, including a supplement requesting that the Secretary determine that the biosimilar biological product meets the standards for interchangeability described in section 351(k)(4) of the Public Health Service Act.

744H.

(a)

Beginning in fiscal year 2013, the Secretary shall assess and collect fees in accordance with this section as follows:

(1)

(A)

(i)

Each person that submits to the Secretary a meeting request described under clause (ii) or a clinical protocol for an investigational new drug protocol described under clause (iii) shall pay for the product named in the meeting request or the investigational new drug application the initial biosimilar biological product development fee established under subsection (b)(1)(A).

(ii)

The meeting request described in this clause is a request for a biosimilar biological product development meeting for a product.

(iii)

A clinical protocol for an investigational new drug protocol described in this clause is a clinical protocol consistent with the provisions of section 505(i), including any regulations promulgated under section 505(i), (referred to in this section as investigational new drug application) describing an investigation that the Secretary determines is intended to support a biosimilar biological product application for a product.

(iv)

The initial biosimilar biological product development fee shall be due by the earlier of the following:

(I)

Not later than 5 days after the Secretary grants a request for a biosimilar biological product development meeting.

(II)

The date of submission of an investigational new drug application describing an investigation that the Secretary determines is intended to support a biosimilar biological product application.

(v)

Each person that has submitted an investigational new drug application prior to the date of enactment of the Biosimilars User Fee Act of 2012 shall pay the initial biosimilar biological product development fee by the earlier of the following:

(I)

Not later than 60 days after the date of the enactment of the Biosimilars User Fee Act of 2012, if the Secretary determines that the investigational new drug application describes an investigation that is intended to support a biosimilar biological product application.

(II)

Not later than 5 days after the Secretary grants a request for a biosimilar biological product development meeting.

(B)

(i)

A person that pays an initial biosimilar biological product development fee for a product shall pay for such product, beginning in the fiscal year following the fiscal year in which the initial biosimilar biological product development fee was paid, an annual fee established under subsection (b)(1)(B) for biosimilar biological product development (referred to in this section as annual biosimilar biological product development fee).

(ii)

The annual biosimilar biological product development program fee for each fiscal year will be due on the later of—

(I)

the first business day on or after October 1 of each such year; or

(II)

the first business day after the enactment of an appropriations Act providing for the collection and obligation of fees for such year under this section.

(iii)

The annual biosimilar development program fee for each fiscal year will be due on the date specified in clause (ii), unless the person has—

(I)

submitted a marketing application for the biological product that was accepted for filing; or

(II)

discontinued participation in the biosimilar biological product development program for the product under subparagraph (C).

(C)

A person may discontinue participation in the biosimilar biological product development program for a product effective October 1 of a fiscal year by, not later than August 1 of the preceding fiscal year—

(i)

if no investigational new drug application concerning the product has been submitted, submitting to the Secretary a written declaration that the person has no present intention of further developing the product as a biosimilar biological product; or

(ii)

if an investigational new drug application concerning the product has been submitted, withdrawing the investigational new drug application in accordance with part 312 of title 21, Code of Federal Regulations (or any successor regulations).

(D)

(i)

A person that has discontinued participation in the biosimilar biological product development program for a product under subparagraph (C) shall pay a fee (referred to in this section as reactivation fee) by the earlier of the following:

(I)

Not later than 5 days after the Secretary grants a request for a biosimilar biological product development meeting for the product (after the date on which such participation was discontinued).

(II)

Upon the date of submission (after the date on which such participation was discontinued) of an investigational new drug application describing an investigation that the Secretary determines is intended to support a biosimilar biological product application for that product.

(ii)

A person that pays a reactivation fee for a product shall pay for such product, beginning in the next fiscal year, the annual biosimilar biological product development fee under subparagraph (B).

(E)

(i)

If a person has failed to pay an initial or annual biosimilar biological product development fee as required under subparagraph (A) or (B), or a reactivation fee as required under subparagraph (D), the Secretary shall not provide a biosimilar biological product development meeting relating to the product for which fees are owed.

(ii)

Except in extraordinary circumstances, the Secretary shall not consider an investigational new drug application to have been received under section 505(i)(2) if—

(I)

the Secretary determines that the investigation is intended to support a biosimilar biological product application; and

(II)

the sponsor has failed to pay an initial or annual biosimilar biological product development fee for the product as required under subparagraph (A) or (B), or a reactivation fee as required under subparagraph (D).

(iii)

Notwithstanding section 505(i)(2), except in extraordinary circumstances, the Secretary shall prohibit the sponsor of a clinical investigation from continuing the investigation if—

(I)

the Secretary determines that the investigation is intended to support a biosimilar biological product application; and

(II)

the sponsor has failed to pay an initial or annual biosimilar biological product development fee for the product as required under subparagraph (A) or (B), or a reactivation fee for the product as required under subparagraph (D).

(iv)

If a person has failed to pay an initial or annual biosimilar biological product development fee as required under subparagraph (A) or (B), or a reactivation fee as required under subparagraph (D), any biosimilar biological product application or supplement submitted by that person shall be considered incomplete and shall not be accepted for filing by the Secretary until all such fees owed by such person have been paid.

(F)

(i)

The Secretary shall not refund any initial or annual biosimilar biological product development fee paid under subparagraph (A) or (B), or any reactivation fee paid under subparagraph (D).

(ii)

The Secretary shall not grant a waiver, exemption, or reduction of any initial or annual biosimilar biological product development fee due or payable under subparagraph (A) or (B), or any reactivation fee due or payable under subparagraph (D).

(2)

(A)

Each person that submits, on or after October 1, 2012, a biosimilar biological product application or a supplement shall be subject to the following fees:

(i)

A fee for a biosimilar biological product application that is equal to—

(I)

the amount of the fee established under subsection (b)(1)(D) for a biosimilar biological product application for which clinical data (other than comparative bioavailability studies) with respect to safety or effectiveness are required for approval; minus

(II)

the cumulative amount of fees paid, if any, under subparagraphs (A), (B), and (D) of paragraph (1) for the product that is the subject of the application.

(ii)

A fee for a biosimilar biological product application for which clinical data (other than comparative bioavailability studies) with respect to safety or effectiveness are not required, that is equal to—

(I)

half of the amount of the fee established under subsection (b)(1)(D) for a biosimilar biological product application; minus

(II)

the cumulative amount of fees paid, if any, under subparagraphs (A), (B), and (D) of paragraph (1) for that product.

(iii)

A fee for a supplement for which clinical data (other than comparative bioavailability studies) with respect to safety or effectiveness are required, that is equal to half of the amount of the fee established under subsection (b)(1)(D) for a biosimilar biological product application.

(B)

Notwithstanding section 404 of the Biosimilars User Fee Act of 2012, any person who pays a fee under subparagraph (A), (B), or (D) of paragraph (1) for a product before October 1, 2017, but submits a biosimilar biological product application for that product after such date, shall be entitled to the reduction of any biosimilar biological product application fees that may be assessed at the time when such biosimilar biological product application is submitted, by the cumulative amount of fees paid under subparagraphs (A), (B), and (D) of paragraph (1) for that product.

(C)

Any fee required by subparagraph (A) shall be due upon submission of the application or supplement for which such fee applies.

(D)

If a biosimilar biological product application or supplement was submitted by a person that paid the fee for such application or supplement, was accepted for filing, and was not approved or was withdrawn (without a waiver), the submission of a biosimilar biological product application or a supplement for the same product by the same person (or the person’s licensee, assignee, or successor) shall not be subject to a fee under subparagraph (A).

(E)

The Secretary shall refund 75 percent of the fee paid under this paragraph for any application or supplement which is refused for filing or withdrawn without a waiver before filing.

(F)

A biosimilar biological product application or supplement that was submitted but was refused for filing, or was withdrawn before being accepted or refused for filing, shall be subject to the full fee under subparagraph (A) upon being resubmitted or filed over protest, unless the fee is waived under subsection (c).

(3)

(A)

Except as provided in subparagraph (E), each person that is named as the applicant in a biosimilar biological product application shall be assessed an annual fee established under subsection (b)(1)(E) for each biosimilar biological product establishment that is listed in the approved biosimilar biological product application as an establishment that manufactures the biosimilar biological product named in such application.

(B)

The establishment fee shall be assessed in each fiscal year for which the biosimilar biological product named in the application is assessed a fee under paragraph (4) unless the biosimilar biological product establishment listed in the application does not engage in the manufacture of the biosimilar biological product during such fiscal year.

(C)

The establishment fee for a fiscal year shall be due on the later of—

(i)

the first business day on or after October 1 of such fiscal year; or

(ii)

the first business day after the enactment of an appropriations Act providing for the collection and obligation of fees for such fiscal year under this section.

(D)

(i)

Each biosimilar biological product establishment shall be assessed only one fee per biosimilar biological product establishment, notwithstanding the number of biosimilar biological products manufactured at the establishment, subject to clause (ii).

(ii)

In the event an establishment is listed in a biosimilar biological product application by more than one applicant, the establishment fee for the fiscal year shall be divided equally and assessed among the applicants whose biosimilar biological products are manufactured by the establishment during the fiscal year and assessed biosimilar biological product fees under paragraph (4).

(E)

If, during the fiscal year, an applicant initiates or causes to be initiated the manufacture of a biosimilar biological product at an establishment listed in its biosimilar biological product application—

(i)

that did not manufacture the biosimilar biological product in the previous fiscal year; and

(ii)

for which the full biosimilar biological product establishment fee has been assessed in the fiscal year at a time before manufacture of the biosimilar biological product was begun,

the applicant shall not be assessed a share of the biosimilar biological product establishment fee for the fiscal year in which the manufacture of the product began.

(4)

(A)

Each person who is named as the applicant in a biosimilar biological product application shall pay for each such biosimilar biological product the annual fee established under subsection (b)(1)(F).

(B)

The biosimilar biological product fee for a fiscal year shall be due on the later of—

(i)

the first business day on or after October 1 of each such year; or

(ii)

the first business day after the enactment of an appropriations Act providing for the collection and obligation of fees for such year under this section.

(C)

The biosimilar biological product fee shall be paid only once for each product for each fiscal year.

(b)

(1)

Subject to paragraph (2), the Secretary shall, 60 days before the start of each fiscal year that begins after September 30, 2012, establish, for the next fiscal year, the fees under subsection (a). Except as provided in subsection (c), such fees shall be in the following amounts:

(A)

The initial biosimilar biological product development fee under subsection (a)(1)(A) for a fiscal year shall be equal to 10 percent of the amount established under section 736(c)(4) for a human drug application described in section 736(a)(1)(A)(i) for that fiscal year.

(B)

The annual biosimilar biological product development fee under subsection (a)(1)(B) for a fiscal year shall be equal to 10 percent of the amount established under section 736(c)(4) for a human drug application described in section 736(a)(1)(A)(i) for that fiscal year.

(C)

The reactivation fee under subsection (a)(1)(D) for a fiscal year shall be equal to 20 percent of the amount of the fee established under section 736(c)(4) for a human drug application described in section 736(a)(1)(A)(i) for that fiscal year.

(D)

The biosimilar biological product application fee under subsection (a)(2) for a fiscal year shall be equal to the amount established under section 736(c)(4) for a human drug application described in section 736(a)(1)(A)(i) for that fiscal year.

(E)

The biosimilar biological product establishment fee under subsection (a)(3) for a fiscal year shall be equal to the amount established under section 736(c)(4) for a prescription drug establishment for that fiscal year.

(F)

The biosimilar biological product fee under subsection (a)(4) for a fiscal year shall be equal to the amount established under section 736(c)(4) for a prescription drug product for that fiscal year.

(2)

The total amount of fees charged for a fiscal year under this section may not exceed the total amount for such fiscal year of the costs of resources allocated for the process for the review of biosimilar biological product applications.

(c)

(1)

The Secretary shall grant to a person who is named in a biosimilar biological product application a waiver from the application fee assessed to that person under subsection (a)(2)(A) for the first biosimilar biological product application that a small business or its affiliate submits to the Secretary for review. After a small business or its affiliate is granted such a waiver, the small business or its affiliate shall pay—

(A)

application fees for all subsequent biosimilar biological product applications submitted to the Secretary for review in the same manner as an entity that is not a small business; and

(B)

all supplement fees for all supplements to biosimilar biological product applications submitted to the Secretary for review in the same manner as an entity that is not a small business.

(2)

In determining whether to grant a waiver of a fee under paragraph (1), the Secretary shall consider only the circumstances and assets of the applicant involved and any affiliate of the applicant.

(3)

In this subsection, the term small business means an entity that has fewer than 500 employees, including employees of affiliates, and does not have a drug product that has been approved under a human drug application (as defined in section 735) or a biosimilar biological product application (as defined in section 744G(4)) and introduced or delivered for introduction into interstate commerce.

(d)

A biosimilar biological product application or supplement submitted by a person subject to fees under subsection (a) shall be considered incomplete and shall not be accepted for filing by the Secretary until all fees owed by such person have been paid.

(e)

(1)

Subject to paragraph (2), fees authorized under subsection (a) shall be collected and available for obligation only to the extent and in the amount provided in advance in appropriations Acts. Such fees are authorized to remain available until expended. Such sums as may be necessary may be transferred from the Food and Drug Administration salaries and expenses appropriation account without fiscal year limitation to such appropriation account for salaries and expenses with such fiscal year limitation. The sums transferred shall be available solely for the process for the review of biosimilar biological product applications.

(2)

(A)

Subject to subparagraphs (C) and (D), the fees authorized by this section shall be collected and available in each fiscal year in an amount not to exceed the amount specified in appropriation Acts, or otherwise made available for obligation for such fiscal year.

(B)

The fees authorized by this section shall be available for a fiscal year beginning after fiscal year 2012 to defray the costs of the process for the review of biosimilar biological product applications (including such costs for an additional number of full-time equivalent positions in the Department of Health and Human Services to be engaged in such process), only if the Secretary allocates for such purpose an amount for such fiscal year (excluding amounts from fees collected under this section) no less than $20,000,000, multiplied by the adjustment factor applicable to the fiscal year involved.

(C)

Until the date of enactment of an Act making appropriations through September 30, 2013, for the salaries and expenses account of the Food and Drug Administration, fees authorized by this section for fiscal year 2013 may be collected and shall be credited to such account and remain available until expended.

(D)

(3)

For each of fiscal years 2013 through 2017, there is authorized to be appropriated for fees under this section an amount equivalent to the total amount of fees assessed for such fiscal year under this section.

(f)

In any case where the Secretary does not receive payment of a fee assessed under subsection (a) within 30 days after it is due, such fee shall be treated as a claim of the United States Government subject to subchapter II of chapter 37 of title 31, United States Code.

(g)

To qualify for consideration for a waiver under subsection (c), or for a refund of any fee collected in accordance with subsection (a)(2)(A), a person shall submit to the Secretary a written request for such waiver or refund not later than 180 days after such fee is due.

(h)

This section may not be construed to require that the number of full-time equivalent positions in the Department of Health and Human Services, for officers, employers, and advisory committees not engaged in the process of the review of biosimilar biological product applications, be reduced to offset the number of officers, employees, and advisory committees so engaged.

403.

Part 8 of subchapter C of chapter VII, as added by section 402, is further amended by inserting after section 744H the following:

744I.

(a)

Beginning with fiscal year 2013, not later than 120 days after the end of each fiscal year for which fees are collected under this part, the Secretary shall prepare and submit to the Committee on Energy and Commerce of the House of Representatives and the Committee on Health, Education, Labor, and Pensions of the Senate a report concerning the progress of the Food and Drug Administration in achieving the goals identified in the letters described in section 401(b) of the Biosimilar User Fee Act of 2012 during such fiscal year and the future plans of the Food and Drug Administration for meeting such goals. The report for a fiscal year shall include information on all previous cohorts for which the Secretary has not given a complete response on all biosimilar biological product applications and supplements in the cohort.

(b)

Not later than 120 days after the end of fiscal year 2013 and each subsequent fiscal year for which fees are collected under this part, the Secretary shall prepare and submit to the Committee on Energy and Commerce of the House of Representatives and the Committee on Health, Education, Labor, and Pensions of the Senate a report on the implementation of the authority for such fees during such fiscal year and the use, by the Food and Drug Administration, of the fees collected for such fiscal year.

(c)

The Secretary shall make the reports required under subsections (a) and (b) available to the public on the Internet Web site of the Food and Drug Administration.

(d)

(1)

The Secretary shall contract with an independent accounting or consulting firm to study the workload volume and full costs associated with the process for the review of biosimilar biological product applications.

(2)

Not later than June 1, 2015, the Secretary shall publish, for public comment, interim results of the study described under paragraph (1).

(3)

Not later than September 30, 2016, the Secretary shall publish, for public comment, the final results of the study described under paragraph (1).

(e)

(1)

In developing recommendations to present to the Congress with respect to the goals described in subsection (a), and plans for meeting the goals, for the process for the review of biosimilar biological product applications for the first 5 fiscal years after fiscal year 2017, and for the reauthorization of this part for such fiscal years, the Secretary shall consult with—

(A)

the Committee on Energy and Commerce of the House of Representatives;

(B)

the Committee on Health, Education, Labor, and Pensions of the Senate;

(C)

scientific and academic experts;

(D)

health care professionals;

(E)

representatives of patient and consumer advocacy groups; and

(F)

the regulated industry.

(2)

After negotiations with the regulated industry, the Secretary shall—

(A)

present the recommendations developed under paragraph (1) to the congressional committees specified in such paragraph;

(B)

publish such recommendations in the Federal Register;

(C)

provide for a period of 30 days for the public to provide written comments on such recommendations;

(D)

hold a meeting at which the public may present its views on such recommendations; and

(E)

after consideration of such public views and comments, revise such recommendations as necessary.

(3)

Not later than January 15, 2017, the Secretary shall transmit to the Congress the revised recommendations under paragraph (2), a summary of the views and comments received under such paragraph, and any changes made to the recommendations in response to such views and comments.

404.

(a)

Sections 744G and 744H of the Federal Food, Drug, and Cosmetic Act, as added by section 402 of this Act, shall cease to be effective October 1, 2017.

(b)

Section 744I of the Federal Food, Drug, and Cosmetic Act, as added by section 403 of this Act, shall cease to be effective January 31, 2018.

405.

(a)

Except as provided under subsection (b), the amendments made by this title shall take effect on the later of—

(1)

October 1, 2012; or

(2)

the date of the enactment of this title.

(b)

Fees under part 8 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act, as added by this title, shall be assessed for all biosimilar biological product applications received on or after October 1, 2012, regardless of the date of the enactment of this title.

406.

Notwithstanding the amendments made by this title, part 2 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act, as in effect on the day before the date of the enactment of this title, shall continue to be in effect with respect to human drug applications and supplements (as defined in such part as of such day) that were accepted by the Food and Drug Administration for filing on or after October 1, 2007, but before October 1, 2012, with respect to assessing and collecting any fee required by such part for a fiscal year prior to fiscal year 2013.

407.

Section 735(1)(B) (21 U.S.C. 379g(1)(B)) is amended by striking or (k).

408.

Section 715, as added by section 308 of this Act, is amended by adding at the end the following:

(b)

(1)

Beginning with fiscal year 2014, not later than 120 days after the end of each fiscal year for which fees are collected under part 8 of subchapter C, the Secretary shall prepare and submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives a report concerning—

(A)

the number of applications for approval filed under section 351(k) of the Public Health Service Act; and

(B)

the percentage of applications described in subparagraph (A) that were approved by the Secretary.

(2)

As part of the performance report described in paragraph (1), the Secretary shall include an explanation of how the Food and Drug Administration is managing the biological product review program to ensure that the user fees collected under part 2 are not used to review an application under section 351(k) of the Public Health Service Act.

501.

(a)

Section 505A (21 U.S.C. 355a) is amended by striking subsection (q) (relating to a sunset).

(b)

Section 505B (21 U.S.C. 355c) is amended—

(1)

by striking subsection (m); and

(2)

by redesignating subsection (n) as subsection (m).

502.

(a)

(1)

Subsection (h) of section 505A (21 U.S.C. 355a) is amended to read as follows:

(h)

Exclusivity under this section shall only be granted for the completion of a study or studies that are the subject of a written request and for which reports are submitted and accepted in accordance with subsection (d)(3). Written requests under this section may consist of a study or studies required under section 505B.

(2)

Section 351(m)(1) of the Public Health Service Act (42 U.S.C. 262(m)(1)) is amended by striking (f), (i), (j), (k), (l), (p), and (q) and inserting (f), (h), (i), (j), (k), (l), (n), and (p).

(b)

Subparagraph (A) of section 505A(d)(1) is amended by adding at the end the following: If a request under this subparagraph does not request studies in neonates, such request shall include a statement describing the rationale for not requesting studies in neonates..

503.

Not later than 1 year after the date of enactment of this Act, the Secretary of Health and Human Services (referred to in this title as the Secretary) shall issue internal standard operating procedures that provide for the review by the internal review committee established under section 505C of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355d) of any significant modifications to initial pediatric study plans, agreed initial pediatric study plans, and written requests under sections 505A and 505B of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355a, 355c). Such internal standard operating procedures shall be made publicly available on the Internet Web site of the Food and Drug Administration.

504.

Not later than 3 years after the date of enactment of this Act, the Secretary shall make available to the public, including through posting on the Internet Web site of the Food and Drug Administration, the medical, statistical, and clinical pharmacology reviews of, and corresponding written requests issued to an applicant, sponsor, or holder for, pediatric studies submitted between January 4, 2002, and September 27, 2007, under subsection (b) or (c) of section 505A of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355a) for which 6 months of market exclusivity was granted and that resulted in a labeling change. The Secretary shall make public the information described in the preceding sentence in a manner consistent with how the Secretary releases information under section 505A(k) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355a(k)).

505.

(a)

Section 505B (21 U.S.C. 355c) is amended—

(1)

in subsection (a)(3)—

(A)

by redesignating subparagraph (B) as subparagraph (C);

(B)

by inserting after subparagraph (A) the following:

(B)

(i)

On the initiative of the Secretary or at the request of the applicant, the Secretary may grant an extension of a deferral approved under subparagraph (A) for submission of some or all assessments required under paragraph (1) if—

(I)

the Secretary determines that the conditions described in subclause (II) or (III) of subparagraph (A)(i) continue to be met; and

(II)

the applicant submits a new timeline under subparagraph (A)(ii)(IV) and any significant updates to the information required under subparagraph (A)(ii).

(ii)

If the deferral extension under this subparagraph is requested by the applicant, the applicant shall submit the deferral extension request containing the information described in this subparagraph not less than 90 days prior to the date that the deferral would expire. The Secretary shall respond to such request not later than 45 days after the receipt of such letter. If the Secretary grants such an extension, the specified date shall be the extended date. The sponsor of the required assessment under paragraph (1) shall not be issued a letter described in subsection (d) unless the specified or extended date of submission for such required studies has passed or if the request for an extension is pending. For a deferral that has expired prior to the date of enactment of the Food and Drug Administration Safety and Innovation Act or that will expire prior to 270 days after the date of enactment of such Act, a deferral extension shall be requested by an applicant not later than 180 days after the date of enactment of such Act. The Secretary shall respond to any such request as soon as practicable, but not later than 1 year after the date of enactment of such Act. Nothing in this clause shall prevent the Secretary from updating the status of a study or studies publicly if components of such study or studies are late or delayed.

; and

(C)

in subparagraph (C), as so redesignated—

(i)

in clause (i), by adding at the end the following:

(III)

Projected completion date for pediatric studies.

(IV)

The reason or reasons why a deferral or deferral extension continues to be necessary.

; and

(ii)

by amending clause (ii) to read as follows:

(ii)

Not later than 90 days after the submission to the Secretary of the information submitted through the annual review under clause (i), the Secretary shall make available to the public in an easily accessible manner, including through the Internet Web site of the Food and Drug Administration—

(I)

such information;

(II)

the name of the applicant for the product subject to the assessment;

(III)

the date on which the product was approved; and

(IV)

the date of each deferral or deferral extension under this paragraph for the product.

; and

(2)

in subsection (f)—

(A)

in the subsection heading, by inserting Deferral Extensions, after Deferrals,;

(B)

in paragraph (1), by inserting , deferral extension, after deferral; and

(C)

in paragraph (4)—

(i)

in the paragraph heading, by inserting deferral extensions, after deferrals,; and

(ii)

by inserting , deferral extensions, after deferrals.

(b)

Section 505B(f)(6)(D) (21 U.S.C. 355c(f)(6)(D)) is amended to read as follows:

(D)

aggregated on an annual basis—

(i)

the total number of deferrals and deferral extensions requested and granted under this section and, if granted, the reasons for each such deferral or deferral extension;

(ii)

the timeline for completion of the assessments; and

(iii)

the number of assessments completed and pending;

(c)

(1)

Subsection (d) of section 505B (21 U.S.C. 355c) is amended to read as follows:

(d)

If a person fails to submit a required assessment described in subsection (a)(2), fails to meet the applicable requirements in subsection (a)(3), or fails to submit a request for approval of a pediatric formulation described in subsection (a) or (b), in accordance with applicable provisions of subsections (a) and (b), the following shall apply:

(1)

Beginning 270 days after the date of enactment of the Food and Drug Administration Safety and Innovation Act, the Secretary shall issue a non-compliance letter to such person informing them of such failure to submit or meet the requirements of the applicable subsection. Such letter shall require the person to respond in writing within 45 calendar days of issuance of such letter. Such response may include the person’s request for a deferral extension if applicable. Such letter and the person’s written response to such letter shall be made publicly available on the Internet Web site of the Food and Drug Administration 60 calendar days after issuance, with redactions for any trade secrets and confidential commercial information. If the Secretary determines that the letter was issued in error, the requirements of this paragraph shall not apply.

(2)

The drug or biological product that is the subject of an assessment described in subsection (a)(2), applicable requirements in subsection (a)(3), or request for approval of a pediatric formulation, may be considered misbranded solely because of that failure and subject to relevant enforcement action (except that the drug or biological product shall not be subject to action under section 303), but such failure shall not be the basis for a proceeding—

(A)

to withdraw approval for a drug under section 505(e); or

(B)

to revoke the license for a biological product under section 351 of the Public Health Service Act.

(2)

Subparagraph (D) of section 505B(f)(6) (21 U.S.C. 355c(f)(6)), as amended by subsection (b), is further amended—

(A)

in clause (ii), by striking ; and and inserting a semicolon;

(B)

in clause (iii), by adding and at the end; and

(C)

by adding at the end the following:

(iv)

the number of postmarket non-compliance letters issued pursuant to subsection (d), and the recipients of such letters;

506.

(a)

Subsection (e) of section 505B (21 U.S.C. 355c) is amended to read as follows:

(e)

(1)

An applicant subject to subsection (a) shall submit to the Secretary an initial pediatric study plan prior to the submission of the assessments described under subsection (a)(2).

(2)

(A)

An applicant shall submit the initial pediatric plan under paragraph (1)—

(i)

before the date on which the applicant submits the assessments under subsection (a)(2); and

(ii)

not later than—

(I)

60 calendar days after the date of the end-of-Phase 2 meeting (as such term is used in section 312.47 of title 21, Code of Federal Regulations, or successor regulations); or

(II)

such other time as may be agreed upon between the Secretary and the applicant.

Nothing in this section shall preclude the Secretary from accepting the submission of an initial pediatric plan earlier than the date otherwise applicable under this subparagraph.

(B)

The initial pediatric study plan shall include—

(i)

an outline of the pediatric study or studies that the applicant plans to conduct (including, to the extent practicable study objectives and design, age groups, relevant endpoints, and statistical approach);

(ii)

any request for a deferral, partial waiver, or waiver under this section, if applicable, along with any supporting information; and

(iii)

other information specified in the regulations promulgated under paragraph (7).

(C)

The Secretary—

(i)

shall meet with the applicant to discuss the initial pediatric study plan as soon as practicable, but not later than 90 calendar days after the receipt of such plan under subparagraph (A);

(ii)

may determine that a written response to the initial pediatric study plan is sufficient to communicate comments on the initial pediatric study plan, and that no meeting is necessary; and

(iii)

if the Secretary determines that no meeting is necessary, shall so notify the applicant and provide written comments of the Secretary as soon as practicable, but not later than 90 calendar days after the receipt of the initial pediatric study plan.

(3)

Not later than 90 calendar days following the meeting under paragraph (2)(C)(i) or the receipt of a written response from the Secretary under paragraph (2)(C)(iii), the applicant shall document agreement on the initial pediatric study plan in a submission to the Secretary marked Agreed Initial Pediatric Study Plan, and the Secretary shall confirm such agreement to the applicant in writing not later than 30 calendar days of receipt of such agreed initial pediatric study plan.

(4)

If the agreed initial pediatric study plan contains a request from the applicant for a deferral, partial waiver, or waiver under this section, the written confirmation under paragraph (3) shall include a recommendation from the Secretary as to whether such request meets the standards under paragraphs (3) or (4) of subsection (a).

(5)

At the initiative of the Secretary or the applicant, the agreed initial pediatric study plan may be amended at any time. The requirements of paragraph (2)(C) shall apply to any such proposed amendment in the same manner and to the same extent as such requirements apply to an initial pediatric study plan under paragraph (1). The requirements of paragraphs (3) and (4) shall apply to any agreement resulting from such proposed amendment in the same manner and to the same extent as such requirements apply to an agreed initial pediatric study plan.

(6)

The Secretary shall consult the internal committee under section 505C on the review of the initial pediatric study plan, agreed initial pediatric plan, and any significant amendments to such plans.

(7)

Not later than 1 year after the date of enactment of the Food and Drug Administration Safety and Innovation Act, the Secretary shall promulgate proposed regulations and issue guidance to implement the provisions of this subsection.

(b)

Section 505B (21 U.S.C. 355c) is amended—

(1)

by amending subclause (II) of subsection (a)(3)(A)(ii) to read as follows:

(II)

a pediatric study plan as described in subsection (e);

; and

(2)

in subsection (f)—

(A)

in the subsection heading, by striking pediatric plans, and inserting pediatric study plans,;

(B)

in paragraph (1), by striking all pediatric plans and inserting initial pediatric study plans, agreed initial pediatric study plans,; and

(C)

in paragraph (4)—

(i)

in the paragraph heading, by striking pediatric plans, and inserting pediatric study plans,; and

(ii)

by striking pediatric plans and inserting initial pediatric study plans, agreed initial pediatric study plans,.

(c)

(1)

Subject to paragraph (2), the amendments made by this section shall take effect 180 calendar days after the date of enactment of this Act, irrespective of whether the Secretary has promulgated final regulations to carry out such amendments.

(2)

Paragraph (1) shall not be construed to affect the deadline for promulgation of proposed regulations under section 505B(e)(7) of the Federal Food, Drug, and Cosmetic Act, as added by subsection (a) of this section.

507.

(a)

Section 14(d) of the Best Pharmaceuticals for Children Act (42 U.S.C. 284m note) is amended by striking during the five-year period beginning on the date of the enactment of the Best Pharmaceuticals for Children Act of 2007 and inserting to carry out the advisory committee’s responsibilities under sections 505A, 505B, and 520(m) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355a, 355c, and 360j(m)).

(b)

Section 15(a)(3) of the Best Pharmaceuticals for Children Act (Public Law 107–109), as amended by section 502(e) of the Food and Drug Administration Amendments Act of 2007 (Public Law 110–85), is amended by striking during the five-year period beginning on the date of the enactment of the Best Pharmaceuticals for Children Act of 2007 and inserting for the duration of the operation of the Oncologic Drugs Advisory Committee.

(c)

Section 520(m)(6)(A)(iv) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360j(m)(6)(A)(iv)) is amended by striking 2012 and inserting 2017.

(d)

Section 409I(e)(1) of the Public Health Service Act (42 U.S.C. 284m(e)(1)) is amended by striking to carry out this section and all that follows through the end of paragraph (1) and inserting to carry out this section, $25,000,000 for each of fiscal years 2013 through 2017..

508.

(a)

Not later than four years after the date of enactment of this Act and every five years thereafter, the Secretary shall prepare and submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives, and make publicly available, including through posting on the Internet Web site of the Food and Drug Administration, a report on the implementation of sections 505A and 505B of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355a, 355c).

(b)

Each report under subsection (a) shall include—

(1)

an assessment of the effectiveness of sections 505A and 505B of the Federal Food, Drug, and Cosmetic Act in improving information about pediatric uses for approved drugs and biological products, including the number and type of labeling changes made since the date of enactment of this Act and the importance of such uses in the improvement of the health of children;

(2)

the number of required studies under such section 505B that have not met the initial deadline provided under such section 505B, including—

(A)

the number of deferrals and deferral extensions granted and the reasons such extensions were granted;

(B)

the number of waivers and partial waivers granted; and

(C)

the number of letters issued under subsection (d) of such section 505B;

(3)

an assessment of the timeliness and effectiveness of pediatric study planning since the date of enactment of this Act, including the number of initial pediatric study plans not submitted in accordance with the requirements of subsection (e) of such section 505B and any resulting rulemaking;

(4)

the number of written requests issued, accepted, and declined under such section 505A since the date of enactment of this Act, and a listing of any important gaps in pediatric information as a result of such declined requests;

(5)

a description and current status of referrals made under subsection (n) of such section 505A;

(6)

an assessment of the effectiveness of studying biological products in pediatric populations under such sections 505A and 505B and section 409I of the Public Health Service Act (42 U.S.C. 284m);

(7)

(A)

the efforts made by the Secretary to increase the number of studies conducted in the neonatal population (including efforts made to encourage the conduct of appropriate studies in neonates by companies with products that have sufficient safety and other information to make the conduct of the studies ethical and safe); and

(B)

the results of such efforts;

(8)

(A)

the number and importance of drugs and biological products for children with cancer that are being tested as a result of the programs under such sections 505A and 505B and under section 409I of the Public Health Service Act; and

(B)

any recommendations for modifications to such programs that would lead to new and better therapies for children with cancer, including a detailed rationale for each recommendation;

(9)

any recommendations for modification to such programs that would improve pediatric drug research and increase pediatric labeling of drugs and biological products;

(10)

an assessment of the successes of and limitations to studying drugs for rare diseases under such sections 505A and 505B; and

(11)

an assessment of the Secretary’s efforts to address the suggestions and options described in any prior report issued by the Comptroller General, Institute of Medicine, or the Secretary, and any subsequent reports, including recommendations therein, regarding the topics addressed in the reports under this section, including with respect to—

(A)

improving public access to information from pediatric studies conducted under such sections 505A and 505B; and

(B)

improving the timeliness of pediatric studies and pediatric study planning under such sections 505A and 505B.

(c)

At least 180 days prior to the submission of each report under subsection (a), the Secretary shall consult with representatives of patient groups (including pediatric patient groups), consumer groups, regulated industry, academia, and other interested parties to obtain any recommendations or information relevant to the report including suggestions for modifications that would improve pediatric drug research and pediatric labeling of drugs and biological products.

509.

(a)

Section 505A (21 U.S.C. 355a) is amended—

(1)

in subsection (k)(2), by striking subsection (f)(3)(F) and inserting subsection (f)(6)(F);

(2)

in subsection (l)—

(A)

in paragraph (1)—

(i)

in the paragraph heading, by striking year one and inserting first 18-month period; and

(ii)

by striking one-year and inserting 18-month;

(B)

in paragraph (2)—

(i)

in the paragraph heading, by striking years and inserting periods; and

(ii)

by striking one-year period and inserting 18-month period;

(C)

by redesignating paragraph (3) as paragraph (4); and

(D)

by inserting after paragraph (2) the following:

(3)

Nothing in this subsection shall prohibit the Office of Pediatric Therapeutics from providing for the review of adverse event reports by the Pediatric Advisory Committee prior to the 18-month period referred to in paragraph (1), if such review is necessary to ensure safe use of a drug in a pediatric population.

;

(3)

in subsection (n)—

(A)

in the subsection heading, by striking completed and inserting submitted; and

(B)

in paragraph (1)—

(i)

in the matter preceding subparagraph (A), by striking have not been completed and inserting have not been submitted by the date specified in the written request issued or if the applicant or holder does not agree to the request;

(ii)

in subparagraph (A)—

(I)

in the first sentence, by inserting , or for which a period of exclusivity eligible for extension under subsection (b)(1) or (c)(1) of this section or under subsection (m)(2) or (m)(3) of section 351 of the Public Health Service Act has not ended after expired; and

(II)

by striking Prior to and all that follows through the period at the end; and

(iii)

in subparagraph (B), by striking no listed patents or has 1 or more listed patents that have expired, and inserting no unexpired listed patents and for which no unexpired periods of exclusivity eligible for extension under subsection (b)(1) or (c)(1) of this section or under subsection (m)(2) or (m)(3) of section 351 of the Public Health Service Act apply,; and

(4)

in subsection (o)(2), by amending subparagraph (B) to read as follows:

(B)

a statement of any appropriate pediatric contraindications, warnings, precautions, or other information that the Secretary considers necessary to assure safe use.

(b)

Section 505B (21 U.S.C. 355c) is amended—

(1)

in subsection (a)—

(A)

in paragraph (1), in the matter before subparagraph (A), by inserting for a drug after (or supplement to an application); and

(B)

in paragraph (4)(C)—

(i)

in the first sentence, by inserting partial before waiver is granted; and

(ii)

in the second sentence, by striking either a full or and inserting such a;

(2)

in subsection (b)(1), in the matter preceding subparagraph (A), by striking After providing notice and all that follows through studies), the and inserting The;

(3)

in subsection (g)—

(A)

in paragraph (1)(A), by inserting that receives a priority review or 330 days after the date of the submission of an application or supplement that receives a standard review after after the date of the submission of the application or supplement; and

(B)

in paragraph (2), by striking the label of such product and inserting the labeling of such product;

(4)

in subsection (h)(1)—

(A)

by inserting an application (or supplement to an application) that contains after date of submission of; and

(B)

by inserting if the application (or supplement) receives a priority review, or not later than 330 days after the date of submission of an application (or supplement to an application) that contains a pediatric assessment under this section, if the application (or supplement) receives a standard review, after under this section,; and

(5)

in subsection (i)—

(A)

in paragraph (1)—

(i)

in the paragraph heading, by striking year one and inserting first 18-month period; and

(ii)

by striking one-year and inserting 18-month;

(B)

in paragraph (2)—

(i)

in the paragraph heading, by striking years and inserting periods; and

(ii)

by striking one-year period and inserting 18-month period;

(C)

by redesignating paragraph (3) as paragraph (4); and

(D)

by inserting after paragraph (2) the following:

(3)

(c)

Section 505C (21 U.S.C. 355d) is amended—

(1)

in the section heading, by inserting deferral extensions, after deferrals,; and

(2)

by inserting neonatology, after pediatric ethics,.

(d)

Section 409I(c) of the Public Health Service Act (42 U.S.C. 284m(c)) is amended—

(1)

in paragraph (1)—

(A)

in the matter preceding subparagraph (A), by inserting or section 351(m) of this Act, after Cosmetic Act,;

(B)

in subparagraph (A)(i), by inserting or section 351(k) of this Act after Cosmetic Act; and

(C)

by amending subparagraph (B) to read as follows:

(B)

there remains no patent listed pursuant to section 505(b)(1) of the Federal Food, Drug, and Cosmetic Act, and every three-year and five-year period referred to in subsection (c)(3)(E)(ii), (c)(3)(E)(iii), (c)(3)(E)(iv), (j)(5)(F)(ii), (j)(5)(F)(iii), or (j)(5)(F)(iv) of section 505 of the Federal Food, Drug, and Cosmetic Act, or applicable twelve-year period referred to in section 351(k)(7) of this Act, and any seven-year period referred to in section 527 of the Federal Food, Drug, and Cosmetic Act has ended for at least one form of the drug; and

; and

(2)

in paragraph (2)—

(A)

in the paragraph heading, by striking for drugs lacking exclusivity;

(B)

by striking under section 505 of the Federal Food, Drug, and Cosmetic Act; and

(C)

by striking 505A of such Act and inserting 505A of the Federal Food, Drug, and Cosmetic Act or section 351(m) of this Act.

(e)

Section 15(a) of the Best Pharmaceuticals for Children Act (Public Law 107–109), as amended by section 502(e) of the Food and Drug Administration Amendments Act of 2007 (Public Law 110–85), is amended in paragraph (1)(D), by striking ‘‘section 505B(f)’’ and inserting section 505C.

(f)

Section 499(c)(1)(C) of the Public Health Service Act (42 U.S.C. 290b(c)(1)(C)) is amended by striking for which the Secretary issues a certification in the affirmative under section 505A(n)(1)(A) of the Federal Food, Drug, and Cosmetic Act.

(g)

(1)

Notwithstanding any provision of section 505A and 505B of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355a, 355c) stating that a provision applies beginning on the date of the enactment of the Best Pharmaceuticals for Children Act of 2007 or the date of the enactment of the Pediatric Research Equity Act of 2007, any amendment made by this Act to such a provision applies beginning on the date of the enactment of this Act.

(2)

With respect to a drug for which a labeling change described under section 505A(l)(1) or 505B(i)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355a(l)(1); 355c(i)(1)) is approved or made, respectively, during the one-year period that ends on the day before the date of enactment of this Act, the Secretary shall apply section 505A(l) and section 505B(i), as applicable, to such drug, as such sections were in effect on such day.

510.

(a)

Not later than 18 months after the date of enactment of this Act, the Secretary shall hold at least one public meeting to discuss ways to encourage and accelerate the development of new therapies for pediatric rare diseases.

(b)

Not later than 180 days after the date of the public meeting under subsection (a), the Secretary shall issue a report that includes a strategic plan for encouraging and accelerating the development of new therapies for treating pediatric rare diseases.

511.

Section 6 of the Best Pharmaceuticals for Children Act (21 U.S.C. 393a) is amended—

(1)

in subsection (c)—

(A)

in paragraph (1), by striking and at the end;

(B)

by redesignating paragraph (2) as paragraph (4); and

(C)

by inserting after paragraph (1) the following:

(2)

subject to subsection (d), one or more additional individuals with necessary expertise in a pediatric subpopulation that is, as determined through consideration of the reports and recommendations issued by the Institute of Medicine and the Comptroller General of the United States, less likely to be studied as a part of a written request issued under section 505A of the Federal Food, Drug, and Cosmetic Act or an assessment under section 505B of such Act;

(3)

one or more additional individuals with expertise in pediatric epidemiology; and

; and

(2)

by adding at the end the following:

(d)

For the 5-year period beginning on the date of enactment of this subsection, at least one of the individuals described in subsection (c)(2) shall have expertise in neonatology.

601.

Section 520(g) (21 U.S.C. 360j(g)) is amended—

(1)

in paragraph (2)(B)(ii), by inserting safety or effectiveness before data obtained; and

(2)

in paragraph (4), by adding at the end the following:

(C)

Consistent with paragraph (1), the Secretary shall not disapprove an application under this subsection because the Secretary determines that—

(i)

the investigation may not support a substantial equivalence or de novo classification determination or approval of the device;

(ii)

the investigation may not meet a requirement, including a data requirement, relating to the approval or clearance of a device; or

(iii)

an additional or different investigation may be necessary to support clearance or approval of the device.

602.

(a)

Section 513(a)(3)(D) (21 U.S.C. 360c(a)(3)(D)) is amended—

(1)

by redesignating clause (iii) as clause (v); and

(2)

by inserting after clause (ii) the following:

(iii)

For purposes of clause (ii), the term necessary means the minimum required information that would support a determination by the Secretary that an application provides reasonable assurance of the effectiveness of the device.

(iv)

Nothing in this subparagraph shall alter the criteria for evaluating an application for premarket approval of a device.

(b)

Section 513(i)(1)(D) (21 U.S.C. 360c(i)(1)(D)) is amended—

(1)

by striking ‘‘(D) Whenever’’ and inserting ‘‘(D)(i) Whenever’’; and

(2)

by adding at the end the following:

(ii)

For purposes of clause (i), the term necessary means the minimum required information that would support a determination of substantial equivalence between a new device and a predicate device.

(iii)

Nothing in this subparagraph shall alter the standard for determining substantial equivalence between a new device and a predicate device.

603.

Chapter V is amended by inserting after section 517 (21 U.S.C. 360g) the following:

517A.

(a)

(1)

The Secretary shall provide a substantive summary of the scientific and regulatory rationale for any significant decision of the Center for Devices and Radiological Health regarding submission or review of a report under section 510(k), an application under section 515, or an application for an exemption under section 520(g), including documentation of significant controversies or differences of opinion and the resolution of such controversies or differences of opinion.

(2)

Upon request, the Secretary shall furnish such substantive summary to the person who is seeking to submit, or who has submitted, such report or application.

(b)

(1)

Any person may request a supervisory review of the significant decision described in subsection (a)(1). Such review may be conducted at the next supervisory level or higher above the individual who made the significant decision.

(2)

A person requesting a supervisory review under paragraph (1) shall submit such request to the Secretary not later than 30 days after such decision and shall indicate in the request whether such person seeks an in-person meeting or a teleconference review.

(3)

(A)

Except as provided in subparagraph (B), the Secretary shall schedule an in-person or teleconference review, if so requested, not later than 30 days after such request is made. The Secretary shall issue a decision to the person requesting a review under this subsection not later than 45 days after the request is made under paragraph (1), or, in the case of a person who requests an in-person meeting or teleconference, 30 days after such meeting or teleconference.

(B)

Subparagraph (A) shall not apply in cases that are referred to experts outside of the Food and Drug Administration.

604.

Section 510(n) (21 U.S.C. 360(n)) is amended by—

(1)

striking (n) The Secretary and inserting (n)(1) The Secretary; and

(2)

by adding at the end the following:

(2)

(A)

Not later than 18 months after the date of enactment of this paragraph, the Secretary shall submit to the Committee on Energy and Commerce of the House of Representatives and the Committee on Health, Education, Labor, and Pensions of the Senate a report regarding when a premarket notification under subsection (k) should be submitted for a modification or change to a legally marketed device. The report shall include the Secretary’s interpretation of the following terms: could significantly affect the safety or effectiveness of the device, a significant change or modification in design, material, chemical composition, energy source, or manufacturing process, and major change or modification in the intended use of the device. The report also shall discuss possible processes for industry to use to determine whether a new submission under subsection (k) is required and shall analyze how to leverage existing quality system requirements to reduce premarket burden, facilitate continual device improvement, and provide reasonable assurance of safety and effectiveness of modified devices. In developing such report, the Secretary shall consider the input of interested stakeholders.

(B)

The Secretary shall withdraw the Food and Drug Administration draft guidance entitled Guidance for Industry and FDA Staff—510(k) Device Modifications: Deciding When to Submit a 510(k) for a Change to an Existing Device, dated July 27, 2011, and shall not use this draft guidance as part of, or for the basis of, any premarket review or any compliance or enforcement decisions or actions. The Secretary shall not issue—

(i)

any draft guidance or proposed regulation that addresses when to submit a premarket notification submission for changes and modifications made to a manufacturer’s previously cleared device before the receipt by the Committee on Energy and Commerce of the House of Representatives and the Committee on Health, Education, Labor, and Pensions of the Senate of the report required in subparagraph (A); and

(ii)

any final guidance or regulation on that topic for one year after date of receipt of such report by the Committee on Energy and Commerce of the House of Representatives and the Committee on Health, Education, Labor, and Pensions of the Senate.

(C)

The Food and Drug Administration guidance entitled Deciding When to Submit a 510(k) for a Change to an Existing Device, dated January 10, 1997, shall be in effect until the subsequent issuance of guidance or promulgation, if appropriate, of a regulation described in subparagraph (B), and the Secretary shall interpret such guidance in a manner that is consistent with the manner in which the Secretary has interpreted such guidance since 1997.

605.

Chapter V is amended by inserting after section 518 (21 U.S.C. 360h) the following:

518A.

(a)

The Secretary shall—

(1)

establish a program to routinely and systematically assess information relating to device recalls and use such information to proactively identify strategies for mitigating health risks presented by defective or unsafe devices;

(2)

clarify procedures for conducting device recall audit checks to improve the ability of investigators to perform those checks in a consistent manner;

(3)

develop detailed criteria for assessing whether a person performing a device recall has performed an effective correction or action plan for the recall; and

(4)

document the basis for each termination by the Food and Drug Administration of a device recall.

(b)

The program established under subsection (a)(1) shall, at a minimum, identify—

(1)

trends in the number and types of device recalls;

(2)

devices that are most frequently the subject of a recall; and

(3)

underlying causes of device recalls.

(c)

The Secretary shall document the basis for the termination by the Food and Drug Administration of a device recall.

(d)

In this section, the term recall means—

(1)

the removal from the market of a device pursuant to an order of the Secretary under subsection (b) or (e) of section 518; or

(2)

the correction or removal from the market of a device at the initiative of the manufacturer or importer of the device that is required to be reported to the Secretary under section 519(g).

606.

Section 520(g) (21 U.S.C. 360j(g)) is amended by adding at the end the following:

(8)

(A)

At any time, the Secretary may prohibit the sponsor of an investigation from conducting the investigation (referred to in this paragraph as a clinical hold) if the Secretary makes a determination described in subparagraph (B). The Secretary shall specify the basis for the clinical hold, including the specific information available to the Secretary which served as the basis for such clinical hold, and confirm such determination in writing.

(B)

For purposes of subparagraph (A), a determination described in this subparagraph with respect to a clinical hold is a determination that—

(i)

the device involved represents an unreasonable risk to the safety of the persons who are the subjects of the clinical investigation, taking into account the qualifications of the clinical investigators, information about the device, the design of the clinical investigation, the condition for which the device is to be investigated, and the health status of the subjects involved; or

(ii)

the clinical hold should be issued for such other reasons as the Secretary may by regulation establish.

(C)

Any written request to the Secretary from the sponsor of an investigation that a clinical hold be removed shall receive a decision, in writing and specifying the reasons therefor, within 30 days after receipt of such request. Any such request shall include sufficient information to support the removal of such clinical hold.

607.

(a)

Section 513(f)(2) (21 U.S.C. 360c(f)(2)) is amended—

(1)

by inserting (i) after (2)(A);

(2)

in subparagraph (A)(i), as so designated by paragraph (1), by striking under the criteria set forth and all that follows through the end of subparagraph (A) and inserting a period;

(3)

by adding at the end of subparagraph (A) the following:

(ii)

In lieu of submitting a report under section 510(k) and submitting a request for classification under clause (i) for a device, if a person determines there is no legally marketed device upon which to base a determination of substantial equivalence (as defined in subsection (i)), a person may submit a request under this clause for the Secretary to classify the device.

(iii)

Upon receipt of a request under clause (i) or (ii), the Secretary shall classify the device subject to the request under the criteria set forth in subparagraphs (A) through (C) of subsection (a)(1) within 120 days.

(iv)

Notwithstanding clause (iii), the Secretary may decline to undertake a classification request submitted under clause (ii) if the Secretary identifies a legally marketed device that could provide a reasonable basis for review of substantial equivalence under paragraph (1), or when the Secretary determines that the device submitted is not of low-moderate risk or that general controls would be inadequate to control the risks and special controls to mitigate the risks cannot be developed.

(v)

The person submitting the request for classification under this subparagraph may recommend to the Secretary a classification for the device and shall, if recommending classification in class II, include in the request an initial draft proposal for applicable special controls, as described in subsection (a)(1)(B), that are necessary, in conjunction with general controls, to provide reasonable assurance of safety and effectiveness and a description of how the special controls provide such assurance. Any such request shall describe the device and provide detailed information and reasons for the recommended classification.

; and

(4)

in subparagraph (B), by striking Not later than 60 days after the date of the submission of the request under subparagraph (A), the Secretary and inserting The Secretary.

(b)

Section 513(f) (21 U.S.C. 360c(f)) is amended in paragraph (1)—

(1)

in subparagraph (A), by striking , or at the end and inserting a semicolon;

(2)

in subparagraph (B), by striking the period and inserting ; or; and

(3)

by inserting after subparagraph (B) the following:

(C)

the device is classified pursuant to a request submitted under paragraph (2).

608.

(a)

(1)

Section 513(e)(1) (21 U.S.C. 360c(e)(1)) is amended to read as follows:

(e)

(1)

(A)

(i)

Based on new information respecting a device, the Secretary may, upon the initiative of the Secretary or upon petition of an interested person, change the classification of such device, and revoke, on account of the change in classification, any regulation or requirement in effect under section 514 or 515 with respect to such device, by administrative order published in the Federal Register following publication of a proposed reclassification order in the Federal Register, a meeting of a device classification panel described in subsection (b), and consideration of comments to a public docket, notwithstanding subchapter II of chapter 5 of title 5, United States Code. The proposed reclassification order published in the Federal Register shall set forth the proposed reclassification, and a substantive summary of the valid scientific evidence concerning the proposed reclassification, including—

(I)

the public health benefit of the use of the device, and the nature and, if known, incidence of the risk of the device;

(II)

in the case of a reclassification from class II to class III, why general controls pursuant to subsection (a)(1)(A) and special controls pursuant to subsection (a)(1)(B) together are not sufficient to provide a reasonable assurance of safety and effectiveness for such device; and

(III)

in the case of reclassification from class III to class II, why general controls pursuant to subsection (a)(1)(A) and special controls pursuant to subsection (a)(1)(B) together are sufficient to provide a reasonable assurance of safety and effectiveness for such device.

(ii)

An order under this subsection changing the classification of a device from class III to class II may provide that such classification shall not take effect until the effective date of a performance standard established under section 514 for such device.

(B)

Authority to issue such administrative order shall not be delegated below the Director of the Center for Devices and Radiological Health, acting in consultation with the Commissioner.

(2)

(A)

Section 513(e)(2) (21 U.S.C. 360c(e)(2)) is amended by striking regulation promulgated and inserting an order issued.

(B)

Section 514(a)(1) (21 U.S.C. 360d(a)(1)) is amended by striking under a regulation under section 513(e) but such regulation and inserting under an administrative order under section 513(e) (or a regulation promulgated under such section prior to the date of enactment of the Food and Drug Administration Safety and Innovation Act) but such order (or regulation).

(C)

Section 517(a)(1) (21 U.S.C. 360g(a)(1)) is amended by striking or changing the classification of a device to class I and inserting , an administrative order changing the classification of a device to class I,.

(3)

(A)

The amendments made by this subsection shall have no effect on a regulation promulgated with respect to the classification of a device under section 513(e) of the Federal Food, Drug, and Cosmetic Act prior to the date of enactment of this Act.

(B)

In the case of a device reclassified under section 513(e) of the Federal Food, Drug, and Cosmetic Act by regulation prior to the date of enactment of this Act, section 517(a)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360g(a)(1)) shall apply to such regulation promulgated under section 513(e) of such Act with respect to such device in the same manner such section 517(a)(1) applies to an administrative order issued with respect to a device reclassified after the date of enactment of this Act.

(b)

(1)

Section 515 (21 U.S.C. 360e) is amended—

(A)

in subsection (a), by striking regulation promulgated under subsection (b) and inserting an order issued under subsection (b) (or a regulation promulgated under such subsection prior to the date of enactment of the Food and Drug Administration Safety and Innovation Act);

(B)

in subsection (b)—

(i)

in paragraph (1)—

(I)

in the heading, by striking Regulation and inserting Order; and

(II)

in the matter following subparagraph (B)—

(aa)

by striking by regulation, promulgated in accordance with this subsection and inserting by administrative order following publication of a proposed order in the Federal Register, a meeting of a device classification panel described in section 513(b), and consideration of comments from all affected stakeholders, including patients, payors, and providers, notwithstanding subchapter II of chapter 5 of title 5, United States Code; and

(bb)

by adding at the end the following: Authority to issue such administrative order shall not be delegated below the Director of the Center for Devices and Radiological Health, acting in consultation with the Commissioner.;

(ii)

in paragraph (2)—

(I)

by striking subparagraph (B); and

(II)

in subparagraph (A)—

(aa)

by striking (2)(A) A proceeding for the promulgation of a regulation under paragraph (1) respecting a device shall be initiated by the publication in the Federal Register of a notice of proposed rulemaking. Such notice shall contain— and inserting (2) A proposed order required under paragraph (1) shall contain—;

(bb)

by redesignating clauses (i) through (iv) as subparagraphs (A) through (D), respectively;

(cc)

in subparagraph (A), as so redesignated, by striking regulation and inserting order; and

(dd)

in subparagraph (C), as so redesignated, by striking regulation and inserting order;

(iii)

in paragraph (3)—

(I)

by striking proposed regulation each place such term appears and inserting proposed order;

(II)

by striking paragraph (2) and after and inserting paragraph (2),;

(III)

by inserting and a meeting of a device classification panel described in section 513(b), after such proposed regulation and findings,;

(IV)

by striking (A) promulgate such regulation and inserting (A) issue an administrative order under paragraph (1);

(V)

by striking paragraph (2)(A)(ii) and inserting paragraph (2)(B); and

(VI)

by striking promulgation of the regulation and inserting issuance of the administrative order; and

(iv)

by striking paragraph (4); and

(C)

in subsection (i)—

(i)

in paragraph (2)—

(I)

in the matter preceding subparagraph (A)—

(aa)

by striking December 1, 1995 and inserting the date that is 2 years after the date of enactment of the Food and Drug Administration Safety and Innovation Act; and

(bb)

by striking publish a regulation in the Federal Register and inserting issue an administrative order following publication of a proposed order in the Federal Register, a meeting of a device classification panel described in section 513(b), and consideration of comments from all affected stakeholders, including patients, payors, and providers, notwithstanding subchapter II of chapter 5 of title 5, United States Code,;

(II)

in subparagraph (B), by striking final regulation has been promulgated under section 515(b) and inserting administrative order has been issued under subsection (b) (or no regulation has been promulgated under such subsection prior to the date of enactment of the Food and Drug Administration Safety and Innovation Act);

(III)

in the matter following subparagraph (B), by striking regulation requires and inserting administrative order issued under this paragraph requires; and

(IV)

by striking the third and fourth sentences; and

(ii)

in paragraph (3)—

(I)

by striking regulation requiring each place such term appears and inserting order requiring; and

(II)

by striking promulgation of a section 515(b) regulation and inserting issuance of an administrative order under subsection (b).

(2)

Section 501(f) (21 U.S.C. 351(f)) is amended—

(A)

in subparagraph (1)(A)—

(i)

in subclause (i), by striking a regulation promulgated and inserting an order issued; and

(ii)

in subclause (ii), by striking promulgation of such regulation and inserting issuance of such order;

(B)

in subparagraph (2)(B)—

(i)

by striking a regulation promulgated and inserting an order issued; and

(ii)

by striking promulgation of such regulation and inserting issuance of such order; and

(C)

by adding at the end the following:

(3)

In the case of a device with respect to which a regulation was promulgated under section 515(b) prior to the date of enactment of the Food and Drug Administration Safety and Innovation Act, a reference in this subsection to an order issued under section 515(b) shall be deemed to include such regulation.

(3)

The amendments made by this subsection shall have no effect on a regulation that was promulgated prior to the date of enactment of this Act requiring that a device have an approval under section 515 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360e) of an application for premarket approval.

(c)

The Secretary of Health and Human Services shall annually post on the Internet Web site of the Food and Drug Administration—

(1)

the number and type of class I and class II devices reclassified as class II or class III in the previous calendar year under section 513(e)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360c(e)(1));

(2)

the number and type of class II and class III devices reclassified as class I or class II in the previous calendar year under such section 513(e)(1); and

(3)

the number and type of devices reclassified in the previous calendar year under section 515 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360e).

609.

Paragraph (4) of section 803(c) (21 U.S.C. 383(c)) is amended to read as follows:

(4)

With respect to devices, the Secretary may, when appropriate, enter into arrangements with nations regarding methods and approaches to harmonizing regulatory requirements for activities, including inspections and common international labeling symbols.

610.

Paragraph (3) of section 803(c) (21 U.S.C. 383(c)) is amended—

(1)

by striking (3) and inserting (3)(A); and

(2)

by adding at the end the following:

(B)

In carrying out subparagraph (A), the Secretary may participate in appropriate fora, including the International Medical Device Regulators Forum, and may—

(i)

provide guidance to such fora on strategies, policies, directions, membership, and other activities of a forum as appropriate;

(ii)

to the extent appropriate, solicit, review, and consider comments from industry, academia, health care professionals, and patient groups regarding the activities of such fora; and

(iii)

to the extent appropriate, inform the public of the Secretary’s activities within such fora, and share with the public any documentation relating to a forum’s strategies, policies, and other activities of such fora.

611.

(a)

Section 523(b)(2) (21 U.S.C. 360m(b)(2)) is amended by adding at the end of the following:

(E)

(i)

Subject to suspension or withdrawal under subparagraph (B), any accreditation under this section shall be valid for a period of 3 years after its issuance.

(ii)

Upon the submission of a request by an accredited person for reaccreditation under this section, the Secretary shall approve or deny such request not later than 60 days after receipt of the request.

(iii)

Not later than 120 days after the date of the enactment of this subparagraph, the Secretary shall establish and publish in the Federal Register criteria to reaccredit or deny reaccreditation to persons under this section. The reaccreditation of persons under this section shall specify the particular activities under subsection (a), and the devices, for which such persons are reaccredited.

(b)

Section 523(c) (21 U.S.C. 360m(c)) is amended by striking October 1, 2012 and inserting October 1, 2017.

612.

Section 704(g)(11) (21 U.S.C. 374(g)(11)) is amended by striking October 1, 2012 and inserting October 1, 2017.

613.

(a)

Section 520(m) (21 U.S.C. 360j(m)) is amended—

(1)

in paragraph (6)—

(A)

in subparagraph (A)—

(i)

by striking clause (i) and inserting the following:

(i)

The device with respect to which the exemption is granted—

(I)

is intended for the treatment or diagnosis of a disease or condition that occurs in pediatric patients or in a pediatric subpopulation, and such device is labeled for use in pediatric patients or in a pediatric subpopulation in which the disease or condition occurs; or

(II)

is intended for the treatment or diagnosis of a disease or condition that does not occur in pediatric patients or that occurs in pediatric patients in such numbers that the development of the device for such patients is impossible, highly impracticable, or unsafe.

; and

(ii)

by striking clause (ii) and inserting the following:

(ii)

During any calendar year, the number of such devices distributed during that year under each exemption granted under this subsection does not exceed the annual distribution number for such device. In this paragraph, the term annual distribution number means the number of such devices reasonably needed to treat, diagnose, or cure a population of 4,000 individuals in the United States. The Secretary shall determine the annual distribution number when the Secretary grants such exemption.

; and

(B)

by amending subparagraph (C) to read as follows:

(C)

A person may petition the Secretary to modify the annual distribution number determined by the Secretary under subparagraph (A)(ii) with respect to a device if additional information arises, and the Secretary may modify such annual distribution number.

;

(2)

in paragraph (7), by striking regarding a device and inserting regarding a device described in paragraph (6)(A)(i)(I); and

(3)

in paragraph (8), by striking of all devices described in paragraph (6) and inserting of all devices described in paragraph (6)(A)(i)(I).

(b)

A sponsor of a device for which an exemption was approved under paragraph (2) of section 520(m) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360j(m)) before the date of enactment of this Act may seek a determination under subclause (I) or (II) of section 520(m)(6)(A)(i) (as amended by subsection (a)). If the Secretary of Health and Human Services determines that such subclause (I) or (II) applies with respect to a device, clauses (ii), (iii), and (iv) of subparagraph (A) and subparagraphs (B), (C), (D), and (E) of paragraph (6) of such section 520(m) shall apply to such device, and the Secretary shall determine the annual distribution number for purposes of clause (ii) of such subparagraph (A) when making the determination under this subsection.

614.

Section 519(f) (21 U.S.C. 360i(f)) is amended—

(1)

by striking The Secretary shall promulgate and inserting Not later than December 31, 2012, the Secretary shall issue proposed; and

(2)

by adding at the end the following: The Secretary shall finalize the proposed regulations not later than 6 months after the close of the comment period and shall implement the final regulations with respect to devices that are implantable, life-saving, and life sustaining not later than 2 years after the regulations are finalized, taking into account patient access to medical devices and therapies..

615.

Section 519 (21 U.S.C. 360i) is amended by adding at the end the following:

(h)

(1)

(A)

The Secretary shall amend the procedures established and maintained under clauses (i), (ii), (iii), and (v) of section 505(k)(3)(C) in order to expand the postmarket risk identification and analysis system established under such section to include and apply to devices.

(B)

Subclause (II) of clause (i) of section 505(k)(3)(C) shall not apply to devices.

(C)

With respect to devices, the private sector health-related electronic data provided under section 505(k)(3)(C)(i)(III)(bb) may include medical device utilization data, health insurance claims data, and procedure and device registries.

(2)

In expanding the system as described in paragraph (1)(A), the Secretary shall use relevant data with respect to devices cleared under section 510(k) or approved under section 515, including claims data, patient survey data, and any other data deemed appropriate by the Secretary.

(3)

To help ensure effective implementation of the system as described in paragraph (1) with respect to devices, the Secretary shall engage outside stakeholders in development of the system, and gather information from outside stakeholders regarding the content of an effective sentinel program, through a public hearing, advisory committee meeting, maintenance of a public docket, or other similar public measures.

(4)

Chapter 35 of title 44, United States Code, shall not apply to the collection of voluntary information from health care providers, such as voluntary surveys or questionnaires, initiated by the Secretary for purposes of postmarket risk identification, mitigation, and analysis for devices.

616.

Section 522 (21 U.S.C. 360l) is amended—

(1)

in subsection (a)(1)(A), in the matter preceding clause (i), by inserting , at the time of approval or clearance of a device or at any time thereafter, after by order; and

(2)

in subsection (b)(1), by inserting The manufacturer shall commence surveillance under this section not later than 15 months after the day on which the Secretary issues an order under this section. after the second sentence.

617.

Section 520(b) (21 U.S.C. 360j(b)) is amended to read as follows:

(b)

(1)

The requirements of sections 514 and 515 shall not apply to a device that—

(A)

is created or modified in order to comply with the order of an individual physician or dentist (or any other specially qualified person designated under regulations promulgated by the Secretary after an opportunity for an oral hearing);

(B)

in order to comply with an order described in subparagraph (A), necessarily deviates from an otherwise applicable performance standard under section 514 or requirement under section 515;

(C)

is not generally available in the United States in finished form through labeling or advertising by the manufacturer, importer, or distributor for commercial distribution;

(D)

is designed to treat a unique pathology or physiological condition that no other device is domestically available to treat;

(E)

(i)

is intended to meet the special needs of such physician or dentist (or other specially qualified person so designated) in the course of the professional practice of such physician or dentist (or other specially qualified person so designated); or

(ii)

is intended for use by an individual patient named in such order of such physician or dentist (or other specially qualified person so designated);

(F)

is assembled from components or manufactured and finished on a case-by-case basis to accommodate the unique needs of individuals described in clause (i) or (ii) of subparagraph (E); and

(G)

may have common, standardized design characteristics, chemical and material compositions, and manufacturing processes as commercially distributed devices.

(2)

Paragraph (1) shall apply to a device only if—

(A)

such device is for the purpose of treating a sufficiently rare condition, such that conducting clinical investigations on such device would be impractical;

(B)

production of such device under paragraph (1) is limited to no more than 5 units per year of a particular device type, provided that such replication otherwise complies with this section; and

(C)

the manufacturer of such device notifies the Secretary on an annual basis, in a manner prescribed by the Secretary, of the manufacture of such device.

(3)

Not later than 2 years after the date of enactment of this section, the Secretary shall issue final guidance on replication of multiple devices described in paragraph (2)(B).

618.

(a)

Not later than 18 months after the date of enactment of this Act, the Secretary of Health and Human Services (referred to in this section as the Secretary), acting through the Commissioner of Food and Drugs, and in consultation with the National Coordinator for Health Information Technology and the Chairman of the Federal Communications Commission, shall post on the Internet Web sites of the Food and Drug Administration, the Federal Communications Commission, and the Office of the National Coordinator for Health Information Technology, a report that contains a proposed strategy and recommendations on an appropriate, risk-based regulatory framework pertaining to health information technology, including mobile medical applications, that promotes innovation, protects patient safety, and avoids regulatory duplication.

(b)

(1)

In carrying out subsection (a), the Secretary may convene a working group of external stakeholders and experts to provide appropriate input on the strategy and recommendations required for the report under subsection (a).

(2)

If the Secretary convenes the working group under paragraph (1), the Secretary, in consultation with the Commissioner of Food and Drugs, the National Coordinator for Health Information Technology, and the Chairman of the Federal Communications Commission, shall determine the number of representatives participating in the working group, and shall, to the extent practicable, ensure that the working group is geographically diverse and includes representatives of patients, consumers, health care providers, startup companies, health plans or other third-party payers, venture capital investors, information technology vendors, health information technology vendors, small businesses, purchasers, employers, and other stakeholders with relevant expertise, as determined by the Secretary.

619.

Subparagraph (C) of section 701(h)(1) (21 U.S.C. 371(h)(1)) is amended—

(1)

by striking (C) For guidance documents and inserting (C)(i) For guidance documents; and

(2)

by adding at the end the following:

(ii)

With respect to devices, if a notice to industry guidance letter, a notice to industry advisory letter, or any similar notice sets forth initial interpretations of a regulation or policy or sets forth changes in interpretation or policy, such notice shall be treated as a guidance document for purposes of this subparagraph.

620.

(a)

Section 305(e) of Pediatric Medical Device Safety and Improvement Act (Public Law 110–85; 42 U.S.C. 282 note)) is amended by striking $6,000,000 for each of fiscal years 2008 through 2012 and inserting $5,250,000 for each of fiscal years 2013 through 2017.

(b)

The Secretary of Health and Human Services shall issue—

(1)

a proposed rule implementing section 515A(a)(2) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360e–1(a)(2)) not later than December 31, 2012; and

(2)

a final rule implementing such section not later than December 31, 2013.

VII

701.

Section 510 (21 U.S.C. 360) is amended—

(1)

in subsection (b)—

(A)

in paragraph (1), by striking On or before and all that follows through the period at the end and inserting the following: “During the period beginning on October 1 and ending on December 31 of each year, every person who owns or operates any establishment in any State engaged in the manufacture, preparation, propagation, compounding, or processing of a drug or drugs shall register with the Secretary the name of such person, places of business of such person, all such establishments, the unique facility identifier of each such establishment, and a point of contact e-mail address.; and

(B)

by adding at the end the following:

(3)

The Secretary shall specify the unique facility identifier system that shall be used by registrants under paragraph (1). The requirement to include a unique facility identifier in a registration under paragraph (1) shall not apply until the date that the identifier system is specified by the Secretary under the preceding sentence.

; and

(2)

in subsection (c), by striking with the Secretary his name, place of business, and such establishment and inserting “with the Secretary—

(1)

with respect to drugs, the information described under subsection (b)(1); and

(2)

with respect to devices, the information described under subsection (b)(2).

702.

(a)

Section 502(o) (21 U.S.C. 352(o)) is amended by striking in any State.

(b)

Section 510(i) (U.S.C. 360(i)) is amended—

(1)

in paragraph (1)—

(A)

by amending the matter preceding subparagraph (A) to read as follows: Every person who owns or operates any establishment within any foreign country engaged in the manufacture, preparation, propagation, compounding, or processing of a drug or device that is imported or offered for import into the United States shall, through electronic means in accordance with the criteria of the Secretary—;

(B)

by amending subparagraph (A) to read as follows:

(A)

upon first engaging in any such activity, immediately submit a registration to the Secretary that includes—

(i)

with respect to drugs, the name and place of business of such person, all such establishments, the unique facility identifier of each such establishment, a point of contact e-mail address, the name of the United States agent of each such establishment, the name of each importer of such drug in the United States that is known to the establishment, and the name of each person who imports or offers for import such drug to the United States for purposes of importation; and

(ii)

with respect to devices, the name and place of business of the establishment, the name of the United States agent for the establishment, the name of each importer of such device in the United States that is known to the establishment, and the name of each person who imports or offers for import such device to the United States for purposes of importation; and

; and

(C)

by amending subparagraph (B) to read as follows:

(B)

each establishment subject to the requirements of subparagraph (A) shall thereafter register with the Secretary during the period beginning on October 1 and ending on December 31 of each year.

; and

(2)

by adding at the end the following:

(4)

The Secretary shall specify the unique facility identifier system that shall be used by registrants under paragraph (1) with respect to drugs. The requirement to include a unique facility identifier in a registration under paragraph (1) with respect to drugs shall not apply until the date that the identifier system is specified by the Secretary under the preceding sentence.

703.

Section 510(j) (21 U.S.C. 360(j)) is amended—

(1)

in paragraph (1)—

(A)

in subparagraph (C), by striking ; and and inserting a semicolon;

(B)

in subparagraph (D), by striking the period at the end and inserting ; and; and

(C)

by adding at the end the following:

(E)

in the case of a drug contained in the applicable list, the name and place of business of each manufacturer of an excipient of the listed drug with which the person listing the drug conducts business, including all establishments used in the production of such excipient, the unique facility identifier of each such establishment, and a point of contact e-mail address for each such excipient manufacturer.

; and

(2)

by adding at the end the following:

(4)

The Secretary shall require persons subject to this subsection to use, for purposes of this subsection, the unique facility identifier systems specified under subsections (b)(3) and (i)(4) with respect to drugs. Such requirement shall not apply until the date that the identifier system under subsection (b)(3) or (i)(4), as applicable, is specified by the Secretary.

704.

Section 510(p) (21 U.S.C. 360(p)) is amended—

(1)

by striking (p) Registrations and listings and inserting the following:

(p)

(1)

Registrations and listings

; and

(2)

by adding at the end the following:

(2)

Not later than 2 years after the Secretary specifies a unique facility identifier system under subsections (b) and (i), the Secretary shall maintain an electronic database, which shall not be subject to inspection under subsection (f), populated with the information submitted as described under paragraph (1) that—

(A)

enables personnel of the Food and Drug Administration to search the database by any field of information submitted in a registration described under paragraph (1), or combination of such fields; and

(B)

uses the unique facility identifier system to link with other relevant databases within the Food and Drug Administration, including the database for submission of information under section 801(r).

(3)

The Secretary shall ensure the accuracy and coordination of relevant Food and Drug Administration databases in order to identify and inform risk-based inspections under section 510(h).

705.

Section 510(h) (21 U.S.C. 360(h)) is amended to read as follows:

(h)

(1)

Every establishment that is required to be registered with the Secretary under this section shall be subject to inspection pursuant to section 704.

(2)

Every establishment described in paragraph (1), in any State, that is engaged in the manufacture, propagation, compounding, or processing of a device or devices classified in class II or III shall be so inspected by one or more officers or employees duly designated by the Secretary, or by persons accredited to conduct inspections under section 704(g), at least once in the 2-year period beginning with the date of registration of such establishment pursuant to this section and at least once in every successive 2-year period thereafter.

(3)

The Secretary, acting through one or more officers or employees duly designated by the Secretary, shall inspect establishments described in paragraph (1) that are engaged in the manufacture, preparation, propagation, compounding, or processing of a drug or drugs (referred to in this subsection as drug establishments) in accordance with a risk-based schedule established by the Secretary.

(4)

In establishing the risk-based scheduled under paragraph (3), the Secretary shall inspect establishments according to the known safety risks of such establishments, which shall be based on the following factors:

(A)

The compliance history of the establishment.

(B)

The record, history, and nature of recalls linked to the establishment.

(C)

The inherent risk of the drug manufactured, prepared, propagated, compounded, or processed at the establishment.

(D)

The inspection frequency and history of the establishment, including whether the establishment has been inspected pursuant to section 704 within the last 4 years.

(E)

Whether the establishment has been inspected by a foreign government or an agency of a foreign government recognized under section 809.

(F)

Any other criteria deemed necessary and appropriate by the Secretary for purposes of allocating inspection resources.

(5)

In determining the risk associated with an establishment for purposes of establishing a risk-based schedule under paragraph (3), the Secretary shall not consider whether the drugs manufactured, prepared, propagated, compounded, or processed by such establishment are drugs described in section 503(b).

(6)

Beginning in 2014, not later than February 1 of each year, the Secretary shall make available on the Internet Web site of the Food and Drug Administration a report regarding—

(A)

(i)

the number of domestic and foreign establishments registered pursuant to this section in the previous fiscal year; and

(ii)

the number of such domestic establishments and the number of such foreign establishments that the Secretary inspected in the previous fiscal year;

(B)

with respect to establishments that manufacture, prepare, propagate, compound, or process an active ingredient of a drug, a finished drug product, or an excipient of a drug, the number of each such type of establishment; and

(C)

the percentage of the budget of the Food and Drug Administration used to fund the inspections described under subparagraph (A).

706.

Section 704(a) (21 U.S.C. 374(a)) is amended by adding at the end the following:

(4)

(A)

Any records or other information that the Secretary may inspect under this section from a person that owns or operates an establishment that is engaged in the manufacture, preparation, propagation, compounding, or processing of a drug shall, upon the request of the Secretary, be provided to the Secretary by such person, in advance of or in lieu of an inspection, within a reasonable timeframe, within reasonable limits, and in a reasonable manner, and in either electronic or physical form, at the expense of such person. The Secretary’s request shall include a sufficient description of the records requested.

(B)

Upon receipt of the records requested under subparagraph (A), the Secretary shall provide to the person confirmation of receipt.

(C)

Nothing in this paragraph supplants the authority of the Secretary to conduct inspections otherwise permitted under this Act in order to ensure compliance with this Act.

707.

(a)

Section 501 (21 U.S.C. 351) is amended by adding at the end the following:

(j)

If it is a drug and it has been manufactured, processed, packed, or held in any factory, warehouse, or establishment and the owner, operator, or agent of such factory, warehouse, or establishment delays, denies, or limits an inspection, or refuses to permit entry or inspection.

(b)

Not later than 1 year after the date of enactment of this section, the Secretary of Health and Human Services shall issue guidance that defines the circumstances that would constitute delaying, denying, or limiting inspection, or refusing to permit entry or inspection, for purposes of section 501(j) of the Federal Food, Drug, and Cosmetic Act (as added by subsection (a)).

708.

(a)

The sixth sentence of section 801(a) (21 U.S.C. 381(a)) is amended by inserting before the period at the end the following: , except that the Secretary of Health and Human Services may destroy, without the opportunity for export, any drug refused admission under this section, if such drug is valued at an amount that is $2,500 or less (or such higher amount as the Secretary of the Treasury may set by regulation pursuant to section 498(a)(1) of the Tariff Act of 1930 (19 U.S.C. 1498(a)(1)) and was not brought into compliance as described under subsection (b)..

(b)

Subsection (a) of section 801 (21 U.S.C. 381), as amended by subsection (a), is further amended by inserting after the sixth sentence the following: The Secretary of Health and Human Services shall issue regulations providing for notice and an opportunity to appear before the Secretary of Health and Human Services and introduce testimony, as described in the first sentence of this subsection, on destruction of a drug under the sixth sentence of this subsection. The regulations shall provide that prior to destruction, appropriate due process is available to the owner or consignee seeking to challenge the decision to destroy the drug. Where the Secretary of Health and Human Services provides notice and an opportunity to appear and introduce testimony on the destruction of a drug, the Secretary of Health and Human Services shall store and, as applicable, dispose of the drug after the issuance of the notice, except that the owner and consignee shall remain liable for costs pursuant to subsection (c). Such process may be combined with the notice and opportunity to appear before the Secretary and introduce testimony, as described in the first sentence of this subsection, as long as appropriate notice is provided to the owner or consignee..

(c)

The amendment made by subsection (a) shall apply beginning on the effective date of the regulations promulgated pursuant to the amendment made by subsection (b).

(d)

(1)

Not later than 2 years after the date of enactment of this Act, the Secretary of Health and Human Services shall adopt final regulations implementing the amendments made this section.

(2)

In promulgating a regulation implementing the amendments made by this section, the Secretary of Health and Human Services shall—

(A)

issue a notice of proposed rulemaking that includes a copy of the proposed regulation;

(B)

provide a period of not less than 60 days for comments on the proposed regulation; and

(C)

publish the final regulation not less than 30 days before the effective date of the regulation.

(3)

Notwithstanding any other provision of law, the Secretary of Health and Human Services shall promulgate regulations implementing the amendments made by this section only as described in paragraph (2).

709.

(a)

Section 304(g) (21 U.S.C. 335a(g)) is amended—

(1)

in paragraph (1), by inserting , drug, after device, each place it appears;

(2)

in paragraph (2)(A), by inserting , drug, after (B), a device; and

(3)

in paragraph (2)(B), by inserting or drug after device each place it appears.

(b)

(1)

Not later than 2 years after the date of the enactment of this Act, the Secretary of Health and Human Services shall promulgate regulations in accordance with section 304(i) of the Federal Food, Drug, and Cosmetic Act, as added by paragraph (2) of this subsection, to implement administrative detention authority with respect to drugs, as authorized by the amendments made by subsection (a). Before promulgating such regulations, the Secretary shall consult with stakeholders, including manufacturers of drugs.

(2)

Section 304 (21 U.S.C. 334) is amended by adding at the end the following:

(i)

(1)

In promulgating a regulation implementing this section, the Secretary shall—

(A)

issue a notice of proposed rulemaking that includes the proposed regulation;

(B)

provide a period of not less than 60 days for comments on the proposed regulation; and

(C)

publish the final regulation not less than 30 days before the regulation’s effective date.

(2)

Notwithstanding any other provision of Federal law, in implementing this section, the Secretary shall only promulgate regulations as described in paragraph (1).

(c)

The amendments made by subsection (a) shall not take effect until the Secretary has issued a final regulation under subsection (b).

710.

Section 708 (21 U.S.C. 379) is amended—

(1)

by striking Confidential Information and all that follows through The Secretary may provide and inserting the following:

708.

(a)

The Secretary may provide

; and

(2)

by adding at the end the following:

(b)

(1)

The Secretary shall not be required to disclose under section 552 of title 5, United States Code (commonly referred to as the Freedom of Information Act), or any other provision of law, any information relating to drugs obtained from a foreign government agency, if—

(A)

the information concerns the inspection of a facility, is part of an investigation, alerts the United States to the potential need for an investigation, or concerns a drug that has a reasonable probability of causing serious adverse health consequences or death to humans or animals;

(B)

the information is provided or made available to the United States Government voluntarily on the condition that it not be released to the public; and

(C)

the information is covered by, and subject to, a written agreement between the Secretary and the foreign government.

(2)

The written agreement described in paragraph (1)(C) shall specify the time period for which paragraph (1) shall apply to the voluntarily disclosed information. Paragraph (1) shall not apply with respect to such information after the date specified in such agreement, but all other applicable legal protections, including the provisions of section 552 of title 5, United States Code, and section 319L(e)(1) of the Public Health Service Act, as applicable, shall continue to apply to such information. If no date is specified in the written agreement, paragraph (1) shall not apply with respect to such information for a period of more than 36 months.

(3)

Nothing in this section authorizes any official to withhold, or to authorize the withholding of, information from Congress or information required to be disclosed pursuant to an order of a court of the United States.

(4)

For purposes of section 552 of title 5, United States Code, this subsection shall be considered a statute described in subsection (b)(3)(B) of such section 552.

(c)

The Secretary may enter into written agreements to provide information referenced in section 301(j) to foreign governments subject to the following criteria:

(1)

The Secretary may enter into a written agreement to provide information under this subsection to a foreign government only if the Secretary has certified such government as having the authority and demonstrated ability to protect trade secret information from disclosure. Responsibility for this certification shall not be delegated to any officer or employee other than the Commissioner of Food and Drugs.

(2)

The written agreement to provide information to the foreign government under this subsection shall include a commitment by the foreign government to protect information exchanged under this subsection from disclosure unless and until the sponsor gives written permission for disclosure or the Secretary makes a declaration of a public health emergency pursuant to section 319 of the Public Health Service Act that is relevant to the information.

(3)

The Secretary may provide to a foreign government that has been certified under paragraph (1) and that has executed a written agreement under paragraph (2) information referenced in section 301(j) in only the following circumstances:

(A)

Information concerning the inspection of a facility may be provided to a foreign government if—

(i)

the Secretary reasonably believes, or the written agreement described in paragraph (2) establishes, that the government has authority to otherwise obtain such information; and

(ii)

the written agreement executed under paragraph (2) limits the recipient’s use of the information to the recipient’s civil regulatory purposes.

(B)

Information not described in subparagraph (A) may be provided as part of an investigation, or to alert the foreign government to the potential need for an investigation, if the Secretary has reasonable grounds to believe that a drug has a reasonable probability of causing serious adverse health consequences or death to humans or animals.

(4)

Nothing in this subsection affects the ability of the Secretary to enter into any written agreement authorized by other provisions of law to share confidential information.

711.

Section 501 (21 U.S.C. 351) is amended by adding at the end the following flush text:

For purposes of paragraph (a)(2)(B), the term current good manufacturing practice includes the implementation of oversight and controls over the manufacture of drugs to ensure quality, including managing the risk of and establishing the safety of raw materials, materials used in the manufacturing of drugs, and finished drug products.

712.

Chapter VIII (21 U.S.C. 381 et seq.) is amended by adding at the end the following:

809.

(a)

The Secretary—

(1)

may enter into arrangements and agreements with a foreign government or an agency of a foreign government to recognize the inspection of foreign establishments registered under section 510(i) in order to facilitate risk-based inspections in accordance with the schedule established in section 510(h)(3);

(2)

may enter into arrangements and agreements with a foreign government or an agency of a foreign government under this section only with a foreign government or an agency of a foreign government that the Secretary has determined as having the capability of conduction inspections that meet the applicable requirements of this Act; and

(3)

shall perform such reviews and audits of drug safety programs, systems, and standards of a foreign government or agency for the foreign government as the Secretary deems necessary to determine that the foreign government or agency of the foreign government is capable of conducting inspections that meet the applicable requirements of this Act.

(b)

The results of inspections performed by a foreign government or an agency of a foreign government under this section may be used as—

(1)

evidence of compliance with section 501(a)(2)(B) or section 801(r); and

(2)

for any other purposes as determined appropriate by the Secretary.

713.

Section 801 (21 U.S.C. 381) is amended—

(1)

in subsection (o), by striking drug or; and

(2)

by adding at the end the following:

(r)

(1)

The Secretary may require, pursuant to the regulations promulgated under paragraph (4)(A), as a condition of granting admission to a drug imported or offered for import into the United States, that the importer electronically submit information demonstrating that the drug complies with applicable requirements of this Act.

(2)

The information described under paragraph (1) may include—

(A)

information demonstrating the regulatory status of the drug, such as the new drug application, abbreviated new drug application, or investigational new drug or drug master file number;

(B)

facility information, such as proof of registration and the unique facility identifier;

(C)

indication of compliance with current good manufacturing practice, testing results, certifications relating to satisfactory inspections, and compliance with the country of export regulations; and

(D)

any other information deemed necessary and appropriate by the Secretary to assess compliance of the article being offered for import.

(3)

Information requirements referred to in paragraph (2)(C) may, at the discretion of the Secretary, be satisfied—

(A)

through representation by a foreign government, if an inspection is conducted by a foreign government using standards and practices as determined appropriate by the Secretary;

(B)

through representation by a foreign government or an agency of a foreign government recognized under section 809; or

(C)

other appropriate documentation or evidence as described by the Secretary.

(4)

(A)

Not later than 18 months after the date of enactment of the Food and Drug Administration Safety and Innovation Act, the Secretary shall adopt final regulations implementing this subsection. Such requirements shall be appropriate for the type of import, such as whether the drug is for import into the United States for use in preclinical research or in a clinical investigation under an investigational new drug exemption under 505(i).

(B)

In promulgating the regulations under subparagraph (A), the Secretary—

(i)

may, as appropriate, take into account differences among importers and types of imports, and, based on the level of risk posed by the imported drug, provide for expedited clearance for those importers that volunteer to participate in partnership programs for highly compliant companies and pass a review of internal controls, including sourcing of foreign manufacturing inputs, and plant inspections; and

(ii)

shall—

(I)

issue a notice of proposed rulemaking that includes the proposed regulation;

(II)

provide a period of not less than 60 days for comments on the proposed regulation; and

(III)

publish the final regulation not less than 30 days before the effective date of the regulation.

(C)

Notwithstanding any other provision of law, the Secretary shall promulgate regulations implementing this subsection only as described in subparagraph (B).

714.

(a)

Section 301 (21 U.S.C. 331) is amended by adding at the end the following:

(aaa)

The failure to register in accordance with section 801(s).

(b)

Section 801 (21 U.S.C. 381), as amended by section 713 of this Act, is further amended by adding at the end the following:

(s)

(1)

The Secretary shall require a commercial importer of drugs—

(A)

to be registered with the Secretary in a form and manner specified by the Secretary; and

(B)

subject to paragraph (4), to submit, at the time of registration, a unique identifier for the principal place of business for which the importer is required to register under this subsection.

(2)

(A)

The Secretary, in consultation with the Secretary of Homeland Security acting through U.S. Customs and Border Protection, shall promulgate regulations to establish good importer practices that specify the measures an importer shall take to ensure imported drugs are in compliance with the requirements of this Act and the Public Health Service Act.

(B)

In promulgating a regulation under subparagraph (A), the Secretary shall—

(i)

issue a notice of proposed rulemaking that includes the proposed regulation;

(ii)

provide a period of not less than 60 days for comments on the proposed regulation; and

(iii)

publish the final regulation not less than 30 days before the regulation’s effective date.

(C)

Notwithstanding any other provision of Federal law, in implementing this subsection, the Secretary shall only promulgate regulations as described in subparagraph (B).

(3)

The Secretary shall discontinue the registration of any commercial importer of drugs that fails to comply with the regulations promulgated under this subsection.

(4)

(5)

The Secretary, by notice in the Federal Register, may establish exemptions from the requirements of this subsection.

(c)

Section 502(o) (21 U.S.C. 352) is amended by inserting if it is a drug and was imported or offered for import by a commercial importer of drugs not duly registered under section 801(s), after not duly registered under section 510,.

(d)

(1)

Not later than 36 months after the date of the enactment of this Act, the Secretary of Health and Human Services, in consultation with the Secretary of Homeland Security acting through U.S. Customs and Border Protection, shall promulgate the regulations required to carry out section 801(s) of the Federal Food, Drug, and Cosmetic Act, as added by subsection (b).

(2)

(A)

In promulgating a regulation under paragraph (1), the Secretary shall—

(i)

issue a notice of proposed rulemaking that includes the proposed regulation;

(ii)

provide a period of not less than 60 days for comments on the proposed regulation; and

(iii)

publish the final regulation not less than 30 days before the regulation’s effective date.

(B)

Notwithstanding any other provision of Federal law, in implementing section 801(s) of the Federal Food, Drug, and Cosmetic Act, as added by subsection (b), the Secretary shall promulgate regulations only as described in subparagraph (A).

(3)

In establishing the effective date of the regulations under paragraph (1), the Secretary of Health and Human Services shall, in consultation with the Secretary of Homeland Security acting through U.S. Customs and Border Protection, as determined appropriate by the Secretary of Health and Human Services, provide a reasonable period of time for an importer of a drug to comply with good importer practices, taking into account differences among importers and types of imports, including based on the level of risk posed by the imported product.

715.

(a)

Section 301 (21 U.S.C. 331), as amended by section 714 of this Act, is further amended by adding at the end the following:

(bbb)

The failure to notify the Secretary in violation of section 568.

(b)

Subchapter E of chapter V (21 U.S.C. 360bbb et seq.) is amended by adding at the end the following:

568.

(a)

With respect to a drug, the Secretary may require notification to the Secretary by a regulated person if the regulated person knows—

(1)

that the use of such drug in the United States may result in serious injury or death;

(2)

of a significant loss or known theft of such drug intended for use in the United States; or

(3)

that—

(A)

such drug has been or is being counterfeited; and

(B)

(i)

the counterfeit product is in commerce in the United States or could be reasonably expected to be introduced into commerce in the United States; or

(ii)

such drug has been or is being imported into the United States or may reasonably be expected to be offered for import into the United States.

(b)

Notification under this section shall be made in such manner and by such means as the Secretary may specify by regulation or guidance.

(c)

Nothing in this section shall be construed as limiting any other authority of the Secretary to require notifications related to a drug under any other provision of this Act or the Public Health Service Act.

(d)

In this section, the term regulated person means—

(1)

a person who is required to register under section 510 or 801(s);

(2)

a wholesale distributor of a drug product; or

(3)

any other person that distributes drugs except a person that distributes drugs exclusively for retail sale.

716.

Section 303(b) (21 U.S.C. 333(b)) is amended by adding at the end the following:

(7)

Notwithstanding subsection (a)(2), any person that knowingly and intentionally adulterates a drug such that the drug is adulterated under subsection (a)(1), (b), (c), or (d) of section 501 and has a reasonable probability of causing serious adverse health consequences or death to humans or animals shall be imprisoned for not more than 20 years or fined not more than $1,000,000, or both.

717.

(a)

(1)

Section 2320(a) of title 18, United States Code, is amended—

(A)

by striking or at the end of paragraph (2);

(B)

by inserting or at the end of paragraph (3);

(C)

by inserting after paragraph (3) the following:

(4)

traffics in a counterfeit drug,

; and

(D)

by striking through (3) and inserting through (4).

(2)

Section 2320(b)(3) of title 18, United States Code, is amended—

(A)

in the heading, by inserting and counterfeit drugs after services; and

(B)

by inserting or counterfeit drug after service.

(3)

Section 2320(f) of title 18, United States Code, is amended—

(A)

by striking and at the end of paragraph (4);

(B)

by striking the period at the end of paragraph (5) and inserting ; and; and

(C)

by adding at the end the following:

(6)

the term counterfeit drug means a drug, as defined by section 201 of the Federal Food, Drug, and Cosmetic Act, that uses a counterfeit mark on or in connection with the drug.

(4)

The Attorney General shall give increased priority to efforts to investigate and prosecute offenses under section 2320 of title 18, United States Code, that involve counterfeit drugs.

(b)

(1)

Pursuant to its authority under section 994(p) of title 28, United States Code, and in accordance with this subsection, the United States Sentencing Commission shall review and amend, if appropriate, its guidelines and its policy statements applicable to persons convicted of an offense described in section 2320(a)(4) of title 18, United States Code, as amended by subsection (a), in order to reflect the intent of Congress that such penalties be increased in comparison to those currently provided by the guidelines and policy statements.

(2)

In carrying out this subsection, the Commission shall—

(A)

ensure that the sentencing guidelines and policy statements reflect the intent of Congress that the guidelines and policy statements reflect the serious nature of the offenses described in paragraph (1) and the need for an effective deterrent and appropriate punishment to prevent such offenses;

(B)

consider the extent to which the guidelines may or may not appropriately account for the potential and actual harm to the public resulting from the offense;

(C)

assure reasonable consistency with other relevant directives and with other sentencing guidelines;

(D)

account for any additional aggravating or mitigating circumstances that might justify exceptions to the generally applicable sentencing ranges;

(E)

make any necessary conforming changes to the sentencing guidelines; and

(F)

assure that the guidelines adequately meet the purposes of sentencing as set forth in section 3553(a)(2) of title 18, United States Code.

718.

Chapter III (21 U.S.C. 331 et seq.) is amended by adding at the end the following:

311.

There is extraterritorial jurisdiction over any violation of this Act relating to any article regulated under this Act if such article was intended for import into the United States or if any act in furtherance of the violation was committed in the United States.

VIII

801.

(a)

Chapter V (21 U.S.C. 351 et seq.) is amended by inserting after section 505D the following:

505E.

(a)

If the Secretary approves an application pursuant to section 505 for a drug that has been designated as a qualified infectious disease product under subsection (d), the 4- and 5-year periods described in subsections (c)(3)(E)(ii) and (j)(5)(F)(ii) of section 505, the 3-year periods described in clauses (iii) and (iv) of subsection (c)(3)(E) and clauses (iii) and (iv) of subsection (j)(5)(F) of section 505, or the 7-year period described in section 527, as applicable, shall be extended by 5 years.

(b)

Any extension under subsection (a) of a period shall be in addition to any extension of the period under section 505A with respect to the drug.

(c)

Subsection (a) does not apply to the approval of—

(1)

a supplement to an application under section 505(b) for any qualified infectious disease product for which an extension described in subsection (a) is in effect or has expired;

(2)

a subsequent application filed with respect to a product approved under section 505 for a change that results in a new indication, route of administration, dosing schedule, dosage form, delivery system, delivery device, or strength; or

(3)

a product that does not meet the definition of a qualified infectious disease product under subsection (g) based upon its approved uses.

(d)

(1)

The manufacturer or sponsor of a drug may request the Secretary to designate a drug as a qualified infectious disease product at any time before the submission of an application under section 505(b) for such drug. The Secretary shall, not later than 60 days after the submission of such a request, determine whether the drug is a qualified infectious disease product.

(2)

Except as provided in paragraph (3), a designation under this subsection shall not be withdrawn for any reason, including modifications to the list of qualifying pathogens under subsection (f)(2)(C).

(3)

The Secretary may revoke a designation of a drug as a qualified infectious disease product if the Secretary finds that the request for such designation contained an untrue statement of material fact.

(e)

(1)

Not later than 2 years after the date of enactment of the Food and Drug Administration Safety and Innovation Act, the Secretary shall adopt final regulations implementing this section, including developing the list of qualifying pathogens described in subsection (f).

(2)

In promulgating a regulation implementing this section, the Secretary shall—

(A)

issue a notice of proposed rulemaking that includes the proposed regulation;

(B)

provide a period of not less than 60 days for comments on the proposed regulation; and

(C)

publish the final regulation not less than 30 days before the effective date of the regulation.

(3)

Notwithstanding any other provision of law, the Secretary shall promulgate regulations implementing this section only as described in paragraph (2), except that the Secretary may issue interim guidance for sponsors seeking designation under subsection (d) prior to the promulgation of such regulations.

(4)

The Secretary shall designate drugs as qualified infectious disease products under subsection (d) prior to the promulgation of regulations under this subsection, if such drugs meet the definition of a qualified infectious disease product described in subsection (g).

(f)

(1)

In this section, the term qualifying pathogen means a pathogen identified and listed by the Secretary under paragraph (2) that has the potential to pose a serious threat to public health, such as—

(A)

resistant gram positive pathogens, including methicillin-resistant Staphylococcus aureus, vancomycin-resistant Staphylococcus aureus, and vancomycin-resistant enterococcus;

(B)

multi-drug resistant gram negative bacteria, including Acinetobacter, Klebsiella, Pseudomonas, and E. coli species;

(C)

multi-drug resistant tuberculosis; and

(D)

Clostridium difficile.

(2)

(A)

The Secretary shall establish and maintain a list of qualifying pathogens, and shall make public the methodology for developing such list.

(B)

In establishing and maintaining the list of pathogens described under this section, the Secretary shall—

(i)

consider—

(I)

the impact on the public health due to drug-resistant organisms in humans;

(II)

the rate of growth of drug-resistant organisms in humans;

(III)

the increase in resistance rates in humans; and

(IV)

the morbidity and mortality in humans; and

(ii)

consult with experts in infectious diseases and antibiotic resistance, including the Centers for Disease Control and Prevention, the Food and Drug Administration, medical professionals, and the clinical research community.

(C)

Every 5 years, or more often as needed, the Secretary shall review, provide modifications to, and publish the list of qualifying pathogens under subparagraph (A) and shall by regulation revise the list as necessary, in accordance with subsection (e).

(g)

The term qualified infectious disease product means an antibacterial or antifungal drug for human use intended to treat serious or life-threatening infections, including those caused by—

(1)

an antibacterial or antifungal resistant pathogen, including novel or emerging infectious pathogens; or

(2)

qualifying pathogens listed by the Secretary under subsection (f).

(b)

Section 505E of the Federal Food, Drug, and Cosmetic Act, as added by subsection (a), applies only with respect to a drug that is first approved under section 505(c) of such Act (21 U.S.C. 355(c)) on or after the date of the enactment of this Act.

802.

(a)

Chapter V (21 U.S.C. 351 et seq.) is amended by inserting after section 524 the following:

524A.

If the Secretary designates a drug under section 505E(d) as a qualified infectious disease product, then the Secretary shall give priority review to any application submitted for approval for such drug under section 505(b).

(b)

Section 524A of the Federal Food, Drug, and Cosmetic Act, as added by subsection (a), applies only with respect to an application that is submitted under section 505(b) of such Act (21 U.S.C. 355(b)) on or after the date of the enactment of this Act.

803.

Section 506(a)(1) (21 U.S.C. 356(a)(1)), as amended by section 901(b) of this Act, is amended by inserting , or if the Secretary designates the drug as a qualified infectious disease product under section 505E(d) before the period at the end of the first sentence.

804.

(a)

(1)

The Secretary of Health and Human Services (referred to in this section as the Secretary) shall review and, as appropriate, revise not fewer than 3 guidance documents per year, which shall include—

(A)

reviewing the guidance documents of the Food and Drug Administration for the conduct of clinical trials with respect to antibacterial and antifungal drugs; and

(B)

as appropriate, revising such guidance documents to reflect developments in scientific and medical information and technology and to ensure clarity regarding the procedures and requirements for approval of antibacterial and antifungal drugs under chapter V of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 351 et seq.).

(2)

At a minimum, the review under paragraph (1) shall address the appropriate animal models of infection, in vitro techniques, valid microbiological surrogate markers, the use of noninferiority versus superiority trials, trial enrollment, data requirements, and appropriate delta values for noninferiority trials.

(3)

Except to the extent to which the Secretary makes revisions under paragraph (1)(B), nothing in this section shall be construed to repeal or otherwise effect the guidance documents of the Food and Drug Administration.

(b)

(1)

The sponsor of a drug intended to be designated as a qualified infectious disease product may request that the Secretary provide written recommendations for nonclinical and clinical investigations which the Secretary believes may be necessary to be conducted with the drug before such drug may be approved under section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) for use in treating, detecting, preventing, or identifying a qualifying pathogen, as defined in section 505E of such Act.

(2)

If the Secretary has reason to believe that a drug for which a request is made under this subsection is a qualified infectious disease product, the Secretary shall provide the person making the request written recommendations for the nonclinical and clinical investigations which the Secretary believes, on the basis of information available to the Secretary at the time of the request, would be necessary for approval under section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) of such drug for the use described in paragraph (1).

(c)

For purposes of this section, the term qualified infectious disease product has the meaning given such term in section 505E(g) of the Federal Food, Drug, and Cosmetic Act, as added by section 801 of this Act.

805.

(a)

Not later than 5 years after the date of enactment of this Act, the Secretary of Health and Human Services shall, in consultation with the Food and Drug Administration, the Centers for Disease Control and Prevention, and other appropriate agencies, submit to the Committee on Energy and Commerce of the House of Representatives and the Committee on Health, Education, Labor, and Pensions of the Senate a report that contains the following:

(1)

(A)

The number of initial designations of drugs as qualified infectious disease products under section 505E of the Federal Food, Drug, and Cosmetic Act.

(B)

The number of qualified infectious disease products approved under such section 505E.

(C)

Whether such products address the need for antibacterial and antifungal drugs to treat serious and life-threatening infections.

(D)

A list of qualified infectious disease products with information on the types of exclusivity granted for each product, consistent with the information published under section 505(j)(7)(A)(iii) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(7)(A)(iii)).

(E)

The progress made regarding the review and revision of the clinical trial guidance documents required under section 804 and the impact such review and revision has had on the review and approval of qualified infectious disease products.

(F)

The Federal contribution, if any, to funding of the clinical trials for each qualified infectious disease product for each phase.

(2)

Recommendations—

(A)

based on the information under paragraph (1) and any other relevant data, on any changes that should be made to the list of pathogens that are defined as qualifying pathogens under section 505E(f)(2) of the Federal Food, Drug, and Cosmetic Act, as added by section 801 of this Act; and

(B)

on whether any additional program (such as the development of public-private collaborations to advance antibacterial drug innovation) or changes to the incentives under this subtitle may be needed to promote the development of antibacterial drugs.

(3)

An examination of—

(A)

the adoption of programs to measure the use of antibacterial drugs in health care settings; and

(B)

the implementation and effectiveness of antimicrobial stewardship protocols across all health care settings.

(4)

Any recommendations for ways to encourage further development and establishment of stewardship programs.

(5)

A description of the regulatory challenges and impediments to clinical development, approval, and licensure of qualified infectious disease products, and the steps the Secretary has taken and will take to address such challenges and ensure regulatory certainty and predictability with respect to qualified infectious disease products.

(b)

806.

(a)

Not later than June 30, 2013, in order to facilitate the development of antibacterial drugs for serious or life-threatening bacterial infections, particularly in areas of unmet need, the Secretary of Health and Human Services shall publish draft guidance that—

(1)

specifies how preclinical and clinical data can be utilized to inform an efficient and streamlined pathogen-focused antibacterial drug development program that meets the approval standards of the Food and Drug Administration; and

(2)

provides advice on approaches for the development of antibacterial drugs that target a more limited spectrum of pathogens.

(b)

Not later than December 31, 2014, after notice and opportunity for public comment on the draft guidance under subsection (a), the Secretary of Health and Human Services shall publish final guidance consistent with this section.

901.

(a)

(1)

Congress finds as follows:

(A)

The Food and Drug Administration (referred to in this section as the FDA) serves a critical role in helping to assure that new medicines are safe and effective. Regulatory innovation is 1 element of the Nation’s strategy to address serious and life-threatening diseases or conditions by promoting investment in and development of innovative treatments for unmet medical needs.

(B)

During the 2 decades following the establishment of the accelerated approval mechanism, advances in medical sciences, including genomics, molecular biology, and bioinformatics, have provided an unprecedented understanding of the underlying biological mechanism and pathogenesis of disease. A new generation of modern, targeted medicines is under development to treat serious and life-threatening diseases, some applying drug development strategies based on biomarkers or pharmacogenomics, predictive toxicology, clinical trial enrichment techniques, and novel clinical trial designs, such as adaptive clinical trials.

(C)

As a result of these remarkable scientific and medical advances, the FDA should be encouraged to implement more broadly effective processes for the expedited development and review of innovative new medicines intended to address unmet medical needs for serious or life-threatening diseases or conditions, including those for rare diseases or conditions, using a broad range of surrogate or clinical endpoints and modern scientific tools earlier in the drug development cycle when appropriate. This may result in fewer, smaller, or shorter clinical trials for the intended patient population or targeted subpopulation without compromising or altering the high standards of the FDA for the approval of drugs.

(D)

Patients benefit from expedited access to safe and effective innovative therapies to treat unmet medical needs for serious or life-threatening diseases or conditions.

(E)

For these reasons, the statutory authority in effect on the day before the date of enactment of this Act governing expedited approval of drugs for serious or life-threatening diseases or conditions should be amended in order to enhance the authority of the FDA to consider appropriate scientific data, methods, and tools, and to expedite development and access to novel treatments for patients with a broad range of serious or life-threatening diseases or conditions.

(2)

It is the sense of Congress that the Food and Drug Administration should apply the accelerated approval and fast track provisions set forth in section 506 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 356), as amended by this section, to help expedite the development and availability to patients of treatments for serious or life-threatening diseases or conditions while maintaining safety and effectiveness standards for such treatments.

(b)

Section 506 (21 U.S.C. 356) is amended to read as follows:

506.

(a)

(1)

The Secretary shall, at the request of the sponsor of a new drug, facilitate the development and expedite the review of such drug if it is intended, whether alone or in combination with one or more other drugs, for the treatment of a serious or life-threatening disease or condition, and it demonstrates the potential to address unmet medical needs for such a disease or condition. (In this section, such a drug is referred to as a fast track product.)

(2)

The sponsor of a new drug may request the Secretary to designate the drug as a fast track product. A request for the designation may be made concurrently with, or at any time after, submission of an application for the investigation of the drug under section 505(i) or section 351(a)(3) of the Public Health Service Act.

(3)

Within 60 calendar days after the receipt of a request under paragraph (2), the Secretary shall determine whether the drug that is the subject of the request meets the criteria described in paragraph (1). If the Secretary finds that the drug meets the criteria, the Secretary shall designate the drug as a fast track product and shall take such actions as are appropriate to expedite the development and review of the application for approval of such product.

(b)

(1)

(A)

The Secretary may approve an application for approval of a product for a serious or life-threatening disease or condition, including a fast track product, under section 505(c) or section 351(a) of the Public Health Service Act upon a determination that the product has an effect on a surrogate endpoint that is reasonably likely to predict clinical benefit, or on a clinical endpoint that can be measured earlier than irreversible morbidity or mortality, that is reasonably likely to predict an effect on irreversible morbidity or mortality or other clinical benefit, taking into account the severity, rarity, or prevalence of the condition and the availability or lack of alternative treatments. The approval described in the preceding sentence is referred to in this section as accelerated approval.

(B)

The evidence to support that an endpoint is reasonably likely to predict clinical benefit under subparagraph (A) may include epidemiological, pathophysiological, therapeutic, pharmacologic, or other evidence developed using biomarkers, for example, or other scientific methods or tools.

(2)

Approval of a product under this subsection may be subject to 1 or both of the following requirements:

(A)

That the sponsor conduct appropriate postapproval studies to verify and describe the predicted effect on irreversible morbidity or mortality or other clinical benefit.

(B)

That the sponsor submit copies of all promotional materials related to the product during the preapproval review period and, following approval and for such period thereafter as the Secretary determines to be appropriate, at least 30 days prior to dissemination of the materials.

(3)

The Secretary may withdraw approval of a product approved under accelerated approval using expedited procedures (as prescribed by the Secretary in regulations which shall include an opportunity for an informal hearing) if—

(A)

the sponsor fails to conduct any required postapproval study of the drug with due diligence;

(B)

a study required to verify and describe the predicted effect on irreversible morbidity or mortality or other clinical benefit of the product fails to verify and describe such effect or benefit;

(C)

other evidence demonstrates that the product is not safe or effective under the conditions of use; or

(D)

the sponsor disseminates false or misleading promotional materials with respect to the product.

(c)

(1)

If the Secretary determines, after preliminary evaluation of clinical data submitted by the sponsor, that a fast track product may be effective, the Secretary shall evaluate for filing, and may commence review of portions of, an application for the approval of the product before the sponsor submits a complete application. The Secretary shall commence such review only if the applicant—

(A)

provides a schedule for submission of information necessary to make the application complete; and

(B)

pays any fee that may be required under section 736.

(2)

Any time period for review of human drug applications that has been agreed to by the Secretary and that has been set forth in goals identified in letters of the Secretary (relating to the use of fees collected under section 736 to expedite the drug development process and the review of human drug applications) shall not apply to an application submitted under paragraph (1) until the date on which the application is complete.

(d)

The Secretary shall—

(1)

develop and disseminate to physicians, patient organizations, pharmaceutical and biotechnology companies, and other appropriate persons a description of the provisions of this section applicable to accelerated approval and fast track products; and

(2)

establish a program to encourage the development of surrogate and clinical endpoints, including biomarkers, and other scientific methods and tools that can assist the Secretary in determining whether the evidence submitted in an application is reasonably likely to predict clinical benefit for serious or life-threatening conditions for which significant unmet medical needs exist.

(e)

(1)

The amendments made by the Food and Drug Administration Safety and Innovation Act to this section are intended to encourage the Secretary to utilize innovative and flexible approaches to the assessment of products under accelerated approval for treatments for patients with serious or life-threatening diseases or conditions and unmet medical needs.

(2)

Nothing in this section shall be construed to alter the standards of evidence under subsection (c) or (d) of section 505 (including the substantial evidence standard in section 505(d)) of this Act or under section 351(a) of the Public Health Service Act. Such sections and standards of evidence apply to the review and approval of products under this section, including whether a product is safe and effective. Nothing in this section alters the ability of the Secretary to rely on evidence that does not come from adequate and well-controlled investigations for the purpose of determining whether an endpoint is reasonably likely to predict clinical benefit as described in subsection (b)(1)(B).

(c)

(1)

Not later than 1 year after the date of enactment of this Act, the Secretary of Health and Human Services (referred to in this section as the Secretary) shall issue draft guidance to implement the amendments made by this section. In developing such guidance, the Secretary shall specifically consider issues arising under the accelerated approval and fast track processes under section 506 of the Federal Food, Drug, and Cosmetic Act, as amended by subsection (b), for drugs designated for a rare disease or condition under section 526 of such Act (21 U.S.C. 360bb) and shall also consider any unique issues associated with very rare diseases.

(2)

Not later than 1 year after the issuance of draft guidance under paragraph (1), and after an opportunity for public comment, the Secretary shall—

(A)

issue final guidance; and

(B)

amend the regulations governing accelerated approval in parts 314 and 601 of title 21, Code of Federal Regulations, as necessary to conform such regulations with the amendment made by subsection (b).

(3)

In developing the guidance under paragraphs (1) and (2)(A) and the amendments under paragraph (2)(B), the Secretary shall consider how to incorporate novel approaches to the review of surrogate endpoints based on pathophysiologic and pharmacologic evidence in such guidance, especially in instances where the low prevalence of a disease renders the existence or collection of other types of data unlikely or impractical.

(4)

The Secretary shall issue, as necessary, conforming amendments to the applicable regulations under title 21, Code of Federal Regulations, governing accelerated approval.

(5)

The issuance (or nonissuance) of guidance or conforming regulations implementing the amendment made by subsection (b) shall not preclude the review of, or action on, a request for designation or an application for approval submitted pursuant to section 506 of the Federal Food, Drug, and Cosmetic Act, as amended by subsection (b).

(d)

The Secretary may, in conjunction with other planned reviews, contract with an independent entity with expertise in assessing the quality and efficiency of biopharmaceutical development and regulatory review programs to evaluate the Food and Drug Administration’s application of the processes described in section 506 of the Federal Food, Drug, and Cosmetic Act, as amended by subsection (b), and the impact of such processes on the development and timely availability of innovative treatments for patients suffering from serious or life-threatening conditions. Any such evaluation shall include consultation with regulated industries, patient advocacy and disease research foundations, and relevant academic medical centers.

902.

(a)

Section 506 (21 U.S.C. 356), as amended by section 901 of this Act, is further amended—

(1)

by redesignating subsections (a) through (c) as subsections (b) through (d), respectively;

(2)

by redesignating subsection (d) as subsection (f);

(3)

by inserting before subsection (b), as so redesignated, the following:

(a)

(1)

The Secretary shall, at the request of the sponsor of a drug, expedite the development and review of such drug if the drug is intended, alone or in combination with 1 or more other drugs, to treat a serious or life-threatening disease or condition and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over existing therapies on 1 or more clinically significant endpoints, such as substantial treatment effects observed early in clinical development. (In this section, such a drug is referred to as a breakthrough therapy.)

(2)

The sponsor of a drug may request the Secretary to designate the drug as a breakthrough therapy. A request for the designation may be made concurrently with, or at any time after, the submission of an application for the investigation of the drug under section 505(i) or section 351(a)(3) of the Public Health Service Act.

(3)

(A)

Not later than 60 calendar days after the receipt of a request under paragraph (2), the Secretary shall determine whether the drug that is the subject of the request meets the criteria described in paragraph (1). If the Secretary finds that the drug meets the criteria, the Secretary shall designate the drug as a breakthrough therapy and shall take such actions as are appropriate to expedite the development and review of the application for approval of such drug.

(B)

The actions to expedite the development and review of an application under subparagraph (A) may include, as appropriate—

(i)

holding meetings with the sponsor and the review team throughout the development of the drug;

(ii)

providing timely advice to, and interactive communication with, the sponsor regarding the development of the drug to ensure that the development program to gather the nonclinical and clinical data necessary for approval is as efficient as practicable;

(iii)

involving senior managers and experienced review staff, as appropriate, in a collaborative, cross-disciplinary review;

(iv)

assigning a cross-disciplinary project lead for the Food and Drug Administration review team to facilitate an efficient review of the development program and to serve as a scientific liaison between the review team and the sponsor; and

(v)

taking steps to ensure that the design of the clinical trials is as efficient as practicable, when scientifically appropriate, such as by minimizing the number of patients exposed to a potentially less efficacious treatment.

; and

(4)

in subsection (f)(1), as so redesignated, by striking applicable to accelerated approval and inserting applicable to breakthrough therapies, accelerated approval, and.

(b)

(1)

(A)

Not later than 18 months after the date of enactment of this Act, the Secretary of Health and Human Services (referred to in this section as the Secretary) shall issue draft guidance on implementing the requirements with respect to breakthrough therapies, as set forth in section 506(a) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 356(a)), as amended by this section. The Secretary shall issue final guidance not later than 1 year after the close of the comment period for the draft guidance.

(B)

(i)

If the Secretary determines that it is necessary to amend the regulations under title 21, Code of Federal Regulations in order to implement the amendments made by this section to section 506(a) of the Federal Food, Drug, and Cosmetic Act, the Secretary shall amend such regulations not later than 2 years after the date of enactment of this Act.

(ii)

In amending regulations under clause (i), the Secretary shall—

(I)

issue a notice of proposed rulemaking that includes the proposed regulation;

(II)

provide a period of not less than 60 days for comments on the proposed regulation; and

(III)

publish the final regulation not less than 30 days before the effective date of the regulation.

(iii)

Notwithstanding any other provision of law, the Secretary shall promulgate regulations implementing the amendments made by this section only as described in clause (ii).

(2)

Guidance issued under this section shall—

(A)

specify the process and criteria by which the Secretary makes a designation under section 506(a)(3) of the Federal Food, Drug, and Cosmetic Act; and

(B)

specify the actions the Secretary shall take to expedite the development and review of a breakthrough therapy pursuant to such designation under such section 506(a)(3), including updating good review management practices to reflect breakthrough therapies.

(c)

Section 506B(e) (21 U.S.C. 356b) is amended by striking section 506(b)(2)(A) each place such term appears and inserting section 506(c)(2)(A).

903.

Subchapter E of chapter V (21 U.S.C. 360bbb et seq.), as amended by section 715 of this Act, is further amended by adding at the end the following:

569.

(a)

For the purpose of promoting the efficiency of and informing the review by the Food and Drug Administration of new drugs and biological products for rare diseases and drugs and biological products that are genetically targeted, the following shall apply:

(1)

Consistent with sections X.C and IX.E.4 of the PDUFA Reauthorization Performance Goals and Procedures Fiscal Years 2013 through 2017, as referenced in the letters described in section 101(b) of the Prescription Drug User Fee Amendments of 2012, the Secretary shall ensure that opportunities exist, at a time the Secretary determines appropriate, for consultations with stakeholders on the topics described in subsection (b).

(2)

(A)

The Secretary shall develop and maintain a list of external experts who, because of their special expertise, are qualified to provide advice on rare disease issues, including topics described in subsection (c). The Secretary may, when appropriate to address a specific regulatory question, consult such external experts on issues related to the review of new drugs and biological products for rare diseases and drugs and biological products that are genetically targeted, including the topics described in subsection (b), when such consultation is necessary because the Secretary lacks the specific scientific, medical, or technical expertise necessary for the performance of the Secretary’s regulatory responsibilities and the necessary expertise can be provided by the external experts.

(B)

For purposes of subparagraph (A), external experts are individuals who possess scientific or medical training that the Secretary lacks with respect to one or more rare diseases.

(b)

Topics for consultation pursuant to this section may include—

(1)

rare diseases;

(2)

the severity of rare diseases;

(3)

the unmet medical need associated with rare diseases;

(4)

the willingness and ability of individuals with a rare disease to participate in clinical trials;

(5)

an assessment of the benefits and risks of therapies to treat rare diseases;

(6)

the general design of clinical trials for rare disease populations and subpopulations; and

(7)

the demographics and the clinical description of patient populations.

(c)

The external experts who are consulted under this section may be considered special government employees, as defined under section 202 of title 18, United States Code.

(d)

(1)

Nothing in this section shall be construed to alter the protections offered by laws, regulations, and policies governing disclosure of confidential commercial or trade secret information, and any other information exempt from disclosure pursuant to section 552(b) of title 5, United States Code, as such provisions would be applied to consultation with individuals and organizations prior to the date of enactment of this section.

(2)

The Secretary shall not disclose confidential commercial or trade secret information to an expert consulted under this section without the written consent of the sponsor unless the expert is a special government employee (as defined under section 202 of title 18, United States Code) or the disclosure is otherwise authorized by law.

(e)

Nothing in this section shall be construed to limit the ability of the Secretary to consult with individuals and organizations as authorized prior to the date of enactment of this section.

(f)

(1)

Nothing in this section shall be construed to create a legal right for a consultation on any matter or require the Secretary to meet with any particular expert or stakeholder.

(2)

Nothing in this section shall be construed to alter agreed upon goals and procedures identified in the letters described in section 101(b) of the Prescription Drug User Fee Amendments of 2012.

(3)

Nothing in this section is intended to increase the number of review cycles as in effect before the date of enactment of this section.

(g)

(1)

Prior to a consultation with an external expert, as described in this section, relating to an investigational new drug application under section 505(i), a new drug application under section 505(b), or a biologics license application under section 351 of the Public Health Service Act, the Director of the Center for Drug Evaluation and Research or the Director of the Center for Biologics Evaluation and Research (or appropriate Division Director), as appropriate, shall determine that—

(A)

such consultation will—

(i)

facilitate the Secretary’s ability to complete the Secretary’s review; and

(ii)

address outstanding deficiencies in the application; or

(B)

the sponsor authorized such consultation.

(2)

The requirements of this subsection shall apply only in instances where the consultation is undertaken solely under the authority of this section. The requirements of this subsection shall not apply to any consultation initiated under any other authority.

904.

(a)

(1)

The Architectural and Transportation Barriers Compliance Board (referred to in this section as the Access Board) shall convene a stakeholder working group (referred to in this section as the working group) to develop best practices on access to information on prescription drug container labels for individuals who are blind or visually impaired.

(2)

The working group shall be comprised of representatives of national organizations representing blind and visually impaired individuals, national organizations representing the elderly, and industry groups representing stakeholders, including retail, mail-order, and independent community pharmacies, who would be impacted by such best practices. Representation within the working group shall be divided equally between consumer and industry advocates.

(3)

(A)

The working group shall develop, not later than 1 year after the date of the enactment of this Act, best practices for pharmacies to ensure that blind and visually impaired individuals have safe, consistent, reliable, and independent access to the information on prescription drug container labels.

(B)

The best practices developed under subparagraph (A) may be made publicly available, including through the Internet Web sites of the working group participant organizations, and through other means, in a manner that provides access to interested individuals, including individuals with disabilities.

(C)

The best practices developed under subparagraph (A) shall not be construed as accessibility guidelines or standards of the Access Board, and shall not confer any rights or impose any obligations on working group participants or other persons. Nothing in this section shall be construed to limit or condition any right, obligation, or remedy available under the Americans with Disabilities Act of 1990 (42 U.S.C. 12101 et seq.) or any other Federal or State law requiring effective communication, barrier removal, or nondiscrimination on the basis of disability.

(4)

In developing and issuing the best practices under paragraph (3)(A), the working group shall consider—

(A)

the use of—

(i)

Braille;

(ii)

auditory means, such as—

(I)

talking bottles that provide audible container label information;

(II)

digital voice recorders attached to the prescription drug container; and

(III)

radio frequency identification tags;

(iii)

enhanced visual means, such as—

(I)

large font labels or large font duplicate labels that are affixed or matched to a prescription drug container;

(II)

high-contrast printing; and

(III)

sans-serif font; and

(iv)

other relevant alternatives as determined by the working group;

(B)

whether there are technical, financial, manpower, or other factors unique to pharmacies with 20 or fewer retail locations which may pose significant challenges to the adoption of the best practices; and

(C)

such other factors as the working group determines to be appropriate.

(5)

Upon completion of development of the best practices under subsection (a)(3), the National Council on Disability, in consultation with the working group, shall conduct an informational and educational campaign designed to inform individuals with disabilities, pharmacists, and the public about such best practices.

(6)

The Federal Advisory Committee Act (5 U.S.C. App.) shall not apply to the working group.

(b)

(1)

Beginning 18 months after the completion of the development of best practices under subsection (a)(3)(A), the Comptroller General of the United States shall conduct a review of the extent to which pharmacies are utilizing such best practices, and the extent to which barriers to accessible information on prescription drug container labels for blind and visually impaired individuals continue.

(2)

Not later than September 30, 2016, the Comptroller General of the United States shall submit to Congress a report on the review conducted under paragraph (1). Such report shall include recommendations about how best to reduce the barriers experienced by blind and visually impaired individuals to independently accessing information on prescription drug container labels.

(c)

In this section—

(1)

the term pharmacy includes a pharmacy that receives prescriptions and dispenses prescription drugs through an Internet Web site or by mail;

(2)

the term prescription drug means a drug subject to section 503(b)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 353(b)(1)); and

(3)

the term prescription drug container label means the label with the directions for use that is affixed to the prescription drug container by the pharmacist and dispensed to the consumer.

905.

Section 505(d) (21 U.S.C. 355(d)) is amended by adding at the end the following: The Secretary shall implement a structured risk-benefit assessment framework in the new drug approval process to facilitate the balanced consideration of benefits and risks, a consistent and systematic approach to the discussion and regulatory decisionmaking, and the communication of the benefits and risks of new drugs. Nothing in the preceding sentence shall alter the criteria for evaluating an application for premarket approval of a drug..

906.

(a)

Section 5(b)(1)(A)(ii) of the Orphan Drug Act (21 U.S.C. 360ee(b)(1)(A)(ii)) is amended by striking after the date such drug is designated under section 526 of such Act and.

(b)

Section 5(c) of the Orphan Drug Act (21 U.S.C. 360ee(c)) is amended to read as follows:

(c)

For grants and contracts under subsection (a), there is authorized to be appropriated $30,000,000 for each of fiscal years 2013 through 2017.

907.

(a)

(1)

Not later than 1 year after the date of enactment of this Act, the Secretary, acting through the Commissioner, shall publish on the Internet Web site of the Food and Drug Administration a report, consistent with the regulations of the Food and Drug Administration pertaining to the protection of sponsors' confidential commercial information as of the date of enactment of this Act, addressing the extent to which clinical trial participation and the inclusion of safety and effectiveness data by demographic subgroups including sex, age, race, and ethnicity, is included in applications submitted to the Food and Drug Administration, and shall provide such publication to Congress.

(2)

The report described in paragraph (1) shall contain the following:

(A)

A description of existing tools to ensure that data to support demographic analyses are submitted in applications for drugs, biological products, and devices, and that these analyses are conducted by applicants consistent with applicable Food and Drug Administration requirements and Guidance for Industry. The report shall address how the Food and Drug Administration makes available information about differences in safety and effectiveness of medical products according to demographic subgroups, such as sex, age, racial, and ethnic subgroups, to health care providers, researchers, and patients.

(B)

An analysis of the extent to which demographic data subset analyses on sex, age, race, and ethnicity is presented in applications for new drug applications for new molecular entities under section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355), in biologics license applications under section 351 of the Public Health Service Act (42 U.S.C. 262), and in premarket approval applications under section 515 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360e) for products approved or licensed by the Food and Drug Administration, consistent with applicable requirements and Guidance for Industry, and consistent with the regulations of the Food and Drug Administration pertaining to the protection of sponsors' confidential commercial information as of the date of enactment of this Act.

(C)

An analysis of the extent to which demographic subgroups, including sex, age, racial, and ethnic subgroups, are represented in clinical studies to support applications for approved or licensed new molecular entities, biological products, and devices.

(D)

An analysis of the extent to which a summary of product safety and effectiveness data by demographic subgroups including sex, age, race, and ethnicity is readily available to the public in a timely manner by means of the product labeling or the Food and Drug Administration's Internet Web site.

(b)

(1)

Not later than 1 year after the publication of the report described in subsection (a), the Secretary, acting through the Commissioner, shall publish an action plan on the Internet Web site of the Food and Drug Administration, and provide such publication to Congress.

(2)

The plan described in paragraph (1) shall include—

(A)

recommendations, as appropriate, to improve the completeness and quality of analyses of data on demographic subgroups in summaries of product safety and effectiveness data and in labeling;

(B)

recommendations, as appropriate, on the inclusion of such data, or the lack of availability of such data in labeling;

(C)

recommendations, as appropriate, to otherwise improve the public availability of such data to patients, health care providers, and researchers; and

(D)

a determination with respect to each recommendation identified in subparagraphs (A) through (C) that distinguishes between product types referenced in subsection (a)(2)(B) insofar as the applicability of each such recommendation to each type of product.

(c)

In this section:

(1)

The term Commissioner means the Commissioner of Food and Drugs.

(2)

The term device has the meaning given such term in section 201(h) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321(h)).

(3)

The term drug has the meaning given such term in section 201(g) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321(g)).

(4)

The term biological product has the meaning given such term in section 351(i) of the Public Health Service Act (42 U.S.C. 262(i)).

(5)

The term Secretary means the Secretary of Health and Human Services.

908.

Subchapter B of chapter V (21 U.S.C. 360aa et seq.) is amended by adding at the end the following:

529.

(a)

In this section:

(1)

The term priority review, with respect to a human drug application as defined in section 735(1), means review and action by the Secretary on such application not later than 6 months after receipt by the Secretary of such application, as described in the Manual of Policies and Procedures of the Food and Drug Administration and goals identified in the letters described in section 101(b) of the Prescription Drug User Fee Amendments of 2012.

(2)

The term priority review voucher means a voucher issued by the Secretary to the sponsor of a rare pediatric disease product application that entitles the holder of such voucher to priority review of a single human drug application submitted under section 505(b)(1) or section 351(a) of the Public Health Service Act after the date of approval of the rare pediatric disease product application.

(3)

The term rare pediatric disease means a disease that meets each of the following criteria:

(A)

The disease primarily affects individuals aged from birth to 18 years, including age groups often called neonates, infants, children, and adolescents.

(B)

The disease is a rare disease or condition, within the meaning of section 526.

(4)

The term rare pediatric disease product application means a human drug application, as defined in section 735(1), that—

(A)

is for a drug or biological product—

(i)

that is for the prevention or treatment of a rare pediatric disease; and

(ii)

that contains no active ingredient (including any ester or salt of the active ingredient) that has been previously approved in any other application under section 505(b)(1), 505(b)(2), or 505(j) of this Act or section 351(a) or 351(k) of the Public Health Service Act;

(B)

is submitted under section 505(b)(1) of this Act or section 351(a) of the Public Health Service Act;

(C)

the Secretary deems eligible for priority review;

(D)

that relies on clinical data derived from studies examining a pediatric population and dosages of the drug intended for that population;

(E)

that does not seek approval for an adult indication in the original rare pediatric disease product application; and

(F)

is approved after the date of the enactment of the Prescription Drug User Fee Amendments of 2012.

(b)

(1)

The Secretary shall award a priority review voucher to the sponsor of a rare pediatric disease product application upon approval by the Secretary of such rare pediatric disease product application.

(2)

(A)

The sponsor of a rare pediatric disease product application that receives a priority review voucher under this section may transfer (including by sale) the entitlement to such voucher. There is no limit on the number of times a priority review voucher may be transferred before such voucher is used.

(B)

Each person to whom a voucher is transferred shall notify the Secretary of such change in ownership of the voucher not later than 30 days after such transfer.

(3)

A sponsor of a rare pediatric disease product application may not receive a priority review voucher under this section if the rare pediatric disease product application was submitted to the Secretary prior to the date that is 90 days after the date of enactment of the Prescription Drug User Fee Amendments of 2012.

(4)

(A)

The sponsor of a human drug application shall notify the Secretary not later than 90 days prior to submission of the human drug application that is the subject of a priority review voucher of an intent to submit the human drug application, including the date on which the sponsor intends to submit the application. Such notification shall be a legally binding commitment to pay for the user fee to be assessed in accordance with this section.

(B)

The sponsor of a human drug application that provides notification of the intent of such sponsor to use the voucher for the human drug application under subparagraph (A) may transfer the voucher after such notification is provided, if such sponsor has not yet submitted the human drug application described in the notification.

(5)

The Secretary may not award any priority review vouchers under paragraph (1) after the last day of the 1-year period that begins on the date that the Secretary awards the third rare pediatric disease priority voucher under this section.

(c)

(1)

The Secretary shall establish a user fee program under which a sponsor of a human drug application that is the subject of a priority review voucher shall pay to the Secretary a fee determined under paragraph (2). Such fee shall be in addition to any fee required to be submitted by the sponsor under chapter VII.

(2)

The amount of the priority review user fee shall be determined each fiscal year by the Secretary, based on the difference between—

(A)

the average cost incurred by the Food and Drug Administration in the review of a human drug application subject to priority review in the previous fiscal year; and

(B)

the average cost incurred by the Food and Drug Administration in the review of a human drug application that is not subject to priority review in the previous fiscal year.

(3)

The Secretary shall establish, before the beginning of each fiscal year beginning after September 30, 2012, the amount of the priority review user fee for that fiscal year.

(4)

(A)

The priority review user fee required by this subsection shall be due upon the notification by a sponsor of the intent of such sponsor to use the voucher, as specified in subsection (b)(4)(A). All other user fees associated with the human drug application shall be due as required by the Secretary or under applicable law.

(B)

An application described under subparagraph (A) for which the sponsor requests the use of a priority review voucher shall be considered incomplete if the fee required by this subsection and all other applicable user fees are not paid in accordance with the Secretary's procedures for paying such fees.

(C)

The Secretary may not grant a waiver, exemption, reduction, or refund of any fees due and payable under this section.

(5)

Fees collected pursuant to this subsection for any fiscal year—

(A)

shall be deposited and credited as offsetting collections to the account providing appropriations to the Food and Drug Administration; and

(B)

shall not be collected for any fiscal year except to the extent provided in advance in appropriations Acts.

(d)

(1)

Upon the request of the manufacturer or the sponsor of a new drug, the Secretary may designate—

(A)

the new drug as a drug for a rare pediatric disease; and

(B)

the application for the new drug as a rare pediatric disease product application.

(2)

The request for a designation under paragraph (1) shall be made at the same time a request for designation of orphan disease status under section 526 or fast-track designation under section 506 is made. Requesting designation under this subsection is not a prerequisite to receiving a priority review voucher under this section.

(3)

Not later than 60 days after a request is submitted under paragraph (1), the Secretary shall determine whether—

(A)

the disease or condition that is the subject of such request is a rare pediatric disease; and

(B)

the application for the new drug is a rare pediatric disease product application.

(e)

(1)

The Secretary may revoke any priority review voucher awarded under subsection (b) if the rare pediatric disease product for which such voucher was awarded is not marketed in the United States within the 365-day period beginning on the date of the approval of such drug under section 505 of this Act or section 351 of the Public Health Service Act.

(2)

The sponsor of an approved rare pediatric disease product shall submit a report to the Secretary not later than 5 years after the approval of the applicable rare pediatric disease product application. Such report shall provide the following information, with respect to each of the first 4 years after approval of such product:

(A)

The estimated population in the United States suffering from the rare pediatric disease.

(B)

The estimated demand in the United States for such rare pediatric disease product.

(C)

The actual amount of such rare pediatric disease product distributed in the United States.

(f)

(1)

The Secretary shall publish a notice in the Federal Register and on the Internet Web site of the Food and Drug Administration not later than 30 days after the occurrence of each of the following:

(A)

The Secretary issues a priority review voucher under this section.

(B)

The Secretary approves a drug pursuant to an application submitted under section 505(b) of this Act or section 351(a) of the Public Health Service Act for which the sponsor of the application used a priority review voucher under this section.

(2)

If, after the last day of the 1-year period that begins on the date that the Secretary awards the third rare pediatric disease priority voucher under this section, a sponsor of an application submitted under section 505(b) of this Act or section 351(a) of the Public Health Service Act for a drug uses a priority review voucher under this section for such application, the Secretary shall submit to the Committee on Energy and Commerce of the House of Representatives and the Committee on Health, Education, Labor, and Pensions of the Senate a document—

(A)

notifying such Committees of the use of such voucher; and

(B)

identifying the drug for which such priority review voucher is used.

(g)

Nothing in this section precludes a sponsor who seeks a priority review voucher under this section from participating in any other incentive program, including under this Act.

S. 3187 (112^th): Food and Drug Administration Safety and Innovation Act

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S. 3187 (112th): Food and Drug Administration Safety and Innovation Act

This bill has 4 versions. Select a version to view: May 16, 2012: Placed on Calendar in the Senate May 24, 2012: Passed the Senate Jun 20, 2012: Passed the House with an Amendment Jun 27, 2012: Passed Congress

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S. 3187 (112^th): Food and Drug Administration Safety and Innovation Act

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