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H.R. 4764: TRANSPLANT Act of 2020


The text of the bill below is as of Sep 29, 2020 (Reported by House Committee).


IB

Union Calendar No. 449

116th CONGRESS

2d Session

H. R. 4764

[Report No. 116–549]

IN THE HOUSE OF REPRESENTATIVES

October 18, 2019

(for herself, Mr. Bilirakis, and Ms. Pingree) introduced the following bill; which was referred to the Committee on Energy and Commerce

September 29, 2020

Additional sponsors: Mr. Fitzpatrick, Ms. Jackson Lee, Mr. Budd, Mr. Aderholt, Mr. Walden, Mr. Swalwell of California, Mr. Hastings, Mr. Neguse, Mr. Young, Mr. Welch, Mr. Brown of Maryland, Mr. Rouda, Mr. Butterfield, Mr. Crist, Mr. Lowenthal, Mr. Schrader, Mr. Harder of California, Mr. Rush, Mr. Casten of Illinois, Ms. DeGette, Mrs. Axne, Mr. Cartwright, Mr. Grijalva, Mr. McGovern, Ms. Sewell of Alabama, Mr. Hudson, Mr. Waltz, Mr. Aguilar, Mrs. Beatty, Mr. Panetta, Mr. Tiffany, Mrs. Rodgers of Washington, Mr. Stanton, Ms. Omar, Mr. Heck, Mr. Trone, Ms. Craig, Mr. Suozzi, Ms. McCollum, Ms. Dean, Mrs. Napolitano, Mr. Case, Mr. Gottheimer, Mr. Emmer, Mr. Johnson of Georgia, Ms. Brownley of California, Mrs. Wagner, Mrs. Hayes, Mr. Smith of Washington, and Mrs. Murphy of Florida

September 29, 2020

Reported from the Committee on Energy and Commerce; committed to the Committee of the Whole House on the State of the Union and ordered to be printed


A BILL

To reauthorize the Stem Cell Therapeutic and Research Act of 2005, and for other purposes.


1.

Short title

This Act may be cited as the Timely ReAuthorization of Necessary Stem-cell Programs Lends Access to Needed Therapies Act of 2019 or the TRANSPLANT Act of 2019.

2.

Reauthorization of the C.W. Bill Young Cell Transplantation Program

(a)

Advisory council meetings

Subsection (a) of section 379 of the Public Health Service Act (42 U.S.C. 274k) is amended by adding at the end the following new paragraph:

(7)

The Secretary shall convene the Advisory Council at least two times each calendar year.

.

(b)

Increasing collection

(1)

Technical clarification

Effective as if included in the enactment of Public Law 114–104 (the Stem Cell Therapeutic and Research Reauthorization Act of 2015), the amendment to section 379(d)(2)(B) of the Public Health Service Act (42 U.S.C. 274k(d)(2)(B)) in section 2(a)(2) of Public Law 114–104 is amended by inserting goal of increasing collections of high quality before cord blood units,.

(2)

Eliminating deadwood

Subparagraph (B) of section 379(d)(2) of the Public Health Service Act (42 U.S.C. 274k(d)(2)) is amended by striking the second and third sentences in such subparagraph.

(c)

Periodic review of state of science

Section 379 of the Public Health Service Act (42 U.S.C. 274k) is amended by adding at the end the following new subsection:

(o)

Periodic review of state of science

(1)

Review

Not less than every two years, the Secretary, in consultation with the Director of the National Institutes of Health, the Commissioner of Food and Drugs, the Administrator of the Health Resources and Services Administration, the Advisory Council, and other stakeholders, where appropriate given relevant expertise, shall conduct a review of the state of the science of using adult stem cells and birthing tissues to develop new types of therapies for patients, for the purpose of considering the potential inclusion of such new types of therapies in the Program.

(2)

Recommendations

Not later than June 30, 2024, the Secretary shall—

(A)

complete the second review required by paragraph (1); and

(B)

informed by such review, 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 recommendations on the appropriateness of the inclusion of new types of therapies in the Program.

.

(d)

Authorization of appropriations

Section 379B of the Public Health Service Act (42 U.S.C. 274m) is amended by striking $33,000,000 for fiscal year 2015 and $30,000,000 for each of fiscal years 2016 through 2020 and inserting $30,000,000 for each of fiscal years 2021 through 2025.

3.

Cord blood inventory

Subsection (g) of section 2 of the Stem Cell Therapeutic and Research Act of 2005 (42 U.S.C. 274k note) is amended to read as follows:

(g)

Authorization of appropriations

To carry out this section, there is authorized to be appropriated $23,000,000 for each of fiscal years 2021 through 2025.

.

September 29, 2020

Reported from the Committee on Energy and Commerce; committed to the Committee of the Whole House on the State of the Union and ordered to be printed