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S. 252 (113th): PREEMIE Reauthorization Act


The text of the bill below is as of Nov 19, 2013 (Passed Congress).


One Hundred Thirteenth Congress of the United States of America

1st Session

S. 252

IN THE SENATE OF THE UNITED STATES

AN ACT

To reduce preterm labor and delivery and the risk of pregnancy-related deaths and complications due to pregnancy, and to reduce infant mortality caused by prematurity, and for other purposes.

1.

Table of contents

The table of contents for this Act is as follows:

Sec. 1. Table of contents.

Title I—PREEMIE Act Reauthorization

Sec. 101. Short title.

Sec. 102. Research and activities at the Centers for Disease Control and Prevention.

Sec. 103. Activities at the Health Resources and Services Administration.

Sec. 104. Other activities.

Title II—National Pediatric Research Network

Sec. 201. Short title.

Sec. 202. National Pediatric Research Network.

Title III—CHIMP Act Amendments

Sec. 301. Short title.

Sec. 302. Care for NIH chimpanzees.

I

PREEMIE Act Reauthorization

101.

Short title

This title may be cited as the Prematurity Research Expansion and Education for Mothers who deliver Infants Early Reauthorization Act or the PREEMIE Reauthorization Act .

102.

Research and activities at the Centers for Disease Control and Prevention

(a)

Epidemiological studies

Section 3 of the Prematurity Research Expansion and Education for Mothers who deliver Infants Early Act ( 42 U.S.C. 247b–4f ) is amended by striking subsection (b) and inserting the following:

(b)

Studies and Activities on Preterm Birth

(1)

In general

The Secretary of Health and Human Services, acting through the Director of the Centers for Disease Control and Prevention, may, subject to the availability of appropriations—

(A)

conduct epidemiological studies on the clinical, biological, social, environmental, genetic, and behavioral factors relating to prematurity, as appropriate;

(B)

conduct activities to improve national data to facilitate tracking the burden of preterm birth; and

(C)

continue efforts to prevent preterm birth, including late preterm birth, through the identification of opportunities for prevention and the assessment of the impact of such efforts.

(2)

Report

Not later than 2 years after the date of enactment of the PREEMIE Reauthorization Act, and every 2 years thereafter, the Secretary of Health and Human Services, acting through the Director of the Centers for Disease Control and Prevention, shall submit to the appropriate committees of Congress reports concerning the progress and any results of studies conducted under paragraph (1).

.

(b)

Reauthorization

Section 3(e) of the Prematurity Research Expansion and Education for Mothers who deliver Infants Early Act (42 U.S.C. 247b–4f(e)) is amended by striking $5,000,000 and all that follows through 2011. and inserting $1,880,000 for each of fiscal years 2014 through 2018. .

103.

Activities at the Health Resources and Services Administration

(a)

Telemedicine and high-Risk pregnancies

Section 330I(i)(1)(B) of the Public Health Service Act ( 42 U.S.C. 254c–14(i)(1)(B) ) is amended by striking or case management services and inserting case management services, or prenatal care for high-risk pregnancies ;

(b)

Public and health care provider education

Section 399Q of the Public Health Service Act ( 42 U.S.C. 280g–5 ) is amended—

(1)

in subsection (b)—

(A)

in paragraph (1), by striking subparagraphs (A) through (F) and inserting the following:

(A)

the core risk factors for preterm labor and delivery;

(B)

medically indicated deliveries before full term;

(C)

the importance of preconception and prenatal care, including—

(i)

smoking cessation;

(ii)

weight maintenance and good nutrition, including folic acid;

(iii)

the screening for and the treatment of infections; and

(iv)

stress management;

(D)

treatments and outcomes for premature infants, including late preterm infants;

(E)

the informational needs of families during the stay of an infant in a neonatal intensive care unit; and

(F)

utilization of evidence-based strategies to prevent birth injuries;

; and

(B)

by striking paragraph (2) and inserting the following:

(2)

programs to increase the availability, awareness, and use of pregnancy and post-term information services that provide evidence-based, clinical information through counselors, community outreach efforts, electronic or telephonic communication, or other appropriate means regarding causes associated with prematurity, birth defects, or health risks to a post-term infant;

; and

(2)

in subsection (c), by striking $5,000,000 and all that follows through 2011. and inserting $1,900,000 for each of fiscal years 2014 through 2018. .

104.

Other activities

(a)

Interagency Coordinating Council on Prematurity and Low Birthweight

The Prematurity Research Expansion and Education for Mothers who deliver Infants Early Act is amended by striking section 5 ( 42 U.S.C. 247b–4g ).

(b)

Advisory Committee on Infant Mortality

(1)

Establishment

The Secretary of Health and Human Services (referred to in this section as the Secretary ) may establish an advisory committee known as the Advisory Committee on Infant Mortality (referred to in this section as the Advisory Committee ).

(2)

Duties

The Advisory Committee shall provide advice and recommendations to the Secretary concerning the following activities:

(A)

Programs of the Department of Health and Human Services that are directed at reducing infant mortality and improving the health status of pregnant women and infants.

(B)

Strategies to coordinate the various Federal programs and activities with State, local, and private programs and efforts that address factors that affect infant mortality.

(C)

Implementation of the Healthy Start program under section 330H of the Public Health Service Act ( 42 U.S.C. 254c–8 ) and Healthy People 2020 infant mortality objectives.

(D)

Strategies to reduce preterm birth rates through research, programs, and education.

(3)

Plan for HHS preterm birth activities

Not later than 1 year after the date of enactment of this section, the Advisory Committee (or an advisory committee in existence as of the date of enactment of this Act and designated by the Secretary) shall develop a plan for conducting and supporting research, education, and programs on preterm birth through the Department of Health and Human Services and shall periodically review and revise the plan, as appropriate. The plan shall—

(A)

examine research and educational activities that receive Federal funding in order to enable the plan to provide informed recommendations to reduce preterm birth and address racial and ethnic disparities in preterm birth rates;

(B)

identify research gaps and opportunities to implement evidence-based strategies to reduce preterm birth rates among the programs and activities of the Department of Health and Human Services regarding preterm birth, including opportunities to minimize duplication; and

(C)

reflect input from a broad range of scientists, patients, and advocacy groups, as appropriate.

(4)

Membership

The Secretary shall ensure that the membership of the Advisory Committee includes the following:

(A)

Representatives provided for in the original charter of the Advisory Committee.

(B)

A representative of the National Center for Health Statistics.

(c)

Patient Safety Studies and report

(1)

In general

The Secretary shall designate an appropriate agency within the Department of Health and Human Services to coordinate existing studies on hospital readmissions of preterm infants.

(2)

Report to Secretary and Congress

Not later than 1 year after the date of the enactment of this Act, the agency designated under paragraph (1) shall submit to the Secretary and to Congress a report containing the findings and recommendations resulting from the studies coordinated under such paragraph, including recommendations for hospital discharge and followup procedures designed to reduce rates of preventable hospital readmissions for preterm infants.

II

National Pediatric Research Network

201.

Short title

This title may be cited as the National Pediatric Research Network Act of 2013 .

202.

National Pediatric Research Network

Section 409D of the Public Health Service Act ( 42 U.S.C. 284h ; relating to the Pediatric Research Initiative) is amended—

(1)

by redesignating subsection (d) as subsection (f); and

(2)

by inserting after subsection (c) the following:

(d)

National Pediatric Research Network

(1)

Network

In carrying out the Initiative, the Director of NIH, in consultation with the Director of the Eunice Kennedy Shriver National Institute of Child Health and Human Development and in collaboration with other appropriate national research institutes and national centers that carry out activities involving pediatric research, may provide for the establishment of a National Pediatric Research Network in order to more effectively support pediatric research and optimize the use of Federal resources. Such National Pediatric Research Network may be comprised of, as appropriate—

(A)

the pediatric research consortia receiving awards under paragraph (2); or

(B)

other consortia, centers, or networks focused on pediatric research that are recognized by the Director of NIH and established pursuant to the authorities vested in the National Institutes of Health by other sections of this Act.

(2)

Pediatric research consortia

(A)

In general

The Director of NIH may award funding, including through grants, contracts, or other mechanisms, to public or private nonprofit entities for providing support for pediatric research consortia, including with respect to—

(i)

basic, clinical, behavioral, or translational research to meet unmet needs for pediatric research; and

(ii)

training researchers in pediatric research techniques in order to address unmet pediatric research needs.

(B)

Research

The Director of NIH shall, as appropriate, ensure that—

(i)

each consortium receiving an award under subparagraph (A) conducts or supports at least one category of research described in subparagraph (A)(i) and collectively such consortia conduct or support such categories of research; and

(ii)

one or more such consortia provide training described in subparagraph (A)(ii).

(C)

Organization of consortium

Each consortium receiving an award under subparagraph (A) shall—

(i)

be formed from a collaboration of cooperating institutions;

(ii)

be coordinated by a lead institution or institutions;

(iii)

agree to disseminate scientific findings, including from clinical trials, rapidly and efficiently, as appropriate, to—

(I)

other consortia;

(II)

the National Institutes of Health;

(III)

the Food and Drug Administration;

(IV)

and other relevant agencies; and

(iv)

meet such requirements as may be prescribed by the Director of NIH.

(D)

Supplement, not supplant

Any support received by a consortium under subparagraph (A) shall be used to supplement, and not supplant, other public or private support for activities authorized to be supported under this paragraph.

(E)

Duration of support

Support of a consortium under subparagraph (A) may be for a period of not to exceed 5 years. Such period may be extended at the discretion of the Director of NIH.

(3)

Coordination of consortia activities

The Director of NIH shall, as appropriate—

(A)

provide for the coordination of activities (including the exchange of information and regular communication) among the consortia established pursuant to paragraph (2); and

(B)

require the periodic preparation and submission to the Director of reports on the activities of each such consortium.

(4)

Assistance with registries

Each consortium receiving an award under paragraph (2)(A) may provide assistance, as appropriate, to the Centers for Disease Control and Prevention for activities related to patient registries and other surveillance systems upon request by the Director of the Centers for Disease Control and Prevention.

(e)

Research on pediatric rare diseases or conditions

In making awards under subsection (d)(2) for pediatric research consortia, the Director of NIH shall ensure that an appropriate number of such awards are awarded to such consortia that agree to—

(1)

consider pediatric rare diseases or conditions, or those related to birth defects; and

(2)

conduct or coordinate one or more multisite clinical trials of therapies for, or approaches to, the prevention, diagnosis, or treatment of one or more pediatric rare diseases or conditions.

.

III

CHIMP Act Amendments

301.

Short title

This title may be cited as the CHIMP Act Amendments of 2013 .

302.

Care for NIH chimpanzees

(a)

In general

Section 404K(g) of the Public Health Service Act ( 42 U.S.C. 283m(g) ) is amended—

(1)

by amending paragraph (1) to read as follows:

(1)

In general

Of the amount appropriated for the National Institutes of Health, there are authorized to be appropriated to carry out this section and for the care, maintenance, and transportation of all chimpanzees otherwise under the ownership or control of the National Institutes of Health, and to enable the National Institutes of Health to operate more efficiently and economically by decreasing the overall Federal cost of providing for the care, maintenance, and transportation of chimpanzees—

(A)

for fiscal year 2014, $12,400,000;

(B)

for fiscal year 2015, $11,650,000;

(C)

for fiscal year 2016, $10,900,000;

(D)

for fiscal year 2017, $10,150,000; and

(E)

for fiscal year 2018, $9,400,000.

;

(2)

by striking paragraph (2);

(3)

by redesignating paragraph (3) as paragraph (2); and

(4)

in paragraph (2), as so redesignated—

(A)

by striking With respect to amounts reserved under paragraph (1) and inserting With respect to amounts authorized to be appropriated by paragraph (1); and

(B)

by striking board of directors and inserting Secretary in consultation with the board of directors.

(b)

GAO study

Not later than 2 years after the date of enactment of this Act, the Comptroller General of the United States shall conduct an independent evaluation, and submit to the appropriate committees of Congress a report, regarding chimpanzees under the ownership or control the National Institutes of Health. Such report shall review and assess—

(1)

the research status of such chimpanzees;

(2)

the cost for the care, maintenance, and transportation of such chimpanzees, including the cost broken down by—

(A)

research or retirement status;

(B)

services included in the care, maintenance, and transportation; and

(C)

location;

(3)

the extent to which matching requirements have been met pursuant to section 404K(e)(4) of the Public Health Service Act ( 42 U.S.C. 283m(e)(4) ); and

(4)

any options for cost savings for the support and maintenance of such chimpanzees.

(c)

Biennial report

Section 404K(g) of the Public Health Service Act ( 42 U.S.C. 283m(g) ) is amended by adding at the end the following:

(3)

Biennial report

Not later than 180 days after the date enactment of this Act, the Director of the National Institutes of Health shall submit to the Committee on Health, Education, Labor, and Pensions and the Committee on Appropriations of the Senate and the Committee on Energy and Commerce and the Committee on Appropriations in the House of Representatives a report, to be updated biennially, regarding—

(A)

the care, maintenance, and transportation of the chimpanzees under the ownership or control of the National Institutes of Health;

(B)

costs related to such care, maintenance, and transportation, and any other related costs; and

(C)

the research status of such chimpanzees.

.

Speaker of the House of Representatives

Vice President of the United States and President of the Senate