S. 1440 – Reading Mode

112th CONGRESS

2d Session

In the House of Representatives, U. S.,

December 19, 2012

AMENDMENTS:

That the bill from the Senate (S. 1440) entitled 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., do pass with the following

Strike out all after the enacting clause and insert:

Short title

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

Table of contents

The table of contents of this Act is as follows:

Sec. 1. Short title.

Sec. 2. Table of contents.

Title I—Prematurity Research Expansion and Education for Mothers who deliver Infants Early

Sec. 101. Research and activities at the Centers for Disease Control and Prevention.

Sec. 102. Activities at the Health Resources and Services Administration.

Sec. 103. Other activities.

Title II—National Pediatric Research Network

Sec. 201. National Pediatric Research Network.

Title III—Children’s Hospital GME Support Reauthorization

Sec. 301. Program of payments to children’s hospitals that operate graduate medical education programs.

Prematurity Research Expansion and Education for Mothers who deliver Infants Early

101.

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 2011 and inserting 2017.

102.

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 2011 and inserting 2017.

103.

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 existing advisory committee 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.

National Pediatric Research Network

201.

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 consisting of the pediatric research consortia receiving awards under paragraph (2).

(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—

(i)

for establishing or strengthening pediatric research consortia; and

(ii)

for providing support for such consortia, including with respect to—

(I)

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

(II)

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

(B)

Research

The Director of NIH may ensure that—

(i)

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

(ii)

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

(C)

Number of consortia

(i)

In general

The Director of NIH may make awards under this paragraph for not more than 8 pediatric research consortia, with a minimum of one pediatric research consortium that prioritizes collaboration with institutions serving rural areas.

(ii)

Exception

Notwithstanding clause (i), the Director of NIH may make awards under this paragraph for more than 8 pediatric research consortia based on a finding of need by the Director. Before making any award pursuant to the preceding sentence, the Director of NIH shall give written notice to the Congress of the Director’s intent to make the award and shall include in the notice an explanation of the Director’s finding of need.

(D)

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;

(iii)

agree to disseminate scientific findings rapidly and efficiently; and

(iv)

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

(E)

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.

(F)

Duration of consortium 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—

(A)

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

(B)

as appropriate, 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) shall provide assistance to the Centers for Disease Control and Prevention in the establishment or expansion of patient registries and other surveillance systems as appropriate and upon request by the Director of the Centers.

(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)

focus primarily on pediatric rare diseases or conditions (including any such diseases or conditions that are genetic disorders or are 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

Children’s Hospital GME Support Reauthorization

301.

Program of payments to children’s hospitals that operate graduate medical education programs

(a)

In general

Section 340E of the Public Health Service Act (42 U.S.C. 256e) is amended—

(1)

in subsection (a), by striking through 2005 and each of fiscal years 2007 through 2011 and inserting through 2005, each of fiscal years 2007 through 2011, and each of fiscal years 2013 through 2017;

(2)

in subsection (f)(1)(A)(iv), by inserting and each of fiscal years 2013 through 2017 after 2011; and

(3)

in subsection (f)(2)(D), by inserting and each of fiscal years 2013 through 2017 after 2011.

(b)

Report to Congress

Section 340E(b)(3)(D) of the Public Health Service Act (42 U.S.C. 256e(b)(3)(D)) is amended by striking Not later than the end of fiscal year 2011 and inserting Not later than the end of fiscal year 2016.

Amend the title so as to read: An Act to reduce preterm labor and delivery and the risk of pregnancy-related deaths and complications due to pregnancy; to reduce infant mortality caused by prematurity; to provide for a National Pediatric Research Network, including with respect to pediatric rare diseases or conditions; and to reauthorize support for graduate medical education programs in children’s hospitals..

Clerk.