One Hundred Thirteenth Congress of the United States of America
1st Session
Begun and held at the City of Washington on Thursday, the third day of January, two thousand and thirteen
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.
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.
PREEMIE Act Reauthorization
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
.
Research and activities at the Centers for Disease Control and Prevention
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:
Studies and Activities on Preterm Birth
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—
conduct epidemiological studies on the clinical, biological, social, environmental, genetic, and behavioral factors relating to prematurity, as appropriate;
conduct activities to improve national data to facilitate tracking the burden of preterm birth; and
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.
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).
.
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.
.
Activities at the Health Resources and Services Administration
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
;
Public and health care provider education
Section 399Q of the Public Health Service Act ( 42 U.S.C. 280g–5 ) is amended—
in subsection (b)—
in paragraph (1), by striking subparagraphs (A) through (F) and inserting the following:
the core risk factors for preterm labor and delivery;
medically indicated deliveries before full term;
the importance of preconception and prenatal care, including—
smoking cessation;
weight maintenance and good nutrition, including folic acid;
the screening for and the treatment of infections; and
stress management;
treatments and outcomes for premature infants, including late preterm infants;
the informational needs of families during the stay of an infant in a neonatal intensive care unit; and
utilization of evidence-based strategies to prevent birth injuries;
; and
by striking paragraph (2) and inserting the following:
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
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.
.
Other activities
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 ).
Advisory Committee on Infant Mortality
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
).
Duties
The Advisory Committee shall provide advice and recommendations to the Secretary concerning the following activities:
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.
Strategies to coordinate the various Federal programs and activities with State, local, and private programs and efforts that address factors that affect infant mortality.
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.
Strategies to reduce preterm birth rates through research, programs, and education.
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—
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;
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
reflect input from a broad range of scientists, patients, and advocacy groups, as appropriate.
Membership
The Secretary shall ensure that the membership of the Advisory Committee includes the following:
Representatives provided for in the original charter of the Advisory Committee.
A representative of the National Center for Health Statistics.
Patient Safety Studies and report
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.
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
Short title
This title may be cited as the
National Pediatric Research Network Act of 2013
.
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—
by redesignating subsection (d) as subsection (f); and
by inserting after subsection (c) the following:
National Pediatric Research Network
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—
the pediatric research consortia receiving awards under paragraph (2); or
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.
Pediatric research consortia
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—
basic, clinical, behavioral, or translational research to meet unmet needs for pediatric research; and
training researchers in pediatric research techniques in order to address unmet pediatric research needs.
Research
The Director of NIH shall, as appropriate, ensure that—
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
one or more such consortia provide training described in subparagraph (A)(ii).
Organization of consortium
Each consortium receiving an award under subparagraph (A) shall—
be formed from a collaboration of cooperating institutions;
be coordinated by a lead institution or institutions;
agree to disseminate scientific findings, including from clinical trials, rapidly and efficiently, as appropriate, to—
other consortia;
the National Institutes of Health;
the Food and Drug Administration;
and other relevant agencies; and
meet such requirements as may be prescribed by the Director of NIH.
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.
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.
Coordination of consortia activities
The Director of NIH shall, 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
require the periodic preparation and submission to the Director of reports on the activities of each such consortium.
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.
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—
consider pediatric rare diseases or conditions, or those related to birth defects; and
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.
.
CHIMP Act Amendments
Short title
This title may be cited as the
CHIMP Act Amendments of 2013
.
Care for NIH chimpanzees
In general
Section 404K(g) of the Public Health Service Act ( 42 U.S.C. 283m(g) ) is amended—
by amending paragraph (1) to read as follows:
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—
for fiscal year 2014, $12,400,000;
for fiscal year 2015, $11,650,000;
for fiscal year 2016, $10,900,000;
for fiscal year 2017, $10,150,000; and
for fiscal year 2018, $9,400,000.
;
by striking paragraph (2);
by redesignating paragraph (3) as paragraph (2); and
in paragraph (2), as so redesignated—
by striking With respect to amounts reserved under paragraph (1)
and inserting With respect to amounts authorized to be appropriated by paragraph (1)
; and
by striking board of directors
and inserting Secretary in consultation with the board of directors
.
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—
the research status of such chimpanzees;
the cost for the care, maintenance, and transportation of such chimpanzees, including the cost broken down by—
research or retirement status;
services included in the care, maintenance, and transportation; and
location;
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
any options for cost savings for the support and maintenance of such chimpanzees.
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:
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—
the care, maintenance, and transportation of the chimpanzees under the ownership or control of the National Institutes of Health;
costs related to such care, maintenance, and transportation, and any other related costs; and
the research status of such chimpanzees.
.
Speaker of the House of Representatives
Vice President of the United States and President of the Senate
