Children and Family HIV/AIDS Research and Care Act of 2004 - Amends the Public Health Service Act to require that recipients of certain grants related to human immunodeficiency virus (HIV) research and services for women, infants, and children agree to provide coordinated, family-centered care. Requires the Secretary of Health and Human Services, acting through the Administrator of the Health Resources and Services Administration (HRSA), to award grants to provide health care and other supportive services to youth with HIV designed to recruit and retain youth in care.
Requires that chief elected officials in eligible areas and States allocate certain grant funds using HIV case data rather than acquired immune deficiency syndrome (AIDS) case data as soon as such data is adopted for other allocation purposes. Requires the Secretary to report on the status of using such HIV case data and the impact of this transition on the resources directed to women, infants, children and youth.
Requires the Secretary to award demonstration grants to public and nonprofit private entities to conduct assessments of the effectiveness of certain strategies in reducing the mother-to-child transmission of HIV.
Requires the Director of NIH, acting through the Director of the Office of AIDS Research, to report on activities related to the testing of potential HIV vaccine candidates in relevant pediatric populations.
Requires the Commission of Food and Drugs to issue guidance on the minimum requirements for obtaining Food and Drug Administration (FDA) approval to test an HIV vaccine in pediatric populations and for a pediatric indication of an HIV vaccine.
Requires the Director of NIH to invest in domestic and international research on specified topics related to HIV and pediatric populations.
[Congressional Bills 108th Congress]
[From the U.S. Government Publishing Office]
[S. 2892 Introduced in Senate (IS)]
2d Session
S. 2892
To amend the Public Health Service Act to reauthorize and extend
certain programs to provide coordinated services and research with
respect to children and families with HIV/AIDS.
_______________________________________________________________________
IN THE SENATE OF THE UNITED STATES
October 5, 2004
Mr. Dodd (for himself and Mr. Bond) introduced the following bill;
which was read twice and referred to the Committee on Health,
Education, Labor, and Pensions
_______________________________________________________________________
A BILL
To amend the Public Health Service Act to reauthorize and extend
certain programs to provide coordinated services and research with
respect to children and families with HIV/AIDS.
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ``Children and Family HIV/AIDS
Research and Care Act of 2004''.
SEC. 2. FINDINGS.
Congress makes the following findings:
(1) More than 2,000 children worldwide are infected with
HIV each day, the vast majority through mother to child
transmission.
(2) More than 3,700 children and youth in the United States
under the age of 13 are living with HIV and AIDS.
(3) Young people ages 15 through 24 represent 50 percent of
all new HIV infections worldwide.
(4) Each day more than 6,000 youth become infected with
HIV.
(5) Of the more than 40,000 Americans newly infected with
HIV every year, half are among people under 25 years old.
(6) Women account for more than a quarter of all new HIV
infections in the United States and young women represent 58
percent of new HIV cases among people ages 13 to 19.
(7) Title IV of the Ryan White Comprehensive AIDS Resources
Emergency Act of 1990 (Public Law 101-381) is a successful
model of family-centered, coordinated health care and
supportive services for women, children, youth and families.
(8) Most programs under title IV of the Ryan White
Comprehensive AIDS Resources Emergency Act of 1990 are the
principal source of medical care for HIV-positive children,
youth, and pregnant women in their geographic area.
(9) Children and youth living with HIV and AIDS have unique
needs for specialized services in medical care and psychosocial
support.
(10) Title IV of the Ryan White Comprehensive AIDS
Resources Emergency Act of 1990, including its Adolescent
Initiative, is the leading national effort to link HIV-positive
youth to comprehensive medical care and support services.
(11) Each year more than 53,000 women, children, and youth
receive services funded under title IV of the Ryan White
Comprehensive AIDS Resources Emergency Act of 1990.
(12) With no preventive intervention, an HIV-positive
pregnant woman has a 25 percent chance of passing on the virus
to her baby. With optimal care, including preventive drug
interventions, the rate of mother-to-child transmission of HIV
drops to 1 to 2 percent.
(13) Services provided by programs funded under title IV of
the Ryan White Comprehensive AIDS Resources Emergency Act of
1990 have been essential in reducing the number of mother-to-
child HIV infections in the United States from approximately
2,000 to fewer than 300 per year.
(14) The Institute of Medicine recommends routine,
voluntary HIV testing of pregnant women as a means to
increasing the proportion of women tested and, ultimately,
reducing mother-to-child transmission of HIV.
(15) The Centers for Disease Control and Prevention also
recommends a routine, voluntary approach to HIV testing of
pregnant women as an effective means to reduce mother-to-child
transmission of HIV.
(16) Experts believe that vaccines to prevent HIV infection
offer the best hope of controlling the global pandemic.
However, some of the populations hardest hit by the disease
(infants, preadolescents, and adolescents) are at risk of being
left behind in the search for an effective vaccine against the
virus.
(17) To date, the vast majority of HIV vaccine trials have
not included pediatric populations. Of the 110 trials that have
been completed, only two of them included these populations. Of
the 40 trials that are currently being conducted, only one
involves pediatric populations.
(18) Because we cannot assume that a vaccine tested in
adults will also be safe and effective when used in pediatric
populations, it will be important to ensure that promising
vaccines are tested in all relevant pediatric populations as
early as is medically and ethically appropriate.
SEC. 3. ENSURING FAMILY-CENTERED, COORDINATED CARE FOR CHILDREN AND
FAMILIES OF HIV/AIDS.
Section 2671 of the Public Health Service Act (42 U.S.C. 300ff-71)
is amended--
(1) in subsection (d)(1), by striking ``for'' and inserting
``coordinated, family-centered care, including''; and
(2) in subsection (k), by striking ``1996 through 2000''
and inserting ``2005 through 2010''.
SEC. 4. EXPANDING CARE FOR YOUTH.
Section 2671(a) of the Public Health Service Act (42 U.S.C. 300ff-
71(a)) is amended by adding at the end thereof the following:
``(3) In the case of youth with HIV, providing health care
and other supportive services designed to recruit and retain
youth in care. For purposes of this paragraph, the term `youth
with HIV' means individuals ages 13 through 24 infected through
all modes of transmission including mother-to-child.''.
SEC. 5. ENSURING ADEQUATE RESOURCES FOR CHILDREN AND FAMILIES.
(a) Women, Infants, Children, and Youth Provisions.--
(1) Emergency relief.--Section 2604(b)(4) of the Public
Health Service Act (42 U.S.C. 300ff-14(b)(4)) is amended by
adding at the end the following:
``(C) Data.--In determining the amount of funds to
use for services under subparagraph (A), the chief
elected official of the eligible area involved shall
use HIV case data (rather than AIDS case data) as soon
as the use of such data is adopted for purposes of
allocating any other funding authorized under this
title.''.
(2) General grants.--Section 2611(b) of the Public Health
Service Act (42 U.S.C. 300ff-21(b)) is amended by adding at the
end the following:
``(3) Data.--In determining the amount of funds to use for
services under paragraph (1), the State involved shall use HIV
case data (rather than AIDS case data) as soon as the use of
such data is adopted for purposes of allocating any other
funding authorized under this title.
``(4) Report.--Not later than October 1, 2007, the
Secretary shall submit to the appropriate committees of
Congress a report on--
``(A) the status of HIV case data implementation in
relation to the allocation of funds under this
subsection and under section 2604(b)(4); and
``(B) if such data is being used for allocating
resources under this title, the impact of the
transition from AIDS case data to HIV case data on the
resources directed to women, infants, children and
youth under this subsection and under section
2604(b)(4).''.
(b) CDC Guidelines for Pregnant Women.--Section 2625 of the Public
Health Service Act (42 U.S.C. 300ff-33) is amended by adding at the end
the following:
``(d) Demonstration Grants.--
``(1) In general.--The Secretary shall award demonstration
grants to public and nonprofit private entities to enable such
entities to conduct assessments of the effectiveness of each of
the following strategies in reducing the mother-to-child
transmission of HIV:
``(A) Increasing the routine, voluntary HIV testing
of pregnant women, including rapid testing at the time
of labor for women whose HIV status is unknown.
``(B) Increasing access to prenatal care for HIV-
positive pregnant women and providing intensive case
management and support services for HIV-positive
pregnant women.
``(2) Priority.--In awarding grants under this subsection,
the Secretary shall give priority to entities that serve
pregnant women in areas where mother-to-child HIV transmission
persists.
``(3) Authorization of appropriations.--There is authorized
to be appropriated to carry out this subsection, $10,000,000
for fiscal year 2005, and such sums as may be necessary for
each of fiscal years 2006 through 2010.''.
SEC. 6. ENSURING ACCESS TO RESEARCH FOR INFANTS, CHILDREN, AND YOUTH.
(a) In General.--Part D of title XXVI of the Public Health Service
Act is amended by inserting after section 2673 (42 U.S.C. 300ff-73) the
following:
``SEC. 2673A. PEDIATRIC HIV VACCINE TESTING.
``(a) In General.--Not later than 120 days after the date of
enactment of the Children and Family HIV/AIDS Research and Care Act of
2004, the Director of the National Institutes of Health, acting through
the Director of the Office of AIDS Research and in collaboration with
the Secretary of Defense, relevant institutes and centers of the
National Institutes of Health, and other federally funded HIV vaccine
research programs, shall 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 on the status of
activities under the most recent plan of the National Institutes of
Health for HIV-related research related to the testing of potential HIV
vaccine candidates in relevant pediatric populations.
``(b) Requirements.--The report submitted under subsection (a)
shall include--
``(1) plans for expanding existing capacity for HIV vaccine
candidate testing in relevant pediatric populations across all
institutes, centers, and clinical trials networks of the
National Institutes of Health, and other federally funded HIV
vaccine research programs;
``(2) plans for increasing coordination across relevant
institutes and centers of the National Institutes of Health,
other federally funded HIV vaccine research programs, the Food
and Drug Administration, the Centers for Disease Control and
Prevention, and the Partnership for AIDS Vaccine Evaluation, in
advancing pediatric HIV vaccine testing and for identifying
opportunities for collaboration with activities under the
authority of the Office of the Global HIV/AIDS Coordinator;
``(3) appropriate principles for initiating HIV vaccine
testing in relevant pediatric populations, including
recommendations for sequencing the enrollment of adults and
relevant pediatric populations and for addressing issues
related to human subjects protections for children involved in
clinical research; and
``(4) proposed community education efforts in support of
the inclusion of relevant pediatric populations in HIV vaccine
clinical trials.
``(c) Guidance.--Not later than 120 days after the date of
enactment of the Children and Family HIV/AIDS Research and Care Act of
2004, the Commissioner of Food and Drugs, in consultation with
appropriate public and private entities, shall issue guidance on--
``(1) the minimum requirements for obtaining approval of
the Food and Drug Administration to test an HIV vaccine in
pediatric populations; and
``(2) the minimum requirements for obtaining Food and Drug
Administration approval of a pediatric indication of an HIV
vaccine.
``(d) Commitment to Additional Research.--The Director of the
National Institutes of Health shall invest in domestic and
international research on the following:
``(1) The long-term health effects of preventive drug
regimens on HIV-exposed pediatric populations.
``(2) The long-term health, psycho-social, and prevention
needs for pediatric populations perinatally HIV-infected.
``(3) The transition to adulthood for HIV-infected
pediatric populations.
``(4) Safer and more effective treatment options for
pediatric populations with HIV disease.
``(e) Pediatric Populations.--In this section, the term `pediatric
populations' includes neonate, infants, children, and adolescents, and
the term `relevant pediatric populations' means pediatric populations
at risk of HIV infection, including infants, preadolescents, and
adolescents.''.
(b) Coordinated Services.--Section 2671(b)(1)(C) of the Public
Health Service Act (42 U.S.C. 300ff-71(b)(1)(C)) is amended by
inserting ``including HIV vaccine research'' after ``linkages to
research''.
<all>
Introduced in Senate
Sponsor introductory remarks on measure. (CR S10440-10442)
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Llama 3.2 · runs locally in your browser
Ask anything about this bill. The AI reads the full text to answer.
Enter to send · Shift+Enter for new line