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.

Summary: 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.

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''.