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.

May 17, 2005

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

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 2005'.

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 200 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 `2006 through 2011'.

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 2603(a)(3)(C)(i) of the Public Health Service Act (42 U.S.C. 300ff-13(a)(3)(C)(i)) is amended by inserting `, or for purposes of granting priority under section 2604(b)(4),' after `pursuant to this paragraph'.

(2) GENERAL GRANTS- Section 2618(a)(2)(D)(i) of the Public Health Service Act (42 U.S.C. 300ff-28(a)(2)(D)(i)) is amended by inserting `, or for purposes of granting priority under section 2611,' after `section 2620'.

(3) REPORT- Not later than October 1, 2007, the Secretary of Health and Human Services 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 sections 2603 and 2618 of the Public Health Service Act (as amended by this subsection); and

(B) if such data is being used for allocating resources under this title XXVI of the Public Health Service Act (42 U.S.C. 300ff-11 et seq.), the impact of the transition from AIDS case data to HIV case data on the resources directed to women, infants, children and youth under section 2603 and section 2618.'.

(b) CDC GUIDELINES FOR PREGNANT WOMEN- Section 2671 of the Public Health Service Act (42 U.S.C. 300ff-71) is amended--

(1) by redesignating subsection (k) as subsection (l); and

(2) by inserting after subsection (j) the following:

`(k) 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 2006, and such sums as may be necessary for each of fiscal years 2007 through 2011.'.

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 2005, 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 2005, 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'.

END