II 

108TH CONGRESS 

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.

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled,

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Children and Family 

5 HIV/AIDS Research and Care Act of 2004’’. 

6 SEC. 2. FINDINGS. 

7 Congress makes the following findings: 
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1 (1) More than 2,000 children worldwide are in2 fected with HIV each day, the vast majority through 

3 mother to child transmission. 

4 (2) More than 3,700 children and youth in the 

5 United States under the age of 13 are living with 

6 HIV and AIDS. 

7 (3) Young people ages 15 through 24 represent 

8 50 percent of all new HIV infections worldwide. 

9 (4) Each day more than 6,000 youth become 

10 infected with HIV. 

11 (5) Of the more than 40,000 Americans newly 

12 infected with HIV every year, half are among people 

13 under 25 years old. 

14 (6) Women account for more than a quarter of 

15 all new HIV infections in the United States and 

16 young women represent 58 percent of new HIV 

17 cases among people ages 13 to 19. 

18 (7) Title IV of the Ryan White Comprehensive 

19 AIDS Resources Emergency Act of 1990 (Public 

20 Law 101–381) is a successful model of family-cen21 tered, coordinated health care and supportive serv22 ices for women, children, youth and families. 

23 (8) Most programs under title IV of the Ryan 

24 White Comprehensive AIDS Resources Emergency 

25 Act of 1990 are the principal source of medical care 
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1 for HIV-positive children, youth, and pregnant 

2 women in their geographic area. 

3 (9) Children and youth living with HIV and 

4 AIDS have unique needs for specialized services in 

5 medical care and psychosocial support. 

6 (10) Title IV of the Ryan White Comprehensive 

7 AIDS Resources Emergency Act of 1990, including 

8 its Adolescent Initiative, is the leading national ef9 fort to link HIV-positive youth to comprehensive 

10 medical care and support services. 

11 (11) Each year more than 53,000 women, chil12 dren, and youth receive services funded under title 

13 IV of the Ryan White Comprehensive AIDS Re14 sources Emergency Act of 1990. 

15 (12) With no preventive intervention, an HIV16 positive pregnant woman has a 25 percent chance of 

17 passing on the virus to her baby. With optimal care, 

18 including preventive drug interventions, the rate of 

19 mother-to-child transmission of HIV drops to 1 to 2 

20 percent. 

21 (13) Services provided by programs funded 

22 under title IV of the Ryan White Comprehensive 

23 AIDS Resources Emergency Act of 1990 have been 

24 essential in reducing the number of mother-to-child 
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1 HIV infections in the United States from approxi2 mately 2,000 to fewer than 300 per year. 

3 (14) The Institute of Medicine recommends 

4 routine, voluntary HIV testing of pregnant women 

5 as a means to increasing the proportion of women 

6 tested and, ultimately, reducing mother-to-child 

7 transmission of HIV. 

8 (15) The Centers for Disease Control and Pre9 vention also recommends a routine, voluntary ap10 proach to HIV testing of pregnant women as an ef11 fective means to reduce mother-to-child transmission 

12 of HIV. 

13 (16) Experts believe that vaccines to prevent 

14 HIV infection offer the best hope of controlling the 

15 global pandemic. However, some of the populations 

16 hardest hit by the disease (infants, preadolescents, 

17 and adolescents) are at risk of being left behind in 

18 the search for an effective vaccine against the virus. 

19 (17) To date, the vast majority of HIV vaccine 

20 trials have not included pediatric populations. Of the 

21 110 trials that have been completed, only two of 

22 them included these populations. Of the 40 trials 

23 that are currently being conducted, only one involves 

24 pediatric populations. 
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1 (18) Because we cannot assume that a vaccine 

2 tested in adults will also be safe and effective when 

3 used in pediatric populations, it will be important to 

4 ensure that promising vaccines are tested in all rel5 evant pediatric populations as early as is medically 

6 and ethically appropriate. 

7 SEC. 3. ENSURING FAMILY-CENTERED, COORDINATED 

8 CARE FOR CHILDREN AND FAMILIES OF HIV/

9 AIDS. 

10 Section 2671 of the Public Health Service Act (42 

11 U.S.C. 300ff–71) is amended—

12 (1) in subsection (d)(1), by striking ‘‘for’’ and 

13 inserting ‘‘coordinated, family-centered care, includ14 ing’’; and 

15 (2) in subsection (k), by striking ‘‘1996 through 

16 2000’’ and inserting ‘‘2005 through 2010’’. 

17 SEC. 4. EXPANDING CARE FOR YOUTH. 

18 Section 2671(a) of the Public Health Service Act (42 

19 U.S.C. 300ff–71(a)) is amended by adding at the end 

20 thereof the following: 

21 ‘‘(3) In the case of youth with HIV, providing 

22 health care and other supportive services designed to 

23 recruit and retain youth in care. For purposes of 

24 this paragraph, the term ‘youth with HIV’ means in-
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1 dividuals ages 13 through 24 infected through all 

2 modes of transmission including mother-to-child.’’. 

3 SEC. 5. ENSURING ADEQUATE RESOURCES FOR CHILDREN 

4 AND FAMILIES. 

5 (a) WOMEN, INFANTS, CHILDREN, AND YOUTH PRO6 VISIONS.—

7 (1) EMERGENCY RELIEF.—Section 2604(b)(4) 

8 of the Public Health Service Act (42 U.S.C. 300ff–

9 14(b)(4)) is amended by adding at the end the fol10 lowing: 

11 ‘‘(C) DATA.—In determining the amount 

12 of funds to use for services under subparagraph 

13 (A), the chief elected official of the eligible area 

14 involved shall use HIV case data (rather than 

15 AIDS case data) as soon as the use of such 

16 data is adopted for purposes of allocating any 

17 other funding authorized under this title.’’. 

18 (2) GENERAL GRANTS.—Section 2611(b) of the 

19 Public Health Service Act (42 U.S.C. 300ff–21(b)) 

20 is amended by adding at the end the following: 

21 ‘‘(3) DATA.—In determining the amount of 

22 funds to use for services under paragraph (1), the 

23 State involved shall use HIV case data (rather than 

24 AIDS case data) as soon as the use of such data is 
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1 adopted for purposes of allocating any other funding 

2 authorized under this title. 

3 ‘‘(4) REPORT.—Not later than October 1, 

4 2007, the Secretary shall submit to the appropriate 

5 committees of Congress a report on—

6 ‘‘(A) the status of HIV case data imple7 mentation in relation to the allocation of funds 

8 under this subsection and under section 

9 2604(b)(4); and 

10 ‘‘(B) if such data is being used for allo11 cating resources under this title, the impact of 

12 the transition from AIDS case data to HIV 

13 case data on the resources directed to women, 

14 infants, children and youth under this sub15 section and under section 2604(b)(4).’’. 

16 (b) CDC GUIDELINES FOR PREGNANT WOMEN.—

17 Section 2625 of the Public Health Service Act (42 U.S.C. 

18 300ff–33) is amended by adding at the end the following: 

19 ‘‘(d) DEMONSTRATION GRANTS.—

20 ‘‘(1) IN GENERAL.—The Secretary shall award 

21 demonstration grants to public and nonprofit private 

22 entities to enable such entities to conduct assess23 ments of the effectiveness of each of the following 

24 strategies in reducing the mother-to-child trans25 mission of HIV: 
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1 ‘‘(A) Increasing the routine, voluntary HIV 

2 testing of pregnant women, including rapid 

3 testing at the time of labor for women whose 

4 HIV status is unknown. 

5 ‘‘(B) Increasing access to prenatal care for 

6 HIV-positive pregnant women and providing in7 tensive case management and support services 

8 for HIV-positive pregnant women. 

9 ‘‘(2) PRIORITY.—In awarding grants under this 

10 subsection, the Secretary shall give priority to enti11 ties that serve pregnant women in areas where 

12 mother-to-child HIV transmission persists. 

13 ‘‘(3) AUTHORIZATION OF APPROPRIATIONS.—

14 There is authorized to be appropriated to carry out 

15 this subsection, $10,000,000 for fiscal year 2005, 

16 and such sums as may be necessary for each of fis17 cal years 2006 through 2010.’’. 

18 SEC. 6. ENSURING ACCESS TO RESEARCH FOR INFANTS, 

19 CHILDREN, AND YOUTH. 

20 (a) IN GENERAL.—Part D of title XXVI of the Pub21 lic Health Service Act is amended by inserting after sec22 tion 2673 (42 U.S.C. 300ff–73) the following: 

23 ‘‘SEC. 2673A. PEDIATRIC HIV VACCINE TESTING. 

24 ‘‘(a) IN GENERAL.—Not later than 120 days after 

25 the date of enactment of the Children and Family HIV/
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1 AIDS Research and Care Act of 2004, the Director of the 

2 National Institutes of Health, acting through the Director 

3 of the Office of AIDS Research and in collaboration with 

4 the Secretary of Defense, relevant institutes and centers 

5 of the National Institutes of Health, and other federally 

6 funded HIV vaccine research programs, shall submit to 

7 the Committee on Health, Education, Labor, and Pen8 sions of the Senate and the Committee on Energy and 

9 Commerce of the House of Representatives, a report on 

10 the status of activities under the most recent plan of the 

11 National Institutes of Health for HIV-related research re12 lated to the testing of potential HIV vaccine candidates 

13 in relevant pediatric populations. 

14 ‘‘(b) REQUIREMENTS.—The report submitted under 

15 subsection (a) shall include—

16 ‘‘(1) plans for expanding existing capacity for 

17 HIV vaccine candidate testing in relevant pediatric 

18 populations across all institutes, centers, and clinical 

19 trials networks of the National Institutes of Health, 

20 and other federally funded HIV vaccine research 

21 programs; 

22 ‘‘(2) plans for increasing coordination across 

23 relevant institutes and centers of the National Insti24 tutes of Health, other federally funded HIV vaccine 

25 research programs, the Food and Drug Administra-
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1 tion, the Centers for Disease Control and Preven2 tion, and the Partnership for AIDS Vaccine Evalua3 tion, in advancing pediatric HIV vaccine testing and 

4 for identifying opportunities for collaboration with 

5 activities under the authority of the Office of the 

6 Global HIV/AIDS Coordinator; 

7 ‘‘(3) appropriate principles for initiating HIV 

8 vaccine testing in relevant pediatric populations, in9 cluding recommendations for sequencing the enroll10 ment of adults and relevant pediatric populations 

11 and for addressing issues related to human subjects 

12 protections for children involved in clinical research; 

13 and 

14 ‘‘(4) proposed community education efforts in 

15 support of the inclusion of relevant pediatric popu16 lations in HIV vaccine clinical trials. 

17 ‘‘(c) GUIDANCE.—Not later than 120 days after the 

18 date of enactment of the Children and Family HIV/AIDS 

19 Research and Care Act of 2004, the Commissioner of 

20 Food and Drugs, in consultation with appropriate public 

21 and private entities, shall issue guidance on—

22 ‘‘(1) the minimum requirements for obtaining 

23 approval of the Food and Drug Administration to 

24 test an HIV vaccine in pediatric populations; and 
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1 ‘‘(2) the minimum requirements for obtaining 

2 Food and Drug Administration approval of a pedi3 atric indication of an HIV vaccine. 

4 ‘‘(d) COMMITMENT TO ADDITIONAL RESEARCH.—

5 The Director of the National Institutes of Health shall 

6 invest in domestic and international research on the fol7 lowing: 

8 ‘‘(1) The long-term health effects of preventive 

9 drug regimens on HIV-exposed pediatric popu10 lations. 

11 ‘‘(2) The long-term health, psycho-social, and 

12 prevention needs for pediatric populations 

13 perinatally HIV-infected. 

14 ‘‘(3) The transition to adulthood for HIV-in15 fected pediatric populations. 

16 ‘‘(4) Safer and more effective treatment options 

17 for pediatric populations with HIV disease. 

18 ‘‘(e) PEDIATRIC POPULATIONS.—In this section, the 

19 term ‘pediatric populations’ includes neonate, infants, chil20 dren, and adolescents, and the term ‘relevant pediatric 

21 populations’ means pediatric populations at risk of HIV 

22 infection, including infants, preadolescents, and adoles23 cents.’’. 

24 (b) COORDINATED SERVICES.—Section 

25 2671(b)(1)(C) of the Public Health Service Act (42 U.S.C. 
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1 300ff–71(b)(1)(C)) is amended by inserting ‘‘including 

2 HIV vaccine research’’ after ‘‘linkages to research’’.

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