II

104TH CONGRESS

1ST SESSION S. 459

To provide surveillance, research, and services aimed at prevention of birth

defects, and for other purposes.

IN THE SENATE OF THE UNITED STATES

FEBRUARY 22, 1995

Mr. BOND introduced the following bill; which was read twice and referred to

the Committee on Labor and Human Resources

A BILL

To provide surveillance, research, and services aimed at

prevention of birth defects, and for other purposes.

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; FINDINGS.

4 (a) SHORT TITLE.—This Act may be cited as the

5 ‘‘Birth Defects Prevention Act of 1995’’.

6 (b) FINDINGS.—The Congress makes the following

7 findings:

8 (1) Birth defects are the leading cause of infant

9 mortality, directly responsible for one out of every

10 five infant deaths.
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1 (2) Thousands of the 250,000 infants born with

2 a birth defect annually face a lifetime of chronic dis3 ability and illness.

4 (3) Birth defects threaten the lives of infants of

5 all racial and ethnic backgrounds. However, some

6 conditions pose excess risks for certain populations.

7 For example, compared to all infants born in the

8 United States, Hispanic-American infants are more

9 likely to be born with anencephaly spina bifida and

10 other neural tube defects and African-American in11 fants are more likely to be born with sickle-cell ane12 mia.

13 (4) Birth defects can be caused by exposure to

14 environmental hazards, adverse health conditions

15 during pregnancy, or genetic mutations. Prevention

16 efforts are slowed by lack of information about the

17 number and causes of birth defects. Outbreaks of

18 birth defects may go undetected because surveillance

19 and research efforts are underdeveloped and poorly

20 coordinated.

21 SEC. 2. BIRTH DEFECTS PREVENTION AND RESEARCH PRO22 GRAM.

23 Part B of title III of the Public Health Service Act

24 (42 U.S.C. 243 et seq.) is amended by inserting after sec25 tion 317D the following new section:
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1 ‘‘BIRTH DEFECTS PREVENTION AND RESEARCH

2 PROGRAMS

3 ‘‘SEC. 317E. (a) NATIONAL BIRTH DEFECTS SUR4 VEILLANCE PROGRAM.—The Secretary, acting through

5 the Director of the Centers for Disease Control, may

6 award grants to, enter into cooperative agreements with,

7 or provide direct technical assistance in lieu of cash to

8 States, State health authorities, or health agencies of po9 litical subdivisions of a State for collection, analysis, and

10 reporting of birth defects statistics from birth certificates,

11 infant death certificates, hospital records, or other sources

12 and to collect and disaggregate such statistics by gender

13 and racial and ethnic group.

14 ‘‘(b) CENTERS FOR EXCELLENCE FOR BIRTH DE15 FECTS PREVENTION RESEARCH.—

16 ‘‘(1) IN GENERAL.—The Secretary shall estab17 lish at least five regional birth defects monitoring

18 and research programs for the purpose of collecting

19 and analyzing information on the number, incidence,

20 correlates, and causes of birth defects, to include in21 formation regarding gender and different racial and

22 ethnic groups, including Hispanics, non-Hispanic

23 whites, African Americans, Native Americans, and

24 Asian Americans.
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1 ‘‘(2) AUTHORITY FOR AWARDS.—For purposes

2 of paragraph (1), the Secretary, acting through the

3 Director of the Centers for Disease Control, may

4 award grants or enter into cooperative agreements

5 with State departments of health, universities, or

6 other private, nonprofit entities engaged in research

7 to enable such entities to serve as Centers of Excel8 lence for Birth Defects Prevention Research.

9 ‘‘(3) APPLICATION.—To be eligible for grants

10 or cooperative agreements under paragraph (2), the

11 entity shall prepare and submit to the Secretary an

12 application at such time, in such manner and con13 taining such information as the Secretary may pre14 scribe, including assurances that—

15 ‘‘(A) the program will collect, analyze, and

16 report birth defects data according to guidelines

17 prescribed by the Director of the Centers for

18 Disease Control;

19 ‘‘(B) the program will coordinate States

20 birth defects surveillance and prevention efforts

21 within a region;

22 ‘‘(C) education, training, and clinical skills

23 improvement for health professionals aimed at

24 the prevention and control of birth defects will

25 be included in the program activities;
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1 ‘‘(D) development and evaluation of birth

2 defects prevention strategies will be included in

3 the program activities, as appropriate; and

4 ‘‘(E) the program funds will not be used to

5 supplant or duplicate State efforts.

6 ‘‘(4) CENTERS TO FOCUS ON RACIAL AND ETH7 NIC DISPARITIES IN BIRTH DEFECTS.—One of the

8 Centers of Excellence shall focus on birth defects

9 among ethnic minorities, and shall be located in a

10 standard metropolitan statistical area that has over

11 a 60 percent ethnic minority population, is federally

12 designated as a health professional shortage area,

13 and has an incidence of one or more birth defects

14 more than four times the national average.

15 ‘‘(c) CLEARINGHOUSE.—The Centers for Disease

16 Control shall serve as the coordinating agency for birth

17 defects prevention activities through establishment of a

18 clearinghouse for the collection and storage of data and

19 generated from birth defects monitoring programs devel20 oped under subsections (a) and (b). Functions of such

21 clearinghouse shall include facilitating the coordination of

22 research and policy development to prevent birth defects.

23 The clearinghouse shall disaggregate data by gender and

24 by racial and ethnic groups, the major Hispanic
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1 subgroups, non-Hispanic whites, African Americans, Na2 tive Americans, and Asian Americans.

3 ‘‘(d) PREVENTION STRATEGIES.—The Secretary, act4 ing through the Director of the Centers for Disease Con5 trol, shall award grants to or enter into cooperative agree6 ments with State departments of health, universities, or

7 other private, or nonprofit entities to enable such entities

8 to develop, evaluate and implement prevention strategies

9 designed to reduce the incidence and effects or birth de10 fects including—

11 ‘‘(1) demonstration projects for the prevention

12 of birth defects, including—

13 ‘‘(A) at least one project aimed at enhanc14 ing prevention services in a ‘high-risk area’ that

15 has a proportion of birth to minority women

16 above the national average, is federally des17 ignated as a health professional shortage area,

18 and has a high incidence of one or more birth

19 defects; and

20 ‘‘(B) at least one outcome research project

21 to study the effectiveness of infant interventions

22 aimed at amelioration of birth defects; and

23 ‘‘(2) public information and education programs

24 for the prevention of birth defects, including but not

25 limited to programs aimed at prevention of alcohol
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1 and illicit drug use during pregnancy and promotion

2 of use of folic acid vitamin supplements for women

3 of childbearing age in a manner which is sensitive to

4 the cultural and linguistic context of a given commu5 nity.

6 ‘‘(e) ADVISORY COMMITTEE.—

7 ‘‘(1) ESTABLISHMENT OF COMMITTEE.—The

8 Secretary shall establish an Advisory Committee for

9 Birth Defects Prevention (in this subsection referred

10 to as the ‘Committee’). The Committee shall provide

11 advice and recommendations on prevention and ame12 lioration of birth defects to the Secretary and the

13 Director of the Centers for Disease Control.

14 ‘‘(2) FUNCTIONS.—With respect to birth de15 fects prevention, the Committee shall—

16 ‘‘(A) make recommendations regarding

17 prevention research and intervention priorities;

18 ‘‘(B) study and recommend ways to pre19 vent birth defects, with emphasis on emerging

20 technologies;

21 ‘‘(C) identify annually the important areas

22 of government and nongovernment cooperation

23 needed to implement prevention strategies;

24 ‘‘(D) identify research and prevention

25 strategies which would be successful in address-
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1 ing birth defects disparities among the major

2 Hispanic subgroups, non-Hispanic whites, Afri3 can Americans, Native Americans, and Asian

4 Americans; and

5 ‘‘(E) review and recommend policies and

6 guidance related to birth defects research and

7 prevention.

8 ‘‘(3) COMPOSITION.—The Committee shall be

9 composed of 15 members appointed by the Sec10 retary, including—

11 ‘‘(A) four health professionals, who are not

12 employees of the United States, who have ex13 pertise in issues related to prevention of or care

14 for children with birth defects;

15 ‘‘(B) two representatives from health pro16 fessional associations;

17 ‘‘(C) four representatives from voluntary

18 health agencies concerned with conditions lead19 ing to birth defects or childhood disability;

20 ‘‘(D) five members of the general public, of

21 whom at least three shall be parents of children

22 with birth defects or persons having birth de23 fects; and

24 ‘‘(E) representatives of the Public Health

25 Service agencies involved in birth defects re-
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1 search and prevention programs and represent2 atives of other appropriate Federal agencies, in3 cluding but not limited to the Department of

4 Education and the Environmental Protection

5 Agency, shall be appointed as ex officio, liaison

6 members for purposes of informing the Com7 mittee regarding Federal agency policies and

8 practices;

9 ‘‘(4) STRUCTURE.—

10 ‘‘(A) TERM OF OFFICE.—Appointed mem11 bers of the Committee shall be appointed for a

12 term of office of 3 years, except that of the

13 members first appointed, 5 shall be appointed

14 for a term of 1 year, 5 shall be appointed for

15 a term of 2 years, and 5 shall be appointed for

16 a term of 3 years, as determined by the Sec17 retary.

18 ‘‘(B) MEETINGS.—The Committee shall

19 meet not less than three times per year and at

20 the call of the Chair.

21 ‘‘(C) COMPENSATION.—Members of the

22 Committee who are employees of the Federal

23 Government shall serve without compensation.

24 Members of the Committee who are not employ25 ees of the Federal Government shall be com-
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1 pensated at a rate not to exceed the daily equiv2 alent of the rate in effect for grade GS–18.

3 ‘‘(f) REPORT.—The Secretary shall prepare and sub4 mit to the Committee on Energy and Commerce of the

5 House of Representatives and the Committee on Labor

6 and Human Resources of the Senate a biennial report re7 garding the incidence of birth defects, the contribution of

8 birth defects to infant mortality, the outcome of implemen9 tation of prevention strategies, and identified needs for re10 search and policy development to include information re11 garding the various racial and ethnic groups, including

12 Hispanic, non-Hispanic whites, African Americans, Native

13 Americans, and Asian Americans.

14 ‘‘(g) APPLICABILITY OF PRIVACY LAWS.—The provi15 sions of this section shall be subject to the requirements

16 of section 552a of title 5, United States Code. All Federal

17 laws relating to the privacy of information shall apply to

18 the data and information that is collected under this sec19 tion.

20 ‘‘(h) AUTHORIZATION OF APPROPRIATIONS.—

21 ‘‘(1) For the purpose of carrying out sub22 sections (a), (b), and (c), there are authorized to be

23 appropriated $15,000,000 for fiscal year 1996,

24 $20,000,000 for fiscal year 1997, and such sums as
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1 may be necessary for each of the fiscal years 1998

2 and 1999.

3 ‘‘(2) For the purpose of carrying out subsection

4 (d), there are authorized to be appropriated

5 $15,000,000 for fiscal year 1996, $20,000,000 for

6 fiscal year 1997, and such sums as may be nec7 essary for each of the fiscal years 1998 and 1999.

8 ‘‘(3) For the purpose of carrying out sub9 sections (e) and (f), there are authorized to be ap10 propriated $2,000,000 for each of the fiscal years

11 1996 through 1999.’’.

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