I

103D CONGRESS

1ST SESSION H. R. 1296

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

defects.

IN THE HOUSE OF REPRESENTATIVES

MARCH 10, 1993

Mr. ORTIZ (for himself, Mr. SLATTERY, Mr. WILSON, Mr. EVANS, Mr. PASTOR, Mr. GONZALEZ, Mr. TOWNS, Mr. MCDERMOTT, Mr. COLEMAN, Mr.

FILNER, Mr. TEJEDA, Ms. PELOSI, Mr. ROMERO-BARCELO ́, Mr. DE LA

GARZA, Mr. GUTIERREZ, Mr. BLACKWELL, Mr. PICKLE, Mr. FROST, Mr.

DIXON, Mr. GENE GREEN of Texas, Mr. LIPINSKI, Mr. KREIDLER, Mr.

TORRES, and Mr. SERRANO) introduced the following bill; which was referred to the Committee on Energy and Commerce

AUGUST 2, 1993

Additional sponsors: Mr. HALL of Texas, Mrs. THURMAN, Mr. BROWN of

Ohio, Miss COLLINS of Michigan, Mr. GORDON, Mrs. CLAYTON, Mr.

CRAMER, Mr. HALL of Ohio, Mr. ROSE, Mr. HUGHES, Mr. MFUME, Mrs.

SCHROEDER, Mrs. LLOYD, Mrs. MORELLA, Mr. UPTON, Mr. LAUGHLIN,

Mr. BRYANT, Mr. OWENS, Mr. ACKERMAN, Mr. SARPALIUS, Mr. LEVIN,

Mr. EDWARDS of Texas, Mr. DOOLEY, Mr. INSLEE, Ms. EDDIE BERNICE

JOHNSON of Texas, Mr. PRICE of North Carolina, Mr. WYNN, Mr. RICHARDSON, Mr. MENENDEZ, Mr. MARKEY, Mr. WASHINGTON, Mr. ROWLAND, and Mr. DELLUMS

A BILL

To provide surveillance, research, and services aimed at

prevention of birth defects.

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled,
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1 SECTION 1. SHORT TITLE; FINDINGS.

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

3 ‘‘Birth Defects Prevention Act of 1993’’.

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

5 findings:

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

7 mortality, directly responsible for one out of every

8 five infant deaths.

9 (2) Thousands of the 250,000 infants born with

10 a birth defect annually face a lifetime of chronic dis11 ability and illness.

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

13 all racial and ethnic backgrounds. However, some

14 conditions pose excess risks for certain populations.

15 For example, compared to all infants born in the

16 United States, Hispanic-American infants are more

17 likely to be born with anencephaly spina bifida and

18 other neural tube defects and African-American in19 fants are more likely to be born with sickle-cell

20 anemia.

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

22 environmental hazards, adverse health conditions

23 during pregnancy, or genetic mutations. Prevention

24 efforts are slowed by lack of information about the

25 number and causes of birth defects. Outbreaks of

26 birth defects may go undetected because surveillance
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1 and research efforts are underdeveloped and poorly

2 coordinated.

3 SEC. 2. BIRTH DEFECTS PREVENTION AND RESEARCH PRO4 GRAM.

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

6 (42 U.S.C. 243 et seq.) is amended by inserting after sec7 tion 317A the following new section:

8 ‘‘BIRTH DEFECTS PREVENTION AND RESEARCH

9 PROGRAMS

10 ‘‘SEC. 317B. (a) NATIONAL BIRTH DEFECTS SUR11 VEILLANCE PROGRAM.—The Secretary, acting through

12 the Director of the Centers for Disease Control, may

13 award grants to, enter into cooperative agreements with,

14 or provide direct technical assistance in lieu of cash to

15 States, State health authorities, or health agencies of po16 litical subdivisions of a State for collection, analysis, and

17 reporting of birth defects statistics from birth certificates,

18 infant death certificates, hospital records, or other sources

19 and to collect and disaggregate such statistics by gender

20 and racial and ethnic group.

21 ‘‘(b) CENTERS FOR EXCELLENCE FOR BIRTH DE22 FECTS PREVENTION RESEARCH.—

23 ‘‘(1) IN GENERAL.—The Secretary shall estab24 lish at least five regional birth defects monitoring

25 and research programs for the purpose of collecting

26 and analyzing information on the number, incidence,
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1 correlates, and causes of birth defects, to include in2 formation regarding gender and different racial and

3 ethnic groups, including Hispanics, non-Hispanic

4 whites, African Americans, Native Americans, and

5 Asian Americans.

6 ‘‘(2) AUTHORITY FOR AWARDS.—For purposes

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

8 Director of the Centers for Disease Control, may

9 award grants or enter into cooperative agreements

10 with State departments of health, universities, or

11 other private, nonprofit entities engaged in research

12 to enable such entities to serve as Centers of Excel13 lence for Birth Defects Prevention Research.

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

15 or cooperative agreements under paragraph (2), the

16 entity shall prepare and submit to the Secretary an

17 application at such time, in such manner and con18 taining such information as the Secretary may pre19 scribe, including assurances that—

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

21 report birth defects data according to guidelines

22 prescribed by the Director of the Centers for

23 Disease Control;
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1 ‘‘(B) the program will coordinate States

2 birth defects surveillance and prevention efforts

3 within a region;

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

5 improvement for health professionals aimed at

6 the prevention and control of birth defects will

7 be included in the program activities;

8 ‘‘(D) development and evaluation of birth

9 defects prevention strategies will be included in

10 the program activities, as appropriate; and

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

12 supplant or duplicate State efforts.

13 ‘‘(4) CENTERS TO FOCUS ON RACIAL AND ETH14 NIC DISPARITIES IN BIRTH DEFECTS.—One of the

15 Centers of Excellence shall focus on birth defects

16 among ethnic minorities, and shall be located in a

17 standard metropolitan statistical area that has over

18 a 60 percent ethnic minority population, is federally

19 designated as a health professional shortage area,

20 and has an incidence of one or more birth defects

21 more than four times the national average.

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

23 Control shall serve as the coordinating agency for birth

24 defects prevention activities through establishment of a

25 clearinghouse for the collection and storage of data and
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1 generated from birth defects monitoring programs devel2 oped under subsections (a) and (b). Functions of such

3 clearinghouse shall include facilitating the coordination of

4 research and policy development to prevent birth defects.

5 The clearinghouse shall disaggregate data by gender and

6 by racial and ethnic groups, the major Hispanic

7 subgroups, non-Hispanic whites, African Americans, Na8 tive Americans, and Asian Americans.

9 ‘‘(d) PREVENTION STRATEGIES.—The Secretary, act10 ing through the Director of the Centers for Disease Con11 trol, shall award grants to or enter into cooperative agree12 ments with State departments of health, universities, or

13 other private, or nonprofit entities to enable such entities

14 to develop, evaluate and implement prevention strategies

15 designed to reduce the incidence and effects or birth de16 fects including—

17 ‘‘(1) demonstration projects for the prevention

18 of birth defects, including—

19 ‘‘(A) at least one project aimed at enhanc20 ing prevention services in a ‘high-risk area’ that

21 has a proportion of birth to minority women

22 above the national average, is federally des23 ignated as a health professional shortage area,

24 and has a high incidence of one or more birth

25 defects; and
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1 ‘‘(B) at least one outcome research project

2 to study the effectiveness of infant interventions

3 aimed at amelioration of birth defects; and

4 ‘‘(2) public information and education programs

5 for the prevention of birth defects, including but not

6 limited to programs aimed at prevention of alcohol

7 and illicit drug use during pregnancy and promotion

8 of use of folic acid vitamin supplements for women

9 of childbearing age in a manner which is sensitive to

10 the cultural and linguistic context of a given commu11 nity.

12 ‘‘(e) ADVISORY COMMITTEE.—

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

14 Secretary shall establish an Advisory Committee for

15 Birth Defects Prevention (in this subsection referred

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

17 advice and recommendations on prevention and ame18 lioration of birth defects to the Secretary and the

19 Director of the Centers for Disease Control.

20 ‘‘(2) FUNCTIONS.—With respect to birth de21 fects prevention, the Committee shall—

22 ‘‘(A) make recommendations regarding

23 prevention research and intervention priorities;
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1 ‘‘(B) study and recommend ways to pre2 vent birth defects, with emphasis on emerging

3 technologies;

4 ‘‘(C) identify annually the important areas

5 of government and nongovernment cooperation

6 needed to implement prevention strategies;

7 ‘‘(D) identify research and prevention

8 strategies which would be successful in address9 ing birth defects disparities among the major

10 Hispanic subgroups, non-Hispanic whites, Afri11 can Americans, Native Americans, and Asian

12 Americans; and

13 ‘‘(E) review and recommend policies and

14 guidance related to birth defects research and

15 prevention.

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

17 composed of 15 members appointed by the Sec18 retary, including—

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

20 employees of the United States, who have ex21 pertise in issues related to prevention of or care

22 for children with birth defects;

23 ‘‘(B) two representatives from health pro24 fessional associations;
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1 ‘‘(C) four representatives from voluntary

2 health agencies concerned with conditions lead3 ing to birth defects or childhood disability;

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

5 whom at least three shall be parents of children

6 with birth defects or persons having birth de7 fects; and

8 ‘‘(E) representatives of the Public Health

9 Service agencies involved in birth defects re10 search and prevention programs and represent11 atives or other appropriate Federal agencies, in12 cluding but not limited to the Department of

13 Education and the Environmental Protection

14 Agency, shall be appointed as ex officio, liaison

15 members for purposes of informing the Com16 mittee regarding Federal agency policies and

17 practices;

18 ‘‘(4) STRUCTURE.—

19 ‘‘(A) TERM OF OFFICE.—Appointed mem20 bers of the Committee shall be appointed for a

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

22 members first appointed, 5 shall be appointed

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

24 a term of 2 years, and 5 shall be appointed for
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1 a term of 3 years, as determined by the Sec2 retary.

3 ‘‘(B) MEETINGS.—The Committee shall

4 meet not less than three times per year and at

5 the call of the chair.

6 ‘‘(C) COMPENSATION.—Members of the

7 Committee who are employees of the Federal

8 Government shall serve without compensation.

9 Members of the Committee who are not employ10 ees of the Federal Government shall be com11 pensated at a rate not to exceed the daily equiv12 alent of the rate in effects for grade GS–18.

13 ‘‘(f) REPORT.—The Secretary shall prepare and sub14 mit to the Committee on Energy and Commerce of the

15 House of Representatives and the Committee on Labor

16 and Human Resources of the Senate a biennial report re17 garding the incidence of birth defects, the contribution of

18 birth defects to infant mortality, the outcome of implemen19 tation of prevention strategies, and identified needs for re20 search and policy development to include information re21 garding the various racial and ethnic groups, including

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

23 Americans, and Asian Americans.

24 ‘‘(g) AUTHORIZATION OF APPROPRIATIONS.—
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1 ‘‘(1) For the purpose of carrying out sub2 sections (a), (b), and (c), there are authorized to be

3 appropriated $15,000,000 for fiscal year 1994,

4 $20,000,000 for fiscal year 1995, and such sums as

5 may be necessary for each of the fiscal years 1996

6 and 1997.

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

8 (d), there are authorized to be appropriated

9 $15,000,000 for fiscal year 1994, $20,000,000 for

10 fiscal year 1995, and such sums as may be nec11 essary for each of the fiscal years 1996 and 1997.

12 ‘‘(3) For the purpose of carrying out sub13 sections (e) and (f), there are authorized to be ap14 propriated $2,000,000 for each of the fiscal years

15 1994 through 1997.’’.

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