89–006 

111TH CONGRESS REPORT " ! HOUSE OF REPRESENTATIVES 2d Session 111–642 

BIRTH DEFECTS PREVENTION, RISK REDUCTION, AND 

AWARENESS ACT OF 2010 

SEPTEMBER 28, 2010.—Committed to the Committee of the Whole House on the 

State of the Union and ordered to be printed 

Mr. WAXMAN, from the Committee on Energy and Commerce, 

submitted the following 

R E P O R T 

[To accompany H.R. 5462] 

[Including cost estimate of the Congressional Budget Office] 

The Committee on Energy and Commerce, to whom was referred 

the bill (H.R. 5462) to authorize the Secretary of Health and 

Human Services, acting through the Director of the Centers for 

Disease Control and Prevention, to establish and implement a birth 

defects prevention, risk reduction, and public awareness program, 

having considered the same, report favorably thereon with amendments and recommend that the bill as amended do pass. 

CONTENTS 

Page 

Amendment .............................................................................................................. 2 

Purpose and Summary ............................................................................................ 3 

Background and Need for Legislation .................................................................... 3 

Committee Consideration ........................................................................................ 3 

Committee Votes ...................................................................................................... 4 

Committee Oversight Findings and Recommendations ........................................ 4 

New Budget Authority, Entitlement Authority, and Tax Expenditures ............. 4 

Statement of General Performance Goals and Objectives .................................... 4 

Constitutional Authority Statement ...................................................................... 4 

Earmarks and Tax and Tariff Benefits .................................................................. 4 

Federal Advisory Committee Statement ................................................................ 4 

Applicability of Law to the Legislative Branch ..................................................... 5 

Federal Mandates Statement ................................................................................. 5 

Committee Cost Estimate ....................................................................................... 5 

Congressional Budget Office Cost Estimate .......................................................... 5 

Section-by-Section Analysis of the Legislation ...................................................... 7 

Explanation of Amendment .................................................................................... 7 

Changes in Existing Law Made by the Bill, as Reported ..................................... 7 


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AMENDMENT

The amendments are as follows: 

Strike all after the enacting clause and insert the following: 

SECTION 1. SHORT TITLE. 

This Act may be cited as the ‘‘Birth Defects Prevention, Risk Reduction, and 

Awareness Act of 2010’’. 

SEC. 2. BIRTH DEFECTS PREVENTION, RISK REDUCTION, AND AWARENESS. 

(a) PROGRAM.—The Public Health Service Act (42 U.S.C. 201 et seq.) is amended 

by inserting after section 317T (42 U.S.C. 247b-22) the following new section: 

‘‘SEC. 317U. BIRTH DEFECTS PREVENTION, RISK REDUCTION, AND AWARENESS. 

‘‘(a) GRANT PROGRAM.—The Secretary shall establish and implement a birth defects prevention and public awareness program to award grants to States or organizations for the provision of pregnancy and breastfeeding information services. 

‘‘(b) PREFERENCE.—In the case of States or organizations that are otherwise equally qualified, the Secretary, in awarding a grant under this section, shall give preference to— 

‘‘(1) States that made pregnancy and breastfeeding information services available on January 1, 2006; and 

‘‘(2) organizations that will provide pregnancy and breastfeeding information 

services in such States. 

‘‘(c) MATCHING FUNDS.—The Secretary may only award a grant under this section 

to a State or organization that agrees, with respect to the costs to be incurred in 

carrying out the grant activities, to make available (directly or through donations 

from public or private entities) non-Federal funds toward such costs in an amount 

equal to not less than 25 percent of the amount of the grant. 

‘‘(d) COORDINATION.—The Secretary shall ensure that activities carried out using 

a grant under this section are coordinated, to the maximum extent practicable, with 

other birth defects prevention and environmental health activities of the Federal 

Government, including activities carried out by the Health Resources and Services 

Administration and the Centers for Disease Control and Prevention with respect to 

pediatric environmental health specialty units and children’s environmental health 

centers. 

‘‘(e) EVALUATION.—In furtherance of the program established under subsection (a), 

the Secretary shall provide for an evaluation of pregnancy and breastfeeding information services to identify efficient and effective models of— 

‘‘(1) providing information; 

‘‘(2) raising awareness and increasing knowledge about birth defects prevention measures; 

‘‘(3) modifying risk behaviors; or 

‘‘(4) other outcome measures as determined appropriate by the Secretary. 

‘‘(f) PREGNANCY AND BREASTFEEDING INFORMATION SERVICES DEFINED.—For purposes of this section, the term ‘pregnancy and breastfeeding information services’ includes only— 

‘‘(1) information services to provide accurate, evidence-based, clinical information regarding maternal exposures during pregnancy or breastfeeding that may 

be associated with birth defects or other health risks to an infant that is 

breastfed, such as exposures to medications, chemicals, infections, foodborne 

pathogens, illnesses, nutrition, or lifestyle factors; 

‘‘(2) the provision of accurate, evidence-based information weighing risks of 

exposures during breastfeeding against the benefits of breastfeeding; and 

‘‘(3) the provision of information described in paragraph (1) or (2) through 

counselors, Web sites, fact sheets, telephonic or electronic communication, community outreach efforts, or other appropriate means. 

‘‘(g) AUTHORIZATION OF APPROPRIATIONS.—To carry out this section, there are authorized to be appropriated $4,500,000 for fiscal year 2012, $5,500,000 for fiscal year 

2013, $6,500,000 for fiscal year 2014, $7,500,000 for fiscal year 2015, and $8,500,000 

for fiscal year 2016.’’. 

Amend the title so as to read: 

A bill to amend title III of the Public Health Service Act to authorize the Secretary of Health and Human Services to establish and implement a birth defects 

prevention, risk reduction, and public awareness program. 


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PURPOSE AND SUMMARY

H.R. 5462, the ‘‘Birth Defects Prevention, Risk Reduction, and 

Awareness Act of 2010’’, was introduced by Rep. Rosa L. DeLauro 

(D–CT) on May 28, 2010, and referred to the Committee on Energy 

and Commerce. 

The goal of H.R. 5462 is to authorize funding for the establishment and implementation of a birth defects prevention and public 

awareness program. The bill amends the Public Health Service Act 

to establish a program to award grants to states or organizations 

for the provision of pregnancy and breastfeeding information services. 

BACKGROUND AND NEED FOR LEGISLATION

Pregnancy risk information services provide clinical information 

and consultation to pregnant women and their healthcare providers 

regarding exposures to medications, chemicals, illicit drugs, alcohol, 

infections, and illnesses that may pose a risk of birth defects, a risk 

to the pregnancy, or a risk to the mother while pregnant. These 

services also provide information on exposures during 

breastfeeding. 

State funding for pregnancy risk information services has declined dramatically in recent years. According to the Organization 

of Teratology Specialists, in 1995 there were more than 30 pregnancy risk information services across the country. Today there are 

fewer than 15 and those that remain have sustained budget cuts 

forcing reductions in staffing, counseling availability, satellite locations, and outreach to both the medical community and the public. 

In addition, there are currently no federal programs that provide 

the grant support proposed in the bill for these counseling services. 

Various efforts based at the Department of Health and Human 

Services (HHS) provide research and information services with respect to birth defects and their causes. One of these efforts is the 

National Center for Birth Defects and Developmental Disabilities 

administered through the Centers for Disease Control and Prevention (CDC). None is designed, however, to provide the counseling 

and clinical information services authorized in H.R. 5462. 

COMMITTEE CONSIDERATION

H.R. 5462, the ‘‘Birth Defects Prevention, Risk Reduction, and 

Awareness Act of 2010’’, was introduced by Ms. DeLauro of Connecticut on May 28, 2010, and referred to the Committee on Energy 

and Commerce. The bill was subsequently referred to the Subcommittee on Health on June 8, 2010. On September 15, 2010, the 

Subcommittee held a legislative hearing on the bill. The Subcommittee met in open markup session to consider H.R. 5462 on 

September 16, 2010. An amendment in the nature of a substitute 

(manager’s amendment) offered by Mr. Pallone of New Jersey was 

adopted by a voice vote. Subsequently, H.R. 5462 was favorably forwarded to the full Committee, amended, by a voice vote. 

On September 23, 2010, the Committee on Energy and Commerce met in open markup session and considered H.R. 5462 as approved by the Subcommittee. There were no amendments offered in 

full Committee and subsequently the Committee ordered H.R. 5462 


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favorably reported to the House, as amended by the Subcommittee 

on Health, by a voice vote. 

COMMITTEE VOTES

Clause 3(b) of rule XIII of the Rules of the House of Representatives requires the Committee to list each record vote on the motion 

to report legislation and amendments thereto. A motion by Mr. 

Waxman ordering H.R. 5462 reported to the House, as amended, 

was approved by a voice vote. There were no record votes taken 

during consideration of this bill. 

COMMITTEE OVERSIGHT FINDINGS AND RECOMMENDATIONS

In compliance with clause 3(c)(1) of rule XIII and clause (2)(b)(1) 

of rule X of the Rules of the House of Representatives, the oversight findings and recommendations are reflected in the descriptive 

portions of this report, including the finding that state funding for 

pregnancy risk information services has declined dramatically in 

recent years. 

NEW BUDGET AUTHORITY, ENTITLEMENT AUTHORITY, AND TAX

EXPENDITURES

Regarding compliance with clause 3(c)(2) of rule XIII of the Rules 

of the House of Representatives, the Committee finds that H.R. 

5462 would result in no new budget authority, entitlement authority, or tax expenditures or revenues. 

STATEMENT OF GENERAL PERFORMANCE GOALS AND OBJECTIVES

In accordance with clause 3(c)(4) of rule XIII of the Rules of the 

House of Representatives, the performance goals and objectives of 

the Committee are reflected in the descriptive portions of this report, including the goal of providing for a grant program regarding 

the provision of pregnancy and breastfeeding information services. 

CONSTITUTIONAL AUTHORITY STATEMENT

Pursuant to clause 3(d)(1) of rule XIII of the Rules of the House 

of Representatives, the Committee finds that the constitutional authority for H.R. 5462 is provided under article I, section 8, clauses 

3 and 18 of the Constitution of the United States. 

EARMARKS AND TAX AND TARIFF BENEFITS

H.R. 5462 does not contain any congressional earmarks, limited 

tax benefits, or limited tariff benefits as defined in clause 9 of rule 

XXI of the Rules of the House of Representatives. 

FEDERAL ADVISORY COMMITTEE STATEMENT

The Committee finds that the legislation does not establish or 

authorize the establishment of an advisory committee within the 

definition of 5 U.S.C. App., section 5(b) of the Federal Advisory 

Committee Act. 


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APPLICABILITY OF LAW TO THE LEGISLATIVE BRANCH

Section 102(b)(3) of Public Law 104–1 requires a description of 

the application of this bill to the legislative branch where the bill 

relates to terms and conditions of employment or access to public 

services and accommodations. H.R. 5462 contains no such provisions. 

FEDERAL MANDATES STATEMENT

Section 423 of the Congressional Budget and Impoundment Control Act of 1974 (as amended by section 101(a)(2) of the Unfunded 

Mandates Reform Act, Public Law 104–4) requires a statement on 

whether the provisions of the report include unfunded mandates. 

In compliance with this requirement the Committee adopts as its 

own the analysis of federal mandates prepared by the Director of 

the Congressional Budget Office regarding H.R. 5462. 

COMMITTEE COST ESTIMATE

Pursuant to clause 3(d)(2) of rule XIII of the Rules of the House 

of Representatives, the Committee adopts as its own the cost estimate of H.R. 5462 prepared by the Director of the Congressional 

Budget Office pursuant to section 402 of the Congressional Budget 

Act of 1974. 

CONGRESSIONAL BUDGET OFFICE COST ESTIMATE

With respect to the requirements of clause (3)(c)(3) of rule XIII 

of the Rules of the House of Representatives and section 402 of the 

Congressional Budget Act of 1974, the Committee has received the 

following cost estimate for H.R. 5462 from the Director of Congressional Budget Office: 

U.S. CONGRESS, 

CONGRESSIONAL BUDGET OFFICE, 

Washington, DC, September 27, 2010. 

Hon. HENRY A. WAXMAN, 

Chairman, Committee on Energy and Commerce, 

House of Representatives, Washington, DC. 

DEAR MR. CHAIRMAN: The Congressional Budget Office has prepared the enclosed cost estimate for H.R. 5462, the Birth Defects 

Prevention, Risk Reduction, and Awareness Act of 2010. 

If you wish further details on this estimate, we will be pleased 

to provide them. The CBO staff contact is Lara Robillard, who can 

be reached at 226–9010. 

Sincerely, 

DOUGLAS W. ELMENDORF. 

Enclosure. 

H.R. 5462—Birth Defects Prevention, Risk Reduction, and Awareness Act of 2010 

Summary: H.R. 5462 would amend the Public Health Service Act 

to establish a program to award grants to states and other organizations for the provision of pregnancy and breastfeeding information services. CBO estimates that implementing H.R. 5462 would 

cost $18 million over the 2011–2015 period, assuming appropriaVerDate Mar 15 2010 03:05 Oct 05, 2010 Jkt 089006 PO 00000 Frm 00005 Fmt 6659 Sfmt 6602 E:\HR\OC\HR642.XXX HR642

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tion of the authorized amounts. Enacting H.R. 5462 would not affect direct spending or revenues; therefore, pay-as-you-go procedures do not apply. 

H.R. 5462 contains no intergovernmental or private-sector mandates as defined in the Unfunded Mandates Reform Act (UMRA). 

Estimated cost to the Federal Government: The estimated budgetary impact of H.R. 5462 is shown in the following table. The costs 

of this legislation fall within budget function 550 (health). 

By fiscal year, in millions of dollars— 

2011 2012 2013 2014 2015 2011– 

2015 

CHANGES IN SPENDING SUBJECT TO APPROPRIATION 

Authorization Level ........................................................... 0 5 6 7 8 24 

Estimated Outlays ............................................................ 0 2 4 5 7 18 

Note: Components may not sum to totals because of rounding. 

Basis of estimate: H.R. 5462 would direct the Secretary of Health 

and Human Services, acting through the Director of the Centers for 

Disease Control and Prevention (CDC), to establish a program to 

promote public awareness for prevention of birth defects. To implement the program, the Secretary would award grants to states or 

organizations for the provision of information about pregnancy and 

breastfeeding. Pregnancy and breastfeeding information is defined 

as clinical information regarding maternal exposure during pregnancy or breastfeeding that may be associated with birth defects or 

other infant health risks. 

In making grant decisions, the Secretary would give preference 

to states that have previously made available pregnancy and 

breastfeeding information and to organizations that will make such 

information available. The Secretary could only award grants to 

states and organizations that make available nonfederal matching 

funds equal to at least 25 percent of the amount of the grant. 

The bill would authorize the appropriation of specific amounts 

each year for fiscal year 2012 through 2016. Based on historical 

patterns of spending for grant programs administered by CDC and 

assuming appropriation of the authorized amounts, CBO estimates 

that implementing the bill would cost $18 million over the 2012– 

2015 period and an additional $14 million after 2015. 

Pay-As-You-Go considerations: None. 

Intergovernmental and private-sector impact: H.R. 5462 contains 

no intergovernmental or private-sector mandates as defined in 

UMRA. Grant funds authorized in the bill would benefit states that 

provide information services regarding pregnancy and 

breastfeeding. Any costs to states, including matching funds, would 

be incurred voluntarily as a condition of federal assistance. 

Estimate prepared by: Federal costs: Lara Robillard; Impact on 

state, local, and tribal governments: Lisa Ramirez-Branum; Impact 

on the private sector: Sarah Axeen. 

Estimate approved by: Holly Harvey, Deputy Assistant Director 

for Budget Analysis. 


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SECTION-BY-SECTION ANALYSIS OF THE LEGISLATION

Section 1. Short title 

Section 1 designates that the Act may be cited as the ‘‘Birth Defects Prevention, Risk Reduction, and Awareness Act of 2010’’. 

Section 2. Birth defects prevention, risk reduction, and awareness 

Section 2 requires the Secretary of Health and Human Services 

to establish and implement a birth defects prevention and public 

awareness program about pregnancy and breastfeeding information 

services. It also requires the Secretary to award grants to states 

and organizations for the provision of pregnancy and breastfeeding 

information services. In awarding such grants, preference is to be 

given to states or organizations providing pregnancy and 

breastfeeding services on January 1, 2006. The section authorizes $4.5 million for FY2012; $5.5 million for 

FY2013; $6.5 million for FY2014; $7.5 million for FY2015; and $8.5 

million for FY2016 to carry out the activities under this section. 

EXPLANATION OF AMENDMENT

During the Subcommittee on Health markup of H.R. 5462, Mr. 

Pallone of New Jersey offered an amendment in the nature of a 

substitute (manager’s amendment), which was adopted by a voice 

vote. The substance of this substitute amendment is reflected in 

the section-by-section analysis contained in this report. 

CHANGES IN EXISTING LAW MADE BY THE BILL, AS REPORTED

In compliance with clause 3(e) of rule XIII of the Rules of the 

House of Representatives, changes in existing law made by the bill, 

as reported, are shown as follows (new matter is printed in italic 

existing law in which no change is proposed is shown in roman): 

PUBLIC HEALTH SERVICE ACT 

* * * * * * * 

TITLE III—GENERAL POWERS AND DUTIES OF PUBLIC 

HEALTH SERVICE 

* * * * * * * 

PART B—FEDERAL-STATE COOPERATION

* * * * * * * 

SEC. 317U. BIRTH DEFECTS PREVENTION, RISK REDUCTION, AND 

AWARENESS. 

(a) GRANT PROGRAM.—The Secretary shall establish and implement a birth defects prevention and public awareness program to 

award grants to States or organizations for the provision of pregnancy and breastfeeding information services. 

(b) PREFERENCE.—In the case of States or organizations that are 

otherwise equally qualified, the Secretary, in awarding a grant 

under this section, shall give preference to— 

(1) States that made pregnancy and breastfeeding information services available on January 1, 2006; and 


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(2) organizations that will provide pregnancy and 

breastfeeding information services in such States. 

(c) MATCHING FUNDS.—The Secretary may only award a grant 

under this section to a State or organization that agrees, with respect to the costs to be incurred in carrying out the grant activities, 

to make available (directly or through donations from public or private entities) non-Federal funds toward such costs in an amount 

equal to not less than 25 percent of the amount of the grant. 

(d) COORDINATION.—The Secretary shall ensure that activities 

carried out using a grant under this section are coordinated, to the 

maximum extent practicable, with other birth defects prevention and 

environmental health activities of the Federal Government, including activities carried out by the Health Resources and Services Administration and the Centers for Disease Control and Prevention 

with respect to pediatric environmental health specialty units and 

children’s environmental health centers. 

(e) EVALUATION.—In furtherance of the program established 

under subsection (a), the Secretary shall provide for an evaluation 

of pregnancy and breastfeeding information services to identify efficient and effective models of— 

(1) providing information; 

(2) raising awareness and increasing knowledge about birth 

defects prevention measures; 

(3) modifying risk behaviors; or 

(4) other outcome measures as determined appropriate by the 

Secretary. 

(f) PREGNANCY AND BREASTFEEDING INFORMATION SERVICES DEFINED.—For purposes of this section, the term ‘‘pregnancy and 

breastfeeding information services’’ includes only— 

(1) information services to provide accurate, evidence-based, 

clinical information regarding maternal exposures during pregnancy or breastfeeding that may be associated with birth defects 

or other health risks to an infant that is breastfed, such as exposures to medications, chemicals, infections, foodborne pathogens, illnesses, nutrition, or lifestyle factors; 

(2) the provision of accurate, evidence-based information 

weighing risks of exposures during breastfeeding against the 

benefits of breastfeeding; and 

(3) the provision of information described in paragraph (1) or 

(2) through counselors, Web sites, fact sheets, telephonic or electronic communication, community outreach efforts, or other appropriate means. 

(g) AUTHORIZATION OF APPROPRIATIONS.—To carry out this section, there are authorized to be appropriated $4,500,000 for fiscal 

year 2012, $5,500,000 for fiscal year 2013, $6,500,000 for fiscal year 

2014, $7,500,000 for fiscal year 2015, and $8,500,000 for fiscal year 

2016. 

* * * * * * * 

Æ 


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