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[House Report 111-642]
[From the U.S. Government Publishing Office]


111th Congress                                                   Report
  2d Session                  HOUSE OF REPRESENTATIVES          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

                               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.

                          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 
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.

             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 
appropriation 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 APPROPRIATIONAuthorization 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.

             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
          (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.

           *       *       *       *       *       *       *