[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.
* * * * * * *