[Senate Report 108-188]
[From the U.S. Government Publishing Office]



                                                       Calendar No. 369
108th Congress                                                   Report
                                 SENATE
 1st Session                                                    108-188

======================================================================



 
  BIRTH DEFECTS AND DEVELOPMENTAL DISABILITIES PREVENTION ACT OF 2003

                                _______
                                

                November 6, 2003.--Ordered to be printed

                                _______
                                

    Mr. Gregg, from the Committee on Health, Education, Labor, and 
                   Pensions, submitted the following

                              R E P O R T

                         [To accompany S. 286]

    The Committee on Health, Education, Labor, and Pensions, to 
which was referred the bill (S. 286) to revise and extend the 
Birth Defects Prevention Act of 1998, having considered the 
same, reports favorably thereon with an amendment in the nature 
of a substitute and recommends that the bill (as amended) do 
pass.

                                CONTENTS

                                                                   Page
  I. Purpose and need for legislation.................................1
 II. Summary..........................................................2
III. History of legislation and votes in committee....................2
 IV. Explanation of bill and committee views..........................2
  V. Cost estimate....................................................3
 VI. Regulatory impact statement......................................5
VII. Application of law to the legislative branch.....................5
VIII.Section-by-section analysis......................................5

 IX. Changes in existing law..........................................6

                  I. Purpose and Need for Legislation

    There is still much work to be done to improve the health 
of all Americans by preventing birth defects and developmental 
disabilities in children. Of the four million babies born each 
year in the United States, approximately 150,000 are born with 
one or more serious birth defects. Birth defects are the 
leading cause of infant mortality and responsible for about 30 
percent of all pediatric hospital admissions. The lifetime 
economic costs of caring for infants born in a single year with 
a serious birth defect have been estimated at $8 billion. The 
causes of about 70 percent of birth defects are still unknown.
    About 17 percent of U.S. children under 18 years of age 
have a developmental disability. Developmental disabilities are 
a diverse group of physical, cognitive, psychological, sensory, 
and speech impairments that begin anytime during development up 
to 18 years of age. In most instances, the cause of the 
disability is not known. State and Federal education 
departments spend about $36 billion each year on special 
education programs for individuals with developmental 
disabilities who are 3-21 years old.
    In 1998, Congress passed the Birth Defects Prevention Act 
(P.L. 105-168), which authorized CDC to provide surveillance, 
research, and services aimed at the prevention of birth 
defects. Then Congress passed the Children's Health Act of 2000 
(P.L. 106-310), which established the National Center on Birth 
Defects and Developmental Disabilities at CDC to focus on 
improving the health of children by preventing birth defects 
and developmental disabilities. Authorization of appropriations 
for the National Center on Birth Defects and Developmental 
Disabilities expired in fiscal year 2002.

                              II. Summary

    S. 286, the Birth Defects and Developmental Disabilities 
Prevention Act, reauthorizes the activities of the National 
Center on Birth Defects and Developmental Disabilities (NCBDDD) 
at the Centers for Disease Control and Prevention (CDC). The 
legislation authorizes the full scope of activities being 
conducted by NCBDDD.
    In addition, the Birth Defects and Developmental 
Disabilities Prevention Act amends the Family Educational 
Rights and Privacy Act to authorize the CDC to collect data 
from educational records necessary for data collection on 
developmental disabilities (such as autism and fetal alcohol 
syndrome).

           III. History of Legislation and Votes in Committee

    On February 4, 2003, Senator Bond, for himself and Senators 
Dodd, Frist and Kennedy, introduced S. 286, to revise and 
extend the Birth Defects Prevention Act of 1998.
    On February 12, 2003, the committee held an executive 
session to consider S. 286. The committee approved S. 286 by 
unanimous voice vote.

              IV. Explanation of Bill and Committee Views

    The Committee sought to authorize the full scope of 
activities for the National Center on Birth Defects and 
Developmental Disabilities, including data collection and 
analysis on not only birth defects, but also developmental 
disabilities.
    In addition, the committee establishes a new national 
program on Spina Bifida at the CDC, recognizing the importance 
of addressing this condition. Spina Bifida is the most common, 
permanently disabling birth defect consistent with life and it 
is largely preventable. To date, very few Federal efforts have 
been directed toward surveillance, prevention, basic research 
and quality of life interventions for Spina Bifida. The 
committee recognizes critical advances in the practice of 
medicine and public health interventions that could prevent 
this tragic disease or intervene early enough during pregnancy 
to mitigate its effects.
    The committee recognizes the importance of allowing the CDC 
to access educational records as part of its research on 
developmental disabilities. The bill amends the Family 
Educational Rights and Privacy Act to allow the CDC to access 
educational records for public health research related to 
developmental disabilities such as autism.
    The committee is pleased that the congressionally mandated 
Spina Bifida Research Conference, sponsored by the CDC, 
occurred in May this year and the bill provides that 
recommendations arising from this conference be included in the 
Secretary's report on the activities of the NCBDDD.
    The bill improves the ability of the NCBDDD to obtain 
technical, scientific and stakeholder input by shifting the 
birth defects expertise from the Advisory Committee at the 
National Center for Environmental Health to an Advisory 
Committee for the NCBDDD.
    The bill corrects a formula error affecting State 
Developmental Disabilities Councils.

                            V. Cost Estimate

                                     U.S. Congress,
                               Congressional Budget Office,
                                     Washington, DC, March 5, 2003.
Hon. Judd Gregg,
Chairman, Committee on Health, Education, Labor, and Pensions, U.S. 
        Senate, Washington, DC.
    Dear Mr. Chairman: The Congressional Budget Office has 
prepared the enclosed cost estimate for S. 286, the Birth 
Defects and Developmental Disabilities Prevention Act of 2003.
    If you wish further details on this estimate, we will be 
pleased to provide them. The CBO staff contact is Jeanne De Sa.
            Sincerely,
                                       Douglas Holtz-Eakin,
                                                          Director.
    Enclosure.

S. 286--Birth Defects and Developmental Disabilities Prevention Act of 
        2003

    Summary: S. 286 would amend the Public Health Service Act 
to reauthorize and clarify activities conducted by the National 
Center on Birth Defects and Developmental Disabilities of the 
Centers for Disease Control and Prevention (CDC). The bill 
would authorize the appropriation of such sums as may be 
necessary for fiscal years 2003 through 2007 for that purpose. 
(The previous authorization for the National Center on Birth 
Defects and Developmental Disabilities expired at the end of 
fiscal year 2002.) Additionally, the bill would change the 
allotment formula for grants to State Councils on Developmental 
Disabilities.
    Assuming appropriation of the necessary amounts (including 
annual adjustments for anticipated inflation), CBO estimates 
that implementing S. 286 would cost $32 million in 2004 and 
$381 million over the 2004-2008 period. (Without such inflation 
adjustments, the change in outlays would total $369 million 
over the 2004-2008 period.) Enacting this legislation would not 
affect direct spending or revenues.
    S. 286 contains no intergovernmental or private-sector 
mandates as defined in the Unfunded Mandates Reform Act (UMRA) 
and would impose no costs on state, local, or tribal 
governments.
    Estimated cost to the Federal Government: The estimated 
budgetary impact of S. 286 is shown in the following table. The 
costs of this legislation fall within budget function 550 
(health).

----------------------------------------------------------------------------------------------------------------
                                                                  By fiscal year, in millions of dollars--
                                                           -----------------------------------------------------
                                                              2003     2004     2005     2006     2007     2008
----------------------------------------------------------------------------------------------------------------
                                        SPENDING SUBJECT TO APPROPRIATION

CDC Spending Under Current Law for Birth Defects and
 Developmental Disabilities:
    Budget Authority \1\..................................       99        0        0        0        0        0
    Estimated Outlays.....................................       31       44       18        4        2        0
Proposed Changes \2\:
    Estimated Authorization Level.........................        0      101      103      106      108        0
    Estimated Outlays.....................................        0       32       77       97      103       72
CDC Spending Under S. 286 for Birth Defects and
 Developmental Disabilities:
    Estimated Authorization Level \1\.....................       99      101      103      106      108        0
    Estimated Outlays.....................................       31       76       95      101      105       72
----------------------------------------------------------------------------------------------------------------
\1\ The 2003 figure is the amount appropriated for that year for activities under CDC's National Center for
  Birth Defects and Developmental Disabilities program.
\2\ The amounts shown reflect adjustments for anticipated inflation for those activities for which the bill
  would authorize such sums as necessary. Without such inflation adjustments, the five-year changes in
  authorization levels would total $404 million (instead of $418 million) and the changes in outlays would total
  $369 million (instead of $381 million).

    Basis of estimate: For this estimate, CBO assumes S. 286 
will be enacted by the end of this fiscal year, and that the 
necessary amounts will be appropriated for each year.
    CDC's National Center on Birth Defects and Developmental 
Disabilities conducts a range of data collection and research 
activities related to the prevention of birth defects and 
developmental disabilities. Those activities include 
surveillance and monitoring of birth defects and developmental 
disabilities such as mental retardation, cerebral palsy, and 
autism, research on the causes of birth defects, and an 
educational campaign to increase the consumption of folic acid 
to prevent spina bifida and anencephaly. Other activities focus 
on surveillance and prevention of Fetal Alcohol Syndrome and 
identification of ways to address the public health needs of 
persons with disabilities. The center's appropriation for 
fiscal year 2003 is $99 million.
    S. 286 would reauthorize the center's activities for the 
2003-2007 period and would authorize appropriations of such 
sums as may be necessary for that purpose. Additionally, the 
bill would clarify that the center's activities should 
encompass data collection on disabilities and health, research 
on the prevention of birth defects and disabilities and the 
prevention of secondary health conditions among people with 
disabilities, and support for a National Spina Bifida program. 
According to CDC, the center currently conducts such 
activities. Therefore, the clarifications in S. 286 would not 
result in a broader set of authorized activities.
    Based on the amount appropriated for the center in fiscal 
year 2003 and taking into account anticipated inflation, CBO 
estimates that the center would require appropriations of $418 
million for fiscal years 2004 and 2007. Assuming appropriation 
of such amounts and spending consistent with historical outlay 
rates, CBO estimates that implementing the bill would result in 
outlays of $32 million in 2004 and $381 million over the 2004-
2008 period.
    S. 286 also would make a technical change to the allotment 
formula for grants to State Councils on Developmental 
Disabilities, a program in which states use federal grant funds 
to provide services to individuals with disabilities. CBO 
estimates this change would have no effect on federal spending.
    Intergovernmental and private-sector impact: S. 286 
contains no intergovernmental or private-sector mandates as 
defined in UMRA and would impose no costs on state, local, or 
tribal governments.
    Previous CBO estimate: On February 11, 2003, CBO 
transmitted a cost estimate for H.R. 398, the Birth Defects and 
Developmental Disabilities Act of 2003, as ordered reported by 
the House Committee on Energy and Commerce on January 28, 2003. 
The bills are identical. CBO estimated that H.R. 398 would 
increase by $29 million in 2004 and $350 million over the 2004-
2008 period--$3 million and $31 million lower, respectively, 
than the current estimate. The difference is due entirely to 
higher projections of spending under current law as a result of 
enactment of the omnibus appropriations act (P.L. 108-7).
    Estimate prepared by: Federal Costs: Jeanne De Sa; Impact 
on State, Local, and Tribal Governments: Leo Lex; and Impact on 
the Private Sector: Samuel Kina.
    Estimate approved by: Robert A. Sunshine, Assistant 
Director for Budget Analysis.

                    VI. Regulatory Impact Statement

    The committee has determined that there will be minimal 
increases in the regulatory burden imposed by this bill.

           VII. Application of Law to the Legislative Branch

    The Committee has determined that there is no legislative 
impact.

                   VIII. Section-by-Section Analysis


Section 1. Short title

    Section 1 provides the short title of the bill, the Birth 
Defects and Developmental Disabilities Prevention Act of 2003.

Section 2. National Center on Birth Defects and Developmental 
        Disabilities

    Section 2 amends section 317C of the Public Health Service 
Act to authorize the National Center on Birth Defects and 
Developmental Disabilities to collect, analyze, and make 
available data on disabilities and health in addition to birth 
defects and developmental disabilities. In addition, NCBDDD has 
authority to support a National Spina Bifida Program to promote 
prevention and enhance the quality of life for those living 
with Spina Bifida. This section gives NCBDDD authority to 
conduct research and programs on the prevention of secondary 
conditions and the promotion of health and wellness in 
individuals living with disabilities. It amends the Family 
Educational Rights and Privacy Act to authorize NCBDDD to 
collect data from educational records that are necessary to 
conduct surveillance research on developmental disabilities 
while protecting the privacy of individuals and their families. 
This section also requires a biennial report to relevant 
congressional committees on the activities of the Center on 
Birth Defects and Developmental Disabilities including birth 
defects, developmental disabilities and disabilities and 
health. This report must include a summary of the 
recommendations from the 2003 Research Conference on Spina 
Bifida sponsored by the CDC, in collaboration with the Agency 
for Healthcare Research and Quality and individual institutes 
at the National Institutes of Health. Finally, this section 
transfers members of the Advisory Committee to the Director of 
the National Center for Environmental Health that have 
expertise in birth defects, developmental disabilities and 
disabilities and health to the Center on Birth Defects and 
Developmental Disabilities. The membership includes scientific 
experts, state health department representatives and parents of 
a child with a birth defect or groups concerned with birth 
defects, developmental disabilities and individuals living with 
a disability. Authorization of appropriations for the NCBDDD is 
permitted at a level of such sums as may be necessary for each 
of fiscal years 2003 through 2007.

Section 3. Technical corrections for state councils on developmental 
        disabilities

    Section 3 amends section 122(a) of the Developmental 
Disabilities Assistance and Bill of Rights Act of 2000 to 
insert additional consideration in the allotment for 
appropriations to States for funding Developmental Disabilities 
Councils. When appropriating dollars to states, this section 
states that the allotment may not be less than $400,000, the 
amount received by the state for the previous year, or the 
amount of Federal appropriations received in fiscal year 2000, 
2001, or 2002, whichever is greater if the amount appropriated 
in a fiscal year is less than $70,000,000. If the amount 
appropriated in a fiscal year is more than $70,000,000, then 
state allotments may not be less than $450,000, the amount 
received by the state for the previous fiscal years, or the 
amount of Federal appropriations received in fiscal year 2000, 
2001, or 2002, whichever is greater.

                      IX. Changes in Existing Law

    In compliance with rule XXVI paragraph 12 of the Standing 
Rules of the Senate, the following provides a print of the 
statute or the part or section thereof to be amended or 
replaced (existing law proposed to be omitted is enclosed in 
black brackets, new matter is printed in italic, existing law 
in which no change is proposed is shown in roman):

PUBLIC HEALTH SERVICE ACT

           *       *       *       *       *       *       *


    Birth Defects and Developmental Disabilities Prevention Act 
of 2003

           *       *       *       *       *       *       *


     TITLE III--GENERAL POWERS AND DUTIES OF PUBLIC HEALTH SERVICE

PART A--RESEARCH AND INVESTIGATION

           *       *       *       *       *       *       *


PART B--FEDERAL-STATE COOPERATION

           *       *       *       *       *       *       *


    NATIONAL CENTER ON BIRTH DEFECTS AND DEVELOPMENTAL DISABILITIES

    Sec. 371C. (a) In General.--
          (1) National center.--* * *
          (2) General duties.--The Secretary shall carry out 
        programs--
                  (A) to collect, analyze, and make available 
                data on birth defects [and developmental 
                disabilities], developmental disabilities, and 
                disabilities and health (in a manner that 
                facilitates compliance with [subsection 
                (d)(2)]), subsection (c)(2), including data on 
                the causes of such defects and disabilities and 
                on the incidence and prevalence of such defects 
                and disabilities;
                  (B) to operate regional centers for the 
                conduct of applied epidemiological research on 
                the prevention of such defects and 
                disabilities; [and]
                  (C) to provide information and education to 
                the public on the prevention of such defects 
                and disabilities[.];
                  (D) to conduct research on and to promote the 
                prevention of such defects and disabilities, 
                and secondary health conditions among 
                individuals with disabilities; and
                  (E) to support a National Spina Bifida 
                Program to prevent and reduce suffering from 
                the Nation's most common permanently disabling 
                birth defect.

           *       *       *       *       *       *       *

    [(b) Additional Provisions Regarding Collection of Data.--
          [(1) In general.--In carrying out subsection 
        (a)(2)(A), the Secretary--
                  [(A) shall collect and analyze data by gender 
                and by racial and ethnic group, including 
                Hispanics, non-Hispanic whites, Blacks, Native 
                Americans, Asian Americans, and Pacific 
                Islanders:
                  [(B) shall collect data under subparagraph 
                (A) from birth certificates, death 
                certificates, hospital records, and such other 
                sources as the Secretary determines to be 
                appropriate; and
                  [(C) shall encourage States to establish or 
                improve programs for the collection and 
                analysis of epidemiological data on birth 
                defects, and to make the data available.
          [(2) National clearinghouse.--In carrying out 
        subsection (a)(1), the Secretary shall establish and 
        maintain a National Information Clearinghouse on Birth 
        Defects to collect and disseminate to health 
        professionals and the general public information on 
        birth defects, including the prevention of such 
        defects.]
    [(c)] (b) Grants and Contracts.--

           *       *       *       *       *       *       *

    [(d) (c)] Biennial Report.--* * *
          [(1) contains information regarding the incidence and 
        prevalence of birth defects and the extent to which 
        birth defects have contributed to the incidence and 
        prevalence of infant mortality;]
          (1) contains information regarding the incidence and 
        prevalence of birth defects, developmental 
        disabilities, and the health status of individuals with 
        disabilities and the extent to which these conditions 
        have contributed to the incidence and prevalence of 
        infant mortality and affected quality of life;

           *       *       *       *       *       *       *

          (3) contains an assessment of the extent to which 
        various approaches of preventing birth defects, 
        developmental disabilities, and secondary health 
        conditions among individuals with disabilities have 
        been effective;
          (4) describes the activities carried out under this 
        section; [and]
          (5) contains information on the incidence and 
        prevalence of individuals living with birth defects and 
        disabilities or developmental disabilities, information 
        on the health status of individuals with disabilities, 
        information on any health disparities experienced by 
        such individuals, and recommendations for improving the 
        health and wellness and quality of life of such 
        individuals;
          (6) contains a summary of recommendations from all 
        birth defects research conferences sponsored by the 
        Centers for Disease Control and Prevention, including 
        conferences related to spina bifida; and
          [(5)] (7) contains any recommendations of the 
        Secretary regarding this section.
    [(e)] (d) Applicability of Privacy Laws.--The provisions of 
this section shall be subject to the requirements of section 
552a of title 5, United States Code. All Federal laws relating 
to the privacy of information shall apply to the data and 
information that is collected under this section.
    (e) Advisory Committee.--Notwithstanding any other 
provision of law, the members of the advisory committee 
appointed by the Director of the National Center for 
Environmental Health that have expertise in birth defects, 
developmental disabilities, and disabilities and health shall 
be transferred to and shall advise the National Center on Birth 
Defects and Developmental Disabilities effective on the date of 
enactment of the Birth Defects and Developmental Disabilities 
Prevention Act of 2003.
    (f) Authorization of Appropriations.--For the purpose of 
carrying out this section, there are authorized to be 
appropriated [$30,000,000 for fiscal year 1999, $40,000,000 for 
fiscal year 2000, and such sums as may be necessary for each of 
the fiscal years 2001 and 2002.] such sums as may be necessary 
for each of fiscal years 2003 through 2007.

           *       *       *       *       *       *       *


DEVELOPMENTAL DISABILITIES ASSISTANCE AND BILL OF RIGHTS ACT OF 2000

           *       *       *       *       *       *       *



   Subtitle B--Federal Assistance to State Councils on Developmental 
Disabilities

           *       *       *       *       *       *       *


SEC. 122. STATE ALLOTMENTS.

    (a) Allotments.--
          (1) In general.--

           *       *       *       *       *       *       *

                  (3) Minimum allotment for appropriations less 
                than or equal to $70,000,000.--* * *
                  (A) In general.--* * *
                          (i) * * *
                          (ii) to any State not described in 
                        clause (i) may not be less than 
                        $400,000, the amount received by the 
                        State for the previous year, or the 
                        amount of Federal appropriations 
                        received in fiscal year 2000, 2001, or 
                        2002, whichever is greater.

           *       *       *       *       *       *       *

          (4) Minimum allotment for appropriations in excess of 
        $70,000,000.--
                  (A) In general.-- * * *
                          (i) * * *
                          (ii) to any State not described in 
                        clause (i) may not be less than 
                        $450,000, the amount received by the 
                        State for the previous year, or the 
                        amount of Federal appropriations 
                        received in fiscal year 2000, 2001, or 
                        2002, whichever is greater.

           *       *       *       *       *       *       *


                                
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