A- Authorizing Legislation

42 USC 247b_4.pdf

Birth Defects Study to Evaluate Pregnancy exposureS (BD-STEPS)

A- Authorizing Legislation

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§ 247b–3a

TITLE 42—THE PUBLIC HEALTH AND WELFARE

which insurance has paid for such treatment);
and
(4) provide for any applied research necessary to improve the effectiveness of programs for the prevention of lead poisoning in
infants and children.
(July 1, 1944, ch. 373, title III, § 317B, as added
Pub. L. 102–531, title III, § 303(b), Oct. 27, 1992, 106
Stat. 3488; amended Pub. L. 103–43, title XX,
§ 2008(i)(1)(B)(i), June 10, 1993, 107 Stat. 212.)
AMENDMENTS
1993—Pub. L. 103–43 made technical amendment to directory language of Pub. L. 102–531, § 303(b), which enacted this section.
CHANGE OF NAME
Committee on Labor and Human Resources of Senate
changed to Committee on Health, Education, Labor,
and Pensions of Senate by Senate Resolution No. 20,
One Hundred Sixth Congress, Jan. 19, 1999.
Committee on Energy and Commerce of House of
Representatives treated as referring to Committee on
Commerce of House of Representatives by section 1(a)
of Pub. L. 104–14, set out as a note preceding section 21
of Title 2, The Congress. Committee on Commerce of
House of Representatives changed to Committee on Energy and Commerce of House of Representatives, and
jurisdiction over matters relating to securities and exchanges and insurance generally transferred to Committee on Financial Services of House of Representatives by House Resolution No. 5, One Hundred Seventh
Congress, Jan. 3, 2001.

§ 247b–3a. Training and reports by the Health Resources and Services Administration
(a) Training
The Secretary of Health and Human Services,
acting through the Administrator of the Health
Resources and Services Administration and in
collaboration with the Administrator of the
Centers for Medicare & Medicaid Services and
the Director of the Centers for Disease Control
and Prevention, shall conduct education and
training programs for physicians and other
health care providers regarding childhood lead
poisoning, current screening and treatment recommendations and requirements, and the scientific, medical, and public health basis for
those policies.
(b) Report
The Secretary of Health and Human Services,
acting through the Administrator of the Health
Resources and Services Administration, annually shall report to Congress on the number of
children who received services through health
centers established under section 254b of this
title and received a blood lead screening test
during the prior fiscal year, noting the percentage that such children represent as compared to
all children who received services through such
health centers.
(c) Authorization of appropriations
There are authorized to be appropriated to
carry out this section such sums as may be necessary for each 1 the fiscal years 2001 through
2005.
(Pub. L. 106–310, div. A, title XXV, § 2503, Oct. 17,
2000, 114 Stat. 1163; Pub. L. 108–173, title IX,
§ 900(e)(6)(E), Dec. 8, 2003, 117 Stat. 2374.)
1 So

in original. Probably should be followed by ‘‘of’’.

Page 162

CODIFICATION
Section was enacted as part of the Children’s Health
Act of 2000, and not as part of the Public Health Service
Act which comprises this chapter.
AMENDMENTS
2003—Subsec. (a). Pub. L. 108–173 substituted ‘‘Centers
for Medicare & Medicaid Services’’ for ‘‘Health Care Financing Administration’’.

§ 247b–4. National Center on Birth Defects and
Developmental Disabilities
(a) In general
(1) National Center
There is established within the Centers for
Disease Control and Prevention a center to be
known as the National Center on Birth Defects
and Developmental Disabilities (referred to in
this section as the ‘‘Center’’), which shall be
headed by a director appointed by the Director
of the Centers for Disease Control and Prevention.
(2) General duties
The Secretary shall carry out programs—
(A) to collect, analyze, and make available
data on birth defects, developmental disabilities, and disabilities and health (in a manner that facilitates compliance with subsection (c)(2) of this section), 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;
(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.
(3) Folic acid
The Secretary shall carry out section 247b–11
of this title through the Center.
(4) Certain programs
(A) Transfers
All programs and functions described in
subparagraph (B) are transferred to the Center, effective upon the expiration of the 180day period beginning on October 17, 2000.
(B) Relevant programs
The programs and functions described in
this subparagraph are all programs and functions that—
(i) relate to birth defects; folic acid; cerebral palsy; intellectual disabilities; child
development; newborn screening; autism;
fragile X syndrome; fetal alcohol syndrome; pediatric genetic disorders; disability prevention; or other relevant diseases,
disorders, or conditions as determined 1 the
Secretary; and
1 So

in original. Probably should be followed by the word ‘‘by’’.

Page 163

TITLE 42—THE PUBLIC HEALTH AND WELFARE

(ii) were carried out through the National Center for Environmental Health as
of the day before October 17, 2000.
(C) Related transfers
Personnel employed in connection with
the programs and functions specified in subparagraph (B), and amounts available for
carrying out the programs and functions, are
transferred to the Center, effective upon the
expiration of the 180-day period beginning on
October 17, 2000. Such transfer of amounts
does not affect the period of availability of
the amounts, or the availability of the
amounts with respect to the purposes for
which the amounts may be expended.
(b) Grants and contracts
(1) In general
In carrying out subsection (a) of this section, the Secretary may make grants to and
enter into contracts with public and nonprofit
private entities.
(2) Supplies and services in lieu of award
funds
(A) Upon the request of a recipient of an
award of a grant or contract under paragraph
(1), the Secretary may, subject to subparagraph (B), provide supplies, equipment, and
services for the purpose of aiding the recipient
in carrying out the purposes for which the
award is made and, for such purposes, may detail to the recipient any officer or employee of
the Department of Health and Human Services.
(B) With respect to a request described in
subparagraph (A), the Secretary shall reduce
the amount of payments under the award involved by an amount equal to the costs of detailing personnel and the fair market value of
any supplies, equipment, or services provided
by the Secretary. The Secretary shall, for the
payment of expenses incurred in complying
with such request, expend the amounts withheld.
(3) Application for award
The Secretary may make an award of a
grant or contract under paragraph (1) only if
an application for the award is submitted to
the Secretary and the application is in such
form, is made in such manner, and contains
such agreements, assurances, and information
as the Secretary determines to be necessary to
carry out the purposes for which the award is
to be made.
(c) Biennial report
Not later than February 1 of fiscal year 1999
and of every second such year thereafter, the
Secretary shall submit to the Committee on
Commerce of the House of Representatives, and
the Committee on Labor and Human Resources
of the Senate, a report that, with respect to the
preceding 2 fiscal years—
(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;

§ 247b–4

(2) contains information under paragraph (1)
that is specific to various racial and ethnic
groups (including Hispanics, non-Hispanic
whites, Blacks, Native Americans, and Asian
Americans);
(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;
(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
(7) contains any recommendations of the
Secretary regarding this section.
(d) Applicability of privacy laws
The provisions of this section shall be subject
to the requirements of section 552a of title 5. 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 December 3, 2003.
(f) Authorization of appropriations
For the purpose of carrying out this section,
there are authorized to be appropriated such
sums as may be necessary for each of fiscal
years 2003 through 2007.
(July 1, 1944, ch. 373, title III, § 317C, as added
Pub. L. 102–531, title III, § 306(a), Oct. 27, 1992, 106
Stat. 3494; amended Pub. L. 103–43, title XX,
§ 2008(i)(1)(B)(iii), June 10, 1993, 107 Stat. 213;
Pub. L. 105–168, § 2, Apr. 21, 1998, 112 Stat. 43;
Pub. L. 106–310, div. A, title VI, § 611, Oct. 17,
2000, 114 Stat. 1119; Pub. L. 108–154, § 2, Dec. 3,
2003, 117 Stat. 1933; Pub. L. 111–256, § 2(f)(1), Oct.
5, 2010, 124 Stat. 2644.)
AMENDMENTS
2010—Subsec. (a)(4)(B)(i). Pub. L. 111–256 substituted
‘‘intellectual disabilities;’’ for ‘‘mental retardation;’’.
2003—Subsec. (a)(2)(A). Pub. L. 108–154, § 2(1)(A), substituted ‘‘, developmental disabilities, and disabilities
and health’’ for ‘‘and developmental disabilities’’ and
‘‘subsection (c)(2)’’ for ‘‘subsection (d)(2)’’.
Subsec. (a)(2)(D), (E). Pub. L. 108–154, § 2(1)(B)–(D),
added subpars. (D) and (E).
Subsecs. (b), (c). Pub. L. 108–154, § 2(2),(4), redesignated subsecs. (c) and (d) as (b) and (c), respectively,

§ 247b–4a

TITLE 42—THE PUBLIC HEALTH AND WELFARE

and struck out former subsec. (b) which related to additional provisions regarding collection of data.
Subsec. (d). Pub. L. 108–154, § 2(4), redesignated subsec.
(e) as (d). Former subsec. (d) redesignated (c).
Subsec. (d)(1). Pub. L. 108–154, § 2(3)(A), added par. (1)
and struck out former par. (1) which read as follows:
‘‘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;’’.
Subsec. (d)(3). Pub. L. 108–154, § 2(3)(B), inserted
‘‘, developmental disabilities, and secondary health
conditions among individuals with disabilities’’ after
‘‘defects’’.
Subsec. (d)(5) to (7). Pub. L. 108–154, § 2(3)(C)–(E),
added pars. (5) and (6) and redesignated former par. (5)
as (7).
Subsec. (e). Pub. L. 108–154, § 2(5), added subsec. (e).
Former subsec. (e) redesignated (d).
Subsec. (f). Pub. L. 108–154, § 2(6) substituted ‘‘such
sums as may be necessary for each of fiscal years 2003
through 2007.’’ for ‘‘$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.’’
2000—Pub. L. 106–310, § 611(1), substituted ‘‘National
Center on Birth Defects and Developmental Disabilities’’ for ‘‘Programs regarding birth defects’’ in section catchline.
Subsec. (a). Pub. L. 106–310, § 611(2), added subsec. (a)
and struck out heading and text of former subsec. (a)
relating to Secretary’s responsibility, acting through
the Centers for Disease Control and Prevention, to
carry out programs regarding birth defects.
Subsec. (b)(1). Pub. L. 106–310, § 611(3), substituted
‘‘subsection (a)(2)(A) of this section’’ for ‘‘subsection
(a)(1) of this section’’ in introductory provisions.
1998—Pub. L. 105–168 amended section generally, substituting present provisions for provisions which directed Secretary to encourage and assist States in collection and analysis of epidemiological data on birth
defects and to establish and maintain National Information Clearinghouse on Birth Defects, required report
not later than July 1, 1993, and biennially thereafter,
and authorized appropriations for fiscal years 1993, 1994,
and 1995.
1993—Pub. L. 103–43 made technical amendment to directory language of Pub. L. 102–531, § 306(a), which enacted this section.
CHANGE OF NAME
Committee on Commerce of House of Representatives
changed to Committee on Energy and Commerce of
House of Representatives, and jurisdiction over matters
relating to securities and exchanges and insurance generally transferred to Committee on Financial Services
of House of Representatives by House Resolution No. 5,
One Hundred Seventh Congress, Jan. 3, 2001.
Committee on Labor and Human Resources of Senate
changed to Committee on Health, Education, Labor,
and Pensions of Senate by Senate Resolution No. 20,
One Hundred Sixth Congress, Jan. 19, 1999.
CONGRESSIONAL FINDINGS
Pub. L. 105–168, § 1(b), Apr. 21, 1998, 112 Stat. 43, provided that: ‘‘Congress makes the following findings:
‘‘(1) Birth defects are the leading cause of infant
mortality, directly responsible for one out of every
five infant deaths.
‘‘(2) Thousands of the 150,000 infants born with a serious birth defect annually face a lifetime of chronic
disability and illness.
‘‘(3) Birth defects threaten the lives of infants of all
racial and ethnic backgrounds. However, some conditions pose excess risks for certain populations. For
example, compared to all infants born in the United
States, Hispanic-American infants are more likely to
be born with anencephaly spina bifida and other neural tube defects and African-American infants are
more likely to be born with sickle-cell anemia.

Page 164

‘‘(4) Birth defects can be caused by exposure to environmental hazards, adverse health conditions during pregnancy, or genetic mutations. Prevention efforts are slowed by lack of information about the
number and causes of birth defects. Outbreaks of
birth defects may go undetected because surveillance
and research efforts are underdeveloped and poorly
coordinated.
‘‘(5) Public awareness strategies, such as programs
using folic acid vitamin supplements to prevent spina
bifida and alcohol avoidance programs to prevent
Fetal Alcohol Syndrome, are essential to prevent the
heartache and costs associated with birth defects.’’
DEFINITIONS
For meaning of references to an intellectual disability and to individuals with intellectual disabilities in
provisions amended by section 2 of Pub. L. 111–256, see
section 2(k) of Pub. L. 111–256, set out as a note under
section 1400 of Title 20, Education.

§ 247b–4a. Early detection, diagnosis, and interventions for newborns and infants with hearing loss
(a) Definitions
For the purposes of this section only, the following terms in this section are defined as follows:
(1) Hearing screening
Newborn and infant hearing screening consists of objective physiologic procedures to detect possible hearing loss and to identify newborns and infants who, after rescreening, require further audiologic and medical evaluations.
(2) Audiologic evaluation
Audiologic evaluation consists of procedures
to assess the status of the auditory system; to
establish the site of the auditory disorder; the
type and degree of hearing loss, and the potential effects of hearing loss on communication;
and to identify appropriate treatment and referral options. Referral options should include
linkage to State IDEA part C coordinating
agencies or other appropriate agencies, medical evaluation, hearing aid/sensory aid assessment, audiologic rehabilitation treatment, national and local consumer, self-help, parent,
and education organizations, and other family-centered services.
(3) Medical evaluation
Medical evaluation by a physician consists
of key components including history, examination, and medical decision making focused
on symptomatic and related body systems for
the purpose of diagnosing the etiology of hearing loss and related physical conditions, and
for identifying appropriate treatment and referral options.
(4) Medical intervention
Medical intervention is the process by which
a physician provides medical diagnosis and direction for medical and/or surgical treatment
options of hearing loss and/or related medical
disorder associated with hearing loss.
(5) Audiologic rehabilitation
Audiologic rehabilitation (intervention) consists of procedures, techniques, and technologies to facilitate the receptive and expres-


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