Attachment B_USCODE-2018-title42-chap6A-subchapIX-partA-sec300b-10 (5)

§ 300b–9

TITLE 42—THE PUBLIC HEALTH AND WELFARE

Subsec. (j). Pub. L. 110–237 added subsec. (j) and
struck out former subsec. (j). Prior to amendment, text
read as follows: ‘‘There is authorized to be appropriated—
‘‘(1) to provide grants for the purpose of carrying
activities under section (a)(1), $15,000,000 for fiscal
year 2008; $15,187,500 for fiscal year 2009, $15,375,000 for
fiscal year 2010, $15,562,500 for fiscal year 2011, and
$15,750,000 for fiscal year 2012; and
‘‘(2) to provide grant for the purpose of carrying out
activities under paragraphs (2), (3), and (4) of subsection (a), $15,000,000 for fiscal year 2008, $15,187,500
for fiscal year 2009, $15,375,000 for fiscal year 2010,
$15,562,500 for fiscal year 2011, and $15,750,000 for fiscal
year 2012.’’
Pub. L. 110–204, § 2(4), added subsec. (j) and struck out
former subsec. (j). Prior to amendment, text read as
follows: ‘‘There are authorized to be appropriated to
carry out this section such sums as may be necessary
for each of the fiscal years 2001 through 2005.’’
Pub. L. 110–204, § 2(2), redesignated subsec. (i) as (j).

§ 300b–9. Evaluating the effectiveness of newborn
and child screening and followup programs
(a) In general
The Secretary shall award grants to eligible
entities to provide for the conduct of demonstration programs to evaluate the effectiveness, including with respect to timeliness, of screening,
followup, counseling or health care services in
reducing the morbidity and mortality caused by
heritable disorders in newborns and children.
(b) Demonstration programs
A demonstration program conducted under a
grant under this section shall be designed to
evaluate and assess, within the jurisdiction of
the entity receiving such grant—
(1) the effectiveness of screening, treatment,
counseling, testing, followup, or specialty
services for newborns and children at risk for
heritable disorders in reducing the morbidity
and mortality associated with such disorders,
including, as appropriate, through the assessment of health and development outcomes for
such children through adolescence;
(2) the effectiveness of screening, treatment,
counseling, testing, followup, or specialty
services in accurately and reliably diagnosing
heritable disorders in newborns and children
in a timely manner;
(3) the availability of screening, counseling,
testing or specialty services for newborns and
children at risk for heritable disorders;
(4) methods that may be identified to improve quality in the diagnosis, treatment, and
disease management of heritable disorders
based on gaps in services or care; or
(5) methods or best practices by which the
eligible entities described in section 300b–8 of
this title can achieve in a timely manner—
(A) collection, delivery, receipt, and
screening of newborn screening specimens;
and
(B) diagnosis of heritable disorders in newborns.
(c) Eligible entities
To be eligible to receive a grant under subsection (a) an entity shall be a State or political
subdivision of a State, or a consortium of two or
more States or political subdivisions of States.
(July 1, 1944, ch. 373, title XI, § 1110, as added
Pub. L. 106–310, div. A, title XXVI, § 2601, Oct. 17,

Page 1010

2000, 114 Stat. 1165; amended Pub. L. 110–204, § 3,
Apr. 24, 2008, 122 Stat. 706; Pub. L. 110–237,
§ 1(a)(2), May 27, 2008, 122 Stat. 1556; Pub. L.
113–240, § 3, Dec. 18, 2014, 128 Stat. 2852.)
AMENDMENTS
2014—Pub. L. 113–240, § 3(1), inserted ‘‘and followup’’
after ‘‘child screening’’ in section catchline.
Subsec. (a). Pub. L. 113–240, § 3(2), substituted
‘‘, including with respect to timeliness, of screening,
followup,’’ for ‘‘of screening,’’.
Subsec. (b)(1). Pub. L. 113–240, § 3(3)(A), substituted
‘‘treatment, counseling, testing, followup,’’ for ‘‘counseling, testing’’ and inserted before semicolon at end
‘‘, including, as appropriate, through the assessment of
health and development outcomes for such children
through adolescence’’.
Subsec. (b)(2). Pub. L. 113–240, § 3(3)(B)(i), (ii), substituted ‘‘treatment, counseling, testing, followup,’’ for
‘‘counseling, testing’’ and inserted ‘‘in a timely manner’’ after ‘‘in newborns and children’’.
Subsec. (b)(4), (5). Pub. L. 113–240, § 3(3)(B)(iii)–(D),
added pars. (4) and (5).
Subsec. (d). Pub. L. 113–240, § 3(4), struck out subsec.
(d). Text read as follows: ‘‘There are authorized to be
appropriated to carry out this section $5,000,000 for fiscal year 2009, $5,062,500 for fiscal year 2010, $5,125,000 for
fiscal year 2011, $5,187,500 for fiscal year 2012, and
$5,250,000 for fiscal year 2013.’’
2008—Subsec. (d). Pub. L. 110–237 substituted ‘‘2009,
$5,062,500 for fiscal year 2010, $5,125,000 for fiscal year
2011, $5,187,500 for fiscal year 2012, and $5,250,000 for fiscal year 2013.’’ for ‘‘2008, $5,062,500 for fiscal year 2009,
$5,125,000 for fiscal year 2010, $5,187,500 for fiscal year
2011, and $5,250,000 for fiscal year 2012.’’
Pub. L. 110–204 added subsec. (d).

§ 300b–10. Advisory Committee on Heritable Disorders in Newborns and Children
(a) Establishment
The Secretary shall establish an advisory
committee to be known as the ‘‘Advisory Committee on Heritable Disorders in Newborns and
Children’’ (referred to in this section as the ‘‘Advisory Committee’’).
(b) Duties
The Advisory Committee shall—
(1) provide advice and recommendations to
the Secretary concerning grants and projects
awarded or funded under section 300b–8 of this
title;
(2) provide technical information to the Secretary for the development of policies and priorities for the administration of grants under
section 300b–8 of this title;
(3) make systematic evidence-based and
peer-reviewed recommendations that include
the heritable disorders that have the potential
to significantly impact public health for which
all newborns should be screened, including secondary conditions that may be identified as a
result of the laboratory methods used for
screening;
(4) provide technical assistance, as appropriate, to individuals and organizations regarding the submission of nominations to the
uniform screening panel, including prior to
the submission of such nominations;
(5) take appropriate steps, at its discretion,
to prepare for the review of nominations prior
to their submission, including for conditions
for which a screening method has been validated but other nomination criteria are not

Page 1011

TITLE 42—THE PUBLIC HEALTH AND WELFARE

yet met, in order to facilitate timely action by
the Advisory Committee once such submission
has been received by the Committee;
(6) develop a model decision-matrix for newborn screening expansion, including an evaluation of the potential public health impact, including the cost of such expansion, and periodically update the recommended uniform
screening panel, as appropriate, based on such
decision-matrix;
(7) consider ways to ensure that all States
attain the capacity to screen for the conditions described in paragraph (3), and include in
such consideration the results of grant funding
under section 300b–8 of this title; and
(8) provide such recommendations, advice or
information as may be necessary to enhance,
expand or improve the ability of the Secretary
to reduce the mortality or morbidity from
heritable disorders, which may include recommendations, advice, or information dealing
with—
(A) follow-up activities, including those
necessary to achieve best practices in rapid
diagnosis and appropriate treatment in the
short-term, and those that ascertain longterm case management outcomes and appropriate access to related services;
(B) implementation, monitoring, and evaluation of newborn screening activities, including diagnosis, screening, follow-up, and
treatment activities;
(C) diagnostic and other technology used
in screening;
(D) the availability and reporting of testing for conditions for which there is no existing treatment, including information on
cost and incidence;
(E) conditions not included in the recommended uniform screening panel that are
treatable with Food and Drug Administration-approved products or other safe and effective treatments, as determined by scientific evidence and peer review;
(F) minimum standards and related policies and procedures used by State newborn
screening programs, such as language and
terminology used by State newborn screening programs to include standardization of
case definitions and names of disorders for
which newborn screening tests are performed;
(G) quality assurance, oversight, and evaluation of State newborn screening programs,
including ensuring that tests and technologies used by each State meet established
standards for detecting and reporting positive screening results;
(H) public and provider awareness and education;
(I) the cost and effectiveness of newborn
screening and medical evaluation systems
and intervention programs conducted by
State-based programs;
(J) identification of the causes of, public
health impacts of, and risk factors for heritable disorders;
(K) coordination of surveillance activities,
including standardized data collection and
reporting, harmonization of laboratory definitions for heritable disorders and testing

§ 300b–10

results, and confirmatory testing and verification of positive results, in order to assess and enhance monitoring of newborn diseases; and
(L) the timeliness of collection, delivery,
receipt, and screening of specimens to be
tested for heritable disorders in newborns in
order to ensure rapid diagnosis and followup.
(c) Membership
(1) In general
The Secretary shall appoint not to exceed 15
members to the Advisory Committee. In appointing such members, the Secretary shall
ensure that the total membership of the Advisory Committee is an odd number.
(2) Required members
The Secretary shall appoint to the Advisory
Committee under paragraph (1)—
(A) the Administrator of the Health Resources and Services Administration;
(B) the Director of the Centers for Disease
Control and Prevention;
(C) the Director of the National Institutes
of Health;
(D) the Director of the Agency for Healthcare Research and Quality;
(E) the Commissioner of the Food and
Drug Administration;
(F) medical, technical, or scientific professionals with special expertise in heritable
disorders, or in providing screening, counseling, testing or specialty services for newborns and children at risk for heritable disorders;
(G) individuals with expertise in ethics and
infectious diseases who have worked and
published material in the area of newborn
screening;
(H) members of the public having special
expertise about or concern with heritable
disorders; and
(I) representatives from such Federal agencies, public health constituencies, and medical professional societies as determined to
be necessary by the Secretary, to fulfill the
duties of the Advisory Committee, as established under subsection (b).
(d) Decision on recommendations
(1) In general
Not later than 120 days after the Advisory
Committee issues a recommendation pursuant
to this section, the Secretary shall adopt or
reject such recommendation. If the Secretary
is unable to make a determination to adopt or
reject such recommendation within such 120day period, the Secretary shall notify the Advisory Committee and the appropriate committees of Congress of such determination together with an explanation for why the Secretary was unable to comply within such 120day period, as well as a plan of action for consideration of such pending recommendation.
(2) Determinations to be made public
The Secretary shall publicize any determination on adopting or rejecting a recommendation of the Advisory Committee pursuant to this subsection, including the justification for the determination.

§ 300b–10

TITLE 42—THE PUBLIC HEALTH AND WELFARE

(3) Deadline for review
For each condition nominated to be added to
the recommended uniform screening panel in
accordance with the requirements of this section, the Advisory Committee shall review and
vote on the nominated condition within 9
months of the date on which the Advisory
Committee referred the nominated condition
to the condition review workgroup.
(e) Annual report
Not later than 3 years after April 24, 2008, and
each fiscal year thereafter, the Advisory Committee shall—
(1) publish a report on peer-reviewed newborn screening guidelines, including follow-up
and treatment, in the United States;
(2) submit such report to the appropriate
committees of Congress, the Secretary, the
Interagency Coordinating Committee established under section 300b–13 of this title, and
the State departments of health; and
(3) disseminate such report on as wide a
basis as practicable, including through posting
on the internet clearinghouse established
under section 300b–11 of this title.
(f) Meetings
The Advisory Committee shall meet at least 4
times each calendar year, or at the discretion of
the Designated Federal Officer in consultation
with the Chair.
(g) Continuation of operation of Committee
(1) In general
Notwithstanding section 14 of the Federal
Advisory Committee Act, the Advisory Committee shall continue to operate through the
end of fiscal year 2019.
(2) Continuation if not reauthorized
If at the end of fiscal year 2019 the duration
of the Advisory Committee has not been extended by statute, the Advisory Committee
may be deemed, for purposes of the Federal
Advisory Committee Act, an advisory committee established by the President or an officer
of the Federal Government under section 9(a)
of such Act.
(July 1, 1944, ch. 373, title XI, § 1111, as added
Pub. L. 106–310, div. A, title XXVI, § 2601, Oct. 17,
2000, 114 Stat. 1166; amended Pub. L. 110–204, § 4,
Apr. 24, 2008, 122 Stat. 706; Pub. L. 110–237,
§ 1(a)(3), (b)(2), May 27, 2008, 122 Stat. 1556, 1557;
Pub. L. 113–240, § 4, Dec. 18, 2014, 128 Stat. 2853.)
REFERENCES IN TEXT
The Federal Advisory Committee Act, referred to in
subsec. (g), is Pub. L. 92–463, Oct. 6, 1972, 86 Stat. 770,
which is set out in the Appendix to Title 5, Government
Organization and Employees.

Page 1012

Subsec. (b)(8)(A). Pub. L. 113–240, § 4(1)(D)(i), substituted ‘‘achieve best practices in rapid diagnosis and
appropriate treatment’’ for ‘‘achieve rapid diagnosis’’.
Subsec. (b)(8)(D). Pub. L. 113–240, § 4(1)(D)(ii), inserted
‘‘, including information on cost and incidence’’ before
semicolon at end.
Subsec. (b)(8)(L). Pub. L. 113–240, § 4(1)(D)(iii)–(v),
added subpar. (L).
Subsec. (d)(1). Pub. L. 113–240, § 4(2)(A), substituted
‘‘120 days’’ for ‘‘180 days’’ and inserted at end ‘‘If the
Secretary is unable to make a determination to adopt
or reject such recommendation within such 120-day period, the Secretary shall notify the Advisory Committee and the appropriate committees of Congress of such
determination together with an explanation for why
the Secretary was unable to comply within such 120day period, as well as a plan of action for consideration
of such pending recommendation.’’
Subsec. (d)(2). Pub. L. 113–240, § 4(2)(B), (C), redesignated par. (3) as (2) and struck out former par. (2). Prior
to amendment, text of par. (2) read as follows: ‘‘The
Secretary shall adopt or reject any recommendation issued by the Advisory Committee that is pending on
April 24, 2008, by not later than 180 days after April 24,
2008.’’
Subsec. (d)(3). Pub. L. 113–240, § 4(2)(D), added par. (3).
Former par. (3) redesignated (2).
Subsec. (f). Pub. L. 113–240, § 4(4), added subsec. (f).
Former subsec. (f) redesignated (g).
Subsec. (g). Pub. L. 113–240, § 4(3), (5), redesignated
subsec. (f) as (g) and amended it generally. Prior to
amendment, text read as follows: ‘‘Notwithstanding
section 14 of the Federal Advisory Committee Act (5
U.S.C. App.), the Advisory Committee shall continue to
operate during the 5-year period beginning on April 24,
2008.’’
Subsec. (h). Pub. L. 113–240, § 4(3), (6), redesignated
subsec. (g) as (h) and struck it out. Prior to amendment, text read as follows: ‘‘There are authorized to be
appropriated to carry out this section, $1,000,000 for fiscal year 2009, $1,012,500 for fiscal year 2010, $1,025,000 for
fiscal year 2011, $1,037,500 for fiscal year 2012, and
$1,050,000 for fiscal year 2013.’’
2008—Subsec. (b)(3) to (5). Pub. L. 110–204, § 4(1)(B), (C),
added pars. (3) to (5). Former par. (3) redesignated (6).
Subsec. (b)(6). Pub. L. 110–204, § 4(1)(A), (D), redesignated par. (3) as (6), substituted ‘‘, which may include
recommendations, advice, or information dealing
with—’’ for period at end, and added subpars. (A) to (K).
Subsec. (c)(2)(E) to (I). Pub. L. 110–204, § 4(2), as
amended by Pub. L. 110–237, § 1(b)(2), added subpars. (E)
and (G) and redesignated former subpars. (E), (F), and
(G) as (F), (H), and (I), respectively.
Subsec. (d). Pub. L. 110–204, § 4(3), added subsec. (d).
Subsec. (d)(2). Pub. L. 110–237, § 1(a)(3)(A), made technical amendment to reference in original act which appears in text as the first reference to April 24, 2008.
Subsecs. (e), (f). Pub. L. 110–237, § 1(a)(3)(B), (C), made
technical amendment to references in original act
which appear in text as references to April 24, 2008.
Pub. L. 110–204, § 4(3), added subsecs. (e) and (f).
Subsec. (g). Pub. L. 110–237, § 1(a)(3)(D), substituted
‘‘2009, $1,012,500 for fiscal year 2010, $1,025,000 for fiscal
year 2011, $1,037,500 for fiscal year 2012, and $1,050,000 for
fiscal year 2013.’’ for ‘‘2008, $1,012,500 for fiscal year 2009,
$1,025,000 for fiscal year 2010, $1,037,500 for fiscal year
2011, and $1,050,000 for fiscal year 2012.’’
Pub. L. 110–204, § 4(3), added subsec. (g).

AMENDMENTS

TERMINATION OF ADVISORY COMMITTEES

2014—Subsec. (b)(4), (5). Pub. L. 113–240, § 4(1)(B),
added pars. (4) and (5). Former pars. (4) and (5) redesignated (6) and (7), respectively.
Subsec. (b)(6). Pub. L. 113–240, § 4(1)(A), (C), redesignated par. (4) as (6) and inserted ‘‘, including the cost’’
after ‘‘public health impact’’. Former par. (6) redesignated (8).
Subsec. (b)(7). Pub. L. 113–240, § 4(1)(A), redesignated
par. (5) as (7).
Subsec. (b)(8). Pub. L. 113–240, § 4(1)(A), redesignated
par. (6) as (8).

Advisory committees established after Jan. 5, 1973, to
terminate not later than the expiration of the 2-year
period beginning on the date of their establishment,
unless, in the case of a committee established by the
President or an officer of the Federal Government, such
committee is renewed by appropriate action prior to
the expiration of such 2-year period, or in the case of
a committee established by the Congress, its duration
is otherwise provided by law. See section 14 of Pub. L.
92–463, Oct. 6, 1972, 86 Stat. 776, set out in the Appendix
to Title 5, Government Organization and Employees.

Page 1013

TITLE 42—THE PUBLIC HEALTH AND WELFARE

Pub. L. 93–641, § 6, Jan. 4, 1975, 88 Stat. 2275, set out as
a note under section 217a of this title, provided that an
advisory committee established pursuant to the Public
Health Service Act shall terminate at such time as
may be specifically prescribed by an Act of Congress
enacted after Jan. 4, 1975.

§ 300b–11. Clearinghouse of newborn screening
information
(a) In general
The Secretary, acting through the Administrator of the Health Resources and Services Administration (referred to in this part as the ‘‘Administrator’’), in consultation with the Director
of the Centers for Disease Control and Prevention and the Director of the National Institutes
of Health, shall establish and maintain a central
clearinghouse of current educational and family
support and services information, materials, resources, research, and data on newborn screening to—
(1) enable parents and family members of
newborns, health professionals, industry representatives, and other members of the public
to increase their awareness, knowledge, and
understanding of newborn screening;
(2) increase awareness, knowledge, and understanding of newborn diseases and screening
services for expectant individuals and families;
(3) maintain current information on quality
indicators to measure performance of newborn
screening, such as false-positive rates and
other quality indicators as determined by the
Advisory Committee under section 300b–10 of
this title;
(4) maintain current information on the
number of conditions for which screening is
conducted in each State; and
(5) disseminate available evidence-based
guidelines related to diagnosis, counseling,
and treatment with respect to conditions detected by newborn screening.
(b) Internet availability
The Secretary, acting through the Administrator, shall ensure that the clearinghouse described under subsection (a)—
(1) is available on the Internet;
(2) includes an interactive forum;
(3) is updated on a regular basis, but not less
than quarterly; and
(4) provides—
(A) links to Government-sponsored, nonprofit, and other Internet websites of laboratories that have demonstrated expertise in
newborn screening that supply researchbased information on newborn screening
tests currently available throughout the
United States;
(B) information about newborn conditions
and screening services available in each
State from laboratories certified under subpart 2 of part F of subchapter II, including
information about supplemental screening
that is available but not required, in the
State where the infant is born;
(C) current research on both treatable and
not-yet treatable conditions for which newborn screening tests are available;
(D) the availability of Federal funding for
newborn and child screening for heritable

§ 300b–12

disorders including grants authorized under
the Newborn Screening Saves Lives Reauthorization Act of 2014; and
(E) other relevant information as determined appropriate by the Secretary.
(c) Nonduplication
In carrying out activities under this section,
the Secretary shall ensure that such activities
minimize duplication and supplement, not supplant, existing information sharing efforts.
(July 1, 1944, ch. 373, title XI, § 1112, as added
Pub. L. 110–204, § 5, Apr. 24, 2008, 122 Stat. 708;
amended Pub. L. 110–237, § 1(a)(4), May 27, 2008,
122 Stat. 1557; Pub. L. 113–240, § 5, Dec. 18, 2014,
128 Stat. 2854.)
REFERENCES IN TEXT
The Newborn Screening Saves Lives Reauthorization
Act of 2014, referred to in subsec. (b)(4)(D), is Pub. L.
113–240, Dec. 18, 2014, 128 Stat. 2851. For complete classification of this Act to the Code, see Short Title of 2014
Amendment note set out under section 201 of this title
and Tables.
AMENDMENTS
2014—Subsec. (a)(3). Pub. L. 113–240, § 5(1)(B)(i), substituted ‘‘information’’ for ‘‘data’’.
Subsec. (a)(4), (5). Pub. L. 113–240, § 5(1)(A), (B)(ii), (C),
added pars. (4) and (5).
Subsec. (b)(4)(D). Pub. L. 113–240, § 5(2), substituted
‘‘Newborn Screening Saves Lives Reauthorization Act
of 2014’’ for ‘‘Newborn Screening Saves Lives Act of
2008’’.
Subsec. (c). Pub. L. 113–240, § 5(3), substituted ‘‘carrying out activities’’ for ‘‘developing the clearinghouse’’
and ‘‘activities minimize duplication and supplement,
not supplant’’ for ‘‘clearinghouse minimizes duplication and supplements, not supplants’’.
Subsec. (d). Pub. L. 113–240, § 5(4), struck out subsec.
(d). Text read as follows: ‘‘There are authorized to be
appropriated to carry out this section, $2,500,000 for fiscal year 2009, $2,531,250 for fiscal year 2010, $2,562,500 for
fiscal year 2011, $2,593,750 for fiscal year 2012, and
$2,625,000 for fiscal year 2013.’’
2008—Subsec. (b)(4)(D). Pub. L. 110–237, § 1(a)(4)(A),
substituted ‘‘2008’’ for ‘‘2007’’.
Subsec. (d). Pub. L. 110–237, § 1(a)(4)(B), substituted
‘‘2009, $2,531,250 for fiscal year 2010, $2,562,500 for fiscal
year 2011, $2,593,750 for fiscal year 2012, and $2,625,000 for
fiscal year 2013.’’ for ‘‘2008, $2,531,250 for fiscal year 2009,
$2,562,500 for fiscal year 2010, $2,593,750 for fiscal year
2011, and $2,625,000 for fiscal year 2012.’’

§ 300b–12. Laboratory quality and surveillance
(a) In general
The Secretary, acting through the Director of
the Centers for Disease Control and Prevention
and taking into consideration the expertise of
the Advisory Committee on Heritable Disorders
in Newborns and Children established under section 300b–10 of this title, shall provide for—
(1) quality assurance for laboratories involved in screening newborns and children for
heritable disorders, including quality assurance for newborn-screening tests, timeliness
for processing such tests, performance evaluation services, and technical assistance and
technology transfer to newborn screening laboratories to ensure analytic validity and utility of screening tests; and
(2) appropriate quality control and other
performance test materials to evaluate the
performance of new screening tools.