Attachment A - Legislation

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42 USC 300b-10: Advisory Committee on Heritable Disorders in Newborns and Children
Text contains those laws in effect on July 31, 2018
From Title 42-THE PUBLIC HEALTH AND WELFARE
CHAPTER 6A-PUBLIC HEALTH SERVICE
SUBCHAPTER IX-GENETIC DISEASES, HEMOPHILIA PROGRAMS, AND SUDDEN INFANT
DEATH SYNDROME
Part A-Genetic Diseases
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References In Text
Amendments
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§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 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 long-term 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;

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(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 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 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 120-day 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.
(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-

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(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.

AMENDMENTS
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).
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 120-day 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

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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).

TERMINATION OF ADVISORY COMMITTEES
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.
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.

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