Legislation

SEC. 4. ADVISORY COMMITTEE ON HERITABLE DISORDERS IN NEWBORNS AND CHILDREN.
Section 1111 of the Public Health Service Act (42 U.S.C. 300b-10) is amended-§ 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 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
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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) of this section.
(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
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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—
(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.

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H. R. 1281—2

H. R. 1281

One Hundred Thirteenth
Congress of the
United States of
America
AT THE SEC OND SESSION
Begun and held at the City of
Washington on Friday, the third day of
January, two thousand and fourteen

An Act
To amend the Public Health Service Act to reauthorize
programs under part A of title XI of such Act.

Be it enacted by the Senate and House of
Representatives of the United States of America in
Congress assembled,
SECTION 1. SHORT TITLE; TABLE OF CONTENTS.

(a) SHORT TITLE.—This Act may be cited as
the ‘‘Newborn Screening Saves Lives Reauthorization
Act of 2014’’.
(b) TABLE OF CONTENTS.—The table of contents
of this Act is as follows:
Sec. 1. Short title; table of contents.
Sec. 2. Improved newborn and child screening and followup for heritable disorders.
Sec. 3. Evaluating the effectiveness of newborn and child screening
and followup programs.
Sec. 4. Advisory Committee on Heritable Disorders in Newborns
and Children. Sec. 5. Clearinghouse of Newborn Screening
Information.
Sec. 6. Laboratory quality and surveillance.
Sec. 7. Interagency Coordinating Committee on Newborn and
Child Screening. Sec. 8. National contingency plan for newborn
screening.
Sec. 9. Hunter Kelly
Research Program. Sec.
10.
Authorization
of
appropriations. Sec. 11.
Reports to Congress.
Sec. 12. Informed consent for newborn screening research.

H. R. 1281—3
SEC.

4.

ADVISORY COMMITTEE ON
NEWBORNS AND CHILDREN.

HERITABLE

DISORDERS

IN

Section 1111 of the Public Health Service Act (42 U.S.C. 300b–
8) is amended—
(1) in subsection (b)—
(A) by redesignating paragraphs (4) through (6) as
paragraphs (6) through (8), respectively;
(B) by inserting after paragraph (3), the following:
‘‘(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;’’;
(C) in paragraph (6) (as so redesignated), by inserting
‘‘, including the cost’’ after ‘‘public health impact’’; and
(D) in paragraph (8) (as so redesignated)—
(i) in subparagraph (A), by striking ‘‘achieve rapid
diagnosis’’ and inserting ‘‘achieve best practices in
rapid diagnosis and appropriate treatment’’;
(ii) in subparagraph (D), by inserting before the
semicolon ‘‘, including information on cost and
incidence’’;
(iii) in subparagraph (J), by striking ‘‘and’’ at the
end;
(iv) in subparagraph (K), by striking the period
and inserting ‘‘; and’’; and
(v) by adding at the end the following:
‘‘(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.’’;
(2) in subsection (d)—
(A) in paragraph (1)—
(i) by striking ‘‘180’’ and inserting ‘‘120’’; and
(ii) by adding at the end the following: ‘‘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.’’;
(B) by striking paragraph (2);
(C) by redesignating paragraph (3) as paragraph (2);
and
(D) by adding at the end the following:
‘‘(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

H. R. 1281—4
referred the nominated condition to the condition review
workgroup.’’;
(3) by redesignating subsections (f) and (g) as subsections
(g) and (h), respectively;
(4) by inserting after subsection (e) the following new subsection:
‘‘(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.’’;
(5) by amending subsection (g) (as so redesignated) to read
as follows:
‘‘(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.’’; and
(6) by striking subsection (h) (relating to authorization
of appropriations), as redesignated by paragraph (3).

Speaker of the House of Representatives.

Vice President of the United States and
President of the Senate.