IIB 
113TH CONGRESS 
2D SESSION 
H. R. 1281 
IN THE SENATE OF THE UNITED STATES 
JUNE 25, 2014 
Received 
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 Representa-
tives of the United States of America in Congress assembled, 
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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 dis-
orders. 
Sec. 3. Evaluating the effectiveness of newborn and child screening and fol-
lowup 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. 2. IMPROVED NEWBORN AND CHILD SCREENING AND 
FOLLOWUP FOR HERITABLE DISORDERS. 
Section 1109 of the Public Health Service Act (42 
U.S.C. 300b–8) is amended— 
(1) in subsection (a)— 
(A) in the matter preceding paragraph 
(1)— 
(i) by striking ‘‘subsection (j)’’ and in-
serting ‘‘section 1117’’; and 
(ii) by striking ‘‘and in consultation 
with the Advisory Committee’’ and insert-
ing ‘‘and taking into consideration the ex-
pertise of the Advisory Committee’’; 
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(B) by amending paragraph (2) to read as 
follows: 
‘‘(2) to assist in providing health care profes-
sionals and newborn screening laboratory personnel 
with education in newborn screening, counseling, 
and training in— 
‘‘(A) relevant and new technologies in new-
born screening and congenital, genetic, and 
metabolic disorders; 
‘‘(B) the importance of the timeliness of 
collection, delivery, receipt, and screening of 
specimens; and 
‘‘(C) sharing of medical and diagnostic in-
formation with providers and families;’’; 
(C) in paragraph (3), by striking ‘‘and’’ at 
the end; 
(D) in paragraph (4)— 
(i) by striking ‘‘treatment’’ and insert-
ing ‘‘followup and treatment’’; and 
(ii) by striking the period and insert-
ing ‘‘; and’’; and 
(E) by adding at the end the following: 
‘‘(5) to improve the timeliness of— 
‘‘(A) the collection, delivery, receipt, and 
screening of specimens; and 
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‘‘(B) the diagnosis of heritable disorders in 
newborns.’’; 
(2) in subsection (c), by striking ‘‘application 
submitted for a grant under subsection (a)(1)’’ and 
inserting ‘‘application for a grant under this sec-
tion’’; 
(3) in subsection (h), by striking ‘‘application 
submitted under subsection (c)(2)’’ each place it ap-
pears and inserting ‘‘application for a grant under 
this section’’; and 
(4) by striking subsection (j) (relating to au-
thorization of appropriations). 
SEC. 3. EVALUATING THE EFFECTIVENESS OF NEWBORN 
AND 
CHILD 
SCREENING 
AND 
FOLLOWUP 
PROGRAMS. 
Section 1110 of the Public Health Service Act (42 
U.S.C. 300b–9) is amended— 
(1) in the section heading, by inserting ‘‘AND 
FOLLOWUP’’ after ‘‘CHILD SCREENING’’; 
(2) in subsection (a), by striking ‘‘of screen-
ing,’’ and inserting ‘‘, including with respect to time-
liness, of screening, followup,’’; 
(3) in subsection (b)— 
(A) in paragraph (1)— 
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‘‘(A) collection, delivery, receipt, and 
screening of newborn screening specimens; and 
‘‘(B) diagnosis of heritable disorders in 
newborns.’’; and 
(4) by striking subsection (d) (relating to au-
thorization of appropriations). 
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— 
(1) in subsection (b)— 
(A) 
by 
redesignating 
paragraphs 
(4) 
through (6) as paragraphs (6) through (8), re-
spectively; 
(B) by inserting after paragraph (3), the 
following: 
‘‘(4) provide technical assistance, as appro-
priate, 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 nomi-
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nation 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 redesig-
nated)— 
(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 informa-
tion 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)— 
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(A) in paragraph (1)— 
(i) by striking ‘‘180’’ and inserting 
‘‘120’’; and 
(ii) by adding at the end the fol-
lowing: ‘‘If the Secretary is unable to make 
a determination to adopt or reject such 
recommendation within such 120-day pe-
riod, the Secretary shall notify the Advi-
sory Committee and the appropriate com-
mittees 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 condi-
tion nominated to be added to the recommended uni-
form screening panel in accordance with the require-
ments of this section, the Advisory Committee shall 
review and vote on the nominated condition within 
9 months of the date on which the Advisory Com-
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mittee referred the nominated condition to the con-
dition review workgroup.’’; 
(3) by redesignating subsections (f) and (g) as 
subsections (g) and (h), respectively; 
(4) by inserting after subsection (e) the fol-
lowing new subsection: 
‘‘(f) MEETINGS.—The Advisory Committee shall 
meet at least 4 times each calendar year, or at the discre-
tion of the Designated Federal Officer in consultation with 
the Chair.’’; 
(5) by amending subsection (g) (as so redesig-
nated) to read as follows: 
‘‘(g) CONTINUATION
OF
OPERATION
OF
COM-
MITTEE.— 
‘‘(1) IN GENERAL.—Notwithstanding section 14 
of the Federal Advisory Committee Act, the Advi-
sory 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 stat-
ute, the Advisory Committee may be deemed, for 
purposes of the Federal Advisory Committee Act, an 
advisory committee established by the President or 
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an officer of the Federal Government under section 
9(a) of such Act.’’; and 
(6) by striking subsection (h) (relating to au-
thorization of appropriations), as redesignated by 
paragraph (3). 
SEC. 5. CLEARINGHOUSE OF NEWBORN SCREENING INFOR-
MATION. 
Section 1112 of the Public Health Service Act (42 
U.S.C. 300b–11) is amended— 
(1) in subsection (a)— 
(A) in paragraph (2), by striking ‘‘and’’ at 
the end; 
(B) in paragraph (3)— 
(i) by striking ‘‘data’’ and inserting 
‘‘information’’; and 
(ii) by striking the period at the end 
and inserting a semicolon; and 
(C) by adding at the end the following new 
paragraphs: 
‘‘(4) maintain current information on the num-
ber of conditions for which screening is conducted in 
each State; and 
‘‘(5) disseminate available evidence-based guide-
lines related to diagnosis, counseling, and treatment 
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with respect to conditions detected by newborn 
screening.’’; 
(2) in subsection (b)(4)(D), by striking ‘‘New-
born Screening Saves Lives Act of 2008’’ and insert-
ing ‘‘Newborn Screening Saves Lives Reauthoriza-
tion Act of 2014’’; 
(3) in subsection (c)— 
(A) by striking ‘‘developing the clearing-
house’’ and inserting ‘‘carrying out activities’’; 
and 
(B) by striking ‘‘clearinghouse minimizes 
duplication and supplements, not supplants’’ 
and inserting ‘‘activities minimize duplication 
and supplement, not supplant’’; and 
(4) by striking subsection (d) (relating to au-
thorization of appropriations). 
SEC. 6. LABORATORY QUALITY AND SURVEILLANCE. 
Section 1113 of the Public Health Service Act (42 
U.S.C. 300b–12) is amended— 
(1) in the section heading, by inserting ‘‘AND 
SURVEILLANCE’’ before the period; 
(2) in subsection (a)— 
(A) in the matter preceding paragraph (1), 
by striking ‘‘and in consultation with the Advi-
sory Committee’’ and inserting ‘‘and taking into 
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