H. R. 1281 
One Hundred Thirteenth Congress 
of the 
United States of America 
AT THE SECOND 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. 
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 inserting ‘‘sec-
tion 1117’’; and 
(ii) by striking ‘‘and in consultation with the 
Advisory Committee’’ and inserting ‘‘and taking into 
consideration the expertise of the Advisory Committee’’; 
(B) by amending paragraph (2) to read as follows: 
‘‘(2) to assist in providing health care professionals and 
newborn screening laboratory personnel with education in new-
born screening, counseling, and training in— 
‘‘(A) relevant and new technologies in newborn 
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 information with 
providers and families;’’; 
(C) in paragraph (3), by striking ‘‘and’’ at the end;
H. R. 1281—2 
(D) in paragraph (4)— 
(i) by striking ‘‘treatment’’ and inserting ‘‘followup 
and treatment’’; and 
(ii) by striking the period and inserting ‘‘; 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 
‘‘(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 section’’; 
(3) in subsection (h), by striking ‘‘application submitted 
under subsection (c)(2)’’ each place it appears and inserting 
‘‘application for a grant under this section’’; and 
(4) by striking subsection (j) (relating to authorization 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 screening,’’ and 
inserting ‘‘, including with respect to timeliness, of screening, 
followup,’’; 
(3) in subsection (b)— 
(A) in paragraph (1)— 
(i) by striking ‘‘counseling, testing’’ and inserting 
‘‘treatment, counseling, testing, followup,’’; and 
(ii) by inserting before the semicolon the following: 
‘‘, including, as appropriate, through the assessment 
of health and development outcomes for such children 
through adolescence’’; 
(B) in paragraph (2)— 
(i) by striking ‘‘counseling, testing’’ and inserting 
‘‘treatment, counseling, testing, followup,’’; 
(ii) by inserting ‘‘in a timely manner’’ after ‘‘in 
newborns and children’’; and 
(iii) by striking ‘‘or’’ at the end; 
(C) in paragraph (3), by striking the period at the 
end and inserting a semicolon; and 
(D) by adding at the end the following: 
‘‘(4) methods that may be identified to improve quality 
in the diagnosis, treatment, and disease management of heri-
table disorders based on gaps in services or care; or 
‘‘(5) methods or best practices by which the eligible entities 
described in section 1109 can achieve in a timely manner— 
‘‘(A) collection, delivery, receipt, and screening of new-
born screening specimens; and 
‘‘(B) diagnosis of heritable disorders in newborns.’’; and 
(4) by striking subsection (d) (relating to authorization 
of appropriations).
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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), respectively; 
(B) by inserting after paragraph (3), the following: 
‘‘(4) provide technical assistance, as appropriate, to individ-
uals and organizations regarding the submission of nominations 
to the uniform screening panel, including prior to the submis-
sion 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 Com-
mittee 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