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’’;
(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
‘‘(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)—
(i) by striking ‘‘counseling, testing’’ 
and inserting ‘‘treatment, counseling, test-
ing, followup,’’; and 
(ii) by inserting before the semicolon 
the following: ‘‘, including, as appropriate, 
through the assessment of health and de-
velopment outcomes for such children 
through adolescence’’; 
(B) in paragraph (2)— 
(i) by striking ‘‘counseling, testing’’ 
and inserting ‘‘treatment, counseling, test-
ing, 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 pe-
riod 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 heritable disorders based on gaps in 
services or care; or 
‘‘(5) methods or best practices by which the eli-
gible entities described in section 1109 can achieve 
in a timely manner—
‘‘(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-
(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-
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
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
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
consideration the expertise of the Advisory 
Committee’’; and 
(B) in paragraph (1), by inserting ‘‘timeli-
ness for processing such tests,’’ after ‘‘newborn- 
screening tests,’’; and 
(3) by striking subsection (b) (relating to au-
thorization of appropriations) and inserting the fol-
lowing: 
‘‘(b) SURVEILLANCE ACTIVITIES.—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 Dis-
orders in Newborns and Children established under sec-
tion 1111, may provide, as appropriate, for the coordina-
tion of surveillance activities, including— 
‘‘(1) through standardized data collection and 
reporting, as well as the use of electronic health 
records; and 
‘‘(2) by promoting data sharing regarding new-
born screening with State-based birth defects and 
developmental disabilities monitoring programs.’’. 
SEC. 7. INTERAGENCY COORDINATING COMMITTEE ON 
NEWBORN AND CHILD SCREENING. 
Section 1114 of the Public Health Service Act (42 
U.S.C. 300b–13) is amended—
(1) in subsection (c), by striking ‘‘the Adminis-
trator, the Director of the Agency for Healthcare 
Research and Quality,’’ and inserting ‘‘the Adminis-
trator of the Health Resources and Services Admin-
istration, the Director of the Agency for Healthcare 
Research and Quality, the Commissioner of Food 
and Drugs,’’; and 
(2) by striking subsection (e) (relating to au-
thorization of appropriations). 
SEC. 8. NATIONAL CONTINGENCY PLAN FOR NEWBORN 
SCREENING. 
Section 1115(a) of the Public Health Service Act (42 
U.S.C. 300b–14(a)) is amended— 
(1) by striking ‘‘consortia’’ and inserting ‘‘con-
sortium’’; and 
(2) by adding at the end the following: ‘‘The 
plan shall be updated as needed and at least every 
five years.’’. 
SEC. 9. HUNTER KELLY RESEARCH PROGRAM. 
Section 1116 of the Public Health Service Act (42 
U.S.C. 300b–15) is amended— 
(1) in subsection (a)(1)— 
(A) in subparagraph (B), by striking ‘‘; 
and’’ and inserting a semicolon;
(B) by redesignating subparagraph (C) as 
subparagraph (E); and 
(C) by inserting after subparagraph (B) 
the following: 
‘‘(C) providing research findings and data 
for newborn conditions under review by the Ad-
visory Committee on Heritable Disorders in 
Newborns and Children to be added to the rec-
ommended uniform screening panel; 
‘‘(D) conducting pilot studies on conditions 
recommended by the Advisory Committee on 
Heritable Disorders in Newborns and Children 
to ensure that screenings are ready for nation-
wide implementation; and’’; and 
(2) in subsection (c), by striking ‘‘of the Na-
tional Institutes of Health Reform Act of 2006’’. 
SEC. 10. AUTHORIZATION OF APPROPRIATIONS. 
Part A of title XI of the Public Health Service Act 
(42 U.S.C. 300b–1 et seq.) is amended by adding at the 
end, the following: 
‘‘SEC. 1117. AUTHORIZATION OF APPROPRIATIONS FOR 
NEWBORN SCREENING PROGRAMS AND AC-
TIVITIES. 
‘‘There are authorized to be appropriated—
‘‘(1) to carry out sections 1109, 1110, 1111, 
and 1112, $11,900,000 for each of fiscal years 2015 
through 2019; and 
‘‘(2) to carry out section 1113, $8,000,000 for 
each of fiscal years 2015 through 2019.’’. 
SEC. 11. REPORTS TO CONGRESS. 
(a) GAO REPORT ON TIMELINESS OF NEWBORN 
SCREENING.— 
(1) IN GENERAL.—Not later than 2 years after 
the date of enactment of this Act, the Comptroller 
General of the United States shall submit a report 
to the Committee on Health, Education, Labor, and 
Pensions of the Senate and the Committee on En-
ergy and Commerce of the House of Representatives 
concerning the timeliness of screening for heritable 
disorders in newborns. 
(2) CONTENTS.—The report submitted under 
paragraph (1) shall include the following: 
(A) An analysis of information regarding 
the timeliness of newborn screening, which may 
include the time elapsed from birth to specimen 
collection, specimen collection to receipt by lab-
oratory, specimen receipt to reporting, reporting 
to followup testing, and followup testing to con-
firmed diagnosis.
(B) A summary of any guidelines, rec-
ommendations, or best practices available to 
States and health care providers intended to 
support a timely newborn screening system. 
(C) An analysis of any barriers to main-
taining a timely newborn screening system 
which may exist and recommendations for ad-
dressing such barriers. 
(b) REPORT BY SECRETARY.— 
(1) IN GENERAL.—The Secretary of Health and 
Human Services shall— 
(A) not later than 1 year after the date of 
enactment of this Act, submit to the Committee 
on Health, Education, Labor, and Pensions of 
the Senate and the Committee on Energy and 
Commerce of the House of Representatives a 
report on activities related to— 
(i) newborn screening; and 
(ii) screening children who have or are 
at risk for heritable disorders; and 
(B) not less than every 2 years, submit to 
such committees an updated version of such re-
port. 
(2) CONTENTS.—The report submitted under 
this subsection shall contain a description of—
(A) the ongoing activities under sections 
1109, 1110, and 1112 through 1115 of the 
Public Health Service Act; and 
(B) the amounts expended on such activi-
ties. 
Passed the House of Representatives June 24, 2014. 
Attest: 
Clerk.