IB 
Union Calendar No. 354 
113TH CONGRESS 
2D SESSION 
H. R. 1281 
[Report No. 113–478] 
To amend the Public Health Service Act to reauthorize programs under 
part A of title XI of such Act. 
IN THE HOUSE OF REPRESENTATIVES 
MARCH 20, 2013 
Ms. ROYBAL-ALLARD (for herself and Mr. SIMPSON) introduced the following 
bill; which was referred to the Committee on Energy and Commerce 
JUNE 19, 2014 
Additional sponsors: Ms. MOORE, Mr. GRIJALVA, Mr. WAXMAN, Mr. ROGERS 
of Kentucky, Mr. HIGGINS, Mr. RANGEL, Ms. LEE of California, Ms. 
SPEIER, Mr. MCGOVERN, Mrs. CAPPS, Ms. JACKSON LEE, Mr. HASTINGS 
of Florida, Ms. MCCOLLUM, Mr. DAVID SCOTT of Georgia, Ms. CLARKE 
of New York, Mr. CONYERS, Mr. DINGELL, Mr. HUFFMAN, Ms. 
DELAURO, Mr. CROWLEY, Mr. COHEN, Ms. SLAUGHTER, Mr. BISHOP of 
Georgia, Ms. CASTOR of Florida, Mr. TAKANO, Ms. WILSON of Florida, 
Mr. LOEBSACK, Mr. BERA of California, Mr. WALDEN, Mr. NADLER, Mr. 
GENE GREEN of Texas, Mr. DELANEY, Mr. COLLINS of New York, Mr. 
POCAN, Mr. HECK of Washington, Mr. FARR, Mr. MATHESON, Mrs. 
BEATTY, Mrs. KIRKPATRICK, Mr. MORAN, Mr. SIRES, Ms. SCHAKOWSKY, 
Mr. COSTA, Ms. LORETTA SANCHEZ of California, Mr. RUIZ, Mrs. 
NEGRETE MCLEOD, Mr. CASTRO of Texas, Mr. GALLEGO, Mr. BECERRA, 
Mr. SABLAN, Ms. MICHELLE LUJAN GRISHAM of New Mexico, Mr. 
CA´RDENAS, Mr. GUTIE´RREZ, Mr. RYAN of Ohio, Mr. BEN RAY LUJA´N 
of New Mexico, Mr. GARCIA, Mr. HINOJOSA, Mrs. NAPOLITANO, Mr. 
VARGAS, Mr. SERRANO, Ms. VELA´ZQUEZ, Mr. KING of New York, Mrs. 
CAPITO, Mr. CALVERT, Mr. ROYCE, Mr. GRAYSON, Ms. ESTY, Mr. GARY 
G. MILLER of California, Mr. JONES, Mr. MCKEON, Mr. PIERLUISI, Mr. 
SCHIFF, Mr. NEAL, Mr. LANGEVIN, Mr. DOYLE, Mr. TONKO, Ms. 
WASSERMAN SCHULTZ, Ms. DEGETTE, Ms. ESHOO, Mrs. LOWEY, Mr. 
BARTON, Mr. DANNY K. DAVIS of Illinois, Mr. GARAMENDI, Mr. 
MCDERMOTT, Mr. NUNES, Mr. COURTNEY, Mr. LEVIN, Mr. CICILLINE, 
Mr. WELCH, Mr. BLUMENAUER, Ms. TITUS, Mr. LIPINSKI, Mr. TIERNEY, 
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Mr. LARSON of Connecticut, Ms. MATSUI, Ms. GRANGER, Mr. LATHAM, 
Mrs. CHRISTENSEN, Mr. LANCE, Mr. ELLISON, Mr. HONDA, Ms. SHEA- 
PORTER, Ms. BROWNLEY of California, Ms. EDWARDS, Mr. MEEKS, Mr. 
MICHAUD, Ms. EDDIE BERNICE JOHNSON of Texas, Mr. PAYNE, Mr. 
PALLONE, Mr. JOHNSON of Georgia, Mr. LOWENTHAL, Mr. THOMPSON 
of California, Mr. CLAY, Mr. CARTWRIGHT, Ms. SCHWARTZ, Mr. PAS-
CRELL, Mr. BURGESS, Mrs. MCMORRIS RODGERS, and Mr. ISRAEL 
JUNE 19, 2014 
Reported with an amendment, committed to the Committee of the Whole 
House on the State of the Union, and ordered to be printed 
[Strike out all after the enacting clause and insert the part printed in italic] 
[For text of introduced bill, see copy of bill as introduced on March 20, 2013] 
A BILL 
To amend the Public Health Service Act to reauthorize 
programs under part A of title XI of such Act. 
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Be it enacted by the Senate and House of Representa-
tives 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 dis-
orders. 
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. 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-
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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 met-
abolic disorders; 
‘‘(B) the importance of the timeliness of col-
lection, delivery, receipt, and screening of speci-
mens; 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— 
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‘‘(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 author-
ization of appropriations). 
SEC. 3. EVALUATING THE EFFECTIVENESS OF NEWBORN 
AND CHILD SCREENING AND FOLLOWUP PRO-
GRAMS. 
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)— 
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(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 devel-
opment 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 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 man-
agement of heritable disorders based on gaps in serv-
ices or care; or 
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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 deter-
mination to adopt or reject such rec-
ommendation 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 con-
sideration of such pending recommenda-
tion.’’; 
(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-
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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 Committee 
referred the nominated condition to the condition re-
view 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 redesig-
nated) 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 Ad-
visory Committee has not been extended by statute, 
the Advisory Committee may be deemed, for purposes 
of the Federal Advisory Committee Act, an advisory 
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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 author-
ization of appropriations), as redesignated by para-
graph (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 screen-
ing.’’; 
(2) in subsection (b)(4)(D), by striking ‘‘New-
born Screening Saves Lives Act of 2008’’ and insert-
ing ‘‘Newborn Screening Saves Lives Reauthorization 
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 author-
ization 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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consideration the expertise of the Advisory Com-
mittee’’; 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 author-
ization of appropriations) and inserting the fol-
lowing: 
‘‘(b) SURVEILLANCE ACTIVITIES.—The Secretary, act-
ing through the Director of the Centers for Disease Control 
and Prevention, and taking into consideration the expertise 
of the Advisory Committee on Heritable Disorders in 
Newborns and Children established under section 1111, may 
provide, as appropriate, for the coordination of surveillance 
activities, including— 
‘‘(1) through standardized data collection and re-
porting, 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 de-
velopmental 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— 
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(1) in subsection (c), by striking ‘‘the Adminis-
trator, the Director of the Agency for Healthcare Re-
search and Quality,’’ and inserting ‘‘the Adminis-
trator of the Health Resources and Services Adminis-
tration, the Director of the Agency for Healthcare Re-
search and Quality, the Commissioner of Food and 
Drugs,’’; and 
(2) by striking subsection (e) (relating to author-
ization 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; 
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