I 
113TH CONGRESS 
1ST SESSION H. R. 1281 
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 
A BILL 
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, 
SECTION 1. SHORT TITLE; TABLE OF CONTENTS. 
(a) SHORT TITLE.—This Act may be cited as the 
‘‘Newborn Screening Saves Lives Reauthorization Act of 
2013’’. 
(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 for heritable disorders. 
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. 
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Sec. 5. Clearinghouse of Newborn Screening Information. 
Sec. 6. Laboratory quality. 
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. Newborn screening surveillance, followup, and applied research. 
Sec. 11. Authorization of appropriations. 
SEC. 2. IMPROVED NEWBORN AND CHILD SCREENING 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), 
by striking ‘‘and in consultation with the Advi-
sory Committee’’ and inserting ‘‘and taking into 
consideration the recommendations of the Advi-
sory Committee’’; 
(B) in paragraph (2), by striking ‘‘screen-
ing and training’’ and inserting ‘‘screening, 
counseling, and training’’; and 
(C) in paragraph (4), by striking ‘‘treat-
ment’’ and inserting ‘‘followup and treatment’’; 
(2) in subsection (b)— 
(A) in paragraph (4), by striking ‘‘or’’ at 
the end; 
(B) by redesignating paragraph (5) as 
paragraph (7); and 
(C) by inserting after paragraph (4) the 
following: 
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‘‘(5) a health professional organization; 
‘‘(6) an early childhood health system; or’’; and 
(3) 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 inserting ‘‘followup,’’ 
after ‘‘the effectiveness of screening,’’; 
(3) in subsection (b)— 
(A) in paragraph (1), by inserting ‘‘ascer-
tainment, treatment,’’ after ‘‘the effectiveness 
of screening, counseling,’’; 
(B) in paragraph (2)— 
(i) by inserting ‘‘ascertainment, treat-
ment,’’ after ‘‘the effectiveness of screen-
ing, counseling,’’; and 
(ii) by striking ‘‘or’’ at the end; 
(C) in paragraph (3), by striking the pe-
riod at the end and inserting ‘‘; or’’; and 
(D) by adding at the end the following: 
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‘‘(f) MEETINGS.—The Advisory Committee shall 
meet in person at least twice each year.’’; 
(4) by amending subsection (g), as redesignated 
by paragraph (2), to read as follows: 
‘‘(g) CONTINUATION
OF
OPERATION
OF
COM-
MITTEE.— 
‘‘(1) IN GENERAL.—Notwithstanding section 14 
of the Federal Advisory Committee Act (5 U.S.C. 
App.), the Advisory Committee shall continue to op-
erate for the period beginning on the date of enact-
ment of the Newborn Screening Saves Lives Reau-
thorization Act of 2013 and concluding at the end 
of the fifth fiscal year which begins after such date. 
‘‘(2) CONTINUATION IF NOT REAUTHORIZED.— 
If at the end of the fifth fiscal year described in 
paragraph (1) the duration of the Advisory Com-
mittee has not been extended by statute— 
‘‘(A) the Advisory Committee may be con-
sidered, for the purposes of the Federal Advi-
sory Committee Act, to be an advisory com-
mittee established by the President or an officer 
of the Federal Government under section 9(a) 
of such Act; and 
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‘‘(B) the Secretary may renew the Advi-
sory Committee under section 14(a)(1)(A) of 
such Act.’’; and 
(5) by striking subsection (h) (relating to au-
thorization of appropriations), as redesignated by 
paragraph (2). 
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’’ 
and inserting a semicolon; 
(B) in paragraph (3), by striking the pe-
riod at the end and inserting a semicolon; and 
(C) by adding at the end the following new 
paragraphs: 
‘‘(4) maintain current data on the number of 
conditions for which screening is conducted in each 
State; and 
‘‘(5) establish or disseminate guidelines for 
services and personnel necessary for followup, diag-
nosis, counseling, and treatment with respect to con-
ditions detected by newborn screening.’’; 
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(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 2013’’; and 
(3) by striking subsection (d) (relating to au-
thorization of appropriations). 
SEC. 6. LABORATORY QUALITY. 
Section 1113 of the Public Health Service Act (42 
U.S.C. 300b–12) is amended— 
(1) in subsection (a)— 
(A) by striking the subsection enumerator 
and heading; and 
(B) by striking ‘‘and in consultation with 
the Advisory Committee’’ and inserting ‘‘and 
taking into consideration the recommendations 
of the Advisory Committee’’; and 
(2) by striking subsection (b) (relating to au-
thorization of appropriations). 
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-
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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) and inserting the fol-
lowing: 
‘‘(e) REPORT TO CONGRESS.— 
‘‘(1) IN GENERAL.—The Secretary shall— 
‘‘(A) not later than 1 year after the date 
of enactment of the Newborn Screening Saves 
Lives Reauthorization Act of 2013, submit to 
the Health, Education, Labor, and Pensions 
Committee of the Senate and the Energy and 
Commerce Committee of the House of Rep-
resentatives 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, shall sub-
mit to such committees an updated version of 
such report. 
‘‘(2) CONTENTS.—The report submitted under 
subsection (a) shall contain a description of— 
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‘‘(A) the implementation of sections 1111 
through 1116B, including this section; and 
‘‘(B) the amounts expended on such imple-
mentation.’’. 
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 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(a)(1) of the Public Health Service Act 
(42 U.S.C. 300b–15(a)(1)) is amended— 
(1) in subparagraph (B), by striking ‘‘; and’’ 
and inserting a semicolon; 
(2) by redesignating subparagraph (C) as sub-
paragraph (E); and 
(3) by inserting after subparagraph (B) the fol-
lowing: 
‘‘(C) providing research and data for new-
born conditions under review by the Advisory 
Committee on Heritable Disorders in Newborns 
and Children to be added to the Recommended 
Uniform Screening Panel; 
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‘‘(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’’. 
SEC. 10. NEWBORN SCREENING SURVEILLANCE, FOL-
LOWUP, AND APPLIED RESEARCH. 
The Public Health Service Act is amended by insert-
ing after section 1116 of such Act (42 U.S.C. 300b–15) 
the following: 
‘‘SEC. 1116A. NEWBORN SCREENING SURVEILLANCE, FOL-
LOWUP, AND APPLIED RESEARCH. 
‘‘(a) IN GENERAL.—The Secretary, acting through 
the Director of the Centers for Disease Control and Pre-
vention, shall award grants to, or enter into cooperative 
agreements with, eligible entities to develop longitudinal 
followup and tracking programs for newborn screening. 
‘‘(b) PROGRAM.—Longitudinal followup and tracking 
programs developed through a grant under subsection (a) 
shall incorporate standardized procedures for data man-
agement and program effectiveness and costs, such as— 
‘‘(1) studying the costs and effectiveness of 
newborn screening, evaluation and intervention pro-
grams, and surveillance systems conducted by State- 
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based programs in order to answer issues of impor-
tance to State and national policymakers; 
‘‘(2) studying the effectiveness of newborn 
screening followup and intervention programs by as-
sessing the health and development of children at 
school age and as young adults; 
‘‘(3) promoting the sharing of data regarding 
newborn screening with State-based birth defects 
and developmental disabilities monitoring programs; 
‘‘(4) ensuring coordination of surveillance ac-
tivities, including— 
‘‘(A) standardized data collection and re-
porting; and 
‘‘(B) use of electronic health records; 
‘‘(5) facilitating quality improvement in treat-
ment and disease management based on gaps in 
services or care identified by longitudinal tracking 
systems; and 
‘‘(6) utilizing data from longitudinal tracking 
systems to support the development and evaluation 
of evidence-based guidelines for diagnosis, treatment, 
and disease management. 
‘‘(c) ELIGIBLE ENTITY.—In this section, the term 
‘eligible entity’ means— 
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‘‘(1) a State or a political subdivision of a 
State; 
‘‘(2) a consortium of 2 or more States or sub-
divisions described in paragraph (1); 
‘‘(3) a health facility or program operated by or 
pursuant to a contract with, or a grant from, the In-
dian Health Service; or 
‘‘(4) any other entity with appropriate expertise 
in newborn screening, as determined by the Sec-
retary.’’. 
SEC. 11. AUTHORIZATION OF APPROPRIATIONS. 
The Public Health Service Act is amended by insert-
ing after section 1116A of such Act, as added by section 
10 of this Act, the following: 
‘‘SEC. 1116B. 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, $13,334,000 for each of fiscal years 2014 
through 2018; 
‘‘(2) to carry out section 1113, $7,500,000 for 
each of fiscal years 2014 through 2018; and 
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‘‘(3) to carry out section 1116A, $5,000,000 for 
each of fiscal years 2014 through 2018.’’. 
Æ 
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