H. R. 1281—5 
(2) in subsection (a)— 
(A) in the matter preceding paragraph (1), by striking 
‘‘and in consultation with the Advisory Committee’’ and 
inserting ‘‘and taking into consideration the expertise of 
the Advisory Committee’’; and 
(B) in paragraph (1), by inserting ‘‘timeliness for proc-
essing such tests,’’ after ‘‘newborn-screening tests,’’; and 
(3) by striking subsection (b) (relating to authorization 
of appropriations) and inserting the following: 
‘‘(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 Com-
mittee on Heritable Disorders in Newborns and Children estab-
lished under section 1111, may provide, as appropriate, for the 
coordination 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 newborn 
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 Administrator, the 
Director of the Agency for Healthcare Research and Quality,’’ 
and inserting ‘‘the Administrator of the Health Resources and 
Services Administration, the Director of the Agency for 
Healthcare Research and Quality, the Commissioner of Food 
and Drugs,’’; and 
(2) by striking subsection (e) (relating to authorization 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 ‘‘consortium’’; 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 subpara-
graph (E); and 
(C) by inserting after subparagraph (B) the following: 
‘‘(C) providing research findings and data for newborn 
conditions under review by the Advisory Committee on 
Heritable Disorders in Newborns and Children to be added 
to the recommended uniform screening panel; 
‘‘(D) conducting pilot studies on conditions rec-
ommended by the Advisory Committee on Heritable Dis-
orders in Newborns and Children to ensure that screenings 
are ready for nationwide implementation; and’’; and
H. R. 1281—6 
(2) in subsection (c), by striking ‘‘of the National 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 ACTIVITIES. 
‘‘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 Com-
mittee on Energy and Commerce of the House of Representa-
tives concerning the timeliness of screening for heritable dis-
orders 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 laboratory, specimen receipt to reporting, 
reporting to followup testing, and followup testing to con-
firmed diagnosis. 
(B) A summary of any guidelines, recommendations, 
or best practices available to States and health care pro-
viders intended to support a timely newborn screening 
system. 
(C) An analysis of any barriers to maintaining a timely 
newborn screening system which may exist and rec-
ommendations for addressing 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 commit-
tees an updated version of such report. 
(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 activities.
H. R. 1281—7 
SEC. 12. INFORMED CONSENT FOR NEWBORN SCREENING RESEARCH. 
(a) IN GENERAL.—Research on newborn dried blood spots shall 
be considered research carried out on human subjects meeting 
the definition of section 46.102(f)(2) of title 45, Code of Federal 
Regulations, for purposes of Federally funded research conducted 
pursuant to the Public Health Service Act until such time as 
updates to the Federal Policy for the Protection of Human Subjects 
(the Common Rule) are promulgated pursuant to subsection (c). 
For purposes of this subsection, sections 46.116(c) and 46.116(d) 
of title 45, Code of Federal Regulations, shall not apply. 
(b) EFFECTIVE DATE.—Subsection (a) shall apply only to new-
born dried blood spots used for purposes of Federally funded 
research that were collected not earlier than 90 days after the 
date of enactment of this Act. 
(c) REGULATIONS.—Not later than 6 months after the date 
of enactment of this Act, the Secretary of Health and Human 
Services shall promulgate proposed regulations related to the 
updating of the Federal Policy for the Protection of Human Subjects 
(the Common Rule), particularly with respect to informed consent. 
Not later than 2 years after such date of enactment, the Secretary 
shall promulgate final regulations based on such proposed regula-
tions. 
Speaker of the House of Representatives. 
Vice President of the United States and
President of the Senate.