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 ‘‘section 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 newborn 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 heritable 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 newborn screening specimens; and 

‘‘(B) diagnosis of heritable disorders in newborns.’’; and 

(4) by striking subsection (d) (relating to authorization 

of appropriations). 
H. R. 1281—3 

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 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 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 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 

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 
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referred the nominated condition to the condition review 

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 redesignated) 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 Advisory Committee 

has not been extended by statute, 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 authorization 

of appropriations), as redesignated by paragraph (3). 

SEC. 5. CLEARINGHOUSE OF NEWBORN SCREENING INFORMATION. 

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 number of conditions for which screening is conducted in each State; and 

‘‘(5) disseminate available evidence-based guidelines related 

to diagnosis, counseling, and treatment with respect to conditions detected by newborn screening.’’; 

(2) in subsection (b)(4)(D), by striking ‘‘Newborn Screening 

Saves Lives Act of 2008’’ and inserting ‘‘Newborn Screening 

Saves Lives Reauthorization Act of 2014’’; 

(3) in subsection (c)— 

(A) by striking ‘‘developing the clearinghouse’’ 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 authorization 

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; 
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 processing 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 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 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 subparagraph (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 recommended by the Advisory Committee on Heritable Disorders in Newborns and Children to ensure that screenings 

are ready for nationwide implementation; and’’; and 
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(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 Committee on Energy 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 laboratory, specimen receipt to reporting, 

reporting to followup testing, and followup testing to confirmed diagnosis. 

(B) A summary of any guidelines, recommendations, 

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 maintaining a timely 

newborn screening system which may exist and recommendations 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 committees 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 newborn 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 regulations. 

Speaker of the House of Representatives. 

Vice President of the United States and

President of the Senate.