113TH CONGRESS 

2D SESSION H. R. 1281 

AN ACT 

To amend the Public Health Service Act to reauthorize 

programs under part A of title XI of such Act. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 
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1 SECTION 1. SHORT TITLE; TABLE OF CONTENTS. 

2 (a) SHORT TITLE.—This Act may be cited as the 

3 ‘‘Newborn Screening Saves Lives Reauthorization Act of 

4 2014’’. 

5 (b) TABLE OF CONTENTS.—The table of contents of 

6 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. 

7 SEC. 2. IMPROVED NEWBORN AND CHILD SCREENING AND 

8 FOLLOWUP FOR HERITABLE DISORDERS. 

9 Section 1109 of the Public Health Service Act (42 

10 U.S.C. 300b–8) is amended— 

11 (1) in subsection (a)— 

12 (A) in the matter preceding paragraph 

13 (1)— 

14 (i) by striking ‘‘subsection (j)’’ and in15 serting ‘‘section 1117’’; and 

16 (ii) by striking ‘‘and in consultation 

17 with the Advisory Committee’’ and insert18 ing ‘‘and taking into consideration the ex19 pertise of the Advisory Committee’’; 
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1 (B) by amending paragraph (2) to read as 

2 follows: 

3 ‘‘(2) to assist in providing health care profes4 sionals and newborn screening laboratory personnel 

5 with education in newborn screening, counseling, 

6 and training in— 

7 ‘‘(A) relevant and new technologies in new8 born screening and congenital, genetic, and 

9 metabolic disorders; 

10 ‘‘(B) the importance of the timeliness of 

11 collection, delivery, receipt, and screening of 

12 specimens; and 

13 ‘‘(C) sharing of medical and diagnostic in14 formation with providers and families;’’; 

15 (C) in paragraph (3), by striking ‘‘and’’ at 

16 the end; 

17 (D) in paragraph (4)— 

18 (i) by striking ‘‘treatment’’ and insert19 ing ‘‘followup and treatment’’; and 

20 (ii) by striking the period and insert21 ing ‘‘; and’’; and 

22 (E) by adding at the end the following: 

23 ‘‘(5) to improve the timeliness of— 

24 ‘‘(A) the collection, delivery, receipt, and 

25 screening of specimens; and 
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1 ‘‘(B) the diagnosis of heritable disorders in 

2 newborns.’’; 

3 (2) in subsection (c), by striking ‘‘application 

4 submitted for a grant under subsection (a)(1)’’ and 

5 inserting ‘‘application for a grant under this sec6 tion’’; 

7 (3) in subsection (h), by striking ‘‘application 

8 submitted under subsection (c)(2)’’ each place it ap9 pears and inserting ‘‘application for a grant under 

10 this section’’; and 

11 (4) by striking subsection (j) (relating to au12 thorization of appropriations). 

13 SEC. 3. EVALUATING THE EFFECTIVENESS OF NEWBORN 

14 AND CHILD SCREENING AND FOLLOWUP 

15 PROGRAMS. 

16 Section 1110 of the Public Health Service Act (42 

17 U.S.C. 300b–9) is amended— 

18 (1) in the section heading, by inserting ‘‘AND

19 FOLLOWUP’’ after ‘‘CHILD SCREENING’’; 

20 (2) in subsection (a), by striking ‘‘of screen21 ing,’’ and inserting ‘‘, including with respect to time22 liness, of screening, followup,’’; 

23 (3) in subsection (b)— 

24 (A) in paragraph (1)— 
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1 (i) by striking ‘‘counseling, testing’’ 

2 and inserting ‘‘treatment, counseling, test3 ing, followup,’’; and 

4 (ii) by inserting before the semicolon 

5 the following: ‘‘, including, as appropriate, 

6 through the assessment of health and de7 velopment outcomes for such children 

8 through adolescence’’; 

9 (B) in paragraph (2)— 

10 (i) by striking ‘‘counseling, testing’’ 

11 and inserting ‘‘treatment, counseling, test12 ing, followup,’’; 

13 (ii) by inserting ‘‘in a timely manner’’ 

14 after ‘‘in newborns and children’’; and 

15 (iii) by striking ‘‘or’’ at the end; 

16 (C) in paragraph (3), by striking the pe17 riod at the end and inserting a semicolon; and 

18 (D) by adding at the end the following: 

19 ‘‘(4) methods that may be identified to improve 

20 quality in the diagnosis, treatment, and disease 

21 management of heritable disorders based on gaps in 

22 services or care; or 

23 ‘‘(5) methods or best practices by which the eli24 gible entities described in section 1109 can achieve 

25 in a timely manner— 
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1 ‘‘(A) collection, delivery, receipt, and 

2 screening of newborn screening specimens; and 

3 ‘‘(B) diagnosis of heritable disorders in 

4 newborns.’’; and 

5 (4) by striking subsection (d) (relating to au6 thorization of appropriations). 

7 SEC. 4. ADVISORY COMMITTEE ON HERITABLE DISORDERS 

8 IN NEWBORNS AND CHILDREN. 

9 Section 1111 of the Public Health Service Act (42 

10 U.S.C. 300b–10) is amended— 

11 (1) in subsection (b)— 

12 (A) by redesignating paragraphs (4) 

13 through (6) as paragraphs (6) through (8), re14 spectively; 

15 (B) by inserting after paragraph (3), the 

16 following: 

17 ‘‘(4) provide technical assistance, as appro18 priate, to individuals and organizations regarding 

19 the submission of nominations to the uniform 

20 screening panel, including prior to the submission of 

21 such nominations; 

22 ‘‘(5) take appropriate steps, at its discretion, to 

23 prepare for the review of nominations prior to their 

24 submission, including for conditions for which a 

25 screening method has been validated but other nomi-
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1 nation criteria are not yet met, in order to facilitate 

2 timely action by the Advisory Committee once such 

3 submission has been received by the Committee;’’; 

4 (C) in paragraph (6) (as so redesignated), 

5 by inserting ‘‘, including the cost’’ after ‘‘public 

6 health impact’’; and 

7 (D) in paragraph (8) (as so redesig8 nated)— 

9 (i) in subparagraph (A), by striking 

10 ‘‘achieve rapid diagnosis’’ and inserting 

11 ‘‘achieve best practices in rapid diagnosis 

12 and appropriate treatment’’; 

13 (ii) in subparagraph (D), by inserting 

14 before the semicolon ‘‘, including informa15 tion on cost and incidence’’; 

16 (iii) in subparagraph (J), by striking 

17 ‘‘and’’ at the end; 

18 (iv) in subparagraph (K), by striking 

19 the period and inserting ‘‘; and’’; and 

20 (v) by adding at the end the following: 

21 ‘‘(L) the timeliness of collection, delivery, 

22 receipt, and screening of specimens to be tested 

23 for heritable disorders in newborns in order to 

24 ensure rapid diagnosis and followup.’’; 

25 (2) in subsection (d)— 
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1 (A) in paragraph (1)— 

2 (i) by striking ‘‘180’’ and inserting 

3 ‘‘120’’; and 

4 (ii) by adding at the end the fol5 lowing: ‘‘If the Secretary is unable to make 

6 a determination to adopt or reject such 

7 recommendation within such 120-day pe8 riod, the Secretary shall notify the Advi9 sory Committee and the appropriate com10 mittees of Congress of such determination 

11 together with an explanation for why the 

12 Secretary was unable to comply within 

13 such 120-day period, as well as a plan of 

14 action for consideration of such pending 

15 recommendation.’’; 

16 (B) by striking paragraph (2); 

17 (C) by redesignating paragraph (3) as 

18 paragraph (2); and 

19 (D) by adding at the end the following: 

20 ‘‘(3) DEADLINE FOR REVIEW.—For each condi21 tion nominated to be added to the recommended uni22 form screening panel in accordance with the require23 ments of this section, the Advisory Committee shall 

24 review and vote on the nominated condition within 

25 9 months of the date on which the Advisory Com-
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1 mittee referred the nominated condition to the con2 dition review workgroup.’’; 

3 (3) by redesignating subsections (f) and (g) as 

4 subsections (g) and (h), respectively; 

5 (4) by inserting after subsection (e) the fol6 lowing new subsection: 

7 ‘‘(f) MEETINGS.—The Advisory Committee shall 

8 meet at least 4 times each calendar year, or at the discre9 tion of the Designated Federal Officer in consultation with 

10 the Chair.’’; 

11 (5) by amending subsection (g) (as so redesig12 nated) to read as follows: 

13 ‘‘(g) CONTINUATION OF OPERATION OF COM14 MITTEE.— 

15 ‘‘(1) IN GENERAL.—Notwithstanding section 14 

16 of the Federal Advisory Committee Act, the Advi17 sory Committee shall continue to operate through 

18 the end of fiscal year 2019. 

19 ‘‘(2) CONTINUATION IF NOT REAUTHORIZED.— 

20 If at the end of fiscal year 2019 the duration of the 

21 Advisory Committee has not been extended by stat22 ute, the Advisory Committee may be deemed, for 

23 purposes of the Federal Advisory Committee Act, an 

24 advisory committee established by the President or 
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1 an officer of the Federal Government under section 

2 9(a) of such Act.’’; and 

3 (6) by striking subsection (h) (relating to au4 thorization of appropriations), as redesignated by 

5 paragraph (3). 

6 SEC. 5. CLEARINGHOUSE OF NEWBORN SCREENING INFOR7 MATION. 

8 Section 1112 of the Public Health Service Act (42 

9 U.S.C. 300b–11) is amended— 

10 (1) in subsection (a)— 

11 (A) in paragraph (2), by striking ‘‘and’’ at 

12 the end; 

13 (B) in paragraph (3)— 

14 (i) by striking ‘‘data’’ and inserting 

15 ‘‘information’’; and 

16 (ii) by striking the period at the end 

17 and inserting a semicolon; and 

18 (C) by adding at the end the following new 

19 paragraphs: 

20 ‘‘(4) maintain current information on the num21 ber of conditions for which screening is conducted in 

22 each State; and 

23 ‘‘(5) disseminate available evidence-based guide24 lines related to diagnosis, counseling, and treatment 
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1 with respect to conditions detected by newborn 

2 screening.’’; 

3 (2) in subsection (b)(4)(D), by striking ‘‘New4 born Screening Saves Lives Act of 2008’’ and insert5 ing ‘‘Newborn Screening Saves Lives Reauthoriza6 tion Act of 2014’’; 

7 (3) in subsection (c)— 

8 (A) by striking ‘‘developing the clearing9 house’’ and inserting ‘‘carrying out activities’’; 

10 and 

11 (B) by striking ‘‘clearinghouse minimizes 

12 duplication and supplements, not supplants’’ 

13 and inserting ‘‘activities minimize duplication 

14 and supplement, not supplant’’; and 

15 (4) by striking subsection (d) (relating to au16 thorization of appropriations). 

17 SEC. 6. LABORATORY QUALITY AND SURVEILLANCE. 

18 Section 1113 of the Public Health Service Act (42 

19 U.S.C. 300b–12) is amended— 

20 (1) in the section heading, by inserting ‘‘AND

21 SURVEILLANCE’’ before the period; 

22 (2) in subsection (a)— 

23 (A) in the matter preceding paragraph (1), 

24 by striking ‘‘and in consultation with the Advi25 sory Committee’’ and inserting ‘‘and taking into 
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1 consideration the expertise of the Advisory 

2 Committee’’; and 

3 (B) in paragraph (1), by inserting ‘‘timeli4 ness for processing such tests,’’ after ‘‘newborn5 screening tests,’’; and 

6 (3) by striking subsection (b) (relating to au7 thorization of appropriations) and inserting the fol8 lowing: 

9 ‘‘(b) SURVEILLANCE ACTIVITIES.—The Secretary, 

10 acting through the Director of the Centers for Disease 

11 Control and Prevention, and taking into consideration the 

12 expertise of the Advisory Committee on Heritable Dis13 orders in Newborns and Children established under sec14 tion 1111, may provide, as appropriate, for the coordina15 tion of surveillance activities, including— 

16 ‘‘(1) through standardized data collection and 

17 reporting, as well as the use of electronic health 

18 records; and 

19 ‘‘(2) by promoting data sharing regarding new20 born screening with State-based birth defects and 

21 developmental disabilities monitoring programs.’’. 

22 SEC. 7. INTERAGENCY COORDINATING COMMITTEE ON 

23 NEWBORN AND CHILD SCREENING. 

24 Section 1114 of the Public Health Service Act (42 

25 U.S.C. 300b–13) is amended— 
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1 (1) in subsection (c), by striking ‘‘the Adminis2 trator, the Director of the Agency for Healthcare 

3 Research and Quality,’’ and inserting ‘‘the Adminis4 trator of the Health Resources and Services Admin5 istration, the Director of the Agency for Healthcare 

6 Research and Quality, the Commissioner of Food 

7 and Drugs,’’; and 

8 (2) by striking subsection (e) (relating to au9 thorization of appropriations). 

10 SEC. 8. NATIONAL CONTINGENCY PLAN FOR NEWBORN 

11 SCREENING. 

12 Section 1115(a) of the Public Health Service Act (42 

13 U.S.C. 300b–14(a)) is amended— 

14 (1) by striking ‘‘consortia’’ and inserting ‘‘con15 sortium’’; and 

16 (2) by adding at the end the following: ‘‘The 

17 plan shall be updated as needed and at least every 

18 five years.’’. 

19 SEC. 9. HUNTER KELLY RESEARCH PROGRAM. 

20 Section 1116 of the Public Health Service Act (42 

21 U.S.C. 300b–15) is amended— 

22 (1) in subsection (a)(1)— 

23 (A) in subparagraph (B), by striking ‘‘; 

24 and’’ and inserting a semicolon; 
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1 (B) by redesignating subparagraph (C) as 

2 subparagraph (E); and 

3 (C) by inserting after subparagraph (B) 

4 the following: 

5 ‘‘(C) providing research findings and data 

6 for newborn conditions under review by the Ad7 visory Committee on Heritable Disorders in 

8 Newborns and Children to be added to the rec9 ommended uniform screening panel; 

10 ‘‘(D) conducting pilot studies on conditions 

11 recommended by the Advisory Committee on 

12 Heritable Disorders in Newborns and Children 

13 to ensure that screenings are ready for nation14 wide implementation; and’’; and 

15 (2) in subsection (c), by striking ‘‘of the Na16 tional Institutes of Health Reform Act of 2006’’. 

17 SEC. 10. AUTHORIZATION OF APPROPRIATIONS. 

18 Part A of title XI of the Public Health Service Act 

19 (42 U.S.C. 300b–1 et seq.) is amended by adding at the 

20 end, the following: 

21 ‘‘SEC. 1117. AUTHORIZATION OF APPROPRIATIONS FOR 

22 NEWBORN SCREENING PROGRAMS AND AC23 TIVITIES. 

24 ‘‘There are authorized to be appropriated— 
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1 ‘‘(1) to carry out sections 1109, 1110, 1111, 

2 and 1112, $11,900,000 for each of fiscal years 2015 

3 through 2019; and 

4 ‘‘(2) to carry out section 1113, $8,000,000 for 

5 each of fiscal years 2015 through 2019.’’. 

6 SEC. 11. REPORTS TO CONGRESS. 

7 (a) GAO REPORT ON TIMELINESS OF NEWBORN

8 SCREENING.— 

9 (1) IN GENERAL.—Not later than 2 years after 

10 the date of enactment of this Act, the Comptroller 

11 General of the United States shall submit a report 

12 to the Committee on Health, Education, Labor, and 

13 Pensions of the Senate and the Committee on En14 ergy and Commerce of the House of Representatives 

15 concerning the timeliness of screening for heritable 

16 disorders in newborns. 

17 (2) CONTENTS.—The report submitted under 

18 paragraph (1) shall include the following: 

19 (A) An analysis of information regarding 

20 the timeliness of newborn screening, which may 

21 include the time elapsed from birth to specimen 

22 collection, specimen collection to receipt by lab23 oratory, specimen receipt to reporting, reporting 

24 to followup testing, and followup testing to con25 firmed diagnosis. 
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1 (B) A summary of any guidelines, rec2 ommendations, or best practices available to 

3 States and health care providers intended to 

4 support a timely newborn screening system. 

5 (C) An analysis of any barriers to main6 taining a timely newborn screening system 

7 which may exist and recommendations for ad8 dressing such barriers. 

9 (b) REPORT BY SECRETARY.— 

10 (1) IN GENERAL.—The Secretary of Health and 

11 Human Services shall— 

12 (A) not later than 1 year after the date of 

13 enactment of this Act, submit to the Committee 

14 on Health, Education, Labor, and Pensions of 

15 the Senate and the Committee on Energy and 

16 Commerce of the House of Representatives a 

17 report on activities related to— 

18 (i) newborn screening; and 

19 (ii) screening children who have or are 

20 at risk for heritable disorders; and 

21 (B) not less than every 2 years, submit to 

22 such committees an updated version of such re23 port. 

24 (2) CONTENTS.—The report submitted under 

25 this subsection shall contain a description of— 
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1 (A) the ongoing activities under sections 

2 1109, 1110, and 1112 through 1115 of the 

3 Public Health Service Act; and 

4 (B) the amounts expended on such activi5 ties. 

Passed the House of Representatives June 24, 2014. 

Attest: 

Clerk. 
113TH CONGRESS 

2D SESSION H. R. 1281 

AN ACT 

To amend the Public Health Service Act to reauAct. thorize programs under part A of title XI of such