II 

113TH CONGRESS 

1ST SESSION S. 1417 

To amend the Public Health Service Act to reauthorize programs under 

part A of title XI of such Act. 

IN THE SENATE OF THE UNITED STATES 

AUGUST 1, 2013 

Mrs. HAGAN (for herself and Mr. HATCH) introduced the following bill; which 

was read twice and referred to the Committee on Health, Education, 

Labor, and Pensions 

A BILL 

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, 

3 SECTION 1. SHORT TITLE; TABLE OF CONTENTS. 

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

5 ‘‘Newborn Screening Saves Lives Reauthorization Act of 

6 2013’’. 

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

8 this Act is as follows: 

Sec. 1. Short title; table of contents. 

Sec. 2. Improved newborn and child screening and follow-up for heritable disorders. 


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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. 

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. 

1 SEC. 2. IMPROVED NEWBORN AND CHILD SCREENING AND 

2 FOLLOW-UP FOR HERITABLE DISORDERS. 

3 Section 1109 of the Public Health Service Act (42 

4 U.S.C. 300b–8) is amended— 

5 (1) in subsection (a)— 

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

7 by striking ‘‘and in consultation with the Advi8 sory Committee’’ and inserting ‘‘and taking into 

9 consideration the recommendations of the Advi10 sory Committee’’; 

11 (B) in paragraph (2), by striking ‘‘screen12 ing and training’’ and inserting ‘‘screening, 

13 counseling, and training’’; and 

14 (C) in paragraph (4), by striking ‘‘treat15 ment’’ and inserting ‘‘follow-up and treatment’’; 

16 (2) in subsection (h), by striking ‘‘subsection 

17 (c)(2)’’ each place that such appears and inserting 

18 ‘‘subsection (c)’’; and 

19 (3) by striking subsection (j) (relating to au20 thorization of appropriations). 


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1 SEC. 3. EVALUATING THE EFFECTIVENESS OF NEWBORN 

2 AND CHILD SCREENING AND FOLLOW-UP 

3 PROGRAMS. 

4 Section 1110 of the Public Health Service Act (42 

5 U.S.C. 300b–9) is amended— 

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

7 FOLLOW-UP’’ after ‘‘CHILD SCREENING’’; 

8 (2) in subsection (a), by inserting ‘‘follow-up,’’ 

9 after ‘‘the effectiveness of screening,’’; 

10 (3) in subsection (b)— 

11 (A) in paragraph (1), by inserting ‘‘ascer12 tainment, treatment,’’ after ‘‘the effectiveness 

13 of screening, counseling,’’; 

14 (B) in paragraph (2)— 

15 (i) by inserting ‘‘ascertainment, treat16 ment,’’ after ‘‘the effectiveness of screen17 ing, counseling,’’; and 

18 (ii) by striking ‘‘or’’ at the end; 

19 (C) in paragraph (3), by striking the pe20 riod at the end and inserting a semicolon; and 

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

22 ‘‘(4) the availability and effectiveness of follow23 up care for newborns and their families after screen24 ing and diagnosis; 

25 ‘‘(5) the costs and effectiveness of newborn 

26 screening, evaluation and intervention programs, and 


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1 surveillance systems conducted by State-based pro2 grams in order to answer issues of importance to 

3 State and national policymakers; 

4 ‘‘(6) the effectiveness of newborn screening fol5 low-up and intervention programs through the as6 sessment of the health and development of children 

7 at school age and as young adults; 

8 ‘‘(7) the level of data sharing regarding new9 born screening with State-based birth defects and 

10 developmental disabilities monitoring programs; 

11 ‘‘(8) the coordination of surveillance activities, 

12 including— 

13 ‘‘(A) standardized data collection and re14 porting; and 

15 ‘‘(B) use of electronic health records; 

16 ‘‘(9) the facilitation of quality improvement in 

17 treatment and disease management based on gaps in 

18 services or care identified by longitudinal tracking 

19 systems; and 

20 ‘‘(10) the utilization of data from longitudinal 

21 tracking systems to support the development and 

22 evaluation of evidence-based guidelines for diagnosis, 

23 treatment, and disease management.’’; and 

24 (4) by striking subsection (d) (relating to au25 thorization of appropriations). 


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1 SEC. 4. ADVISORY COMMITTEE ON HERITABLE DISORDERS 

2 IN NEWBORNS AND CHILDREN. 

3 Section 1111 of the Public Health Service Act (42 

4 U.S.C. 300b–10) is amended— 

5 (1) in subsection (b)— 

6 (A) in paragraph (4), by striking ‘‘public 

7 health impact’’ and inserting ‘‘public health im8 pact, including the cost’’; and 

9 (B) in paragraph (6)— 

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

11 ‘‘achieve rapid diagnosis’’ and inserting 

12 ‘‘achieve best practices in rapid diagnosis 

13 and appropriate treatment’’; 

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

15 before the semicolon ‘‘, including informa16 tion on cost and incidence’’; 

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

18 ‘‘and’’ at the end; and 

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

20 the period and inserting ‘‘; and’’; 

21 (2) in subsection (d)— 

22 (A) in paragraph (1), by striking ‘‘180’’ 

23 and inserting ‘‘60’’; 

24 (B) in paragraph (2), by striking ‘‘New25 born Screening Saves Lives Act of 2008’’ and 


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1 insert ‘‘Newborn Screening Saves Lives Reau2 thorization Act of 2013’’; and 

3 (C) by adding at the end the following: 

4 ‘‘(4) PRIORITY REVIEW.— 

5 ‘‘(A) IN GENERAL.—For each nomination 

6 to the recommended uniform screening panel 

7 that meets the criteria of subparagraph (B), the 

8 Advisory Committee on Heritable Disorders in 

9 Newborns and Children shall provide a priority 

10 review as described in this paragraph and sub11 ject to the deadlines in subparagraph (C). 

12 ‘‘(B) CRITERIA FOR PRIORITY REVIEW.— 

13 The Advisory Committee on Heritable Dis14 orders in Newborns and Children shall provide 

15 a priority review with respect to a nomination 

16 to the recommended uniform screening panel 

17 that meets each of the following criteria: 

18 ‘‘(i) A human drug application, as de19 fined in section 735(1) of the Federal 

20 Food, Drug, and Cosmetic Act (21 U.S.C. 

21 379g(1)), has been submitted to the Sec22 retary for treatment of such disease or 

23 condition. 

24 ‘‘(ii) The application described in 

25 clause (i) has been granted priority review 


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1 or has received fast track or breakthrough 

2 therapy designations by the Secretary as 

3 described in section 529(a)(1) of the Fed4 eral Food, Drug, and Cosmetic Act (21 

5 U.S.C. 360ff(a)(1)). 

6 ‘‘(C) DEADLINES FOR PRIORITY RE7 VIEW.—The Advisory Committee on Heritable 

8 Disorders in Newborns and Children shall vote 

9 on the nominated condition that is under pri10 ority review within 8 months of the later of— 

11 ‘‘(i) the date on which the Advisory 

12 Committee refers the nomination to the 

13 condition review workgroup; or 

14 ‘‘(ii) the date of the approval, by the 

15 Food and Drug Administration, of the 

16 treatment associated with the nomination 

17 to the recommended uniform screening 

18 panel. 

19 ‘‘(D) FAILURE TO ACT.—If the Secretary 

20 fails to act on a recommendation within the 

21 time period provided for in paragraph (1), the 

22 Secretary shall adopt the recommendation and 

23 include the screening recommended by the Advi24 sory Committee on Heritable Disorders in 


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1 Newborns and Children in the recommended 

2 uniform screening panel. 

3 ‘‘(E) OTHER REVIEWS.—For each nomina4 tion to the recommended uniform screening 

5 panel that does not meet the criteria of sub6 paragraph (B), the Advisory Committee on 

7 Heritable Disorders in Newborns and Children 

8 shall provide for a review and vote on the nomi9 nated condition that is under review within 10 

10 months of the date on which the Advisory Com11 mittee referred the nomination to the condition 

12 review workgroup.’’; 

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

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

15 (4) by inserting after subsection (e) the fol16 lowing new subsection: 

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

18 meet at least 4 times each calendar year with at least 2 

19 meetings in person.’’; and 

20 (5) by striking subsection (h) (relating to au21 thorization of appropriations), as redesignated by 

22 paragraph (2). 


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1 SEC. 5. CLEARINGHOUSE OF NEWBORN SCREENING INFOR2 MATION. 

3 Section 1112 of the Public Health Service Act (42 

4 U.S.C. 300b–11) is amended— 

5 (1) in subsection (a)— 

6 (A) in paragraph (2), by striking ‘‘; and’’ 

7 and inserting a semicolon; 

8 (B) in paragraph (3), by striking the pe9 riod at the end and inserting a semicolon; and 

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

11 paragraphs: 

12 ‘‘(4) maintain current data on the number of 

13 conditions for which screening is conducted in each 

14 State; and 

15 ‘‘(5) disseminate available evidence-informed 

16 guidelines related to diagnosis, counseling, and 

17 treatment with respect to conditions detected by 

18 newborn screening.’’; 

19 (2) in subsection (b)(4)(D), by striking ‘‘New20 born Screening Saves Lives Act of 2008’’ and insert21 ing ‘‘Newborn Screening Saves Lives Reauthoriza22 tion Act of 2013’’; and 

23 (3) by striking subsection (d) (relating to au24 thorization of appropriations). 


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1 SEC. 6. LABORATORY QUALITY. 

2 Section 1113 of the Public Health Service Act (42 

3 U.S.C. 300b–12) is amended— 

4 (1) in subsection (a)— 

5 (A) by striking the subsection enumerator 

6 and heading; and 

7 (B) by striking ‘‘and in consultation with 

8 the Advisory Committee’’ and inserting ‘‘and 

9 taking into consideration the recommendations 

10 of the Advisory Committee’’; and 

11 (2) by striking subsection (b) (relating to au12 thorization of appropriations). 

13 SEC. 7. INTERAGENCY COORDINATING COMMITTEE ON 

14 NEWBORN AND CHILD SCREENING. 

15 Section 1114 of the Public Health Service Act (42 

16 U.S.C. 300b–13) is amended— 

17 (1) in subsection (c), by striking ‘‘the Adminis18 trator, the Director of the Agency for Healthcare 

19 Research and Quality’’ and inserting ‘‘the Adminis20 trator of the Health Resources and Services Admin21 istration, the Director of the Agency for Healthcare 

22 Research and Quality, the Commissioner of Food 

23 and Drugs,’’; and 

24 (2) by striking subsection (e) (relating to au25 thorization of appropriations) and inserting the fol26 lowing: 


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1 ‘‘(e) REPORT TO CONGRESS.— 

2 ‘‘(1) IN GENERAL.—The Secretary shall— 

3 ‘‘(A) not later than 1 year after the date 

4 of enactment of the Newborn Screening Saves 

5 Lives Reauthorization Act of 2013, submit to 

6 the Health, Education, Labor, and Pensions 

7 Committee of the Senate and the Energy and 

8 Commerce Committee of the House of Rep9 resentatives a report on activities related to— 

10 ‘‘(i) newborn screening; and 

11 ‘‘(ii) screening children who have or 

12 are at risk for heritable disorders; and 

13 ‘‘(B) not less than every 2 years, shall sub14 mit to such committees an updated version of 

15 such report. 

16 ‘‘(2) CONTENTS.—The report submitted under 

17 subsection (a) shall contain a description of— 

18 ‘‘(A) the implementation of sections 1111 

19 through 1116B, including this section; and 

20 ‘‘(B) the amounts expended on such imple21 mentation.’’. 

22 SEC. 8. NATIONAL CONTINGENCY PLAN FOR NEWBORN 

23 SCREENING. 

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

25 U.S.C. 300b–14(a)) is amended by adding at the end the 


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1 following: ‘‘The plan shall be updated as needed and at 

2 least every five years.’’. 

3 SEC. 9. HUNTER KELLY RESEARCH PROGRAM. 

4 Section 1116(a)(1) of the Public Health Service Act 

5 (42 U.S.C. 300b–15(a)(1)) is amended— 

6 (1) in subparagraph (B), by striking ‘‘; and’’ 

7 and inserting a semicolon; 

8 (2) by redesignating subparagraph (C) as sub9 paragraph (E); and 

10 (3) by inserting after subparagraph (B) the fol11 lowing: 

12 ‘‘(C) providing research and data for new13 born conditions under review by the Advisory 

14 Committee on Heritable Disorders in Newborns 

15 and Children to be added to the recommended 

16 uniform screening panel; 

17 ‘‘(D) conducting pilot studies on conditions 

18 recommended by the Advisory Committee on 

19 Heritable Disorders in Newborns and Children 

20 to ensure that screenings are ready for nation21 wide implementation; and’’. 

22 SEC. 10. AUTHORIZATION OF APPROPRIATIONS. 

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

24 is amended by adding at the end, the following: 


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1 ‘‘SEC. 1117. AUTHORIZATION OF APPROPRIATIONS FOR 

2 NEWBORN SCREENING PROGRAMS AND AC3 TIVITIES. 

4 ‘‘There are authorized to be appropriated— 

5 ‘‘(1) to carry out sections 1109, 1110, 1111, 

6 and 1112, $18,334,000 for each of fiscal years 2014 

7 through 2018; and 

8 ‘‘(2) to carry out section 1113, $7,500,000 for 

9 each of fiscal years 2014 through 2018.’’. 

Æ 


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