II 

Calendar No. 282 

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, Mr. HATCH, Mr. ENZI, Mr. CASEY, Ms. COLLINS, 

Mr. SCHUMER, Mr. COCHRAN, Mr. BENNET, Ms. CANTWELL, Mr. DONNELLY, Mr. MURPHY, Mr. SCHATZ, Mr. FRANKEN, Mr. HARKIN, and Mr. 

WICKER) introduced the following bill; which was read twice and referred 

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

DECEMBER 19, 2013 

Reported by Mr. HARKIN, with an amendment 

[Strike out all after the enacting clause and insert the part printed in italic] 

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, 


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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 2013’’. 

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 follow-up 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. 

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. 

7 SEC. 2. IMPROVED NEWBORN AND CHILD SCREENING AND 

8 FOLLOW-UP 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 (1), 

13 by striking ‘‘and in consultation with the Advi14 sory Committee’’ and inserting ‘‘and taking into 

15 consideration the recommendations of the Advi16 sory Committee’’; 

17 (B) in paragraph (2), by striking ‘‘screen18 ing and training’’ and inserting ‘‘screening, 

19 counseling, and training’’; and 


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1 (C) in paragraph (4), by striking ‘‘treat2 ment’’ and inserting ‘‘follow-up and treatment’’; 

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

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

5 ‘‘subsection (c)’’; and 

6 (3) by striking subsection (j) (relating to au7 thorization of appropriations). 

8 SEC. 3. EVALUATING THE EFFECTIVENESS OF NEWBORN 

9 AND CHILD SCREENING AND FOLLOW-UP 

10 PROGRAMS. 

11 Section 1110 of the Public Health Service Act (42 

12 U.S.C. 300b–9) is amended— 

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

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

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

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

17 (3) in subsection (b)— 

18 (A) in paragraph (1), by inserting ‘‘ascer19 tainment, treatment,’’ after ‘‘the effectiveness 

20 of screening, counseling,’’; 

21 (B) in paragraph (2)— 

22 (i) by inserting ‘‘ascertainment, treat23 ment,’’ after ‘‘the effectiveness of screen24 ing, counseling,’’; and 

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


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1 (C) in paragraph (3), by striking the pe2 riod at the end and inserting a semicolon; and 

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

4 ‘‘(4) the availability and effectiveness of follow5 up care for newborns and their families after screen6 ing and diagnosis; 

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

8 screening, evaluation and intervention programs, and 

9 surveillance systems conducted by State-based pro10 grams in order to answer issues of importance to 

11 State and national policymakers; 

12 ‘‘(6) the effectiveness of newborn screening fol13 low-up and intervention programs through the as14 sessment of the health and development of children 

15 at school age and as young adults; 

16 ‘‘(7) the level of data sharing regarding new17 born screening with State-based birth defects and 

18 developmental disabilities monitoring programs; 

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

20 including— 

21 ‘‘(A) standardized data collection and re22 porting; and 

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

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

25 treatment and disease management based on gaps in 


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1 services or care identified by longitudinal tracking 

2 systems; and 

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

4 tracking systems to support the development and 

5 evaluation of evidence-based guidelines for diagnosis, 

6 treatment, and disease management.’’; and 

7 (4) by striking subsection (d) (relating to au8 thorization of appropriations). 

9 SEC. 4. ADVISORY COMMITTEE ON HERITABLE DISORDERS 

10 IN NEWBORNS AND CHILDREN. 

11 Section 1111 of the Public Health Service Act (42 

12 U.S.C. 300b–10) is amended— 

13 (1) in subsection (b)— 

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

15 health impact’’ and inserting ‘‘public health im16 pact, including the cost’’; and 

17 (B) in paragraph (6)— 

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

19 ‘‘achieve rapid diagnosis’’ and inserting 

20 ‘‘achieve best practices in rapid diagnosis 

21 and appropriate treatment’’; 

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

23 before the semicolon ‘‘, including informa24 tion on cost and incidence’’; 


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

2 ‘‘and’’ at the end; and 

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

4 the period and inserting ‘‘; and’’; 

5 (2) in subsection (d)— 

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

7 and inserting ‘‘60’’; 

8 (B) in paragraph (2), by striking ‘‘New9 born Screening Saves Lives Act of 2008’’ and 

10 insert ‘‘Newborn Screening Saves Lives Reau11 thorization Act of 2013’’; and 

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

13 ‘‘(4) PRIORITY REVIEW.— 

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

15 to the recommended uniform screening panel 

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

17 Advisory Committee on Heritable Disorders in 

18 Newborns and Children shall provide a priority 

19 review as described in this paragraph and sub20 ject to the deadlines in subparagraph (C). 

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

22 The Advisory Committee on Heritable Dis23 orders in Newborns and Children shall provide 

24 a priority review with respect to a nomination 


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1 to the recommended uniform screening panel 

2 that meets each of the following criteria: 

3 ‘‘(i) A human drug application, as de4 fined in section 735(1) of the Federal 

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

6 379g(1)), has been submitted to the Sec7 retary for treatment of such disease or 

8 condition. 

9 ‘‘(ii) The application described in 

10 clause (i) has been granted priority review 

11 or has received fast track or breakthrough 

12 therapy designations by the Secretary as 

13 described in section 529(a)(1) of the Fed14 eral Food, Drug, and Cosmetic Act (21 

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

16 ‘‘(C) DEADLINES FOR PRIORITY RE17 VIEW.—The Advisory Committee on Heritable 

18 Disorders in Newborns and Children shall vote 

19 on the nominated condition that is under pri20 ority review within 8 months of the later of— 

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

22 Committee refers the nomination to the 

23 condition review workgroup; or 

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

25 Food and Drug Administration, of the 


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1 treatment associated with the nomination 

2 to the recommended uniform screening 

3 panel. 

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

5 fails to act on a recommendation within the 

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

7 Secretary shall adopt the recommendation and 

8 include the screening recommended by the Advi9 sory Committee on Heritable Disorders in 

10 Newborns and Children in the recommended 

11 uniform screening panel. 

12 ‘‘(E) OTHER REVIEWS.—For each nomina13 tion to the recommended uniform screening 

14 panel that does not meet the criteria of sub15 paragraph (B), the Advisory Committee on 

16 Heritable Disorders in Newborns and Children 

17 shall provide for a review and vote on the nomi18 nated condition that is under review within 10 

19 months of the date on which the Advisory Com20 mittee referred the nomination to the condition 

21 review workgroup.’’; 

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

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

24 (4) by inserting after subsection (e) the fol25 lowing new subsection: 


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

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

3 meetings in person.’’; and 

4 (5) by striking subsection (h) (relating to au5 thorization of appropriations), as redesignated by 

6 paragraph (2). 

7 SEC. 5. CLEARINGHOUSE OF NEWBORN SCREENING INFOR8 MATION. 

9 Section 1112 of the Public Health Service Act (42 

10 U.S.C. 300b–11) is amended— 

11 (1) in subsection (a)— 

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

13 and inserting a semicolon; 

14 (B) in paragraph (3), by striking the pe15 riod at the end and inserting a semicolon; and 

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

17 paragraphs: 

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

19 conditions for which screening is conducted in each 

20 State; and 

21 ‘‘(5) disseminate available evidence-informed 

22 guidelines related to diagnosis, counseling, and 

23 treatment with respect to conditions detected by 

24 newborn screening.’’; 


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1 (2) in subsection (b)(4)(D), by striking ‘‘New2 born Screening Saves Lives Act of 2008’’ and insert3 ing ‘‘Newborn Screening Saves Lives Reauthoriza4 tion Act of 2013’’; and 

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

7 SEC. 6. LABORATORY QUALITY. 

8 Section 1113 of the Public Health Service Act (42 

9 U.S.C. 300b–12) is amended— 

10 (1) in subsection (a)— 

11 (A) by striking the subsection enumerator 

12 and heading; and 

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

14 the Advisory Committee’’ and inserting ‘‘and 

15 taking into consideration the recommendations 

16 of the Advisory Committee’’; and 

17 (2) by striking subsection (b) (relating to au18 thorization of appropriations). 

19 SEC. 7. INTERAGENCY COORDINATING COMMITTEE ON 

20 NEWBORN AND CHILD SCREENING. 

21 Section 1114 of the Public Health Service Act (42 

22 U.S.C. 300b–13) is amended— 

23 (1) in subsection (c), by striking ‘‘the Adminis24 trator, the Director of the Agency for Healthcare 

25 Research and Quality’’ and inserting ‘‘the AdminisVerDate Mar 15 2010 03:56 Dec 20, 2013 Jkt 039200 PO 00000 Frm 00010 Fmt 6652 Sfmt 6401 E:\BILLS\S1417.RS S1417

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1 trator of the Health Resources and Services Admin2 istration, the Director of the Agency for Healthcare 

3 Research and Quality, the Commissioner of Food 

4 and Drugs,’’; and 

5 (2) by striking subsection (e) (relating to au6 thorization of appropriations) and inserting the fol7 lowing: 

8 ‘‘(e) REPORT TO CONGRESS.— 

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

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

11 of enactment of the Newborn Screening Saves 

12 Lives Reauthorization Act of 2013, submit to 

13 the Health, Education, Labor, and Pensions 

14 Committee of the Senate and the Energy and 

15 Commerce Committee of the House of Rep16 resentatives a report on activities related to— 

17 ‘‘(i) newborn screening; and 

18 ‘‘(ii) screening children who have or 

19 are at risk for heritable disorders; and 

20 ‘‘(B) not less than every 2 years, shall sub21 mit to such committees an updated version of 

22 such report. 

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

24 subsection (a) shall contain a description of— 


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1 ‘‘(A) the implementation of sections 1111 

2 through 1116B, including this section; and 

3 ‘‘(B) the amounts expended on such imple4 mentation.’’. 

5 SEC. 8. NATIONAL CONTINGENCY PLAN FOR NEWBORN 

6 SCREENING. 

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

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

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

10 least every five years.’’. 

11 SEC. 9. HUNTER KELLY RESEARCH PROGRAM. 

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

13 (42 U.S.C. 300b–15(a)(1)) is amended— 

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

15 and inserting a semicolon; 

16 (2) by redesignating subparagraph (C) as sub17 paragraph (E); and 

18 (3) by inserting after subparagraph (B) the fol19 lowing: 

20 ‘‘(C) providing research and data for new21 born conditions under review by the Advisory 

22 Committee on Heritable Disorders in Newborns 

23 and Children to be added to the recommended 

24 uniform screening panel; 


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1 ‘‘(D) conducting pilot studies on conditions 

2 recommended by the Advisory Committee on 

3 Heritable Disorders in Newborns and Children 

4 to ensure that screenings are ready for nation5 wide implementation; and’’. 

6 SEC. 10. AUTHORIZATION OF APPROPRIATIONS. 

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

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

9 ‘‘SEC. 1117. AUTHORIZATION OF APPROPRIATIONS FOR 

10 NEWBORN SCREENING PROGRAMS AND AC11 TIVITIES. 

12 ‘‘There are authorized to be appropriated— 

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

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

15 through 2018; and 

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

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

18 SECTION 1. SHORT TITLE; TABLE OF CONTENTS. 

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

20 ‘‘Newborn Screening Saves Lives Reauthorization Act of 

21 2013’’. 

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

23 Act is as follows: 

Sec. 1. Short title; table of contents. 

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

Sec. 3. Evaluating the effectiveness of newborn and child screening and follow-up 

programs. 


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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 

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 

7 (1)— 

8 (i) by striking ‘‘subsection (j)’’ and in9 serting ‘‘section 1117’’; and 

10 (ii) by striking ‘‘and in consultation 

11 with the Advisory Committee’’ and insert12 ing ‘‘and taking into consideration the ex13 pertise of the Advisory Committee’’; 

14 (B) in paragraph (2), by striking ‘‘screen15 ing and training’’ and inserting ‘‘screening, 

16 counseling, and training’’; 

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

18 the end; 

19 (D) in paragraph (4)— 

20 (i) by striking ‘‘treatment’’ and insert21 ing ‘‘follow-up and treatment’’; and 


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1 (ii) by striking the period and insert2 ing ‘‘; and’’; and 

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

4 ‘‘(5) to improve the timely collection, delivery, 

5 receipt, and screening of specimens, and the timely 

6 diagnosis of heritable disorders in newborns.’’; 

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

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

9 ‘‘subsection (c)’’; and 

10 (3) by striking subsection (j) (relating to author11 ization of appropriations). 

12 SEC. 3. EVALUATING THE EFFECTIVENESS OF NEWBORN 

13 AND CHILD SCREENING AND FOLLOW-UP 

14 PROGRAMS. 

15 Section 1110 of the Public Health Service Act (42 

16 U.S.C. 300b–9) is amended— 

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

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

19 (2) in subsection (a), by striking ‘‘of screening,’’ 

20 and inserting ‘‘, including with respect to timeliness, 

21 of screening, follow-up,’’; 

22 (3) in subsection (b)— 

23 (A) in paragraph (1)— 


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

2 and inserting ‘‘treatment, counseling, test3 ing, follow-up,’’; and 

4 (ii) by inserting before the semicolon 

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

6 through the assessment of health and devel7 opment outcomes for such children through 

8 adolescence’’; 

9 (B) in paragraph (2)— 

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

11 and inserting ‘‘treatment, counseling, test12 ing, follow-up,’’; and 

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

14 (C) in paragraph (3), by striking the period 

15 at the end and inserting a semicolon; and 

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

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

18 quality in the diagnosis, treatment, and disease man19 agement of heritable disorders based on gaps in serv20 ices or care; or 

21 ‘‘(5) methods or best practices by which the eligi22 ble entities described in section 1109 can achieve the 

23 timely collection, delivery, receipt, and screening of 

24 newborn screening specimens, and the timely diag25 nosis of heritable disorders in newborns.’’; and 


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1 (4) by striking subsection (d) (relating to author2 ization of appropriations). 

3 SEC. 4. ADVISORY COMMITTEE ON HERITABLE DISORDERS 

4 IN NEWBORNS AND CHILDREN. 

5 Section 1111 of the Public Health Service Act (42 

6 U.S.C. 300b–10) is amended— 

7 (1) in subsection (b)— 

8 (A) by redesignating paragraphs (4) 

9 through (6) as paragraphs (5) through (7), re10 spectively; 

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

12 following: 

13 ‘‘(4) provide technical assistance, as appropriate, 

14 to individuals and organizations regarding the sub15 mission of nominations to the uniform screening 

16 panel, including prior to the submission of such 

17 nominations;’’; 

18 (C) in paragraph (5) (as so redesignated), 

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

20 health impact’’; and 

21 (D) in paragraph (7) (as so redesignated)— 

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

23 ‘‘achieve rapid diagnosis’’ and inserting 

24 ‘‘achieve best practices in rapid diagnosis 

25 and appropriate treatment’’; 


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

2 before the semicolon ‘‘, including informa3 tion on cost and incidence’’; 

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

5 ‘‘and’’ at the end; 

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

7 the period and inserting ‘‘; and’’; and 

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

9 ‘‘(L) the timely collection, delivery, receipt, 

10 and screening of specimens to be tested for heri11 table disorders in newborns in order to ensure 

12 rapid diagnosis and follow-up.’’; 

13 (2) in subsection (d)— 

14 (A) in paragraph (1)— 

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

16 ‘‘120’’; and 

17 (ii) by adding at the end the following: 

18 ‘‘If the Secretary is unable to make a deter19 mination to adopt or reject such rec20 ommendation within such 120-day period, 

21 the Secretary shall notify the Advisory 

22 Committee and the appropriate committees 

23 of Congress of such determination together 

24 with an explanation for why the Secretary 

25 was unable to comply within such 120-day 


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1 period, as well as a plan of action for con2 sideration of such pending recommenda3 tions.’’; 

4 (B) by striking paragraph (2); 

5 (C) by redesignating paragraph (3) as 

6 paragraph (2); and 

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

8 ‘‘(3) DEADLINE FOR REVIEW.—For each nomina9 tion to the recommended uniform screening panel, the 

10 Advisory Committee on Heritable Disorders in 

11 Newborns and Children shall review and vote on the 

12 nominated condition within 9 months of the date on 

13 which the Advisory Committee referred the nomina14 tion to the condition review workgroup.’’; 

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

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

17 (4) by inserting after subsection (e) the following 

18 new subsection: 

19 ‘‘(f) MEETINGS.—The Advisory Committee shall meet 

20 at least 4 times each calendar year, or as subject to the 

21 discretion of the Designated Federal Officer in consultation 

22 with the Chair.’’; 

23 (5) in subsection (g) (as so redesignated), by 

24 striking ‘‘Newborn Screening Saves Lives Act of 


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1 2008’’ and inserting ‘‘Newborn Screening Saves Lives 

2 Reauthorization Act of 2013’’; and 

3 (6) by striking subsection (h) (relating to author4 ization of appropriations), as redesignated by para5 graph (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’’ 

12 and inserting a semicolon; 

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 screen2 ing.’’; 

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

6 Act of 2013’’; 

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 and inserting ‘‘activities minimize’’; and 

13 (4) by striking subsection (d) (relating to author14 ization of appropriations). 

15 SEC. 6. LABORATORY QUALITY AND SURVEILLANCE. 

16 Section 1113 of the Public Health Service Act (42 

17 U.S.C. 300b–12) is amended— 

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

19 SURVEILLANCE’’ before the period; 

20 (2) in subsection (a)— 

21 (A) by striking the subsection enumerator 

22 and heading; 

23 (B) 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 Com2 mittee’’; 

3 (C) in paragraph (1)— 

4 (i) by inserting ‘‘timeliness for proc5 essing such tests,’’ after ‘‘newborn screening 

6 tests’’; and 

7 (ii) by striking ‘‘and’’ at the end; and 

8 (D) in paragraph (2), by striking the pe9 riod and inserting ‘‘; and’’; and 

10 (3) by striking subsection (b) (relating to author11 ization of appropriations) and inserting the fol12 lowing: 

13 ‘‘(b) SURVEILLANCE ACTIVITIES.—The Secretary, act14 ing through the Director of the Centers for Disease Control 

15 and Prevention, and taking into consideration the expertise 

16 of the Advisory Committee on Heritable Disorders in 

17 Newborns and Children established under section 1111, may 

18 provide, as appropriate, for the coordination of surveillance 

19 activities, including— 

20 ‘‘(1) through standardized data collection and re21 porting, as well as the use of electronic health records; 

22 and 

23 ‘‘(2) by promoting data sharing regarding new24 born screening with State-based birth defects and de25 velopmental disabilities monitoring programs.’’. 


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1 SEC. 7. INTERAGENCY COORDINATING COMMITTEE ON 

2 NEWBORN AND CHILD SCREENING. 

3 Section 1114 of the Public Health Service Act (42 

4 U.S.C. 300b–13) is amended— 

5 (1) in subsection (c), by striking ‘‘the Adminis6 trator, the Director of the Agency for Healthcare Re7 search and Quality’’ and inserting ‘‘the Adminis8 trator of the Health Resources and Services Adminis9 tration, the Director of the Agency for Healthcare Re10 search and Quality, the Commissioner of Food and 

11 Drugs,’’; and 

12 (2) by striking subsection (e) (relating to author13 ization of appropriations). 

14 SEC. 8. NATIONAL CONTINGENCY PLAN FOR NEWBORN 

15 SCREENING. 

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

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

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

19 every five years.’’. 

20 SEC. 9. HUNTER KELLY RESEARCH PROGRAM. 

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

22 (42 U.S.C. 300b–15(a)(1)) is amended— 

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

24 and inserting a semicolon; 

25 (2) by redesignating subparagraph (C) as sub26 paragraph (E); and 


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1 (3) by inserting after subparagraph (B) the fol2 lowing: 

3 ‘‘(C) by providing research findings and 

4 data for newborn conditions under review by the 

5 Advisory Committee on Heritable Disorders in 

6 Newborns and Children to be added to the rec7 ommended uniform screening panel; 

8 ‘‘(D) conducting pilot studies on conditions 

9 recommended by the Advisory Committee on 

10 Heritable Disorders in Newborns and Children 

11 to ensure that screenings are ready for nation12 wide implementation; and’’. 

13 SEC. 10. AUTHORIZATION OF APPROPRIATIONS. 

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

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

16 ‘‘SEC. 1117. AUTHORIZATION OF APPROPRIATIONS FOR 

17 NEWBORN SCREENING PROGRAMS AND AC18 TIVITIES. 

19 ‘‘There are authorized to be appropriated— 

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

21 1112, $18,334,000 for each of fiscal years 2014 

22 through 2018; and 

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

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


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25 

•S 1417 RS

1 SEC. 11. REPORTS TO CONGRESS. 

2 (a) GAO REPORT ON TIMELINESS OF NEWBORN

3 SCREENING.— 

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

5 the date of enactment of this Act, the Comptroller 

6 General of the United States shall submit a report to 

7 the Committee on Health, Education, Labor and Pen8 sions of the Senate and the Committee on Energy and 

9 Commerce of the House of Representatives concerning 

10 the timeliness of screening for heritable disorders in 

11 newborns. 

12 (2) CONTENTS.—The report submitted under 

13 paragraph (1) shall include the following: 

14 (A) An analysis of information regarding 

15 the timeliness of newborn screening, which may 

16 include the time elapsed from birth to specimen 

17 collection, specimen collection to receipt by lab18 oratory, specimen receipt to reporting, reporting 

19 to follow-up testing, and follow-up testing to con20 firmed diagnosis. 

21 (B) A summary of any guidelines, rec22 ommendations, or best practices available to 

23 States and health care providers intended to sup24 port a timely newborn screening system. 

25 (C) An analysis of any barriers to main26 taining a timely newborn screening system 


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26 

•S 1417 RS

1 which may exist and recommendations for ad2 dressing such barriers. 

3 (b) REPORT BY SECRETARY.— 

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

5 Human Services shall— 

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

7 enactment of the Newborn Screening Saves Lives 

8 Reauthorization Act of 2013, submit to the Com9 mittee on Health, Education, Labor and Pen10 sions of the Senate and the Committee on En11 ergy and Commerce of the House of Representa12 tives a report on activities related to— 

13 (i) newborn screening; and 

14 (ii) screening children who have or are 

15 at risk for heritable disorders; and 

16 (B) not less than every 2 years, shall submit 

17 to such committees an updated version of such 

18 report. 

19 (2) CONTENTS.—The report submitted under this 

20 subsection shall contain a description of— 

21 (A) the ongoing activities under sections 

22 1109, 1110, and 1112 through 1115 of the Public 

23 Health Service Act; and 

24 (B) the amounts expended on such activi25 ties. 


smartinez on DSK6TPTVN1PROD with BILLS

smartinez on DSK6TPTVN1PROD with BILLS
Calendar No. 282 

113TH CONGRESS 

1ST SESSION S. 1417 

A BILL 

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

DECEMBER 19, 2013 

Reported with an amendment 


smartinez on DSK6TPTVN1PROD with BILLS