IC 

113TH CONGRESS 

2D SESSION S. 1417 

IN THE HOUSE OF REPRESENTATIVES 

JANUARY 31, 2014 

Referred to the Committee on Energy and Commerce 

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 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 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 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 

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) in paragraph (2), by striking ‘‘screen2 ing and training’’ and inserting ‘‘screening, 

3 counseling, and training’’; 

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

5 the end; 

6 (D) in paragraph (4)— 

7 (i) by striking ‘‘treatment’’ and insert8 ing ‘‘follow-up and treatment’’; and 

9 (ii) by striking the period and insert10 ing ‘‘; and’’; and 

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

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

13 receipt, and screening of specimens, and the timely 

14 diagnosis of heritable disorders in newborns.’’; 

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

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

17 ‘‘subsection (c)’’; and 

18 (3) by striking subsection (j) (relating to au19 thorization of appropriations). 

20 SEC. 3. EVALUATING THE EFFECTIVENESS OF NEWBORN 

21 AND CHILD SCREENING AND FOLLOW-UP 

22 PROGRAMS. 

23 Section 1110 of the Public Health Service Act (42 

24 U.S.C. 300b–9) is amended— 

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

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

3 (2) in subsection (a), by striking ‘‘of screen4 ing,’’ and inserting ‘‘, including with respect to time5 liness, of screening, follow-up,’’; 

6 (3) in subsection (b)— 

7 (A) in paragraph (1)— 

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

9 and inserting ‘‘treatment, counseling, test10 ing, follow-up,’’; and 

11 (ii) by inserting before the semicolon 

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

13 through the assessment of health and de14 velopment outcomes for such children 

15 through adolescence’’; 

16 (B) in paragraph (2)— 

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

18 and inserting ‘‘treatment, counseling, test19 ing, follow-up,’’; and 

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

21 (C) in paragraph (3), by striking the pe22 riod at the end and inserting a semicolon; and 

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

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

25 quality in the diagnosis, treatment, and disease 

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1 management of heritable disorders based on gaps in 

2 services or care; or 

3 ‘‘(5) methods or best practices by which the eli4 gible entities described in section 1109 can achieve 

5 the timely collection, delivery, receipt, and screening 

6 of newborn screening specimens, and the timely di7 agnosis of heritable disorders in newborns.’’; and 

8 (4) by striking subsection (d) (relating to au9 thorization of appropriations). 

10 SEC. 4. ADVISORY COMMITTEE ON HERITABLE DISORDERS 

11 IN NEWBORNS AND CHILDREN. 

12 Section 1111 of the Public Health Service Act (42 

13 U.S.C. 300b–10) is amended— 

14 (1) in subsection (b)— 

15 (A) by redesignating paragraphs (4) 

16 through (6) as paragraphs (5) through (7), re17 spectively; 

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

19 following: 

20 ‘‘(4) provide technical assistance, as appro21 priate, to individuals and organizations regarding 

22 the submission of nominations to the uniform 

23 screening panel, including prior to the submission of 

24 such nominations;’’; 

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

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

3 health impact’’; and 

4 (D) in paragraph (7) (as so redesig5 nated)— 

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

7 ‘‘achieve rapid diagnosis’’ and inserting 

8 ‘‘achieve best practices in rapid diagnosis 

9 and appropriate treatment’’; 

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

11 before the semicolon ‘‘, including informa12 tion on cost and incidence’’; 

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

14 ‘‘and’’ at the end; 

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

16 the period and inserting ‘‘; and’’; and 

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

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

19 and screening of specimens to be tested for 

20 heritable disorders in newborns in order to en21 sure rapid diagnosis and follow-up.’’; 

22 (2) in subsection (d)— 

23 (A) in paragraph (1)— 

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

25 ‘‘120’’; and 

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1 (ii) by adding at the end the fol2 lowing: ‘‘If the Secretary is unable to make 

3 a determination to adopt or reject such 

4 recommendation within such 120-day pe5 riod, the Secretary shall notify the Advi6 sory Committee and the appropriate com7 mittees of Congress of such determination 

8 together with an explanation for why the 

9 Secretary was unable to comply within 

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

11 action for consideration of such pending 

12 recommendations.’’; 

13 (B) by striking paragraph (2); 

14 (C) by redesignating paragraph (3) as 

15 paragraph (2); and 

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

17 ‘‘(3) DEADLINE FOR REVIEW.—For each nomi18 nation to the recommended uniform screening panel, 

19 the Advisory Committee on Heritable Disorders in 

20 Newborns and Children shall review and vote on the 

21 nominated condition within 9 months of the date on 

22 which the Advisory Committee referred the nomina23 tion to the condition review workgroup.’’; 

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

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

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1 (4) by inserting after subsection (e) the fol2 lowing new subsection: 

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

4 meet at least 4 times each calendar year, or as subject 

5 to the discretion of the Designated Federal Officer in con6 sultation with the Chair.’’; 

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

8 striking ‘‘Newborn Screening Saves Lives Act of 

9 2008’’ and inserting ‘‘Newborn Screening Saves 

10 Lives Reauthorization Act of 2013’’; and 

11 (6) by striking subsection (h) (relating to au12 thorization of appropriations), as redesignated by 

13 paragraph (3). 

14 SEC. 5. CLEARINGHOUSE OF NEWBORN SCREENING INFOR15 MATION. 

16 Section 1112 of the Public Health Service Act (42 

17 U.S.C. 300b–11) is amended— 

18 (1) in subsection (a)— 

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

20 and inserting a semicolon; 

21 (B) in paragraph (3)— 

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

23 ‘‘information’’; and 

24 (ii) by striking the period at the end 

25 and inserting a semicolon; and 

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

2 paragraphs: 

3 ‘‘(4) maintain current information on the num4 ber of conditions for which screening is conducted in 

5 each State; and 

6 ‘‘(5) disseminate available evidence-based guide7 lines related to diagnosis, counseling, and treatment 

8 with respect to conditions detected by newborn 

9 screening.’’; 

10 (2) in subsection (b)(4)(D), by striking ‘‘New11 born Screening Saves Lives Act of 2008’’ and insert12 ing ‘‘Newborn Screening Saves Lives Reauthoriza13 tion Act of 2013’’; 

14 (3) in subsection (c)— 

15 (A) by striking ‘‘developing the clearing16 house’’ and inserting ‘‘carrying out activities’’; 

17 and 

18 (B) by striking ‘‘clearinghouse minimizes’’ 

19 and inserting ‘‘activities minimize’’; and 

20 (4) by striking subsection (d) (relating to au21 thorization of appropriations). 

22 SEC. 6. LABORATORY QUALITY AND SURVEILLANCE. 

23 Section 1113 of the Public Health Service Act (42 

24 U.S.C. 300b–12) is amended— 

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

2 SURVEILLANCE’’ before the period; 

3 (2) in subsection (a)— 

4 (A) by striking the subsection enumerator 

5 and heading; 

6 (B) 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 expertise of the Advisory 

10 Committee’’; 

11 (C) in paragraph (1)— 

12 (i) by inserting ‘‘timeliness for proc13 essing such tests,’’ after ‘‘newborn screen14 ing tests’’; and 

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

16 (D) in paragraph (2), by striking the pe17 riod and inserting ‘‘; and’’; and 

18 (3) by striking subsection (b) (relating to au19 thorization of appropriations) and inserting the fol20 lowing: 

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

22 acting through the Director of the Centers for Disease 

23 Control and Prevention, and taking into consideration the 

24 expertise of the Advisory Committee on Heritable Dis25 orders in Newborns and Children established under secmstockstill on DSK4VPTVN1PROD with BILLS

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1 tion 1111, may provide, as appropriate, for the coordina2 tion of surveillance activities, including— 

3 ‘‘(1) through standardized data collection and 

4 reporting, as well as the use of electronic health 

5 records; and 

6 ‘‘(2) by promoting data sharing regarding new7 born screening with State-based birth defects and 

8 developmental disabilities monitoring programs.’’. 

9 SEC. 7. INTERAGENCY COORDINATING COMMITTEE ON 

10 NEWBORN AND CHILD SCREENING. 

11 Section 1114 of the Public Health Service Act (42 

12 U.S.C. 300b–13) is amended— 

13 (1) in subsection (c), by striking ‘‘the Adminis14 trator, the Director of the Agency for Healthcare 

15 Research and Quality’’ and inserting ‘‘the Adminis16 trator of the Health Resources and Services Admin17 istration, the Director of the Agency for Healthcare 

18 Research and Quality, the Commissioner of Food 

19 and Drugs,’’; and 

20 (2) by striking subsection (e) (relating to au21 thorization of appropriations). 

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) by providing research findings and 

13 data for newborn conditions under review by 

14 the Advisory Committee on Heritable Disorders 

15 in Newborns and Children to be added to the 

16 recommended 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.’’. 

10 SEC. 11. REPORTS TO CONGRESS. 

11 (a) GAO REPORT ON TIMELINESS OF NEWBORN

12 SCREENING.— 

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

14 the date of enactment of this Act, the Comptroller 

15 General of the United States shall submit a report 

16 to the Committee on Health, Education, Labor and 

17 Pensions of the Senate and the Committee on En18 ergy and Commerce of the House of Representatives 

19 concerning the timeliness of screening for heritable 

20 disorders in newborns. 

21 (2) CONTENTS.—The report submitted under 

22 paragraph (1) shall include the following: 

23 (A) An analysis of information regarding 

24 the timeliness of newborn screening, which may 

25 include the time elapsed from birth to specimen 

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1 oratory, specimen receipt to reporting, reporting 

2 to follow-up testing, and follow-up testing to 

3 confirmed diagnosis. 

4 (B) A summary of any guidelines, rec5 ommendations, or best practices available to 

6 States and health care providers intended to 

7 support a timely newborn screening system. 

8 (C) An analysis of any barriers to main9 taining a timely newborn screening system 

10 which may exist and recommendations for ad11 dressing such barriers. 

12 (b) REPORT BY SECRETARY.— 

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

14 Human Services shall— 

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

16 enactment of the Newborn Screening Saves 

17 Lives Reauthorization Act of 2013, submit to 

18 the Committee on Health, Education, Labor 

19 and Pensions of the Senate and the Committee 

20 on Energy and Commerce of the House of Rep21 resentatives a report on activities related to— 

22 (i) newborn screening; and 

23 (ii) screening children who have or are 

24 at risk for heritable disorders; and 

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1 (B) not less than every 2 years, shall sub2 mit to such committees an updated version of 

3 such report. 

4 (2) CONTENTS.—The report submitted under 

5 this subsection shall contain a description of— 

6 (A) the ongoing activities under sections 

7 1109, 1110, and 1112 through 1115 of the 

8 Public Health Service Act; and 

9 (B) the amounts expended on such activi10 ties. 

Passed the Senate January 29, 2014. 

Attest: NANCY ERICKSON, 

Secretary. 

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