I 

113TH CONGRESS 

1ST SESSION H. R. 1281 

To amend the Public Health Service Act to reauthorize programs under 

part A of title XI of such Act. 

IN THE HOUSE OF REPRESENTATIVES 

MARCH 20, 2013 

Ms. ROYBAL-ALLARD (for herself and Mr. SIMPSON) introduced the following 

bill; which was referred to the Committee on Energy and Commerce 

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 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. 


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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. Newborn screening surveillance, followup, and applied research. 

Sec. 11. Authorization of appropriations. 

1 SEC. 2. IMPROVED NEWBORN AND CHILD SCREENING FOR 

2 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 ‘‘followup and treatment’’; 

16 (2) in subsection (b)— 

17 (A) in paragraph (4), by striking ‘‘or’’ at 

18 the end; 

19 (B) by redesignating paragraph (5) as 

20 paragraph (7); and 

21 (C) by inserting after paragraph (4) the 

22 following: 


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1 ‘‘(5) a health professional organization; 

2 ‘‘(6) an early childhood health system; or’’; and 

3 (3) by striking subsection (j) (relating to au4 thorization of appropriations). 

5 SEC. 3. EVALUATING THE EFFECTIVENESS OF NEWBORN 

6 AND CHILD SCREENING AND FOLLOWUP 

7 PROGRAMS. 

8 Section 1110 of the Public Health Service Act (42 

9 U.S.C. 300b–9) is amended— 

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

11 FOLLOWUP’’ after ‘‘CHILD SCREENING’’; 

12 (2) in subsection (a), by inserting ‘‘followup,’’ 

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

14 (3) in subsection (b)— 

15 (A) in paragraph (1), by inserting ‘‘ascer16 tainment, treatment,’’ after ‘‘the effectiveness 

17 of screening, counseling,’’; 

18 (B) in paragraph (2)— 

19 (i) by inserting ‘‘ascertainment, treat20 ment,’’ after ‘‘the effectiveness of screen21 ing, counseling,’’; and 

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

23 (C) in paragraph (3), by striking the pe24 riod at the end and inserting ‘‘; or’’; and 

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


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1 ‘‘(4) the availability and effectiveness of treat2 ment and followup care for newborns and their fami3 lies after screening and diagnosis.’’; and 

4 (4) by striking subsection (d) (relating to au5 thorization of appropriations). 

6 SEC. 4. ADVISORY COMMITTEE ON HERITABLE DISORDERS 

7 IN NEWBORNS AND CHILDREN. 

8 Section 1111 of the Public Health Service Act (42 

9 U.S.C. 300b–10) is amended— 

10 (1) in subsection (b)— 

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

12 health impact’’ and inserting ‘‘public health im13 pact and cost’’; and 

14 (B) in paragraph (6)— 

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

16 ‘‘achieve rapid diagnosis’’ and inserting 

17 ‘‘achieve best practices in rapid diagnosis 

18 and appropriate treatment’’; and 

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

20 before the semicolon ‘‘, including informa21 tion on cost and incidence’’; 

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

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

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


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

2 meet in person at least twice each year.’’; 

3 (4) by amending subsection (g), as redesignated 

4 by paragraph (2), to read as follows: 

5 ‘‘(g) CONTINUATION OF OPERATION OF COM6 MITTEE.— 

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

8 of the Federal Advisory Committee Act (5 U.S.C. 

9 App.), the Advisory Committee shall continue to op10 erate for the period beginning on the date of enact11 ment of the Newborn Screening Saves Lives Reau12 thorization Act of 2013 and concluding at the end 

13 of the fifth fiscal year which begins after such date. 

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

15 If at the end of the fifth fiscal year described in 

16 paragraph (1) the duration of the Advisory Com17 mittee has not been extended by statute— 

18 ‘‘(A) the Advisory Committee may be con19 sidered, for the purposes of the Federal Advi20 sory Committee Act, to be an advisory com21 mittee established by the President or an officer 

22 of the Federal Government under section 9(a) 

23 of such Act; and 


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1 ‘‘(B) the Secretary may renew the Advi2 sory Committee under section 14(a)(1)(A) of 

3 such Act.’’; 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) establish or disseminate guidelines for 

22 services and personnel necessary for followup, diag23 nosis, counseling, and treatment with respect to con24 ditions detected by 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 02:10 Mar 26, 2013 Jkt 029200 PO 00000 Frm 00007 Fmt 6652 Sfmt 6201 E:\BILLS\H1281.IH H1281

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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. NEWBORN SCREENING SURVEILLANCE, FOL7 LOWUP, AND APPLIED RESEARCH. 

8 The Public Health Service Act is amended by insert9 ing after section 1116 of such Act (42 U.S.C. 300b–15) 

10 the following: 

11 ‘‘SEC. 1116A. NEWBORN SCREENING SURVEILLANCE, FOL12 LOWUP, AND APPLIED RESEARCH. 

13 ‘‘(a) IN GENERAL.—The Secretary, acting through 

14 the Director of the Centers for Disease Control and Pre15 vention, shall award grants to, or enter into cooperative 

16 agreements with, eligible entities to develop longitudinal 

17 followup and tracking programs for newborn screening. 

18 ‘‘(b) PROGRAM.—Longitudinal followup and tracking 

19 programs developed through a grant under subsection (a) 

20 shall incorporate standardized procedures for data man21 agement and program effectiveness and costs, such as— 

22 ‘‘(1) studying the costs and effectiveness of 

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1 based programs in order to answer issues of impor2 tance to State and national policymakers; 

3 ‘‘(2) studying the effectiveness of newborn 

4 screening followup and intervention programs by as5 sessing the health and development of children at 

6 school age and as young adults; 

7 ‘‘(3) promoting the sharing of data regarding 

8 newborn screening with State-based birth defects 

9 and developmental disabilities monitoring programs; 

10 ‘‘(4) ensuring coordination of surveillance ac11 tivities, including— 

12 ‘‘(A) standardized data collection and re13 porting; and 

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

15 ‘‘(5) facilitating quality improvement in treat16 ment and disease management based on gaps in 

17 services or care identified by longitudinal tracking 

18 systems; and 

19 ‘‘(6) utilizing data from longitudinal tracking 

20 systems to support the development and evaluation 

21 of evidence-based guidelines for diagnosis, treatment, 

22 and disease management. 

23 ‘‘(c) ELIGIBLE ENTITY.—In this section, the term 

24 ‘eligible entity’ means— 


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1 ‘‘(1) a State or a political subdivision of a 

2 State; 

3 ‘‘(2) a consortium of 2 or more States or sub4 divisions described in paragraph (1); 

5 ‘‘(3) a health facility or program operated by or 

6 pursuant to a contract with, or a grant from, the In7 dian Health Service; or 

8 ‘‘(4) any other entity with appropriate expertise 

9 in newborn screening, as determined by the Sec10 retary.’’. 

11 SEC. 11. AUTHORIZATION OF APPROPRIATIONS. 

12 The Public Health Service Act is amended by insert13 ing after section 1116A of such Act, as added by section 

14 10 of this Act, the following: 

15 ‘‘SEC. 1116B. AUTHORIZATION OF APPROPRIATIONS FOR 

16 NEWBORN SCREENING PROGRAMS AND AC17 TIVITIES. 

18 ‘‘There are authorized to be appropriated— 

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

20 and 1112, $13,334,000 for each of fiscal years 2014 

21 through 2018; 

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

23 each of fiscal years 2014 through 2018; and 


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1 ‘‘(3) to carry out section 1116A, $5,000,000 for 

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

Æ 


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