IB 

Union Calendar No. 354 

113TH CONGRESS 

2D SESSION H. R. 1281 

[Report No. 113–478] 

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 

JUNE 19, 2014 

Additional sponsors: Ms. MOORE, Mr. GRIJALVA, Mr. WAXMAN, Mr. ROGERS

of Kentucky, Mr. HIGGINS, Mr. RANGEL, Ms. LEE of California, Ms. 

SPEIER, Mr. MCGOVERN, Mrs. CAPPS, Ms. JACKSON LEE, Mr. HASTINGS

of Florida, Ms. MCCOLLUM, Mr. DAVID SCOTT of Georgia, Ms. CLARKE

of New York, Mr. CONYERS, Mr. DINGELL, Mr. HUFFMAN, Ms. 

DELAURO, Mr. CROWLEY, Mr. COHEN, Ms. SLAUGHTER, Mr. BISHOP of 

Georgia, Ms. CASTOR of Florida, Mr. TAKANO, Ms. WILSON of Florida, 

Mr. LOEBSACK, Mr. BERA of California, Mr. WALDEN, Mr. NADLER, Mr. 

GENE GREEN of Texas, Mr. DELANEY, Mr. COLLINS of New York, Mr. 

POCAN, Mr. HECK of Washington, Mr. FARR, Mr. MATHESON, Mrs. 

BEATTY, Mrs. KIRKPATRICK, Mr. MORAN, Mr. SIRES, Ms. SCHAKOWSKY, 

Mr. COSTA, Ms. LORETTA SANCHEZ of California, Mr. RUIZ, Mrs. 

NEGRETE MCLEOD, Mr. CASTRO of Texas, Mr. GALLEGO, Mr. BECERRA, 

Mr. SABLAN, Ms. MICHELLE LUJAN GRISHAM of New Mexico, Mr. 

CA ́RDENAS, Mr. GUTIE ́RREZ, Mr. RYAN of Ohio, Mr. BEN RAY LUJA ́N

of New Mexico, Mr. GARCIA, Mr. HINOJOSA, Mrs. NAPOLITANO, Mr. 

VARGAS, Mr. SERRANO, Ms. VELA ́ZQUEZ, Mr. KING of New York, Mrs. 

CAPITO, Mr. CALVERT, Mr. ROYCE, Mr. GRAYSON, Ms. ESTY, Mr. GARY

G. MILLER of California, Mr. JONES, Mr. MCKEON, Mr. PIERLUISI, Mr. 

SCHIFF, Mr. NEAL, Mr. LANGEVIN, Mr. DOYLE, Mr. TONKO, Ms. 

WASSERMAN SCHULTZ, Ms. DEGETTE, Ms. ESHOO, Mrs. LOWEY, Mr. 

BARTON, Mr. DANNY K. DAVIS of Illinois, Mr. GARAMENDI, Mr. 

MCDERMOTT, Mr. NUNES, Mr. COURTNEY, Mr. LEVIN, Mr. CICILLINE, 

Mr. WELCH, Mr. BLUMENAUER, Ms. TITUS, Mr. LIPINSKI, Mr. TIERNEY, 


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Mr. LARSON of Connecticut, Ms. MATSUI, Ms. GRANGER, Mr. LATHAM, 

Mrs. CHRISTENSEN, Mr. LANCE, Mr. ELLISON, Mr. HONDA, Ms. SHEAPORTER, Ms. BROWNLEY of California, Ms. EDWARDS, Mr. MEEKS, Mr. 

MICHAUD, Ms. EDDIE BERNICE JOHNSON of Texas, Mr. PAYNE, Mr. 

PALLONE, Mr. JOHNSON of Georgia, Mr. LOWENTHAL, Mr. THOMPSON

of California, Mr. CLAY, Mr. CARTWRIGHT, Ms. SCHWARTZ, Mr. PASCRELL, Mr. BURGESS, Mrs. MCMORRIS RODGERS, and Mr. ISRAEL

JUNE 19, 2014 

Reported with an amendment, committed to the Committee of the Whole 

House on the State of the Union, and ordered to be printed 

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

[For text of introduced bill, see copy of bill as introduced on March 20, 2013] 

A BILL 

To amend the Public Health Service Act to reauthorize 

programs under part A of title XI of such Act. 


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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 2014’’. 

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

8 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. 

9 SEC. 2. IMPROVED NEWBORN AND CHILD SCREENING AND 

10 FOLLOWUP FOR HERITABLE DISORDERS. 

11 Section 1109 of the Public Health Service Act (42 

12 U.S.C. 300b–8) is amended— 

13 (1) in subsection (a)— 

14 (A) in the matter preceding paragraph 

15 (1)— 

16 (i) by striking ‘‘subsection (j)’’ and in17 serting ‘‘section 1117’’; and 

18 (ii) by striking ‘‘and in consultation 

19 with the Advisory Committee’’ and insertVerDate Mar 15 2010 23:13 Jun 19, 2014 Jkt 039200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6203 E:\BILLS\H1281.RH H1281

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1 ing ‘‘and taking into consideration the ex2 pertise of the Advisory Committee’’; 

3 (B) by amending paragraph (2) to read as 

4 follows: 

5 ‘‘(2) to assist in providing health care profes6 sionals and newborn screening laboratory personnel 

7 with education in newborn screening, counseling, and 

8 training in— 

9 ‘‘(A) relevant and new technologies in new10 born screening and congenital, genetic, and met11 abolic disorders; 

12 ‘‘(B) the importance of the timeliness of col13 lection, delivery, receipt, and screening of speci14 mens; and 

15 ‘‘(C) sharing of medical and diagnostic in16 formation with providers and families;’’; 

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 ‘‘followup and treatment’’; and 

22 (ii) by striking the period and insert23 ing ‘‘; and’’; and 

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

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


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

2 screening of specimens; and 

3 ‘‘(B) the diagnosis of heritable disorders in 

4 newborns.’’; 

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

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

7 inserting ‘‘application for a grant under this sec8 tion’’; 

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

10 submitted under subsection (c)(2)’’ each place it ap11 pears and inserting ‘‘application for a grant under 

12 this section’’; and 

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

15 SEC. 3. EVALUATING THE EFFECTIVENESS OF NEWBORN 

16 AND CHILD SCREENING AND FOLLOWUP PRO17 GRAMS. 

18 Section 1110 of the Public Health Service Act (42 

19 U.S.C. 300b–9) is amended— 

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

21 FOLLOWUP’’ after ‘‘CHILD SCREENING’’; 

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

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

24 of screening, followup,’’; 

25 (3) in subsection (b)— 


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1 (A) in paragraph (1)— 

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

3 and inserting ‘‘treatment, counseling, test4 ing, followup,’’; and 

5 (ii) by inserting before the semicolon 

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

7 through the assessment of health and devel8 opment outcomes for such children through 

9 adolescence’’; 

10 (B) in paragraph (2)— 

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

12 and inserting ‘‘treatment, counseling, test13 ing, followup,’’; 

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

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

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

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

18 at the end and inserting a semicolon; and 

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

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

21 quality in the diagnosis, treatment, and disease man22 agement of heritable disorders based on gaps in serv23 ices or care; or 


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1 ‘‘(5) methods or best practices by which the eligi2 ble entities described in section 1109 can achieve in 

3 a timely manner— 

4 ‘‘(A) collection, delivery, receipt, and screen5 ing of newborn screening specimens; and 

6 ‘‘(B) diagnosis of heritable disorders in 

7 newborns.’’; and 

8 (4) by striking subsection (d) (relating to author9 ization 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 (6) through (8), re17 spectively; 

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

19 following: 

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

21 to individuals and organizations regarding the sub22 mission of nominations to the uniform screening 

23 panel, including prior to the submission of such 

24 nominations; 


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

2 prepare for the review of nominations prior to their 

3 submission, including for conditions for which a 

4 screening method has been validated but other nomi5 nation criteria are not yet met, in order to facilitate 

6 timely action by the Advisory Committee once such 

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

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

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

10 health impact’’; and 

11 (D) in paragraph (8) (as so redesignated)— 

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

13 ‘‘achieve rapid diagnosis’’ and inserting 

14 ‘‘achieve best practices in rapid diagnosis 

15 and appropriate treatment’’; 

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

17 before the semicolon ‘‘, including informa18 tion on cost and incidence’’; 

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

20 ‘‘and’’ at the end; 

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

22 the period and inserting ‘‘; and’’; and 

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

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

25 receipt, and screening of specimens to be tested 


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1 for heritable disorders in newborns in order to 

2 ensure rapid diagnosis and followup.’’; 

3 (2) in subsection (d)— 

4 (A) in paragraph (1)— 

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

6 ‘‘120’’; and 

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

8 ‘‘If the Secretary is unable to make a deter9 mination to adopt or reject such rec10 ommendation within such 120-day period, 

11 the Secretary shall notify the Advisory 

12 Committee and the appropriate committees 

13 of Congress of such determination together 

14 with an explanation for why the Secretary 

15 was unable to comply within such 120-day 

16 period, as well as a plan of action for con17 sideration of such pending recommenda18 tion.’’; 

19 (B) by striking paragraph (2); 

20 (C) by redesignating paragraph (3) as 

21 paragraph (2); and 

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

23 ‘‘(3) DEADLINE FOR REVIEW.—For each condi24 tion nominated to be added to the recommended uni25 form screening panel in accordance with the requireVerDate Mar 15 2010 23:13 Jun 19, 2014 Jkt 039200 PO 00000 Frm 00009 Fmt 6652 Sfmt 6203 E:\BILLS\H1281.RH H1281

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1 ments of this section, the Advisory Committee shall 

2 review and vote on the nominated condition within 9 

3 months of the date on which the Advisory Committee 

4 referred the nominated condition to the condition re5 view workgroup.’’; 

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

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

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

9 new subsection: 

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

11 at least 4 times each calendar year, or at the discretion 

12 of the Designated Federal Officer in consultation with the 

13 Chair.’’; 

14 (5) by amending subsection (g) (as so redesig15 nated) to read as follows: 

16 ‘‘(g) CONTINUATION OF OPERATION OF COMMITTEE.— 

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

18 of the Federal Advisory Committee Act, the Advisory 

19 Committee shall continue to operate through the end 

20 of fiscal year 2019. 

21 ‘‘(2) CONTINUATION IF NOT REAUTHORIZED.—If 

22 at the end of fiscal year 2019 the duration of the Ad23 visory Committee has not been extended by statute, 

24 the Advisory Committee may be deemed, for purposes 

25 of the Federal Advisory Committee Act, an advisory 


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1 committee established by the President or an officer of 

2 the Federal Government under section 9(a) of such 

3 Act.’’; and 

4 (6) by striking subsection (h) (relating to author5 ization of appropriations), as redesignated by para6 graph (3). 

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’’ at 

13 the end; 

14 (B) in paragraph (3)— 

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

16 ‘‘information’’; and 

17 (ii) by striking the period at the end 

18 and inserting a semicolon; and 

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

20 paragraphs: 

21 ‘‘(4) maintain current information on the num22 ber of conditions for which screening is conducted in 

23 each State; and 

24 ‘‘(5) disseminate available evidence-based guide25 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 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 author16 ization 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 Com2 mittee’’; 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 author7 ization of appropriations) and inserting the fol8 lowing: 

9 ‘‘(b) SURVEILLANCE ACTIVITIES.—The Secretary, act10 ing through the Director of the Centers for Disease Control 

11 and Prevention, and taking into consideration the expertise 

12 of the Advisory Committee on Heritable Disorders in 

13 Newborns and Children established under section 1111, may 

14 provide, as appropriate, for the coordination of surveillance 

15 activities, including— 

16 ‘‘(1) through standardized data collection and re17 porting, as well as the use of electronic health records; 

18 and 

19 ‘‘(2) by promoting data sharing regarding new20 born screening with State-based birth defects and de21 velopmental 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 Re3 search and Quality,’’ and inserting ‘‘the Adminis4 trator of the Health Resources and Services Adminis5 tration, the Director of the Agency for Healthcare Re6 search and Quality, the Commissioner of Food and 

7 Drugs,’’; and 

8 (2) by striking subsection (e) (relating to author9 ization 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) the 

4 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 National 

16 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, and 

2 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 to 

12 the Committee on Health, Education, Labor, and 

13 Pensions of the Senate and the Committee on Energy 

14 and Commerce of the House of Representatives con15 cerning the timeliness of screening for heritable dis16 orders 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 sup4 port 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 re17 port 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 this 

25 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 Public 

3 Health Service Act; and 

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


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Union Calendar No. 354 

113TH CONGRESS 

2D SESSION H. R. 1281 

[Report No. 113–478] 

A BILL 

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

JUNE 19, 2014 

Reported with an amendment, committed to the Comand ordered to be printed mittee of the Whole House on the State of the Union, 


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