II 

109TH CONGRESS 

2D SESSION S. 3743 

To amend the Public Health Service Act to improve newborn screening 

activities, and for other purposes. 

IN THE SENATE OF THE UNITED STATES 

JULY 26, 2006 

Mrs. CLINTON (for herself and Mr. ALLEN) 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 improve newborn 

screening activities, and for other purposes. 

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. 

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

5 ‘‘Screening for Health of Infants and Newborns Act’’ or 

6 the ‘‘SHINE Act’’. 

7 SEC. 2. PURPOSES. 

8 The purposes of this Act are the following: 

9 (1) To ensure the health and quality of life of 

10 all newborns in the United States by enhancing the 


ccoleman on PROD1PC71 with BILLS
2 

•S 3743 IS

1 capacity to screen for heritable diseases. This en2 hanced capacity will assist the States in making 

3 progress toward the following goals: 

4 (A) All babies born in hospitals in the 

5 United States and the territories of the United 

6 States should have access to, and be screened 

7 for, certain core conditions. 

8 (B) Appropriate newborn screening evalua9 tions should be conducted for all newborns to 

10 allow appropriate referrals and provisions for 

11 early medical intervention. 

12 (C) Newborn screening data collection 

13 should be standardized, and conditions detected 

14 by newborn screening should be tracked and 

15 monitored. 

16 (D) Information on newborn screening and 

17 conditions for which a patient can be screened 

18 should be readily accessible, current, and under19 standable to both health care providers and par20 ents. Information should include the following: 

21 (i) A component for rehabilitation, 

22 medical, and early intervention options 

23 that ensure linkage to any new and exist24 ing national or State system of interven25 tion. 


ccoleman on PROD1PC71 with BILLS
3 

•S 3743 IS

1 (ii) Rehabilitative services for 

2 newborns with the conditions. 

3 (E) Newborn screening should be expanded 

4 to include more conditions, and additional new5 born screening tests should be developed to en6 hance the health of newborns. 

7 (2) To expand newborn screening, and improve 

8 systems to make newborn screening more efficient 

9 and effective, by authorizing— 

10 (A) statewide newborn screening and med11 ical evaluation systems and intervention pro12 grams; 

13 (B) technical assistance; 

14 (C) national demonstration grant pro15 grams; and 

16 (D) interagency collaborations between the 

17 appropriate Federal agencies, including the 

18 Agency for Healthcare Research and Quality, 

19 Centers for Disease Control and Prevention, 

20 Food and Drug Administration, Health Re21 sources and Services Administration, and Na22 tional Institutes of Health. 


ccoleman on PROD1PC71 with BILLS
4 

•S 3743 IS

1 SEC. 3. NEWBORN SCREENING GUIDELINES AND GRANT 

2 PROGRAMS. 

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

4 (42 U.S.C. 300b–1 et seq.) is amended by adding at the 

5 end the following: 

6 ‘‘SEC. 1112. RECOMMENDED GUIDELINES FOR NEWBORN 

7 SCREENING AND DATA COLLECTION; MONI8 TORING AND EVALUATION. 

9 ‘‘(a) RECOMMENDED GUIDELINES FOR NEWBORN

10 SCREENING AND DATA COLLECTION.— 

11 ‘‘(1) IN GENERAL.—The Director of the Cen12 ters for Disease Control and Prevention (referred to 

13 in this section as the ‘Director’), in collaboration 

14 with the Associate Administrator of the Maternal 

15 and Child Health Bureau of the Health Resources 

16 and Services Administration and the Advisory Com17 mittee on Heritable Disorders and Genetic Diseases 

18 in Newborns and Children (referred to in this sec19 tion as the ‘Advisory Committee’), shall develop spe20 cific guidelines that the States may follow in report21 ing newborn screening data, as requested by the Ad22 visory Committee, from newborn screening tests, in23 cluding the screening tests for the core conditions 

24 designated by the Newborn Screening Expert Group 

25 convened by the American College of Medical GenetVerDate Aug 31 2005 04:52 Jul 30, 2006 Jkt 049200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\S3743.IS S3743

ccoleman on PROD1PC71 with BILLS
5 

•S 3743 IS

1 ics, as commissioned by the Health Resources and 

2 Services Administration. 

3 ‘‘(2) GUIDELINES.—The guidelines developed 

4 under paragraph (1) shall include— 

5 ‘‘(A) standardizing the case definitions and 

6 names of the disorders for which newborn 

7 screening tests are performed and the defini8 tions of performance measures used to evaluate 

9 such tests so that performance criteria and out10 comes among all States may be evaluated; 

11 ‘‘(B) establishing procedures for standard12 ized newborn screening data collection and re13 porting; and 

14 ‘‘(C) ensuring that tests and technologies 

15 used by each State meet established standards 

16 for detecting and reporting positive screening 

17 results. 

18 ‘‘(3) IMPLEMENTATION.—The Director shall 

19 submit the guidelines described in this subsection to 

20 the Secretary. Not later than 90 days after receiving 

21 the guidelines, the Secretary, in consultation with 

22 the Director, the Administrator of the Health Re23 sources and Services Administration (referred to in 

24 this section as the ‘Administrator’), and the AssistVerDate Aug 31 2005 04:52 Jul 30, 2006 Jkt 049200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\S3743.IS S3743

ccoleman on PROD1PC71 with BILLS
6 

•S 3743 IS

1 ant Administrator of the Maternal and Child Health 

2 Bureau, shall implement such guidelines. 

3 ‘‘(4) ANNUAL REPORT.—Not later than 2 years 

4 after the date of enactment of the Screening for 

5 Health of Infants and Newborns Act, and each year 

6 thereafter, the Advisory Committee shall— 

7 ‘‘(A) publish an annual report on newborn 

8 screening guidelines in the United States; 

9 ‘‘(B) submit such report to the appropriate 

10 committees of Congress, the Secretary, and the 

11 State departments of health; and 

12 ‘‘(C) disseminate such report on as wide a 

13 basis as practicable. 

14 ‘‘(b) RECOMMENDED GUIDELINES FOR MONITORING, 

15 EVALUATION, AND SURVEILLANCE OF NEWBORN

16 SCREENING.— 

17 ‘‘(1) IN GENERAL.— 

18 ‘‘(A) DEVELOPMENT.—The Secretary, act19 ing through the Administrator and in consulta20 tion with the Director and the Advisory Com21 mittee, shall develop guidelines to— 

22 ‘‘(i) monitor and evaluate newborn 

23 screening activities, including diagnosis, 

24 screening, follow-up, and treatment activi25 ties, in the United States; and 


ccoleman on PROD1PC71 with BILLS
7 

•S 3743 IS

1 ‘‘(ii) coordinate the results of surveil2 lance activities in order to enhance moni3 toring of newborn diseases. 

4 ‘‘(B) DUTIES.—In carrying out this para5 graph, the Administrator, in consultation with 

6 the Advisory Committee and the Director, shall 

7 collaborate with non-Governmental organiza8 tions, such as the Joint Commission on Accredi9 tation of Hospital Organizations, laboratories 

10 certified by the Clinical Laboratory Improve11 ment Amendment (referred to in the part as 

12 ‘CLIA’), and the Association of Public Health 

13 Laboratories to ensure effective monitoring and 

14 evaluation of newborn screening activities. 

15 ‘‘(2) IMPLEMENTATION.—Not later than 90 

16 days after the development of the guidelines under 

17 paragraph (1), the Secretary, in consultation with 

18 the Director, the Administrator, and the Assistant 

19 Administrator of the Maternal and Child Health Bu20 reau, shall implement such guidelines. 

21 ‘‘(c) SURVEILLANCE AND IDENTIFICATION RE22 SEARCH.—The Secretary, acting through the Director and 

23 the National Center on Birth Defects and Developmental 

24 Disabilities, and in consultation with the Administrator 

25 and Advisory Committee, shall develop a surveillance sysVerDate Aug 31 2005 04:52 Jul 30, 2006 Jkt 049200 PO 00000 Frm 00007 Fmt 6652 Sfmt 6201 E:\BILLS\S3743.IS S3743

ccoleman on PROD1PC71 with BILLS
8 

•S 3743 IS

1 tem for newborn screening. The system shall use the 

2 standardized procedures and guidelines developed under 

3 subsection (b) for data management and tracking program 

4 effectiveness and costs, in order to— 

5 ‘‘(1) ensure quality monitoring of newborn 

6 screening and medical evaluation systems and inter7 vention programs; 

8 ‘‘(2) provide technical assistance on data collec9 tion and management; 

10 ‘‘(3) study the cost and effectiveness of new11 born screening and medical evaluation systems and 

12 intervention programs conducted by State-based pro13 grams in order to answer issues of importance to na14 tional and State policymakers; and 

15 ‘‘(4) identify the causes of, and risk factors for, 

16 heritable disorders. 

17 ‘‘(d) ADVISORY COMMITTEE MEETINGS.—The Advi18 sory Committee shall meet not less than annually to— 

19 ‘‘(1) assess the implementation of the guidelines 

20 and surveillance activities developed under this sec21 tion; 

22 ‘‘(2) advise the Secretary with respect to— 

23 ‘‘(A) such guidelines; and 

24 ‘‘(B) monitoring and evaluating newborn 

25 screening and surveillance activities; 


ccoleman on PROD1PC71 with BILLS
9 

•S 3743 IS

1 ‘‘(3) consider ways to ensure that States attain 

2 the capacity to screen for the core conditions de3 scribed in subsection (a)(1), and include in such con4 sideration the results of the demonstration projects 

5 funded under section 1115; and 

6 ‘‘(4) consider any addition to the list of the core 

7 conditions described in subsection (a)(1), and in8 clude in such consideration the results of the dem9 onstration projects funded under section 1116. 

10 ‘‘(e) AUTHORIZATION OF APPROPRIATIONS.—There 

11 are authorized to be appropriated to carry out this sec12 tion— 

13 ‘‘(1) $10,000,000 for fiscal year 2007; and 

14 ‘‘(2) such sums as necessary for fiscal year 

15 2008 through 2011. 

16 ‘‘SEC. 1113. CLEARINGHOUSE OF NEWBORN SCREENING IN17 FORMATION. 

18 ‘‘(a) CLEARINGHOUSE.—The Secretary shall direct 

19 the Maternal and Child Health Bureau of the Health Re20 sources and Services Administration, working through the 

21 Regional Genetic and Newborn Screening Collaborative 

22 Groups of such Bureau, the National Coordinating Center, 

23 and the National Newborn Screening and Genetic Re24 source Center, to collaborate with the Director of the Cen25 ters for Disease Control and Prevention and the National 


ccoleman on PROD1PC71 with BILLS
10 

•S 3743 IS

1 Library of Medicine of the National Institutes of Health 

2 to establish and maintain a central clearinghouse of cur3 rent educational and family support and services informa4 tion, materials, resources, research, and data on newborn 

5 screening to— 

6 ‘‘(1) enable parents and family members of 

7 newborns, health professionals, industry representa8 tives, and other members of the public to increase 

9 their awareness, knowledge, and understanding of 

10 newborn screening; 

11 ‘‘(2) increase awareness, knowledge, and under12 standing of newborn diseases and screening services 

13 for individuals wishing to have children and expect14 ant families; and 

15 ‘‘(3) develop and maintain current data on 

16 quality indicators to measure performance of new17 born screening entities, such as false-positive rates 

18 and other quality indicators as determined by the 

19 Advisory Committee described under section 1112. 

20 ‘‘(b) INTERNET AVAILABILITY.—The Health Re21 sources and Services Administration shall ensure that the 

22 clearinghouse described under subsection (a)— 

23 ‘‘(1) is available on the Internet; 

24 ‘‘(2) includes an interactive forum; 


ccoleman on PROD1PC71 with BILLS
11 

•S 3743 IS

1 ‘‘(3) is updated on a regular basis, but not less 

2 than quarterly; and 

3 ‘‘(4) provides— 

4 ‘‘(A) links to Government-sponsored, non5 profit, and other websites of laboratories that 

6 have demonstrated expertise in newborn screen7 ing that supply research-based information on 

8 newborn screening tests currently available 

9 throughout the United States; 

10 ‘‘(B) information about newborn conditions 

11 and screening services available in each State, 

12 including the ability of infants to obtain addi13 tional comprehensive screening services that 

14 may not be required in the State where the in15 fant is born, from CLIA-certified laboratories 

16 for disorders; 

17 ‘‘(C) current research on both treatable 

18 and not-yet treatable conditions for which new19 born screening tests are available; 

20 ‘‘(D) information about newborn diseases 

21 and screening services available in each State; 

22 and 

23 ‘‘(E) other relevant information as deter24 mined appropriate by the Secretary. 


ccoleman on PROD1PC71 with BILLS
12 

•S 3743 IS

1 ‘‘(c) AUTHORIZATION OF APPROPRIATIONS.—There 

2 are authorized to be appropriated to carry out this sec3 tion— 

4 ‘‘(1) $5,000,000 for fiscal year 2007; and 

5 ‘‘(2) such sums as necessary for fiscal years 

6 2008 through 2011. 

7 ‘‘SEC. 1114. INTERAGENCY GRANT REVIEW PANEL. 

8 ‘‘(a) DEFINITION OF SHINE GRANT PROGRAM.—In 

9 this section, the term ‘Screening for Health of Infants and 

10 Newborns grant program’ or ‘SHINE grant program’ 

11 means any grant program under section 1115 or 1116. 

12 ‘‘(b) REVIEW PANEL.—The Secretary shall appoint 

13 an Interagency Grant Review Panel to review grant appli14 cations and provide oversight of the SHINE grant pro15 gram. 

16 ‘‘(c) MEMBERSHIP.—The Secretary shall ensure that 

17 the Interagency Grant Review Panel includes representa18 tion from all appropriate Federal agencies, including the 

19 Agency for Healthcare Research and Quality, the Centers 

20 for Disease Control and Prevention, the Food and Drug 

21 Administration, the Health Resources and Services Ad22 ministration, and the National Institutes of Health. 

23 ‘‘(d) DUTIES.— 

24 ‘‘(1) DUTIES OF THE SECRETARY.—After the 

25 last day of the application period for a SHINE 


ccoleman on PROD1PC71 with BILLS
13 

•S 3743 IS

1 grant program, the Secretary shall forward the 

2 grant applications received for the program to the 

3 Interagency Grant Review Panel. 

4 ‘‘(2) DUTIES OF THE INTERAGENCY GRANT RE5 VIEW PANEL.— 

6 ‘‘(A) SELECTION OF GRANT RECIPIENTS.— 

7 Upon receipt of the grant applications for a 

8 SHINE grant program from the Secretary, the 

9 Interagency Grant Review Panel shall review 

10 the applications for grants under the program 

11 and shall select, on a competitive basis, all of 

12 the grant recipients for the program and the 

13 amount of each grant award. 

14 ‘‘(B) SUBMISSION OF GRANT RECIPI15 ENTS.—The Interagency Grant Review Panel 

16 shall submit the list of award recipients for 

17 grants under a SHINE grant program to the 

18 Secretary at a time determined by the Sec19 retary, but not later than 90 days after the last 

20 day of the application period for a grant under 

21 such program. 

22 ‘‘(C) OVERSIGHT OF GRANTS.—The Inter23 agency Grant Review Panel shall provide over24 sight of the programs and activities funded by 

25 grants under a SHINE grant program, and 


ccoleman on PROD1PC71 with BILLS
14 

•S 3743 IS

1 shall report to the Secretary on the program 

2 and activities as the Secretary or the Panel de3 termines necessary. 

4 ‘‘SEC. 1115. CAPACITY GRANT PROGRAM. 

5 ‘‘(a) IN GENERAL.—The Secretary shall award 

6 grants, in conjunction with the Interagency Grant Review 

7 Panel established under section 1114, to eligible entities 

8 for demonstration projects that increase the capacity of 

9 a State to screen for all of the core conditions designated 

10 by the Advisory Committee described under section 1112. 

11 Such grants shall be made on a competitive basis. 

12 ‘‘(b) ELIGIBILITY.—To be eligible to receive a grant 

13 under this section, an entity shall— 

14 ‘‘(1) submit to the Secretary an application at 

15 such time, in such manner, and containing such in16 formation as the Secretary may require; 

17 ‘‘(2) be a public or private organization, includ18 ing an academic research center, medical center, 

19 physician group, newborn screening program, or 

20 CLIA-certified laboratory with expertise in newborn 

21 metabolic screening; 

22 ‘‘(3) provide assurance that such organization 

23 will work in consultation with the appropriate State 

24 department of health; 


ccoleman on PROD1PC71 with BILLS
15 

•S 3743 IS

1 ‘‘(4) have the capacity to perform the core new2 born screening tests described in subsection (a) and 

3 to collect and report data on the costs, benefits, and 

4 effectiveness of such tests, in consultation with the 

5 appropriate State department of health and in ac6 cordance with the guidelines implemented under sec7 tion 1112; 

8 ‘‘(5) demonstrate sustainability of such activi9 ties based on the outcomes of the demonstration 

10 project; and 

11 ‘‘(6) if applicable, submit to the Secretary a 

12 plan for follow-up, diagnosis, and treatment of those 

13 infants who test positive on newborn screening tests 

14 developed under this section. 

15 ‘‘(c) REPORT TO SECRETARY AND INTERAGENCY

16 PANEL.—An organization that receives a grant under this 

17 section shall, on an annual basis, submit to the Secretary 

18 and the Interagency Grant Review Panel established 

19 under section 1114 a report that describes the activities 

20 conducted pursuant to such grant and the outcomes of 

21 such activities. 

22 ‘‘(d) EVALUATION AND RESULTS.—The Secretary 

23 shall— 

24 ‘‘(1) evaluate the demonstration projects funded 

25 under this section; and 


ccoleman on PROD1PC71 with BILLS
16 

•S 3743 IS

1 ‘‘(2) on an annual basis— 

2 ‘‘(A) publish and disseminate the results of 

3 such evaluation on as wide a basis as is prac4 ticable; and 

5 ‘‘(B) submit to the appropriate committees 

6 of Congress the results of such evaluation. 

7 ‘‘(e) AUTHORIZATION OF APPROPRIATIONS.—There 

8 are authorized to be appropriated to carry out this sec9 tion— 

10 ‘‘(1) $10,000,000 for fiscal year 2007; and 

11 ‘‘(2) such sums as necessary for fiscal years 

12 2008 through 2011. 

13 ‘‘SEC. 1116. HUNTER KELLY GRANT PROGRAM. 

14 ‘‘(a) ADDITIONAL NEWBORN SCREENING TESTS

15 GRANTS.— 

16 ‘‘(1) IN GENERAL.—The Secretary shall award 

17 grants (to be known as Hunter Kelly Newborn 

18 Screening grants), in conjunction with the Inter19 agency Grant Review Panel established under sec20 tion 1114, to eligible entities to carry out dem21 onstration projects that develop screening tests for 

22 additional newborn conditions, such as tests for 

23 Krabbe disease and Insulin Dependent Diabetes 

24 Mellitus, or develop multiple markers to increase the 


ccoleman on PROD1PC71 with BILLS
17 

•S 3743 IS

1 specificity of newborn screening tests. Such grants 

2 shall be made on a competitive basis. 

3 ‘‘(2) ADDITIONAL NEWBORN CONDITION.—For 

4 purposes of this subsection, the term ‘additional 

5 newborn condition’ means any condition that is not 

6 one of the core conditions designated by the Advi7 sory Committee described under section 1112. 

8 ‘‘(b) ELIGIBILITY.—To be eligible to receive a grant 

9 under this section, an entity shall— 

10 ‘‘(1) submit to the Secretary an application at 

11 such time, in such manner, and containing such in12 formation as the Secretary may require; 

13 ‘‘(2) be a public or private organization includ14 ing, an academic research center, medical center, 

15 physician group, newborn screening program, or 

16 CLIA-certified laboratory with expertise in newborn 

17 metabolic screening; 

18 ‘‘(3) provide assurance that such entity will 

19 work in consultation with the appropriate State de20 partment of health; 

21 ‘‘(4) submit to the Secretary a strategic plan 

22 for performing additional newborn screening tests 

23 and for collecting and reporting data on the costs, 

24 benefits, and effectiveness of such tests, in consultaVerDate Aug 31 2005 04:52 Jul 30, 2006 Jkt 049200 PO 00000 Frm 00017 Fmt 6652 Sfmt 6201 E:\BILLS\S3743.IS S3743

ccoleman on PROD1PC71 with BILLS
18 

•S 3743 IS

1 tion with the appropriate State department of 

2 health; 

3 ‘‘(5) demonstrate sustainability of such activi4 ties based on the outcomes of the demonstration 

5 project; 

6 ‘‘(6) provide assurance that the entity will de7 velop newborn screening tests that are not currently 

8 performed in the State in which the entity is located; 

9 and 

10 ‘‘(7) if applicable, submit to the Secretary a 

11 plan for short- and long-term follow-up, diagnosis, 

12 and treatment of those infants who test positive on 

13 newborn screening tests developed under this sec14 tion. 

15 ‘‘(c) REPORT TO SECRETARY AND INTERAGENCY

16 PANEL.—An organization that receives a grant under this 

17 section shall, on an annual basis, submit to the Secretary 

18 and the Interagency Grant Review Panel established 

19 under section 1114 a report that describes the activities 

20 conducted pursuant to such grant and the outcomes of 

21 such activities. 

22 ‘‘(d) EVALUATION AND RESULTS.—The Secretary 

23 shall— 

24 ‘‘(1) evaluate the demonstration projects funded 

25 under this section; and 


ccoleman on PROD1PC71 with BILLS
19 

•S 3743 IS

1 ‘‘(2) on an annual basis— 

2 ‘‘(A) publish and disseminate the results of 

3 such evaluation on as wide a basis as is prac4 ticable; and 

5 ‘‘(B) submit to the appropriate committees 

6 of Congress the results of such evaluation. 

7 ‘‘(e) AUTHORIZATION OF APPROPRIATIONS.—There 

8 are authorized to be appropriated to carry out this sec9 tion— 

10 ‘‘(1) $30,000,000 for fiscal year 2007; and 

11 ‘‘(2) such sums as necessary for fiscal years 

12 2008 through 2011. 

13 ‘‘SEC. 1117. PRIVACY PROTECTIONS. 

14 ‘‘Except to the extent inconsistent with this part, the 

15 provision of information pursuant to sections 1112 

16 through 1116, and any subsequent transfer of such infor17 mation in accordance with those sections, are subject to 

18 any requirement that would otherwise apply under the reg19 ulations promulgated pursuant to section 264(c) of the 

20 Health Insurance Portability and Accountability Act of 

21 1996.’’. 

Æ 


ccoleman on PROD1PC71 with BILLS