I 

110TH CONGRESS 

1ST SESSION S. 1858 

IN THE HOUSE OF REPRESENTATIVES 

DECEMBER 17, 2007 

Referred to the Committee on Energy and Commerce 

AN ACT 

To amend the Public Health Service Act to establish grant 

programs to provide for education and outreach on newborn screening and coordinated followup care once newborn screening has been conducted, to reauthorize programs under part A of title XI of such Act, and for 

other purposes. 


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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. 

4 This Act may be cited as the ‘‘Newborn Screening 

5 Saves Lives Act of 2007’’. 

6 SEC. 2. IMPROVED NEWBORN AND CHILD SCREENING FOR 

7 HERITABLE DISORDER. 

8 Section 1109 of the Public Health Service Act (42 

9 U.S.C. 300b–8) is amended— 

10 (1) by striking subsections (a), (b), and (c) and 

11 inserting the following: 

12 ‘‘(a) AUTHORIZATION OF GRANT PROGRAM.—From 

13 amounts appropriated under subsection (j), the Secretary, 

14 acting through the Administrator of the Health Resources 

15 and Services Administration (referred to in this section 

16 as the ‘Administrator’) and in consultation with the Advi17 sory Committee on Heritable Disorders in Newborns and 

18 Children (referred to in this section as the ‘Advisory Com19 mittee’), shall award grants to eligible entities to enable 

20 such entities— 

21 ‘‘(1) to enhance, improve or expand the ability 

22 of State and local public health agencies to provide 

23 screening, counseling, or health care services to 

24 newborns and children having or at risk for heritable 

25 disorders; 


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1 ‘‘(2) to assist in providing health care profes2 sionals and newborn screening laboratory personnel 

3 with education in newborn screening and training in 

4 relevant and new technologies in newborn screening 

5 and congenital, genetic, and metabolic disorders; 

6 ‘‘(3) to develop and deliver educational pro7 grams (at appropriate literacy levels) about newborn 

8 screening counseling, testing, follow-up, treatment, 

9 and specialty services to parents, families, and pa10 tient advocacy and support groups; and 

11 ‘‘(4) to establish, maintain, and operate a sys12 tem to assess and coordinate treatment relating to 

13 congenital, genetic, and metabolic disorders. 

14 ‘‘(b) ELIGIBLE ENTITY.—In this section, the term 

15 ‘eligible entity’ means— 

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

17 State; 

18 ‘‘(2) a consortium of 2 or more States or polit19 ical subdivisions of States; 

20 ‘‘(3) a territory; 

21 ‘‘(4) a health facility or program operated by or 

22 pursuant to a contract with or grant from the In23 dian Health Service; or 


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1 ‘‘(5) any other entity with appropriate expertise 

2 in newborn screening, as determined by the Sec3 retary. 

4 ‘‘(c) APPROVAL FACTORS.—An application submitted 

5 for a grant under subsection (a)(1) shall not be approved 

6 by the Secretary unless the application contains assur7 ances that the eligible entity has adopted and imple8 mented, is in the process of adopting and implementing, 

9 or will use amounts received under such grant to adopt 

10 and implement the guidelines and recommendations of the 

11 Advisory Committee that are adopted by the Secretary 

12 and in effect at the time the grant is awarded or renewed 

13 under this section, which shall include the screening of 

14 each newborn for the heritable disorders recommended by 

15 the Advisory Committee and adopted by the Secretary.’’; 

16 (2) by redesignating subsections (d) through (i) 

17 as subsections (e) through (j), respectively; 

18 (3) by inserting after subsection (c), the fol19 lowing: 

20 ‘‘(d) COORDINATION.—The Secretary shall take all 

21 necessary steps to coordinate programs funded with 

22 grants received under this section and to coordinate with 

23 existing newborn screening activities.’’; and 

24 (4) by striking subsection (j) (as so redesig25 nated) and inserting the following: 


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

2 is authorized to be appropriated— 

3 ‘‘(1) to provide grants for the purpose of car4 rying activities under section (a)(1), $15,000,000 for 

5 fiscal year 2008; $15,187,500 for fiscal year 2009, 

6 $15,375,000 for fiscal year 2010, $15,562,500 for 

7 fiscal year 2011, and $15,750,000 for fiscal year 

8 2012; and 

9 ‘‘(2) to provide grant for the purpose of car10 rying out activities under paragraphs (2), (3), and 

11 (4) of subsection (a), $15,000,000 for fiscal year 

12 2008, $15,187,500 for fiscal year 2009, 

13 $15,375,000 for fiscal year 2010, $15,562,500 for 

14 fiscal year 2011, and $15,750,000 for fiscal year 

15 2012.’’. 

16 SEC. 3. EVALUATING THE EFFECTIVENESS OF NEWBORN 

17 AND CHILD SCREENING PROGRAMS. 

18 Section 1110 of the Public Health Service Act (42 

19 U.S.C. 300b–9) is amended by adding at the end the fol20 lowing: 

21 ‘‘(d) AUTHORIZATION OF APPROPRIATIONS.—There 

22 are authorized to be appropriated to carry out this section 

23 $5,000,000 for fiscal year 2008, $5,062,500 for fiscal year 

24 2009, $5,125,000 for fiscal year 2010, $5,187,500 for fis25 cal year 2011, and $5,250,000 for fiscal year 2012.’’. 


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1 SEC. 4. ADVISORY COMMITTEE ON HERITABLE DISORDERS 

2 IN NEWBORNS AND CHILDREN. 

3 Section 1111 of the Public Health Service Act (42 

4 U.S.C. 300b–10) is amended— 

5 (1) in subsection (b)— 

6 (A) by redesignating paragraph (3) as 

7 paragraph (6); 

8 (B) in paragraph (2), by striking ‘‘and’’ 

9 after the semicolon; 

10 (C) by inserting after paragraph (2) the 

11 following: 

12 ‘‘(3) make systematic evidence-based and peer13 reviewed recommendations that include the heritable 

14 disorders that have the potential to significantly im15 pact public health for which all newborns should be 

16 screened, including secondary conditions that may be 

17 identified as a result of the laboratory methods used 

18 for screening; 

19 ‘‘(4) develop a model decision-matrix for new20 born screening expansion, including an evaluation of 

21 the potential public health impact of such expansion, 

22 and periodically update the recommended uniform 

23 screening panel, as appropriate, based on such deci24 sion-matrix; 

25 ‘‘(5) consider ways to ensure that all States at26 tain the capacity to screen for the conditions deVerDate Aug 31 2005 04:09 Dec 19, 2007 Jkt 069200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6201 E:\BILLS\S1858.RFH S1858

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1 scribed in paragraph (3), and include in such consid2 eration the results of grant funding under section 

3 1109; and’’; 

4 (D) in paragraph (6) (as so redesignated 

5 by subparagraph (A)), by striking the period at 

6 the end and inserting ‘‘, which may include rec7 ommendations, advice, or information dealing 

8 with— 

9 ‘‘(A) follow-up activities, including those 

10 necessary to achieve rapid diagnosis in the 

11 short-term, and those that ascertain long-term 

12 case management outcomes and appropriate ac13 cess to related services; 

14 ‘‘(B) implementation, monitoring, and 

15 evaluation of newborn screening activities, in16 cluding diagnosis, screening, follow-up, and 

17 treatment activities; 

18 ‘‘(C) diagnostic and other technology used 

19 in screening; 

20 ‘‘(D) the availability and reporting of test21 ing for conditions for which there is no existing 

22 treatment; 

23 ‘‘(E) conditions not included in the rec24 ommended uniform screening panel that are 

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1 approved products or other safe and effective 

2 treatments, as determined by scientific evidence 

3 and peer review; 

4 ‘‘(F) minimum standards and related poli5 cies and procedures used by State newborn 

6 screening programs, such as language and ter7 minology used by State newborn screening pro8 grams to include standardization of case defini9 tions and names of disorders for which newborn 

10 screening tests are performed; 

11 ‘‘(G) quality assurance, oversight, and 

12 evaluation of State newborn screening pro13 grams, including ensuring that tests and tech14 nologies used by each State meet established 

15 standards for detecting and reporting positive 

16 screening results; 

17 ‘‘(H) public and provider awareness and 

18 education; 

19 ‘‘(I) the cost and effectiveness of newborn 

20 screening and medical evaluation systems and 

21 intervention programs conducted by State-based 

22 programs; 

23 ‘‘(J) identification of the causes of, public 

24 health impacts of, and risk factors for heritable 

25 disorders; and 


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1 ‘‘(K) coordination of surveillance activities, 

2 including standardized data collection and re3 porting, harmonization of laboratory definitions 

4 for heritable disorders and testing results, and 

5 confirmatory testing and verification of positive 

6 results, in order to assess and enhance moni7 toring of newborn diseases.’’; and 

8 (2) in subsection (c)(2)— 

9 (A) by redesignating subparagraphs (E), 

10 (F) and (G) as subparagraphs (F), (H), and 

11 (I); 

12 (B) by inserting after subparagraph (D) 

13 the following: 

14 ‘‘(E) the Commissioner of the Food and 

15 Drug Administration;’’; and 

16 (C) by inserting after subparagraph (F), 

17 as so redesignated, the following: 

18 ‘‘(G) individuals with expertise in ethics 

19 and infectious diseases who have worked and 

20 published material in the area of newborn 

21 screening;’’; and 

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

23 ‘‘(d) DECISION ON RECOMMENDATIONS.— 

24 ‘‘(1) IN GENERAL.—Not later than 180 days 

25 after the Advisory Committee issues a recommendaVerDate Aug 31 2005 04:09 Dec 19, 2007 Jkt 069200 PO 00000 Frm 00009 Fmt 6652 Sfmt 6201 E:\BILLS\S1858.RFH S1858

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1 tion pursuant to this section, the Secretary shall 

2 adopt or reject such recommendation. 

3 ‘‘(2) PENDING RECOMMENDATIONS.—The Sec4 retary shall adopt or reject any recommendation 

5 issued by the Advisory Committee that is pending on 

6 the date of enactment of the Newborn Screening 

7 Saves Lives Act of 2007 by not later than 180 days 

8 after the date of enactment of such Act. 

9 ‘‘(3) DETERMINATIONS TO BE MADE PUBLIC.— 

10 The Secretary shall publicize any determination on 

11 adopting or rejecting a recommendation of the Advi12 sory Committee pursuant to this subsection, includ13 ing the justification for the determination. 

14 ‘‘(e) ANNUAL REPORT.—Not later than 3 years after 

15 the date of enactment of the Newborn Screening Saves 

16 Lives Act of 2007, and each fiscal year thereafter, the Ad17 visory Committee shall— 

18 ‘‘(1) publish a report on peer-reviewed newborn 

19 screening guidelines, including follow-up and treat20 ment, in the United States; 

21 ‘‘(2) submit such report to the appropriate com22 mittees of Congress, the Secretary, the Interagency 

23 Coordinating Committee established under Section 

24 1114, and the State departments of health; and 


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1 ‘‘(3) disseminate such report on as wide a basis 

2 as practicable, including through posting on the 

3 internet clearinghouse established under section 

4 1112. 

5 ‘‘(f) CONTINUATION OF OPERATION OF COM6 MITTEE.—Notwithstanding section 14 of the Federal Ad7 visory Committee Act (5 U.S.C. App.), the Advisory Com8 mittee shall continue to operate during the 5-year period 

9 beginning on the date of enactment of the Newborn 

10 Screening Saves Lives Act of 2007. 

11 ‘‘(g) AUTHORIZATION OF APPROPRIATIONS.—There 

12 are authorized to be appropriated to carry out this section, 

13 $1,000,000 for fiscal year 2008, $1,012,500 for fiscal year 

14 2009, $1,025,000 for fiscal year 2010, $1,037,500 for fis15 cal year 2011, and $1,050,000 for fiscal year 2012.’’. 

16 SEC. 5. INFORMATION CLEARINGHOUSE. 

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

18 (42 U.S.C. 300b–1 et seq.) is amended by adding at the 

19 end the following: 

20 ‘‘SEC. 1112. CLEARINGHOUSE OF NEWBORN SCREENING IN21 FORMATION. 

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

23 the Administrator of the Health Resources and Services 

24 Administration (referred to in this part as the ‘Adminis25 trator’), in consultation with the Director of the Centers 


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1 for Disease Control and Prevention and the Director of 

2 the National Institutes of Health, shall establish and 

3 maintain a central clearinghouse of current educational 

4 and family support and services information, materials, re5 sources, research, and data on newborn 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 expectant individuals and families; and 

14 ‘‘(3) maintain current data on quality indica15 tors to measure performance of newborn screening, 

16 such as false-positive rates and other quality indica17 tors as determined by the Advisory Committee under 

18 section 1111. 

19 ‘‘(b) INTERNET AVAILABILITY.—The Secretary, act20 ing through the Administrator, shall ensure that the clear21 inghouse described under subsection (a)— 

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

23 ‘‘(2) includes an interactive forum; 

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

25 than quarterly; and 


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1 ‘‘(4) provides— 

2 ‘‘(A) links to Government-sponsored, non3 profit, and other Internet websites of labora4 tories that have demonstrated expertise in new5 born screening that supply research-based infor6 mation on newborn screening tests currently 

7 available throughout the United States; 

8 ‘‘(B) information about newborn conditions 

9 and screening services available in each State 

10 from laboratories certified under subpart 2 of 

11 part F of title III, including information about 

12 supplemental screening that is available but not 

13 required, in the State where the infant is born; 

14 ‘‘(C) current research on both treatable 

15 and not-yet treatable conditions for which new16 born screening tests are available; 

17 ‘‘(D) the availability of Federal funding for 

18 newborn and child screening for heritable dis19 orders including grants authorized under the 

20 Newborn Screening Saves Lives Act of 2007; 

21 and 

22 ‘‘(E) other relevant information as deter23 mined appropriate by the Secretary. 

24 ‘‘(c) NONDUPLICATION.—In developing the clearing25 house under this section, the Secretary shall ensure that 


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1 such clearinghouse minimizes duplication and supple2 ments, not supplants, existing information sharing efforts. 

3 ‘‘(d) AUTHORIZATION OF APPROPRIATIONS.—There 

4 are authorized to be appropriated to carry out this section, 

5 $2,500,000 for fiscal year 2008, $2,531,250 for fiscal year 

6 2009, $2,562,500 for fiscal year 2010, $2,593,750 for fis7 cal year 2011, and $2,625,000 for fiscal year 2012.’’. 

8 SEC. 6. LABORATORY QUALITY AND SURVEILLANCE. 

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

10 (42 U.S.C. 300b–1 et seq.), as amended by section 5, is 

11 further amended by adding at the end the following: 

12 ‘‘SEC. 1113. LABORATORY QUALITY. 

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

14 the Director of the Centers for Disease Control and Pre15 vention and in consultation with the Advisory Committee 

16 on Heritable Disorders in Newborns and Children estab17 lished under section 1111, shall provide for— 

18 ‘‘(1) quality assurance for laboratories involved 

19 in screening newborns and children for heritable dis20 orders, including quality assurance for newborn21 screening tests, performance evaluation services, and 

22 technical assistance and technology transfer to new23 born screening laboratories to ensure analytic valid24 ity and utility of screening tests; and 


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1 ‘‘(2) appropriate quality control and other per2 formance test materials to evaluate the performance 

3 of new screening tools. 

4 ‘‘(b) AUTHORIZATION OF APPROPRIATIONS.—For the 

5 purpose of carrying out this section, there are authorized 

6 to be appropriated $5,000,000 for fiscal year 2008, 

7 $5,062,500 for fiscal year 2009, $5,125,000 for fiscal year 

8 2010, $5,187,500 for fiscal year 2011, and $5,250,000 

9 for fiscal year 2012. 

10 ‘‘SEC. 1114. INTERAGENCY COORDINATING COMMITTEE ON 

11 NEWBORN AND CHILD SCREENING. 

12 ‘‘(a) PURPOSE.—It is the purpose of this section to— 

13 ‘‘(1) assess existing activities and infrastruc14 ture, including activities on birth defects and devel15 opmental disabilities authorized under section 317C, 

16 in order to make recommendations for programs to 

17 collect, analyze, and make available data on the heri18 table disorders recommended by the Advisory Com19 mittee on Heritable Disorders in Newborns and 

20 Children under section 1111, including data on the 

21 incidence and prevalence of, as well as poor health 

22 outcomes resulting from, such disorders; and 

23 ‘‘(2) make recommendations for the establish24 ment of regional centers for the conduct of applied 

25 epidemiological research on effective interventions to 


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1 promote the prevention of poor health outcomes re2 sulting from such disorders as well as providing in3 formation and education to the public on such effec4 tive interventions. 

5 ‘‘(b) ESTABLISHMENT.—The Secretary shall estab6 lish an Interagency Coordinating Committee on Newborn 

7 and Child Screening (referred to in this section as the 

8 ‘Interagency Coordinating Committee’) to carry out the 

9 purpose of this section. 

10 ‘‘(c) COMPOSITION.—The Interagency Coordinating 

11 Committee shall be composed of the Director of the Cen12 ters for Disease Control and Prevention, the Adminis13 trator, the Director of the Agency for Healthcare Research 

14 and Quality, and the Director of the National Institutes 

15 of Health, or their designees. 

16 ‘‘(d) ACTIVITIES.—The Interagency Coordinating 

17 Committee shall— 

18 ‘‘(1) report to the Secretary and the appro19 priate committees of Congress on its recommenda20 tions related to the purpose described in subsection 

21 (a); and 

22 ‘‘(2) carry out other activities determined ap23 propriate by the Secretary. 

24 ‘‘(e) AUTHORIZATION OF APPROPRIATIONS.—For the 

25 purpose of carrying out this section, there are authorized 


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1 to be appropriated $1,000,000 for fiscal year 2008, 

2 $1,012,500 for fiscal year 2009, $1,025,000 for fiscal year 

3 2010, $1,037,500 for fiscal year 2011, and $1,050,000 

4 for fiscal year 2012.’’. 

5 SEC. 7. CONTINGENCY PLANNING. 

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

7 (42 U.S.C. 300b–1 et seq.), as amended by section 6, is 

8 further amended by adding at the end the following: 

9 ‘‘SEC. 1115. NATIONAL CONTINGENCY PLAN FOR NEWBORN 

10 SCREENING. 

11 ‘‘(a) IN GENERAL.—Not later than 180 days after 

12 the date of enactment of this section, the Secretary, acting 

13 through the Director of the Centers for Disease Control 

14 and Prevention and in consultation with the Administrator 

15 and State departments of health (or related agencies), 

16 shall develop a national contingency plan for newborn 

17 screening for use by a State, region, or consortia of States 

18 in the event of a public health emergency. 

19 ‘‘(b) CONTENTS.—The contingency plan developed 

20 under subsection (a) shall include a plan for— 

21 ‘‘(1) the collection and transport of specimens; 

22 ‘‘(2) the shipment of specimens to State new23 born screening laboratories; 

24 ‘‘(3) the processing of specimens; 


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1 ‘‘(4) the reporting of screening results to physi2 cians and families; 

3 ‘‘(5) the diagnostic confirmation of positive 

4 screening results; 

5 ‘‘(6) ensuring the availability of treatment and 

6 management resources; 

7 ‘‘(7) educating families about newborn screen8 ing; and 

9 ‘‘(8) carrying out other activities determined 

10 appropriate by the Secretary. 

11 ‘‘SEC. 1116. HUNTER KELLY RESEARCH PROGRAM. 

12 ‘‘(a) NEWBORN SCREENING ACTIVITIES.— 

13 ‘‘(1) IN GENERAL.—The Secretary, in conjunc14 tion with the Director of the National Institutes of 

15 Health and taking into consideration the rec16 ommendations of the Advisory Committee, may con17 tinue carrying out, coordinating, and expanding re18 search in newborn screening (to be known as 

19 ‘Hunter Kelly Newborn Screening Research Pro20 gram’) including— 

21 ‘‘(A) identifying, developing, and testing 

22 the most promising new screening technologies, 

23 in order to improve already existing screening 

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1 ing, and expand the number of conditions for 

2 which screening tests are available; 

3 ‘‘(B) experimental treatments and disease 

4 management strategies for additional newborn 

5 conditions, and other genetic, metabolic, hor6 monal and or functional conditions that can be 

7 detected through newborn screening for which 

8 treatment is not yet available; and 

9 ‘‘(C) other activities that would improve 

10 newborn screening, as identified by the Direc11 tor. 

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

13 purposes of this subsection, the term ‘additional 

14 newborn condition’ means any condition that is not 

15 one of the core conditions recommended by the Advi16 sory Committee and adopted by the Secretary. 

17 ‘‘(b) FUNDING.—In carrying out the research pro18 gram under this section, the Secretary and the Director 

19 shall ensure that entities receiving funding through the 

20 program will provide assurances, as practicable, that such 

21 entities will work in consultation with the appropriate 

22 State departments of health, and, as practicable, focus 

23 their research on screening technology not currently per24 formed in the States in which the entities are located, and 


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1 the conditions on the uniform screening panel (or the 

2 standard test existing on the uniform screening panel). 

3 ‘‘(c) REPORTS.—The Director is encouraged to in4 clude information about the activities carried out under 

5 this section in the biennial report required under section 

6 403 of the National Institutes of Health Reform Act of 

7 2006. If such information is included, the Director shall 

8 make such information available to be included on the 

9 Internet Clearinghouse established under section 1112. 

10 ‘‘(d) NONDUPLICATION.—In carrying out programs 

11 under this section, the Secretary shall minimize duplica12 tion and supplement, not supplant, existing efforts of the 

13 type carried out under this section. 

14 ‘‘(e) PEER REVIEW.—Nothing in this section shall be 

15 construed to interfere with the scientific peer-review proc16 ess at the National Institutes of Health.’’. 

Passed the Senate December 13, 2007. 

Attest: NANCY ERICKSON, 

Secretary. 


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