II 

110TH CONGRESS 

1ST SESSION S. 1858 

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. 

IN THE SENATE OF THE UNITED STATES 

JULY 23, 2007 

Mr. DODD (for himself, Mr. HATCH, Mrs. CLINTON, and Mr. KENNEDY) 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 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. 

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’’. 


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1 SEC. 2. FINDINGS. 

2 Congress finds the following: 

3 (1) Each year more than 4,000,000 babies born 

4 in the United States are screened by State and pri5 vate laboratories to detect some conditions that may 

6 threaten their long-term health. 

7 (2) However, there is a lack of uniformity in 

8 the number of conditions for which newborns are 

9 screened throughout the United States. While a new10 born may be screened and treated for a debilitating 

11 condition in one State, in another State, the condi12 tion may go undetected and result in permanent dis13 ability or even death. 

14 (3) Approximately 4,000 infants born each year 

15 are diagnosed with these detectable and treatable 

16 disorders. If diagnosed early, these conditions can be 

17 successfully managed or treated to prevent severe 

18 and often lifelong health consequences. 

19 (4) In 2004, the American College of Medical 

20 Genetics (ACMG) completed a report commissioned 

21 by the Department of Health and Human Services 

22 which recommended that every baby born in the 

23 United States be screened for 29 specific disorders, 

24 including certain metabolic conditions and hearing 

25 deficiencies. 


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1 (5) Currently only 11 States and the District of 

2 Columbia require infants to be screened for all 29 of 

3 these recommended disorders. 

4 (6) Continuity, especially during a public health 

5 emergency, plays a critical role in the screening, di6 agnosis, referral, and treatment of these disorders. 

7 Currently there is no national contingency plan for 

8 maintaining continuity of newborn screening systems 

9 following a public health emergency. 

10 SEC. 3. AMENDMENT TO TITLE III OF THE PUBLIC HEALTH 

11 SERVICE ACT. 

12 Part Q of title III of the Public Health Service Act 

13 (42 U.S.C. 280h et seq.) is amended by adding at the end 

14 the following: 

15 ‘‘SEC. 399Z–1. NEWBORN SCREENING. 

16 ‘‘(a) AUTHORIZATION OF GRANT PROGRAMS.—From 

17 funds appropriated under subsection (h), the Secretary, 

18 acting through the Administrator of the Health Resources 

19 and Services Administration (referred to in this section 

20 as the ‘Administrator’) and in consultation with the Advi21 sory Committee on Heritable Disorders in Newborns and 

22 Children (referred to in this section as the ‘Advisory Com23 mittee’), shall award grants to eligible entities to enable 

24 such entities to assist in providing health care profesVerDate Aug 31 2005 00:09 Aug 01, 2007 Jkt 059200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\S1858.IS S1858

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1 sionals and newborn screening laboratory personnel 

2 with— 

3 ‘‘(1) education in newborn screening; and 

4 ‘‘(2) training in— 

5 ‘‘(A) relevant and new technologies in new6 born screening; and 

7 ‘‘(B) congenital, genetic, and metabolic 

8 disorders. 

9 ‘‘(b) APPLICATION.—An eligible entity that desires to 

10 receive a grant under this section shall submit an applica11 tion to the Secretary at such time, in such manner, and 

12 accompanied by such information as the Secretary may 

13 require. 

14 ‘‘(c) SELECTION OF GRANT RECIPIENTS.— 

15 ‘‘(1) IN GENERAL.—Not later than 120 days 

16 after receiving an application under subsection (b), 

17 the Secretary, after considering the approval factors 

18 under paragraph (2), shall determine whether to 

19 award the eligible entity a grant under this section. 

20 ‘‘(2) APPROVAL FACTORS.— 

21 ‘‘(A) REQUIREMENTS FOR APPROVAL.—An 

22 application submitted under subsection (b) may 

23 not be approved by the Secretary unless the ap24 plication contains assurances that the eligible 

25 entity— 


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1 ‘‘(i) will use grant funds only for the 

2 purposes specified in the approved applica3 tion and in accordance with the require4 ments of this section; and 

5 ‘‘(ii) will establish such fiscal control 

6 and fund accounting procedures as may be 

7 necessary to assure proper disbursement 

8 and accounting of Federal funds paid to 

9 the eligible entity under the grant. 

10 ‘‘(B) EXISTING PROGRAMS.—Prior to 

11 awarding a grant under this section, the Sec12 retary shall— 

13 ‘‘(i) conduct an assessment of existing 

14 educational resources and training pro15 grams with respect to newborn screening; 

16 and 

17 ‘‘(ii) take all necessary steps to mini18 mize the duplication of the resources and 

19 programs described in clause (i) and en20 sure that funding under this section will 

21 supplement, not supplant, existing funding 

22 for such activities. 

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

24 necessary steps to coordinate programs funded with 


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1 grants received under this section and to coordinate with 

2 existing newborn screening activities. 

3 ‘‘(e) USE OF GRANT FUNDS.—An eligible entity that 

4 receives a grant under subsection (a)(1) may use the grant 

5 funds to work with appropriate medical schools, nursing 

6 schools, schools of public health, schools of genetic coun7 seling, internal education programs in State agencies, non8 governmental organizations, and professional organiza9 tions and societies to develop and deliver education and 

10 training programs that include— 

11 ‘‘(1) continuing medical education programs for 

12 health care professionals and newborn screening lab13 oratory personnel in newborn screening; 

14 ‘‘(2) education, technical assistance, and train15 ing on new discoveries in newborn screening and the 

16 use of any related technology; 

17 ‘‘(3) models to evaluate the prevalence of, and 

18 assess and communicate the risks of, congenital con19 ditions, including the prevalence and risk of some of 

20 these conditions based on family history; 

21 ‘‘(4) models to communicate effectively with 

22 parents and families about— 

23 ‘‘(A) the process and benefits of newborn 

24 screening and the meaning of screening results, 


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1 including the possibility of false positive find2 ings; 

3 ‘‘(B) how to use information gathered from 

4 newborn screening; 

5 ‘‘(C) the right of refusal of newborn 

6 screening, if applicable; and 

7 ‘‘(D) the potential need for followup care 

8 after newborns are screened; 

9 ‘‘(5) information and resources on coordinated 

10 systems of followup care after newborns are 

11 screened; 

12 ‘‘(6) information on the disorders for which 

13 States require and offer newborn screening and op14 tions for newborn screening relating to conditions in 

15 addition to such disorders; 

16 ‘‘(7) information on additional newborn screen17 ing that may not be required by the State, but that 

18 may be available from other sources; and 

19 ‘‘(8) other items to carry out the purpose de20 scribed in subsection (a)(1) as determined appro21 priate by the Secretary. 

22 ‘‘(f) REPORTS TO CONGRESS.— 

23 ‘‘(1) IN GENERAL.—Subject to paragraph (2), 

24 the Secretary shall submit to the relevant commit25 tees of Congress reports— 


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1 ‘‘(A) evaluating the effectiveness and the 

2 impact of the grants awarded under this sec3 tion— 

4 ‘‘(i) in promoting newborn screening 

5 education, resources, and training for 

6 health care professionals; 

7 ‘‘(ii) on the successful diagnosis and 

8 treatment of congenital, genetic, and meta9 bolic disorders; and 

10 ‘‘(iii) on the continued development of 

11 coordinated systems of followup care after 

12 newborns are screened; 

13 ‘‘(B) describing and evaluating the effec14 tiveness of the activities carried out with grant 

15 funds received under this section; and 

16 ‘‘(C) that include recommendations for 

17 Federal, State, and local actions to support— 

18 ‘‘(i) education and training in new19 born screening; and 

20 ‘‘(ii) followup care after newborns are 

21 screened. 

22 ‘‘(2) TIMING OF REPORTS.—The Secretary shall 

23 submit— 

24 ‘‘(A) an interim report that includes the 

25 information described in paragraph (1), not 


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1 later than 30 months after the date on which 

2 the first grant funds are awarded under this 

3 section; and 

4 ‘‘(B) a subsequent report that includes the 

5 information described in paragraph (1), not 

6 later than 60 months after the date on which 

7 the first grant funds are awarded under this 

8 section. 

9 ‘‘(g) DEFINITION OF ELIGIBLE ENTITY.—In this sec10 tion, the term ‘eligible entity’ means— 

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

12 State; 

13 ‘‘(2) a consortium of 2 or more States or polit14 ical subdivisions of States; 

15 ‘‘(3) a territory; 

16 ‘‘(4) an Indian tribe or a hospital or outpatient 

17 health care facility of the Indian Health Service; or 

18 ‘‘(5) other entities with appropriate expertise in 

19 newborn screening, as determined by the Secretary. 

20 ‘‘(h) AUTHORIZATION OF APPROPRIATIONS.—There 

21 are authorized to be appropriated to carry out this sec22 tion— 

23 ‘‘(1) $5,000,000 for fiscal year 2008; and 

24 ‘‘(2) such sums as may be necessary for each 

25 of fiscal years 2009 through 2012.’’. 


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1 SEC. 4. 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 (c)(2)— 

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

7 ‘‘and’’ after the semicolon; 

8 (B) by redesignating subparagraph (F) as 

9 subparagraph (G); and 

10 (C) by inserting after subparagraph (E) 

11 the following: 

12 ‘‘(F) an assurance that the entity has 

13 adopted and implemented, is in the process of 

14 adopting and implementing, or will use grant 

15 amounts received under this section to adopt 

16 and implement the guidelines and recommenda17 tions of the Advisory Committee on Heritable 

18 Disorders in Newborns and Children established 

19 under section 1111 (referred to in this section 

20 as the ‘Advisory Committee’) that are adopted 

21 by the Secretary and in effect at the time the 

22 grant is awarded or renewed under this section, 

23 which shall include the screening of each new24 born for the heritable disorders recommended 

25 by the Advisory Committee and adopted by the 


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1 Secretary and the reporting of results; and’’; 

2 and 

3 (2) in subsection (i), by striking ‘‘such sums’’ 

4 and all that follows through the period at the end 

5 and inserting ‘‘$15,000,000 for fiscal year 2008 and 

6 such sums as may be necessary for each of the fiscal 

7 years 2009 through 2012.’’. 

8 SEC. 5. EVALUATING THE EFFECTIVENESS OF NEWBORN9 AND CHILD-SCREENING PROGRAMS. 

10 Section 1110 of the Public Health Service Act (42 

11 U.S.C. 300b–9) is amended by adding at the end the fol12 lowing: 

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

14 are authorized to be appropriated to carry out this section 

15 $5,000,000 for fiscal year 2008 and such sums as may 

16 be necessary for each of the fiscal years 2009 through 

17 2012.’’. 

18 SEC. 6. ADVISORY COMMITTEE ON HERITABLE DISORDERS 

19 IN NEWBORNS AND CHILDREN. 

20 Section 1111 of the Public Health Service Act (42 

21 U.S.C. 300b–10) is amended— 

22 (1) in subsection (b)— 

23 (A) in paragraph (1), by inserting ‘‘and 

24 grants awarded under section 399Z–1’’ before 

25 the semicolon; 


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1 (B) by redesignating paragraph (3) as 

2 paragraph (6); 

3 (C) in paragraph (2), by striking ‘‘and’’ 

4 after the semicolon; 

5 (D) by inserting after paragraph (2) the 

6 following: 

7 ‘‘(3) make systematic evidence-based and peer8 reviewed recommendations that include the heritable 

9 disorders for which all newborns should be screened, 

10 including secondary conditions that may be identi11 fied as a result of the laboratory methods used for 

12 screening; 

13 ‘‘(4) develop a model decision-matrix for new14 born screening program expansion, and periodically 

15 update the recommended uniform screening panel, 

16 as appropriate, based on such decision-matrix; 

17 ‘‘(5) consider ways to ensure that States attain 

18 the capacity to screen for the conditions described in 

19 paragraph (3), and include in such consideration the 

20 results of grant funding under section 1109; and’’; 

21 (E) in paragraph (6) (as so redesignated 

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

23 the end and inserting ‘‘, which may include rec24 ommendations, advice, or information dealing 

25 with— 


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1 ‘‘(A) followup activities, including those 

2 necessary to achieve rapid diagnosis in the 

3 short term, and those that ascertain long-term 

4 case management outcomes and appropriate ac5 cess to related services; 

6 ‘‘(B) implementation, monitoring, and 

7 evaluation of newborn screening activities, in8 cluding diagnosis, screening, follow-up, and 

9 treatment activities; 

10 ‘‘(C) diagnostic and other technology used 

11 in screening; 

12 ‘‘(D) the availability and reporting of test13 ing for conditions for which there is no existing 

14 treatment; 

15 ‘‘(E) conditions not included in the rec16 ommended uniform screening panel that are 

17 treatable with Food and Drug Administration18 approved products; 

19 ‘‘(F) minimum standards and related poli20 cies and procedures used by State newborn 

21 screening programs, such as language and ter22 minology used by State newborn screening pro23 grams to include standardization of case defini24 tions and names of disorders for which newborn 

25 screening tests are performed; 


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

2 evaluation of State newborn screening pro3 grams, including ensuring that tests and tech4 nologies used by each State meet established 

5 standards for detecting and reporting positive 

6 screening results; 

7 ‘‘(H) public and provider awareness and 

8 education; 

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

10 screening and medical evaluation systems and 

11 intervention programs conducted by State-based 

12 programs; 

13 ‘‘(J) identification of the causes of, and 

14 risk factors for heritable disorders; and 

15 ‘‘(K) coordination of surveillance activities, 

16 including standardized data collection and re17 porting, harmonization of laboratory definitions 

18 for heritable disorders and testing results, and 

19 confirmatory testing and verification of positive 

20 results, in order to assess and enhance moni21 toring of newborn diseases.’’; and 

22 (2) in subsection (c)(2)— 

23 (A) by redesignating subparagraphs (E), 

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

25 (I); 


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1 (B) by inserting after subparagraph (D) 

2 the following: 

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

4 Drug Administration;’’; and 

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

6 as so redesignated, the following: 

7 ‘‘(G) individuals with expertise in ethics 

8 who have worked and published material in the 

9 area of newborn screening;’’; and 

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

11 ‘‘(d) DECISION ON RECOMMENDATIONS.— 

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

13 after the Advisory Committee issues a recommenda14 tion pursuant to this section, the Secretary shall 

15 adopt or reject such recommendation. 

16 ‘‘(2) PENDING RECOMMENDATIONS.—The Sec17 retary shall adopt or reject any recommendation 

18 issued by the Advisory Committee that is pending on 

19 the date of enactment of the Newborn Screening 

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

21 after the date of enactment of such Act. 

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

23 The Secretary shall publicize any determination on 

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1 sory Committee pursuant to this subsection, includ2 ing the justification for the determination. 

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

4 the date of enactment of the Newborn Screening Saves 

5 Lives Act of 2007, and each fiscal year thereafter, the Ad6 visory Committee shall— 

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

8 screening guidelines in the United States; 

9 ‘‘(2) submit such report to the appropriate com10 mittees of Congress, the Secretary, and the State de11 partments of health; and 

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

13 as practicable, including through posting on the 

14 internet clearinghouse established under section 

15 1112. 

16 ‘‘(f) CONTINUATION OF OPERATION OF COM17 MITTEE.—Notwithstanding section 14 of the Federal Ad18 visory Committee Act (5 U.S.C. App.), the Advisory Com19 mittee shall continue to operate during the 5-year period 

20 beginning on the date of enactment of the Newborn 

21 Screening Saves Lives Act of 2007. 

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

23 are authorized to be appropriated to carry out this sec24 tion— 

25 ‘‘(1) $1,000,000 for fiscal year 2008; and 


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1 ‘‘(2) such sums as may be necessary for each 

2 of the fiscal years 2009 through 2012.’’. 

3 SEC. 7. INFORMATION CLEARINGHOUSE. 

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

5 (42 U.S.C. 300b–1 et seq.) is amended by adding at the 

6 end the following: 

7 ‘‘SEC. 1112. CLEARINGHOUSE OF NEWBORN SCREENING IN8 FORMATION. 

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

10 the Administrator of the Health Resources and Services 

11 Administration (referred to in this part as the ‘Adminis12 trator’), in consultation with the Director of the Centers 

13 for Disease Control and Prevention and the Director of 

14 the National Institutes of Health, shall establish and 

15 maintain a central clearinghouse of current educational 

16 and family support and services information, materials, re17 sources, research, and data on newborn screening to— 

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

19 newborns, health professionals, industry representa20 tives, and other members of the public to increase 

21 their awareness, knowledge, and understanding of 

22 newborn screening; 

23 ‘‘(2) increase awareness, knowledge, and under24 standing of newborn diseases and screening services 


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1 for individuals wanting to have children and expect2 ant families; and 

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

4 quality indicators to measure performance of new5 born screening, such as false-positive rates and other 

6 quality indicators as determined by the Advisory 

7 Committee under section 1111. 

8 ‘‘(b) INTERNET AVAILABILITY.—The Secretary, act9 ing through the Administrator, shall ensure that the clear10 inghouse described under subsection (a)— 

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

12 ‘‘(2) includes an interactive forum; 

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

14 than quarterly; and 

15 ‘‘(4) provides— 

16 ‘‘(A) links to Government-sponsored, non17 profit, and other Internet websites of labora18 tories as determined appropriate by the Sec19 retary that have demonstrated expertise in new20 born screening that supply research-based infor21 mation on newborn screening tests currently 

22 available throughout the United States; 

23 ‘‘(B) information about newborn conditions 

24 and screening services available in each State 

25 from laboratories certified under subpart 2 of 


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1 part F of title III, including information about 

2 supplemental screening that is available but not 

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

4 ‘‘(C) current research on both treatable 

5 and not-yet treatable conditions for which new6 born screening tests are available; 

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

8 newborn and child screening for heritable dis9 orders including grants authorized under the 

10 Newborn Screening Saves Lives Act of 2007; 

11 and 

12 ‘‘(E) other relevant information as deter13 mined appropriate by the Secretary. 

14 ‘‘(c) NONDUPLICATION.—In developing the clearing15 house under this section, the Secretary shall ensure that 

16 such clearinghouse minimizes duplication and supple17 ments, not supplants, existing information sharing efforts. 

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

19 are authorized to be appropriated to carry out this sec20 tion— 

21 ‘‘(1) $2,500,000 for fiscal year 2008; and 

22 ‘‘(2) such sums as may be necessary for each 

23 of the fiscal years 2009 through 2012.’’. 


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1 SEC. 8. LABORATORY QUALITY AND SURVEILLANCE. 

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

3 (42 U.S.C. 300b–1 et seq.), as amended by section 7, is 

4 further amended by adding at the end the following: 

5 ‘‘SEC. 1113. LABORATORY QUALITY. 

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

7 the Director of the Centers for Disease Control and Pre8 vention and in consultation with the Advisory Committee 

9 on Heritable Disorders in Newborns and Children estab10 lished under section 1111, shall provide for— 

11 ‘‘(1) quality assurance for laboratories involved 

12 in screening newborns and children for heritable dis13 orders, including quality assurance for newborn14 screening tests, performance evaluation services, and 

15 technical assistance and technology transfer to new16 born screening laboratories to ensure analytic valid17 ity and utility of screening tests; and 

18 ‘‘(2) population-based pilot testing for new 

19 screening tools for evaluating use on a mass scale. 

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

21 purpose of carrying out this section, there are authorized 

22 to be appropriated $5,000,000 for fiscal year 2008 and 

23 such sums as may be necessary for each of the fiscal years 

24 2009 through 2012. 


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1 ‘‘SEC. 1114. SURVEILLANCE PROGRAMS FOR HERITABLE 

2 DISORDERS SCREENING. 

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

4 an Interagency Group consisting of the Director of the 

5 Agency for Healthcare Research and Quality, the Director 

6 of the Centers for Disease Control and Prevention, the Ad7 ministrator, and the Director of the National Institutes 

8 of Health, shall build upon existing activities and infra9 structure to carry out programs— 

10 ‘‘(1) to collect, analyze, and make available data 

11 on the heritable disorders recommended by the Advi12 sory Committee on Heritable Disorders in Newborns 

13 and Children established under section 1111, includ14 ing data on the incidence and prevalence of, as well 

15 as poor health outcomes resulting from, such dis16 orders; 

17 ‘‘(2) to operate regional centers for the conduct 

18 of applied epidemiological research on effective inter19 ventions for such disorders for the prevention of 

20 poor health outcomes; 

21 ‘‘(3) to provide information and education to 

22 the public on effective interventions for the preven23 tion of poor health outcomes resulting from such dis24 orders; and 

25 ‘‘(4) to conduct research on and to promote the 

26 prevention of poor health outcomes resulting from 


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1 such disorders, and secondary health conditions 

2 among individuals with such disorders. 

3 ‘‘(b) GRANTS AND CONTRACTS.— 

4 ‘‘(1) IN GENERAL.—In carrying out subsection 

5 (a), the Secretary may make grants to and enter 

6 into contracts with public and nonprofit private enti7 ties. 

8 ‘‘(2) SUPPLIES AND SERVICES IN LIEU OF

9 AWARD FUNDS.— 

10 ‘‘(A) IN GENERAL.—Upon the request of a 

11 recipient of an award of a grant or contract 

12 under paragraph (1), the Secretary may, sub13 ject to subparagraph (B), provide supplies, 

14 equipment, and services for the purpose of aid15 ing the recipient in carrying out the purposes 

16 for which the award is made and, for such pur17 poses, may detail to the recipient any officer or 

18 employee of the Department of Health and 

19 Human Services. 

20 ‘‘(B) REDUCTION.—With respect to a re21 quest described in subparagraph (A), the Sec22 retary shall reduce the amount of payments 

23 under the award involved by an amount equal 

24 to the costs of detailing personnel and the fair 

25 market value of any supplies, equipment, or 


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1 services provided by the Secretary. The Sec2 retary shall, for the payment of expenses in3 curred in complying with such request, expend 

4 the amounts withheld. 

5 ‘‘(3) APPLICATION FOR AWARD.—The Secretary 

6 may make an award of a grant or contract under 

7 paragraph (1) only if an application for the award 

8 is submitted to the Secretary and the application is 

9 in such form, is made in such manner, and contains 

10 such agreements, assurances, and information as the 

11 Secretary determines to be necessary to carry out 

12 the purposes for which the award is to be made. 

13 ‘‘(c) REPORTS TO CONGRESS.— 

14 ‘‘(1) IN GENERAL.—Subject to paragraph (2), 

15 the Secretary shall submit to the relevant commit16 tees of Congress reports— 

17 ‘‘(A) containing information under para18 graph (1) that is specific to various racial, eth19 nic, and socioeconomic groups; 

20 ‘‘(B) containing an assessment of the ex21 tent to which various approaches of preventing 

22 heritable disorders and secondary health condi23 tions among individuals with such disorders 

24 have been effective; 


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1 ‘‘(C) describing the activities carried out 

2 under this section; 

3 ‘‘(D) containing information on the inci4 dence and prevalence of individuals living with 

5 heritable disorders, information on the health 

6 status of individuals with such disorders includ7 ing the extent to which such disorders have con8 tributed to the incidence and prevalence of in9 fant mortality, information on any health dis10 parities experienced by such individuals, and 

11 recommendations for improving the health and 

12 wellness and quality of life of such individuals; 

13 ‘‘(E) containing a summary of rec14 ommendations from all heritable disorders re15 search conferences sponsored by the Centers for 

16 Disease Control and Prevention; and 

17 ‘‘(F) containing any recommendations of 

18 the Secretary regarding this section. 

19 ‘‘(2) TIMING OF REPORTS.—The Secretary shall 

20 submit— 

21 ‘‘(A) an interim report that includes the 

22 information described in paragraph (1), not 

23 later than 30 months after the date on which 

24 the first grant funds are awarded under this 

25 section; and 


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1 ‘‘(B) a subsequent report that includes the 

2 information described in paragraph 1, not later 

3 than 60 months after the date on which the 

4 first grant funds are awarded under this sec5 tion. 

6 ‘‘(d) APPLICABILITY OF PRIVACY LAWS.—The provi7 sions of this section shall be subject to the requirements 

8 of section 552a of title 5, United States Code. All Federal 

9 laws relating to the privacy of information shall apply to 

10 the data and information that is collected under this sec11 tion. 

12 ‘‘(e) COORDINATION.— 

13 ‘‘(1) IN GENERAL.—In carrying out this sec14 tion, the Secretary shall coordinate, to the extent 

15 practicable, programs under this section with pro16 grams on birth defects and developmental disabilities 

17 authorized under section 317C. 

18 ‘‘(2) PRIORITY IN GRANTS AND CONTRACTS.— 

19 In making grants and contracts under this section, 

20 the Secretary shall give priority to entities that dem21 onstrate the ability to coordinate activities under a 

22 grant or contract made under this section with exist23 ing birth defects surveillance activities. 

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

25 purpose of carrying out this section, there are authorized 


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1 to be appropriated $15,000,000 for fiscal year 2008 and 

2 such sums as may be necessary for each of the fiscal years 

3 2009 through 2012.’’. 

4 SEC. 9. GRANTS. 

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

6 (42 U.S.C. 300b–1 et seq.), as amended by section 8, is 

7 further amended by adding at the end the following: 

8 ‘‘SEC. 1115. GRANTS. 

9 ‘‘(a) AUTHORIZATION OF GRANT PROGRAM.— 

10 ‘‘(1) IN GENERAL.—From funds appropriated 

11 under subsection (h), the Secretary, acting through 

12 the Administrator and in consultation with the Advi13 sory Committee, shall award grants to eligible enti14 ties to— 

15 ‘‘(A) enable such entities to develop and 

16 deliver educational programs about newborn 

17 screening to parents, families, and patient advo18 cacy and support groups, such educational ma19 terials accompanying such educational pro20 grams to be provided at appropriate literacy 

21 levels; and 

22 ‘‘(B) enable such entities to establish, 

23 maintain, and operate a system to assess and 

24 coordinate treatment relating to congenital, ge25 netic, and metabolic disorders. 


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1 ‘‘(2) AWARENESS OF THE AVAILABILITY OF

2 PROGRAMS.—To the extent practicable, the Sec3 retary shall make relevant health care providers 

4 aware of the availability of the educational programs 

5 supported pursuant to paragraph (1). 

6 ‘‘(b) APPLICATION.—An eligible entity that desires to 

7 receive a grant under this section shall submit an applica8 tion to the Secretary at such time, in such manner, and 

9 accompanied by such information as the Secretary may 

10 require. 

11 ‘‘(c) SELECTION OF GRANT RECIPIENTS.— 

12 ‘‘(1) IN GENERAL.—Not later than 120 days 

13 after receiving an application under subsection (b), 

14 the Secretary, after considering the approval factors 

15 under paragraph (2), shall determine whether to 

16 award the eligible entity a grant under this section. 

17 ‘‘(2) APPROVAL FACTORS.— 

18 ‘‘(A) REQUIREMENTS.—An application 

19 submitted under subsection (b) may not be ap20 proved by the Secretary unless the application 

21 contains assurances that the eligible entity— 

22 ‘‘(i) will use grant funds only for the 

23 purposes specified in the approved applica24 tion and in accordance with the require25 ments of this section; and 


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1 ‘‘(ii) will establish such fiscal control 

2 and fund accounting procedures as may be 

3 necessary to assure proper disbursement 

4 and accounting of Federal funds paid to 

5 the eligible entity under the grant. 

6 ‘‘(B) EXISTING PROGRAMS.—Prior to 

7 awarding a grant under this section, the Sec8 retary shall— 

9 ‘‘(i) conduct an assessment of existing 

10 educational resources and training pro11 grams and coordinated systems of followup 

12 care with respect to newborn screening; 

13 and 

14 ‘‘(ii) take all necessary steps to mini15 mize the duplication of the resources and 

16 programs described in clause (i) and en17 sure that funding under this section will 

18 supplement, not supplant, existing funding 

19 for such activities. 

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. 

24 ‘‘(e) USE OF GRANT FUNDS.— 


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1 ‘‘(1) IN GENERAL.—An eligible entity that re2 ceives a grant under this section may use the grant 

3 funds— 

4 ‘‘(A) for purposes of grants under sub5 section (a)(1)(A), to develop and deliver to par6 ents, families, and patient advocacy and sup7 port groups, educational programs about new8 born screening that include information on— 

9 ‘‘(i) what newborn screening is and 

10 how it is performed; 

11 ‘‘(ii) who performs newborn screening; 

12 ‘‘(iii) where newborn screening is per13 formed; 

14 ‘‘(iv) the disorders for which the State 

15 requires newborns to be screened; 

16 ‘‘(v) different options for newborn 

17 screening for disorders other than those in18 cluded by the State in the mandated new19 born screening program; 

20 ‘‘(vi) the meaning of various screening 

21 results, including the possibility of false 

22 positive and false negative findings; 

23 ‘‘(vii) the prevalence and risk of new24 born disorders, including the increased risk 


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1 of disorders that may stem from family 

2 history; 

3 ‘‘(viii) coordinated systems of followup 

4 care after newborns are screened; and 

5 ‘‘(ix) other items to carry out the pur6 pose described in subsection (a)(1) as de7 termined appropriate by the Secretary; and 

8 ‘‘(B) for purposes of grants under sub9 section (a)(1)(B), to— 

10 ‘‘(i) expand on existing procedures 

11 and systems, where appropriate and avail12 able, for the timely reporting of newborn 

13 screening results to individuals, families, 

14 primary care physicians, and appropriate 

15 subspecialists such as in congenital, ge16 netic, and metabolic disorders; 

17 ‘‘(ii) coordinate ongoing followup 

18 treatment with individuals, families, pri19 mary care physicians, and appropriate sub20 specialists such as in congenital, genetic, 

21 and metabolic disorders after a newborn 

22 receives an indication of the presence or in23 creased risk of a disorder on a screening 

24 test; 


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1 ‘‘(iii) ensure the seamless integration 

2 of confirmatory testing, tertiary care med3 ical services, comprehensive genetic serv4 ices including genetic counseling, and in5 formation about Food and Drug Adminis6 tration-approved treatments as well as ac7 cess to developing therapies by participa8 tion in approved clinical trials involving the 

9 primary health care of the infant; 

10 ‘‘(iv) analyze data, if appropriate and 

11 available, collected from newborn 

12 screenings to identify populations at risk 

13 for disorders affecting newborns, examine 

14 and respond to health concerns, recognize 

15 and address relevant environmental, behav16 ioral, socioeconomic, demographic, and 

17 other relevant risk factors; 

18 ‘‘(v) collect, analyze and report data 

19 on the costs, benefits and effectiveness of 

20 such tests; and 

21 ‘‘(vi) carry out such other activities as 

22 the Secretary may determine necessary. 

23 ‘‘(f) REPORTS TO CONGRESS.— 


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1 ‘‘(1) IN GENERAL.—Subject to paragraph (2), 

2 the Secretary shall submit to the relevant commit3 tees of Congress reports— 

4 ‘‘(A) evaluating the effectiveness and the 

5 impact of the grants awarded under this sec6 tion— 

7 ‘‘(i) in promoting newborn screen8 ing— 

9 ‘‘(I) education and resources for 

10 families; and 

11 ‘‘(II) education, resources, and 

12 training for health care professionals; 

13 ‘‘(ii) on the successful diagnosis and 

14 treatment of congenital, genetic, and meta15 bolic disorders; and 

16 ‘‘(iii) on the continued development of 

17 coordinated systems of followup care after 

18 newborns are screened; 

19 ‘‘(B) describing and evaluating the effec20 tiveness of the activities carried out with grant 

21 funds received under this section; and 

22 ‘‘(C) that include recommendations for 

23 Federal, State, and local actions to support— 

24 ‘‘(i) education and training in new25 born screening; and 


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1 ‘‘(ii) followup care after newborns are 

2 screened. 

3 ‘‘(2) TIMING OF REPORTS.—The Secretary shall 

4 submit— 

5 ‘‘(A) an interim report that includes the 

6 information described in paragraph (1), not 

7 later than 30 months after the date on which 

8 the first grant funds are awarded under this 

9 section; and 

10 ‘‘(i) a subsequent report that includes 

11 the information described in paragraph 

12 (1), not later than 60 months after the 

13 date on which the first grant funds are 

14 awarded under this section. 

15 ‘‘(g) ELIGIBLE ENTITY.—In this section, the term 

16 ‘eligible entity’ means— 

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

18 State; 

19 ‘‘(2) a consortium of 2 or more States or polit20 ical subdivisions of States; 

21 ‘‘(3) a territory; 

22 ‘‘(4) an Indian tribe or a hospital or outpatient 

23 health care facility of the Indian Health Service; or 

24 ‘‘(5) other entities with appropriate expertise in 

25 newborn screening, as determined by the Secretary. 


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

2 is authorized to be appropriated to carry out this section— 

3 ‘‘(1) $10,000,000 for fiscal year 2008; and 

4 ‘‘(2) such sums as may be necessary for each 

5 of fiscal years 2009 through 2012.’’. 

6 SEC. 10. CONTINGENCY PLANNING. 

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

8 (42 U.S.C. 300b–1 et seq.), as amended by section 9, is 

9 further amended by adding at the end the following: 

10 ‘‘SEC. 1116. NATIONAL CONTINGENCY PLAN FOR NEWBORN 

11 SCREENING. 

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

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

14 through the Director of the Centers for Disease Control 

15 and Prevention and in consultation with the Administrator 

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

17 shall develop a national contingency plan for newborn 

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

19 in the event of a public health emergency. 

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

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

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

23 ‘‘(2) the shipment of specimens to State new24 born screening laboratories; 

25 ‘‘(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. 1117. HUNTER KELLY RESEARCH PROGRAM. 

12 ‘‘(a) ADDITIONAL NEWBORN SCREENING TESTS

13 GRANTS.— 

14 ‘‘(1) IN GENERAL.—The Secretary, in conjunc15 tion with the Director of the National Institutes of 

16 Health and taking into consideration the rec17 ommendations of the Advisory Committee, shall es18 tablish a research program (to be known as ‘Hunter 

19 Kelly Newborn Screening Research Program’) by ex20 panding, carrying out, and coordinating research 

21 in— 

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

23 the most promising new screening technologies, 

24 in order to improve already existing screening 

25 tests, which may include tests for Krabbe DisVerDate Aug 31 2005 00:09 Aug 01, 2007 Jkt 059200 PO 00000 Frm 00035 Fmt 6652 Sfmt 6201 E:\BILLS\S1858.IS S1858

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1 ease and Insulin Dependent Diabetes Mellitus, 

2 and Turner Syndrome, increase the specificity 

3 of newborn screening, and expand the number 

4 of conditions for which screening tests are 

5 available; 

6 ‘‘(B) experimental treatments and disease 

7 management strategies for additional newborn 

8 conditions, and other genetic, metabolic, hor9 monal and/or functional conditions that can be 

10 detected through newborn screening for which 

11 treatment is not yet available; and 

12 ‘‘(C) other activities that would improve 

13 newborn screening, as identified by the Direc14 tor. 

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

16 purposes of this subsection, the term ‘additional 

17 newborn condition’ means any condition that is not 

18 one of the core conditions designated by the Advi19 sory Committee. 

20 ‘‘(b) FUNDING.—In carrying out the research pro21 gram under this section, the Secretary and the Director 

22 shall ensure that entities receiving funding through the 

23 program will provide assurances, as practicable, that such 

24 entities will work in consultation with the appropriate 

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


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1 their research on screening technology not currently per2 formed in the States in which the entities are located, and 

3 the conditions on the uniform screening panel (or the 

4 standard test existing on the uniform screening panel). 

5 ‘‘(c) MONITORING AND RESULTS.—The Director 

6 shall— 

7 ‘‘(1) monitor and report on the activities result8 ing from any funding distributed under this section; 

9 and 

10 ‘‘(2) on an annual basis— 

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

12 such monitoring on as wide a basis as is prac13 ticable, which may include incorporation of 

14 these results in other newborn screening reports 

15 and posting on the Internet Clearinghouse es16 tablished under section 1112; 

17 ‘‘(B) submit to the relevant committees of 

18 Congress the results of such evaluation, which 

19 may include incorporation of such results in 

20 other newborn screening reports being sub21 mitted to Congress. 

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

23 under this section, the Secretary shall minimize duplica24 tion and supplement, not supplant, existing efforts of the 

25 type carried out under this section. 


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

2 construed to interfere with the scientific peer-review proc3 ess at the National Institutes of Health. 

4 ‘‘(f) AUTHORIZATION OF APPROPRIATIONS.—There 

5 are authorized to be appropriated to carry out this sec6 tion— 

7 ‘‘(1) $7,000,000 for fiscal year 2008; and 

8 ‘‘(2) such sums as may be necessary for fiscal 

9 years 2009 through 2012.’’. 

Æ 


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