II 

Calendar No. 522 

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, Mr. KENNEDY, Mr. 

BOND, Mrs. MURRAY, Ms. COLLINS, Mr. INOUYE, Ms. CANTWELL, Mr. 

SANDERS, Mr. JOHNSON, Mr. WHITEHOUSE, Mr. BROWN, Mr. DURBIN, 

Mr. LUGAR, Mr. CARDIN, Mrs. LINCOLN, Mr. CASEY, Mr. HARKIN, Ms. 

MIKULSKI, and Mr. COLEMAN) introduced the following bill; which was 

read twice and referred to the Committee on Health, Education, Labor, 

and Pensions 

DECEMBER 5, 2007 

Reported by Mr. KENNEDY, with an amendment 

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

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. 


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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. FINDINGS. 

7 Congress finds the following: 

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

9 in the United States are screened by State and pri10 vate laboratories to detect some conditions that may 

11 threaten their long-term health. 

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

13 the number of conditions for which newborns are 

14 screened throughout the United States. While a new15 born may be screened and treated for a debilitating 

16 condition in one State, in another State, the condi17 tion may go undetected and result in permanent dis18 ability or even death. 

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

20 are diagnosed with these detectable and treatable 

21 disorders. If diagnosed early, these conditions can be 

22 successfully managed or treated to prevent severe 

23 and often lifelong health consequences. 

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

25 Genetics (ACMG) completed a report commissioned 


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1 by the Department of Health and Human Services 

2 which recommended that every baby born in the 

3 United States be screened for 29 specific disorders, 

4 including certain metabolic conditions and hearing 

5 deficiencies. 

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

7 Columbia require infants to be screened for all 29 of 

8 these recommended disorders. 

9 (6) Continuity, especially during a public health 

10 emergency, plays a critical role in the screening, di11 agnosis, referral, and treatment of these disorders. 

12 Currently there is no national contingency plan for 

13 maintaining continuity of newborn screening systems 

14 following a public health emergency. 

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

16 SERVICE ACT. 

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

18 (42 U.S.C. 280h et seq.) is amended by adding at the end 

19 the following: 

20 ‘‘SEC. 399Z–1. NEWBORN SCREENING. 

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

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

23 acting through the Administrator of the Health Resources 

24 and Services Administration (referred to in this section 

25 as the ‘Administrator’) and in consultation with the AdviVerDate Aug 31 2005 02:27 Dec 06, 2007 Jkt 069200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6401 E:\BILLS\S1858.RS S1858

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1 sory Committee on Heritable Disorders in Newborns and 

2 Children (referred to in this section as the ‘Advisory Com3 mittee’), shall award grants to eligible entities to enable 

4 such entities to assist in providing health care profes5 sionals and newborn screening laboratory personnel 

6 with— 

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

8 ‘‘(2) training in— 

9 ‘‘(A) relevant and new technologies in new10 born screening; and 

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

12 disorders. 

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

14 receive a grant under this section shall submit an applica15 tion to the Secretary at such time, in such manner, and 

16 accompanied by such information as the Secretary may 

17 require. 

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

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

20 after receiving an application under subsection (b), 

21 the Secretary, after considering the approval factors 

22 under paragraph (2), shall determine whether to 

23 award the eligible entity a grant under this section. 

24 ‘‘(2) APPROVAL FACTORS.— 


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

2 application submitted under subsection (b) may 

3 not be approved by the Secretary unless the ap4 plication contains assurances that the eligible 

5 entity— 

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

7 purposes specified in the approved applica8 tion and in accordance with the require9 ments of this section; and 

10 ‘‘(ii) will establish such fiscal control 

11 and fund accounting procedures as may be 

12 necessary to assure proper disbursement 

13 and accounting of Federal funds paid to 

14 the eligible entity under the grant. 

15 ‘‘(B) EXISTING PROGRAMS.—Prior to 

16 awarding a grant under this section, the Sec17 retary shall— 

18 ‘‘(i) conduct an assessment of existing 

19 educational resources and training pro20 grams with respect to newborn screening; 

21 and 

22 ‘‘(ii) take all necessary steps to mini23 mize the duplication of the resources and 

24 programs described in clause (i) and en25 sure that funding under this section will 


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1 supplement, not supplant, existing funding 

2 for such activities. 

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

4 necessary steps to coordinate programs funded with 

5 grants received under this section and to coordinate with 

6 existing newborn screening activities. 

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

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

9 funds to work with appropriate medical schools, nursing 

10 schools, schools of public health, schools of genetic coun11 seling, internal education programs in State agencies, non12 governmental organizations, and professional organiza13 tions and societies to develop and deliver education and 

14 training programs that include— 

15 ‘‘(1) continuing medical education programs for 

16 health care professionals and newborn screening lab17 oratory personnel in newborn screening; 

18 ‘‘(2) education, technical assistance, and train19 ing on new discoveries in newborn screening and the 

20 use of any related technology; 

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

22 assess and communicate the risks of, congenital con23 ditions, including the prevalence and risk of some of 

24 these conditions based on family history; 


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1 ‘‘(4) models to communicate effectively with 

2 parents and families about— 

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

4 screening and the meaning of screening results, 

5 including the possibility of false positive find6 ings; 

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

8 newborn screening; 

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

10 screening, if applicable; and 

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

12 after newborns are screened; 

13 ‘‘(5) information and resources on coordinated 

14 systems of followup care after newborns are 

15 screened; 

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

17 States require and offer newborn screening and op18 tions for newborn screening relating to conditions in 

19 addition to such disorders; 

20 ‘‘(7) information on additional newborn screen21 ing that may not be required by the State, but that 

22 may be available from other sources; and 

23 ‘‘(8) other items to carry out the purpose de24 scribed in subsection (a)(1) as determined appro25 priate by the Secretary. 


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1 ‘‘(f) REPORTS TO CONGRESS.— 

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

3 the Secretary shall submit to the relevant commit4 tees of Congress reports— 

5 ‘‘(A) evaluating the effectiveness and the 

6 impact of the grants awarded under this sec7 tion— 

8 ‘‘(i) in promoting newborn screening 

9 education, resources, and training for 

10 health care professionals; 

11 ‘‘(ii) on the successful diagnosis and 

12 treatment of congenital, genetic, and meta13 bolic disorders; and 

14 ‘‘(iii) on the continued development of 

15 coordinated systems of followup care after 

16 newborns are screened; 

17 ‘‘(B) describing and evaluating the effec18 tiveness of the activities carried out with grant 

19 funds received under this section; and 

20 ‘‘(C) that include recommendations for 

21 Federal, State, and local actions to support— 

22 ‘‘(i) education and training in new23 born screening; and 

24 ‘‘(ii) followup care after newborns are 

25 screened. 


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

2 submit— 

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

4 information described in paragraph (1), not 

5 later than 30 months after the date on which 

6 the first grant funds are awarded under this 

7 section; and 

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

9 information described in paragraph (1), not 

10 later than 60 months after the date on which 

11 the first grant funds are awarded under this 

12 section. 

13 ‘‘(g) DEFINITION OF ELIGIBLE ENTITY.—In this sec14 tion, the term ‘eligible entity’ means— 

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

16 State; 

17 ‘‘(2) a consortium of 2 or more States or polit18 ical subdivisions of States; 

19 ‘‘(3) a territory; 

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

21 health care facility of the Indian Health Service; or 

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

23 newborn screening, as determined by the Secretary. 


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

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

4 ‘‘(1) $5,000,000 for fiscal year 2008; and 

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

6 of fiscal years 2009 through 2012.’’. 

7 SEC. 4. IMPROVED NEWBORN AND CHILD SCREENING FOR 

8 HERITABLE DISORDERS. 

9 Section 1109 of the Public Health Service Act (42 

10 U.S.C. 300b–8) is amended— 

11 (1) in subsection (c)(2)— 

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

13 ‘‘and’’ after the semicolon; 

14 (B) by redesignating subparagraph (F) as 

15 subparagraph (G); and 

16 (C) by inserting after subparagraph (E) 

17 the following: 

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

19 adopted and implemented, is in the process of 

20 adopting and implementing, or will use grant 

21 amounts received under this section to adopt 

22 and implement the guidelines and recommenda23 tions of the Advisory Committee on Heritable 

24 Disorders in Newborns and Children established 

25 under section 1111 (referred to in this section 


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1 as the ‘Advisory Committee’) that are adopted 

2 by the Secretary and in effect at the time the 

3 grant is awarded or renewed under this section, 

4 which shall include the screening of each new5 born for the heritable disorders recommended 

6 by the Advisory Committee and adopted by the 

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

8 and 

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

10 and all that follows through the period at the end 

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

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

13 years 2009 through 2012.’’. 

14 SEC. 5. EVALUATING THE EFFECTIVENESS OF NEWBORN15 AND CHILD-SCREENING PROGRAMS. 

16 Section 1110 of the Public Health Service Act (42 

17 U.S.C. 300b–9) is amended by adding at the end the fol18 lowing: 

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

20 are authorized to be appropriated to carry out this section 

21 $5,000,000 for fiscal year 2008 and such sums as may 

22 be necessary for each of the fiscal years 2009 through 

23 2012.’’. 


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1 SEC. 6. 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) in paragraph (1), by inserting ‘‘and 

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

8 the semicolon; 

9 (B) by redesignating paragraph (3) as 

10 paragraph (6); 

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

12 after the semicolon; 

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

14 following: 

15 ‘‘(3) make systematic evidence-based and peer16 reviewed recommendations that include the heritable 

17 disorders for which all newborns should be screened, 

18 including secondary conditions that may be identi19 fied as a result of the laboratory methods used for 

20 screening; 

21 ‘‘(4) develop a model decision-matrix for new22 born screening program expansion, and periodically 

23 update the recommended uniform screening panel, 

24 as appropriate, based on such decision-matrix; 

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

26 the capacity to screen for the conditions described in 


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

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

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

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

5 the end and inserting ‘‘, which may include rec6 ommendations, advice, or information dealing 

7 with— 

8 ‘‘(A) followup activities, including those 

9 necessary to achieve rapid diagnosis in the 

10 short term, and those that ascertain long-term 

11 case management outcomes and appropriate ac12 cess to related services; 

13 ‘‘(B) implementation, monitoring, and 

14 evaluation of newborn screening activities, in15 cluding diagnosis, screening, follow-up, and 

16 treatment activities; 

17 ‘‘(C) diagnostic and other technology used 

18 in screening; 

19 ‘‘(D) the availability and reporting of test20 ing for conditions for which there is no existing 

21 treatment; 

22 ‘‘(E) conditions not included in the rec23 ommended uniform screening panel that are 

24 treatable with Food and Drug Administration25 approved products; 


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1 ‘‘(F) minimum standards and related poli2 cies and procedures used by State newborn 

3 screening programs, such as language and ter4 minology used by State newborn screening pro5 grams to include standardization of case defini6 tions and names of disorders for which newborn 

7 screening tests are performed; 

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

9 evaluation of State newborn screening pro10 grams, including ensuring that tests and tech11 nologies used by each State meet established 

12 standards for detecting and reporting positive 

13 screening results; 

14 ‘‘(H) public and provider awareness and 

15 education; 

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

17 screening and medical evaluation systems and 

18 intervention programs conducted by State-based 

19 programs; 

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

21 risk factors for heritable disorders; and 

22 ‘‘(K) coordination of surveillance activities, 

23 including standardized data collection and re24 porting, harmonization of laboratory definitions 

25 for heritable disorders and testing results, and 


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1 confirmatory testing and verification of positive 

2 results, in order to assess and enhance moni3 toring of newborn diseases.’’; and 

4 (2) in subsection (c)(2)— 

5 (A) by redesignating subparagraphs (E), 

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

7 (I); 

8 (B) by inserting after subparagraph (D) 

9 the following: 

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

11 Drug Administration;’’; and 

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

13 as so redesignated, the following: 

14 ‘‘(G) individuals with expertise in ethics 

15 who have worked and published material in the 

16 area of newborn screening;’’; and 

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

18 ‘‘(d) DECISION ON RECOMMENDATIONS.— 

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

20 after the Advisory Committee issues a recommenda21 tion pursuant to this section, the Secretary shall 

22 adopt or reject such recommendation. 

23 ‘‘(2) PENDING RECOMMENDATIONS.—The Sec24 retary shall adopt or reject any recommendation 

25 issued by the Advisory Committee that is pending on 


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1 the date of enactment of the Newborn Screening 

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

3 after the date of enactment of such Act. 

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

5 The Secretary shall publicize any determination on 

6 adopting or rejecting a recommendation of the Advi7 sory Committee pursuant to this subsection, includ8 ing the justification for the determination. 

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

10 the date of enactment of the Newborn Screening Saves 

11 Lives Act of 2007, and each fiscal year thereafter, the Ad12 visory Committee shall— 

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

14 screening guidelines in the United States; 

15 ‘‘(2) submit such report to the appropriate com16 mittees of Congress, the Secretary, and the State de17 partments of health; and 

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

19 as practicable, including through posting on the 

20 internet clearinghouse established under section 

21 1112. 

22 ‘‘(f) CONTINUATION OF OPERATION OF COM23 MITTEE.—Notwithstanding section 14 of the Federal Ad24 visory Committee Act (5 U.S.C. App.), the Advisory Com25 mittee shall continue to operate during the 5-year period 


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1 beginning on the date of enactment of the Newborn 

2 Screening Saves Lives Act of 2007. 

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

4 are authorized to be appropriated to carry out this sec5 tion— 

6 ‘‘(1) $1,000,000 for fiscal year 2008; and 

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

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

9 SEC. 7. INFORMATION CLEARINGHOUSE. 

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

11 (42 U.S.C. 300b–1 et seq.) is amended by adding at the 

12 end the following: 

13 ‘‘SEC. 1112. CLEARINGHOUSE OF NEWBORN SCREENING IN14 FORMATION. 

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

16 the Administrator of the Health Resources and Services 

17 Administration (referred to in this part as the ‘Adminis18 trator’), in consultation with the Director of the Centers 

19 for Disease Control and Prevention and the Director of 

20 the National Institutes of Health, shall establish and 

21 maintain a central clearinghouse of current educational 

22 and family support and services information, materials, re23 sources, research, and data on newborn screening to— 

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

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1 tives, and other members of the public to increase 

2 their awareness, knowledge, and understanding of 

3 newborn screening; 

4 ‘‘(2) increase awareness, knowledge, and under5 standing of newborn diseases and screening services 

6 for individuals wanting to have children and expect7 ant families; and 

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

9 quality indicators to measure performance of new10 born screening, such as false-positive rates and other 

11 quality indicators as determined by the Advisory 

12 Committee under section 1111. 

13 ‘‘(b) INTERNET AVAILABILITY.—The Secretary, act14 ing through the Administrator, shall ensure that the clear15 inghouse described under subsection (a)— 

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

17 ‘‘(2) includes an interactive forum; 

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

19 than quarterly; and 

20 ‘‘(4) provides— 

21 ‘‘(A) links to Government-sponsored, non22 profit, and other Internet websites of labora23 tories as determined appropriate by the Sec24 retary that have demonstrated expertise in new25 born screening that supply research-based inforVerDate Aug 31 2005 02:27 Dec 06, 2007 Jkt 069200 PO 00000 Frm 00018 Fmt 6652 Sfmt 6401 E:\BILLS\S1858.RS S1858

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1 mation on newborn screening tests currently 

2 available throughout the United States; 

3 ‘‘(B) information about newborn conditions 

4 and screening services available in each State 

5 from laboratories certified under subpart 2 of 

6 part F of title III, including information about 

7 supplemental screening that is available but not 

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

9 ‘‘(C) current research on both treatable 

10 and not-yet treatable conditions for which new11 born screening tests are available; 

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

13 newborn and child screening for heritable dis14 orders including grants authorized under the 

15 Newborn Screening Saves Lives Act of 2007; 

16 and 

17 ‘‘(E) other relevant information as deter18 mined appropriate by the Secretary. 

19 ‘‘(c) NONDUPLICATION.—In developing the clearing20 house under this section, the Secretary shall ensure that 

21 such clearinghouse minimizes duplication and supple22 ments, not supplants, existing information sharing efforts. 

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

24 are authorized to be appropriated to carry out this sec25 tion— 


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

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

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

4 SEC. 8. LABORATORY QUALITY AND SURVEILLANCE. 

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 7, is 

7 further amended by adding at the end the following: 

8 ‘‘SEC. 1113. LABORATORY QUALITY. 

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

10 the Director of the Centers for Disease Control and Pre11 vention and in consultation with the Advisory Committee 

12 on Heritable Disorders in Newborns and Children estab13 lished under section 1111, shall provide for— 

14 ‘‘(1) quality assurance for laboratories involved 

15 in screening newborns and children for heritable dis16 orders, including quality assurance for newborn17 screening tests, performance evaluation services, and 

18 technical assistance and technology transfer to new19 born screening laboratories to ensure analytic valid20 ity and utility of screening tests; and 

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

22 screening tools for evaluating use on a mass scale. 

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

24 purpose of carrying out this section, there are authorized 

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


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

2 2009 through 2012. 

3 ‘‘SEC. 1114. SURVEILLANCE PROGRAMS FOR HERITABLE 

4 DISORDERS SCREENING. 

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

6 an Interagency Group consisting of the Director of the 

7 Agency for Healthcare Research and Quality, the Director 

8 of the Centers for Disease Control and Prevention, the Ad9 ministrator, and the Director of the National Institutes 

10 of Health, shall build upon existing activities and infra11 structure to carry out programs— 

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

13 on the heritable disorders recommended by the Advi14 sory Committee on Heritable Disorders in Newborns 

15 and Children established under section 1111, includ16 ing data on the incidence and prevalence of, as well 

17 as poor health outcomes resulting from, such dis18 orders; 

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

20 of applied epidemiological research on effective inter21 ventions for such disorders for the prevention of 

22 poor health outcomes; 

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

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1 tion of poor health outcomes resulting from such dis2 orders; and 

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

4 prevention of poor health outcomes resulting from 

5 such disorders, and secondary health conditions 

6 among individuals with such disorders. 

7 ‘‘(b) GRANTS AND CONTRACTS.— 

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

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

10 into contracts with public and nonprofit private enti11 ties. 

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

13 AWARD FUNDS.— 

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

15 recipient of an award of a grant or contract 

16 under paragraph (1), the Secretary may, sub17 ject to subparagraph (B), provide supplies, 

18 equipment, and services for the purpose of aid19 ing the recipient in carrying out the purposes 

20 for which the award is made and, for such pur21 poses, may detail to the recipient any officer or 

22 employee of the Department of Health and 

23 Human Services. 

24 ‘‘(B) REDUCTION.—With respect to a re25 quest described in subparagraph (A), the SecVerDate Aug 31 2005 02:27 Dec 06, 2007 Jkt 069200 PO 00000 Frm 00022 Fmt 6652 Sfmt 6401 E:\BILLS\S1858.RS S1858

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1 retary shall reduce the amount of payments 

2 under the award involved by an amount equal 

3 to the costs of detailing personnel and the fair 

4 market value of any supplies, equipment, or 

5 services provided by the Secretary. The Sec6 retary shall, for the payment of expenses in7 curred in complying with such request, expend 

8 the amounts withheld. 

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

10 may make an award of a grant or contract under 

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

12 is submitted to the Secretary and the application is 

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

14 such agreements, assurances, and information as the 

15 Secretary determines to be necessary to carry out 

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

17 ‘‘(c) REPORTS TO CONGRESS.— 

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

19 the Secretary shall submit to the relevant commit20 tees of Congress reports— 

21 ‘‘(A) containing information under para22 graph (1) that is specific to various racial, eth23 nic, and socioeconomic groups; 

24 ‘‘(B) containing an assessment of the ex25 tent to which various approaches of preventing 


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1 heritable disorders and secondary health condi2 tions among individuals with such disorders 

3 have been effective; 

4 ‘‘(C) describing the activities carried out 

5 under this section; 

6 ‘‘(D) containing information on the inci7 dence and prevalence of individuals living with 

8 heritable disorders, information on the health 

9 status of individuals with such disorders includ10 ing the extent to which such disorders have con11 tributed to the incidence and prevalence of in12 fant mortality, information on any health dis13 parities experienced by such individuals, and 

14 recommendations for improving the health and 

15 wellness and quality of life of such individuals; 

16 ‘‘(E) containing a summary of rec17 ommendations from all heritable disorders re18 search conferences sponsored by the Centers for 

19 Disease Control and Prevention; and 

20 ‘‘(F) containing any recommendations of 

21 the Secretary regarding this section. 

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 later 

6 than 60 months after the date on which the 

7 first grant funds are awarded under this sec8 tion. 

9 ‘‘(d) APPLICABILITY OF PRIVACY LAWS.—The provi10 sions of this section shall be subject to the requirements 

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

12 laws relating to the privacy of information shall apply to 

13 the data and information that is collected under this sec14 tion. 

15 ‘‘(e) COORDINATION.— 

16 ‘‘(1) IN GENERAL.—In carrying out this sec17 tion, the Secretary shall coordinate, to the extent 

18 practicable, programs under this section with pro19 grams on birth defects and developmental disabilities 

20 authorized under section 317C. 

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

22 In making grants and contracts under this section, 

23 the Secretary shall give priority to entities that dem24 onstrate the ability to coordinate activities under a 


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1 grant or contract made under this section with exist2 ing birth defects surveillance activities. 

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

4 purpose of carrying out this section, there are authorized 

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

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

7 2009 through 2012.’’. 

8 SEC. 9. GRANTS. 

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 8, is 

11 further amended by adding at the end the following: 

12 ‘‘SEC. 1115. GRANTS. 

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

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

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

16 the Administrator and in consultation with the Advi17 sory Committee, shall award grants to eligible enti18 ties to— 

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

20 deliver educational programs about newborn 

21 screening to parents, families, and patient advo22 cacy and support groups, such educational ma23 terials accompanying such educational pro24 grams to be provided at appropriate literacy 

25 levels; and 


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

2 maintain, and operate a system to assess and 

3 coordinate treatment relating to congenital, ge4 netic, and metabolic disorders. 

5 ‘‘(2) AWARENESS OF THE AVAILABILITY OF

6 PROGRAMS.—To the extent practicable, the Sec7 retary shall make relevant health care providers 

8 aware of the availability of the educational programs 

9 supported pursuant to paragraph (1). 

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

11 receive a grant under this section shall submit an applica12 tion to the Secretary at such time, in such manner, and 

13 accompanied by such information as the Secretary may 

14 require. 

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

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

17 after receiving an application under subsection (b), 

18 the Secretary, after considering the approval factors 

19 under paragraph (2), shall determine whether to 

20 award the eligible entity a grant under this section. 

21 ‘‘(2) APPROVAL FACTORS.— 

22 ‘‘(A) REQUIREMENTS.—An application 

23 submitted under subsection (b) may not be ap24 proved by the Secretary unless the application 

25 contains assurances that the eligible 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 and coordinated systems of followup 

16 care with respect to newborn screening; 

17 and 

18 ‘‘(ii) take all necessary steps to mini19 mize the duplication of the resources and 

20 programs described in clause (i) and en21 sure that funding under this section will 

22 supplement, not supplant, existing funding 

23 for such activities. 

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

25 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.— 

4 ‘‘(1) IN GENERAL.—An eligible entity that re5 ceives a grant under this section may use the grant 

6 funds— 

7 ‘‘(A) for purposes of grants under sub8 section (a)(1)(A), to develop and deliver to par9 ents, families, and patient advocacy and sup10 port groups, educational programs about new11 born screening that include information on— 

12 ‘‘(i) what newborn screening is and 

13 how it is performed; 

14 ‘‘(ii) who performs newborn screening; 

15 ‘‘(iii) where newborn screening is per16 formed; 

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

18 requires newborns to be screened; 

19 ‘‘(v) different options for newborn 

20 screening for disorders other than those in21 cluded by the State in the mandated new22 born screening program; 

23 ‘‘(vi) the meaning of various screening 

24 results, including the possibility of false 

25 positive and false negative findings; 


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1 ‘‘(vii) the prevalence and risk of new2 born disorders, including the increased risk 

3 of disorders that may stem from family 

4 history; 

5 ‘‘(viii) coordinated systems of followup 

6 care after newborns are screened; and 

7 ‘‘(ix) other items to carry out the pur8 pose described in subsection (a)(1) as de9 termined appropriate by the Secretary; and 

10 ‘‘(B) for purposes of grants under sub11 section (a)(1)(B), to— 

12 ‘‘(i) expand on existing procedures 

13 and systems, where appropriate and avail14 able, for the timely reporting of newborn 

15 screening results to individuals, families, 

16 primary care physicians, and appropriate 

17 subspecialists such as in congenital, ge18 netic, and metabolic disorders; 

19 ‘‘(ii) coordinate ongoing followup 

20 treatment with individuals, families, pri21 mary care physicians, and appropriate sub22 specialists such as in congenital, genetic, 

23 and metabolic disorders after a newborn 

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1 creased risk of a disorder on a screening 

2 test; 

3 ‘‘(iii) ensure the seamless integration 

4 of confirmatory testing, tertiary care med5 ical services, comprehensive genetic serv6 ices including genetic counseling, and in7 formation about Food and Drug Adminis8 tration-approved treatments as well as ac9 cess to developing therapies by participa10 tion in approved clinical trials involving the 

11 primary health care of the infant; 

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

13 available, collected from newborn 

14 screenings to identify populations at risk 

15 for disorders affecting newborns, examine 

16 and respond to health concerns, recognize 

17 and address relevant environmental, behav18 ioral, socioeconomic, demographic, and 

19 other relevant risk factors; 

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

21 on the costs, benefits and effectiveness of 

22 such tests; and 

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

24 the Secretary may determine necessary. 

25 ‘‘(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 02:27 Dec 06, 2007 Jkt 069200 PO 00000 Frm 00035 Fmt 6652 Sfmt 6401 E:\BILLS\S1858.RS 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.’’. 

10 SECTION 1. SHORT TITLE. 

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

12 Saves Lives Act of 2007’’. 

13 SEC. 2. IMPROVED NEWBORN AND CHILD SCREENING FOR 

14 HERITABLE DISORDER. 

15 Section 1109 of the Public Health Service Act (42 

16 U.S.C. 300b–8) is amended— 

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

18 inserting the following: 

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

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

21 acting through the Administrator of the Health Resources 

22 and Services Administration (referred to in this section as 

23 the ‘Administrator’) and in consultation with the Advisory 

24 Committee on Heritable Disorders in Newborns and Chil25 dren (referred to in this section as the ‘Advisory ComVerDate Aug 31 2005 02:27 Dec 06, 2007 Jkt 069200 PO 00000 Frm 00038 Fmt 6652 Sfmt 6203 E:\BILLS\S1858.RS S1858

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1 mittee’), shall award grants to eligible entities to enable 

2 such entities— 

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

4 of State and local public health agencies to provide 

5 screening, counseling, or health care services to 

6 newborns and children having or at risk for heritable 

7 disorders; 

8 ‘‘(2) to assist in providing health care profes9 sionals and newborn screening laboratory personnel 

10 with education in newborn screening and training in 

11 relevant and new technologies in newborn screening 

12 and congenital, genetic, and metabolic disorders; 

13 ‘‘(3) to develop and deliver educational programs 

14 (at appropriate literacy levels) about newborn screen15 ing counseling, testing, follow-up, treatment, and spe16 cialty services to parents, families, and patient advo17 cacy and support groups; and 

18 ‘‘(4) to establish, maintain, and operate a system 

19 to assess and coordinate treatment relating to con20 genital, genetic, and metabolic disorders 

21 ‘‘(b) ELIGIBLE ENTITY.—In this section, the term ‘eli22 gible entity’ means— 

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

24 ‘‘(2) a consortium of 2 or more States or polit25 ical subdivisions of States; 


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1 ‘‘(3) a territory; 

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

3 pursuant to a contract with or grant from the Indian 

4 Health Service; or 

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

6 in newborn screening, as determined by the Secretary. 

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

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

9 by the Secretary unless the application contains assurances 

10 that the eligible entity has adopted and implemented, is in 

11 the process of adopting and implementing, or will use 

12 amounts received under such grant to adopt and implement 

13 the guidelines and recommendations of the Advisory Com14 mittee that are adopted by the Secretary and in effect at 

15 the time the grant is awarded or renewed under this section, 

16 which shall include the screening of each newborn for the 

17 heritable disorders recommended by the Advisory Com18 mittee and adopted by the Secretary.’’; 

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

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

21 (3) by inserting after subsection (c), the fol22 lowing: 

23 ‘‘(d) COORDINATION.—The Secretary shall take all nec24 essary steps to coordinate programs funded with grants reVerDate Aug 31 2005 02:27 Dec 06, 2007 Jkt 069200 PO 00000 Frm 00040 Fmt 6652 Sfmt 6203 E:\BILLS\S1858.RS S1858

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1 ceived under this section and to coordinate with existing 

2 newborn screening activities.’’; and 

3 (4) by striking subsection (j) (as so redesignated) 

4 and inserting the following: 

5 ‘‘(j) AUTHORIZATION OF APPROPRIATIONS.—There is 

6 authorized to be appropriated— 

7 ‘‘(1) to provide grants for the purpose of car8 rying activities under section (a)(1), $15,000,000 for 

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

10 $15,375,000 for fiscal year 2010, $15,562,500 for fis11 cal year 2011, and $15,750,000 for fiscal year 2012; 

12 and 

13 ‘‘(2) to provide grant for the purpose of carrying 

14 out activities under paragraphs (2), (3), and (4) of 

15 subsection (a), $15,000,000 for fiscal year 2008, 

16 $15,187,500 for fiscal year 2009, $15,375,000 for fis17 cal year 2010, $15,562,500 for fiscal year 2011, and 

18 $15,750,000 for fiscal year 2012.’’. 

19 SEC. 3. EVALUATING THE EFFECTIVENESS OF NEWBORN 

20 AND CHILD SCREENING PROGRAMS. 

21 Section 1110 of the Public Health Service Act (42 

22 U.S.C. 300b–9) is amended by adding at the end the fol23 lowing: 

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

25 are authorized to be appropriated to carry out this section 


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1 $5,000,000 for fiscal year 2008, $5,062,500 for fiscal year 

2 2009, $5,125,000 for fiscal year 2010, $5,187,500 for fiscal 

3 year 2011, and $5,250,000 for fiscal year 2012.’’. 

4 SEC. 4. ADVISORY COMMITTEE ON HERITABLE DISORDERS 

5 IN NEWBORNS AND CHILDREN. 

6 Section 1111 of the Public Health Service Act (42 

7 U.S.C. 300b–10) is amended— 

8 (1) in subsection (b)— 

9 (A) by redesignating paragraph (3) as 

10 paragraph (6); 

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

12 after the semicolon; 

13 (C) by inserting after paragraph (2) the fol14 lowing: 

15 ‘‘(3) make systematic evidence-based and peer-re16 viewed recommendations that include the heritable 

17 disorders that have the potential to significantly im18 pact public health for which all newborns should be 

19 screened, including secondary conditions that may be 

20 identified as a result of the laboratory methods used 

21 for screening; 

22 ‘‘(4) develop a model decision-matrix for new23 born screening expansion, including an evaluation of 

24 the potential public health impact of such expansion, 

25 and periodically update the recommended uniform 


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1 screening panel, as appropriate, based on such deci2 sion-matrix; 

3 ‘‘(5) consider ways to ensure that all States at4 tain the capacity to screen for the conditions de5 scribed in paragraph (3), and include in such consid6 eration the results of grant funding under section 

7 1109; and’’; 

8 (E) in paragraph (6) (as so redesignated by 

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

10 end and inserting ‘‘, which may include rec11 ommendations, advice, or information dealing 

12 with— 

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

14 necessary to achieve rapid diagnosis in the short15 term, and those that ascertain long-term case 

16 management outcomes and appropriate access to 

17 related services; 

18 ‘‘(B) implementation, monitoring, and eval19 uation of newborn screening activities, including 

20 diagnosis, screening, follow-up, and treatment 

21 activities; 

22 ‘‘(C) diagnostic and other technology used 

23 in screening; 


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1 ‘‘(D) the availability and reporting of test2 ing for conditions for which there is no existing 

3 treatment; 

4 ‘‘(E) conditions not included in the rec5 ommended uniform screening panel that are 

6 treatable with Food and Drug Administration7 approved products or other safe and effective 

8 treatments, as determined by scientific evidence 

9 and peer review; 

10 ‘‘(F) minimum standards and related poli11 cies and procedures used by State newborn 

12 screening programs, such as language and termi13 nology used by State newborn screening pro14 grams to include standardization of case defini15 tions and names of disorders for which newborn 

16 screening tests are performed; 

17 ‘‘(G) quality assurance, oversight, and eval18 uation of State newborn screening programs, in19 cluding ensuring that tests and technologies used 

20 by each State meet established standards for de21 tecting and reporting positive screening results; 

22 ‘‘(H) public and provider awareness and 

23 education; 

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

25 screening and medical evaluation systems and 


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1 intervention programs conducted by State-based 

2 programs; 

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

4 health impacts of, and risk factors for heritable 

5 disorders; and 

6 ‘‘(K) coordination of surveillance activities, 

7 including standardized data collection and re8 porting, harmonization of laboratory definitions 

9 for heritable disorders and testing results, and 

10 confirmatory testing and verification of positive 

11 results, in order to assess and enhance moni12 toring of newborn diseases.’’; and 

13 (2) in subsection (c)(2)— 

14 (A) by redesignating subparagraphs (E), 

15 (F) and (G) as subparagraphs (F), (H), and (I); 

16 (B) by inserting after subparagraph (D) the 

17 following: 

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

19 Drug Administration;’’; and 

20 (C) by inserting after subparagraph (F), as 

21 so redesignated, the following: 

22 ‘‘(G) individuals with expertise in ethics 

23 and infectious diseases who have worked and 

24 published material in the area of newborn 

25 screening;’’; and 


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

2 ‘‘(d) DECISION ON RECOMMENDATIONS.— 

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

4 after the Advisory Committee issues a recommenda5 tion pursuant to this section, the Secretary shall 

6 adopt or reject such recommendation. 

7 ‘‘(2) PENDING RECOMMENDATIONS.—The Sec8 retary shall adopt or reject any recommendation 

9 issued by the Advisory Committee that is pending on 

10 the date of enactment of the Newborn Screening Saves 

11 Lives Act of 2007 by not later than 180 days after 

12 the date of enactment of such Act. 

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

14 The Secretary shall publicize any determination on 

15 adopting or rejecting a recommendation of the Advi16 sory Committee pursuant to this subsection, including 

17 the justification for the determination. 

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

19 the date of enactment of the Newborn Screening Saves Lives 

20 Act of 2007, and each fiscal year thereafter, the Advisory 

21 Committee shall— 

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

23 screening guidelines, including follow-up and treat24 ment, in the United States; 


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1 ‘‘(2) submit such report to the appropriate com2 mittees of Congress, the Secretary, and the State de3 partments of health; and 

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

5 as practicable, including through posting on the inter6 net clearinghouse established under section 1112. 

7 ‘‘(f) CONTINUATION OF OPERATION OF COMMITTEE.— 

8 Notwithstanding section 14 of the Federal Advisory Com9 mittee Act (5 U.S.C. App.), the Advisory Committee shall 

10 continue to operate during the 5-year period beginning on 

11 the date of enactment of the Newborn Screening Saves Lives 

12 Act of 2007. 

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

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

15 $1,000,000 for fiscal year 2008, $1,012,500 for fiscal year 

16 2009, $1,025,000 for fiscal year 2010, $1,037,500 for fiscal 

17 year 2011, and $1,050,000 for fiscal year 2012.’’. 

18 SEC. 5. INFORMATION CLEARINGHOUSE. 

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

20 (42 U.S.C. 300b–1 et seq.) is amended by adding at the 

21 end the following: 

22 ‘‘SEC. 1112. CLEARINGHOUSE OF NEWBORN SCREENING IN23 FORMATION. 

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

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1 istration (referred to in this part as the ‘Administrator’), 

2 in consultation with the Director of the Centers for Disease 

3 Control and Prevention and the Director of the National 

4 Institutes of Health, shall establish and maintain a central 

5 clearinghouse of current educational and family support 

6 and services information, materials, resources, research, 

7 and data on newborn screening to— 

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

9 newborns, health professionals, industry representa10 tives, and other members of the public to increase 

11 their awareness, knowledge, and understanding of 

12 newborn screening; 

13 ‘‘(2) increase awareness, knowledge, and under14 standing of newborn diseases and screening services 

15 for expectant individuals and families; and 

16 ‘‘(3) maintain current data on quality indica17 tors to measure performance of newborn screening, 

18 such as false-positive rates and other quality indica19 tors as determined by the Advisory Committee under 

20 section 1111. 

21 ‘‘(b) INTERNET AVAILABILITY.—The Secretary, acting 

22 through the Administrator, shall ensure that the clearing23 house described under subsection (a)— 

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

25 ‘‘(2) includes an interactive forum; 


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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 Internet websites of laboratories 

6 that have demonstrated expertise in newborn 

7 screening that supply research-based information 

8 on 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 from laboratories certified under subpart 2 of 

13 part F of title III, including information about 

14 supplemental screening that is available but not 

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

16 ‘‘(C) current research on both treatable and 

17 not-yet treatable conditions for which newborn 

18 screening tests are available; 

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

20 newborn and child screening for heritable dis21 orders including grants authorized under the 

22 Newborn Screening Saves Lives Act of 2007; and 

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


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1 ‘‘(c) NONDUPLICATION.—In developing the clearing2 house under this section, the Secretary shall ensure that 

3 such clearinghouse minimizes duplication and supplements, 

4 not supplants, existing information sharing efforts. 

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

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

7 $2,500,000 for fiscal year 2008, $2,531,250 for fiscal year 

8 2009, $2,562,500 for fiscal year 2010, $2,593,750 for fiscal 

9 year 2011, and $2,625,000 for fiscal year 2012.’’. 

10 SEC. 6. LABORATORY QUALITY AND SURVEILLANCE. 

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

12 (42 U.S.C. 300b–1 et seq.), as amended by section 5, is fur13 ther amended by adding at the end the following: 

14 ‘‘SEC. 1113. LABORATORY QUALITY. 

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

16 Director of the Centers for Disease Control and Prevention 

17 and in consultation with the Advisory Committee on Heri18 table Disorders in Newborns and Children established under 

19 section 1111, shall provide for— 

20 ‘‘(1) quality assurance for laboratories involved 

21 in screening newborns and children for heritable dis22 orders, including quality assurance for newborn23 screening tests, performance evaluation services, and 

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1 born screening laboratories to ensure analytic validity 

2 and utility of screening tests; and 

3 ‘‘(2) appropriate quality control and other per4 formance test materials to evaluate the performance of 

5 new screening tools. 

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

7 purpose of carrying out this section, there are authorized 

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

9 $5,062,500 for fiscal year 2009, $5,125,000 for fiscal year 

10 2010, $5,187,500 for fiscal year 2011, and $5,250,000 for 

11 fiscal year 2012. 

12 ‘‘SEC. 1114. SURVEILLANCE PROGRAMS FOR HERITABLE 

13 DISORDERS SCREENING. 

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

15 Interagency Group consisting of the Director of the Agency 

16 for Healthcare Research and Quality, the Director of the 

17 Centers for Disease Control and Prevention, the Adminis18 trator, and the Director of the National Institutes of Health, 

19 shall build upon existing activities and infrastructure to 

20 carry out programs— 

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

22 on the heritable disorders recommended by the Advi23 sory Committee on Heritable Disorders in Newborns 

24 and Children established under section 1111, includ25 ing data on the incidence and prevalence of, as well 


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1 as poor health outcomes resulting from, such dis2 orders; 

3 ‘‘(2) to identify regional centers for the conduct 

4 of applied epidemiological research on effective inter5 ventions for such disorders for the prevention of poor 

6 health outcomes; 

7 ‘‘(3) to provide information and education to the 

8 public on effective interventions for the prevention of 

9 poor health outcomes resulting from such disorders; 

10 and 

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

12 prevention of poor health outcomes resulting from 

13 such disorders, and secondary health conditions 

14 among individuals with such disorders. 

15 ‘‘(b) GRANTS AND CONTRACTS.— 

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

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

18 contracts with public and nonprofit private entities. 

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

20 AWARD FUNDS.— 

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

22 recipient of an award of a grant or contract 

23 under paragraph (1), the Secretary may, subject 

24 to subparagraph (B), provide supplies, equip25 ment, and services for the purpose of aiding the 


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1 recipient in carrying out the purposes for which 

2 the award is made and, for such purposes, may 

3 detail to the recipient any officer or employee of 

4 the Department of Health and Human Services. 

5 ‘‘(B) REDUCTION.—With respect to a re6 quest described in subparagraph (A), the Sec7 retary shall reduce the amount of payments 

8 under the award involved by an amount equal to 

9 the costs of detailing personnel and the fair mar10 ket value of any supplies, equipment, or services 

11 provided by the Secretary. The Secretary shall, 

12 for the payment of expenses incurred in com13 plying with such request, expend the amounts 

14 withheld. 

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

16 may make an award of a grant or contract under 

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

18 is submitted to the Secretary and the application is 

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

20 such agreements, assurances, and information as the 

21 Secretary determines to be necessary to carry out the 

22 purposes for which the award is to be made. 

23 ‘‘(c) REPORTS TO CONGRESS.— 


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

2 Secretary shall submit to the relevant committees of 

3 Congress reports— 

4 ‘‘(A) containing information under para5 graph (1) that is specific to various racial, eth6 nic, and socioeconomic groups; 

7 ‘‘(B) containing an assessment of the extent 

8 to which various approaches of preventing heri9 table disorders and secondary health conditions 

10 among individuals with such disorders have been 

11 effective; 

12 ‘‘(C) describing the activities carried out 

13 under this section; 

14 ‘‘(D) containing information on the inci15 dence and prevalence of individuals living with 

16 heritable disorders, information on the health 

17 status of individuals with such disorders includ18 ing the extent to which such disorders have con19 tributed to the incidence and prevalence of infant 

20 mortality, information on any health disparities 

21 experienced by such individuals, and rec22 ommendations for improving the health and 

23 wellness and quality of life of such individuals; 

24 ‘‘(E) containing a summary of rec25 ommendations from all heritable disorders reVerDate Aug 31 2005 02:27 Dec 06, 2007 Jkt 069200 PO 00000 Frm 00054 Fmt 6652 Sfmt 6203 E:\BILLS\S1858.RS S1858

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1 search conferences sponsored by the Centers for 

2 Disease Control and Prevention or the National 

3 Institutes of Health; and 

4 ‘‘(F) containing any recommendations of 

5 the Secretary regarding this section. 

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

7 submit— 

8 ‘‘(A) an interim report that includes the in9 formation described in paragraph (1), not later 

10 than 30 months after the date on which the first 

11 grant funds are awarded under this section; and 

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

13 information described in paragraph (1), not 

14 later than 60 months after the date on which the 

15 first grant funds are awarded under this section. 

16 ‘‘(d) COORDINATION.— 

17 ‘‘(1) IN GENERAL.—In carrying out this section, 

18 the Secretary shall coordinate, to the extent prac19 ticable, programs under this section with programs on 

20 birth defects and developmental disabilities authorized 

21 under section 317C. 

22 ‘‘(2) PRIORITY IN GRANTS AND CONTRACTS.—In 

23 making grants and contracts under this section, the 

24 Secretary shall give priority to entities that dem25 onstrate the ability to coordinate activities under a 


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1 grant or contract made under this section with exist2 ing birth defects surveillance activities. 

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

4 purpose of carrying out this section, there are authorized 

5 to be appropriated $15,000,000 for fiscal year 2008, 

6 $15,187,500 for fiscal year 2009, $15,375,000 for fiscal year 

7 2010, $15,562,500 for fiscal year 2011, and $15,750,000 for 

8 fiscal year 2012.’’. 

9 SEC. 7. CONTINGENCY PLANNING. 

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

11 (42 U.S.C. 300b–1 et seq.), as amended by section 6, is fur12 ther amended by adding at the end the following: 

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

14 SCREENING. 

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

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

17 through the Director of the Centers for Disease Control and 

18 Prevention and in consultation with the Administrator and 

19 State departments of health (or related agencies), shall de20 velop a national contingency plan for newborn screening 

21 for use by a State, region, or consortia of States in the event 

22 of a public health emergency. 

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

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

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


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1 ‘‘(2) the shipment of specimens to State newborn 

2 screening laboratories; 

3 ‘‘(3) the processing of specimens; 

4 ‘‘(4) the reporting of screening results to physi5 cians and families; 

6 ‘‘(5) the diagnostic confirmation of positive 

7 screening results; 

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

9 management resources; 

10 ‘‘(7) educating families about newborn screening; 

11 and 

12 ‘‘(8) carrying out other activities determined ap13 propriate by the Secretary. 

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

15 ‘‘(a) NEWBORN SCREENING ACTIVITIES.— 

16 ‘‘(1) IN GENERAL.—The Secretary, in conjunc17 tion with the Director of the National Institutes of 

18 Health and taking into consideration the rec19 ommendations of the Advisory Committee, may con20 tinue carrying out, coordinating, and expanding re21 search in newborn screening (to be known as ‘Hunter 

22 Kelly Newborn Screening Research Program’) includ23 ing— 

24 ‘‘(A) identifying, developing, and testing the 

25 most promising new screening technologies, in 


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1 order to improve already existing screening tests, 

2 increase the specificity of newborn screening, and 

3 expand the number of conditions for which 

4 screening tests are available; 

5 ‘‘(B) experimental treatments and disease 

6 management strategies for additional newborn 

7 conditions, and other genetic, metabolic, hor8 monal and or functional conditions that can be 

9 detected through newborn screening for which 

10 treatment is not yet available; and 

11 ‘‘(C) other activities that would improve 

12 newborn screening, as identified by the Director. 

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

14 purposes of this subsection, the term ‘additional new15 born condition’ means any condition that is not one 

16 of the core conditions recommended by the Advisory 

17 Committee and adopted by the Secretary. 

18 ‘‘(b) FUNDING.—In carrying out the research program 

19 under this section, the Secretary and the Director shall en20 sure that entities receiving funding through the program 

21 will provide assurances, as practicable, that such entities 

22 will work in consultation with the appropriate State de23 partments of health, and, as practicable, focus their research 

24 on screening technology not currently performed in the 

25 States in which the entities are located, and the conditions 


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1 on the uniform screening panel (or the standard test exist2 ing on the uniform screening panel). 

3 ‘‘(c) REPORTS.—The Director is encouraged to include 

4 information about the activities carried out under this sec5 tion in the biennial report required under section 403 of 

6 the National Institutes of Health Reform Act of 2006. If 

7 such information is included, the Director shall make such 

8 information available to be included on the Internet Clear9 inghouse established under section 1112. 

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

11 under this section, the Secretary shall minimize duplication 

12 and supplement, not supplant, existing efforts of the type 

13 carried out under this section. 

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

15 construed to interfere with the scientific peer-review process 

16 at the National Institutes of Health.’’. 


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Calendar No. 522 

110TH CONGRESS 

1ST SESSION S. 1858 

A BILL 

To amend the Public Health Service Act to estabof title XI of such Act, and for other purposes. conducted, to reauthorize programs under part A followup care once newborn screening has been outreach on newborn screening and coordinated lish grant programs to provide for education and 

DECEMBER 5, 2007 

Reported with an amendment 


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