II 

110TH CONGRESS 

1ST SESSION S. 634 

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 

FEBRUARY 15, 2007 

Mr. DODD (for himself and Mr. HATCH) 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. 399AA. NEWBORN SCREENING. 

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

17 ‘‘(1) GRANTS TO ASSIST HEALTH CARE PROFES18 SIONALS.—From funds appropriated under sub19 section (h), the Secretary, acting through the Asso20 ciate Administrator of the Maternal and Child 

21 Health Bureau of the Health Resources and Services 

22 Administration (referred to in this section as the 

23 ‘Associate Administrator’) and in consultation with 

24 the Advisory Committee on Heritable Disorders in 

25 Newborns and Children (referred to in this section 


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1 as the ‘Advisory Committee’), shall award grants to 

2 eligible entities to enable such entities to assist in 

3 providing health care professionals and newborn 

4 screening laboratory personnel with— 

5 ‘‘(A) education in newborn screening; and 

6 ‘‘(B) training in— 

7 ‘‘(i) relevant and new technologies in 

8 newborn screening; and 

9 ‘‘(ii) congenital, genetic, and meta10 bolic disorders. 

11 ‘‘(2) GRANTS TO ASSIST FAMILIES.— 

12 ‘‘(A) IN GENERAL.—From funds appro13 priated under subsection (h), the Secretary, act14 ing through the Associate Administrator and in 

15 consultation with the Advisory Committee, shall 

16 award grants to eligible entities to enable such 

17 entities to develop and deliver educational pro18 grams about newborn screening to parents, 

19 families, and patient advocacy and support 

20 groups. The educational materials accom21 panying such educational programs shall be 

22 provided at appropriate literacy levels. 

23 ‘‘(B) AWARENESS OF THE AVAILABILITY

24 OF PROGRAMS.—To the extent practicable, the 

25 Secretary shall make relevant health care proVerDate Aug 31 2005 02:54 Feb 18, 2007 Jkt 059200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\S634.IS S634

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1 viders aware of the availability of the edu2 cational programs supported pursuant to sub3 paragraph (A). 

4 ‘‘(3) GRANTS FOR QUALITY NEWBORN SCREEN5 ING FOLLOWUP.—From funds appropriated under 

6 subsection (h), the Secretary, acting through the As7 sociate Administrator and in consultation with the 

8 Advisory Committee, shall award grants to eligible 

9 entities to enable such entities to establish, main10 tain, and operate a system to assess and coordinate 

11 treatment relating to congenital, genetic, and meta12 bolic 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 and coordinated systems of followup 

21 care with respect to newborn screening; 

22 and 

23 ‘‘(ii) take all necessary steps to mini24 mize the duplication of the resources and 

25 programs described in clause (i). 


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

2 necessary steps to coordinate programs funded with 

3 grants received under this section. 

4 ‘‘(e) USE OF GRANT FUNDS.— 

5 ‘‘(1) GRANTS TO ASSIST HEALTH CARE PROFES6 SIONALS.—An eligible entity that receives a grant 

7 under subsection (a)(1) may use the grant funds to 

8 work with appropriate medical schools, nursing 

9 schools, schools of public health, schools of genetic 

10 counseling, internal education programs in State 

11 agencies, nongovernmental organizations, and pro12 fessional organizations and societies to develop and 

13 deliver education and training programs that in14 clude— 

15 ‘‘(A) continuing medical education pro16 grams for health care professionals and new17 born screening laboratory personnel in newborn 

18 screening; 

19 ‘‘(B) education, technical assistance, and 

20 training on new discoveries in newborn screen21 ing and the use of any related technology; 

22 ‘‘(C) models to evaluate the prevalence of, 

23 and assess and communicate the risks of, con24 genital conditions, including the prevalence and 


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1 risk of some of these conditions based on family 

2 history; 

3 ‘‘(D) models to communicate effectively 

4 with parents and families about— 

5 ‘‘(i) the process and benefits of new6 born screening; 

7 ‘‘(ii) how to use information gathered 

8 from newborn screening; 

9 ‘‘(iii) the meaning of screening re10 sults, including the possibility of false posi11 tive findings; 

12 ‘‘(iv) the right of refusal of newborn 

13 screening, if applicable; and 

14 ‘‘(v) the potential need for followup 

15 care after newborns are screened; 

16 ‘‘(E) information and resources on coordi17 nated systems of followup care after newborns 

18 are screened; 

19 ‘‘(F) information on the disorders for 

20 which States require and offer newborn screen21 ing and options for newborn screening relating 

22 to conditions in addition to such disorders; 

23 ‘‘(G) information on additional newborn 

24 screening that may not be required by the 


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1 State, but that may be available from other 

2 sources; and 

3 ‘‘(H) other items to carry out the purpose 

4 described in subsection (a)(1) as determined ap5 propriate by the Secretary. 

6 ‘‘(2) GRANTS TO ASSIST FAMILIES.—An eligible 

7 entity that receives a grant under subsection (a)(2) 

8 may use the grant funds to develop and deliver to 

9 parents, families, and patient advocacy and support 

10 groups, educational programs about newborn screen11 ing that include information on— 

12 ‘‘(A) what newborn screening is; 

13 ‘‘(B) how newborn screening is performed; 

14 ‘‘(C) who performs newborn screening; 

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

17 ‘‘(E) the disorders for which the State re18 quires newborns to be screened; 

19 ‘‘(F) different options for newborn screen20 ing for disorders other than those included by 

21 the State in the mandated newborn screening 

22 program; 

23 ‘‘(G) the meaning of various screening re24 sults, including the possibility of false positive 

25 and false negative findings; 


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1 ‘‘(H) the prevalence and risk of newborn 

2 disorders, including the increased risk of dis3 orders that may stem from family history; 

4 ‘‘(I) coordinated systems of followup care 

5 after newborns are screened; and 

6 ‘‘(J) other items to carry out the purpose 

7 described in subsection (a)(2) as determined ap8 propriate by the Secretary. 

9 ‘‘(3) GRANTS FOR QUALITY NEWBORN SCREEN10 ING FOLLOWUP.—An eligible entity that receives a 

11 grant under subsection (a)(3) shall use the grant 

12 funds to— 

13 ‘‘(A) expand on existing procedures and 

14 systems, where appropriate and available, for 

15 the timely reporting of newborn screening re16 sults to individuals, families, primary care phy17 sicians, and subspecialists in congenital, ge18 netic, and metabolic disorders; 

19 ‘‘(B) coordinate ongoing followup treat20 ment with individuals, families, primary care 

21 physicians, and subspecialists in congenital, ge22 netic, and metabolic disorders after a newborn 

23 receives an indication of the presence or in24 creased risk of a disorder on a screening test; 


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1 ‘‘(C) ensure the seamless integration of 

2 confirmatory testing, tertiary care medical serv3 ices, comprehensive genetic services including 

4 genetic counseling, and information about ac5 cess to developing therapies by participation in 

6 approved clinical trials involving the primary 

7 health care of the infant; 

8 ‘‘(D) analyze data, if appropriate and 

9 available, collected from newborn screenings to 

10 identify populations at risk for disorders affect11 ing newborns, examine and respond to health 

12 concerns, recognize and address relevant envi13 ronmental, behavioral, socioeconomic, demo14 graphic, and other relevant risk factors; and 

15 ‘‘(E) carry out such other activities as the 

16 Secretary may determine necessary. 

17 ‘‘(f) REPORTS TO CONGRESS.— 

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

19 the Secretary shall submit to the appropriate com20 mittees of Congress reports— 

21 ‘‘(A) evaluating the effectiveness and the 

22 impact of the grants awarded under this sec23 tion— 

24 ‘‘(i) in promoting newborn screen25 ing— 


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1 ‘‘(I) education and resources for 

2 families; and 

3 ‘‘(II) education, resources, and 

4 training for health care professionals; 

5 ‘‘(ii) on the successful diagnosis and 

6 treatment of congenital, genetic, and meta7 bolic disorders; and 

8 ‘‘(iii) on the continued development of 

9 coordinated systems of followup care after 

10 newborns are screened; 

11 ‘‘(B) describing and evaluating the effec12 tiveness of the activities carried out with grant 

13 funds received under this section; and 

14 ‘‘(C) that include recommendations for 

15 Federal actions to support— 

16 ‘‘(i) education and training in new17 born screening; and 

18 ‘‘(ii) followup care after newborns are 

19 screened. 

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

21 submit— 

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

23 information described in paragraph (1), not 

24 later than 30 months after the date on which 


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1 the first grant funds are awarded under this 

2 section; and 

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

4 information described in paragraph (1), not 

5 later than 60 months after the date on which 

6 the first grant funds are awarded under this 

7 section. 

8 ‘‘(g) DEFINITION OF ELIGIBLE ENTITY.—In this sec9 tion, the term ‘eligible entity’ means— 

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

11 State; 

12 ‘‘(2) a consortium of 2 or more States or polit13 ical subdivisions of States; 

14 ‘‘(3) a territory; 

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

16 health care facility of the Indian Health Service; or 

17 ‘‘(5) a nongovernmental organization with ap18 propriate expertise in newborn screening, as deter19 mined by the Secretary. 

20 ‘‘(h) NATIONAL CONTINGENCY PLAN FOR NEWBORN

21 SCREENING.— 

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

23 after the date of enactment of this section, the Sec24 retary, acting through the Director of the Centers 

25 for Disease Control and Prevention and in consultaVerDate Aug 31 2005 02:54 Feb 18, 2007 Jkt 059200 PO 00000 Frm 00013 Fmt 6652 Sfmt 6201 E:\BILLS\S634.IS S634

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1 tion with the Associate Administrator, shall develop 

2 a national contingency plan for newborn screening 

3 for use in the event of a public health emergency. 

4 ‘‘(2) REQUIREMENTS.—The contingency plan 

5 developed under paragraph (1) shall include a plan 

6 for— 

7 ‘‘(A) the collection and transport of speci8 mens; 

9 ‘‘(B) the shipment of specimens to State 

10 newborn screening laboratories; 

11 ‘‘(C) the processing of specimens; 

12 ‘‘(D) the reporting of screening results to 

13 physicians and families; 

14 ‘‘(E) the diagnostic confirmation of posi15 tive screening results; 

16 ‘‘(F) ensuring the availability of treatment 

17 and management resources; 

18 ‘‘(G) educating families about newborn 

19 screening; and 

20 ‘‘(H) carrying out other activities deter21 mined appropriate by the Secretary. 

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

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

25 ‘‘(1) $15,000,000 for fiscal year 2008; and 


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

2 of fiscal years 2009 through 2012.’’. 

3 SEC. 4. IMPROVED NEWBORN AND CHILD SCREENING FOR 

4 HERITABLE DISORDERS. 

5 Section 1109 of the Public Health Service Act (42 

6 U.S.C. 300b–8) is amended— 

7 (1) in subsection (c)(2)— 

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

9 ‘‘and’’ after the semicolon; 

10 (B) by redesignating subparagraph (F) as 

11 subparagraph (G); and 

12 (C) by inserting after subparagraph (E) 

13 the following: 

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

15 adopted and implemented, is in the process of 

16 adopting and implementing, or will use grant 

17 amounts received under this section to adopt 

18 and implement the guidelines and recommenda19 tions of the Advisory Committee on Heritable 

20 Disorders in Newborns and Children established 

21 under section 1111 (referred to in this section 

22 as the ‘Advisory Committee’) that are adopted 

23 by the Secretary and in effect at the time the 

24 grant is awarded or renewed under this section, 

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1 born for the heritable disorders recommended 

2 by the Advisory Committee and adopted by the 

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

4 and 

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

6 and all that follows through the period at the end 

7 and inserting ‘‘$25,000,000 for fiscal year 2008 and 

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

9 years 2009 through 2012.’’. 

10 SEC. 5. EVALUATING THE EFFECTIVENESS OF NEWBORN11 AND CHILD-SCREENING PROGRAMS. 

12 Section 1110 of the Public Health Service Act (42 

13 U.S.C. 300b–9) is amended by adding at the end the fol14 lowing: 

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

16 are authorized to be appropriated to carry out this section 

17 $5,000,000 for fiscal year 2008 and such sums as may 

18 be necessary for each of the fiscal years 2009 through 

19 2012.’’. 

20 SEC. 6. ADVISORY COMMITTEE ON HERITABLE DISORDERS 

21 IN NEWBORNS AND CHILDREN. 

22 Section 1111 of the Public Health Service Act (42 

23 U.S.C. 300b–10) is amended— 

24 (1) in subsection (b)— 


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1 (A) by redesignating paragraph (3) as 

2 paragraph (5); 

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

4 after the semicolon; 

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

6 following: 

7 ‘‘(3) recommend a uniform screening panel for 

8 newborn screening programs that includes the heri9 table disorders for which all newborns should be 

10 screened, including secondary conditions that may be 

11 identified as a result of the laboratory methods used 

12 for screening; 

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

15 update the recommended uniform screening panel 

16 described in paragraph (3) based on such decision17 matrix; and’’; and 

18 (D) in paragraph (5) (as redesignated by 

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

20 end and inserting ‘‘, including recommenda21 tions, advice, or information dealing with— 

22 ‘‘(A) followup activities, including those 

23 necessary to achieve rapid diagnosis in the 

24 short term, and those that ascertain long-term 


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1 case management outcomes and appropriate ac2 cess to related services; 

3 ‘‘(B) diagnostic and other technology used 

4 in screening; 

5 ‘‘(C) the availability and reporting of test6 ing for conditions for which there is no existing 

7 treatment; 

8 ‘‘(D) minimum standards and related poli9 cies and procedures for State newborn screen10 ing programs; 

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

12 evaluation of State newborn screening pro13 grams; 

14 ‘‘(F) data collection for assessment of new15 born screening programs; 

16 ‘‘(G) public and provider awareness and 

17 education; 

18 ‘‘(H) language and terminology used by 

19 State newborn screening programs; 

20 ‘‘(I) confirmatory testing and verification 

21 of positive results; and 

22 ‘‘(J) harmonization of laboratory defini23 tions for results that are within the expected 

24 range and results that are outside of the ex25 pected range.’’; and 


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1 (2) 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 

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

12 after 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, includ17 ing the justification for the determination. 

18 ‘‘(e) CONTINUATION OF OPERATION OF COM19 MITTEE.—Notwithstanding section 14 of the Federal Ad20 visory Committee Act (5 U.S.C. App.), the Advisory Com21 mittee shall continue to operate during the 5-year period 

22 beginning on the date of enactment of the Newborn 

23 Screening Saves Lives Act of 2007.’’. 


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1 SEC. 7. 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.) is amended by adding at the 

4 end the following: 

5 ‘‘SEC. 1112. 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. 1113. SURVEILLANCE PROGRAMS FOR HERITABLE 

2 DISORDERS SCREENING. 

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

4 the Director of the Centers for Disease Control and Pre5 vention, in consultation with the Associate Administrator 

6 of the Maternal and Child Health Bureau of the Health 

7 Resources and Services Administration, shall carry out 

8 programs— 

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

10 on the heritable disorders recommended by the Advi11 sory Committee on Heritable Disorders in Newborns 

12 and Children established under section 1111, includ13 ing data on the causes of such disorders and on the 

14 incidence and prevalence of such disorders; 

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

16 of applied epidemiological research on the prevention 

17 of such disorders; 

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

19 the public on the prevention of such disorders; and 

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

21 prevention of such disorders, and secondary health 

22 conditions among individuals with such disorders. 

23 ‘‘(b) GRANTS AND CONTRACTS.— 

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

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


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1 into contracts with public and nonprofit private enti2 ties. 

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

4 AWARD FUNDS.— 

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

6 recipient of an award of a grant or contract 

7 under paragraph (1), the Secretary may, sub8 ject to subparagraph (B), provide supplies, 

9 equipment, and services for the purpose of aid10 ing the recipient in carrying out the purposes 

11 for which the award is made and, for such pur12 poses, may detail to the recipient any officer or 

13 employee of the Department of Health and 

14 Human Services. 

15 ‘‘(B) REDUCTION.—With respect to a re16 quest described in subparagraph (A), the Sec17 retary shall reduce the amount of payments 

18 under the award involved by an amount equal 

19 to the costs of detailing personnel and the fair 

20 market value of any supplies, equipment, or 

21 services provided by the Secretary. The Sec22 retary shall, for the payment of expenses in23 curred in complying with such request, expend 

24 the amounts withheld. 


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

2 may make an award of a grant or contract under 

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

4 is submitted to the Secretary and the application is 

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

6 such agreements, assurances, and information as the 

7 Secretary determines to be necessary to carry out 

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

9 ‘‘(c) BIENNIAL REPORT.—Not later than February 

10 1 of fiscal year 2008 and of every second such year there11 after, the Secretary shall submit to the Committee on En12 ergy and Commerce of the House of Representatives, and 

13 the Committee on Health, Education, Labor, and Pen14 sions of the Senate, a report that, with respect to the pre15 ceding 2 fiscal years— 

16 ‘‘(1) contains information regarding the inci17 dence and prevalence of heritable disorders and the 

18 health status of individuals with such disorders and 

19 the extent to which such disorders have contributed 

20 to the incidence and prevalence of infant mortality 

21 and affected quality of life; 

22 ‘‘(2) contains information under paragraph (1) 

23 that is specific to various racial and ethnic groups 

24 (including Hispanics, non-Hispanic whites, Blacks, 

25 Native Americans, and Asian Americans); 


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1 ‘‘(3) contains an assessment of the extent to 

2 which various approaches of preventing heritable dis3 orders and secondary health conditions among indi4 viduals with such disorders have been effective; 

5 ‘‘(4) describes the activities carried out under 

6 this section; 

7 ‘‘(5) contains information on the incidence and 

8 prevalence of individuals living with heritable dis9 orders, information on the health status of individ10 uals with such disorders, information on any health 

11 disparities experienced by such individuals, and rec12 ommendations for improving the health and wellness 

13 and quality of life of such individuals; 

14 ‘‘(6) contains a summary of recommendations 

15 from all heritable disorders research conferences 

16 sponsored by the Centers for Disease Control and 

17 Prevention; and 

18 ‘‘(7) contains any recommendations of the Sec19 retary regarding this section. 

20 ‘‘(d) APPLICABILITY OF PRIVACY LAWS.—The provi21 sions of this section shall be subject to the requirements 

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

23 laws relating to the privacy of information shall apply to 

24 the data and information that is collected under this sec25 tion. 


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1 ‘‘(e) COORDINATION.— 

2 ‘‘(1) IN GENERAL.—In carrying out this sec3 tion, the Secretary shall coordinate, to the extent 

4 practicable, programs under this section with pro5 grams on birth defects and developmental disabilities 

6 authorized under section 317C. 

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

8 In making grants and contracts under this section, 

9 the Secretary shall give priority to entities that dem10 onstrate the ability to coordinate activities under a 

11 grant or contract made under this section with exist12 ing birth defects surveillance activities. 

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

14 purpose of carrying out this section, there are authorized 

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

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

17 2009 through 2012.’’. 

Æ 


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