I 

110TH CONGRESS 

1ST SESSION H. R. 1634 

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 HOUSE OF REPRESENTATIVES 

MARCH 21, 2007 

Ms. ROYBAL-ALLARD (for herself and Mr. SIMPSON) introduced the following 

bill; which was referred to the Committee on Energy and Commerce 

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, approximately 4,000,000 babies 

4 are born in the United States, and all are offered 

5 some type of newborn screening by State and private 

6 laboratories to detect certain conditions that may 

7 threaten their long-term health. 

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

9 the number of conditions for which newborns are 

10 screened through State-based programs. Although a 

11 newborn may be screened and treated for a debili12 tating condition in one State, in another State the 

13 condition may go undetected and result in perma14 nent disability or even death. 

15 (3) In 2004, the American College of Medical 

16 Genetics (ACMG) completed a report commissioned 

17 by the Department of Health and Human Services 

18 which recommended that every baby born in the 

19 United States be screened for 29 specific disorders, 

20 which, if diagnosed early, can be successfully man21 aged or treated to prevent severe and often lifelong 

22 health consequences. 

23 (4) Currently only 11 States and the District of 

24 Columbia require infants to be screened for all 29 of 

25 these recommended disorders. 

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1 (5) The March of Dimes estimates that 1,000 

2 of the 5,000 babies born every year in the United 

3 States with one of the 29 core conditions do not re4 ceive comprehensive newborn screening that includes 

5 their particular disorder. This results in catastrophic 

6 consequences for the child and the family and enor7 mous costs for society. 

8 (6) Continuity plays a critical role in the 

9 screening, diagnosis, referral, and treatment of these 

10 disorders. Currently there is no national contingency 

11 plan for maintaining continuity of newborn screen12 ing systems during a public health emergency, such 

13 as a catastrophic natural disaster or a widespread 

14 terrorist event, that results in State or regional dis15 ruption of newborn screening services. 

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

17 SERVICE ACT. 

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

19 (42 U.S.C. 280h et seq.) is amended by adding at the end 

20 the following: 

21 ‘‘SEC. 399Z–1. NEWBORN SCREENING. 

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

23 ‘‘(1) GRANTS TO ASSIST HEALTH CARE PROFES24 SIONALS.—From funds appropriated under sub25 section (h), the Secretary, acting through the Assomstockstill on PROD1PC66 with BILLS

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1 ciate Administrator of the Maternal and Child 

2 Health Bureau of the Health Resources and Services 

3 Administration (referred to in this section as the 

4 ‘Associate Administrator’) and in consultation with 

5 the Advisory Committee on Heritable Disorders in 

6 Newborns and Children (referred to in this section 

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

8 eligible entities to enable such entities to assist in 

9 providing health care professionals and newborn 

10 screening laboratory personnel with— 

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

12 ‘‘(B) training in— 

13 ‘‘(i) relevant and new technologies in 

14 newborn screening; and 

15 ‘‘(ii) congenital, genetic, and meta16 bolic disorders. 

17 ‘‘(2) GRANTS TO ASSIST FAMILIES.— 

18 ‘‘(A) IN GENERAL.—From funds appro19 priated under subsection (h), the Secretary, act20 ing through the Associate Administrator and in 

21 consultation with the Advisory Committee, shall 

22 award grants to eligible entities to enable such 

23 entities to develop and deliver educational pro24 grams about newborn screening to parents, 

25 families, and patient advocacy and support 

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1 groups. The educational materials accom2 panying such educational programs shall be 

3 provided at appropriate literacy levels. 

4 ‘‘(B) AWARENESS OF THE AVAILABILITY

5 OF PROGRAMS.—To the extent practicable, the 

6 Secretary shall make relevant health care pro7 viders aware of the availability of the edu8 cational programs supported pursuant to sub9 paragraph (A). 

10 ‘‘(3) GRANTS FOR QUALITY NEWBORN SCREEN11 ING FOLLOWUP.—From funds appropriated under 

12 subsection (h), the Secretary, acting through the As13 sociate Administrator and in consultation with the 

14 Advisory Committee, shall award grants to eligible 

15 entities to enable such entities to establish, main16 tain, and operate a system to assess and coordinate 

17 treatment relating to congenital, genetic, and meta18 bolic disorders. 

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

20 receive a grant under this section shall submit an applica21 tion to the Secretary at such time, in such manner, and 

22 accompanied by such information as the Secretary may 

23 require. 

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

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

2 after receiving an application under subsection (b), 

3 the Secretary, after considering the approval factors 

4 under paragraph (2), shall determine whether to 

5 award the eligible entity a grant under this section. 

6 ‘‘(2) APPROVAL FACTORS.— 

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

8 application submitted under subsection (b) may 

9 not be approved by the Secretary unless the ap10 plication contains assurances that the eligible 

11 entity— 

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

13 purposes specified in the approved applica14 tion and in accordance with the require15 ments of this section; and 

16 ‘‘(ii) will establish such fiscal control 

17 and fund accounting procedures as may be 

18 necessary to assure proper disbursement 

19 and accounting of Federal funds paid to 

20 the eligible entity under the grant. 

21 ‘‘(B) EXISTING PROGRAMS.—Prior to 

22 awarding a grant under this section, the Sec23 retary shall— 

24 ‘‘(i) conduct an assessment of existing 

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1 grams and coordinated systems of followup 

2 care with respect to newborn screening; 

3 and 

4 ‘‘(ii) take all necessary steps to mini5 mize the duplication of the resources and 

6 programs described in clause (i). 

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

8 necessary steps to coordinate programs funded with 

9 grants received under this section. 

10 ‘‘(e) USE OF GRANT FUNDS.— 

11 ‘‘(1) GRANTS TO ASSIST HEALTH CARE PROFES12 SIONALS.—An eligible entity that receives a grant 

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

14 work with appropriate medical schools, nursing 

15 schools, schools of public health, schools of genetic 

16 counseling, internal education programs in State 

17 agencies, nongovernmental organizations, and pro18 fessional organizations and societies to develop and 

19 deliver education and training programs that in20 clude— 

21 ‘‘(A) continuing medical education pro22 grams for health care professionals and new23 born screening laboratory personnel in newborn 

24 screening; 

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

2 training on new discoveries in newborn screen3 ing and the use of any related technology; 

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

5 and assess and communicate the risks of, con6 genital conditions, including the prevalence and 

7 risk of some of these conditions based on family 

8 history; 

9 ‘‘(D) models to communicate effectively 

10 with parents and families about— 

11 ‘‘(i) the process and benefits of new12 born screening; 

13 ‘‘(ii) how to use information gathered 

14 from newborn screening; 

15 ‘‘(iii) the meaning of screening re16 sults, including the possibility of false posi17 tive findings; 

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

19 screening, if applicable; and 

20 ‘‘(v) the potential need for followup 

21 care after newborns are screened; 

22 ‘‘(E) information and resources on coordi23 nated systems of followup care after newborns 

24 are screened; 

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1 ‘‘(F) information on the disorders for 

2 which States require and offer newborn screen3 ing and options for newborn screening relating 

4 to conditions in addition to such disorders; 

5 ‘‘(G) information on additional newborn 

6 screening that may not be required by the 

7 State, but that may be available from other 

8 sources; and 

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

10 described in subsection (a)(1) as determined ap11 propriate by the Secretary. 

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

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

14 may use the grant funds to develop and deliver to 

15 parents, families, and patient advocacy and support 

16 groups, educational programs about newborn screen17 ing that include information on— 

18 ‘‘(A) what newborn screening is; 

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

20 ‘‘(C) who performs newborn screening; 

21 ‘‘(D) where newborn screening is per22 formed; 

23 ‘‘(E) the disorders for which the State re24 quires newborns to be screened; 

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1 ‘‘(F) different options for newborn screen2 ing for disorders other than those included by 

3 the State in the mandated newborn screening 

4 program; 

5 ‘‘(G) the meaning of various screening re6 sults, including the possibility of false positive 

7 and false negative findings; 

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

9 disorders, including the increased risk of dis10 orders that may stem from family history; 

11 ‘‘(I) coordinated systems of followup care 

12 after newborns are screened; and 

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

14 described in subsection (a)(2) as determined ap15 propriate by the Secretary. 

16 ‘‘(3) GRANTS FOR QUALITY NEWBORN SCREEN17 ING FOLLOWUP.—An eligible entity that receives a 

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

19 funds to— 

20 ‘‘(A) expand on existing procedures and 

21 systems, where appropriate and available, for 

22 the timely reporting of newborn screening re23 sults to individuals, families, primary care phy24 sicians, and subspecialists in congenital, ge25 netic, and metabolic disorders; 

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1 ‘‘(B) coordinate ongoing followup treat2 ment with individuals, families, primary care 

3 physicians, and subspecialists in congenital, ge4 netic, and metabolic disorders after a newborn 

5 receives an indication of the presence or in6 creased risk of a disorder on a screening test; 

7 ‘‘(C) ensure the seamless integration of 

8 confirmatory testing, tertiary care medical serv9 ices, comprehensive genetic services including 

10 genetic counseling, and information about ac11 cess to developing therapies by participation in 

12 approved clinical trials involving the primary 

13 health care of the infant; 

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

15 available, collected from newborn screenings to 

16 identify populations at risk for disorders affect17 ing newborns, examine and respond to health 

18 concerns, recognize and address relevant envi19 ronmental, behavioral, socioeconomic, demo20 graphic, and other relevant risk factors; and 

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

22 Secretary may determine necessary. 

23 ‘‘(f) REPORTS TO CONGRESS.— 

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

2 the Secretary shall submit to the appropriate com3 mittees 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 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 ‘‘(B) a subsequent report that includes the 

11 information described in paragraph (1), not 

12 later than 60 months after the date on which 

13 the first grant funds are awarded under this 

14 section. 

15 ‘‘(g) DEFINITION OF ELIGIBLE ENTITY.—In this sec16 tion, the term ‘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 

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1 ‘‘(5) a nongovernmental organization with ap2 propriate expertise in newborn screening, as deter3 mined by the Secretary. 

4 ‘‘(h) NATIONAL CONTINGENCY PLAN FOR NEWBORN

5 SCREENING.— 

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

7 after the date of enactment of this section, the Sec8 retary, acting through the Director of the Centers 

9 for Disease Control and Prevention and in consulta10 tion with the Associate Administrator, shall develop 

11 a national contingency plan for newborn screening 

12 for use in the event of a public health emergency 

13 that results in State or regional disruption of new14 born screening services. 

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

16 developed under paragraph (1) shall include a plan 

17 for— 

18 ‘‘(A) the collection and transport of speci19 mens; 

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

21 newborn screening laboratories; 

22 ‘‘(C) the processing of specimens; 

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

24 physicians and families; 

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1 ‘‘(E) the diagnostic confirmation of posi2 tive screening results; 

3 ‘‘(F) ensuring the availability of treatment 

4 and management resources; 

5 ‘‘(G) educating families about newborn 

6 screening; and 

7 ‘‘(H) carrying out other activities deter8 mined appropriate by the Secretary. 

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

10 are authorized to be appropriated to carry out this sec11 tion— 

12 ‘‘(1) $15,000,000 for fiscal year 2008; and 

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

14 of fiscal years 2009 through 2012.’’. 

15 SEC. 4. IMPROVED NEWBORN AND CHILD SCREENING FOR 

16 HERITABLE DISORDERS. 

17 Section 1109 of the Public Health Service Act (42 

18 U.S.C. 300b–8) is amended— 

19 (1) in subsection (c)(2)— 

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

21 ‘‘and’’ after the semicolon; 

22 (B) by redesignating subparagraph (F) as 

23 subparagraph (G); and 

24 (C) by inserting after subparagraph (E) 

25 the following: 

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

2 adopted and implemented, is in the process of 

3 adopting and implementing, or will use grant 

4 amounts received under this section to adopt 

5 and implement the guidelines and recommenda6 tions of the Advisory Committee on Heritable 

7 Disorders in Newborns and Children established 

8 under section 1111 (referred to in this section 

9 as the ‘Advisory Committee’) that are adopted 

10 by the Secretary and in effect at the time the 

11 grant is awarded or renewed under this section, 

12 which shall include the screening of each new13 born for the heritable disorders recommended 

14 by the Advisory Committee and adopted by the 

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

16 and 

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

18 and all that follows through the period at the end 

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

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

21 years 2009 through 2012.’’. 

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1 SEC. 5. EVALUATING THE EFFECTIVENESS OF NEWBORN2 AND CHILD-SCREENING PROGRAMS. 

3 Section 1110 of the Public Health Service Act (42 

4 U.S.C. 300b–9) is amended by adding at the end the fol5 lowing: 

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

7 are authorized to be appropriated to carry out this section 

8 $5,000,000 for fiscal year 2008 and such sums as may 

9 be necessary for each of the fiscal years 2009 through 

10 2012.’’. 

11 SEC. 6. ADVISORY COMMITTEE ON HERITABLE DISORDERS 

12 IN NEWBORNS AND CHILDREN. 

13 Section 1111 of the Public Health Service Act (42 

14 U.S.C. 300b–10) is amended— 

15 (1) in subsection (b)— 

16 (A) by redesignating paragraph (3) as 

17 paragraph (5); 

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

19 after the semicolon; 

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

21 following: 

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

23 newborn screening programs that includes the heri24 table disorders for which all newborns should be 

25 screened, including secondary conditions that may be 

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1 identified as a result of the laboratory methods used 

2 for screening; 

3 ‘‘(4) develop a model decision-matrix for new4 born screening program expansion, and periodically 

5 update the recommended uniform screening panel 

6 described in paragraph (3) based on such decision7 matrix; and’’; and 

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

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

10 end and inserting ‘‘, including recommenda11 tions, advice, or information dealing with— 

12 ‘‘(A) followup activities, including those 

13 necessary to achieve rapid diagnosis in the 

14 short term, and those that ascertain long-term 

15 case management outcomes and appropriate ac16 cess to related services; 

17 ‘‘(B) diagnostic and other technology used 

18 in screening; 

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

21 treatment; 

22 ‘‘(D) minimum standards and related poli23 cies and procedures for State newborn screen24 ing programs; 

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

2 evaluation of State newborn screening pro3 grams; 

4 ‘‘(F) data collection for assessment of new5 born screening programs; 

6 ‘‘(G) public and provider awareness and 

7 education; 

8 ‘‘(H) language and terminology used by 

9 State newborn screening programs; 

10 ‘‘(I) confirmatory testing and verification 

11 of positive results; and 

12 ‘‘(J) harmonization of laboratory defini13 tions for results that are within the expected 

14 range and results that are outside of the ex15 pected range.’’; and 

16 (2) by adding at the end the following: 

17 ‘‘(d) DECISION ON RECOMMENDATIONS.— 

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

19 after the Advisory Committee issues a recommenda20 tion pursuant to this section, the Secretary shall 

21 adopt or reject such recommendation. 

22 ‘‘(2) PENDING RECOMMENDATIONS.—The Sec23 retary shall adopt or reject any recommendation 

24 issued by the Advisory Committee that is pending on 

25 the date of enactment of the Newborn Screening 

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

2 after the date of enactment of such Act. 

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

4 The Secretary shall publicize any determination on 

5 adopting or rejecting a recommendation of the Advi6 sory Committee pursuant to this subsection, includ7 ing the justification for the determination. 

8 ‘‘(e) CONTINUATION OF OPERATION OF COM9 MITTEE.—Notwithstanding section 14 of the Federal Ad10 visory Committee Act (5 U.S.C. App.), the Advisory Com11 mittee shall continue to operate during the 5-year period 

12 beginning on the date of enactment of the Newborn 

13 Screening Saves Lives Act of 2007.’’. 

14 SEC. 7. LABORATORY QUALITY AND SURVEILLANCE. 

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

16 (42 U.S.C. 300b–1 et seq.) is amended by adding at the 

17 end the following: 

18 ‘‘SEC. 1112. LABORATORY QUALITY. 

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

20 the Director of the Centers for Disease Control and Pre21 vention and in consultation with the Advisory Committee 

22 on Heritable Disorders in Newborns and Children estab23 lished under section 1111, shall provide for— 

24 ‘‘(1) quality assurance for laboratories involved 

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1 orders, including quality assurance for newborn2 screening tests, performance evaluation services, and 

3 technical assistance and technology transfer to new4 born screening laboratories to ensure analytic valid5 ity and utility of screening tests; and 

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

7 screening tools for evaluating use on a mass scale. 

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

9 purpose of carrying out this section, there are authorized 

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

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

12 2009 through 2012. 

13 ‘‘SEC. 1113. SURVEILLANCE PROGRAMS FOR HERITABLE 

14 DISORDERS SCREENING. 

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

16 the Director of the Centers for Disease Control and Pre17 vention, in consultation with the Associate Administrator 

18 of the Maternal and Child Health Bureau of the Health 

19 Resources and Services Administration, shall carry out 

20 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 

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1 ing data on the causes of such disorders and on the 

2 incidence and prevalence of such disorders; 

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

4 of applied epidemiological research on the prevention 

5 of such disorders; 

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

7 the public on the prevention of such disorders; and 

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

9 prevention of such disorders, and secondary health 

10 conditions among individuals with such disorders. 

11 ‘‘(b) GRANTS AND CONTRACTS.— 

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

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

14 into contracts with public and nonprofit private enti15 ties. 

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

17 AWARD FUNDS.— 

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

19 recipient of an award of a grant or contract 

20 under paragraph (1), the Secretary may, sub21 ject to subparagraph (B), provide supplies, 

22 equipment, and services for the purpose of aid23 ing the recipient in carrying out the purposes 

24 for which the award is made and, for such pur25 poses, may detail to the recipient any officer or 

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1 employee of the Department of Health and 

2 Human Services. 

3 ‘‘(B) REDUCTION.—With respect to a re4 quest described in subparagraph (A), the Sec5 retary shall reduce the amount of payments 

6 under the award involved by an amount equal 

7 to the costs of detailing personnel and the fair 

8 market value of any supplies, equipment, or 

9 services provided by the Secretary. The Sec10 retary shall, for the payment of expenses in11 curred in complying with such request, expend 

12 the amounts withheld. 

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

14 may make an award of a grant or contract under 

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

16 is submitted to the Secretary and the application is 

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

18 such agreements, assurances, and information as the 

19 Secretary determines to be necessary to carry out 

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

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

22 1 of fiscal year 2008 and of every second such year there23 after, the Secretary shall submit to the Committee on En24 ergy and Commerce of the House of Representatives, and 

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1 sions of the Senate, a report that, with respect to the pre2 ceding 2 fiscal years— 

3 ‘‘(1) contains information regarding the inci4 dence and prevalence of heritable disorders and the 

5 health status of individuals with such disorders and 

6 the extent to which such disorders have contributed 

7 to the incidence and prevalence of infant mortality 

8 and affected quality of life; 

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

10 that is specific to various racial and ethnic groups 

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

12 Native Americans, and Asian Americans); 

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

14 which various approaches of preventing heritable dis15 orders and secondary health conditions among indi16 viduals with such disorders have been effective; 

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

18 this section; 

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

20 prevalence of individuals living with heritable dis21 orders, information on the health status of individ22 uals with such disorders, information on any health 

23 disparities experienced by such individuals, and rec24 ommendations for improving the health and wellness 

25 and quality of life of such individuals; 

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1 ‘‘(6) contains a summary of recommendations 

2 from all heritable disorders research conferences 

3 sponsored by the Centers for Disease Control and 

4 Prevention; and 

5 ‘‘(7) contains any recommendations of the Sec6 retary regarding this section. 

7 ‘‘(d) APPLICABILITY OF PRIVACY LAWS.—The provi8 sions of this section shall be subject to the requirements 

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

10 laws relating to the privacy of information shall apply to 

11 the data and information that is collected under this sec12 tion. 

13 ‘‘(e) COORDINATION.— 

14 ‘‘(1) IN GENERAL.—In carrying out this sec15 tion, the Secretary shall coordinate, to the extent 

16 practicable, programs under this section with pro17 grams on birth defects and developmental disabilities 

18 authorized under section 317C. 

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

20 In making grants and contracts under this section, 

21 the Secretary shall give priority to entities that dem22 onstrate the ability to coordinate activities under a 

23 grant or contract made under this section with exist24 ing birth defects surveillance activities. 

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

2 purpose of carrying out this section, there are authorized 

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

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

5 2009 through 2012.’’. 

Æ 

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