I 

108TH CONGRESS 

2D SESSION H. R. 4493 

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, and for other 

purposes. 

IN THE HOUSE OF REPRESENTATIVES 

JUNE 2, 2004 

Ms. ROYBAL-ALLARD (for herself, Mr. SIMPSON, Mr. SERRANO, Mr. KILDEE, 

Mr. GORDON, Mr. ANDREWS, Mr. GREEN of Texas, Mr. WALSH, Mr. 

WEXLER, Mr. MEEHAN, Mr. CUNNINGHAM, and Mr. SCHIFF) 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, 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 2004’’. 
2 

•HR 4493 IH 

1 SEC. 2. FINDINGS. 

2 Congress finds the following: 

3 (1) Currently, it is possible to test for at least 

4 30 disorders through newborn screening. 

5 (2) There is a lack of uniform newborn screen6 ing throughout the United States. While a newborn 

7 with a debilitating condition may receive screening, 

8 early detection, and treatment in one location, in an9 other location the condition may go undetected and 

10 result in catastrophic consequences. 

11 (3) Each year more than 4,000,000 babies are 

12 screened to detect conditions that may threaten their 

13 long-term health. 

14 (4) There are more than 2,000 babies born 

15 every year in the United States with detectable and 

16 treatable disorders that go unscreened through new17 born screening. 

18 SEC. 3. AMENDMENT TO PUBLIC HEALTH SERVICE ACT. 

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

20 (42 U.S.C. 280h et seq.) is amended by adding at the end 

21 the following: 

22 ‘‘SEC. 399AA. NEWBORN SCREENING. 

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

24 ‘‘(1) GRANTS TO ASSIST HEALTH CARE PROFES25 SIONALS.—From funds appropriated under sub26 section (h), the Secretary, acting through the Asso-
3 

•HR 4493 IH 

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 State health 

10 department 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.—From 

18 funds appropriated under subsection (h), the Sec19 retary, acting through the Associate Administrator 

20 and in consultation with the Advisory Committee, 

21 shall award grants to eligible entities to enable such 

22 entities to develop and deliver educational programs 

23 about newborn screening to parents, families, and 

24 patient advocacy and support groups. 
4 

•HR 4493 IH 

1 ‘‘(3) GRANTS FOR NEWBORN SCREENING FOL2 LOWUP.—From funds appropriated under subsection 

3 (h), the Secretary, acting through the Associate Ad4 ministrator and in consultation with the Advisory 

5 Committee, shall award grants to eligible entities to 

6 enable such entities to establish, maintain, and oper7 ate a system to assess and coordinate treatment re8 lating to congenital, genetic, and metabolic dis9 orders. 

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 FOR APPROVAL.—An 

23 application submitted under subsection (b) may 

24 not be approved by the Secretary unless the ap-
5 

•HR 4493 IH 

1 plication contains assurances that the eligible 

2 entity— 

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

4 purposes specified in the approved applica5 tion and in accordance with the require6 ments of this section; and 

7 ‘‘(ii) will establish such fiscal control 

8 and fund accounting procedures as may be 

9 necessary to assure proper disbursement 

10 and accounting of Federal funds paid to 

11 the eligible entity under the grant. 

12 ‘‘(B) EXISTING PROGRAMS.—Prior to 

13 awarding a grant under this section, the Sec14 retary shall— 

15 ‘‘(i) conduct an assessment of existing 

16 educational resources and training pro17 grams and coordinated systems of followup 

18 care with respect to newborn screening; 

19 and 

20 ‘‘(ii) take all necessary steps to mini21 mize the duplication of the resources and 

22 programs described in clause (i). 

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

24 necessary steps to coordinate programs funded with 

25 grants received under this section. 
6 

•HR 4493 IH 

1 ‘‘(e) USE OF GRANT FUNDS.— 

2 ‘‘(1) GRANTS TO ASSIST HEALTH CARE PROFES3 SIONALS.—An eligible entity that receives a grant 

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

5 work with appropriate medical schools, nursing 

6 schools, schools of public health, internal education 

7 programs in State agencies, nongovernmental orga8 nizations, and professional organizations and soci9 eties to develop and deliver education and training 

10 programs that include— 

11 ‘‘(A) continuing medical education pro12 grams for health care professionals and State 

13 health department laboratory personnel in new14 born screening; 

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

16 training on new discoveries in newborn screen17 ing and the use of any related technology; 

18 ‘‘(C) models to evaluate what a newborn 

19 should be screened for and when and where 

20 that screening should take place; 

21 ‘‘(D) models to evaluate the prevalence of, 

22 and assess and communicate the risks of, new23 born disorders, including the prevalence and 

24 risk of certain newborn disorders based on fam25 ily history; 
7 

•HR 4493 IH 

1 ‘‘(E) models to communicate effectively 

2 with parents and families about— 

3 ‘‘(i) the process and benefits of new4 born screening; 

5 ‘‘(ii) how to use information gathered 

6 from newborn screening; 

7 ‘‘(iii) the meaning of screening re8 sults, including the rate of false positives; 

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

10 screening; and 

11 ‘‘(v) the potential need for followup 

12 care after newborns are screened; 

13 ‘‘(F) information and resources on coordi14 nated systems of followup care after newborns 

15 are screened; 

16 ‘‘(G) information on the disorders for 

17 which States require and offer newborn screen18 ing and options for newborn screening relating 

19 to conditions in addition to such disorders; 

20 ‘‘(H) information on supplemental newborn 

21 screening that the States do not require and 

22 offer but that parents may want; and 

23 ‘‘(I) other items to carry out the purpose 

24 described in subsection (a)(1) as determined ap25 propriate by the Secretary. 
8 

•HR 4493 IH 

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

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

3 may use the grant funds to develop and deliver to 

4 parents, families, and patient advocacy and support 

5 groups, educational programs about newborn screen6 ing that include information on— 

7 ‘‘(A) what is newborn screening; 

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

9 ‘‘(C) who performs newborn screening; 

10 ‘‘(D) where newborn screening is per11 formed; 

12 ‘‘(E) the disorders for which the State re13 quires newborns to be screened; 

14 ‘‘(F) different options for newborn screen15 ing for disorders other than those included by 

16 the State in the mandated newborn screening 

17 program; 

18 ‘‘(G) the meaning of various screening re19 sults including the rate of false positives; 

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

21 disorders, including the increased risk of dis22 orders that may stem from family history; 

23 ‘‘(I) coordinated systems of followup care 

24 after newborns are screened; and 
9 

•HR 4493 IH 

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

2 described in subsection (a)(2) as determined ap3 propriate by the Secretary. 

4 ‘‘(3) GRANTS FOR QUALITY NEWBORN SCREEN5 ING FOLLOWUP.—An eligible entity that receives a 

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

7 funds to— 

8 ‘‘(A) expand on existing procedures and 

9 systems, where appropriate and available, for 

10 the timely reporting of newborn screening re11 sults to individuals, families, primary care phy12 sicians, and subspecialists in congenital, ge13 netic, and metabolic disorders; 

14 ‘‘(B) coordinate ongoing followup treat15 ment with individuals, families, primary care 

16 physicians, and subspecialists in congenital, ge17 netic, and metabolic disorders after a newborn 

18 receives an indication of the presence of a dis19 order on a screening test; 

20 ‘‘(C) ensure the seamless integration of 

21 confirmatory testing, tertiary care medical serv22 ices, comprehensive genetic services including 

23 genetic counseling, and information about ac24 cess to developing therapies by participation in 
10 

•HR 4493 IH 

1 approved clinical trials involving the primary 

2 health care of the infant; 

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

4 available, collected from newborn screenings to 

5 identify populations at risk for disorders affect6 ing newborns, examine and respond to health 

7 concerns, recognize and address relevant envi8 ronmental, behavioral, socioeconomic, demo9 graphic, and other relevant risk factors; and 

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

11 Secretary may determine necessary. 

12 ‘‘(f) REPORTS TO CONGRESS.— 

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

14 the Secretary shall submit to the appropriate com15 mittees of Congress reports— 

16 ‘‘(A) evaluating the effectiveness and the 

17 impact of the grants awarded under this sec18 tion— 

19 ‘‘(i) in promoting newborn screen20 ing— 

21 ‘‘(I) education and resources for 

22 families; and 

23 ‘‘(II) education, resources, and 

24 training for health care professionals; 
11 

•HR 4493 IH 

1 ‘‘(ii) on the successful diagnosis and 

2 treatment of congenital, genetic, and meta3 bolic disorders; and 

4 ‘‘(iii) on the continued development of 

5 coordinated systems of followup care after 

6 newborns are screened; 

7 ‘‘(B) describing and evaluating the effec8 tiveness of the activities carried out with grant 

9 funds received under this section; and 

10 ‘‘(C) that include recommendations for 

11 Federal actions to support— 

12 ‘‘(i) education and training in new13 born screening; and 

14 ‘‘(ii) followup care after newborns are 

15 screened. 

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

17 submit— 

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

19 information described in paragraph (1), not 

20 later than 30 months after the date on which 

21 the first grant funds are awarded under this 

22 section; and 

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

24 information described in paragraph (1), not 

25 later than 60 months after the date on which 
12 

•HR 4493 IH 

1 the first grant funds are awarded under this 

2 section. 

3 ‘‘(g) DEFINITION OF ELIGIBLE ENTITY.—In this sec4 tion, the term ‘eligible entity’ means— 

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

6 State; 

7 ‘‘(2) a consortium of 2 or more States or polit8 ical subdivisions of States; 

9 ‘‘(3) a territory; 

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

11 health care facility of the Indian Health Service; or 

12 ‘‘(5) a nongovernmental organization with ap13 propriate expertise in newborn screening, as deter14 mined by the Secretary. 

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

16 are authorized to be appropriated to carry out this sec17 tion— 

18 ‘‘(1) $15,000,000 for fiscal year 2005; and 

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

20 of fiscal years 2006 through 2009.’’. 

Æ