I

106TH CONGRESS

2D SESSION H. R. 5260

To amend the Public Health Service Act to provide for a national system

of screening newborn infants for hereditary disorders, and for other purposes.

IN THE HOUSE OF REPRESENTATIVES

SEPTEMBER 21, 2000

Mr. PALLONE (for himself, Mr. FROST, Mr. BROWN of Ohio, Ms. CARSON,

Mr. MURTHA, and Mr. WAXMAN) introduced the following bill; which was

referred to the Committee on Commerce

A BILL

To amend the Public Health Service Act to provide for

a national system of screening newborn infants for hereditary disorders, 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,
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1 SECTION 1. SHORT TITLE.

2 This Act may be cited as the ‘‘Hereditary Disorders

3 Newborn Screening Act of 2000’’.

4 SEC. 2. PROGRAM TO IMPROVE THE ABILITY OF STATES TO

5 PROVIDE NEWBORN AND CHILD SCREENING

6 FOR HERITABLE DISORDERS.

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

8 (42 U.S.C. 300b–1 et seq.) is amended by adding at the

9 end the following:

10 ‘‘SEC. 1108. IMPROVED NEWBORN AND CHILD SCREENING

11 FOR HERITABLE DISORDERS.

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

13 the Administrator of the Health Resources and Services

14 Administration, shall award grants to eligible entities to

15 enhance, improve or expand the ability of State and local

16 public health agencies to provide screening, counseling or

17 preventive care services to newborns and children having

18 or at risk for heritable disorders.

19 ‘‘(b) USE OF FUNDS.—Amounts provided under a

20 grant awarded under subsection (a) shall be used to—

21 ‘‘(1) establish, expand, or improve systems or

22 programs to provide screening, counseling, testing or

23 specialty services for newborns and children at risk

24 for heritable disorders;
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1 ‘‘(2) establish, expand, or improve programs or

2 services to reduce mortality or morbidity from heri3 table disorders;

4 ‘‘(3) establish, expand, or improve systems or

5 programs to provide information and counseling on

6 available therapies for newborns and children with

7 heritable disorders;

8 ‘‘(4) improve the access of medically under9 served populations to screening, counseling, testing

10 and specialty services for newborns and children

11 having or at risk for heritable disorders; or

12 ‘‘(5) conduct such other activities as may be

13 necessary to enable newborns and children having or

14 at risk for heritable disorders to receive screening,

15 counseling, testing or specialty services, regardless of

16 income, race, color, religion, sex, national origin,

17 age, or disability.

18 ‘‘(c) ELIGIBLE ENTITIES.—To be eligible to receive

19 a grant under subsection (a) an entity shall—

20 ‘‘(1) be a State or political subdivision of a

21 State, or a consortium of 2 or more States or polit22 ical subdivisions of States; and

23 ‘‘(2) prepare and submit to the Secretary an

24 application that includes—
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1 ‘‘(A) a plan to use amounts awarded under

2 the grant to meet specific health status goals

3 and objectives relative to heritable disorders, in4 cluding attention to needs of medically under5 served populations;

6 ‘‘(B) a plan for the collection of outcome

7 data or other methods of evaluating the degree

8 to which amounts awarded under this grant will

9 be used to achieve the goals and objectives iden10 tified under subparagraph (A);

11 ‘‘(C) a plan for monitoring and ensuring

12 the quality of services provided under the grant;

13 ‘‘(D) an assurance that amounts awarded

14 under the grant will be used only to implement

15 the approved plan for the State;

16 ‘‘(E) an assurance that the provision of

17 services under the plan is coordinated with serv18 ices provided under programs implemented in

19 the State under titles V, XVIII, XIX, XX, or

20 XXI of the Social Security Act (subject to Fed21 eral regulations applicable to such programs) so

22 that the coverage of services under such titles

23 is not substantially diminished by the use of

24 granted funds; and
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1 ‘‘(F) such other information determined by

2 the Secretary to be necessary.

3 ‘‘(d) LIMITATION.—An eligible entity may not use

4 amounts received under this section to—

5 ‘‘(1) provide cash payments to or on behalf of

6 affected individuals;

7 ‘‘(2) provide inpatient services;

8 ‘‘(3) purchase land or make capital improve9 ments to property; or

10 ‘‘(4) provide for proprietary research or train11 ing.

12 ‘‘(e) VOLUNTARY PARTICIPATION.—The participa13 tion by any individual in any program or portion thereof

14 established or operated with funds received under this sec15 tion shall be wholly voluntary and shall not be a pre16 requisite to eligibility for or receipt of any other service

17 or assistance from, or to participation in, another Federal

18 or State program.

19 ‘‘(f) SUPPLEMENT NOT SUPPLANT.—Funds appro20 priated under this section shall be used to supplement and

21 not supplant other Federal, State, and local public funds

22 provided for activities of the type described in this section.

23 ‘‘(g) PUBLICATION.

24 ‘‘(1) IN GENERAL.—An application submitted

25 under subsection (c)(2) shall be made public by the
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1 State in such a manner as to facilitate comment

2 from any person, including through hearings and

3 other methods used to facilitate comments from the

4 public.

5 ‘‘(2) COMMENTS.—Comments received by the

6 State after the publication described in paragraph

7 (1) shall be addressed in the application submitted

8 under subsection (c)(2).

9 ‘‘(h) TECHNICAL ASSISTANCE.—The Secretary shall

10 provide to entities receiving grants under subsection (a)

11 such technical assistance as may be necessary to ensure

12 the quality of programs conducted under this section.

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

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

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

16 2001 through 2011.

17 ‘‘SEC. 1109. EVALUATING THE EFFECTIVENESS OF NEW18 BORN AND CHILD SCREENING PROGRAMS.

19 ‘‘(a) IN GENERAL.—The Secretary shall award

20 grants to eligible entities to provide for the conduct of

21 demonstration programs to evaluate the effectiveness of

22 screening, counseling or preventive care services in reduc23 ing the morbidity and mortality caused by heritable dis24 orders in newborns and children.
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1 ‘‘(b) DEMONSTRATION PROGRAMS.—A demonstra2 tion program conducted under a grant under this section

3 shall be designed to evaluate and assess, within the juris4 diction of the entity receiving such grant—

5 ‘‘(1) the effectiveness of screening, counseling,

6 testing or specialty services for newborns and chil7 dren at risk for heritable disorders in reducing the

8 morbidity and mortality associated with such dis9 orders;

10 ‘‘(2) the effectiveness of screening, counseling,

11 testing or specialty services in accurately and reli12 ably diagnosing heritable disorders in newborns and

13 children; or

14 ‘‘(3) the availability of screening, counseling,

15 testing or specialty services for newborns and chil16 dren at risk for heritable disorders.

17 ‘‘(c) ELIGIBLE ENTITIES.—To be eligible to receive

18 a grant under subsection (a) an entity shall be a State

19 or political subdivision of a State, or a consortium of 2

20 or more States or political subdivisions of States.

21 ‘‘SEC. 1110. ADVISORY COMMITTEE ON HERITABLE DIS22 ORDERS IN NEWBORNS AND CHILDREN.

23 ‘‘(a) ESTABLISHMENT.—The Secretary shall estab24 lish an advisory committee to be known as the ‘Advisory

25 Committee on Heritable Disorders in Newborns and Chil-
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1 dren’ (referred to in this section as the ‘Advisory Com2 mittee’).

3 ‘‘(b) DUTIES.—The Advisory Committee shall—

4 ‘‘(1) provide advice and recommendations to the

5 Secretary concerning grants and projects awarded or

6 funded under section 1108;

7 ‘‘(2) provide technical information to the Sec8 retary for the development of policies and priorities

9 for the administration of grants under section 1108;

10 and

11 ‘‘(3) provide such recommendations, advice or

12 information as may be necessary to enhance, expand

13 or improve the ability of the Secretary to reduce the

14 mortality or morbidity from heritable disorders.

15 ‘‘(c) MEMBERSHIP.—

16 ‘‘(1) IN GENERAL.—The Secretary shall appoint

17 not to exceed 15 members to the Advisory Com18 mittee. In appointing such members, the Secretary

19 shall ensure that the total membership of the Advi20 sory Committee is an odd number.

21 ‘‘(2) REQUIRED MEMBERS.—The Secretary

22 shall appoint to the Advisory Committee under para23 graph (1)—

24 ‘‘(A) the Administrator of the Health Re25 sources and Services Administration;
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1 ‘‘(B) the Director of the Centers for Dis2 ease Control and Prevention;

3 ‘‘(C) the Director of the National Insti4 tutes of Health;

5 ‘‘(D) the Director of the Agency for

6 Healthcare Research and Quality;

7 ‘‘(E) medical or scientific professionals

8 with special expertise in heritable disorders, or

9 in providing screening, counseling, testing or

10 specialty services for newborns and children at

11 risk for heritable disorders;

12 ‘‘(F) members of the public having special

13 expertise about or concern with heritable dis14 orders; and

15 ‘‘(G) representatives from such Federal

16 agencies, public health constituencies, and med17 ical professional societies as determined to be

18 necessary by the Secretary, to fulfill the duties

19 of the Advisory Committee, as established

20 under subsection (b).’’.

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