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 hered-
itary disorders, and for other purposes.
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ‘‘Hereditary Disorders
Newborn Screening Act of 2000’’.
SEC. 2. PROGRAM TO IMPROVE THE ABILITY OF STATES TO
PROVIDE NEWBORN AND CHILD SCREENING
FOR HERITABLE DISORDERS.
Part A of title XI of the Public Health Service Act
(42 U.S.C. 300b–1 et seq.) is amended by adding at the
end the following:
‘‘SEC. 1108. IMPROVED NEWBORN AND CHILD SCREENING
FOR HERITABLE DISORDERS.
‘‘(a) IN GENERAL.—The Secretary, acting through
the Administrator of the Health Resources and Services
Administration, shall award grants to eligible entities to
enhance, improve or expand the ability of State and local
public health agencies to provide screening, counseling or
preventive care services to newborns and children having
or at risk for heritable disorders.
‘‘(b) USE OF FUNDS.—Amounts provided under a
grant awarded under subsection (a) shall be used to—
‘‘(1) establish, expand, or improve systems or
programs to provide screening, counseling, testing or
specialty services for newborns and children at risk
for heritable disorders;
‘‘(2) establish, expand, or improve programs or
services to reduce mortality or morbidity from heri-
table disorders;
‘‘(3) establish, expand, or improve systems or
programs to provide information and counseling on
available therapies for newborns and children with
heritable disorders;
‘‘(4) improve the access of medically under-
served populations to screening, counseling, testing
and specialty services for newborns and children
having or at risk for heritable disorders; or
‘‘(5) conduct such other activities as may be
necessary to enable newborns and children having or
at risk for heritable disorders to receive screening,
counseling, testing or specialty services, regardless of
income, race, color, religion, sex, national origin,
age, or disability.
‘‘(c) ELIGIBLE ENTITIES.—To be eligible to receive
a grant under subsection (a) an entity shall—
‘‘(1) be a State or political subdivision of a
State, or a consortium of 2 or more States or polit-
ical subdivisions of States; and
‘‘(2) prepare and submit to the Secretary an
application that includes—
‘‘(A) a plan to use amounts awarded under
the grant to meet specific health status goals
and objectives relative to heritable disorders, in-
cluding attention to needs of medically under-
served populations;
‘‘(B) a plan for the collection of outcome
data or other methods of evaluating the degree
to which amounts awarded under this grant will
be used to achieve the goals and objectives iden-
tified under subparagraph (A);
‘‘(C) a plan for monitoring and ensuring
the quality of services provided under the grant;
‘‘(D) an assurance that amounts awarded
under the grant will be used only to implement
the approved plan for the State;
‘‘(E) an assurance that the provision of
services under the plan is coordinated with serv-
ices provided under programs implemented in
the State under titles V, XVIII, XIX, XX, or
XXI of the Social Security Act (subject to Fed-
eral regulations applicable to such programs) so
that the coverage of services under such titles
is not substantially diminished by the use of
granted funds; and
‘‘(F) such other information determined by
the Secretary to be necessary.
‘‘(d) LIMITATION.—An eligible entity may not use
amounts received under this section to—
‘‘(1) provide cash payments to or on behalf of
affected individuals;
‘‘(2) provide inpatient services;
‘‘(3) purchase land or make capital improve-
ments to property; or
‘‘(4) provide for proprietary research or train-
ing.
‘‘(e) VOLUNTARY PARTICIPATION.—The participa-
tion by any individual in any program or portion thereof
established or operated with funds received under this sec-
tion shall be wholly voluntary and shall not be a pre-
requisite to eligibility for or receipt of any other service
or assistance from, or to participation in, another Federal
or State program.
‘‘(f) SUPPLEMENT NOT SUPPLANT.—Funds appro-
priated under this section shall be used to supplement and
not supplant other Federal, State, and local public funds
provided for activities of the type described in this section.
‘‘(g) PUBLICATION.
‘‘(1) IN GENERAL.—An application submitted
under subsection (c)(2) shall be made public by the
State in such a manner as to facilitate comment
from any person, including through hearings and
other methods used to facilitate comments from the
public.
‘‘(2) COMMENTS.—Comments received by the
State after the publication described in paragraph
(1) shall be addressed in the application submitted
under subsection (c)(2).
‘‘(h) TECHNICAL ASSISTANCE.—The Secretary shall
provide to entities receiving grants under subsection (a)
such technical assistance as may be necessary to ensure
the quality of programs conducted under this section.
‘‘(i) AUTHORIZATION OF APPROPRIATIONS.—There
are authorized to be appropriated to carry out this section,
such sums as may be necessary for each of the fiscal years
2001 through 2011.
‘‘SEC. 1109. EVALUATING THE EFFECTIVENESS OF NEW-
BORN AND CHILD SCREENING PROGRAMS.
‘‘(a) IN
GENERAL.—The Secretary shall award
grants to eligible entities to provide for the conduct of
demonstration programs to evaluate the effectiveness of
screening, counseling or preventive care services in reduc-
ing the morbidity and mortality caused by heritable dis-
orders in newborns and children.
‘‘(b) DEMONSTRATION PROGRAMS.—A demonstra-
tion program conducted under a grant under this section
shall be designed to evaluate and assess, within the juris-
diction of the entity receiving such grant—
‘‘(1) the effectiveness of screening, counseling,
testing or specialty services for newborns and chil-
dren at risk for heritable disorders in reducing the
morbidity and mortality associated with such dis-
orders;
‘‘(2) the effectiveness of screening, counseling,
testing or specialty services in accurately and reli-
ably diagnosing heritable disorders in newborns and
children; or
‘‘(3) the availability of screening, counseling,
testing or specialty services for newborns and chil-
dren at risk for heritable disorders.
‘‘(c) ELIGIBLE ENTITIES.—To be eligible to receive
a grant under subsection (a) an entity shall be a State
or political subdivision of a State, or a consortium of 2
or more States or political subdivisions of States.
‘‘SEC. 1110. ADVISORY COMMITTEE ON HERITABLE DIS-
ORDERS IN NEWBORNS AND CHILDREN.
‘‘(a) ESTABLISHMENT.—The Secretary shall estab-
lish an advisory committee to be known as the ‘Advisory
Committee on Heritable Disorders in Newborns and Chil-
dren’ (referred to in this section as the ‘Advisory Com-
mittee’).
‘‘(b) DUTIES.—The Advisory Committee shall—
‘‘(1) provide advice and recommendations to the
Secretary concerning grants and projects awarded or
funded under section 1108;
‘‘(2) provide technical information to the Sec-
retary for the development of policies and priorities
for the administration of grants under section 1108;
and
‘‘(3) provide such recommendations, advice or
information as may be necessary to enhance, expand
or improve the ability of the Secretary to reduce the
mortality or morbidity from heritable disorders.
‘‘(c) MEMBERSHIP.—
‘‘(1) IN GENERAL.—The Secretary shall appoint
not to exceed 15 members to the Advisory Com-
mittee. In appointing such members, the Secretary
shall ensure that the total membership of the Advi-
sory Committee is an odd number.
‘‘(2) REQUIRED
MEMBERS.—The Secretary
shall appoint to the Advisory Committee under para-
graph (1)—
‘‘(A) the Administrator of the Health Re-
sources and Services Administration;
‘‘(B) the Director of the Centers for Dis-
ease Control and Prevention;
‘‘(C) the Director of the National Insti-
tutes of Health;
‘‘(D) the Director of the Agency for
Healthcare Research and Quality;
‘‘(E) medical or scientific professionals
with special expertise in heritable disorders, or
in providing screening, counseling, testing or
specialty services for newborns and children at
risk for heritable disorders;
‘‘(F) members of the public having special
expertise about or concern with heritable dis-
orders; and
‘‘(G) representatives from such Federal
agencies, public health constituencies, and med-
ical professional societies as determined to be
necessary by the Secretary, to fulfill the duties
of the Advisory Committee, as established
under subsection (b).’’.
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