II

106TH CONGRESS

1ST SESSION S. 1131

To promote research into, and the development of an ultimate cure for,

the disease known as Fragile X.

IN THE SENATE OF THE UNITED STATES

MAY 26, 1999

Mr. EDWARDS (for himself and Mr. HAGEL) introduced the following bill;

which was read twice and referred to the Committee on Health, Education, Labor, and Pensions

A BILL

To promote research into, and the development of an

ultimate cure for, the disease known as Fragile X.

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 ‘‘Fragile X Research

5 Breakthrough Act of 1999’’.

6 SEC. 2. FINDINGS.

7 Congress makes the following findings:

8 (1) Fragile X is the most common inherited

9 cause of mental retardation. It affects 1 in every
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1 2,000 boys and 1 in every 4,000 girls. One in 260

2 women is a carrier.

3 (2) Most children with Fragile X require a life4 time of special care at a cost of over $2,000,000 per

5 child.

6 (3) Relatively newly-discovered and relatively

7 unknown, even in the medical profession, Fragile X

8 is caused by the absence of a single protein that can

9 be produced synthetically but that cannot yet be ef10 fectively assimilated.

11 (4) Fragile X research, both basic and applied,

12 is vastly underfunded in view of its prevalence, the

13 potential for the development of a cure, the estab14 lished benefits of currently available interventions,

15 and the significance that Fragile X research has for

16 related disorders.

17 (5) Fragile X is a powerful research model for

18 other forms of X-linked mental retardation, as well

19 as neuropsychiatric disorders, including autism,

20 schizophrenia, mood disorders, and pervasive devel21 opmental disorder. Individuals with Fragile X are a

22 homogeneous study population for advancing under23 standing of these disorders.
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1 SEC. 3. NATIONAL INSTITUTE OF CHILD HEALTH AND

2 HUMAN DEVELOPMENT; RESEARCH ON FRAG3 ILE X.

4 Subpart 7 of part C of title IV of the Public Health

5 Service Act (42 U.S.C. 285g et seq.) is amended by adding

6 at the end the following:

7 ‘‘SEC. 452E. FRAGILE X.

8 ‘‘(a) EXPANSION AND COORDINATION OF RESEARCH

9 ACTIVITIES.—The Director of the Institute, after con10 sultation with the advisory council for the Institute, shall

11 expand, intensify, and coordinate the activities of the In12 stitute with respect to research on the disease known as

13 Fragile X.

14 ‘‘(b) RESEARCH CENTERS.—

15 ‘‘(1) IN GENERAL.—The Director of the Insti16 tute, after consultation with the advisory council for

17 the Institute, shall make grants to, or enter into

18 contracts with, public or nonprofit private entities

19 for the development and operation of centers to con20 duct research for the purposes of improving the di21 agnosis and treatment of, and finding the cure for,

22 Fragile X.

23 ‘‘(2) NUMBER OF CENTERS.—In carrying out

24 paragraph (1), the Director of the Institute shall, to

25 the extent that amounts are appropriated, provide
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1 for the establishment of at least 3 Fragile X re2 search centers.

3 ‘‘(3) ACTIVITIES.—

4 ‘‘(A) IN GENERAL.—Each center assisted

5 under paragraph (1) shall, with respect to

6 Fragile X—

7 ‘‘(i) conduct basic and clinical re8 search, which may include clinical trials

9 of—

10 ‘‘(I) new or improved diagnostic

11 methods; and

12 ‘‘(II) drugs or other treatment

13 approaches; and

14 ‘‘(ii) conduct research to find a cure.

15 ‘‘(B) FEES.—A center may use funds pro16 vided under paragraph (1) to provide fees to in17 dividuals serving as subjects in clinical trials

18 conducted under subparagraph (A).

19 ‘‘(4) COORDINATION AMONG CENTERS.—The

20 Director of the Institute shall, as appropriate, pro21 vide for the coordination of the activities of the cen22 ters assisted under this section, including providing

23 for the exchange of information among the centers.

24 ‘‘(5) CERTAIN ADMINISTRATIVE REQUIRE25 MENTS.—Each center assisted under paragraph (1)
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1 shall use the facilities of a single institution, or be

2 formed from a consortium of cooperating institu3 tions, meeting such requirements as may be pre4 scribed by the Director of the Institute.

5 ‘‘(6) DURATION OF SUPPORT.—Support may be

6 provided to a center under paragraph (1) for a pe7 riod of not to exceed 5 years. Such period may be

8 extended for 1 or more additional periods, each of

9 which may not exceed 5 years, if the operations of

10 such center have been reviewed by an appropriate

11 technical and scientific peer review group established

12 by the Director and if such group has recommended

13 to the Director that such period be extended.

14 ‘‘(7) AUTHORIZATION OF APPROPRIATIONS.—

15 For the purpose of carrying out this subsection,

16 there are authorized to be appropriated $10,000,000

17 for fiscal year 2000, and such sums as may be nec18 essary for each subsequent fiscal year.’’.

19 SEC. 4. NATIONAL INSTITUTE OF CHILD HEALTH AND

20 HUMAN DEVELOPMENT; LOAN REPAYMENT

21 PROGRAM REGARDING RESEARCH ON FRAG22 ILE X.

23 Part G of title IV of the Public Health Service Act

24 (42 U.S.C. 288 et seq.) is amended by inserting after sec25 tion 487E the following:
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1 ‘‘SEC. 487F. LOAN REPAYMENT PROGRAM REGARDING RE2 SEARCH ON FRAGILE X.

3 ‘‘(a) IN GENERAL.—The Secretary, in consultation

4 with the Director of the National Institute of Child Health

5 and Human Development, shall establish a program under

6 which the Federal Government enters into contracts with

7 qualified health professionals (including graduate stu8 dents) who agree to conduct research regarding Fragile

9 X in consideration of the Federal Government’s agreement

10 to repay, for each year of such service, not more than

11 $35,000 of the principal and interest of the educational

12 loans owed by such health professionals.

13 ‘‘(b) APPLICABILITY OF CERTAIN PROVISIONS.—

14 With respect to the National Health Service Corps Loan

15 Repayment Program established in subpart III of part D

16 of title III, the provisions of such subpart (including sec17 tion 338B(g)(3)) shall, except as inconsistent with sub18 section (a) of this section, apply to the program estab19 lished in such subsection in the same manner and to the

20 same extent as such provisions apply to the National

21 Health Service Corps Loan Repayment Program estab22 lished in such subpart.

23 ‘‘(c) AUTHORIZATION OF APPROPRIATIONS.—For the

24 purpose of carrying out this section, there are authorized

25 to be appropriated $2,000,000 for fiscal year 2000, and

26 such sums as may be necessary for each subsequent fiscal
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1 year. Amounts appropriated for a fiscal year under the

2 preceding sentence shall remain available until the expira3 tion of the second fiscal year beginning after the fiscal

4 year for which the amounts were appropriated.’’.

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