II

Calendar No. 104

104TH CONGRESS

1ST SESSION S. 184

[Report No. 104–79]

To establish an Office for Rare Disease Research in the National Institutes

of Health, and for other purposes.

IN THE SENATE OF THE UNITED STATES

JANUARY 9, 1995

Mr. HATFIELD introduced the following bill; which was read twice and

referred to the Committee on Labor and Human Resources

MAY 4 (legislative day, MAY 1), 1995

Reported by Mrs. KASSEBAUM, without amendment

A BILL

To establish an Office for Rare Disease Research in the

National Institutes of Health, 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 ‘‘Office for Rare Disease

5 Research Act of 1995’’.
2

•S 184 RS

1 SEC. 2. ESTABLISHMENT OF OFFICE FOR RARE DISEASE

2 RESEARCH.

3 Part A of title IV of the Public Health Service Act

4 (42 U.S.C. 281 et seq.) is amended by adding at the end

5 thereof the following new section:

6 ‘‘SEC. 404F. OFFICE FOR RARE DISEASE RESEARCH.

7 ‘‘(a) ESTABLISHMENT.—There is established within

8 the Office of the Director of the National Institutes of

9 Health an office to be known as the Office for Rare Dis10 ease Research (in this section referred to as the ‘Office’).

11 The Office shall be headed by a director, who shall be ap12 pointed by the Director of the National Institutes of

13 Health.

14 ‘‘(b) PURPOSE.—The purpose of the Office is to pro15 mote and coordinate the conduct of research on rare dis16 eases through a strategic research plan and to establish

17 and manage a rare disease research clinical database.

18 ‘‘(c) ADVISORY COUNCIL.—The Secretary shall es19 tablish an advisory council for the purpose of providing

20 advice to the director of the Office concerning carrying

21 out the strategic research plan and other duties under this

22 section. Section 222 shall apply to such council to the

23 same extent and in the same manner as such section ap24 plies to committees or councils established under such sec25 tion.
3

•S 184 RS

1 ‘‘(d) DUTIES.—In carrying out subsection (b), the di2 rector of the Office shall—

3 ‘‘(1) develop a comprehensive plan for the con4 duct and support of research on rare diseases;

5 ‘‘(2) coordinate and disseminate information

6 among the institutes and the public on rare diseases;

7 ‘‘(3) support research training and encourage

8 the participation of a diversity of individuals in the

9 conduct of rare disease research;

10 ‘‘(4) identify projects or research on rare dis11 eases that should be conducted or supported by the

12 National Institutes of Health;

13 ‘‘(5) develop and maintain a central database

14 on current government sponsored clinical research

15 projects for rare diseases;

16 ‘‘(6) determine the need for registries of re17 search subjects and epidemiological studies of rare

18 disease populations; and

19 ‘‘(7) prepare biennial reports on the activities

20 carried out or to be carried out by the Office and

21 submit such reports to the Secretary and the Con22 gress.’’.
Calendar No. 104

104TH CONGRESS

1ST SESSION S. 184

[Report No. 104–79]

A BILL

To establish an Office for Rare Disease Research in

purposes.the National Institutes of Health, and for other

MAY 4 (legislative day, MAY 1), 1995

Reported without amendment