[Federal Register Volume 59, Number 114 (Wednesday, June 15, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-14518]
[[Page Unknown]]
[Federal Register: June 15, 1994]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Public Health Service
[GN 2254]
Orphan Products Board; Public Meeting
AGENCY: Office of the Assistant Secretary for Health, DHHS.
ACTION: Notice of public meeting; Orphan Products Board.
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SUMMARY: The Department of Health and Human Services and the Office of
the Assistant Secretary for Health announce that a public meeting of
the Orphan Products Board will be held on June 29, 1994 in Washington,
DC. During the session there will be an opportunity for interested
persons to present information and views on the issue of orphan
products development. The meeting will be chaired by the Assistant
Secretary for Health and Chairman, Orphan Products Board. It will
commence at 1 p.m., in room 729-G. Hubert H. Humphrey Building, 200
Independence Avenue, SW., Washington, DC 20201.
ADDRESSES: Written requests to participate should be sent to Dr.
Richard J. Bertin, Executive Secretary, Orphan Products Board, Food and
Drug Administration (HF-35), Room 8-73, 5600 Fishers Lane, Rockville,
Maryland 20857, and should be received by June 22, 1994.
FOR FURTHER INFORMATION CONTACT:Dr. Richard J. Bertin, Executive
Secretary, Orphan Products Board, Food and Drug Administration (HF-35),
5600 Fishers Lane, Rockville, Maryland 20857. (301) 443-4903.
SUPPLEMENTARY INFORMATION: An orphan drug is a drug for the treatment
of a rare disease or condition which either (1) has a prevalence in the
United States of Under 200,000 persons or (2) has a higher prevalence
and for which there is no reasonable expectation that the cost of
developing and making available in the United States a drug for such
disease or condition will be recovered from sales in the United States
of such drug. The Orphan Drug Act, Public Law 97-414 enacted on January
4, 1983, as amended, established a number of incentives to encourage
the development and marketing of orphan drugs.
The act also established an Orphan Products Board to promote the
development of drugs and devices for rare diseases or conditions and to
assure appropriate coordination among all interested Federal agencies,
manufacturers, and organizations representing patients with rare
diseases.
The Orphan Products Board is chaired by the Assistant Secretary for
Health. The Board is composed of representatives from the Department of
Health and Human Services (DHHS), the Department of Veterans Affairs
(DVA), The National Institute for Disability and Rehabilitation
Research (NIDRR), and the Department of Defense (DoD), Within DHHS,
representatives from the Agency for Health Care Policy and Research
(AHCPR), the Centers for Disease Control and Prevention (CDC), the Food
and Drug Administration (FDA), the Health Care Financing Administration
(HCFA), the National Institutes of Health (NIH), the Office of the
Assistant Secretary for Health (OASH), and the Social Security
Administration (SSA), serve on the Board. This public meeting will have
two purposes.
1. An update will be provided on the activities of the Orphan
Products Board, and members of the Board will discuss their agencies'
recent orphan product development activities.
2. In keeping with its mandate to foster actions within the
Department to facilitate the research, development, and approval of
orphan products and to coordinate government activities with the
private sector in order to achieve these goals, the Board encourages
presentations by members of the public on any issues involving the
development and availability of orphan products. Those persons wishing
to make a presentation at the meeting should submit a written request
for a time slot to the Executive Secretary of the Orphan Products
Board. the request for participation should be submitted by June 22,
1994, and should include:
a. Name, address, and telephone number of the person desiring to
make a presentation;
b. Affiliation, if any;
c. A summary of the presentation; and
d. The approximate amount of time required for the presentation (no
more than 10 minutes, unless more time can be justified.)
Individuals and organizations with common interests or proposals
are urged to coordinate or consolidate their presentations. Joint
presentations may be required of persons or organizations with a common
interest. The time available will be allocated among the individuals
who request an opportunity for a presentation. Formal written
statements or extension of remarks (five copies may be presented to the
Chairman on the day of the meeting for inclusion in the record of the
meeting. At the discretion of the Chairman, and as time permits, any
person in attendance may be heard. This time will, most likely, be at
the end of the scheduled session. For those unable to attend the
meeting, comments may be sent to the Executive Secretary of the Orphan
Products Board at the address listed above.
Dated: May 31, 1994.
Phillip R. Lee,
Assistant Secretary for Health.
Orphan Products Board Public Meeting, Wednesday, June 29, 1994, 1:00
p.m.-3:00 p.m., Room 729-G, Hubert Humphrey Building
Agenda
1:00-1:20 p.m.--Welcome and Introductory Remarks
Presiding: Philip R. Lee, M.D., Assistant Secretary for Health,
Chairman Secretary, Orphan Products Board
Richard J. Bertin, Ph.D., Executive Secretary, Orphan Products
Board
1:20-2:10 p.m.--Presentations by Members of the Orphan Products
Board
(Dr. Bertin, Presiding)
Agency for Health Care Policy and Research
Centers for Disease Control and Prevention
Food and Drug Administration
National Institutes of Health
Health Care Financing Administration
Department of Veterans Affairs
Department of Defense
National Institute on Disability and Rehabilitation Research
Social Security Administration
2:10-2:20 p.m.--Break
2:20-3:30 p.m.--Public Comments and Responses
(Dr. Haffner, Presiding)
[FR Doc. 94-14518 Filed 6-14-94; 8:45 am]
BILLING CODE 4160-17-M
