[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