[Federal Register Volume 62, Number 249 (Tuesday, December 30, 1997)]
[Notices]
[Pages 67873-67874]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-33869]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Office of the Secretary
Orphan Products Board; Notice of Public Meeting
AGENCY: Office of Public Health and Science.
ACTION: Notice of meeting.
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SUMMARY: The Department of Health and Human Services and the Office of
Public Health and Science (Office of the Assistant Secretary for
Health) are announcing a public meeting of the Orphan Products Board.
The purpose of this meeting is to facilitate the research, development,
and approval of orphan products and to coordinate Government activities
with the private sector to achieve these goals. In this meeting there
will be an opportunity for interested persons to present information
and views on the issue of orphan products development.
DATES: The public meeting be held on Thursday, February 12, 1998, from
2 p.m. to 5 p.m. Requests to attend or participate should be sent by
February 4, 1998.
ADDRESSES: The public meeting will be held at the Hubert H. Humphrey
Bldg., 200 Independence Ave. S.W., Washington, DC. Written requests to
attend or participate should be sent to Robert F. Steeves, Orphan
Products Board, Food and Drug Administration (HF-35), 5600 Fishers
Lane, rm. 8-73, Rockville, MD 20857, FAX 301-443-4915. Requests from
nongovernmental persons should include full name, address, affiliation,
and social security number for use in obtaining security clearance for
entry into the facility.
FOR FURTHER INFORMATION CONTACT:
Robert F. Steeves, Orphan Products Board, Food and Drug Administration
(HF-35), 5600 Fishers Lane, Rockville, MD 20857, 301-827-3666.
SUPPLEMENTARY INFORMATION: An orphan drug is a drug for the treatment
of a rare disease or condition which either has: (1) A prevalence in
the United States of under 200,000 persons; or (2) 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 (Pub. L. 97-414) enacted on January
4, 1983, as amended, established a number of incentives to encourage
the development and marketing of orphan drugs.
The Orphan Drug 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 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 of Disability and Rehabilitation Research
(NIDRR), the Social Security Administration (SSA), and the Department
of Defense (DOD). Within DHHS, representatives from the
[[Page 67874]]
Agency for Health Care Policy and Research (AHCPR), the Centers for
Disease Control (CDC), the Food and Drug Administration (FDA), the
Health Care Financing Administration (HCFA), the National Institutes of
Health (NIH), and the Office of Public Health and Science (OPHS), serve
on the Board. This public meeting will have two purposes:
1. Members of the Orphan Products Board will discuss their agencies
recent orphan product development activities.
2. In keeping with its mandate to foster actions within the
Department of Health and Human Services 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
Director of the Orphan Products Board. The request for participation
should be submitted before February 4, 1998, 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 extensions of remarks (five copies) should be presented
to the Executive Director 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 listed contact
person.
Dated: December 18, 1997.
John M. Eisenberg,
Acting Assistant Secretary for Health.
[FR Doc. 97-33869 Filed 12-29-97; 8:30 am]
BILLING CODE 4160-17-M
