[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]


-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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