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Small Business Guide to FDA
(last revised on 03/31/04)
HOW TO PARTICIPATE IN AGENCY DECISION-MAKING
In addition to commenting on Federal Register documents and petitioning
the Agency, there are a number of ways that can interact with FDA to
make your viewpoint known. Here are a few examples:
Public Meetings or Conferences
FDA uses public meetings and conferences to discuss significant issues
with the public. The Agency may schedule public meetings, sometimes
referred to as "exchange meetings," before developing
a proposal, or after proposing a program change. The meetings offer
a chance for you and FDA managers to discuss issues informally before
the rulemaking process begins. FDA announces meetings in the Federal
Register and trade publications.
Industry Information/Education Meetings
Many meetings and workshops are conducted in which key representatives
from industry, government, academia, and professional, consumer,
ethnic, and patient groups discuss subjects of vital concern to
industry and the FDA.
Public Hearings
A hearing is an opportunity for you to take part in a rule-making
proceeding. FDA always announces hearings in the Federal Register
and usually in other publications (e.g., industry newsletters) related
to the topic of the hearing. Depending on the subject of the hearing,
you can testify on specific issues that are included in an Agency
proposal, or you can present your views about general issues on
Agency programs. At all hearings, your testimony, whether it is
presented orally or in writing, will become part of an official
record of evidence which will help the Agency make policy decisions.
Public Advisory Committees and Panels
FDA routinely looks for qualified people to serve on a variety of
public advisory committees and panels. Many of the Agency's committees
and panels include members representing consumer and industry interests.
FDA requests nominations for these members through announcements
in the Federal Register. The committees generally study current
scientific work and make recommendations to the Agency on product
approvals, regulations, and other actions. Membership on most committees
requires a scientific background. A free copy of "FDA Public
Advisory Groups" or further information about FDA advisory
committees, can be obtained by contacting the Office of Committee
Management (HFA-306), Food and Drug Administration, Room 4B-17,
Parklawn Building, 5600 Fishers Lane, Rockville, MD 20857; (301)
827-5496 or FAX (301) 827-5891. For current information or information
updates on FDA advisory committee meetings, call the Advisory Committee
Information Line by dialing (1-800) 741-8138 or (301) 443-0572,
and the five digit number assigned to each advisory committee. This
number will appear in each notice of meeting.
How Regulated Industry Can Communicate with FDA
Main FDA Address and Phone Number (for general inquiries):
U.S. Food and Drug Administration
5600 Fishers Lane (HF-40)
Rockville, MD 20857
Phone: (301) 827-4450)
(888) INFO-FDA (1-888-463-6332)
FAX: (301) 443-1863
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