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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