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Small Business Guide to FDA
(last revised on 03/31/04)

THE FEDERAL REGISTER - WHAT IT IS AND HOW TO USE IT

The Federal Register is one of the most important sources for information on what FDA -- or for that matter, what any government agency is doing. Published daily, Monday through Friday, the Federal Register carries all proposed and finalized regulations and many significant legal notices issued by the various agencies, as well as presidential proclamations and executive orders.

Subscriptions to the Federal Register can be purchased from the Superintendent of Documents. For price and order information, call (888) 293-6498 or (202) 512-1530 for online subscriptions. As an alternative, copies can usually be found in local libraries, county courthouses, federal buildings or on the Internet at http://www.gpoaccess.gov/fr/index.html. The following are examples of how the Federal Register can be used to keep informed of FDA issues and activities:

ADVANCE NOTICE - Often, FDA will publish "Notices of Intent" in the Federal Register to give you the earliest possible opportunity to participate in its decisions. These notices inform you that FDA is considering an issue and that your views are welcome before a formal proposal is made.

PROPOSED REGULATIONS - When a formal proposal is developed, FDA publishes a "Notice of Proposed Rulemaking" in the Federal Register. The notice gives the timeframe in which you have to submit written comments about the proposed action. If you do not feel you have enough time to study the proposal and comment on it, you can submit a written request that Agency officials extend the comment period. If FDA extends the period, a notice of the extension is published in the Federal Register. Occasionally, a second or third proposal is published in the Federal Register because of the nature of the comments received. Each time a proposal is substantively revised or amended, a notice is published in the Federal Register.

FINAL REGULATIONS - Ultimately, a "Final Rule" is published, and the rule specifies the date when the new regulatory requirements or regulations become effective.

REGULATORY AGENDA - Twice a year -- in April and October - FDA, along with the entire Department of Health and Human Services, publishes an agenda in the Federal Register that summarizes policy-significant regulations, regulations that are likely to have a significant economic impact on small entities, and other actions under development. This agenda will help you identify actions of interest early to plan your participation. Each item listed includes the name, address and telephone number of an Agency official to contact if you need more information.

MEETINGS AND HEARINGS - Notices are published in the Federal Register announcing all meetings of the Agency's advisory committees (see public hearings) and all public meetings that provide an information exchange between FDA and industry, health professionals, consumers, and the scientific and medical communities. The notice contains the date, time and place of the meeting, as well as its agenda. The Federal Register also announces administrative hearings before the Agency and public hearings to gain citizen input into Agency activities (see citizen petition). Information about meetings of advisory committees is also available by calling (1-800) 741-8138.