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.
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