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

HOW TO OBTAIN AGENCY DOCUMENTS

A Handbook for Requesting Information and Records from FDA (BG 97-6)

Obtaining Public Information

Certain documents that are prepared for public distribution--such as press releases, consumer publications, speeches, and congressional testimony--are available from FDA without having to file a Freedom of Information Act (FOIA) request. Many of these documents are available on FDA's Internet site (www.fda.gov). We encourage you to browse the site for documents you want to look at. Public information may also be obtained by contacting the appropriate FDA information officer.

Obtaining Information Through FOIA

FOIA allows anyone to request copies of records not normally prepared for public distribution. FOIA pertains to existing records only and does not require agencies to create new records to comply with a request. It also does not require agencies to collect information they do not have or to do research or analyze data for a requestor. In addition, FOIA requests must be specific enough to permit an FDA employee who is familiar with the subject matter to locate records in a reasonable period of time. Under FOIA, certain records may be withheld in whole or in part from the requestor if they fall within FOIA exemptions.