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(FDA Backgrounder 9/94)
 
          How to Make a Freedom of Information Act Request to FDA
 
     The Freedom of Information Act allows anyone to request
information from FDA records not normally prepared for public
distribution. Certain materials that are prepared for public
distribution-such as press releases, consumer publications,
speeches, and congressional testimony-are available from FDA
without having to file an FOI request. Simply contact the
appropriate FDA office. Also consumers can ask questions about FDA-
related matters by writing to the Consumer Inquiries Office, HFE-
88, Food and Drug Administration, 5600 Fishers Lane, Rockville, Md.
20857.
 
How to Make an FOI Request
     All FOI requests should be in writing. Address your request to:
               Food and Drug Administration
               Freedom of Information Staff (HFI-35)
               5600 Fishers Lane
               Rockville, MD 20857
     Or send requests via facsimile to: 301-443-1726(facsimile
         operator 301-443-2706).
     Your letter should include the following:
 
   Your name, address and telephone number.
   A statement of the records being sought, identified as
specifically as possible. A request of specific information that is
releasable to the public can be processed much more quickly than a
request for "all information" on a particular subject. Also, a more
specific and limited request will cost less for search, review and
duplication fees.
     The Freedom of Information Act pertains only to existing
records and is not a research service that complies information not
already available and identifiable. Make your request specific
enough to permit an FDA employee familiar with the subject matter
to locate the record in a reasonable period of time.
     Separate requests should be submitted for each firm or product
involved.
 
Fees
     Since FOI requesters may have to pay fees covering some or all
of the cost of processing a request, you may want to mention the
maximum dollar amount you are willing to pay. If the fees will
exceed this amount, FDA will contact you before filling the
request.
     The current schedule for commercial requesters is as follows:
 
   Search and review time: $13, $26 or $46 per hour, depending on
   the level of FDA employee filling the request.
   Photocopying: 10 cents a page for standard-size paper or the
   actual cost per page for add-size paper.
   Microfiche: 50 cents per fiche
   Certifications: $10 each
   Computer charge: actual cost for the time involved.
     For noncommercial requesters such as representatives of
educational institutions, public interest groups and the news
media, fees are charged only for duplication (with no charge for
the first 100 pages). Consumers are charged for search time and
duplication (with no charge for the first two hours of search time
and the first 100 pages of duplication).
     Do not send payment with your request. You will be billed if
the total charges are $10 or more. FDA does not accept credit
cards. Payments must be made by check or money order.
 
FDA Backgrounder:  September 1994