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A Handbook for Requesting
Information and Records from FDA

The guidance given in this handbook is intended to facilitate requests for both public information and records not originally prepared for distribution by FDA. This handbook has been updated in response to the Electronic Freedom of Information Act Amendments of 1996.

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.

Consumers with questions about FDA-related matters also may call toll-free 1-888-INFO-FDA (1-888-463-6332).

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 one of nine FOIA exemptions. Six of these exemptions most often form the basis for the withholding of information by the FDA:

Exemption 2: Protects certain records related solely to FDA's internal rules and practices.

Exemption 3: Protects information that is prohibited from disclosure by other laws.

Exemption 4: Protects trade secrets and confidential commercial or financial information.

Exemption 5: Protects certain interagency and intra-agency communications.

Exemption 6: Protects information about individuals in personnel, medical, and similar files when disclosure would constitute a clearly unwarranted invasion of privacy.

Exemption 7: Protects records or information compiled for law enforcement purposes when disclosure (A) could reasonably be expected to interfere with enforcement proceedings; (B) would deprive a person of a right to a fair trial or an impartial adjudication; (C) could reasonably be expected to constitute an unwarranted invasion of personal privacy; (D) could reasonably be expected to disclose the identity of a confidential source; (E) would disclose techniques and procedures for law enforcement investigations or prosecutions, or would disclose guidelines for law enforcement investigations or prosecutions, if such disclosure could reasonably be expected to risk circumvention of the law; or (F) could reasonably be expected to endanger the life or physical safety of an individual.

In the event FDA relies on one or more FOIA exemptions to deny a requestor access to records, a letter stating the reasons for denying the records will be sent to the requestor. The letter will also notify the requestor of the right to appeal the agency's denial determination. More specific information on these exemptions and on other aspects of our FOIA program are contained in FDA's FOIA implementation regulations, 21 CFR Part 20.

How to Make an FOIA Request

All FOIA requests must be in writing and should include the following information:

a. Requestor's name, address, and telephone number.

b. A description of the records being sought. The records should be identified as specifically as possible. A request for specific records that are releasable to the public can be processed much more quickly than a request for "all information" on a particular subject. Also fees for a more specific and limited request will generally be less. Information on major information systems maintained by FDA can be obtained by using the Department of Health and Human Services Government Information Locator Service (GILS) site. This information may be useful in narrowing a request.

c. Separate requests should be submitted for each firm or product involved.

d. A statement concerning willingness to pay fees, including any limitations.

All FOIA requests must be in writing. FDA does not accept FOIA requests sent via e-mail. Requests should be mailed to the following address:

Food and Drug Administration
Office of Management Programs
Division of Freedom of Information (HFI-35)
5600 Fishers Lane
Rockville, MD 20857

Or requests may be sent via fax to: (301) 443-1726. If there are problems sending a fax, call (301) 443-2414.

Fees

FOIA requestors may have to pay fees covering some or all of the costs of processing their request. Requestors may want to include the maximum dollar amount they are willing to pay. If the fees exceed the maximum amount stated, FDA will contact the requestor before filling the request. Requestors are generally billed for fees after their requests have been processed; however, if total fees are expected to exceed $250.00 FDA may require payment in advance of processing.

Commercial Use Requestors:

Noncommercial Use Requestors, Such as Representatives of the News Media, Public Interest Groups, and Educational and Noncommercial Scientific Institutions:

Other Requestors, Including Consumers:

Requestors should not send payment with their requests. They will be billed if the total processing charges are $15 or more. FDA does not accept credit cards. Payment must be made by check or money order.

BG 98-2

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