The guidance given below 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 of interest to you. 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 members of the public 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. The agency may charge you a fee for processing your FOIA request.
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 inter-agency 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 is contained in FDA's FOIA implementation regulations, 21 CFR Part 20.