Inspections, Compliance, Enforcement, and Criminal Investigations
SUBCHAPTER 1.4 - DISCLOSURE OF OFFICIAL INFORMATION
1.4 - DISCLOSURE OF OFFICIAL INFORMATION
1.4.1 - SUBPOENA
1.4.2 - REQUESTS BY THE PUBLIC, INCLUDING TRADE
1.4.3 - SHARING NON-PUBLIC INFORMATION WITH OTHER GOVERNMENT OFFICIALS
1.4.4 - FREEDOM OF INFORMATION ACT
188.8.131.52 - Procedures
184.108.40.206 - Requests for Documents
1.4.5 - INTERNAL FDA DOCUMENTS
You are not to release or divulge any information obtained during FDA investigative or inspectional operations, unless you are authorized to do so and the sharing (regardless of the manner) complies with FDA’s information disclosure laws and procedures. This includes information contained in diaries and field notes, except for official issuance of forms or documents to addressees. Do not release any originals or copies of reports, memos, diaries, forms (e.g., FDA-483, 484, 464, etc.), or similar investigational documents to anyone outside the Agency without express concurrence of district or regional management and without following FDA's laws and procedures (21 CFR 20.85 - federal, 21 CFR 20.88 - state/local, 21 CFR 20.89 - foreign, 21 CFR Part 20 - Freedom of Information Act (FOIA), and 21 CFR Part 21 - Privacy Act). See IOM 1.4.4.
If you are served a subpoena (commanding your appearance in court) or a subpoena duces tecum, (commanding the production of any record or testimony, or the giving of information relating to official FDA matters), immediately advise your supervisor. You will be instructed by your District officials as to the proper procedures and actions on your part in complying with the subpoena. See 21 CFR 20.1, 20.2 and the Regulatory Procedures Manual (RPM) chapter 10-9, "Testimony; Production of Records; Certification of Records."
Be guided by IOM 1.4.4 on requests for information desired by the public under the Freedom of Information Act (FOIA). Refer to FDA's "Information Disclosure Manual" (IDM) for procedures for sharing non-public information with federal, state, local, or foreign government officials. (See IOM 1.4.3).
In the case of complaints where a sample has been collected from the complainant, your District may inform the complainant of FDA's findings when an examination is actually made of the sample. When you collect a sample from a complainant, and he/she asks for analytical results, he/she may be told that the FDA will advise him by letter of the general nature of the findings. See IOM 4.1.6 and IOM 220.127.116.11 for cautions on collecting this type sample.
If you receive requests for non-public information from officials of other federal agencies or from state, local or foreign government officials, be guided by the current Information Disclosure Manual (IDM) published by the Office of Policy and Risk Management (OPRM). You may not share FDA non-public information with such officials without being authorized to do so under FDA's procedures. The most current IDM is available at http://inside.fda.gov:9003/PolicyProcedures/GuidanceRegulations/Enforcement/ucm024219.htm. Relevant sections on non-public disclosure may be found in the IDM, Section 4 as follows:
- Sharing Non-Public Information with Foreign Government Officials,
- Sharing Non-Public Information with Federal Government Officials,
- Sharing Non-Public Information with State and Local Government Officials
The Public Information section of the Administrative Procedures Act, 5 U.S.C 552, more commonly known as the FOIA, adopts a general rule that, except where specifically exempt, all documents in government files shall be made available to the public. There are various exemptions in certain areas, and it is these that mostly affect your operations in FDA. The regulations exempt certain information, such as personal privacy, deliberative process, open investigatory, as well as a company’s trade secrets or confidential commercial information.
Study and become familiar with the general provisions of the FOIA and the regulations in the Code of Federal Regulations (CFR) regarding the release of information to the public. In particular, study 21 CFR Parts 20 and 21, 21 CFR 71.15, 171.1, 314.430, 514.11, 514.12 and others, all of which contain provisions regarding confidentiality in various FDA records and documents. Also, see the IDM.
In addition to the FOIA, various other Acts such as the Federal Food, Drug, and Cosmetic (FD&C) Act, the Public Health Services (PHS) Act, and 18 U.S.C. 1905 each contain information relating to the confidentiality of information in government files, and are of particular interest. Special care should be taken to protect the identity of confidential sources. See IOM 5.2.9 for further guidance.
No field FDA employee has authority to deny any request for documents, no matter what form the request takes. Authority to deny requests rests with the Associate Commissioner for Public Affairs.
Each field and district office is responsible for the internal handling of requests. Information disclosure personnel, e.g. FOI Officers, designated by their respective RFDDs, are responsible for coordinating the implementation of the regulations, for development of procedures within their organization to handle requests, and for adherence to FDA’s laws and procedures regarding the maintenance of confidentiality of non-public information. If you receive a request for information under the FOIA, advise the requester to write to the Food and Drug Administration, Division of Freedom of Information (HFI-35), 12420 Parklawn Drive, Rockville, MD 20857. See DFOI’s website at http://www.fda.gov/foi/default.htm.
FDA records that are intended for internal use only, may contain information protected from disclosure to the public by a FOIA exemption. An example would be “work plans.”
Work Plans - Do not divulge district work planning operations without authority from your supervisor.