Inspections, Compliance, Enforcement, and Criminal Investigations

SUBCHAPTER 1.4 - DISCLOSURE OF OFFICIAL INFORMATION

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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 Headquarters management or disclosure personnel and without following FDA's laws, disclosure regulations (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), 21 CFR Part 21 - Privacy Act),and other disclosure procedures, as noted below.Highlighted to denote updated text

1.4.1 - SUBPOENA

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 and ORA's Testimony Specialist in ORA Headquarters.Highlighted to denote updated text You will be instructed by the Testimony SpecialistHighlighted to denote updated text 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 10-11,Highlighted to denote updated text "Testimony; Production of Records; Certification of Records."

1.4.2 - REQUESTS BY THE PUBLIC, INCLUDING TRADE

Be guided by IOM 1.4.4 on requests for information desired by the public under the Freedom of Information Act (FOIA). For procedures for sharing non-public information with federal, state, local, or foreign government officials, see IOM 1.4.3.Highlighted to denote updated text

In the case where a complainant requests sample results, see IOM 8.2.5.4. For procedures on the release of Establishment Inspection Reports to the establishment inspected see Field Management Directive (FMD)-145, and for the disclosure of analytical results to establishments pursuant to Section 704(d) of the FD&C Act [21 U.S.C. 374 (d)], see IOM 4.1.1.4.Highlighted to denote updated text

1.4.3 - SHARING NON-PUBLIC INFORMATION WITH OTHER GOVERNMENT OFFICIALS

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 guidance:Highlighted to denote updated text

  1. SMG 2830.3 Sharing Non-Public Information with Foreign Government Officials,Highlighted to denote updated text
  2. RPM 3-6-4 Sharing Non-Public Information with Federal Government Officials,Highlighted to denote updated text
  3. RPM 3-6-3 Sharing Non-Public Information with State and Local Government OfficialsHighlighted to denote updated text

1.4.4 - FREEDOM OF INFORMATION ACT

The Public Information section of the Administrative Procedures Act, 5 U.S.C 552Highlighted to denote updated text, 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.

1.4.4.1 - Procedures

Study and become familiar with the general provisions of the FOIA and the Privacy ActHighlighted to denote updated text 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, 170.102, 312.130, 314.430, 514.11, 514.12, 601.50, 814.9, and others, all of which contain provisions regarding confidentiality in various FDA records and documents. See also SMG 3297.1 (FOI Internal Procedures and Existing Policy) and SMG 3297.2 (FOI Operational Responsibilities),and SMG 3297.4 (Procedures for Implementation of the Privacy Act).Highlighted to denote updated text 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 5.2.9.3.

Each Field and District office is responsible for the internal handling of FOI requests. Information disclosure personnel, e.g. FOI Officers, designated by their respective offices, are responsible for coordinating with ORA Headquarters and FDA's Division of Freedom of Information (DFOI) disclosure staff on the implementation of FDA's regulations and procedures, 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. Highlighted to denote updated text

No Field FDA employee has authority to deny any request for documents under FOIA, no matter what form the request takes. Authority to deny requests rests with the Associate Commissioner for Public Affairs, who may delegate this authority. For recommending denials, contact the Deputy Director of DFOI, who coordinates denials and appeals for the agency. Highlighted to denote updated text

1.4.4.2 - Requests for Documents

If you receive an inquiry requesting information under the FOIA, advise the requester to submit a FOIA request as directed at http://www.fda.gov/RegulatoryInformation/FOI/HowtoMakeaFOIARequest/default.htm. If you received a written request inadvertently, you may forward the request to the Deputy Director of DFOI, who centrally logs FOI requests for the agency.Highlighted to denote updated text

1.4.5 - INTERNAL FDA DOCUMENTS

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", internal decision memos, or attorney-client communication. Do not divulge such records without consultation from an information disclosure expert in ORA Headquarters.Highlighted to denote updated text If you receive requests for internal documents or for parts of them, refer to IOM 1.4.4 and IOM 1.10.2.6.

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Page Last Updated: 12/18/2014
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