- What is the Freedom of Information Act (FOIA), and why is it necessary?
- How does the FDA handle FOIA requests?
- How does the FDA handle requests for FDA testimony?
- How does the FDA handle requests to receive an FDA Position in an affidavit or declaration format?
- Who do I contact to submit an inquiry or to ask a question regarding FOIA, FDA Testimony, or an FDA Position?
The Freedom of Information Act (FOIA) is a law that gives you the right to access information from the federal government. It is often described as the law that keeps citizens in the know about their government. More information about the FOIA can be found on FOIA.gov.
Correspondence from state and local officials addressed to the FDA's Freedom of Information Staff, Associate Commissioner for Public Affairs (HFI-35) are logged in, immediately logged out, and then forwarded to Intergovernmental Affairs (IA) for appropriate response. Under most circumstances, IA staff will provide a written acknowledgement to the requestor advising of the receipt of the correspondence and action taken to get an FDA reply. When an appropriate response to the issues raised is obtained, IA prepares a formal reply to the requestor in as timely a fashion as is possible.
Title 21, Code of Federal Regulations, Part 20.1, Testimony by FDA employees, discusses the general procedures for obtaining FDA testimony and Staff Manual Guide #2127.2 entitled "Requests for Testimony of FDA Personnel in Non-FDA Proceedings" provides detailed processing information.
It is the policy of FDA to assist, upon request, state and local governments deliberating on issues relevant to the functions and responsibilities of FDA by authorizing the appearance and testimony of FDA personnel at such proceedings. These proceedings may be legislative, administrative or judicial in nature. The subject of the testimony may include: the FDA investigator’s observations during their inspection of a particular establishment; an analyst's findings on a sample analyzed in an FDA laboratory; the FDA's position on a bill introduced in a state legislature; an interpretation of the FD&C Act or regulations; a change in a state agency's rules on a particular subject; etc.
The referenced CFR provides that no FDA employee may testify before any tribunal pertaining to any function of the FDA or with respect to any information acquired in the discharge of his official duties except as authorized by the Commissioner of Food and Drugs. Requests for testimony received from state and local officials are processed through this Division.
As noted under the caption "Testimony", it is the policy of the FDA to assist, upon request, state and local government agencies deliberating on issues relevant to the functions and responsibilities of the FDA by authorizing the appearance and testimony of FDA personnel at such proceedings. In an attempt to conserve the Agency's resources, on many occasions the requester will be offered a Certified Affidavit or a Declaration in lieu of "live" testimony if either of these documents serve the requesters needs. The use of these documents is especially useful when the requester simply wants to know the FDA's position on the "approval status of a drug or device", whether a drug product requires an Rx legend, etc., which they can then present in a judicial or administrative setting to support an action they are taking. These documents are prepared by the appropriate center holding the record(s) involved and are processed in a fashion similar to live testimony.
Who do I contact to submit an inquiry or to ask a question regarding FOIA, FDA Testimony, or an FDA Position?
- Inquiries for FDA from State, Local, Tribal and Territorial Officials can be directed to the following mailbox: ORAinfoshare@fda.hhs.gov.
- Inquiries to FDA from other Federal Governments can be directed to the following mailbox: ORAinfoshare@fda.hhs.gov.