Skip to main content
          Skip to FDA Search
          Skip to in this section menu
          Skip to footer links


U.S. flagAn official website of the United States government

					Here’s how you know
          			Dot gov**The .gov means it’s official.**Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.
							      SSL**The site is secure.** The **https://** ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. 
			U.S. Food and Drug Administration
				
        Search
            Menu
							
						Search FDA
									
									Submit search 
		Featured
							Contact FDA
	                FDA Guidance Documents
	                Recalls, Market Withdrawals and Safety Alerts
	                Press Announcements
	                Warning Letters
	                Advisory Committees
	                En Español

					Products
            Food
							Drugs
							Medical Devices
							Radiation-Emitting Products
							Vaccines, Blood, and Biologics
							Animal and Veterinary
							Cosmetics
							Tobacco ProductsTopics
            About FDA
							Combination Products
							Regulatory Information
							Safety
							Emergency Preparedness
							International Programs
							News and Events
							Training and Continuing Education
							Inspections and Compliance
							Science and ResearchInformation For
            Consumers
	            Patients
	            Industry
	            Health Professionals
	            Federal, State and Local Officials 
 In this section:

                Communications & Outreach

Communications & Outreach

                        FDA Commission Validation
          Non-Binding Agreements with the FDA Office of Regulatory Affairs
          ORA’s Return-on-Investment Assessment  for State Partnership Agreements
          Commissioning
          Information Sharing
          Methods Of Communication
          Regulatory Associations
          State and Local Inquiries


                        News & Events Home
          For Federal, State, Local, Tribal, and Territorial Officials
          Communications & Outreach
          State and Local InquiriesCommunications & Outreach State and Local Inquiries
  
  	
    Share
    Post
    Linkedin

    Email
    PrintWhat 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?What is the Freedom of Information Act (FOIA), and why is it necessary?

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.

Back to top

How does the FDA handle FOIA requests?

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.

Back to top

How does the FDA handle requests for FDA testimony?

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.

Back to top

How does the FDA handle requests to receive an FDA Position in an affidavit or declaration format?

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.

Back to top

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.Back to top

                                                                                  Content current as of:
      01/11/2016Communications & Outreach

          
                        FDA Commission Validation
          Non-Binding Agreements with the FDA Office of Regulatory Affairs
          ORA’s Return-on-Investment Assessment  for State Partnership Agreements
          Commissioning
          Information Sharing
          Methods Of Communication
          Regulatory Associations
          State and Local Inquiries


                        News & Events
 
 Footer Links
    FDA Archive
          About FDA
          Accessibility
      Visitor Information
          Website Policies / Privacy
          No FEAR Act
          Vulnerability Disclosure Policy
      FOIA
          HHS.gov
          USA.gov
    Contact FDA
      Follow FDA on Facebook
      Follow FDA on X
      Follow FDA on Instagram
      Follow FDA on LinkedIn
      View FDA videos on YouTube
      Subscribe to FDA RSS feeds
    FDA Homepage
    Contact Number
      1-888-INFO-FDA (1-888-463-6332) Back toTop