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U.S. Department of Health and Human Services

Regulatory Information

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Frequently Asked Questions (FAQ) for Freedom of Information

Topics on this Page:

Where should I send my FOIA request?
Should I send my request by both mail and fax?
Can I submit my request online?
How will I know that FDA received my FOIA request?
Will the Division of Freedom of Information fill my request?
Are there fees associated with the processing of FOIA requests?
How will I receive my records?
Can I pay my bill online with a credit card?
How can I qualify for a fee waiver?
How will my request be processed?
Who should I call for information about the status of my request, or for more information about how to submit a request?
 

 Q. Where should I send my FOIA request?

Requests submitted by mail should be sent to:

NEW ADDRESS AND FAX NUMBER:

Food and Drug Administration
Division of Freedom of Information
5630 Fishers Lane
Room-1035
Rockville, MD 20857

Requests submitted by fax should be sent to (301) 827-9267.

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 Q. Should I send my request by both mail and fax?

No. In order to avoid duplication in processing, please send your request by only one method of delivery.

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 Q. Can I submit my request online?

FDA expects that online submission of FOIA requests will be available in the near future.

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 Q. How will I know that FDA received my FOIA request?

You will receive an acknowledgement letter by U.S. mail within one week of FDA’s receipt of your request. The acknowledgement letter will provide you with a control number for your request, a telephone number for any future contacts regarding your request, and a link to our webpage that explains FOIA processing fees. Please be sure to include your control number on any correspondence with the agency.

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 Q. Will the Division of Freedom of Information fill my request?

In most cases, no. FDA maintains a decentralized FOIA process. Therefore, most requests will be processed by the agency component that maintains the records you requested. For example, a request for a medical device approval document would be processed by the Center for Devices and Radiological Health (CDRH). Some requests will be processed by more than one agency component, in which case you may receive more than one response.

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 Q. Are there fees associated with the processing of FOIA requests?

Yes. However, there is no initial fee to make a FOIA request, and in some cases no fees are charged. For detailed information on processing fees, please see How to Make a FOIA Request. We encourage requesters to search for records on our website prior to making a request, as all materials on our website can be downloaded free of charge. If the agency estimates that processing your request will cost more than $250, the agency can require prepayment before records are released.

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 Q. How will I receive my records?

Unless you request otherwise, you will receive your records via U.S. mail. If you would like to receive records via email, please provide a valid email address in your request, and ask that the records be provided to that address. In some situations, the size or content of the responsive records make them unsuitable for email delivery. In such cases, records will be released via U.S. mail.

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 Q. Can I pay my bill online with a credit card?

Yes. For detailed instructions, please see https://userfees.fda.gov/OA_HTML/irecPortal.html.

 

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 Q. How can I qualify for a fee waiver?

Fee waivers are limited to situations in which a requester can show that disclosure of the requested information is in the public interest because it is likely to contribute significantly to public understanding of the operations and activities of the government and is not primarily in the commercial interest of the requester. In order to qualify for a fee waiver, you must meet the criteria set forth at 21 C.F.R. 20.46. For further information, please see http://www.access.gpo.gov/nara/cfr/waisidx_04/21cfr20_04.html.

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 Q. How will my request be processed?

After DFOI receives your request, it will be logged into the agency’s tracking system and assigned a control number. DFOI will assign your request to the appropriate component(s) for processing, and then send you the acknowledgement letter. The assigned component(s) will search for the responsive records and then review each page for deletion of information that is deemed non-public under the FOIA’s statutory exemptions and FDA’s regulations. The components will then release the records to you and assess applicable processing fees. If you accrue fees, you will receive an invoice. If no records responsive to your request were found, the agency will inform you of that result in writing. If records are located but the agency denies access to those records under the FOIA’s statutory exemptions, you will receive a formal letter of denial, which includes an explanation of your appeal rights.

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 Q. Who should I call for information about the status of my request, or for more information about how to submit a request?

You can call the telephone number provided in your acknowledgment letter, or you can call the Public Reading Room at 301-796-3900.

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