FDA Freedom of Information Act (FOIA)

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The 1996 amendments to the Freedom of Information Act (FOIA) mandate publicly accessible "electronic reading rooms" with agency FOIA response materials and other information routinely available to the public, with electronic search and indexing features.

Before submitting an FOIA request, please check to see if the information you are looking for is already available on FDA's Web site. You can use our search engine to help you find what you're looking for.

You may be charged a fee for processing your FOIA request. Information about fees is at: https://www.fda.gov/RegulatoryInformation/FOI/FOIAFees/default.htm

You may go to the FOIA request page and submit a request online. Please note that requests for information under the Privacy Act cannot be submitted online, and must be sent by mail to FDA’s Division of Freedom of Information. For contact information, please see FDA’s FOIA page.

If you submit your request(s) online, submission of an additional confirmation copy by mail or fax is unnecessary and may result in double processing and double billing.

Please note that processing time for requests for medical device approval records, including PMAs, 510Ks, and De Novo Classifications, is currently 18 to 24 months.

**Please read before submitting your online FOIA Request**

If you are seeking inspection records for a facility in the United States, please include the location (city and state) of the inspected facility. If you are seeking inspection records for a facility not in the United States, please indicate the product type at issue in the inspection (ie human drugs, vaccines, devices, animal drugs, etc) so that we can properly assign your request.
- Please note that processing time for Forms 483 (Notice of Inspectional Observations) is generally faster than processing time for Establishment Inspection Reports, and therefore processing fees for 483s are lower as well.
If you are seeking medical device adverse event reports,please see: https://www.fda.gov/medicaldevices/deviceregulationandguidance/postmarketrequirements/reportingadverseevents/ucm127891.htm.
If you are seeking human drug adverse event reports, please see: https://www.fda.gov/drugs/guidancecomplianceregulatoryinformation/surveillance/adversedrugeffects/ucm070093.htm. Please note that any FOIA requests for adverse event reports must include the name(s) of the specific product(s).
If you are a third party seeking records about a patient, employee, or other named individual, please include a signed authorization from that individual with your request.
Limiting your request to records previously released under FOIA for a particular subject will significantly reduce processing time and fees (assuming records on that subject have ever been released).
Please read the requirement for a grant of expedited processing prior to checking the box for expedited processing:
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm?fr=20.44
If you are a media/nonprofit/educational institution/student/scientific institution requester, you will not incur processing fees for search or review time; therefore, a request for a fee waiver is likely unnecessary. In the unlikely event that you receive an invoice, you can seek a waiver of fees at that time.

Privacy Act Statement

The collection of this information is authorized by the Freedom of Information Act (FOIA, 5 U.S.C. § 552). The collected information is used by FOIA staff to respond to your requests, and by appeals officials and members of the Office of the General Counsel. Provision of the requested information is voluntary (as that word is used by the Privacy Act of 1976), but may be required in order to process and respond to your request. Failure to provide your personally identifying information may result in FDA’s inability to respond to your request. A full list of the agency’s routine uses (disclosures) of the PII you submit is available at [this link].

Privacy Act Notice: This notice is provided pursuant to the Privacy Act of 1974, 5 U.S.C. §552a(e)(3).

(1) The collection of personally identifiable information (PII) through this system is authorized by 5 U.S.C. section 552, the Freedom of Information Act.
(2) FDA will use the personally identifiable information (PII) submitted through this system to respond to requests under the Freedom of Information Act (FOIA), which permits individuals to request information from any federal agency; and to coordinate and monitor the processing of the approximately 10,000 FOIA requests the agency receives annually; to generate reports concerning requests received, responded to, and pending; and to calculate and track user fees charged to FOIA requestors.
(3) FDA may disclose information to recipients outside the FDA and the Department of Health and Human Services (HHS, the Department) as follows:

Records will be routinely disclosed to the Treasury Department in order to effect payment.
Records may be disclosed to members of Congress concerning a federal financial assistance program in order for members to make informed opinions on programs and/or activities impacting on legislative decisions. Also, disclosure may be made to a congressional office from an individual's record in response to an inquiry from the congressional office made at the request of the individual.
In the event HHS deems it desirable or necessary, in determining whether particular records are required to be disclosed under the Freedom of Information Act, disclosure may be made to the Department of Justice for the purpose of obtaining its advice.
A record from this system may be disclosed as a “routine use” to a federal, state or local agency maintaining civil, criminal or other relevant enforcement records or other pertinent records, such as current licenses, if necessary to obtain a record relevant to an agency decision concerning the hiring or retention of an employee, the issuance of a security clearance, the letting of a contract or the issuance of a license, grant or other benefit.
A record from this system may be disclosed to a federal agency, in response to its request, in connection with the hiring or retention of an employee, the issuance of a security clearance, the reporting of an investigation of an employee, the letting of a contract or the issuance of a license, grant or other benefit by the requesting agency, to the extent that the record is relevant and necessary to its decision on the matter.
Where federal agencies having the power to subpoena other federal agencies'' records, such as the Internal Revenue Service (IRS) or the Civil Rights Commission, issue a subpoena to HHS for records in this system of records, HHS will make such records available, provided however, that in each case, HHS determines that such disclosure is compatible with the purpose for which the records were collected.
Where a contract between a component of HHS and a labor organization recognized under E.O. 11491 provides that the agency will disclose personal records relevant to the organization''s mission, records in the system of records may be disclosed to such organization.
A record may be disclosed to the Department of Justice, to a court, or other tribunal, or to another party before such tribunal, when: (1) HHS, or any component thereof; (2) Any HHS employee in his/her official capacity; (3) Any HHS employee in his/her individual capacity where the Department of Justice (or HHS, where it is authorized to do so) has agreed to represent the employee; or (4) the United States or any agency thereof where HHS determines that the litigation is likely to affect HHS or any of its components, is a party to litigation or has an interest in such litigation, and HHS determines that the use of such records by the Department of Justice, the tribunal, or the other party is relevant and necessary to the litigation and would help in the effective representation of the governmental party, provided however, that in each case, HHS determines that such disclosure is compatible with the purpose for which the records were collected.
A record about a loan applicant or potential contractor or grantee may be disclosed from the system of records to credit reporting agencies to obtain a credit report in order to determine the person''s credit worthiness and ability to repay debts owed to the federal government.
When a person applies for a loan under a loan program as to which the Office of Management and Budget (OMB) has made a determination under Internal Revenue Code (IRC) 6103(a)(3), a record about his/her application may be disclosed to the Treasury Department to find out whether he/she has a delinquent tax account, for the sole purpose of determining the person''s creditworthiness.

A record from this system may be disclosed to the following entities in order to help collect a debt owed the United States:

a.	To another federal agency so that agency can effect a salary offset;
b.	To the Treasury Department or another federal agency in order to effect an administrative offset under common law or under 31 USC 3716 (withholding from money payable to, or held on behalf of, the individual);
c.	To the Treasury Department to request the person''s mailing address under IRC 6103(m)(2) in order to help locate the person or to have a credit report prepared;
d.	To agents of HHS and to other third parties, including credit reporting agencies, to help locate the person or to obtain a credit report on him/her, in order to help collect or compromise a debt;
e.	To debt collection agents or contractors under 31 USC 3718 or under common law to help collect a past due amount or locate or recover debtor''s assets;
f.	To the Justice Department for litigation or for further administrative action; and
g.	To the public, as provided by 31 USC 3720E, in order to publish or otherwise publicly disseminate information regarding the identity of the person and the existence of a non-tax debt.

Disclosure under part (d) and (g) of this routine use is limited to the individual''s name, address, Social Security number, and other information necessary to identify the person. Disclosure under parts (a)-(c) and (e) is limited to those items; the amount, status, and history of the claim; and the agency or program under which the claim arose. An address obtained from IRS may be disclosed to a credit reporting agency under part (d) only for purposes of preparing a credit report on the individual.

A record from this system may be disclosed to another federal agency that has asked HHS to effect an administrative offset under common law or under 31 USC 3716 to help collect a debt owed the United States. Disclosure under this routine use is limited to: Name and address, Social Security number, and other information necessary to identify the individual; information about the money payable to or held for the individual; and other information concerning the administrative offset.
Disclosure with regard to claims or debts arising under or payable under the Social Security Act may be made from this system to “consumer reporting agencies” as defined in the Fair Credit Reporting Act (15 USC 1681a(f)) or the Federal Claims Collection Act of 1966 (31 USC 1701(a)(3)). The purpose of this disclosure is to aid in the collection of outstanding debts owed the federal government. Disclosure of records is limited to the individual's name, address, Social Security number, and other information necessary to establish the individual's identity; the amount, status and history of the claim; and the agency or program under which the claim arose.
Information in this system of records is used to prepare W-2s and 1099 forms to submit to the Internal Revenue Service and applicable state and local governments items considered to be included as income to a person: certain travel-related payments to employees, all payments made to persons not treated as employees (e.g., fees to consultants and experts), and amounts written-off as legally or administratively uncollectible, in whole or in part.
A record may be disclosed to banks enrolled in the Treasury Credit Card Network to collect a payment or debt when the person has given his/her credit card number for this purpose.
Records may be disclosed to a contractor (and/or to its subcontractor) who has been engaged to perform services on an automated data processing (ADP) system used in processing financial transactions. The contractor may have been engaged to develop, modify and test a new ADP system, including both software and hardware upgrades or enhancements to such a system; perform periodic or major maintenance on an existing ADP system; audit or otherwise evaluate the performance of such an ADP system; and/or operate such a system.
Records may be disclosed to a contractor for the purpose of collating, aggregating, analyzing, or otherwise refining records in this system. The contractor shall be required to maintain Privacy Act safeguards in working with such records.
Records may be disclosed to student volunteers, individuals working under a personal services contract, and other individuals performing functions HHS but technically not having the status of agency employees, if they need access to the records in order to perform their assigned agency functions.
A record from this system may be disclosed to any federal agency or its agents in order to participate in a computer matching of a list of debtors against a list of federal employees. Disclosure of records is limited to debtors' names, names of employers, taxpayers identifying numbers, addresses (including addresses of employers), and dates of birth, and other information necessary to establish the person's identity.
A record may be disclosed to a commercial reporting agency that a person is responsible for a current claim, in order to aid in the collection of claims, typically by providing an incentive to the person to repay the claim or a debt timely. Disclosure of records is limited to information about a person as is relevant and necessary to meet the principal purpose(s) for which it is intended to be used under the law.
A record from this system may be disclosed to the Treasury Department or to an agency operating a Debt Collection Center designated by the Treasury in order to effect a collection of past due amounts.
If HHS decides to sell a debt pursuant to 31 USC 3711(I), a record from the system may be disclosed to purchasers, potential purchasers, and contractors engaged to assist in the sale or to obtain information necessary for potential purchasers to formulate bids and information necessary for purchasers to pursue collection remedies.
If HHS decides to administratively garnish wages of a delinquent debtor under the wage garnishment provision in 31 USC 3720D, a record from the system may be disclosed to the debtor's employer. This disclosure will take the form of a wage garnishment order directing that the employer pay a portion of the employee/debtor's wages to the federal government. Disclosure of records is limited to debtor's name, address, and Social Security number. Also a record from this system may be disclosed to other systems, federal agencies or its agents in order to participate in a computer matching of a list of debtors against a list of federal employees.
Disclosure pursuant to 5 USC 552a(b)(12): Disclosure may be made from this system to “consumer reporting agencies,” as defined in 31 USC 3701(a)(3). The purpose of this disclosure is to aid in the collection of outstanding debts owed to the federal government, typically, to provide an incentive for debtors to repay their debts timely, by making these debts part of their credit records. Disclosure of records is limited to the individual's name, address, social security number, and other information necessary to establish the individual's identity; the amount, status and history of the claim; and the agency or program under which the claim arose. The disclosure will be made only after the procedural requirements of 31 USC 3711(e) have been followed.

(4) Submission of PII through this information system is voluntary. However, the submission of PII is required in order to communicate and send responses to requests. If you choose not to provide PII, FDA may not be able to respond to your request.

Additional details regarding HHS and FDA use of application records is available online: http://www.hhs.gov/foia/privacy/recordsnotices/09900058.html and http://www.hhs.gov/foia/privacy/recordsnotices/09900024.html.

General FDA policies on privacy and information management are also available online at http://www.fda.gov/RegulatoryInformation/FOI/PrivacyAct/default.htm and http://www.fda.gov/AboutFDA/AboutThisWebsite/WebsitePolicies/default.htm.

FDA Freedom of Information Act (FOIA)

Electronic FOIA Request

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