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FDA
updated 1/7/09
The guidance given in this handbook is intended to facilitate requests for both public information and records not originally prepared for distribution by FDA. This handbook has been updated in response to the Electronic Freedom of Information Act Amendments of 1996.
Certain documents that are prepared for public distribution--such as press releases, consumer publications, speeches, and congressional testimony--are available from FDA without having to file a Freedom of Information Act (FOIA) request. Many of these documents are available on FDA's Internet site (www.fda.gov). We encourage you to browse the site for documents you want to look at. Public information may also be obtained by contacting the appropriate FDA information officer.
Consumers with questions about FDA-related matters also may call toll-free 1-888-INFO-FDA (1-888-463-6332).
FOIA allows anyone to request copies of records not normally prepared for public distribution. FOIA pertains to existing records only and does not require agencies to create new records to comply with a request. It also does not require agencies to collect information they do not have or to do research or analyze data for a requestor. In addition, FOIA requests must be specific enough to permit an FDA employee who is familiar with the subject matter to locate records in a reasonable period of time.
Under FOIA, certain records may be withheld in whole or in part from the requestor if they fall within one of nine FOIA exemptions. Six of these exemptions most often form the basis for the withholding of information by the FDA:
Exemption 2: Protects certain records related solely to FDA's internal rules and practices.
Exemption 3: Protects information that is prohibited from disclosure by other laws.
Exemption 4: Protects trade secrets and confidential commercial or financial information.
Exemption 5: Protects certain interagency and intra-agency communications.
Exemption 6: Protects information about individuals in personnel, medical, and similar files when disclosure would constitute a clearly unwarranted invasion of privacy.
Exemption 7: Protects records or information compiled for law enforcement purposes when disclosure (A) could reasonably be expected to interfere with enforcement proceedings; (B) would deprive a person of a right to a fair trial or an impartial adjudication; (C) could reasonably be expected to constitute an unwarranted invasion of personal privacy; (D) could reasonably be expected to disclose the identity of a confidential source; (E) would disclose techniques and procedures for law enforcement investigations or prosecutions, or would disclose guidelines for law enforcement investigations or prosecutions, if such disclosure could reasonably be expected to risk circumvention of the law; or (F) could reasonably be expected to endanger the life or physical safety of an individual.
In the event FDA relies on one or more FOIA exemptions to deny a requestor access to records, a letter stating the reasons for denying the records will be sent to the requestor. The letter will also notify the requestor of the right to appeal the agency's denial determination. More specific information on these exemptions and on other aspects of our FOIA program are contained in FDA's FOIA implementation regulations, 21 CFR Part 20.
All FOIA requests must be in writing and should include the following information:
a. Requestor's name, address, and telephone number.
b. A description of the records being sought. The records should be identified as specifically as possible. A request for specific records that are releasable to the public can be processed much more quickly than a request for "all information" on a particular subject. Also fees for a more specific and limited request will generally be less.
c. Separate requests should be submitted for each firm or product involved.
d. A statement concerning willingness to pay fees, including any limitations.
Questions relating to FOI requests may be addressed to the Division of the Freedom of Information Offices at 301-827-6567.
All FOIA requests must be in writing. FDA does not accept FOIA requests sent via e-mail. Requests should be mailed to the following address:
Food and Drug Administration
Office of Management Programs
Division
of Freedom of Information (HFI-35)
5600 Fishers Lane
Rockville, MD 20857
Or requests may be sent via fax to: fax number 301-443-1726 or 301-443-1719. If there are problems sending a fax, call (301) 443-2414.
FOIA requestors may have to pay fees covering some or all of the costs of processing their request. Requestors may want to include the maximum dollar amount they are willing to pay. If the fees exceed the maximum amount stated, FDA will contact the requestor before filling the request. Requestors are generally billed for fees after their requests have been processed; however, if total fees are expected to exceed $250.00 FDA may require payment in advance of processing. Please note that no invoice will issue unless aggregate charges for the 30 day billing cycle exceed $25.
For Requests Received Prior to January 1, 2009, processing fees are as follows:
Commercial Use Requestors:
Noncommercial Use Requestors, Such as Representatives of the News Media, and Educational and Noncommercial Scientific Institutions:
Other Requestors, Including Consumers:
For Requests Received On or After January 1, 2009, fees are as follows:
Fees for requests processed within 20 workings days of the agency’s receipt
of the request will be billed as explained above. For requests that are
processed in more than 20 working days, and for which no unusual or exceptional
circumstances exist (as provided by the OPEN Government Act of 2007), the following
fee schedule shall apply:
Commercial Use Requestors:
Noncommercial Use Requestors, Such as Representatives of the News Media, and Educational and Noncommercial Scientific Institutions:
Other Requestors, Including Consumers:
Requestors should NOT send payment with their requests. Please only remit payment in response to an invoice. Failure to promptly remit payment in response to an invoice will prevent a requester from making future FOIA requests until all outstanding bills have been paid.
Notice to Customers Making Payment by Personal Check
If you send us a personal check, it will be converted into an electronic funds transfer (EFT). This means we will copy your check and use the account information on it to electronically debit your account for the amount of the check. The debit from your account will usually occur within 24 hours, and will be shown on your regular account statement.
You will not receive your original check back. We will destroy your original check, but we will keep the copy of it. If the EFT cannot be processed for technical reasons, you authorize us to process the copy in place of your original check. If the EFT cannot be completed because of insufficient funds, we may try to make the transfer up to 2 times.
Online Payment
Prefer to pay online? Need to review your invoices? Want to know how much you owe?
With the new Account Management System you can pay your invoices by ACH (electronic check) or Credit Card! You can also review your account transactions and balances, all from one website.
FOIA Invoice changes:
Payment can be forwarded to FDA by one of the following methods:
1. Online Payment:
Sign in and access your invoice at https://fdasfinapp8.fda.gov/OA_HTML/irecLogin.jsp.
Select the invoice you would like to pay and then click the 'Pay' button. On
the next screen, click on the 'Pay Now' button to pay online through Pay.gov.
For more help, see the 'How To Guide'.
2. U.S. Mail:
Food and Drug Administration
P.O. Box 70963
Charlotte, NC 28272-0963
3. Courier Delivery:
Wachovia Bank
Attn: Food and Drug Administration Lockbox 70963
1525 West WT Harris Blvd, Room NC0810
Charlotte, NC 28262
Note: Courier Address is for delivery only. Make sure the FDA Post Office Box number (P.O.Box 70963) is on the enclosed check.
If a phone number is also required for the courier delivery, note (800) 590-7868 an automated operator will ask for a three digit team number, please enter 622, followed by extension 85749.
Your invoice number must be noted on your remittance.