• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

About FDA

  • Print
  • Share
  • E-mail

SMG 3297.1

FDA STAFF MANUAL GUIDES, VOLUME III - GENERAL ADMINISTRATION

INFORMATION RESOURCES MANAGEMENT

FREEDOM OF INFORMATION ACT

FREEDOM OF INFORMATION (FOI) ACT INTERNAL PROCEDURES AND EXISTING POLICY

Effective Date: May 1, 2007

[PDF Version]

 1. Purpose and Policy
 2. Responsibilities and Procedures
 3. Authorities
 4. References
 5. Background
 6. Public Reading Rooms and the Repository
 7. Requests and Records Subject to FOI
 8. Disclosure Policy
 9. Time Frames for Responding to Requests
 10. Fees
 11. Testimony, Affidavits, and Subpoenas
 12. Effective Date
 13. Document History

1. PURPOSE AND POLICY 

The purpose of this Staff Manual Guide (SMG) is to set forth internal FDA procedures and previously-communicated policy for complying with the Freedom of Information Act (FOIA) as amended by the Electronic Freedom of Information Act Amendments (EFOIA).

2. RESPONSIBILITIES AND PROCEDURES 

This SMG is intended to be used in conjunction with SMG 3297.2, "Freedom of Information (FOI) Act Operational Responsibilities" which addresses overall operational responsibilities and specific Division of Freedom of Information (DFOI) and component organization responsibilities for carrying out the Agency FOIA program.

3. AUTHORITIES 

A. Freedom of Information Act (FOIA), 5 U.S.C. 552

B. Electronic Freedom of Information Act Amendments of 1996 (EFOIA), P.L. 104-231 (codified throughout 5 U.S.C. 552)

C. HHS FOI Regulations, 45 CFR Part 5

D. FDA FOI Regulations, 21 CFR Part 20

E. FDA Privacy Act Regulations, 21 CFR Part 21

F. Executive Order No. 12600, Predisclosure Notification Procedures for Trade Secret and Confidential Commercial Information

4. REFERENCES 

A. FDA FOI Intranet web site (http://intranet.fda.gov/omp/foi/)

B. FDA Regulatory Procedures Manual (http://web.ora.fda.gov/qms/drafts/RPM-master.htm)

C. Freedom of Information Act Guide”, U.S. Department of Justice, March 2007 (http://www.usdoj.gov/oip/foi-act.htm)

D. “Information Disclosure Manual,” Office of Regulatory Affairs, Office of Enforcement, Division of Compliance Policy, 1999 (http://web.ora.fda.gov/oe/info%5Fdisclose/default%5Fidm.htm)

E. ORA Quick Reference Disclosure Guides (http://intranet.fda.gov/omp/foi/oraquickreference.htm).

E. FDA FOI Internet web site (http://www.fda.gov/foi/foia2.htm)

5. BACKGROUND 

A. FREEDOM OF INFORMATION ACT

The Freedom of Information Act generally provides that any person has the right, enforceable in court, to access Federal agency records, except to the extent that the records (or portions thereof) are protected from public disclosure by one of nine Exemptions contained within the FOI Act, or by one of three special law enforcement record exclusions.

B. ELECTRONIC FREEDOM OF INFORMATION ACT AMENDMENTS OF 1996 (EFOIA)

The EFOI Act amended the FOIA and authorizes, and in some instances requires, agencies to issue regulations implementing its provisions (including aggregation of FOIA requests, expedited processing, and multi-track processing). The EFOIA amends the time limit for responding from 10 to 20 working days, the process to extend the time to respond to an FOIA request, and certain reporting requirements. The EFOIA also requires the creation of electronic reading rooms, and requires agencies to provide records in the format and/or format requested, such as in an electronic format, if the record is readily reproducible in that format.

C. PRIVACY ACT

The Privacy Act protects individuals against unwarranted invasion of privacy stemming from the collection, maintenance, use, and disclosure of personal information. The Privacy Act applies to information about an individual that is contained within a Privacy Act System of Records. To be in a Privacy Act System of Records, the information must be retrieved by an individual's name or other personal identifier. Not all information about a person in FDA files is covered by the Privacy Act. A list of FDA’s Privacy Act Systems of Records is published in the Federal Register and the FOI Intranet.

References: 21 CFR part 21; Staff Manual Guide 3291.4, http://intranet.fda.gov/omp/smg/smg-htm/3291_4.htm; Privacy Act, 5 U.S.C. 552a, http://www.usdoj.gov/04foia/privstat.htm; FDA's Privacy Act Systems of Records Notice, http://intranet.fda.gov/omp/foi/panotices.htm

6. PUBLIC READING ROOMS AND REPOSITORY 

A. Public Reading Rooms

1. FOIA Requirements

Certain records must be routinely made available for public inspection and copying in the Agency FOI reading room. The following four categories of records are specifically required to be on display:

  • Final opinions and orders; and
  • Policy statements; and
  • Administrative staff manuals and instructions to staff that affect members of the public; and

In addition, the EFOI requires that certain records be maintained in an Electronic Reading Room when those records were created after November 11, 1996. This requirement may be met by posting records on the FDA Internet web site.

Reference: 21 CFR 20.120(d)

2. FDA's Public Reading Rooms

a. Hard-copy reading rooms

The FDA operates two public reading rooms for hard copies: (1) the Freedom of Information Public Reading Room maintained by the DFOI; and (2) the Dockets Management Public Reading Room.

b. Electronic Reading Room

In addition, the FDA maintains part of its Freedom of Information Public Reading Room electronically on its website. The DFOI maintains the main web page, which contains FDA-wide documents as well as links to electronic reading rooms that each Center, and ORA, maintains separately. The main web page is http://www.fda.gov/foi/foia2.htm. The index link goes to http://www.fda.gov/foi/electrr.htm, which contains links to each separate reading room.

The following records are available in FDA's Electronic Reading Room:

  • A guide for submitting requests for records to FDA; and
  • Administrative staff manuals and instructions to staff that affect members of the public; and
  • FDA records released in response to a FOI request and that have become or are likely to become the subject of subsequent requests for substantially the same records; and
  • Indexes of records maintained in the FOI Public Reading Room.

References: 5 USC 552(a)(2); 21 CFR 20.26; FDA's Electronic FOI Reading Room, http://www.fda.gov/foi/foia2.htm

B. REPOSITORY

The Repository is the electronic document storage system for FOI requests. Responses from component offices should also be scanned into the Repository for long-term storage by the responding office, except for those records provided under a first-party release. Scanning a response into the Repository fulfills the requirement that DFOI receive a copy of all outgoing responses to FOIA requests.

Records should be scanned and labeled individually, to facilitate retrieval.

Reference: Instructions for use of the Repository, http://intranet.fda.gov/omp/foi/repositoryguide.pdf.

7. REQUESTS and RECORDS SUBJECT TO FOIA 

A. FOI REQUEST

A FOIA request may be submitted, in writing, for copies of existing records, which were not prepared for routine distribution to the public. Requests must "reasonably" describe the requested records. Requests need not specifically or individually identify the records, and do not have to be designated or labeled as a “FOI request.”

References: 21 CFR 20.23; 21 CFR 20.30; 21 CFR 20.40; 5 USC 552(a)(3)(A)

B. RECORDS SUBJECT TO FOIA

Identifiable records not normally prepared for distribution to the public, which are already in existence and in the possession or control of the FDA, are subject to review and possible release under the FOIA, after any appropriate redactions. "Records" include any handwritten, typed, or printed document (e.g., email, memoranda, studies, writings, drafts, letters, transcripts, and minutes) and documentary material in other forms (e.g., tapes, cards, discs, audio or video recordings, maps, photographs, slides, and microfilm).

References: 21 CFR 20.20(e); 21 CFR 20.22 - 20.24; 21 CFR 20.40; 45 CFR 5.5; 5 USC 552(f)(2)

C. SUBMISSION REQUIREMENTS

1. Written Requests

All requests for Agency records subject to FOIA should be submitted in writing to:

Division of Freedom of Information (HFI 35)
Office of Management Programs
U.S. Food & Drug Administration
5600 Fishers Lane
Rockville, MD 20857

At this time, the FDA does not accept emailed FOIA requests, but does accept requests submitted by fax.

References: 21 CFR 20.30; 21 CFR 20.40(a); 5 USC 552(a)(3)(A)

2. Requests Addressed Directly to FDA Organizational Components

Notwithstanding 21 CFR sections 20.30 and 20.40(a), which direct requesters to submit requests directly to the DFOI, FDA organizational components that receive requests addressed to them should, in the interest of being helpful to the public, immediately forward those requests to the DFOI for logging and administrative controls, prior to processing the request.

If, however, the request is for a copy of a record which is clearly disclosable, contains no information which is to be redacted, is readily available, and for which no payment will be required, the FOI component officer may respond to the requester, and then forward the request to DFOI for logging as a closed FOIA request.

D. FORM OR FORMAT

1. Preference Specified

Under EFOIA, a requester may specify the form or format in which the requested records are preferred. FDA should provide the records in that form or format, as long as the records are readily reproducible in that form or format. FDA must make "reasonable efforts" to meet any such request.

2. No Preference Specified

If the requester does not state a preference, the FOIA component officer provides the record in the form or format of the Agency's choice.

References: 21 CFR 20.33; 5 U.S.C. 552(a)(3)(B)

E. AGGREGATION OF CERTAIN REQUESTS

1. Criteria

The FOIA, as amended by the EFOIA, allows aggregating certain FOIA requests from the same requester, or group of requesters acting together, if the requests involve clearly related matters and the Agency believes that such requests actually constitute a single request.

References: 21 CFR 20.42; 5 U.S.C. 552(a)(6)(B)(iv)

2. Time Requirement

FDA may extend the response time in accordance with the unusual circumstances provision of the FDA Public Information Regulations.

References: 21 CFR 20.42; 21 CFR 20.41(b)(3)(ii)(B)

F. EXCLUSIONS FROM FOI

1. Objects or Articles

Records do not include objects or articles such as exhibits, models, or equipment.

Reference: 45 CFR 5.5

2. Materials in Officially Designated HHS Libraries

Records do not include books, magazines, pamphlets, or other reference material in formally organized and officially designated HHS libraries.

Reference: 45 CFR 5.5

3. Records Prepared for Public Distribution

The FOIA does not apply to release of records that are prepared for routine public distribution (e.g., press releases, Talk Papers, Federal Register notices, information brochures, speeches, and congressional testimony). As long as supplies last, such records will be provided promptly, at no cost, to any requester without reference to the FOIA or referral to the DFOI by other FDA components.

Reference: 21 CFR 20.23(b)

G. FOIA Exemptions 

Records may be withheld or redacted if they fall within one of nine FOIA exemptions. The FOIA requires that a record must be released only to the extent that none of the FOIA exemptions, as interpreted by FDA’s and HHS's implementing regulations, apply. Historically, FDA has used only seven of the nine FOIA exemptions:

1. Exemption 1 - National Defense and Foreign Policy

Records specifically authorized under criteria established by Executive Order 12958, to be kept secret in the interests of national defense or foreign policy, and properly classified pursuant to that Executive Order.

References: 21 CFR 20.65; 45 CFR 5.62

2. Exemption 2 - Internal Personnel Rules and Practices

Records related solely to FDA's internal rules and practices. This Exemption includes special techniques or procedures of investigation or prosecution, not otherwise generally known to the public, and guidelines for law enforcement investigations or prosecutions, if disclosure would allow circumvention of law or regulation; this is referred to as "High 2." Trivial issues are referred to as "Low 2," although Low 2 is not generally used as the basis for a denial under the FOIA, in the FDA.

References: 21 CFR 20.66; 45 CFR 5.63

3. Exemption 3 - Records Exempted by Other Federal Laws

Records which may be specifically withheld under another statute, or withheld under criteria provided in another statute, which sufficiently describes the information or records at issue.

References: 21 CFR 20.67; 45 CFR 5.64

4. Exemption 4: Trade Secrets and Confidential Commercial or Financial Information

Trade secrets are found in records containing secret, commercially valuable plans, formulas, processes, or devices used for making, preparing, compounding or processing trade commodities that are the end product of either innovation or substantial effort. Confidential commercial or financial information is found in records containing valuable, non-public data or information relating to businesses, commerce, trade, employment, profits, or finances (including personal finances).

References: 45 CFR 5.65; 21 CFR 20.61; ORA Quick Reference Disclosure Guide: Trade Secrets; ORA Quick Reference Guide: Confidential Commercial Information

5. Exemption 5 - Internal Memoranda

Certain inter- or intra-agency communications that fall within a generally recognized evidentiary privilege (e.g., deliberative process memoranda and other pre-decisional information; attorney work product documents prepared in anticipation of litigation or for trial; and attorney-client communications).

References: 21 CFR 20.62; 45 CFR 5.66

6. Exemption 6 - Clearly Unwarranted Invasion of Personal Privacy

Information that, if disclosed, would constitute a clearly unwarranted invasion of personal privacy (e.g., names and other identifying information about patients and research subjects).

References: 21 CFR 20.63; 45 CFR 5.67; ORA Quick Reference Disclosure Guide: Privacy

7. Exemption 7 - Law Enforcement

Records or information compiled for law enforcement purposes, also considered an open investigatory record, when disclosure:

a. Could reasonably be expected to interfere with prospective or ongoing law enforcement proceedings; or

b. Would deprive any person of the right to a fair trial or an impartial adjudication, such as because of prejudicial publicity; or

c. Could reasonably be expected to constitute an unwarranted invasion of personal privacy; or

d. Could reasonably be expected to disclose the identity of a confidential source (including an individual, a State, local, or foreign government agency, or any private organization) which furnished information on either an expressed or reasonably inferred confidential basis, or disclose information furnished by a confidential source where a record or information in it has been compiled by a criminal law enforcement authority in the course of a criminal investigation or by an agency conducting a lawful national security investigation; or

e. Would disclose special techniques, guidelines, and procedures for investigations or prosecutions, not otherwise generally known to the public, 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 any individual.

References: 21 CFR 20.64; 45 CFR 5.68

8. DISCLOSURE POLICY 

A. FULLEST POSSIBLE DISCLOSURE

Under 21 CFR 20.20(b), all FDA records shall be made available for public disclosure except where specifically exempt from disclosure under the provisions of 21 CFR Part 20, which implement the FOIA as it relates specifically to FDA records.

In addition, for records that are specifically exempt but are not prohibited by law from being disclosed, FDA policy is to make the fullest possible disclosure of those records to the public consistent with the rights of individuals to privacy, the property rights of persons in trade secrets and confidential commercial or financial information, and the need for the agency to promote frank internal policy deliberations and to pursue its regulatory activities without disruption (21 CFR 20.20(a)).

Consequently, 21 CFR 20.82 provides the Commissioner with discretion to disclose documents that otherwise would be exempt from disclosure, with certain limitations and guidelines. First, as to limitations, under subsection 20.82(b) the Commissioner may not disclose:

1. trade secrets or confidential commercial or financial information that is exempt under 21 CFR 20.61;

2. personal privacy information that is exempt under 21 CFR 21.63;

3. records prohibited from public disclosure by statute; or

4. Privacy Act Records where disclosure would constitute a clearly unwarranted invasion of personal privacy or is otherwise in violation of the Privacy Act, as implemented by FDA regulations.

In practical terms, that means that in general records protected by FOIA Exemptions 1, 3, 4, 6, 7(B) - 7(D), or by the Privacy Act, may not be disclosed, but that those protected by Exemptions 2 (internal personnel rules and practices), 5 (deliberative process), or 7(A) or 7(E) (certain investigatory records) may be subject to discretionary disclosure, under the guidelines in 21 CFR 20.82(a).

Second, as to those guidelines, the Commissioner shall exercise his discretion to disclose otherwise exempt documents whenever he determines that public disclosure:

1. is in the public interest;

2. will promote the objectives of the Food, Drug, and Cosmetic Act and FDA; and

3. is consistent with:

a. the rights of individuals to privacy;

b. the property rights of persons in trade secrets;

c. the need for FDA to promote frank internal policy deliberations; and

d. the need for FDA to pursue its regulatory activities without disruption.

FDA employees reviewing otherwise exempt documents for disclosure purposes should consider the above guidelines and, where appropriate, recommend that the Commissioner, or an employee to whom the Commissioner has delegated authority in Staff Manual Guide 1410.21(1)(b) or 1410.24(1)(a)(3), authorize public disclosure of those otherwise exempt documents.

References: 21 CFR 20.20; 21 CFR 20.82

B. UNIFORM ACCESS

If any record or information is disclosed through appropriate or authorized channels to any member of the public, that record must be made available to all members of the public (except when the regulations in 21 CFR 20.21 (a), (b), and (c) authorize a more limited disclosure).

Reference: 21 CFR 20.21

C. ANY AVAILABLE/ALL DISCLOSABLE INFORMATION

Certain requesters specify "any available information" or "all disclosable information." FDA interprets this to mean that, when appropriate, it is acceptable to issue a response indicating that no disclosable records are available. No formal denial is necessary under these circumstances.

D. PARTIAL RELEASE/PARTIAL DENIAL OF RECORDS 

If the requested records are partially releasable, the clearly disclosable records may be sent to the requester. The response should indicate that the requester will receive a further response under separate cover; the letter should not state that a denial is under consideration. If the remaining records are not releasable, a denial recommendation should be processed through appropriate channels.

All denial recommendations should include:

1. a copy of the records, as they were released, with minor deletions, if any; and

2. a copy of all the withheld information, including unredacted copies of records you released with minor deletions; and

3. the circumstances relating to the proposed withholding, to include the status of any pending action or review; and

4. applicable citations to regulations in 21 CFR part 20, and any other applicable agency regulation; and

5. documentation of any contact between the FOI officer and the requester, especially those contacts that resulted in a narrowing of the request.

The DFOI Denials and Appeals Officer will review the proposal and make the final determination for the Agency.

E. MINOR DELETIONS POLICY

FDA does not treat “minor deletions” made to otherwise releasable records as formal denials in the first instance. The overwhelming majority of requesters who receive documents with minor deletions are satisfied with the material they receive and do not request the withheld material. When making minor deletions, the FOI component office response letter should include the following paragraph:

"Certain material has been deleted from the records furnished to you because a preliminary review of the records indicated that the deleted information is not required to be publicly disclosed and that disclosure is not appropriate. FDA has taken this approach to facilitate the process of responding to you. If you dispute FDA's preliminary determination and would like FDA to reconsider a particular deletion, please let us know in writing at the address listed below within 30 days from the date of this letter. If we do not receive a response in that time period, we will consider the matter closed. If you do request further consideration and if the agency then formally denies your request for any or all of the previously-withheld information, you would have the right to appeal that decision. Any letter of denial will explain how to make this appeal."

If, after reviewing and redacting the requested records, the FOI officer determines that a significant amount of material must be withheld, the FOI officer should prepare a partial denial recommendation, and submit the recommendation to DFOI.

F. VOLUME ESTIMATION

When all or part of a record is redacted or withheld, EFOI requires that the Agency must make a “reasonable effort to estimate the volume” of information being denied and provide that estimate to the requester.

If minor deletions are made to a releasable record, that copy must indicate how much information was deleted (e.g., 2 words, 15 lines, 1 page), and where the redaction was made, whenever it is technically feasible to do so. This shows the requester that some data elements have been suppressed which might not be apparent otherwise.

References: 21 CFR 20.22(b); 5 U.S.C. 552(b)

G. FIRST PARTY REQUESTS

When a FOIA request is made for records, and the requester is the submitter or subject of the record (e.g., the requester represents the firm which submitted the records, or is a patient requesting his own records), information may be provided that is not releasable to a third party. That is true for both Privacy Act requests and FOIA requests.

1. Privacy Act Requests

When the requester is the subject of the record, or that person's authorized representative acting on the person's behalf, and the records he seeks about himself are retrieved by a personal identifier (such as his name or Social Security number), special Privacy Act rules apply, (see 21 CFR 20.40(d)(1)) and the FDA Privacy Act Coordinator ordinarily handles those requests. (See 21 CFR 21.41(c)).

For Privacy Act record requests, giving a requester a Privacy Act System Record about himself does not subject that record to uniform access under the FOIA. (See 21 CFR 20.21(c)). That is true even if the requester labels his request a FOIA request and does not mention the Privacy Act. In rare situations, however, Privacy Act records are exempt from disclosure to the subject of the records. (See, e.g., 21 CFR 21.41(f) and 21 CFR Part 21 Subpart F.) In those situations, the FDA Privacy Act Coordinator may perform an additional FOIA analysis and apply the regulations in 21 CFR Part 20.

Each Component Office is responsible for the Privacy Act accounting for the records under their control. (see 21 CFR 21.71)

2. FOIA Requests

When a requester is a person seeking records about himself that are not retrieved by the individual’s name or other personal identifier, then the request is a FOIA request and the rules in 21 CFR Part 20 apply. (See 21 CFR 20.40(d)(2)). Similarly, when the requester is a business or otherwise does not meet the definition of “individual” in 21 CFR 21.3(a), the request is a FOIA request subject to 21 CFR Part 20. If those records contain the requester’s own trade secrets or confidential commercial or financial information, or the requester’s own personal privacy information, however, FDA will disclose that information to the requester only. (See 21 CFR 20.21(a)). That disclosure does not subject the records to uniform public access under the FOIA. (See 21 CFR 20.21(a)). In such cases, the FOIA component officer should redact protected information from the records other than trade secrets, confidential commercial or financial information, and personal privacy information, and use the following paragraph in the response letter:

"As you will note, the enclosed records contain certain business or personal information that is disclosable only to you or your firm. Copies of these records will be disclosed to other requesters only after thorough review and deletion of those portions that are not disclosable to the general public." Records which are not releasable to a third party should not be scanned into the AIMS FOI Repository.

References: 21 CFR 20.21; 21 CFR 20.40; 21 CFR 21.3; 21 CFR 21.41; 21 CFR Part 21 Subpart F

H. ILLEGIBLE COPIES of RECORDS

If a record is disclosable but a legible copy of the record cannot be located or reproduced, no attempt to reconstruct the record will be made. Instead, send the requester the best copy available, and note the poor quality in the response.

I. CREATION OF NEW RECORDS & REQUESTS FOR INFORMATION NOT CONTAINED IN RECORDS

The FOIA does not require FDA to create new records to respond to a request. If a requester is only asking for information (not copies of records), the request is not a FOI request. Such inquiries should not be referred to the DFOI, but should be answered promptly, as part of FDA's general effort to be responsive to the public.

Reference: 21 CFR 20.24

J. RECORDS NOT IN FDA’s POSSESSION

The FOIA does not require FDA to accept a request for a record that is not in the possession of the Agency. The FDA (Component FOI Officer) should provide the requester with information on how to contact the appropriate agency, if the record is in the possession of another federal agency. A list of FOI contacts in other agencies is posted on the FDA FOI Intranet page.

Reference: 21 CFR 20.51; 21 CFR 20.24(a)

K. RECORDS NOT YET IN EXISTENCE

Sometimes FDA receives a request for a record which does not yet exist. For example, requests have sought copies of Establishment Inspection Reports not yet written, and other requests sought automatic distribution of all documents in a certain category that FDA receives over the next six months. As mentioned above, the FOIA and FDA regulations in 21 CFR Part 20 apply only to existing records. (See 21 CFR 20.24(a)). Nevertheless, if possible, the Component FOI Officer should provide the requester with an estimate of when the record will be completed to facilitate the requester's resubmitting the request. No offer should be made to provide the record when it is completed. This response closes the FOI request.

Reference: 21 CFR 20.24.

L. PREDISCLOSURE NOTIFICATION (PDN) FOR CONFIDENTIAL COMMERCIAL INFORMATION 

Executive Order 12600 required agencies to establish procedures to permit those who submit documents to agencies to designate which information in those documents, if disclosed publicly, could reasonably be expected to cause them substantial competitive harm. The Order also required agencies to establish Predisclosure Notification (PDN) procedures. Specifically, before publicly disclosing information that a submitter has designated for protection, or information that the agency has reason to believe could reasonably be expected to cause substantial competitive harm, the agency must notify the submitters and give them an opportunity to object. 21 CFR 20.61(d) and (f) set forth criteria for when PDN applies, and 21 CFR 20.61(e) sets forth the procedures for PDN in those few situations where it does apply. Paragraphs (a) and (b) below summarize criteria for when to use PDN, and for when such notification is not necessary:

1. Predisclosure Notification Is Only Considered When:

  • The records were submitted to FDA (PDN only applies to submitted records; agency-generated records are not subject to PDN); and either:
  • The submitter designated, in writing, part or all of the information in the records as exempt from disclosure under Exemption 4 of the FOIA (any such designation expires 10 years after submission of the records to the FDA); or
  • The FDA has substantial reason to believe that the information could reasonably be considered exempt under Exemption 4 of the FOIA (for trade secret and/or confidential, commercial information).

References: 21 CFR 20.61(e); Executive Order 12600, http://www.archives.gov/federal-register/codification/executive-order/12600.html

2. But Predisclosure Notification Is Not Applicable When:

  • The FDA has determined that the record should not be disclosed (i.e., should be completely denied); or
  • The information has been published or has been officially made available to the public (i.e., previously released under FOI); or
  • Disclosure is required by a regulation, issued after notice and public comment, that specifies narrow categories of records to be released under the FOIA (but consult the DFOI if the requester designated those records as protected); or
  • The records were submitted more than 10 years ago.

These criteria exempt many FDA records from PDN. That is true largely because FDA has promulgated many regulations, in 21 CFR Part 20 as well as in other sections of title 21 of the CFR, which do specify narrow categories of records to be released under FOIA. For a list of many such regulations, see 21 CFR 20.100(c).

References: 21 CFR 20.61(d) – (f); 21 CFR 20.100; Executive Order 12600, http://www.archives.gov/federal_register/codification/executive_order/12600.html

9. TIME FRAMES FOR RESPONDING TO REQUESTS 

A. 20 WORKING DAYS

FOI requests should be answered within 20 working days after the date of receipt by the DFOI. A standard Letter of Acknowledgement does not meet the requirement for responding within 20 working days. FDA meets this requirement by sending a:

1. Response to the request (i.e., releasing the record, or writing to explain that the records do not exist or cannot be located), or

2. Denial Letter, signed by the ACPA, or designee.

References: 21 CFR 20.41; 5 U.S.C. 552(a)(6)

B. 30 WORKING DAYS OR LONGER

In unusual circumstances, the time for responding may be extended by an additional 10 working days. (See 21 CFR 20.41(b)(3)(i)(A)). Only the Director, DFOI can make the decision to utilize the 10-day extension.

To obtain an extension longer than 30 working days through the FOIA process, the agency may provide written notice to the requester setting out the reasons for needing a greater extension. The notice must give the requester an opportunity to limit the scope of the request so that it may be processed in a shorter time frame, or alternatively, an opportunity to agree on a timeframe longer than the 10 extra working days for processing the request. (See 21 CFR 20.41(b)(3)(i)(B)).

Before invoking this regulation, consult with DFOI. The existence of an Open America stay (see below) may impact on the use of this section.

Reference: 21 CFR 20.41(b)(3)(i)

C. Open America STAY REQUIREMENTS

Absent an agreement by the requester to grant FDA an extension longer than an additional 10 working days, FDA itself does not have authority to extend the deadline. If FDA does not meet the applicable time limit provisions, the requester is deemed to have exhausted his administrative remedies, and may immediately sue in Court. (See 5 U.S.C. 552(a)(6)(C)(i)). Nevertheless, to prevent the deadline provisions from becoming rigid and unworkable, Congress provided in the FOIA that "[i]f the Government can show exceptional circumstances exist and that the agency is exercising due diligence in responding to the request, the court may retain jurisdiction and allow the agency additional time to complete its review of the records." Such a court-ordered stay of the lawsuit is often called an "Open America stay,” after the D.C. Circuit Court of Appeals opinion, Open America v. Special Prosecution Force, that pioneered such stays. Courts generally have found that for agencies to qualify for an Open America stay, they must demonstrate that they are making good-faith efforts and are exercising due diligence in processing requests on a first-in, first-out basis, and in reducing their backlogs. The component FOI Officer may be asked to give a declaration or affidavit to support the request for an Open America stay. FDA has had occasions when it has needed to seek and obtain Open America stays, and FDA may need to do so in the future.

For that reason, it is very important that all FDA Component FOI Offices process FOIA requests on a first-in, first-out basis, and reduce their backlogs.

References: 5 U.S.C. 552(a)(6)(C)(i); Open America v. Special Prosecution Force, 547 F.2d 605, 610, 616 (D.C. Cir. 1976); Ohoegbu v. FBI, 936 F. Sup. 7, 8 (D.D.C. 1996)

D. EXPEDITED PROCESSING

Any requester who asks for expedited processing, either in the body of the FOIA request or separately, must provide the agency with sufficient information to justify taking the request out of turn. Only the Assistant Commissioner for Public Affairs (ACPA), or someone delegated authority from the ACPA, has authority to grant or deny an expedited processing request. The ACPA will grant the request if the requester demonstrates a “compelling need,” or in other cases, as the agency determines. A "compelling need" exists when:

1. Failure to obtain the records on an expedited basis could reasonably be expected to pose an imminent threat to the life or physical safety of an individual; or

2. With respect to a request from a person primarily engaged in disseminating information (i.e., the media), that there is demonstrated urgency to inform the public concerning actual or alleged Federal Government activity.

To qualify for the imminent-threat ground for expedited processing, the requester must be the specific individual who is subject to the imminent threat, or a family member, medical or health care professional, or other authorized representative of the individual. In addition, the requester must demonstrate a reasonable basis for concluding that failure to obtain the requested records on an expedited basis could reasonably be expected to pose a specific and identifiable imminent threat to the individual's life or safety.

To qualify for the information-disseminator ground for expedited processing, the requestor must demonstrate that:

1. The requestor is primarily engaged in disseminating information to the general public and not merely to a narrow interest group, and

2. An urgent need for the requested information exists and the information has a particular value that will be lost if the requester does not obtain and disseminate it quickly. A news media publication or broadcast deadline alone does not qualify as an urgent need, nor does a request for historical information; and

3. The request for records specifically concerns identifiable Federal Government operations or activities.

Although Component FOI Officers do not have authority to grant or deny an expedited processing request, they should submit recommendations to the ACPA, through the DFOI, for any expedited processing requests for documents within their component. In making the recommendation, component FOI Officers should follow the criteria above, and should consult 21 CFR 20.44.

Reference: 21 CFR 20.44

10. FEES 

A. ASSESSMENT

Under FOIA-mandated rules, fees are assessed for the production of records based on the requester category and on the GS level of the FDA staffer who fills the request. The DFOI assigns the user/requester category; the Component FOI Officer should only include the applicable charges, based on the requester category, in any response letters.

References: 21 CFR 20.45(a) and (c); 45 CFR 5.41 and 5.43; 5 U.S.C. 552(a)(4)(A)

B. USER/REQUESTER CATEGORIES AND APPLICABLE FEES

1. Category “C” (Commercial Users)

Fees should be assessed for search, duplication, and review of records.

2. Category “N” (News Media, including the Trade Press, and Educational and non-commercial Scientific Institutions)

Fees may only be charged only for duplication. While there is no charge for the first 100 pages of duplication, component offices should include all applicable charges in the response to the requester; DFOI will aggregate any invoices from the same requester, and make appropriate reductions in charges.

3. Category “O” (all Others, including Public Interest Groups, Nonprofit Organizations, and Consumers)

Fees are limited to duplication and search costs only.

Fees may only be charged only for search and duplication. While there is no charge for the first 2 hours of search time and the first 100 pages of duplication, component offices should include all applicable charges in the response to the requester; DFOI will aggregate all invoices within a 30 day timeframe, and make appropriate reductions in charges.

References: 21 CFR 20.45(a) and (b); 45 CFR 5.41 and 5.42

C. CHARGES--BASIS

1. Criteria

Fees are set by the Department of Health and Human Services. Charges are based on a three-level hourly rate (GS-1 through GS-8; GS-9 through 14; and GS-15 or above) and are rounded up to the nearest 15-minute increment. When employees are involved at more than one level, the appropriate rate for each is charged.

The component office responding to the FOIA request should include all applicable charges in a response letter. DFOI will issue invoices based on the charges in the response letters.

2. Fee Schedule

Any increase in the fee schedule must first be authorized by the Department of Health and Human Services. The fee schedule may be subject to annual increases—check the Intranet FOIA site for the current schedule.

References: 21 CFR 20.45(c); 45 CFR 5.43; FDA FOI Intranet http://intranet.fda.gov/omp/foi/FEES.htm; FDA FOI web site (http://www.fda.gov/foi/foia2.htm)

D. CHARGEABLE SERVICES

FDA charges fees for a number of activities -- searching for, and reviewing of, records; photocopying; certifying; and sending records by special methods -- when responding to a FOIA request. Search fees may be charged, even if the responsive records are exempt from disclosure, or if no records are found.

1. Manual Searching for or Reviewing of Records

Charges in the Fee Schedule for searching (reading and interpreting a FOIA request and locating responsive records) and reviewing (examining a record and determining whether it can be released either with or without redaction) are based on three factors:

a. Grade level (e.g. “GS” level) of the individual filling the request;

b. Requester category; and

c. Standard Agency Charge for reading and interpreting a request for Types C and O requesters (assessed only by DFOI). The standard charge will be added to any invoice, mailed from DFOI.

2. Computer Searching and Printing

Charges are for actual costs of operating the computer to obtain records, plus charges for the time of computer programmers, operators, or other employees at the rates in the Fee Schedule.

3. Photocopying Standard Size Pages

The standard charge in the Fee Schedule may be lowered only if the:

a. Document has already been printed in large numbers.

b. Agency uses existing stock to answer the request, and any other anticipated FOI requests, will not interfere with program requirements.

c. Lower fee is adequate to recover the prorated share of the original printing costs.

4. Photocopying Odd-Sized Documents

Charges for copying odd-size pages (such as punch cards or blueprints) or reproducing other records (such as tapes, microfilm, or microfiche) include the actual costs of operating the machine and the materials used plus the operator's time, at the rate in the Fee Schedule. If it is necessary to use a contractor or other outside firm, the requester may be charged actual costs.

5. Certifying Records

Charges to certify that records are "true copies" will be assessed in accordance with the Fee Schedule.

References: 21 CFR 20.45(c); 45 CFR 5.43

6. Mailing

Charges are not assessed for regular mail. The Agency may use special carriers (e.g., Fed Ex, DHL, and UPS), express mail, or other special methods if charges are billed directly to the FOI requester (using the requester’s account number).

E. FEE WAIVER OR REDUCTION

Any decision to grant a reduction or waiver of fees may only be approved by the ACPA, or delegatee, after the requester provides adequate justification. Waiver requests will be processed by DFOI, using the criteria below, and in 21 CFR 20.46.

1. Criteria

All requests for waiver or reduction of fees should be submitted in writing to the DFOI. The request should address two significant points:

a. Public Interest

Explain how disclosure would further the public interest because it is likely to contribute significantly to public understanding of government operations or activities.

b. Commercial Interest

Explain how disclosure is not primarily in requester's commercial interest.

References: 21 CFR 20.46; Department of Justice Fee Waiver Guidance (May 2000); FOI Intranet Page, "fees," (http://intranet.fda.gov/omp/foi/FEES.htm)

2. Time Requirement

Requests to reduce or waive fees must be made at the same time a records request is submitted.

Reference: 21 CFR 20.46(e)

F. PRE-PAYMENT REQUIREMENTS

1. Criteria

a. Pre-payment Not Required

Records may be sent prior to obtaining payment, when the total applicable charges are under $250.

b. Pre-payment Required

Records may only be sent after pre-payment, when the following occur:

  • Fee exceeds $250; or
  • Fee exceeds limit specified by the requester; or
  • Requester's status is "debtor" from failure to pay previous bills.

DFOI will notify component offices when a FOIA request in a component office's pending queue is put in debtor status, and place such requests on hold in the tracking system.

Reference: 2l CFR 20.45(d)(2)

2. Time Requirement (Debtor Status)

A debtor request should not be filled until all previous invoices are paid. The DFOI maintains current information on status of debtors.

11. TESTIMONY, AFFIDAVITS, AND SUBPOENAS 

Requests for testimony and affidavits, subpoenas, and disclosure to other government entities, including Congress, other federal departments, state governments, and foreign governments, are handled by specialized components within FDA. To find out where to refer such matters, consult SMG 3297.2 section #7. Component FOI Offices -- Operating Responsibilities: C. Preparing Recommended Responses for Specialized Requests.

12. EFFECTIVE DATE 

The effective date of this guide is May 1, 2007. This guide supersedes SMG 3291.5, "Procedures For Implementing The Freedom of Information (FOI) ACT" (formerly 2460.7).

 13. Document History -- SMG 3297.1, Freedom of Information (FOI) Act Internal Procedures and Existing Policy

STATUS (I, R, C)DATE APPROVEDLOCATION OF CHANGE HISTORYCONTACTAPPROVING OFFICIAL
initial06/21/2007n/aOffice of Management Programs (HFA-400)Irene Diehl, Director, OMP
change01/24/20115.C. linksOffice of Management Programs (HFA-400)Fred Sadler, Director, DFOI