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SMG 3297.2

FDA STAFF MANUAL GUIDES, VOLUME III - GENERAL ADMINISTRATION

INFORMATION RESOURCES MANAGEMENT

FREEDOM OF INFORMATION ACT

FREEDOM OF INFORMATION (FOI) ACT OPERATIONAL RESPONSIBILITIES

Effective Date: May 1, 2007

[PDF Version]

 1. Purpose and Policy
 2. Responsibilities and Procedures
 3. Authorities
 4. References
 5. General Operational Responsibilities
  A. Incoming Requests
  B. Responses to Requests
  C. Fees
 6. Division of Freedom of Information (DFOI) Operational Responsibilities
  A. Agencywide FOIA Oversight and Management
  B. Initial Processing of FOIA Requests
  C. Responses Prepared by DFOI
  D. Denials, Appeals, and Litigation
  E. Billing Requesters
 7. Component FOI Officers--Operational Responsibilities
  A. Component FOIA Oversight and Management
  B. Processing FOIA Requests and Responses
  C. Preparing Recommended Responses for Specialized Requests
  D. Denials, Appeals, and Litigation
 8. Roles of Other Agency Organizational Components
 9. Effective Date
 10. Document History
  Attachment A - Initial Triage by Action Offices of Assigned FOIA Requests
  Attachment B - Categorizing Requests When Using a Mult-track FOIA Processing System
  Attachment C - Standard Acknowledgement Letter, issued by DFOI, on receipt of a FOIA request
  Attachment D - Sample letter to requester
  Attachment E - Sample letter to requester, with minor deletions paragraph
  Attachment F - Sample Predisclosure Notification (PDN) letter
  Attachment G - Sample Certification and Affidavit letter (2 pages)

1. PURPOSE AND POLICY 

The purpose of this Staff Manual Guide (SMG) is to set forth the different FDA personnel's responsibilities for complying with the Freedom of Information Act (FOIA) as amended by the Electronic Freedom of Information Act Amendments (EFOIA) OF 1996.

2. RESPONSIBILITIES AND PROCEDURES 

This SMG is intended to be used in conjunction with SMG 3297.1, "Freedom of Information (FOI) Act Internal Procedures and Existing Policy" which provides specific Agency internal procedures and existing policy for those component offices within the FDA, that are assigned responsibility for carrying out the FOIA program.

3. AUTHORITIES 

A. Freedom of Information Act (FOIA), 5 U.S.C. 552, http://www.usdoj.gov/oip/foiastat.htm

B. Electronic Freedom of Information Act Amendments of 1996 (EFOIA), Pub. L. No. 104-231, 110 Stat. 3048 (codified throughout 5 U.S.C. 552)

C. Department of Health and Human Services FOI Regulations, 45 CFR Part 5 http://www.access.gpo.gov/nara/cfr/waisidx_06/45cfr5_06.html

D. Food and Drug Administration Public Information Regulations, 21 CFR Part 20, http://www.access.gpo.gov/nara/cfr/waisidx_04/21cfr20_04.html

E. Executive Order No. 12600, "Predisclosure Notification Procedures for Confidential Commercial Information" (July 23, 1987), http://www.archives.gov/federal-register/codification/executive-order/12600.html

4. REFERENCES 

A. FDA FOI Intranet Web Site (http://intranet.fda.gov/omp/foi/)

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

C. "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)

D. FDA FOI Internet Web Site (http://www.fda.gov/foi/default.htm)

5. GENERAL OPERATIONAL RESPONSIBILITIES 

This section outlining general Operational Responsibilities is organized into four topics:

A. Incoming Requests

B. Responses to Requests

C. Fees

A. INCOMING REQUESTS 

A Checklist for Initial Triage is provided for component FOI offices to use, on receipt of incoming FOI requests.

Reference: Attachment A, Initial Triage by Action Offices of Assigned FOI Requests.

1. EXPEDITED PROCESSING OF REQUESTS

If you receive a request for expedited processing directly from the requester (i.e., outside of official channels), you must promptly forward that request to the DFOI, and may not take any independent action on it.

When the DFOI receives a request for expedited processing, the DFOI will:

  • assign administrative controls;
  • flag the request in the tracking system; and
  • transmit the request electronically to each component with responsibility for the requested documents.

Because the regulation requires a final decision on expedited processing within 10 days after the DFOI staff has received all information required to make a decision, each Component that receives the request from the DFOI should, as soon as possible and no more than 7 business days later, recommend to the DFOI whether to grant or deny the expedited processing request. Each Component should base its recommendation on the criteria set forth in 21 CFR 20.44. (For an explanation of how FDA applies those criteria, see SMG 3297.1, "Internal Procedures and Existing Policy," 8, D. If you have questions, you may call the DFOI to discuss the matter.)

After reviewing each recommendation that it receives in a timely manner, the DFOI will submit its recommendation to the Assistant Commissioner for Public Affairs (ACPA). The ACPA, or the ACPA's delegatee, is the only person authorized to grant or deny a request for expedited processing. If the ACPA grants expedited processing, the DFOI will notify each FOI Component Officer with responsibility for the requested documents that the request is to be taken out of turn. The Component Officer or Officers must then process the request as soon as practicable, before all other non-expedited requests. If the ACPA denies the request, the DFOI will notify each Component FOI Officer, and will instruct each Officer to place the request in the office's queue, and to process it in turn. The DFOI will issue a letter, notifying the requester whether or not expedited processing was granted.

Reference: 21 CFR 20.44

Attachment B, Categorizing Requests When Using a Multi-track FOIA Processing System.

2. MULTI-AGENCY REQUESTS -- REQUESTS THAT SEEK BOTH FDA RECORDS AND RECORDS THAT ANOTHER FEDERAL AGENCY GENERATED

Component FOI Officers are responsible for issuing the FDA portion of any response to a request seeking both FDA records and records that another federal agency generated and that are in FDA files. This applies to both records generated by another federal agency within HHS, and outside of the Department.

When the Component FOI Office responds to the FDA portion of the request, it should state in the cover letter that FDA found records from another federal agency in its files and that FDA has sent those records to the other agency to review them and to respond. The cover letter ordinarily should name that agency or those agencies, but if doing so would compromise a protected interest, the Component FOI Officer should consult the DFOI.

As to the portion of the request seeking records from another federal agency, each Component FOI Office should send those records to the DFOI for referral to the other agency to process under the FOIA. All contacts with the other agency (including the act of forwarding the request and/or records to the other agency) should be made through the DFOI.

Reference: 21 CFR 20.41(b)(3)(ii)(C)

3. MULTI-TRACK PROCESSING OF REQUESTS

The EFOIA authorizes, but does not require, a Component Office to establish two or more tracks for processing FOIA requests based on the amount of work, time, or both necessary to process the requests (e.g. simple request processing track, complex request processing track, and expedited processing). Because the multi-track system is based on the complexity of the requests, the Component Office may give requesters the option of limiting the scope of a request to qualify for faster processing.

Each FDA Component is responsible for determining whether to use a multi-track system for records that the Component maintains, for deciding how many tracks to establish, and for establishing the specific criteria for assigning requests to each track (based on the amount of time, work, or both required to process the requests). Component Offices should process requests on a first-in, first-out basis within each track.

If a Component FOI Office opts not to establish a multi-track procedure, all requests should be answered on a "first in, first out" basis.

References: 5 U.S.C. 552(a)(6)(D); 21 CFR 20.43; Attachment B, “Initial Triage with by Action Offices

4. PRIVACY ACT SYSTEM OF RECORDS APPLICABILITY

a. Privacy Act Request for the Requester's Own Records

If an individual requests access to a record concerning him- or herself that is contained in a designated Privacy Act System of Records, the Privacy Act Coordinator (DFOI, HFI-30) processes the request.

Reference: 21 CFR 21.41(c)

b. FOIA Request for Another Individual's Record

If a requester asks for a record concerning someone other than him- or herself, and the records are contained within a designated Privacy Act System of Records, the request is handled under FOIA, not the Privacy Act, and the Component FOI Officers handle it. The appropriate FOI regulations must then be considered when determining whether the record may be disclosed. If a clearly unwarranted invasion of privacy would occur through disclosure of the record, the request should be denied.

Note: the Agency may not proactively disclose privacy records to a person other than the subject individual or his or her legal guardian unless the disclosure is made pursuant to 21 C.F.R. 21.71.

References: FDA Intranet at http://intranet.fda.gov/omp/foi/; SMG 3297.4, Privacy Act; 21 CFR 20.63(e); 21 CFR 21.3(c) and (d)

B. RESPONSES TO REQUESTS 

1. CERTIFICATION OF RESPONSES

The FDA may certify the authenticity of copies of records requested to be disclosed. FDA officials listed in Staff Manual Guide 1410.23 (on delegations of authority) are authorized to certify. The FOI Officers for the component in which the certifying official works should process certification requests as FOI requests and should assess charges following the fee calculations worksheet on the FDA intranet.

References: 21 CFR 20.3; Regulatory Procedures Manual, Chapter 10, “Testimony: Production of Records; Certification of Records” http://web.ora.fda.gov/qms/drafts/RPM-master.htm; Staff Manual Guide 1410.23, "Delegations of Authority"; Fee calculations worksheet on the intranet: http://intranet.fda.gov/omp/foi/FEES.htm

2. 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 submitted 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, unless certain exceptions apply.

In general, Component FOI Officers are responsible for implementing PDN in those circumstances where it is required. For details on PDN, see 21 CFR 20.61(d), (e), and (f), as well as SMG 3297.1 "Internal Procedures and Existing Policy," 8 "Disclosure Policy;" and Section L "Predisclosure Notification." When submitters object to the Agency's proposed disclosures, Component FOI Officers should make a recommendation to the DFOI, stating whether they agree or disagree with the objections. Where FDA determines that it must disclose information over submitters' objections, however, only the DFOI may issue the Predisclosure Notification Disagreement Letter, required by 21 CFR 20.61(e)(3).

References: 21 CFR 20.61(d), (e), (f); Executive Order 12600, http://www.archives.gov/federal_register/codification/executive_order/12600.html; SMG 3297.1, "Internal Procedures and Existing Policy"

3. REASONABLE SEARCH

The EFOI requires that an agency conduct a "reasonable search," which is calculated to uncover all relevant records that are responsive, including records kept in electronic form or format. This provision is designed to promote database and other electronic searches, in addition to searching for hard-copy records. The DFOI distributes FOIA requests to each Agency Component that the DFOI reasonably believes may have responsive records. All FDA employees are responsible for searching their own records for responsive documents if they receive a FOIA request from the DFOI. Employees should consult the FOI Officer for their component if they have questions.

Reference: 21 CFR 20.34

4. REDACTION OF RESPONSIVE RECORDS

a. Responsibility for Redacting

Redaction is the process of reviewing and deleting (removing or purging) information from a record prior to release. Each Component FOI Office is responsible for reviewing and redacting documents before disclosing them to requesters. For details on redacting, see SMG 3297.1, "Internal Procedures and Existing Policy", 7, Requests and Records Subject to FOIA, item G, FOIA Exemptions

b. Responsibility for Maintaining Redacted Records

Electronically redacted records (computer software used to redact non-releasable information) can be transferred to the DFOI through the Repository. Component offices should consult with technical or IT staff, to ensure that a FOIA requester cannot restore electronic redactions.

All responses should be scanned into the Agency Information Management System (AIMS) FOI Repository, by the component FOI office that responds to the FOIA request except those provided under first-party release. When scanned, no hard copy needs to be provided to DFOI, for public display.

C. FEES 

1. PAYMENT -- HANDLING

Payments should only be handled by the Office of Financial Management (OFM). Any misdirected payments should be forwarded immediately to OFM. Payments may only be by check or money order, payable to the Food and Drug Administration and sent directly to:

Food and Drug Administration
Office of Financial Management
Accounting Branch (HFA-120), Room 11-68
5600 Fishers Lane
Rockville, MD 20857
 

2. WAIVER OR REDUCTION OF FEES

A requester may ask that fees be reduced or waived. 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 are processed by DFOI.

Component offices should prepare a memo for DFOI, addressing the request for waiver or reduction in fees, either concurring or disagreeing with the request for waiver. Processing any waiver requests is the responsibility of DFOI.

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)

6. DIVISION OF FREEDOM OF INFORMATION -- OPERATING RESPONSIBILITIES 

The Operational Responsibilities specific to the DFOI, the Agency focal point for FOIA matters, are organized below into five primary headings:

A. Agencywide FOIA Oversight and Management

B. Initial Processing of FOIA Requests

C. Responses Prepared by DFOI

D. Denials, Appeals, and Litigation

E. Billing Requesters

A. AGENCYWIDE FOIA OVERSIGHT AND MANAGEMENT 

The DFOI provides advice and guidance on FOI policies and procedures (including maintenance of the FOI Intranet site) to facilitate actions and responses that comply with the FOIA and Agency regulations.

Specifically, the DFOI does the following:

1. QUALITY CONTROL

a. Timeliness

Serves as focal point to facilitate timely responses by Component FOI Officers

b. Content

Helps ensure that Component Office responses include one of the following:

(1) Release of the requested records, appropriately redacted, with a transmittal letter containing appropriate charges; or

(2) Letter explaining that no responsive records could be found, to include any appropriate charges; or

(3) Letter explaining that the records are not contained within FDA files and referring the requester to an alternative source, to include any appropriate charges; or

(4) Memorandum to DFOI requesting a 10-day extension (unless advised differently by DFOI or OCC); or

(5) Memorandum to DFOI, proposing a Denial;

And also, if appropriate:

  • Memorandum to DFOI proposing a response to a request for fee waiver or reduction; and/or
  • Memorandum to DFOI proposing a response to a request for expedited processing.

c. Tracking Pending Requests

Applies initial administrative controls for all incoming requests, within the agency tracking system.

2. RECORDS MANAGEMENT

Maintains the official Agency file of all FOI requests and responses (including copies of records sent). Maintains these files in accordance with applicable legal requirements for records retention.

Reference: 21 CFR 20.31

3. TRAINING

Provides and/or coordinates Agency-level FOI training.

4. LIAISON WITH THE PUBLIC

a. Public Reading Room

Maintains the Agency public reading room and Electronic Reading Room as required by the FOIA and EFOIA.

Reference: 21 CFR 20.120(a)

b. Pubic Display Copies

Maintains the public display copies of all FOI requests and responses in either hard copy or electronic format.

Reference: 21 CFR 20.120(b)

B. INITIAL PROCESSING OF FOIA REQUESTS 

The DFOI also does the following regarding initial processing of FOIA requests:

1. RECEIPT AND LOGGING

Serves as the Agency focal point for receiving and logging all FOI requests. The date received by the DFOI is the official date of receipt.

Reference: 21 CFR 20.30 and 21 CFR 20.40

2. ACKNOWLEDGMENT LETTER

Automatically generates and sends a standard acknowledgement letter to each requester. The letter provides notification that the request has been received and includes the FOI control number for use in subsequent communications and a telephone number if there are questions.

See Attachment C - Standard Acknowledgment Letter

3. UNCLEAR REQUESTS

Contacts requesters to clarify requests that are vague, confusing, or inordinately extensive. Component offices may also contact a requester for clarification; all such contacts must be documented for the administrative record in the comment section of the repository and in the cover letter to the response.

4. CATEGORY OF REQUESTER

Assigns all requesters to one of three categories, in accordance with the criteria set forth in the agency regulations, as the basis for determining fees.

Reference: 21 CFR 20.45(a)

5. DISTRIBUTION TO RESPONDENTS

a. To Component FOI Offices

(1) Type of Requests

Distributes all incoming requests, except requests for records assigned to DFOI, to the component FOI Office or Offices with jurisdiction over the requested records, for direct response. This includes requests for expedited processing, reduction or waiver of fees, and certification.

(2) Transmission and Tracking

Transmits a copy of the incoming FOI request to the appropriate component FOI Officer, through the Repository. Distributes the request to all known involved offices when records from more than one component are needed to respond to a single request. Enters the routing and distribution in the tracking system.

b. To Another Government Agency

Refers requests for records that either originated in another Government agency, or are primarily concerned with the internal matters of another Government agency, to that agency and informs the requester accordingly. This applies to both records generated by another federal agency within HHS, and outside of the Department. Coordinates this function for Component FOI Officers when records from another agency are located when searching for responsive records.

C. RESPONSES PREPARED BY DFOI 

1. RESPONSE TO REQUEST FOR RECORDS MAINTAINED BY DFOI

Locates responsive records, and sends responses to requests for records maintained by the DFOI. These records include DFOI-generated records (e.g., the FOI log) and component FOI Office-generated records previously released in response to requests. A response for previously released records may result from a DFOI-initiated search or a component FOI Office “Fill From” request that provides DFOI with the file number where the previously released records may be found.

2. RESPONSE TO REQUEST FOR EXPEDITED PROCESSING

Coordinates with component FOI officers, to prepare the draft response to grant or deny a request for expedited processing (based on recommendation from FOI component Officer where the requested records are located) for Assistant Commissioner for Public Affairs (ACPA) signature. The final decision to grant or deny expedited processing may only be made by the ACPA.

DFOI scans the final decision letter into the Repository and notifies the requester.

3. RESPONSE TO REQUEST FOR REDUCTION OR WAIVER OF FEES

Coordinates with component FOI officers to prepare the draft responses to grant or deny a request to reduce or waive fees (based on recommendation from the FOI component Officer where the requested records are located) for Assistant Commissioner for Public Affairs signature. Granting a reduction or waiver of fees must clearly fall within the waiver guidelines established by the Department of Justice. The final decision to grant or deny reduction or waiver of fees can only be made by the ACPA.

DFOI scans the final decision letter into the Repository and notifies the requester.

4. PREDISCLOSURE NOTIFICATION DISAGREEMENT LETTER

Prepares all Predisclosure Notification Disagreement Letters, based on the component FOI Officer recommendation, when the Agency disagrees with a submitter's proposed withholdings set forth in response to an Agency Predisclosure Notification Letter.

a. Contents of Letter Must Include:

(1) Explanation of the Agency’s intent to disclose; and

(2). Reason for the proposed disclosure; and

(3) Copy of the records FDA intends to release; and

(4) Time limit (5-days) after receipt of notification to institute suit in a U.S. District Court to prevent disclosure, if the recipient continues to disagree with the Agency position on release.

Consults with the Office of Chief Counsel, as appropriate, prior to issuance of the letter. A copy of the letter should also be sent to the FOI requester.

b. Release of the Records

(1) If Suit is Brought

The records will not be disclosed until the courts have made a final decision.

(2) If Suit is Not Brought

The records will be disclosed after the 5 working days have lapsed.

Reference: 21 CFR 20.61(d) and (e)

D. DENIALS, APPEALS AND LITIGATION 

The DFOI performs the following functions relating to denials, appeals, and litigation:

1. DENIALS

Coordinates and prepares all letters, based on written recommendation from the component FOI Officer, to deny a request for a record in whole or in part. A denial letter is the official response to a FOIA request that partially or wholly denies access to, or copies of, requested records. Obtains concurrence of the Office of Chief Counsel for denials that are precedent setting or are likely to be involved in litigation. The denial letter must be signed by the Assistant Commissioner for Public Affairs (ACPA), or a designee.

a. Contents of Letter

(1) Denial letters must include all applicable exemptions of the FOIA, and FDA's implementing regulations, to support exemption from disclosure.

(2) Any denial must include the statement that an appeal may be made to the Deputy Assistant Secretary for Public Affairs (Media), Department of HHS pursuant to the provisions of 45 CFR 5.82.

References: 21 CFR 20.49; 45 CFR 5.82

b. Confidentiality of Records Accompanying Denial Recommendation

Keeps records submitted with recommendation for denial separate from DFOI files (which are open to public inspection). These records may contain confidential information (unredacted copy of the requested records).

2. APPEALS TO DENIALS

a. Process

All denials of a FOIA request, which only the DFOI may prepare, must notify the requester of the right to appeal that denial. Appeals to FDA denials should be submitted directly to the Deputy Assistant Secretary for Public Affairs (Media), HHS. The processing of such appeals has been delegated to the FOI Officer for the Public Health Service.

Reference: 21 CFR 20.49(c)

b. FDA Role

The FDA Denials and Appeals Officer serves as liaison between FDA and the PHS FOI Officer and performs the following roles in support of the appeals process:

(1) Second Review of Records

Notifies the FOI Component Officer that a denial has been appealed and coordinates or conducts a second level review of the records at issue.

(2) Recommendation to PHS

Prepares a memorandum to the PHS within 5 days, either recommending that the appeal be upheld or overturned (usually due to a change in the regulatory status of the records). The memorandum should respond to the grounds of the appeal, including sufficient explanation and justification to support the Agency's final position, and be accompanied by both redacted and unredacted copies of the denied records for Departmental review as needed.

3. LITIGATION ASSISTANCE

Assists the FDA Office of Chief Counsel, and the HHS General Law Division, or the Department of Justice, in reviewing and preparing records for litigation, as necessary.

E. BILLING REQUESTERS 

1. BILLING: INVOICES

The DFOI is the Agency billing focal point, issuing invoices for records disclosed under the FOIA, and is responsible for the following:

a. Billing Cycle

Monthly, prepares and sends all invoices for payment to requesters.

b. Basis for Charges

Determines final charges based on information provided by the component FOI officers in component response letters.

c. Aggregation of Charges

Aggregates, in consultation with Component FOI Officers, costs of requests made by the same person, organization, or related persons or organizations on a monthly basis. Aggregated bills ensure that requesters submitting multiple requests that result in lesser dollar costs--which might otherwise be exempt from payment--are appropriately charged.

d. Minimum Charge

Bills the requesters when the monthly total is more than $25.

7. COMPONENT FOI OFFICES -- OPERATING RESPONSIBILITIES 

The authority and responsibility for granting most FOI requests (i.e., disclosing official records under the FOIA) is vested in the component FOI Officers and other component employees engaged in Freedom of Information activities for the organizational components maintaining the records. See SMG 1410.24(i)(f)(ix). Discretionary disclosure can only be made as authorized by 21 CFR 20.82.

The Operational Responsibilities specific to Component FOI Officers are organized below under four primary headings:

A. Component FOIA Oversight and Management

B. Processing FOIA Requests and Responses

C. Preparing Recommended Responses for Specialized Requests

D. Denials, Appeals, and Litigation

A. COMPONENT FOIA OVERSIGHT AND MANAGEMENT 

1. POLICY AND PROCEDURES

Component FOI Officers provide direction and instruction to the component organization on FOI and disclosure policies and procedures.

2. PROGRAM MANAGEMENT

Component FOI Officers are responsible for directing the search, review, and final determination regarding disclosable records and the release of the responsive records in a timely manner.

B. PROCESSING FOIA REQUESTS AND RESPONSES 

A Component FOI Officer ensures that the following functions related to FOIA request processing are performed:

1. INITIAL PROCESSING OF REQUESTS

a. Unclear Requests

Contacts the requester to clarify or narrow requests that are vague, confusing, or inordinately extensive.

b. Disclosable Determination

Locates and reviews the records within the component office, and determines whether the records are disclosable.

c. Alternative Forms or Formats

Releases records in the form and/or format of the Agency’s choice unless the requester specifies a particular form or format. If the record cannot be provided in the form or format requested, notifies the requester of alternative forms or formats available.

References: 21 CFR 20.33; 5 USC 552(a)(3)(B)

d. “Fill-From" Requests

Identifies FOI requests that can be filled by records previously released by Component FOI Offices and stored electronically in the Repository. The Component FOI Office routes the request back to DFOI through the tracking system to complete the request. DFOI will complete the processing for the request.

e. Aggregating Requests

Proposes, and on approval from DFOI, aggregates requests from the same requester or group of requesters when the Agency believes that such requests actually constitute a single request.

References: 21 CFR 20.42; 5 USC 552(a)(6)(B)(iv)

f. Records that other FDA components generated

Checks the DFOI circulation list when records are located that another FOI component generated, and notifies the DFOI if that component is not listed. DFOI will add that component to the list of offices assigned to respond to the FOI request. Only the component that generated the records reviews them and determines whether they are disclosable. If the record contains marginal notations or other changes since the generating component created the document, however, the component that made those changes should also review the record, determine whether the changes constitute disclosable information, and coordinate with the generating component (or components) about whether to release the underlying document.

2. PREPARING RESPONSES TO REQUESTS

a. Prepayment

Determines whether prepayment is required, in accordance with 20.45(d)(2).

b. Preparing and Releasing Records

(1) When Prepayment Is Not Required:

Locates responsive records, redacts all non-disclosable material, releases the responsive records promptly to requester, and scans a copy into the FOI Repository.

(2) When Prepayment Is Required

Sends a letter notifying the requester that prepayment is required, which encloses the prepayment invoice or requests that DFOI send a prepayment letter on behalf of the component office. Locates responsive records, redacts all non-disclosable material, and releases the responsive record only after notification by the DFOI that payment has been received.

c. Assessing Fees

Assesses fees for the search, review and production of records, based on the Requestor Category, in accordance with the fee schedule. For current fee schedule, see the FOI Intranet web site.

References: 21 CFR 20.45; FOI intranet, "fees," http://intranet.fda.gov/omp/foi/FEES.htm

3. PROCESSING REQUESTS FOR RECORDS

If the Component FOI Office determines that a request should be denied in its entirety, the FOI Office is responsible for sending a written denial recommendation to the DFOI. The recommendation should include:

a. Copies of the records that the FOI Officer proposes to be withheld; and

b. A justification for withholding those documents, including the statutory and regulatory citations supporting that withholding.

If a partial denial is forwarded for DFOI review, the component officer may release appropriately redacted, responsive records as a partial reply. That letter should indicate that the response is a partial reply, and the redacted records should be scanned into the Repository.

4. First Party Release: When a Record Contains Confidential Information Concerning a Requester

When a person or organization requests records which are releasable only to that requester (e.g., records contain information not releasable to a third party, such as patients obtaining their own medical records, or a company receiving its own EIR) the record is not considered to be publicly disclosed. The FOI Component Office takes the following steps to protect the information from public release:

a. Verification of Identity

Ensures that sufficient information and/or documentation is provided to verify the identity of requester and confirm the appropriateness of providing a first-party release. Obtains sufficient proof prior to providing records to support any claims that a person or organization requesting records, who is not the first party, is authorized to act on behalf of the first party.

b. Letter to Requester

Sends a letter, accompanying the records, to the requester stating that the information is not releasable in this form or format, to any other requester, using the standard phrasing in the sample letter. Uniform release is not triggered under 21 CFR 20.21(c)).

See Attachment D: Sample Letter to Requester

c. Notification to DFOI (Without Records Released)

Updates the comment section in the tracking system, explaining that copies of the released documents are not copied to the system because they are not releasable to third parties. The FOI Component Office should also upload the response letter. The FOI Office should not send the DFOI an unredacted copy of the record disclosed nor purge the record for public display.

The FOI component office will redact the record only if requested by a third party (i.e., someone other than the subject of the record). If a third-party request is received, the DFOI staff refers the request to the Component FOI Office which will then process the request in turn, as a new request.

5. PROCESSING REQUESTS FOR RECORDS CONTAINING BOTH DISCLOSABLE AND NONDISCLOSABLE INFORMATION

A Component FOI Officer ensures that the following functions for records that contain both disclosable and nondisclosable information are performed:

a. Minor Deletions Only

Takes the following steps if a record containing both disclosable and nondisclosable information requires only minor deletions of information (relatively isolated deletions of information clearly exempt from disclosure):

(1) Deletes the nondisclosable information.

(2). Sends a letter to the requester, with the disclosable information attached.

(3) Uploads the response package to the tracking system.

See b. Substantive Withholding, or Inextricably Intertwined Information

Prepares, and submits to the DFOI, a recommendation for a formal denial if:

(1) the disclosable and nondisclosable information in a record is so inextricably intertwined that it is not feasible to separate it; or

(2) substantial deletions are required.

6. PROCESSING REQUESTS SUBJECT TO PREDISCLOSURE NOTIFICATION (PDN)

A Component FOI Officer ensures that the following functions are performed when PDN is required:

a. Predisclosure Notification Letter

Prepares the standard letter to the submitter of the records, which should contain the following:

(1) Explanation of the PDN procedures; and

(2) Time limit for submitter's response (5 working days after receipt) to object to disclosure and state all bases for objections; and

(3) Copy of the FOIA request; and

(4) Copy of the records which require the PDN, as they appear in FDA’s files.

Reference: 21 CFR 20.61(e) and (f); See Attachment F: Predisclosure Notification (PDN) Letter

b. Receipt of Delivery

Sends letter through a delivery service which requires a signature on receipt of a PDN, demonstrating that the recipient had an opportunity to participate in the PDN process.

c. Submitter's Response/Non-Response to PDN Letter

Takes one of the following actions as appropriate:

(1) In Agreement with Submitter's Redactions

Releases the records, if the Component FOI Officer is in agreement with the submitter's proposed withholdings (redactions), with deletions as indicated, or prepares a denial recommendation for DFOI, if no records are releasable.

(2) Not in Agreement with Submitter's Redactions

Sends a memorandum to the Director, DFOI, proposing to overturn the submitter’s response and explaining the reasons for the proposal for further action.

Reference: 21 CFR 20.61(e)(3)

(3) No Response from Submitter

Redacts and releases the records according to the disclosure regulations in 21 CFR Part 20.

7. PROCESSING REQUESTS FOR CERTIFICATION OF RECORDS

Requests for certification of documents should be processed as FOI requests. Certification consists of an affidavit and a certificate, which should be attached to the records, along with the Department Seal. The authorizing signature must be by an individual identified in the Staff Manual Guide as authorized to sign a certification.

See Attachment G: Certification and Affidavit Letter (2 pages)

References: 21 CFR 20.3; Staff Manual Guide 1410.23; Regulatory Procedures Manual, Chapter 10, “Testimony: Production of Records; Certification of Records” http://web.ora.fda.gov/qms/drafts/RPM-master.htm

C. PREPARING RECOMMENDED RESPONSES FOR SPECIALIZED REQUESTS 

A Component FOI Officer ensures the following functions for specialized requests are performed:

1. EXPEDITED PROCESSING REQUESTS

Prepares recommendation to grant or deny expedited processing, and submits recommendation to DFOI for preparation of response letter for ACPA signature (or delegatee's signature).

Reference: 21 CFR 20.44

2. WAIVER OR REDUCTION OF FEES

Prepares recommendation to grant or deny all reductions or waivers of fees. Submits recommendation to DFOI, for preparation of a response letter under the signature of the ACPA (or delegatee).

Reference: 21 CFR 20.46

3. TESTIMONY AND AFFIDAVITS

Forwards a request, pursuant to 21 CFR 20.1., for the testimony of an FDA employee, including affidavits, to the Office of Regulatory Affairs (ORA), Office of Enforcement (OE), Division of Compliance Policy (DCP) if the subpoena came from a party other than a state government agency. If a state government agency requests testimony, send the subpoena to ORA’s Office of Regional Operations, Division of Federal-State Relations (DFSR).

Reference: 21 CFR 20.1

4. SUBPOENAS

With one exception, sends any subpoena, including one for records (“Subpoena Duces Tecum”) to ORA, OE, DCP. For a subpoena, including one for records, from a state government agency, send the subpoena to DFSR. These offices will consult with the Office of Chief Counsel as needed.

References: 21 CFR 20.1 and 20.2; Regulatory Procedures Manual, Chapter 10, Section 10-9, “Testimony: Production of Records; Certification of Records” http://web.ora.fda.gov/qms/drafts/RPM-master.htm; Staff Manual Guide 1410.21, "Delegations of Authority"; Staff Manual Guide 2127.2, "Requests for Testimony of FDA Personnel in Non-FDA Proceedings"

5. DISCLOSURE TO OTHER GOVERNMENT ORGANIZATIONS

Requests for records from other Federal government organizations are not handled through the FOIA process. These requests are not subject to FOI administrative controls (i.e., should not be placed in the FOIA queue), nor are any fees charged.

FDA may opt to share only redacted materials, depending on agreements between the requesting organization and the FDA. The FDA organizations responsible for these government organizations are identified.

a. CONGRESSIONAL COMMITTEES AND SUBCOMMITTEES AND THE GENERAL ACCOUNTING OFFICE (GAO)

The Office of Legislation (OL) controls, coordinates and/or responds to these requests if the request is from a Committee or Sub-committee chair, acting on behalf of that Committee or Sub-committee. Requests made on behalf of a constituent, or by a member of Congress other than a Chairperson are generally handled as FOI requests, and should be answered with publicly releasable information only.

It is important that requests from GAO be coordinated through the Agency Office of the Executive Secretariat.

Reference: 21 CFR 20.87

b. FEDERAL DEPARTMENTS AND AGENCIES

FDA records, otherwise exempt from public disclosure, may be disclosed to other Federal government departments and agencies pursuant to Agency procedures. This applies to both records generated by another federal agency within HHS, as well as a federal agency outside of the Department, although different criteria for sharing may be applied for agencies within HHS. These procedures are used for oral as well as documentary disclosures of non-public information. The Federal government requester must provide written assurances to FDA that it will not disclose the information, and the Director of ORA, OE, DCP, or the Commissioner's designee, must specifically authorize the sharing of information or records.

Section 301(j) of the Federal Food, Drug and Cosmetic Act generally prohibits release of trade secret information outside of the Department of Health and Human Services. Trade secret information may be shared with other public health agencies within the Department, including the HHS Inspector General, or with the written authorization from the sponsor/submitter of the records at issue.

References: 21 CFR 20.85; ORA Disclosure Manual, http://web.ora.fda.gov/oe/info_disclose/default_IDM.htm

c. STATE AND LOCAL GOVERNMENT AGENCIES

ORA's Division of Federal-State Relations controls, coordinates and/or responds to requests from State and local government agencies which perform counterpart functions to the FDA at the State and local levels.

Reference: 21 CFR 20.88; ORA Information Disclosure Manual, http://web.ora.fda.gov/oe/info_disclose/default_IDM.htm

d. FOREIGN GOVERNMENTS

The Office of International Programs, Office of International Activities and Strategic Initiatives controls, coordinates and/or responds to requests from foreign governments.

Reference: 21 CFR 20.89

D. DENIALS, APPEALS, AND LITIGATION 

A Component FOI Officer ensures that the following functions related to denials, appeals, and litigation are performed:

1. DENIAL RECOMMENDATIONS

a. Contents

Prepares memorandum (clearly marked “Recommended for Denial”) recommending partial or complete denial of records. Denial recommendations should include the following:

(1) Identification of each record; and

(2) FOIA statutory Exemption under which each record, or data within a record, may be withheld; and

(3) All appropriate citations in the CFR, both for part 20 and any other citation which is specific to a center or a record; and

(4) Reason for withholding each record; and

(5) Estimate of the volume of records being denied; and

(6) Copy of unredacted records (with certain exceptions, if agreed to in advance with the Denials & Appeals Officer) proposed for withholding, bearing notation "Recommended for Denial;" and

(7) Copy of records released (when partial release has been made to requester).

Reference: 21 CFR 20.49

b. Submission Procedure

Submits memorandum, copy of unredacted records, and the request, to the DFOI Denials and Appeals Officer, DFOI, for action. The denial recommendation should be uploaded into the Repository and the action office status changed to reflect that a denial has been recommended. If the records involved are voluminous and are generally denied (e.g., an active Investigational New Drug Exemption or an open Establishment Inspection Report), the denied records may not need to be submitted to DFOI. Contact the Denials and Appeals Officer for concurrence.

c. Partially Releasable Response

Provides the clearly disclosable records directly to the requester if a request is partially releasable, and notes that it is a partial reply. The partial reply should not discuss the recommendation for denial, since only the ACPA (or delegatee) may deny access to an agency record.

d. Denial Recommendation Not Approved

If a decision is made to release the records, the component FOIA officer will receive written notice from the Denials & Appeals Officer, DFOI, with specific instructions on how to proceed.

2. APPEALS TO DENIALS

a. Additional Justification Support

Responds to the Denials Officer, within 5 working days, on receipt of an appeal.

Conducts second review of the records at issue and provides additional justification in response to the appeal of a denial. Additional assistance may be required by DFOI, OCC or PHS, as appropriate.

b. Restrictions

Component FOI Officers may not contact or respond to the appellant without advance authorization from the Denials & Appeals Officer, DFOI. It is important that the proposed response go back to the Denials and Appeals Officer.

3. LITIGATION SUPPORT

May be requested to assist the Office of Chief Counsel, when an Agency decision to deny records results in litigation, by conducting additional searches and preparing documentation to defend the Agency action.

8. ROLES OF OTHER AGENCY ORGANIZATIONAL COMPONENTS 

Two other organizational components--the Office of Financial Management and the Assistant Commissioner for Public Affairs--have an integral role in carrying out the Agency FOI program. The specific responsibilities are:

A. OFFICE OF FINANCIAL MANAGEMENT

Serves as the Agency focal point for all FOI payments received by the Agency in response to the DFOI billing process through the following actions:

1. Receives all payments submitted in relation to FOI requests.

2. Promptly notifies the DFOI on receipt of any payment for bills issued for records received by requesters and for prepayment required for costs exceeding $250.

B. ASSISTANT COMMISSIONER FOR PUBLIC AFFAIRS (or delegatee)

Serves as the Agency official with delegated authority to make the final Agency determination, based on DFOI recommendations, for the following types of actions:

1. Waive or reduce fees.

2. Expedite the processing of an FOI request.

3. Deny a request.

The applicable final action letters must be signed by the Assistant Commissioner for Public Affairs (or delegatee).

References: 21 CFR 20.44(e); 21 CFR 20.46(a); 21 CFR 20.49(a)

9. 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).

 10. Document History -- SMG 3297.2, Freedom of Information (FOI) Act Operational Responsibilities

STATUS (I, R, C)DATE APPROVEDLOCATION OF CHANGE HISTORYCONTACTAPPROVING OFFICIAL
initial06/21/2007n/aOffice of Management Programs (HFA-400)Irene Diehl, Director, OMP