10-11 - TESTIMONY; PRODUCTION OF RECORDS; CERTIFICATION OF RECORDS

10-11-1 - Requests for Testimony

FDA may authorize FDA employees to provide testimony if the testimony will be in the public interest and promote FDA’s objectives (21 CFR 20.1). While interrupting the normal duties of FDA employees to provide testimony in a proceeding to which the agency is not a party is generally not considered to be in the public interest, FDA may be able to honor a request for testimony by providing responsive documents. FDA can also certify these documents for presentation in court.

FDA processes written requests for testimony in accordance with 21 CFR 20.1. Affidavits, declarations, and employees’ responses to depositions, interrogatories, or rogatory letters are considered to be testimony covered by this regulation. (See Definitions) FDA does not process verbal requests for testimony.

FDA employees are not permitted to provide testimony pertaining to any function of the FDA, or with respect to any information acquired in performing their official duties, unless authorized by the Commissioner (21 CFR 20.1(a)), or another FDA official to whom this authority has been delegated.

The Director, Division of Compliance Policy (DCP), OE, ORA has been delegated the authority to authorize the giving of testimony under 21 CFR 20.1, and is the Agency lead for authorizing all testimony. In addition to the Director, DCP, the following officials have the authority to authorize the giving of testimony under 21 CFR 20.1: the Associate Commissioner for Regulatory Affairs (ACRA); the Deputy ACRA, ORA; and the Director and Deputy Director, Office of Enforcement (OE), ORA. See Staff Manual Guide 1410.24(a)(2)) for these delegations and SMG 1410.21 for General Redelegations of Authority from the Commissioner.

In addition to the DCP director’s role in authorizing testimony, DCP conducts the initial review of all requests for testimony, except for requests from a state government agency.

The Division of Federal State Relations (DFSR) conducts the initial review of requests for testimony from a state government agency, and then prepares a 21 CFR 20.1 package for the review and signature of the Director, DCP, except as follows. If the testimony (e.g., affidavit, declaration) only addresses the absence of records or only identifies documents for the purpose of certifying records for a FOIA request, it does not require DCP (or OCC) review.

FDA employees may be asked to assist DCP and DFSR in responding to a request for testimony, by identifying suitable individual(s) to testify, drafting authorized testimony, or identifying records (instead of testimony) that are responsive to the request.

If a request involves Congress, employee personnel records, the DHHS Office of Equal Employment Opportunity, the investigation of an FDA employee by the DHHS Inspector General, the testimony of an FDA employee as a private citizen, or the testimony of a former employee regarding FDA-related matters, see the instructions in “Requests involving Special Circumstances” below. Otherwise,

1. If you receive a written request for testimony (whether by letter or subpoena) that was submitted by, or on the behalf of:
   
   
   1. A person other than a state government agency, contact DCP and send the request to that office.
      
      
      1. U.S. Food and Drug Administration
         Office of Enforcement
         Division of Compliance Policy (HFC-230)
         5600 Fishers Lane
         Rockville, MD 20857
         Phone: (240) 632-6860
         Facsimile: (240) 632-6861
         
   2. A state government agency, contact DFSR and send the request to that office.
      
      
      1. U.S. Food and Drug Administration
         Office of Regional Operations
         Division of Federal-State Relations (HFC-150)
         5600 Fishers Lane
         Rockville, MD 20857
         Phone: (301) 827-2898
         Facsimile: (301) 443-2143
         
2. If you are contacted by an individual requesting testimony:
   
   
   1. Either refer the person to the Director, DCP or, as appropriate, the Director, DFSR; or advise them that FDA does not process verbal requests for testimony and that they should submit a written testimony request to the address for DCP or, if appropriate, DFSR shown above, well in advance of their desired due date to allow time for evaluating and processing the request; and that they should include information about the hearing body, date, location, and purpose of the proceeding; the nature and scope of the testimony FDA is being asked to provide and the use to which it will be put; the name(s) of the FDA employees, if known, being asked to testify; the requester's interest in the matter sought to be disclosed; the requester's rationale for considering that the testimony is in the public interest and will promote the objectives of FDA and the laws it enforces; and any other relevant background. Refer them to 21 CFR 20.1(c) for FDA’s procedures on how to make these requests.
   2. Do not make any commitment regarding the availability or willingness of a witness to testify in any particular case.
   3. Document the conversation, and send DCP (or DFSR) a memorandum by email or facsimile at the telephone numbers above, and contact that office to confirm receipt.
      
3. If you have been authorized to testify:
   
   1. Before presenting testimony, contact the assigned OCC attorney, if any, to obtain
      legal advice; and the appropriate FDA component, to obtain technical advice and, if
      needed, information about funding travel.
   2. After presenting testimony, submit a summary or copy of the testimony or a transcript
      of the testimony to DCP, OCC, and, if involved, DFSR. If the Director, DCP,
      authorizes the testimony for a hearing in a state court, the summary memorandum
      should address not only the individual's testimony, but also any other portions of the
      hearing that the individual attended.

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10-11-2 - Requests for Production of Records

The Director, DCP, is the Agency lead for responding to subpoenas for the production of records.

FDA processes requests for records in accordance with 21 CFR 20.2. This regulation provides that any request for FDA records, whether it be by letter or by a subpoena duces tecum or by any other writing, will be handled according to the FOIA provisions of 21 CFR Part 20.

If a request involves Congress, employee personnel records, the DHHS Office of Equal Employment Opportunity, the investigation of an FDA employee by the DHHS Inspector General, the testimony of an FDA employee as a private citizen, or the testimony of a former employee regarding FDA-related matters, see the instructions in “Requests involving Special Circumstances” below. Otherwise,

1. If you receive a written request or a subpoena, including a subpoena duces tecum, for the production or certification of records:
   
   Send the request to the address for DCP or, if appropriate, DFSR shown above in “If you receive a written request for testimony.”
   
2. If you are contacted by an individual requesting the production or certification of records
   1. Either refer the person to the Director, DCP or, if appropriate, the Director, DFSR; or advise them that FDA does not process verbal requests for records and that they should submit a written request to the address for DCP or, if appropriate, DFSR (shown above in “If you receive a written request for testimony”) well in advance of their desired due date to allow time for evaluating and processing the request; and that they should include specific information about the records requested, the requested due date, and any other relevant background. Refer them to 21 CFR 20.2 for FDA’s procedures for processing these requests.
   2. Do not make any commitment regarding the availability of records.
   3. Document the conversation, and send DCP (or DFSR) a memorandum by email or facsimile (at the numbers shown above in “If you receive a written request for testimony”), and contact that office to confirm receipt.

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10-11-3 - Multi-issue Subpoena - Requests for Samples

If you receive a subpoena or a request that seeks FDA records, testimony, and actual samples, you should: (1) refer the sender of the request/subpoena for the samples to the Director, DCP, who, if needed, will consult with OCC for a response pursuant to 21 CFR 2.10, and if involved, OCI; and (2) process the remaining portion of the request/subpoena as a request for testimony and for records.

FDA considers a request/subpoena for analytical results to be a request for records.

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10-11-4 - Requests for Certification of Records

FDA processes requests for certification of records in accordance with 21 CFR 20.3. DCP will forward requests for the certification of records to the appropriate component for direct response.

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10-11-5 - Requests involving Special Circumstances

If you receive a request that involves:

1. An FDA proceeding or a DHHS proceeding where FDA is involved – contact OCC, if that office is not already involved or aware of the request.
2. Congress – contact FDA’s Office of Legislation.
3. Employee personnel records related to litigation – contact the Employee and Labor Relations Branch in DHHS’s Rockville Human Resources Center.
4. An investigation of an FDA employee by the DHHS Inspector General - contact FDA’s Office of Internal Affairs (HFH-560) in the Office of Criminal Investigations.
5. The DHHS Office of Equal Employment Opportunity – contact FDA’s EEO and Diversity Management Office (HF-15), in the Office of Shared Services.
6. Testimony as a private citizen - Some testimony as a "private citizen" (i.e., not in one's official FDA capacity) may raise special concerns such as possible conflict of interest or may require approval as an outside activity. NOTE: If the individual’s planned testimony is based on information derived during FDA employment, the employee must contact the Office of Regulatory Affairs (ORA), Office of Enforcement (OE), Division of Compliance Policy (DCP) (HFC-230) for clearance of this testimony under 21 CFR 20.1. For testimony as a private citizen, employees also should refer to the Standards of Ethical Conduct for Employees of the Executive Branch, 5 CFR 2635.805, and the HHS Supplemental Standards of Ethical Conduct, 5 CFR 5501.106. Contact FDA’s Ethics and Integrity Staff for further information regarding approval of the testimony as an outside activity.
7. Testimony by former FDA employees - Requests for the testimony of former FDA employees are not covered specifically by 21 CFR 20.1. Encourage former employees to contact the Office of Regulatory Affairs (ORA), Office of Enforcement (OE), Division of Compliance Policy (DCP) (HFC-230) if they receive a request or subpoena to provide testimony regarding FDA-related matters, because FDA may assist that individual. Advise former employees that there may be other restrictions on their ability to provide the requested testimony, including possible conflict of interest concerns and statutory and regulatory restrictions on the release of trade secrets and other kinds of confidential information.

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10-11-6 - Disclosure of Non-public information

FDA generally discloses information pursuant to a request or subpoena if that information is neither exempt from disclosure under FOIA nor prohibited from disclosure by other law. In certain circumstances, however, the law allows FDA to share certain non-public information that is otherwise exempt or prohibited from disclosure, e.g., 21 CFR 20.85 (disclosure to other federal agencies), 21 CFR 20.88 (disclosure to state and local agencies), or 21 CFR 20.89 (disclosure to foreign agencies). Other examples of instances in which FDA may share non-public information are set forth below.

1. FDA may share certain non-public information with federal or state officials commissioned by FDA under law.
2. FDA may share certain non-public information with other government officials under agreements or contracts that contain appropriate confidentiality provisions.
3. FDA may share personal privacy information that a state or federal prosecuting attorney seeks without redaction for use as evidence at trial, if the release is allowed under the Privacy Act (5 U.S.C. 552a). Contact OCC and FDA’s Privacy Act Officer in DFOI before sharing this non-public information.
4. If OCI is involved in joint investigations with other law enforcement agencies for violations of the FD&C Act, contact OCI before sharing non-public information related to the investigation. Applicable regulations in 21 CFR Part 20, the law enforcement exemption of the Privacy Act, and 21 U.S.C. 331(j) govern disclosures of certain non-public information during the course of open multi-agency investigations. In all multiagency investigations, OCI has obtained or, prior to the sharing, will obtain confidentiality assurances that the non-public information disclosed by FDA will be used for law enforcement purposes only, and in accordance with the provisions of the applicable statutes.

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10-11-7 - Other Requests for Information – Informal Meetings

A person (individual, company, corporation, etc.) might request an informal meeting with an FDA employee to discuss information the employee obtained during the course of his or her employment.

1. If the requester is not an official from another government agency, and if private civil litigation is involved, decline the request and suggest that the requester submit a request for testimony under 21 CFR 20.1. Also, advise the requester that FDA has a long-standing policy against granting one-sided interviews or informal testimony to avoid creating the impression that FDA is biased toward a party.
2. If the requester is not an official from another government agency, if the request relates to a matter other than private civil litigation (e.g., the requester seeks general information about FDA’s activities), advise the requester to submit a written request to FDA, to be handled as general correspondence under routine office procedures.
3. If the requester is an official from another government agency, advise the requester to submit a written request to FDA to be handled under appropriate agency procedures for the sharing of publicly releasable or non-public information. Contact OCI’s information disclosure senior investigator if the request is from a law enforcement agency and the request is for non-public information.
4. Consult with DCP if needed.

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10-11-8 - Definitions

The following list contains definitions of commonly used terms in the context of testimony, subpoenas, or production of records.

Affidavit - A written document signed in the presence of a notary public under a sworn oath that the statement is true. FDA considers an affidavit to be testimony covered by 21 CFR 20.1.

Certification (also known as “certificate”) - A written assurance, or official representation, that some act has or has not been done, or some event occurred, or some legal formality has been complied with. Typically, a requester will ask that FDA certify as to the authenticity of an FDA record as a true copy. FDA processes requests or subpoenas for certification under 21 CFR 20.3.

Declaration - A written statement signed under the penalty of perjury. A declaration can substitute for an affidavit in federal court proceedings. 28 U.S.C. 1746. FDA considers a declaration to be testimony covered by 21 CFR 20.1.

Deposition - The taking and recording of testimony of a witness under oath, in front of a court reporter prior to trial and away from the courtroom. FDA considers an employee’s responses in a deposition to be testimony covered by 21 CFR 20.1.

Interrogatories - Written questions sent by one party in a lawsuit to the other party during the discovery process prior to trial. Interrogatories must be answered in writing under oath or under penalty of perjury. FDA considers the employee’s response to interrogatories to be testimony covered by 21 CFR 20.1.

Notary Public - A person authorized by the state in which they reside to administer an oath of truth to a person making an affidavit, and to apply their signature and seal or stamp to attest to the oath.

Rogatory Letters - A written request from a judge in one state to a judge in another, asking that the latter take the testimony of a witness. FDA considers testimony in response to rogatory letters to be covered by 21 CFR 20.1.

Subpoena - A court order commanding a witness to appear at a certain time and place to testify on a certain matter. For purposes of this section, a “subpoena” means a subpoena for verbal or written testimony (e.g., an affidavit). A subpoena for testimony also might include a request for records. In that case, FDA would process the subpoena under 21 CFR 20.1 and 20.2.

Subpoena Duces Tecum - A court order commanding a witness to produce documents at a certain time and place. FDA processes these subpoenas, which are intended for the production of records, under 21 CFR 20.2.

Testimony - For purposes of this section, testimony is an individual’s statement given in writing (such as an affidavit or a declaration) or by appearance under oath at a proceeding. The statement might be in response to a deposition or interrogatories. Testimony is covered by 21 CFR 20.1.

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10-11-9 - References

1. "Enforcement Notes,” Issue No. 85, September 18, 2002, Testimony, available on ORA’s Intranet
2. Staff Manual Guide 1410.21(General Redelegations of Authority from the Commissioner to other Officers of the Food and Drug Administration)
3. Staff Manual Guide 1410.23 (Certification of True Copies and Use of Department Seal)
4. Staff Manual Guide 1410.24 (Disclosure of Official Records and Authorization of Testimony)
5. Staff Manual Guide 2127.1 (Attendance by FDA Employees at Congressional Hearings)
6. Staff Manual Guide 2127.2 (Requests for Testimony of FDA Personnel in Non-FDA Proceedings)
7. Staff Manual Guide 2460.7 (Procedures for Implementing the Freedom of Information Act) (Not on Intranet)
8. 5 U.S.C. 552a (Privacy Act); 21 CFR Part 21(Privacy Act regulations)
9. 5 U.S.C. 552(b) (Freedom of Information Act (FOIA)); 21 CFR Part 20 (FOIA regulations), particularly 21 CFR 20.1, 20.2, and 20.3
10. 5 CFR 2635.805 (Standards of Ethical Conduct for Employees of the Executive Branch; Service as an expert witness)
11. 5 CFR 5501.106 (HHS Supplemental Standards of Ethical Conduct; Outside employment and other outside activities
12. Information Disclosure Manual on ORA’s Intranet Information Disclosure Main Page
13. FDA’s FOIA Page on FDA’s Intranet

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