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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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3-4 - DOCUMENTATION; POCKET CREDENTIALS

3-4 - DOCUMENTATION; POCKET CREDENTIALS
     3-4-1 - Request For Commissioning A State Or Local Official
     3-4-2 - Written Assurances
     3-4-3 - Pocket credentials
     3-4-4 - Commissioning Package
     3-4-5 - Privacy Act
     3-4-6 - Commission Documents

 3-4 - DOCUMENTATION; POCKET CREDENTIALS

 3-4-1 - Request For Commissioning A State Or Local Official

The request for commissioning a state or local official shall contain:

  1. The full name, title, and agency of the individual for whom the commission is being requested.
  2. The reasons for which the commission is requested.
  3. The program area or areas for which the commission will be issued (see "Program Areas, Commissioning Activities").
  4. Which of the four activities the individual will be authorized to perform (see "Program Areas, Commissioning Activities").
  5. Whether the individual is to be issued a certificate, pocket credentials, or both (see "Pocket credentials").
  6. A concurrence or non-concurrence line for the RFDD.

 3-4-2 - Written Assurances

FDA will commission a state or local government official only if the official signs the "Acceptance of Commission" which includes applicable provisions about conflict of interest and confidentiality matters (see Exhibit 3-2). Additionally, all information provided to FDA, including the C.V. and for the background investigation, must be found accurate and complete. For Federal officials, the MOU may set out provisions about written assurances.

 3-4-3 - Pocket credentials

  1. Pocket credentials issued
    FDA issues pocket credentials for State and local officials who are commissioned for activities other than the activity "Receive and review official FDA documents.” (see “Program Areas”; see Exhibits 3-3 and 3-4). The pocket credentials will identify:
    1. The program area or areas covered.
    2. The state in which the official operates.
    3. The pocket credential number and expiration date.
    4. A color picture of the commissioned official.
  2. No pocket credentials
    FDA generally does not issue pocket credentials for:
    1. State and local officials that FDA commissions for the activity, "Receive and review official FDA documents." Those individuals will receive a Certificate of Commission (Exhibit 3-5).
    2. Federal officials that FDA commissions. Since FDA confers the "Commission Authority" under the MOU with the collaborating federal agency, typically FDA will not issue a separate set of commissioning pocket credentials. The Federal officials will have identification/ pocket credentials from their agency.
  3. Lost pocket credentials
    FDA considers the loss of pocket credentials to be a serious matter. FDA requires commissioned state and local officials to report the loss of their pocket credentials immediately to the RFDD or designated official. The RFDD or designee should provide detailed information on the loss of the pocket credentials to the Office of Partnerships. Additionally the commissioned official must report the loss to their local police department and have the pocket credentials entered into the National Crime Information Center (NCIC) system. If the police department cannot enter the lost pocket credentials into the NCIC system, a police report will need to be filed. A copy of the entry into the NCIC system or the police report will need to be sent to the Office of Partnerships before replacement pocket credentials will be issued.

    FDA should clearly inform commissioned state and local officials who receive pocket credentials that they may not retain the pocket credentials as mementos or souvenirs. The Certificate of Commission may serve this purpose. If the pocket credentials are not returned to the FDA within two months of leaving the commissioning program, the FDA will report the pocket credentials to the FBI for retrieval.

 3-4-4 - Commissioning Package

  1. State or local officials
    Upon confirmation to the RFDD that a commission will be accepted by a state or local employee, FDA will send a commissioning package to each candidate. This package generally contains: 
    1. A letter signed by the RFDD offering the candidate a commission;
      1. In the case of an agency head, the letter will cite the Commissioner's desire that the candidate have a FDA commission (see Exhibit 3-6). 
      2. In the case of a program director or an individual subordinate to the program director, the letter goes to the agency Head, but these letters will not mention the Commissioner (see Exhibit 3-7).
    2. A copy of the most recent edition of the brochure "The FDA Commission".
    3. Acceptance of Commission form (see Exhibit 3-2).
    4. A request for a CV (only at RFDD's specific instructions) (see Exhibit 3-1). If the candidate or commission holder has not completed a CV, FDA may request one from the individual. Failure of that individual to supply a CV to the RFDD upon request may be considered grounds for withdrawing the offer of a commission, or revoking a previously issued commission.
    5. "Basic Information from Candidate" form (see Exhibit 3-8).
    6. "E-QIP Initiation" form (see Exhibit 3-9).
    7. "State Credential Record" Form 2115s (see Exhibit 3-3).
    8. "Instructions to Candidate" form (see Exhibit 3-10).
    9. Any other information that the Office of Partnerships deems relevant.
  2. Federal Officials
    For Federal officials, the MOU may contain provisions about documentation for the commissioning process. FDA expects that there will be minimal paperwork for a Federal official. Since a level five public trust background investigation is mandatory for all government employees and contractors, a subsequent background investigation will not be necessary for federal officials seeking a commission.

 3-4-5 - Privacy Act

  1. The FDA Regional Office and the Office of Partnerships maintain records on individuals who have applied to be commissioned (e.g., background investigation, commissioning package).
  2. Any person may review his or her own file by requesting a copy of it from RFDD under the Privacy Act. All other questions about Privacy Act records should be addressed to FDA’s Division Freedom of Information (HFI-35), Food and Drug Administration, 12420 Parklawn Drive, Rockville, MD 20857.

 3-4-6 - Commission Documents

  1. State and local officials
    For state and local officials, after FDA checks the information from the candidate, the regional commissioning contact will prepare and send the following materials to the newly commissioned state or local official:
    1. A letter, signed by the RFDD, thanking the individual for accepting a commission.
    2. If issued, pocket credentials in a pocket credential case (issued by the Office of Security Operations).
    3. A "Certificate of Commission," signed by the Commissioner (see Exhibit 3-5).
    4. Any other information that the Office of Partnerships deems relevant.
  2. Federal officials
    For Federal officials, the MOU may contain provisions about documentation for the commissioning process. FDA expects that there will be minimal paperwork for a Federal official.