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Compliance References
Regulatory Procedures Manual 2008
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3-4 - DOCUMENTATION; CREDENTIALS
     3-4-1 - Request Or Recommendation For Commissioning A State Or Local Official
     3-4-2 - Written Assurances
     3-4-3 - Credentials
     3-4-4 - Commissioning Package
     3-4-5 - Commission Documents

3-4 - DOCUMENTATION; CREDENTIALS

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

The request or recommendation for commissioning a state or local official should 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, credentials, or both (see “Credentials”); 

  6. The nature of the assignment, when possible; and,

  7. A concurrence or non-concurrence line for the RFDD. 

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3-4-2 - Written Assurances

FDA will commission a state or local government official only if the official provides a written assurance, e.g., by signing the "Acceptance of Commission" that includes provisions about conflict of interest and confidentiality matters (see Exhibit 3-2).  For Federal officials, the MOU may set out provisions about written assurances.

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3-4-3 - Credentials

  1. Credentials issued
    FDA issues 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 credentials will show:

    1. The program area or areas (see Exhibit 3-4) covered;
    2. The state where the official may operate.
    3. Other information, such as the credential number and expiration date.
    4. The picture of the individual.
  2. No credentials
    FDA generally does not issue credentials for:
    1. State and local officials that FDA commissions for activity, "Receive and review official FDA documents.”   Those individuals usually receive a Certificate of Commission (Exhibit 3-5).
    2. State and local officials that FDA commissions under FDA’s “streamlined” commissioning program.  For additional information, contact DFSR.
    3. 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 credentials.  The Federal officials will have identification/ credentials from their agency.
  3. Lost credentials
    FDA considers the loss of credentials to be a serious matter. FDA asks commissioned state and local officials to report the loss of their credentials immediately to the RFDD or designated official.  The RFDD or designee should provide detailed information on the loss of the credentials to DFSR for transmittal to the Federal Bureau of Investigation (FBI).   Also, FDA should clearly inform commissioned state and local officials who receive credentials that they may not retain the credentials as mementos or souvenirs.  The Certificate of Commission may serve this purpose.

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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 deliver 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. One blank Identification Card, FDA Form 200A (see Exhibit 3-3). (If copies are needed contact DFSR);
    5. 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;
    6. "Basic Information from a Candidate" form (see Exhibit 3-8);
    7. "Instructions to Candidate” form (see Exhibit 3-9); and,
    8. Any other information that DFSR deems relevant. 

    Upon receipt of the requested portions of the commissioning package, FDA will check the material for accuracy and completeness.  Forms that have been partially completed or apparently completed incorrectly will be returned to the candidate with a request for correction(s).

  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.

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3-4-5 - Commission Documents

  1. State and local officials
    For state and local officials, after FDA checks the information from the candidate, it generally 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, laminated credentials in a credential case (see Exhibits 3-3 and 3-4);
    3. A "Certificate of Commission," signed by the Commissioner (see Exhibit 3-5).  A small stock of "FDA Form 1990A" and "Certificates of Commission" pre-signed by the Commissioner may be obtained from DFSR (HFC-150) and  should  be kept in a locked file or desk;
    4. A form to be returned to the RFDD on which the Commissioned Official can order certain FDA material without charge (see "Relationship with Commissioned Officials" and Exhibit 3-10); and,
    5. Any other information that DFSR 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.

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