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Compliance References
Regulatory Procedures Manual 2008
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3-8 - ADMINISTRATIVE CONSIDERATIONS
     3-8-1 - RFDD Responsibilities
     3-8-2 - DFSR Responsibilities:

3-8 - ADMINISTRATIVE CONSIDERATIONS

The following sections set out some of the responsibilities of the regional office management and the DFSR personnel regarding management review and record keeping. For Federal officials, the MOU should specify who will conduct management review and the scope of the review of an individual’s commission, and who will submit reports to the House of Representatives and the Senate of the details of that year’s accomplishments (see Subparagraph C, Section 314, of the BT Act). The following information relates to commissioning state or local officials:

3-8-1 - RFDD Responsibilities

The RFDD or designee should:

  1. ensure that the regional office has established a file on each commissioned state or local official within the region. This record shall include:
    1. credential number, date issued, and expiration date. This information, along with other data, may be entered on (optional) Form FDA 2081 (Exhibit 3-12);
    2. data on commission holder contained on the Basic Information from Candidate for an FDA Commission form (Exhibit 3-8);
    3. copy of naturalization papers if the official was not born in the United States;
    4. official’s CV, if the RFDD specifically requested that one be furnished;
    5. signed Acceptance of Commission form (Exhibit 3-2);
    6. all correspondence including awards;
    7. photocopies of credential forms (FDA 1990A and FDA 200A) (Exhibit 3-3 and 3-4);
    8. one color photograph of commission holder; and,
    9. any other information relevant to the commission.
  2. maintain a record of the annual validation of all credentials issued in the region (Exhibit 3-13), and send DFSR copies of the validation forms, and relevant information on the official (full name, credential number (if any) or certificate only designation, state, agency, program area(s), and expiration date;
  3. annually validate credentials issued to state or local personnel to maintain strict accountability for FDA credentials and to make sure that the list of credential holders is up-to-date;
  4. notify the appropriate district director of the issuance of the commission;
  5. electronically send DFSR (cvassar@ora.fda.gov) information for the national inventory maintained by that office;
  6. periodically review each state or local commission to determine whether it should be renewed or revoked;
  7. review the commissioned official's record approximately two months prior to expiration of the commission;
  8. send DFSR a written decision to revoke a commission or to not renew a commission;
  9. send an accounting letter (see Exhibit 3-14) to each State or local agency head, together with a form listing the members of that agency holding credentials (Exhibit 3-13), and send DFSR a copy; and,
  10. notify DFSR about the results of an assignment issued to a commissioned state or local official.

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3-8-2 - DFSR Responsibilities:

The DFSR should:

  1. maintain a current national inventory of Federal, state and local officials holding commissions issued by FDA and periodically review the inventory for currency;
  2. periodically review the inventory of commissioned officials and advise the appropriate regional commissioning contact of any commissions that have expired;
  3. notify the regional commissioning contact person for resolution if commissions have expired, and have not been renewed, of if there are other issues;
  4. when requested by a RFDD, arrange for initiation of special checks, e.g., background check, of a candidate for a FDA commission, if the field manager has determined such an eligibility review is necessary;
  5. notify the FBI of lost state or local commissioned official’s credentials;
  6. provide copies of commissioning forms if needed, upon request;
  7. facilitate resolution of matters arising about conflict of interest, confidentiality, legal restriction, and other areas related to the commissioning process, and notify appropriate agency personnel;
  8. facilitate the signing of letters by the Commissioner, and other headquarters management regarding commissioning of state or local officials; and,
  9. stop subscriptions and routine mailings of information to an individual whose commission will not be renewed or has been revoked, and close the file.

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