3-7 - CONSIDERATIONS AFTER COMMISSIONING

3-7-1 - Duration

Generally, each state or local commission is issued for a period of three years. For Federal officials, the MOU should include the duration of commission, which might be a term other than three years.

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3-7-2 - Background check

1. State or local officials
   In its discretion FDA, may conduct a background check on a state or local government official after FDA commissions that official if substantive questions subsequently arise, and should inform the official of FDA’s authority to do so.

2. Federal officials
   For Federal officials, the MOU may contain provisions about a background check.

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3-7-3 - Legal restrictions

1. General
   The United States is liable for torts of its employees under the Federal Tort Claims Act as further clarified by the Federal Employees Liability Reform and Tort Compensation Act of 1988. The definition of employee includes persons acting on behalf of a Federal agency in an official capacity, temporarily or permanently in the service of the United States, with or without compensation. This definition would include all individuals commissioned under this Program. However, the Federal Tort Claims Act would only apply if the individual holding a commission were performing Federal duties.

2. State or local officials
   FDA considers the commissioned state or local official to be an official of the Department of Health and Human Services. However, accepting a commission does not subject the state or local commissioned official to the restrictions on political activity set forth in the Hatch Act, except on days in which the Federal service under the commission is actually rendered.

3. Federal officials
   For Federal officials, the MOU may contain provisions about legal restrictions, such as those imposed by the Federal Tort Claims Act. If legal restrictions arise, contact DFSR, who may consult with the Office of Chief Counsel.

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3-7-4 - Renewal of Commission

1. State or local officials
   Commissions of state or local officials are valid for three years. The region will review the commissioned official's record approximately two months prior to expiration of the commission. This review considers all pertinent aspects the commission including inspections, collection of samples, consultation extended, cooperation in routine and emergency situations, and any breaches of confidentiality. For state or local officials, a memorandum recommending whether or not to renew the commission, with details, should be sent to the RFDD by a district director, assistant regional director, executive official, director of state programs, or other official specifically charged with oversight of the commissioning program.

   If the RFDD agrees to a renewal, a new Form FDA 1990A and Form FDA 200A (Exhibits 3-3 and 3-4) is prepared and exchanged for the ones about to expire. This exchange may be handled in any convenient way, provided the old Form FDA 1990A and Form FDA 200A are returned to the RFDD for cancellation. The RFDD also may send the commissioned official a new Acceptance of Commission form (Exhibit 3-2) to be completed and sent back to the Regional Office.

2. Federal officials
   For Federal officials, the MOU should contain provisions about the duration of the commission and procedures about renewal of a commission.

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3-7-5 - Non-renewal of Commission

1. General
   FDA will not renew a commission for any official if the person who holds it has changed positions, resigned, or retired. FDA’s decision not to renew a commission may be made at any time if the conditions so warrant. If the commission is not renewed, FDA should send a letter to that effect to the supervisor of the individual. This letter should briefly cite the reason. Examples of reasons include: "change of position," "resigned," "retired," "no longer involved in FDA contract work," "inactive," or "at holder's request."

2. State or local officials
   For state or local officials, commissions for which only a certificate was issued may be allowed to expire without correspondence indicating that the commission will not be renewed. Instead, send a letter thanking the commission holder for their service. For state or local officials who received credentials, FDA collects the credentials as soon as a decision is made that a commission will not be renewed. These credentials are cancelled by cutting them in two pieces and placing the pieces in the regional file record of that commission. Notify DFSR.Non renewal of a commission is done without prejudice. That is, FDA might commission that official later should conditions change.

3. Federal officials
   For Federal officials, the MOU may contain provisions about non-renewal of a commission.

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3-7-6 - Revocation of commission

1. General
   FDA may revoke a commission for cause. A reason for revocation could be the abuse or misuse of the commission, including transmittal of FDA’s confidential information from a commissioned state or local official to individuals who are not employees of the Department of Health and Human Services. Other appropriate causes for revocation include a conflict of interest, arrest and conviction for a felony, substance abuse, and behavior that may discredit the agency.
   
2. State or local officials
   For state or local officials, a memorandum recommending such action, with details, should be sent to the RFDD by a district director, assistant regional director, executive official, director of state programs, or other official specifically charged with oversight of the commissioning program. If the RFDD concurs, a letter signed by the RFDD should be sent to the agency head stating the details of the revocation and requesting that the certificate of commission, credentials (if any), and any documents belonging to FDA be collected and returned to the RFDD by registered mail. Notify DFSR. Revocation of a commission is done with prejudice. That is, the official is no longer eligible for an FDA commission.
   
3. Federal officials
   For Federal officials, the MOU may contain provisions about revocation of a commission.

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3-7-7 - Relationship With Commissioned Officials

FDA's relationship with state and local agencies is very important, because close coordination and cooperation provides a high level of consumer protection. Having state and local officials hold FDA commissions helps promote FDA’s efforts to foster better understanding of FDA's mission and functions. Having an FDA commission is, for most holders, both a tangible and intangible benefit. Not only can the commission help the holder get his or her job done, but FDA considers a commission as its recognition of the individual's competence, experience, and training in the subject area.

To encourage closer ties with cooperating state and local officials who hold FDA commissions, to inform them about FDA, and to let FDA benefit from their knowledge and experience, the RFDD should consider the following steps:

1. Regional meetings
   Plan to hold a yearly one-day meeting for all commissioned agency heads. This event may include a discussion on FDA priority decisions, presentations by senior agency officials on new developments, policy matters, state contracts, and training. Spend as much of the meeting as possible in soliciting participant views and suggestions. Include examples of effective state-federal cooperation and individual recognition to those who performed outstanding work on joint projects. If the meeting cannot be held due to travel restrictions on out-of-state agency heads, or lack of funds, consider visiting the offices of each commissioned agency head, or invite the agency head to a closer FDA facility for a meeting.
   
   
2. Recognition from the Commissioner
   Prepare a letter for the Commissioner's signature recognizing outstanding efforts by a state or local commissioned individual, his or her unit, division, or agency. If used, send the letter to DFSR to arrange for signing and mailing.
   
   
3. Awards
   Nominate commissioned individuals, or groups of commissioned individuals, for FDA awards, medals, or commendations similar to those awarded to FDA employees.
   
   
4. Binders
   Give each commissioned official a binder(s) appropriate for the material FDA provides them.
   
   
5. Literature and publications
   Offer subscriptions/copies to selected FDA publications and reports to commissioned officials. Share only those publications that are appropriate for the commissioned official to meet their particular needs. The commissioned officials may request publications from FDA using a Request for FDA Materials form (Exhibit 3-14). Examples of publications to offer are:
   1. FDA Investigations Operation Manual (also available on the Internet);
   2. FDA Compliance Policy Guides Manual (also available on the Internet);
   3. FDA Regulatory Procedures Manual (also available on the Internet);
   4. Catalog of Courses and Training Materials (ORA/DHRD);
   5. Annual Directory of State & Local Officials (only available on Internet);
   6. Laboratory Information Bulletin (LIB);
   7. Approved Drug Products With Therapeutic Equivalence Evaluations (and cumulative supplements)(also available on the Internet); and,
   8. Special reports in the area in which the commission is held
      
      
6. Training
   Provide headquarter-initiated training bulletins. Announce training courses sponsored or held within a commissioned official in the area for which the course is intended. Give priority to commissioned officials for attendance when possible.
   
   
7. State Activity Information Letter (SAIL)
   Assist, when requested, in providing material for SAIL.
   
   
8. Visibility
   Consider notifying commissioned state and local officials when disseminating information to the public about FDA activities. For example, Public Affairs Specialists who have radio or television programs, or who write columns for newspapers or magazines, should report interesting and meaningful activities of commissioned officials. Regional and district officials compiling material for the FDA Consumer magazine should include stories concerning the activities of commissioned officials.
   
   
9. District meetings
   Invite commissioned officials to all or part of annual district meetings.
   
   
10. Laboratory support
    When possible, permit commissioned officials to use FDA laboratories to run state samples, and state personnel to use laboratory facilities.

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