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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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3-7 - CONSIDERATIONS AFTER COMMISSIONING

3-7 - CONSIDERATIONS AFTER COMMISSIONING
     3-7-1 - Duration
     3-7-2 - Background Investigation
     3-7-3 - Legal restrictions
     3-7-4 - Renewal of Commission
     3-7-5 - Non-renewal of Commission
     3-7-6 - Suspension of Commission
     3-7-7 - Revocation of Commission
     3-7-8 - Relationship With Commissioned Officials

 3-7 - CONSIDERATIONS AFTER COMMISSIONING

 3-7-1 - Duration

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

 3-7-2 - Background Investigation

  1. State or local officials
    In addition to background investigations conducted prior to commissioning (See 3-3-3), in its discretion, FDA may conduct a background investigation on a state or local government official after FDA commissions that official (e.g., when a commission is renewed) 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 investigation.

 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 the Office of Partnerships.

 3-7-4 - Renewal of Commission

  1. State or local officials
    Commissions of state or local officials are valid for five years. The region will review the commissioned official's record approximately three (3) months prior to expiration of the commission. This review considers all pertinent aspects of 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, deputy 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 2115s and picture (Exhibit 3-3) must be filled out and mailed to the Office of Security Operations along with the expired pocket credential, so a new updated pocket credential can be prepared. This exchange must go through the regional commissioning contact so that the complete renewal package is sent to the Office of Security Operations. If there is no break in employment and commission status for the individual seeking renewal, an additional background investigation will not be completed. However, FDA has the option to conduct a background investigation at any time during the renewal process, if deemed necessary.
  2. Federal officials
    For Federal officials, the MOU should contain provisions about the duration of the commission and procedures about renewal of a commission.

 3-7-5 - Non-renewal of Commission

  1. General
    FDA will not renew a commission if the holder has changed positions outside of the organization/agency, resigned, or retired. 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 pocket credentials, the regional commissioning contact collects the pocket credentials as soon as a decision is made that a commission will not be renewed. The regional commissioning contact will destroy the expired pocket credential in accordance with their regional procedures and will inform the Office of Partnerships, when the destruction has been completed. Non-renewal of a commission is without prejudice; that is, FDA may commission that official later should conditions change.
  3. Federal officials
    For Federal officials, the governing MOU may contain provisions about non-renewal of a commission.

 3-7-6 - Suspension of Commission

  1. General
    ORA may use discretion at any time to revoke or suspend the commission of such authorized officials who is in violation of the following:
    1. Charges of a felony.
    2. Charges of a misdemeanor, excluding minor traffic offenses where the fine is less than $500.
    3. Pending trial for a felony or misdemeanor charge, excluding minor traffic offenses where the fine is less than $500. 
    4. Pending investigation related to a felony or misdemeanor charge, excluding minor traffic offenses where the fine is less than $500.

    The decision to revoke or suspend an FDA commission will be communicated within 30 calendar days to both the individual and his/her supervisor.
  2. State or local officials
    For commissioned state or local officials, within ten (10) calendar days after receiving a felony or misdemeanor charge, the details of the applicable charge must be communicated to their employer, and to the FDA Regional Office RFDD, deputy regional director, executive official, director of state programs, or other official specifically charged with oversight of the commissioning program. Within five (5) calendar days after receiving details of the charge, the RFDD must inform the Office of Partnerships National Commissioning Coordinator. The Office of Partnerships National Commissioning Coordinator will work with Office of Security and the Office of Partnerships Senior Management to decide if suspension  of the commission is required. After a decision has been reached, the Office of Partnerships National Commissioning Coordinator will write a memorandum recommending the appropriate action, to the RFDD, deputy regional director, executive official, director of State programs, or other official specifically charged with oversight of the commissioning program.

    If suspension of commission is not required and the RFDD concurs, a letter signed by the RFDD should be sent to the agency head stating that no further action will be taken.

    If suspension of commission is required and the RFDD concurs, a letter signed by the RFDD should be sent to the agency head stating the details of the suspension and requesting that the certificate of commission, pocket credentials (if any), and any documents belonging to FDA be collected and returned to the Office of Partnerships. The documents and all additional documentation from the Regional office must then be sent via e-mail ORAHQOFFICEOFPARTNERSHIPS@fda.hhs.gov.

    Once a commission has been suspended, the FDA will wait for the final verdict of the charge to make its decision on revoking or reinstating the commission. If the state or local official is not charged with the felony or misdemeanor, FDA will use discretion to reinstate their commission. A follow up letter signed by the RFDD including the officials certificate of commission and pocket credential (if any), should be sent to the agency head stating the decision to reinstate. If the state or local official is charged with the felony or misdemeanor their commission will be revoked immediately. A follow up letter signed by the RFDD should be sent to the agency head stating the decision of revocation. Once a commission has been revoked, that individual is no longer eligible for an FDA commission.

    If there is a dissenting opinion between the RFDD and another FDA official regarding the suspension of an individual’s commission, the ACRA, or appropriate senior ORA official, will be consulted for a final decision.

 3-7-7 - Revocation of Commission

  1. General
    The issuance of a commission is discretionary and ORA may revoke a commission at any time. Reasons for revocation could include:
    1. The abuse or misuse of the commission.
    2. The transmittal of confidential information from a commissioned state or local official to individuals who are not employees or commissioned officials of the Department of Health and Human Services.
    3. A conflict of interest.
    4. Change in criminal or credit history.
    5. Conviction of a crime.
    6. Substance abuse.
    7. Behavior that may discredit the agency.
    The decision to revoke an FDA commission will be communicated in 30 calendar days to both the individual and his/her supervisor.
  2. State or local officials
    For state or local officials, within ten(10) calendar days after violation for revocation has occurred, details of the violation must be communicated to their place of employment who must then communicate the details to the FDA Regional Office RFDD, deputy regional director, executive official, director of state programs, or other official specifically charged with oversight of the commissioning program. Within five (5) calendar days after receiving details of the charge, the Region must inform the Office of Partnership’s National Commissioning Coordinator. The Office of Partnership’s National Commissioning Coordinator will work with Office of Security and the Office of Partnership’s senior management to decide if revocation of commissions is required. After a decision has been reached the Office of Partnership’s National Commissioning Coordinator will write a memorandum recommending the appropriate action, to the RFDD, district director, deputy 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, pocket credentials (if any), and any documents belonging to FDA be collected and returned to the Office of Partnerships. The documents and all additional documentation from the Regional office must then be sent via e-mail ORAHQOFFICEOFPARTNERSHIPS@fda.hhs.gov. Once a commission has been revoked, that individual is no longer eligible for an FDA commission. If there is a dissenting opinion between the RFDD and another FDA official regarding the revocation of an individual’s commission, the ACRA will be consulted for a final decision.
  3. Federal officials
    For Federal officials, the MOU may contain provisions about revocation of a commission.

 3-7-8 - 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. State and local officials who hold FDA commissions help FDA enforce its laws and regulations. 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 options:

  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 the Office of Partnerships 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
    The manuals listed below are available on the FDA internet and can be accessed at: www.fda.gov. For further assistance please contact the Office of Partnerships at (301) 827-6906 or ORAHQOFFICEOFPARTNERSHIPS@fda.hhs.gov
    1. FDA Investigations Operation Manual: http://www.fda.gov/ICECI/Inspections/IOM/default.htm
    2. FDA Compliance Policy Guides Manual: http://www.fda.gov/ICECI/ComplianceManuals/CompliancePolicyGuidanceManual/default.htm
    3. FDA Regulatory Procedures Manual: http://www.fda.gov/ICECI/ComplianceManuals/RegulatoryProceduresManual/default.htm
    4. Catalog of Courses and Training Materials: http://www.fda.gov/Training/ForStateLocalTribalRegulators/ucm118435.htm
    5. Annual Directory of State & Local Officials: http://dslo.afdo.org/disclaimer icon
    6. Laboratory Information Bulletin: http://www.fda.gov/Food/ScienceResearch/LaboratoryMethods/DrugChemicalResiduesMethodology/default.htm
    7. Approved Drug Products With Therapeutic Equivalence Evaluations (and cumulative supplements): http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/UCM071436.pdf
    8. Special reports in the area in which the commission is held.
  6. Training
    Provide training course announcements to state officials and when possible, give priority to commissioned officials to attend courses.
  7. 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.
  8. District meetings
    Invite commissioned officials to all or part of annual district meetings.
  9. Laboratory support
    When possible, permit commissioned officials to use FDA laboratories to run state samples, and state personnel to use laboratory facilities.