Inspections, Compliance, Enforcement, and Criminal Investigations



3-3-1 - Initiating the Process
3-3-2 - Qualification; Eligibility
3-3-3 - Background Investigation
3-3-4 - Program Areas; Commissioning Activities
3-3-5 - Reasons for Commissioning
3-3-6 - Contacting the Candidate


3-3-1 - Initiating the Process

  1. Introduction

    Either an FDA official or the director of a state or local program can initiate the process for commissioning by sending a written recommendation to either the district or regional director. Recommendations from a state or local program should be sent to the RFDDs or through the director of state programs. The RFDD will then decide whether or not to commission the candidate.

    The commissioning of Federal officials generally begins at the time specified in the MOU that FDA and the other agency signs.
  2. Alternative procedure for information sharing with State and Local Officials

    In cases where there is a need to share non-public information, the Office of Partnerships may consider implementing a 20.88 confidentiality agreement instead of commissioning, for information sharing purposes only. See 3-6-3 "Sharing Non-Public Information Under 21 CFR § 20.88 (State)." A 20.88 agreement does not preclude a state or local official from being commissioned.

3-3-2 - Qualification; Eligibility

The RFDD determines the eligibility of a state or local official for a commission. ORA management may also review the eligibility of the candidate to be commissioned.

  1. Agency heads of health, food or drug agencies

    FDA considers all heads of state health, food, and drug regulatory agencies, appointed by the governor of the state, to be qualified and eligible for commissioning. Heads of state regulatory agencies not appointed directly by the governor, and heads of local agencies, are eligible to receive a commission if they are qualified. Qualifying factors to be considered include the individual's:

    1. Educational achievements.
    2. Subsequent training.
    3. Career experience.
    4. Knowledge and skills to represent FDA to regulated industry and the public.
    5. Any other consideration bearing on the individual’s propensity to act under an FDA commission with tact, discretion, propriety and in conformance with the highest ethical standards while bringing credit to FDA.

    FDA usually recommends that when an agency currently has or will have one or more officials that are commissioned by FDA, the agency head should also hold a FDA commission. It is also recommended that supervisors of individuals holding FDA commissions also be commissioned. This is advisable, but not mandatory, to avoid situations in which a commissioned official is unable, and therefore refuses, to share confidential information obtained under their commission with their non-commissioned supervisor. If the agency head declines to accept a FDA commission, a commissioned deputy commissioner, center director, etc., may be designated by the agency head to act in his or her place when a commissioning issue arises. If this is not possible, FDA may commission one or more of the agency’s operating personnel. This should be infrequent and should be done only if needed to achieve program goals. In specific situations, as needed, FDA will also determine whether certain confidential information obtained under a commission may be shared with non-commissioned officials under 21 CFR 20.88. See 3-6-3 "Sharing Non-Public Information Under 21 CFR § 20.88 (State)."

  2. Other health, food, and drug state and local officials

    A program director or subordinate official is eligible to receive a commission if qualified. The RFDD may request pertinent information on the official, including curriculum vitae (CV) (see Exhibit 3-1 for examples of questions usually answered by information recorded on a CV). Factors to be considered include:

    1. The written recommendation of the head of the agency in which the individual works.
    2. The training and experience of the candidate.
    3. Reports of appropriate FDA field personnel and State Program Specialists who have worked with the candidate.
    4. Knowledge and skills to represent FDA to regulated industry and the public.
    5. Any other consideration bearing on the individual’s propensity to act under an FDA commission with tact, discretion, propriety and in conformance with the highest ethical standards while bringing credit to FDA.
  3. Federal officials

    The MOU may specify procedures regarding the commissioning of designated Federal officials, e.g., who determines whether all commissioning requirements under the BT Act, such as training, have been met.

3-3-3 - Background Investigation

  1. General

    Obtaining an FDA commission is a privilege FDA extends to a select and limited number of health, food, or drug officials. FDA will conduct background investigations on all commission candidates seeking pocket credentials. For commission candidates seeking certificates of commission only, FDA, in its discretion, may conduct a background investigation, as described below. FDA will not commission any official if it determines that there is a conflict of interest regarding that individual. Commissioned officials must be citizens of the United States or United States nationals. For Federal officials, the governing MOU may contain provisions about a background check.

    If the candidate objects to the background investigation process, or challenges the right to make such an investigation, FDA considers the individual as having withdrawn his or her candidacy. If this case arises, both the individual who was seeking the commission and his or her supervisor will be informed of the decision not to commission.

  2. Commissions with Pocket Credentials

    As part of the commissioning process for all individuals seeking pocket credentials, a mandatory level five public trust background investigation will be conducted. As outlined in the HHS Personnel Security/Suitability Handbook, Section 3-H Public Trust Positions, positions of public trust are "positions in which the incumbents’ actions or inactions could diminish public confidence in the integrity, efficiency, or effectiveness of assigned Government activities, whether or not actual damage occurs; and positions in which the incumbents are being entrusted with control over information which the Department has legal or contractual obligations not to divulge."

    If an individual fails to cooperate with a background investigation at any point, their request to be commissioned will be denied and both the individual and his or her supervisor will be notified. The background investigations will be completed by the FDA Office of Security Operations. Background investigations will include the following:

    1. Criminal Background Check- consists of a fingerprint set that is run through the Federal Bureau of Investigation criminal database.
    2. Credit Check- candidates must complete and submit the E-QIP form online (see exhibit 3-9). The check uses an automated system to search various major credit bureaus.
    3. An Interview with an OPM Investigator. After the criminal and credit checks have been satisfactorily completed, the candidate will be contacted by an OPM investigator for an in-person sit-down interview.
    4. A Reference Check- the candidate submits three references with contact information along with the E-QIP Initiation Form. The references are then contacted by the Office of Security Operations.
  3. Commissions with Certificates

    For all commissioned officials receiving certificates of commission only, the RFDD may decide to conduct a background investigation. If an RFDD determines that a background investigation should be conducted, the RFDD has the option of issuing the commission certificate prior to receiving the results of the investigation or waiting until the background investigation has been made. If the RFDD requires a background investigation, he/she will:

    1. independently arrange, procure and complete the background investigation prior to making the decision whether to commission the individual or
    2. request the background investigations to be completed by the Office of Security Operations.

3-3-4 - Program Areas; Commissioning Activities

  1. Program areas

    The FDA will commission a health, food, or drug official only in program areas in which the official is qualified. FDA will commission such a state or local official to act in specific program areas that correspond to the laws administered by FDA. Commissions may be obtained in the following program areas: Human Foods, Drugs, Medicated Feeds, Shellfish, Medical Devices, Radiological Health, Biologics, Cosmetics, Eggs, Tobacco, Bioterrorism, BSE Activity, Dairy, Interstate Travel Program, Methadone, Compressed Medical Gases, Pesticide Residue, and Tissue Residue.

  2. Commissioning activities

    In addition to considering the appropriate program area for an individual, FDA will also consider the scope of the activity. FDA may commission a state or local official to perform one or more of the following four activities in a specific state:

    1. Conduct examinations, inspections, and investigations.
    2. Collect samples.
    3. Copy and verify records.
    4. Receive and review official FDA documents.

    Because of their knowledge and/or training, some state or local officials may be commissioned to act in all program areas, but only for the purpose of receiving and reviewing official FDA documents.

  3. Federal officials

    The BT Act authorizes FDA to commission a federal official to act in areas "jointly regulated by the Secretary and the other Department or agency." The inter-agency MOU should include provisions to address the types of program areas covered by the commission, the extent of the four activities (listed in section 3-3-4(2)) covered by the commission, and training for those activities.

3-3-5 - Reasons for Commissioning

After review of the necessary information regarding a state or local official, an RFDD might conclude that offering a commission to a state or local government employee is in the interest of the agency. The following are examples of why FDA might decide to offer a commission to a State or local official.

  1. The official is by position, training, and/or experience a person whose advice and counsel on confidential or sensitive matters is desired on the district, regional, or national level.
  2. The official is, by position, a person who would have to review the recommendations of a commissioned subordinate in order to ensure FDA that the recommendations represent the official views of the state or local agency. Since only holders of FDA commissions can review certain FDA documents, it would be necessary that the supervisory individual be commissioned.
  3. The official is engaged in joint state/FDA investigation operations.
  4. The official is engaged in carrying out a contract issued by FDA for which the application of federal law is required for successful completion of the contract.
  5. The official requires access to FDA information on an investigation or of an otherwise confidential nature.
  6. The state or local official is performing work for FDA in which pocket credentials are required. For example, an FDA district may require samples to be collected on a routine basis from a plant that is distant from an FDA office. Therefore in order to increase FDA’s resources, a commissioned state official, located in close proximity to the plant, could pick up the samples.

3-3-6 - Contacting the Candidate

  1. General

    FDA must contact all state and local officials who have been nominated for a FDA commission before a commission is prepared. This is to ensure that the individual understands the terms and conditions attached to holding a commission and is willing to accept the commission when presented. Specific points to cover include:

    1. General description of the commissioning program.
    2. Purpose for which this particular commission is offered.
    3. The importance of maintaining confidentiality of FDA non-public information shared (see "Confidentiality" for detailed information).
    4. FDA’s expectations of the candidate.
    5. Conflict of interest safeguards and what they mean (see "Conflict of Interest" for detailed information).
    6. Proof of United States citizenship or verification as a U.S. national (individual will need to provide proof during mandatory background investigation process).
    7. Background investigations mandatory for pocket credentials and discretionary for those receiving certificates of commission only.
    8. Appreciation of the individual's willingness to serve.

    At the conclusion of this discussion, it must be clear that the individual sees no obstacle to holding a commission and will accept the commission if it is formally offered.

  2. Eligible

    If there is reasonable assurance that the state or local candidate for commissioning is eligible and will accept the commission(s), the "commissioning package" discussed in the next section will be sent to the candidate for their completion. Upon completion of the package, the candidate will then send the completed paperwork back to the regional commissioning contact. If a candidate fails to return the required documentation to the regional commissioning contact within ninety (90) calendar days, the individual shall be considered as having withdrawn his or her candidacy. Commissioning packages received after ninety (90) calendar days will not be accepted or processed and subsequently the candidate will have to reapply.

  3. Not eligible

    If FDA determines that the state or local candidate for commissioning is not eligible, a letter must be sent to the candidate and his/her supervisor informing them of the reasons for denying the commission.


Page Last Updated: 05/02/2016
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