Skip page top navigationFDA Logo--links to FDA home page Logo of and Link to start page of Office of Regulatory Affairs, U.S. Food and Drug Administration U.S. Food and Drug Administration Office of Regulatory Affairs HHS Logo and link to Department of Health and Human Services website

FDA Home Page | Compliance | Federal-State | Inspection | Import Program | Science Ref | ORA Search  Vignette Managed Content: Click here for Metadata

Compliance References
Regulatory Procedures Manual 2008
Previous Page | Document TOC | Chapter TOC | Next Page

     3-3-1 - Initiating the Process
     3-3-2 - Qualification; Eligibility
     3-3-3 - Background Check
     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 DFSR.  Recommendations from the field offices should be sent to the RFDDs through district directors. Recommendations from the state or local program should be sent to the RFDDs through the director of state programs.  The commissioning of Federal officials generally begins at the time specified in the MOU that FDA and the other agency signs.
  2. “Streamlined” procedure for commissioning state or local officials
    In a contract situation, FDA may rely on a variation of streamlining that, in part, depends on the state agency head certification that the state or local official:
    1. met the requirements the state has established to credential its own official to carry out state government regulatory or enforcement responsibilities; and,
    2. has provided written assurances regarding conflict of interest and prohibited financial interests, and maintaining the confidentiality of non-public information provided.

Page Top

3-3-2 - Qualification; Eligibility

The RFDD determines the eligibility of a state or local official for a commission.

  1. State and local agency heads
    FDA considers all agency heads of state regulatory agencies appointed by the governor of the state to be qualified and eligible for commissioning. Agency heads of state regulatory agencies not appointed directly by the governor, and agency heads of local agencies are eligible to receive a commission if they are qualified.  Factors include the individual's educational achievements, subsequent training, and career experience. 

    FDA usually suggests that the head of the agency in which one or more officials will be or currently are commissioned by FDA, also hold a FDA commission.  This is advisable, but not mandatory, to avoid any situations in which a commissioned official refuses to share with their non-commissioned supervisor, confidential information obtained under their commission.  If the agency head declines to accept a FDA commission, the deputy commissioner, center director, etc., may be designated by the agency head to act in his place when a commissioning issue arises.  If this is not possible, FDA may commission one or more of the operating personnel but this would be infrequent and would be done only if needed to achieve program goals.
  2. Other 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 a curriculum vitae (CV) (see Exhibit 3-1 for examples of questions usually answered by information recorded on a CV).  Factors include:
    1. the recommendation of the head of the agency in which the individual works;
    2. the training and experience of the candidate; and,
    3. reports of appropriate FDA field personnel and State Program Specialists who have worked with the candidate.
  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. 

Page Top

3-3-3 - Background Check

  1. General
    FDA will not commission any official, if FDA determines that there is conflict of interest regarding that individual. Commissioned officials must be citizens of the United States. For Federal officials, the MOU may contain provisions about a background check.  FDA, in its discretion, may conduct a background check on a state or local government official, as described below.
  2. State or local officials
    Prior to commissioning, in the unusual event that a state or local official has not had a background check by his or her own agency, the RFDD may decide: 
    1. not to offer a commission;
    2. to offer a commission on the basis of other information on the candidate; or,
    3. to require a background check.

    If FDA decides to conduct a background check, the RFDD or other designated official should inform the state or local official of FDA’s authority to conduct that activity.

If an RFDD determines that a background check should be made, the RFDD has the option of issuing the commission prior to receiving the results of the check, or waiting until the background check has been made. If the RFDD requires a background check, he/she will compile a package of all information gathered on the candidate, including the candidate’s CV, and send it to DFSR, which will obtain the background check through the Office of the Inspector General of the Department.

Obtaining an FDA commission is a privilege FDA extends to a select and limited number of regulatory officials.  If the candidate objects to the process, or challenges the right to make such a check, FDA considers the individual as having withdrawn his or her candidacy and FDA will not conduct the background check.

Page Top

3-3-4 - Program Areas; Commissioning Activities

  1. Program areas
    The FDA will commission a government official only in program areas in which the official is qualified.  FDA will commission a state or local official to act in specific program areas that correspond to the laws administered by FDA.  Program areas may include the following:  Foods, Drugs, Medicated Feeds, Shellfish, Medical Devices, Radiological Health, Biologics, and Cosmetics.

  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 and obtain samples;
    3. Copy and verify records; and,
    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 (Activity d). 

  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 MOU should include provisions to address the types of program areas covered by the commission, the extent of the four activities covered by the commission, and training for those activities.

Page Top

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 examples are some reasons why FDA might decide to offer a commission to a State or local official:

  1. The individual 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 individual 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 individual is engaged in joint state/FDA investigation operations. 

  4. The individual 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. It is necessary to have access to FDA information of an investigation or otherwise confidential nature.

  6. The state or local official is helping FDA in a special manner for which FDA credentials are required. For example, an FDA district may require samples to be collected on a routine basis from a plant that is located about a half-day's journey from the closest FDA post. However, a state employee, located near the plant, could, if commissioned, pick up the samples at a tremendous savings in time and money to FDA (it is assumed that FDA would make arrangements for this with the state agency that are satisfactory to that agency). 

Page Top

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. The requirement of American citizenship;
    7. FDA’s right to conduct a background check at any time; and,
    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 when 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 packets" discussed in the next section may be prepared in advance and brought to the meeting. The FDA official may remain and be available to answer questions while the forms in the commission package that have to be returned to FDA are filled out and handed back. 

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

Page Top

Previous Page |Document TOC | Chapter TOC | Next Page