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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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3-5 - CONFLICT OF INTEREST

3-5 - CONFLICT OF INTEREST
     3-5-1 - Written Assurances
     3-5-2 - Conflict of Interest Considerations Before Commissioning
     3-5-3 - Conflict of Interest Considerations After Commissioning

 3-5 - CONFLICT OF INTEREST

 3-5-1 - Written Assurances

  1. State or local officials
    State or local officials seeking commissioning and Commissioned Officials considered for renewal are asked to attest in writing, e.g., through the Acceptance of the Commission form (Exhibit 3-2), that they do not have certain personal financial interests or financial or business relationships with firms operating in the specific fields where authority would be granted to the official under the Commission.
  2. Federal officials
    For Federal officials, the governing MOU may contain provisions about the conflict of interest standard, e.g., the standard that is imposed by that other Federal agency.

 3-5-2 - Conflict of Interest Considerations Before Commissioning

  1. General
    FDA will not commission any official if he/she is determined to have a conflict of interest. All issues affecting candidate's financial interests must be resolved prior to granting a commission.
  2. State or local officials
    A state or local government employee recommended for a commission may discuss questions about the conflict of interest with his/her sponsoring FDA official. If the candidate becomes aware of a potential financial interest that would affect participation under the FDA Commissioning Program, the sponsoring FDA official will summarize the issues and submit them along with other documentation to the FDA Regional Office and the Office of Partnerships for resolution. The Office of Partnerships will discuss the matter with the RFDD and a decision will be reached as to whether or not the individual can be commissioned. The Office of Partnerships may contact the FDA's Ethics and Integrity Staff (HFA-320). This discussion should be conducted in person by the RFDD in the case of a state agency head. If circumstances make this impractical, a district director, director of state programs, or deputy regional director may make a visit for this purpose for intergovernmental affairs. Agency heads who are already familiar with the program and for whom this information need not be duplicated may be contacted by telephone to get the assurance that the commission, when offered, will be accepted.

    In the case of a program director or a subordinate official, a district director, deputy regional director for intergovernmental affairs, or the director of state programs should conduct this discussion. However, in situations where the commissioning program is ongoing and well understood by the program director, the discussion may be held with a supervisory investigator with whom the program director already works. Since it is not always practical to meet with each subordinate, the program director may vouch for his or her subordinate.

 3-5-3 - Conflict of Interest Considerations After Commissioning

  1. General
    The FDA commissioned official must remain free from financial interests that may affect the specified authorities in the FDA commission. If the official acquires a financial interest after receiving a commission, he/she must notify FDA and not participate in any assignment related to the financial interest. 
  2. State or local officials
    For state and local officials, if problems arise about conflict of interest, the sponsoring FDA official will summarize the issues and submit them along with other documentation to the FDA Regional Office and the Office of Partnerships for resolution. If problems arise about the commissioned status of any official, FDA's resolution may range from disqualification from participating in any commission related activities pertaining to the firm, to revocation of the commission and return of the FDA pocket credentials. If FDA determines that the problem is resolved, it may consider commissioning the official again.