In 2005, HHS addressed concerns over conflicting outside activities by making substantial amendments to strengthen the HHS Supplemental Ethics Standards. For activities requiring prior approval, the rules state that before undertaking the outside activity an affirmative determination must be made that the activity will not involve conduct prohibited by statute or regulation.
The outside employment prohibitions and the prior approval requirements apply to all employees of the Department with the exception of Special Government Employees (SGE). Here are some frequently asked questions and answers on this topic:
The important reason for these rules is to prevent conflicts of interest between your outside activities and your official duties and to ensure that you are acting, and being seen to act, solely in the public interest and without divided loyalties. It is critical that the public has total confidence that your actions and decisions for FDA are not influenced by your private interests.
The foundation for the rules on outside activities can be found among the fundamental Principles of Ethical Conduct, including the following two principles which are particularly pertinent:
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You often do need approval for the outside activity, but not in all cases. If approval is required, it must be granted BEFORE you engage in the activity. Ask the following questions:
Is the activity professional or consultative in nature (see question 3), or have you been asked to serve as an expert witness?
Does the activity involve teaching, speaking, writing, or editing about, or related to, your government duties, or about any topic if the invitation to teach, speak, or write comes from a prohibited source (see question 4) of your agency?
Are you providing services to a non-Federal entity as an officer, director, or board member, or as a member of a group (e.g., editorial board, advisory group, or other position requiring that you provide advice, counsel, or consultation)?
Are you engaged in outside employment with any prohibited source of FDA (as defined in Question 4, below)?
If you answered "yes" to any of these questions, then you must seek prior approval through your supervisor and obtain permission from an authorized agency designee before undertaking the activity.
Professional or Consultative in Nature
This means that you are providing advice, consultation or other services using the skills of a profession requiring specialized knowledge. This customarily requires a course of specialized instruction in an institution of higher education or other similar facility. An example of an activity that is not professional or consultative would be working as a sales associate in a retail establishment. Working as an accountant is an example of a professional activity. Where it is a close call, seek the advice of ethics officials.
A prohibited source is a person, company, or organization that (1) is seeking official action by the FDA, (2) does business, or seeks to do business, with the FDA, (3) conducts activities regulated by the FDA, (4) has interests that may be substantially affected by the performance or nonperformance of your official duties, or (5) is an organization a majority of whose members are described in this definition.
Exceptions regarding Prior Approval
Yes. You do not need prior approval if you are participating in the activities of a political, religious, social, fraternal, or recreational organization, unless the position requires the provision of professional services or the activity is performed for compensation other than the reimbursement of expenses. For example, you can be an active member, including board or committee service, for a hiking club or sports team, organizations such as the Lions, Jaycees, or Optimists, or your church, temple, or mosque without approval.
The Department's chief ethics officer, the Designated Agency Ethics Official (DAEO), may exempt other activities from the prior approval requirement. The DAEO has exempted the following activities from the prior approval requirement:
Service as an Officer, Director, Board or Advisory Group Member of a Condominium Association or Similar Organization (DAEO 98-2
You must complete Parts I, II, and III of the HHS 520
"Request for Approval of Outside Activity" form. You must then sign and submit it, electronically if possible, to your supervisor who must complete Part IV. Your Center’s DECPOC will review the form and help obtain Center approval in Part V.
A DEI Ethics Specialist will review your HHS 520 for completeness and draft you specific guidance depending upon the activity you intend to perform. The agency designee will approve your activity, subject to certain conditions. Before completing the HHS 520 form, please review the Instructions for FDA Employees Completing HHS 520
to ensure that you are providing all the information necessary for FDA to review your request.
You and your supervisor will receive a copy of the approved HHS 520 via email with guidance that describes certain conditions to the approved activity. In situations where the activity is denied, you will be provided specific reasons why it was denied.
Please remember that the approval is effective for only one year. If you want to continue the activity, you have to renew your request for approval no later than 30 days prior to the expiration of the period authorized.
You must complete Parts I and II of the HHS 521 and sign and submit it, electronically if possible, to your supervisor. Your supervisor must complete and sign Part III and will provide you instructions on any necessary corrective actions. Please then contact your Center’s DEC POC
who can help you obtain Center approval in Part IV, if required by your Center. Once you have obtained the required signatures, please email the form to DEI at: FDA_Outside_Activity@fda.hhs.gov
A DEI Ethics Specialist will review your HHS 521 and any corrective actions provided by your supervisor and will transmit the approved form to you and your supervisor. If there are any corrective actions, DEI and your supervisor will provide you additional counseling.
An outside activity is not permissible if it conflicts with your official duties. An activity conflicts with official duties if (1) it is prohibited by statute or an agency supplemental regulation, or (2) would require you to be removed from matters so central or critical to the performance of your official duties that your ability to perform the duties of your position would be materially impaired.
Two important categories of activities are never allowed for any HHS employee:
Providing compensated assistance in the preparation of grant applications, contract proposals, program reports, or other documents intended for submission by outside entities to HHS.
Working for pay in particular activities funded by HHS.
Since HHS funds flow out to such a wide variety of projects, it is important to be alert to this restriction and to be sure that the funding source for your specific activity is not HHS.
HHS Supplemental Standards of Conduct provide additional prohibitions for two categories of FDA employees.
FDA employees who are either public or confidential financial disclosure report filers may not:
Engage in self-employment where the sale or promotion of FDA regulated products accounts for ten percent or more of gross annual sales; OR
the employment involves the practice of medicine, dentistry, pharmacy, or similar practices and does not involve substantial unrelated non-professional duties, and does not involve employment by a medical product manufacturer in the conduct of biomedical research; OR
employment involves manual or unskilled labor or utilizes talents, skills or interests in areas unrelated to the substantive programmatic activities of the FDA, such as clerical work or retail sales.
OCC attorneys cannot practice law where the outside activity, in fact or in appearance, may require the assertion of a legal position that conflicts with the interests of the Department. The attorney also may not practice law where he might be required to interpret a statute, regulation, or rule administered by the Department.
It might be possible to resolve the conflict by removing yourself from any involvement at FDA with activities that affect the outside entity (known as recusal or disqualification).
Length of Approval for Activity
The approval is effective for one year. If you want to continue the activity, you have to renew your request for approval no later than 30 days prior to the expiration of the period authorized.
Self-monitoring is an important part of the outside activities rules as well as other ethics rules. If either the nature of the outside activity or your official duties change in significant ways, you must submit a revised request for approval using the regular procedures. Because of the changed circumstances, you might have a conflict of interest now where none previously existed.
Also, if the outside company that you are working for or the organization you consult with undergoes a substantial change, you might now have a conflict of interest. For example, the company might come up with a new product that is regulated by HHS, or the organization might seek a grant from the Department, where before there was no connection at all.
Definitely. You still must abide by all applicable laws governing employee conduct. Approval simply indicates that the general activity is unlikely to pose ethical concerns. During the course of an otherwise approvable activity, situations may arise, or actions may be contemplated, that, nevertheless, pose ethical concerns.
There is also a reporting requirement that recaps the outside activities you performed each year. In addition to the HHS Form 520, you must submit an annual report on all activities approved or undertaken during a calendar year using the HHS Form 521
, Annual Report of Outside Activity. This report, which concerns activities undertaken in the previous year, is due by February 28.
You should first contact the Deputy Ethics Counselor Point of Contact (DECPOC) . If you have any questions about guidance that you received from DEI regarding an outside activity that you submitted, please contact FDAEthics_Advice@fda.hhs.gov
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