(5 CFR 5501.106 - Outside Employment and Other Outside Activities)                     

General Requirements:

Employees who seek to engage in an outside activity for which advanced approval is required must submit a Form HHS 520 “Request for Approval of Outside Activity.  A HHS 520 form is also required for a revision to an existing activity if significant changes in circumstances occurred with the employee’s official duties or in the nature of the outside organization; or for a renewal of an existing activity.  All requests for approval, revision, or renewal should be made in a reasonable amount of time before beginning the activity. 

Prior approval is required for the activities in which the employee seeks to:

• Provide consultative or professional services, including service as an expert witness;
• Engage in teaching, speaking, writing, or editing that:

a) relates to the employee's official duties; or        

b) would be undertaken as a result of an invitation to engage in the activity that was extended to the employee by a person or organization that is a prohibited source;

• Provide services to a non-Federal entity as an officer, director, or board member, or as a member of a group, such as a planning commission, advisory council, edit oral board, or scientific or technical advisory board or panel, which requires the provision of advice, counsel, or consultation;
• Engage in employment or other activities including self-employment that involves the sale or promotion of products or services of any person or organization that is a prohibited source.

Prior approval is not required for participation in a political, religious, social, fraternal, or recreational organization, unless the position requires the provision of professional services or the activity is performed for compensation.

Due Date:       An approved Form HHS 520, Request for Approval of Outside Activity is required prior to participating in certain outside activities and outside employment.  A reasonable amount of time should be allowed for an adequate review by Agency reviewing officials and review by the designated Agency approving official.  The term “reasonable” is not defined, however, 4 weeks is a good “rule of thumb.”

Submit To:     After completing Parts I, II and III of the form, employees should provide the form to their supervisor to complete Part IV.  The supervisor, upon completion of their review, will submit the form to the Center or Deputy Center Director to complete Part V (p. 8 Management/Committee/Other Reviewer). Please ensure both the Supervisor and whomever completes Part V provides a comment along with their signature.

(For Office of the Commissioner employees, the Office Director completes Part V.  For Office of Regulatory Affairs (field) employees, the District Director (DD), Acting District Director, or Regional Food Drug Director (RFDD) completes Part V.  Note: The Lab Director or The Director of Investigations Branch is not authorized to sign for any of the persons listed above unless in an official acting capacity. 

At Headquarters, the Associate Commissioner for Regulatory Affairs signs Part V.  The HHS 520 form should not be forwarded to the Associate Commissioner for Regulatory Affairs from the field unless the request for approval is for the RFDD or the DD.)

Note:  Parts IV and V must be completed before the form is submitted to the Ethics and Integrity Staff.

Definitions:   

* Teaching, speaking or writing relates to the employee's official duties if:

1. The activity is undertaken as part of the employee's official duties;
2. The circumstances indicate that the invitation to engage in the activity was extended to the employee primarily because of his official position rather than his expertise on the particular subject matter;
3. The invitation to engage in the activity or the offer of compensation for the activity was extended to the employee, directly or indirectly, by a person who has interests that may be affected substantially by performance or nonperformance of the employee's official duties;
4. The information conveyed through the activity draws substantially on ideas or official data that are nonpublic information as defined in 5 CFR 2635.703(b); or
5. The subject of the activity deals in significant part with:

a)  Any matter to which the employee presently is assigned or to which the employee had been assigned during the previous one-year period;

b) Any ongoing or announced policy, program or operation of the agency; or

c) In the case of a non-career employee (defined in Sec. 2636.303(a)) the general subject matter area, industry, or economic sector primarily affected by the programs and operations of his agency.             

* Prohibited source means any person who:

1. Is seeking official action by the employee's agency;
2. Does business or seeks to do business with the employee's agency;
3. Conducts activities regulated by the employee's agency;
4. Has interests that may be substantially affected by performance or nonperformance of the employee's official duties; or
5. Is an organization a majority of whose members are described in (1) through (4) above.

* Professional services means the provision of personal services by an employee, including the rendering of advice or consultation, which involves the skills of a profession as defined in 5 CFR 2636.305(b)(1).

* Consultative services means the provision of personal services by an employee, including the rendering of advice or consultation, which requires advanced knowledge in a field of science or learning customarily acquired by a course of specialized instruction and study in an institution of higher education, hospital, or other similar facility.

Obtaining a Form HHS 520:

Form HHS 520 can be accessed on the FDA Ethics and Integrity Staff intranet site (refer to link at bottom of page.)  Please note that the January 2006 version of the HHS 520 form must be used.  All previous versions are obsolete.

Instructions for Completing the Form HHS 520:

Page 1:

Check the relevant box to indicate the type of request:

• Initial Request
• Revised Request
• Renewal           

Date Filed:  Enter the date the form was submitted to you supervisor. 

I.  Employee Information

1. Employee’s Name: Enter your name (Last, First, Middle)
2. Agency: FDA

       Operating/Staff Division:   Example: CDER (including mail code)

       Subcomponent:   Example: DTD (Division of Training and Development) 

  3. Title of Position:  Enter the title of your official position.

  4. Grade/Step: Enter your grade and step: Example: GS, CC, SBRS, SES, AD                      

  5. Federal Salary: Enter the amount of your federal salary including specialty pay.

  6.  Check the relevant box to indicate your appointment type:

• PAS/PA = Presidential Appointee Senate Confirmed/Presidential Appointee
• Non-Career SES
• Schedule C
• Career SES: applies to Senior Executive Service appointees
• General Schedule: GS
• Title 42: SBRS, AD
• Commissioned Corps
• Other: indicate the appointment type if none of the above fit

  7. Financial Disclosure Filing Status: Indicate which financial disclosure form you are required to file (Public SES level SF-278 or Confidential OGE form 450), or “NONE” if you do not file a financial disclosure report.

  8. Office Address: Provide complete address.

  9. Office Contact Information: Provide complete information.  If you have nothing to report in any block, please indicate “None,” or “N/A.”

  10. Name of immediate supervisor: Provide name of supervisor.

  11. Title of supervisor: Enter the title of your immediate supervisor.

  12. Supervisor Contact Information: Provide complete information on how to contact

            your supervisor.  If no information is available, please indicate “None,” or “N/A”

 II. Outside Activity Information

1. Nature of Activity Information:  Check the relevant box to indicate the type of activity for which you are requesting approval and provide a detailed description of the activity to be performed. There should be sufficient detail in the description as to what the outside activity involves. 

If you are participating in a “Self-Employed Activity”, check the appropriate box and estimate the total number of clients, patients, customers, or persons to whom you would provide services.

If you check the box for “Teaching, Speaking, Writing or Editing”, you must:

a)  Check the “subject matter of activity” box and provide a syllabus, draft, or similar description of the content involved in the course, speech, or written product.

b) Check the “Text of Disclaimer” box and insert the proposed text of any disclaimer that indicates that the views expressed do not necessarily represent those of the Food and Drug Administration or the Federal government.”

  2. Outside Employer or Other Entity: 

Outside Entity Name:  List complete name

Contact Person: List name and title of contact person. If you are self-employed, provide your contact information.

  3. Outside Entity Address: Provide complete address.

  4. Contact Information: Provide complete information on how to contact outside employer or outside entity.  If no information is available foe any one block, please indicate “None,” or “N/A.” 

  5. Location: List where the activity will actually be taking place. 

  6. Travel:  Check the relevant box to indicate whether travel is involved. Use the space below to include the additional information requested. 

  7. Time: Respond to each question from a. through c. 

 a) The period covered should not exceed one year from the date of approval.  The date of approval is the date that the FDA Approving Official signs the form indicating that the activity is approved. 

 b) Estimate the time you will devote to the activity including the hours per day, days per week and weeks per year.  This information must be provided.

 c) Check the relevant box to indicate when the activity will be performed. If the work will not be performed entirely outside of normal working hours, you must explain what kind of leave will be taken.  Because the activity will be performed in your private capacity, official time may not be used to carry out any portion of the activity.

  8. Compensation: Indicate whether compensation will be received by checking “yes,” or “no.”  If compensation will be received, you must complete sections 8a through 8f.  If you will not be compensated, please check “no” in box 8 and proceed to 8e.

a) Check all the boxes that describe the method or basis of compensation

b) Provide an amount or description of the total amount of compensation that is anticipated.  If none, state so.

c) Identify the payor and provide an explanation if any compensation will be received from a payor other than the outside entity listed in Question 2.  If none, state so.

d) Indicate whether any compensation will be derived from an HHS grant, contract agreement, or other source of HHS funding or if the services to be performed are related to an activity funded by HHS.  If you are not receiving compensation, answer may be “None.” HHS employees can not, for compensation, engage in employment, as defined in 5 CFR 2635.603(a), with respect to a particular activity funded by an HHS grant, contract, cooperative agreement, cooperative research and development agreement, or other funding mechanism authorized by statute.

e) For activities involving the provision of consultative or professional services, indicate whether the outside entity intends to seek an HHS grant, contract, cooperative agreement or other funding relationship.  If the answer is “Yes”, you must provide a description.

f) Provide all information of prior compensation from the same outside entity for the last six years. If there is no record or prior compensation, answer may be “none.”

III.  Official Duty Information

1. Nature of Official Duties:  In the space provided describe the duties and responsibilities of your FDA position.  You may attach your FDA Position Description in lieu of providing a written description of your official duties. 
2. Relationship to Official Duties to Outside Activity:  Use the space provided to describe how your outside activity relates to your official duties at FDA.  If there is no relationship, please provide an explanation.  Simply indicating “None” is not sufficient. 
3. Effect of Official on Outside Employer:  Use the space provided to describe how your official FDA duties might or might not affect the person or organization for which the proposed activity will be performed.  If the answer is none, you must explain why. 
4. Assignments Involving Outside Employer: Use the space provided to describe any other interactions between your official FDA duties and the outside activity that have already occurred.  If the answer is none, you must explain why.
5. Certification:  By signing you are indicating that you have read the notices in Part VIII and that the statements you have made are correct to the best of your knowledge.

Once the form is completed and signed, forward the Form HHS 520 to your supervisor. It is your responsibility to ensure that the form reaches the appropriate individuals for sign-off and approval.  You should not participate in the outside activity until you receive notification from the Ethics and Integrity Staff that your form has been approved.  

IV.  Supervisor Review:  This part is to be completed by the requesting employee’s immediate supervisor. 

1. Read the Summary of Applicable Law. 
2. Review the report and any additional information provided by the requesting employee.  You must provide a statement indicating how the requesting employee’s official duties are related to the outside activity.  For example, “Employee’s official FDA duties do not relate to the proposed outside activity and will have no impact on the interests of the outside entity.”
3. Mark the appropriate box indicating that you recommend approval or disapproval.  Sign and date the form. 
4. The form should be forwarded to the Center Director not to the Ethics and Integrity Staff. (If the employee is in the Office of the Commissioner (OC), the form should be forwarded to the employee’s Office Director.   If the employee is in the Office of Regulatory Affairs (ORA), the form should be forwarded to the employee’s District Director, Acting District Director, or Regional Food Director.)  

V. Management/Committee/Other Intermediate Review:  This part is to be completed by the appropriate reviewing official (see #4 above)

1. Name of reviewer:  Center Director or OC/ORA reviewing official  
2. Title of reviewer:  Provide official title
3. Center Director Contact Information:  Must provide all information.  If there is no information for any block, please indicate “N/A,” or “None.”
4. Organization:  Provide name of Center and operating component.
5. Committee: Not Applicable.
6. Review:  Review the employee’s statements and indicate whether you concur with the supervisor’s recommendation.  Check the appropriate box – “concur” or “non-concur.”
7. Comments: A statement must be provided explaining your reason(s) for concurrence or non-concurrence with the supervisor's recommendation. For example, “I agree with the supervisor’s recommendation that the proposed activity does not conflict with the employee’s official duties.”
8. Forward the completed Form HHS 520 to the Ethics and Integrity Staff at the following email address: FDA_Outside_Activity@fda.hhs.gov.
9. Note:  Employees who submit a Form HHS 520 for an outside employment or outside activity are also subject to the annual requirement to complete Form HHS 521 “Annual Report of Outside Employment or Activities.” (5 CFR 5502.102)  This form is due on or before February 28 of each year and requires information concerning all activities that were approved or undertaken in the previous calendar year.

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