Conflict of Interest Form

Form Approved: OMB No. 0910-XXXX, Expiration Date: Month XX, 20XX. See PRA Statement at End of Form

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Collection Form
Report of Financial Interests and
Other Relationships for Non-Employee Scientists at FDA
New Entrant
Renewal

Start Date:

Date Report Filed:

NON- EMPLOYEE SCIENTIST INFORMATION
1.

NAME ( Last, First, MI)

2.

Center:

3. Office:

4. Division:

5. Non- Employee Program:
ORISE
Other

Guest Scientist

Traineeship

(provide program name)

_________________________________________________________
6.

Office Address

7.

City

10. Office Telephone

8. State

9. Zip Code

11. FAX

12. Cell

17. Mentor’s/Sponsor’s FAX

18. Mentor’s/Sponsor’s Cell

13. Email

14. Name of Mentor/Sponsor (Last, First, MI):

15. Title of Mentor/Sponsor:

16. Mentor’s/Sponsor’s Telephone

19. Mentor’s/Sponsor’s email:

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II. FINANCIAL INTERESTS AND OTHER RELATIONSHIPS
As a condition of starting at FDA, you are required to submit the following information, to the best of your knowledge, and
provide follow-up information to your Center and/or FDA, as necessary. You will be required to complete this form as part of your
onboarding orientation at FDA with annual follow -up during your time at the agency.
For you, your spouse and your minor children, report all financial interests, such as stocks, bonds, stock options and other investments
or ownership interests, in significantly regulated organizations (SROs) that you held as of the date that you entered with or were
assigned to FDA. The term “significantly regulated organization (SRO),”
( https://www.fda.gov/AboutFDA/WorkingatFDA/Ethics/ucm079482.htm ) means an organization for which the sales of products
regulated by the FDA constitute ten percent or more of annual gross sales in the organization’s previous fiscal year. Where an
organization does not have a record of sales of FDA-regulated products, it will be deemed to be significantly regulated if its operations
are predominately in fields regulated by FDA, or if its research, development, or other business activities are reasonably expected to
result in the development of products that are regulated by FDA.
In addition, for you, your spouse and your minor children, report all interests in investments funds that have a stated a policy or practice
of investing in companies that are SROs. The most common examples of such funds are mutual funds or ETFs that invest in a range
of sectors ( https://www.fda.gov/AboutFDA/WorkingatFDA/Ethics/ucm527948.htm ).
Consult your Mentor/Sponsor for assistance in identifying companies in the food, beverage, cosmetics, biotechnology, pharmaceutical,
medical device, and related industries and any other organizations that are significantly regulated. A listing of SROs can be found at:
https://www.fda.gov/about-fda/ethics/prohibited-financial-interests-fda-employees
Describe the financial interest and indicate the type of investment. If the interest was acquired as a form of compensation or
other benefit derived from prior or current employment with an SRO, check the employee benefit (EB) column. Check the
column that indicates the value, and specify whether the financial interest is owned individually ( I ), by your spouse (S), or minor
child(ren) (MC),or jointly (J ). If held jointly with a spouse, minor child(ren), or others (0), indicate the co-owner(s), for example,
J/S,J/MC, or J/O.
Note: If you acquire an interest in an SRO, a prohibited mutual fund, a privately held SRO or a mutual fund consisting of
privately held SROs, after you have started at FDA, but before your annual review of the iss ues addressed in this form, you are
required to report this information using this form to your Mentor/Sponsor within 30 days of acquiring the interest.

If none, check this box.

Description

Type ofInvestment

Example: Zyzex
Pharmaceucticals

Bonds

Example:MedicalProducts
TechnologyCo

CommonStockin401(k)pension
fromprioremployment

EB

Value
$15,000 or
less

Value Over
$15,000

X
X

2

I/S./J/MC/O

S
X

I

Description

Type ofInvestment

Example: Zyzex
Pharmaceucticals

Bonds

Example:MedicalProducts
TechnologyCo

CommonStockin401(k)pension
fromprioremployment

EB

Value
$15,000 or
less

Value Over
$15,000

X
X

3

I/S./J/MC/O

S
X

I

llI. OTHER RELATIONSHIPS AND INTERESTS

Please indicate and report the following for yourself, your spouse, and/or your minor child(ren):
• An employment relationship with an SRO, including business ownership, employment, service as officer,
director, trustee; and/or,
• service as consultant to an SRO; and/or,
• proprietary interest(s) in one or more product(s) regulated by FDA, including patent, trademark, copyright, or
licensing agreement and/or,
• Other interest (please describe).

If none, check this box.
Note: If you begin an employment relationship with and/or service as a consultant to an SRO or acquire proprietary interest(s) in
one or more products regulated by FDA, including patent, trademark, copyright or licensing agreement and/or other interest, after
you have started at FDA, but before your annual review of the issues addressed in this form you are required to report this
information using this form to your Mentor/Sponsor within 30 days of beginning the relationship or acquiring the interest.

Name of Organization

Description

Owner of

Date Interest

Date Interest

of Interest or

Interest

Acquired or

Acquired or

Relationship

(Indicate

Relationship

Relationship

l/S/J/MC/O)

Started

Terminated

A.

B.

C.

D.

E.

F.

G.

H.

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Signature

Date

Printed Name

Annual Review

If there are no changes, then certify below. If there are changes, then complete a new form.

Signature

Date

Printed Name

Signature

Date

Printed Name

Signature

Date

Printed Name

Signature

Date

Printed Name

Signature

Date

Printed Name

Signature

Date

Printed Name

PRIVACY ACT STATEMENT
Authority: The information
collected in this form is provided
to comply with the Privacy Act of
1974 (P.L. 93-579) for individuals
seeking non-employee student,
post-graduate or senior scientist
training opportunities from the
Food and Drug Administration.
Purpose and Uses: All
information collected in this form
is required to determine if there
is potential conflict of interest
with FDA assignments.
Completed forms are used by
the FDA Mentor and Ethics Staff
to determine if there is conflict of
interest. Information is also
shared with the FDA personnel
authorized to administer the
program.
Effects of nondisclosure:
Disclosure of the information is
voluntary; however, collection of
this information is necessary to
continue with the FDA
This section applies only to requirements of the Paperwork Reduction Act of 1995.
*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW. *

The burden time for this collection of information is estimated to average 60 minutes per response, including the time
to review instructions, search existing data sources, gather and maintain the data needed and complete and review the
collection of information. Send comments regarding this burden estimate or any other aspect of this information
collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Operations Paperwork Reduction
Act (PRA) Staff, [email protected].
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a
currently valid OMB control number."

LEGAL AND ETHICS REQUIREMENTS
The information collected in this form is in compliance with section 746(b) of the Food, Drug and Cosmetic Act.

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