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To be completed by the FDA Principal Investigator

I. General Information (Use attachments if needed)

CRADA Title CRADA Number


Collaborating Organization(s)


II. Financial Interest Statement

A "financial interest" is any thing of monetary value which may be directly or predictably affected by the official action of an employee. There is no minimum amount of value or control that constitutes a financial interest. Financial Interest includes holdings of your spouse and dependent child/children. Normally, "financial interest" includes, salaries, stocks, and bonds but not royalties from inventions licensed by the Government.

To the best of your knowledge do any of the following persons or institutions have a financial interest in the collaborating organization(s)?

YES NO You, Your Spouse or Your Minor Child(ren)

YES NO An organization in which you serve as an officer, director, trustee, partner or employee

YES NO A person or organization with which you are negotiating for prospective employment or have an arrangement for prospective employment

If you answered "YES" to any of the above: Has a waiver of the financial interest been approved by the Division of Ethics and Labor Management Relations? Please attach a copy of the approved waiver to this Statement.


III. Appearance of Conflict of Interest Statement (Use attachments if needed)

YES NO Were you previously involved in an approved outside work activity with the proposed collaborator(s)?

 If YES: What was the nature of the activity? _________________________________________

When did the activity end? _______________________________________________

YES NO Are you involved in decisions to fund grants, cooperative agreements or contracts?

If YES: With what organizations? _________________________________________

What has been the nature of your involvement?

YES NO Are you responsible for any regulatory activities regarding the collaborator’s products or other companies’ similar type products?

 If YES, please explain. ___________________________________________________________



IV. Collaborator Selection (Use attachments if needed)

Approximately when did you begin negotiating a CRADA with the proposed collaborator(s)?

YES NO Have you had any past or present CRADAs with the proposed collaborator(s)?

If yes, please give CRADA titles, CRADA numbers and period of collaboration?

Why was the proposed collaborator(s) selected? (Describe all that apply).

YES Previous or ongoing informal collaboration since (date)

YES Unique technology (DESCRIBE)

YES Unique expertise (DESCRIBE)

YES Unique materials/equipment (DESCRIBE)

YES Unique facilities (DESCRIBE)

YES Government invention licensed to Collaborator (DESCRIBE)


NOTE: If the Collaborator is a foreign company, attach an additional paragraph identifying what other domestic companies that might have been interested in the CRADA project and explaining why this Collaborator was selected to be the CRADA partner.

If it was announced publicly, was the proposed CRADA project advertised in:

YES A PHS Technology Transfer Forum? YES The Federal Register?

YES PHS Technology Transfer Directory? YES Other? (specify)


FDA Principal Investigator’s Signature _______________________________ Date

I have reviewed the information provided and made the following determination:

YES NO Conflict noted

YES NO Conflict satisfactorily resolved

YES NO Further action needs to be taken to resolve conflict (see attached comments).


FDA Ethics Official Review

(July 9, 1998)

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