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Form Approved: OMB No. 0910-0396

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Expiration Date: December 31, 2015

Food and Drug Administration

CERTIFICATION: FINANCIAL INTERESTS AND

ARRANGEMENTS OF CLINICAL INVESTIGATORS

TO BE COMPLETED BY APPLICANT

With respect to all covered clinical studies (or specific clinical studies listed below (if appropriate)) submitted in

support of this application, I certify to one of the statements below as appropriate. I understand that this

certification is made in compliance with 21 CFR part 54 and that for the purposes of this statement, a clinical

investigator includes the spouse and each dependent child of the investigator as defined in 21 CFR 54.2(d).

Please mark the applicable check box.

(1) As the sponsor of the submitted studies, I certify that I have not entered into any financial arrangement

with the listed clinical investigators (enter names of clinical investigators below or attach list of names to

this form) whereby the value of compensation to the investigator could be affected by the outcome of the

study as defined in 21 CFR 54.2(a). I also certify that each listed clinical investigator required to disclose

to the sponsor whether the investigator had a proprietary interest in this product or a significant equity in

the sponsor as defined in 21 CFR 54.2(b) did not disclose any such interests. I further certify that no

listed investigator was the recipient of significant payments of other sorts as defined in 21 CFR 54.2(f).

(2) As the applicant who is submitting a study or studies sponsored by a firm or party other than the

applicant, I certify that based on information obtained from the sponsor or from participating clinical

investigators, the listed clinical investigators (attach list of names to this form) did not participate in any

financial arrangement with the sponsor of a covered study whereby the value of compensation to the

investigator for conducting the study could be affected by the outcome of the study (as defined in 21

CFR 54.2(a)); had no proprietary interest in this product or significant equity interest in the sponsor of

the covered study (as defined in 21 CFR 54.2(b)); and was not the recipient of significant payments of

other sorts (as defined in 21 CFR 54.2(f)).

(3) As the applicant who is submitting a study or studies sponsored by a firm or party other than the

applicant, I certify that I have acted with due diligence to obtain from the listed clinical investigators

(attach list of names) or from the sponsor the information required under 54.4 and it was not possible to

do so. The reason why this information could not be obtained is attached.

NAME

TITLE

FIRM/ORGANIZATION

SIGNATURE

DATE (mm/dd/yyyy)

This section applies only to the requirements of the Paperwork Reduction Act of 1995.

Do NOT send your completed form to

the PRA Staff email address below.

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. Public reporting burden for this

Department of Health and Human Services

collection of information is estimated to average 1 hour per response, including time for reviewing

Food and Drug Administration

instructions, searching existing data sources, gathering and maintaining the necessary data, and

Office of Chief Information Officer

completing and reviewing the collection of information. Send comments regarding this burden estimate

PRAStaff@fda.hhs.gov

or any other aspect of this collection of information to the address to the right:

"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 number."

FORM FDA 3454 (4/13)

PSC Publishing Services (301) 443-6740

Form Fda 3454 - Certification: Financial Interests And Arrangements Of Clinical Investigators

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