Form 3454 FDA Form 3454

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Form Approved: OMB No. 0910-0396
Expiration Date: December 31, 2015

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.

Clinical Investigators

(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

This section applies only to the requirements of the Paperwork Reduction Act of 1995.
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
collection of information is estimated to average 1 hour per response, including time for reviewing
instructions, searching existing data sources, gathering and maintaining the necessary data, and
completing and reviewing the collection of information. Send comments regarding this burden estimate
or any other aspect of this collection of information to the address to the right:

DATE (mm/dd/yyyy)

Do NOT send your completed form to
the PRA Staff email address below.
Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer
PRAStaff@fda.hhs.gov

"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)

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