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<td colspan="11" rowspan="2"><p
id="department-of-health-and-human-services" class="heading">DEPARTMENT
OF HEALTH AND HUMAN SERVICES</p>
<p>Food and Drug Administration</p>
<p id="certification-financial-interests-and"
class="heading">CERTIFICATION: FINANCIAL INTERESTS AND</p>
<h5 id="arrangements-of-clinical-investigators">ARRANGEMENTS OF CLINICAL
INVESTIGATORS</h5></td>
<td colspan="4"><p><strong>Form Approved: OMB No. 0910-0396</strong></p>
<p><strong>Expiration Date: April 30, 2009.</strong></p></td>
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<td colspan="4">     </td>
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<td colspan="15"><p id="to-be-completed-by-applicant" class="heading">TO
BE COMPLETED BY APPLICANT</p></td>
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<td colspan="15"><blockquote>
<p>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).</p>
</blockquote></td>
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<td colspan="4"></td>
<td colspan="5"><em>Please mark the applicable checkbox.</em></td>
<td colspan="6"></td>
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<td colspan="15"><blockquote>
<p> (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).</p>
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<td colspan="2" rowspan="3"></td>
<td rowspan="3">Clinical Investigators</td>
<td colspan="4">     </td>
<td colspan="7">     </td>
<td rowspan="3"></td>
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<td colspan="4">     </td>
<td colspan="7">     </td>
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<td colspan="4">     </td>
<td colspan="7">     </td>
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<td colspan="15"><blockquote>
<p> (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)).</p>
<p> (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.</p>
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<td></td>
<td colspan="5">NAME</td>
<td colspan="8">TITLE</td>
<td></td>
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<td></td>
<td colspan="5">     </td>
<td colspan="8">     </td>
<td></td>
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<td></td>
<td colspan="13">FIRM / ORGANIZATION</td>
<td></td>
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<td></td>
<td colspan="13">     </td>
<td></td>
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<td></td>
<td colspan="11">SIGNATURE</td>
<td colspan="2">DATE</td>
<td></td>
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<tr class="even">
<td></td>
<td colspan="11"></td>
<td colspan="2">     </td>
<td></td>
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<td colspan="15"></td>
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<tr class="even">
<td colspan="15"><blockquote>
<p><strong>Paperwork Reduction Act Statement</strong></p>
</blockquote></td>
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<td colspan="8">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:</td>
<td colspan="2"></td>
<td colspan="5"><p>Department of Health and Human Services</p>
<p>Food and Drug Administration</p>
<p>5600 Fishers Lane, Room 14C-03</p>
<p>Rockville, MD 20857</p></td>
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<td colspan="5"><strong>FORM FDA 3454 (4/06)</strong></td>
<td colspan="8"></td>
<td colspan="2">PSC Graphics: (301) 443-1090 EF</td>
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