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<tr class="odd">
<td colspan="6" rowspan="2"><h1
id="department-of-health-and-human-services">DEPARTMENT OF HEALTH AND
HUMAN SERVICES</h1>
<p>FOOD AND DRUG ADMINISTRATION</p>
<p><strong>INVESTIGATIONAL NEW DRUG APPLICATION (IND)</strong></p>
<p><em><strong>(TITLE 21, CODE OF FEDERAL REGULATIONS (CFR) PART
312)</strong></em></p></td>
<td colspan="14"><p><em>Form Approved:</em> OMB No. 0910-0014.</p>
<p><em>Expiration Date: May 31, 2009</em></p>
<p><em>See OMB Statement on Reverse.</em></p></td>
</tr>
<tr class="even">
<td colspan="14"><strong>NOTE:</strong> No drug may be shipped or
clinical investigation begun until an IND for that investigation is in
effect (21 CFR 312.40).</td>
</tr>
<tr class="odd">
<td colspan="6">1. NAME OF SPONSOR</td>
<td colspan="14">2. DATE OF SUBMISSION</td>
</tr>
<tr class="even">
<td colspan="6"><blockquote>
<p>     </p>
</blockquote></td>
<td colspan="14">     </td>
</tr>
<tr class="odd">
<td colspan="6">3. ADDRESS <em>(Number, Street, City, State and Zip
Code)</em></td>
<td colspan="14">4. TELEPHONE NUMBER <em>(Include Area Code)</em></td>
</tr>
<tr class="even">
<td colspan="6"><blockquote>
<p>     </p>
</blockquote></td>
<td colspan="14">     </td>
</tr>
<tr class="odd">
<td colspan="6">5. NAME(S) OF DRUG <em>(Include all available names:
Trade, Generic, Chemical, Code)</em></td>
<td colspan="14">6. IND NUMBER <em>(If previously assigned)</em></td>
</tr>
<tr class="even">
<td colspan="6"><blockquote>
<p>     </p>
</blockquote></td>
<td colspan="14">     </td>
</tr>
<tr class="odd">
<td colspan="20">7. INDICATION(S) <em>(Covered by this
submission)</em></td>
</tr>
<tr class="even">
<td colspan="20"><blockquote>
<p>     </p>
</blockquote></td>
</tr>
<tr class="odd">
<td colspan="8" rowspan="2"><p>8. PHASE(S) OF CLINICAL INVESTIGATION TO
BE CONDUCTED:</p>
<p> PHASE 1 PHASE 2 PHASE 3 OTHER</p></td>
<td colspan="10">     </td>
<td colspan="2"></td>
</tr>
<tr class="even">
<td colspan="10"><blockquote>
<p><em>(Specify)</em></p>
</blockquote></td>
<td colspan="2"></td>
</tr>
<tr class="odd">
<td colspan="20">9. LIST NUMBERS OF ALL INVESTIGATIONAL NEW DRUG
APPLICATIONS <em>(21 CFR Part 312),</em> NEW DRUG OR ANTIBIOTIC
APPLICATIONS <em>(21 CFR Part 314)</em>, DRUG MASTER FILES <em>(21 CFR
Part 314.420),</em> AND PRODUCT LICENSE APPLICATIONS <em>(21 CFR Part
601)</em> REFERRED TO IN THIS APPLICATION.</td>
</tr>
<tr class="even">
<td colspan="20"><blockquote>
<p>     </p>
</blockquote></td>
</tr>
<tr class="odd">
<td colspan="9" rowspan="3">10<em>. <strong>IND submission should be
consecutively numbered. The initial IND should be numbered "Serial
number: 0000." The next submission (e.g., amendment, report, or
correspondence) should be numbered "Serial Number: 0001." Subsequent
submissions should be numbered consecutively in the order in which they
are submitted.</strong></em></td>
<td colspan="11">SERIAL NUMBER</td>
</tr>
<tr class="even">
<td></td>
<td colspan="2"> </td>
<td></td>
<td> </td>
<td></td>
<td> </td>
<td></td>
<td colspan="2"> </td>
<td></td>
</tr>
<tr class="odd">
<td></td>
<td colspan="2"></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td colspan="2"></td>
<td></td>
</tr>
<tr class="even">
<td colspan="20"><p>11. THIS SUBMISSION CONTAINS THE FOLLOWING:
<em><strong>(Check all that apply)</strong></em></p>
<p> INITIAL INVESTIGATIONAL NEW DRUG APPLICATION (IND) RESPONSE TO
CLINICAL HOLD</p>
<p>PROTOCOL AMENDMENT(S): INFORMATION AMENDMENT(S): IND SAFETY
REPORT(S):</p>
<p> NEW PROTOCOL CHEMISTRY/MICROBIOLOGY INITIAL WRITTEN REPORT</p>
<p> CHANGE IN PROTOCOL PHARMACOLOGY/TOXICOLOGY FOLLOW-UP TO A WRITTEN
REPORT</p>
<p> NEW INVESTIGATOR CLINICAL</p>
<p> RESPONSE TO FDA REQUEST FOR INFORMATION ANNUAL REPORT GENERAL
CORRESPONDENCE</p></td>
</tr>
<tr class="odd">
<td colspan="4" rowspan="2"><p> REQUEST FOR REINSTATEMENT OF IND THAT IS
WITHDRAWN, OTHER</p>
<p>INACTIVATED, TERMINATED OR DISCONTINUED</p></td>
<td colspan="14">     </td>
<td colspan="2"></td>
</tr>
<tr class="even">
<td colspan="14"><blockquote>
<p><em>(Specify)</em></p>
</blockquote></td>
<td colspan="2"></td>
</tr>
<tr class="odd">
<td colspan="20"><h2 id="check-only-if-applicable">CHECK ONLY IF
APPLICABLE</h2></td>
</tr>
<tr class="even">
<td colspan="20"><h3
id="justification-statement-must-be-submitted-with-application-for-any-checked-below.-refer-to-the-cited-cfr">JUSTIFICATION
STATEMENT MUST BE SUBMITTED WITH APPLICATION FOR ANY CHECKED BELOW.
REFER TO THE CITED CFR</h3>
<p><strong>SECTION FOR FURTHER INFORMATION.</strong></p>
<p> <strong>TREATMENT IND 21 CFR 312.35(b)</strong> <strong>TREATMENT
PROTOCOL 21 CFR 312.35(a)</strong> <strong>CHARGE REQUEST/NOTIFICATION
21 CFR312.7(d)</strong></p></td>
</tr>
<tr class="odd">
<td colspan="20"><h2 id="for-fda-use-only">FOR FDA USE ONLY</h2></td>
</tr>
<tr class="even">
<td colspan="2" rowspan="2">CDR/DBIND/DGD RECEIPT STAMP</td>
<td colspan="3" rowspan="2">DDR RECEIPT STAMP</td>
<td colspan="15">DIVISION ASSIGNMENT:</td>
</tr>
<tr class="odd">
<td colspan="15">IND NUMBER ASSIGNED:</td>
</tr>
<tr class="even">
<td colspan="20"><p>12. <strong>CONTENTS OF APPLICATION</strong></p>
<p>This application contains the following items: <em>(Check all that
apply)</em></p>
<p> 1. Form FDA 1571 <em>[21 CFR 312.23(a)(1)]</em></p>
<p> 2. Table of Contents <em>[21 CFR 312.23(a)(2)]</em></p>
<p> 3. Introductory statement <em>[21 CFR 312.23(a)(3)]</em></p>
<p> 4. General Investigational plan <em>[21 CFR 312.23(a)(3)]</em></p>
<p> 5. Investigator’s brochure <em>[21 CFR 312.23(a)(5)]</em></p>
<p> 6. Protocol(s) <em>[21 CFR 312.23(a)(6)]</em></p>
<p> a. Study protocol(s) <em>[21 CFR 312.23(a)(6)]</em></p>
<p> b. Investigator data <em>[21 CFR 312.23(a)(6)(iii)(b)]</em> or
completed Form(s) FDA 1572</p>
<p> c. Facilities data <em>[21 CFR 312.23(a)(6)(iii)(b)]</em> or
completed Form(s) FDA 1572</p>
<p> d. Institutional Review Board data <em>[21 CFR
312.23(a)(6)(iii)(b)]</em> or completed Form(s) FDA 1572</p>
<p> 7. Chemistry, manufacturing, and control data <em>[21 CFR
312.23(a)(7)]</em></p>
<p> Environmental assessment or claim for exclusion <em>[21 CFR
312.23(a)(7)(iv)(e)]</em></p>
<p> 8. Pharmacology and toxicology data <em>[21 CFR
312.23(a)(8)]</em></p>
<p> 9. Previous human experience <em>[21 CFR 312.23(a)(9)]</em></p>
<p> 10. Additional information <em>[21 CFR 312.23(a)(10)]</em></p></td>
</tr>
<tr class="odd">
<td colspan="20"><p>13. IS ANY PART OF THE CLINICAL STUDY TO BE
CONDUCTED BY A CONTRACT RESEARCH ORGANIZATION? YES NO</p>
<p>IF YES, WILL ANY SPONSOR OBLIGATIONS BE TRANSFERRED TO THE CONTRACT
RESEARCH ORGANIZATION? YES NO</p>
<p>IF YES, ATTACH A STATEMENT CONTAINING THE NAME AND ADDRESS OF THE
CONTRACT RESEARCH ORGANIZATION,<br />
IDENTIFICATION OF THE CLINICAL STUDY, AND A LISTING OF THE OBLIGATIONS
TRANSFERRED.</p></td>
</tr>
<tr class="even">
<td colspan="20">14. NAME AND TITLE OF THE PERSON RESPONSIBLE FOR
MONITORING THE CONDUCT AND PROGRESS OF THE CLINICAL<br />
INVESTIGATIONS</td>
</tr>
<tr class="odd">
<td colspan="20"><blockquote>
<p>     </p>
</blockquote></td>
</tr>
<tr class="even">
<td colspan="20">15. NAME(S) AND TITLE(S) OF THE PERSON(S) RESPONSIBLE
FOR REVIEW AND EVALUATION OF INFORMATION RELEVANT TO THE<br />
SAFETY OF THE DRUG</td>
</tr>
<tr class="odd">
<td colspan="20"><blockquote>
<p>     </p>
</blockquote></td>
</tr>
<tr class="even">
<td colspan="20"><strong>I agree not to begin clinical investigations
until 30 days after FDA’s receipt of the IND unless I receive earlier
notification by FDA that the studies may begin. I also agree not to
begin or continue clinical investigations covered by the IND if those
studies are placed on clinical hold. I agree that an Institutional
Review Board (IRB) that complies with the requirements set fourth in 21
CFR Part 56 will be responsible for initial and continuing review and
approval of each of the studies in the proposed clinical investigation.
I agree to conduct the investigation in accordance with all other
applicable regulatory requirements.</strong></td>
</tr>
<tr class="odd">
<td colspan="3"><p>16. NAME OF SPONSOR OR SPONSOR’S AUTHORIZED</p>
<p>REPRESENTATIVE</p></td>
<td colspan="17">17. SIGNATURE OF SPONSOR OR SPONSOR’S AUTHORIZED<br />
REPRESENTATIVE</td>
</tr>
<tr class="even">
<td colspan="3">     </td>
<td colspan="17"></td>
</tr>
<tr class="odd">
<td colspan="3">18. ADDRESS <em>(Number, Street, City, State and Zip
Code)</em></td>
<td colspan="8">19. TELEPHONE NUMBER <em>(Include Area Code)</em></td>
<td colspan="9">20. DATE</td>
</tr>
<tr class="even">
<td colspan="3"><blockquote>
<p>     </p>
</blockquote></td>
<td colspan="8">     </td>
<td colspan="9">     </td>
</tr>
<tr class="odd">
<td colspan="20"><strong>(WARNING:</strong> A willfully false statement
is a criminal offense. U.S.C. Title 18, Sec. 1001.)</td>
</tr>
<tr class="even">
<td colspan="20">Public reporting burden for this collection of
information is estimated to average 100 hours per response, including
the time for reviewing instructions, searching existing data sources,
gathering and maintaining the data needed, and completing reviewing the
collection of information. Send comments regarding this burden estimate
or any other aspect of this collection of information, including
suggestions for reducing this burden to:</td>
</tr>
<tr class="odd">
<td><p>Department of Health and Human Services</p>
<p>Food and Drug Administration</p>
<p>Center for Drug Evaluation and Research</p>
<p>Central Document Room</p>
<p>5901-B Ammendale Road</p>
<p>Beltsville, MD 20705-1266</p></td>
<td colspan="6"><p>Department of Health and Human Services</p>
<p>Food and Drug Administration</p>
<p>Center for Biologics Evaluation and Research (HFM-99)</p>
<p>1401 Rockville Pike</p>
<p>Rockville, MD 20852-1448</p></td>
<td colspan="13">"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."</td>
</tr>
<tr class="even">
<td colspan="20"><strong>Please DO NOT RETURN this application to this
address.</strong></td>
</tr>
</tbody>
</table>