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12.
CONTENTS OF APPLICATION
This application contains the following items: (Check all that apply)
1. Form FDA 1571 (21 CFR 312.23(a)(1)]
2. Table of Contents (21 CFR 312.23(a)(2))
3. Introductory statement (21 CFR 312.23(a)(3)]
4. General Investigational plan (21 CFR 312.23(a)(3)]
05. Investigator's brochure (21 CFR 312.23(a)(5))
( 6. Protocol(s) [21 CFR 312.23()(6))
a. Study protocol(#) (21 CFR 312.23(e)(6)/
b. investigator data (21 CFR 312.23()(6)(if)(b)] or completed Form(s) FDA 1572
C. Facilities data (21 CFR 312.23(a)(6)(Ill)(b)/ or completed Form(s) FDA 1572
.d. Institutional Review Board data (21 CFR 312.23(a)(6)(i)(b)] or completed Form(s) FDA 1572
7. Chemistry, manufacturing, and control data (21 CFR 312.23(@)(7))
( Environmental assessment of claim for exclusion (21 CFR 312.23(@)(7)(iv)(@)/
8. Pharmacology and toxicology data [21 CFR 312.23(@)(8)]
( Previous human experience [21 CFR.312.23(@)(9)]
10. Additional information (21 CFR 312,23(a)(10)]
13. IS ANY PART OF THE CLINICAL STUDY TO BE CONDUCTED BY A CONTRACT RESEARCH ORGANIZATION? DYES ONO
IF YES. WILL ANY SPONSOR OBLIGATIONS BE TRANSFERRED TO THE CONTRACT RESEARCH ORGANIZATION? DYES CINO
IF YES, ATTACH A STATEMENT CONTAINING THE NAME AND ADDRESS OF THE CONTRACT RESEARCH ORGANIZATION,
IDENTIFICATION OF THE CLINICAL STUDY, AND A LISTING OF THE OBLIGATIONS TRANSFERRED.
14: NAME AND TITLE OF THE PERSON RESPONSIBLE FOR MONITORING THE CONDUCT AND PROGRESS OF THE CLINICAL
INVESTIGATIONS
NA
15. NAME(S) AND TITLE(S) OF THE PERSON(S) RESPONSIBLE FOR REVIEW AND EVALUATION OF INFORMATION RELEVANT TO THE
SAFETY OF THE DRUG
N/A
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 OFR 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.
16. NAME OF SPONSOR OR SPONSOR'S AUTHORIZED
REPRESENTATIVE
. 17. SIGNATURE OF SPONSOR OR SPONSOR'S AUTHORIZED
REPRESENTATIVE
Janet L. Haskins
18. ADDRESS (Number, Street, City, State and Zip Code)
475 Half Day Road, Suite 500
19. "TELEPHONE NUMBER (include Area Code)
/847-383-3243
20. DATE
Lincolnshire, IL 60069
11/18/02
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Food and Drug Administration
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Food and Drug Administration
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Please DO NOT RETURN this application to this address.
FORM FDA 1571 (9/02)
PREVIOUS EDITION IS OBSOLETE.
PAGE # OF 2
Confidential - Subject to Protective Order
TAK-INDNDA-01273550
Produced in MDL on 09/11/2012
Source: https://www.induptus/qcoooozts.ucsf.edu/docs/gyjf0226

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