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DEPARTMENT OF HEALTH AND HUMAN SERVICES
FOOD AND DRUG ADMINISTRATION

Form Approved: OMB No. 0910-0014. Expiration Date: May 31, 2009 See OMB Statement on Reverse. NOTE: No drug may be shipped or clinical investigation begun until an IND for that investigation is in effect (21 CFR 312.40).
2. DATE OF SUBMISSION

INVESTIGATIONAL NEW DRUG APPLICATION (IND)
(TITLE 21, CODE OF FEDERAL REGULATIONS (CFR) PART 312)
1. NAME OF SPONSOR

3. ADDRESS (Number, Street, City, State and Zip Code)

4. TELEPHONE NUMBER (Include Area Code)

5. NAME(S) OF DRUG (Include all available names: Trade, Generic, Chemical, Code)

6. IND NUMBER (If previously assigned)

7. INDICATION(S) (Covered by this submission)

8. PHASE(S) OF CLINICAL INVESTIGATION TO BE CONDUCTED: PHASE 1 PHASE 2 PHASE 3 OTHER (Specify) 9. LIST NUMBERS OF ALL INVESTIGATIONAL NEW DRUG APPLICATIONS (21 CFR Part 312), NEW DRUG OR ANTIBIOTIC APPLICATIONS (21 CFR Part 314), DRUG MASTER FILES (21 CFR Part 314.420), AND PRODUCT LICENSE APPLICATIONS (21 CFR Part 601) REFERRED TO IN THIS APPLICATION.

10.

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.
THIS SUBMISSION CONTAINS THE FOLLOWING: (Check all that apply) INITIAL INVESTIGATIONAL NEW DRUG APPLICATION (IND) INFORMATION AMENDMENT(S): CHEMISTRY/MICROBIOLOGY PHARMACOLOGY/TOXICOLOGY CLINICAL

SERIAL NUMBER

11.

RESPONSE TO CLINICAL HOLD IND SAFETY REPORT(S): INITIAL WRITTEN REPORT FOLLOW-UP TO A WRITTEN REPORT

PROTOCOL AMENDMENT(S): NEW PROTOCOL CHANGE IN PROTOCOL NEW INVESTIGATOR

RESPONSE TO FDA REQUEST FOR INFORMATION REQUEST FOR REINSTATEMENT OF IND THAT IS WITHDRAWN, INACTIVATED, TERMINATED OR DISCONTINUED

ANNUAL REPORT OTHER

GENERAL CORRESPONDENCE (Specify)

CHECK ONLY IF APPLICABLE JUSTIFICATION STATEMENT MUST BE SUBMITTED WITH APPLICATION FOR ANY CHECKED BELOW. REFER TO THE CITED CFR SECTION FOR FURTHER INFORMATION.
TREATMENT IND 21 CFR 312.35(b) TREATMENT PROTOCOL 21 CFR 312.35(a) CHARGE REQUEST/NOTIFICATION 21 CFR312.7(d)

FOR FDA USE ONLY
CDR/DBIND/DGD RECEIPT STAMP DDR RECEIPT STAMP DIVISION ASSIGNMENT:

IND NUMBER ASSIGNED:

FORM FDA 1571 (4/06)

PREVIOUS EDITION IS OBSOLETE.

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PSC Media Arts (301) 443-1090

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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)] 5. Investigator's brochure [21 CFR 312.23(a)(5)] 6. Protocol(s) [21 CFR 312.23(a)(6)] a. Study protocol(s) [21 CFR 312.23(a)(6)] b. Investigator data [21 CFR 312.23(a)(6)(iii)(b)] or completed Form(s) FDA 1572 c. Facilities data [21 CFR 312.23(a)(6)(iii)(b)] or completed Form(s) FDA 1572 d. Institutional Review Board data [21 CFR 312.23(a)(6)(iii)(b)] or completed Form(s) FDA 1572 7. Chemistry, manufacturing, and control data [21 CFR 312.23(a)(7)] Environmental assessment or claim for exclusion [21 CFR 312.23(a)(7)(iv)(e)] 8. Pharmacology and toxicology data [21 CFR 312.23(a)(8)] 9. Previous human experience [21 CFR 312.23(a)(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? YES NO YES NO

IF YES, WILL ANY SPONSOR OBLIGATIONS BE TRANSFERRED TO THE CONTRACT RESEARCH ORGANIZATION?

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

15. NAME(S) AND TITLE(S) OF THE PERSON(S) RESPONSIBLE FOR REVIEW AND EVALUATION OF INFORMATION RELEVANT TO THE SAFETY OF THE DRUG

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.
16. NAME OF SPONSOR OR SPONSOR'S AUTHORIZED REPRESENTATIVE 17. SIGNATURE OF SPONSOR OR SPONSOR'S AUTHORIZED REPRESENTATIVE

Sign

18. ADDRESS (Number, Street, City, State and Zip Code)

19. TELEPHONE NUMBER (Include Area Code)

20. DATE

(WARNING: A willfully false statement is a criminal offense. U.S.C. Title 18, Sec. 1001.)
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: Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research Central Document Room 5901-B Ammendale Road Beltsville, MD 20705-1266 Department of Health and Human Services Food and Drug Administration Center for Biologics Evaluation and Research (HFM-99) 1401 Rockville Pike Rockville, MD 20852-1448

"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."

Please DO NOT RETURN this application to this address.

FORM FDA 1571 (4/06)

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