Attachment D1 - FDA Form 1571

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Form Approved: OMB No. 0910-0014
Expiration Date: September 30, 2026
See PRA Statement on page 3.

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

INVESTIGATIONAL NEW DRUG APPLICATION (IND)

NOTE: No drug/biologic may be shipped or
clinical investigation begun until an IND for that
investigation is in effect (21 CFR 312.40)

(Title 21, Code of Federal Regulations (CFR) Part 312)

1. Center (select one)

CDER

CBER

3. Date of Submission

(mm/dd/yyyy)

2. Name of Sponsor

5. Telephone Number (Include country code if
applicable and area code)

4. Sponsor Address

Address 1 (Street address, P.O. box, company name c/o)
Address 2 (Apartment, suite, unit, building, floor, etc.)

7A. IND Number (If previously assigned)
City

State/Province/Region

Country

ZIP or Postal Code

7B. IND Type (select one)

Commercial
Research

6. Name of Drug (Include all available names: Trade, Generic, Chemical, or Code) Continuation
Page for #6

8A. (Proposed) Indication for Use

Is this indication for a rare disease (prevalence <200,000 in U.S.)?

Yes

Does this product have an FDA
Orphan Designation for this
indication?
No
Yes

Continuation
Page for #8

If yes, provide the Orphan
Designation number for this
indication:

No

8B. SNOMED CT Indication Disease Term (Use continuation page for each additional indication and respective coded disease term) 9. Phase of Clinical Investigation to be conducted

Phase 1

Phase 2

Phase 3

Other (Specify):

10. List numbers of all Investigational New Drug Applications (21 CFR Part 312), New Drug Applications (21 CFR Part 314), Drug Master Files (21 CFR Part 314.420), and Biologics License Applications (21 CFR Part 601) referred to in this application.

11. 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..

Serial Number

12A. This submission contains the following (Select all that apply) Initial Investigational New Drug Application (IND)

Response to Clinical Hold

Response To FDA Request For Information

Request For Reactivation Or Reinstatement

Annual Report

General Correspondence

Development Safety Update Report (DSUR)

Other (Specify):

Protocol Amendment

Information Amendment

Request for

New Protocol

Chemistry/Microbiology

Meeting

IND Safety Report
Initial Written Report

Change in Protocol