Attachment D1 - FDA Form 1571.pdf

FORM FDA 1571 (3/25) - PREVIOUS EDITION OBSOLETE Page of PSC Publishing Services (301) 443-6740 EF

Next Page Reset Form

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

INVESTIGATIONAL NEW DRUG APPLICATION (IND)

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

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

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

1. Center (select one)

CDER CBER

2. Name of Sponsor 3. Date of Submission (mm/dd/yyyy)

4. Sponsor Address

Address 1 (Street address, P.O. box, company name c/o)

Address 2 (Apartment, suite, unit, building, floor, etc.)

City State/Province/Region

Country ZIP or Postal Code

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

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

Continuation Page for #6

7A. IND Number (If previously assigned)

7B. IND Type (select one) Commercial

Research

8A. (Proposed) Indication for Use Is this indication for a rare disease (prevalence <200,000 in U.S.)? Yes No

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

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

Continuation Page for #8

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

New Protocol

Change in Protocol

New Investigator

PMR/PMC Protocol

HF Validation Protocol

Use-Related Risk Analysis

Information Amendment

Chemistry/Microbiology

Pharmacology/Toxicology

Clinical/Safety

Statistics

Clinical Pharmacology

Request for

Meeting

Proprietary Name Review

Special Protocol Assessment

Formal Dispute Resolution

IND Safety Report

Initial Written Report

Follow-up to a Written Report

12B. Does the submission contain: Digital Health Technology (DHT) data or a proposal to collect DHT data?

Yes No

13. For Originals, is the product a combination product (21 CFR 3.2(e))?

Yes No

Combination Product Type (See instructions)

Request for Designation (RFD) Number

For FDA Use Only CBER/DCC Receipt Stamp DDR Receipt Stamp Division Assignment

IND Number Assigned

FORM FDA 1571 (3/25) - PREVIOUS EDITION OBSOLETE Page of

Previous Page Next Page

14. Select the following only if applicable. (Justification statement must be submitted with application for any items selected below.

Refer to the cited CFR section for further information.)

Emergency Research Exception From Informed Consent Requirements, 21 CFR 312.23 (f)

Charge Request, 21 CFR 312.8

Expanded Access Use, 21 CFR 312.300

Individual Patient, Non- Emergency 21 CFR 312.310

Individual Patient, Emergency 21 CFR 312.310(d)

Intermediate Size Patient Population, 21 CFR 312.315

Treatment IND or Protocol, 21 CFR 312.320

15. Contents of Application – This application contains the following items (Select 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 (21 CFR 312.23(a)(6))

a. Study protocol (21 CFR 312.23(a)(6))

b. Investigator data (21 CFR 312.23(a)(6)(iii)(b)) or completed Form FDA 1572

c. Facilities data (21 CFR 312.23(a)(6)(iii)(b)) or completed Form FDA 1572

6. Protocol (Continued)

d. Institutional Review Board data (21 CFR 312.23(a)(6)(iii) (b)) or completed Form 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))

11. Biosimilar User Fee Cover Sheet (Form FDA 3792)

12. Clinical Trials Certification of Compliance (Form FDA 3674)

16. Is any part of the clinical study to be conducted by a contract research organization? (21 CFR 312.52) Yes No

If yes, use the Continuation Page to provide a statement containing the name and address of the CRO, identification of the clinical study and a listing of the obligations transferred (21 CFR 312.23(a)(1)(viii) and 21 CFR 312.52).

17. Name and Title of the person responsible for monitoring the conduct and progress of the clinical investigations

18. Name and Title of the person 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 or financial hold. I agree that an Institutional Review Board (IRB) that complies with the requirements set forth 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.

19. Sponsor or Sponsor’s Authorized Representative

Prefix First Name Middle Last Name Title

20. Telephone Number (Include country code if applicable and area code) 21. Facsimile (FAX) Number (Include country code if applicable and area code)

22. Address

Address 1 (Street address, P.O. box, company name c/o)

Address 2 (Apartment, suite, unit, building, floor, etc.)

City State/Province/Region

Country ZIP or Postal Code

23. Email Address

24. Date of Sponsor’s Signature (mm/dd/yyyy)

FORM FDA 1571 (3/25) - PREVIOUS EDITION OBSOLETE Page of

25. Name of Countersigner

26. Address of Countersigner

Address 1 (Street address, P.O. box, company name c/o)

Address 2 (Apartment, suite, unit, building, floor, etc.)

City State/Province/Region

Country United States of America

ZIP or Postal Code

27. Email Address

WARNING : A willfully false statement is a criminal offense (U.S.C. Title 18, Sec. 1001).

28. Signature of Sponsor or Sponsor’s Authorized Representative

Sign

29. Signature of Countersigner

Sign

The information below applies only to requirements of the Paperwork Reduction Act of 1995.

The burden time for this collection of information is estimated to average 100 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden to the address to the right:

Department of Health and Human Services Food and Drug Administration Office of Operations Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

“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 number.”

Please do NOT send your completed form to this PRA Staff email address.

mailto:PRAStaff@fda.hhs.gov mailto:PRAStaff@fda.hhs.gov mailto:PRAStaff@fda.hhs.gov mailto:PRAStaff@fda.hhs.gov