FDA Form 1571 PROPOSED

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Form Approved: OMB No. 0910-0014
Expiration Date: February 28, 2019
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. Name of Sponsor

2. Date of Submission (mm/dd/yyyy)
4. Telephone Number (Include country code if
applicable and area code)

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

6A. IND Number (If previously assigned)

State/Province/Region

Country

ZIP or Postal Code

6B. Select One:

Commercial
Research

5. Name of Drug (Include all available names: Trade, Generic, Chemical, or Code)
Continuation
Page for #5

7A. (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?
Yes
No

Continuation
Page for #7

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

No

7B. SNOMED CT Indication Disease Term (Use continuation page for each additional indication and respective coded disease term)
8. Phase 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 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.
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..

Serial Number

11. 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

Information Amendment

Request for

IND Safety Report

PMR/PMC
Protocol

Chemistry/Microbiology

Meeting

Initial Written Report

Pharmacology/Toxicology

Proprietary Name Review

Human Factors
Protocol

Clinical/Safety

Special Protocol Assessment

Follow-up to a Written
Report

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

Statistics

Clinical Pharmacology
Yes

No

Formal Dispute Resolution

Combination Product
Type (See instructions)

Request for Designation
(RFD) Number

13. 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.)
Expanded Access Use, 21 CFR 312.300
Emergency Research Exception From Informed Consent
Requirements, 21 CFR 312.23 (f)

Individual Patient, NonEmergency 21 CFR 312.310

Intermediate Size Patient
Population, 21 CFR 312.315

Charge Request, 21 CFR 312.8

Individual Patient, Emergency
21 CFR 312.310(d)

Treatment IND or Protocol,
21 CFR 312.320

For FDA Use Only
CBER/DCC Receipt Stamp

DDR Receipt Stamp

Division Assignment
IND Number Assigned

FORM FDA 1571 (02/18)

Page 1 of 8

PSC Publishing Services (301) 443-6740

EF

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14. Contents of Application – This application contains the following items (Select all that apply)
1. Form FDA 1571 (21 CFR 312.23(a)(1))

6. Protocol (Continued)

2. Table of Contents (21 CFR 312.23(a)(2))

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))

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))

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))

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

9. Previous human experience (21 CFR 312.23(a)(9))

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

10. Additional information (21 CFR 312.23(a)(10))
11. Biosimilar User Fee Cover Sheet (Form FDA 3792)

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

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

15. Is any part of the clinical study to be conducted by a contract research organization?
If Yes, will any sponsor obligations be transferred to the contract research organization?

Yes

No

Yes

No
Continuation
Page for #14

If Yes, provide a statement containing the name and address of the contract research organization,
identification of the clinical study, and a listing of the obligations transferred (use continuation page).

16. Name and Title of the person responsible for monitoring the conduct and progress of the clinical investigations
17. 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.
18. Name of Sponsor or Sponsor’s Authorized Representative
19. Telephone Number (Include country code if applicable and area code)

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

21. Address

22. Email Address

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

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

State/Province/Region
ZIP or Postal Code

Country

24. Name of Countersigner
25. Address of Countersigner

26. Email Address

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

State/Province/Region
ZIP or Postal Code

27. Signature of Sponsor or Sponsor’s Authorized Representative

28. Signature of Countersigner

Sign

FORM FDA 1571 (02/18)

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

Page 2 of 8

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FORM FDA 1571 (02/18)

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CONTINUATION PAGE FOR ITEM 5 – Name of Drug
Name of Drug (Include all available names: Trade, Generic, Chemical, Code) – Continue your answer in the space below.

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FORM FDA 1571 (02/18)

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Page 4 of 8

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FIRST CONTINUATION PAGE FOR ITEM 7 – (Proposed) Indication for Use
Please fill out as many sets of answers as needed, completing all elements within each set that you start.
7A. (Proposed) Indication for Use

Is this indication for a rare disease (prevalence <200,000 in U.S.)?
Does this product have an FDA
Orphan Designation for this
indication?
Yes
No

Yes

No

Yes

No

Yes

No

Yes

No

Yes

No

Yes

No

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

7B. SNOMED CT Indication Disease Term
7A. (Proposed) Indication for Use

Is this indication for a rare disease (prevalence <200,000 in U.S.)?
Does this product have an FDA
Orphan Designation for this
indication?
Yes
No

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

7B. SNOMED CT Indication Disease Term

7A. (Proposed) Indication for Use

Is this indication for a rare disease (prevalence <200,000 in U.S.)?
Does this product have an FDA
Orphan Designation for this
indication?
Yes
No

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

7B. SNOMED CT Indication Disease Term

7A. (Proposed) Indication for Use

Is this indication for a rare disease (prevalence <200,000 in U.S.)?
Does this product have an FDA
Orphan Designation for this
indication?
Yes
No

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

7B. SNOMED CT Indication Disease Term
7A. (Proposed) Indication for Use

Is this indication for a rare disease (prevalence <200,000 in U.S.)?
Does this product have an FDA
Orphan Designation for this
indication?
Yes
No

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

7B. SNOMED CT Indication Disease Term

7A. (Proposed) Indication for Use

Is this indication for a rare disease (prevalence <200,000 in U.S.)?
Does this product have an FDA
Orphan Designation for this
indication?
Yes
No

7B. SNOMED CT Indication Disease Term

Remove Continuation Page

FORM FDA 1571 (02/18)

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Page 5 of 8

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

Remove Continuation Page

Return to Form

SECOND CONTINUATION PAGE FOR ITEM 7 – (Proposed) Indication for Use
Please fill out as many sets of answers as needed, completing all elements within each set that you start.
7A. (Proposed) Indication for Use

Is this indication for a rare disease (prevalence <200,000 in U.S.)?
Does this product have an FDA
Orphan Designation for this
indication?
Yes
No

Yes

No

Yes

No

Yes

No

Yes

No

Yes

No

Yes

No

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

7B. SNOMED CT Indication Disease Term
7A. (Proposed) Indication for Use

Is this indication for a rare disease (prevalence <200,000 in U.S.)?
Does this product have an FDA
Orphan Designation for this
indication?
Yes
No

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

7B. SNOMED CT Indication Disease Term

7A. (Proposed) Indication for Use

Is this indication for a rare disease (prevalence <200,000 in U.S.)?
Does this product have an FDA
Orphan Designation for this
indication?
Yes
No

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

7B. SNOMED CT Indication Disease Term

7A. (Proposed) Indication for Use

Is this indication for a rare disease (prevalence <200,000 in U.S.)?
Does this product have an FDA
Orphan Designation for this
indication?
Yes
No

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

7B. SNOMED CT Indication Disease Term
7A. (Proposed) Indication for Use

Is this indication for a rare disease (prevalence <200,000 in U.S.)?
Does this product have an FDA
Orphan Designation for this
indication?
Yes
No

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

7B. SNOMED CT Indication Disease Term

7A. (Proposed) Indication for Use

Is this indication for a rare disease (prevalence <200,000 in U.S.)?
Does this product have an FDA
Orphan Designation for this
indication?
Yes
No

7B. SNOMED CT Indication Disease Term

Remove Continuation Page

FORM FDA 1571 (02/18)

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Page 6 of 8

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

Remove Continuation Page

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FIRST CONTINUATION PAGE FOR ITEM 14 – Information on Contract Research Organization
For each (as applicable below) contract service organization involved in the clinical study, please provide a statement containing the name
and address of the contract research organization, identification of the clinical study, and a listing of the obligations transferred.
Contract Service Organization

Contract Service Organization

Contract Service Organization

Contract Service Organization

Contract Service Organization

Remove Continuation Page

FORM FDA 1571 (02/18)

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Page 7 of 8

Remove Continuation Page

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SECOND CONTINUATION PAGE FOR ITEM 14 – Information on Contract Research Organization
For each (as applicable below) contract service organization involved in the clinical study, please provide a statement containing the name
and address of the contract research organization, identification of the clinical study, and a listing of the obligations transferred.
Contract Service Organization

Contract Service Organization

Contract Service Organization

Contract Service Organization

Contract Service Organization

Remove Continuation Page

FORM FDA 1571 (02/18)

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Page 8 of 8