Form Fda 1571 Instructions - Investigational New Drug Application (Ind) (Page 3 of 5) in pdf

Information Amendment(s): Select the review discipline(s) to which the submission applies (21 CFR 312.31)

Request For: Select the type(s) of request(s) contained within the submission.

IND Safety Report(s):

– Initial Written Report: 21 CFR 312.32(c)

– Follow-up to a Written Report: 21 CFR 312.32(d)

Field 12. SUBMISSIONS REQUIRING A JUSTIFICATION STATEMENT

Select the following only if applicable. A justification statement must be submitted with the application for any

items selected. Refer to the cited CFR section for further information.

Expanded Access Use, 21 CFR 312.300: Note that Treatment INDs and Treatment Protocols are not

intended for single patient use. Before checking this box, the sponsor should be thoroughly familiar with the

cited regulations and contact the appropriate FDA review division to discuss the proposed treatment use (21

CFR 312.320).

Field 13: CONTENTS OF APPLICATION

This section contains items 1 through 12 which is a checklist that should be used to indicate the types of

information contained within a particular application or submission. Check all that apply.

• For a Sponsor-Investigator IND, Items 2 – 4 may be briefly addressed in the cover letter or

in a summary.

• When the investigational drug is obtained from a supplier in a final dosage form, Items 5, 7, 8 and

9 may be referenced if authorization is given by the supplier (see explanation in field 9 above). If

the investigational drug is prepared or altered in any way after shipment by the supplier, complete

manufacturing (or compounding) and controls information, including information on sterility and

pyrogenicity testing for parenteral drugs, must be submitted for that process in Item 7.

• Item 6 requires that a protocol be submitted, along with information on the investigators, facilities,

and Institutional Review Board. Completed Form(s) FDA 1572 with attachments would suffice

for Items 6 b-d.

• Item 7 also requires submission of either a claim of categorical exclusion from the requirement to

submit an environmental assessment or an environmental assessment (21 CFR 25.15(a)). When

claiming a categorical exclusion, the sponsor should include the following statements: “I claim

categorical exclusion (under 21 CFR 25.31(e)) for the study(ies) under this IND. To my knowledge, no

extraordinary circumstances exist.”

• In certain applications, information on special topics may be needed (Item 10). Refer to the cited CFR

section for further information. Additional information may also include the Generic Drug User Fee

(GDUFA) Coversheet (Form FDA 3794) for GDUFA Master Files (Type II APIs), when applicable.

• Include the Biosimilar User Fee Cover Sheet (Form FDA 3792) (Item 11) and / or the Clinical Trials

Certification of Compliance (Form FDA 3674) (Item 12) as applicable.

Field 14: CONTRACT RESEARCH ORGANIZATIONS (CROs)

Check the appropriate box to indicate if the clinical study will be conducted by a CRO.

If yes, check the appropriate box to indicate if any sponsor obligations will be transferred to the CRO.

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)).

Field 15: Provide the Name and Title of the person responsible for monitoring the conduct and progress of

the clinical investigations (21 CFR 312.23(a)(1)(vi)). For Sponsor-Investigator INDs, the investigator has this

responsibility.

FORM FDA 1571 SUPPLEMENT (7/17) – FORM INSTRUCTIONS

Page 3 of 5

Form Fda 1571 Instructions - Investigational New Drug Application (Ind) Page 3

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