Attachment D2 - FDA Form 1571 Instructions (REFERENCE ONLY)

INSTRUCTIONS FOR FILLING OUT FORM FDA 1571

INVESTIGATIONAL NEW DRUG APPLICATION (IND)

(The field numbers below correspond to the numbered boxes on the Form FDA 1571)

Field 1: SELECT APPROPRIATE CENTER

Field 2: NAME OF SPONSOR

The sponsor is the person who takes responsibility for and initiates a clinical investigation. The sponsor may be an individual, pharmaceutical company, governmental agency, academic institution, private organization or other organization (21 CFR 312.3(b)). A Sponsor-Investigator is an individual who both initiates and conducts a clinical investigation and under whose immediate direction the investigational drug is being administered or dispensed (21 CFR 312.3(b)). For administrative reasons, only one individual should be designated as sponsor-investigator.
If a pharmaceutical company will be supplying the drug, but will not itself be submitting the IND, the company is not the sponsor.

Field 3: DATE OF SUBMISSION

Enter the date the submission is being submitted to the FDA. The date entered should match the date of the cover letter for the submission.
Fields 4–5: SPONSOR ADDRESS AND TELEPHONE NUMBER.
Provide the address and telephone number of the sponsor identified in field 1 (21 CFR 312.23(a)(1)(i)). If this address is a post office box number, a street address should also be provided on line 2. The telephone number is the number where the sponsor is usually available during normal working hours. Field 6: NAME(S) of DRUG
For name(s) of drug (21 CFR 312.23(a)(1)(i)), list the established name(s) and trade name, if available. Also, provide the dosage form(s), and the unique ingredient identifier (UNII) term and code for active substances (if applicable). Use the Continuation Page if additional space is needed.

Field 7A: IND NUMBER

Provide the IND number if it was previously assigned. If an IND number has not been assigned, leave the field blank. For IND numbers less than six digits, the IND number should be preceded using leading zeros (i.e., for IND 12345 enter 012345).
Field 7B: IND TYPE
Select Commercial IND if the product under investigation is intended to be commercialized at a later date. (21 CFR 312.320).
Select Research IND* if the product under investigation is not intended to be commercialized at a later date. Research INDs are generally sponsored by individual investigators, academic institutions and nonprofit entities. Includes INDs for emergency use or other expanded access. (21 CFR 312.310, 312.315 and 312.320).
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