Form Fda 1571 Instructions - Investigational New Drug Application (Ind) (Page 4 of 5) in pdf

Field 16: Provide the Name(s) and Title(s) of the person(s) responsible under 21 CFR 312.32 for review and

evaluation of information relevant to the safety of the drug (21 CFR 312.23(a)(1)(vii)). For Sponsor-Investigator

INDs, the investigator has this responsibility.

Certain important commitments that the IND sponsor makes by signing Form FDA 1571 are listed below field

16. Under Section 744G (11) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act), as added by the

Biosimilar User Fee Act of 2012 (BsUFA), the term “financial hold” means an order issued by FDA to prohibit

the sponsor of a clinical investigation from continuing the investigation if FDA determines that the investigation

is intended to support a biosimilar biological product application and the sponsor has failed to pay any required

initial biosimilar biological product development (BPD) fee, annual BPD fee, or reactivation fee. The term

“financial hold” does not mean that any of the bases for a clinical hold identified in section 505(i)(3) of the

FD&C Act have been determined by FDA to exist concerning the investigation.

Field 17: NAME OF SPONSOR OR SPONSOR’S AUTHORIZED REPRESENTATIVE

For a sponsor-investigator IND, the sponsor-investigator should be named and must sign the form. For an

IND sponsored by a pharmaceutical firm or research organization, the name of the sponsor’s authorizing

representative should be entered and that individual must sign the form.

Fields 18-20: Provide the telephone number, facsimile number, and full mailing address of the individual

identified in field 17.

Field 21: Provide the email address of the person identified in field 17. For INDs submitted to the Center for

Biologics Evaluation and Research (CBER), a specific statement authorizing communication via non-secure

email should be included in the cover letter as applicable.

Field 22: Provide the date the form is signed by the sponsor or sponsor’s authorized representative. This date

may be different from the date provided in field 2.

Field 23: NAME OF COUNTERSIGNER

If the person signing the application in field 25 does not reside or have a place of business within the United

States, the submission must be countersigned by an attorney, agent, or other authorized official who resides or

maintains a place of business within the United States (21 CFR 312.23(a)(1)(ix)).

If applicable, provide the name of the attorney, agent or other authorized official countersigning the

application in field 26.

Field 24: ADDRESS OF COUNTERSIGNER

If applicable, provide the full mailing address of the individual identified in field 23. If the sponsor or sponsor’s

authorized representative identified in field 17 does not reside or have a place of business within the United

States, this mailing address is the address to which written correspondence from the FDA should be directed.

Field 25: EMAIL ADDRESS

Enter the email address of the Countersigner named in Field 23.

Field 26: SIGNATURE OF SPONSOR OR SPONSOR’S AUTHORIZED REPRESENTATIVE

The person identified in field 17 must sign in this field (21 CFR 312.23(a)(1)(ix)).

Field 27: SIGNATURE OF COUNTERSIGNER

If applicable, the person identified in field 23 must countersign in this field.

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

Page 4 of 5

Form Fda 1571 Instructions - Investigational New Drug Application (Ind) Page 4