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

FORM FDA 1572

Copies of Form FDA 1572 with its attachments may be sent by the sponsor-investigator to FDA to satisfy Form

FDA 1571, field 13, item 6 b-d. Information can be supplied in the form of attachments (such as curriculum

vitae) rather than entering that information directly onto the form, but this should be noted under the relevant

section numbers.

FORM FDA 3674

The Food and Drug Administration Amendments Act of 2007 (FDAAA) (Public Law 110-85) was enacted on

September 27, 2007. Title VIII of FDAAA added new Section 402(j) to the Public Health Service Act (42 USC §

282(j)) and expanded the current database known as

ClinicalTrials.gov

to include mandatory registration and

reporting of results for applicable clinical trials of human drugs (including biological products) and devices.

Title VIII further requires that, at the time of submission of an application under section 505 of the FDCA,

including an Investigational New Drug application, the application must be accompanied by a certification

that all applicable requirements of 42 USC § 282(j) have been met. Where available, such certification must

include the appropriate National Clinical Trial (NCT) numbers. You may use Form

FDA

3674, Certification of

Compliance, under 42 U.S.C. § 282(j)(5)(B), with Requirements of ClinicalTrials.gov Data Bank, to comply with

the certification requirement. The form may also be found on the

FDA Forms

page.

In completing Form FDA 3674, you should review 42 USC § 282(j) to determine whether the requirements of

that subsection apply to any clinical trial(s) referenced in your application. Additional information regarding the

certification form is available on the

FDAAA Certification to Accompany Drug, Biological Product, and Device

Applications or Submissions

Web page. Additional information regarding the expansion of ClinicalTrials.gov

is available at: https://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-014.html. Additional information on

registering your clinical trials is available on the

Protocol Registration System

Web site.

Please note that FDA has published a guidance,

Guidance for Sponsors, Industry, Researchers, Investigators,

and FDA Staff – Certifications to Accompany Drug, Biological Product, and Device Applications/Submissions:

Compliance with Section 402(j) of The Public Health Service Act, Added by Title VIII of the Food and Drug

Administration Amendments Act of

2007. In this guidance, FDA recognizes that certain information and

documents submitted to FDA typically bear no relationship to the type of information that Title VIII is designed

to capture and that it would not further the purposes of the legislation if a certification were to accompany

every type of information or document submitted to the Agency regarding a medical product regulated by

FDA. Consequently, FDA identifies in the guidance several types of information and documents that typically

need not be accompanied by this certification. For assistance in determining whether your submission of

an application under section 505 of the FDCA must be accompanied by a certification, you may consult

this guidance.

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

Page 5 of 5

Form Fda 1571 Instructions - Investigational New Drug Application (Ind) Page 5

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