NINDS Policy for the Requirement of Authorization from the Food and Drug Administration (FDA) to use an Investigational Drug, Biologic Product or Device in a Clinical Trial Prior to Submission of an Application


Notice Number: NOT-NS-11-018

Update: The following update relating to this announcement has been issued:

Key Dates

Release Date:  July 15, 2011

Issued by

National Institute of Neurological Disorders and Stroke (NINDS)

Purpose

The purpose of this Notice is to inform NINDS grant applicants that, beginning with applications intended for the September 25, 2011 due date and beyond, the following conditions related to FDA regulations must be met before NINDS will allow the submission of an application involving a clinical trial for scientific and technical review.  This Notice applies to grant applications submitted under the Exploratory Clinical Trials FOA PAR-10-199 (http://grants.nih.gov/grants/guide/pa-files/PAR-10-199.html) and the Phase III Clinical Trials FOA PAR-11-173 (http://grants.nih.gov/grants/guide/pa-files/PAR-11-173.html) and all subsequent NINDS FOAs where clinical trials of FDA regulated interventions may be proposed”.

At the time of grant submission, applicants must provide documentation from the FDA providing information on one of the following three scenarios:

(A)  The protocol has been submitted under an open IND/IDE and the IND/IDE is not under full or partial hold.  Under this scenario, applicants must provide documentation such as a “may proceed” email or letter from the FDA.

(B)  The protocol has been submitted under an IND/IDE and is on full or partial hold.  Under this scenario applicants must provide full documentation from the FDA on the reasons for hold and the FDA recommendations.

(C)  The protocol is exempt from an IND/IDE.  Under this scenario applicants must provide a copy of the exemption letter from the FDA.

Applications that do not include the information described under scenarios (A), (B), or (C) will be withdrawn and not reviewed. 

Prior to grant award the NINDS will require that awardees who do not have a previously documented study exemption provide documentation that their IND/IDE remains open and that it has not been placed under full or partial hold.

For purposes of this policy, a clinical trial (as defined by NIH policy http://grants.nih.gov/grants/policy/nihgps_2010/index. .htm) is a “biomedical research study of human subjects that is designed to answer specific questions about biomedical interventions (drugs, treatments, devices, or new ways of using known drugs, treatments, or devices). Clinical trials are used to determine whether new interventions are safe and effective”.

Inquiries

Inquiries concerning this policy should be sent to:

Scott Janis, Ph.D.
Office of Clinical Research
National Institute of Neurological Disorders and Stroke
Room 2170, MSC 9525
6001 Executive Blvd.
Bethesda, MD 20892-9525
Telephone: (301) 496-9135
Fax: (301) 410-1080
Email: janiss@ninds.nih.gov

D Elizabeth McNeil, M.D. MSc
Office of Clinical Research
National Institute of Neurological Disorders and Stroke
Room 2215, MSC 9520
6001 Executive Blvd.
Bethesda, MD 20892-9520
Telephone: (301) 496-9135
Fax: (301) 410-1080
Email: mcneilde@ninds.nih.gov

For inquiries about review issues contact:

Chief, Scientific Review Branch
National Institute of Neurological Disorders and Stroke
Room 3201, MSC 9529
6001 Executive Blvd.
Bethesda, MD 20892-9529
Telephone: (301) 496-9223
Fax: (301) 402-0182
Email: nindsreview@ninds.nih.gov


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