New NIDCD Clinical Trials Policy on Post-Submission Application Materials

Notice Number: NOT-DC-13-002

Release Date: March 5, 2013

PAR-12-123
PAR-12-124
NOT-OD-10-115

National Institute on Deafness and Other Communication Disorders (NIDCD)

This Notice serves to announce that a new NIDCD policy on post-submission grant application materials will be effective for PAR-12-123 "NIDCD Phase I/II/III Clinical Trials in Communication Disorders (U01)" and PAR-12-124 "NIDCD Planning Grant for Phase III Clinical Trials in Communication Disorders (U34)" applications submitted for the June 4, 2013 receipt date and thereafter.  This policy does not modify the existing Just-In-Time requirements or any other requests for additional information after the initial peer review. 

Policy

In addition to post-submission application materials allowed by the NIH (see https://grants.nih.gov/grants/guide/notice-files/NOT-OD-10-115.html ) the NIDCD Scientific Review Branch will accept Food and Drug Administration (FDA) Investigational New Drug (IND) and Investigation Device Exemption (IDE) Letters of Conditional Approval and Letters of Approval. Note: send only Letters; do not send the entire brochure.

Deadline

Post-submission materials must be received by the NIDCD Scientific Review Officer (SRO) one month (30 calendar days) prior to the peer review meeting. Post-submission materials will not be accepted if fewer than 30 calendar days remain before the peer review meeting.

Authorized Organization Representative (AOR) Concurrence

Concurrence from the Authorized Organization Representative (AOR) of the applicant organization is required.  Although the content of post-submission materials may originate from the PD/PI, Contact PD/PI for multiple PD/PI applications, or organizational officials, the AOR must send the materials directly to the SRO, or must send his/her concurrence to the PD/PI who will forward the materials and concurrence to the SRO.  A communication from the PD/PI only or with a cc to the AOR will not be accepted.

Instructions

Submission via email of post-submission materials as a PDF attachment is required. NIDCD recommends producing the documents electronically using text or word-processing software and then converting the documents to PDF. This will allow the text to be searched electronically (i.e., do not scan files that have text as an image, scan as text file only).

The SRO is responsible for uploading acceptable materials into the official electronic grant file maintained in the eRA Commons. The PD/PI can check his/her application via the Commons to see these materials in the section titled Additions for Review . This allows the information to be available to reviewers in a secure manner. 

Please direct inquiries to, and send FDA IND and IDE Letters to:

Melissa Stick, Ph.D., MPH
Chief Scientific Review Branch, Division of Extramural Activities
National Institute on Deafness and Other Communication Disorders, NIH
6120 Executive Blvd.
EPS-400C MSC 7180
Bethesda, MD 20892-7180
Telephone: (301) 496-8683
Fax: (301) 402-6250
Email: stickm@nidcd.nih.gov