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RFA-NS-21-010 - HEAL Initiative: Non-addictive Analgesic Therapeutics Development [Small Molecules and Biologics] to Treat Pain (UG3/UH3 Clinical Trial Optional)

Issued by

National Institute of Neurological Disorders and Stroke (NINDS)

Purpose

The purpose of this notice is to inform potential applicants of the removal of the Cost Matching Requirement Instructions for RFA-NS-21-010 "HEAL Initiative: Non-addictive Analgesic Therapeutics Development [Small Molecules and Biologics] to Treat Pain (UG3/UH3 Clinical Trial Optional)". This information was erroneously published in the FOA. NINDS has removed the Cost Matching Requirement instructions from the R&R Budget and the letters of support, under the PHS 398 Research Plan, as shown below.  This notice is effective for the March 24, 2021 receipt date and subsequent due dates.

Currently Reads:

Section IV. Application and Submission Information

R&R Budget

All instructions in the SF424 (R&R) Application Guide must be followed.

Budget Justification: All for-profit applicants must document the matching (non-Federal) component and the federal (non-matching) component in the total project budget. That is, the requested budget plus the cost-matching budget must be detailed in tabular format to document the cost-matching (non-Federal) component and the federal (non-cost matching) component. The amount of matching is subject to adjustment based on total allowable costs incurred. All costs and contributions used to satisfy the matching requirement must be documented by the recipient, including how the value for in-kind contributions was determined, and are subject to audit. The cost matching requirement is not negotiable for for-profit organizations.

PHS 398 Research Plan

Letters of Support

Applicants must include letters of support from consultants, contractors, and collaborators not provided through NIH.

If applying from an academic institution, include a letter of support from the technology transfer official who will be managing intellectual property associated with this project.

• If research will be performed at more than one institution, include a letter of support from each institution clarifying how intellectual property will be shared or otherwise managed across the institutions.
• If collaborating with a private entity, include a letter of support that addresses any agreement to provide agent(s), any limits on the studies that can be performed with said agent(s), any limitations on sharing of data (including negative results), and whether a licensing agreement(s) will be needed and in place once the project is funded. This letter should come from a high official within the private entity who has authority to speak on these issues.
• For-profit applicants must include a letter(s) of support confirming that the required secured cost matching (cash; in-kind commitments such as salary, consultant costs, equipment) is available and confirm that the essential personnel have the authority within the organization to allocate resources.

Modified to Read:

Section IV. Application and Submission Information

R&R Budget

All instructions in the SF424 (R&R) Application Guide must be followed.

PHS 398 Research Plan

Letters of Support

Applicants must include letters of support from consultants, contractors, and collaborators not provided through NIH.

If applying from an academic institution, include a letter of support from the technology transfer official who will be managing intellectual property associated with this project.

• If research will be performed at more than one institution, include a letter of support from each institution clarifying how intellectual property will be shared or otherwise managed across the institutions.
• If collaborating with a private entity, include a letter of support that addresses any agreement to provide agent(s), any limits on the studies that can be performed with said agent(s), any limitations on sharing of data (including negative results), and whether a licensing agreement(s) will be needed and in place once the project is funded. This letter should come from a high official within the private entity who has authority to speak on these issues.

All other aspects of this notice remain unchanged.

Inquiries

Please direct all inquiries to:

Charles Cywin, Ph.D.
National Institute of Neurological Disorders and Stroke (NINDS)
Telephone: 301-496-1779
Email: charles.cywin@nih.gov