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Related Announcements

PAR-22-184: Clinical Trial Readiness for Rare Neurological and Neuromuscular Diseases (U01 Clinical Trial Not Allowed)

Issued by

National Institute of Neurological Disorders and Stroke (NINDS)

Purpose

The purpose of this notice is to inform applicants of a change in the submission requirements for applications requesting $500,000 or more in direct costs in any year in response to PAR-22-184: Clinical Trial Readiness for Rare Neurological and Neuromuscular Diseases (U01 Clinical Trial Not Allowed).  Applicants requesting $500,000 or more in direct costs in any year (excluding consortium F&A) must contact a Scientific/ Research Contact at least 6 weeks before submitting the application and follow the Policy on the Acceptance for Review of Unsolicited Applications that Request $500,000 or More in Direct Costs as described in the SF424 (R&R) Application Guide. Application budgets are limited to $750,000 in direct costs in any project year (exclusive of facilities and administrative costs of subcontracts with collaborating organizations). Furthermore, the requirements in Section IV of PAR-22-184 under “Appendix” have changed as described below. Replace “Protocols describing the procedures for measuring the biomarkers or evaluating the COA proposed are required, but clinical protocols should not be submitted.” with “Protocols describing the procedures for measuring the biomarkers or evaluating the COA proposed are encouraged.” Changes will be effective for the August 17, 2023 due date and subsequent due dates. Changes to the notice of funding opportunity (NOFO) are shown below.

Currently Reads:

Section IV: Application and Submission Information

2. Content and Form of Application Submission

PHS 398 Research Plan

Appendix

Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

The following modifications also apply:

• Protocols describing the procedures for measuring the biomarkers or evaluating the COA proposed are required but clinical protocols should not be submitted.
• If an ancillary study is proposed, the most recently approved protocol for the parent clinical trial or longitudinal study and the consent form for the parent study are required.
• If the investigators have had communications with the FDA through a Critical Path Innovation Meeting or other meeting(s) about the proposed biomarker(s) or COA measure(s), a summary of the meeting or documentation of guidance from the FDA is required.
• If the proposed study involves the expanded access regulatory pathway, protocols used for expanded access studies or documentation submitted to FDA to initiate and amend expanded access protocols are required.

7. Other Submission Requirements and Information

Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review, NIH. Applications that are incomplete or non-compliant and/or non-responsive will not be reviewed.

Post Submission Materials

Applicants are required to follow the instructions for post-submission materials, as described in the policy. Any instructions provided here are in addition to the instructions in the policy.

Modified to Read:

Section IV: Application and Submission Information

2. Content and Form of Application Submission

PHS 398 Research Plan

Appendix

Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

The following modifications also apply:

• Protocols describing the procedures for measuring the biomarkers or evaluating the COA proposed are encouraged.
• If an ancillary study is proposed, the most recently approved protocol for the parent clinical trial or longitudinal study and the consent form for the parent study are required.
• If the investigators have had communications with the FDA through a Critical Path Innovation Meeting or other meeting(s) about the proposed biomarker(s) or COA measure(s), a summary of the meeting or documentation of guidance from the FDA is required.
• If the proposed study involves the expanded access regulatory pathway, protocols used for expanded access studies or documentation submitted to FDA to initiate and amend expanded access protocols are required.

7. Other Submission Requirements and Information

Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review, NIH. Applications that are incomplete or non-compliant and/or non-responsive will not be reviewed.

Requests of $500,000 or more for direct costs in any year

Applicants requesting $500,000 or more in direct costs in any year (excluding consortium F&A) must contact the Scientific/ Research Contact at least 6 weeks before submitting the application and follow the Policy on the Acceptance for Review of Unsolicited Applications that Request $500,000 or More in Direct Costs as described in the SF424 (R&R) Application Guide.

Post Submission Materials

Applicants are required to follow the instructions for post-submission materials, as described in the policy. Any instructions provided here are in addition to the instructions in the policy.

All other aspects of this NOFO remain unchanged.

Inquiries

Please direct all inquiries to:

Glen H. Nuckolls PhD
Telephone: 301-496-5876
Email: glen.nuckolls@nih.gov