Notice of Change to Key Dates and Change to Matching Requirement Instructions for RFA-NS-19-010 "Optimization of Non-Addictive Therapies (Small Molecules and Biologics) to Treat Pain (UG3/UH3 Clinical Trial Not Allowed)"

Notice Number: NOT-NS-19-026

Key Dates
Release Date: December 3, 2018

Related Announcements
RFA-NS-19-010

Issued by
National Institute of Neurological Disorders and Stroke (NINDS)

Purpose

The purpose of this notice is to inform applicants of a change to the Key Dates in RFA-NS-19-010 "Optimization of Non-Addictive Therapies (Small Molecules and Biologics) to Treat Pain (UG3/UH3 Clinical Trial Not Allowed) and to revise the Matching Requirement Instructions. Specifically, the first receipt date will change from January 4, 2019 to January 9, 2019. Additionally, there will no longer be a Cost Matching Requirement for this Funding Opportunity Announcement (FOA).

Currently Reads:

Part 1. Overview

Key Dates

Open Date (Earliest Submission Date) December 04, 2018
Application Due Date(s) January 4, 2019 and March 6, 2019, by 5:00PM local time of applicant organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on these dates.

Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.

AIDS Application Due Date(s) January 4, 2019 and March 6, 2019, by 5:00 PM local time of applicant organization. All types of AIDS and AIDS-related applications allowed for this funding opportunity announcement are due on these dates.

Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.

Modified to Read:

Part 1. Overview

Key Dates

Open Date (Earliest Submission Date) December 9, 2018
Application Due Date(s) January 9, 2019 and March 6, 2019, by 5:00PM local time of applicant organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on these dates.

Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.

AIDS Application Due Date(s) January 9, 2019 and March 6, 2019, by 5:00 PM local time of applicant organization. All types of AIDS and AIDS-related applications allowed for this funding opportunity announcement are due on these dates.

Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.

Currently Reads:

Part 2. Full Announcement of Text Announcement

Section I. Funding Opportunity Description

Implementation:

The program provides funding through the UG3/UH3 cooperative agreement mechanism. As a cooperative agreement, implementation will involve participation of NIH program staff in the planning and execution of the therapy-directed projects. This program is envisioned as a 5-year program in two stages UG3 and UH3. The UG3 portion of the award is designed to support optimization research for two years. Our goal is to fund 6-8 projects with a limited budget for the first 2 years during the UG3 phase. Based on the progress to milestones, only a limited number of projects will proceed to the UH3 phase (3 years) for the remainder of the award period which will include final optimization and development leading to IND-enabling studies, either through the grant budget or through additional contract resources outlined above.

Matching Requirement:

As part of the HEAL Initiative, this FOA is subject to certain requirements for for-profit applicant organizations. Public Law 115-141, the Consolidated Appropriations Act of 2018 (signed March 23, 2018) includes a requirement that grantees from for-profit applicant organizations must provide a 50% match and/or in-kind contributionof all federally awarded dollars under the grant award (direct costs, as well as facilities and administrative costs) for research related to opioid addiction, development of opioid alternatives, pain management and addiction treatment.

A grantee from a for-profit organization funded under this funding opportunity announcement must match funds or provide documented in-kind contributions at a rate of not less than 50% of the total-Federally awarded amount, as stipulated by Public Law 115-141, the Consolidated Appropriations Act of 2018. The applicant will be required to demonstrate that matching funds and/or in-kind contributions are committed or available at the time of, and for the duration of, the award. Applications must identify the source and amount of funds proposed to meet the matching requirement and how the value for in-kind contributions was determined. All matching funds and/or in-kind contributions must be used for the portion of allowable project costs not paid by Federal funds under the grant award.NIH will not be the recipient, nor serve as a pass-through entity, of any such matching funds and/or in-kind contributionsrequired under this announcement. See 45 CFR 75.306for additional details.

Modified toRead:

Part 2. Full Announcement of Text Announcement

Section I. Funding Opportunity Description

Implementation:

The program provides funding through the UG3/UH3 cooperative agreement mechanism. As a cooperative agreement, implementation will involve participation of NIH program staff in the planning and execution of the therapy-directed projects. This program is envisioned as a 5-year program in two stages UG3 and UH3. The UG3 portion of the award is designed to support optimization research for two years. Our goal is to fund 6-8 projects with a limited budget for the first 2 years during the UG3 phase. Based on the progress to milestones, only a limited number of projects will proceed to the UH3 phase (3 years) for the remainder of the award period which will include final optimization and development leading to IND-enabling studies, either through the grant budget or through additional contract resources outlined above.

Currently Reads:

Section III. Eligibility Information

2. Cost Sharing

For grantees from a for-profit organization, this FOA does require cost sharing, as defined in the NIH Grants Policy Statement. More information on cost matching requirements is in Section IV.2 R&R or Modular Budget.

Modified to Read:

Section III. Eligibility Information

2. Cost Sharing

This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.

Currently Reads:

Section IV. Application and Submission Information

2. Content and Form of Application Submission

R&R Budget:

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

Cost Matching Requirement for For-profit Applicants

Cost matching or documented in-kind contributions is required for for-profit organizations responding to this FOA. The for-profit awardee is required to match funds or provide at least a 50% matching of funds or documented in-kind contributions at a rate of not less than 50% of the for the total-Federally awarded amount (direct costs, as well as facilities and administrative costs), as stipulated by Public Law 115-141, the Consolidated Appropriations Act of 2018.

Federal funds may not be used as a source of matching funds. Generally, cost matching requirements may not be met from the following sources:

a) Costs borne by another Federal grant or sub award;

b) Costs or contributions toward cost sharing on another Federal grant, a Federal procurement contract, or any other award of Federal funds;

c) Cost of services or property financed by income earned by contractors under a contract from the recipient (or sub recipient);

(d) Program income; and

(e) Patient incentives.

The for-profit organization will be required to demonstrate that matching funds and/or in-kind contributions are committed or available at the time of, and for the duration of, the award. Applicants must submit budgets that clearly document the total costs, the source and amount of matching funds, and how valuation was determined in the case of in-kind contributions, as well as the Federal and Institutional (non-Federal) components of the budget. All matching funds and/or in-kind contributions must be used for the portion of allowable project costs not paid by Federal funds under the grant award. NIH will not be the recipient, nor serve as a pass-through entity, of any such matching funds and/or in-kind contributions required under this announcement. See45 CFR 75.306for additional details.

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.

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.

Modified to Read:

Section IV. Application and Submission Information

2. Content and Form of Application Submission

R&R Budget:

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

Currently Reads:

Section IV. Application Submission Information

2. Content and Form of Application Submission

PHS 398 Research Plan

Letters of Support:

  • If an application plans to utilize the infrastructure or resources of existing projects, whether funded by the NIH, other governmental or non-governmental entities, letters of support detailing the terms of collaboration, data sharing , and intellectual property must be included.
  • 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 Submission Information

2. Content and Form of Application Submission

PHS 398 Research Plan

Letters of Support:

  • If an application plans to utilize the infrastructure or resources of existing projects, whether funded by the NIH, other governmental or non-governmental entities, letters of support detailing the terms of collaboration, data sharing , and intellectual property must be included.

Currently Reads:

Section VI. Award Administration Information

1. Award Notices

Any application awarded in response to this FOA will be subject to terms and conditions found on the Award Conditions and Information for NIH Grants website. This includes any recent legislation and policy applicable to awards that is highlighted on this website.

Special award condition specific to this FOA: A grantee from a for-profit organization funded under this announcement must match funds or provide documented in-kind contributions at a rate of not less than 50% of the total-Federally awarded amount, as stipulated by Public Law 115-141, the Consolidated Appropriations Act of 2018. See45 CFR 75.306for additional details. Matching funds must be non-Federal funds set aside for this project and are available from the source(s) identified in the application, as committed to by the recipient.Cost matching will be evaluated by the awarding office to ensure that this requirement is being met. Compliance with the matching requirement must be verified on an annual basis and must be documented in the annual and final FFR.

Modified to Read:

Section VI. Award Administration Information

1. Award Notices

Any application awarded in response to this FOA will be subject to terms and conditions found on the Award Conditions and Information for NIH Grants website. This includes any recent legislation and policy applicable to awards that is highlighted on this website.

All other aspects of this FOA remain unchanged.

 

Inquiries

Please direct all inquiries to:

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