Notice of Change of Requirements for RFA-DA-19-002, "Development of Medications to Prevent and Treat Opioid Use Disorders and Overdose (UG3/UH3) (Clinical Trial Optional)

Notice Number: NOT-DA-18-016

Key Dates
Release Date: July 9, 2018

Related Announcements
RFA-DA-19-002
NOT-OD-18-181

Issued by
National Institute on Drug Abuse (NIDA)

Purpose

The purpose of this Notice is to update the research community about a new requirement for matching funds and/or documented in-kind contributions applicable to grants to for-profit applicant organizations for research related to opioid addiction, development of opioid alternatives, pain management and addiction treatment.  This notice outlines modifications to RFA-DA-19-002, "Development of Medications to Prevent and Treat Opioid Use Disorders and Overdose (UG3/UH3) (Clinical Trial Optional)”.
 
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 of funds and/or in-kind contributions equal to 50% of 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. This Notice details the matching/in-kind contribution  requirement and how it applies to for-profit organizations that apply to RFA-DA-19-002, and amends the sections of RFA-DA-19-002 listed below. Applications submitted 30 DAYS AFTER NOTICE PUBLICATION or later must comply with these application requirements. Applications from for-profit organizations that do not comply with the budget instructions or include the required letter(s) of support documenting cost-sharing will be withdrawn as non-compliant. Applications submitted between March 23, 2018 and DAY BEFORE NOTICE PUBLICATION will be required to provide these materials as just-in-time.

This funding opportunity is being offered as part of the NIH’s Helping to End Addiction Long-term (HEAL) initiative to speed scientific solutions to the national opioid public health crisis. The NIH HEAL Initiative will bolster research across NIH to (1) improve treatment for opioid misuse and addiction and (2) enhance pain management. More information about the HEAL Initiative is available at: https://www.nih.gov/research-training/medical-research-initiatives/heal-initiative .  

Part 2, Section I, Funding Opportunity Description, Background 
Part 2, Section IV, R&R Budget 
Part 2, Section IV, Letters of Support
Part 2, Section VI, Award Administration Information, Cooperative Agreement Terms and Conditions of Award 
Part 2, Section VI, Reporting 


Part 2, Section I, Funding Opportunity Description 
Background 

Additional language:
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 contribution of 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.


Matching Requirement: In each budget period, a grantee from a for-profit organization funded under RFA-DA-19-002 must have at least a 50% matching of funds or documented in-kind contributions, 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 contributions required under RFA-DA-19-002.  See 45 CFR 75.306 for additional details.



Part 2, Section IV, R&R Budget
Current language:
All instructions in the SF424 (R&R) Application Guide must be followed.

Revised language:
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 applicants responding to this FOA. The awardee is required to match and/or document in-kind contributions for at least 50% of the total Federally-awarded dollars (direct costs, as well as facilities and administrative costs). For-profit organizations must be able to document 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.

Federal funds may not be used as a source of matching funds. Generally, matching may not be met from the following sources:
a) Costs borne by another Federal grant or sub-award;
b) Costs or contributions toward matching 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.

Budget Justification: All for-profit applicants must document the matching and/or in-kind (non-Federal) component and the federal (non-matching) component in the total project budget.  That is, the requested budget plus the matching and/or in-kind contribution budget must be detailed in tabular format to document the matching and/or in-kind (non-Federal) component and the federal (non-matching) component. The amount of matching and/or in-kind contribution 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 matching and/or in-kind requirement is not negotiable for for-profit organizations.

Part 2, Section IV, Letters of Support

Additional language:
Letters of Support
For-profit applicant organizations 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.  

Part 2, Section VI, Award Administration Information, Cooperative Agreement Terms and Conditions of Award 

Additional language:
Award condition specific to this FOA for for-profit recipients: In each budget period, a grantee from a for-profit organization funded under this RFA-DA-19-002 must have at least a 50% matching of funds or documented in-kind contributions, as stipulated by Public Law 115-141, the Consolidated Appropriations Act of 2018.  See 45 CFR 75.306 for additional details.   Matching and/or in-kind contributions 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 FFR.

Part 2, Section VI, Reporting 
Current language:
When multiple years are involved, awardees will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement.

A final RPPR, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement.

Revised language:
When multiple years are involved, awardees will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement.

A final Research Performance Progress Report (F-RPPR), invention statement, and the expenditure data portion of the Federal Financial Report, including Federal and non-Federal share for cost matching, are required for closeout of an award, as described in the NIH Grants Policy Statement.

All other aspects of the FOA remain unchanged.

Inquiries

Please direct all inquiries to:

Financial/Grants Management Contact(s)
Pam Fleming
National Institute on Drug Abuse (NIDA)
Telephone: 301-480-1159
Email: pfleming@mail.nih.gov
 
Scientific/Research Contact(s)
Ivan D. Montoya, M.D., M.P.H.
National Institute on Drug Abuse (NIDA)
Telephone: 301-827-5936
Email: imontoya@mail.nih.gov
 
Peer Review Contact(s)
Gerald McLaughlin, PhD
National Institute on Drug Abuse (NIDA)
Telephone: 301-827-5819
Email: gmclaughlin@nida.nih.gov