Notice of Change of Requirements for PAR-18-219, "Grand Opportunity in Medications Development for Substance-Use Disorders (U01 Clinical Trial Optional)"

Notice Number: NOT-DA-18-019

Key Dates
Release Date: July 17, 2018

Related Announcements
PAR-18-219 
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 that for-profit recipients of funds are subject to a matching requirement of funds or documented in-kind contributions of not less than 50 percent of the total funds awarded.   This new requirement is 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  PAR-18-219 , "Grand Opportunity in Medications Development for Substance-Use Disorders (U01 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 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. This Notice details the matching/in-kind contribution requirement and how it applies to for-profit organizations that apply to PAR-18-219, and amends the following sections of PAR-18-219 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not comply with the budget instructions or include the required letter(s) of support documenting cost-sharing will be withdrawn as non-compliant.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 for the March 27, 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 III, Cost Sharing 

Part 2, Section IV, R&R Budget

Part 2, Section IV, Letters of Support

Part 2, Section V, Budget and Period 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: A grantee from a for-profit organization funded PAR-18-219 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.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 this announcement.  See 45 CFR 75.306 for additional details. 

Part 2, Section III, Cost Sharing

Current language:

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

Revised language:

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

 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 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.  See 45 CFR 75.306 for 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. 

Part 2, Section IV, Letters of Support

Additional language:

Letters of Support

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. 

Part 2, Section V, Budget and Period of Support

Additional language:

Budget and Period of Support

Specific to this FOA:

How likely is it that the plans for cost matching will be adequate?

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

Additional language:

Special award condition specific to this FOA: A grantee from a for-profit organization funded under PAR-18-219

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.  See 45 CFR 75.306 for 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.

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