Notice of Change of Requirements and Interest in Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) Applications Directed at Enhanced Pain Management and Improved Treatments for Opioid Misuse and Addiction

Notice Number: NOT-NS-18-076

Key Dates
Release Date: July 23, 2018

Related Announcements

PA-18-573

PA-18-574

PA-18-575

PA-18-576

PAR-18-617

PAR-18-618

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

National Institute on Drug Abuse (NIDA)

Purpose

The purpose of this Notice is to inform potential SBIR and STTR applicants about areas of special interest related to the NIH Helping End Addiction Long-term (HEAL) Initiative, an effort to speed scientific solutions to stem the national opioid public health crisis. The National Institute of Neurological Disorders and Stroke (NINDS) is interested in receiving applications directed at improving pain treatment, including the development of new non-addictive medications and devices and objective pain measurement. In addition, NINDS is interested in new screening tools and models focused specifically on pain and development of pain therapies. The National Institute on Drug Abuse (NIDA) is specifically interested in receiving applications to develop new approaches for the prevention and treatment of opioid misuse, overdose and addiction that will help people with opioid use disorder (OUD) achieve and maintain a meaningful and sustained recovery.

This Notice also informs the small business community about a new requirement for matching funds when awarding grants through the HEAL Initiative to 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 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 for the HEAL Initiative and how it applies to for-profit organizations that apply to PA-18-573PA-18-574, PA-18-575, PA-18-576PAR-18-617, and PAR-18-618, and amends the following sections of PA-18-573PA-18-574, PA-18-575, PA-18-576PAR-18-617, and PAR-18-618 listed below.

Part 2, Section I, Funding Opportunity Description

Additional language:

NIH Helping End Addiction Long-term (HEAL) Initiative: The HEAL Initiative is an NIH wide effort to speed scientific solutions to stem the national opioid public health crisis. The NIH is interested in receiving research related to opioid addition, development of opioid alternatives, pain management and addiction treatment. 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 through the HEAL Initiative under PA-18-573PA-18-574, PA-18-575, PA-18-576PAR-18-617, and PAR-18-618 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 for research through the HEAL Initiative related to opioid addition, development of opioid alternatives, pain management and addiction treatment 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 funded through the HEAL Initiative:

Cost matching or documented in-kind contributions is required for for-profit organizations funded through the HEAL Initiative for research related to opioid addition, development of opioid alternatives, pain management and addiction treatment.  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: HEAL Initiative

 For-profit applicants for research related to opioid addition, development of opioid alternatives, pain management and addiction treatment seeking funding through the HEAL Initiative 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

Budget and Period of Support

Additional language:

Specific to this FOA:

For research related to opioid addition, development of opioid alternatives, pain management and addiction treatment seeking funding through the HEAL Initiative: How likely is it that the plans for cost matching will be adequate?

Part 2, Section VI, Award Administration Information, Award Notices

Additional language:

Special award condition specific to this FOA: A grantee from a for-profit organization funded through the HEAL Initiative for research related to opioid addiction, development of opioid alternatives, pain management and addiction treatment 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.  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:

NIH requires that SBIR/STTR grantees submit the following reports within 90 days of the end of the grant budget period unless the grantee is under an extension. 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.

Revised language:

NIH requires that SBIR/STTR grantees submit the following reports within 90 days of the end of the grant budget period unless the grantee is under an extension. 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.

All other aspects of the FOA remain unchanged.

Inquiries

Please direct all inquiries to:

Stephanie Fertig, MBA
National Institute of Neurological Disorders and Stroke (NINDS)
Telephone:301-496-1779
Email: fertigs@ninds.nih.gov

Elena Koustova, PhD, MBA
National Institute on Drug Abuse (NIDA)
Telephone: 301-496-8768 
Email: koustovae@mail.nih.gov