Notice of Removal of Matching Requirements for RFA-NS-18-046 Analytical and/or Clinical Validation of a Candidate Biomarker for Pain (R61/R33 Clinical Trial Optional)

Notice Removal Matching Requirements RFA-NS-18-046 Analytical and/or Clinical Validation a Candidate Biomarker Pain R61/R33 Clinical Trial Optional)” Notice Number: NOT-NS-19-037 Key Dates Release Date: March 6, 2019 Related Announcements RFA-NS-18-046 Issued National Institute Neurological Disorders Stroke NINDS) Purpose purpose this notice to inform applicants the removal the Cost Matching Requirement Instructions for RFA-NS-18-046 “Analytical and/or Clinical Validation a Candidate Biomarker Pain R61/R33 Clinical Trial Optional)”. will longer a Cost Matching Requirement this Funding Opportunity Announcement FOA).  Notice only applies the November 25, 2019 application due date subsequent application due dates. Currently Reads: Section III. Eligibility Information 2. Cost Sharing FOA does require cost sharing defined the NIH Grants Policy Statement. grantees a for-profit organization, FOA does require cost sharing, defined the NIH Grants Policy Statement. information cost matching requirements in Section IV.2 R&R Modular Budget. Modified Read: Section III. Eligibility Information 2. Cost Sharing FOA does require cost sharing defined the NIH Grants Policy Statement. grantees a for-profit organization, FOA does not-require cost sharing. Currently Reads: Section IV. Application Submission Information 2. Content Form Application Submission R&R Budget:  instructions the SF424 R&R) Application Guide must followed. Cost Matching Requirement For-profit Applicants Cost matching documented in-kind contributions required for-profit organizations responding this FOA.  for-profit awardee required match funds provide least 50% matching funds documented in-kind contributions a rate not less 50% the the total-Federally awarded amount direct costs, well facilities administrative costs), stipulated Public Law 115-141, Consolidated Appropriations Act 2018.   Federal funds not used a source matching funds. Generally, cost matching requirements not met the following sources: a) Costs borne another Federal grant sub award; b) Costs contributions toward cost sharing another Federal grant, Federal procurement contract, any award Federal funds; c) Cost services property financed income earned contractors under contract the recipient sub recipient); d) Program income; e) Patient incentives. for-profit organization be required demonstrate matching funds and/or in-kind contributions committed available the time of, for duration of, award. Applicants must submit budgets clearly document total costs, source amount matching funds, how valuation determined the case in-kind contributions, well the Federal Institutional non-Federal) components the budget. matching funds and/or in-kind contributions must used the portion allowable project costs paid Federal funds under grant award.  NIH not the recipient, nor serve a pass-through entity, any such matching funds and/or in-kind contributions required under announcement.  45 CFR 75.306 additional details. Budget Justification: All for-profit applicants must document matching non-Federal) component the federal non-matching) component the total project budget. is, requested budget plus cost-matching budget must detailed tabular format document cost-matching non-Federal) component the federal non-cost matching) component. amount matching subject adjustment based total allowable costs incurred.  costs contributions used satisfy matching requirement must documented the recipient, including the value in-kind contributions determined, are subject audit. cost matching requirement not negotiable for-profit organizations. Modified Read: Section IV. Application Submission Information 2. Content Form Application Submission R&R Budget:  instructions the SF424 R&R) Application Guide must followed. Currently Reads: Section IV. Application Submission Information 2. Content Form Application Submission PHS 398 Research Plan Letters Support: Applicants should include letters support consultants, contractors, collaborators. applying an academic institution, include letter support the technology transfer official will managing intellectual property associated this project. research be performed more one institution, include letter support each institution clarifying intellectual property be shared otherwise managed across institutions. collaborating a private entity, include letter support addresses any agreement provide agent(s), any limits the studies can performed said agent(s), any limitations sharing data including negative results), whether licensing agreement(s) be needed in place once project funded. letter should from designated official within private entity has authority speak these issues. an application plans utilize infrastructure resources existing projects, whether funded the NIH, governmental non-governmental entities, letters support detailing terms collaboration data sharing must included. utilization extant samples proposed a component the study, letters support approval use those samples should included. For-profit applicants must include letter(s) support confirming the required secured cost matching cash; in-kind commitments such salary, consultant costs, equipment) available confirm the essential personnel the authority within organization allocate resources.  Modified Read: Section IV. Application Submission Information 2. Content Form Application Submission PHS 398 Research Plan Letters Support: Applicants should include letters support consultants, contractors, collaborators. applying an academic institution, include letter support the technology transfer official will managing intellectual property associated this project. research be performed more one institution, include letter support each institution clarifying intellectual property be shared otherwise managed across institutions. collaborating a private entity, include letter support addresses any agreement provide agent(s), any limits the studies can performed said agent(s), any limitations sharing data including negative results), whether licensing agreement(s) be needed in place once project funded. letter should from designated official within private entity has authority speak these issues. an application plans utilize infrastructure resources existing projects, whether funded the NIH, governmental non-governmental entities, letters support detailing terms collaboration data sharing must included. utilization extant samples proposed a component the study, letters support approval use those samples should included. Currently Reads: Section V. Application Review Information 1. Criteria Additional Review Considerations Budget Period Support  Reviewers consider whether budget the requested period support fully justified reasonable relation the proposed research.  Specific this FOA: likely it the plans cost matching be adequate? Modified Read: Section V. Application Review Information 1. Criteria Additional Review Considerations Budget Period Support  Reviewers consider whether budget the requested period support fully justified reasonable relation the proposed research. Currently Reads: Section VI. Award Administration Information 3. Reporting multiple years involved, awardees be required submit the Research Performance Progress Report RPPR) annually financial statements required the NIH Grants Policy Statement. multiple years involved, awardees be required submit the Research Performance Progress Report RPPR) annually financial statements required the NIH Grants Policy Statement. final Research Performance Progress Report F-RPPR), invention statement, the expenditure data portion the Federal Financial Report, including Federal non-Federal share cost matching, required closeout an award, described the NIH Grants Policy Statement. Special award condition specific this FOA: grantee a for-profit organization funded under announcement must match funds provide documented in-kind contributions a rate not less 50% the total-Federally awarded amount, stipulated Public Law 115-141, Consolidated Appropriations Act 2018. 45 CFR 75.306 additional details. Matching funds must non-Federal funds set aside this project are available the source(s) identified the application, committed by recipient. Cost matching be evaluated the awarding office ensure this requirement being met. Compliance the matching requirement must verified an annual basis must documented the annual final FFR. final RPPR, invention statement, the expenditure data portion the Federal Financial Report required closeout an award, described the NIH Grants Policy Statement. Federal Funding Accountability Transparency Act 2006 Transparency Act), includes requirement awardees Federal grants report information first-tier subawards executive compensation under Federal assistance awards issued FY2011 later.  awardees applicable NIH grants cooperative agreements are required report the Federal Subaward Reporting System FSRS) available at www.fsrs.gov on subawards over 25,000.  the NIH Grants Policy Statement for additional information this reporting requirement. accordance the regulatory requirements provided 45 CFR 75.113 Appendix XII 45 CFR Part 75, recipients have currently active Federal grants, cooperative agreements, procurement contracts all Federal awarding agencies a cumulative total value greater 10,000,000 any period time during period performance a Federal award, must report maintain currency information reported the System Award Management SAM) about civil, criminal, administrative proceedings connection the award performance a Federal award reached final disposition within most recent five-year period.  recipient must also semiannual disclosures regarding such proceedings. Proceedings information be publicly available the designated integrity performance system currently FAPIIS).  is statutory requirement under section 872 Public Law 110-417, amended 41 U.S.C. 2313).  required section 3010 Public Law 111-212, information posted the designated integrity performance system or after April 15, 2011, except past performance reviews required Federal procurement contracts, be publicly available.  Full reporting requirements procedures found Appendix XII 45 CFR Part 75 – Award Term Conditions Recipient Integrity Performance Matters. Modified Read: Section VI. Award Administration Information 3. Reporting multiple years involved, awardees be required submit the Research Performance Progress Report RPPR) annually financial statements required the NIH Grants Policy Statement. final RPPR, invention statement, the expenditure data portion the Federal Financial Report required closeout an award, described the NIH Grants Policy Statement. Federal Funding Accountability Transparency Act 2006 Transparency Act), includes requirement awardees Federal grants report information first-tier subawards executive compensation under Federal assistance awards issued FY2011 later.  awardees applicable NIH grants cooperative agreements are required report the Federal Subaward Reporting System FSRS) available at www.fsrs.gov on subawards over 25,000.  the NIH Grants Policy Statement for additional information this reporting requirement. accordance the regulatory requirements provided 45 CFR 75.113 Appendix XII 45 CFR Part 75, recipients have currently active Federal grants, cooperative agreements, procurement contracts all Federal awarding agencies a cumulative total value greater 10,000,000 any period time during period performance a Federal award, must report maintain currency information reported the System Award Management SAM) about civil, criminal, administrative proceedings connection the award performance a Federal award reached final disposition within most recent five-year period.  recipient must also semiannual disclosures regarding such proceedings. Proceedings information be publicly available the designated integrity performance system currently FAPIIS).  is statutory requirement under section 872 Public Law 110-417, amended 41 U.S.C. 2313).  required section 3010 Public Law 111-212, information posted the designated integrity performance system or after April 15, 2011, except past performance reviews required Federal procurement contracts, be publicly available.  Full reporting requirements procedures found Appendix XII 45 CFR Part 75 – Award Term Conditions Recipient Integrity Performance Matters. other aspects this FOA remain unchanged. Inquiries Please direct inquiries to: Mary Ann Pelleymounter, PhD  National Institute Neurological Disorders Stroke NINDS) Telephone: 301-496-1779  Email: mary.pelleymounter@nih.gov