Ins and Outs of SBIR Grants and Contracts. A Grants Manager Perspective

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Ins and Outs of SBIR Grants and Contracts A Grants Manager Perspective Andre D. Walker Outline Differences Between a Grant and Contract Eligibility Budget Just In Time Post Award Activities 1

So What s Different? Contracts Versus Grants Scope of the proposal Omnibus Solicitation for SBIR Grants Investigator-defined (within mission of NIH) Solicitation for SBIR Contracts Defined by the NIH (focused topics) Solicitation Frequency January, April, September ~ August (Once per year) Questions pre-award? Basis for Award May speak with Program Officer and Grants Management Specialist Priority Score/Programmatic Review MUST contact the contracting officer Proposal Scores, PO review, Negotiations with Offeror Submission Electronic (Grants.gov) Paper Submission Awardee Dashboard era Commons No dashboard Reporting Phase II transition Set-aside of funds for particular areas? Final report (Phase I); Annual progress reports (Phase II) May apply as soon as Phase I aims are completed NO Monthly/Quarterly progress reports All contractors invited by the NIH 1x/year to submit Phase II proposal* YES Organization Eligibility A For-Profit legally formed in the US More than 50% directly owned & controlled by citizens or permanent resident aliens of the US No more than 500 employees More than 50% owned by multiple venture capital (VC) operating companies; not more than 50% owned by any single VC, hedge fund or private equity firm. APPLIES TO SBIR ONLY. 2

Budget Phase I & II Total Funding Support Phase I - $150,000/$225,000 (Hard Cap) Phase II - $1,000,000/$1,500,000 (Hard Cap) Waiver Topics required for cost over $225,000 and $1.5M. Third Party Agreements (consultants, consortium participants, contractors, etc.) Phase I SBIR: May not exceed 33% of total funds requested (direct, indirect, fee) Phase II SBIR: May not exceed 50% of the total funds requested (direct, indirect, fee) Phase I & II STTR: Minimum Performance 30%research institution / 40% small business Get Your Award Sooner Just In Time Information - Current Other Support - Certifications SBIR/STTR Funding Agreement Financial Systems Questionnaire Vertebrate Animal Subjects Human Subjects SBA Company Registry Venture Capital Operating Companies ORI Assurance 3

Just In Time: Other Support Person Months Grant Number/PI Approved Performance Dates/Annual DC Pending Just In Time: Other Support Identifying Overlap 4

Just In Time: SBIR Funding Agreement Certification Grant Number & PI Name Just In Time: SBIR Funding Agreement Certification What does this mean?? 5

Just In Time: SBIR Funding Agreement Certification 14. It is a Covered Small Business Concern (a small business concern that: (a) was not majorityowned by multiple venture capital operating companies (VCOCs), hedge funds, or private equity firms on the data on which it submitted an application in response to an SBIR solicitation; and (b) on the date of the SBIR award, which is made more than 9 months after the closing date of the solicitation, is majority-owned by multiple venture capital operating companies, hedge funds, or private equity firms). Just In Time: SBIR Funding Agreement Certification 6

Just In Time: Financial Systems Questionnaire Evaluation of Financial Management Systems Accounting Internal Controls Budgetary Controls Just In Time: Human Subjects Involvement Institutional Review Board (IRB) Approval If the HS research is conducted by a subcontract; the subcontractor s IRB is sufficient Human Subjects Research Assurance Federalwide Assurance (FWA) http://www.hhs.gov/ohrp/register-irbs-and-obtainfwas/fwas/file-a-new-fwa/ Human Education Certifications Anyone involved in the design or conduct of HS research Includes third-party subcontracts NIH provides a free tutorial which satisfies the training requirement https://phrp.nihtraining.com/users/login.php 7

Just In Time: Vertebrate Animal Subjects Involvement Vertebrate Animal Subjects Research Assurance OLAW (Office of Laboratory Animal Welfare) Must be received prior to conducting any animal research Institutional Animal Care and Use Committee (IACUC) Approval Provides guidance and oversight of animal care program to maintain compliance with laws, regulations and policies Post Award Review your Notice of Award - Account Setup Contact Payment Management System (PMS) https://pms.psc.gov/grant_recipients/grantrecipientinfo.ht ml - Terms and Conditions - Closeout Talk to your Program Official Talk to your Grants Management contact Maintain your SAM registration (annually) 8

Rule of Thumb Whenever an awardee contemplates a postaward change and is uncertain about the need for prior approval, they should consult, in advance, with: Written policies and regulations - i.e. NIH Grants Policy Statement Grants Management Specialist - named in your award s era Commons record SBIR/STTR Final Reporting Requirements Final Progress Report (see the NOT-OD-12-152 for current requirements) - http://grants.nih.gov/grants/funding/sbirsttr1/2014-2_sbir-sttr-topics.pdf Final Invention Statement and Certification (HHS 568) - http://grants.nih.gov/grants/hhs568.pdf Federal Financial Report (FFR) - http://era.nih.gov/files/ffr_user_guide.pdf 9

Andre Walker Grants Management Specialist NHLBI, NIH walkera@mail.nih.gov 10