1 / 39

SBIR Grants and Contracts: “All Things SBIR”

SBIR Grants and Contracts: “All Things SBIR”. Sustaining Distance Learning MCHB DL Grantees May 27, 2011. Augie Diana, NIDA 301-443-1942 dianaa@nida.nih.gov. NIDA. NATIONAL INSTITUTE ON DRUG ABUSE. NIH Staff Roles and Responsibilities for SBIR Grants and Contracts.

judson
Download Presentation

SBIR Grants and Contracts: “All Things SBIR”

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  1. SBIR Grants and Contracts: “All Things SBIR” Sustaining Distance Learning MCHB DL Grantees May 27, 2011 Augie Diana, NIDA 301-443-1942 dianaa@nida.nih.gov NIDA NATIONAL INSTITUTE ON DRUG ABUSE

  2. NIH Staff Roles and Responsibilities for SBIR Grants and Contracts • Program/Project Officer (PO) • Grant applicants’ primary contact for SBIR grant applications. • Can’t be a member of a Scientific Review Group either for Contract concept approval or the review of proposals/ grant applications • May not join in the technical discussions at the review • Works with Contract Specialist to develop broad agency announcement; after award, monitors progress and performance. • Contracting Officer (CO) • Primary contact/guide for potential and actual contract proposal offerors, both before and after the receipt and review of SBIR contract proposals • Scientific Review Officer (SRO) • Grant applicants’ primary contact after the receipt of SBIR grant applications • Selects and instructs scientific review groups • Summarizes results of reviews • Grants Management (GM) Specialist • Assures that budget and administrative issues are addressed and makes awards for grants

  3. SMALL BUSINESS INNOVATION RESEARCH PROGRAM (SBIR) • Established in 1982 • 2.5% set-aside of extramural budget • Domestic small businesses • Engage in research/research and development that has the potential for commercialization • 51% of work must be conducted by the small business • The PI must have his/her primary employment with the small business • Grants (65% of budget) and contracts (35% of budget)

  4. SMALL BUSINESS TECHNOLOGY TRANSFER PROGRAM (STTR) • Established in 1992 • 0.3% set-aside of extramural budget • Domestic small businesses • Partnership between small business and universities and/or other non-profits • Engage in research/research and development that has the potential for commercialization • 40% of work must be conducted by small business • 30% of work must be conducted by the university or other nonprofit • Primary employment of the PI is not stipulated • Grants only

  5. SBIR & STTR Programs Goals • Stimulate technological innovation in the private sector • Strengthen the role of small business in meeting Federal research or research and development needs • Increase the commercial application of Federally-supported research results • Foster and encourage participation by socially and economically disadvantaged small business concerns and women-owned business concerns in the SBIR program • Improve the return on investment from Federally-funded research for economic and social benefits to the Nation

  6. SBIR/STTR GRANTS • Phase I – R43 and R41 • Establish technical feasibility and potential for commercialization of the project • Determine quality of performance of the small business • 6 months • $100K

  7. SBIR/STTR GRANTS • Phase II – R44 and R42 • Continue projects initiated in Phase I • More extensive R&D to further develop scientific merit and commercial potential • 2 years • $750K • Phase II Continuation • Advanced stage development of pharmacological treatment agents for drug and nicotine abuse and addiction • Bridge the “valley of death” • 3 years • $750K/year

  8. SBIR/STTR GRANTS • 3 submission dates/year – April 5, August 5, December 5 • Review conducted by CSR • Total Budget (approximate) ~ $25,000,000 • Success rate in FY09: • R43 - 21% of applications were funded (18) • R44 – 28% of applications were funded (9) • R41 - 60% of applications were funded (6) • R42 – 0% of applications were funded

  9. SBIR/STTR Omnibus Grant Solicitation • NIH publishes a listing of each ICs program areas of interest. • NIDA can ensure that grants in a particular area are assigned to us by including that topic in the solicitation. • Potential grantees use this to determine which IC might be interested in their project – will frequently call the PO. • Division SBIR contacts put together the NIDA program areas that are included in the solicitation. If you have a program area of interest that is not included in the omnibus solicitation, let your division SBIR contact know. • The current omnibus solicitation can be found at: http://grants.nih.gov/funding/sbir.htm • Note that the current solicitation is being updated and the new one will be out soon. • Potential grantees who are interested in a topic that isn’t included in the solicitation can still apply. • Applicants can include a cover letter requesting a NIDA assignment

  10. SBIR/STTR RFAs and PAs • In addition to the Omnibus Solicitation, NIDA is currently on numerous PAs and RFAs under the SBIR/STTR program • Likewise, if there is an already existing PA or RFA that NIDA should be on but isn’t, contact the IC that issued the PA to see if NIDA can be included. • http://grants.nih.gov/grants/funding/sbir_announcements.htm#recovery

  11. Role of NIDA Project Officers in the SBIR/STTR Grant Program • Similar to R01s but… • Potential applicants frequently are not familiar with NIH grant writing and may need coaching/help with putting an application together • Applicants are sometimes from a very small business that relies on SBIR/STTR funding for payrolls etc. – so may contact NIDA POs frequently to determine funding status. Note that NIH tries to fund SBIR/STTR applications more quickly than R01s but often isn’t able to. • NIDA program staff review the progress reports for SBIR/STTR grants similarly to how they review those for an R01 – but a marketable product should be developed rather than (or in addition to) papers. • Frequently have more contact with SBIR grantees than with other grantees at NIDA – this is a good opportunity for NIDA program to keep up on what is being developed and how it might impact the field.

  12. SBIR CONTRACTS • One submission date/year – usually early November • Contract solicitations are generally more specific than grant solicitations • Contract concepts are proposed by program staff • Generally 10-14 contract concepts/year • Reviewed by NIDA – coordinated by Lyle Furr. NIDA review helps to ensure that the reviewers are the best for your solicitation. • Unlike grants, NIDA program CANNOT communicate with applicants about the SBIR Contract Solicitation.

  13. SBIR CONTRACTS • Phase I – N43, • Establish technical feasibility and potential for commercialization of the project • Determine quality of performance of the small business • 6 months • $100K

  14. SBIR CONTRACTS • Phase II – N44 • Continue projects initiated in Phase I • More extensive R&D to further develop scientific merit and commercial potential • 2 years • $750K

  15. SBIR CONTRACTS • FY09 • ~$6,771,000 • 9 phase I contracts awarded • 11 phase II contracts awarded • FY10 contract solicitation is now on the street – there are 14 contracts topics (keep in mind, you can’t talk with offerors!)

  16. Manual for SBIR Contract Idea Development • NIDA’s “Bridging Science and Business Workgroup” is developing a “how to” for NIDA staff to use when developing a contract concept • Goes through concept development, how to determine whether the concept is better as a grant or contract, etc. • Once fully developed, it will be available for all NIDA staff

  17. REAUTHORIZATION BILLS • SBIR program is under a continuing resolution • H.R. 2965 • Increases the award level to $250,000 for phase I and $2 million for phase II • No increase in the amount agencies must put into the SBIR/STTR program • S. 1233 • Increases the award level to $150,000 for phase I and $1 million for phase II • Limits awards from exceeding 50% above recommended levels • Increases the SBIR set-aside to 3.5% over the period FY 2011-2020 and STTR set-aside from 0.3% to 0.6% from FY2011-2015

  18. Small Business Administration • www.sba.gov/aboutsba/sbaprograms/sbir/index.html

  19. DIVISION SBIR CONTACTS • DESPR – Augie Diana, Ph.D. • DCNBR – Cece Spitznas, Ph.D. • DPMCDA – Kris Bough, Ph.D. • CCTN - Quandra Scudder • DBNBR – Elena Koustova, Ph.D. • OSPC – Cathrine Sasek, Ph.D.

  20. Additional Review Criteria for R43/R44 SBIR Grant Applications • Hyperlink: http://grants.nih.gov/grants/funding/sbirsttr_ReviewCriteria.htm • Phase II Applications • How well did the applicant demonstrate progress toward meeting the Phase I objectives, demonstrating feasibility, and providing a solid foundation for the proposed Phase II activity? • Did the applicant submit a concise Commercialization Plan that adequately addresses the specific areas described in Item K of the Phase II Research Plan? • Does the project carry a high degree of commercial potential, as described in the Commercialization Plan?

  21. Additional Review Criteria for R43/R44 SBIR Grant Applications • Hyperlink: http://grants.nih.gov/grants/funding/sbirsttr_ReviewCriteria.htm • Phase I/Phase II Fast-Track Applications • Does the Phase I application specify clear, appropriate, measurable goals (milestones) that should be achieved prior to initiating Phase II? • Did the applicant submit a concise Commercialization Plan that adequately addresses the specific areas described in Item K of the Phase II Research Plan? • To what extent was the applicant able to obtain letters of interest, additional funding commitments, and/or resources from the private sector or non-SBIR/STTR funding sources that would enhance the likelihood for commercialization? • Does the project carry a high degree of commercial potential, as described in the Commercialization Plan?

  22. Additional Review Criteria for R43/R44 SBIR Grant Applications • Hyperlink: http://grants.nih.gov/grants/funding/sbirsttr_ReviewCriteria.htm • Phase II Competing Renewal Application • PA-09-080 • Did the applicant submit a concise Commercialization Plan that adequately addresses the specific areas described in the SF 424 (R&R) SBIR/STTR Application Guide and the SBIR/STTR information component? • Does the project carry a high degree of commercial potential, as described in the Commercialization Plan?

  23. Review of SBIR Contract Proposals Acquisition Process • SBIR Concept Reviews (May – June) • SBIR Omnibus Solicitation (August; NIDA has had around 14 topics per year: hyperlink- http://grants.nih.gov/grants/guide/notice-files/NOT-OD-09-137.html • Scientific Review Group Review. SRO identifies reviewer expertise including business expertise; recruits reviewers according to FACA requirements, instructs and oversees reviewers, and prepares Technical Evaluation Report. • The Contracting Officer oversees the acquisition process, working with Program (January – August)

  24. SBIR Contract Technical Evaluation Criteria - PHASE I

  25. SBIR Contract Technical Evaluation Criteria - PHASE II

  26. Technical Acceptability Rating of Contract Proposals • The final SRG contracts review meeting task is to determine the technical acceptability or unacceptability of the proposals. • If an offeror's proposal indicates sufficient technical understanding and capabilities to fulfill the specifications of the FOA, the members should recommend that it is acceptable. • If on the other hand, the proposal demonstrates a significant lack of understanding or ability to perform required tasks, it should be considered unacceptable. • The SRG should consider the potential for correcting minor weaknesses or deficiencies. Proposals rated as acceptable should not require major revisions. Use of predetermined cut-off scores is not permitted. (Hyperlink: 6315-1 - Initiation, Review, Evaluation and Award of R&D Contracts; NIH Policy Manual)

  27. Contrasts between SBIR Grant Summary Statement and SBIR Contract Technical Evaluation Report • The summary statement for SBIR grants is like those for traditional grants, with an SRO-prepared Resume and assigned reviewers’ detailed critiques with lists of Strengths and Weaknesses and 1-9 scores by each reviewer for each criterion and a 10-90 average overall Impact Score. • The technical evaluation report for SBIR contracts is a consolidated summary of all of the reviewers’ comments for all of the offerors. Numerical scores are 0-100 for each proposal without break-downs by evaluation criteria, and each proposal is reported as either technically acceptable or unacceptable. • The summary statement and detailed scores for SBIR grants is made available to applicants and Program staff in eCommons. • After SBIR contract proposal reviews, offerors receive from the Contracting Officer, a summary of the part of the TER relevant to their proposal, without numbers for each criterion.

  28. SBIR in the Contracts Arena • The objectives of the SBIR program include • Stimulating technological innovation in the private sector, • Strengthening the role of small business in meeting Federal R&D needs, • Increasing private sector commercialization of innovations developed through Federal SBIR R&D, • Increasing small business participation in Federal R&D, and • Fostering and encouraging participation by socially and economically disadvantaged small business concerns and women-owned small business concerns in the SBIR program. (page 1 Solicitation) • Hyperlink: http://grants.nih.gov/grants/funding/SBIRContract/PHS2010-1.pdf

  29. SBIR in the Contracts Arena (Continued) • Phase I- The objective of Phase I is to determine the scientific or technical feasibility and commercial merit of the proposed research or R&D efforts and the quality of performance of the small business concern, prior to providing further Federal support in Phase II. Phase I awards normally may not exceed $100,000 for direct costs, indirect costs, and profit (fixed fee) for a period normally not to exceed 6 months. (page 1 Solicitation) • Hyperlink: http://grants.nih.gov/grants/funding/SBIRContract/PHS2010-1.pdf

  30. SBIR in the Contracts Arena (Continued) • Phase II –The objective is to continue the research or R&D efforts initiated in Phase I. Funding shall be based on the results of Phase I and the scientific and technical merit and commercial potential of the Phase II proposal. Phase II awards normally may not exceed $750,000 for direct costs, indirect costs, and profit (fixed fee) for a period normally not to exceed two years. Phase II proposals may only be submitted upon the request of the Contracting Officer, if not submitted concurrently with the initial Phase I proposal under the Fast-Track procedure (described in Section 5). Only one Phase II award may result from a single Phase I SBIR contract. (page 2 Solicitation) • Hyperlink: http://grants.nih.gov/grants/funding/SBIRContract/PHS2010-1.pdf

  31. SBIR in the Contracts Arena (Continued) • Differs from grants - Communication, Competition, Collaboration (with Technical Staff) • Communications/Contracts Office only P.O.C./ Contracts Office Outreach • Importance in ensuring fair competition

  32. SBIR in the Contracts Arena (Continued) • Frequently Asked Questions: • advice? • is more information available? • Technical information limited to topic • Individual proposal preparation, unique, innovative (as SBIR program implies), not sponsored • electronic submission?

  33. SBIR in the Contracts Arena (Continued) • Things Potential Offerors can do after Solicitation is released: • Familiarize with entire solicitation • Ask clarification questions in order to properly understand formatting, • Ask how you will be evaluated, • Ask how the process will work

  34. SBIR in the Contracts Arena (Final) • Acquisition Process: • Solicitation → Screening → Proposal review → Program evaluation and selection input → potential negotiations → award → debriefings

  35. Pre-award and Post-award Accounting and Budget Oversight. Websites. NIDA and the grantees are responsible for the stewardship of Federal funds. I. Pre-award A. Financial systems and personnel policies must be in place. For example, time and effort reporting is required, and the company policy must state that the nature of the work determines the distributions of time—not the availability of funding, mechanism or other reasons. The policy is spelled out in the instructions for the grantee. Documentation is required. B. Instructions can be found in the application. 1. DUNS number 2. EIN/IRS number 3. Animal/humans subjects requirements 4. Other support/effort—express in person months 5. Page limits—see new policy NOT-OD-09-145 for all due dates after January 2010—currently Phase I: 15 pages, Phase II: 25 pages, and fast-track: 25 pages. New forms: Phase I: 6 pages, Phase II and fast-track: 12 pages.

  36. Grants Management (Cntd) 6. Problem—some organizations won’t release PI for work on SBIR/STTR 7. New organizations or PIs may not understand the policy and procedures; they can find guidelines through the NIH Welcome Wagon Letter for New Grantees found on the NIH website 8. Sometimes it can take six months to fund an SBIR/STTR before all required documentation has been received 9. Other clearances such as office of research integrity (ORI), civil rights are certified by the grantee when the application is signed 10. The Verification Statement and rest of JIT must be sent in prior to award. SBIRs/STTRs are governed by legislations, and requirements differ from research grants 11. Phase I and Phase II applicants may request up to 40% of total direct costs for facility and administrative (F&A) costs. Greater rates must be negotiated with the Division of Financial Advisory Services (DFAS) at NIH. DFAS negotiates rates for the NIH for-profit organizations only. 12. This is a catch-22, because the grantee must complete the grant work with a provisional rate before the DFAS can finalize the rate.

  37. Grants Management (Post-Award) II. Post-award • The grantee “per regulations, a for-profit (commercial) organization is subject to audit requirements for a non-Federal audit if, during its fiscal year, it expended $500,000 or more under DHHS awards and at least one award is a DHHS grant.” Audits must be completed and submitted within a period that is either the earlier of 30 days after receipt of the auditor’s report(s) or nine months after the end of the audit period or the organization’s fiscal year and sent to: • National External Audit Resources, DHHS Office of Audit Services, Lucas Place, • 323 West 8th Street, Room 514, Kansas City, MO 64105 • Frequently there will be name changes or successors-in-interest and changes of institution. This could mean the revisiting of the entire setup—financial and personnel systems evaluation, F&A rate agreement, new EIN, even sometimes a new PI. This is not simple, because other offices are involved to make the changes in the system. The Institute may have to reevaluate the continuation of the grant. • Finalization of the rate agreement could mean a higher rate and greater amount of funds requested. DFAS and NIDA will sometimes allow the DFAS estimated rate to be used for either provisional rate or restricted until the rate agreement has been negotiated. Reimbursement for final rate may be accomplished provided funds are available.

  38. Grants Management General Guide • Program and grants management work as a team to ensure the meeting of the application research objectives and compliance with NIH policy. • Grant funds must be allocable, allowable, and reasonable. • The grantees may contact grants management for administrative issues and program for scientific issues.

  39. Grants Management • “Implementing the final Phase of Enhancing Peer Review,” Megan Columbus, EPMC September 2, 2009—See Teri Levitin’s September 3, 2009 email, its attached power point, and Enhancing Peer Review Notice in NIH Guide http://grants.nih.gov/grants/guide/notice-files/not-od-09-149.html • “Grants to For-Profit Organizations,” NIH Policy Statement • http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part13.htm#_Toc54600282 • “Small Business Innovation Research and Small Business Technology Transfer Programs,” NIH Policy Statement • http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part13.htm#_Toc54600295 • Office of Acquisition Management and Policy at National Institutes of Health: DFAS-FAQ: “Non-Federal Audit Requirements for Commercial (For-Profit) Organizations”: • http://oamp.od.nih.gov/dfas/faqforprofitaudits.asp •  Indirect Cost Submission to DFAS, basic information: • http://oamp.od.nih.gov/dfas/IdCSubmission.asp • Office of Extramural Research: Small Business Research Funding Opportunities • http://grants.nih.gov/grants/funding/sbir.htm

More Related