SBIR Grants and Contracts: “All Things SBIR”

SBIR Grants and Contracts: “All Things SBIR”

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Augie Diana, NIDA301-443-1942

[email protected] INSTITUTE

ON DRUG ABUSE

NIDA

Sustaining Distance LearningMCHB DL Grantees

May 27, 2011

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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

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SMALL BUSINESS INNOVATION RESEARCH PROGRAM (SBIR)

Established in 19822.5% set-aside of extramural budgetDomestic small businessesEngage in research/research and development that has

the potential for commercialization51% of work must be conducted by the small businessThe PI must have his/her primary employment with the

small businessGrants (65% of budget) and contracts (35% of budget)

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SMALL BUSINESS TECHNOLOGY TRANSFER PROGRAM (STTR)

Established in 19920.3% set-aside of extramural budgetDomestic small businessesPartnership between small business and universities and/or other

non-profitsEngage in research/research and development that has the

potential for commercialization40% of work must be conducted by small business30% of work must be conducted by the university or other

nonprofitPrimary employment of the PI is not stipulatedGrants only

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SBIR & STTR Programs Goals

Stimulate technological innovation in the private sectorStrengthen the role of small business in meeting Federal

research or research and development needsIncrease the commercial application of Federally-

supported research resultsFoster 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

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SBIR/STTR GRANTSPhase 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

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SBIR/STTR GRANTSPhase II – R44 and R42

Continue projects initiated in Phase IMore extensive R&D to further develop scientific merit and

commercial potential2 years$750K

Phase II ContinuationAdvanced stage development of pharmacological treatment

agents for drug and nicotine abuse and addictionBridge the “valley of death”3 years$750K/year

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SBIR/STTR GRANTS3 submission dates/year – April 5, August 5,

December 5Review conducted by CSRTotal 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

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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

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SBIR/STTR RFAs and PAsIn 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

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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 togetherApplicants 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.

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SBIR CONTRACTSOne submission date/year – usually early NovemberContract solicitations are generally more specific

than grant solicitationsContract concepts are proposed by program staffGenerally 10-14 contract concepts/yearReviewed 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.

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SBIR CONTRACTSPhase I – N43,Establish technical feasibility and potential for

commercialization of the projectDetermine quality of performance of the small

business6 months$100K

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SBIR CONTRACTSPhase II – N44

Continue projects initiated in Phase IMore extensive R&D to further develop scientific merit

and commercial potential2 years$750K

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SBIR CONTRACTSFY09

~$6,771,000 9 phase I contracts awarded11 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!)

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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

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REAUTHORIZATION BILLSSBIR program is under a continuing resolutionH.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 IILimits 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

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Small Business Administrationwww.sba.gov/aboutsba/sbaprograms/sbir/

index.html

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DIVISION SBIR CONTACTSDESPR – Augie Diana, Ph.D.DCNBR – Cece Spitznas, Ph.D.DPMCDA – Kris Bough, Ph.D.CCTN - Quandra ScudderDBNBR – Elena Koustova, Ph.D.OSPC – Cathrine Sasek, Ph.D.

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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?

http://grants.nih.gov/grants/funding/sbirsttr_ReviewCriteria.htm

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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?



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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?



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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)

http://grants.nih.gov/grants/guide/notice-files/NOT-OD-09-137.html

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SBIR Contract Technical Evaluation Criteria - PHASE I

FACTORS FOR PHASE I PROPOSALS WEIGHT

1. The soundness and technical merit of the proposed approach and identification of clear measurable goals (milestones) to be achieved during Phase I.

For proposals designating multiple PDs/PIs, is the leadership approach, including the designated roles and responsibilities, governance, and organizational structure, consistent with and justified by the aims of the project and the expertise of each of the PDs/PIs? (Preliminary data are not required for Phase I proposals.)

40%

2. The qualifications of the proposed PDs/PIs, supporting staff, and consultants 20%

3. The potential of the proposed research for technological innovation 15%

4. The potential of the proposed research for commercial application. The commercial potential of a proposal will be assessed using the following criteria:

a. Whether the outcome of the proposed research activity will likely lead to a

marketable product or process. b. The offeror’s discussion of the potential barriers to entry and the

Competitive market landscape.

15%

5. The adequacy and suitability of the facilities and research environment. 10%

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SBIR Contract Technical Evaluation Criteria - PHASE II

FACTORS FOR PHASE II PROPOSALS WEIGHT

1. The scientific/technical merit of the proposed research, including adequacy of the approach and methodology, and identification of clear, measurable goals to be achieved during Phase II.

For proposals designating multiple PDs/PIs, is the leadership approach, including the designated roles and responsibilities, governance, and organizational structure, consistent with and justified by the aims of the project and the expertise of each of the PDs/PIs?

30%

2. The potential of the proposed research for commercialization, as documented in the offeror’s Commercialization Plan and evidenced by:

a)the offeror’s record of successfully commercializing its prior SBIR/STTR or other research projects, b) commitments of additional investment during Phase II and Phase III from

private sector or other non-SBIR funding sources, and c) any other indicators of commercial potential for the proposed research.

30%

3. The qualifications of the proposed PDs/PIs, supporting staff and consultants. 25%

4. The adequacy and suitability of the facilities and research environment. 15%

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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)

http://www1.od.nih.gov/oma/manualchapters/contracts/6315-1/

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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.

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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

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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)


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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)


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• Differs from grants - Communication, Competition, Collaboration (with Technical Staff)

• Communications/Contracts Office only P.O.C./ Contracts Office Outreach

• Importance in ensuring fair competition

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• 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?

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• 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

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SBIR in the Contracts Arena (Final)

• Acquisition Process:–Solicitation → Screening →

Proposal review → Program evaluation and selection input → potential negotiations → award → debriefings

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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 number2. 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.

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Grants Management (Cntd)6. Problem—some organizations won’t release PI for work on SBIR/STTR7. 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 website8. Sometimes it can take six months to fund an SBIR/STTR before all required documentation has been received9. Other clearances such as office of research integrity (ORI), civil rights are certified by the grantee when the application is signed10. 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 grants11. 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.

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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.

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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.

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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

http://grants.nih.gov/grants/guide/notice-files/not-od-09-149.html

http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part13.htm#_Toc54600282

http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part13.htm#_Toc54600295

http://oamp.od.nih.gov/dfas/faqforprofitaudits.asp

http://oamp.od.nih.gov/dfas/IdCSubmission.asp

http://grants.nih.gov/grants/funding/sbir.htm

SBIR Grants and Contracts: “All Things SBIR”

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