Best Practices in Funding Extramural Research
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SBIR/STTR Programs

Providing NCI Support for R&D by Small Businesses

Soliciting Applications

Defining the Structure of SBIR and STTR Awards

Applying for SBIR/STTR Awards

Communicating with Applicants

Using Contracts to Achieve SBIR/STTR Goals

Providing NCI Support for R&D by Small Businesses

The Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) programs are set-asides designed to provide an economic incentive for the small business community to undertake projects relevant to the goals of NCI. These programs were established by Congress, and are intended to:

  • Stimulate technological innovation in the private sector.

  • Strengthen the role of small business in meeting federal research and development needs.

  • Increase the commercial application of federally supported research.

  • Encourage technological innovation by socially and economically disadvantaged and woman-owned businesses.

  • Foster cooperative research and development partnerships between small businesses and non-profit research institutions.

Applicants compete for funding, and award decisions are based on the outcome of peer reviews.

Information about NIH SBIR/STTR programs is available at http://grants.nih.gov/grants/funding/sbirsttr_sites.htm. The NCI SBIR/STTR program is coordinated through the Office of Technology and Industrial Relations. For information about these programs, see http://otir.cancer.gov/ir/small_biz.html.

The programs described in this section are mandated by Congress. In addition to participating in these programs, NCI supports the development and testing of new technologies through the Phased Innovation Award and the Phased Technology Award programs, which are funded under the R21/R33 mechanisms. For information about these programs, see Soliciting Applications for Technology Research (R21 and R33) or the Office of Technology and Industrial Relations website identified in the previous paragraph.

Meeting Eligibility Requirements

To be eligible for SBIR or STTR awards, organization must:

  • Be at least 51% owned and independently operated by American citizens.

  • Have no more than 500 employees.

  • Be a for-profit US corporation.

  • Be the primary employer of the principal investigator (SBIRs only).

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Soliciting Applications

Both NIH and NCI have special programs for soliciting applications for SBIR and STTR awards. In addition, PDs are encouraged to use information channels relevant to their programs to notify potential applicants about the availability of such funds.

Using Publications to Solicit Applications

NCI research priority areas are published annually in the "Omnibus Solicitation of the National Institutes of Health, Centers for Disease Control and Prevention, and Food and Drug Administration for Small Business Innovation Research and Small Business Technology Transfer."

Instructions for applicants and application forms are included in the solicitation book. The solicitation book is not issued in hardcopy, but it is available online at http://grants.nih.gov/grants/funding/sbirsttr1/index.pdf.

Using PARs and RFAs to Solicit Applications

The SBIR/STTR programs are important to NCI, but some SBIR/STTR projects require more flexibility in project budgets and duration than is consistent with statutory guidelines.

To support such projects, NCI uses PARs and RFAs to solicit applications from organizations that are eligible to receive grants under the criteria established by Congress. NCI also establishes contracts with eligible organizations. For more information about RFAs, PARs, and contracts in the context of SBIR, see Soliciting Applications for Technology Research (R21 and R33).

Using Outreach Activities to Solicit Applications

To encourage potential applicants to submit applications for SBIR/STTR awards, PDs and other NCI program staff should attend SBIR/STTR conferences to discuss the programs and notify for-profit organizations about the availability of R&D funds through SBIR/STTR programs.

In these discussions, PDs may:

  • Define eligibility and feasibility criteria for applicant organizations and principal investigators.

  • Advise potential applicants as to whether their project ideas are more compatible with the goals and guidelines of the SBIR program or with those of the STTR program.

  • Explain the application and review process.

  • Caution potential applicants about conflict of interest problems.

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Defining the Structure of SBIR and STTR Awards

SBIR and STTR awards are separated into three phases, with each phase depending on the success of the previous phase. Only the first and second phases are eligible for support through set-aside funds. Support for the third phase must come from private sources or from federal sources other than the funds set aside for SBIR/STTR programs.

The activities to be carried out in each phase are as follows:

  • In Phase I, the business undertakes feasibility studies with the goal of providing proof of the technical merit of the R & D work proposed in its application.

  • In Phase II, the business works to develop or improve its product. Phase II applications may be submitted at any time following the Phase I award.

  • In Phase III, the business conducts any additional research that may be needed and commercializes its product.

The Fast Track program allows applicants to apply for Phase I and Phase II funding simultaneously.

Statutory guidelines govern the amount of money that can be awarded to SBIR/STTR applicants for Phase I and Phase II work and also specify the duration of each phase. Deviations from these guidelines are permitted but must be well justified.

The chart below specifies characteristics of and application requirements for Phase I and Phase II awards.

 

SBIR

STTR

Phase I

 

 

Total Cost*

$100,000

$100,000

Duration

Six months

One year

Collaboration**

33% of total cost

Minimum of 30% of total cost
Maximum of 60% of total cost

Application Format
- Budget = $100,000

Modular

Modular

- Budget > $100,000

Traditional

Traditional

 

 

 

Phase II

 

 

Total Cost

$750,000

$500,000

Duration

Up to 24 months

Up to 24 months

Collaboration*

50% of total cost

Minimum of 30% of total cost

Application Format

Traditional

Traditional

* In general, Phase I awards are not to exceed $100,000, but if the project cannot reasonably be accomplished within this limitation, a larger budget may be requested. If the application is approved on merit and the additional funding is justified, larger budgets may be supported. As indicated in the preceding chart, applicants who are seeking more than $100,000 in research funds must submit traditional, rather than modular applications.

** For SBIR grants, collaboration refers to subcontracts, consultants and so on. For STTR grants, collaboration includes a well-defined partnership between the small business and a nonprofit research institution. This agreement must be specified in detail before the award is issued.

Specifying Requirements

Some special requirements apply to both SBIR and STTR applications, and other requirements apply to each type of award individually.

 

Requirements for SBIR and STTR Awards

 
  • The applicant organization, as well as the applicant, must meet eligibility requirements for small business grants.

  • All research supported by SBIR and STTR awards must take place within the United States.

  • The applicant must control access to its research facilities, provide appropriate maintenance, secure data collected during the research, and otherwise protect research equipment and resources.

  • To be eligible for Phase II awards, the small business must have been awarded a Phase I award and must have demonstrated the feasibility of its product during the term of the Phase I award.

 

Additional Requirements for SBIR Awards

 
  • The individual named as the principal investigator must be employed by the applicant organization at at least 51% effort

 

Additional Requirements for STTR Awards

 
  • The individual named as the principal investigator may be employed by the collaborating research institution and must spend a minimum of 10% effort on the work specified in the application.

  • If the individual named as the principal investigator is employed by the collaborating research organization, he or she must have a formal appointment with or commitment to the applicant organization.

  • The applicant organization must perform at least 40% of the research proposed in the application, and the collaborating nonprofit organization must perform at least 30% of the research. The percentage of each organization's contribution is based on its contribution to the project budget.

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Applying for SBIR/STTR Awards

Applications for SBIR and STTR awards may be submitted on or before April 1, August 1, and December 1 of each year.

Potential applicants are encouraged to speak with PDs before they submit applications so as to ensure that they are eligible for an SBIR or STTR award under the statutory guidelines. In most cases, applications are initially funded for Phase I, and only Phase I awardees are eligible to participate in Phase II.

Applicants may, however, request funds for Phase I and Phase II work in a single application. Awards issued for such applications are called Fast Track awards.

Using the Fast-Track Process

The SBIR/STTR program provides an expedited submission and review process. This process is called the Fast Track Process. Under this system, applicants submit plans for both Phase I and Phase II work in a single application, and reviewers consider the merit of the work proposed for both stages.

This process is intended to reduce or eliminate the gap between Phase I and Phase II funding and to encourage rapid transition from the "proof of concept" phase into an expanded development and commercialization phase. It can be used for applications that:

  • Propose work that is of significant value in cancer research and treatment.

  • Propose work with high potential for commercialization.

  • Provide sufficient preliminary data to clearly define milestones that would provide proof of feasibility

An application submitted for Fast Track funding must:

  • Include clear measurable milestones to be achieved before Phase II funding is made available.

  • Include a product development plan, limited to ten pages, which defines the commercial potential based on analyses of the market and competing products or services.

In discussing the Fast Track process with applicants, PDs should point out its limitations. In particular, specifying the schedule for the product development and projecting costs may be difficult without having completed Phase I work, and these uncertainties may affect reviewers' judgments of the application. If members of the SRG are not sufficiently confident that the applicant can achieve the Phase I milestones, they may disapprove the Phase II component and review and score only the Phase I component.

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Communicating with Applicants

The PD's responsibilities for communicating with applicants for SBIR/STTR funds, both before awards are issued and afterward, are much the same as is the case with applicants for traditional grants. There are, however, some important differences.

In general, the organizational environment of applicants for SBIR/STTR funds is likely to be quite different from that of applicants for traditional grants. Applicants for SBIR/STTR funds are less likely to be affiliated with universities or other research organizations, and, hence, less likely to benefit from in-house expertise in grant management.

Thus, PDs and NCI GMSs may need to be especially careful in ensuring that all details of the application and the specific conditions of the award are in order before an award is issued. PDs may also need to communicate more frequently and in more detail as Phase I ends and applicants are considering applications for Phase II awards.

Communicating with Applicants before Awards Are Issued

For the most part, pre-award communication between PDs and SBIR/STTR applicants mirrors communication between PDs and applicants for traditional grants. The issues to be addressed are described in Communicating about Applications Prior to Submission.

Communicating with Applicants after Awards Are Issued

As with pre-award communication, most aspects of post-award communication with SBIR/STTR grantees are the same as those carried out with grantees to whom traditional awards were issued. There are, however, some important differences.

In post-award communications with PIs, PDs may want to discuss:

  • The success of Phase I work as the basis for a Phase II application.

    The PD and the PI should attempt to determine whether scientific progress in Phase I has been sufficient to justify Phase II funding. If feasibility has not been clearly demonstrated, the PD may recommend that the PI apply for a new Phase I grant. A thorough discussion of scientific progress during Phase I is especially important for Fast Track grantees as the administrative responsibility for determining whether the agreed-upon milestones have been reached rests with the PD.

    A thorough discussion of scientific progress during Phase I is especially important for Fast Track grantees as the administrative responsibility for determining whether the agreed-upon milestones have been reached rests with the PD.

  • Conversion of an SBIR or STTR award to a cooperative agreement (U43 or U44).

    PDs may determine that government resources would help to ensure the success of the work proposed in the application. PDs should present this option to the awardee. If the awardee agrees that such an arrangement would be desirable, the PD may recommend conversion of the grant to a cooperative agreement.

    In most cases, such a conversion would take place after Phase I is completed and before a Phase II award is issued. Occasionally, however, assessments of progress and the need for additional resources may indicate that converting a grant to a cooperative agreement during Phase I would be desirable.

    For more information about converting grants to cooperative agreements, see Converting Grants to Cooperative Agreements.

  • The development of a Phase III business plan.

    To help grantees seek Phase III funding, PDs should inform small business awardees of potential resources that may be available for their specific needs. Such Phase III activities may include establishing websites listing new products made possible by SBIR/STTR grants and holding marketing conferences during which grantees demonstrate their products. Such conferences may help expedite the adoption of these products in the marketplace.

    More generally, PDs should maintain contact with SBIR/STTR grantees to track the outcome of Phase II funding. Success stories should be reported to the SBIR Special Program Officer in the NIH Office of Extramural Research.

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Using Contracts to Achieve SBIR/STTR Goals

In addition to supporting SBIR applications through grants, NCI establishes contracts as a means of achieving the goals of the SBIR program. A contract mechanism should be considered when, and only when:

  • Significant direction by NCI staff is required for the execution of the project.

  • A distinct deliverable–such as an instrument, software, or data–is expected.

PDs who plan to serve as project officers for an SBIR contract must have successfully completed the project officer training course. These courses are presented at least twice each year. The Administrative Resource Center notifies NCI about the dates and times of these courses by email.

The PD's division and the EC must approve the concept for the contract, and notices about the contract opportunity must be published in the NIH contract solicitation, which is published once each year. Thus, planning the approval process so as to meet the publication deadline is essential.

Applications are reviewed by a special review group convened by DEA, according to standard contract procedures.

For more information about the use of contracts, see http://rcb-intranet.nci.nih.gov.

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