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Questions and Answers for PAR-13-250, NIAID SBIR Phase II Clinical Trial Implementation Cooperative Agreement (U44)

NIH published this funding opportunity announcement (FOA) in a June 24, 2013, Guide notice.

1. Can I submit a grant application for phase I with this FOA?

No, this FOA is for SBIR phase II and Fast-Track applications only.

SBIR Phase II:  Applicants seeking SBIR phase II support must have received a prior SBIR phase I award that is appropriate and relevant to this phase II FOA (e.g., preclinical studies, planning activities, etc.).

Fast-Track: The Fast-Track mechanism for SBIR applications allows for an expedited decision-making and award process aimed specifically at scientifically meritorious applications with high potential for commercialization. In the Fast-Track review process, both phase I and phase II proposals are submitted and reviewed together. The Specific Aims section of the phase I portion of a Fast-Track must specify clear, measurable goals (milestones) that should be achieved before initiating phase II work. In addition, as is required for all phase II applications, the phase II portion of a Fast-Track application must present a Commercialization Plan (maximum 12 pages) that addresses specific points  (see SF 424 Section 4.8, page 91).

2. With this FOA, may I apply directly to phase II without having the phase I-awarded grant?

No, this is not a Direct-to-Phase II FOA. Applicants must have received a prior SBIR phase I award that is appropriate and relevant to this phase II FOA (e.g., preclinical studies, planning activities, etc.).

3. What limitations does this FOA have?

Awards made under the this FOA (except Fast Track applications) will NOT provide support for:

  • Clinical trial planning tasks, such as:
    • Identifying collaborators and enrollment sites.
    • Developing:
      • study design
      • clinical protocol and informed consent forms
      • statistical analysis plans
      • data management plans
      • investigator’s brochure or equivalent.
  • Clinical trials that fall outside the mission and goals of NIAID.
  • Clinical trials that propose to use dedicated resources that are part of an existing NIAID-supported clinical trial network.
  • More than one proposed clinical trial per application (applicants should not propose more than one clinical trial within an application).

4. May applicants facilitate partnerships with third-party investors and strategic partners?

Yes, this FOA aims to encourage business relationships between applicant small business concerns and third-party investors and strategic partners. Investors and partners may provide substantial financing (cofunding) that helps accelerate the commercialization of promising new interventions, products, and technologies initiated with NIH SBIR funding.

5. How much of my small business research project may I outsource?

You may outsource up to 33 percent of your project for a phase I SBIR award or 50 percent for a phase II SBIR award.

6. Must all of the work on an SBIR project be completed by the small business?

No. Normally, on an SBIR phase I project, a minimum of two-thirds (67 percent) of the research or analytical effort must be carried out by the small business concern. The total amount of all consultant and contractual agreements to third parties for portions of the scientific and technical effort typically may not exceed 33 percent of the total amount requested.

For phase II or phase IIB, typically a minimum of fifty percent of the research or analytical effort must be carried out by the small business concern. The total amount of all consultant and contractual agreements to third parties for portions of the scientific and technical effort generally may not exceed 50 percent of the total amount requested. Applicants are strongly encouraged to discuss deviations from these guidelines with NIH program staff listed in the funding opportunity announcement.

7. Are subcontractors on an SBIR application required to provide a letter of support?

Yes. Each individual and/or collaborating organization must include a letter confirming their role on the proposed project.

8. Whom should I contact if I have more questions about this announcement?

Contact Natalia Kruchinin.

Last Updated March 04, 2014

Last Reviewed December 19, 2013