Questions and Answers for PAR-21-082, NIAID SBIR Phase II Clinical Trial Implementation Cooperative Agreement (U44, Clinical Trial Required)

NIH published this funding opportunity announcement (FOA) in a January 14, 2021 Guide announcement.

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Eligibility and Application Types

No, the NIAID SBIR Phase II Clinical Trial Implementation Cooperative Agreement (U44, Clinical Trial Required) FOA is for small business innovation research (SBIR) Phase II/IIB, Direct Phase II, and Fast-Track applications only.

SBIR Phase II/IIB: Applicants eligible for SBIR Phase II support must have received a previous SBIR Phase I award that is appropriate and relevant to this Phase II FOA (e.g., preclinical studies, planning activities). Applicants who have received a similarly relevant Phase II award may apply for a Phase IIB competing renewal with this FOA. Phase II/IIB applications are considered renewals (Type 2).

SBIR Direct Phase II: Applicants that have completed Phase I equivalent milestones (scientific and technical merit and feasibility) using non-SBIR funds are eligible to submit a Direct Phase II application to this FOA. Direct Phase II applications are considered new (Type 1). Applicants who have received a previous relevant SBIR Phase I award are expected to submit a standard Phase II application as described above.

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 pathway, 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.

Phase I Aims may include clinical trial planning tasks (see What limitations does this FOA have?) and/or relevant research and development activities. Applicants are encouraged to discuss how any outstanding clinical trial planning tasks and incomplete documentation will be addressed before the start of Phase II, even if they are not included as a part of proposed Phase I Aims.

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.

Fast-Track applications are considered new (Type 1).

Yes, provided that your project is applicable and relevant to NIAID. Applicants seeking a cross-agency application should contact the NIAID Small Business Team prior to submission.

No, only one Phase IIB competing renewal is allowed per Phase II award, regardless of funding mechanism. However, previous Phase IIB awardees may consider submitting a new Fast-Track, or Direct-Phase II application.

No, NIAID does not participate in these FOAs and will consider SBIR clinical trial applications received only through the U44 FOA. You may submit other clinical and human subjects studies that do not meet NIH’s Definition of a Clinical Trial through the SBIR or STTR Clinical Trial Not Allowed Omnibus Solicitations.

FOA Requirements

Awards made under the U44 FOA (excluding Fast-Track awards) will NOT provide support for clinical trial planning tasks except when included in the Phase I Aims of a Fast-Track application. Clinical trial planning includes tasks such as:

  • Development of study design
  • Identification of collaborators and enrollment sites
  • Development of the clinical protocol and informed consent form
  • Development of the statistical analysis plan
  • Development of the data management plan
  • Development of the investigator’s brochure or equivalent

The following are inappropriate and will not be supported by this FOA:

  • 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)

Yes, manufacture of test materials and related investigational products can be included as “investigational product costs” and are allowed as part of a well-justified budget request. The Research Plan and Budget Justification should reflect these activities as appropriate.

Yes, the U44 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.

No, normally on an SBIR Phase I project, the small business concern must carry out a minimum of two-thirds (67 percent) of the research or analytical effort. 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.

Typically for Phase II or Phase IIB, the small business concerned must carry out a minimum of 50 percent of the research or analytical effort. 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 FOA.

Yes, each individual or collaborating organization must include a letter confirming its role on the proposed project.

More Information

Contact Dr. Natalia Kruchinin, NIAID’s SBIR/STTR program coordinator.

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