SBIR Phase IIb Awards

NIMH will accept Phase IIb SBIR grant applications from Phase II SBIR awardees to continue the process of developing technologies that ultimately require federal regulatory approval. Such technologies include, but are not limited to, pharmacologic agents and drugs, biological products, devices, vaccines, etc., related to the mission of NIMH. In addition, NIMH will accept Phase IIb SBIR grant applications from Phase II SBIR awardees to continue the process of developing complex instrumentation, clinical research tools, or behavioral interventions and treatments. The Phase IIb grants should allow small businesses to get to a stage where interest and investment by third parties is more likely, and/or the technology has advanced to the commercialization phase.

Companies engaging in drug development for the treatment of mental health disorders may be eligible to submit competing renewal applications through the specific funding opportunity announcement “Complex Technologies and Therapeutics Development for Mental Health Research and Practice (R43/R44).”  NIMH strongly encourages cost sharing.

Companies that are developing technologies that do not focus on drug development, but that require federal regulatory approval prior to commercialization, may be eligible to submit a competing renewal application through the Reissue PHS 2013-02 Omnibus Solicitation of the NIH, CDC, FDA and ACF for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44]) . Cost sharing is strongly encouraged.

Companies that are developing technologies that do not require federal regulatory approval prior to commercialization, may be eligible to submit a competing renewal application through the funding opportunity announcement “Competing Renewal Awards of SBIR Phase IIb Grants for Brain and Behavior Tools (R44). ” For this opportunity, budget limits of up to $800,000 total costs per year and time periods up to 3 years may be requested. As in the cases above, cost sharing is strongly encouraged.

In all cases, Phase IIb grant applications are expected to include major developments that will bring the technology significantly closer to commercialization. Adaptations to existing technologies would not be appropriate for this program, unless NIMH concurred that the adaptation required significant research and development work and would make the technology unique.

Please contact your Program Director or Dr. Margaret Grabb (contact information provided below) before beginning the process of putting an application together. Prospective applicants are strongly encouraged to contact NIH staff prior to submission of a type 2 competing continuation application. In addition, prospective applicants are strongly encouraged to submit to the program contact a letter of intent that includes the following information:

• Descriptive title of the proposed research
• Name, address, and telephone number of the Principal Investigator
• Names of other key personnel
• Participating institutions
• Grant # for the original Phase II grant

Direct your questions about scientific/research issues to:
Margaret C. Grabb, Ph.D.
National Institute of Mental Health
6001 Executive Boulevard, Room 7201, MSC 9645
Bethesda, MD 20892-9645
(Rockville, MD 20852 for express/courier service)
Telephone: 301-443-3563 Fax: (301) 443-1731
E-mail: mgrabb@mail.nih.gov