Phase I and II Small Business Innovation Research-Small Business Technology Transfer (SBIR/STTR) Solicitation
The 2004 SBIR Omnibus Solicitation is available in three sections at:
Important Features of the SBIR-STTR Phase I and Phase II Grant Application Forms
SBIR-STTR Forms
NIH uses the Revised Public Health Service Grant Application (PHS Form 398) for both SBIR and STTR Phase I and Phase II applications. The current PHS Form 398 and PHS Form 2590 maintain Office of Management and Budget clearance through May 2004. NIH’s Office of Extramural Research is making revisions to the PHS Form 398 and the PHS Form 2590. The PHS Form 398 is available at: http://grants.nih.gov/grants/funding/phs398/phs398.html.
NIH will publish an announcement in the NIH Guide for Grants and Contracts (available at: http://grants1.nih.gov/grants/guide/index.html) when the new forms and instructions are available. There will be a transition period in which the current or revised forms will be accepted.
Submissions Before April 1, 2004, Receipt Date
Applicants planning to submit new or revised SBIR or STTR applications on or before this receipt date should use the current PHS 398 forms at: http://grants.nih.gov/grants/funding/phs398/phs398.html#forms.
Submissions After April 1, 2004, Receipt Date
Applicants planning to submit new or revised SBIR or STTR grant applications after this receipt date should consult the NIH Small Business Funding Opportunities for more specific details and instructions.
Type 2 Competing Continuation Awards for Phase II SBIR-STTR Applications
NIA offers certain Phase II SBIR-STTR awardees the opportunity to apply for Type 2 Competing Continuation (T2CC) Phase II awards, as stated in the 2004 SBIR-STTR Omnibus Solicitation. Currently, only the Neuroscience and Neuropsychology of Aging Program is considering T2CC applications (see the 2004 SBIR-STTR Omnibus Solicitation for terms). Only small business concerns that have received Phase II awards are eligible to apply for a T2CC award.
This opportunity is only for Phase II awardees that propose to continue assessing and improving drugs or devices or propose to conduct preclinical trials of drugs or devices that require: (1) clinical evaluation, (2) approval by a Federal regulatory agency, and/or (3) continuing refinements to durable medical equipment designs such as cost reduction, tests for safety, durability and reliability, and meeting and/or establishing standards.
Such products include—but are not limited to—devices, drugs, vaccines, therapeutics, and medical implants related to the mission of NIA. The product being developed must be one for which Federal regulatory approval (e.g., U.S. Food and Drug Administration) is a required step toward commercialization. Prospective applicants are expected to contact NIA staff prior to submission of a T2CC application. Additional requirements and instructions are available in Part II: Research Topics of the 2004 SBIR-STTR Omnibus Solicitation (http://grants1.nih.gov/grants/funding/sbirsttr1/2006-2_SBIR-STTR-topics.pdf).
Phase II Data Collection Requirement
Each Phase II SBIR-STTR applicant is required to provide information to the Small Business Administration (SBA) Tech-Net Database System (http://technet.sba.gov). Questions about this requirement may be submitted to SBA directly through the Tech-Net Web site. Each Phase II awardee is required to update the appropriate information on the award in the Tech-Net database upon completion of the last deliverable under the funding agreement or grant closeout document (e.g., Final Report, Financial Status Report, Invention Report) and is requested to voluntarily update the information in the Tech-Net database annually for a minimum of 5 years.
Required Education in the Protection of Human Research Participants
For investigators submitting applications for grants or proposals for contracts or receiving new or noncompeting awards for research involving human subjects, NIH requires education on the protection of human research participants. Information about this policy may be found at: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.
Frequently asked questions (http://grants.nih.gov/grants/policy/hs_educ_faq.htm) regarding this policy also are included in the NIH Guide notice/announcement.
Collaboration Opportunities and Research Partnerships (CORP)
If a potential applicant or an applicant requires a collaborator or researcher to provide specific expertise on an SBIR-STTR project, he or she should visit: http://grants1.nih.gov/cfdocs/corp/add.htm, where a request for collaborators can be submitted. Submissions considered appropriate for this site will be added to the CORP list at: http://grants1.nih.gov/grants/funding/corp.htm.
