A Tour Through the NIH SBIRSTTR Review Process

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A Tour Through the NIH SBIR/STTR Review Process

• Sally A. Amero, Ph.D.
• Scientific Review Administrator
• Suzanne E. Fisher, Ph.D.
• Director, Division of Receipt and Referral
• Center for Scientific Review, NIH

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FOCUS ON THREE ASPECTS

• Submission
• Assignment
• Review

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SUBMISSION

• CSR receives all competitive applications for NIH
  - 45,000/year
• About 4500 are SBIR/STTR
• Three receipt dates per year
• April 1, August 1, December 1
• (CDC only December 1)

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HOW TO GET INFORMATION

• NIH Home Page (http//www.nih.gov)
• CSR Home Page (http//www.csr.nih.gov)
• Reviewer Guidelines
• SRAs
• NIH SBIR/STTR Coordinator
• 301-435-2688
• Division of Receipt and Referral, CSR
• 301-435-0715

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PREPARING AN APPLICATION

• Start early
• Read and follow instructions
• Clarify any confusing instructions early
• Do not assume staff or reviewers will know what
  you mean
• Include well designed tables and figures
• Format - consider the reviewers
• Proofread and check before sending

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PREPARING AN APPLICATION (cont.)

• Explicitly state the purpose of the proposed work
• Refer to the literature thoroughly but
  thoughtfully
• Present an organized, lucid write-up
• Be mindful of the review criteria to be used
• Get advice from colleagues

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REFERRAL

• Application Number
• SBIR (R43/R44) or STTR (R41/R42)
• Institute/Center for Funding Consideration
• Dual assignments frequent
• Study Section
• Indicate preferences via cover letter
• Principal Investigator and Organization notified

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BASIS FOR ASSIGNMENTS

• Referral Guidelines for Institutes and Review
• Applicant Requests
• Institute Requests
• Program Announcements
• Assignment History

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ASSIGNMENT NOTIFICATION

• Scientific Review Administrator
• Address, telephone number, etc.
• Institute Assignment
• Primary and any dual
• General contact number
• Unique Identifier (1 R43 xx123456-01)
• Should receive within one month

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ASSIGNMENT

• Concerns regarding review or Institute assignment
• Contact SRA
• Institute Home Page and telephone number
• Request for change in writing to CSR (fax
  301-480-1987)
• More efficient to include cover letter with
  submission

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REVIEW

• Dual Review - Study Section and Advisory Council
• Study Section Streamlined Review
• Generally only the top half of the applications
  discussed must be unanimous agreement to be
  unscored
• Remainder discussed and scored
• National Advisory Council

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SCIENTIFIC REVIEW ADMINISTRATOR

• Point of contact during the review process
• Discuss before sending additional material
• Administrative review
• Responsible for recruitment and assignment of
  reviewers
• Designated Federal Official
• Prepares Summary Statement

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PEER REVIEWERS

• Scientific and technical expertise
• Stature in field
• Mature and objective judgement
• Oral and written communication skills
• Ability to work in group setting
• Geographic, gender, and minority group balance
• At least one small business affiliated reviewer
  is required

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REVIEW CRITERIA

• Significance
• Important problem
• Commercial potential
• Commercial/societal benefit
• Advance scientific knowledge
• Enabling technologies
• Competitive advantage

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REVIEW CRITERIA (cont.)

• Approach
• Framework, design, methods
• Technical and commercial feasibility
• Problems/alternate strategies
• Milestones/evaluation
• Innovation
• New paradigm/novel technology

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REVIEW CRITERIA (cont.)

• Investigator(s)
• Principal Investigator
• Experience level
• Environment
• Access to resources
• Contribute to success
• Unique features/collaborations

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REVIEW CRITERIA (cont.)

• Phase II
• Progress in Phase I/Demonstration of feasibility
• Fast Track
• Measurable goals in Phase I
• Product Development Plan
• Commercialization

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REVIEW ALSO CONSIDERS

• If human subjects are involved, plans to include
  both genders, minorities and subgroups, and
  children as appropriate for scientific goals of
  research
• Proposed protection for humans, animals, and the
  environment
• Reasonableness of the proposed budget and
  duration

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RESULTS OF REVIEW

• Unscored (approximately bottom half) or priority
  score
• Score (generally between 100 and 300)
• Deferral (very rare)
• Not Recommended for Further Consideration (very
  rare serious concerns)
• Notification of Principal Investigator
• Summary Statement

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SUMMARY STATEMENT

• Study Section Recommendation
• Resume and Summary of Discussion (if scored)
• Essentially unedited comments of reviewers
• Organized by review criteria

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SUMMARY STATEMENT (cont.)

• Administrative notes
• Coding for human subjects, animals, gender,
  minorities, children
• Program Directors name and telephone number
• Primary contact after review

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COMMON PROBLEMS

• Overly ambitious
• Lack of novel ideas/approach
• Diffuse, unfocused research plan
• Lack of evidence of understanding published
  relevant work
• Lack of experience in critical methodology
• Uncritical approach lack of scientific rationale
• Lack of commercial potential/societal benefit

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REVISED APPLICATION

• 2 amendment / 2 year limitation
• Must have received summary statement
• Need to make changes in Research Plan
• Need to include Introduction and mark text to
  show changes
• Next review may be by same or different study
  section

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COUNCIL REVIEW AND FUNDING DECISIONS

• Handled by the Institutes and Centers