# Presentation: 356555

## 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**

## FOCUS ON THREE ASPECTS

- Submission
- Assignment
- Review

## 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)

## 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

## 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

## 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

## 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

## BASIS FOR ASSIGNMENTS

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

## 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

## 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

## 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

## 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

## 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

##  REVIEW CRITERIA

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

## REVIEW CRITERIA (cont.)

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

## REVIEW CRITERIA (cont.)

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

## REVIEW CRITERIA (cont.)

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

## 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

## 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

## SUMMARY STATEMENT

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

## SUMMARY STATEMENT (cont.)

- Administrative notes
- Coding for human subjects, animals, gender, minorities, children
- Program Director’s name and telephone number
- Primary contact after review

## 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

## 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

## COUNCIL REVIEW AND FUNDING DECISIONS

- Handled by the Institutes and Centers