SUBMISSION, ASSIGNMENT AND PEER REVIEW OF SBIRSTTR APPLICATIONS

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SUBMISSION, ASSIGNMENT AND PEER REVIEW OF
SBIR/STTR APPLICATIONS

• Suzanne E. Fisher, Ph.D.
• Director, Division of Receipt and Referral
• Marian R. Wachtel, Ph.D.
• Scientific Review Administrator, Infectious
  Diseases and Microbiology IRG
• Center for Scientific Review
• July 2005

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FOCUS ON THREE ASPECTS

• Submission
• Assignment
• Peer Review

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SUBMISSION

• CSR receives all competing applications for NIH
• For 2005 this will be nearly 80,000 applications
• Almost 7000 are SBIR/STTR applications
• Three dates a year April 1, August 1, and
  December 1
• RFAs have special receipt dates

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My application was so big I sent it in two boxes
I hope that is not a problem.
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Did you receive my application yesterday? I sent
it by Fed Ex.
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I need to make a correction on page 32 can you
find my application?
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A NEW AND BETTER WAY TO SUBMIT APPLICATIONS

• Electronic submission via grants.gov
• Use of 424 Research and Related form plus NIH
  specific information/instructions
• Required for December 1, 2005 submission of SBIR
  and STTR applications Phase I, Phase II, and
  Fast Track (new and revised)
• Required for any RFAs after December 1, 2005
• Should start registration process now!
• More information will be provided in other talks
  and at eRA table

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ADVANTAGES OF ELECTRONIC SUBMISSION

• Data goes directly into appropriate fields for
  NIH database saving time and avoiding
  transcription errors.
• Quality of figures color, detail
• Save costs paper, delivery
• Validation checks for consistency, completeness
• Access to assignment, review outcome, and Summary
  Statement via NIH Commons
• Fundamental aspects of submission, assignment,
  review are not changed.

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IMPORTANT SUBMISSION TOPICS

• Standing submission dates/special receipt dates
• Postmark versus receipt dates
• Weekends and holidays
• Omitted/additional information
• Before deadline complete resubmission
• After deadline contact SRA
• Late applications

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LATE APPLICATIONS

• NIH Guide Announcement http//grants1.nih.gov/gr
  ants/guide/notice-files/NOT-OD-05-030.html
• Advance approval is not given
• Window of consideration
• 2 weeks for standard dates
• 1 week for expedited dates
• None for special dates (RFAs/PARs)
• Expectation is that applications will be on time.
  

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IMPORTANT POLICIES FOR APPLICATION SUBMISSION

• Duplicate applications are not allowed.
• Derivative applications should not be submitted.
• Organizations are responsible for assuring the
  materials submitted are original work, not used
  in previous applications.
• Revised Applications
• Two revisions
• No time limit
• Must have received Summary Statement
• Change in Content
• Introduction/Mark Text
• Virtual A3 applications

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SBIR/STTR SPECIFIC POLICIES FOR SUBMISSION

• Must have received Phase I award to submit Phase
  II
• Fast Track applications must propose work and
  request for Phase I (no leap frogging)
• Only one Phase II from an awarded Phase I

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RECENT CHANGES IN NIH REQUIREMENTS

• All SBIR/STTR applications must use full budget
  format no modular budgets allowed.
• Titles may now be 81 characters and spaces.
• Describe relevance to public health in
  Description.
• New category Other Significant Contributors
• Require eRA Commons User Name (Grants.gov
  registration)
• Specific location for designation of HESC cell
  lines

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CHANGES IN REQUIREMENTS (cont.)

• All applications to have a Human Subjects
  Research Section. If no human subjects involved,
  need to state this.
• New guidance for studies involving coded human
  subjects information
• Updated review criteria
• Data sharing and model organism sharing
  instructions
• Format requirements changed

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FORMAT COMPLIANCE

• Approved fonts Arial, Helvetica, Palatino, or
  Georgia
• 11 point, 15 cpi, 6 lpi, 1/2 inch margins
• Applies to entire application all pdf
  attachments
• Use common sense consider reviewers
• Failure to comply will likely lead to a delay in
  review

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THREE COMPONENTS OF EACH ASSIGNMENT

• Mechanism
• SBIR/STTR
• Phase I/Phase
• Institute/Center for funding consideration
• Dual Assignments by Referral or IC
• Review location

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INSTITUTE/CENTER ASSIGNMENTS

• Referral Guidelines for Funding Components of PHS
• ICs Shared Interests
• Overall Mission
• Specific Program Mandates
• Establishment/Evolution Over Time
• Principal Investigator Requests
• IC requests
• Program Announcements
• Assignment History

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NIH FUNDING COMPONENTS

• NCI
• NEI
• NHLBI
• NHGRI
• NIA
• NIAAA
• NIAID
• NIAMS
• NICHD
• NIDCD
• NIDCR
• NIDDK

• NIDA
• NIEHS
• NIGMS
• NIMH
• NINDS
• NINR
• NLM
• NIBIB
• NCCAM
• NCRR
• NCMHD
• FIC

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INITIAL REVIEW GROUP ASSIGNMENT

• SBIR/STTR Special Emphasis Panels
• http//www.csr.nih.gov/review/irgdesc.htm
• Principal Investigator requests generally always
  show application to requested IRG
• CSR practice is that if request cannot be
  honored, accepting/welcoming IRG must communicate
  with PI.
• Previous assignment history
• IRG considerations
• Conflict of Interest
• Workload

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REFERRAL OUTCOME

• Information available in the NIH commons three
  days after assignment completed
• PI and SO have different views
• May need separate registration
• Application Number
• Mechanism
• Phase I/Phase II/Revision
• Institute/Center for Funding Consideration
• General contact number for primary
• Dual assignments
• Special Emphasis Panel or Study Section
• SRA address, telephone number, etc.

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COMMONS STATUS
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COMMONS STATUS
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ASSIGNMENT ISSUES PRINCIPAL INVESTIGATOR

• Verify correct mechanism
• Concerns regarding review
• Contact SRA
• Contact DRR
• Concerns regarding IC assignment
• Contact DRR
• Request for change in writing to DRR (fax
  301-480-1987)
• More efficient to include cover letter with
  submission

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PRACTICAL ADVICE

• Start early
• Read and follow all instructions
• Clarify instructions early
• Register for Commons, DUNS number, etc. well in
  advance
• Format use common sense/ask a friends opinion
  avoid the legal but ugly application
• Check and proofread before submitting
• Track the progress via the Commons

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PEER REVIEW

• The next stage