1. SUBMITTING AN SBIR/STTR APPLICATION FOR DECEMBER 5? November 25, 2008 National Institutes of Health U.S. Department of Health and Human Services Suzanne E. Fisher, Ph.D. Director Division of Receipt and Referral

2. SUBMISSION REMINDERS Must complete Grants.gov and NIH/eRA Commons registrations in advance – may take several weeks; if not registered now, probably too late to submit for December 5. Every individual with the PD/PI role must have a Commons ID number and must include that information in the application. On time submission is successful submission to Grants.gov by 5 p.m. local time. Two day error correction window (shortened from five days) http://grants1.nih.gov/grants/guide/notice-files/NOT-OD-08-018.htmhttp://grants1.nih.gov/grants/guide/notice-files/NOT-OD-08-018.htm l Must include cover letter for changed/corrected application submitted after due date. Late applications - NIH Guide Announcement http://grants1.nih.gov/grants/guide/notice-files/not-od-08-027.html Advance approval is not given. Window of consideration is 1 week. 2

3. MORE SUBMISSION REMINDERS Format requirements 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 Omitted/additional information http://grants1.nih.gov/grants/guide/notice-files/not-od-08- 082.html Must contact Scientific Review Officer after assignment Will be displayed in grant folder as “ Additions to review” and available to reviewers and NIH staff SBIR/STTR Specifics Must have received Phase I award to submit Phase II Fast Track applications must propose work and request $ for Phase I Only one Phase II from an awarded Phase I Full Budgets (no modular budgets) 3

4. COVER LETTER The cover letter should be used for a number of important purposes: Suggest Institute/Center Assignment Suggest review assignment Identify individuals in conflict Identify areas of expertise needed to evaluate the application Discuss any special situations Required for a changed/corrected submission But it is not appropriate to use the cover letter to suggest specific reviewers. 4

5. SUGGESTED COVER LETTER FORMAT Designed to facilitate knowledge management approaches as an aid to referral process One request per line Separate positive and negative requests Separate IC and review requests Include name of IC and SRG followed by dash and acronym; do not use parentheses Provide explanation in separate paragraph 5

6. 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. Resubmission/Amended Applications Two resubmissions No time limit Must have received Summary Statement Change in Content Introduction/Mark Text 6

7. IF YOU REMEMBER ONLY ONE THING… If you do not see the application image in eRA Commons, the NIH does not see it either. Be sure to follow up on the process and use eRA Commons to check. We need to know you have submitted an application in order to assign, review and award! 7

8. ASSIGNMENT ISSUES – PRINCIPAL INVESTIGATOR Verify correct Activity Code Concerns regarding review Contact SRO 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

9. QUESTIONS Before submission call the Division of Receipt and Referral (301-435-0715) ; all staff members will be able to help. Identify Institute, Center, other agency Identify Scientific Review Group Questions on submission policies, format, structure Sorry, we cannot help with G.gov or eRA issues After submission requests for change in assignment Do not use email to a specific individual Fax 301-480-1987 Regular mail Division of Receipt and Referral, CSR, NIH 6701 Rockledge Drive MSC 7720 Bethesda, MD 20892-7720 9