AN INDEPTH LOOK AT THE NIH SBIR/STTR RECEIPT, REFERRAL, AND REVIEW PROCESSES

1. AN INDEPTH LOOK AT THE NIH SBIR/STTR RECEIPT, REFERRAL, AND REVIEW PROCESSES Suzanne E. Fisher, Ph.D. Director Division of Receipt and Referral Eleventh NIH SBIR/STTR Conference June 2009 National Institutes of HealthU.S. Department of Health and Human Services

2. MAJOR TOPICS • Baseline Information • Submission • Assignment • Review • Award • Resources and Help

3. Baseline information

4. TERMINOLOGY & ABBREVIATIONS • Institute/Center = IC • Principal Investigator = PD/PI • FOA = Funding Opportunity Announcement • PA = Program Announcement • RFA = Request for Applications • SRG = Scientific Review Group =Study Section = Review Committee • Grant Application  Grant

5. APPLICATION TYPES • NEW= new (A0) • RESUBMISSION= Revised/amended application (A1, A2) • RENEWAL= Competing continuation application (type 2) • COMPETITIVE REVISION = Competing supplemental application (type 3 – S1, S2) • CHANGED/CORRECTED application = response to errors/warnings

6. MULTIPLE ACTIVE APPLICATIONS • Implemented in 2008 • Faster review/summary statement preparation and special opportunities for new PD/PIs and study section members leads to applications being submitted for consecutive cycles • If withdraw previous version, would not get council review • Submission of A1, A2 does not withdraw previous version. A0, A1, A2 all active until any one awarded or normal inactivation time.

7. USEFUL WEBSITES/LIST SERVES • Center for Scientific Review (CSR) http://cms.csr.nih.gov/ • Office of Extramural Research (OER) Grants Page http://grants1.nih.gov/grants/oer.htm • eRA Commons https://commons.era.nih.gov/commons/ • Electronic Submission http://era.nih.gov/ElectronicReceipt/ PI List Serve: http://era.nih.gov/about_era/get_connected.cfm • NIH Guide for Grants and Contracts http://era.nih.gov/about_era/get_connected.cfm Table of Contents List Serve: http://grants1.nih.gov/grants/guide/listserv.htm

8. CENTER FOR SCIENTIFIC REVIEW

9. OFFICE OF EXTRAMURAL RESEARCH

11. Allows investigator and AOR to see: • Status of application • Meeting dates • Assembled electronic applications • Summary Statement (PI only) • Notice of Grant Award • When non-competing continuation is due • Used for submission of Just in Time information https://commons.era.nih.gov/commons

12. NIH GUIDE FOR GRANTS & CONTRACTS

13. SUBMISSION/RECEIPT

14. SUBMISSION PROCESS • CSR receives all competing applications for NIH; for FY 2009 this will be nearly 75,000 regular applications and 25,000ARRA (Economic Stimulus) applications. • CSR receives competing small business applications for NIH, CDC, and FDA • FY 2009 over 5200 SBIR/STTR grant applications • For FY 2010 have already received over 2500 SBIR/STTR applications • Three dates a year for “unsolicited” applications”: new, resubmission/amended, renewal/competing continuation/Phase II • April 5, August 5, and December 5 • May 7, September 7, and January 7 for AIDS applications • Requests for Applications (RFAs) have special receipt dates. • Small business organizations also apply for other activities – R01, R21, Challenge Grants, etc.

15. SUBMISSION TOPICS • On time submission – electronic • Successful submission to Grants.gov by 5 p.m. local time • Weekends/holidays – standard date is next business day • Any error corrections within window • Late applications http://grants1.nih.gov/grants/guide/notice-files/not-od-08-027.html • Advance approval is not given • Cover letter required • PD/PI only; not other roles • Multi-PI; only one needed • If reviewer, recent review service • Window of consideration • 1 week for expedited dates (SBIR/STTR) • None for special dates (RFAs/PARs)

16. MORE SUBMISSION TOPICS Problems related to electronic submission • Need to document with eRA Help Desk, include Grants.gov ticket number if applicable • Need to promptly and diligently address issues, submit changed/corrected application. Turn around in hours, not days. • Failure to complete all registrations (CCR for Grants.gov and eRA Commons for NIH) in advance of due date is not a problem that will lead to acceptance of a late application. • Cover letter must describe entire change of events; cover letter is not retained from previous submission and thus must add to the saga and retain any original requests.

17. STILL MORE SUBMISSION TOPICS Format requirements • Approved fonts: Arial, Helvetica, Palatino, or Georgia • 11 point, 15 cpi, 6 lpi, 1/2 inch margins • Applies to entire application; all PDFs • Use common sense; consider reviewers Appendix requirements http://grants1.nih.gov/grants/guide/notice-files/NOT-OD-07-018.html • Phase I applications generally not allowed – contact SRO if special circumstance • Phase II applications • 3 non-publicly available publications • No submitted manuscripts • Surveys, questionnaires, consent forms, protocols allowed

18. 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.

19. 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

20. SAMPLE COVER LETTER Please assign this Phase I SBIR “Drugs for Retinoblastoma Treatment” to the following: Institutes/Centers National Cancer Institute – NCI National Eye Institute – NEI Scientific Review Group Oncology Translational and Clinical IRG - OTC Please do not assign this application to the following: Scientific Review Group Biological Chemistry and Macromolecular Biophysics - BCMB This study focuses on a new invitro model for testing drugs for treatment of retinoblastoma, not the synthesis of new chemotherapeutic agents.

21. POST SUBMISSION TOPICS 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 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!

22. 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. • Use of Human Embryonic Stem Cells – final policy due by July 7. • Leadership Plan required for Multiple PD/PIs • Resource Sharing – Data, Model Organisms, GWAS

23. RESUBMISSION POLICY • Resubmission Applications • Must have received Summary Statement • Must change content • Introduction & mark text to show changes • NIH is moving to allow only one resubmission (A1) • Effective for A0 applications submitted for January 25, 2009 and beyond • Applications at A0 or A1 before 1/25/2009 are allowed an A2 but must submit before January 7, 2011 http://grants1.nih.gov/grants/guide/notice-files/not-od-09-016.html http://grants.nih.gov/grants/guide/notice-files/NOT-OD-09-003.html • Applies to all types and all activity codes, including Phase I and II SBIR and STTR applications

24. VIRTUAL A2/A3 APPLICATIONS • If funding is not obtained by A1/A2 version, it is not appropriate to submit “virtual A2/A3.” • Next version must have substantial changes in Specific Aims and Approach • Greater change than for resubmission application; not just response to issues in Summary Statement • Request for different review location or Institute/Center assignment not sufficient to constitute a new application. • Further guidance (includes FAQs): http://grants1.nih.gov/grants/guide/notice-files/NOT-OD-07-015.html

25. SBIR/STTR SPECIFIC POLICIES • 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 • Full Budgets (no modular budgets)

26. ARRA RFAS • OD-09-008 Recovery Act Limited Competition: Biomedical Research, Development, and Growth to Spur the Acceleration of New Technologies (BRDG-SPAN) Pilot Program (RC3) • OD-09-009 Recovery Act Limited Competition: Small Business Catalyst Awards for Accelerating Innovative Research (R43) • Due date for both is September 1, 2009

27. IF YOU PLAN TO APPLY • Start/check registration for G.gov and eRA Commons now! • Starting G.gov submission at 4:45 p.m. on September 1 is a bad idea! • Special date – no late window • May not submit same application for both and/or for August 5 due date • Follow all special rules in each RFA – page limits, biosketch, bibliography, use of PDF attachments, etc. These applications are different than others may have submitted. • No supplemental/update/post-submission information will be allowed.

28. ASSIGNMENT

29. ASSIGNMENT COMPONENTS • Activity Code • SBIR/STTR • Phase I/Phase II • Identify via FOA and SBIR/STTR information in application • Institute/Center for funding consideration Dual Assignments by Referral or IC • Review location

30. INSTITUTE/CENTER ASSIGNMENTS • Referral Guidelines for Funding Components of PHS and topics in annual Omnibus Solicitation • ICs Shared Interests • Overall Mission • Specific program mandates • Establishment/Evolution over time • Principal Investigator requests • IC requests • Funding Opportunity Announcements • Assignment history • Generally liberal with dual assignments

31. NIH FUNDING COMPONENTS: SBIR & STTR • National Cancer Institute (CA) • National Eye Institute (EY) • National Heart, Lung, and Blood Institute (HL) • National Human Genome Research Institute (HG) • National Institute on Aging (AG) • National Institute on Alcohol Abuse and Alcoholism (AA) • National Institute of Allergy and Infectious Diseases (AI) • National Institute of Arthritis and Musculoskeletal and Skin Diseases (AR) • National Institute of Biomedical Imaging and Bioengineering (EB) • National Institute of Child Health and Human Development (HD) • National Institute on Deafness and Other Communication Disorders (DC) • National Institute of Dental and Craniofacial Research (DE) • National Institute of Diabetes and Digestive and Kidney Diseases (DK) • National Institute on Drug Abuse (DA) • National Institute of Environmental Health Sciences (ES) • National Institute of General Medical Sciences (GM) • National Institute of Mental Health (MH) • National Institute of Neurological Disorders and Stroke (NS) • National Institute of Nursing Research (NR) • National Library of Medicine (LM) • National Center for Complementary and Alternative Medicine (AT) • National Center on Minority Health and Health Disparities (MD) • National Center for Research Resources (RR)

32. 2009 OTHER HHS FUNDING COMPONENTS: SBIR ONLY Centers for Disease Control* • National Institute for Occupational Safety and Health (OH) • National Center on Birth Defects and Developmental Disabilities (DD) • National Center for Chronic Disease Prevention and Health Promotion (DP) • National Center for Health Statistics (SH) • National Center for Injury Prevention and Control (CE) • National Center for Environmental Health (EH) • National Center for Public Health Informatics (HK) • National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention (PS) • Coordinating Office for Terrorism Preparedness and Emergency Response (TP) *Participating components vary each year

33. 2009 OTHER HHS FUNDING COMPONENTS: SBIR ONLY • Food and Drug Administration (FD) • Center for Biologics Evaluation and Research • Center for Devices and Radiological Health • Center for Drug Evaluation and Research • Center for Food Safety and Applied Nutrition • Center for Veterinary Medicine • Office of Orphan Products Development • Administration for Children and Families (AF)

34. REVIEW GROUP ASSIGNMENT • SBIR/STTR Special Emphasis Panels: http://www.csr.nih.gov/Roster_proto/sbir_section.asp • 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 • Avoid small SEPs

35. REFERRAL OUTCOME Principal Investigator and Organization access information in the eRA Commons Application Number Activity Code Phase I/Phase II/Resubmission Institute/Center for Funding Consideration General contact number for primary Dual assignments Special Emphasis Panel or Study Section SRO address, telephone number, etc. Scientific Review Officer is main point of contact throughout review stage

36. ASSIGNMENT QUESTIONS 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 Contact Division of Receipt and Referral (301-435-0715) if do not see via Commons in timely fashion (2 weeks)

37. REVIEW

38. ADVISORY COUNCIL/BOARD • Second required step in dual peer review process • Most applications considered in enbloc action; a few are specifically discussed (budget change, deferral)

39. AWARD

40. FUNDING DECISIONS • Funding decisions made by Institute/Center Director/staff based on • Scientific merit • Program considerations • Availability of funds • Institute/Center assignment may be changed for funding to make best use of set aside funds. • Specifics may vary by fiscal year and Institute/Center.

41. AWARD PROCESS • Involves interaction with • Program Director • Grants Management Specialist • Need to address Just in Time issues (human subjects protection, vertebrate animal welfare, etc.) • May be other considerations (biohazards, select agents, etc.) • Budget negotiations, contractual arrangements, etc.

42. WHO TO CONTACT & WHEN • Your computer – make use of websites • Prior to submission • Grants Info • Division of Receipt and Referral • NIH Small Business office • CSR Scientific Review Officers http://www.csr.nih.gov/Roster_proto/sbir_section.asp • Institute/Center Program Staff; http://www.nih.gov/icd/ • Submission • Grants.gov • eRA Commons • Review – Scientific Review Officer* • Post Review – Program Director* • Award – Program Director* and Grants Management Specialist* *Contact information on eRA Commons

43. QUESTIONS Your turn!