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

Eleventh NIH SBIR/STTR Conference

June 2009

National Institutes of HealthU.S. Department of Health and Human Services

Suzanne E. Fisher, Ph.D.DirectorDivision of Receipt and Referral

MAJOR TOPICS

• Baseline Information

• Submission

• Assignment

• Review

• Award

• Resources and Help

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BASELINE INFORMATION

TERMINOLOGY & ABBREVIATIONS

• Institute/Center = IC• Principal Investigator = PD/PI• FOA = Funding Opportunity Announcement

PA = Program AnnouncementRFA = Request for Applications

• SRG = Scientific Review Group =Study Section = Review Committee

• Grant Application Grant

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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

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.

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

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CENTER FOR SCIENTIFIC REVIEW

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OFFICE OF EXTRAMURAL RESEARCH

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• 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

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https://commons.era.nih.gov/commons https://commons.era.nih.gov/commons

NIH GUIDE FOR GRANTS & CONTRACTS

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SUBMISSION/RECEIPT

SUBMISSION PROCESS

• CSR receives all competing applications for NIH; for FY 2009 this will be nearly 75,000 regular applications and 25,000 ARRA (Economic Stimulus) applications.

• CSR receives competing small business applications for NIH, CDC, and FDA

FY 2009 over 5200 SBIR/STTR grant applicationsFor FY 2010 have already received over 2500 SBIR/STTR applicationsThree dates a year for “unsolicited” applications”: new, resubmission/amended, renewal/competing continuation/Phase II

o April 5, August 5, and December 5o 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.

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SUBMISSION TOPICS• On time submission – electronic

Successful submission to Grants.gov by 5 p.m. local timeWeekends/holidays – standard date is next business dayAny error corrections within window

• Late applications http://grants1.nih.gov/grants/guide/notice-files/not-od-08-027.html

Advance approval is not givenCover letter requiredPD/PI only; not other rolesMulti-PI; only one neededIf reviewer, recent review serviceWindow of consideration

o 1 week for expedited dates (SBIR/STTR)o None for special dates (RFAs/PARs)

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MORE SUBMISSION TOPICSProblems 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.

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STILL MORE SUBMISSION TOPICS

Format requirementsApproved fonts: Arial, Helvetica, Palatino, or Georgia11 point, 15 cpi, 6 lpi, 1/2 inch marginsApplies to entire application; all PDFsUse common sense; consider reviewers

Appendix requirementshttp://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

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COVER LETTER

The cover letter should be used for a number of important purposes:

Suggest Institute/Center AssignmentSuggest review assignmentIdentify individuals in conflictIdentify areas of expertise needed to evaluate the application Discuss any special situationsRequired for a changed/corrected submission

But it is not appropriate to use the cover letter to suggest specific reviewers.

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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

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SAMPLE COVER LETTERPlease 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 in vitro model for testing drugs for treatment of retinoblastoma, not the synthesis of new chemotherapeutic agents.

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POST SUBMISSION TOPICS

Omitted/additional informationhttp://grants1.nih.gov/grants/guide/notice-files/not-od-08-082.html

Must contact Scientific Review Officer after assignmentWill 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!

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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

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RESUBMISSION POLICY

• Resubmission ApplicationsMust have received Summary StatementMust change contentIntroduction & mark text to show changes

• NIH is moving to allow only one resubmission (A1)

Effective for A0 applications submitted for January 25, 2009 and beyondApplications 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

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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

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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)

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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

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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.

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ASSIGNMENT

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

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INSTITUTE/CENTER ASSIGNMENTS• Referral Guidelines for Funding

Components of PHS and topics in annual Omnibus Solicitation

• ICs Shared InterestsOverall MissionSpecific program mandatesEstablishment/Evolution over time

• Principal Investigator requests• IC requests• Funding Opportunity Announcements• Assignment history• Generally liberal with dual assignments

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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)

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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

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2009 OTHER HHS FUNDING COMPONENTS: SBIR ONLY

• Food and Drug Administration (FD)Center for Biologics Evaluation and ResearchCenter for Devices and Radiological HealthCenter for Drug Evaluation and ResearchCenter for Food Safety and Applied NutritionCenter for Veterinary MedicineOffice of Orphan Products Development

• Administration for Children and Families (AF)

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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 InterestWorkloadAvoid small SEPs

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REFERRAL OUTCOME• Principal Investigator and Organization access

information in the eRA Commons• Application Number

Activity CodePhase I/Phase II/Resubmission

• Institute/Center for Funding ConsiderationGeneral contact number for primaryDual assignments

• Special Emphasis Panel or Study SectionSRO address, telephone number, etc.Scientific Review Officer is main point of contact throughout review stage

ASSIGNMENT QUESTIONS• Verify correct Activity Code• Concerns regarding review

Contact SROContact DRR

• Concerns regarding IC assignmentContact 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)

REVIEW

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ADVISORY COUNCIL/BOARD

• Second required step in dual peer review process

• Most applications considered in en bloc action; a few are specifically discussed (budget change, deferral)

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AWARD

FUNDING DECISIONS

• Funding decisions made by Institute/Center Director/staff based on

Scientific meritProgram considerationsAvailability 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.

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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.

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WHO TO CONTACT & WHEN• Your computer – make use of websites• Prior to submission

Grants InfoDivision of Receipt and ReferralNIH Small Business officeCSR Scientific Review Officershttp://www.csr.nih.gov/Roster_proto/sbir_section.asp

Institute/Center Program Staff; http://www.nih.gov/icd/ • Submission

Grants.goveRA Commons

• Review – Scientific Review Officer* • Post Review – Program Director*• Award – Program Director* and Grants Management

Specialist**Contact information on eRA Commons

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QUESTIONS

Your turn!