RECEIPT AND REFERRAL OF GRANT APPLICATIONS

1. RECEIPT AND REFERRAL OF GRANT APPLICATIONS Suzanne E. Fisher, Ph.D. Director Division of Receipt and Referral Center for Scientific Review HACU 2006

2. National Institutes of Health Office of the Director National Institute on Aging National Institute on Alcohol Abuse and Alcoholism National Institute of Allergy and Infectious Diseases National Institute of Arthritis and Musculoskeletal and Skin Diseases National Cancer Institute National Institute of Child Health and Human Development National Institute on Deafness and Other Communication Disorders National Institute of Dental and Craniofacial Research National Institute of Diabetes and Digestive and Kidney Diseases National Institute on Drug Abuse National Institute of Environmental Health Sciences National Eye Institute National Institute of General Medical Sciences National Heart, Lung, and Blood Institute National Human Genome Research Institute National Institute of Mental Health National Institute of Neurological Disorders and Stroke National Institute of Nursing Research National Institute of Biomedical Imaging and Bioengineering National Center for Complementary and Alternative Medicine National Library of Medicine National Center on Minority Health and Health Disparities Fogarty International Center National Center for Research Resources Clinical Center Center for Information Technology Center for Scientific Review

3. In 2006 expect to receive nearly 80,000 applications (paper and electronic)

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

5. TYPE OF APPLICATION DETERMINES SUBMISSION DATE • January, May September 10: Institutional Training Grant • February, June, October 1: New Research, Research Career, and all Program Project/Center • February, June, October 25: AREA • March, July, November 1: Renewal/Competing Continuation, Resubmission/Amended, and Revised/Supplemental • April, August, December 1: STTR and SBIR • April, August, December 5: Individual NRSA Fellowship • April, August, December 15: Conference • May, September1, January 2: All AIDS applications

6. NEW LEXICON • New application = new • Revised/amended application (A1, A2) = resubmission • Competing continuation application (type 2) = renewal • Competing supplemental application (type 3) = revision • Changed/corrected application = response to errors/warnings • Continuation = noncompeting continuation (type 5); do not use Grants.gov!

7. APPLICATION TYPE DETERMINES PAPER OR ELECTRONIC SUBMISSION • Conversion is by grant mechanism • Small Business – December 1, 2005 • AREA (R15) – February 25, 2006 • R03, R21, R33, R21/R33 R34 – June 1, 2006 • R18, R25 – October 1, 2006 • R01 – February 1, 2007 • Career (K series) – June 1, 2007 • Fellowships – August 5, 2007 • All by October 2007 • After conversion all applications (RFAs, PAs, PARs, PAs) must be submitted via Grants.gov; applications submitted in paper or using PHS 398 will not be accepted.

8. NIH Planned Transition Dates of Mechanisms for Electronic Submission using the SF424 (R&R) Resource (G7, G8, G11, G13, G20), Career Development (K), S11, S21, S22 (Jun. 1, 2007) SBIR/STTR (Dec. 1, 2005) R13/U13(Dec. 15, 2005) R18/U18, R25, C06/UC6 (Oct. 1, 2006) Fellowship (F) (Aug. 5, 2007) R36 (Feb. 17, 2006) Potential R01 Multi-PI Pilot (Oct. 1, 2006) R15 (Feb. 25, 2006) Training (T&D), U45, D71/U2R (Sep. 10, 2007) S10 (Mar. 22, 2006) DP1(Jan. 22, 2007) X02 (April 18, 2006) X01 (May 18, 2006) Project/Center (P), G12, M01, S06, R10/U10, U01, U19, U54, U56, R24/U24 (Oct. 1, 2007) R01(Feb. 1, 2007) R03,R21, R21/R33, R34(June 1, 2006) 08 10 08 10 12 01 02 03 04 05 06 07 09 11 12 01 02 03 04 05 06 07 09 2006 2007 • Current as of February 21, 2006. Visit the Web site for the latest version: http://era.nih.gov/ElectronicReceipt/ Mechanism Abbreviation Key: C06/UC6 Research Facilities Construction Grants DP1 NIH Director’s Pioneer Award Program D71/U2R International Training Cooperative Agreement/ Phase 2 of FIC mechanism D71 G Resource Program P Research Program Projects and Centers R01 Research Project Grant Program R03 Small Grant Programs R10/U10 Cooperative Clinical Research Grants R13/U13 Support for Conferences & Scientific Meetings R15 Academic Research Enhancement Awards (AREA) R18/U18 Research Demonstration and Dissemination Projects R21/R33 Exploratory/Development Research R24/U24 Resource Related Research Projects R25 Education Projects R34 Clinical Trial Planning Grant Program R36 Research Dissertation Grant Program SBIR Small Business Innovation Research STTR Small Business Technology Transfer S06,S10,S11 Biomedical Research S21,22 Health Disparities Endowment Grants U Cooperative Agreement Awards X01 High Throughput Screening X02 Preapplication

9. ELECTRONIC SUBMISSION • Grants.gov – single portal for applications to all Federal Agencies • eRA Commons – the NIH electronic Research Administration system that allows applicants/grantees to electronically receive and transmit application and award information. • Registration is required in advance (may take 4 weeks) • Grants.gov – Organization: DUNS and CCR • NIH – Commons for organization and PI • Start early and register now • Computer Requirements • Pure Edge Viewer (free at Grants.gov) • PDF generation • PC or PC emulation software or CITRIX service (free)

10. ELECTRONIC SUBMISSION (cont.) • Start with Funding Opportunity Announcement (FOA) in the NIH Guide and Contracts (http://grants2.nih.gov/grants/guide/) • Combination of SF 424RR and PHS 398 specific elements (information on Principal Investigator, new investigators, clinical studies, Human Embryonic Stem Cells, etc.) • Submit to Grants.gov by 5 p.m. local time – limited validations • NIH retrieves application from Grants.gov – standard and mechanism specific validations • Utilize Commons to get information on validations – errors that must be corrected (starting at Grants.gov) and warnings (optional correction)

11. Searching the NIH Guide The NIH Guide for Grants and Contractshttp://grants2.nih.gov/grants/guide/index.html Enter search criteria or Select Advanced Search

12. Searching the NIH Guide Applicants will identify an FOA of interest and download the application package. Selecting the FOA number opens the announcement

13. Searching the NIH Guide Button added to the NIH Guide announcements allows applicants to access the Grants.gov application package directly from the NIH Guide.

14. Searching the NIH Guide Download FOA instructions and applications package from Grants.gov

15. Preparing an Application Select “Save” to save the application package to your local hard drive. All mandatory Grants.gov fields are high-lighted and denoted with an asterisk. See Application Guide for additional NIH requirements.

16. Preparing an Application All Mandatory Documents must be completed in order to submit the application Optional documents may or may not need to be filled out – refer to the agency specific instructions NIH will use agency-specific forms labeled PHS 398

17. Preparing an Application To open a form, highlight the form and then select “Open Form”

18. Preparing an Application Submit button will not become activated until the following has been completed: • All Mandatory Fields have been completed • All Mandatory Documents have been completed and move to the Completed box • All applicable Optional Documents have been completed and moved to the Completed box • Only a AOR/SO can submit a grant!

19. Preparing Text Attachments • NIH only accepts attachments in PureEdge or PDF format. Do not submit attachments in other formats (Word, Word Perfect, etc.) • Do not put special characters in file names. • Disable all security features in the PDF document. • Do not send PDF documents with editable fields (fields that can be changed).

20. Check Submission Status in Commons • Once the application has been submitted, Grants.gov and eRA Commons will send a series of status Email notifications. • Errors/Warnings • Two business days to look at application; make sure complete/correct. AOR only has option of rejecting • Grants.gov sends notifications to the AOR only; eRA Commons sends notifications to the AOR/SO and the PI.A full list of notification messages can be found at: http://era.nih.gov/ElectronicReceipt/tips_tools.htm#5. • Email can be unreliable – applicants should proactively check the status of their applications in eRA Commons after submission.

21. Viewing Errors/Warnings 1. Click the Status tab to view the PI Status. 2. Find application that shows “eSubmission Error” in Application Status. 3. Follow the link on the Application ID to see specific error/warning messages.

22. Application Errors/Warnings

23. Errors and Warnings • Warnings can be fixed at the applicant’s discretion but do not require action for the application to move on. • Errors must be addressed before the application can move on. • After making all corrections, the entire changed/corrected application must be resubmitted through Grants.gov. • Once all errors are corrected, a new grant image is generated and made available for checking.

24. PRACTICAL DETAILS -ELECTRONIC SUBMISSION • Grants.gov/424RR applications look different • Some sections in more pages • High quality images, color • Form pages, organization a bit different • Best Advice – Read and follow all instructions! • Most frequent mistakes • Not completing registration in advance • Not allowing time for potential problems/corrections • Omitting PI’s Commons User ID • Attachments not in pdf format • While the mode of submission is changing the fundamental policies and processes of the NIH extramural process are not changing

25. Where To Go For Help • General information on Electronic Submission/SF424 (R&R): http://era.nih.gov/ElectronicReceipt • Grants.gov registration, submission and Pure Edge questions: http://www.grants.gov/CustomerSupport • Grants.gov Customer Service • E-mail: support@grants.gov • Phone: 1-800-518-4726 • eRA Commons registration and post submission questions • http://era.nih.gov/commons/index.cfm • E-mail: commons@od.nih.gov • Phone: 1-866-504-9552 OR 301-402-7469 • Forms transition and questions on NIH’s plan for electronic receipt - NIH Grants Information • E-mail: grantsinfo@nih.gov • Phone: 301-435-0714

26. APPLICATION POLICIES • Late Applications – Notice OD-05-030 • IC approval needed for all applications requesting $500,000 or more direct costs in any year • Modular budgets for R01, R03, R15, R21, and R34 under $250,000 • Resubmission Applications • Applications to and following RFA • Applications changing mechanisms • Duplicate applications not allowed (P series exception) • Format Requirements (within pdfs!): • Arial, Helvetica, Georgia, Palatino • 11 point, 15 cpi, 6 lpi, ½ in margins • Use common sense

27. RECENT CHANGES IN APPLICATION POLICIES • Institutions now maintain record of PI signature; no need for PI to sign paper application or verify electronic submission http://grants1.nih.gov/grants/guide/notice-files/NOT-OD-06-054.html http://grants1.nih.gov/grants/guide/notice-files/NOT-OD-06-055.html • Commons User Name required for all PIs • Multiple PI option – contact PI, Leadership Plan; limited FOAs • Effort reported in person months • Include information on select agents when appropriate • Appendix materials – use url for publicly available articles • Changes in PHS 398: http://grants1.nih.gov/grants/guide/notice-files/NOT-OD-06-056.html • Changes in SF 424RR: http://grants1.nih.gov/grants/guide/notice-files/NOT-OD-06-057.html • Changes in PHS 2590: http://grants1.nih.gov/grants/guide/notice-files/NOT-OD-06-058.htm l

28. WHAT KIND OF APPLICATION TO SUBMIT • Many different grant mechanisms used by the Institutes/Centers • Support ranges from individual predoctoral level to very large resources • Each Institute/Center uses a different array of mechanisms and may have special requirements • Investigator-initiated and solicited applications (RFAs) • Application kits and deadlines vary

29. INFORMATION SOURCES NIH Home Page (http://www.nih.gov) Funding Opportunities/Grants Page: http://grants1.nih.gov/grants/oer.htm NIH Guide to Grants and Contracts http://grants2.nih.gov/grants/guide/index.html Individual Institutes/Centers (http://www.nih.gov/icd/) Special Programs and Staff Contacts Center for Scientific Review (http://www.csr.nih.gov) Descriptions of review groups Meeting schedule Review Guidelines Mock Study Section Contact Information

30. THREE COMPONENTS OF EACH ASSIGNMENT • Mechanism • Institute/Center for funding consideration; dual assignments based on IC interests • Review location • Institute/Center • CSR • Principal Investigators are encouraged to include a request letter. • Institute/Center • Review – IRG or Study Section • Areas of Expertise Needed (but not names) • Conflicts

31. MECHANISM • Different Institutes/Centers use different arrays of mechanisms • For some mechanisms (R03, R21, P series) ICs may have different eligibility criteria, budget caps, page limits for research plan, etc. • Paper - Identify PA/RFA on line 2 and mechanism in cover letter • Electronic – pick correct F0A

32. INSTITUTE/CENTER ASSIGNMENTS • Referral Guidelines for Funding Components of PHS • ICs Have Many Shared Interests • Overall Mission • Specific Program Mandates • 24 Institutes/Centers have evolved over time, many shared interests • Principal Investigator Requests • Institute/Center Requests • Program Announcements • Assignment History

33. INITIAL REVIEW GROUP ASSIGNMENT • Referral Guidelines for IRG and Study Section http://www.csr.nih.gov/review/irgdesc.htm • Principal Investigator requests; generally 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: • Study Section or Special Emphasis Panel (SEP) • Conflict of Interest • Workload

34. PHILOSOPHY OF ASSIGNMENTS • Consider major focus of application – “center of gravity” • Consider all aspects of application, not just title or Description • Review Guidelines are the fundamental basis of decisions • Guidelines cannot cover every topic • Often consider secondary/tertiary factors • Panel on Scientific Boundaries for Review • Basic science reviewed in context of organ/disease studied • Also need review location for fundamental science studies • Ideally have two “homes” for review for every application

35. ASSIGNMENT NOTIFICATION Study Section or Special Emphasis Panel Scientific Review Administrator Address, telephone number, etc. Institute Assignment Primary and any dual General contact number Unique Identifier (1 R01 xx123456-01) Should receive within four to six weeks Utilize Commons to get assignment information, review outcome; Summary Statements - NIH is phasing out paper notifications Contact Division of Receipt and Referral if not available in Commons in a timely fashion!

36. ASSIGNMENT Verify correct mechanism 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 (electronic submission has cover letter option)

37. RESUBMISSION APPLICATION 2 amendment / No time 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

38. THE NEXT STAGE • Peer Review • Questions?