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

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, September 1, 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. Mechanism Abbreviation Key: C06/UC6 Research Facilities Construction Grants DP1NIH Director’s Pioneer Award Program D71/U2R International Training Cooperative Agreement/ Phase 2 of FIC mechanism D71 GResource Program PResearch 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,S11Biomedical Research S21,22Health Disparities Endowment Grants U Cooperative Agreement Awards X01High Throughput Screening X02Preapplication Current as of February 21, 2006. Visit the Web site for the latest version: http://era.nih.gov/ElectronicReceipt/http://era.nih.gov/ElectronicReceipt/ NIH Planned Transition Dates of Mechanisms for Electronic Submission using the SF424 (R&R) 2006 12 10 11 Resource (G7, G8, G11, G13, G20), Career Development (K), S11, S21, S22 (Jun. 1, 2007) 05071209010203 R03,R21, R21/R33, R34 (June 1, 2006) 0405 2007 R18/U18, R25, C06/UC6 (Oct. 1, 2006) Fellowship (F) (Aug. 5, 2007) Project/Center (P), G12, M01, S06, R10/U10, U01, U19, U54, U56, R24/U24 (Oct. 1, 2007) 0102030406 08 06 S10 (Mar. 22, 2006) R15 (Feb. 25, 2006) R36 (Feb. 17, 2006) R13/U13 (Dec. 15, 2005) SBIR/STTR (Dec. 1, 2005) 10 0709 08 X02 (April 18, 2006) R01 (Feb. 1, 2007) Training (T&D), U45, D71/U2R (Sep. 10, 2007) Potential R01 Multi-PI Pilot (Oct. 1, 2006) DP1 (Jan. 22, 2007) X01 (May 18, 2006)

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/)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 Contracts http://grants2.nih.gov/grants/guide/index.html Enter search criteria or Select Advanced Search

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

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 Optional documents may or may not need to be filled out – refer to the agency specific instructions All Mandatory Documents must be completed in order to submit the application 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. 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/ElectronicReceipthttp://era.nih.gov/ElectronicReceipt Grants.gov registration, submission and Pure Edge questions: http://www.grants.gov/CustomerSupporthttp://www.grants.gov/CustomerSupport Grants.gov Customer Service E-mail: support@grants.govsupport@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.govcommons@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.govgrantsinfo@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 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.htmhttp://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)http://www.nih.gov Funding Opportunities/Grants Page: http://grants1.nih.gov/grants/oer.htm http://grants1.nih.gov/grants/oer.htm NIH Guide to Grants and Contracts http://grants2.nih.gov/grants/guide/index.h tml Individual Institutes/Centers (http://www.nih.gov/icd/)http://www.nih.gov/icd/ Special Programs and Staff Contacts Center for Scientific Review (http://www.csr.nih.gov)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?