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Christopher L. Hatch, Ph.D. Chief, Program Coordination and Referral Branch

Christopher L. Hatch, Ph.D. Chief, Program Coordination and Referral Branch Division of Extramural Activities, NCI. Update on “eSubmissions” of Grant Applications to the NIH Presentation to the CCOP, MBCCOP, and Research Base PIs and Administrators September 17, 2007.

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Christopher L. Hatch, Ph.D. Chief, Program Coordination and Referral Branch

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  1. Christopher L. Hatch, Ph.D. Chief, Program Coordination and Referral Branch Division of Extramural Activities, NCI Update on “eSubmissions” of Grant Applications to the NIH Presentation to the CCOP, MBCCOP, and Research Base PIs and Administrators September 17, 2007

  2. Timeline of Transition SBIR/STTR (Dec. 1, 2005) SC1, SC2, SC3 (Jan. 2008) R13/U13(Dec. 15, 2005) R36 (Feb. 17, 2006) Ks, Ts, Fs (2008?*) R15 (Feb. 25, 2006) R18/U18, R25, C06/UC6 (Oct. 1, 2006) S10 (Mar. 22, 2006) DP1(Jan. 22, 2007) Complex mechanisms (2009?**) X02 (April 18, 2006) R01(Feb. 1, 2007) Potential R01 Multi-PI Pilot (Oct. 1, 2006) R03, 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 NIH Timeline Current as of September 14, 2007. Visit the Web site for the latest version: http://era.nih.gov/ElectronicReceipt/ *NIH is working with Grants.gov to develop eApplication forms for Fellowship (F), Training (T&D), and Career (K) mechanisms. The ‘base’ application package will be the SF424 (R&R) with the addition of agency-specific forms. **eApplications for complex mechanisms (e.g., research program and center grants) are WAY down the pike (literally a year or two) unless the NIH can come up with an alternate solution. Grants.gov cannot yet provide the system requirements needed to capture complex data and relationships.

  3. Grants.gov Grants.gov hosts standardized federal forms SF424 (R&R) and agency-specific forms (PHS 398) Electronic application through Grants.gov using these forms is mandatory for most FOAs. Grants.gov checks the application for federal-wide requirements. eRA Commons NIH retrieves the data from Grants.gov and checks the application against NIH-specific requirements eRA Commons allows applicants to electronically track the status of submissions and to receive/transmit application and award information NIH Uses Two Linked Systems for Processing Submitted eApplications

  4. Phases of eSubmission Pre-Submission Submission Post-Submission

  5. Pre-eSubmission Steps • Finding funding opportunities and figuring out what to apply for. • Making sure that your institution is registered with Grants.gov (including DUNS and CCR registrations) and with the NIH eRA Commons • Registering yourself with the eRA Commons (in conjunction with your institution) • Downloading PureEdgeTm [or other] and pdf software • Downloading the specific application forms

  6. eSubmission Steps • Downloading the correct grant application package; • Understanding application requirements; • Writing components of the application; • Generating and loading pdf files; • Assembling and completing the application; • Submitting the application electronically; • Checking for warnings and/or errors; and • Correcting and resubmitting the application.

  7. Post-eSubmission Steps • Seeing the SF424 (R&R)-based grant image appear (if it passes NIH rules); • Checking the application within 2 days after successfully submitting; • Making changes, if necessary and/or desired; • Verifying the application in the Commons; • Knowing that the data and grant image have been saved; • Knowing that the application will be processed; • Checking the status of the application.

  8. Funding OpportunityAnnouncements (FOAs) • All FOAs will be posted on Grants.gov by NIH staff along with the appropriate application package. • All FOAs will continue to be posted in the NIH Guide for Grants and Contracts. • NIH will continue to use the terms Requests for Applications (RFAs) and Program Announcements (PAs), but all grants “solicitations” will be referred to as FOAs in Grants.gov. • All eApplications must be created with use of an appropriate SF424 and submitted to the NIH through Grants.gov in response to an FOA.

  9. Latest statistics • Out of 839 active NIH FOAs, nearly 700 (~ 83%) currently require the electronic submission of grant applications created with use of the SF424 (R&R) to and through Grants.gov and eRA Commons. • About 82% of the grant applications submitted to the NIH in 2007 (so far) came through Grants.gov and eRA Commons.

  10. NIH Guide for Grants and Contracts(http://grants1.nih.gov/grants/guide/index.html) • Search For Exact Keyword(s) or Phrase(s): • Active Funding Opportunities only (RFAs & PAs) • Recent Notices only (Released in Last 12 Months) • Both Active Funding Opportunities & Recent Notices • Search Hints: • Search by number (e.g., RFA-CA-07-037 or PA-07-177) • Search by title or keyword • Search matches exact keyword or phrase (leave blank to display all records) • Separate Multiple Search Terms with comma (e.g., cancer, oncology, community, diversity) • Search for Active and Inactive Announcements using Advanced Search

  11. Searching Grants.gov • To perform a basic search for a grant, go to http://www.grants.gov/search/basic.do and complete: • Keyword Search; • Search by Funding Opportunity Announcement number; OR • Search by Catalog of Federal Domestic Assistance (CFDA) number field; then click the "Search" button. • For the Advanced Search capability, go to http://www.grants.gov/search/advanced.do

  12. NCI’s Catalog of Federal Domestic Assistance (CFDA) Numbers and Categories 93392 Cancer Construction 93393 Cancer Cause and Prevention 93394 Cancer Detection and Diagnosis 93395 Cancer Treatment 93396 Cancer Biology 93397 Cancer Centers Support 93398 Cancer Research Manpower 93399 Cancer Control

  13. Find FOA in NIH Guide or on Grants.gov, then download application package by clicking “button” on first page • Program Announcement (PA) Number: PA-07-298 • For Assistance downloading this or any Grants.gov application package, please contact Grants.gov Customer Support at http://grants.gov/CustomerSupport APPLY FOR GRANT ELECTRONICALLY

  14. Current Funding OpportunityAnnouncements (FOAs) NCI’sNCI on other ICs’*NIH’s R03 FOAs 7 16 91 R21 FOAs 38 42 201 R01 FOAs 29 53 277 *ICs’ = NIH Institutes’ and Centers’ [FOAs]

  15. Using Standard Forms to Apply through Grants.gov is a Very Different Model • The application form and instructions (i.e., for the SF424 (R&R)) will now be part of a package that NIH posts on Grants.gov along with each FOA – a direct link to this package can also be found on the first page of the FOA in the NIH Guide • After downloading a free PureEdgeTm software package onto their desktops, applicants can download the application package for the specific FOA from within Grants.gov

  16. Features of the SF424 (R&R) • SF424 (R&R) Components include: • SF424 (R&R)—An application cover component • R&R Project/Performance Site Location(s) • R&R Other Project Information • R&R Senior/Key Person • Biosketches of Key Personnel • R&R Budget • R&R Personal Data (NIH does not use) • R&R Subaward Budget Attachment Form • SBIR/STTR Information

  17. Modifications of SF424 (R&R) Grant Application Package for NIH • NIH requires additional data collection to accommodate the unique information required for review of its biomedical research portfolio. • In addition to the standard components, the following “agency specific” components will be used by NIH as part of the application package: • PHS 398 Cover Letter File • PHS 398 Cover Page Supplement • PHS 398 Research Plan • PHS 398 Modular or Detailed Budget • PHS 398 Checklist • Appendices

  18. Preparing for eSubmission– Registration with Grants.gov Applicant institutions must complete a one-time-only registration • Detailed instructions at http://grants.gov/GetStarted • Grants.gov registration requires institutions to: • Obtain a D&B Data Universal Numbering System (DUNS) number; and • Register in Central Contractor Registry (CCR) • Registration not required to find funding opportunities or to download application packages, only to submit completed grant applications It is critical for institutions to begin this registration process at least 4 weeks before applications are due!

  19. Preparing for eSubmission– Registration with eRA Commons • Applicant institutions must complete one-time only registration (NIH now has over 9,700 registered organizations in Commons with over 250,000 logons each month). • PI’s must work through their institutions to register. • PI’s currently registered only for NIH’s Internet-Assisted Review (IAR) system must work through their institutions for full Commons registration. It is critical for institutions and applicants to begin this registration process at least 4 weeks before applications are due!

  20. Authorized Organizational Representative (AOR) and Signing Official (SO) Authorized Organizational Representative (AOR) and Signing Official (SO) are the titles used for the person in an institution’s Sponsored Research Office (or equivalent) who interacts with Grants.gov and the NIH electronic Research Administration (eRA) Commons, respectively, during the electronic submission of an grant application on the SF424. In addition to having institutional authority to legally bind the institution in grants administration matters, the SO can register the institution, and create and modify the institutional profile and user accounts in the eRA Commons. An SO can view all grants within the institution, including status and award information.

  21. Other Administrator Roles in eRA Commons An SO can create additional SO accounts as well as accounts for other roles. Other roles include: • Administrative Official (AO) • An AO can review an eApplication for accuracy before SO submits it (AO can be same person as SO). • An AO can create other AO and PI accounts. • Account Administrator (AA) • AA is designated by SO to facilitate administration of eRA Commons accounts (e.g., for AO, AA, ASST, FSR, PI) • Assistant (ASST) • ASST can receive delegated authority from PI to enter data on grant information and to update PI’s personal profile. • Financial Status Report (FSR) • FSR role allows designated persons to process FSRs for eSubmission to the NIH.

  22. Electronic Receipt: How It Works Applying for Grants at Grants.gov After finding the funding opportunity on Grants.gov, the applicant: Step 1: Downloads the grant application package (PureEdgeTm [or other] software required to view); Step 2: Completes the grant application; Step 3: Submits the application to Grants.gov (through Authorized Organizational Representative [AOR]); Step 4: Tracks status of the submitted application (e.g., notification of retrieval by NIH);

  23. Electronic Receipt: How It Works Applying for Grants (continued); the applicant: Step 5: Waits for electronic Research Administration (eRA) software to check the application against NIH business rules; Step 6: Receives notification (with simultaneous notification of AOR) via email to check eRA Commons for results of NIH rule-checking; Step 7: Sees errors and warnings (if application does not pass NIH rules), then • fixes errors within the 2-day window, and AOR resubmits entire application to Grants.gov;

  24. Electronic Receipt: How It Works Applying for Grants (continued); the applicant: Step 8: Sees SF424 (R&R)-based grant image appear (if it passes NIH rules), and, • If acceptable to PI and AOR, AOR verifies application in Commons; and Step 9: Knows that data and grant image have been saved, and that the application will be processed by NIH staff. Grant image becomes available to NIH staff and to assigned peer reviewers Applicant can follow progress of application via the NIH eRA Commons

  25. System-to-System eSubmission Advantages, which vary among Service Providers, include: • Platform independence (work with Macintosh, Linux, Unix, etc.). • Choice of an entire grants administration system or individual eSubmissions of eApplications, depending on needs and budgets. • Ability to view and/or print a generated PDF version of the entire eApplication prior to eSubmission. • Ability to check eApplications against Grants.gov and eRA Commons validations before eSubmission, so applicants do not need to deal with error corrections later. • Integration of system with other institutional systems (i.e., Human Resources, Administration, etc.) to allow data such as salaries to be “auto-loaded.” • Conversion of text documents to PDF for the applicant. • Provision by PI of a single document for the research plan and “auto-divisions” and “auto-conversions” of the document into the required component attachments and PDFs. • Institutional routing, review, and approval with multiple levels of authority prior to the submission. • Ability for an AOR to lock down all parts of the application except for the research plan so the PI can tweak the Research Plan as needed. • “Auto-fill” of repeated fields, such as Institutional profile. • Data storage that can help institutions in reporting. • Large numbers of eSubmissions handled efficiently.

  26. System-to-System Service Providers Cayuse Inc. (http://www.cayuse.com) Click Commerce (http://research.clickcommerce.com) Clinical Tools (http://www.healthproposal.net) eRA Software Systems (http://www.gams.com) Formatta Corp. (http://www.formatta.com/about/partners/nih/) iMedRIS Data Corp. (http://www.imedris.com) InfoEd International (http://infoed.org) Research & Management Systems (RAMS) (http://www.ramscompany.com/grantsera.html) SciMed Solutions (http://www.scimedsolutions.com/)

  27. Generic Validations of eApplications Means that NIH can automatically: • Check for type of application; • Match to prior application(s) when applicable; • Check numbers of resubmissions (amendments); • Verify and match DUNS number and Commons ID(s); • Check Exception and Assurance numbers; • Ensure one page limit for project summary; • Ensure one page Introduction for resubmissions; • Ensure adherence to other page limitations; • Check budgets for basic eligibility and accuracy; • Verify presence of components of Research Plan; • Check for Inclusion Plans, Clinical Trials, etc.; and • Check for other required elements.

  28. Advice From Experience • IMPORTANT: Read and follow all application instructions! • Failure to follow instructions has resulted in applicants having to submit corrected applications. • The HHS logo denotes any special instructions or fields not marked as mandatory on the federal-wide form that are required by NIH. • Two most common problems with eApplications to date: • The credential field of the R&R Senior/Key Person Profile component MUST contain the PI’s assigned eRA Commons User ID for NIH to process the application. • All non-PureEdge attachments MUST be in PDF format. Important!

  29. NIH Electronic Submission Validations and the 80-20 Rule The Pareto Principle, also known as the 80-20 rule, states that for many phenomena, 80% of the consequences stem from 20% of the causes. This principle holds true for eApplication errors identified by the eRA Commons. Of the 98 different errors that R01 applicants received during a recent eSubmission cycle, the top 20 errors accounted for 84% of the total errors flagged.

  30. The 10 Top Errors on eApplications • Senior/Key Person, listed on the 424 RR Detailed Budget Page for budget year {1}, must include effort of a value greater than zero in calendar months, academic months, or summer months. • The attachment is not in PDF format, or the filename is invalid. • The organization name for Key Person must be provided on the Senior/ Key Person page. • The eRA Commons Username has not been specified in the 'Credential' field on the Senior/Key Person page for PD/PI. • Federal Identifier format (SF 424 RR Cover page) is not valid (please include only the IC and serial number of the prior grant number [e.g., CA123456]). • The eRA Commons Username in the PD/PI Credential field on the Senior/Key Person page is not a recognized eRA Commons account. • Either Exemption Number or Assurance Number must be provided if Human Subjects is "Yes" (Other Project Information, item 1). • There must be a Personnel entry (with a role of "PD/PI") listed for the PI or PD on the 424 RR Detailed Budget Page (section A&B) for budget year {0}. • The Targeted/Planned Enrollment Table Attachment must be included on the PHS 398 Research Plan page if the response to the Human Subjects question on the Other Project Information Page is 'Yes' and if the Exemption Number is not 4. • The Inclusion of Children Attachment must be included on the PHS 398 Research Plan page if the response to the Human Subjects question on the Other Project InformationPage is 'Yes' and if the Exemption Number is not 4.

  31. eReview of Grant eApplications Means that: • CSR and NCI scientific review administrators will no longer receive and review paper copies of grant applications; • Peer reviewers will generally not receive paper copies of grant applications to read and critique; • Internet-Assisted Review (IAR) will hopefully improve the efficiency of the peer review process; and • Applicants will be able to more easily check milestones for their applications.

  32. Where to Go for Help • General information on Electronic Submission and the SF424 (R&R) • Visit: http://era.nih.gov/ElectronicReceipt • Forms transition and questions on NIH’s overall plan for electronic receipt • Visit GrantsInfo.gov • E-mail: grantsinfo@nih.gov • Phone: 301-435-0714 • eRA Commons registration and post submission questions on Commons functionality • Visit: http://era.nih.gov/commons/index.cfm • E-mail: commons@od.nih.gov • Phone: 1-866-504-9552 or 301-402-7469 • Grants.gov registration and submission questions • Visit: http://www.grants.gov/CustomerSupport • E-mail: support@grants.gov • Phone: 1-800-518-4726

  33. Thanks for Listening! My contact information: Christopher L. Hatch, Ph.D. Chief, Program Coordination and Referral Branch Division of Extramural Activities National Cancer Institute 6116 Executive Boulevard, Room 8047 Bethesda, MD 20892-8329 Rockville, MD 20852 (for express delivery) Telephone: 301-594-1403 Fax: 301-402-0275 E-mail: ch29v@nih.gov or ncirefgrp@mail.nih.gov

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