SF 424 R R Cover Component Page 1 1

SF 424 (R&R) Cover Component Page 1 1

SF 424 (R&R) Cover Component Page 2 2

Component: SF 424 (R&R) – A Cover Component • Similar to the PHS 398 Face Page • Provides general information about the applicant organization, contact information for the PD/PI and AOR/SO • Provides application-specific information (type, title etc. ) 3

SF 424 (R&R) - A Cover Component: A Few Data Issues • Item 1, Type of Submission – Pre-application - do not use unless specifically noted in FOA – Changed/Corrected Application—To be used only when correcting an application that failed system validations. This is NOT a resubmission (amendment). • Item 5, Applicant Information: This is for the applicant organization 4

SF 424 (R&R) - A Cover Component: A Few Data Issues • Item 5, Organizational DUNS: Must match DUNS in e. RA Commons profile for Applicant Institution – AOR should verify DUNS in Commons profile before submission – Use Organizational DUNS (not any DUNS for a specific individual) – If Organization has multiple DUNS, pick a single one for NIH grants 5

SF 424 (R&R) - A Cover Component: A Few Data Issues • Item 8, Type of Application--New Terminology – New is the same – Resubmission is equivalent to a Revision (a revised or amended application) – Renewal is equivalent to a Competing Continuation – Continuation is equivalent to a Progress Report. For the purposes of NIH and other PHS agencies, the box for Continuation will not be used and should not be checked. – Revision is somewhat equivalent to a Competing Supplement • Terminology crosswalk provided in instructions 6

SF 424 (R&R) - A Cover Component: A Few Data Issues • Item 10, CFDA Number & Title – CFDA = Catalog of Federal Domestic Assistance – Fields are pre-filled based on the specific announcement – Fields may be blank for applications in response to an FOA that includes multiple CFDAs – When multiple CFDAs are listed in an announcement, a CFDA will be assigned by the e. RA system once a specific Institute assignment is made 7

Project/Performance Site Locations 8

R&R Project/Performance Site Locations • Equivalent to the PHS 398 Form Page 2 Performance Site section • Collects individual data for up to 8 locations • >8 locations – information is provided in an attachment (not structured data, just text) • Format for the >8 attachment available on SF 424 (R&R) Forms Page: http: //grants. nih. gov/grants/funding/424/index. htm 9

Other Project Information 10

R&R Other Project Information • Includes information on involvement of Human Subjects, Vertebrate Animals, Environmental Impact, Foreign Involvement • Includes separate PDF attachments for – Project Summary/Abstract (Description) – Project Narrative • NIH will use this upload for the “Relevance” section of the Abstract • Separate component developed for Research Plan – Bibliography & References (previously section G. Literature cited) – Facilities & Other Resources – Equipment Resources 11

Senior/Key Person Profile 12

R&R Senior/Key Person Version 1 & 2 • Captures personal profile information on the PD/PI, Key Personnel, and Other Significant Contributors • Captures structured data for 8 individuals (PI and 7 others) • >8 information is provided in an attachment (not structured data, just text) • Format for the >8 attachment available on SF 424 (R&R) Forms Page: http: //grants. nih. gov/grants/funding/424/index. htm 13

Senior/Key Person Profile (Expanded) 14

Research & Related Senior/Key Person (Expanded) Version 2 A • This is the only change in the forms for packages noted as Version 2 A. • Captures structured data for up to 40 Senior/Key Persons. 15

Senior/Key Person Profile (Expanded) Additional Senior/Key Person Form Attachments 16

Version 2 A: Research & Related Senior/Key Person (Expanded) • Enter Senior/Key Person 1, click the Next Person button to display the fields for Profile – Senior/Key Person 2. • After the first 8 are entered (PI + 7 others), the Select to Extract the R&R Additional Senior/Key Person Form button becomes active. • Click to open a new page that allows up to four additional Senior/Key Person (Pure. Edge) components to be attached (each containing another 8 individuals). 17

Senior/Key Person Profile (Expanded) Additional Senior/Key Person Form Attachments Clicking on the “Select to Extract the R&R Additional Senior/Key Person Form” button produces the Pure. Edge form shown above. 18

R&R Senior/Key Person & Sr. /Key Expanded • Credential: Must enter the e. RA Commons User Name - for the PD/PI, this is a mandatory field for NIH submissions. (Most common validation failure to date) • Biosketch is attached for each person – Same data requirements exist; however, page limits slightly change to just 4 pages – Eliminated the 2 -page limit for subsections 19

R&R Senior/Key Person & Sr. /Key Expanded • Attachment for Current & Pending Support (a. k. a. Other Support) is not required at submission unless specified in FOA. • For most applications, this will continue to be a Just-In-Time submission 20

R&R Budget Sections A & B 21

R&R Budget, Sections A & B Personnel separated into 2 sections • A. Senior/Key Person – Allows 8 as named individuals & structured data – > 8 information is provided in an attachment (not structured data, just text) – Info for PD/PI must be entered, even if $ = 0 • B. Other Personnel – Postdocs, Grad Students, Undergrads: captures # only – NIH will request more detail in Budget Justification 22

R&R Budget, Sections A & B • Change from Percent Effort to Person Months – Must enter either Calendar, Academic and/or Summer for all Senior/Key Persons – Incorporated this business process change throughout--See 4/2006 Interim change to PHS 398 & PHS 2590 Progress Report, including Budget Pages, Other Support documentation, Key Personnel Reports, etc. – FAQs and Calculator available at: http: //grants. nih. gov/grants/policy/person_months_faqs. htm 23

R&R Budget Sections C - E 24

R&R Budget, Sections C - D • C. Equipment – Allows itemization of up to 10 – >10 equipment items: details provided in an attachment – total funds requested in attachment are entered in Line 11 • D. Travel – R&R separates out Domestic & Foreign – This will not change any NIH policy/practice. We will continue to award as a single category. 25

R&R Budget, Section E • E. Participant/Trainee Support Costs – Will not be used by NIH unless specifically noted in an announcement – Tuition Remission will continue to be included in Section F Other Direct Costs 26

R&R Budget Sections F - K 27

R&R Budget, Sections F - I • F. Other Direct Costs – Itemizes: Supplies, Publication Costs, Consultants, ADP/Computer Services, Consortium Costs, Equipment or Facility Rental/User Fees, Alterations & Renovations – Have included agency-specific instructions to use this section to also account for patient care costs & tuition remission • G. Total Direct Costs (A – F) • H. Indirect Costs • I. Total Costs (G+H) 28

R&R Budget, Sections J - K • J. Fee • K. Budget Justification – a PDF text attachment • Next Period Button: At the top of the last budget page. All required data fields in this component must be entered before this button is available. This includes the Budget Justification. 29

R&R Budget, General Notes • Applicant prepares a detailed budget for every budget period • There is no summary budget page like the PHS 398 Form Page 5 • A detailed Cumulative budget is systemgenerated 30

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R&R Subaward Budget Attachment Form • Use for detailed budget from any consortium grantee only when the prime is submitting detailed budget • Do not use if prime is submitting Modular Budget • Consortium grantee(s) must have Pure. Edge installed 32

R&R Subaward Budget Attachment Form • Allows up to 10 separate budget attachments— one for each consortium grantee • Applicant sends the R&R budget component to the consortium grantee for completion; it is returned to the applicant; applicant attaches it in this component • Applicant still needs to include the total costs for all consortiums in their own detailed budget, Section F. 5 33

SBIR/STTR Information Page 1 34

SBIR/STTR Information Page 2 35

SBIR/STTR Information • Includes eligibility questions answered by both SBIR & STTR applicants as well as separate sections for SBIR & STTRspecific questions • Includes Commercialization Plan as PDF Attachment 36

Agency-specific Components (a. k. a. PHS 398 Components) • PHS 398 Cover Letter File • PHS 398 Cover Page Supplement (supplements the R&R Cover) • PHS 398 Modular Budget • PHS 398 Research Plan • PHS 398 Checklist 37

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PHS 398 Cover Letter • Provides a text attachment for a cover letter • Instructions to applicant remain the same as in the PHS 398 • Is stored separately in the e. RA Grant Folder, not as a part of the main application grant image 39

PHS 398 Cover Letter • Is seen only by appropriate NIH staff; not peer reviewers • Required when submitting a Changed/Corrected Application after submission date • If revising the cover letter for a Changed/Corrected application, include all previously submitted letter text 40

PHS 398 Cover Page Supplement Page 1 41

PHS 398 Cover Page Supplement Page 2 42

PHS 398 Cover Page Supplement • Companion form to the (R&R) Cover Component • For the PI, includes New Investigator Code & Degree fields (Note, PD/PI info at the top is pre-filled. Provided here for reference only. ) • Includes Clinical Trial & Phase-III defined clinical trial indicators 43

PHS 398 Cover Page Supplement • For the Business Official Contact, includes complete contact information (title & mailing address missing from section 5 of the R&R Cover) • Includes Human Embryonic Stem Cells section 44

PHS 398 Modular Budget 45

PHS 398 Modular Budget • Provides data entry for each budget period – A. Direct Costs • DC less consortium F&A • Consortium F&A • Total DC – B. Indirect Costs Calculation section – C. Total Costs (A + B) • Cumulative Budget is system-generated • Budget Justification: PDF text attachments for Personnel, Consortium and Other 46

PHS 398 Research Plan 47

PHS 398 Research Plan • Separate PDF attachments for each section (designed to maximize benefits of system validations & to accommodate bookmarking of the image) • Same formatting requirements in the PHS 398 continue here – margins, page limits, etc. 48

PHS 398 Research Plan • Appendix Material – Allows up to 10 separate attachments – Will be stored separately in the e. RA Grant Folder, not as a part of the main application grant image – Will be accessible to appropriate NIH staff and peer reviewers – See recent changes in Appendix Material, Guide Notice NOT-OD-07 -018: http: //grants. nih. gov/grants/guide/notice-files/NOT-OD-07 -018. html 49

PHS 398 Research Plan Helpful Hints • Create as a single document using any word processing software. Separate at the end before uploading. • Do not include headers or footers • Include a section heading as part of the text (i. e. , Specific Aims, Background & Significance) • Avoid 2 -column format for text (difficult for reviewers to read electronically) 50

PHS 398 Checklist Page 1 51

PHS 398 Checklist Page 2 52

PHS 398 Checklist • Captures additional information currently in the PHS 398 Checklist – Change of PI – Change of Grantee Institution – Inventions & Patents – Program Income – PDF text upload for an Assurances/Certifications explanation 53

Application Complete… Next Steps Megan Columbus

Be sure to “Save” the completed application package to your local hard drive. Be sure all Mandatory Documents are completed and moved to the submission list. Refer to the agency-specific instructions for which Optional Documents are required. 55

The Check Package for Errors button will ONLY show Grants. gov errors. You must Submit the application for it to go through the NIH validation process. NIH errors will be shown in the e. RA Commons. 56

The AOR submits the application to Grants. gov. Registration with Grants. gov and e. RA Commons must be 57 complete to successfully submit.

The AOR Signs & Submits Only the AOR may sign and submit the application on behalf of the organization. 58

AOR Submits 59

Submit Application Scroll to the bottom of the Grants. gov confirmation screen to receive your Tracking Number and Date/Time Stamp. Applications are due 5 p. m. local time of the applicant org. on day of submission deadline. 60

Expected Turnaround Times • Grants. gov response to an application submission – generally within hours, up to 2 weekdays • e. RA Commons response to an application submission – generally within hours, up to 1 weekday • AOR/SO and PI review of application image – within 2 weekdays of availability in e. RA Commons 61

Grants. gov Validations • All Grants. gov mandatory fields have been completed • All mandatory documents have been completed and moved to the Completed Documents box (Submission List) • Checks the DUNS # • Checks date format, email address format, and scans for viruses 62

Email Notifications – Grants. gov • AOR receives emails • Submission Receipt – app received and is being validated • Rejection Notice – app is not validated because of Grants. gov errors • Submission Validation Receipt – app has been validated • Grantor Agency Retrieval Receipt – app has been retrieved by the agency • Agency Tracking Number – app has been assigned a tracking number by the grantor agency 63

Check Status in e. RA Commons After submission, the e. RA Commons system will: – Apply the NIH validations – Assemble the grant image – Generate a Table of Contents – Include headers (PI name) & footers (page numbers) on all pages 64

e. RA Commons Validations • The e. RA Commons checks the application against NIH business rules – Detailed check against the instructions in the application guide – Validates against the instructions in the specific FOA – For a detailed list of NIH validations: http: //era. nih. gov/Electronic. Receipt/prepare_app. htm#5 65

Email Notifications - e. RA Commons AOR/SO and PI receive emails Validations Complete/Check Assembled Application – Warnings Only Action Required: Errors and/or Warnings, Missing or Invalid Commons Username, System Error SO has refused application – SO rejected the application 66

Check Status in Commons – PD/PI 1. Click the Status tab to view the PI Status. 67 2. Find application that shows “e. Submission Error” in the Application Status column. 3. Follow the link on the Application ID to see specific Error/Warning messages.

View Errors/Warnings 68

Errors & Warnings • Errors must be addressed before the application can move on to Referral. • Warnings may be fixed at the applicant’s discretion but do not require action for the application to move on. • If the PI corrects any Warnings or Errors, they should contact the AOR/SO. The AOR/SO must submit the entire changed/corrected application again through Grants. gov. 69

Check Status in Commons AOR/SO Search screen allows the AOR/SO to narrow the list of results. Click Show Prior e. Submission Errors to view application errors. 70

Check Assembled Application View the Application Image by clicking on the Application ID 71

Check Assembled Application Next, click on the e-Application link to view the image. 72

Application Image Be sure to review the entire application carefully! Your application is not considered received by NIH until you see the application image in the e. RA Commons. 73

Check Assembled Application The AOR/SO has a 2 weekday viewing window to reject an application that has system formatting errors. If the application is not rejected within the 2 weekdays it will automatically proceed to Receipt & Referral. 74

Application Complete! 75

Resources for Assistance

Electronic Submission Information: http: //era. nih. gov/Electronic. Receipt/ 77

Resources Sample Document: “e. RA Assembly of the SF 424 (R&R) Application” – Includes a sample Table of Contents, and; – a chart cross-referencing the location in the forms components for each piece of the grant image. http: //grants. nih. gov/grants/funding/424/index. htm 78

Application Guide(s), Sample Application Packages, Additional Format Pages found at: http: //grants. nih. gov/grants/funding/424/index. htm 79

Training Tools Registration • e. RA Commons Registration – Automated Training Demo http: //era. nih. gov/virtualschool/external/c 101_Grantee. Registration. Pr ocess. htm Working with the Application Form • A “Walk Through the SF 424 (R&R)” - Video http: //helix. od. nih. gov/oervideo/grantsgov/A_Walk_Through_SF 424/i ndex. html • “Completing an Application Package” – Grants. gov Automated Demo http: //www. grants. gov/images/Application_Package. swf 80

Training Tools Learning the Electronic Submission Process • Interacting Electronically with NIH – Part I & II – Videos Hands-On Learning • Creating a Commons Demo Account – Learn the system and get familiar with the forms BEFORE you submit! – Check the status of sample applications in various stages of submission – View errors & warnings – See application images Videos/Hands-On: http: //era. nih. gov/Electronic. Receipt/training. htm 81

Training Tools Presentations • Archive of this training session will be available in streaming video and downloadable formats: http: //era. nih. gov/Electronic. Receipt/training. htm Review the Application Guides & Sample Application Packages • SF 424 (R&R) application guides, sample application packages and related resources http: //grants. nih. gov/grants/funding/424/index. htm 82

Training Tools • Registration in the e. RA Commons (Demo) http: //era. nih. gov/virtualschool/external/c 101_Grantee. Registration. Pr ocess. htm • Grants. gov’s “How to Complete An Application Package” Demo • SF 424 (R&R) application guides, sample application packages and related resources http: //grants. nih. gov/grants/funding/424/index. htm 83

Other Tools • Frequently Asked Questions http: //era. nih. gov/Electronic. Receipt/faq. htm • Electronic Submission Transition Timeline http: //era. nih. gov/Electronic. Receipt/strategy_timeline. htm • Avoiding Common Errors http: //era. nih. gov/Electronic. Receipt/avoiding_errors. htm • Communications and Outreach Resources (brochures, presentations, drop-in newsletter articles) http: //era. nih. gov/Electronic. Receipt/communication. htm 84

Finding Help: Grants. gov Registration & Submission If help is needed with the Grants. gov registration process or with technical aspects of submitting through the Grants. gov system or Pure. Edge: – Check the resources available on the Grants. gov website (http: //grants. gov/ ) – Grants. gov help is also provided by the following office: Grants. gov Customer Support Contact Center Phone: 1 -800 -518 -4726 Business Hours M-F 7 a. m. - 9 p. m. EST Email support@grants. gov 85

Finding Help: e. RA Commons Registration & Validations Processes If help is needed with e. RA Commons registration or validations after submission through Grants. gov: – Check the e. RA Commons website: https: //commons. era. nih. gov/commons/index. jsp – e. RA Commons Help Desk Use the web support! Enter your own help ticket! Phone: 301 -402 -7469 Toll Free: 866 -504 -9552 TTY: 301 -451 -5939 Business hours M-F, 7 am-8 pm EST Web support: http: //ithelpdesk. nih. gov/e. RA/ 86

Finding Help: Application Preparation • Review the Application Instruction Guide(s) • Contact Grants Info: Grants Info Phone: 301 -435 -0714 TTY: 301 -451 -0088 Email Grants. Info@nih. gov 87

Finding Help All of these resources and forms are found on the Electronic Submission website at: http: //era. nih. gov/Electronic. Receipt/ 88

Lessons Learned NIH Panel of Experts

NIH Electronic Submission Panel of Experts Megan Columbus, NIH Program Manager for Electronic Submission of Grant Applications Suzanne Fisher, Director, Division of Receipt and Referral, Center for Scientific Review Jennifer Flach, e. Submission Technical Development Manager Scarlett Gibb, Manager, e. RA Help Desk Marcia Hahn, Director, Division of Grants Policy, Office of Policy for Extramural Research Administration 90

Lessons Learned • Work with your Office of Sponsored Research to determine your internal process flow (review, approval, document sharing etc. ) • Register now to be prepared – All PIs and Fellows need to be registered – Can take 2 – 4 weeks; up to 8 weeks for newly established organizations • Read and follow all instructions in the FOA & the application package instructions! 91

Lessons Learned • All non-Pure. Edge attachments MUST be in PDF format DO NOT: • Use special characters in file names • Write-protect the PDF file; you should disable all security features in the PDF • Scan text attachments. Generate using word processing package and then convert to PDF. For more information: http: //era. nih. gov/Electronic. Receipt/faq_prepare_app. htm#2 e 92

Lessons Learned • Organizational DUNS in the application must match DUNS in the e. RA Commons profile for the Applicant Institution • The “credential e. g. , agency login” field on the R&R Senior/Key Person Profile component MUST contain the PI’s e. RA Commons User ID for NIH to process the application submission 93

Lessons Learned • When submitting a Changed/Corrected application, make sure you check the “Changed/Corrected” box in Field #1 Type of Submission • Allow extra time for corrections 94

Lessons Learned • Take time to closely review the grant image within 2 weekdays of availability – Ensure ALL PDFs are attached – Check each one for proper conversion & formatting • New Process…but It’s Still About the Science! Our philosophy and policy has not changed! 95

Q&A with the NIH Panel of Experts

How To Submit Questions • Live Audience – Index cards in your folder – One question per card please! • Videocast Audience – Submit questions online using the Live Event Feedback Form or; – Send an email to the NIH Electronic Submission mailbox NIHElectronic. Submiss@mail. nih. gov 97

Collecting User Feedback • NIH has established an email address to collect comments and/or suggestions from users: NIHElectronic. Submiss@mail. nih. gov • Share specific suggestions for improvement • Share what resources are most useful (Targeted Emails, FAQs, Avoiding Common Errors, Commons Alerts, Training Tools etc. ) 98

Thank You!