F-award grant submission process

1. December 2017 OGC Pre-Award Team F-award grant submission process

2. Getting Started • Identify an NIH announcement to which you would like to respond • Obtain approval from the Concept Review Committee 6 months prior to internal deadline • Send “Planning to Submit a Grant” form to OGC: A Pre-Award Specialist will be assigned to your project (Handout #1) • Pre-Award will send a start-up email containing all the relevant information about due dates and other requirements for the grant to be submitted (Handout #2) • Obtain WPIC Research Committee approval

3. Getting Started Current Parent Announcements: • PA-16-305: Ruth L. Kirschstein National Research Service Award (NRSA) Fellowship for Students at Institutions With NIH-Funded Institutional Predoctoral Dual-Degree Training Programs (Parent F30) • PA-16-306: Ruth L. Kirschstein National Research Service Award (NRSA) Fellowship for Students at Institutions Without NIH-Funded Institutional Predoctoral Dual-Degree Training Programs (Parent F30) • PA-16-308: Ruth L. Kirschstein National Research Service Award Individual Predoctoral Fellowship to Promote Diversity in Health-Related Research (Parent F31 - Diversity) • PA-16-309: Ruth L. Kirschstein National Research Service Award (NRSA) Individual Predoctoral Fellowship (Parent F31) • PA-16-307: Ruth L. Kirschstein National Research Service Award (NRSA) Individual Postdoctoral Fellowship (Parent F32) • PA-16-310: Ruth L. Kirschstein National Research Service Award (NRSA) Individual Senior Fellowship (Parent F33)

4. Getting Started • The University of Pittsburgh requires that any individual directly involved in the design, conduct, or reporting of research except consultants complete the following trainings: • Conflict of Interest Superform: University of Pittsburgh Faculty/Researcher (PHS Funded) must be updated annually by April 15th • Training Modules updated every 4 years: • All Investigators • CITI Conflict of Interest Module • CITI Responsible Conduct of Research Module • Human Subjects Research • CITI Human Subjects Research in Social and Behavioral Sciences and/or in Biomedical Science • Animal Research • ISER Use of Laboratory Animals in Research and Education • ISER Animal Species Specific modules • CITI Animal Species Specific modules (amphibians, guinea pigs, hamsters) • An Intellectual Property Rights Assignment form is also required and can be provided by your pre-award specialist • OGC will check for compliance prior to submission • A full list of required trainings can be found at http://rcco.pitt.edu/training-courses/required-training

5. Getting Started • Once you receive the start-up email from your Pre-Award Specialist provide an estimation of your tuition and fees, including degree program or course list and their corresponding graduate school • OGC will create a budget for you in Excel using the current NRSA rates that will consist of: • Stipend • Tuition and Fees • Institutional Allowance

6. Budget Process

7. Budget • Know your funding agency’s & funding announcement’s parameters! • Sponsor specific information can be found by going to your funding announcement and clicking on the link for “Table of IC-Specific Information, Requirements and Staff Contacts” • Several resources are available: • For a list that covers institute parameters for F30s only, go to: http://grants.nih.gov/grants/guide/contacts/parent_F30a.htmlhttp://grants.nih.gov/grants/guide/contacts/parent_F30b.html • For a list that covers institute parameters for F31s only, go to: http://grants.nih.gov/grants/guide/contacts/parent_F31_diversity.htmlhttp://grants.nih.gov/grants/guide/contacts/parent_F31.html • For a list that covers institute parameters for F32s only, go to: http://grants.nih.gov/grants/guide/contacts/parent_F32.html • For a list that covers institute parameters for F33s only, go to: http://grants.nih.gov/grants/guide/contacts/parent_F33.html

8. Budget • Stipend & Institutional Allowance are based on the current NRSA rates: • Ruth L. Kirschstein National Research Service Awards (NRSA) Postdoctoral Stipends, Training Related Expenses, Institutional Allowance, and Tuition/Fees Effective for Fiscal Year 2017 https://grants.nih.gov/grants/guide/notice-files/NOT-OD-17-003.html • Ruth L. Kirschstein National Research Service Awards (NRSA) Predoctoral Stipends, Training Related Expenses, Institutional Allowance, and Tuition/Fees Effective for Fiscal Year 2017 https://grants.nih.gov/grants/guide/notice-files/NOT-OD-17-084.html • Individuals may receive up to 5 years of aggregate Kirschstein-NRSA support at the predoctoral level (up to 6 years for dual degree training, e.g., MD/PhD), and up to 3 years of aggregate Kirschstein-NRSA support at the postdoctoral level, including any combination of support from institutional training grants (e.g., T32) and an individual fellowship award

9. Budget Example of a two year Postdoctoral Budget: Example of a tuition and fees calculation: Your pre-award specialist can help you figure out tuition and fees based on Pitt’s current tuition rate http://ir.pitt.edu/graduate-tuition/ This amount will be included on your application Cover Page Item 15.

10. Budget Example of a three year Predoctoral Budget: Example of a tuition and fees calculation: Your pre-award specialist can help you figure out tuition and fees based on Pitt’s current tuition rate http://ir.pitt.edu/graduate-tuition/ This amount will be included on your application Cover Page Item 15.

11. NIH Application Package

12. NIH Application Package • Use both the Funding Opportunity Announcement and the NIH instructions to complete the application • NIH instructions can be found at http://grants.nih.gov/grants/funding/424/index.htm • Refer to PHS Fellowship Supplemental Form for F-award specific instructions • NIH periodically updates instructions and they should always be reviewed prior to any submission • Supplemental instructions for human subjects and other policies are included in the main link • Funding Opportunity Announcement instructions always supersede the general NIH instructions

13. NIH Application Package • There are currently 4 application options: • ASSIST: NIH web-based service for the preparation, submission & tracking of grant applications – recommended • Institutional Solutions (System-to-System, S2S): Institution’s own system to prepare and submit application data to Grants.gov – not yet available • Grants.gov Workspace: shared, online environment managed by Grants.gov where multiple users can simultaneously work on different forms within an application package – not yet available • Grants.gov Downloadable Forms: offline solution where applicants can download the entire application package as a single, stitched together PDF, complete the forms offline and submit – will retire at the end of 2017 • The current application package is FORMS-D Upcoming changes to NIH applications (Will not effect December Applications!): • Grants.gov to Retire Legacy PDF Application Packages at end of 2017 and all applications will go through ASSIST • NOT-OD-17-062: New NIH "FORMS-E" Grant Application Forms and Instructions Coming for Due Dates On or After January 25, 2018

14. Benefits in ASSIST • Pre-populates data from eRA Commons profiles • Validates Grants.gov and NIH business rules BEFORE you submit • Provides preview of the compiled application • Generates table of contents, headers and footers • Tracks Grants.gov and eRA Commons submission status • Multiple users can access at once and simultaneously work in different sections of the application

15. Initiating the ASSIST Application • It is always recommended to initiate from the announcement that you plan to apply under and find the following section: • The application may also be initiated directly at https://public.era.nih.gov/assist • Make sure you initiate the correct application by FOA number and the Competition ID says FORMS-D • Log in using your eRA Commons User Name and Password and type the announcement and click “Go” • On next page, enter your application title – limited to 200 characters and can be changed at any time • Click “Initiate Application” to proceed to the application overview

16. After Initiating Application • Tips for using ASSIST • The Search Application feature on the home page can be used to find applications in progress – search using PI last name and choose the appropriate grant • Not all forms are included in the active application by default – use the “Add Optional Form” button in the actions menu to include any necessary additional forms • Each form in ASSIST is a separate tab in the top menu • To update information in any form, click the “Edit” button in the upper left corner of the form • There are three saving options while working in a given form: • Save and Keep Lock: saves your progress and while blocking access to others • Save and Release Lock: saves your progress and releases the form for editing by a reviewer; use when moving to another tab and when your pre-award specialist goes to review • Cancel and Release Lock: only use to cancel changes you do not want saved

17. After Initiating Application • Mandatory fields and attachments are indicated with an asterisk (*) • All indicated fields are required • Not all required fields are indicated • Use the application guidelines to determine additional mandatory items or consult your Pre-Award Specialist for guidance

18. R&R Cover Form • Item 1: Type of Submission – Always choose “Application” • Item 8: Type of Application • New – an application submitted for the first time • Resubmission – revised or amended application to address reviewer feedback • Renewal – competing for additional years of funding to continue project • Continuation – NIH does not use SF424 R&R continuation applications • Revision – request for additional funds to expand scope (supplement) • Don’t be discouraged if your grant isn’t funded after two tries! NIH and departmental policies have been established regarding submission of these grants – contact OGC if you have questions

19. R&R Cover Form • Item 4: Federal Identifier • This field is required for resubmissions only – input the grant ID from the initial submission in box 4.a (i.e. MH123456) • Item 5: Applicant Information • The applicant is the University of Pittsburgh, not the PI • This is the Office of Research contact information • Additional OR contact information is entered in Item 19 • Item 12: Proposed project period is all years of the grant • Item 14: In ASSIST PD/PI contact information must be updated in the Senior/Key person profile and will transfer to the Cover form • Refer to Handout #3 for the University application information that must be entered in the Cover Form

20. R&R Cover Form • Update your application title on this form – 200 characters • Your PD/PI contact information must be updated under your Senior Key Profile and will reference back to the Cover Form • List your current office address or WPIC address under PD/PI contact information • Always list Department as “Psychiatry” and Division as “Medicine” • Psychiatry faculty must list Psychiatry only in the department field, even if they have a dual appointment • Ensures grant application is linked to our Department • Organization name is a required field – make sure University of Pittsburgh for the PD/PI • Item 15: Enter the total dollar amount requested for all years including indirect costs in 15.a & 15.c • 15.b & 15.d should be zero

21. R&R Cover Form • The cover letter is required for F awards and must contain the following items: • Application title • Funding Opportunity title (PA or RFA) • A list of your Referees including name, departmental affiliation, and institution • Aggregate Kirschstein-NRSA support and specify project period, if applicable

22. Other Project Information Form • Check boxes for Human Subjects and Animals • If answer “No” to IRB/IACUC Pending question, copy of approval must be provided to the Pre-Award Specialist for the internal approval process • Human Subject Assurance Number: 00006790 • Animal Welfare Assurance Number: D16-00118 • Project Summary/Abstract – cannot exceed 30 lines • Project Narrative – cannot exceed 3 sentences • Facilities & Other Resources – no page limit • Equipment – this attachment is required and should explain existing equipment available that will be used for the project

23. Performance Sites Form • Primary Performance Site • Use the WPIC address or the address of where the work will physically be done (Handout #4) • Information does not pre-populate from other application sections so it must be entered manually • Additional Project/Performance Site Locations • Other sites should be listed as applicable • Should reflect any site where a substantial portion of the work will be completed including subaward sites or secondary human subjects enrollment sites • Secondary Pitt locations do not need to be listed

24. Senior Key Person Profile Form • Must include eRA Commons username for the PD/PI and Sponsors • Your eRA Commons account must list the PI role and be affiliated with the University of Pittsburgh • If needed, an eRA Commons username can be obtained at: http://www.research.pitt.edu/nih-era-commons-registration-request • Sponsors, Co-sponsors and Doctoral Dissertation Advisors role should be listed as "Other (Specify)" then manually enter Sponsor, Co-sponsor, etc. • Organization name is required for all Senior/Key personnel • ASSIST will pre-populate information using an eRA Commons username • All information should be double checked! eRA profiles often contain old or missing contact information! • Ensure faculty role, organization, actual work location address, nine-digit zip code, etc. are accurate and complete • Biosketch must be submitted for all key personnel – 5 page limit • Make sure biosketches are on current version with 10/31/18 expiration date

25. Fellowship Supplement Form • Read the guidelines carefully! https://grants.nih.gov/grants/how-to-apply-application-guide/forms-d/general/g.430-phs-fellowship-supplemental-form.htm# • Pay attention to page limits! https://grants.nih.gov/grants/how-to-apply-application-guide/format-and-write/page-limits.htm

26. Fellowship Supplement Form • Introduction to Application – 1 page required for resubmissions only • Applicant's Background and Goals for Fellowship Training – 6 pages • Specific Aims – 1 page • Research Strategy – 6 pages • Respective Contributions – 1 page • Selection of Sponsor and Institution – 1 page • Training in the Responsible Conduct of Research – 1 page • Sponsor and Co-Sponsor Statements – 6 pages • Progress Report Publication List – required for renewals only

27. Fellowship Supplement Form • Letters of Support from Collaborators, Contributors, and Consultants – 6 pages • Start gathering these from your mentors, consultants, etc. • Description of Institutional Environment and Commitment to Training – 2 pages • Describe opportunities for intellectual interactions, facilities and resources available for both career enhancement and the research proposed • F30 and F31 applications must include educational information and the name of the individual providing this information at the end of the description, typically the director of the graduate program or department chair

28. Fellowship Supplement Form • Protection of Human Subjects, Inclusion of Women and Minorities, and Inclusion of Children • Must be completed by applicants answering “Yes” to the question “Are human subjects involved?” on the Other Project Information form • Data Safety and Monitoring Plan required for grants including clinical trials • Vertebrate Animals • Must be completed by applicants answering “Yes” to the question “Are vertebrate animals used?” on the Other Project Information form • Other Research Training Plan Information – only include if applicable • Resource Sharing Plan – brief 1-paragraph description • Authentication of Key Biological and/or Chemical Resources – 1 page • Appendix • NIH no longer permits most previously allowable items NOT-OD-17-035 • Blank informed consent/assent forms, blank surveys, questionnaires, data collection instruments, and FOA-specified items are the only items allowable • NIH will withdraw non-compliant applications prior to merit review

29. Fellowship Supplement Form • Additional Information Section • Enter degree, field of training, alternate phone number, current or prior NRSA support, concurrent support, and citizenship information • Budget Section • Enter funds requested for tuition and fees in each year • Do not include funds requested for stipends and institutional allowance • Budget Justification is not required

30. Inclusion Enrollment Report Form • Required for applicants answering “Yes” to the question “Are human subjects involved?” on the Other Project Information form • A single form is used to create both planned and cumulative enrollment • If you have multiple studies, or are including cumulative enrollment from a prior grant or an existing dataset, you will need to add additional reports • Each enrollment report must have a unique study title • Complete the initial set up questions (i.e. delayed onset, enrollment type, etc.) • Refer to G.500 - PHS Inclusion Enrollment Report for additional guidance regarding enrollment reports • Contact your Pre-Award Specialist if you have any questions!

31. PHS Assignment Request Form • Used to request specific NIH awarding institutes or study section assignments • Can be used to indicate individuals on study section who should not review your application and why • Allows for inclusion of up to five key words to help form the review group for your grant • Used in place of this information being included in the cover letter attachment • Study section or NIH agency requests made only in the cover letter will not be honored

32. Next Steps • Review the application and check for Common Errors (Handout #5) • Make sure COI Superform and training modules are complete • Notify your Pre-Award Specialist that the ASSIST application is ready to review by the deadline given in the start-up email • Pre-Award Specialist will review and make any necessary corrections and provide feedback • For ASSIST applications, OGC will run an application validation and explain any errors or warnings that may need to be addressed • Once all changes are finalized, an ASSIST application preview version will be emailed to you for approval to submit • Your Pre-Award Specialist with forward the application to the Office of Research for review and submission

33. Internal Processing

34. Internal Processing Timeline What’s due when? • Unlike most grants, F-awards have one internal deadline for submitting the following items to your pre-award specialist: • Final SF424 Application Package • Final Budget • Draft Abstract • PI Signature Template • All items are due: • March 29th for April 8th applications • July 27th for August 8th applications • November 28th for December 8th applications • Internal due dates for F31 Diversity Fellowship deadlines are December 1st, April 3rd, and August 2nd respectively

35. PI Signature Verification • Blank template will be included with start-up email • Complete template and send to your Pre-Award Specialist • Submit as a signed paper original OR • Email: • Signed PDF Attachment OR • Copy content and paste into the body of the email • We cannot accept an unsigned attachment

36. PI Signature Verification Application Title NIH PI’s name Effort on Grant First Year of Project NIH Deadline

37. Internal Processing • Internal Review Process: • OGC – Pre-Award Specialist and Director • School of Medicine Dean’s Office • Office of Research • The application must go through all three offices • The Office of Research requires 3 business days for review and the OGC and Dean’s office share the other 5 for a total of 8 business days • If anything comes up as it goes through approval, your Pre-Award Specialist will touch base regarding any items that need to be addressed • No news is good news!

38. Internal Processing • Once the application has been approved by the Office of Research, they will submit it to Grants.gov • Grants.gov will generate an email notifying you the grant has been submitted and list any warnings or errors that exist • Notify your pre-award specialist if you receive any warnings or errors as soon as possible • Errors must be corrected • Your pre-award specialist will help assess if warnings should be corrected • The Office of Research may not always alert the OGC of warnings • The Grants.gov email will contain the application tracking number that can be viewed in eRA Commons • You will have 2 business days to view the compiled application • Once the 2-day viewing window expires, the grant will automatically work its way through the NIH and updates will post in the Commons

39. Important Reminder • Letters of Reference • At least three but no more than five Letters of Reference are required for all applications (Handout #6) • Instructions for Referees can be found at:https://grants.nih.gov/grants/how-to-apply-application-guide/submission-process/reference-letters.htm • Letters must be submitted directly to the eRA Commons by the referee any time after the FOA opens and must be received by the grant application submission deadline (NOT-OD-11-047): https://era.nih.gov/applicants/reference_letter.cfm

40. After NIH Merit Review • You will receive a notice indicating your grant was reviewed and you will receive a summary statement with reviewer feedback • When you receive your review results, forward the score information to Kasey Godard, antolka@upmc.edu in OGC so we can monitor potential funding status • You may also receive an email requesting Just-In-Time (JIT) information • Your Pre-Award Specialist will receive this email as well • Depending on the review results, it may or may not be necessary to respond at this stage • For some grants OGC will initiate the process, but the PI can always notify their Pre-Award Specialist if they wish to respond

41. Just-In-Time From:era-notify@mail.nih.govSent: Friday, November 18, 2016 10:04:03 PM (UTC-05:00) Eastern Time (US & Canada)To: Cc:Offres - ornihSubject: REQUEST FOR JUST-IN-TIME INFORMATION *** This is an automated notification - Please do not reply to this message. *** Principal Investigator: Application 1 F31 MH000000-01 entitled ________ has completed the first phase of peer review. This is NOT a Notice of Grant Award, nor should it be construed as an indicator of possible award. This notification requests Just-In-Time information. Please follow the instructions contained on the following website: http://grants1.nih.gov/grants/peer/jit.pdf. The requested information must be submitted using the Just-In-Time submission feature of the NIH commons found in the Commons Status section. For information on the Commons, see: https://public.era.nih.gov:443/commons/ If you have questions about this request, contact your assigned Grants Management Specialist or Program Official. Contact information for these individuals can be found in the Commons Status system.

42. Just-In-Time • JIT materials should not be submitted until the request email is received from NIH • The JIT link may activate in Commons prior to receipt of the email • Receipt of the email ensures the correct information is submitted • The most common JIT materials requested at this stage are: • Other Support (OS): a list of active and pending support used by NIH to determine available effort for key personnel on the grant • Human Subjects Education (HS Certs): for grants involving human subjects we submit CITI Human Subjects module certificates to meet the proof of training in human subjects research requirement • OGC will work with the PI and WPIC faculty to obtain OS & HS Certs • For non-WPIC personnel, it is the PI’s responsibility to obtain these items (OS & HS Certs are not required for consultants)

43. Just-in-Time • The JIT request will also ask for IRB and/or IACUC approval • It is the PI’s responsibility to submit their application to the appropriate review board and obtain the necessary approval letter(s): • University’s Institutional Review Board (IRB): http://www.irb.pitt.edu/ • Institutional Animal Care and Use Committee (IACUC): http://www.iacuc.pitt.edu/ • If IRB or IACUC approvals are required for the grant but are not yet available, it is still possible to submit the other requested documents and provide these approvals at a later date

44. Just-in-Time • The JIT information must be uploaded through the link associated with your grant in the eRA Commons and submitted electronically • Notify your Pre-Award Specialist when the materials are uploaded and we will alert the Office of Research • Office of Research will review the materials and complete the submission it to NIH • The PI will be notified when the information has been submitted • IMPORTANT: A JIT request is not an indication of likelihood of funding; only receipt of an NGA is a guarantee of funding

45. Page Limits for Fellowships Table of Page Limits for Fellowship Award (F) Applications

46. Questions?