NIH Updates Feb/March 2014

1. NIH UpdatesFeb/March 2014 OGC Pre-Award Team

2. Current NIH Announcements • Current Parent Announcements: • PA-13-302:  Research Project Grant (Parent R01) • PA-13-304: NIH Small Research Grant Program (Parent R03) • PA-13-303: NIH Exploratory Developmental Research Grant Program (Parent R21) • PA-12-212: NIH Support for Conferences and Scientific Meetings (Parent R13/U13) • For applications due on or after Sept 25th, a new SF424 package is now required for most announcements: ADOBE-FORMS-C (ADOBE-FORMS-B are still applicable for certain RFPs)

3. Updated Grants.gov Forms: FORMS-C Roll Out Schedule • NIH has introduced application packages with a Competition ID of ‘FORMS-C’ following the schedule outlined in NOT-OD-13-074. • Individual Research Career Development Award Programs (Ks), Institutional Training and Career Development Programs (Ts and Ds) and Individual National Research Service Awards (Fs) applicants are also now available and are required to use FORMS-C packages for due dates on or after January 25, 2014. Center Grants • NIH is also in the process of transitioning Program Project/Center Grants and Resource Grants from paper to electronic applications. The new software they have launched is called ASSIST and is a web-based system. • September 25, 2013 — All applications submitted in response to FOAs with the following activity codes will require electronic submission: P01, P20, P50, R24, U24, U19. • January 25, 2014 — All applications submitted in response to FOAs with the following activity codes will require electronic submission: G12, P30, P40, P41, P42, P51, P60, R28, U10, U41, U42, U45, U54, U56, UC7, UM1.

4. When you click on the link to download the application, you will receive this window first. Pitt is registered in the SAM system so you can ignore this and just hit the “Proceed to Application Download Screen” button.

5. Make sure opportunity number matches FOA Form Version • Some of the optional documents may be required depending on the announcement or if the grant includes a subaward. New form requires that you check the boxes rather than move documents from the left to the right.

6. Changes to Grants.gov federal-wide forms included in ‘FORMS-C’ packages SF424 (R&R) Cover • A new field for the ‘Previous Grants.gov Tracking ID’ will be included in item 4 of the SF424 (R&R) cover. • The Person to be contacted section of the Applicant Information on the SF424 (R&R) cover will be expanded to include the additional contact information we have been including on the PHS 398 Cover Page Supplement form. The additional contact information will be removed from the PHS 398 Cover Page Supplement.

7. Information moved to the Face Page – was previously on the Cover Page Supplement form

8. PI address, etc, has now shifted down to the 2nd part of the Face Page

9. 3. The “Cover Letter Attachment” has been moved! It no longer has it’s own page and will be uploaded at the end of the “Face Page” instead.. NIH will continue to keep the Cover Letter separate from the assembled application image and available only to authorized staff.

10. Other Project Information 4. The question ‘Does the Project have an actual or potential impact on the environment’ has been changed to ‘Does the Project have an Actual or Perceived Impact – positive or negative – on the environment.’ R&R Sr/Key Person Expanded 5. Allowing data entry for up to 100 Sr/key persons (old limit was 40) Project/Performance Site Locations 6. Allowing data entry for up to 300 sites (old limit was 30) Planned Enrollment Report form & Cumulative Inclusion Enrollment Report Form 7. These forms are no longer separate PDF attachments. They each now have their own page within the packet and are fillable forms. They have also been reformatted so be careful entering the data. Please see Packet #6 & #7 for examples PHS 398 Research Plan 8. Since the inclusion attachments have been removed, the numbering in this section has shifted a little.

11. PHS 398 Cover Page Supplement • Applicant Organization Contact information has been removed and is now on the SF424 R&R cover • PHS 398 Checklist form has been removed and items are now part of the Cover Page Supplement section. Supplemental Grant Application Instructions 11. Parts II (Supplemental Instructions for Preparing the Protection of Human Subjects Section of the Research Plan and Policies) and III (Policies, Assurances, Definitions, and Other Information) of the instructions are now located in a separate “Supplemental Grant Application Instructions” document. Notice of Proprietary Information 12. Policy in regards to the Freedom of Information Act (FOIA) has been clarified.

12. Biographical Sketch 13. For those of you who have any Patents, a “Patent Citations” has been added to section C, Selected Peer Reviewed Publications so you can now include them if necessary. Letters of Support • There are clarifications regarding the content. • Letters should stipulate expectations for co-authorship, and whether cell lines, samples or other resources promised in the letter are freely available to other investigators in the scientific community or will be provided to the particular investigators only. • For consultants, letters should include rate/charge for consulting services and level of effort/number of hours per year anticipated. • In addition, letters ensuring access to core facilities and resources should stipulate whether access will be provided as a fee-for-service. Appendix 15. Photographs or color images of gels, micrographs, etc., are no longer accepted as Appendix material. These images must be included in the Research Strategy.

13. Paper Applications PHS 398 Forms • All PHS 398 paper application submissions intended for due dates on or after September 25, 2013, must use the 8/2012 version of the PHS 398 instructions and forms (http://grants.nih.gov/grants/funding/phs398/phs398.html). The 06/09 version of the form remains available at this time for use in responding to FOAs that have due dates prior to September 25, 2013. • Please note that some of the documents have been renamed. • The Inclusion Enrollment Reports have been renamed and modified and are now “Planned Enrollment Report” and “Cumulative Inclusion Enrollment Report”. See NIH Guide Notice NOT-OD-13-092 "Modifications to NIH’s Planned and Cumulative Inclusion Enrollment Forms".

14. Important Note • Whether you are submitting an electronic or a paper grant, any application submitted using incorrect application forms (including applications that have an incorrect mix of old and new forms) may be delayed and may not be reviewed

15. Planned Enrollment Report and the Cumulative Inclusion Enrollment Report • The layout of both the Planned Enrollment Report and the Cumulative Inclusion Enrollment Report has been modified to reduce confusion about racial and ethnic information being distinct concepts. • The modified forms will be required for all electronic applications submitted on Forms C and in paper applications using the new PHS 398 (rev. 08/2012) forms. • Non-competing continuation applications will continue to use the current forms for inclusion data provided in the PHS 2590 or RPPR until further notice. Key changes: • The Planned Enrollment Report will now include the "More than one race" category. The "More than one race" category will be used for reporting the planned number of individuals who you believe will identify with more than one racial category. Currently, this category has only been available when reporting actual cumulative enrollment.

16. Planned Enrollment Report and the Cumulative Inclusion Enrollment Report (cont) • Additional Resources: Additional guidance regarding these changes as well as other topics related to the inclusion of women and minorities in clinical research can be found at: http://grants.nih.gov/grants/funding/women_min/women_min.htm. • The policies for the inclusion of women and minorities in clinical research and the required collection of participants' sex/gender, race, and ethnicity have not been modified.

17. Multi-Project Applications: Transition Plan • The transition will be done by activity code. As each activity code transitions, all applications submitted in response to funding opportunity announcements (FOAs) for programs with that activity code will require electronic submission (including new, resubmission, renewal and revision applications). Updated plans/milestones are as follows: • September 25, 2013 — Electronic submission required for all applications submitted in response to FOAs with the following activity codes: P01, P20, P50, U19, R24, U24. • As part of the transition process, R24 and U24 activity codes have been designated as single project activity codes and will require submission using Grants.gov downloadable forms rather than ASSIST. Current programs that have used the R24 and U24 activity codes in a way consistent with multi-project applications will transition to newly created multi-project activity codes using ASSIST in the same timeframe. • January 25, 2014 — Electronic submission required for all applications submitted in response to FOAs with the following activity codes: G12, P30, P40, P41, P42, P51, P60, R28, S06, U10, U41, U42, U45, U56, UC7. • May 25, 2014 — Electronic submission required for all applications submitted in response to FOAs with the following activity codes: U54, UM1.

18. What’s Due When? • Due to the OGC 13 business days before the NIH deadline: • Final Budget • Final Budget Justification • SF 424 (R&R) Face Page • Abstract (draft) • PI Signature Template • Due to the OGC 8 business days before the NIH deadline: • Final, full SF424 application package • For a full list of deadlines, please go to our website https://inet.psychiatry.upmc.com/OGC/EGADueDates.htm

19. SF424 complete – what next? • 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 5 business days for review and the OGC and Dean’s office share the other 3 for a total of 8 business days • If anything comes up as it goes through approval, your specialist will touch base with you regarding any items that need addressed – no news is good news!

20. For R01, R03, R21, and all other Applications *   FOA instructions always supersede these instructions.** Each project or core will follow the page limit of the equivalent activity code.  For example, if a project is equivalent to an R01, the project will be allowed 12 pages.  Review the FOA and IC website for details.

21. For Research Education (R25) Applications *   FOA instructions always supersede these instructions.** Each project or core will follow the page limit of the equivalent activity code.  For example, if a project is equivalent to an R01, the project will be allowed 12 pages.  Review the FOA and IC website for details.