Scott Cooper & Emily Linde Office of Policy for Extramural Research Administration

1. Current Issues at NIH FALL 2012 October 30, 2012 Scott Cooper & Emily Linde Office of Policy for Extramural Research Administration

2. HHS, including NIH, operates under a Continuing Resolution (CR) (H. J. Resolution 117). Until FY 2013 appropriations are enacted, NIH will issue non-competing research grant awards at a level below that indicated on the most recent Notice of Award (generally up to 90% of the previously committed level). Funding levels determined by awarding IC More at: NOT-OD-13-002 FY 2012 legislative mandates remain in effect, including salary limitation set at Executive Level II of the Federal Pay Scale ($179,700), More at: NOT-OD-12-034 See Frequently Asked Questions website at http://grants.nih.gov/grants/policy/fy2012_salary_cap_faqs.htm FY 2013 Continuing Resolution

3. The End of the Era of ARRA

4. Timely Quarterly and Closeout Reports Required; Accelerating Unspent ARRA Awards OMB Memorandum M-11-34 Issued 9/15/2011, directs agencies to assure ARRA funds are spent by 9/30/2013 and to “revise the terms of Recovery Act discretionary grant agreements, to the extent permitted by law, to provide for reclamation of funds that remain unspent after September 30, 2013, absent a waiver issued by OMB pursuant to this memorandum.” NIH waiver requests pending HHS & OMB review We continue to strongly encourage grantees to accelerate expenditures for all active ARRA grants regardless of the current or projected project period end date. NIH issued on December 13, 2011, NOT-OD-12-014, Notice of Revised Term of Award for All Recovery Act Awards to Ensure Project Completion by September 30, 2013. The End of the Era of ARRA More at: http://www.grants.nih.gov/recovery/

5. Financial Conflict of Interest (FCOI) Regulations

6. 42 CFR Part 50 Subpart F (grants and cooperative agreements) 45 CFR Part 94 (contracts) Revised Final Rule published on 8-25-11 http://www.gpo.gov/fdsys/pkg/FR-2011-08-25/pdf/2011-21633.pdf Compliance Date: August 24, 2012 2011 Revised FCOI Regulations

7. FCOI Compliance Oversight • NIH Proactive FCOI Compliance Oversight Program • Assess institutional compliance with the 2011 revised FCOI regulation • Obtain and evaluate publicly accessible FCOI policies for a sample of grantee institutions and provide assistance through constructive feedback • Share results with NIH research community to improve and enhance compliance with the regulation • NIH Guide NOT-OD-12-159

8. Mailbox for inquiries FCOICompliance@mail.nih.gov OER FCOI Web Site http://grants.nih.gov/grants/policy/coi/ FCOI Resources

9. Policy Updates

10. NIH Grants Policy StatementRevision – FY2013 • Effective October 1, 2012. • Supersedes previous October 1, 2011 version • Incorporates changes in statutes, regulations, and policies already implemented through other appropriate legal/policy processes. • Clarifies certain existing policies • Incorporates minor edits for clarity in response to user input, and updated URLs when applicable • Available at http://grants.nih.gov/grants/policy/nihgps_2012/index.htm • See Guide Notice NOT-OD-12-157 at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-12-157.html

11. New HHS Policy on Conference Grants • New HHS policy modifies grantee use of NIH funds for conferences, meetings, food, promotional items, and printing and publications. • Applies to NIH Grants and Cooperative Agreements where the primary purpose of the grant is to support a Conference and/or Scientific Meeting (i.e., R13s and U13s). • Implications for Grants • Effective with awards issued on or after 01/27/12, a new term and condition prohibiting food/meal costs from being supported by or charged to NIH-supported conference grants will be included on all competing and noncompeting NIH R13 and U13 awards: “Direct charges for meals/food and beverages are unallowable charges to this project.” • Implications for Applications • Applications for the April 12, 2012 and subsequent due dates must comply with this new policy; • The parent conference grant FOA and other active R13/U13 FOAs have been revised to reflect the new term and condition. • Implications for Grants Not Specifically to Support Conferences • The policy does not apply. More at: NOT-OD-12-041 and NOT-OD-12-048

12. Guidance: Prior Approval for Changes to Human Subjects Involvement on Active Awards • Change in scope requires prior approval from IC (NIH GPS§8.1.2.5); • Change from the approved involvement of human subjects is a potential indicator of a change in scope. • NOT-OD-12-129 • Detailed guidance on types of changes in human subjects research awards that require prior NIH approval • Information on process for submitting prior approval requests

13. Delayed Onset Human Subjects Research • Certain research applications may be submitted to NIH with the knowledge that human subjects will be involved during the period of support, but definite plans for this involvement cannot be described in the application (Delayed Onset Human Subjects Research); • Grantee must submit to the awarding IC a detailed human subjects section prior to the involvement of human subjects. • Guide Notice NOT-OD-12-130 clarifies the description of the types of delayed onset awards and the process for submitting prior approval requests. More at: NOT-OD-12-130

14. Human Embryonic Stem Cells • Impending changes in the PHS 398 and SF424(S&R) instructions for applications involving the use of human embryonic stem cells (hESC). • NIH Stem Cell Registry now lists more than180 approved cell lines. • Applications submitted on or after September 25, 2012, proposing the use of hESC must: • Specify a cell line(s) from the NIH Stem Cell Registry that will be used in the proposed research, or; • Provide a strong justification for why an appropriate cell line cannot be chosen from the Registry at this time and a certification that one from the Registry will be used.  The justification should be included in the Research Strategy section of the application. • This evaluation will be allowed to affect individual criterion scores, assessments of overall merit, and overall impact scores during initial peer review. More at: NOT-OD-12-111

15. DRR & Communication with Applicants • As of May 25, 2012 communications from the Division of Receipt and Referral (DRR) will be accessible to applicants and applicant organizations in the eRA Commons in a new ‘Correspondence’ section of the Commons detailed status screen for the application. Applicants will be notified by email to check their Commons account. More at: NOT-OD-12-108

16. Updated Forms/Instructions Posted • NIH Forms & Applicationspage has updated forms/instructions for progress reports, other post award actions, and NRSA (http://grants.nih.gov/grants/forms.htm) • New location for Final Progress Report instructions under Closeout • Revised competing applications and instructions to be implemented in the summer of 2013, following development of applicable electronic forms More at: NOT-OD-12-152

17. Changes to Policies and Procedures for FY2013 NIH Awards to Foreign Institutions • Payment for all foreign awards issued after October 1, 2012 will transition to the Payment Management System; see NIH Guide Notice NOT-OD-12-139. • Awards will use PMS “B” subaccounts • This transition affects carryover regardless of the carryover authority noted in the NoA.  Carryover of an unobligated balance from an award issued prior to October 1, 201,2 to an award issued after that date must be done with NIH assistance.

18. Changes to Policies and Procedures for FY2013 NIH Awards to Foreign Institutions • For initial awards to foreign grantees issued after October 1, 2012, grantees must use the currency rate in effect at the time the funds are drawn down when preparing the FFR expenditure data. • For initial awards to foreign grantees issued after October 1, 2012 under SNAP, FFR expenditure data is required only at the end of a competitive segment. • Aligns foreign SNAP awards with domestic SNAP awards

19. Fed-wide Streamlining Efforts

20. Research Performance Progress Report (RPPR) • OMB mandated format standardizes interim progress reports submitted to agencies • NIH implementing as a module in Commons; will replace PHS 2590, including eSNAP, and 416-9 • Initial pilot with limited institutions, April 2012 • Access expanded to FDP institutions, June 2012 • Access expanded to all institutions, Oct 2012 • Mandated use of the new RPPR module is expected for all SNAP and Fellowship awards Spring 2013 • Schedule for complex mechanisms and non-SNAP to be determined More at: NOT OD-12-142

21. NIH RPPR TIMELINE All NIH grantees given access to RPPR module Use of RPPR is OPTIONAL Progress Report Additional Materials (PRAM) functionality available All FDP institutions given early access to RPPR module RPPR Pilot with 7 grantee Institutions begins NIH mandates use of RPPR for all SNAP and F awards APRIL 2012 JUNE 2012 AUGUST 2012 OCTOBER 2012 JANUARY 2013 April 2013 RPPR for non SNAP awards TBD

22. RPPR - What’s new about this progress report? • Uses Federal-wide standardized questions and NIH-specific data elements; • Format is different from eSNAP, but the information requested is similar; • SNAP awards will still not require budget • Publications from PI’s MyNCBI indicates Public Access Policy compliance status; • Includes live links to Notice of Award; • Streamlines ClinicalTrials.gov reporting; • Dynamic display of questions; questions determined by activity code.

23. RPPR - Significant Differences • New data collection on foreign components, dollars to foreign countries, and foreign affiliation of personnel; • Effort for all participants must be rounded to nearest whole person month; • Other support only required if change; • Clarifies when report may be used to request prior approval (ONLY for reduction in level of effort for PD/PI or Senior/Key listed in NoA).

24. RPPR Page: http://grants.nih.gov/grants/rppr/ Background Information RPPR Instruction Guide Screen shots Training webinar Archived recording of Oct. 17, 2012 webinar Relevant Guide Notices Learn how the RPPR differs from eSNAP RPPR - Information and Resources

25. Policy Reminders

26. Where is information on subawards reported? To FFATA Subaward reporting system (FSRS) fsrs.gov; FSRS.gov also used for the executive compensation of subawardees when information not available in CCR; XML Upload available; Information made publicly available at USASpending.gov; FSRS User support through the Federal Service Desk www.fsd.gov; Where can I get more information? Direct questions concerning reporting on NIH grants to: GrantsPolicy@mail.nih.gov ; FAQs: Federal Funding Accountability and Transparency Act Transparency ActSubaward Reporting

27. Previously, requirement for Subrecipient Reporting only applied to “New” (Type 1) grants issued in FY2011 and beyond; In FY2012 and beyond, this expands to MOST awards where the Type 1 was awarded after October 1, 2010. This includes: Non-competing Type 5 and Type 7 awards (that follow an FY2011 T-1); and, Type 2s competing continuations when the original Type 1 was awarded on or after October 1, 2010. Since FY2012, awards have more definitive “Yes/No” award term for this requirement. More at: NOT-OD-12-010 Transparency Act—Subrecipient Reporting Reminder

28. Need Assistance with the NIH FFATA Requirements? • Visit the NIH FFATA/Public Accountability Web Page • http://grants.nih.gov/grants/public_accountability/ffata.htm • Includes Frequently Asked Questions • Send your NIH-specific questions by e-mail to GrantsPolicy@mail.nih.gov

29. Common Problem: Can’t Find Grant in FSRS to Report Trouble-Shooting: • Does the FFATA reporting requirement apply? • Confirm that the award is a Type 1 award issued on or after October 1, 2010 or subsequent award to such a Type 1; • Are you using the correct identifier? • The FAIN for NIH awards is based on the NIH award number but only the activity code, IC, and serial number. Example: NIH award 1R01CA987654-01A1 appears as FAIN R01CA987654. • Is the award in USASpending? • Search for award at http://www.usaspending.gov/advanced-search. If your award is listed on USASpending.gov, it should also appear in FSRS.gov. If it does not, contact the Federal Service Desk (www.fsd.gov) to have the record addedand include the USASpendingURL.

30. Update on Electronic Submission& eRA Commons

31. Update on eRA Commons: LikeThis • A Thesaurus-Based Search Tool • LikeThis provides a powerful and integrated search tool in a user friendly interface. With the ability to find similar projects and publications, Principal Investigators can more quickly and efficiently: • find out new ideas for research based on what NIH has awarded in the past; • see what NIH is doing in his or her area of interest; • use the information as a decision tool to determine if they need to come up with a fresh research idea; • and figure out in which study section his or her application should be reviewed. • More at: http://era.nih.gov/services_for_applicants/like_this/likethis.cfm

32. Complex Applications • NIH issued a Guide Notice on Friday, September 28, 2012 announcing the transition timeline for the ability to accept multi-project applications. • NIH plans to transition all multi-project applications to electronic submission by January 2014. • Refer to NOT-OD-12-161 for details related to the timeline.

33. Electronic Administrative Supplements • Electronic submission of administrative supplement pilot began February 1, 2012. • Optional for all single project grantees • Complex, multi-project grants not included in pilot; • Parent FOA PA-12-100 used for submission • Can submit through the eRA Commons • To take advantage of pre-population of fields; OR • Can submit through Grants.gov • For schools who have built systems to interact directly with Grants.gov. • Contact IC or review IC web site before submitting More at: NOT-OD-12-024

34. Electronic Post-Award Change of Grantee Organization • Pilot of electronic submission of post-award Change of Grantee Organization applications (Type 7) • Available only if activity code of award has transitioned to electronic submission of competing application • NIH Guide NOT OD-12-134 • Must use Parent FOA for Change of Grantee Organization Applications: PA-12-270

35. Electronic Post-Award Change in Grantee Status (Successor-in-Interest) • Pilot of electronic submission of post-award Change of Grantee Organizational Status Successor-in-interest Applications (Type 6) • Available only if activity code of award has transitioned to electronic submission of competing application • NIH Guide NOT OD-12-133 • Must use Parent FOA for Change of Grantee Organizational Status: PA-12-269

36. Electronic Post-Award Relinquishing Statements • Pilot of electronic submission of Official Statement Relinquishing Interests and Rights in a PHS Grant (PHS 3734) • eRA Change of Institution module • Does not require activity code to have transitioned to electronic application submission • NIH Guide NOT OD-12-132

37. Just-In-Time Changes • Link broadly for all; decoupling this from any impact score/percentile; • Modified eRA-generated eNotifications to tighten up for which applications these will be sent; • Mandates use as of April 20, 2012 • More at: NOT-OD-12-101

38. Tips for eSubmission Success • Register Early! • Registration with both Grants.gov (organizations only) and eRA Commons (organizations & PD/PIs); must be completed before the submission deadline • Allow 4 weeks to complete new registrations. • Keep registrations active • Central Contractor Registry (CCR) information must be updated at least every 12 months to remain active; • As of August 2011, Grants.gov rejects submissions from applicants with expired CCR; • Use your organization’s DUNS to view your CCR registration status at http://www.bpn.gov/CCRSearch/Search.aspx

39. Helpful NIH Contacts

40. General Application Questions: E-Mail: GrantsInfo@nih.gov Phone: 301-435-0714 Grants.gov Customer Support: E-Mail: support@grants.gov Webpage: http://grants.gov/ Phone: 800-518-4726 eRA Commons Helpdesk: Webpage: http://ithelpdesk.nih.gov/era/ Phone: 301-402-7469 or 800-504-9552 Grants Information:Who to Contact!

41. Division of Grants Policy: E-Mail: GrantsPolicy@mail.nih.gov Phone: 301-435-0949 Division of Grants Compliance & Oversight: E-Mail: GrantsCompliance@mail.nih.gov Phone: 301-435-0949 Grants Information:Who to Contact (cont’d)

42. Thank You! Questions?