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Current Issues at NIH Spring 2012

Current Issues at NIH Spring 2012. Presented By: Michelle Bulls & Carol Wigglesworth Office of Policy for Extramural Research Administration. NIH Budget and Recovery Act News. H.R. 2055, Consolidated Appropriations Act, 2012 (12/23/11) $30.7 billion to NIH for FY2012

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Current Issues at NIH Spring 2012

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  1. Current Issues at NIH Spring 2012 Presented By: Michelle Bulls & Carol Wigglesworth Office of Policy for Extramural Research Administration

  2. NIH Budget and Recovery Act News

  3. H.R. 2055, Consolidated Appropriations Act, 2012 (12/23/11) $30.7 billion to NIH for FY2012 <1% increase from FY11 Reduced salary cap to Executive Level II ($179,700) NIH Budget News More at: http://officeofbudget.od.nih.gov/br.html

  4. Breakdown of FY 2012 Budget for NIH $30.7 Billion $16.5 B

  5. FY 2012 Funding Levels Non-competing awards issued without cost of living/inflationary adjustments Future years No inflationary increases for competing and non-competing awards issued in FY 2012 Effort to keep average size of grants at FY2011 level, or lower NRSA: 2% increase at all stipend levels More at: NOT-OD-12-036 NIH Fiscal Policy for FY 2012

  6. New Investigators: Continue to support new investigators on R01 equivalent awards at success rates equivalent to that of established investigators submitting new R01 equivalent applications Additional Information on Fiscal Operations, including specific IC funding strategies: http://grants.nih.gov/grants/financial/index.htm; Salary Limit (Executive Level II) More at: NOT-OD-12-036 NIH Fiscal Policy for FY 2012(cont’d)

  7. Executive Level II applied to all awards issued on or after 12/23/11 EL-I was applied to awards issued on or before 12/22/11 for FY12 only, future years adjusted to EL-II Grantees may rebudget where applicable Salary limit does not apply to consultant payments Salary limit does apply to subawards/contracts FAQs: http://grants.nih.gov/grants/policy/fy2012_salary_cap_faqs.htm NIH Salary Limit News More at: NOT-OD-12-035

  8. FY2013 President’s Budget • Request for $30.9 billion • Highlights • Continued focus on resources for young, first time researchers • Continued exclusion of inflationary allowances • Reduce non-competing continuation grants by 1% below FY2012 level • Manage competing awards to avoid growth in average award size • Provide consideration by IC Advisory Councils of awards to PD/PIs with existing grants of $1.5 million or more in total costs

  9. Timely Quarterly and Closeout Reports Required All standard closeout documents required for ARRA funded awards (Final Progress Report, Final Invention Statement, Final FFR), even for ARRA funded Supplement to a non-ARRA parent award Financial closeout requirements for multiple ARRA supplements: NOT-OD-10-066 Closing out the Era of ARRA More at: http://www.grants.nih.gov/recovery/

  10. Unspent ARRA Funds More at: NOT-OD-12-014 • OMB Memorandum M-11-34 (9/15/2011): assure ARRA funds are spent by 9/30/2013, and “revise the terms…to provide for reclamation of funds that remain unspent after September 30, 2013, absent a waiver issued by OMB…"   • NIH Revised Term of Award for All Recovery Act Awards to Ensure Project Completion by 9/30/2013 • Amend the automatic no-cost extension authority by limiting the ability for awardees to extend the final budget period to no later than 9/30/2013 without prior NIH approval • procedure for recipients to request prior NIH approval for waivers to extend beyond 9/30/2013 • process for those recipients unable to accept the revised terms of award 

  11. Unspent ARRA Funds(cont’d) • NIH strongly encourages grantees to accelerate expenditures for all active Recovery Act grants regardless of the current or projected project period end date.At this time NIH has not determined the need for waiver requests to OMB. More at: NOT-OD-12-014

  12. Financial Conflict of Interest (FCOI) Regulations

  13. Revised Final Rule – 8/25/2011 http://www.gpo.gov/fdsys/pkg/FR-2011-08-25/pdf/2011-21633.pdf 42 CFR Part 50 Subpart F (grants and cooperative agreements) http://grants.nih.gov/grants/compliance/42_CFR_50_Subpart_F.htm 45 CFR Part 94 (contracts) Financial Conflict of Interest (FCOI) Regulations

  14. Revised 2011 Regulation • Responsibility of Applicants for Promoting Objectivity in Research for which Public Health Service Funding is Sought and Responsible Prospective Contractors • Federal Register August 25, 2011 • Implementation no later than 365 days after publication (8/24/12) • In the interim: • Institutions comply with 1995 regulations; • Institutions revise policies, establish procedures for compliance, train Investigators, and continue to report FCOIs to NIH; • Basic FCOI framework remains the same regarding responsibilities and compliance. • eRA Commons FCOI Module update

  15. Major Changes to the Regulations • Significant Financial Interest (SFI) • Investigator Disclosure • Reporting to NIH • Public Accessibility • Investigator Training • Annual FCOI reports • Mitigation Reports

  16. Mailbox for inquiries FCOICompliance@mail.nih.gov OER FCOI Web Site http://grants.nih.gov/grants/policy/coi/ FAQs posted on 9/30/2011. See NIH Guide Notice NOT-11-121 Checklist for Policy Development. See NIH Guide Notice NOT-OD-12-103 Resources

  17. New Post Award • Electronic Processes

  18. Administrative Supplements • Electronic submission of admin 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 See: NOT-OD-12-024

  19. An electronic business process for post-award Change of Grantee Institution (T-7s) and Successor-in-Interest (T-6) applications April 2012 pilot Restricted to post award actions Process: Old institution submits relinquishing statement through the Commons. New institution receives notification of relinquishing statement from the Commons. Open to all institutions New institution submits application through Grants.gov Uses new change of grantee application parent FOA Available for applications currently submitted through Grants.gov Selects appropriate application package from parent FOA for the activity code Organization Changes

  20. An electronic tool for applications routinely submitted on paper; Paper-based process still allowable Grantees should discuss potential organization changes with the awarding IC prior to submitting application Organization Changes (cont’d)

  21. Research Performance Progress Report (RPPR) • Federal-wide research and research-related interim progress report (Final Format) • Mandated by OMB and OSTP, after years of development under the Research Business Models Subcommittee • Standardizes information required by federal agencies • Goal to reduce administrative burden on grantees http://www.nsf.gov/bfa/dias/policy/rppr/index.jsp

  22. NIH Implementation Plan • Commitment to electronic implementation • RPPR will replace: • PHS 2590 Non-competing Continuation Progress Report • eSNAP module in the eRA Commons • PHS 416-9 National Research Service Award Individual Fellowship Progress Report for Continuation Support • NIH implementation will include other PHS agencies: • Food and Drug Administration • Agency for Healthcare Research and Quality • Centers for Disease Control and Prevention http://www.nsf.gov/bfa/dias/policy/rppr/agency_imp/nihupdate.pdf

  23. Timeline: Pilot and Early Access • 7 NIH grantee institutions began to pilot RPPR in April 2012 • Federal Demonstration Partnership (FDP) grantees provided early access to RPPR module in June 2012

  24. Timeline: Implementation • All grantees to be provided with option to use RPPR module for SNAP and Fellowship progress reports in Fall, 2012 • Mandated use of RPPR for all SNAP and Fellowship awards expected in Spring, 2013 • Schedule for complex mechanisms and non-SNAP awards (i.e., those requiring budget) to be determined • Stay tuned

  25. RPPR Format • Seven components (separate screens for each): A. Cover Page B. Accomplishments C. Products D. Participants E. Impact F. Changes G. Special (NIH) Reporting Requirements H. Budget – SF424 (R&R) forms

  26. RPPR Similarities to eSNAP • Module in the eRA Commons • Requests similar information (accomplishments, plan, changes, etc.) • System pre-population (personnel, performance sites) • SNAP awards will NOT require a budget • Publications from the PIs MyNCBI account displayed for easy association with award

  27. RPPR New Features • Enhanced publications reporting • Live link to Notice of Award (NoA) • Streamlined ClinicalTrials.gov reporting • New information collections: foreign components, dollars, and personnel affiliation • Person months rounded to whole number • Other support only required if change • Prior approval for significant reduction in LOE • Dynamic display of content • SF424(R&R) budget (when implemented)

  28. Stay Tuned • Watch for Guide Notices, webinar training – live and archived, and Nexus articles • RPPR Training Webinar for grantees scheduled for October 17, 2012 • All materials and training will be posted at: http://grants.nih.gov/grants/RPPR/

  29. Policy News and Updates

  30. As a potential way to manage resources during austere times, NIH will pilot procedures for Special Council Review (SCR) of PD/PIs already receiving more than $1.5 million in total costs. Pilot limited to May 2012 Council rounds. Not a cap on total funding for any one PD/PI. SCR limited to most (not all) RPGs. Councils will receive list of applications from PD/PIs above the SCR threshold along with justification of IC recommendation. Additional details will be provided if NIH implements SCR policy. More at: NOT-OD-12-110 Pilot of Special Council Review of Applicants with more than $1.5 Million

  31. NIH Working Group considering modifications to the biographical sketch Potential change would be to allow investigators to include a short explanation of their most important scientific contributions Purpose: Provide better indication of individual’s capabilities and accomplishments than list of publications Help level playing field; allow for collaborative advances Increase quality and relevance of information for peer reviewers Comments accepted through 6/29/2012 More at: NOT-OD-12-115 RFI on Modifications to the Biosketch

  32. New Correspondence section of Commons detailed status screen Applicants will be notified by email to check their Commons account DRR will notify applicant when: Additional info is required before application assignment Applicant request for IC assignment cannot be honored Application does not comply with NIH Policy Applicants must ensure that email addresses in Commons are accurate More at: NOT-OD-12-108 Div of Receipt and Referral to use eRA Commons to Communicate

  33. Mandated Use of Commons to Submit No-Cost Extension Notifications • Required use of the eRA Commons No-Cost Extension link to notify NIH when exercising one-time authority to extend, without additional funds, the final budget period of a grant • link available 90 days before project end date • link closes at midnight on project end date • if link is closed, action becomes a prior approval request and must be submitted for consideration to the IC GM office More at: NOT-OD-11-098

  34. Required Use of xTrain • xTrain required to prepare and submit appointments (PHS 2271) and terminations notices (PHS 416-7) for research training grants, institutional career development awards, individual fellowships, and research education awards; • A new role of “Sponsor,” similar to PD/PI role, exists for termination of fellowships; • See xTrain overview presentations, FAQs and quick reference sheets. • New resources can be found at: http://era.nih.gov/training_career/index.cfm

  35. Revised policy acknowledges that it may not be essential to require peer review to change from single- to multiple-PD/PI award, or from a multiple- to single-PD/PI award Requires AOR prior approval request to IC GMO Justification must be based on scientific needs of the project; will not be considered if based on administrative convenience; Revised policy consistent with prior approval requirements for a change in PD/PI (GPS, 8.1.2.6) NOT-OD-11-118 specifies the information to be included in the request Change may not be implemented without GMO approval and revised NoA More at: NOT-OD-11-118 Revised Multiple-PD/PI Policy Allows PD/PI Change with Prior Approval

  36. New Appeals Policy More at: NOT-OD-11-101; NOT-OD-11-064 • Applicable to Competing Applications submitted on/after 1/25/2011 • Requires formal appeal letter from the AOR • Will not be accepted before the summary statement has been made available to the PD/PI, or later than 30 calendar days after the relevant Council meeting • Specific appeal letter criteria and basis for appeal • Questions: ReviewPolicyOfficer@mail.nih.gov

  37. Information allowed as post-submission material to update the Sponsor(s)’ funding information in the originally submitted application Must not exceed 1 page and limited to: project title funding source (e.g. grant number) brief description of specific aims, and relevance to the fellowship application under review. Due no later than 30 days prior to the meeting of the review committee. More at: NOT-OD-12-022 New Policy on Post-Submission Information: Sponsor’s Research Funding for NRSA & other Fellowship Applications

  38. HHS Policy - Conference Funding • New award term prohibiting food/meal costs from being supported by or charged to NIH-supported conference grants (R13 and U13) “Direct charges for meals/food and beverages are unallowable charges to this project.” More at: NOT-OD-12-041 and NOT-OD-12-048

  39. NIH Grants Policy Statement Revision - FY2012 • Effective October 2011, revision superseded the October 1, 2010 version • Incorporates policy changes since 10/01/10, and clarifies existing policy • Incorporates new business process changes • Minor edits for clarity in response to user input • Updated URLs • OPERA commitment to update annually

  40. Looking Ahead • Council on Financial Assistance Reform (CoFAR) • Created by OMB; • Co-Chaired by HHS; • Interagency group of Executive Branch officials; • Replaces the Grants Policy Council and the Grants Executive Board; • Intended to foster more efficient and effective Federal financial management; • Advanced Notice of Proposed Rule outlined potential reform ideas for federal policies on cost principles and administrative requirements for grants and cooperative agreements; • Ideas include: reforms to audit requirements (Circulars A-133 & A-50); reforms to cost principles (Circulars A-21, A-87, and A-122, and the Cost Principles for Hospitals); reforms to administrative requirements (Circulars A-102, A-110, & A-89) – Omni Circular • 300 public comments received. • Stakeholder calls continue.

  41. Changing Payment Process for Foreign Grantees • Transitioning Payment of Foreign Grantees from a manual quarterly check to drawdowns through Payment Management System (PMS) • Aligning payment and FFR reporting processes (same as for domestic grantees) • Anticipated Date = October 2012 (FY2013 awards) • Stay tuned for Guide Notice on details

  42. Policy Reminders

  43. FFATA • Visit the NIH FFATA/Public Accountability Web Page • http://grants.nih.gov/grants/public_accountability/ffata.htm • Includes Frequently Asked Questions (FAQs) • Send your NIH-specific questions by e-mail to TransparencyActReporting@mail.nih.gov

  44. Common Problems: Can’t Find Grant in FSRS to Report • Trouble-Shooting: • Does the award require FFATA reporting? Confirm it is a Type 1 award issued on or after October 1, 2010 or subsequent award to such a Type 1; • Did you use 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 found in USASpending (http://www.usaspending.gov/advanced-search)? If the award is listed on USASpending.gov, then it should also appear in FSRS.gov.

  45. All NIH Grantees that expend $500,000 or more within a year in Federal awards are subject to an audit requirement. Audits are due within the earlier of 30 days after receipt of the auditor’s report(s) or 9 months after the end of the grantee’s audit period. Grantees delinquent in submitting audits risk the imposition of sanctions and potential loss of Federal funds. Audit Requirements

  46. Grantees are strongly encouraged to submit closeout documents through eRA Commons Closeout Final Reports • Documents are due within 90 days of project period end date: • Final Federal Financial Report SF-425 Expenditure Data • Final Inventions Statement & Certification • Final Progress Report • Grantees must ensure there are no discrepancies between the final FFR expenditure data (in eRA Commons) and the FFR cash transaction data in the Payment Management System • NIH Central Closeout Center accepts non-financial, paper-based closeout documents (Final Invention Statement and Progress Report)

  47. Failure to submit complete and timely progress reports may affect future funding to the organization; Non-SNAP annual progress reports are due two months prior to the anniversary date (paper submission); SNAP progress reports (e-SNAP) are due 45 days prior to the anniversary date (electronically submitted through eRA Commons eSNAP Module); All grantees have access to a searchable list to determine which progress reports are due at: http://era.nih.gov/userreports/pr_due.cfm Non-Competing Continuation Progress Reports

  48. Human Subjects and Vertebrate Animal Resources

  49. OHRP Posts New/Updated Guidance and Clarification: Revisions to Federalwide Assurance document and processes – 6/20/2011; Guidance on Written IRB Procedures – updated 7/5/2011; OHRP & FDA Draft Guidance on Exculpatory Language - 9/7/2011; OHRP Correspondence on “Non-engaged” Scenarios – 9/22/2011; More at: http://www.hhs.gov/ohrp/newsroom/index.html News from the Office for Human Research Protections

  50. Mission: Provide expert advice and leadership in the areas of policy development, evaluation and implementation for human subjects protection issues related to the NIH Extramural research programs; Help ensure the compliance of NIH grantees with Federal regulations regarding the protection of human subjects in research; Assess and approve resolution of human subjects concerns noted by NIH review groups for fundable applications; As a public service, the NIH Office of Extramural Research offers a free tutorial on Protecting Human Research Participants.This training is also available in Spanish. Office of Extramural Research Human Subjects Program

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