Current Issues at NIH FALL 2012 Michelle Bulls & Maria Koszalka Office of Policy for Extramural Research Administration NCURA November 2012
FY13 Budget • Continuing Resolution signed by President on September 28, 2012 (Public Law 112-175) • Extends until March 27, 2013 • Implications on NIH budget still under discussion • More at: NOT-OD-13-002
FY 2012 Funding Levels Non-competing awards issued without cost of living/inflationary adjustments No Inflationary Increases for Future Years Note that application instructions are unchanged; grantees may still request COL increases in accord with institutional policy Overall effort to keep average size of grants consistent to the FY2011 levels or lower NRSA 2% stipend increase More at: NOT-OD-12-036 NIH Fiscal Policy for Grant AwardsFY 2012
New Investigators: NIH will continue to support new investigators on R01 equivalent awards at success rates equivalent to that of established investigators submitting new (Type 1) R01 equivalent applications; Salary Limits: Applies Executive Level II; Additional Information: Additional details on Fiscal Operations, including specific funding strategies for ICs are at http://grants.nih.gov/grants/financial/index.htm; More at: NOT-OD-12-036 NIH Fiscal Policy for Grant AwardsFY 2012 (cont’d)
Prior year awards (awards made in FY 2011, 2010, etc.) are not impacted; If the President signs an additional CR for any part of FY 2013, unless legislative language provides otherwise, the EL-II salary cap will apply regardless of what level was applied in FY 2012; Salary cap does not apply to payments made to consultants under a grant; Salary cap applies to subawards/contracts for substantive work under a NIH grant; See Frequently Asked Questions website at http://grants.nih.gov/grants/policy/fy2012_salary_cap_faqs.htm More at: NOT-OD-12-035 FY12 NIH Salary Cap News
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/
Financial Conflict of Interest (FCOI) Regulations
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
NIH Implementation Updates and Activities Updated eRA FCOI Module 8/12/2012 Training Webinar on FCOI Reporting Requirements and eRA FCOI Module Demo (archived) found at http://grants.nih.gov/grants/policy/coi/index.htm Checklist for Policy Development for grantees Presentations and Case Studies Summary Charts on FCOI Reporting Requirements FAQs Tutorial (with certificate of completion) Summary of Changes to the Regulation
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
FCOI Reporting Requirements • Initial and annual FCOI Reports are provided to NIH through the FCOI Module • Prior to the expenditure of funds • During the period of award • Within 60 days of identifying a new FCOI • Annually • At the same time as when the annual progress report or multi-year progress report is due or at time of extension
Mailbox for inquiries FCOICompliance@mail.nih.gov OER FCOI Web Site http://grants.nih.gov/grants/policy/coi/ FCOI Resources
NIH Special Council Review • New Special Council Review (SCR) policy to help NIH effectively manage resources. • Piloted May 2012 • Requires NIH IC Advisory Councils to provide additional consideration of new and renewal applications from well-supported investigators who currently receive $1 million or more in direct costs of NIH funding to support Research Project Grants (RPG). • Council members will receive a list of competing applications that will be considered for funding from PD/PIs that meet the SCR threshold along with a justification of the IC’s recommendation to consider for funding or not consider for funding. • Does not represent a cap on NIH funding. • For additional details, please see NIH Guide Notice NOT-OD-12-140.
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 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, 2012 to an award issued after that date must be done with NIH assistance; • For all initial SNAP awards issued to foreign institutions after October 1, 2012, foreign grantees are not required to report expenditure data annually via the FFR. FFR expenditure data is required only at the end of a competitive segment for SNAP awards; • For initial awards issued after October 1, 2012 when preparing the FFR expenditure data, grantees must use the currency rate in effect at the time the funds are drawn down from PMS; • For additional information, including the process for foreign grantees to register for PMS, please see NIH Guide Notice NOT-OD-12-139.
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
Guidance Regarding Changes that Involve Human Subjects in Active Awards Requiring Prior NIH Approval Current NIH policy requires prior approval from the NIH IC for a change in scope (NIH GPS§22.214.171.124); One of the potential indicators of a change in scope is a change from the approved involvement of human subjects; NIH Guide Notice NOT-OD-12-129provides detailed guidance on the types of changes in human subjects research awards that will require prior NIH approval and provides information on the process for submission of such requests. More at: NOT-OD-12-129
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); After award and prior to the involvement of human subjects, the grantee must submit to the awarding IC for approval, a detailed human subjects section in accord with the NIH competing application instructions; NIH 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
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 than160 approved cell lines. • Beginning with applications submitted for the September 25, 2012 due date and thereafter, applications 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
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
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
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) • Revised competing applications and instructions to be implemented in the summer of 2013, following electronic development of applicable forms • Note new location for Final Progress Report instructions under Closeout on Forms & Applications Page More at: NOT-OD-12-152
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 • Includes standard fed-wide questions and NIH-specific data elements • 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
RPPR - What’s new about it? • Format is different from eSNAP, but the information requested is similar; • SNAP awards will still not require budget • Publications from PI’s MyNCBI indicate Public Access Policy compliance status; • Includes live links to Notice of Award; • Streamlines ClinicalTrials.gov reporting; • Content varies depending on activity code.
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).
RPPR – Grantee Training • October 17, 2012 Webinar for Grantees • Registration required in advance • Limited to 1,000 logins • Archive of webinar available at: http://grants.nih.gov/grants/rppr/
OMB Potential Reforms to Federal Grants Policy • Published in Federal Register 2/28/2012: http://www.gpo.gov/fdsys/pkg/FR-2012-02-28/pdf/2012-4521.pdf • Includes ideas that would standardize information collection, adopt a risk-based model for single audits, & provide new administrative approaches for determining & monitoring allocation of Federal funds • Ideas of Interest: • Exploring time & effort reporting alternatives • Charging allocable admin support costs directly • Including computing device costs as allowable direct costs • Consolidating cost principles into single document • For F&A costs, using flat rates instead of negotiated rates
Electronic 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 More at: NOT-OD-12-024
Electronic Post-Award Change of Grantee Organization • Pilot of electronic submission of post-award Change of Grantee Organization applications (Type 7) • Available only if the 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
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 the 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
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
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
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
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. Beginning in FY2012, awards have more definitive “Yes/No” award term for this requirement. More at: NOT-OD-12-010 Transparency Act—Subrecipient Reporting Reminder
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
Common Problem: Can’t Find Grant in FSRS to Report • Trouble-Shooting: • Is it truly part of the FFATA reporting requirement? 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? Do a grant search at http://www.usaspending.gov/advanced-search. If your award is listed on USASpending.gov it should also appear in FSRS.gov.
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
Grantee Type Source of Audit Requirement Where to Submit Audit Reports State & Local Governments OMB Circular A-133 45 CFR Part 74.26 45 CFR Part 74.26 (d) NIH GPS, uses 45 CFR Part 74.26(d) Online to: http://harvester.census.gov/fac/collect/ddeindex.html Questions: 1-800-253-0696 HHS Office of Inspector General HHS Office of Audit Services National External Audit Review Center 1100 Walnut Street, Suite 850 Kansas City, MO 64106-2197 Phone: 800-732-0679/816-426-7720 Colleges & Universities Non-Profits Hospitals For-Profits Foreign (same as For-Profits) Summary of Audit Requirements
Grantees are strongly encouraged to submit closeout documents electronically through the eRA Commons Closeout Final Reports • Failure to submit timely reports may affect future funding to the organization; • Documents are due within 90 days of project period end date: • Final Federal Financial Report (FFR) SF-425 Expenditure Data (submitted through eRA Commons); • 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.
Centralized office accepts receipt of all non-financial, paper-based closeout documents; Final Progress Report; Final Invention Statement and Certification. If not using eRA Commons Closeout Module, mail closeout documents to the Central NIH unit at: NIH Centralized Processing Center 6705 Rockledge Drive, Room 5016 Bethesda, MD 20892-7987 (for regular or US Postal Service Express mail) Bethesda, MD 20817 (for other courier/express mail only) Closeout NIH Centralized Processing Center
Failure to submit complete and timely progress reports may affect future funding to the organization Non-SNAP annual progress reports are due the 1st of the month preceding the month in which the budget period ends (paper submission) SNAP progress reports are due the 15th of the month preceding the month in which the budget ends (electronic submission either RPPR or eSNAP) Multi-year funded progress reports due on the anniversary (http://grants.nih.gov/grants/policy/myf.htm Searchable list to determine which progress reports are due: http://era.nih.gov/userreports/pr_due.cfm Progress Reports
OHRP Posts New/Updated Guidance and Clarification: 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; Draft Guidance on Considerations in Transferring a Previously- Approved Research Project to a New IRB or Research Institution – 6/12/2012 More at: http://www.hhs.gov/ohrp/newsroom/index.html News from the Office for Human Research Protections
Office of Laboratory Animal Welfare (OLAW) …provides guidance and interpretation of the PHS Policy, supports educational programs, and monitors compliance with the Policy by Assured institutions and PHS funding components to ensure the humane care and use of animals in PHS-supported research, testing, and training, thereby contributing to the quality of PHS-supported research. New in 2012: Effective 1/1/12, the NIH adopted the 8th Edition of the Guide for the Care and Use of Laboratory Animals (Guide). PHS Assured institutions are expected to implement the Guide in 2012 and OLAW issued guidance to facilitate implementation. See FAQ C7 on Departures from the Guide, NOT–OD-12-148 Guidance on Departures from the Provisions of the Guide for the Care and Use of Laboratory Animals, and OLAW recorded Online Seminars. OLAW also issued NOT-OD-12-81 Change in Criteria for Renewal of Animal Welfare Assurances for Foreign Institutions.
http://olaw.nih.gov OLAW Educational Outreach • FAQs at http://grants.nih.gov/grants/olaw/faqs.htm • OLAW online free quarterly webinars series: • OLAW Online http://grants.nih.gov/grants/olaw/e-seminars.htm • Recordings of past webinarshttp://grants.nih.gov/grants/olaw/educational_resources.htm
Planned Upcoming OLAW-supported Workshops http://grants.nih.gov/grants/olaw/workshop.htm