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NIH Update – Spring 2011

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  1. NIH Update – Spring 2011 April 5, 2011 National Council of University Research Administrators Regions VI and VII Spring Meeting, Denver, CO Carol Wigglesworth Grants Policy Analyst Office of Policy for Extramural Research Administration

  2. NIH Leadership News Lawrence Tabak, DDS, PhD Principal Deputy Director Sally J. Rockey, PhD Deputy Director for Extramural Research

  3. NIH Budget and Recovery Act News

  4. NIH Budget FY 2011 • President’s 2011 Budget Request: $32.2 billion • Increase of 3.2% from FY 2010 • Increase will support Innovative high throughput technologies, including DNA sequencing, imaging, and computational biology • 6th Continuing Resolution provides funding through April 8

  5. NIH Budget FY 2012 • President’s 2012 Budget Request: $31.987 billion • Increase of 2.4% from FY 2010 • Areas of emphasis: • National Center for Advancing Translational Sciences (NCATS) • Technologies to accelerate discovery • Enhancing evidence for health care decisions • New Innovator and Early Independence Awards

  6. Breakdown of FY 2012 Budget Request $31.987 Billion $16.4 B

  7. Recovery Act - ARRA • Last ARRA awards issued September 2010 • Reminders: • Timely quarterly and Closeout reports required • Standard NIH Terms of Award and ARRA specific terms • Spending should be timely, expeditious ,and in accordance with expected pace of research • Grantee has authority to extend project period end dates up to 12 months (separate from the non-ARRA parent for Type 3s) • Limitations on additional extensions (NOT-OD-10-067)

  8. Transparency Act

  9. Transparency Act (FFATA) Federal Funding Accountability and Transparency Act of 2006 (P.L. 109-282) Mandates single searchable website: freely accessible to the public information on Federal financial assistance and contracts over $25K (recipient and subrecipients) DUNS and CCR requirements First tier subaward reporting Executive Compensation reporting for prime and first tier sub-recipient

  10. DUNS Requirement(effective 10-1-2010) All applicants required to have DUNS at time of application (required since 2003) New: All subrecipients required to have DUNS prior to subaward DUNS for subrecipient is not required at time of application Grantee organization responsible for informing subrecipient that a DUNS is required Subrecipients are not required to register in the eRA Commons

  11. CCR Requirement(effective 10-1-2010) New: All grantees and applicants must maintainactive registration in CCR Does not apply to subrecipients Already required for electronic applications Is now being checked at time of award at

  12. First Tier Subaward Reporting(effective 10-1-2010) First tier subawards (new type 1 awards): What: subawards obligations of $25,000 or more When: by end of the month following month the subaward obligation was made Where: FFATA Subaward Reporting System ( Exempt from subaward reporting requirement: ARRA awards; awards to individuals; when federal agency is prime recipient; classified awards; recipients with under $300,000 gross income in previous tax year

  13. Executive CompensationReporting for Prime Grantee New competing awards made on or after 10/01/10 WHAT triggers reporting? Awards of $25,000 or more, and In previous fiscal year, entity received 80% or more in annual gross revenue from Federal grants, subaward, contracts, and subcontracts subject to the Act, and $25,000,000 or more annual gross revenue from Federal grants, subaward, contracts, and subcontracts, and Public access to the information is not already available WHEN: due at the end of the month following the month in which award was issued. WHERE: to CCR as part of institution’s registration profile

  14. Executive Compensation Reportingfor First Tier Subrecipient New competing awards made on or after 10/01/10 WHAT triggers reporting? Awards of $25,000 or more, and In previous fiscal year, entity received 80% or more in annual gross revenue from Federal grants, subaward, contracts, and subcontracts subject to the Act, and $25,000,000 or more annual gross revenue from Federal grants, subaward, contracts, and subcontracts, and Public access to the information is not already available WHEN: due the end of the month following the month in which award was issued. WHERE: Subrecipient reports to Prime and Prime reports to FSRS

  15. Transparency ActResources DUNS/CCR Federal Register Notice 9/14/2010: NIH Guide Notice/Award Terms 10/22/2010: NOT-OD-11-004: Subaward Reporting & Executive Compensation Federal Register Notice 9/14/2010: NIH Guide Notice/Award Terms 10/22/2010: NOT-OD-11-005: NIH FFATA Website:

  16. Additional TransparencyAct Resources FSRS: FSRS User support through the Federal Service Desk (See “What’s New” for some FFATA-related resources)

  17. Update on Federal-wide Initiatives (FFR and RPPR)

  18. Federal Financial Report(FFR) SF 425 • Replaces Cash Transaction Report (SF 272) and Financial Status Reports (SF 269, SF 269A) • Federal cash data portion of FFR submitted to Payment Management System (PMS) • Expenditure data portion of FFR submitted to NIH via eRA Commons eFFR/FSR module • Implemented 2/1/11 • Differences from former FSR (SF 269, SF 269A) • grantee submits cumulative data only • due dates for annual FFRs are now 90 days after end of calendar quarter in which budget period ends (see next slide)

  19. Due dates for FFR Expenditure Data

  20. Research Performance Progress Report (RPPR) • Greater consistency in the administration of Federal research awards to relieve administrative burden on recipients • OMB Final RPPR format Spring 2010 (result of effort begun in 2004) • NIH implementation plan posted Jan 2011 • Implement electronically for ALL mechanisms • Pilot in January 2012; full implementation summer 2012 • NIH goal to collection information that is scientifically and administratively necessary for monitoring progress, and to minimize impact on grantees • Stay tuned…

  21. New Scientific and Grants Management Policies

  22. NIH Grants Policy Statement Revision - FY2011 • October 1, 2010 • Supersedes December 2003 version • incorporates policy changes since 12/03, public policy changes, and clarification of existing policies • new chapters (Career Awards, Multiple PD/PI) • updated terminology • improved organization • • NIH commitment to update annually

  23. Required use of eSNAP • SNAP progress reports must be submitted through the eRA Commons eSNAP module (effective 8-1-2010)  • SNAP provisions include: • IRB/IACUC dates not routinely required in progress report • Reports due 45 days instead of 60 days before anniversary • Ability to delegate submit authority to the PD/PI • PHS 2590 Instructions updated: • Revised eSNAP User Guide posted at

  24. Revised Policy for Just-in-Time Submissions • Applicants are responsible for verifying the accuracy and validity of all administrative, fiscal, and programmatic information at the time of submission  • NOT-OD-10-120 formally extends that policy to information submitted through the JIT process, and standardizes policy across NIH ICs  • Applicants are responsible for promptly notifying NIH of any substantive changes to previously submitted JIT information up to the time of award, including: • Current other support, certifications, hESCs, other information requested by awarding IC • Information considered current for up to 120 days

  25. Progress Reports forMulti-year Funded Awards • Multi-year funded awards are not funded incrementally (1 yr at a time) • Budget period and project period are the same, and are longer than 1 year • Traditionally multi-year funded are C06, DP2, DP3, and R15 • Standardized submission process of reports • Standardized content of progress reports • Supports NIH monitoring of progress and enforcement of terms of award

  26. Progress Reports forMulti-year Funded Awards • Due on or before anniversary date of award • PDF uploaded through eRA Commons (NOT eSNAP) • Instructions for Grantees on how and what to submit: • • Reporting period is calendar year preceding anniversary date of the award • Notifications • PD/PI receives due date eNotification two months prior to anniversary date of award • Past due eNotification sent if report not received

  27. Genomic Array CostsBudgeting Guidance High-throughput biomedical research requiring purchase of Genomic Arrays from external source Use of facilities and administrative (indirect) costs First $50,000 treated as supplies Amount in excess of $50,000 treated as subcontract costs, i.e., F&A rate applied to first $25,000 of excess each year

  28. Changes Affecting Applications

  29. Application Materials – Post submissionand prior to peer review Allowed: Materials resulting from unforeseen administrative issues, such as revised budget pages, biographical sketches, letters of support or collaboration, adjustments resulting from change of institution Adjustments resulting from natural disaster Adjustments resulting from change of institution News of article accepted for publication Page limits for supplemental information Must submit no later than 30 days before review Must submit with the concurrence of AOR Effective September 25, 2010 due date New FAQs available:

  30. Training and Related Application Materials –Post submission and prior to peer review Allowed: Updated information and data on the applicant pool, admissions, enrollment, appointments and/or achievements Updated faculty research support Exceptions to this policy and other training-related activity codes will appear in FOA (e.g., R25) Up to 3 pages allowed Must submit no later than 30 days before review Must submit with the concurrence of AOR Effective September 25, 2010 due date New FAQs available:

  31. K and F Letters of Reference • Elimination of the 5-day grace period for receipt of letters for reference • Letters of reference will be due on application due date • Applications missing required references in the appropriate format will not be reviewed • Effective dates: • April 8, 2011 due dates for Fellowship (F) applications • June 12, 2011 due dates for Individual Career Development (K) applications

  32. Restructured Applications andNew Page Limits for Ks • Effective for Individual CDA (K) applications due after January 7, 2011

  33. Restructured Applications and New Page Limits for Ts and Ds • Effective for Institutional Research Training applications (including NRSA) for May 25, 2011, and subsequent due dates

  34. Modification to Biographical Sketch • Intended to accommodate personal issues such as illness, disability, military service, and family care responsibilities • Effective for applications submitted 5/25/2011 and beyond • PD/PIs may describe personal factors that may have delayed their scientific advancement or productivity, or caused a hiatus in training • Consistent with Early Stage Investigator policy • Provision of information is optional • Also applicable to biosketch for fellowship applicants

  35. New Time Limit for Resubmissions • To stimulate new research directions for projects that were not successful and may now be dated • NIH will not accept a Resubmission that is submitted later than 37 months after the date of receipt (“receipt date”) of the initial New, Renewal, or Revision application • Effective 1/25/11 receipt date

  36. Highlights of New and Existing Grant Requirements

  37. Financial Conflict of Interest "The public trust in what we do is just essential, and we cannot afford to take any chances with the integrity of the research process.“ - Dr. Francis Collins Director, NIH

  38. Current FCOIRegulations (10/1/95) • 42 CFR Part 50, Subpart F • Requires that grantee institutions: • maintain an appropriate written, enforced policy on conflict of interest that complies with the regulations • establish adequate enforcement mechanisms and provide for sanctions, where appropriate

  39. Important FCOI Reminders • Definition of Investigator is broad • Includes spouse and dependents • Reporting Requirements • At time of application • Prior to expenditure of funds • Within 60 days if FCOI identified after initial report • Reasonable steps to ensure subrecipient compliance • Subrecipient complies with grantee’s policy or provides assurance to grantee that it will comply with regulations • Subrecipient reports FCOI to grantee; grantee reports to NIH • Proper documentation • All financial disclosures, actions taken by institution for each FCOI • Maintain for at least 3 years following submission of final FFR or as specified in 45 CFR 74.53(b) for different situations

  40. Proposed Revisionto FCOI Regulations • Notice of Proposed Rule Making (NPRM) published in the 5/21/10 Federal Register for public comment • Purpose to strengthen accountability and transparency of current FCOI rules at the government, institutional and investigator levels • Next Step – publication of new final rule • Stay tuned

  41. FCOI Resources • OER FCOI Web Site • • Frequently Asked Questions • • Web-based tutorial • fcoi.htm • Mailbox for inquiries •

  42. HHS Audit Requirements 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.

  43. Summary of Audit Requirements Grantee Type Source of Audit Requirement Where to Submit Audit Reports • • Federal Audit Clearinghouse • 1201 East 10th Street • Jeffersonville, IN 47132 • 800-253-0696 • National External Audit Review Ctr • HHS Office of Inspector General • HHS Office of Audit Services1100 Walnut Street, Suite 850 • Kansas City, MO 64106-2197 • 800-732-0679/816-426-7725 State & Local Governments OMB Circular A-133 45 CFR Part 74.26 (d) Colleges & Universities Non-Profits Hospitals For-Profits Foreign

  44. CloseoutFinal Reports Grantees are strongly encouraged to submit closeout documents electronically via eRA Commons • Documents are due within 90 days of project period end date • Expenditure data portion of FFR (must be submitted electronically) • Final Inventions Statement & Certification • Final Progress Report • Grantees must ensure no discrepancies between the final expenditure data portion of the FFR (submitted to NIH), and the final cash transaction data portion of the FFR (submitted to the Payment Management System) • Failure to submit timely reports may affect future funding

  45. NIH Centralized Processing Center • Accepts non-financial, hard copy closeout documents • Final Progress Report • Final Invention Statement and Certification • If not submitting documents via eRA Commons, mail hard copy to: NIH Centralized Processing Center 6705 Rockledge Drive, Room 2207, MSC 7987 Bethesda, MD 20892-7987 (for regular or US Postal Service Express mail) Bethesda, MD 20817 (for other courier/express mail only)

  46. Non-Competing Continuation Progress Reports • Failure to submit timely progress reports may affect future funding to the organization • Non-SNAP annual progress reports are due two months prior to the anniversary date • SNAP progress reports are due 45 days prior to the anniversary date (must use eSNAP) • All grantees have access to a searchable list to determine which progress reports are due at:

  47. Human Subjects and Animals: Requirements and Compliance

  48. Office of Extramural Research Human Subjects Program • OER Office providing 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 compliance of NIH grantees with Federal regulations • Assess and approve resolution of human subjects concerns noted by NIH review groups • Free tutorial on Protecting Human Research Participants (now also available in Spanish):

  49. HHS Office for HumanResearch Protections (OHRP) • HHS human subject regulations (45CFR46) • Leadership and guidance on ethical and regulatory issues in biomedical and behavioral research • Compliance – regulatory oversight • Education - programs and materials • Policy – clarification and guidance • Assurances – Federalwide Assurances of Compliance and registration of IRBs • Secretary’s Advisory Committee • International Activities

  50. New from OHRP • Guidance on IRB Continuing Review of Research: • Guidance on IRB Approval of Research with Conditions: • Use of Centralized IRB in Multi-site Research: