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OPERA 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
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OPERA NIH Update – Spring 2011 April 5, 2011 National Council of University Research Administrators Regions VI and VII Spring Meeting, Denver, CO Carol.

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Page 1: OPERA NIH Update – Spring 2011 April 5, 2011 National Council of University Research Administrators Regions VI and VII Spring Meeting, Denver, CO Carol.

OPERA

NIH Update – Spring 2011April 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

Page 2: OPERA NIH Update – Spring 2011 April 5, 2011 National Council of University Research Administrators Regions VI and VII Spring Meeting, Denver, CO Carol.

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NIH Leadership News

Sally J. Rockey, PhDDeputy Director for ExtramuralResearch

Lawrence Tabak, DDS, PhD Principal Deputy Director

Page 3: OPERA NIH Update – Spring 2011 April 5, 2011 National Council of University Research Administrators Regions VI and VII Spring Meeting, Denver, CO Carol.

OPERA

NIH Budget and Recovery Act News

Page 4: OPERA NIH Update – Spring 2011 April 5, 2011 National Council of University Research Administrators Regions VI and VII Spring Meeting, Denver, CO Carol.

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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

http://officeofbudget.od.nih.gov/br.html

Page 5: OPERA NIH Update – Spring 2011 April 5, 2011 National Council of University Research Administrators Regions VI and VII Spring Meeting, Denver, CO Carol.

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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

http://officeofbudget.od.nih.gov/br.html

Page 6: OPERA NIH Update – Spring 2011 April 5, 2011 National Council of University Research Administrators Regions VI and VII Spring Meeting, Denver, CO Carol.

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Breakdown of FY 2012 Budget Request

$31.987 Billion

$16.4 B

Page 7: OPERA NIH Update – Spring 2011 April 5, 2011 National Council of University Research Administrators Regions VI and VII Spring Meeting, Denver, CO Carol.

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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)

http://www.grants.nih.gov/recovery/

Page 8: OPERA NIH Update – Spring 2011 April 5, 2011 National Council of University Research Administrators Regions VI and VII Spring Meeting, Denver, CO Carol.

OPERA

Transparency Act

Page 9: OPERA NIH Update – Spring 2011 April 5, 2011 National Council of University Research Administrators Regions VI and VII Spring Meeting, Denver, CO Carol.

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Transparency Act (FFATA)

• Federal Funding Accountability and Transparency Act of 2006 (P.L. 109-282)

• Mandates single searchable website:– www.usaspending.gov – 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

http://grants.nih.gov/grants/public_accountability/ffata.htm

Page 10: OPERA NIH Update – Spring 2011 April 5, 2011 National Council of University Research Administrators Regions VI and VII Spring Meeting, Denver, CO Carol.

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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

http://grants.nih.gov/grants/guide/notice-files/NOT-OD-11-004.html

Page 11: OPERA NIH Update – Spring 2011 April 5, 2011 National Council of University Research Administrators Regions VI and VII Spring Meeting, Denver, CO Carol.

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CCR Requirement(effective 10-1-2010)

• New: All grantees and applicants must maintain active registration in CCR – Does not apply to subrecipients – Already required for electronic applications– Is now being checked at time of award at

USASpending.gov

http://grants.nih.gov/grants/guide/notice-files/NOT-OD-11-004.html

Page 12: OPERA NIH Update – Spring 2011 April 5, 2011 National Council of University Research Administrators Regions VI and VII Spring Meeting, Denver, CO Carol.

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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 (

www.fsrs.gov)

• 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

http://grants.nih.gov/grants/guide/notice-files/NOT-OD-11-005.html

Page 13: OPERA NIH Update – Spring 2011 April 5, 2011 National Council of University Research Administrators Regions VI and VII Spring Meeting, Denver, CO Carol.

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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

http://grants.nih.gov/grants/guide/notice-files/NOT-OD-11-005.html

Page 14: OPERA NIH Update – Spring 2011 April 5, 2011 National Council of University Research Administrators Regions VI and VII Spring Meeting, Denver, CO Carol.

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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

http://grants.nih.gov/grants/guide/notice-files/NOT-OD-11-005.html

Page 15: OPERA NIH Update – Spring 2011 April 5, 2011 National Council of University Research Administrators Regions VI and VII Spring Meeting, Denver, CO Carol.

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Transparency ActResources

• DUNS/CCR– Federal Register Notice 9/14/2010:

http://www.gpo.gov/fdsys/pkg/FR-2010-09-14/pdf/2010-22706.pdf – NIH Guide Notice/Award Terms 10/22/2010: NOT-OD-11-004:

http://grants.nih.gov/grants/guide/notice-files/NOT-OD-11-004.html

• Subaward Reporting & Executive Compensation– Federal Register Notice 9/14/2010:

http://www.gpo.gov/fdsys/pkg/FR-2010-09-14/pdf/2010-22705.pdf– NIH Guide Notice/Award Terms 10/22/2010: NOT-OD-11-005:

http://grants.nih.gov/grants/guide/notice-files/NOT-OD-11-005.html

• NIH FFATA Website: http://grants.nih.gov/grants/public_accountability/ffata.htm

Page 16: OPERA NIH Update – Spring 2011 April 5, 2011 National Council of University Research Administrators Regions VI and VII Spring Meeting, Denver, CO Carol.

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Additional TransparencyAct Resources

• FSRS: http://www.fsrs.gov/ • FSRS User support through the Federal

Service Desk www.fsd.gov • USASpending.gov (See “What’s New” for

some FFATA-related resources)

Page 17: OPERA NIH Update – Spring 2011 April 5, 2011 National Council of University Research Administrators Regions VI and VII Spring Meeting, Denver, CO Carol.

OPERA

Update on Federal-wide Initiatives (FFR and RPPR)

Page 18: OPERA NIH Update – Spring 2011 April 5, 2011 National Council of University Research Administrators Regions VI and VII Spring Meeting, Denver, CO Carol.

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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)

http://grants.nih.gov/grants/guide/notice-files/NOT-OD-11-017.html

Page 19: OPERA NIH Update – Spring 2011 April 5, 2011 National Council of University Research Administrators Regions VI and VII Spring Meeting, Denver, CO Carol.

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Due dates for FFR Expenditure Data

http://grants.nih.gov/grants/ffr_supplemental_inst.doc

Budget End Calendar

Quarter End

Annual FFR Due (90 days after

end of quarter)

Final FFR Due (90 days after

end of project)1/31 3/31 6/30 5/12/28 3/31 6/30 5/293/31 3/31 6/30 6/294/30 6/30 9/30 7/295/31 6/30 9/30 8/296/30 6/30 9/30 9/287/31 9/30 12/31 10/298/31 9/30 12/31 11/299/30 9/30 12/31 12/29

10/31 12/31 3/31 1/2911/30 12/31 3/31 2/2812/31 12/31 3/31 3/31

Page 20: OPERA NIH Update – Spring 2011 April 5, 2011 National Council of University Research Administrators Regions VI and VII Spring Meeting, Denver, CO Carol.

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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…

http://www.nsf.gov/bfa/dias/policy/rppr/index.jsp

Page 21: OPERA NIH Update – Spring 2011 April 5, 2011 National Council of University Research Administrators Regions VI and VII Spring Meeting, Denver, CO Carol.

OPERA

New Scientific and Grants Management Policies

Page 22: OPERA NIH Update – Spring 2011 April 5, 2011 National Council of University Research Administrators Regions VI and VII Spring Meeting, Denver, CO Carol.

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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

• http://grants.nih.gov/grants/policy/nihgps_2010/index.htm • NIH commitment to update annually

http://grants.nih.gov/grants/guide/notice-files/NOT-OD-11-003.html

Page 23: OPERA NIH Update – Spring 2011 April 5, 2011 National Council of University Research Administrators Regions VI and VII Spring Meeting, Denver, CO Carol.

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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: http://grants.nih.gov/grants/funding/2590/2590.htm

• Revised eSNAP User Guide posted at http://era.nih.gov/docs/eSNAP_UG_v2.25.0.0_041210.pdf.

http://grants.nih.gov/grants/guide/notice-files/NOT-OD-10-093.html

Page 24: OPERA NIH Update – Spring 2011 April 5, 2011 National Council of University Research Administrators Regions VI and VII Spring Meeting, Denver, CO Carol.

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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

http://grants.nih.gov/grants/guide/notice-files/NOT-OD-10-120.html

Page 25: OPERA NIH Update – Spring 2011 April 5, 2011 National Council of University Research Administrators Regions VI and VII Spring Meeting, Denver, CO Carol.

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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

Page 26: OPERA NIH Update – Spring 2011 April 5, 2011 National Council of University Research Administrators Regions VI and VII Spring Meeting, Denver, CO Carol.

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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:

– http://grants.nih.gov/grants/policy/myf.htm

• 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

http://grants.nih.gov/grants/guide/notice-files/NOT-OD-11-010.html

Page 27: OPERA NIH Update – Spring 2011 April 5, 2011 National Council of University Research Administrators Regions VI and VII Spring Meeting, Denver, CO Carol.

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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

http://grants.nih.gov/grants/guide/notice-files/NOT-OD-10-097.html

Page 28: OPERA NIH Update – Spring 2011 April 5, 2011 National Council of University Research Administrators Regions VI and VII Spring Meeting, Denver, CO Carol.

OPERA

Changes Affecting Applications

Page 29: OPERA NIH Update – Spring 2011 April 5, 2011 National Council of University Research Administrators Regions VI and VII Spring Meeting, Denver, CO Carol.

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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:

http://grants.nih.gov/grants/funding/post_submission_faq.htm

http://grants.nih.gov/grants/guide/notice-files/NOT-OD-10-115.html

Page 30: OPERA NIH Update – Spring 2011 April 5, 2011 National Council of University Research Administrators Regions VI and VII Spring Meeting, Denver, CO Carol.

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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:

http://grants.nih.gov/grants/funding/post_submission_faq.htm

http://grants.nih.gov/grants/guide/notice-files/NOT-OD-10-104.html

Page 31: OPERA NIH Update – Spring 2011 April 5, 2011 National Council of University Research Administrators Regions VI and VII Spring Meeting, Denver, CO Carol.

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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

http://grants.nih.gov/grants/guide/notice-files/NOT-OD-11-036.htmlhttp://grants.nih.gov/grants/guide/notice-files/NOT-OD-11-047.html

Page 32: OPERA NIH Update – Spring 2011 April 5, 2011 National Council of University Research Administrators Regions VI and VII Spring Meeting, Denver, CO Carol.

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Restructured Applications andNew Page Limits for Ks

• Effective for Individual CDA (K) applications due after January 7, 2011

http://grants.nih.gov/grants/guide/notice-files/NOT-OD-11-027.html

Section of Application Limit

Mentoring Plan 6 pages

Statements by Mentor, Co-Mentors and contributors

6 pages

Description of Institutional Environment 1 page

Commitment to Candidate's Research Career Development

1 page

Page 33: OPERA NIH Update – Spring 2011 April 5, 2011 National Council of University Research Administrators Regions VI and VII Spring Meeting, Denver, CO Carol.

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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

Section of Application Limit

Plan for instruction in Responsible Conduct of Research 3 pages

Combined Research Training Program Plan attachments: •Background•Program Plan•Recruitment and Retention Plan to Enhance Diversity

25 pages

http://grants.nih.gov/grants/guide/notice-files/NOT-OD-11-039.html

Page 34: OPERA NIH Update – Spring 2011 April 5, 2011 National Council of University Research Administrators Regions VI and VII Spring Meeting, Denver, CO Carol.

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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

http://grants.nih.gov/grants/guide/notice-files/NOT-OD-11-045.html

Page 35: OPERA NIH Update – Spring 2011 April 5, 2011 National Council of University Research Administrators Regions VI and VII Spring Meeting, Denver, CO Carol.

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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

http://grants.nih.gov/grants/guide/notice-files/NOT-OD-10-140.html

Page 36: OPERA NIH Update – Spring 2011 April 5, 2011 National Council of University Research Administrators Regions VI and VII Spring Meeting, Denver, CO Carol.

OPERA

Highlights of New and Existing Grant Requirements

Page 37: OPERA NIH Update – Spring 2011 April 5, 2011 National Council of University Research Administrators Regions VI and VII Spring Meeting, Denver, CO Carol.

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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

Page 38: OPERA NIH Update – Spring 2011 April 5, 2011 National Council of University Research Administrators Regions VI and VII Spring Meeting, Denver, CO Carol.

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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

Page 39: OPERA NIH Update – Spring 2011 April 5, 2011 National Council of University Research Administrators Regions VI and VII Spring Meeting, Denver, CO Carol.

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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

Page 40: OPERA NIH Update – Spring 2011 April 5, 2011 National Council of University Research Administrators Regions VI and VII Spring Meeting, Denver, CO Carol.

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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

Page 41: OPERA NIH Update – Spring 2011 April 5, 2011 National Council of University Research Administrators Regions VI and VII Spring Meeting, Denver, CO Carol.

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FCOI Resources

• OER FCOI Web Site– http://grants.nih.gov/grants/policy/coi/

• Frequently Asked Questions– http://grants.nih.gov/grants/policy/coifaq.htm

• Web-based tutorial– http://grants.nih.gov/grants/policy/coi/tutorial/ fcoi.

htm

• Mailbox for inquiries– [email protected]

Page 42: OPERA NIH Update – Spring 2011 April 5, 2011 National Council of University Research Administrators Regions VI and VII Spring Meeting, Denver, CO Carol.

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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.

Page 43: OPERA NIH Update – Spring 2011 April 5, 2011 National Council of University Research Administrators Regions VI and VII Spring Meeting, Denver, CO Carol.

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Summary of Audit Requirements

Foreign

For-Profits

Hospitals

Non-Profits

Colleges &

Universities

http://harvester.census.gov/fac/collect/ddeindex.html Federal Audit Clearinghouse1201 East 10th StreetJeffersonville, IN 47132800-253-0696

National External Audit Review CtrHHS Office of Inspector GeneralHHS Office of Audit Services1100 Walnut Street, Suite 850Kansas City, MO 64106-2197 800-732-0679/816-426-7725

OMB Circular A-133

45 CFR Part 74.26 (d)

State & Local

Governments

Where to Submit Audit ReportsSource of Audit Requirement

Grantee Type

Page 44: OPERA NIH Update – Spring 2011 April 5, 2011 National Council of University Research Administrators Regions VI and VII Spring Meeting, Denver, CO Carol.

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Closeout Final 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

Page 45: OPERA NIH Update – Spring 2011 April 5, 2011 National Council of University Research Administrators Regions VI and VII Spring Meeting, Denver, CO Carol.

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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)

Page 46: OPERA NIH Update – Spring 2011 April 5, 2011 National Council of University Research Administrators Regions VI and VII Spring Meeting, Denver, CO Carol.

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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: http://era.nih.gov/userreports/pr_due.cfm

Page 47: OPERA NIH Update – Spring 2011 April 5, 2011 National Council of University Research Administrators Regions VI and VII Spring Meeting, Denver, CO Carol.

OPERA

Human Subjects and Animals: Requirements and Compliance

Page 48: OPERA NIH Update – Spring 2011 April 5, 2011 National Council of University Research Administrators Regions VI and VII Spring Meeting, Denver, CO Carol.

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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): http://phrp.nihtraining.com/users/login.php

http://grants.nih.gov/grants/policy/hs/index.htm

Page 49: OPERA NIH Update – Spring 2011 April 5, 2011 National Council of University Research Administrators Regions VI and VII Spring Meeting, Denver, CO Carol.

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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

http://www.hhs.gov/ohrp

Page 50: OPERA NIH Update – Spring 2011 April 5, 2011 National Council of University Research Administrators Regions VI and VII Spring Meeting, Denver, CO Carol.

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New from OHRP

• Guidance on IRB Continuing Review of Research: http://www.hhs.gov/ohrp/policy/continuingreview2010.pdf

• Guidance on IRB Approval of Research with Conditions: http://www.hhs.gov/ohrp/policy/conditionalapproval2010.pdf

• Use of Centralized IRB in Multi-site Research: http://www.hhs.gov/ohrp/policy/protocol/cirb20100430.html

http://www.hhs.gov/ohrp

Page 51: OPERA NIH Update – Spring 2011 April 5, 2011 National Council of University Research Administrators Regions VI and VII Spring Meeting, Denver, CO Carol.

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• Guide Notices• FAQs• IACUC 101 and other conferences• Online seminars for IACUC staff• Online seminars for Institutional Officials• Recordings of past webinars• Comment period on adoption of 8th edition of Guide for

Care and Use of Laboratory Animals extended to 4/24/11 http://grants.nih.gov/grants/olaw/2011guidecomments/add.htm

Office of LaboratoryAnimal Welfare

http://grants.nih.gov/grants/olaw/olaw.htm

Page 52: OPERA NIH Update – Spring 2011 April 5, 2011 National Council of University Research Administrators Regions VI and VII Spring Meeting, Denver, CO Carol.

OPERA

Update on Electronic Submission & eRA Commons

Page 53: OPERA NIH Update – Spring 2011 April 5, 2011 National Council of University Research Administrators Regions VI and VII Spring Meeting, Denver, CO Carol.

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Elimination of ErrorCorrection Window

• Does not affect the two business day application viewing window

• Applicants may still view and reject their application and submit a changed/corrected application prior to the submission deadline

• Early submission is the best way to ensure success

http://grants.nih.gov/grants/guide/notice-files/NOT-OD-10-123.html

Page 54: OPERA NIH Update – Spring 2011 April 5, 2011 National Council of University Research Administrators Regions VI and VII Spring Meeting, Denver, CO Carol.

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B1 Forms Packages

• Updated SF424 (R&R) application forms are identified with a competition ID of ADOBE-FORMS-B1

• F, K, T & D applicants are required to use the new forms for all submissions as of January 25, 2011

• Form requirements for all other submissions:– Deadlines on or before May 7, 2011, may use either the current

ADOBE-FORMS-B or the new ADOBE-FORMS-B1– Deadlines after May 7, must use ADOBE-FORMS-B1

• If more than one forms set is available, use the most recent (highest numbered) package

http://grants.nih.gov/grants/guide/notice-files/NOT-OD-11-008.html

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Form Updates Reflectedin ADOBE-FORMS-B1

• Project/Performance Site Location(s): DUNS number no longer required by Grants.gov for primary performance site but remains an NIH requirement and enforced by NIH business rules

• R&R Other Project Information: updated to enable the Human Subject Assurance Number field when Human Subjects yes/no box checked yes

• Program-specific page limits for K submissions: now electronically enforced

• Fellowship Supplemental Form: new Sponsor(s) and Co-Sponsor(s) attachment

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Tips for Successful eSubmission

• Register early Registration with Grants.gov and eRA Commons must be completed before the submission deadline. Grants.gov and eRA Commons registrations may be completed simultaneously once a DUNS# is obtained

• Follow the Application Guide and any specific instructions in the Funding Opportunity Announcement (FOA) Instructions in the FOA always trump those found in the application guide

• Check application for common errors before you submit If errors are found in the submission process, you must submit a changed/corrected application before you can view the application in the eRA Commons

• Correct all errors before the submission deadline • Verify that application is viewable in the eRA Commons

• Best way to ensure success is to submit early

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Commons Publication Integration

• Link to the National Center for Biotechnology Information’s personal online tool My NCBI

• My Bibliography tool• Manually entered citations is no longer an option• Citations must be entered in MyBib for the Person Profile, and to

associate with a progress report in eSNAP• Assists compliance with NIH Public Access Policy• Resources:

– Overview & Benefits: http://era.nih.gov/ncbi/ncbi_overview.cfm – eRA Virtual School web-based demos:

http://era.nih.gov/virtualschool/external/class_bib.htm

http://grants.nih.gov/grants/guide/notice-files/NOT-OD-10-103.html

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Other Recent Commons Enhancements

• Multi-PD/PI functionality:• Multi PD/PIs and Contact PD/PI indicated on Commons Closeout

screens and Submit FSR screen• Any PD/PIs on a MPI award may upload Final Progress Report • Final Progress Reports must be submitted as PDF • PD/PIs no longer required to verify Final Invention Statement before

SO may submit to Agency. Any PD/PI can upload; only SO can approve/submit.

• PDs at each training institution may approve appointments, reappointments, amendments and termination notices in xTrain

• Multi-year Progress Reports:• Multi-Year PR link becomes available to PD/PI 2 months prior to

anniversary of award• New No-cost Extension drop-down:

• Drop-down menu allows users to choose an extension of 1-12 months.

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xTrain Mandate and Enhancements

• xTrain allows termination of Fellowship grants (effective October 22, 2010)

• New role of Sponsor (similar to PD/PI role) created for the termination of Fellowships - register Sponsors early to avoid processing delays

• Effective January 1, 2011, NIH requires electronic submission of appointment forms and termination notices for research training, fellowship, education and career development awards via xTrain. Paper forms will not be accepted.

http://era.nih.gov/training_career/index.cfm

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eRA: Stay Tuned Items

• Single project U01s now submitted electronically; as of 5/25/11 U01 redefined as single project

• Piloting FFR/FSR module for HHS partners• Electronic submission of change of grantee

institution • Electronic submission of administrative supplements• Federated authentication to log in to eRA Commons • Changes to Financial Conflict of Interest module to

meet compliance needs• Implementation of Research Performance Progress

Report

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OPERA

Resources

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NIH Regional Seminars on Program Funding and Grants Administration

DATES LOCATION PROGRAM INFO

April 27-29, 2011 Scottsdale, Arizona Registration Open

June 22-24, 2011 Ft. Lauderdale, Florida Registration Open

2012 - Exact Date TBD Indianapolis, Indiana Stay tuned

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63 http://nexus.od.nih.gov/all/rock-talk/

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NIH Listservs for Extramural Information

• NIH Guide for Grants and Contracts– http://grants.nih.gov/grants/guide/listserv.htm

• Extramural Nexus and Rock Talk Blog (RSS and Twitter)– http://nexus.od.nih.gov/all/subscribe/

• eSubmission (separate listservs for scientists and administrators) – http://era.nih.gov/ElectronicReceipt/listserv.htm

• Office for Human Research Protections (OHRP) – http://www.hhs.gov/ohrp/news/distributionlist.html

• Office of Laboratory Animal Welfare (OLAW)– http://grants.nih.gov/grants/olaw/references/list.htm

• Office of Biotechnology Activities (OBA)– https://list.nih.gov/archives/oba_news.html

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65 http://grants.nih.gov/grants/frequent_questions.htm

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66 http://report.nih.gov

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NIH Extramural Response to Natural Disasters

NIH is commitment to the health of the biomedical community in the impacted areas,

and concern for the health and safety of people and animals in the programs we

overseeWebsite:

– Recent Guide Notices and any event-specific web pages

– Links to other Federal web sites for disasters– NIH Emergency Contact Information– Examples of extramural assistance provided to

previous natural disasters and emergencies– Frequently Asked Questions

http://grants.nih.gov/grants/natural_disasters.htm

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Web Resource Pages• Office of Extramural Research (OER) Web Page

http://grants.nih.gov/grants/oer.htm

• NIH Searchable Database of RFAs, PAs, and Guide Notices http://grants.nih.gov/grants/guide/index.html

• NIH Grants Policy Statement (Rev. 12/03) http://grants.nih.gov/grants/policy/nihgps_2003/index.htm

• NIH Extramural Nexus – Monthly newsletter (previously bimonthly) for the extramural communityhttp://grants.nih.gov/grants/nexus.htm

• RePORTER - Search to analyze an Institute’s portfolio of funded projects, research areas, and more http://projectreporter.nih.gov/reporter.cfm

• Grant Application Basics http://grants.nih.gov/grants/grant_basics.htm

• Intellectual Property Policyhttp://grants.nih.gov/grants/intell-property.htm

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Have a question about an application or award?

Institutional Resources – utilize the expertise of your organization’s Office of Sponsored Programs

Specific Questions• Administrative - Contact the Grants Management

Specialist at the awarding Institute/Center• Scientific/Programmatic - Contact the designated

Program Official/Director at awarding Institute/Center

• Review Questions - Contact the assigned Scientific Review Officer

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NIH Contacts

• Grants Administration staff at NIH ICs:http://grants.nih.gov/grants/staff_list_grants_admin.htm

• NIH Chief Grants Management Officers: http://grants.nih.gov/grants/stafflist_gmos.htm

• Grants Policy Interpretation & Consultation:– E-Mail: [email protected]– Phone: 301-435-0949

• Compliance Issues:– E-Mail: [email protected]– Phone: 301-435-0949

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NIH Contacts

• General Application Questions: (e-Submission guidelines, resources, referrals, application review, award process)– E-Mail: [email protected]– Phone: 301-435-0714

• Customer Support for Grants.gov: (navigating forms, aspects of submitting through the system, resources available)– E-Mail: [email protected]– Webpage: http://grants.gov/– Phone: 1-800-518-4726

• eRA Commons Help Desk: (Commons registration help, application verification, Commons functionality questions)– Webpage: http://ithelpdesk.nih.gov/era/– Phone: 301-402-7469 (Toll Free: 866-504-9552)

Enter your own help ticket!

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OPERA

Thank You