After the Award is Made…THEN WHAT? Rebecca D. Claycamp, MS, CRA Chief Grants Management Officer National Institute of Mental Health, NIH Terri Jarosik Supervisory Grants Management Specialist JUNE 2012

When Does a Grantee Need to Contact NIH After the Initial Award? When there is an issue with the Notice of Award (NOA) Annual continuation progress reports, including multiyear funded grants When an FCOI is identified Required prior approvals Consultation when a question needs to be answered or a problem arises Closeout

Notice of Award (NoA) What is the Notice of Award letter? What are the components of the NoA letter? Grantee acceptance of award

What is the Notice of Award letter? Legally Binding Document Identifies grant number, grantee, PI Establishes funding level, support period Sets forth terms and conditions Includes NIH Contact Information for assigned Program Director & Grants Management Specialist E-mailed to the grantee-provided address Available in Commons Status

Components of the NoA NoA Section I: NoA Section II: Award Data & Fiscal Information Summary totals for current and future years Fiscal year of award Indicates whether an unobligated balance has been applied to the award amount Cofunding by another NIH Institute/Center or Office NoA Section II: http://grants.nih.gov/grants/policy/awardconditions.htm, info about: Grant Payment Information OIG Hotline Information Other terms/info that apply to all awards

Components of the NoA (continued) NoA Section III: Terms & Conditions Standard terms, by reference: Grant program legislation and regulations Restrictions on the expenditure of funds in appropriation acts 45 CFR 74 or 92 as applicable NIH Grants Policy Statement

Components of the NoA (continued) NoA Section III: Terms & Conditions Dependent on award characteristics…. Federal Demonstration Partnership institutions noted Carryover - automatic or prior approval Included/excluded from Streamlined Noncompeting Award Process (SNAP) Phase III Clinical Trials (when applicable) ClinicalTrials.gov

Components of the NoA (continued) NoA Section III: Terms & Conditions Requirements for DUNS # and CCR registration Transparency Act Multi-Year Funded Public Access Closeout term (when applicable) Co-funding (when applicable) Program Income

Components of the NoA (continued) NoA Section IV: IC Special Terms and Conditions Cooperative Agreement Restrictive terms Information items Staff Contact Information Spreadsheet Summary

Grantee Acceptance The grantee indicates acceptance of the terms and conditions of the award by drawing down funds from the Payment Management System

FCOI Reporting Requirements Initial and annual FCOI Reports are provided to the NIH through the eRA Commons 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 multiyear progress report is doe or at time of extension http://grants.nih.gov/grants/policy/coi/index.htm

Progress Reports SNAP or Non-SNAP Elements of a Progress Report How to submit When to submit

SNAP Progress Reports - Administrative & Fiscal Requirements Grants Policy Statement, 8.4.1.2 Streamlined Non-Competing Award Process http://grants.nih.gov/grants/policy/nihgps_2012/nihgps_ch8.htm#_Toc271264971 Detailed budgets not required Federal Financial Report due at end of competing segment eSNAP retiring, RPPR required

Research Performance Progress Report - Update Guide Notice for RPPR changes (Feb. 2013) Progress reports for SNAP grants and Fellowships with budget start dates on or after 7/1/13 must be submitted using the RPPR. eSNAPs will be “returned”. Progress Report Additional Materials (PRAM) functionality expanded to include requests from ICs RPPR for non-SNAP and multi-year funded awards implementation timeline TBD More at: NOT-OD-13-035 and NOT-OD-13-061

RPPR – Resources NIH RPPR webpage Background NIH RPPR Instruction Guide Archive of Webinar for NIH Grantees Frequently Asked Questions More at: http://grants.nih.gov/grants/rppr/index.htm 17

Key Elements of the RPPR Progress Report A. Cover Page B. Accomplishments C. Products D. Participants E. Impact F. Changes G. Special Reporting Requirements H. Budget Are there still the three questions?

Describe and justify the planned reductions D.2a - Will there be, in the next budget period, either (1) a reduction of 25% or more in the level of effort from what was approved by the agency for the PD/PI(s) or other senior/key personnel designated on the Notice of Grant Award, or (2) a reduction in the level of effort below the minimum amount required by the Notice of Award? Describe and justify the planned reductions D.2b - Has there been change in the active other support of senior/key personnel since the last reporting period? Provide complete other support only if active support has changed for the PI and key personnel, or new senior/key personnel are added G.10 - Is it anticipated that an estimated unobligated balance (including prior year carryover) will be greater than 25% of the current year’s total budget? Explain why there is a balance, (including prior year carryovers), > 25% of the current year’s total budget and how you plan to use the funds

Submitting a SNAP Progress Report Electronically via eRA Commons, 45 days before next budget start date Commons-registered institutions and PIs: Due date information accessible through the Commons Status system (electronic submission for SNAP) Have access to pre-populated face pages via Status eRA Commons Website: https://commons.era.nih.gov/commons/index.jsp

Non-SNAP Progress Report Requirements Submit complete PHS2590 application Detailed budget, justification, and updated other support, IRB and IACUC if appropriate Address unobligated balance > 25% Total Costs as commitment base Annual Federal Financial Report (separate electronic submission) RPPR implementation timeline TBD

Key Elements of Non-SNAP Progress Report Face Page Correct contact information Human Subjects/Animals FWAs/Assurances IRB/IACUC dates Education Certification for new key personnel Budget Page At committed level with written justification Updated Other Support Progress Report Summary Checklist All Personnel Report

How to submit a Non-SNAP Progress Report Hard copy to centralized mailing address, two months before next budget start date: Division of Extramural Activities Support, OER, NIH 6705 Rockledge Drive, Room 2207, MSC 7987 Bethesda, M.D. 20892-7987 Bethesda, M.D. 20817 (courier/express) Telephone: (301) 594-6584

What Not to Submit with the Non-Competing Progress Reports Carryover requests Requests for supplemental funding Requests for additional time to the final budget and project period These are administrative actions that need to be addressed separately.

What Can Delay the Award Process? Missing information for Key Personnel Out-of-date IRB/IACUC approvals Lack of population data for clinical trials Budgets with inadequate justification Other Support for an individual that exceeds 12 CM (100%)

Timeliness All grantees have access to a searchable list of due progress reports at: http://era.nih.gov/commons/quick_queries/index.cfm#progress Two separate progress report reminders e-mailed to the PI Two months prior to the due date Two weeks after the due date for overdue reports

Federal Financial Report Beginning 2/1/2011 NIH implemented the expenditure data portion (i.e., FSR info) of the FFR Annual FFR due 90 days after the end of calendar quarter in which the budget period ends Final FFRs due 90 days after the project period end FSR info under expenditure data of FFR. Only cumulative data reported on FFR In the eRA Commons (Federal Cash Transaction Reporting completed in Payment Management System on the FFR using cash transaction data elements)

Federal Financial Report (continued) FFR SHOULD BE SUBMITTED BEFORE CARRYOVER REQUESTS ARE CONSIDERED Grant might not be processed if a prior year FFR has not been submitted to and accepted by NIH Expenditure data and cash transaction data on the final FFR must reconcile Grants Policy Statement, 8.4.1.5 Financial Reports http://grants.nih.gov/grants/policy/nihgps_2012/nihgps_ch8.htm#_Toc271264973

Carryover/Offset – What’s the Difference? Carryover increases the approved budget authorization using prior year funds A carryover is a “$0” transaction on the NoA but the current approved budget is increased An offset “partially pays” the current year’s grant with funds from a prior year – no increased budget authorization An offset decreases the amount of the award

Requesting a Carryover… You must have an UNOBLIGATED BALANCE reported on a FFR Funds awarded in one year but not spent Carried forward from one budget period to another Requires a written request from the grantee including a detailed budget page and budget justification Justification requires a rationale for why funds were not spent in the year in which they were awarded and how they will be spent in the next year. Justification must be tied to the scientific aims of the project

Carryover reflected on NoA ($50k TC carryover; original award of $250k TC)

Offset Unobligated funds used to “partially pay” the current fiscal year budget period When a grant is offset: The approved budget DOES NOT increase or decrease The total federal award amount DECREASES the current fiscal year’s dollars May use an offset due to large unexplained unobligated balances or when the need for funds changes (such as a post-doc slot on a training grant going unfilled)

Offset reflected on NoA ($50K TC offset; $250K TC approved)

Prior Approvals Certain post-award actions require the prior approval of the NIH Grants Management Officer NIH Grants Policy Statement, 8.1.2 Prior Approval Requirements: http://grants.nih.gov/grants/policy/nihgps_2012/nihgps_ch8.htm#prior_approval_requirements

Prior Approval All requests for prior approval must be: Submitted in writing or via email – include complete grant number, PI name and contact information, grantee name Submitted to the awarding IC’s Grants Management Specialist no later than 30 days before the proposed change Signed by the AOR Only responses to prior approval requests signed by the GMO are valid

Required Prior Approvals … Alterations and renovations Capital expenditures Addition of a foreign component Preaward Costs >90 days prior to effective date of new or competing award Deviation from award terms and conditions Changes in grantee organizational status

Required Prior Approvals … Transferring of funds between construction and nonconstruction work Retention of research grant salary/fringe benefit funds when a K Award is made Transferring amounts from trainee costs Second no-cost extension or extension > 12 months

Required Prior Approvals … Need for additional NIH funds—aka supplement Carryover of unobligated balances Change in scope Change in key personnel named in NGA Change in grantee Institution

Requests for additional funding: Revision Application (Type 3) (formerly a competing supplement) Supports an expansion in scope of the research Peer-reviewed and council review Standard application dates at: http://grants.nih.gov/grants/funding/submissionschedule.htm 39

Requests for additional funding: Administrative Supplement To meet increased costs within the original scope of the research Provide funds for unanticipated costs not included in competitive application Provide funds for special populations to enter or re-enter biomedical research Requires prior approval Limited $/requires exceptional justification

Administrative Supplement – New - Electronic Submission Administrative Supplements to Existing NIH Grants and Cooperative Agreements, PA-12-100 - February 8, 2012 http://grants.nih.gov/grants/guide/pa-files/PA-12-100.html For grants with activity codes that have transitioned to electronic submission using the SF424 (R&R) application forms, requests may be submitted electronically through grants.gov Other activity codes still use paper-based PHS398 application forms

Prior Approval Change in scope: Grantee makes initial determination of significance of a change, consulting the Grants Management Specialist as needed. The following items may indicate a change in scope: Change in aims Significant rebudgeting (deviation between categories of more than 25% of total awarded costs) Change in use of animals or humans Significant change in key personnel Shift in research emphasis Application of new technology Refer to NIH Grants Policy Statement for further information

Prior Approval Change in status, including absence, of PD/PI and other Senior/Key Personnel named in NoA: Grantee must notify NIH if individual will: Reduce his/her time by 25% or more of effort level approved at time of award Withdraw from the project Be absent for 3 or more months This is only for key personnel named in the NoA, NOT for key personnel designated in the application (our key not yours)

Prior Approval Change in status, including absence, of PD/PI and other Senior/Key Personnel named in NoA (continued): Prior approval must be from NIH for the replacement of the PI Request should include: Justification for the change Biographical sketch of the individual proposed Other sources of support Budget changes resulting from the change Human Subject Education Certification (if applicable)

Prior Approval Change of Grantee Institution (Transfer) Grants Policy Statement, 8.1.2.7 Change of Grantee Organization http://grants.nih.gov/grants/policy/nihgps_2012/nihgps_ch8.htm#_Toc271264936 Original grantee must complete: Relinquishing Statement Final Federal Financial Report and Final Invention Statement

Relinquishing Statement PHS 3734 An ESTIMATE of amount relinquished Do not include unobligated balance from prior years: it will transfer automatically

Prior Approval/Transfer Proposed new grantee must complete: Application w/ face page Budget (current and future years) based on Direct Costs committed/relinquished Updated biosketches for PD/PI and senior/key personnel (existing and proposed new) Updated resources statement Progress report (for transfer on anniversary date) Statement whether research plans/aims have changed from original submission New IRB/IACUCs List of equipment purchased with grant funds to transfer to new organization

Prior Approval /Transfer Trouble spots? The PI is moving… TOMORROW (or MOVED A MONTH AGO)!!! The PI is relocating to WHERE? Establishing consortium Relinquishing Statement delays Equipment Final Federal Financial Report from original grantee

Change of Institution– New - Electronic Submission Change of Grantee Organization, PA-12-270–August 24, 2012 http://grants.nih.gov/grants/guide/pa-files/PA-12-270.html Electronic submission not yet required, but highly recommended Unless instructed by awarding IC, budgets are limited to direct costs relinquished by the original institution, plus applicable F&A costs for the new institution

Closeout: Final Reports Final Progress Report Final Invention Statement Final Federal Financial Report (FFR) Failure to submit timely and accurate closeout reports may affect future funding! 90-day requirement is a term and condition of NIH grant awards

Select Resources at the NIH Grants Management Specialist on NGA - If unknown, contact Chief GMO of IC http://grants2.nih.gov/grants/stafflist_gmos.htm Program Official on NGA Division of Financial Advisory Services http://oamp.od.nih.gov/dfas/dfas.asp Office of Extramural Research http://grants.nih.gov/grants/oer.htm NIH Grants Policy Inbox (policy questions not specific to NGA) grantspolicy@mail.nih.gov NIH Helpdesk (technical questions) nihhelpdesk@mail.nih.gov or http://support.nih.gov/

More Resources at the NIH NIH Grants Compliance and Oversight – website has compendium of observations, and presentations http://grants1.nih.gov/grants/compliance/compliance.htm NIH Outreach Activities and Resources http://grants1.nih.gov/grants/outreach.htm NIH Grants Policy Statement (10/12): http://grants.nih.gov/grants/policy/nihgps_2012/index.htm PHS 398 Application (form pages are PDF-fillable): http://grants1.nih.gov/grants/funding/phs398/phs398.html PHS2590 Progress Report (form pages are PDF-fillable): http://grants.nih.gov/grants/funding/2590/2590.htm

Questions??