1 NIH Office of Policy for Extramural - PowerPoint Presentation

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NIH Office of Policy for Extramural Research Administration:Tony Corio, Assistant Grants Policy OfficerLauren Ruane, Assistant Grants Policy OfficerNIH electronic Research Administration (eRA):Scarlett Gibb, Customer Relationship ManagerNIH Office of Extramural Research (OER)WebinarAugust 30, 2017

Interim and Final Research Performance Progress Report Slide2

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Background on the Federal-wide RPPRInitial ImplementationPolicy ChangesImpact on Recipient CommunityAccessing and Submitting the Interim and Final RPPRUpcoming eRA Changes OutlineSlide3

Background on the Federal-wide RPPR

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RPPR BackgroundNational Science and Technology Council (NSTC) – Committee on Science (CoS) Research Business Models (RBM) Subcommittee initiative to:

Create greater administrative consistency across federal agenciesProvide a consistent reporting format for interim progress reportsDecrease burden on recipients by standardizing reporting elements across federal agenciesMake it easier to compare the outputs, outcomes of research programs across the government4Slide5

Initial Implementation

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Initial NIH Implementation

NIH introduced the RPPR in October 2012, based on a policy memorandum from OMB and NSTC.RPPR replaced previous interim performance reporting formats used by NIH and other agenciesUsed for annual progress reportingUse of RPPR became mandatory for all type 5 progress reports on October 17, 2014 6Slide7

Recent Fed-wide Developments

In order to keep its promise, the RBM expanded the original charge and asked NSF and NIH to continue to serve as co-chairs of a workgroup tasked with incorporating lessons learned by agencies during the initial implementation to develop a standard format for use in reporting final progress.Participating agencies included:7NIH (co-Chair)NSF (co-chair)Department of Agriculture: NIFA Department of Commerce: NIST/NOAADepartment of Defense Department of EducationDepartment of EnergyDepartment of Homeland SecurityDepartment of JusticeEnvironmental Protection Agency (EPA)NASANational Endowment of the HumanitiesSlide8

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This interagency workgroup completed its task and on November 16, 2016, published a Federal Register notice announcing the updated standardized RPPR to be used for final performance progress reporting.Recent Fed-wide Developments (Cont’d.)Slide9

NIH Closeout Requirements

NIH Recipients Must Submit 3 Final Reports within 120 days of the project period end date:Final RPPRFinal Federal Financial ReportFinal Invention StatementAs of January 2017, NIH replaced the Final Progress Report (FPR) with the Final RPPR to satisfy grant closeout requirements.9Slide10

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Cover PageAccomplishmentsProductsParticipants and Other CollaboratorsImpact – SBIR/STTR onlyChangesSpecial Reporting RequirementsBudgetProject OutcomesNIH Final RPPR Cover PageAccomplishmentsProductsParticipantsImpactChangesSpecial Reporting RequirementsBudgetNIH Annual RPPRDifferences Between the Annual RPPR vs. Final RPPRSlide11

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A new section of the RPPR specifically designed to be made publicly available by the agency (analogous to the abstract in the competing application)Reporting in the Outcomes section is limited (by the federal-wide RPPR format) to 8,000 charactersThe Outcomes should provide a concise summary of the findings of the award written in lay language for the general publicIn an effort to increase transparency NIH will make the Outcomes data available in RePORTERProject Outcomes RequirementsSlide12

Policy Changes

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What’s Going Away and Why?

Previous NIH Policy:NIH Grants Policy Statement Section 8.6.2 Final Progress Report:If a competitive renewal (Type 2) application has been submitted, whether funded or not, the progress report contained in that application may serve in lieu of a separate final progress report.Limitations and Challenges:Must use RPPR format for all performance reporting based on NSTC/CoS/RBM Federalwide policy otherwise NIH’s final performance reporting requirement is misaligned with the requirements of other Federal research awarding agencies.Missed opportunity for structured data collection on last year of competitive segment without a change.13Slide14

What’s New for Type 2s: The Interim Research Performance Progress Reports (I-RPPR)

Effective February 9, 2017, NIH requires that organizations submit an “Interim-RPPR” while their renewal application (Type 2) is under considerationIn the event that the Type 2 is funded, NIH will treat the Interim-RPPR as the annual performance report for the final year of the previous competitive segmentIf the Type 2 is not funded, NIH will treat the Interim-RPPR as the institution’s Final-RPPRLike the Final-RPPR, recipients are required to report on Project outcomes in the Interim-RPPR.To reduce burden NIH will not require recipients to submit an additional Final-RPPR if the renewal application is not funded See NOT-OD-17-037 for additional information. 14Slide15

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NIH requires recipients to report on Project Outcomes in Section I of the Interim and Final-RPPR. Therefore, in each scenario listed above, Project Outcomes must be provided by the recipient in order for the recipient to submit their final report in eRA Commons. Otherwise, eRA Commons will not allow recipients to submit the required report and recipients will be considered non-compliant.If a recipient fails to comply with this reporting requirement, NIH may take one or more enforcement actions, such as a decision to withhold a non-competing continuation award, consistent with NIHGPS Chapter 8.5.2.Workflow ProcessSlide16

NIH Implementation of the F-RPPR for Small Business and Innovation R

esearch (SBIR) and Small Business Technology Transfer (STTR) Grants and Cooperative AgreementsEffective June 30, 2017, all SBIR/STTR Phase II final reports must be submitted using the F-RPPR. The renewal policy has also been discontinued for SBIR/STTRsFor Phase I or Phase II SBIR/STTR grants and cooperative agreements, this means that an I-RPPR is required if an application for a Phase II or Phase IIB has been submittedIn the event that the Type 2/Phase II/IIB application is funded, NIH will treat the Interim-RPPR as the annual performance report for the final year of the previous competitive segment. If the Type 2 is not funded, the Interim-RPPR will be treated by NIH staff as the institution's Final-RPPR. See NOT-OD-17-085 for additional information. 16Slide17

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NIH requires recipients to report on Project Outcomes in Section I of the Interim and Final-RPPR. Therefore, in each scenario listed above, Project Outcomes must be provided by the recipient in order for the recipient to submit their final report in eRA Commons. Otherwise, eRA Commons will not allow recipients to submit the required report and recipients will be considered non-compliant.If a recipient fails to comply with this reporting requirement, NIH may take one or more enforcement actions, such as a decision to withhold a non-competing continuation award, consistent with NIHGPS Chapter 8.5.2.ScenarioStatus of Phase II/IIB Application following Phase I/II AwardWorkflow Process1Not submitted Submit a Final-RPPR no later than 120 calendar days from the Phase I/II period of performance end date.2Submitted

Submit an Interim-RPPR no later than 120 calendar days from the period of performance end date. If the Phase II/IIB is funded, NIH will treat the Interim-RPPR as the annual performance report for the final year of the previous competitive segment.

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Submitted but not funded

Submit an Interim-RPPR no later than 120 calendar days from the period of performance end date. If the Phase II/IIB is not funded, NIH will treat the Interim-RPPR as the institution's Final-RPPR. To reduce burden NIH will not require recipients to submit an additional Final-RPPR if the renewal application is not funded.

Workflow

Process

SBIR/STTRSlide18

SBIR/STTR only

Added Section E.3.a - Describe Sales Revenue Added Section E.3.b – Describe the Regulator Approval StatusAdded Section G.4.d - Status of Clinical Trials for Your ProductAdded Section G.13.a - Describe Company OutcomesAdded Section G.13.b - Reimbursement Approval Status18Slide19

NIH Implementation - RPPRs

19As of February 9th, 2017, there are three types of RPPRs, each one is outlined in the NIH RPPR Instruction Guide. Annual RPPR – Use to describe a grant’s scientific progress, identify significant changes, report on personnel, and describe plans for the subsequent budget period or year. Interim RPPR – Use when submitting a renewal

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2) application. If the Type 2 is not funded, the Interim RPPR will serve as the Final RPPR for the project. If the Type 2 is funded, the Interim RPPR will serve as the annual RPPR for the final year of the previous competitive segment. The data elements collected on the Interim RPPR are the same as for the Final RPPR, including project outcomes.

Final RPPR

– Use as part of the grant closeout process to submit project outcomes in addition to the information submitted on the annual RPPR, except budget and plans for the upcoming year. Slide20

Impact on the Recipient Community

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How Do These

Changes Impact the Recipient Community?Reporting on project outcomes is a new requirementFailure to report on project outcomes may result in remedies for non-compliance, which may result in enforcement actions by the ICRecipient’s should ensure that project outcomes are written in concise lay language, which can be understandable to the general public.Once submitted for review to the NIH, the accuracy and completeness of all elements (including project outcomes) of the I-RPPR and F-RPPR is the responsibility of the assigned POAdditional materials and/or clarifying information will be requested and submitted using the Final Report Additional Materials (FRAM)21Slide22

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FRAM ModuleSlide23

RPPR FAQs

FAQs: https://grants.nih.gov/grants/rppr/faqs.htmSection D.1 Individuals who worked on the project: Should this section report on individuals/staff from the past year of the project or the whole project? This section should report on the individuals/staff that worked on the project during the last budget period minus any approved no-cost extensions. Where can recipients find instructions on how to submit the Final or Interim-RPPR?Information on submitting a Final or Interim-RPPR can be found in the RPPR Instruction Guide or on the eRA Online Help website.23Slide24

RPPR FAQs (cont.)

FAQs: https://grants.nih.gov/grants/rppr/faqs.htmWill the information reported under Project Outcomes be made public? Yes. The information submitted in this section will be accessible to the general public via NIH's Research Portfolio On-line Reporting Tools (RePORT). Thus, PD/PI's are encouraged to ensure the narrative is understandable to a lay person audience. The report form itself includes the following instruction:Provide a concise summary (for NIH grants not to exceed half a page) that:is written for the general public in in clear, concise, and comprehensible language;is suitable for dissemination to the general public, as the information may be available electronically;does not include proprietary, confidential information or trade secretsAre there any differences in the format of the Final RPPR? The format of the Final RPPR is very similar to that of the annual RPPR. The notable differences being the Final RPPR does not have sections F (Changes), and H (Budget). Likewise, the following items do not require responses: B.1.a, B.6, D.2, G.10, G.11, and G.12.The Final RPPR does have a new section: Section 1 (Outcomes) 24Slide25

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RPPR FAQs (cont.)Slide26

Accessing and Submitting the Interim and final RPPR

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Accessing and Submitting your Interim or Final RPPR

For Interim RPPR’s the link will be displayed from the Status search resultsFor Final RPPRs the link will be displayed in the Closeout Status screen27Slide28

Who Can Submit the Interim and Final RPPR?

Currently the Interim and Final RPPR can be submitted by the Principal Investigator (PI) and the Signing Official (SO)Delegating authority to other users is under consideration.e.g., applying same institutional delegations in Commons used for Annual RPPRs28Slide29

Upcoming eRA Changes

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eRA System Implementation: PO Approval of Interim RPPRs

The implementation of PO approval will be conducted in three phases and will be implemented the following way:Phase I (mid-July)-ImplementedProgram has the ability to approve an interim RPPR in the Program Management Module (PMM)Requests for clarifying information or additional materials will temporarily need to be requested and submitted by email30Slide31

eRA System Implementation: PO Approval of Interim RPPRs (cont.)

Phase 2 (mid-August) - ImplementedNIH approval status will be maintained when an I-RPPR goes into closeout and is converted into a F-RPPR and the status may be seen in the Grants Closeout Tab31Slide32

eRA System Implementation: Request for Additional Materials

Phase 3 (mid-September)Request for Additional Material functionality for the I-RPPR will be automated32Slide33

Requesting/ Receiving Revised Project Outcomes

Requests for revised project outcomes for F-RPPR and I-RPPR will be made by the PO and submitted by the recipient using the applicable additional material functionality (i.e. for F-RPPR use FRAM)Note: The full automation for the Additional Material functionality for the I-RPPR is planned for mid-SeptemberBoth modules will be enhanced in order to capture revised project outcomes in a format that could be reported out to the public33Slide34

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FRAM Module Enhanced to Capture Revised Project OutcomesSlide35

Test your knowledge

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Resources

RPPR Instruction GuideeRA Online HelpRPPR FAQs36Slide37

Questions?

GrantsPolicy@OD.NIH.goveRA Service Desk: https://grants.nih.gov/support/index.html 1-866-504-9552 37