1. COBRE Post Award Management Christy Leake Grants Administration Branch National Institute of General Medical Sciences, NIH

2. Post Award Management Non-Competing Continuation Progress Reports Prior Approval Actions Questionable Costs

3. Non-Competing Continuation Progress Reports Failure to submit complete and timely progress reports may affect future funding to the organization; Non-SNAP annual progress reports are due two months prior to the anniversary date (paper submission); All grantees have access to a searchable list to determine which progress reports are due at: http://era.nih.gov/userreports/pr_due.cfm http://era.nih.gov/userreports/pr_due.cfm

4. Prior Approvals Prior Approval Requests must be submitted by an Authorized Institutional Signing Official to the NIGMS Grants Management Specialist and Program Officer. The following are some issues that require Prior Approval: Carryover of Unobligated Balances Change of Scope Change of Key Personnel Addition of new research projects NIGMS tries to respond to all prior approval requests within 30 days of receiving all necessary information from the grantee.

5. Carryover Requests A carryover request should include the following : Grant number. Authorized signing official’s name, title, telephone number and e-mail address. PI’s name, title, telephone number and e-mail address. The reason that the funds requested for carryover were not expended in the year they were awarded. An overall plan for the use of the carryover funds, including a description of activities and materials to be supported. Budget and justification pages in a format such as that found in the PHS398 or SF424. A calculation of F&A costs in a format such as the checklist page found in the PHS398 or SF424. Appropriate Just In Time (JIT) documents (e.g., biosketches for new key personnel, human subjects education documentation). Budget and justification information should be provided for subcontract site(s) if funds are to be spent at site(s). An explanation of how any request that will generate recurring costs in future years will be supported without future use of unobligated balances or new supplemental funding. Document that the request: ▫is reasonable, allowable, and necessary; ▫does not duplicate activities and costs included in the current year’s support; ▫is within the scope of the current grant.

6. Reasons why Carryover Requests are Rejected: The prior year Federal Financial Report (FFR) must be received and approved by NIH first. The request was not signed by an authorized institutional signing official. Requested costs appear to duplicate costs in the current year’s award (e.g. extra salary for someone already at 12 months of effort). All carryover funds must be spent in the budget period they are requested (so get your requests in early!) Carryover funds must be within the currently approved scope of the grant. Carryover requests should only reflect immediate needs (therefore, try to avoid salary for “TBN” positions).

7. Change of Scope Actions likely to be considered a change in scope: Change in the specific aims approved at the time of award Substitution of one animal model for another Any change from the approved use of animals or human subjects Shifting research emphasis from one disease area to another Applying a new technology; i.e., changing assays from those approved to a different type of assay Change in key personnel Significant rebudgeting resulting from a change in scope Purchase of a unit of equipment exceeding $25,000 due to a change in scope

8. Addition of Human Subjects If a grant is awarded with no human subjects, an addition of human subjects in the project period will need prior approval from NIGMS. As soon as it becomes apparent that a change will occur, notify your PO and GMS so they can provide guidance. To add human subjects, the following information should be submitted: ▫IRB approval of project involving human subjects ▫Human subjects education for anyone involved in the design or conduct of the human subjects work ▫Scientific justification regarding the proposed change in scope ▫Risk to the subjects in the study ▫Adequacy of protections against risks to the subjects ▫Potential benefits of the research to subjects and others ▫Importance of the knowledge gained from study

9. Addition of Vertebrate Animals If a grant is awarded with no human subjects, an addition of human subjects in the project period will need prior approval from NIGMS. As soon as it becomes apparent that a change will occur, notify your PO and GMS so they can provide guidance. To add human subjects, the following information should be submitted: ▫IACUC approval for project involving vertebrate animals ▫Scientific justification regarding the proposed change in scope ▫Vertebrate animal five points  http://grants.nih.gov/grants/funding/phs398/phs398.p df http://grants.nih.gov/grants/funding/phs398/phs398.p df

10. Key Personnel Named on the Notice of Award Prior approval is required for the following changes regarding key personnel named on the Notice of Award: ▫Reduction in effort of 25% or more of the originally approved effort level ▫Removal from grant ▫Addition of new key personnel

11. Key Personnel Named on the Notice of Award To add a new person to the award who may be considered key personnel, submit a request with the following information: ▫Why the person is necessary to the award ▫Biographical sketch for new person ▫Updated other support for new person ▫Human subjects education if person is involved in the design and conduct of human subjects work

12. Addition of Research Project Approval of new project and project PI from EAC Biographical Sketch of new PI Updated other support for new PI Detailed budget and budget justifications for project Specific aims of project IRB approval, human subjects education and Targeted/Planned Enrollment Tables if project involves human subjects IACUC approval if project involves vertebrate animals

13. Questionable Costs Honorarium – not allowable when it is used to confer distinction on a speaker General Supplies – only costs directly related to the grant and/or project are allowable as direct costs Computers/laptops – are only allowable if they are used solely for the grant/project for which they are being requested Meals/Food – only allowable as part of meeting necessary for disseminating information Retreat – Break out the costs associated with the retreat Stipends – only allowable on training grants

14. Lessons Learned Start working on the Non-competing Progress Report early to avoid delays in submission Be aware of specific terms and conditions on the NoA (such as named key personnel and information regarding pilot projects and carryover) in order to assure compliance When a questions arises, contact your Office of Sponsored Programs and your Grants Management Specialist and Program Officer if necessary. Always provide as much detail as possible when communicating with NIGMS Program Officers and Grants Management Specialists

15. Questions? Please feel free to contact me directly with any additional questions: Christy Leake cleake@mail.nih.gov