What Require Prior Approval. Debbie Pettitt 2018 SRA Western/Northeast Section Meeting March 2018

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1 What Require Prior Approval Debbie Pettitt 2018 SRA Western/Northeast Section Meeting March

2 Discussion Topics Definitions to know NIH Standard Terms of Award Expanded Authorities Prior Approval Requirements o Things to Remember o What Constitutes a Change in Scope o Carryover Requirements o Change in PI Resources 2

3 DEFINITIONS NIH STANDARD TERMS OF AWARD EXPANDED AUTHORITY NIH waives the need for prior approval, providing recipient with operating authority for specified issues. PRIOR APPROVAL Specified post award changes that require a written approval from the designated Grants Management Office (GMO) CARRYOVER Reallocate unspent funds from one budget period to the next CHANGE IN SCOPE A change in the methodology, approach or other aspects of the project objectives constitutes a change in scope. ALL changes in scope require prior approval 3

4 NIH Standard Terms of Award Expanded Authorities Expanded Authority provides recipients the flexibility to make some changes in their approved project or budget without prior approval Foreign Grants ARE included under Expanded Authorities unless specifically excluded on the Notice of Award (NoA) NIH Standard Terms of Award 5/section_8/8.1_changes_in_project_and_budg et.htm#nih 4

5 NIH Standard Terms of Award Expanded Authorities Some Award-Expanded Authorities Include: Extend the final budget period of a project for up to 12 months beyond the original expiration date, if: Additional funds are not required Original approved scope will not change Transfer work to a third party through consortium agreement, if: It does not constitute a change in scope Not a foreign subcontract 5

NIH Standard Terms of Award Expanded Authorities Make cost-related changes, including significant rebudgeting of funds UNLESS these changes constitute a change in scope An unobligated balance may be

6 NIH Standard Terms of Award Expanded Authorities Make cost-related changes, including significant rebudgeting of funds UNLESS these changes constitute a change in scope An unobligated balance may be carried over into the next budget period without Grants Management Officer approval if the award has automatic carryover authority. Exceptions: Centers (P50, P60, P30 and others), cooperative agreements (U), Kirschsteing-NRSA institutional research training grants (T), non-fast Track Phase I SBIR and STTR awards (R43), clinical trials and awards to individuals, or if the NoA indicates otherwise 6

7 Prior Approval: Things to Remember ALL requests for Prior Approval must be: Submitted in writing via letter or Signed or sent by the Authorizing Official Submitted no later than 30 days before the proposed change 7

8 Prior Approval: Things to Remember Official approval/disapproval of a prior approval request can only be given by the Grants Management Officer Notification of Prior Approval will be issued either by a: Revised NoA noted in the terms and conditions of award Written/ approval or disapproval 8

9 Prior Approval Items Grantees are required to request prior approval for: 2 nd no-cost extension or late notification of initial no-cost extension Change of Grantee Institution (transfer of award) Change of Grantee Organizational Status Change of PI Change from single PI to multi-pi and multi-pi to single PI Reduction of PI effort by 25% or more 9

10 Prior Approval Items Recipients are required to request prior approval for: Deviations from the terms and conditions or restrictions of the Notice of Award (NoA) Actions needing additional NIH funds Addition of a foreign component Alterations & Renovations only minor A&R <$500,000 allowable costs Pre-Award costs more than 90 days (competing award) 10

11 Change in Scope What Constitutes a Change in Scope Change in specific aims Shifting the research emphasis from one disease to another Changing any aspect of research involving animals or human subjects Changing the principal investigator or other key personnel PI on leave for more than 90 days 11

12 Change in Scope What Constitutes a Change in Scope Using new technology Purchasing equipment for $25,000 or more Rebudgeting funds in or out of a budget category by more than 25% of the total costs of the award Rebudgeting funds so that an alterations and renovations project exceeds $500,000 Not sure? Contact your Grants Management Specialist 12

13 Prior Approval Requirements for. Carryover request - If the recipient does not have automatic carryover authority Submit Final FFR Sign and submit carryover request with: Grant number and PI name Reason for unobligated balance Amounts being carried over (DC, F&A and TC) F&A costs using the rate for the year in which the funds are being carried over Budgetary/Scientific justifications Contact information for PI and BO IF new personnel added, appropriate information, HS education certificate, bio sketch and other support Reasons why work cannot be accomplished through rebudgeting from current period funds Must be signed or submitted by Authorizing Official 13

14 Change of PI Institutional Training Grants 2010 Request a change of PI by sending a letter or to the Grants Management Specialist through the Authorizing Official and include: Reasons for change Date original PI will return (if applicable) Bio Sketch Certificate of HS education (if applicable) The request should be signed by the current PI, proposed replacement PI and authorized organizational official 14

15 Overall Prior Approval Requirements Submit the prior approval request in writing by the authorized business official 30 days before the proposed change All request should include: The number in the subject line Your name, title, organization, telephone number and address Justification for the proposed change The Grants Management Officer will work with the Program Official to review the request and required documentation 15

16 Prior Approval Required???? In the competing application the PI s level of effort was listed as 3.6 calendar months per year. In year 2 of the award the PI reduced his level of effort to 3.0 calendar months. In year 3 of the award the PI reduced his level to 2.4 calendar months. Does the recipient need to request NIH prior approval for the reduction in level of effort to 2.4 calendar months? 16

Answer Yes, per the Grants Policy Statement, Section 8.1.2.6 Change in Status, Including Absence of PD/PI and Other Senior/Key Personnel Named in the NoA, reductions are cumulative, i.e., the 25% threshold may be reached by two or more successive reductions that total 25% or more.

17 Answer Yes, per the Grants Policy Statement, Section Change in Status, Including Absence of PD/PI and Other Senior/Key Personnel Named in the NoA, reductions are cumulative, i.e., the 25% threshold may be reached by two or more successive reductions that total 25% or more. Once agency approval has been given for a significant change in the level of effort, then all subsequent reductions are measured against the approved adjusted level. 17

18 What If The PI comes to you and wants to request a first no cost extension but the project period end date has already passed. Since this is his first no cost extension, is prior approval required. 18

19 Yes, even though this is a first no cost extension, the project period has ended and a formal request must be made to NIH. The request will need to include a justification as to why the extension was not requested through era Commons under expanded authorities. 19

20 The PI wants to use funds from a previous grant year to purchase a piece of equipment costing $38,000. Does this require NIH prior approval since the grant has automatic carryover? 20

21 Yes, NIH prior approval is required since the piece of equipment is over $25,000. A formal request will need to be submitted and must include 3 estimates for the equipment. 21

22 The PI comes to you and wants to take a sabbatical for 6 months. They plan to continue working on the grant and do not plan to list an interim PI. Does the PI need NIH prior approval for the sabbatical even though they are planning to continue their level of effort on the award? Do they have to list an interim PI? 22

23 Yes, once the PI has approval from the institution to take the sabbatical, the institution must submit a request to NIH outlining how the aims of the grant will be carried out during the PIs absence. NIH will not approve a sabbatical.they will approve the plan the institution has in place for the work to be completed during the PIs absence. With a sabbatical of 6 months, NIH most likely will require an interim PI be named for the duration of the sabbatical. 23

24 Resources NIH Grants Policy Statement: TML5/introduction.htm 24

Prior Approval Request What is taking so long?

Prior Approval Request What is taking so long? Mark Langer National Institute of Arthritis Musculoskeletal and Skin Diseases SOCIETY OF RESEARCH ADMINISTRATORS INTERNATIONAL ANNUAL MEETING VANCOUVER, CANADA