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 OCTOBER 14 18

the only NIH official authorized to obligate NIH to the expenditure of Federal funds CGMO GMO Chief Grants Management Officer The Grants Management Officer within an awarding agency who is the principal Grants Officer in the agency. The Chief Grants Management Officer provides leadership to an organizational component that is responsible for the business and fiscal management of an IC s grant portfolio. Generally, the CGMO will have the authority to appoint and exercise line authority over one or more GMOs. Grants Management Officer The GMO whose name appears in the Notice of Award is the NIH official responsible for the business management and other non-programmatic aspects of the award. These activities include, but are not limited to, evaluating grant applications for administrative content and compliance with statutes, regulations, and guidelines; negotiating grants; providing consultation and technical assistance to applicants and recipients, including interpretation of grants administration policies and provisions; and administering and closing out grants. The GMO works closely with his or her counterparts in other NIH ICs and with the designated PO. The GMO is the focal point for receiving and acting on requests for NIH prior approval or for changes in the terms and conditions of award, and is the only NIH official authorized to obligate NIH to the expenditure of Federal funds or to change the funding, duration, or other terms and conditions of award. GMS Grants Management Specialist Grants Management Specialist. The GMS whose name appears in the NoA is an agent of the GMO and is assigned responsibility for the day-to-day management of a portfolio of grants.

E-mail Requests must include: In the subject line: clearly identified as a prior approval request the complete grant number In the body: the name of the Recipient Organization Principal Investigator and Authorized Organization Representative o name o telephone number o fax number o email address

The Grants Management Specialist: Evaluates the request for: Administrative content and compliance reviews the active award terms of award Federal Financial Report (if applicable) prior year(s) post award actions Perform Analysis What is being requested Does it require prior approval What is the policy From a fiscal and administrative standpoint is it appropriate? Summarizes the request Send the request along with the GMS review/recommendation to the Program officer (PO) Program reviews the scientific progress and recommends (by providing a justification) supporting or deny the request.

Cast Study (Example) SO Email: I am writing to request your approval for a re-budget on R21AR000000. Please see attached justification from [PI]. Please let me know if additional information is needed. SO Grants and Contracts Administrator University Office of Research Services 100 Address Street 000-000-0000 (Fax) SO@university.edu Attached [PI] Justification: We would like to request approval for re-budgeting 5R21AR000000-02 to purchase a chemiluminescent imager as special purpose equipment. Estimated cost of the imager we are expecting to obtain is approximately $15,000. Western blotting detects protein expression quantitatively on membranes. This technique is essential to complete research project currently funded by R21AR000000, in which we will compare expression levels of various proteinases in inflamed joints from several different transgenic mouse lines. For precise quantitative detection, high resolution and sensitive imaging device specific for chemiluminescent detection is necessary. We do not have the equipment available to meet to current standard of sensitivity and this piece of equipment is essential to meeting the aims of the grant. I hope you kindly consider our current situation and allow us to purchase the imager after rebudgeting 5R21AR000000. Sincerely, [PI]

Case Study (Example) o What is being requested? Re budget approximately $15,000 to purchase equipment. o Does it require prior approval? No o What is the policy? 8.1.1.2 Cost Related Prior Approvals NIH prior approval is not required to rebudget funds for any direct cost item that the applicable cost principles identify as requiring the Federal awarding agency s prior approval, unless the incurrence of costs is associated with or is considered to be a change in scope. 6

A Case Study This is a 2 Year U34 Clinical Trial Planning Cooperative Agreement excluded from Carryover Authority and Streamlined Non Competing Award Process (SNAP). This is a Multi PI award, both investigator s approved effort at the time of the initial competing year award was 1.8 person months. The Budget/Project Period End Date is 03/31/2017 The unobligated balance reported on the 01 year Federal Financial Report (FFR) is $80,696.24 The following requested was received as an email attachment on March 20th with the subject No Cost Extension Request. Three days after receiving the request a Project Extension was completed by the Signing Official through the era Commons. The new project end date is: 09/30/2017.

A Case Study (continued) We are requesting a six month no cost extension for U34AR000000. During the no cost extension, we are requesting to use the year one remaining carry forward of $80,696.24 total cost as well as approximately $44,271 total cost that will remain at the end of year two. This funding totals $124,967.24 total cost. We apologize for the delay in requesting the year one carry forward for this project. We experienced a change in grants management staffing after filing the year one financial report and, unfortunately, the year one carry forward request was never formally submitted. During the no cost extension we will focus on six main activities: IRB Approval, Site Recruitment, Development of site Training Manual and Site Contracting Preparation, Imaging Core Training Preparation, and Imaging Work on Articular PET. To complete these activities, we (the two named PI s) would like to reduce our effort to five percent each during the no cost extension period. We will oversee all six activities and work to broaden the project s site recruitment. The no cost extension period will also support sixty percent of a project manager and fifteen percent of an administrative coordinator. The Project Manager and Administrative Coordinator will focus on preparing the necessary IRB protocols, developing the site annual and the site contract preparation

A Case Study What is being requested? Carryover and reduction of Multi-PI effort during the No-cost extension period. The no-cost extension was completed by the grantee through the era Commons. Does it require prior approval? Yes What is the policy? 8.1.1.1 Carryover of Unobligated Balances from One Budget Period to Any Subsequent Budget Period Automatic carryover of unobligated balances applies to all awards except centers(p50, P60, P30, other), cooperative agreements (U), Kirschstein-NRSA institutional research training grants (T), non-fast Track Phase I SBIR and STTR awards (R43 and R41), clinical trials (regardless of activity code), and awards to individuals. For these grants, carryover of unobligated balances requires NIH awarding IC prior approval unless otherwise noted in the NoA. Other awards may be excluded from this authority through a special term or condition in the NoA.

A Case Study (continued) What is the policy? (continued) 8.1.2.6 Change in status of the Program Director/Principal Investigator (PD/PI) or senior/key personnel named in the Notice of Award (NoA) Change in status is defined as withdrawal from the project, absence from the project for any continuous period of three months or more, or reduction of time devoted to the project by 25 percent or more from the level that was approved at the time of initial competing year award. For example, a proposed change from 2 calendar months effort to 1.5 calendar or fewer months effort would require prior approval. Prior approval is only required for a change in status for the PD/PI or other senior/key personnel specifically named in the NoA. 8.1.3 Requests for Prior Approval All requests for NIH awarding IC prior approval must be made in writing (including submission by e mail) to the GMO no later than 30 days before the proposed change, and signed by the AOR.

B Case Study We recently discussed with the Program Office our request to purchase a large passenger van with current project funds. The van is needed so that our Field Manager can modify the van for the creation of a mobile office. Getting subjects to show up for scheduled appointments has been a significant problem, despite a generous cash incentive. We believe that meeting subjects at a location that is convenient for them will make all the difference in enrolling subjects into the study and in accomplishing two study related follow up visits with each of 523 (goal) subjects. The cost to purchase the used van, along with some modifications and new tires is approximately $15,000. It will be used several times per week over the next 3 to 4 years. The cost of leasing a similar vehicle would cost as much as $1,500 per month. The van will be the Recipient Organizations property and all registration fees, insurance costs, maintenance and other related expenses will be charged to the project. The van will only be used for the benefit of the project (no personal use). Before the project ends, the van will be sold and the proceeds will be credited back to the grant. Thank you in advance for your assistance. We look forward to hearing from you soon. 11

B Case Study What is being requested? To purchase a large passenger van with current project funds. Does it require prior approval? No. Unless it represents a change in scope. What is the policy? Prior approval for the purchase of equipment is required if it will represent a change of scope for the project (see NIHGPS 8.1.2.5). Two potential change of scope indicators that apply are: 1) significant rebudgeting; and, 2) purchase of a unit of equipment exceeding $25,000. 12

C Case Study We wish to bring to your attention an overlap in funding between R01AR111111 (NIAMS) and P01AG222222 (NIA). Program project grant P01AG222222 was awarded in June therefore, associated costs for 25 of the women needed in aims 2 and 3 of R01AR111111 will be concurrently covered in project 1, aim 2 of the program project. Therefore, the requested associated costs related to 50% of the subjects for subject remuneration, subject screening, cell separation, RNA extraction, RNA Seq and bioinformatics are already provided for in that award and have been removed from the budget of R01AR111111. Due to removing the funds associated with this overlap, we are requesting prior approval to reduce the patient care dollars awarded in years 1 through 3, see breakdown below, and to re budget the difference into personnel. 13

C Case Study What is being requested? Rebudget patient care cost into personnel Does it require prior approval? Not Applicable. Budgetary overlap cannot be rebudgeted What is the policy? 2.5.1 Just in Time Procedures The requirement for applicants to verify the accuracy and validity of all administrative, fiscal, and programmatic information extends to information submitted through the Just in Time process. Applicants are responsible for promptly notifying NIH of any substantive changes to previously submitted Just in Time information up to the time of award.