Costing and Procurement Updates - National...
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Costing and Procurement Updates Sara Bible, Stanford University Jim Luther, Duke University Joe Gindhart, Washington University in St. Louis Nate Martinez-Wayman, Duke University September 7, 2017
Transcript of Costing and Procurement Updates - National...
Costing and Procurement Updates
Sara Bible, Stanford UniversityJim Luther, Duke University
Joe Gindhart, Washington University in St. LouisNate Martinez-Wayman, Duke University
September 7, 2017
Agenda
• Single IRB costing update• Costing for public data access
requirements • NIH Clinical trial definition• Procurement update• Uniform Guidance FAQs
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sIRB Implementation
• Extended to January 25, 2018• Effective for applications submitted
on or after this date• Institutions have an additional four
months… in addition to the previous four month extension
• Updated FAQs issued in June 2017• FAQ 6 changed; slight edits to other
FAQs; three new FAQs3
sIRB Costing FAQs Updated June 2017: FAQ 6
• May recipient institutions develop standard fees for single IRB review costs, and charge these fees to NIH awards as direct costs according to a set schedule (e.g., per site, per year, per event, etc.)?
• Recipient institutions have the flexibility to develop their own fee structures … including a service center, fixed fee, or other appropriate methods. NIH will not dictate how recipients implement these structures, except to apply cost principles and administrative requirements.
• Some fee structure arrangements may meet the criteria for a specialized service facility…found at 45 CFR 75.468.
• NIH encourages recipients to identify an appropriate fee structure that supports the recipient’s requirements and audit structure.
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New sIRB FAQs
13. Our next F&A proposal is not due for several years. May we alter our manner of charging IRB costs prior to renegotiating our F&A rate?The cost principles have always allowed for recipients to charge IRB costs as direct charges.Recipients must ensure that costs are not recovered as both direct and indirect costs. We encourage institutions that are considering changes to their cost allocations to consult with their cognizant Federal agency for indirect costs so that the potential impact on the institution’s indirect cost rates can be assessed. It is not necessary to wait until the next F&A rate negotiation to consult with your cognizant Federal agency. Recipients may determine if and when to approach their cognizant Federal agency for indirect costs. 5
New sIRB FAQs
14. If the proposed single IRB must be renegotiated at the time of award, will there be an opportunity to change the budget for single IRB costs at that time as well?As always, NIH IC staff will engage the applicant in pre-award evaluation and negotiation of the award to ensure that the budget is appropriate to the work proposed. If it is necessary to revise the budget based on the selection of the single IRB, revised budget information may be requested prior to award.15. May recipient institutions work with commercial IRBs or other organizations in order to identify pricing options for a single IRB?Yes. NIH encourages applicant and recipient institutions to consult any available resources as needed, including commercial IRBs, in order to obtain needed costing information. 6
• Reminder: May 2017 Meeting• NIH (Dina Paltoo)• University Perspective: Utah State and
Purdue• PAWG - Public Access Working Group
• Current Status and Related Issues
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Public Data Access Requirements
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Public Data Access Requirements
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Public Data Access Requirements
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Public Data Access Requirements
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Public Data Access Requirements
Public Data Access Requirements
• October One-day Workshop co-hosted by the NIH Office of Science Policy and the NSF Science of Science and Innovation Policy (SciSIP) program, focusing on The Value of Data Sharing
• Objective• Bring together NIH staff and external speakers with
expertise in data sharing, data management, …• Address the overarching question of how we
prospectively identify those data that would be valuable to share…
• Inform decisions and priorities regarding data management and sharing policies…
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NIH Clinical Trials Definition
• Issue: Recent interpretation by Brain/Neuro/Psych researchers have concerns that much of their “discovery-based” research will now be classified as a clinical trial
• Background• NOT-OD-15-015 - Notice of Revised NIH Definition of
“Clinical Trial” – Oct 2014• “Open Mike” Dialogue• August 11, 2017 Lauer Memo
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NIH Clinical Trials Definition
• Dr. Mike Lauer Communication• Email from Mike Lauer to Grantee Community
• From: NIH-Alert (NIH/OD) Sent: August 11, 2017Subject: Changing policies impact NIH-funded studies involving human subjects
• First, familiarize yourself with the new PHS Human Subject and Clinical Trial Information form.
• Second, take a moment to answer these four questions about your current or proposed research:
• Third, familiarize yourself with NIH policy changes related to enhancing stewardship of clinical trials.
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FOAs for clinical trial
applications & solicitations
for due dates on/after 1/25/18
NIH Clinical Trials Definition
• Case Studies: The simplified case studies illustrate the differences between clinical trials and clinical studies using the following four questions:
• Does the study involve human participants? • Are the participants prospectively assigned to an
intervention? • Is the study designed to evaluate the effect of the
intervention on the participants? • Is the effect being evaluated a health-related biomedical
or behavioral outcome? • The cases are grouped into studies involving
biomedical interventions and studies involving behavioral interventions.
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NIH Clinical Trials Definition
• Concerns• FABBS memo (http://fabbs.org/wp-content/uploads/2017/07/Letter-to-NIH-
Collins-Re-Clinical-Trials-FINAL.pdf)• Impact on basic research• Significant implications but not consulted• Public confusion about CT.Gov• NIH policy may decrease funding opportunities for basic scientists• Increases burden on investigators without a clear rationale• Penalties for noncompliance are significant• Mandatory training is focused on clinical trials, not the type of research
actually being funded and conducted.
• University• Grad Students: marginalized into “technician” role• Understanding Funding Opps and Panel Review Criteria• Burden: grant submission with new format, CT.Gov reporting, etc.
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NIH Clinical Trials Definition
• What’s Next• Reach out to you Brain/Neuro/Psych faculty
• Are they concerned? Ready for the transition?• Revised case studies on the way from NIH• 5th criteria?
• "Will the study affect the participant's treatment course?" • Advocacy underway (e.g. AAU, COGR)• Consider letter to NiH articulating concerns and impact
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Procurement: micro-purchase threshold
• An additional one year extension has been granted; for IHEs with a fiscal year end of June 30th implementation is required by July 1, 2018
• Micro-purchase threshold (MPT)• Originally set at $3,000, was revised to
$3,500 in 2015 (FAR update)
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National Defense Authorization Act
• NDAA 12/23/16• Raised MPT to $10,000 or higher – applies to
Grants, Cooperative Agreements and Contracts for all federal agencies
• Per the NDAA: $10,000 or higher threshold as determined by the head of the relevant executive agency and consistent with clean audit findings, institutional risk assessment, or State law.
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Procurement micro-purchase threshold: Case Study
• Data: • Number of transactions and dollar value:
• less than $3,500, ... $10,000, …. $25,000, …• Review and analyze the data• Where is the risk?
• High dollar value purchases• Clean audits/reviews
• A-133/Single Audits• ONR Contracting Purchasing System Reviews• Other?
• Justify the increase in the MPT20
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WashU Risk Analysis
Purchasing Services
Competitive Bid
Review & Approve
Functional expenses excluded (FDP):– Human Subject Payments – Travel – Outgoing Sub-Awards – Student Financial Aid – Employee Reimbursement
Preferred Supplier Program (PSP)
Contracts
Goal: Minimize Cost
– Purchase Orders (PO)– Check requests (CR)– Purchase Card (RP)
Utility and Construction services are excluded from Risk Analysis
Minority Business Enterprises (MBE)
Contracts
Under UG, the new threshold is $10K.Therefore, transactions between $10K and $25K are at risk.
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WashU – Procurement Data
FY17 $0-$10K $10K-$25K $25K and over Total (#)
Non-Preferred Preferred Non-
Preferred Preferred Non-Preferred Preferred
Total(#) 97,436 99,541 2,582 772 2,057 548 202,936
Fed (#) 30,047 37,064 402 133 396 81 68,123
FY17 $0-$10K $10K-$25K $25K and over Total ($)
Non-Preferred Preferred
Non-Preferred Preferred
Non-Preferred Preferred
Total ($) 79,168,444 47,115,078 40,090,470 11,985,693 232,922,960 243,367,239 654,649,883 Fed ($) 16,779,367 16,431,072 6,063,409 1,965,551 51,192,048 12,850,010 105,281,457
Risk Exposure = 6,063,409/105,281,457 =5.76%
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WashU – Procurement, cont.
FY17 $10K-$15K $15K-$20K $20K-$25K Total (#)
Non-Preferred Preferred
Non-Preferred Preferred
Non-Preferred Preferred
Total (#) 1,325 382 727 225 530 165 3,354
Fed (#) 228 79 107 35 67 19 535
FY17 $10K-$15K $15K-$20K $20K-$25K Total ($)
Non-Preferred Preferred
Non-Preferred Preferred
Non-Preferred Preferred
Total ($) 15,878,412 4,496,862 12,414,962 3,814,970 11,797,097 3,673,860 52,076,163
Fed ($) 2,733,045 934,073 1,856,924 606,029 1,473,441 425,448 8,028,960 Risk Exposure = 2.60% Risk Exposure = 1.76% Risk Exposure = 1.40% Total = 5.76%
UG Compliance Supplement
Reimbursement/Advance Payment Methodology• Some single audit firms applying a strict
interpretation of reimbursement requirements:• Grantees must verify payments have “cleared” (cash left
the bank account) prior to requesting reimbursement
• Standard practice often relies on the “posting” of the expense to an AP system
• Comments encouraged to OMB (Gil Tran) to clarify requirements around documenting expenses prior to reimbursement request
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200.305-2 Advance or Reimbursement?• Advance payment is default method• UG states:
• When entities are funded on a reimbursement basis, program costs must be paid for by entity funds before reimbursement is requested.
• But also:• Payment methods must minimize the time elapsing
between the transfer of funds from the Treasury… and the disbursement by the non-Federal entity…by issuance…of checks.
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OMB Uniform Guidance FAQs
OMB Uniform Guidance FAQs
200.56-1 Indirect v. Administrative Costs• The 26% “A” cap in F&A is regulatory, not statutory;
should not apply to F&A rate assessment• But…if statutes authorizing the program restrict
administrative costs…there could be operational complexities
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OMB Uniform Guidance FAQs
200.56-2 Facilities Costs & Administrative Cap• OMB expects a review of “authorizing program
statute” for definition of admin costs• Reference to “not including direct admin costs”
suggests an admin cap applies to the total of direct admin and the A of F&A
• Not common with research programs• How to operationalize – no direct admin costs?
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OMB Uniform Guidance FAQs
200.33-1 Capitalization Level for Software• Software bundled in with equipment items is part of
capitalized cost.
• A $40k software acquisition purchased on federal funds that is necessary to do research is not a capitalizable item
• “Internally developed software projects which are to capitalized in accordance with GAAP for financial statement purposes.”
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OMB Uniform Guidance FAQs
200.331-9 Negotiating F&A with State Agencies• Requires public universities to know if a subrecipient
has ever received a subaward from any other state agency
• Accept negotiated rate from other state agency OR negotiate its own rate
• Sub cannot have a negotiated rate with one State agency and 10% de minimis rate with another State agency
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OMB Uniform Guidance FAQs
200.414-12 & 13 De Minimis Rates• Pass-through entity should continue to negotiate F&A
rate in accordance with their prior practice (.331-18)
• Non-fed that accepts 10% rate does not need to provide proof of its indirect costs. (.414-12)
• 10% de minimis rate is not de facto rate (.414-13)
• If no rate exists, negotiate a rate between pass-through entity and subrecipient, or utilize the 10% de minimisrate (.414-13)
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200.430-3 Documenting Personnel Costs• Changing method of documenting personnel costs
does not require Federal cognizant approval• Grantees may adopt the payroll certification model
from the FDP pilot without modifying their DS-2
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OMB Uniform Guidance FAQs
OMB Uniform Guidance FAQs
200.331-10 & 11 Requirements for PTEs• Subrecipient risk assessments are not required
before issuing a subaward• Procedures should be documented; monitoring plans
should be based on risk assessment
• PTEs can rely on written confirmation from subrecipient of whether single audit was performed and included any findings
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Discussion and Questions
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