The Department of Health and Services (HHS) published Interim Final Regulation 45 CFR Part 75 on December 19, 2014, in conformance with the Office of Management and Budget’s (OMB) Uniform Guidance for federal grants. The HHS Interim Final Regulation implemented OMB’s Uniform Guidance for HHS grants and went into effect on December 26, 2014; however, it allowed for a 60 day public comment period.
NIH’s “Interim General Grant Conditions” document is intended to highlight Uniform Guidance Grants-related changes to previous NIH grant policies that went into effect December 26, 2014. It also summarizes selected policies that remain in effect to provide the reader with further context. However, it is not a full delineation of the comprehensive terms contained in the annual NIH Grants Policy Statement.
Yes, NIH will release a revised version of the NIH GPS. However, this will occur after the comment period on Interim Final Regulation 45 CFR Part 75 has ended and HHS has made revisions, if any, to the final regulation.
Yes, NIH is a Federal participating research agency and will adopt the Federal-wide Research Terms and Conditions Overlay to the Uniform Guidance. The overlay document will incorporate the entire Uniform Guidance by reference. However, it will provide additional clarity for select provisions where appropriate and consistent with government-wide research policy. Once completed, the overlay document will be published on the National Science Foundation’s (NSF) website.
Since the revision did not include additional funds, the pre-Uniform Guidance regulations would apply. That is, 45 CFR Part 74 or 45 CFR Part 92—as applicable.
Since a new increment of funds was received, the new regulations at 45 CFR Part 75, would apply along with the NIH Interim General Grant Terms. The new regulations and NIH Interim General Grants Terms will also apply to any previous fiscal year funds that are uncommitted or unobligated (carryover) as of the Federal award date.
The NoA will basically look the same. However, NIH has added several data fields to the NoA based on 45 CFR Part 75.210. Therefore, NoAs issued on or after December 26, 2014, include the following new, revised, or renamed data labels:
Federal award date
Federal award identification number (FAIN)
Approved period of performance start and end dates
Budget approved by the NIH awarding IC
Total amount of Federal funds obligated (Federal share)
Total approved cost sharing or matching, where applicable (Non-Federal share)
Total amount of the Federal award
Federal award project description (Project title)
CFDA Name and Program Name
Indirect cost rate for the Federal award (including if the de minimis rate is charged per 45 CFR 75.414)
Federal award performance goals (as required by the periodic report in the RPPR or in the final progress report when applicable)
Reference: 45 CFR 75.210 /NIH Grants Policy Statement (Chapter 5 - The Notice of Award)
The HHS regulations at 45 CFR Part 74 or 45 CFR Part 92 would apply as applicable.
However, once a new increment of funds (supplement) is received, the new HHS regulations at 45 CFR Part 75 will apply to any previous fiscal year funds that are uncommitted or unobligated (carryover) as of the Federal award date.
Yes, the NoA will indicate that all awards issued by the National Institutes of Health (NIH) meet the definition of “Research and Development” at 45 CFR 75.2. As such, auditees should identify NIH awards as part of the R&D cluster on the Schedule of Expenditures of Federal Awards (SEFA).
Reference: 45 CFR 75.210 /NIH Grants Policy Statement (Chapter 5 - The Notice of Award)
Yes, the provisions that apply to awards to commercial organizations are located in 45 CFR 75.215. Commercial organizations are also subject to the provisions that are located in Grants to For-profit organizations in IIB in the most recent edition of the NIH Grants Policy Statement.
No, NIH will not penalize recipients for making entity-wide system changes in order to comply with the new regulations.
The NIH Interim General Grant Terms apply retroactively as of the effective date of December 26, 2014. As a result, the provisions within the Interim General Grant Terms will be the standard to which NIH will hold grantees accountable.
Yes, NIH has waived the prior approval needed in order to direct charge the salaries of administrative and clerical staff. As a result, NIH prior approval is not required to rebudget funds for this direct costs item. The only time a prior approval request would need to be submitted is when additional funds are requested for such a position or the incurrence of such costs constitutes a change of scope.
Although there is no prior approval requirement, 45 CFR 75.413(c)(3) requires that costs for salaries of administrative and clerical staff must be explicitly included in the budget. Therefore, for modular grants these costs must be included in the Personnel Justification.
Reference: 45 CFR 75.413(c) /NIH Grants Policy Statement (Chapter 8.1.1 - NIH Standard Terms of Award)
Yes, a grantee may, at its own risk and without NIH prior approval, incur obligations and expenditures to cover cost 90 days before the beginning date of the initial budget period of a new or renewal.
However, NIH prior approval is required for any costs to be incurred more than 90 days before the beginning date of the initial budget period of a new or competing continuation award.
Prior approval is not required every time the exchange rate changes and a Federal award is charged. Prior approval of exchange rate fluctuations is required only when the charge results in the need for additional Federal funding, or the increased costs result in the need to significantly reduce the scope of the project.
Subsequent adjustments for currency increases may be allowable only when the non-Federal entity provides the awarding IC with adequate source documentation from a commonly used source in effect at the time the expense was made, and to the extent that sufficient Federal funds are available.
Yes, as a NIH Standard Term of Award grantees still have the authority to initiate a one-time extension of the final end date of the period of performance of up to 12 months unless one or more of the following conditions applies:
(i) The terms and conditions of the Federal award prohibit the extension.
(ii) The extension requires additional Federal funds.
(iii) The extension involves any change in the approved objectives or scope of the project.
Please note that the one-time no-cost extension justification is required but is not an additional prior approval.
Reference: 45 CFR 75.308(d)(2) /NIH Grants Policy Statement (Chapter 8.1.1.3 - Extension of Final Budget Period of a Previously Approved Project Period without Additional NIH Funds)
No, NIH policy regarding the disposition of unobligated balances has not changed. Therefore, NIH will continue to include a term and condition in the NoA to indicate the disposition of unobligated balances. The term and condition will state whether the recipient has automatic carryover authority, or if prior approval is required by the NIH awarding IC.
Reference: 45 CFR 75.308(d)(3) /NIH Grants Policy Statement (Chapter 8.1.1.1 - Carryover of Unobligated Balances from One Budget Period to Any Subsequent Budget Period)
Yes, administrative and clerical staff can be charged as a direct cost only if all of the following conditions are met:
(1) Administrative or clerical services are integral to a project or activity;
(2) Individuals involved can be specifically identified with the project or activity;
(3) Such costs are explicitly included in the budget or have the prior written approval of the Federal awarding agency; and
(4) The costs are not also recovered as indirect costs.
Please note that NIH has waived the prior approval requirement contained within 45 CFR 75.413(c)(3). Therefore, NIH prior approval is not required to rebudget funds for this direct cost item, the only time a prior approval request would need to be submitted is when additional funds are requested for such a position.
Reference: 45 CFR 75.413(c) /NIH Grants Policy Statement (Chapter 8.1.1.6 - Direct Charging Salaries of Administrative and Clerical Staff)
While the Modular budget does not itemize costs, it does require a Personnel Justification with instructions on what should/shouldn’t be included. Therefore, for all individuals classified as administrative/secretarial/clerical, in addition to their name, percent effort and role, applicants must provide a justification documenting how they meet all four requirements contained in 45 CFR 75.413(c).
For NIH awards these cost are only allowable when specifically identified in the funding opportunity announcement (FOA). For the purposes of Kirschstein-NRSA programs, this term does not apply. NIH will continue to use the terms trainees, trainee-related expenses, and trainee travel in accordance with NRSA Regulations.
For NIH awards, temporary dependent care costs above and beyond regular dependent care that directly results from travel to conferences is allowable provided that:
(i) The costs are a direct result of the individual's travel for the Federal award;
(ii) The costs are consistent with the non-Federal entity's documented travel policy for all entity travel; and
(iii) Are only temporary during the travel period.
Travel costs for dependents are unallowable, except for travel of duration of six months or more with the prior approval of the NIH awarding IC.
VAT is an allowable expense under Federal research awards, except for research grants involving countries as a performance site where an exemption of this tax for research exists.
Yes, a computing device is a supply if the acquisition cost is less than the lesser of the capitalization level established by the non-Federal entity for financial statement purposes or $5,000, regardless of the length of its useful life.
Yes, charging computing devices as a direct cost is allowable for devices that are essential and allocable, but not solely dedicated to the performance of the Federal award.
There is no difference in the definition. The Uniform Guidance introduced the term renovation and reconversion to define what NIH has termed alteration and renovations costs. NIH is incorporating renovation and reconversion to align with the Uniform Guidance and 45 CFR Part 75 by cross referencing this term to alteration and renovation costs in NIH policy.
NIH will provide 10% of modified total direct costs (MTDC) to recipients that do not have a negotiated F&A rate in place at the time of award.
This represents a change in NIH grants policy. Previously if a recipient did not have a negotiated F&A rate, the use of a temporary rate of 10% of salaries and wages (S&W), could be used until a rate agreement was negotiated. However, in order to align with 45 CFR 75.414(f), this option is no longer available.
Reference: 45 CFR 75.414(f) /NIH Grants Policy Statement (Chapter 7.4 - Reimbursement of Facilities and Administrative Costs)
NIH will continue to reimburse F&A costs under Kirschstein-NRSA institutional research training grants and K awards at a rate of 8 percent of modified total direct costs, exclusive of tuition and fees, health insurance (when awarded as part of tuition and fees), expenditures for equipment, and consortiums in excess of $25,000.
Reference: 45 CFR 75.414(c)(1) /NIH Grants Policy Statement (Chapter 7.4 - Reimbursement of Facilities and Administrative Costs)
NIH will continue to reimburse F&A costs to foreign and international organizations at a rate of 8 percent of modified total direct costs (MTDC) less only equipment.
In addition, NIH has removed the requirement that only allows F&A costs to be recovered in order to support the costs of compliance with NIH requirements. This policy change will be reflected in the NIH GPS and will apply retroactively as of December 26, 2014.
Reference: 45 CFR 75.414(c)(1) /NIH Grants Policy Statement (Chapter 7.4 - Reimbursement of Facilities and Administrative Costs)
Yes. The Uniform Guidance adopted the more stringent requirements previously contained within OMB Circular A-102 compared with A-110. States may follow the same policies and procedures they use for procurements from non-Federal funds and ensure that every purchase order or other contract includes any clauses required by 75.335. All other recipients must follow the requirements detailed in 45 CFR parts 75.327 through 75.335 for the purchase of goods or services through contracts under grants.
Note: OMB has provided a one-year grace period for implementation of these subsections for institutions of higher education (IHEs and nonprofit organizations). Thus, these requirements are expected to take effect for these entities for their first fiscal year after December 26, 2015.
Reference: 45 CFR 75.110(a) /NIH Grants Policy Statement (Chapter 8.3.4 - Procurement System Standards and Requirements)
The deadline for submission of final reports has already been extended to within 120 calendar days from the period of performance end date. Thus, recipients must submit a final Federal Financial Report, Final Progress Report, and Final Invention Statement and Certification, as applicable, within 120 calendar days of the end of the period of performance. The reports become overdue on the day after the 120 calendar day period ends. Because NIH effectively provided a 30-day extension by increasing the reporting deadline to 120 days, requests for additional extensions will not be considered. (Also see NOT-OD-14-084 regarding NIH’s updated Grant Closeout policies and procedures aligned with new HHS closeout requirements.)
NIH is adopting this timeframe to align with forthcoming award terms and conditions for participating Federal research agencies. Other HHS agencies are not research agencies.
Yes, there will be a transition. NIH will apply this date to projects ending on or after October 1, 2014. For any grants with a period of performance (project period) end date prior to that, the reporting deadline would be 90 days from the project period end date.
NoAs issued following the eRA enterprise release in January 2015 contain a term referencing the 120 day closeout reporting timeline. The upcoming (or pending) grant closeout search by institution will reflect this timeline with the next eRA enterprise release next month (April 2015).
