Purpose
The purpose of this notice is to provide guidance to the extramural community on the criteria that support direct charges for Personal Protective Equipment (PPE) to NIH grants. This guidance applies to all applicants and recipients of NIH grants conducting clinical trials (CT) and clinical research (CR) as defined in the NIH Grants Policy Statement (GPS) section 1.2. This guidance does not apply to grants nor cooperative agreements that are not conducting clinical trials/clinical research.
Background
NIH has received many inquiries from recipients regarding their ability to direct charge PPE costs to their CT and CR awards. These requests for voluminous amounts of PPE as a direct cost have led to concerns that indirect costs will be disproportionate to the actual administrative burden associated with the high cost of these PPE purchases.
As a result, NIH is providing the following criteria to applicants/recipients with respect to when it is appropriate to direct charge PPE costs in order to meet the needs of CT and CR awards. As outlined in the NIH GPS 8.1.1, recipients must ensure that costs charged to awards are consistently applied regardless of the source of funds.
- PPE purchased with grant funds must directly assist in safely carrying out the clinical activities and direct interactions with the patients participating in clinical trials and clinical research studies. Therefore, the costs are allowable for researchers and patients directly linked to the clinical studies (CT and respectively CR).
- For PPE expenses totaling $500,000 direct cost or less in a budget period, applicants/recipients may charge PPE as a direct cost, with associated F&A, for all CT and CR awards regardless of the activity code. Charges must align with the institution’s negotiated F&A rate agreement, which is consistently applied regardless of the source of funds. The $500,000 direct cost limit is cumulative. Applicants/recipients must not submit multiple requests for lower amounts in order to by-pass the $500,000 direct cost limit.
- Recipients must identify a need to purchase PPE totaling more than $500,000 direct cost. In these cases, applicants must apply for an S10 award to provide funds solely to support the PPE costs to directly assist in safely carrying out the clinical activities and direct interactions with the patients participating in clinical trials and clinical research studies. S10 awards do not allow indirect costs. Non-domestic entities are not eligible to apply for S10 awards. )
- Pursuant to the NIH Revitalization Act (P.L. 103-43, June 10, 1993), section 2004, when purchasing equipment or products under an award, applicants/recipients should, whenever possible, purchase only American-made items.