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Policy for Charging Personal Protective Equipment to NIH Grants and Cooperative Agreements as Direct Costs - Clinical Trials and Clinical Research - NOT-OD-20-164 (09/11/2020)

Please see the recently released NIH notice below on charging Personal Protective Equipment (PPE) to NIH grants and cooperative agreements as direct costs.

Policy for Charging Personal Protective Equipment to NIH Grants and Cooperative Agreements as Direct Costs

Notice Number: NOT-OD-20-164

Key Dates – Release Date: September 11, 2020

Related Announcements

None

Issued by

Office of The Director, National Institutes of Health (OD)

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.

Inquiries

Please direct all inquiries to:

Division of Grants Policy
Office of Policy for Extramural Research Administration
Office of Extramural Research
GrantsPolicy@nih.gov

Guidance for Applicants Preparing Applications for the Fall 2020 Due Dates During the COVID-19 Pandemic (NOT-OD-20-122)

Coronavirus Disease 2019 (COVID-19): Information for NIH Applicants and Recipients of NIH Funding

Using Your NIH Grant to Donate Personal Protective Equipment (PPE) (03/27/2020)

NIH awardees can donate Personal Protective Equipment (PPE) from their awards.

FAQ From NIH

Can recipients donate Personal Protective Equipment (PPE) and supplies acquired with NIH grant funds to local hospitals and health care facilities in support of COVID-19 efforts?

Answer: Yes, recipients may donate PPE and other lab supplies in support of efforts related to COVID-19. Recipients may re-budget grant funds to repurchase supplies at a later date, use large unobligated balances, or submit an administrative supplement request to the funding IC.

Instructions from Dr. Miller

As we ramp down our lab operations the question has come up of whether the labs have any Personal Protective Equipment (Gloves, Gowns, Mask) that could be donated to the hospital. The specific ask is for Surgical Masks, N95 Masks, and Protective Gowns. These must be in unopened boxes or packing materials. If your lab can donate any of the above please respond directly to reginald.miller@mssm.edu.

In your response please indicate:

  • Type of PPE
  • Quantity of material (s)
  • Lab location
  • Best time to pickup

Med students will come to your areas to pick up the supplies. Thanks in advance for your assistance.

NIH Updates: COVID-19 Guidance for CT/HS studies; Flexibilities for IACUC Activities (03/23/2020)

NIH Update: COVID-19 Flexibilities for Applicants and Recipients of NIH Funding (03/17/2020)

https://nexus.od.nih.gov/all/2020/03/13/covid-19-resources-for-applicants-and-recipients-of-nih-funding/

Special Edition: Coronavirus Update – March 17, 2020

COVID-19 Resources for Applicants and Recipients of NIH Funding

By Mike Lauer

Due to the potential exceptional impact of the declared public health emergency, we want to assure our recipient community that NIH will be doing our part to help you continue your research. See a video message from Dr. Mike Lauer discussing the flexibilities available for applicants and recipients. Continue reading →

Top Stories

Guidance for NIH-Funded Clinical Trials and Human Subjects Studies Affected by COVID-19

For details on expanded flexibilities, such as mid-project period extensions and administrative supplements for unanticipated costs, see NOT-OD-20-087Continue reading →

NIH Late Application Policy, Administrative Flexibilities, and FAQs Related to 2019 Novel Coronavirus (COVID-19)

When delays occur because the applicant or recipient organization is officially closed or unable to submit grant applications due to the effects of COVID-19, the NIH will consider accepting applications late, on a case-by-case basis. Continue reading →

Flexibilities for Assured Institutions for Activities of Institutional Animal Care and Use Committees (IACUCs) Due to COVID-19

See NOT-OD-20-088 for flexibilities provided in the Public Health Service (PHS) Policy on Humane Care and Use of Laboratory Animals (Policy) that are applicable to implementing a pandemic plan for animal care and use programs. Continue reading →

Special OLAW Webinar on March 19: Pandemic Contingency Planning and Its Impact on Animal Care

Are you testing or implementing your institution’s pandemic response plan for the first time? Do you have questions about flexibilities provided by the PHS Policy that may be helpful during a pandemic? We are hosting a special webinar on March 19th to help your institution prepare for a pandemic that may impact the animal care and use program. Continue reading →

Calendar

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Guidance for NIH-funded Clinical Trials and Human Subjects Studies Affected by COVID-19 (03/16/2020)

Notice Number:NOT-OD-20-087

Key Dates
Release Date: March 16, 2020

Related Announcements

NOT-OD-20-082
NOT-OD-20-083
NOT-OD-20-086

Issued by
National Institutes of Health (NIH)

Purpose

The purpose of this notice is to provide guidance outlining the flexibilities available to recipients conducting NIH-funded clinical trials and human subject studies, that are impacted by the declared public health emergency for COVID-19. NIH recognizes the significant effects that this emergency is having on NIH-funded clinical trials and other human subjects studies. First and foremost, NIH is concerned about the safety and welfare of human subject participants and research staff. Institutions should take all steps necessary to ensure the safety of all human participants and research staff involved in NIH-funded clinical trials and human subjects studies.

At this time, NIH encourages recipients to consult with their IRB and institutions about potential measures to protect participants and research staff. Examples of such measures are:

  • Limiting study visits to those needed for participant safety or coincident with clinical care.
  • Conducting virtual study visits
  • Arranging flexibilities for required laboratory tests or imaging needed for safety monitoring to occur at local laboratories or clinics
  • Canceling large gatherings of 50 or more people
  • Limiting or suspending unnecessary travel

Recipients will likely encounter delays to ongoing research based on the effects of COVID-19. As outlined in NOT-OD-20-086, recipients may submit late financial and progress reports, if research is delayed due to COVID-19, and may carryover unobligated balances on active grants without requesting prior approval.

Below are additional details related to current and expanded flexibilities.

Delays in Research Progress:

As outlined in the NIH Grants Policy Statement 8.1.1.3, recipients may extend the final budget period of the approved project on active grants one time for up to 12 months without requesting prior approval from NIH.

To support participant health and safety, and continuity of research during this public health emergency, NIH will allow for additional extensions, including mid-project period extensions, for awards supporting NIH-funded clinical trials and human subjects research. Recipients should contact the awarding Institute or Center (IC) to provide details on the effects of COVID-19, and the need for an extension. NIH is committed to working with its recipients during this public health emergency.

Typically, project periods for NIH awards supporting clinical trials and other human subjects research are limited to seven years. NIH will allow project periods to extend beyond the 7-year timeframe for extensions related to COVID-19.

Unanticipated Costs

As a result of COVID-19, recipients may incur unanticipated costs. For example:

  • Costs incurred to arrange for participants to receive care at their local sites or virtually, rather than the study site, for required visits.
  • Supply chain disruptions
  • Personnel disruptions due to illness or closure of facilities
  • Additional lab testing (e.g. for COVID-19)
  • Increased transportation costs

If unanticipated costs are identified due to impacts of COVID-19, and unobligated balances are not available to rebudget, recipients may request administrative supplements from the funding ICs (see PA-18-591Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp Clinical Trial Optional). ICs will make funding decisions on a case by case basis in an effort to support the safety and welfare of participants and sustain research during any delays.

Additional NIH resources related to COVID-19 are available here which includes FAQs that include, but are not limited to, human research and clinical trials specific questions. NIH is continuing to monitor the situation and will publish any additional information regarding this ongoing public health emergency in the NIH Guide.

Inquiries

Please direct all inquiries to:

Division of Grants Policy
Office of Policy for Extramural Research Administration
Office of Extramural Research
Telephone: 301-435-0949
GrantsPolicy@nih.gov

SPF

Flexibilities Available to Recipients of Federal Financial Assistance Affected by COVID-19 (03/19/2020)

Dear Research Community,

Icahn School of Medicine at Mount Sinai (ISM) is deeply concerned for the health and safety of its staff and employees involved in the day to day operations and sponsored programs including those supported by Federal and Non Federal sponsors, and about effects on its biomedical enterprises.

The purpose of the new policy (link below) is to set forth the administrative flexibilities that will apply to all sponsored programs.
https://icahn.mssm.edu/files/ISMMS/Assets/About%20the%20School/Flexibilities-Available-to-Recipients-for-Federal-Financial-Assistance-Affected-by-COVID-19.pdf

Please review the policy in its entirety. Below is an excpert re: salaries and stipends.

Please contact Sponsored Projects Finance at 646-605-4023 if you have any questions about this policy.