Key Dates

Related Announcements

PAR-20-256 - Limited Competition Emergency Awards: Shared Personal Protective Equipment Resources for COVID-19 Related Vaccine and Treatment Clinical Trials and Clinical Studies (S10 Clinical Trial Not Allowed)

Issued by

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

Purpose

This Notice clarifies the reporting requirements for Personal protective equipment (PPE) usage such that it is consistent throughout PAR-20-256, "Limited Competition Emergency Awards: Shared Personal Protective Equipment Resources for COVID-19 Related Vaccine and Treatment Clinical Trials and Clinical Studies (S10 Clinical Trial Not Allowed)".

Personal protective equipment (PPE) usage reports are required semi-annually. References to quarterly reports were included in error.

The Section I. Funding Opportunity Description of PAR-20-256 has been modified as follows:

Currently Reads:

Each applicant institution must propose a Program Director/Principal Investigator (PD/PI) who will assume administrative and scientific oversight responsibility for the requested PPE. See Section III.1 for qualifications for the PD/PI. The PD/PI also will be responsible for:

• Requesting no-cost extensions of the project period, if needed;
• At the end of the project period, preparing (and working with the institution to submit) a Final Research Performance Progress Report (Final RPPR) that describes the purchased equipment, lists all users and publications resulting from use of the PPE, and outlines the value of PPE to the investigators and to the institution as a whole, see Section VI.3;
• Submitting semi-annual usage reports on the PPE to NIH during the project period and each quarter thereafter, until the PPE resources are fully depleted, see Section VI.3.

Each PD/PI must develop a PPE use, management and distribution plan (“PPE Usage Plan”). The PD/PI is responsible for:

• Implementation of a detailed plan for the day-to-day management and appropriate distribution of the PPE to the clinical trial and clinical study sites and laboratories.
• A plan to ensure that access to the PPE is limited to users conducting activities under the COVID-19 clinical trial.
• Reviewing and approving quarterly usage reports.
• Recommending a new PD/PI, if such a need arises.

Modified to read (changes are shown below in bold italics):

Each applicant institution must propose a Program Director/Principal Investigator (PD/PI) who will assume administrative and scientific oversight responsibility for the requested PPE. See Section III.1 for qualifications for the PD/PI. The PD/PI also will be responsible for:

• Requesting no-cost extensions of the project period, if needed;
• At the end of the project period, preparing (and working with the institution to submit) a Final Research Performance Progress Report (Final RPPR) that describes the purchased equipment, lists all users and publications resulting from use of the PPE, and outlines the value of PPE to the investigators and to the institution as a whole, see Section VI.3;
• Submitting semi-annual usage reports on the PPE to NIH during the project period and semi-annually thereafter, until the PPE resources are fully depleted, see Section VI.3.

Each PD/PI must develop a PPE use, management and distribution plan (“PPE Usage Plan”). The PD/PI is responsible for:

• Implementation of a detailed plan for the day-to-day management and appropriate distribution of the PPE to the clinical trial and clinical study sites and laboratories.
• A plan to ensure that access to the PPE is limited to users conducting activities under the COVID-19 clinical trial.
• Reviewing and approving semi-annual usage reports.
• Recommending a new PD/PI, if such a need arises.

All other aspects of this Funding Opportunity Announcement remain unchanged.

Inquiries

Please direct all inquiries to:

The point(s) of contact listed in PAR-20-256.