Department of Health
and Human Services (HHS)
and Human Services (HHS)
EXPIRED
National Institutes of Health (NIH)
National Institute of Allergy and Infectious Diseases (NIAID)
S10 Biomedical Research Support Shared Instrumentation Grants
New
July 16, 2021 - This PAR has been reissued as PAR-21-276.
February 02, 2021 - Notice of Correction to PAR-20-256. See Notice NOT-OD-21-048.
August 26, 2020 - Notice of Correction to Eligibility in NIH Funding Opportunity Announcements. See Notice NOT-OD-20-171.
None.
93.855
The purpose of this public health emergency funding opportunity is to provide Personal Protective Equipment (PPE) to directly support the needs of the NIAID’s vaccine and treatment clinical trials and clinical studies for COVID-19. This program will ensure that adequate protective equipment is available to directly assist in safely carrying out the clinical activities and direct interactions with the patients participating in the trial. Eligibility is limited to recipients conducting COVID-related clinical research and clinical studies supported by NIAID’s emergency appropriation provided by The Coronavirus Preparedness and Response Supplemental Appropriations Act, 2020 and The Coronavirus Aid, Relief and Economic Security (CARES) Act .
Not applicable.
Applications for this limited competition FOA will be accepted on a rolling basis, beginning July 13, 2020.
All applications are due by 5:00 PM local time of applicant organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on the listed date(s).
Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.
Not applicable.
Not applicable.
Not applicable.
Not Applicable.
Not Applicable
It is critical that applicants follow the instructions in the Research (R) Instructions in the SF424 (R&R) Application Guide,except where instructed to do otherwise (in this FOA or in a Notice from NIH Guide for Grants and Contracts ).
Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions.
Applications that do not comply with these instructions may be delayed or not accepted for review.
The purpose of this public health emergency funding opportunity is to provide Personal Protective Equipment (PPE) to directly support the needs of the NIAID’s vaccine and treatment clinical trials for COVID-19. This program will ensure that adequate protective equipment is available and distributed across clinical sites to directly assist in safely carrying out the clinical activities and direct interactions with the patients participating in clinical trials and clinical studies.
Eligibility is limited to recipients planning and conducting COVID-19-related vaccine or treatment clinical trials and clinical studies supported by NIAID’s emergency appropriation. Clinical studies are defined here as prospective non-interventional studies using human subjects, such as natural history, observational, genetic, and serological studies.
Types of PPE supported by this FOA include:
This FOA will not support applications requesting:
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.1for qualifications for the PD/PI. The PD/PI also will be responsible for:
Each PD/PI must develop a PPE use, management and distribution plan ( PPE Usage Plan ). The PD/PI is responsible for:
Applicants are encouraged to coordinate management and reporting with other affiliated clinical trial and clinical study sites and grantees.
See Section VIII. Other Information for award authorities and regulations.
Note: For more information, please refer to the Question and Answers web site for this FOA.
See Section VIII. Other Information for award authorities and regulations.
Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.
The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types. Only those application types listed here are allowed for this FOA.
Need help determining whether you are doing a clinical trial?
NIAID intends to commit up to $25M for this initiative.
Application budgets are not limited but need to reflect the actual needs of the proposed project.
S10 awards do not allow indirect (F&A) costs.
It is expected that applicants will employ the most economical approaches, including securing academic discounts, to formulate a cost-effective budget while meeting users' needs.Section IV. 6. Funding Restrictions Funding Restrictions for additional details.
Awards are made for one year only.
NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from this FOA.
Higher Education Institutions
The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:
Nonprofits Other Than Institutions of Higher Education
For-Profit Organizations
Local Governments
Federal Governments
Other
Eligibility is limited to recipients conducting COVID-19-related vaccine or treatment clinical trials and studies supported by NIAID’s emergency appropriation provided by The Coronavirus Preparedness and Response Supplemental Appropriations Act, 2020 and The Coronavirus Aid, Relief and Economic Security (CARES) Act .
Pursuant to the NIH Revitalization Act (P.L. 103-43, June 10, 1993), section 2004, when purchasing equipment or products under this assistance award, the recipient should, whenever possible, purchase only American-made items.
Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.
Foreign components, as defined in the NIH Grants Policy Statement, are allowed.
Applicant organizations
Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.
Program Directors/Principal Investigators (PD(s)/PI(s))
All PD(s)/PI(s) must have an eRA Commons account. PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.
Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.
Multiple PDs/PIs are not allowed under the S10 mechanism "
Multiple PDs/PIs are not allowed under the S10 mechanism.
This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.
Applicant organizations may submit more than one application, provided that each application is scientifically distinct.
The NIH will not accept duplicate or highly overlapping applications under review at the same time. This means that the NIH will not accept:
The application forms package specific to this opportunity must be accessed through ASSIST, Grants.gov Workspace or an institutional system-to-system solution. Links to apply using ASSIST or Grants.gov Workspace are available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.
All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed.
For this FOA, there is no overall page limit for the entire PPE Usage Plan. However, there are specified page limits for each section of the PPE Usage Plan as described below. All tables, graphs, figures, diagrams, and charts must be included within the page limits for these sections. The applicants should make every effort to be succinct. To be successful, an application does not have to reach the page limits described here.
The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an application to this FOA.
All instructions in the SF424 (R&R) Application Guide must be followed.
Descriptive Title:PPE Request
Proposed Project: one year
Estimated Project Funding:
Total Federal Funds Requested:Enter the total Federal funds for the requested PPE.
Total Non-Federal Funds:Not applicable.
Total Federal & Non-Federal Funds:Enter the total cost of the PPE.
Program Income:Enter zero as this does not apply to this program.
NOTE: A warning will be generated during submission for any S10 with a budget in excess of $500,000. This warning can be ignored.
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
Project Summary/Abstract:The Project Summary/Abstract should contain a succinct and accurate description of the requested PPE and an explanation of the need for the PPE to support the safe conduct of the associated COVID-19 clinical trials and studies, and how access to the PPE will enhance the health-related goals of the research project. This section should be informative to other persons working in the same or related fields and understandable to a scientifically or technically literate reader.
NOTE: The Project Summary/Abstract must be no longer than 30 lines of text.
Project Narrative:Using no more than two or three sentences, describe the relevance of the use of this PPE to the public health emergency. In this section, be succinct and use plain language that can be understood by a general, lay audience.
Bibliography & References Cited:List only publications that demonstrate the researchers' expertise in conducting clinical trials and studies, which will be supported by the PPE. References of the Research Projects Section may appear in this section or may be listed at the end of individual research subsections.
Facilities & Other Resources:Not Applicable. Do not include an attachment here.
Equipment:Describe the requested PPE and provide a detailed budget breakdown of items to be purchased, including tax and import duties, if applicable. As described above in SF424 Cover form, include an explanation of Total Non-Federal Funds in this section (if applicable).
Do not describe the need for the PPE in this section; such narrative should be a part of the Justification of Need section of the PPE Usage Plan.
Other Attachments:
I) PPE Usage Plan (in lieu of Research Plan section).
The entire PPE Usage Plan (with the sections described below) must be saved as a single PDF file - named PPE Usage Plan - and attached via Other Attachments. Organize the PPE Usage Plan in the specified order as described below, starting each section with the appropriate section heading (i.e., Justification of Need, Technical Expertise, etc.). Do not include links to websites for further information. Do not include animations/videos.
Note: A warning will be generated during submission, stating the Instrumentation Plan is required to be submitted as an Other Attachment for this application. Since the PPE usage plan fulfills the attachment requirement, this warning can be ignored.
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
Applications to this FOA require an PPE Usage Plan in lieu of a Research Plan. See Other Attachments above.
Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide.
The following modifications also apply:
Appendix materials are not allowed for this FOA.
When involving human subjects research, clinical research, and/or NIH-defined clinical trials (and when applicable, clinical trials research experience) follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:
If you answered Yes to the question Are Human Subjects Involved? on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or Delayed Onset Study record.
Study Record: PHS Human Subjects and Clinical Trials Information
All instructions in the SF424 (R&R) Application Guide must be followed.
Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start).All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
See Part 1. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov
Part I. Overview Information contains information about Key Dates and times. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission. When a submission date falls on a weekend or Federal holiday, the application deadline is automatically extended to the next business day.
Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies). Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date and time. If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Policy on Late Application Submission.
Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission.
Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.
This initiative is not subject to intergovernmental review.
All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.
Pre-award costs may be incurred from January 20, 2020 through the COVID-19 public health emergency period and prior to the date of the federal award.
Under the S10 mechanism, funding requests are limited to the purchase cost of the PPE only and should be consistent with the Buy American Act
This Program does not provide facilities and administrative (F&A) costs nor support costs for construction alterations or renovations. Matching funds are not required. The grant(s) will be awarded for a period of one year and are not renewable.
Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide. Paper applications will not be accepted.
Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.
For assistance with your electronic application or for more information on the electronic submission process, visit How to Apply Application Guide. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Dealing with System Issues guidance. For assistance with application submission, contact the Application Submission Contacts in Section VII.
Important reminders:
All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH. See Section III of this FOA for information on registration requirements.
The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in the SF424 (R&R) Application Guide.
See more tips for avoiding common errors.
Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review, NIH. Applications that are incomplete or non-compliant will not be reviewed.
Applicants are required to follow the instructions for post-submission materials, as described in the policy. Any instructions provided here are in addition to the instructions in the policy.
Only the review criteria described below will be considered in the internal evaluation process.
For this particular announcement, note the following:
Overall Benefit
Evaluators will provide an overall assessment to reflect the likelihood that the requested PPE will exert a sustained, powerful influence on the conduct of research projects and their scientific outcomes, in consideration of the following review criteria.
Evaluators will consider each of the criteria below in the determination of an overall assessment.
Justification of Need
Evaluators will determine if the need for the PPE is clearly and adequately justified and the PPE is essential and appropriate, specific to the COVID clinical trials and clinical studies.
Administration
Is the plan for the purchase, management and distribution of the requested PPE appropriate? Are the plans for the use of the PPE well-documented?
As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items.
Not Applicable
Not Applicable
Not Applicable
Not Applicable
Not Applicable.
Not Applicable.
Not Applicable.
As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact score.
Not Applicable.
Not Applicable
Not Applicable.
Not Applicable
Evaluators will consider whether the budget is fully justified and reasonable in relation to the proposed clinical trials and clinical studies. Evaluators will consider whether applicants employed the best economical approaches, including securing academic discounts, to formulate the cost-effective budget while meeting users' scientific needs.
Applications will be evaluated for scientific and technical merit by an appropriate internal review panel convened by NIAID, in accordance with the stated review criteria.
Not Applicable
A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the grantee’s business official.
Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.
Any application awarded in response to this FOA will be subject to terms and conditions found on the Award Conditions and Information for NIH Grants website. This includes any recent legislation and policy applicable to awards that is highlighted on this website.
All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities. More information is provided at Award Conditions and Information for NIH Grants.
Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights laws that prohibit discrimination on the basis of race, color, national origin, disability, age and, in some circumstances, religion, conscience, and sex. This includes ensuring programs are accessible to persons with limited English proficiency. The HHS Office for Civil Rights provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-providers/provider-obligations/index.html and http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html.
HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research. For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA.
Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at https://www.hhs.gov/ocr/about-us/contact-us/index.html or call 1-800-368-1019 or TDD 1-800-537-7697.
In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements. FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award. An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a Federal agency previously entered and is currently in FAPIIS. The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgement about the applicant’s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 45 CFR Part 75.205 Federal awarding agency review of risk posed by applicants. This provision will apply to all NIH grants and cooperative agreements except fellowships.
Pursuant to the NIH Revitalization Act (P.L. 103-43, June 10, 1993), section 2004, when purchasing equipment or products under this assistance award, the recipient should, whenever possible, purchase only American-made items.
Not Applicable
Funds awarded using appropriations provided by the Coronavirus Preparedness and Response Supplemental Appropriations Act, 2020 and The Coronavirus Aid, Relief, and. Economic Security (CARES) Act will be issued in unique subaccounts in the HHS Payment Management System and will require separate financial reporting from any other funds awarded.
During the project period, recipients are required to submit semi-annual reports on the usage of PPE purchased, and to certify that the PPE is being used solely to support COVID-19 clinical trials and clinical studies conducted by the NIAID grantees. After the project period of the S10 award ends, recipients will continue to provide semi-annual reports to NIAID on the usage of the PPE, until the PPE resources are depleted. If the trial or study ends prior to the depletion of the PPE resources, the recipient will contact NIAID for disposition instructions for the remaining equipment.
A final RPPR, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement.
The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All awardees of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000. See the NIH Grants Policy Statement for additional information on this reporting requirement.
In accordance with the regulatory requirements provided at 45 CFR 75.113 and Appendix XII to 45 CFR Part 75, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM) about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period. The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (currently FAPIIS). This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313). As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available. Full reporting requirements and procedures are found in Appendix XII to 45 CFR Part 75 Award Term and Conditions for Recipient Integrity and Performance Matters.
We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.
eRA Service Desk (Questions regarding ASSIST, eRA Commons, application errors and warnings, documenting system problems that threaten submission by the due date, and post-submission issues)
Finding Help Online: http://grants.nih.gov/support/ (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)
General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources)
Email: [email protected] (preferred method of contact)
Telephone: 301-945-7573
Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email: [email protected]
Dr. Andrea Wurster
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases, NIH
Tel: 301-496-7291
Email: [email protected]
Not applicable.
Vandhana Khurana
Grants Management Program, DMID Coordinator
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 240-669-2966
Email: [email protected]
Donna R. Sullivan
Grants Management Program, DAIT Coordinator
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 240-669-2979
Email: [email protected]
Ann Devine
Grants Management Program, DAIDS Coordinator
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 240-669-2988
Email: [email protected]
Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.
Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Part 75.