It is critical that applicants follow 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 the 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.

Part 1. Overview Information
Part 2. Full Text of the Announcement
Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information

Purpose

The purpose of this Funding Opportunity Announcement (FOA) is to support pandemic preparedness by providing an opportunity for facility improvements and building systems upgrades at existing BSL3 and BSL4 biocontainment laboratories engaged in research on RNA viruses of pandemic potential to facilitate the conduct of biomedical research on vaccines and therapeutics.

These proposed facility enhancements are expected to add value to the applicant institution's research efforts relevant to pandemic preparedness by providing support for activities that cannot easily be obtained through standard research awards. The added value contribution of this support should go beyond the resources, services and collaborations that currently exist at the institution.

NIAID is issuing this FOA in response to the declared public health emergency issued by the Secretary, HHS, for 2019 Novel Coronavirus (COVID-19).

Background

NIAID seeks to accomplish the ambitious research agenda laid out in the American Pandemic Preparedness: Transforming Our Capabilities plan, the NIAID Pandemic Preparedness Plan and the Antiviral Program for Pandemics (APP), focusing on the viruses of greatest pandemic concern in 7 RNA virus families or orders: Bunyavirales, Coronaviridae (including SARS-CoV-2), Filoviridae, Flaviviridae, Paramyxoviridae, Picornaviridae, and Togaviridae. Therefore, it is critical to provide adequate biocontainment laboratory capacity that meets the demands for increasing research related to pandemic preparedness while ensuring that NIH requirements for safety and function are maintained.

Objectives and Scope

To achieve the objectives outlined above, NIAID seeks to support facility improvements and building systems upgrades at existing BSL3 or BSL4 biocontainment laboratories engaged in research on RNA viruses of pandemic potential to facilitate the conduct of biomedical research on vaccines and therapeutics. Applicant institutions must serve multiple individual investigators each with demonstrated experience (e.g., United States Government (USG) funding, publications) over the past 5 years covering at least one RNA virus family relevant under the APP/pandemic preparedness effort. The cumulative experience of the investigators must cover at least two APP/pandemic preparedness-relevant viral families. Examples of activities that are covered under this FOA include but are not limited to:

• Repair, renovation, and modernization of building systems to enhance functions and operations of existing research facilities, i.e., renovating space and finishes or updating the facility’s HVAC, plumbing or electrical systems.
• New fixed Equipment connected to building systems that modernizes, streamlines, or improves efficiencies of the operations of the facility and novel nonfixed scientific equipment and advanced tools which directly support the BSL3 or BSL4 laboratory. Examples of allowable equipment include autoclaves, cage washing equipment, ventilated animal caging, Biosafety Cabinets (BSCs), cell sorters/FACs, and PCR equipment. Examples of equipment not considered allowable is typical laboratory nonfixed equipment such as refrigerators, incubators, and centrifuges.
• Building automation systems related to functioning of the facility.

The following activities are considered non-responsive and will not be reviewed:

• Applications not solely addressing facility improvements and building systems upgrades at existing BSL3 or BSL4 biocontainment laboratories engaged in research on RNA viruses of pandemic potential as demonstrated by USG funding, other funding and/or publications over the past 5 years covering at least two families of pandemic potential viruses and multiple individual investigators.
• Applications that propose construction as defined in the NIH Grants Policy Statement. https://grants.nih.gov/policy/nihgps/index.htm
• Operational costs.
• Clinical trials: Clinical research may be supported; however, clinical trials are not to be initiated or conducted through this funding opportunity. See NOT-OD-15-015 for the NIH Definition of a Clinical Trial.

Please refer to the Frequently Asked Questions (FAQ) page for additional guidance.

See Section VIII. Other Information for award authorities and regulations.

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

• Public/State Controlled Institutions of Higher Education
• Private Institutions of Higher Education

The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:

• Hispanic-serving Institutions
• Historically Black Colleges and Universities (HBCUs)
• Tribally Controlled Colleges and Universities (TCCUs)
• Alaska Native and Native Hawaiian Serving Institutions
• Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)

Nonprofits Other Than Institution of Higher Education

• Nonprofits with 501(c)(3) IRS Status (Other than Institution of Higher Education)
• Nonprofits without 501(c)(3) IRS Status (Other than Institution of Higher Education)

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 not 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.

• System for Award Management (SAM) Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code. In the case of Emergency awards, if the applicant is unable to comply with the requirement to complete and maintain SAM registration at the time of application submission, contact the agency immediately.
• NATO Commercial and Government Entity (NCAGE) Code Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.
• Unique Entity Identifier (UEI)- A UEI is issued as part of the SAM.gov registration process. SAM registrations prior to fall 2021 were updated to include a UEI. For applications due on or after January 25, 2022, the UEI must be provided on the application forms (e.g., FORMS-G); the same UEI must be used for all registrations, as well as on the grant application.
• Dun and Bradstreet Universal Numbering System (DUNS) Organization registrations prior to April 2022 require applicants to obtain a DUNS prior to registering in SAM. By April 2022, the federal government will stop using the DUNS number as an entity identifier and will transition to the Unique Entity Identifier (UEI) issued by SAM. Prior to April 2022, after obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.
• eRA Commons - Once the unique organization identifier (DUNS prior to April 2022; UEI after April 2022) is established, organizations can register with eRA Commons in tandem with completing their full SAM and Grants.gov registrations; all registrations must be in place by time of submission. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
• Grants.gov Applicants must have an active SAM registration in order to complete the Grants.gov registration.

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 project as the Program Director/Principal Investigator (PD/PI) 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.

This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.

Only one application per institution (identified by NIH IPF number) is allowed.

The NIH will not accept duplicate or highly overlapping applications under review at the same time, per 2.3.7.4 Submission of Resubmission Application. This means that the NIH will not accept:

• A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.
• A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.
• An application that has substantial overlap with another application pending appeal of initial peer review (2.3.9.4 Similar, Essentially Identical, or Identical Applications).

Applicant organizations must at the time of application submission operate a BSL3 or BSL4 biocontainment facility and have a current or previous permit by CDC/USDA to work on the identified agents of pandemic preparedness. All permits must be up to date at the time of award.

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.

It is critical that applicants follow the the Research (R) Instructions in the SF424 (R&R) Application Guide, except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.

By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:

• Descriptive title of proposed activity
• Name(s), address(es), and telephone number(s) of the PD/PI
• Names of other key personnel
• Participating institution(s)
• Number and title of this funding opportunity

The letter of intent should be sent to:

Brenda Lange-Gustafson, Ph.D.
Telephone: 240-669-5047
Email: bgustafson@niaid.nih.gov

All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed, with the following exceptions or additional requirements:

• For this FOA, there is no Research Strategy.
• Project Narrative 12 pages

Instructions for Application Submission

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.

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 abstract should briefly describe the scope of the planned facility upgrades and discussion of how the upgrades to this biocontainment laboratory will enhance APP/pandemic preparedness-relevant research.

Project Narrative: The Project Narrative should describe the facility where the project is to be located, justify the upgrade needs, and present the proposed improvement plan with technical details necessary to demonstrate the feasibility of the project. Include the following sections (assembled in this order): Specific Aims, Significance and Need, Description of the Facility, Justification of the Project, Modernization Plan, and Project Management and Institutional Commitment.

Begin each section with a header (e.g., Specific Aims, Significance and Need, etc.).

Specific Aims: State the specific goals set for the project and the proposed strategy to accomplish them. In particular, describe the proposed facility and equipment upgrades. State how the project will contribute to the research infrastructure at the Institution and enhance research contributing to Pandemic Preparedness.

Significance and Need: Present the current status of the facility. Describe the space that will be improved, noting any current deficiencies. Describe how the planned project will correct these deficiencies and anticipated benefit of such efforts. Explain how the proposed project, if accomplished, will contribute to Pandemic Preparedness, and enhance research capabilities.

Description of the Facility: Include information about the location of the facility, areas of research supported, types of research services offered, and the research community that relies on services provided by the facility. The narrative should also describe the Institutional commitment to support long-term operations and maintenance of the facility. Describe deficiencies of the facility’s existing physical infrastructure that limit or threaten the ability to provide dependable services and the research-related activities it supports. This will serve as the basis for the justification of the upgrade needs.

Justification of the Project: Describe how the proposed improvements will remedy the infrastructure’s deficiencies, improve the facility s operations, and modernize the facility. If the project includes the upgrade of animal laboratory space, planned improvements in animal management, maintenance, or care should be presented and connected (as applicable) to improvements of the accuracy of the models that will be used in research. Applicants must provide a table listing the names and expertise of current researchers who will utilize the APP/pandemic preparedness-relevant facilities.

Modernization Plan: In this section, describe the architectural and engineering design of the project. Provide sufficient details about its implementation including any technical challenges that will need to be overcome. The level of detail of the Floor Plans, Line Drawings, and engineering criteria narrative (see other attachments ) must show adherence to the current NIH Design Policy and Guidelines (https://orf.od.nih.gov/TechnicalResources/Pages/DesignRequirementsManual2016.aspx ) and provide sufficient information for reviewers to determine the functionality, safety and reliability of the project and how it satisfies the needs identified for APP/pandemic preparedness support.

Describe the equipment requested and demonstrate that the chosen model(s) when installed will optimally address current deficiencies and meet the research-driven demands. The location of the equipment must be marked on the floor plan (required to be uploaded in Other Attachments) to indicate that its installation and operations will meet architectural and engineering standards. Technical specification of the equipment together with its demands on building systems (HVAC, electrical, plumbing) should also be described to demonstrate the feasibility of the project. The use of green technologies offering savings in energy, water and other functional efficiencies is encouraged.

There should also be an outline of the plans leading to the successful completion of the projects, including how the PD/PI will leverage their own expertise and leadership skills to work with other scientific and technical experts.

Project Management and Institutional Commitment: Describe the administrative structure and the oversight for the project: present the role that the PD/PI will play in coordinating and overseeing the activities of planning and conducting the project. Describe the ability of the PD/PI, the Project Manager (if other than PD/PI), Institutional Biosafety Officer, and other personnel associated with the operation of the Biocontainment Facility to work together.

Other Attachments: Include the following, each as a separate PDF attachment. Only those items specifically mentioned in "Other Attachments" will not count towards the page limits of the Project Narrative.

Timeline: The filename "Timeline.pdf" should be used and will be reflected in the final image bookmarking for easy access for reviewers. Include a timeline for the conduct of the project, including space preparations, adjustments to the building systems, equipment ordering, delivery, and installation; securing any permits, as applicable.

Floor Plan: The filename "Floor Plan.pdf" should be used and will be reflected in the final image bookmarking for easy access for reviewers. Include:

• Functional layout of the area, showing dimensions, square footages, and the location of entries and exits, egress routes, clearances, and the location of fixed equipment.
• Changes or additions to existing mechanical, electrical, and plumbing systems; notes that annotate the changes may be directly included on the plan.
• Information on the utility capacities and distribution must be provided when changes or additions are being proposed to any system.
• Provide sufficient information to allow the evaluation of plans for impact on Biological Safety.

Biosafety Evaluation: The filename "Biosafety Evaluation.pdf" should be used and will be reflected in the final image bookmarking for easy access for reviewers. Include:

• Narrative of past success and challenges with operating a biocontainment facility including a brief summary of CDC/ USDA permitting inspections or select agent inspections. Please provide a copy of the most current certificate from the Federal Select Agent Program if program is registered.
• Evaluation of the proposed design and/or equipment additions as to how it contributes to the overall biosafety and biocontainment features for the facility and the program.
• Statement from Institutional Biosafety Officer and/or Select Agent Responsible Official that they have reviewed the proposal and support its implementation.

Budget Justification: The filename "Budget Justification.pdf" should be used and will be reflected in the final image bookmarking for easy access for reviewers. Include itemized valid manufacturer’s quotes and budget justification. Provide quotes from manufacturer(s) for all items of equipment requested. Also, describe and justify any costs associated with the installation of the equipment and the modification of space or building systems (as applicable) to ensure proper functioning of the equipment. Provide a justification for all other items in the budget.

Institutional Support: The filename "Institutional Support.pdf" should be used and will be reflected in the final image bookmarking for easy access for reviewers. Include a letter from a high-ranking institutional official (e.g., Dean, Provost, President) indicating institutional financial support for the operations of the shared facility and research activities conducted therein. If any term-limited software licenses are requested, a detailed financial commitment to support renewal of licenses in outward years must be included.

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:

In addition to PD/PI, a Facilities Person must be identified for this application. Please include a profile of this person in the Research & Related Senior/Key Personnel Form (following the PD/PI's profile) and, in particular, specify the project role as Facilities Person in the Other Project Category field. Also, attach a biographical sketch of this person. A Facilities Person will directly communicate with NIH technical staff about the design of the project. Typically, he/she is familiar with systems of biomedical research buildings and many times is an architect, engineer, or the project person. In addition, include information such as Profile and biographical sketch of the Director of the Animal Facility. Among the listed Key Personnel identify Project Manager and (if other than PD/PI) specify this person's role in the Other Project Role Category fields as Other or Other Professional . A Project Manager has full responsibility and the level of authority for completing the project.

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:

This FOA does not cover construction or construction related costs. When completing "The Budget Information for Construction Programs (SF424C)" form applicants should NOT complete the following fields:

2. Land, structures, rights-of-way, appraisals, etc.

7. Site work

9. Construction

13. Contingencies

15. Project (program) income

All other fields should be completed.

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.

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 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 are allowable only as described in the NIH Grants Policy Statement.

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 PDs/PIs must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile form 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.

The applicant organization must ensure that the unique entity identifier (DUNS number or UEI as required) provided 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 by the Center for Scientific Review and responsiveness by components of participating organizations, NIH. Applications that are incomplete and/or nonresponsive 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.

Applications submitted to the NIH in support of the NIH mission are evaluated for scientific and technical merit through an NIH objective review system.

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).

Reviewers will consider each of the review criteria below in the determination of scientific merit of the Overall application and will not provide a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.

Scientific Merit and Organization of the Total Program and Its Component Parts to be Carried Out in the Facility

How will the proposed repair, renovation, or modernization activity facilitate the applicant institution’s ability to conduct, expand, or improve research that supports Pandemic Preparedness?

Is there sufficient justification for improving this core facility? To what extent will the proposed change in the research environment facilitate the applicant institution’s ability to conduct, expand, or improve research that supports Pandemic Preparedness? How will the proposed repair, renovation, or modernization activity increase efficiency in the use of energy, water, and/or materials to reduce adverse effects on the environment?

Administrative and Leadership Capabilities of the Applicant’s Officers and Staff

How effective is the facility manager likely to be, based on 1) the administrative approach to managing the facility, 2) the ability to interact with appropriate institutional officials to see that the ongoing needs of the facility are satisfied, and 3) the skills necessary to complete the project on time and within budget?

How effective is the PD/PI likely to be, based on 1) leadership qualities and experience, 2) institutional commitment and support, and 3) the appropriate scientific and fiscal administration skills necessary to complete this project on time and within budget? Does the applicant provide evidence of future commitment in maintaining this facility?

Need for the Project

How compelling are: 1) the identified need(s) in the research capabilities in the applicant organization and elsewhere that the proposed repair, renovation, or modernization activity is intended to address; 2) tangible benefits to the institutional research capability of the proposed activity; and 3) state-of-the-art research capabilities or efficiencies that would otherwise not be available?

Are requests for equipment justified and of direct benefit to the facility? Will the requested equipment remedy identified deficiencies or fill gaps that will facilitate Pandemic Preparedness?

Project Design

Design Plan: How likely is the design plan to meet the identified need(s), based on: 1) proposed demolition areas and/or renovation areas, including associated room adjacencies, traffic patterns for the movement of people, animals, and materials (clean and dirty) through the facility, and relative location of needed ancillary areas (e.g., changing rooms for animal facilities); 2) total net and gross square feet of space to be renovated; 3) proposed timeline and sequence of work to be performed; 4) potential problems, alternative strategies, and benchmarks for success presented; and 5) implement sustainable design principles?

Engineering Criteria: How likely are the engineering systems to meet the identified need(s), based on: 1) the engineering criteria, including information about the mechanical, electrical, and plumbing systems, and utilities in the renovation; 2) descriptions of changes or additions to existing mechanical and electrical systems; and 3) the number of air changes per hour, electrical power, light levels, hot and cold water, and steam?

Architectural Criteria: How likely are the architectural criteria and finishes to meet the identified need(s), based on: 1) the size dimensions, function, and net and gross square feet for each component; 2) architectural criteria such as the width of corridors and doors and surface finishes for the project; and 3) quality of life issues (e.g., natural lighting, noise, vibration)?

Line Drawings: How likely are the line drawings to meet the identified need(s), based on: 1) the indicated function of the space; 2) the scale of the line drawings, and indication of adjacencies and operational relationships of equipment; 3) changes to be made to the space; and 4) location of major equipment, fume hoods, sinks, showers, and other major items indicated in the drawings?

Equipment: How likely will the proposed equipment meet the needs of the facility based on 1) identified deficiencies; 2)enhance the operation and increase efficiency of research.

As applicable for the project proposed, reviewers will evaluate the following additional items while determining the merit of the project, and in providing an overall impact score, but will not give separate scores for these items.

Protections for Human Subjects

Generally not applicable. Reviewers should bring any concerns to the attention of the Scientific Review Officer.

Inclusion of Women, Minorities, and Individuals Across the Lifespan

Generally not applicable. Reviewers should bring any concerns to the attention of the Scientific Review Officer.

Vertebrate Animals

Generally not applicable. Reviewers should bring any concerns to the attention of the Scientific Review Officer.

Biohazards

Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.

Resubmissions

Not Applicable

Renewals

Not Applicable

Revisions

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.

Applications from Foreign Organizations

Not Applicable

Select Agent Research

Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).

Resource Sharing Plans

Generally not applicable. Reviewers should bring any concerns to the attention of the Scientific Review Officer.

Budget and Period of Support

Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.

Applications will be evaluated by (an) appropriate Objective Review Group(s), convened by the National Institute of Allergy and Infectious Diseases, using the stated review criteria. Assignment to an Objective Review Group will be shown in the eRA Commons.
As part of the scientific objective review, all applications:

• May undergo a selection process in which only those applications deemed to have the merit (generally the top half of applications under review) will be discussed and assigned an overall impact score.
• May receive a written critique.

Appeals of initial objective review will not be accepted for applications submitted in response to this FOA.

Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. The following will be considered in making funding decisions:

• Impact score assigned to the application by the NIH objective review group
• Availability, by affiliation or other association, of other scientific or health personnel and facilities to the extent necessary to carry out effectively the program proposed for the facility, including the adequacy of an acceptable biohazard control and containment program when warranted
• The need for the facility and its total effects on similar or related facilities in the locale, and the need for appropriate geographic distribution of similar facilities
• The project cost and design
• Availability of funds.
• Required number of investigators with demonstrated experience in research with at least two APP/pandemic preparedness-relevant viral families.

Not Applicable

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement.

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 recipient’s business official.

Recipients 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.

Any work that modifies the floor plan, installs fixed equipment, or ties into or provides new building systems must be reviewed by the NIAID program office as outlined in NIH Grants Policy Statement (GPS) section 10.4 (https://grants.nih.gov/grants/policy/nihgps/HTML5/section_10/10.4_design_documentation_requirements.htm).

Final architectural drawings, specifications, modernization schedule, equipment data, and updated cost estimates are reviewed and approved by the NIAID. Final design documents (95 100% complete design documents) shall include detailed drawings, specifications, equipment cuts, and detailed cost estimates. The purpose of the NIAID design review is to ensure that applicable design standards, including, as applicable, the minimum requirements contained in 42 CFR 52b.12, have been incorporated into the working drawings and specifications to ensure that program requirements are met, and that the facility will suitably accommodate the activities for which it is planned to be used.

Please submit all documents for review in PDF format to your NIAID Program Officer and Grants Management Specialist with the grant number in the subject line. Material may be sent as soon as it is ready but no later than November 30, 2022.

For more complex projects, design material in progress may be submitted for discussion prior to the final document submittal.

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, Recipients, and Activities, including of note, but not limited to:

• Federalwide Research Terms and Conditions
• Prohibition on Certain Telecommunications and Video Surveillance Services or Equipment
• Acknowledgment of Federal Funding

If a recipient is successful and receives a Notice of Award, in accepting the award, the recipient agrees that any activities under the award are subject to all provisions currently in effect or implemented during the period of the award, other Department regulations and policies in effect at the time of the award, and applicable statutory provisions.

Should the applicant organization successfully compete for an award, 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 (including gender identity, sexual orientation, and pregnancy). This includes ensuring programs are accessible to persons with limited English proficiency and persons with disabilities. 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 https://www.hhs.gov/civil-rights/for-individuals/nondiscrimination/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.

Recipients of FFA must ensure that their programs are accessible to persons with limited English proficiency. For guidance on meeting the legal obligation to take reasonable steps to ensure meaningful access to programs or activities by limited English proficient individuals see https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/fact-sheet-guidance/index.html and https://www.lep.gov.

• For information on an institution's specific legal obligations for serving qualified individuals with disabilities, including reasonable accommodations and making services accessible to them, see http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html.
• HHS funded health and education programs must be administered in an environment free of sexual harassment, see https://www.hhs.gov/civil-rights/for-individuals/sex-discrimination/index.html; For information about NIH's commitment to supporting a safe and respectful work environment, who to contact with questions or concerns, and what NIH's expectations are for institutions and the individuals supported on NIH-funded awards, please see https://grants.nih.gov/grants/policy/harassment.htm.
• For guidance on administering programs in compliance with applicable federal conscience protection and associated anti-discrimination laws see https://www.hhs.gov/conscience/conscience-protections/index.html and https://www.hhs.gov/conscience/religious-freedom/index.html.

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 and 2 CFR Part 200.206 Federal awarding agency review of risk posed by applicants. This provision will apply to all NIH grants and cooperative agreements except fellowships.

Cooperative Agreement Terms and Conditions of Award

Not Applicable

Funds awarded using appropriations provided by the American Rescue Plan Act 2021 will be issued in unique subaccounts in the HHS Payment Management System, and will require separate financial reporting from any other funds awarded

A final RPPR 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. NIH FOAs outline intended research goals and objectives. Post award, NIH will review and measure performance based on the details and outcomes that are shared within the RPPR, as described at 45 CFR Part 75.301 and 2 CFR 200.301.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for recipients of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All recipients 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 the threshold. 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 2 CFR Part 200.113 and Appendix XII to 45 CFR Part 75 and 2 CFR Part 200, 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 and 2 CFR Part 200 Award Term and Condition 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: https://grants.nih.gov/support/index.html(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: GrantsInfo@nih.gov (preferred method of contact)
Telephone: 301-480-7075

Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email: support@grants.gov

Gary Zackowitz, RA
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 240-627-3397
Email: GZ6h@nih.gov

Brenda Lange- Gustafson, Ph.D.
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 240-669-5047
Email: bgustafson@niaid.nih.gov

Michael Fato
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: (240) 669-2968 (Phone)
Email: -mf59e@nih.gov

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), 42 USC 283k, and under Federal Regulations 42 CFR Part 52b and 45 CFR Part 75 and 2 CFR Part 200.