It is critical that applicants follow the Multi-Project (M) 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

The purpose of this Funding Opportunity Announcement (FOA) is to provide an opportunity for the Regional Biocontainment Laboratories (RBLs) established by the National Institute of Allergy and Infectious Diseases (NIAID) to request support for costs associated with the everyday operation of the RBL Biosafety Level 3 (BSL-3) laboratory to facilitate the conduct of research and medical countermeasure development for biodefense, emerging infectious diseases, and pandemic preparedness and response (BSL-3 in this FOA refers to RBL BSL-3s only, and not any other BSL-3 space at the same institution). This is a limited competition for the RBLs at the following institutions: University of Alabama at Birmingham; Tulane University; University of Tennessee; George Mason University; Duke University; Rutgers University; Tufts University; University of Pittsburgh; University of Chicago; University of Missouri; University of Louisville; and Colorado State University.

In February 2002, NIAID, as the lead NIH Institute for biodefense research, initiated a systematic planning process for its biodefense research program. As a first step, NIAID convened the Blue-Ribbon Panel on Bioterrorism and Its Implications for Biomedical Research (Panel) to determine key priorities and short- and long-term goals for biodefense research in the United States. The Panel noted a shortage of BSL-3 and BSL-4 laboratory space as a significant obstacle to the development of medical countermeasures for biodefense pathogens. In response, NIAID released funding announcements and ultimately made awards for the construction of two National Biocontainment Laboratories and 12 Regional Biocontainment Laboratories (RBLs). Since their inception, the RBLs have been an important resource. They assist national, state, and local public health efforts by providing safe and secure state-of-the-art BSL-3 laboratory space to the scientific community to advance research on biodefense pathogens and emerging infectious diseases.

To achieve the objectives of this FOA, an RBL's application for support must consist of the following two required Cores, and may contain a third optional Core:

Required: Facility Management, Maintenance and Operation Core activities may include, but are not limited to:

• BSL-3 management and oversight
• Continuous monitoring of BSL-3 containment systems
• Required decontamination, retesting, and certification of BSL-3 containment facilities
• Preventive maintenance in accordance with a repair and lifecycle replacement plan for critical existing equipment and building systems necessary for operating the RBL at BSL-3
• Emergency repairs or replacement of critical existing equipment and building systems necessary for operating the BSL-3
• Ensuring compliance with all evolving biosecurity regulations related to control of select agents and other highly pathogenic agents to include the management of pathogen and select agent inventories for accountability
• Ensuring Environmental Health and Biosafety Regulations and Requirements are followed

Required: BSL-3 Practices Core - develop and maintain Standard Operating Procedures (SOPs) and provide training for personnel working in the BSL-3 space and associated building systems: activities may include, but are not limited to:

• Providing biosafety theory education and hands-on instruction to include, but not limited to:
  • Entry and exit procedures
  • Removal of materials and equipment from the BSL-3
  • Policies for shipping/receiving materials
  • Waste management
• Critical health and safety training, including incident response and reporting and emergency management (e.g., spills, HVAC failures, fire alarms, accidental exposures, security issues, natural disasters, etc.)
• Establishing best practices for the safe, effective, and efficient conduct of research in BSL-3 facilities (e.g., maintenance of biocontainment systems and equipment, how to use equipment within biocontainment, animal husbandry practices in biocontainment, etc.)
• Ensuring and maintaining consistency in biosafety and biocontainment best practices
• Prospective BSL-3 staff screenings and background checks required for working in a select agent facility
• Special handling of select agents (e.g., agent-specific safety), to include inventory and accountability
• Conducting required biosecurity drills

Optional: Biocontainment Research Support Service(s) Core This optional component may provide specialized services essential to supporting research activities in the BSL-3. Efforts supported could include shared laboratory services and equipment, support for state-of-the-art emerging technologies, and staff with specialized scientific expertise. If proposed, possible support services may include, for example:

• pathogen isolation and propagation
• animal models
• virology
• imaging
• pathology
• medical countermeasure screening
• immunoassays
• insectary
• aerobiology

The proposed support service(s) must be provided within the RBL's BSL-3 space and must be made available to investigators across NIAID's Biodefense Facilities Network.

The service(s) proposed should not duplicate existing services supported by other research funds. Award recipients are encouraged to develop and implement cost reimbursement business models that will generate support for the direct costs of the service(s) provided.

Biodefense Facilities Network

To ensure that the RBLs contributes maximally and effectively to the NIAID biodefense and emerging infectious diseases effort, the overall direction and scope of activities of the Program will be coordinated and monitored by NIAID’s Office of Biodefense, Research Resources, and Translational Research (OBRRTR), in collaboration with the RBL Program Directors/Principal Investigators (PDs/PIs). The RBLs will be members of, and contribute to, the NIAID Biodefense Facilities Network. The network consists of the PDs/PIs of the National and Regional Biocontainment Laboratories, as well as their respective key staff/personnel for biosafety, animal care, and facilities maintenance/operations. NIAID staff also participate. The Network will meet annually to discuss matters of mutual interest and to coordinate activities.

The RBL staff are encouraged to collaborate with other NIH-funded investigators. In addition, the RBLs are expected to organize and promote relationships with pharmaceutical and biotechnology companies; with federal, state, and local agencies; and with other qualified investigators to foster translational research and promote maximal use of the Core facilities and RBL expertise by a broad range of qualified scientists. In times of a national biodefense or emerging infectious disease (EID) emergency, the RBLs may be expected to rapidly realign their activities to assist response efforts within the US under the direction of NIAID. This includes making their core facilities, scientific expertise, and other resources available to assist in the implementation of national emergency plans.

Non-allowable costs

The following activities are considered non-allowable costs and will not be funded under this Cooperative Agreement:

• Direct costs for expenses that are covered by the recipient's negotiated indirect cost rate agreement
• Costs for purchasing equipment are allowable only to replace existing BSL-3 equipment, or if required for operating the BSL-3, or if required to establish the optional Biocontainment Research Support Service(s) Core (as approved by NIAID program); no other equipment purchases are allowable costs
• Construction, renovation, or modernization of building systems
• Conduct of research and purchase of research supplies and reagents
• Purchase of animals, animal housing, or animal per diem costs

For more information about this FOA, see Frequently Asked Questions. NIAID plans to hold an informational webinar for this FOA. Details about the webinar will be available at this same link after FOA publication. Participation in the webinar is not required to submit an application in response to this FOA.

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.

The following organizations/institutions are eligible to apply:

Colorado State University

Duke University

George Mason University

Rutgers University

Tufts University

Tulane University

University of Alabama at Birmingham

University of Chicago

University of Louisville

University of Missouri

University of Pittsburgh

University of Tennessee

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.
  • 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. The same UEI must be used for all registrations, as well as on the grant application.
• eRA Commons - Once the unique organization identifier is established, organizations can register with eRA Commons in tandem with completing their Grants.gov registration; 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 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 diverse backgrounds, including underrepresented racial and ethnic groups, individuals with disabilities, and women are always encouraged to apply for NIH support.

For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide.

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

Only one application per institution (normally identified by having a unique UEI number or 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 (see 2.3.9.4 Similar, Essentially Identical, or Identical Applications).

The application forms package specific to this opportunity must be accessed through ASSIST or an institutional system-to-system solution. A button to apply using ASSIST is 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 Multi-Project (M) Instructions in the SF424 (R&R) Application Guide, except where instructed in this funding opportunity announcement to do otherwise and where instructions in the Application Guide are directly related to the Grants.gov downloadable forms currently used with most NIH opportunities. 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(s)/PI(s)
• Names of other key personnel
• Participating institution(s)
• Number and title of this funding opportunity

The letter of intent should be sent to:

Scott Jakes, Ph.D.
Telephone: 240-627-3710
Email: scott.jakes@nih.gov

All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed.

Available Components	Component Type for Submission	Page Limit	Required/Optional	Minimum	Maximum
Overall	Overall	12	Required	1	1
Facility Management, Maintenance and Operations Core	Core	12	Required	1	1
BSL-3 Practices Core	Core	12	Required	1	1
Biocontainment Research Support Service(s) Core - Optional	Core	12	Optional	0	1

The following section supplements the instructions found in the SF424 (R&R) Application Guide, and should be used for preparing a multi-component application.

Note: Effective for due dates on or after January 25, 2023, the Data Management and Sharing Plan will be attached in the Other Plan(s) attachment in FORMS-H application forms packages. If required, the Data Management and Sharing (DMS) Plan must be provided in the Overall component.

The application should consist of the following components:

• Overall: required, maximum of 1
• Facility Management, Maintenance and Operation Core: required, maximum of 1
• BSL-3 Practices Core: required, maximum of 1
• Biocontainment Research Support Service(s) Core: optional, maximum of 1

When preparing your application, use Component Type Overall .

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

Complete entire form.

Note: Human Embryonic Stem Cell lines from other components should be repeated in cell line table in Overall component.

Follow standard instructions.

Enter primary site only.

A summary of Project/Performance Sites in the Overall section of the assembled application image in eRA Commons compiled from data collected in the other components will be generated upon submission.

Include only the Project Director/Principal Investigator (PD/PI) and any multi-PDs/PIs (if applicable to this FOA) for the entire application.

A summary of Senior/Key Persons followed by their Biographical Sketches in the Overall section of the assembled application image in eRA Commons will be generated upon submission.

The only budget information included in the Overall component is the Estimated Project Funding section of the SF424 (R&R) Cover.

A budget summary in the Overall section of the assembled application image in eRA Commons compiled from detailed budget data collected in the other components will be generated upon submission.

Specific Aims: List in priority order, the broad, long-range objectives and goals of the RBL.

Research Strategy: Summarize the overall objectives and strategic plan for the operation and use of the RBL and its Cores. Describe the RBL organization and management plans and the processes to be used to operate the facility at BSL-3. Address how the RBL and the proposed Cores will interface with, support, and be supported by, the parent institution including the existing management and operations systems, processes, and facilities. Address plans for maintenance of the facility including the portions of the work that will be subcontracted, anticipated maintenance schedules, quality control, and performance standards. Include a description of the RBLs preventive maintenance plan for the repair and lifecycle replacement of critical equipment and systems unique and necessary for operating the RBL at BSL-3. Address how the RBL will interface with the NIAID Biodefense Facilities Network. Address how the RBL will influence research and medical countermeasure development for biodefense, emerging infectious diseases, and pandemic preparedness and response. Address how the RBL will be prepared to respond in the event of a public health emergency, such as a bio-incident or infectious disease outbreak. Summarize plans for staff training and development. Training that can be supported by the RBL is limited to targeted instruction in best practices for conducting research in BSL-3/ABSL-3 biocontainment facilities, including the specialized training for maintenance of BSL-3 containment facilities and the essential training needed for personnel of the proposed Cores.

Other Plan(s):

Note: Effective for due dates on or after January 25, 2023, the Data Management and Sharing Plan will be attached in the Other Plan(s) attachment in FORMS-H application forms packages.

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

• All applicants planning research (funded or conducted in whole or in part by NIH) that results in the generation of scientific data are required to comply with the instructions for the Data Management and Sharing Plan. All applications, regardless of the amount of direct costs requested for any one year, must address a Data Management and Sharing Plan. The Data Management and Sharing (DMS) Plan must be provided in the Overall component.

Appendix:

Only limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions.

PHS Human Subjects and Clinical Trials Information (Overall)

When involving human subjects research, clinical research, and/or NIH-defined clinical trials 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, there must be at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record within the application. The study record(s) must be included in the component(s) where the work is being done, unless the same study spans multiple components. To avoid the creation of duplicate study records, a single study record with sufficient information for all involved components must be included in the Overall component when the same study spans multiple components.

Study Record: PHS Human Subjects and Clinical Trials Information

All instructions in the SF424 (R&R) Application Guide must be followed

Delayed Onset Study

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.

When preparing your application, use Component Type Core .

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

Note: Effective for due dates on or after January 25, 2023, the Data Management and Sharing Plan will be attached in the Other Plan(s) attachment in FORMS-H application forms packages. If required, the Data Management and Sharing (DMS) Plan must be provided in the Overall component.

Complete only the following fields:

• Applicant Information
• Type of Applicant (optional)
• Descriptive Title of Applicant’s Project
• Proposed Project Start/Ending Dates

Enter Human Embryonic Stem Cells in each relevant component.

Human Subjects: Answer only the Are Human Subjects Involved? and 'Is the Project Exempt from Federal regulations? questions.

Vertebrate Animals: Answer only the Are Vertebrate Animals Used? question.

Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

Facilities and Other Resources: Describe the unique facilities and resources available for the Core. If there are multiple performance sites, describe the unique resources available at each site. Describe any special facilities used for working with biohazards or other potentially dangerous substances.

Equipment: Provide information on equipment available for the Core. If there are multiple performance sites, describe the equipment available at each site. Describe any special equipment used for working with biohazards or other potentially dangerous substances.

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

• In the Project Director/Principal Investigator section of the form, use Project Role of Other with Category of Core Lead and provide a valid eRA Commons ID in the Credential field.
• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
• Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.
• The Core Lead can be the same for this and other Cores described in this program.
• Describe the qualifications, training and experience of the Core leaders/Principal Investigators and the staffing effort that will be provided to the individual Cores.

Budget forms appropriate for the specific component will be included in the application package.

The following activities are considered non-allowable costs and will not be funded under this Cooperative Agreement:

• Direct costs for expenses that are covered by the recipient's negotiated indirect cost rate agreement
• Costs for purchasing equipment are allowable only to replace existing BSL-3 equipment, or if required for operating the BSL-3, or if required to establish the optional Biocontainment Research Support Service(s) Core (as approved by NIAID program); no other equipment purchases are allowable costs
• Construction, renovation, or modernization of building systems
• Conduct of research and purchase of research supplies and reagents
• Purchase of animals, animal housing, or animal per diem costs

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

Specific Aims: List in priority order, the broad, long-range objectives and goals of the proposed Core.

Research Strategy: Provide the rationale for the Core and describe the Core’s relationship to the RBL s mission and how it relates to the other Cores in the application. Describe the functions, services, technologies, and efficiencies to be provided. Discuss how the Core will contribute to the management and operation of the RBL, increase the efficiency of the research programs it supports and enhance the research productivity of the investigators. Indicate how these activities will interface with existing programs or processes at the institution and describe how the Core provides support to the institutional research goals for biodefense, emerging infectious diseases, and pandemic preparedness and response.

Outline policies and plans for Core operation and describe how the Core will ensure safe and secure operations of the laboratory to include compliance with biosecurity, select-agent, environment health, and biosafety regulations. Describe plans and procedures for the monitoring of BSL-3 systems, preventative maintenance and emergency repair of critical equipment, and required decontamination, retesting, and certification of BSL-3 containment facilities. Provide a management plan that includes the organizational structure, a staffing plan that details the roles of scientific staff, an overview of how the RBL will manage and prioritize access and use of the laboratory, and a discussion of how the management structure will provide oversight and governance over fiscal and resource management. Discuss user fees and other sources of program income if appropriate; any program income must be directed back into the program.

Other Plan(s):

Note: Effective for due dates on or after January 25, 2023, the Data Management and Sharing Plan will be attached in the Other Plan(s) attachment of the Overall component in FORMS-H application forms packages.

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

• All applicants planning research (funded or conducted in whole or in part by NIH) that results in the generation of scientific data are required to comply with the instructions for the Data Management and Sharing Plan. All applications, regardless of the amount of direct costs requested for any one year, must address a Data Management and Sharing Plan. The Data Management and Sharing (DMS) Plan must be provided in the Overall component.

Appendix:

Only limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions.

When involving human subjects research, clinical research, and/or NIH-defined clinical trials 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 a 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

Delayed Onset Study

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

When preparing your application, use Component Type Core.

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

Note: Effective for due dates on or after January 25, 2023, the Data Management and Sharing Plan will be attached in the Other Plan(s) attachment in FORMS-H application forms packages. If required, the Data Management and Sharing (DMS) Plan must be provided in the Overall component.

Complete only the following fields:

• Applicant Information
• Type of Applicant (optional)
• Descriptive Title of Applicant’s Project
• Proposed Project Start/Ending Dates

Enter Human Embryonic Stem Cells in each relevant component.

Human Subjects: Answer only the Are Human Subjects Involved? and 'Is the Project Exempt from Federal regulations? questions.

Vertebrate Animals: Answer only the Are Vertebrate Animals Used? question.

Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

• In the Project Director/Principal Investigator section of the form, use Project Role of Other with Category of Core Lead and provide a valid eRA Commons ID in the Credential field.
• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
• Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.
• The Core Lead can be the same for this and other Cores described in this program.
• Describe the qualifications, training, and experience of the Core leaders/Principal Investigators and the staffing effort that will be provided to the individual Cores.

Budget forms appropriate for the specific component will be included in the application package.

The following activities are considered non-allowable costs and will not be funded under this Cooperative Agreement:

• Direct costs for expenses that are covered by the recipient's negotiated indirect cost rate agreement
• Costs for purchasing equipment are allowable only to replace existing BSL-3 equipment, or if required for operating the BSL-3, or if required to establish the optional Biocontainment Research Support Service(s) Core (as approved by NIAID program); no other equipment purchases are allowable costs
• Construction, renovation, or modernization of building systems
• Conduct of research and purchase of research supplies and reagents
• Purchase of animals, animal housing, or animal per diem costs

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

Specific Aims: List in priority order, the broad, long-range objectives and goals of the proposed Core.

Research Strategy: Provide the rationale for the Core and describe the Core’s relationship to the RBL’s mission and how it relates to the other Cores in the application. Describe the functions, services, technologies, and efficiencies to be provided. Discuss how the Core will contribute to the management and operation of the RBL, increase the efficiency of the research programs it supports and enhance the research productivity of the investigators. Indicate how these activities will interface with existing programs or processes at the institution and describe how the Core provides support to the institutional research goals for biodefense, emerging infectious diseases, and pandemic preparedness and response.

Describe processes for updating existing and/or establishing new training and/or BSL-3 best practices SOPs, in order to ensure a safe and secure work environment within the RBL and to support the RBLs mission to support research goals for biodefense, emerging infectious diseases, and pandemic preparedness and response. Outline training requirements for staff working in the BSL-3 and with select agents, as well as the processes to maintain required certifications and consistency in biosafety and biocontainment best practices. Include critical health and safety training, staff screenings and background checks required for working in a select agent facility, special handling of select agents. Describe processes for pathogen and select agent inventory and accountability that will support the research conducted at the RBL. Discuss user fees and other sources of program income if appropriate; any program income must be directed back into the program.

Other Plan(s):

Note: Effective for due dates on or after January 25, 2023, the Data Management and Sharing Plan will be attached in the Other Plan(s) attachment of the Overall component in FORMS-H application forms packages.

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

• All applicants planning research (funded or conducted in whole or in part by NIH) that results in the generation of scientific data are required to comply with the instructions for the Data Management and Sharing Plan. All applications, regardless of the amount of direct costs requested for any one year, must address a Data Management and Sharing Plan. The Data Management and Sharing (DMS) Plan must be provided in the Overall component.

Appendix:

Only limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions.

When involving human subjects research, clinical research, and/or NIH-defined clinical trials 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 a 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

Delayed Onset Study

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

When preparing your application, use Component Type Core.

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

Note: Effective for due dates on or after January 25, 2023, the Data Management and Sharing Plan will be attached in the Other Plan(s) attachment in FORMS-H application forms packages. If required, the Data Management and Sharing (DMS) Plan must be provided in the Overall component.

Complete only the following fields:

• Applicant Information
• Type of Applicant (optional)
• Descriptive Title of Applicant’s Project
• Proposed Project Start/Ending Dates

Enter Human Embryonic Stem Cells in each relevant component.

Human Subjects: Answer only the Are Human Subjects Involved? and 'Is the Project Exempt from Federal regulations? questions.

Vertebrate Animals: Answer only the Are Vertebrate Animals Used? question.

Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

• In the Project Director/Principal Investigator section of the form, use Project Role of Other with Category of Core Lead and provide a valid eRA Commons ID in the Credential field.
• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
• Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.
• The Core Lead can be the same for this and other Cores described in this program
• Describe the qualifications, training, and experience of the Core leaders/Principal Investigators and the staffing effort that will be provided to the individual Cores.

Budget forms appropriate for the specific component will be included in the application package.

The following activities are considered non-allowable costs and will not be funded under this Cooperative Agreement:

• Direct costs for expenses that are covered by the recipient's negotiated indirect cost rate agreement
• Costs for purchasing equipment are allowable only to replace existing BSL-3 equipment, or if required for operating the BSL-3, or if required to establish the optional Biocontainment Research Support Service(s) Core (as approved by NIAID program); no other equipment purchases are allowable costs
• Construction, renovation, or modernization of building systems
• Conduct of research and purchase of research supplies and reagents
• Purchase of animals, animal housing, or animal per diem costs

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

Specific Aims: List in priority order, the broad, long-range objectives and goals of the proposed Core.

Research Strategy: Provide the rationale for the Core and describe the Core’s relationship to the RBL’s mission and how it relates to the other cores in the application. Describe how the core will be managed. Describe the functions, services, technologies, and efficiencies to be provided. Discuss how the Core will contribute to the management and operation of the RBL, increase the efficiency of the research programs it supports and enhance the research productivity of the investigators. Indicate how these activities will interface with existing programs or processes at the institution and describe how the Core provides support to the institutional research goals for biodefense, emerging infectious diseases, and pandemic preparedness and response.

Succinctly summarize relevant biodefense and emerging infectious disease research at the institution that justifies the need for the proposed Biocontainment Research Service(s) Core. Describe how the program provides added value and/or impact to NIAID's mission to develop medical countermeasures for biodefense, emerging infectious diseases, and pandemic preparedness and response. Describe how the Core maintains up-to-date services and incorporates state-of-the-art, innovative technologies and resources to advance Biodefense and Emerging Infectious Diseases research. Describe how the proposed Core and support services provided within the RBL BSL-3 space will be made available to and benefit research across the NIAID Biodefense Facilities Network, and with outside academic and private collaborators. Describe the leadership plan for the Core, including a rationale for the leadership structure and how decisions are made within the leadership team. If needed, include an organizational chart. Provide a management plan that describes the day-to-day operations, communications, safety measures, training of Core staff, as needed. Based on the service(s) provided by this Core, as applicable, describe the plans to monitor quality control of the services offered, responded to problems as they arise, remediate issues of quality control, and communicate these issues to the end users. Describe the policies and procedures for prioritizing workload and individual Core usage with respect to evolving scientific priorities at the applicant institution, procedures for assessment of overall progress, and the process for reallocating funds within the Core, as needed and in consultation with leadership. For this Core, discuss potential problems, alternative strategies, and benchmarks for success. Describe the communication plan to solicit feedback from end users regarding the Core services, functions, and ability of the Core to meet institutional research needs. Discuss user fees and other sources of program income if appropriate; any program income must be directed back into the program.

Letters of Support:

Applicants must provide Letters of Support from organizations or institutions that may provide biological specimens, reagents, assays, or equipment services that may not be available through host institution agreements.

Other Plan(s):

Note: Effective for due dates on or after January 25, 2023, the Data Management and Sharing Plan will be attached in the Other Plan(s) attachment of the Overall component in FORMS-H application forms packages.

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

• All applicants planning research (funded or conducted in whole or in part by NIH) that results in the generation of scientific data are required to comply with the instructions for the Data Management and Sharing Plan. All applications, regardless of the amount of direct costs requested for any one year, must address a Data Management and Sharing Plan. The Data Management and Sharing (DMS) Plan must be provided in the Overall component.

Appendix:

Only limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions.

When involving human subjects research, clinical research, and/or NIH-defined clinical trials 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 a 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

Delayed Onset Study

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.

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) using ASSIST or other electronic submission systems. 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 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.

For information on how your application will be automatically assembled for review and funding consideration after submission go to: http://grants.nih.gov/grants/ElectronicReceipt/files/Electronic_Multi-project_Application_Image_Assembly.pdf.

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) and component Project Leads 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 provided on the application is the same identifier 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 and responsiveness NIAID, NIH. Applications that are incomplete, non-compliant 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.

Only the review criteria described below will be considered in the review process. Applications submitted to the NIH in support of the NIH mission are evaluated for scientific and technical merit through the NIH peer review system.

Note: Effective for due dates on or after January 25, 2023, the Data Sharing Plan and Genomic Data Sharing Plan (GDS) will not be evaluated at time of review.

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 and give 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.

Does the project address an important problem or a critical barrier to progress in the field? Is the prior research that serves as the key support for the proposed project rigorous? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

Specific for this FOA:

• Will the proposed Cores adequately support RBL operations and enhance and facilitate medical countermeasure research for biodefense, emerging infectious diseases, and pandemic preparedness and response at the RBL?
• Will the program as a whole provide the needed support to enhance productivity at the RBL?

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or those in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?

Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Have investigators included plans to address weaknesses in the rigor of prior research that serves as the key support for the proposed project? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?

If the project involves human subjects and/or NIH-defined clinical research, are the plans to address:

1) the protection of human subjects from research risks, and

2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of individuals of all ages (including children and older adults), justified in terms of the scientific goals and research strategy proposed?

Specific for this FOA:

• Is the program as a whole well-justified and does it provide the required resources and support to meet biodefense and infectious disease research needs?
• Are the management and operation plans adequate and feasible for the RBL to function as a regional resource for biodefense and emerging infectious diseases research?

Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?

Specific for this FOA:

• How well will the facility influence research towards the development of medical countermeasures for biodefense, emerging infectious diseases, and pandemic preparedness and response?

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the Core activities to meet the needs of individual Research Projects or other Cores, and to contribute to Center goals and objectives, in consideration of the following points (as applicable for the Core proposed).

Reviewers will consider each of the review criteria below, as appropriate for the individual core, in the determination of merit and will give an overall impact score for each Core but will not give separate scores for each criterion.

Facility Management, Maintenance and Operations Core

• Are the management and staffing plans for the Core appropriate for the proposed activities?
• Will the management structure provide adequate oversight and governance over fiscal and resource management for the RBL?
• Does the Core adequately ensure safe and secure operations of the laboratory; including compliance with biosecurity, select-agent, environment health and biosafety regulations?
• Are there appropriately defined plans and procedures for the monitoring of BSL-3 systems, preventative maintenance, and emergency repair of critical equipment, and required decontamination, retesting, and certification of BSL-3 containment facilities?
• If the Core Lead is different from the PD(s)/PI(s), do they have the appropriate qualifications, training, experience, and level of effort for the work described? Is the staffing for the Core reasonable and appropriate?

BSL-3 Practices Core

• How well will the plans for updating existing training and/or establishing new training for BSL-3 best practices ensure a safe and secure work environment within the RBL and support the RBLs mission to support research goals for biodefense, emerging infectious diseases, and pandemic preparedness and response.
• Will the processes described for pathogen and select agent inventory and accountability adequately support the research conducted at the RBL?
• If the Core Lead is different from the PD(s)/PI(s), do they have the appropriate qualifications, training, experience, and level of effort for the work described? Is the staffing for the Core reasonable and appropriate?

Biocontainment Research Support Service(s) Core (if applicable)

• How well does the proposed Core add significant value and impact to the RBL's mission to support and advance biodefense and emerging infectious disease research?
• Are the management plans for the Core appropriate for the proposed activities?
• If the Core Lead is different from the PD(s)/PI(s), do they have the appropriate qualifications, training, experience, and level of effort for the work described? Is the staffing for the Core reasonable and appropriate?

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.

For research that involves human subjects but does not involve one of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or more of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.

When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of individuals of all ages (including children and older adults) to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animals Section.

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.

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

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).

Reviewers will comment on whether the Resource Sharing Plan(s) (i.e., Sharing Model Organisms) or the rationale for not sharing the resources, is reasonable.

For projects involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.

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 for scientific and technical merit by (an) appropriate Scientific Review Group(s), convened by the National Institute of Allergy and Infectious Diseases (NIAID) in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.

As part of the scientific peer review, all applications:

• Will receive a written critique.

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

Applications will be assigned to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA . Following initial peer review, recommended applications will receive a second level of review by the National Advisory Allergy and Infectious Diseases Council . The following will be considered in making funding decisions:

• Scientific and technical merit of the proposed project as determined by scientific peer review.
• Availability of funds.
• Relevance of the proposed project to program priorities.

After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons. Refer to Part 1 for dates for peer review, advisory council review, and earliest start date.

Information regarding the disposition of applications is available in the NIH Grants Policy Statement.

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.

Institutional Review Board or Independent Ethics Committee Approval: Recipient institutions must ensure that protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in NIH-funded studies, the recipient must provide NIH copies of documents related to all major changes in the status of ongoing protocols.

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 will be required to complete an HHS Assurance of Compliance form (HHS 690) in which the recipient agrees, as a term and condition of receiving the grant, to administer their programs in compliance with federal civil rights laws that prohibit discrimination on the basis of race, color, national origin, age, sex and disability, and agreeing to comply with federal conscience laws, where applicable. This includes ensuring that entities take meaningful steps to provide meaningful access to persons with limited English proficiency; and ensuring effective communication with persons with disabilities. Where applicable, Title XI and Section 1557 prohibit discrimination on the basis of sexual orientation, and gender identity. 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 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 providing program access, reasonable modifications, and to provide effective communication, 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 religious nondiscrimination laws and 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

The following special terms of award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (DHHS) grant administration regulations at 45 CFR Part 75, and other HHS, PHS, and NIH grant administration policies.

The administrative and funding instrument used for this program will be the cooperative agreement, an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the recipients is anticipated during the performance of the activities. Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the award recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the recipients for the project as a whole, although specific tasks and activities may be shared among the recipients and the NIH as defined below.

The PD(s)/PI(s) will have the primary responsibility for:

• Ensuring that the facilities of the RBL are utilized to the fullest extent possible and that processes remain in place to facilitate collaborations with researchers outside of the RBL's institution.
• Attending the annual NIAID Biodefense Facilities Network meeting
• Operating the facility in a manner consistent with biosafety guidelines in the Biosafety in Microbiological and Biomedical Laboratories (BMBL) (https://www.cdc.gov/labs/BMBL.html), the Select Agent Rule (https://www.selectagents.gov/regulations/index.htm), and all other applicable federal, state, and local laws, regulations, and guidelines.
• Ensuring that non-human primate BSL-3 studies in the RBLs, including non-Good Laboratory Practices (GLP)studies, must be justified, conducted and well-documented in compliance with the Public Health Service (PHS) Policy on Humane Care and Use of Laboratory Animals, the NIH policy on Enhancing Reproducibility through Rigor and Transparency and the Food and Drug Administration’s Guidance for Industry: Product Development Under the Animal Rule.
• Recipients(s) will retain custody of and have primary rights to the data and software developed under these awards, subject to Government policies regarding rights of access consistent with current DHHS, PHS, and NIH policies.

NIH staff have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:

The role of NIH Project Scientists in the cooperative agreement arrangement is to support and stimulate the recipient's activities by substantial involvement as facilitators without assuming responsibilities that remain with the PD/PI. NIAID Project Scientists will work closely with PD(s)/PI(s) and other RBL member scientists to facilitate collaborations with other research groups and to leverage the resources available in the RBL. NIAID Project Scientists will monitor the progress of each RBL as well as help coordinate activities between them and contribute to the adjustment of research projects or approaches as warranted. NIAID Project Scientists will assist and facilitate the above activities but not direct it.

The NIAID Project Scientists will have the primary responsibility for:

• Monitoring activities to assure consistency with the overall goals of the RBL Program and the NIAID biodefense and emerging infectious diseases mission and will bring issues to the NIAID Biodefense Facilities Network as needed.
• Participating in and organizing the annual meeting of the NIAID Biodefense Facilities Network
• Being a resource for scientific and federal policy information as well as federal regulations required for the BSL-3, as appropriate
• Keeping the RBL informed about other ongoing studies supported by NIAID to avoid unnecessary duplication of effort and to encourage sharing and collaboration in the development of new clinically useful reagents and methodologies for biodefense and emerging infectious diseases research
• Advising the RBL of NIAID research priorities to facilitate and/or coordinate response activities (if appropriate) during a Biodefense incident or infectious disease outbreak
• Advising the RBL about other NIAID resources available to the research community, including NIAID sponsored contracts for preclinical and clinical testing, drug screening, preclinical toxicology testing, and assistance in IND filing, etc.

Additionally, a separate Program Official will be responsible for the normal scientific and programmatic stewardship of the award, including approval of equipment purchases, and will be named in the award notice.

Areas of Joint Responsibility include:

• The PD(s)/PI(s) will work with NIAID staff to schedule site visits (as requested by NIAID).
• Participation in the NIAID Biodefense Facilities Network to facilitate coordination and collaboration among the RBLs and NBLs and other biocontainment facilities; PD(s)/PI(s) of the RBLs and NBLs (BSL-3/4 facilities), and NIAID Program Officials will be members. Additional NIAID staff and scientists other than PD(s)/PI(s) may attend when additional expertise is required, as well as members of other federal agencies such as the FDA, USDA, and CDC.

Dispute Resolution Process

Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and the NIH may be brought to Dispute Resolution. A Dispute Resolution Panel composed of three members will be convened. It will have three members: a designee of the Steering Committee chosen without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual recipient. This special dispute resolution procedure does not alter the recipient's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulation 42 CFR Part 50, Subpart D and DHHS regulation 45 CFR Part 16.

Note: The NIH Policy for Data Management and Sharing is effective for due dates on or after January 25, 2023.

Consistent with the NIH Policy for Data Management and Sharing, when data management and sharing is applicable to the award, recipients will be required to adhere to the Data Management and Sharing requirements as outlined in the NIH Grants Policy Statement. Upon the approval of a Data Management and Sharing Plan, it is required for recipients to implement the plan as described.

When multiple years are involved, recipients will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement.

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. 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://www.era.nih.gov/need-help (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

Mark S. Williams, Ph.D.
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 240-627-3327
Email: mark.williams4@nih.gov

Scott Jakes, Ph.D.
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 240-627-3710
Email: scott.jakes@nih.gov

Michael Fato
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 240-669-2968
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) and under Federal Regulations 42 CFR Part 52 and 45 CFR Part 75 and 2 CFR Part 200.