Department of Health and Human Services

Part 1. Overview Information

Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

National Institute of Allergy and Infectious Diseases (NIAID)

Funding Opportunity Title

Limited Competition: National Biocontainment Laboratories (NBLs) Operations Support (UC7 Clinical Trials Not Allowed)

Activity Code

UC7 National Biocontainment Laboratory Operation Cooperative Agreement

Announcement Type

Reissue of RFA-AI-20-026

Related Notices

April 4, 2024 - Overview of Grant Application and Review Changes for Due Dates on or after January 25, 2025. See Notice NOT-OD-24-084.
August 31, 2022- Implementation Changes for Genomic Data Sharing Plans Included with Applications Due on or after January 25, 2023. See Notice NOT-OD-22-198.
August 5, 2022- Implementation Details for the NIH Data Management and Sharing Policy. See Notice NOT-OD-22-189.

Funding Opportunity Number (FON)

RFA-AI-25-013

Companion Notice of Funding Opportunity

None

Number of Applications

Only one application per institution is allowed, as defined in Section III. 3. Additional Information on Eligibility.

Assistance Listing Number(s)

93.855

Notice of Funding Opportunity Purpose

The goal of this notice of funding opportunity (NOFO) is to continue to provide operations support to the National Biocontainment Laboratories (NBLs) at the University of Texas Medical Branch (UTMB) in Galveston, Texas and Boston University in Boston, Massachusetts, if each application is meritorious. Operations support is provided in the following areas: facility maintenance and operations; biosecurity; environmental health and safety regulations and requirements; regulatory compliance; and specialized research support services. The NBLs serve as a national resource for efforts in conducting pre-clinical and laboratory (in vitro and in vivo) research and testing on hazardous biological agents in support of NIAID’s biodefense research efforts. Additionally, in times of a national biodefense emergency, the NBLs may be expected to rapidly realign their activities to assist response efforts within the United States (U.S.) under the direction of NIAID.

Funding Opportunity Goal(s)

To assist public and private nonprofit institutions and individuals to establish, expand and improve biomedical research and research training in infectious diseases and related areas; to conduct developmental research, to produce and test research materials. To assist public, private and commercial institutions to conduct developmental research, to produce and test research materials, to provide research services as required by the agency for programs in infectious diseases, and controlling disease caused by infectious or parasitic agents, allergic and immunologic diseases and related areas. Projects range from studies of microbial physiology and antigenic structure to collaborative trials of experimental drugs and vaccines, mechanisms of resistance to antibiotics as well as research dealing with epidemiological observations in hospitalized patients or community populations and progress in allergic and immunologic diseases. Because of this dual focus, the program encompasses both basic research and clinical research.

Key Dates

Posted Date

September 18, 2025

Open Date (Earliest Submission Date)

October 07, 2025

Letter of Intent Due Date(s)

Not Applicable

Application Due Dates			Review and Award Cycles
New	Renewal / Resubmission / Revision (as allowed)	AIDS - New/Renewal/Resubmission/Revision, as allowed	Scientific Merit Review	Advisory Council Review	Earliest Start Date
Not Applicable	November 07, 2025	Not Applicable	March 2026	May 2026	July 2026

All applications are due by 5:00 PM local time of applicant organization.

Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.

Expiration Date

November 08, 2025

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the Multi-Project (M) Instructions in the How to Apply - Application Guide, except where instructed to do otherwise (in this NOFO or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the How to Apply - Application Guide and the NOFO) is required and strictly enforced. Applicants must read and follow all application instructions in the How to Apply - Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the How to Apply - Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

There are several options available to submit your application through Grants.gov to NIH and Department of Health and Human Services partners. You must use one of these submission options to access the application forms for this opportunity.

Use the NIH ASSIST system to prepare, submit and track your application online.
Use an institutional system-to-system (S2S) solution to prepare and submit your application to Grants.gov and eRA Commons to track your application. Check with your institutional officials regarding availability.

Table of Contents

Part 1. Overview Information

Key Dates

Part 2. Full Text of Announcement

Section I. Notice of 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

Part 2. Full Text of Announcement

Section I. Notice of Funding Opportunity Description

Purpose

The purpose of this notice of funding opportunity (NOFO) is to continue to provide operations support to the National Biocontainment Laboratories (NBLs) at the University of Texas Medical Branch (UTMB) in Galveston, Texas and Boston University in Boston, Massachusetts, if each application is meritorious. Operations support is provided in the following areas: facility maintenance and operations; biosecurity; environmental health and biosafety regulations and requirements; regulatory compliance; and specialized research support services.

The overall goal of the NBL Operations Support Program is to enable the NBLs to maintain the research resources infrastructure and facilities required to conduct research that will facilitate the development of next generation therapeutics, diagnostics and vaccines for infectious diseases. NBLs are expected to be a national resource and to provide maximum containment research facilities for NIAID funded investigators and other research entities, as appropriate. Additionally, the NBLs must be prepared and available to provide facilities and support to first-line responders in the event of a public health emergency.

Background

In July 2006, NIAID awarded two NBL operations support cooperative agreements under "Notice of Limited Competition: NBL Operations Cooperative Agreements (NOT-AI-05-044)," to Boston University and the University of Texas Medical Branch at Galveston. Three additional five-year cycles were awarded in 2011, 2016 and 2021 for operations support. This NOFO is intended to continue operations support. The objectives of the NBLs extend beyond the scope of typical university-owned facilities. The cost of operating Biosafety Level-4 (BSL-4) laboratories is extraordinary compared to that of a typical biomedical research laboratory, due in large part to the rigorous Standard Operating Procedures, additional security requirements and safety precautions, as well as significantly higher utility costs. Neither the universities nor the research grants themselves can fully absorb the additional costs that these BSL-4 facilities and associated laboratories bear. It is essential to provide operations support in order to maintain the essential infrastructure to perform critical research on biodefense pathogens in a safe and secure environment.

Research Objectives

To achieve the objectives of this NOFO, the NBLs must consist of Operation Support Cores that address the following five areas:

Facility Maintenance and Operation - Provides high-containment operational management, monitoring and oversight; preventive maintenance in accordance with a lifecycle replacement and repair plan for critical equipment and systems necessary for operating a BSL-4 biocontainment laboratory (e.g., breathing air, effluent decontamination system, chemical showers); non-routine emergency repairs of BSL-4 biocontainment equipment and systems; and specialized training for facilities personnel working in and around the BSL-4 biocontainment space and associated laboratories and building systems.

Biosecurity – Ensures compliance with all evolving legislation and regulations related to control of select agents and other highly pathogenic agents; devises and directs relevant staff training activities; develops and implements prospective BSL-4 staff screenings and background checks; assists in planning for required biosecurity drills; and manages inventory and access to select agent inventories, including modernized tracking systems (e.g., unique identifiers for individual units of larger stocks). Components of a laboratory biosecurity program include physical security, personnel security, material control & accountability, transport security, and information security.

Environmental Health and Biosafety Regulations and Requirements - Provides critical health, safety, and training services; maintains consistency in biosafety and biocontainment practices; provides biosafety theory education and hands-on training; and leads registration, record keeping and administrative activities of the Federal Select Agent Program. Continuously maintains and monitors the integrity of the biocontainment areas; provides expertise in areas of primary containment operations, maintenance and certification; leads decontamination, retesting, and certification of biocontainment facilities; maintains the capability to respond to potential emergency events; and establishes a plan for the orderly shutdown and decontamination of containment due to weather or other events.

Regulatory Compliance - Provides oversight and coordination of all research functions that require compliance with regulatory statutes and guidelines for the purpose of supporting product licensure, promoting accuracy and integrity of any data generated in such studies; conducts relevant Good Laboratory Practice (GLP) compliance training for Core directors and key staff; develops and maintains policies and procedures pertaining to GLP research; and provides advice and oversight for equipment procurement and facility commissioning activities.

Integrated Support Services – Provides specialized services essential to support biocontainment activities in cores, such as for example veterinary, imaging, insectary, and aerobiology services. These services are to provide only partial costs of specialized biocontainment support resources and therefore the NBLs are required to develop and implement cost reimbursement business models that will generate grant or contract support for the direct costs of the research.

The NBL Core directors and support services staff are encouraged to collaborate with other NIH-funded investigators. It is expected that recipients will participate with other NIAID funded research activities including NIAID’s preclinical services programs. In addition, the NBLs should 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 NBL expertise by a broad range of qualified scientists. In times of a national biodefense emergency, the NBLs may be expected to rapidly realign their activities to participate and assist in response efforts within the United States (U.S.). This includes making their Core facilities, scientific expertise, and other resources available to assist in the implementation of national emergency plans.

National Biocontainment Laboratory/Regional Biocontainment Laboratory (NBL/RBL) Network

To ensure that the NBL Operations Support Program contributes maximally and effectively to the NIAID biodefense 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 NBL Program Directors/Principal Investigators (PDs/PIs). The NBLs will be members of, and contribute to, the NIAID NBL/RBL Network. The Network consists of the PDs/PIs of the National and Regional Biocontainment Laboratories and their respective key Core directors for biosafety, animal care, facilities maintenance/operations, and community relations. NIAID staff also participate. The Network will meet at least annually to discuss matters of mutual interest and to coordinate activities.

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

Section II. Award Information

Funding Instrument

Cooperative Agreement: A financial assistance mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, NIH scientific or program staff will assist, guide, coordinate, or participate in project activities. See Section VI.2 for additional information about the substantial involvement for this NOFO.

Application Types Allowed

Renewal - Renewals of RFA-AI-20-026

The OER Glossary and the How to Apply - Application Guide provides details on these application types. Only those application types listed here are allowed for this NOFO.

Clinical Trial?

Not Allowed: Only accepting applications that do not propose clinical trials.

Need help determining whether you are doing a clinical trial?

Funds Available and Anticipated Number of Awards

NIAID intends to commit up to $23 million in total costs in FY 2026 to fund 2 awards, contingent upon the submission of meritorious applications.

Award Budget

Application budgets are not expected to exceed $10 million direct costs per year and need to reflect the actual needs of the proposed project.
Moreover, the operation support provided to each site will be limited to a level commensurate with the site’s scientific capacity and capability for research activities as determined by NIAID.

Award Project Period

The maximum project period is 5 years.

NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from this NOFO.

Section III. Eligibility Information

1. Eligible Applicants

Eligible Organizations

The University of Texas Medical Branch at Galveston, TX
Boston University, Boston, MA

Foreign Organizations

Non-domestic (non-U.S.) Entities (Foreign Organization) 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.

Required Registrations

Applicant organizations

Applicant organizations must complete and maintain the following registrations as described in the How to Apply- 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. Failure to complete registrations in advance of a due date is not a valid reason for a late submission, please reference NIH Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications for additional information.

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.

Eligible Individuals (Program Director/Principal Investigator)

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.

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 How to Apply - Application Guide.

2. Cost Sharing

This NOFO does not require cost sharing as defined in the NIH Grants Policy Statement Section 1.2- Definitions of Terms.

3. Additional Information on Eligibility

Number of Applications

Only one application per institution (normally identified by having a unique entity identifier (UEI) number of NIH IPF number) is allowed.

The NIH will not accept duplicate or highly overlapping applications under review at the same time per NIH Grants Policy Statement Section 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 NIH Grants Policy Statement 2.3.9.4 Similar, Essentially Identical, or Identical Applications).

Section IV. Application and Submission Information

1. Requesting an Application Package

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 NOFO. See the administrative office for instructions if planning to use an institutional system-to-system solution.

2. Content and Form of Application Submission

It is critical that applicants follow the Multi-Project (M) Instructions in the How to Apply - Application Guide, except where instructed in this notice of funding opportunity to do otherwise and where instructions in the How to Apply - Application Guide are directly related to the Grants.gov downloadable forms currently used with most NIH opportunities. Conformance to the requirements in the How to Apply - Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

Page Limitations

All page limitations described in the How to Apply- Application Guide and the Table of Page Limits must be followed.

Component	Component Type for Submission	Page Limit	Required/Optional	Minimum	Maximum
Overall	Overall	12	Required	1	1
Admin Core	Admin Core	12	Required	1	1
Facility Maintenance and Operation Core	FMO Core	12	Required	1	1
Biosecurity Core	Biosecurity Core	12	Required	1	1
Environmental Health and Biosafety Regulations and Requirements Core	EHBRR Core	12	Required	1	1
Regulatory Compliance Core	Regulatory Core	12	Required	1	1
Integrated Support Services Core	Services Core	12	Required	1	1

Instructions for the Submission of Multi-Component Applications

The following section supplements the instructions found in How to Apply- Application Guide and should be used for preparing a multi-component application.

The application should consist of the following components:

Overall: required, 1
Administrative Core: required, 1
Facility Maintenance and Operation Core: required, maximum of 1
Biosecurity Core: required, maximum of 1
Environmental Health and Biosafety Regulations and Requirements Core: required, maximum of 1
Regulatory Compliance Core: required, maximum of 1
Integrated Support Services Core: required, maximum of 1

Overall Component

When preparing the application, use Component Type ‘Overall’.

All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions, as noted.

SF424(R&R) Cover (Overall)

Complete entire form.

PHS 398 Cover Page Supplement (Overall)

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

Research & Related Other Project Information (Overall)

Follow standard instructions.

Project/Performance Site Locations (Overall)

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.

Research and Related Senior/Key Person Profile (Overall)

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

Budget (Overall)

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.

PHS 398 Research Plan (Overall)

Specific Aims: List in priority order, the broad, long-range objectives and goals of the NBL. Recipients and subrecipients must transparently certify that they have completed all specific aims, as outlined in applicable prior awards received in the last 5 years, before receiving new awards.

Research Strategy: This section summarizes the overall objectives and strategic plan for the operation and use of the NBL and its Cores. Describe the NBL organization and management plans and the processes to be used to continue operations support priorities. Describe the purpose, structure, and functions of any advisors or advisory groups to the NBL. While advisors or advisory groups involved in the past funding cycle should be listed in the application, any new advisors or advisory groups should not be listed in the application or contacted until peer review activities have concluded. Address how the NBL 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 NBLs preventive maintenance plan for the lifecycle replacement and repair of critical equipment and systems necessary for operating BSL-4 biocontainment laboratories (e.g., breathing air, effluent decontamination system, chemical showers). Address how the NBL will interface with the NBL/RBL Network. Address how the NBL will be prepared to respond in the event of a national public health emergency. Address proposed methods for recovering costs of support for research projects conducted, in whole or in part, at the NBL. Briefly summarize plans for staff training and development. Training that can be supported by the NBL is limited to targeted instruction in the conduct of research in BSL-4 biocontainment facilities, including the specialized training for maintenance of maximum containment facilities and the essential training needed for personnel of the proposed Cores.

Resource Sharing Plan:
Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the How to Apply - Application Guide.

Other Plan(s):

All instructions in the How to Apply- 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.

Appendix:

Only limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in How to Apply- Application Guide; any instructions provided here are in addition to the How to Apply - 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 How to Apply - 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 How to Apply - 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 How to Apply- Application Guide must be followed.

PHS Assignment Request Form (Overall)

All instructions in the How to Apply- Application Guide must be followed.

Administrative Core

When preparing your application, use Component Type ‘Admin Core.’

All instructions in the How to Apply- Application Guide must be followed, with the following additional instructions, as noted.

SF424 (R&R) Cover (Administrative Core)

Complete only the following fields:

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

PHS 398 Cover Page Supplement (Administrative Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Administrative Core)

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.

Project/Performance Site Location(s) (Administrative Core)

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.

Research & Related Senior/Key Person Profile (Administrative Core)

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.

Budget (Administrative Core)

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

Applicants must budget for and request funds in the Administrative Core budget to alternately host the Biodefence Facilities Annual Meeting between the two NBL sites in Boston, MA and Galveston, TX and should also request funds in the Administrative Core budget for Core Leaders and other key personnel to attend the annual meeting.

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.

PHS 398 Research Plan (Administrative Core)

Specific Aims: List in priority order, the broad, long-range objectives and goals of the proposed Administrative Core. Recipients and subrecipients must transparently certify that they have completed all specific aims, as outlined in applicable prior awards received in the last 5 years, before receiving new awards.

Research Strategy: Describe plans and procedures for the Administrative Core. Describe approaches to the following activities:

Coordinate, supervise and manage all NBL activities.
Provide a supportive structure sufficient to ensure the accomplishment of all NBL goals.
Assist Core Leaders with administrative aspects of their Cores, such as gathering of progress reports.
Promote collaboration and coordination among Core Leaders.
Promote collaborations with the pertinent scientific communities, e.g., through presentations at scientific symposia and seminars.
Coordinate detailed communication of NBL efforts and progress with NIAID program staff, including organizing site-visits.

Management Plan: The Administrative Core should include a Management Plan that describes the organization of the proposed program and its management structure. The Management Plan should include:

The organization of the NBL and its management structure to form a cohesive, integrated and efficient program that provides scientific and administrative oversight (including fiscal accountability) of all NBL Cores; and
An overview of how the NBL will manage and prioritize multiple Research Projects.
A discussion of how the Administrative Core Lead will a) provide programmatic direction, coordination, and administrative management of the NBL; b) create within the Administrative Core an infrastructure that promotes cross-discipline interactions among all of the Cores; and c) provide oversight and governance over fiscal and resource management.

The Management Plan should include a Staffing Plan that describes the structure and roles of administrative and scientific staff, including their functions, and how the proposed structure will contribute to effectiveness of the management plan.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the How to Apply- Application Guide.

Appendix:

Only limited items are allowed in the Appendix. Follow all instructions for the How to Apply- Application Guide; any instructions provided here are in addition to those in the How to Apply- Application Guide instructions.

PHS Human Subjects and Clinical Trials Information (Administrative Core)

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 How to Apply- 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 How to Apply- 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 How to Apply- Application Guide must be followed.

Facility Maintenance and Operation Core

When preparing your application, use Component Type ‘FMO Core.’

All instructions in the How to Apply- Application Guide must be followed, with the following additional instructions, as noted.

SF424 (R&R) Cover (Facility Maintenance and Operation Core)

Complete only the following fields:

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

PHS 398 Cover Page Supplement (Facility Maintenance and Operation Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Facility Maintenance and Operation Core)

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.

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.

Project/Performance Site Location(s) (Facility Maintenance and Operation Core)

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.

Research & Related Senior/Key Person Profile (Facility Maintenance and Operation Core)

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 Leader biosketch should clearly reflect the appropriate qualification, training, and expertise to successfully manage all aspects of the Core.
The key personnel and any other significant contributors Biosketch must include the expertise each contributes to the Core.

Budget (Facility Maintenance and Operation Core)

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

PHS 398 Research Plan (Facility Maintenance and Operation Core)

Specific Aims: List in priority order, the broad, long-range objectives and goals of the proposed Core. Recipients and subrecipients must transparently certify that they have completed all specific aims, as outlined in applicable prior awards received in the last 5 years, before receiving new awards.

Research Strategy: Provide the rationale for the Core and describe the Core’s relationship to the NBL’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 NBL, increase the efficiency of the research programs it is supporting and enhance the research productivity of the investigators. In addition, indicate how these activities will interface with parallel, existing programs or processes at the institution and describe how the Core provides support to the institutional environment. Outline policies and plans for Core operation and quality control and describe the procedures for Core access and use prioritization. If the Core is used to train investigators in special techniques, the extent of, and approach to, this training should be included. Describe the cost reimbursement plan, including efforts to secure reimbursement from all users of the Core. Discuss user fees and other sources of program income if appropriate.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the How to Apply- Application Guide.

Appendix:

PHS Human Subjects and Clinical Trials Information (Facility Maintenance and Operation Core)

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 How to Apply- Application Guide, with the following additional instructions:

Study Record: PHS Human Subjects and Clinical Trials Information

All instructions in the How to Apply- 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 How to Apply- Application Guide must be followed.

Biosecurity Core

When preparing your application, use Component Type ‘Biosecurity Core.’

All instructions in the How to Apply- Application Guide must be followed, with the following additional instructions, as noted.

SF424 (R&R) Cover (Biosecurity Core)

Complete only the following fields:

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

PHS 398 Cover Page Supplement (Biosecurity Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Biosecurity Core)

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/Performance Site Location(s) (Biosecurity Core)

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.

Research & Related Senior/Key Person Profile (Biosecurity Core)

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 Leader expertise should be appropriate to successfully manage all aspects of the Core.
The key personnel and any other significant contributors Biosketch must include the expertise each contributes to the Core.

Budget (Biosecurity Core)

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

PHS 398 Research Plan (Biosecurity Core)

Research Strategy: Provide the rationale for the Core and describe the Core’s relationship to the NBL’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 NBL, increase the efficiency of the research programs it is supporting and enhance the research productivity of the investigators. Discuss how the Core will contribute to oversight of select agent inventories including modernized tracking systems (e.g., unique identifiers for individual units of larger stocks). In addition, indicate how these activities will interface with parallel, existing programs or processes at the institution and describe how the Core provides support to the institutional environment. Outline policies and plans for Core operation and quality control and describe the procedures for Core access and use prioritization. If the Core is used to train investigators in special techniques, the extent of, and approach to, this training should be included. Describe the cost reimbursement plan, including efforts to secure reimbursement from all users of the Core. Discuss user fees and other sources of program income if appropriate.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the How to Apply- Application Guide.

Appendix:

PHS Human Subjects and Clinical Trials Information (Biosecurity Core)

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 How to Apply- Application Guide, with the following additional instructions:

Study Record: PHS Human Subjects and Clinical Trials Information

All instructions in the How to Apply- 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 How to Apply- Application Guide must be followed.

Environmental Health and Biosafety Regulations and Requirements Core

When preparing your application, use Component Type ‘EHBRR Core.’

All instructions in the How to Apply- Application Guide must be followed, with the following additional instructions, as noted.

SF424 (R&R) Cover (Environmental Health and Biosafety Regulations and Requirements Core)

Complete only the following fields:

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

PHS 398 Cover Page Supplement (Environmental Health and Biosafety Regulations and Requirements Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Environmental Health and Biosafety Regulations and Requirements Core)

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/Performance Site Location(s) (Environmental Health and Biosafety Regulations and Requirements Core)

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.

Research & Related Senior/Key Person Profile (Environmental Health and Biosafety Regulations and Requirements Core)

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 Leader expertise should be appropriate to successfully manage all aspects of the Core.
The key personnel and any other significant contributors Biosketch should include the expertise each contributes to the Core.

Budget (Environmental Health and Biosafety Regulations and Requirements Core)

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

PHS 398 Research Plan (Environmental Health and Biosafety Regulations and Requirements Core)

Research Strategy: Provide the rationale for the Core and describe the Core’s relationship to the NBL’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 NBL, increase the efficiency of the research programs it is supporting and enhance the research productivity of the investigators. In addition, indicate how these activities will interface with parallel, existing programs or processes at the institution and describe how the Core provides support to the institutional environment. Outline policies and plans for Core operation and quality control and describe the procedures for Core access and use prioritization. If the core is used to train investigators in special techniques, the extent of, and approach to, this training should be included. Describe the cost reimbursement plan, including efforts to secure reimbursement from all users of the Core. Discuss user fees and other sources of program income if appropriate.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the How to Apply- Application Guide.

Appendix:

PHS Human Subjects and Clinical Trials Information (Environmental Health and Biosafety Regulations and Requirements Core)

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 How to Apply- Application Guide, with the following additional instructions:

Study Record: PHS Human Subjects and Clinical Trials Information

All instructions in the How to Apply- 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 How to Apply- Application Guide must be followed.

Regulatory Compliance Core

When preparing your application, use Component Type ‘Regulatory Core.’

All instructions in the How to Apply- Application Guide must be followed, with the following additional instructions, as noted.

SF424 (R&R) Cover (Regulatory Compliance Core)

Complete only the following fields:

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

PHS 398 Cover Page Supplement (Regulatory Compliance Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Regulatory Compliance Core)

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/Performance Site Location(s) (Regulatory Compliance Core)

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.

Research & Related Senior/Key Person Profile (Regulatory Compliance Core)

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 Leader expertise should be appropriate to successfully manage all aspects of the Core.
The key personnel and any other significant contributors Biosketch must include the expertise each contributes to the Core.

Budget (Regulatory Compliance Core)

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

PHS 398 Research Plan (Regulatory Compliance Core)

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the How to Apply- Application Guide.

Appendix:

PHS Human Subjects and Clinical Trials Information (Regulatory Compliance Core)

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 How to Apply- Application Guide, with the following additional instructions:

Study Record: PHS Human Subjects and Clinical Trials Information

All instructions in the How to Apply- 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 How to Apply- Application Guide must be followed.

Integrated Support Services Core

When preparing your application, use Component Type ‘Services Core.’

All instructions in the How to Apply- Application Guide must be followed, with the following additional instructions, as noted.

SF424 (R&R) Cover (Integrated Support Services Core)

Complete only the following fields:

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

PHS 398 Cover Page Supplement (Integrated Support Services Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Integrated Support Services Core)

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/Performance Site Location(s) (Integrated Support Services Core)

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.

Research & Related Senior/Key Person Profile (Integrated Support Services Core)

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 Leader expertise should be appropriate to successfully manage all aspects of the Core.
The key personnel and any other significant contributors Biosketch must include the expertise each contributes to the Core.

Budget (Integrated Support Services Core)

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

PHS 398 Research Plan (Integrated Support Services Core)

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the How to Apply- Application Guide.

Appendix:

PHS Human Subjects and Clinical Trials Information (Integrated Support Services Core)

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 How to Apply- Application Guide, with the following additional instructions:

Study Record: PHS Human Subjects and Clinical Trials Information

All instructions in the How to Apply- 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 How to Apply- Application Guide must be followed.

3. Unique Entity Identifier and System for Award Management (SAM)

See Part 2. 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

4. Submission Dates and Times

Part I. 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 Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications.

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 How to Apply- Application Guide.

5. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

6. Funding Restrictions

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 Section 7.9.1 Selected Items of Cost.

7. Other Submission Requirements and Information

Applications must be submitted electronically following the instructions described in the How to Apply - Application Guide. Paper applications will not be accepted.

For information on how applications will be automatically assembled for review and funding consideration after submission, refer 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 How to Apply - 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 by the National Institute of Allergy and Infectious Diseases, NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.

Mandatory Disclosure

Recipients or subrecipients must submit any information related to violations of federal criminal law involving fraud, bribery, or gratuity violations potentially affecting the federal award. See Mandatory Disclosures, 2 CFR 200.113 and NIH Grants Policy Statement Section 4.1.35.

Send written disclosures to the NIH Chief Grants Management Officer listed on the Notice of Award for the IC that funded the award and to the HHS Office of Inspector Grant Self Disclosure Program at [email protected].

Post Submission Materials

Applicants are required to follow the instructions for post-submission materials, as described in the policy.

Section V. Application Review Information

1. Criteria

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

Overall Impact - Overall

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).

Scored Review Criteria - Overall

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.

Significance

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?

Investigator(s)

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?

Specific for this NOFO:
How adequate are the qualifications, training, experience, and availability for the proposed Core leaders for the work described? To what extent are the staffing, expertise of the workforce and level of effort for individual Cores reasonable and appropriate?

Innovation

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?

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Have the 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, 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?

Environment

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?

Additional Review Criteria - Overall

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.

Protections for Human Subjects

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.

Inclusion of Human Subjects Policies

When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for inclusion. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.

Vertebrate Animals

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following three points: (1) a complete description of all proposed procedures including the species, strains, ages, sex, and total numbers of animals to be used; (2) justifications that the species is appropriate for the proposed research and why the research goals cannot be accomplished using an alternative non-animal model; and (3) interventions including analgesia, anesthesia, sedation, palliative care, and humane endpoints that will be used to limit any unavoidable discomfort, distress, pain and injury in the conduct of scientifically valuable research. Methods of euthanasia and justification for selected methods, if NOT consistent with the American Veterinary Medicine Association (AVMA) Guidelines for the Euthanasia of Animals, is also required but is found in a separate section of the application. For additional information on review of the Vertebrate Animals Section, please refer to the Worksheet for Review of the Vertebrate Animals Section.

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

For Renewals, the committee will consider the progress made in the last funding period.

Revisions

Not Applicable

Additional Review Considerations - Overall

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

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

Authentication of Key Biological and/or Chemical Resources:

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.

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.

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by the Center for Scientific Review (CSR), in accordance with NIH peer review policies and practices, 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.

Applications may undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review) will be discussed and assigned an overall impact score.

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

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 NOFO. 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.

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 Section 2.5.1. Just-in-Time Procedures. This request is not a Notice of Award nor should it be construed to be an indicator of possible funding.

Prior to making an award, NIH reviews an applicant’s federal award history in SAM.gov to ensure sound business practices. An applicant can review and comment on any information in the Responsibility/Qualification records available in SAM.gov. NIH will consider any comments by the applicant in the Responsibility/Qualification records in SAM.gov to ascertain the applicant’s integrity, business ethics, and performance record of managing Federal awards per 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.

3. Anticipated Announcement and Award Dates

After the peer review of the application is completed, the PD/PI will be able to access their 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 Section 2.4.4 Disposition of Applications.

Section VI. Award Administration Information

1. Award Notices

A Notice of Award (NoA) is the official authorizing document notifying the applicant that an award has been made and that funds may be requested from the designated HHS payment system or office. The NoA is signed by the Grants Management Officer and emailed to the recipient’s business official.

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.

Recipients must comply with any funding restrictions described in Section IV.6. Funding Restrictions. Any pre-award costs incurred before receipt of the NoA are at the applicant's own risk. For more information on the Notice of Award, please refer to the NIH Grants Policy Statement Section 5. The Notice of Award and NIH Grants & Funding website, see Award Process.

Institutional Review Board or Independent Ethics Committee Approval: Grantee 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.

2. Administrative and National Policy Requirements

The following Federal wide and HHS-specific policy requirements apply to awards funded through NIH:

The rules listed at 2 CFR Part 200, Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards.
The requirements established by Executive Order 14292, which prevents any awards from funding gain of function research.
Policies, actions, and definitions defined Executive Order 14292, supersede NIH’s implementation of the White House Office of Science and Technology Policy (OSTP) May 2024 U.S. Government Policy for Oversight of Dual Use Research of Concern and Pathogens with Enhanced Pandemic Potential (DURC/PEPP Policy). Accordingly, NIH has rescinded NOT-OD-25-061.
NIH will not accept competitive applications for grants and cooperative agreements submitted for due dates after today and/or R&D contract proposals submitted to solicitations issued after today for dangerous gain-of-function research, as defined in Section 8 of the Executive Order.
NIH intends to suspend ongoing funding in accordance with guidance developed under Section 3(b) of the Executive Order. All NIH awardees should review ongoing research activities to proactively identify potential dangerous gain-of-function research and identify safe actions to halt such research and to effectively comply with guidance once established.
All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the terms and conditions in the Notice of Award (NoA). The NoA includes the requirements of this NOFO. 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.

All federal statutes and regulations relevant to federal financial assistance, including those highlighted in NIH Grants Policy Statement Section 4 Public Policy Requirements, Objectives and Other Appropriation Mandates.

Recipients are responsible for ensuring that their activities comply with all applicable federal regulations. NIH may terminate awards under certain circumstances. See 2 CFR Part 200.340 Termination and NIH Grants Policy Statement Section 8.5.2 Remedies for Noncompliance or Enforcement Actions: Suspension, Termination, and Withholding of Support.

Pursuant to the Cybersecurity Act of 2015, Div. N, § 405, Pub. Law 114-113, 6 USC § 1533(d), the HHS Secretary has established a common set of voluntary, consensus-based, and industry-led guidelines, best practices, methodologies, procedures, and processes.

Successful recipients under this NOFO agree that:

When recipients, subrecipients, or third-party entities have:

ongoing and consistent access to HHS owned or operated information or operational technology systems; and
receive, maintain, transmit, store, access, exchange, process, or utilize personal identifiable information (PII) or personal health information (PHI) obtained from the awarding HHS agency for the purposes of executing the award.

Recipients shall develop plans and procedures, modeled after the NIST Cybersecurity framework, to protect HHS systems and data. Please refer to NIH Post-Award Monitoring and Reporting for additional information.

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 (HHS) grant administration regulations at 2 CFR Part 200, 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 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 NIH as defined below.

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

Recipients will have primary responsibility for the project as a whole, including all phases of the management, operation and maintenance of the National Biocontainment Laboratory (NBL). Such activities include research design and conduct, data collection, data quality control, data analysis and interpretation and preparation of publications, as well as collaborations with other recipients.
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 Regulations (https://www.selectagents.gov/regulations/), and all other applicable federal, state, and local laws, regulations, and guidelines.
Communicating within 24 hours with NIAID program staff in the case of any reportable incident with a biocontainment pathogen (e.g., exposure, inventory, release) commensurate with BMBL guidelinesand/or Federal Select Agent Program (FSAP) regulations. Communication should continue post-initial notification to include regular and timely updates with corrective actions to demonstrate adherence to guidelines/regulations.
Operating and maintaining the physical plant (facilities) in such a way that deterioration of the facility is prevented and that its ability to serve its intended purpose of providing an environment where biological research may be conducted in a safe, secure and efficient manner is preserved.
Supporting NIAID’s biodefense research efforts or other NIAID approved biomedical research activities for which it was constructed, including NIAID preclinical services programs (NIAID Preclinical Services to Address Key Product Development Gaps | NIAID: National Institute of Allergy and Infectious Diseases), for twenty years after occupancy unless prior written approval has been obtained from NIAID.
Making the therapeutic, vaccine and diagnostic products and other research tools and research materials they develop available to the biodefense research community through the NIAID Resources for Researchers or other appropriate vehicles.
Establishing and maintaining appropriate committees or other oversight groups for the NBL that include external scientific advisors as well as appropriate community members.
Maintaining community outreach and education efforts throughout the period of support.
Participating in projects that address specific biodefense problems or pathogens.
Participating, as needed, in regular meetings of the associated NBL to discuss progress and directions of research and to ensure that the necessary interdisciplinary interactions are taking place.
Ensuring that the facilities of the NBL are utilized to the fullest extent possible and that procedures remain in place to make facilities available to qualified users in the region/country.
Attending the annual NBL/RBL Network meeting and to host the meeting in alternating years.
Working with NIAID staff to schedule site visits as requested by NIAID.
Assisting national, state, and local public health effort in the event of a national biodefense emergency.
Recipients will retain custody of and have primary rights to the data and software developed under these awards, subject to Government rights of access consistent with current HHS, 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 NIAID staff in the cooperative agreement is to:

Support and stimulate the recipient's activities by substantial involvement as facilitators in the process without assuming responsibilities that remain with the PD(s)/PI(s).
Work closely with the PD(s)/PI(s) and other NBL member scientists to facilitate collaborations with other NIAID-funded research groups and to leverage the resources available in the NBL. They will assist and facilitate this process and not direct it.
Monitor the progress of the NBL as well as other participants in the NBL program, helping coordinate activities between them, and contributing to the adjustment of research projects or approaches as warranted. The NIAID Project Scientist will assist and facilitate this process and not direct it.
Monitor activities to assure consistency with the overall goals of the NBL Program and the NIAID biodefense mission. When appropriate, issues may be brought to the NBL/RBL Network for advice.
Help organize an annual meeting of the NBL/RBL Network.
Keep the NBL informed about other ongoing studies supported by NIAID to avoid duplication of effort and to encourage sharing and collaboration in the development of new clinically useful reagents and methodologies for biodefense research.
Coordinate access for the NBL to other resources from NIAID, including NIAID sponsored contracts for preclinical and clinical testing, drug screening, preclinical toxicology testing, and assistance in IND filing, etc.
Assist the research efforts of the NBL by facilitating access to fiscal and intellectual resources provided by industry, private foundations, NIH intramural scientists and other federal government agencies.
Additionally, an agency program official or IC program director will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice.

Areas of Joint Responsibility include:

The NBL/RBL Network will provide overall scientific operations 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 the NIAID Office of Biodefense, Research Resources and Translational Research Program Officers will be members. Additional NIAID Program Staff and scientists other than PIs may attend when additional expertise is required.
The NBL/RBL Network will meet yearly. The purpose of these meetings is to share biocontainment operations strategies in the areas of building systems maintenance, biosafety, and biosecurity as well as scientific information, to assess scientific progress, to identify new research and development opportunities and potential avenues of collaborations such as with industry, private foundations, NIH intramural scientists, and other federal government agencies and to establish priorities that will accelerate the translation of preclinical findings into clinical applications, reallocate resources and conduct other business of the biodefense facilities program.
The Network will be called upon to make recommendations regarding approaches to specific threat agents and emerging diseases that require attention as the need arises. The Network will also seek input from the scientific research communities. The Network will provide a forum for coordinating NBL/RBL activities that require a liaison function with other federal agencies such as FDA, USDA, and CDC.

Dispute Resolution:

Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between recipients and NIH may be brought to Dispute Resolution. A Dispute Resolution Panel composed of three members will be convened: a designee of the recipient, 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 HHS regulation 45 CFR Part 16.

3. Data Management and Sharing

Consistent with the 2023 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.

4. Reporting

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 Section 8.4.1 Reporting. To learn more about post-award monitoring and reporting, see the NIH Grants & Funding website, see Post-Award Monitoring and Reporting.

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 Section 8.6 Closeout. NIH NOFOs 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 2 CFR Part 200.301.

Section VII. Agency Contacts

We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.

Application Submission Contacts

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: [email protected] (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: [email protected]

Scientific/Research Contact(s)

Fayna Diaz San Segundo
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 240-921-3931
Email: [email protected]

Peer Review Contact(s)

Examine your eRA Commons account for review assignment and contact information (information appears two weeks after the submission due date).

Financial/Grants Management Contact(s)

Jordan Kindbom
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 240-669-2983
Email: [email protected]

Section VIII. Other Information

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.

Authority and Regulations

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 2 CFR Part 200.