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 FOA 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 for Biosafety Level 4 (BSL4) facilities. 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.

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. Two additional five-year cycles were awarded in 2011 and 2016 for operations support. This FOA is intended to continue operations support. The objectives of the NBLs extend beyond the scope of typical university-owned facilities. The cost of operating BSL4 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 BSL4 facilities bear. It is essential to provide operations support in order to maintain the infrastructure essential to perform critical research on biodefense and emerging infectious diseases in a safe and secure environment.

To achieve the objectives of this FOA 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 unique and necessary for operating a BSL4 laboratory (e.g., breathing air, effluent decontamination system, chemical showers); non-routine emergency repairs of BSL4 equipment and systems; and specialized training for facilities personnel working in and around BSL4 space and associated 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 BSL4 staff screenings and background checks; assists in planning for required biosecurity drills; and manages inventory and access to select agent inventories. 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 Select Agent program. Continuously maintains and monitors the integrity of the BSL4 containment areas; provides expertise in areas of primary containment operations, maintenance and certification; leads decontamination, retesting, and certification of BSL4 containment 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 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 BSL4 activities in such cores as veterinary, imaging, insectary, and aerobiology services. These services are to provide only partial costs of specialized BSL4 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.  In addition, the NBLs 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 or emerging infectious disease (EID) emergency, the NBLs 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. 

Examples of anticipated research areas using the NBLs as a resource include, but are not limited to, the following:

• Pathogen isolate characterization and propagation.
• Basic biology of NIAID Category A-C Priority Pathogens and EID agents (https://www.niaid.nih.gov/research/emerging-infectious-diseases-pathogens).
• Mechanisms of pathogenesis.
• Basic aspects of the innate and adaptive immune responses.
• Rapid, sensitive, and specific diagnostic approaches for detection and identification of infectious diseases.
• Target identification for diagnostics, therapeutics, and vaccines, including assay development.
• Development of new animal models for pathogenesis studies, for therapeutics and vaccine evaluation, and for rapid diagnostic studies. 
• Preclinical studies to facilitate translation of research findings into clinical interventions.
• Testing through clinical trials of potential therapeutics, diagnostics and vaccines.
• Zoonotic diseases research may be supported if it is relevant to the biology, diagnosis and treatment of the disease in humans

To ensure that the NBL Operations Support Program 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 the NIAID Extramural Biodefense Facilities Section, in collaboration with the NBL Program Directors/Principal Investigators (PDs/PIs). The NBLs will be members of the Biodefense Facilities Network, a group consisting 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, and staff from the NIAID Extramural Biodefense Facilities Section.  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.

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

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

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.

• Dun and Bradstreet Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number. After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.
• 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.
• eRA Commons - Applicants must have an active DUNS number to register in eRA Commons. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration, but 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 DUNS number and 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 underrepresented racial and ethnic groups as well as individuals with disabilities 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 DUNS number or NIH IPF number) is allowed."

The NIH will not accept duplicate or highly overlapping applications under review at the same time.  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 NOT-OD-11-101).

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.

Available Component Types	Research Strategy/Program Plan Page Limits
Overall	12 pages
Admin Core	12 pages
Core (use for Facility Maintenance and Operation; BioSecurity; Environmental Health and Biosafety Regulations and Requirements; Regulatory Compliance; and Integrated Support Services Cores)	12 pages each

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

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

The application should consist of the following components:

• Overall: required, maximum of 1
• Administrative Core: required, maximum of 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

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 NBL.

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 contacted or listed in the application. 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 unique and necessary for operating a BSL4 laboratory (e.g., breathing air, effluent decontamination system, chemical showers). Address how the NBL will interface with the Biodefense Facilities 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 BSL4 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 SF424 (R&R) Application Guide, with the following modification:

All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.

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 Admin Core .

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

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.

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

Budgeted costs may include support staff and travel. Applicants should request funds in the Administrative Core budget for the NBL Directors, Core Leaders and other key personnel to attend the annual Biodefense Facilities Network Meeting. The meeting site will alternate annually between the two NBL sites in Boston, MA and Galveston, TX.

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 Administrative Core.

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, including ongoing evaluation of research progress and encouraging data sharing.
• 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.
• Communicate and interact with NIAID staff.

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 SF424 (R&R) Application Guide, with the following modification:

All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.

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 in ASSIST, use Component Type Core.

All instructions in the SF424 (R&R) 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.

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.

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 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 (Facility Maintenance and Operation Core)

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

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 (Facility Maintenance and Operation Core)

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 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 SF424 (R&R) Application Guide, with the following modification:

All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.

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 in ASSIST, use Component Type Core.

All instructions in the SF424 (R&R) 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 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.

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.

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 (Biosecurity Core)

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 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 SF424 (R&R) Application Guide, with the following modification:

• All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.

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 in ASSIST, use Component Type Core.

All instructions in the SF424 (R&R) 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 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.

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.

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 (Environmental Health and Biosafety Regulations and Requirements Core)

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 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 SF424 (R&R) Application Guide, with the following modification:

All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.

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 in ASSIST, use Component Type Core.

All instructions in the SF424 (R&R) 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 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.

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.

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 (Regulatory Compliance Core)

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 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 SF424 (R&R) Application Guide, with the following modification:

All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.

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 in ASSIST, use Component Type Core.

All instructions in the SF424 (R&R) 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 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.

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.

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 (Integrated Support Services Core)

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 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 SF424 (R&R) Application Guide, with the following modification:

All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.

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 Component of the SF424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH.

The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the System for Award Management (SAM). 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 by components of participating organizations, 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.

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the program 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 program proposed).

Reviewers will consider each of the review criteria below in the determination of scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items.

• 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 there coordination and synergy of the individual cores towards the achievement of the central objectives of the proposed NBL?
• Are the overall goals significant and is the program as a whole focused?
• Will the program as a whole provide the needed support to ensure productivity at the NBL?
• Are the management and operation plans for the NBL to function as a regional and national resource for biodefense and emerging infectious diseases research adequate and feasible?

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the program 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 program 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 core that by its nature is not innovative may be essential to advance a field.

Does the core 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 core 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?

Are the Core leaders collaborators, and other researchers well suited to the core ? 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 core 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 core?

Specific for this FOA:

Do the proposed Core leaders have the appropriate qualifications, training, experience, availability and level of effort for the work described? Is the staffing of individual cores reasonable and appropriate?

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 core ? Have investigators included plans to address weaknesses in the rigor of prior research that serves as the key support for the proposed core? 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 core 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 core 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:

Will the proposed core adequately support NBL operations and enhance the NBL research base? Is the research base for use of the NBL and the plans for sustaining the research program(s) appropriate and reasonable? Are the administrative and management plans for the cores, appropriate for the proposed activities? Are the plans and procedures for quality control, cost effectiveness and cost reimbursement clear and reasonable?

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

Are the facilities and equipment appropriate for the proposed level of work?

As applicable for the cores 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 core 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 Animal 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

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

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 following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: 1) Data Sharing Plan; 2) Sharing Model Organisms; and 3) Genomic Data Sharing Plan .

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 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:

• 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.
• 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 grantee’s business official.

Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.

Any application awarded in response to this FOA will be subject to terms and conditions found on the Award Conditions and Information for NIH Grants website.  This includes any recent legislation and policy applicable to awards that is highlighted on this website.

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 awardee 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, Grantees, and Activities. More information is provided at Award Conditions and Information for NIH Grants.

Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights laws that prohibit discrimination on the basis of race, color, national origin, disability, age and, in some circumstances, religion, conscience, and sex.  This includes ensuring programs are accessible to persons with limited English proficiency. The HHS Office for Civil Rights provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-providers/provider-obligations/index.html and http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html.

HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research. For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA.

• Recipients of FFA must ensure that their programs are accessible to persons with limited English proficiency. HHS provides guidance to recipients of FFA on meeting their legal obligation to take reasonable steps to provide meaningful access to their programs by persons with limited English proficiency.  Please 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 further guidance on providing culturally and linguistically appropriate services, recipients should review the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care at https://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.
• Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please 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.  Please see https://www.hhs.gov/civil-rights/for-individuals/sex-discrimination/index.html; https://www2.ed.gov/about/offices/list/ocr/docs/shguide.html; and https://www.eeoc.gov/eeoc/publications/upload/fs-sex.pdf. 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.
• Recipients of FFA must also administer their programs in compliance with applicable federal religious nondiscrimination laws and applicable federal conscience protection and associated anti-discrimination laws.  Collectively, these laws prohibit exclusion, adverse treatment, coercion, or other discrimination against persons or entities on the basis of their consciences, religious beliefs, or moral convictions.  Please 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 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 awardees 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 awardees for the project as a whole, although specific tasks and activities may be shared among the awardees and the NIH as defined below.

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

• Awardees will have primary responsibility for the project as a whole, including all phases of the management, operation and maintenance of the 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 awardees. However, awardees must be committed to making the therapeutic, vaccine and diagnostic products and other research tools and research materials they develop available to the biodefense and emerging infectious disease research community through the NIAID Resources for Researchers Programs or other appropriate vehicles.
• Awardees agree to establish and maintain appropriate committees or other oversight groups for the NBL that include external scientific advisors as well as appropriate community members. Awardees also agree to maintain community outreach and education efforts throughout the period of support.
• Awardees agree to participate in projects that address specific biodefense problems or emerging infectious diseases.
• The Principal Investigator must participate, 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. Additionally, the Principal investigator must ensure 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.
• Each NBL will submit annual progress reports to NIAID that describe activities and accomplishments during the previous funding/reporting period. Each NBL is expected to attend the annual Biodefense Facilities Network meeting and to host the meeting in alternating years. Each NBL will also work with NIAID staff to schedule site visits as requested by NIAID.
• Awardees agree to operate 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.html), and all other applicable federal, state, and local laws, regulations, and guidelines.
• Awardees will be responsible for 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.
• Awardees agree that the facilities must be used in support of the NIAID’s biodefense and emerging infectious diseases research efforts or other NIAID approved biomedical research activities for which is was constructed for twenty years after occupancy unless prior written approval has been obtained from the NIAID. In addition, the facility must be available and prepared to assist national, state, and local public health effort in the event of a national biodefense or emerging infectious disease (EID) emergency.
• Non-human primate BSL4 studies in the NBLs, including non-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.
• Consortium Plan. In order to promote discussion and early consensus among the participants regarding intellectual property (IP) and management matters that may arise during NBL supported projects, the applicants are required to maintain a consortium plan as a term of award. While the specific terms of such a plan are left to the parties involved, NIAID recommends that the applicants consider the following points in the plan:
• Measures to ensure the rapid utilization of inventions to benefit the public health through, inter alia, diligence in seeking patent protection for and licensing of new inventions when appropriate and the timely publication of research results.
• Access by the NBL participants to each other’s pre-existing IP rights to background technology (inventions, know-how, materials, information) required for performing projects -through, for example, non-assertion clauses or cross-licenses.
• Ownership and management of inventions to include items such as assignment of IP rights to employers, recognition of controlling U.S. law for U.S. Government-funded inventions and, for joint inventions, agreements that address licensing strategy and royalty sharing.
• Exclusive/non-exclusive licensing option for commercial NBL participants.
• Notice of rights retained by the U.S. Government in inventions arising from federally funded NBL projects.
• Publication reporting and confidentiality to promote the preservation of patent filing rights.
• Other technology transfer activities among the various NBL participants, including but not limited to transfers of biological materials and other tangibles.
• Disposition of IP rights and tangible materials at the expiration/termination of the NBL project and also upon the early departure of NBL participants.
• Sharing of research reagents and research tools for research purposes among NBL participants and with other parties in accordance with the NIH Sharing Policies and Related Guidance on NIH-Funded Research Resources https://grants.nih.gov/policy/sharing.htm).
• Coordination of IP/technology transfer matters between the technology transfer/legal offices and the grants/contracts/sponsored research offices of academic/non-profit NBL participants.
• Overall management and, for major NBL projects that will utilize IP, tangible property and other resources of the NBL’s commercial participants (e.g., proprietary materials, trade secrets and other confidential information, personnel, budget, facilities/equipment, etc.), a management scheme that encourages the participation of those commercial participants.
• A mechanism for resolving disputes among the NBL participants.
• Terms for the potential addition and departure of NBL participants.
• Legal liability of consortium participants.
• Protection of Proprietary Data. Raw and primary data may be provided exclusively to the NIAID, industrial collaborators, and the FDA, as appropriate. This provision shall not affect the investigators' right to disseminate their research findings through publications or presentations.
• Awardees 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 NIH staff in the cooperative agreement arrangement 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/PI. The NIAID Program Officer assigned to each NBL will 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. The NIAID Program Officer will 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 Program Officer will assist and facilitate this process and not direct it.

• The Program Officer will monitor activities to assure consistency with the overall goals of the NBL Program and the NIAID biodefense and emerging infectious diseases mission. When appropriate, issues may be brought to the Biodefense Facilities Network for advice.
• The NIAID NBL Program Officer will help organize an annual meeting of the Biodefense Facilities Network.
• The NIAID Program Officer will 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 and emerging infectious diseases research. The NIAID Program Officer will 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. The NIAID Program Officer will 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 NIAID 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 Biodefense Facilities 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 (BSL3/4 facilities), and the NIAID NBL Program Officers will be members. Additional NIAID Program Staff and scientists other than PIs may attend when additional expertise is required.
• The Biodefense Facilities Network will meet yearly or as needed. 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 may recommend redirection of certain efforts in NBLs when results and data suggest that ongoing activities are no longer feasible or progressing toward desired goals. 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 also provide a forum for coordinating RBL/NBL activities that require a liaison function with other federal agencies such as 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 awardee. This special dispute resolution procedure does not alter the awardee'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.

When multiple years are involved, awardees 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.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All awardees of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000. See the NIH Grants Policy Statement for additional information on this reporting requirement.

In accordance with the regulatory requirements provided at 45 CFR 75.113 and Appendix XII to 45 CFR Part 75, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM) about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period.  The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (currently FAPIIS). This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313). As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available. Full reporting requirements and procedures are found in Appendix XII to 45 CFR Part 75 Award Term and Conditions for Recipient Integrity and Performance Matters.

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

eRA Service Desk (Questions regarding ASSIST, eRA Commons, application errors and warnings, documenting system problems that threaten submission by the due date, and post-submission issues)

Finding Help Online: http://grants.nih.gov/support/ (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources)
Email: GrantsInfo@nih.gov (preferred method of contact)
Telephone: 301-945-7573

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

Nancy Boyd
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 240-292-4119
Email: nboyd@niaid.nih.gov

Zhuqing Charlie Li, PhD
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 240-669-5068
Email: liz@niaid.nih.gov

Michael Fato
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 240-669-2968
Email:mfato@niaid.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.