NIH’s new Application Submission System & Interface for Submission Tracking (ASSIST) is available for the electronic preparation and submission of multi-project applications through Grants.gov to NIH. Applications to this FOA must be submitted electronically; paper applications will not be accepted. ASSIST replaces the Grants.gov downloadable forms currently used with most NIH opportunities and provides many features to enable electronic multi-project application submission and improve data quality, including: pre-population of organization and PD/PI data, pre-submission validation of many agency business rules and the generation of data summaries in the application image used for review.

Required Application Instructions

It is critical that applicants follow the 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) and where instructions in the Application Guide are directly related to the Grants.gov downloadable forms currently used with most NIH opportunities. 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 for Biosafety Level 4 (BSL4) facilities at the National Biocontainment Laboratories (NBLs) at the University of Texas Medical Branch (UTMB) in Galveston, Texas and Boston University in Boston, Massachusetts. Operations support is provided in the following areas: facility maintenance and operations; biosecurity (including biosafety) 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 develop and 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. As part of the NIAID Biodefense Network, NBLs are expected to be a national resource and to provide maximum containment research facilities for NIAID funded investigators and other research, 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.

NIAID awarded construction grants to the University of Texas Medical Branch and Boston University in 2003 to construct state-of-the-art BSL2/3/4 facilities to provide critical research resources, as recommended in 2002 by the NIAID Blue Ribbon Panel on Bioterrorism and Its Implications for Biomedical Research. As noted in the original solicitation issued by NIAID for the construction, recipients of NBL awards may compete for anticipated operations funding to support on-going costs. To that end, NIAID funded operations support grants in 2006 (http://www.grants.nih.gov/grants/guide/notice-files/NOT-AI-05-044.html) while construction of the facilities was ongoing to support the development and establishment of the NBLs organizational structure and operations support cores. Subsequent funding was awarded in 2011 to continue efforts to ramp up the organizational structure as well as maintain building operating systems; this FOA is intended to continue operations support. The costs associated with operating maximum containment laboratories are considered extraordinary for a typical university research facility. Therefore, continuing NBL operations funding support is essential.

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; routine facilities maintenance and upkeep of the physical plant that supports the high containment space including a preventative maintenance plan for all BSL 4 equipment and systems; non-routine emergency repairs of BSL4 equipment and systems; specialized training for facilities personnel working in and around BSL4 space and associated building systems; and community outreach and communications.

BioSecurity Ensures compliance with all evolving legislation and regulations related to control of select agents and other highly pathogenic agents; devises and directs relevant staff training activities; develops and implements prospective BSL 4 staff screenings and background checks; assists in planning for required biosecurity drills; and manages inventory and access to select agent inventories. 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 BSL 4 activities in such cores as veterinary, imaging, insectary, and aerobiology services. These services are to provide only partial costs of specialized 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 will be expected to rapidly realign their activities to assist response efforts within the US. 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:

• Basic biology of NIAID Category A-C Priority Pathogens and EID agents.
• Mechanisms of pathogenesis.
• Basic aspects of the innate and adaptive immune responses.
• Rapid, sensitive, and specific approaches for detection and identification for use in a clinical setting.
• 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 NBLs 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 Biodefense Facilities Program Office, in collaboration with the NBL Program Directors/Principal Investigators (PDs/PIs). The NBLs will be members of the NIAID 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 the NIAID Biodefense Facilities Program Officials. The Network will meet at least annually to discuss matters of mutual interest and to coordinate activities.

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

The following organizations/institutions are eligible to apply:

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) (formerly CCR) 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 and SAM registration in order to complete the eRA Commons registration. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration. 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).

In addition, the NIH will not accept a resubmission (A1) application that is submitted later than 37 months after submission of the new (A0) application that it follows. The NIH will accept submission:

• To an RFA of an application that was submitted previously as an investigator-initiated application but not paid;
• Of an investigator-initiated application that was originally submitted to an RFA but not paid; or
• Of an application with a changed grant activity code.

Applicants can access the SF424 (R&R) application package associated with this funding opportunity using the Apply for Grant Electronically button in this FOA or following the directions provided at Grants.gov.

Most applicants will use NIH’s ASSIST system to prepare and submit applications through Grants.gov to NIH. Applications prepared and submitted using applicant systems capable of submitting electronic multi-project applications to Grants.gov will also be accepted.

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, including Supplemental Grant Application Instructions 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.

For information on Application Submission and Receipt, visit Frequently Asked Questions Application Guide, Electronic Submission of Grant Applications.

Component Types Available in ASSIST	Research Strategy/Program Plan Page Limits
Overall	12
Admin Core	12
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
• Administrative Core: required
• Facility Maintenance and Operation Core: required
• BioSecurity Core: required
• Environmental Health and Biosafety Regulations and Requirements Core: required
• Regulatory Compliance Core: required
• Integrated Support Services Core: required

When preparing your application in ASSIST, 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 establish operations support priorities. Describe the purpose, structure, and functions of any advisors or advisory groups to the NBL. Address how the NBL and the proposed cores will interface with, support, and be supported by, the parent institution environment 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. Address how the NBL will interface with the NIAID Biodefense Facilities Network. Address how the NBL will be prepared to and 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. Summarize plans addressed in Cores to ensure staff preparedness for operating within BSL 4 biocontainment facilities. Training that can be supported by the NBL is limited to 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: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

When preparing your application in ASSIST, 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 NIAID Biodefense Facilities Network Meetings. These meetings are anticipated to be held at a location at/near Bethesda, Maryland.

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 establishing and managing an Administrative Core that provides the organizational capacity to ensure the following:

• 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 multiple Research Projects will be coordinated, integrated, and scientifically and technically managed to answer the scientific questions and hypotheses proposed within the application and within the scope of this FOA.
• 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 also include a Staffing Plan that describes the structure and roles of administrative and scientific staff, including their functions.

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: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

When conducting clinical research, follow all instructions for completing Planned Enrollment Reports as described in the SF424 (R&R) Application Guide.

When conducting clinical research, follow all instructions for completing Cumulative Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide.

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: Provide information on resources available for the Core. If there are multiple performance sites, describe the 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 should 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. NBL Cores are to be justified on the basis of need for NBL management and operation and use by independently funded NBL or NBL-linked investigators. 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 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: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

Planned Enrollment Report (Facility Maintenance and Operation Core)

When conducting clinical research, follow all instructions for completing Planned Enrollment Reports as described in the SF424 (R&R) Application Guide.

PHS 398 Cumulative Inclusion Enrollment Report (Facility Maintenance and Operation Core)

When conducting clinical research, follow all instructions for completing Cumulative Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide.

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: Provide information on resources available for the Core. If there are multiple performance sites, describe the 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 should 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. NBL Cores are to be justified on the basis of need for NBL management and operation and use by independently funded NBL or NBL-linked investigators. 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 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: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

Planned Enrollment Report (Biosecurity Core)

When conducting clinical research, follow all instructions for completing Planned Enrollment Reports as described in the SF424 (R&R) Application Guide.

PHS 398 Cumulative Inclusion Enrollment Report (Biosecurity Core)

When conducting clinical research, follow all instructions for completing Cumulative Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide.

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: Provide information on resources available for the Core. If there are multiple performance sites, describe the 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. NBL Cores are to be justified on the basis of need for NBL management and operation and use by independently funded NBL or NBL-linked investigators. 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 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: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

Planned Enrollment Report (Environmental Health and Biosafety Regulations and Requirements Core)

When conducting clinical research, follow all instructions for completing Planned Enrollment Reports as described in the SF424 (R&R) Application Guide.

PHS 398 Cumulative Inclusion Enrollment Report (Environmental Health and Biosafety Regulations and Requirements Core)

When conducting clinical research, follow all instructions for completing Cumulative Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide.

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: Provide information on resources available for the Core. If there are multiple performance sites, describe the 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 should 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. NBL Cores are to be justified on the basis of need for NBL management and operation and use by independently funded NBL or NBL-linked investigators. 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 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: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

Planned Enrollment Report (Regulatory Compliance Core)

When conducting clinical research, follow all instructions for completing Planned Enrollment Reports as described in the SF424 (R&R) Application Guide.

PHS 398 Cumulative Inclusion Enrollment Report (Regulatory Compliance Core)

When conducting clinical research, follow all instructions for completing Cumulative Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide.

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: Provide information on resources available for the Core. If there are multiple performance sites, describe the 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 should 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. NBL Cores are to be justified on the basis of need for NBL management and operation and use by independently funded NBL or NBL-linked investigators. 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 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: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

Planned Enrollment Report (Integrated Support Services Core)

When conducting clinical research, follow all instructions for completing Planned Enrollment Reports as described in the SF424 (R&R) Application Guide.

PHS 398 Cumulative Inclusion Enrollment Report (Integrated Support Services Core)

When conducting clinical research, follow all instructions for completing Cumulative Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide.

Part I. Overview Information contains information about Key Dates. 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.

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.

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 Applying Electronically. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Guidelines for Applicants Experiencing System Issues.

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 NOT-OD-13-030.

Only the review criteria described below will be considered in the review process. As part of the NIH mission, all applications submitted to the NIH in support of biomedical and behavioral research 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 programto 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 scientifically compelling?
• 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 focused on studies that meet the objectives of the FOA?
• Will the integration of the individual Cores be more beneficial than pursuing each project independently?

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

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

Significance

Does the program address an important problem or a critical barrier to progress in the field? If the aims of the program are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

Investigator(s)

Are the Core leaders, collaborators, and other researchers well suited to the program? If Early Stage Investigators or New Investigators, or 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 program is collaborative or multi-core lead, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the program?

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?

Innovation

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

Approach

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

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 children, justified in terms of the scientific goals and research strategy proposed?

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? Is the plan for the core to promote NBL interdisciplinary research and to provide unique research opportunities well documented and meritorious? Are the administrative plans for the management of the program, including plans for resolving conflicts, appropriate, effective and efficient? Are the management and operation plans for the NBL to function as a regional and national resource for Biodefense research adequate and feasible? Are the plans and procedures for quality control, cost effectiveness and cost reimbursement clear and reasonable?

Environment

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

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

As applicable for the program 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 six 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 six 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 program 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 children 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 five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia. 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 program 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) Genome Wide Association Studies (GWAS)/Genomic Data Sharing Plan .

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

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s), convened by the 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.

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.

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.

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 identified by the NIAID Biodefense Facilities Network that include common research interests that address specific biodefense problems or emerging infectious diseases.
• The Principal Investigator must participate, as needed, in regular, local meetings of the associated NBL and RBLs 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 the NIAID that describe activities and accomplishments during the previous funding/reporting period and attend an annual program meeting. Each NBL will also work with NIAID staff to schedule site visits or reverse site visits as requested by NIAID.
• Awardees agree to operate the facility in a manner consistent with biosafety guidelines in the BMBL, the Select Agent Rule, 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 Biodefense Agenda 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 bioterrorism emergency.
• 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 (http://grants.nih.gov/grants/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 Project Collaborators assigned to each NBL will work closely with the PD(s)/PI(s) and other RBL/NBL member scientists to facilitate collaborations with other NIAID-funded research groups and to leverage the resources available in the NBL. NIAID Project Collaborators will monitor the progress of the NBL as well as other participants in the RBL/NBL program, helping coordinate activities between them, and contributing to the adjustment of research projects or approaches as warranted. They will assist and facilitate this process and not direct it.

• The Project Collaborators as well as program officials or IC program director will also monitor activities to assure consistency with the overall goals of the RBL/NBL Program and the NIAID biodefense and emerging infectious diseases mission. When appropriate, issues may be brought to the NIAID Biodefense Network for advice.
• NIAID RBL/NBL Project Collaborators will help organize an annual meeting of The NIAID Biodefense Network.
• The NIAID Project Collaborators as well as program officials or IC program director 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 Project Collaborators 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. NIAID Project Collaborators 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.

Areas of Joint Responsibility include:

• The NIAID Biodefense Facilities Network will provide overall scientific coordination of the RBL/NBL Program; PD(s)/PI(s) of the RBL/NBLs (BSL3/4 facilities), and the NIAID NBL/RBL Program Officers will be members. Additional NIAID Program Staff and scientists other than PIs may attend when additional expertise is required.
• The NIAID Biodefense Network will meet yearly or as needed. The purpose of these meetings is to share 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 RBL/NBL Programs.
• The Network may recommend redirection of certain efforts in RBL/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 progress report, 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.

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

eRA Commons Help Desk (Questions regarding eRA Commons registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, post submission issues)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)
Finding Help Online: http://grants.nih.gov/support/index.html
Email: [email protected]

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading forms and application packages)
Contact Center Telephone: 800-518-4726
Web ticketing system: https://grants-portal.psc.gov/ContactUs.aspx
Email: [email protected]

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone: 301-710-0267
Email: [email protected]

Nancy Boyd
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 240-292-4119
Email: [email protected]

Travis Taylor, Ph.D.
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 240-669-5082
Email: [email protected]

Michael Fato
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 240-669-2968
Email: [email protected]

Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Part 75 .