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

This FOA encourages revision applications (formerly known as competitive supplements) to active NIH Center Grant awards of participating NIH Institutes and Centers. Specifically, the FOA invites revisions to support improvements in the physical infrastructure of animal research facilities to enhance scientific projects conducted by investigators associated with the Center who depend on and use animal models in their work. The scope of applications will vary and depend on particular research-related needs of investigators associated with the Center, with requests ranging from specialized equipment to alteration and renovation (A&R) projects.

This FOA targets currently active NIH Center project grants with project period end dates sufficiently far in the future to allow ample time to complete the revision project before the end date of the parent grant award. See Part 2. Section III.3 for more information on eligible projects.

It is expected that the PD/PI and Key Personnel of the revised application will have the capability and be in a position to successfully manage and accomplish the project; they are expected to have the relevant standing within the institutional administration structure, knowledge and experience in animal care, and appropriate technical expertise. Usually the PD/PI has broad understanding of research needs of investigators associated with the Center to oversee the scientific demands of the project. However, depending on the specific situation, a well-established animal model researcher or a scientific director of animal research facilities may need to be recruited to Key Personnel to strengthen expertise related to animal care and welfare, as well as animal research protocols. In addition, for projects with an A&R part, an individual with technical proficiency in engineering and architectural matters must be included as Key Personnel, to ensure that the technical issues related to the design and implementation of the projects are handled and solved with expertise and efficiency.

Biomedical research relies on animal models to explore fundamentals of biology, to investigate physiological and pathological conditions, to build models of human diseases, and to interrogate clinically-relevant procedures. This FOA does not offer direct funding for research activities; instead, it offers support of on-going research activities by providing assistance towards improvements of management of animal colonies, strengthening the rigor of the experimental set-ups, development of novel experimental protocols, and other enhancements of research conducted using animal models. This FOA encourages NIH-funded Centers to modernize the physical infrastructure to advance animal care and oversight, to strengthen the precision of experimental protocols, and to improve the reliability of research data generated from the use of animal models. As science progresses, the need for specific physical infrastructure supporting research activities evolves: new technologies become available to advance emerging research topics; understanding of factors contributing to experimental outcomes deepens and so increases the necessity for their control and assessment. This FOA focuses on infrastructure needs directly connected to on-going research dependent on the use of animal models. Support can be requested to purchase and install instruments and equipment, and to carry out A&R projects to enhance research using animal models, to improve the rigor of experimental protocols relying on animal models, and to advance the accuracy of animal models. It is expected that applicants will propose sustainable designs and use green technologies.

The requested equipment must be placed at a Center-affiliated or institutional animal facility, so that the equipment can be used by many investigators and have a broad impact on the institutional animal model research program. Similarly, if the focus of the request is on A&R, the modernized space must serve and benefit a group of investigators.

Support can be requested for, but is not limited to, the following activities:

• Purchasing and installing equipment and instruments for scientific laboratories and barrier facilities, including: microisolator cages, ventilated cages, metabolic cages, socializing cage systems, and specialized equipment for behavioral testing.
• Establishing animal model surgical suites.
• Creating specialized animal model facilities such as gnotobiotic facilities.
• Setting up computerized animal control and management systems, including tagging systems.

The proposed project must be standalone, self-contained and well-defined so that it can be accomplished within the one-year period of the budget support. Requests for replacement of aging or failing standard building infrastructure equipment, or routine maintenance and repair of the institution’s physical plant are not appropriate for this FOA.

Any project which includes an A&R part must be consistent with the following criteria and documentation requirements:

• The A&R project is essential for research activities supported by the parent grant and the space involved will be used for these activities.
• The building has a useful life consistent with program purposes and is architecturally and structurally suitable for conversion to the type of space required.
• If the space is rented, evidence is provided that the terms of the lease are compatible with the proposed A&R project and the expected subsequent uses of the improved facility.
• If the A&R will affect a site listed in (or eligible for inclusion in) the National Register of Historic Places, the requirements specified in "Preservation of Cultural and Historic Resources" have been followed.

In summary, this FOA supports revision applications of Center Grant awards provided the applicant team has the requisite scientific and technical expertise to carry out an improvement project to benefit research using the animal models..

Investigators are strongly encouraged to contact the Scientific/Research Contact listed in Section VII. Agency Contacts to discuss their planned projects before submitting applications.

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 in response to this FOA.

Higher Education Institutions

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

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

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

Nonprofits Other Than Institutions of Higher Education

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

Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.
Foreign components, as defined in the NIH Grants Policy Statement, are not allowed.

Applicant Organizations

Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.

• 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.

Applicant organizations may submit more than one application, provided that each application is scientifically distinct.

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).

Only one revision application per parent application is allowed.

In all cases, the parent project end date must be after February 2018; that is, at least one year from the earliest anticipated start date. Awards entering into an extension prior to the earliest anticipated start date, February/March 2017, are not eligible to apply.

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
Project (use for Animal Research Infrastructural Improvements)	12

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
• Animal Research Infrastructure Improvements: required; maximum of 1

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.

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.

Introduction to Application: For Revision applications, an Introduction to Application is required in the Overall component.

Specific Aims: State the specific goals set for the project to enhance animal model research projects conducted at the Center and summarize the proposed strategy to accomplish them. Describe the broad impact of the proposed improvements on animal model research at the Center and your institution; describe the scientific community associated with the Center who will benefit from the request.

Research Strategy: The Research Strategy should consist of the Center/Institutional Resources and the Research Projects sections as follows.

In the Center/Institutional Resources section provide a brief description of the animal-research resources at the Center or the animal research facility on which the Center depends. Present the current status of the Center/facility in the context of the number of animals it houses, the number of users it serves, and its role within the overall animal research program at the Institution.

Follow up with the Research Projects section to provide the justification for the request. Describe research projects which will benefit from the request in sufficient details for the reviewers to be able to judge the need for the request and its potential benefit for research activities at the Center. Describe animal models and experimental protocols; show how the request will contribute to experimental rigor and accuracy of experimental outcomes. Describe how current and future scientific needs will be accommodated by the proposed improvements. Give details of the budgetary support for the specific research projects, explaining whether they are directly supported by the Center or are funded by other grants. Describe how access to the facilities and equipment will be managed to ensure fair use on a shared basis. Describe any broader impact of the improvements on the animal model research program at your institution.

Resource Sharing Plan: Not Applicable

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.

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

When preparing your application in ASSIST, use Component Type Project.

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

Other Attachments: Include the following, each as a separate PDF attachment. Each attachment must be given a file name using the headings below (e.g., Requested Equipment).

• Requested Equipment: In Table 1, list all requested equipment. Include information such as the manufacturer, model number, size, capacity, and total cost. Total cost of each item must be supported by Vendor Quotes in the Budget Justification Section.
• Letter from Institution: A letter from a high ranking institutional official (e.g., Department Chairman, Dean, Vice President of Research etc.) indicating institutional engagement in the project. In addition, if the same institution simultaneously submits more than one application in response to this FOA and/or the related revision FOAs (RFA-OD-16-008, RFA-OD-16-007, RFA-OD-16-009), the letter must indicate that the multiple applications are not duplicates, but rather a campus wide plan for enhancements of animal models research and improvements of the related infrastructure.

Line Drawings: The line drawings must be included for all applications submitted to this FOA to indicate the location of the equipment and the A&R project (if applicable). Applications submitted that propose A&R without corresponding line drawings will be deemed incomplete and will not be reviewed. Although the line drawings do not count toward the page limits, additional text must not be included in the line drawings to circumvent the page limits.

Each Line Drawing must fit on one 8.5 x 11 sheet of paper. All floor plans must be legible with the scale clearly indicated.

Do not include construction design documents in the application. If an application is selected to be funded, the applicants will be asked to submit such documents for approval before proceeding with the project.

Provide the following information, as relevant to the project:

• Indicate the location of the proposed A&R area in the existing building, including any changes or additions to the existing mechanical, electrical, and plumbing (MEP) systems;
• Include floor plans of existing and proposed facilities;
• Give the net and gross square feet of space which will be affected by the project; in particular, indicate dimensions, functions, and the net and gross square feet for each room;
• Indicate the functional layout of the proposed facility showing the entries and exits; indicate the location of equipment (including racks and cages) and illustrate safety clearances and workspace; indicate traffic flow patterns of personnel, animals, and equipment.
• Reports: If applicable, include the Institutional Animal Care and Use Committee (IACUC) and (if accredited) the Association for Assessment and Accreditation of Laboratory Animal Care (AAALAC) summary reports, and/or sections of these reports that describe deficiencies of the facility and the animal care program.
• Institutional Occupational Health Program: Include information about your Institutional Occupational Health Program as it pertains to animal care staff.

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 Project 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.
• Applicants must justify the request by research needs and demonstrate Key Personnel’s expertise necessary to execute and complete the project. For example, an individual with technical proficiency in engineering must be included as Key Personnel on a project with an A&R part.

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

Contingency fees are NOT allowed.

F&A costs are not allowed.

The application must include:

• Vendor Quotes for each piece of the requested equipment;
• An itemized budget for the A&R part of the project design costs, costs of any alteration of existing structure, equipment and its installation costs.

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

Introduction to Application: For Revision applications, an Introduction to Application is allowed for each component.

Specific Aims: State the specific goals set for the project to enhance physical infrastructure of the animal facility and summarize the proposed strategy to accomplish them. State whether your request is for equipment only, or whether it combines equipment and related A&R, or the focus is on A&R efforts.

Research Strategy: Divide the Research Strategy narrative into four sub-sections: Current Infrastructure, Project Management, Requested Equipment, and Design Considerations. Begin each sub-section with an appropriate heading, as given below.

Current Infrastructure: Describe the infrastructure which will be improved by the project; address current deficiencies, how the planned project will correct these deficiencies and benefit animal model research. Describe the modifications to the existing facility to accommodate the proposed functions and the requested equipment.

Requested Equipment: State technical specifications of the equipment requested, if any. State where the equipment will be installed and give details about mechanical, electrical and plumbing needs, as applicable. Justify all requested equipment in the context of animal model research at the Center/facility. Compare any requested device, instrument, or equipment to other similar products on the market to show that the choice proposed is the best to meet the Center’s research needs. Describe how the animal model research will benefit from the request and how the Center/animal facility function will be enhanced.

Design Considerations: In this section, describe the architectural and engineering design of the project, as applicable. Provide sufficient details about its implementation, including any technical challenges that will need to be overcome. The level of detail of the application's Line Drawings, data in Table 1 (See "Research & Related Other Project Information"), and the engineering and architectural criteria narrative in this sub-section must provide sufficient information for reviewers to determine the functionality of the design plans, and the safety, reliability, and sustainability of the final product. Discuss the facility's placement in the building that houses it, and its relevance to the project.

Provide Engineering Criteria as relevant/applicable to the project:

• MEP specifications such as hot and cold water, and steam requirements; number of air changes per hour and any special ventilation requirements.
• Fire protection requirements; building automation systems; security/surveillance.
• Biohazard and radiation safety requirements; chemicals used.
• Provide Architectural Criteria as relevant to the project: width of corridors and doors, and surface finishes; quality of life issues (e.g., light levels, natural lighting, noise, vibration); functional relationships, and zoning of the renovated area.

Project Management: Describe the administrative structure and the oversight for the project; present the role that the PD/PI will play in coordinating and overseeing the activities of planning and conducting the project. Describe the specific roles of Key Personnel on the project, and how they will work together to complete the project on time and within budget.

Make sure that your narrative clearly defines the project as self-contained and feasible for completion within a one-year period of the budget. Show the timeline for completion of the project.

Letters of Support: A maximum of two optional letters of support may be attached in this section of the application

Resource Sharing Plan: Not Applicable

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.

PHS Inclusion Enrollment Report (Animal Research Infrastructure Improvements)

Not Applicable

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.

This revision provides support for equipment and A&R costs only. Grant personnel, supplies, travel, contingency fees and/or facilities and administrative costs are not allowable and if requested, will not be provided.

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. 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.

Your project should follow established guidelines regarding the use and care of laboratory animals, and the design requirements for animal facilities. Documents with relevant information are:

• NIH Design Requirements Manual
  http://orf.od.nih.gov/PoliciesAndGuidelines/BiomedicalandAnimalResearchFacilitiesDesignPoliciesandGuidelines/Pages/DesignRequirementsManualPDF.aspx
• Biosafety in Microbiological and Biomedical Laboratories, CDC/NIH, 5th Edition, http://www.cdc.gov/biosafety/.
• Information about the Select Agent Rule and related matters. http://www.selectagents.gov/
• Guide for the Care and Use of Laboratory Animals, National Research Council, National Academy Press, Washington, D.C. http://grants.nih.gov/grants/olaw/Guide-for-the-Care-and-Use-of-Laboratory-Animals.pdf .

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 project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).

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

Is there a strong scientific premise for the project? If the aims of the project are achieved, how will technical capability be improved?

Will the proposed project benefit animal model research at the Center? To what extent does the proposed change in the research infrastructure facilitate the Center’s ability to conduct, expand, improve, or maintain biomedical or behavioral research? Will the project, if successfully accomplished, permit implementation of research protocols which would not be possible otherwise? Will the project contribute to the accuracy of animal models and the rigor of experimental protocols?

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If the project is collaborative, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?

Are the PD/PI and Key Personnel qualified and experienced to carry out the technical aspect of the project, and to complete it on time and within the budget? Do PD/PI and Key Personnel show complementary scientific and technical skills necessary for this project? Do PD/PI and Key Personnel have a record of previous team work?

Do Key Personnel have the ability to communicate and interact with institutional officials to ensure successful completion of the project? Is there a letter from a senior official indicating appropriate Institutional engagement in the project (if it contains an A&R part)?

Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel instrumentation? Are approaches or instrumentation, 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?

How will the project improve the efficiency and utility of the animal research facility? Are innovative or efficient technical solutions proposed? Will the project, when implemented as proposed, enhance animal model research at the Center?

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented?

Is the choice of equipment, materials and construction methods well-justified and appropriate for the project?

Are requested equipment and instruments compared to other similar items on the market? Is the choice well explained in the context of the research needs of investigators associated with the Center?

Is the proposed design based on solid engineering principles? Are the design concepts well-chosen for the needs of the project and well-motivated? Does the design use efficient technical solutions that increase efficiency in the use of energy, water, and/or materials to reduce adverse effects to the environment? Can the project be accomplished as proposed within the budget and on time?

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?

Is the Institutional environment conducive for animal model research? Does the environment support collaborations and the shared use of resources? How compelling are the tangible benefits to the institutional research capability of the proposed project? Will the proposed project bring in state-of-the-art research capabilities or efficiencies that would otherwise not be available?

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

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

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

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

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

Not Applicable

Not Applicable

For Revisions, the committee will consider the appropriateness of the proposed expansion of the scope of the project. If the Revision application relates to a specific line of investigation presented in the original application that was not recommended for approval by the committee, then the committee will consider whether the responses to comments from the previous scientific review group are adequate and whether substantial changes are clearly evident.

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 Center for Scientific Review 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 on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the Council of Councils. 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. This includes, but is not limited to, geographical location, type of facilities, animal models, and overall impact on biomedical research.
• Ability to complete the project within a year and before the project end date for the parent grant award.

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. All projects that include A&R must submit 100% complete construction design documents within four months following the receipt of NoA. The construction documents must be approved by the NIH prior to beginning the A&R work. The PD/PI must plan and show how to complete the project within the remaining months following NIH approval of construction documents; that is, one year from the receipt of NoA. Hence, the earliest possible submission of the design documents is encouraged following the receipt of the NOA.

The environmental analysis (http://dpcpsi.nih.gov/sites/default/files/environmental_Analysis_Form.pdf) is not required at the time of the submission of the application. Instead, this information will be requested by a Grants Management Specialist as part of the Just-in-Time process (NOT-OD-10-120

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.

Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights law. This means that recipients of HHS funds must ensure equal access to their programs without regard to a person’s race, color, national origin, disability, age and, in some circumstances, sex and religion. This includes ensuring your programs are accessible to persons with limited English proficiency. 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. HHS provides general 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 http://www.hhs.gov/ocr/civilrights/resources/laws/revisedlep.html. The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html; and http://www.hhs.gov/ocr/civilrights/understanding/index.html. 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. Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at http://www.hhs.gov/ocr/office/about/rgn-hqaddresses.html or call 1-800-368-1019 or TDD 1-800-537-7697. Also note it is an HHS Departmental goal to ensure access to quality, culturally competent care, including long-term services and supports, for vulnerable populations. 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 http://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.

Cooperative Agreement Terms and Conditions of Award

Not Applicable

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 Service Desk (Questions regarding ASSIST, eRA Commons registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, 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)

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)
Email: [email protected] (preferred method of contact)
Telephone: 301-710-0267

Willie D. McCullough, Ph.D.
Office of Research Infrastructure Programs (ORIP)
Telephone: 301-435-0783
Email: [email protected]

Ross D. Shonat, Ph.D.
Center for Scientific Review (CSR)
Telephone: 301-435-2786
Email: [email protected].

Gloria Velez
National Center for Advancing Translational Sciences (NCATS)
Office of Research Infrastructure Programs (ORIP)
Telephone: 301-435-0875
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.