Part 1. Overview Information

Key Dates

It is critical that applicants follow the instructions in the Research (R) Instructions in the How to Apply - Application Guide, except where instructed to do otherwise (in this NOFO or in a Notice from NIH Guide for Grants and Contracts).

Conformance to all requirements (both in the Application Guide and the NOFO) 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.

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

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



Table of Contents
Part 1. Overview Information
Key Dates
Part 2. Full Text of Announcement
Section I. Notice of Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information

Part 2. Full Text of Announcement

Section I. Notice of Funding Opportunity Description

This Notice of Funding Opportunity (NOFO) invites applications from eligible institutions to seek support for the development of modern facilities that will expand the breeding capacity of active NIH-supported specific pathogen free (SPF) non-human primate (NHP) facilities to enable and enhance the conduct of cutting-edge biomedical and behavioral research on HIV/AIDS. NIH recognizes NHPs serve as critical animal models for broad biomedical research including several HIV/AIDS research areas and the COVID-19 pandemic exacerbated the shortage of SPF NHPs. Despite NIH efforts to improve the NHP availability, limited biomedical research resources still hamper the safe and effective production of these models. Therefore, through this NOFO, NIH intends to expand the support of NHP breeding resources to increase the output of NHP models substantively and cost-effectively and address the ongoing needs for HIV/AIDS research. Any facility supported by this NOFO must serve a broad basic, translational, clinical, and social and behavioral science HIV/AIDS research community locally or regionally. Targeted are NHP resource or breeding facilities that currently house NIH-supported SPF NHP colonies. For additional eligibility conditions check Section III.3.

Applications funded via this NOFO will be able to, through their enhancement of breeding facility and increase the SPF NHP colonies, support the NIH Office of AIDS Research priorities (see https://www.oar.nih.gov/hiv-policy-and-research/research-priorities), supporting activities that could ultimately help reduce HIV incidence thought the development and evaluation of vaccines, microbicides and prep, the development of effective and safe therapies, a better understanding of HIV-associated comorbidities, coinfections and complications:

NIH recognizes that modern physical infrastructure is necessary for the conduct of cutting-edge research or support specialized breeding operation. Dedicated space is required to house specialized equipment and to carry out experimental protocols. Equipment that enables automation and husbandry of the breeding facility, enhances modern operation, allows telemetry for field/corral monitoring, facilitates social behavioral interactions may be eligible under this NOFO. The scope of individual applications will vary and depend on the currently available infrastructure at the applicant institution, as well as the present and anticipated HIV/AIDS research needs. Requests must be justified by the needs for expanding the breeding capacity for support of HIV/AIDS research. The project, when completed, is expected to provide significant long-term cost-effective support for HIV/AIDS research, bringing the capacities and capabilities to a new level. Consequently, the applicant institution should demonstrate future-looking commitments towards the facility and HIV/AIDS research therein, by attaching a letter of support from a high-ranking institutional official.

Responses to this NOFO are restricted to SPF NHP colonies that are currently supported by NIH. Those facilities that were adversely affected by recent natural disasters such as Hurricane Maria and Fiona are highly encouraged to apply. Any request must be well justified by current and projected research needs.

For applications submitted to this NOFO, it is expected that each project will implement the best engineering solutions and modern technologies. Specific requested engineering solutions will be driven by research demands, such as the need to create shielded space to house certain equipment or to meet specific needs of social science and biobehavioral or biomedical research work.

Requests for regular maintenance, replacement of aging or failing equipment, and other routine work are not appropriate for this NOFO. Also inappropriate are requests for upgrades of a space serving a single investigator, facilities for billable medical care, office space, and classrooms. Such inappropriate requests will not be supported.

Applicants may request funds to cover design and implementation costs of the project. Specifically, the allowable costs include the architectural and engineering design fees, contingency fees, construction and fixed equipment expenses, and fees for commissioning of the facility. See the Funding Restrictions section for further details on allowable and non-allowable costs. Applicants are encouraged to follow sustainable design principles and to use green technologies.

To appropriately conceive, develop, construct, and successfully complete the project, a Program Director/Principal Investigator (PD/PI) should possess knowledge of the NHP breeding as well as NHP-related HIV/AIDS research field, have a vested professional interest in the success of the project, demonstrate leadership skills, and assemble a team with technical expertise related to all aspects of the project. The PD/PI does not need to be a currently NIH-funded investigator but should have the appropriate standing in the institutional administration and the research community to lead and oversee the project.

The project should meet the following criteria and documentation requirements:

? The project must be essential to expand breeding SPF NHPs to support high priority HIV/AIDS-related research.

? The facility must have a useful life of 10 years or longer following occupancy, consistent with program purposes, including the time to construct and complete the project.

? For modernization and renovation projects, the structure must be architecturally and physically suitable for conversion to the type of research space required.

? If the space is rented, evidence must be provided that the terms of the lease and expected subsequent use of the facility are consistent with the proposed project. Specifically, a signed document from the building owner must be provided, detailing that the terms of the lease agreement and subsequent use of the facility will comply with the 10-year term of the Notice of Federal Interest (NFI) requirement following the occupancy of the facility. A statement of agreement by the owner of the space must be included at the time of application submission. These documents will be verified if/when the application is considered for funding.

? If the project will affect a site listed (or eligible for inclusion) in the National Register of Historic Places, the requirements specified in "Preservation of Cultural and Historic Resources" must be followed.

Funding for awards will be allocated by OAR and administered by ORIP.

PDs/PIs 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.

Section II. Award Information

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

Section III. Eligibility Information

1. Eligible Applicants

Only institutions with SPF NHP colonies currently supported by NIH are eligible to apply, with the support mechanisms clearly identified.

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 Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.

• System for Award Management (SAM) Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.

• NATO Commercial and Government Entity (NCAGE) Code Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.
• Unique Entity Identifier (UEI)- A UEI is issued as part of the SAM.gov registration process. The same UEI must be used for all registrations, as well as on the grant application.
• eRA Commons - Once the unique organization identifier is established, organizations can register with eRA Commons in tandem with completing their Grants.gov registration; all registrations must be in place by time of submission. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
• Grants.gov Applicants must have an active SAM registration in order to complete the Grants.gov registration.

Program Directors/Principal Investigators (PD(s)/PI(s))

All PD(s)/PI(s) must have an eRA Commons account. PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director/Principal Investigator (PD/PI) is invited to work with his/her organization to develop an application for support. Individuals from diverse backgrounds, including underrepresented racial and ethnic groups, individuals with disabilities, and women are always encouraged to apply for NIH support. See, Reminder: Notice of NIH's Encouragement of Applications Supporting Individuals from Underrepresented Ethnic and Racial Groups as well as Individuals with Disabilities, NOT-OD-22-019.

Multiple PDs/PIs are not allowed.

The PD/PI should hold appropriate stature within the institutional administration structure and NHP-related HIV/AIDS research community to be able to oversee various facets of the entire project. The PD/PI should also have a demonstrated record of leadership skills to recruit and guide expert Key Personnel with complementary technical and scientific skills to successfully accomplish the construction project.

For the description of roles of Key Personnel, see Senior/Key Person Profile Expanded.

2. Cost Sharing

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

3. Additional Information on Eligibility

Number of Applications

Only one application per institution (identified by NIH IPF number) is allowed.

NIH will not accept duplicate or highly overlapping applications under review at the same time per NIH Grants Policy Statement Section 2.3.7.4 Submission of Resubmission Application. This means that the NIH will not accept:

• A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.
• A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.
• An application that has substantial overlap with another application pending appeal of initial peer review (see NIH Grants Policy Statement 2.3.9.4 Similar, Essentially Identical, or Identical Applications).

Only institutions with SPF NHP colonies currently supported by NIH are eligible to apply, with the support mechanisms clearly identified.

Section IV. Application and Submission Information

1. Requesting an Application Package

The application forms package specific to this opportunity must be accessed through ASSIST, Grants.gov Workspace or an institutional system-to-system solution. See the administrative office for instructions for plans to use an institutional system-to-system solution.

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in the Research (R) Instructions in the How to Apply - Application Guide, except where instructed in this notice of funding opportunity to do otherwise. 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.

Letter of Intent

Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.

By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:

• Descriptive title of proposed activity
• Name(s), address(es), and telephone number(s) of the PD/PI
• Names of other key personnel
• Participating institution(s)
• Number and title of this funding opportunity

The letter of intent should be sent to:

Monika Aggarwal, PhD
Office of Research Infrastructure Programs (ORIP)
Telephone: 301-435-0777
Email: [email protected]

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

The following exceptions or additional requirements apply:

• For this NOFO, there is no Research Strategy.

The Project Information attachment of the SF424 (R&R) Other Project Information form is limited to:

• Overview (in lieu of Specific Aims): 1 page
• Scientific Justifications and Project Description sections: 12 pages in total, excluding Line Drawings and specifically required Tables

The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an application to this NOFO.

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

The following additional instructions apply:

Estimated Project Funding: Applicants must provide the 'Total Federal Funds Requested', 'Total Federal and Non-Federal Funds', and 'Estimated Program Income .

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

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

Other Project Information attachment should consist of three sections: Overview, Scientific Justification, and Development of the Facility.

Overview (in lieu of Specific Aims) cannot exceed 1 page and must summarize the project, stating its goals, and outlining the proposed approaches to achieve them. Specifically, this section should include a description of the space affected by the project and any equipment which is requested in this application Tables 1 and 2 in Other Attachments may be referenced to simplify the presentation. This section should also state how the proposed project will address current and projected SPF NHP needs and advance HIV/AIDS research using SPF NHPs locally, regionally, and nationally Table 3 in Other Attachments may be referenced.

It is up to the PD/PI to allocate 12 pages to two sections Scientific Justification, and Development of the Facility. A successful application does not need to reach the page limitation; however, it must justify the request from a scientific perspective and describe technical design approaches with enough details to make clear the merits of the overall project.

The Scientific Justification section should describe current and projected SPF NHP needs in HIV/AIDS research, including justification of how the improvement to the physical infrastructure will meet the identified needs.

The text should include an overview of research programs and the spaces available for these research activities at the institution. The applicant should outline the breadth of local, regional, and national collaborations involved in these projects. Currently active HIV/AIDS research projects using SPF NHPs funded by NIH to the applicant institution and other institutions that would benefit from the proposed infrastructure projects - along with funding from other sources, including other federal agencies, private foundations, and institutional research support should be discussed to illustrate present needs and breadth of research involving SPF NHPs, and to establish a basis for future demands. Deficits in the available research infrastructure and plans to address them should be a part of the justification for the new infrastructure. This justification should be specific about the required infrastructure and address the relevant expertise and other available resources on which plans for the research expansion are based. To summarize this narrative, Table in other Attachments may be referenced. Current research operations should be linked to anticipated future activities, as the proposed infrastructure improvements should offer remedy of current needs and long-term benefits for the conduct of research using SPF NHPs. The applicant should specify how the proposed improvements will impact and enhance future research activities requiring SPF NHPs.

Without duplicating information in bio-sketches, this section should conclude with a paragraph about the qualifications of the PD/PI to lead the construction/modernization project from conception to completion, by working with Key Personnel on overseeing the planning process and its execution see Senior/Key Person Profile Expanded Section. It is important for the PD/PI to document that the team has the expertise and skills necessary to design and construct the facility to meet the project objectives. The text should outline the qualifications of a Construction Project Manager to oversee the technical aspect of the project and present the administrative and communication plan between that person and other team members for the duration of construction, inspection, and commissioning of the facility. This section should also include qualifications of the Facility Manager (if different from the PD/PI), administrative approach to managing the facility, and communication plan with institutional officials of the appropriate level.

The Development of the Facility section should present details of the architectural and engineering designs, their technical specifications, and proposed construction processes. The PD/PI should delineate implementation plans of the project, including any technical and practical challenges that will need to be overcome.

This narrative should start with the description of the location of the structures and the facilities that are affected by the project, and their placement in relation to other buildings in the immediate area. The design specifications must meet the requirements set by research needs and operating procedures described in the Scientific Justification section. The level of detail of the narrative of this section together with the application's Line Drawings, data in Tables 1 and 2 (see below) in Other Attachments must provide sufficient information for reviewers to determine the functionality of the overall design plans and the safety and reliability of the proposed facilities. Similarly, the narrative should justify all requested fixed equipment by its relevance to the function of the facility. Also, the mechanical, electrical, and plumbing (MEP) specifications for all fixed equipment should be presented compare data in Table 2 in the Other Attachments section. The facility should be designed to current engineering standards that will ensure the construction of a fully functional and operational facility.

Facility design must be compliant with the Public Health Service (PHS) Policy on Humane Care and Use of Laboratory Animals (Policy) and Guide for the Care and Use of Laboratory Animals (Guide) by balancing engineering and performance standards and setting a target for optimal practices, management, and operations while encouraging flexibility and judgment. All institutions are also required to comply, as applicable, with the standards described in the Animal Welfare Act, and other Federal statutes and regulations.

The PD/PI should provide engineering and architectural design criteria relevant to the proposed project, such as:

• MEP specifications such as hot and cold water and steam requirements; number of air exchanges per hour and heating, cooling, and ventilation requirements;
• Fire protection requirements; building automation systems; security/surveillance;
• Biohazard and radiation safety requirements; chemicals used;
• Width of corridors and doors and surface finishes;
• Quality of life issues (e.g., light levels, natural lighting, noise, vibration);
• Access and egress routes;
• Structural specifications for elements such as buildings, their roofs, fences, loading docks;
• Functional relationships and zoning of the area.

All these criteria should be justified in the context of the specific function of the requested facility to support SPF NHP-based HIV/AIDS research. Construction design for the NIH-funded facilities shall conform to the latest edition of the NIH Design Requirements Manual (DRM).

Whenever practicable, the applicant should employ sustainable design practices and green technologies. Sustainability is the outcome of an integrated process of facility development and operation, incorporating a balance of life-cycle cost, environmental impact, and occupant health, safety, security, and productivity. The following primary elements of sustainable design should be discussed, as applicable:

• Optimization of energy use;
• Protection and conservation of indoor and outdoor water (e.g., fixtures that reduce the amount of water used; recycling of wastewater, natural site drainage, and low impact stormwater retention);
• Indoor environmental quality, including ventilation and thermal comfort, humidity control, and day lighting;
• Reducing the environmental impact of materials by using low-emitting materials and minimizing use of ozone depleting compounds, construction waste reuse and recycling, and maximizing recycled and bio-based content.

If an award is made, for all improvements and repair projects that impact 40% or more of the overall floor area of a building, the applicant must obtain certification, during the design phase, from the U.S. Green Building Council's Leadership in Energy and Environmental Design (LEED) or the Green Building Initiative's Green Globes System Certification rating system.

Other Attachments (required): Other Attachments do not count towards the page limit, but please do not include additional text to circumvent that limit. The PD/PI must include the following required documents as indicated below, each as a separate attachment with a filename using the headings below (e.g., Line Drawings, Budget Justification, and so forth):

1) Line Drawings (required): Each line drawing must be formatted to fit in an 8.5" x 11" sheet of paper. Do not submit "blueprints" or construction documents. All line drawings must be legible with the scale clearly indicated on each page. The line drawings must indicate the location of the proposed construction on the site, including:

• Functional layout of the entire area;
• Locations of existing and proposed access and egress routes, buildings, corrals, fences, and their approximate dimensions;
• Floor plans of the building indicating the location of fixed equipment and illustrating safety clearances and workspace.

If applicable, submit drawings of the existing space along with the proposed space. The line drawings must indicate:

• Location of the proposed construction/renovation area in the existing building;
• Size, dimensions, function, and the net and gross square footage for each room;
• Functional layout of the proposed facility showing the location of entries and exits, egress routes, clearances, and the location of fixed equipment;
• Changes or additions to existing mechanical, electrical, and plumbing systems; notes that annotate these changes may be made directly on the plan.

Although the line drawings do not count toward the page limits, do not include additional text to circumvent these limits.

2) Table 1 (required): List the size (dimensions) and square footage of each component (e.g., clean room, laboratory, closet) that will be directly affected by the project.

3) Table 2 (required): List of requested fixed equipment. This table should include information such as the manufacturer, model number, size, functional capacity, total cost, and location in the facility. Total cost of each item must be supported by a vendor quote in the Budget Justification Attachments.

4) Table 3 (required): Provide a list of active HIV/AIDS research awards using SPF NHPs that drive the need for this project. These awards may include awards to internal investigators, and awards to external collaborators

Select these awards as representative projects, demonstrating their relation to the NIH-established priorities for HIV/AIDS research. The table must have the following columns: Source of Funding, Grant Number, Principal Investigator, Grant Title, Institution, State, Project Start Date, and Project End Date.

5) Budget Justification and Vendor Quotes (required): All vendor quotes should be attached here, along with a justification for each piece of fixed equipment. In addition to supplying vendor quotes, as applicable, the budget justification should include detailed breakdowns of the costs that comprise each of the categories below:

• Administrative and legal expenses;
• Land, structures, rights-of-way, appraisals, etc.;
• Relocation expenses and payments;
• Architectural and engineering fees:
• Site preparation work;
• Demolition and removal;
• Construction;
• Equipment;
• Project inspection fees;
• Contingencies.

6) Institutional Commitment Letter (required): A letter from a high-ranking institutional official (e.g., Dean, Provost, President) should document the long-term institutional support for the laboratory space and research involving NHPs and include plans to support such expenses as operating and maintenance costs, staff salaries, and user training (if needed).

7) Certification of Title to Site (required): Applicants must include a legal opinion describing the interest the applicant has in the performance site. The legal opinion should describe any mortgages or other foreclosable liens on the property, including the principal amount of the mortgage (and rate of interest); the dates of the mortgage; the terms and conditions of repayment; the appraised value of the property; and any provisions designed to protect the federal interest in the property. The facility must be utilized for NIH-supported NHP biomedical research purposes for at least 10 years beginning on the date of occupancy of the space. Any lease agreement must cover a time period to allow for the completion of construction and the 10-year facility usage requirement (i.e., a minimum of 10 years from the occupancy date of the constructed or restored facility).

8) Project timeline (required): The timeline should demonstrate how the project will be completed within the sixty-month budget and award period. The project timeline should account for 3 stages of the NIH design approval process see Funding Restriction section.

9) Letters of Support (optional): A maximum of 5 optional support letters may be attached. Additional evidence of support beyond 5 key collaborators/users may be provided as a brief narrative in the Scientific Justification section.

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

The PD/PI should be a PhD-level scientist who possesses knowledge of the NHP breeding as well as NHP-related HIV/AIDS research field using SPF NHPs and has a vested interest in the success of the project; for example, a College Dean who oversees research space, Director of an Institute or Center, or a Scientific Director of a Core Facility.

The PD/PI must recruit Key Personnel with complementary scientific and technical skills.

An individual with technical proficiency in engineering or architectural matters who will serve as a Construction Project Manager must be identified. This person's responsibility will include oversight of the design, implementation of the project, and communication between the scientific and technical staff at every step of the development of the application and subsequent execution of the project. A project role for this person should be specified as "Other" or "Other Professional" and a bio-sketch with relevant information about professional qualifications and expertise should be attached.

If support for a specialized facility is requested (e.g., an ABSL3 facility or Imaging center), the team should also include a PhD-level scientist, the Facility Manager, with experience in managing such facilities. The PD/PI may serve in this role. This person will be tasked with communicating with other Key Personnel about specific research-driven scientific requirements for the design and construction of the facility.

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

The following additional instructions apply:

The Budget Information for Construction Programs (SF424C) must be used to attach an overall application budget page for the total requested funds.

Applicants must provide the Total Federal Funds Requested , Total Federal and Non-Federal Funds , and Estimated Program Income on the SF424 (R&R) Cover form.

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

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

4. Submission Dates and Times

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). Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date and time. If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications.

Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission.

Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.

5. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

6. Funding Restrictions

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Pre-award costs are allowable only as described in the NIH Grants Policy Statement.

Funds will be awarded in a single action using a fifty-six -month budget and project period. The requested budget can support design, construction activity, and purchase of fixed equipment and its installation costs. The fixed equipment may include infrastructure equipment, such as HVAC units serving the facility and other large-fixed equipment connected to the building structure and services, and specialized equipment used in the indoor housing or outdoor corral to support the operation of the breeding facility. Also, requests can be made for fixed laboratory equipment and its installation costs. Examples of such equipment include, but are not limited to:

• Large cages, corral fencing, specialized corral equipment or other field fixtures
• Indoor and outdoor tunnel/link between enclosures, animal enrichment, trapping space or capture chute
• Telemetry for monitoring and measuring NHP physical activities and physiological conditions
• Equipment for NHP social and biobehavioral monitoring and recording
• Auto-feeding or other NHP husbandry equipment
• fume hoods and laminar flow stations;
• biosafety cabinets;
• casework and laboratory benches;
• autoclaves and other sterilizing equipment;
• dishwashers and cage wash equipment;
• pens.

Allowable costs also include:

• appraisals;
• bid advertising;
• inspection and commissioning fees;
• project management;
• contingency fees (Allowable contingency fees are limited to 15 percent of the total allowable costs before bids are received and must be reduced to 10 percent after a construction contract has been awarded.)
• filing fees for recording of Notice of Federal Interest (NFI).

Not-allowable costs include:

• personnel costs not related to actual construction;
• bonus payments to contractors;
• consultant fees not related to actual construction;
• damage judgement suits;
• movable equipment and furniture;
• scientific instruments (e.g., microscopes, biomedical imagers, spectrometers);
• FDA approval process following the completion of the construction project;
• F&A costs;
• supplies;
• fund-raising expenses;
• interior and exterior decorating fees (e.g., purchase of artwork, sculpture, etc.).

To protect the federal interest in improved real property, grantees will be required to file a Notice of Federal Interest (NFI) in the Land Record Office of the jurisdiction where the facility will be located as required by 45 CFR 75.323 and the NIH Grant Policy Statement. The NFI is required when use and disposition conditions apply to the property as stated in the NoA. The time of recordation shall be when construction begins. A copy of the recorded NFI must be provided to the Grants Management Office within 10 days following the date of recordation see Section VII Agency Contacts. Funds will be awarded in a single action using a sixty-month budget and project period.

If awarded, all funds will be restricted except for Project Design and Engineering Fees. NIH must approve the design documents before releasing the restricted funds. The awardee will be asked to submit the design documents for technical review, in agreement with the NIH DRM. The purpose of the NIH design review is to ensure that applicable design standards are incorporated into the drawings and specifications so that the program requirements can be met. It is expected that the technical review process will be conducted in three stages for:

• Schematic Design Documents (SDDs) (15-30%),
• Development Design Documents (DDDs) (50-65%), and
• Construction Design Documents (CDDs) (95-100%).

Review at each stage may take 4 6 weeks. The applicant must submit SDDs within 4 months following the receipt of the Notice of Award (NoA), but considering the overall technical review timeline, the earliest possible submission of the design documents is encouraged following the receipt of the NoA.

The Environmental Analysis Form is not required at the time of the application submission. Instead, a Grants Management Specialist will request this information as part of the Just-in-Time process (NOT-OD-10-120).

7. Other Submission Requirements and Information

Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide. Paper applications will not be accepted.

Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.

For assistance with preparing the electronic application or for more information on the electronic submission process, visit the How to Apply - Application Guide. If applicants encounter a system issue that threatens the applicant's ability to complete the submission process on-time, the applicant must follow the Dealing with System Issues guidance. For assistance with application submission, contact the Application Submission Contacts in Section VII.

Important reminders:

All PDs/PIs must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile form. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH.

The applicant organization must ensure that the unique entity identifier provided on the application is the same identifier used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in the SF424 (R&R) Application Guide.

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review and responsiveness by components of participating organizations, NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.

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

Any instructions provided here are in addition to the instructions in the policy.

Section V. Application Review Information

1. Criteria

Applications submitted to the NIH in support of the NIH mission are evaluated for scientific and technical merit through the NIH peer review system.

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

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.

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.

2. Review and Selection Process

Applications will be evaluated by (an) appropriate Scientific Review Group(s), convened by The Center for Scientific Review in accordance with NIH peer review policies and practices, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.

As part of the scientific peer review, all applications:

• May undergo a selection process in which only those applications deemed to have the 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 NOFO.

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 NOFO. Following initial peer review, recommended applications will receive a second level of review by the appropriate national Advisory Council or Board. The following will be considered in making funding decisions:

• Impact score assigned to the application by the NIH peer review group
• Relevance of the project for which construction is proposed to the objectives and priorities of the particular program authorized by the Public Health Service Act
• Scientific merit of the research activities that will be carried out in the proposed facility
• Scientific or professional standing or reputation of the applicant and of its existing or proposed officers and research staff
• Availability, by affiliation or other association, of other scientific or health personnel and facilities to the extent necessary to carry out effectively the program proposed for the facility, including the adequacy of an acceptable biohazard control and containment program when warranted
• The need for the facility and its total effects on similar or related facilities in the locale, and the need for appropriate geographic distribution of similar facilities
• The project cost and design
• Availability of funds.
• Geographical location.

3. Anticipated Announcement and Award Dates

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 Section 2.4.4 Disposition of Applications.

Section VI. Award Administration Information

1. Award Notices

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.6. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.

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

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

2. Administrative and National Policy Requirements

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Recipients, and Activities, including of note, but not limited to:

• Federal-wide Standard Terms and Conditions for Research Grants
• Prohibition on Certain Telecommunications and Video Surveillance Services or Equipment
• Acknowledgment of Federal Funding

If a recipient is successful and receives a Notice of Award, in accepting the award, the recipient agrees that any activities under the award are subject to all provisions currently in effect or implemented during the period of the award, other Department regulations and policies in effect at the time of the award, and applicable statutory provisions.

Should the applicant organization successfully compete for an award, recipients of federal financial assistance (FFA) from HHS will be required to complete an HHS Assurance of Compliance form (HHS Assurance of Compliance form (HHS 690)) in which the recipient agrees, as a condition of receiving the grant, to administer programs in compliance with federal civil rights laws that prohibit discrimination on the basis of race, color, national origin, age, sex and disability, and agreeing to comply with federal conscience laws, where applicable. This includes ensuring that entities take meaningful steps to provide meaningful access to persons with limited English proficiency; and ensuring effective communication with persons with disabilities. Where applicable, Title XI and Section 1557 prohibit discrimination on the basis of sexual orientation, and gender identity, The HHS Office for Civil Rights provides guidance on complying with civil rights laws enforced by HHS. See https://www.hhs.gov/civil-rights/for-providers/provider-obligations/index.html and https://www.hhs.gov/civil-rights/for-individuals/nondiscrimination/index.html.

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

• For guidance on meeting the legal obligation to take reasonable steps to ensure meaningful access to programs or activities by limited English proficient individuals see https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/fact-sheet-guidance/index.htmlandhttps://www.lep.gov.

• For information on an institution’s specific legal obligations for serving qualified individuals with disabilities, including providing program access, reasonable modifications, and to provide effective communication, see https://www.hhs.gov/civil-rights/for-individuals/disability/index.html.

• HHS funded health and education programs must be administered in an environment free of sexual harassment, see https://www.hhs.gov/civil-rights/for-individuals/sex-discrimination/index.html. For information about NIH's commitment to supporting a safe and respectful work environment, who to contact with questions or concerns, and what NIH's expectations are for institutions and the individuals supported on NIH-funded awards, please see https://grants.nih.gov/grants/policy/harassment.htm.

• For guidance on administering programs in compliance with applicable federal religious nondiscrimination laws and applicable federal conscience protection and associated anti-discrimination laws see https://www.hhs.gov/conscience/conscience-protections/index.html and https://www.hhs.gov/conscience/religious-freedom/index.html.

Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at https://www.hhs.gov/ocr/about-us/contact-us/index.html or call 1-800-368-1019 or TDD 1-800-537-7697.

In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements. FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award. An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a federal agency previously entered and is currently in FAPIIS. The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgement about the applicant’s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 45 CFR Part 75.205 and 2 CFR Part 200.206 Federal awarding agency review of risk posed by applicants. This provision will apply to all NIH grants and cooperative agreements except fellowships.

Not Applicable

3. Data Management and Sharing

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

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

Not Applicable for construction awards.

4. Reporting

Progress reports for multiyear funded awards are due annually on or before the anniversary of the budget/project period start date of award. The reporting period for multiyear funded award progress report is the calendar year preceding the anniversary date of the award. Information on the content of the progress report and instructions on how to submit the report are posted at http://grants.nih.gov/grants/policy/myf.htm.

A final RPPR, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement. Following completion and occupancy of the facility, recipients must certify on a yearly basis for 20 years that the facility is used to conduct biomedical research.

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

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

Section VII. Agency Contacts

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

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

Finding Help Online: https://www.era.nih.gov/need-help (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources)
Email: [email protected] (preferred method of contact)
Telephone: 301-480-7075

Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email: [email protected]

Elisabet V Caler
OAR - Office of AIDS Research
Phone: 301-435-0222
E-mail: [email protected]

Monika Aggarwal, PhD
Office of Research Infrastructure Programs (ORIP)
Telephone: 301-435-0777
Email: [email protected]

Jonathan Ivins, PhD
Center for Scientific Review (CSR)
Telephone: 301-594-1245
Email: [email protected]

Felecia Bush
OAR - Office of AIDS Research
Phone: none
E-mail: [email protected]

Kenneth Holiness
NHLBI ORIP Team
Telephone: 301-480-6854
Email: [email protected]

Section VIII. Other Information

Recently issued trans-NIH policy notices may impact an applicant's 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), 42 USC 283k, and under Federal Regulations 42 CFR Part 52b and 45 CFR Part 75.