It is critical that applicants follow the Research (R) Instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

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

This Funding Opportunity Announcement (FOA) invites applications to develop physical infrastructure of nonhuman primate (NHP) facilities, focusing on the needs related to the expansion of Rhesus macaques colonies. These needs include constructing new or upgrading existing space required for breeding and housing of the animals as well as research facilities for carrying out HIV/AIDS-related studies linked to the expansion of the breeding space.

The NIH-established priorities for HIV/AIDS research, detailed on the Office of AIDS Research (OAR) website, encompass several areas of research, including activities directed towards:

• reducing the incidence of HIV infection by developing effective vaccines;
• reducing the severity of HIV infection by developing next-generation therapies;
• developing better treatments for HIV-associated comorbidities and co-infections;
• finding an HIV cure;
• basic science research that crosscuts the priorities.

The NHP models are essential for progress of HIV/AIDS-related research and have proven valuable in advancing many sub-areas of the NIH-established priorities outlined above. Furthermore, the NIH/ORIP-commissioned 2018 report Nonhuman Primate (NHP) Evaluation and Analysis Report indicates an increased demand for NHP models, and particularly Rhesus macaques, in the next 5 years. The current limited availability already hinders many high-priority studies (such as those on vaccines, prophylaxis, eradication, among others), delaying them for months. In addition, the projected rising needs will further exacerbate the shortages of the available animals. This FOA seeks to address this problem by inviting applications to build, develop, or modernize physical infrastructure for the expansion Rhesus macaque colonies.

This FOA targets the Rhesus macaque model as widely used for HIV/AIDS-related research and as proven especially effective in areas covered by NIH-established HIV/AIDS research priorities.

Rhesus macaques are physiologically and anatomically similar to humans and respond similarly to a modified simian form of HIV (SIV/SHIV). These similarities allow researchers to investigate transmission, early stages of infection, follow AIDS disease progression, explore effectiveness of vaccines and treatments, as well as identify viral reservoirs. Rhesus macaques are susceptible to vaginal and anal routes of infection, mirroring the most common routes of human infection. Thus, they can be used for studies of prevention and pre- and post-exposure prophylaxis. NHP models such as Rhesus macaques allow for studies that cannot be performed in humans due to unacceptable safety risks. The fact that current antiretroviral treatments for AIDS were developed using SIV-infected Rhesus macaque model exemplifies how these types of studies can directly impact human health.

The availability of genetically well-characterized and specific pathogen free (SPF) animals is of increasing importance in HIV/AIDS-related research. Genetically characterized Rhesus macaques with specific cell markers that are homologous to those found in humans (such as major histocompatibility complex (MHC) haplotypes) allow for detailed and in-depth HIV infection studies. SPF animals that are free of Simian Immunodeficiency Virus (SIV), Type D simian retrovirus (SRV), simian T-lymphotropic virus (STLV-1) and herpes B virus (Macacine herpesvirus-1), are necessary for studies where the cofounding effects of other infections blur the immune responses to HIV. Some facilities have derived sub-colonies of expanded SPF macaques that are free of additional viruses, such as cytomegalovirus (CMV), human papillomavirus (HPV), and herpes simplex virus (HSV). These expanded SPF animals are used for investigations of novel vector studies as well as co-infection research. Applications focusing on the expansion of SPF Rhesus macaque colonies are encouraged.

The scope of individual projects will vary and depend on the currently available infrastructure at the applicant institution, as well as the present and anticipated HIV/AIDS-related research needs for Rhesus macaques. Requests must be justified by the needs related to the expansion of animal colonies. Any project, when completed, should provide long-term advantages for the HIV/AIDS-related research. Consequently, the applicant institution should demonstrate future-looking commitments towards the NHP facility and HIV/AIDS-related research therein, by attaching a letter of support for the application from a high-ranking institutional official.

An applicant may request funds to construct new or to modernize existing animal housing, corrals, and other animal holding spaces. Especially targeted are projects directly supporting breeding of animals, including expanding SPF colonies. Also appropriate are requests for research space for activities directly linked to the breeding and expansions projects. Specific examples include neonatal intensive care units, nurseries, space to perform procedures such as tissue sampling, genotyping, and behavioral assessment suites, and holding space for specific breeding needs. Similarly, various functions that assist in caring for and maintaining colonies may require additional specialized structures, including cage washing, high containment space, and storage. Any project, when completed, should provide long-term benefits for the broad HIV/AIDS research community by increasing the capacity for breeding and housing of Rhesus macaques.

Various factors are typically considered when planning for and modernizing the infrastructure of facilities. For applications submitted to this FOA, it is expected that each project will implement the best engineering solutions and modern technologies to ensure animal welfare, high-quality animal care, and enable cutting-edge research activities. All projects must be justified by their relevance to the NIH-established HIV/AIDS research priorities as related to the increasing demand for Rhesus macaques. These priorities will drive the requests for the implementation of specific original engineering designs and leading-edge technological solutions.

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

The project should be consistent with the following criteria and documentation requirements:

• The project is essential to the support of high priority HIV/AIDS-related research activities.
• The facility must have a useful life consistent with program purposes, including the time to construct and complete the project, plus 20 years of use following occupancy;
• 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 20-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.

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

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

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) Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
• NATO Commercial and Government Entity (NCAGE) Code Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.
• eRA Commons - Applicants must have an active DUNS number to register in eRA Commons. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration, but all registrations must be in place by time of submission. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
• Grants.gov Applicants must have an active DUNS number and SAM registration in order to complete the Grants.gov registration.

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

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

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed construction as the Program Director/Principal Investigator (PD/PI) 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.

Multiple PDs/PIs are not allowed.

The PD/PI should hold appropriate stature within the institutional administration structure and non-human primate HIV/AIDS-related research community to be able to oversee various facets of the entire project.

The PD/PI should also demonstrate his/her 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 Section Senior/Key Person Profile Expanded.

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

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

The NIH will not accept duplicate or highly overlapping applications under review at the same time. This means that the NIH will not accept:

• A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.
• A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.
• An application that has substantial overlap with another application pending appeal of initial peer review (see NOT-OD-11-101).

The application forms package specific to this opportunity must be accessed through ASSIST, Grants.gov Workspace or an institutional system-to-system solution. Links to apply using ASSIST or Grants.gov Workspace are available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

It is critical that applicants follow the the Research (R) Instructions in the SF424 (R&R) Application Guide, except where instructed in this funding opportunity announcement 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.

All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed, with the following exceptions or additional requirements:

• For this FOA, there is no Research Strategy.
• The Project Narrative attachment of the SF424 (R&R) Other Project Information form is limited to 12 pages, excluding Line Drawings and specifically required Tables.

Instructions for Application Submission

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

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

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

Is Application Subject to Review by State Executive Order 12372 Process: Applicants should indicate "yes" and provide the date the application was submitted to the State.

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

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

Project Narrative: (to be assembled in order shown below): The Project Narrative should consist of three sections: Overview, Scientific Justification, and Facility Improvement Plan, and should be submitted in a single PDF attachment.

The Overview section (in lieu of Specific Aims): This section cannot exceed one page and must summarize the project, stating its goals and outlining the proposed approaches to achieve them. This section should include a brief description of the current operations of the animal facility and its physical infrastructure, as relevant to this project. Tables 1 and 2 in the Other Attachments section may be used to simplify the description of the space affected by the proposed project and the requested fixed equipment. This section should state how the proposed project activities will support breeding and expanding the Rhesus macaque colony for the benefit of HIV/AIDS-related research. A connection to research activities, especially NIH-funded HIV/AIDS-related research projects at the applicant institution and institutions nationwide (if any), that rely on the Rhesus macaques to be bred and distributed should be stated Table 3 in Other Attachments may be used as a reference.

A timeline for different stages of the project and its completion within the sixty-month budget period must be included in Other Attachments and can be used as a refenced in this section.

It is up to the PD/PI to allocate the remaining 11 pages of the Project Narrative to the 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 the scientific perspective and describe technical design approaches with enough details to make clear the merits of the overall project.

The Scientific Justification section: This section should make clear the needs for the improvement to the physical infrastructure for the expansion of the Rhesus macaque colony, in connection to HIV/AIDS-related research. A description of the animal colony, including their characteristics such as age and sex distributions, genetic profiles, and pathogen status (including SPF status, as appropriate) should link the demand for specific types and numbers of animals needed by HIV/AIDS-related to research programs supported by the facility. This text should also connect activities related to the care and maintenance of animals to the current facility capabilities and the requested infrastructure improvements.

The text should include an overview of HIV/AIDS-related research programs that rely on and benefit from access to the Rhesus macaques. The applicant should outline the breadth of local and nationwide collaborations and the numbers/types of animals involved in these projects. Currently active research projects funded by NIH and other agencies and organization should illustrate present needs and establish a base for future demands. To summarize this narrative, Table 3 in Other Attachments may be included. Today’s NHP facility operations should be linked to the anticipated future activities, as the proposed infrastructure improvements should offer long-term benefits for the conduct of HIV/AIDS-related research. It should be made clear how the proposed improvements will impact future research activities.

Without duplicating information in biosketches, this section should conclude with a paragraph about the qualifications of the PD/PI to lead the construction/ modernization project from its 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 expertise and skills necessary to design and construct the facility to meet the project objectives. For example, describing the qualifications and the prior experience of the design team with the similar facilities would be of value. 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 than the PD/PI), administrative approach to managing the facility, and communication plan with appropriate level institutional officials.

The Facility Improvement Plan section: This section should present details of the architectural and engineering designs, their technical specifications, and proposed construction processes to support the expansion of the animal colony and support related activities. 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 this project, and their placement in relation to other buildings in the immediate area. The design specifications must meet the requirements set by processes and operating procedures described in the Scientific Justification section. The level of detail of the application's Line Drawings, data in Tables 1 and 2 in Other Attachments, and the narrative of this section, 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.

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 changes 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 structures such as buildings, their roofs, fences, loading docks, etc.;
• Functional relationships and zoning of the area.

All these criteria should be justified in the context of the specific function of the requested facility and explain how the requirements for NIH-funded research will be met. 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 storm water retention);
• Indoor environmental quality, including ventilation and thermal comfort, humidity control, 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, 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 section: 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 fit on 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;
• The line drawings must also include floor plans of the building indicating the location of fixed equipment and illustrate 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 feet 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, animal holding room) 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 Vendor Quotes in the Budget Justification Attachments.

4) Table 3 (required): List no more than 10 active HIV/AIDS-related research awards whose needs for Rhesus macaques drive the request to expand the NHP facility. These awards may include internal projects, awards to internal investigators, or awards to external collaborators planning to use NHP distributed by the facility. Select these awards as representative projects, demonstrating their relation to the NIH-established priorities of HIV/AIDS research. The table must have the following columns: Source of Funding, Grant Number, Principal Investigator, Grant Title, Project Start Date, and Project End Date.

5) Budget Justification and Vendor Quotes (required): All vendor quotes should be attached here, along with 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 in 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 NHP facility and HIV/AIDS-related research and include the 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 the biomedical research purposes for which it was improved for at least 20 years beginning on the date of beneficial occupancy of the space, subsequent to completion of the project. Any lease agreement must cover a time period sufficient for the completion of construction, and the 20-year facility usage requirement (i.e., a minimum of 20 years in length from the occupancy date of the restored facility).

8) Project timeline (required): To demonstrate how the project will be completed within the sixty-month budget and award period. 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, including those from external collaborators planning to use SPF Rhesus macaques resulting from the proposed colony expansion. Additional evidence of support beyond 5 key collaborators/users may be provided as a brief narrative in the Other Project Information Section.

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

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

Key Personnel must include an individual with technical proficiency in engineering or architectural matters who will serve as a construction Project Manager (Facilities Person). 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 biosketch with relevant information about professional qualifications and expertise must be attached.

The team must also include a PhD-level scientist, the Facility Manager, with experience in managing non-human primate colonies and overseeing HIV/AIDS-related research. The PD/PI may serve in this role. This person will be tasked with communicating with other Key Personnel about the scientific- and animal welfare-based requirements for the design and construction of the facility.

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

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.

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

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

See Part 1. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov.

Part I. Overview Information contains information about Key Dates and times. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission. When a submission date falls on a weekend or Federal holiday, the application deadline is automatically extended to the next business day.

Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies). 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 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.

Funds will be awarded in a single action using a sixty-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. Also, requests can be made for fixed laboratory equipment and its installation costs. Examples of such equipment include, but are not limited to:

• fume hoods and laminar flow stations;
• biosafety cabinets;
• fixed casework and laboratory benches;
• autoclaves and other sterilizing equipment.

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;
• 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 GPS. 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 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 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).

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

Important reminders:
All PDs/PIs must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH.

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

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review, NIH. Applications that are incomplete or non-compliant 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.

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.

Scientific Merit and Organization of the Total Program and Its Component Parts to be Carried Out in the Facility

Does the applicant provide sufficient evidence of HIV/AIDS-related research program(s) that will benefit from completion of the project? How well are the component parts of the research program (that will be carried out in the facility) coordinated and managed? How will the proposed repair, renovation, or modernization activity facilitate the applicant institution s ability to conduct, expand, improve, or maintain HIV/AIDS-related research?

Is there sufficient justification for improving this NHP facility? To what extent will the proposed change in the research environment facilitate the applicant institution’s ability to conduct, expand, improve, or maintain biomedical or behavioral research? How will the proposed repair, renovation, or modernization activity increase efficiency in the use of energy, water, and/or materials to reduce adverse effects on the environment?

Administrative and Leadership Capabilities of the Applicant’s Officers and Staff

How effective are the construction Project Manager and the facility manager likely to be, based on 1) the administrative approach to managing the facility, 2) the ability to interact with appropriate institutional officials to see that the ongoing needs of the facility are satisfied, and 3) the skills necessary to complete the project on time and within budget?

How effective is the PD/PI likely to be, based on 1) leadership qualities and experience, 2) institutional commitment and support, and 3) the appropriate scientific and fiscal administration skills necessary to complete this project on time and within budget? Does the applicant provide evidence of future commitment in maintaining this facility?

Anticipated Effect of the Project on Other Relevant Research Programs and Facilities in the Geographic Area and Nationwide

How likely is the proposed expansion of infrastructure to benefit HIV/AIDS-related research using Rhesus macaques at other institutions in the local geographic area, given the availability or absence of similar or related facilities? In which ways is the proposed activity likely to affect similar or related national facilities or benefit research nationwide?

Need for the Project or Additional Space

How compelling are: 1) the identified need(s) for the expansion of Rhesus macaques as related to HIV/AIDS-related in the research capabilities in the applicant organization and elsewhere that the proposed repair, renovation, or modernization activity is intended to address; 2) tangible benefits to the institutional research capability of the proposed activity; and 3) state-of-the-art research capabilities or efficiencies that would otherwise not be available?

Are requests for equipment justified and of direct benefit to the facility? Will the requested equipment remedy identified deficiencies or fill gaps in the animal facility?

Project Design

Design Plan: How likely is the design plan to meet the identified need(s), based on: 1) proposed demolition areas and/or renovation areas, including associated room adjacencies, traffic patterns for the movement of people, animals, and materials (clean and dirty) through the facility, and relative location of needed ancillary areas (e.g., changing rooms for animal facilities); 2) total net and gross square feet of space to be renovated; 3) proposed timeline and sequence of construction; 4) potential problems, alternative strategies, and benchmarks for success presented; and 5) implement sustainable design principles?

Engineering Criteria: How likely are the engineering systems to meet the identified need(s), based on: 1) the engineering criteria, including information about the mechanical, electrical, and plumbing systems, and utilities in the renovation; 2) descriptions of changes or additions to existing mechanical and electrical systems; and 3) the number of air changes per hour, electrical power, light levels, hot and cold water, and steam?

Architectural Criteria: How likely are the architectural criteria and finishes to meet the identified need(s), based on: 1) the size dimensions, function, and net and gross square feet for each component; 2) architectural criteria such as the width of corridors and doors and surface finishes for the project; and 3) quality of life issues (e.g., natural lighting, noise, vibration)?

Line Drawings: How likely are the line drawings to meet the identified need(s), based on: 1) the indicated function of the space; 2) the scale of the line drawings, and indication of adjacencies and operational relationships of equipment; 3) changes to be made to the space; and 4) location of major equipment, fume hoods, sinks, showers, and other major items indicated in the drawings?

Does the proposed design meet the engineering criteria for the NHP facility? Does the proposed design meet the engineering criteria for space to support HIV/AIDS-related research?

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

Protections for Human Subjects

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

Inclusion of Women, Minorities, and Children

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

Vertebrate Animals

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

Biohazards

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

Resubmissions

Not Applicable

Renewals

Not Applicable

Revisions

Not Applicable

As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact score.

Applications from Foreign Organizations

Not Applicable

Select Agent Research

Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).

Resource Sharing Plans

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

Budget and Period of Support

Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed project, including the detailed budget breakdowns of the costs associated with individual categories of the project design, administration, and construction.

Applications will be evaluated by (an) appropriate Scientific Review Group(s), convened by CSR, 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.

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. 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:

• 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.
• The geographical location of the facilities.

After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons. Refer to Part 1 for dates for peer review, advisory council review, and earliest start date.

Information regarding the disposition of applications is available in the NIH Grants Policy Statement.

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement.

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the grantee’s business official.

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

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

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 https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/index.html. The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-individuals/section-1557/index.html; and https://www.hhs.gov/civil-rights/for-providers/laws-regulations-guidance/index.html. Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see https://www.hhs.gov/civil-rights/for-individuals/disability/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. 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.

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

Cooperative Agreement Terms and Conditions of Award

Not Applicable

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.

When multiple years are involved, awardees will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement.

A final RPPR, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement. Following completion and occupancy of the facility, grantees 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.

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

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

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

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

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

Malgorzata Klosek, PhD
Office of Research Infrastructure Programs (ORIP)
Telephone: 301-435-0766
Email: klosekm@mail.nih.gov

Mark Caprara, Ph.D.
Center for Scientific Review
Telephone: 301-613-5228
Email: mark.caprara@nih.gov

Gavin Wilkom, M.I.M.
National Institute for (HLBI)
Office of Research Infrastructure Programs (ORIP)
Telephone: 301-827-7078
Email: wilkomg@mail.nih.gov

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

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284), 42 USC 283k, and under Federal Regulations 42 CFR Part 52b and 45 CFR Part 75.