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.

Part 2. Full Text of Announcement

Section I. Notice of Funding Opportunity Description

This Notice of Funding Opportunity Announcement (NOFO) invites eligible institutions of higher education and research organizations to seek funding to modernize and improve existing shared-use research facilities (e.g., core laboratories, animal research facilities, or other collaborative research spaces), or to construct new biomedical research space that will be furnished with essential infrastructure and eligible integrated equipment (subject to the requirements described below under Funding Restrictions), or other necessary casework. The objective of this NOFO is to support the development of modern facilities that will enable and enhance the conduct of high impact, cutting-edge biomedical research with national or regional significance. Thus, any facility supported by this NOFO must serve a broad research community at local (within the applicant's own institution), regional (beyond the applicant's own institution), or national level.

NIH recognizes that modern physical infrastructure is necessary for the conduct of advanced, innovative research. As science progresses and new technologies become available, dedicated space is required to house specialized equipment and to carry out novel experimental protocols. Both Institutions of Emerging Excellence (IEE, as defined in 42 USC 283k(c)(2)) and non-IEE institutions as well as highly resourced and low resourced institutions are encouraged to apply. Projects will vary and depend on the current institutional infrastructure and long-term institutional strategic plans. Focusing on the advancement of science through the modernization of physical space will be an essential and integral feature of all proposed projects. When completed, construction/modernization projects will have a significant impact by enabling innovative and new research opportunities and/or by raising the research capacities and capabilities to a new and higher level. An institution may request funds to modernize a core facility to create an environment required for research-driven specialized technological services. Likewise, funds may be requested to consolidate space for an institution-wide core which would provide streamlined workflows for contemporary multi-disciplinary investigations. Modernizing laboratory space used on a shared basis to meet the growing needs consistent with an institutional strategic vision for biomedical research is another example of a suitable request. A successful construction/modernization project will serve research teams and a broad range of research efforts. Laboratory space exclusively dedicated to individual Program Directors/Principal Investigators (PDs/PIs), or single research groups, is not supported under this NOFO.

Various factors are typically considered when developing or modernizing research infrastructure. For applications submitted to this NOFO, defined research needs will drive the requests for modern engineering solutions. As science progresses and new technologies become available, required dedicated space must comply with relevant technical specifications to provide a proper and well-controlled environment, to enable novel experimental approaches, and to house specialized equipment. It is encouraged that these new spaces adhere to the highest possible standards of green engineering designs and operations.

Modern physical infrastructure requires the implementation of advanced engineering designs. Some protocols may only be conducted in designated clean rooms, such as barrier facilities for pathogen-free research or space for synthesis of compounds meeting standards for human subject experiments. Certain equipment and/or research protocols require specially shielded rooms or rigorous control of environmental variables such as temperature or humidity. The shared space also needs to be adequately maintained to serve its desired function over many years. The formal structure of an institutional core typically offers effective oversight to ensure that the required engineering standards of a space it occupies are met and maintained over time. Also, such centralized facilities are organized to provide rigorous scientific support for the conduct of research.

NIH recognizes the importance of all institutions of higher learning and research organizations in contributing to the nation's research capacity. NIH intends to award at least 25% of the available funds to support projects from IEEs. These institutions play a special role in advancing biomedical research as they leverage their research abilities to address a problem, concern, or unmet health need. Often these institutions are located in a geographic area whose population includes a significant number of individuals with health status deficit, and the applicant provides health services to such individuals; or is located in a geographic area in which a deficit in health care technology, services, or research resources may adversely affect the health status of the population of the area in the future, and the applicant is carrying out activities with respect to protecting the health status of such population. As a part of their mission, IEEs must have plans and the ability to carry out the plans to conduct biomedical research or provide training to enhance the health of individuals from such population. These institutions often serve as centers for dissemination of health information, training development, and advancement of research. At times, low levels of research funding from NIH, other federal agencies, private foundations, and other sources, as well as a deficit in health care technology, services, or research resources such as a physical research infrastructure, may curtail the full potential of these efforts.

Many IEEs are located in designated geographic locations; however, geographical location, alone, is not sufficient to define an IEE. An institution in an Institutional Development Award (IDeA)-eligible state may qualify as an IEE if the institution has deficient or inadequate physical infrastructure that deters it from achieving well-defined and well-focused research-related goals. These goals build on local capacity for research that encompasses various factors such as in-house scientific expertise, unique local resources, or special local populations and their health-related needs. Many institutions in non-IDeA-eligible states also meet these criteria and are equally qualified to apply as IEEs.

As IEEs often have low levels of federal and private funding for biomedical research, faculty at these institutions usually contribute a significant amount of their time to teaching either undergraduate or graduate curriculum courses, or both. Note, however, projects that would serve purely didactic activities are not appropriate under this NOFO.

IEE applicants should be striving to establish a particular research or research training capacity that serves the needs described above. Improvements in physical infrastructure are one element that can help meet these needs. An applicant should explain in what domain of biomedical research the institution is seeking to achieve excellence and how this proposed project will advance the effort. Ultimately, to be considered as an IEE for the purpose of this NOFO, an applicant institution must identify itself as an IEE and justify its status see the Project Narrative section for more information.

It is expected that all projects - both from research-intensive institutions and IEEs - will have long-term effects and will benefit broad biomedical research community at the applicant institution by providing a modern research environment that is accessible on a shared basis. It is also expected that projects awarded under this NOFO will have a transformative impact on research at the recipient institution.

Applications based entirely on regular maintenance, replacement of aging or failing equipment, and other routine work are not appropriate for this NOFO, and such applications will not be supported. Applications for upgrades of a space serving a single investigator are also inappropriate as are applications to support facilities for billable medical care, office space, or classrooms.

To appropriately conceive, develop, construct, and successfully complete the construction/modernization project, a PD/PI should possess knowledge of the relevant scientific field(s) to be served by the proposed facility, 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 an 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 be consistent with the following criteria and documentation requirements:

• The project is essential for biomedical research activities supported and the space involved will be used for these activities.
• The facility must be utilized for biomedical research purposes for which it was constructed or improved for at least 10 years beginning on the date of beneficial occupancy of the space.
• If the project is located in an existing building, the building must have a useful life consistent with program purposes, including the time to construct and complete the project plus 10 years of use following the occupancy of the research space; the building must be architecturally and structurally 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 10-year use of the facility are consistent with the proposed project. Specifically, a signed document from the building owner must be provided showing 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. 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.

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. Potential applicants are also encouraged to visit the C06 Frequently Asked Questions web page for additional guidance.

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

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.

For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide.

Multiple PDs/PIs are not allowed.

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).

Moreover, institutions with C06 awards funded under the Biomedical Research Facility Program (NOFOs PAR-21-139, PAR-22-088 or PAR-23-045) are not eligible to apply to this NOFO, provided the awards are active on the receipt date for this NOFO. Thus, only one C06 Biomedical Research Facility active award per institution would be allowed at any given time.

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:

Yong Chen, PhD
Office of Research Infrastructure Programs (ORIP)
Telephone: 301-594-1187
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 (use Specific Aims page): 1 page
  • Scientific Justifications and Project Description sections: 12 pages in total

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.

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. Otherwise, the applicant should select "no".

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 Summary/Abstract: The Project Summary/Abstract should contain a succinct and accurate description of the proposed construction project and an explanation of the need for the facility. The application's broad, long-term objectives should be stated, concisely describing how the facility will enhance the infrastructure and biomedical research at the applicant institution.

NOTE: The Project Summary/Abstract must be no longer than 30 lines of text.

Project Narrative: In this section, using no more than two or three sentences, describe the project and the relevance of this project to public health. Be succinct and use plain language that can be understood by a general, lay audience. In addition, using this section to declare the IEE status of the applicant institution. If an IEE Status is claimed, briefly explain the justification, such as indicating the specific underrepresented or underserved populations that will benefit from the biomedical research supported by the proposed project.

Bibliography & References Cited: List only publications that are applicable to the construction proposal.

Facilities & Other Resources: Not Applicable. Do not include an attachment here.

Equipment: Not Applicable. Do not include an attachment here.

Other Attachments:

For this NOFO, the following 12 components are expected in the Other Attachments.

1) Overview (required) (File Name: Overview).

The Overview 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 may be referenced to simplify the presentation. A short statement should also be included to summarize how the project will enhance institutional-wide research programs and benefit research groups. As a part of this statement, if applicable, an applicant that is an Institution of Emerging Excellence (IEE) must identify and briefly justify its status. In this section, as part of the justification, an applicant should state the long-term goals of improving a particular research or research training capacity or enhancing a research or research training area and how the proposed investments in the physical infrastructure will advance the institution to excellence in that domain.

2) Scientific Justification and Facility Development (required) (File Name: Scientific Justification and Facility Development)

This space is used for Scientific Justification and Development of the Facility. It is up to the PD/PI to allocate the 12 pages allowed for the project description 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 a scientific perspective and describe technical design approaches with enough details to make clear the merits of the overall project. These merits include plans for long-term use of the space by many researchers.

The Scientific Justification section should focus on how the project will increase the institution-wide biomedical research capabilities and capacities. Defined biomedical research needs should drive the request and this section should make connections to the research community which would benefit from the project. To justify the need for the modernization of a core facility or an institutional laboratory, the PD/PI should describe the space and/or fixed equipment currently available to the institutional research community. The PD/PI should also identify present infrastructure deficiencies that impede biomedical research. The PD/PI should briefly describe the research needs of the community who will rely on the proposed facility.

In the case of an IEE institution, the PD/PI should outline ongoing efforts at the institution for the advancement of biomedical research and relate these efforts to the long-term growth plans at the institution. Plans to solve deficits in the available research infrastructure and funding should be a part of the justification of needs for the new infrastructure. This justification should be specific about the research area to be supported and address the relevant expertise and other available resources on which plans for the research expansion are built. Current NIH research funding is not an eligibility requirement but if available should be included in this project's justification, along with research funding from other sources, including other Federal agencies, private foundations, and the institution (e.g., endowments). Table 3 may be included, as applicable.

At an IEE, new infrastructure is critically needed to further the growth and development of the institution's research or research development and training. IEE applicants should be striving to establish a particular research or research training capacity or research or research training focus that serves the needs described above. Thus, as part of the justification for this project an IEE applicant should explain in what domain they are seeking to become excellent and how this project advances the institution to excellence in that domain.

In the case of research-intensive institutions, a presentation of how the conduct of selected active NIH-funded research projects would be advanced by the new or improved infrastructure, will strengthen the justification. Table 3 may be used to reference individual projects active, at the time of the application submission, and the specific infrastructure needs of the research program these projects are part of. It should be made clear that these needs won't expire when the listed grants end and there is an existing sufficiently strong research community at the institution which will be able to rely on the new infrastructure.

Centers and other resources which support a regional or nation-wide community of researchers should describe their role in enabling specific research activities and illustrate this point by giving examples of NIH-funded research projects which would be directly enhanced by the proposed infrastructure improvements. Here, Table 3 may be referenced. Long-term plans for support of infrastructure and research programs should be outlined to illustrate the institutional commitment for the scientific program.

For all applications, the presentation of this section should provide a bridge between the long-term institutional vision for biomedical research and the proposed infrastructure development. The narrative of this section should make it clear how the facility will be used by or provide services to many researchers.

This section should conclude with a paragraph about how the PD/PI will work with the project Key Personnel on overseeing the planning process and its execution. The team members' individual roles and their responsibilities at different stages of the project should establish their expected contribution towards the overall goal. It is also important for the PD/PI to describe how the team will be organized and demonstrate how its members will work together at different stages of the project. The PD/PI should document that the team as a group has expertise and skills necessary to design and construct the facility so that the scientific objectives are met.

The Development of the Facility section should present technical specifications, details of the architectural and engineering design, and the proposed construction processes. The PD/PI should provide enough details about implementation of the project, including technical challenges that will need to be overcome. This narrative should start with the location of the building in which the facility is to be housed (if a new structure is to be erected) or the location of the existing building (if a present facility is to be modernized) in relation to other buildings in the immediate area. In either case the narrative should also describe the location of the project in the building. The level of detail of the application's Line Drawings, data in Tables 1 and 2 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 facility. The design specifications must adhere to the federal and industry standards and meet the requirements set by standard operating procedures described in the section Scientific Justification, as applicable. Schematic-level designs are not necessary at this stage, as long as the provided designs clearly answer design related questions.

In the narrative, all requested fixed equipment should be justified as being relevant to the function of the facility. Fixed equipment may include infrastructure equipment, such as HVAC units serving the facility and other large, fixed equipment that is built into the building structure such as plumbing and electrical systems. In addition to these very essential items for building operations, requests can be made for casework, fixed laboratory equipment or other equipment required to achieve full functionality of the facility as proposed. Also, the installation needs of all fixed equipment in the context of the engineering aspects of the project such as mechanical, electrical, and plumbing (MEP) specifications for their installation, should be presented - see data in Table 2, below.

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

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

All these criteria should be justified in the context of the specific function(s) of the requested facility, and a description of how they will be met should be provided. Construction design for the NIH-funded facilities shall conform to the latest edition of the NIH Design Requirements Manual (DRM).

In summary, all requests must be justified in terms of both the scientific needs and the corresponding technical requirements for the facility. In particular, to address the rationale for the technical design, plans for the use of the facility must be clearly outlined. Attention must be paid to federal and industry biosafety standards and codes, so upon the completion of this project, the occupancy permit can be secured, and the facility can serve its research purpose.

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 water (i.e., fixtures that reduce amount of water used; recycling of wastewater when appropriate) and outdoor water (i.e., 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 the 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.

3) Annotated satellite and/or map views of the envisioned construction site: illustrate the location of the construction and relationship with respect to adjacent buildings, areas, and roads (name the attachment: Annotated map views).

4) Line Drawings (required, name the attachment: Line drawings): Each line drawing must be formatted to fit on an 8.5" x 11" sheet of paper. (Do not submit "blueprints".) All floor plans must be legible, with the scale clearly indicated on each page. The floor plans must indicate the location of equipment and illustrate safety clearances and workspace. If applicable, submit drawings of the existing and proposed space. The drawings must indicate:

• functional layout of the entire area;
• size dimensions, function, and the net and gross square feet for each room;
• location of the proposed construction/renovation area in the existing building including building name/ address and the floor(s) affected) with affected/ renovated areas clearly marked;
• changes or additions to existing mechanical, electrical and plumbing systems; notes that annotate these changes may be made directly on the plan;
• functional layout of the proposed facility, showing the location of entries and exits, egress routes, clearances, and the location of fixed equipment.

Note, construction designs for NIH-funded facilities shall conform to the latest edition of the NIH Design Requirements Manual (DRM). Although the line drawings do not count toward the page limits, do not include additional text.

5) Table 1 (required): list the size (dimensions) and square footage of each component (e.g., clean room, laboratory, closet etc.) that will be directly affected by the project. (name the attachment: Dimension Table)

6) Table 2 (required): list of requested fixed equipment. Table 2 should include information such as the manufacturer, model number, size, capacity, total cost, and location in the facility. Total cost of each item must be supported by vendor quotes in the Budget Justification and Vendor Quotes attachment (see below). (name the attachment: Equipment Table)

7) Table 3 (optional): list of active research grants which are directly related to the project. This table must have the following columns: (1) Funding Agency; (2) Grant Number; (3) PD/PI Name; (4) Annual Direct Costs for the current fiscal year; (5) Start and End Dates. Do not list more than 12 relevant grants. (name the attachment: Active grants)

8) Project timeline (required): To demonstrate how the project will be completed within the five-year budget and award period. Please include the major steps in the project. (name the attachment: Project timelines)

9) Budget Justification and Vendor Quotes (required, name the attachment: Budget Justification and Quotes): Justify and describe the application budget for the project. All vendor quotes should be attached here. In addition to supplying vendor quotes as applicable, the budget justification should include detailed breakdowns of the costs that comprise each of the budget categories:

• 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.

10) Institutional Support Letter (required, name the attachment: Institutional Support Letter(s)). A letter from a high-ranking institutional official (e.g., Dean, Provost, President) indicating institutional support for the research activities to be conducted in the new facility and to document that it will be used as proposed. The letter must be co-signed by an institutional Signing Official. This letter should include plans to support such expenses as future operating and maintenance costs, staff salaries, and user training (if needed).

11) Certification of Title to Site (required, name the attachment: Certification of Title to Site): Applicants must include a legal opinion describing the interest the applicant institution 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 biomedical research purposes for which it was approved for at least 10 years beginning on the date of beneficial occupancy of the space. Any lease agreement must cover a length of time sufficient for the usage requirement and be a minimum of 10 years in length from the completion of the facility.

12) Support Letters (optional): A maximum of seven optional support letters may be attached. Attach all the support letters in a single file (name the attachment: Support Letters).

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

The following additional instructions apply:

The PD/PI must recruit Key Personnel with complementary scientific and technical skills. The PD/PI should be a PhD-level scientist who has a significant role at the applicant institution to ensure the success of the construction/modernization project, for example, a College Dean who oversees research space, Director of an Institute or Center, or a Scientific Director of a Core Facility. Also, an individual with technical proficiency in engineering or architectural matters related to the design and oversight of the technical aspect of the operation of the facilities must be identified for this application. This person, the construction Project Manager, will closely work with the PD/PI and an outside consulting firm on all technical aspects of the project, including planning, designing, constructing, completing, and commissioning of the facility. A project role for this person should be specified as "Other" or "Other Professional" and a biographical sketch with relevant information about their professional qualifications and expertise must be attached.

Depending on the scope of the project other Key Personnel, such as a Facility Manager, may be identified. The Facility Manager should provide appropriate expertise to assist with setting scientific requirements for the technical design and to make possible the immediate use of the completed facility. Often, this person would be a PhD-level scientist; for example, a DVM/VMD if an animal facility is requested or a scientist/core director if a specialized-used facility is planned.

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.

There are no indirect costs permitted under the C06 mechanism.

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.

The requested budget can support design, construction activity and purchase of fixed equipment and its installation costs. The total amount of these essential fixed equipment items, e.g., fume hoods, biosafety hoods, autoclaves, ice makers, etc, may not exceed 10% of the total federal request to NIH. This 10% does NOT include the HVAC, plumbing, electrical, etc. that are integral to obtaining a certificate of beneficial occupancy, but only research-related equipment as described above.

Allowable costs include:

• appraisals;
• bid advertising;
• inspection and commissioning fees;
• 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 NFI.

Not-allowable costs include:

• bonus payments to contractors;
• consultant fees not related to actual construction;
• damage judgement suits;
• non-fixed equipment;
• scientific instruments (e.g., microscopes, scanners, spectrometers);
• FDA approval process following the completion of the construction project;
• F&A costs;
• supplies;
• fundraising expenses;
• interior and exterior decorating fees (e.g., purchase of artwork, sculpture, etc.)
• parking lot construction, exterior bike racks, electric car charging stations, and/or exterior landscaping

To protect the Federal interest in improved real property, grantees will be required to file an 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 its 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 five-year 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. 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) (15-35%),
• 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. In general, most applicants require 16 months to complete the technical design phase, although this timeframe can be longer or shorter.

Note, changing scope of a construction project requires substantial redesigns, extra round of submissions of all three phases of design documents, and additional technical design reviews. Changing project scope inevitably increases the costs and shortens the available time for construction. As the C06 budget period cannot be extended, the institution must pay for any construction components completed after the budget period of the C06 award. It is unlikely to obtain an approval of a request for major changes of the scope of the construction project after the technical review process is completed and the revised NoA is issued.

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 , 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:

• Scientific and technical merit of the proposed project as determined by scientific peer review.
• Scientific merit of the research activities that will be carried out in the proposed facility
• Available funds under NIH extramural construction appropriation.
• 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
• 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 design and cost effectiveness.

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.

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 10 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]

Yong Chen, PhD
Office of Research Infrastructure Programs (ORIP)
Telephone: 301-594-1187
Email: [email protected]

Jonathan Ivins, Ph.D.
Center for Scientific Review (CSR)
Email: [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.