Department of Health and Human Services
Part 1. Overview Information

 

Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

Division of Program Coordination, Planning and Strategic Initiatives, Office of Research Infrastructure Programs (ORIP)

Funding Opportunity Title

Limited Competition: HIV/AIDS-related Non-Human Primate Animal Research Facilities Restoration Program in the Aftermath of Hurricane Maria (C06 Clinical Trial Not Allowed)

Activity Code

C06 Research Facilities Construction Grant

Announcement Type

New

Related Notices

None

Funding Opportunity Announcement (FOA) Number

PAR-18-693

Companion Funding Opportunity

None

Number of Applications

 The number of applications per institution is restricted  as defined in Section III. 3. Additional Information on Eligibility.

Catalog of Federal Domestic Assistance (CFDA) Number(s)

93.352

Funding Opportunity Purpose

This Funding Opportunity Announcement (FOA) seeks applications from qualified academic institutions in Puerto Rico whose non-human primate research facilities were damaged by Hurricane Maria. Institutions may request funds to recover, restore, and modernize the physical infrastructure of non-human primate facilities. The rebuilt structures shall comply with the relevant engineering standards applicable to the requirements of the environment, the geographical location, animal welfare and care, and research-related demands. Any request must be justified by the needs of the HIV/AIDS-related NIH-funded research projects that use non-human primates raised, maintained, and housed in these facilities.

Key Dates

 

Posted Date

March 1, 2018

Open Date (Earliest Submission Date)

March 30, 2018

Letter of Intent Due Date(s)

Not Applicable

Application Due Date(s)

April 30, 2018, by 5:00 PM local time of applicant organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on this date.

Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.

AIDS Application Due Date(s)

Not Applicable

Scientific Merit Review

June 2018

Advisory Council Review

August 2018

Earliest Start Date

September 15, 2018

Expiration Date

May 1, 2018

Due Dates for E.O. 12372

As described in the NIH Grants Policy Statement, an applicant must provide a copy of the application to the State Single Point of Contact (SPOC) no later than the time the application is submitted to NIH. SPOC comments must be submitted to NIH with the application, or the application must indicate the date on which the application was provided to the SPOC for review.

Required Application Instructions

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.


Table of Contents

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


Part 2. Full Text of Announcement
Section I. Funding Opportunity Description

In September 2017, Hurricane Maria devastated parts of Puerto Rico. This funding Opportunity Announcement (FOA) targets research institutions in Puerto Rico which maintain non-human primate facilities supporting HIV/AIDS-related research. Applicant institutions may request funds to recover, restore, and modernize the physical infrastructure of such facilities. Specifically, this FOA focuses on facilities that breed, raise, maintain, and house non-human primates for HIV/AIDS-related research funded by NIH and other organizations.

HIV/AIDS researchers depend on the availability and access to well characterized and defined colonies of non-human primates to study basic pathobiology of the virus and progression of infection, and to develop potential treatments of the disease for translation to humans, and evaluate HIV-1 vaccines for prevention. Maintaining breeding colonies requires long-term efforts and stable environments to ensure the welfare of animals used for HIV/AIDS-related research. These functions of facilities in Puerto Rico are now significantly disrupted due to the devastation of structures and the alteration of the physical environment. Restoring the physical infrastructure is necessary and must be undertaken immediately for the benefit of the animals and future needs of NIH-funded research projects. Any construction request must be justified by urgent animal husbandry needs, including access to animal colonies, housing of animals, and abilities to care for them. Also, the request must be justified by the needs of HIV/AIDS researchers for animals raised and housed there. The applicant should explain how the construction will contribute towards the restoration of animal research capabilities. 

Pre-Maria operations and the current state of a facility should drive the best approaches and timelines to restore its functionality. The applicant may consider submitting separate applications for projects in different locations, so that independent plans can focus on project's individual needs, engineering requirements, and design execution. For example, facilities at different locations can perform distinct functions for different populations of animals, so that different physical infrastructure needs may require different engineering solutions. As different facilities may support diverse research groups, different justifications would be relevant in such cases.

Restoration of the functionality of the non-human primate facilities should be the main goal of each request. The applicant may request funds to repair damages. However, rebuilding to the original state may not be the optimal solution due to potentially altered scientific objectives, the level of recently experienced damages, and changes in the accepted standards for the type of facility. Any repairs should implement modern technologies and be based on current engineering guidelines to ensure usefulness, reliability, and durability. In particular, improved structures should be able to withstand extreme weather conditions. Storm-altered local topography may dictate further changes; the applicant may request funds for new structures, provided they are needed to restore the function of the facility. Whenever practicable, the applicant should employ sustainable design practices and green technologies.

The applicant may request funds for design and construction activities to build, repair, or modernize permanent structures such as buildings, corrals, loading docks, passageways, fences, and water collection cisterns. Similarly, relevant repairs and upgrades to water, electrical, and security systems are allowed. The applicant may request funds to purchase and install fixed equipment that is connected to building structures and services, such as heating, ventilation, and air conditioning (HVAC) systems, chiller systems, and backup generators. Purchases of moveable equipment cannot be funded under this FOA – see Funding Restrictions Section for budgetary restrictions.

The applicant institution shall name a Principal Director/ Principal Investigator (PD/PI) who has appropriate standing within the institutional administration, and experience with management of non-human primate colonies and knowledge about the role of the facilities for HIV/AIDS-related research. This person should recruit a key personnel team with complementary skills and abilities as describe in Senior /Key Person Profile Expanded Section to ensure successful design and execution of the construction project.

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

  • The project is essential for NIH-supported research-related activities and the facilities involved will be used for these activities.
  • If the facilities are rented or land is leased, copies of leases must be provided, and the terms of the lease and expected subsequent use of the facility are consistent with the proposed project. Specifically, evidence must be provided that the terms of the lease agreement and subsequent use of the facility will comply with the 20-year facility use term. A statement of agreement by the owner of the space must be included.
  • If the project will affect a site listed in (or eligible for inclusion in) the National Register of Historic Places, the requirements specified in "Preservation of Cultural and Historic Resources" have been followed.
  • In accordance with federal regulation, a Notice of Federal Interest must be filed and recorded for any property constructed under this award. A statement of agreement by the owner of the space to file and record a Notice of Federal Interest must be included.

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.

This is a one-time funding opportunity.

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

Section II. Award Information
Funding Instrument

Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.

Application Types Allowed

New

The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types.

Clinical Trial?

Not Allowed: Only accepting applications that do not propose clinical trials

Need help determining whether you are doing a clinical trial?

Funds Available and Anticipated Number of Awards

The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications.

ORIP intends to commit up to $7,800,000.00 in FY 2018 to fund 1-3 awards.

Award Budget

Application budgets are limited by available funds and need to reflect the actual needs of the proposed project.

Award Project Period

 The project period is 5 years.

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

Section III. Eligibility Information
1. Eligible Applicants
Eligible Organizations
  • Only institutions of higher education in Puerto Rico whose non-human primate facilities supporting HIV/AIDS-related research were severely damaged by Hurricane Maria, are eligible to apply.
Foreign Institutions

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.

Required Registrations

Applicant Organizations

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

  • Dun and Bradstreet Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number. After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.
  • System for Award Management (SAM) (formerly CCR) – Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
  • NATO Commercial and Government Entity (NCAGE) Code – Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM. 
  • eRA Commons - Applicants must have an active DUNS number and SAM registration in order to complete the eRA Commons registration. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
  • Grants.gov – Applicants must have an active DUNS number and SAM registration in order to complete the Grants.gov registration.

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

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

Eligible Individuals (Program Director/Principal Investigator)

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 scientific and technical skills to successfully accomplish the construction project.

2. Cost Sharing

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

3. Additional Information on Eligibility
Number of Applications

An institution (identified by NIH IPF number) may submit multiple applications, provided projects are in different locations and have distinct infrastructure restoration needs.

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).
Section IV. Application and Submission Information
1. Requesting an Application Package

Buttons to access the online ASSIST system or to download application forms 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.

2. Content and Form of Application Submission

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.

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

Page Limitations

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 to the SF424 (R&R) Other Project Information form is limited to 18 pages, excluding line drawing 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.

SF424(R&R) Cover

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.     

SF424(R&R) Project/Performance Site Locations

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

SF424(R&R) Other Project Information

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

Project Narrative (assemble in order shown below): The Project Narrative should consist of three sections: Overview, Scientific Justification, and Restoration of the Facility.

The Overview section, in lieu of Specific Aims, cannot exceed 1 page and must summarize the project, stating its goals and outlining the proposed approaches to achieve them. This section should include a brief description of the infrastructure affected by this project, including any fixed equipment that is requested in this application – Tables 1 and 2 in Other Attachments may be referenced to simplify the presentation. This section should state how the project will restore capabilities to raise, maintain, and house non-human primates for the benefit of HIV/AIDS-related research programs, locally and nationally.  

It is up to the PD/PI to allocate the remaining 17 pages of the Project Information narrative to the sections: Scientific Justification and Restoration 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 also describe technical design with sufficient details to make clear the merits of the overall project.

The Scientific Justification section should make clear the needs for the restored physical infrastructure by detailing the scope of the supported research and research-related activities. The applicant should briefly describe the facility prior to Hurricane Maria and the scientific value of the animal resource. Details about the non-human primates bred, managed, and housed in the facility should be given, including the numbers of animals and their significance for NIH-funded research. The sources of funding directly supporting the resources and the scope of resource operations should be outlined. The text should include an overview of HIV/AIDS-related research that relied on the use of these animals, immediately prior to Hurricane Maria. Similarly, research plans disrupted by the Hurricane should be presented. Specifically, the applicant should outline the breadth of local and nation-wide collaborations, including scientific fields and numbers of animals involved in these projects. A table may be included in this text with a listing of names of current collaborators, their funding sources, and the number of animals needed. Also, the narrative should explain plans for the restoration of scientific activities to the pre-Hurricane levels, following the completion of the construction project.

A separate paragraph should describe the present status of the animals in the facility and ongoing efforts to maintain and care for them. This paragraph should clarify that with the restoration of the facility, it is feasible to bring back lost animal care and research capabilities. In addition, breeding procedures and special care protocols (if any) should be described to make a supporting argument for any related engineering solutions proposed in the Restoration of the Facility section.

This section should conclude with a paragraph about the qualifications of the PD/PI to lead the project from its conception to completion, by working with Key Personnel on overseeing the planning process and its execution – see Eligible Individuals Section. Also, the qualifications of Key Personnel, including their complementary scientific and technical expertise should be described. Their individual roles and responsibilities at different stages of the project should show their expected contribution towards the overall goal and show how they will work together to accomplish the project. It is important for the PD/PI to document that the team has expertise and skills necessary to design and construct the facilities to meet the project objectives.

The Restoration of the Facility section should present technical specifications, details of the architectural and engineering design, and proposed construction processes to restore the function of the animal facility. The PD/PI should provide sufficient details about implementation of the project, including any technical and practical challenges that will need to be overcome. This narrative should start with the location of the facility and component structures 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 (See "Other Attachments", below), 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 engineering needs of all fixed equipment such as mechanical, electrical and plumbing (MEP) specifications for installation, should be presented - compare data in Table 2 (See "Other Attachments", below).

The facility should be designed to current technical and engineering standards that will ensure welfare and safety of animals, appropriate implementation of their care and maintenance protocols, access to research space (as appropriate), and the ability of the structures to withstand storms and hurricane force winds, and other severe weather events.

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

  • Mechanical, electrical and plumbing (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);
  • 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 explained how the requirements for animal care and animal HIV/AIDS research will be met.

A useful document giving design guidelines for the proposed project is:

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 waste water) and outdoor water (i.e., natural site drainage and low impact storm water retention)
  • Indoor environmental quality, including ventilation and thermal comfort, moisture 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.

Useful documents giving guidelines on sustainable design are:

Whole Building Design Guide http://www.wbdg.org

In the Other Attachments section, the PD/PI should include the following documents, each as a separate attachment with a filename using the headings below (e.g., Line Drawings, Budget Justification, and so forth)

1) Line Drawings: 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 buildings 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:

  • Size, dimensions, function, and the net and gross square feet for each room;
  • Location of the proposed construction/renovation area in the existing building;
  • 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.

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

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

3)  Table 2: list of requested fixed equipment. Table 2 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 Vendor Quotes in the Budget Justification Section.

4)  Budget Justification and Vendor Quotes: All vendor quotes should be attached here, along with justification for each piece of fixed equipment.

The budget justification should detail:

  • Administrative and legal expenses;
  • Land, structures, rights-of-way, appraisals, etc.;
  • Relocation expenses and payments;
  • Architectural and engineering fees:
  • Project inspection fees;
  • Site preparation work;
  • Demolition and removal;   
  • Construction;
  • Equipment;
  • Contingencies;
  • Miscellaneous (cost of any needed allowable item(s) not assignable to other cost classification areas listed above).

5)  Institutional Endorsement Letters.  No institutional cost sharing is required, but proof of strong support for the non-human primate facilities and HIV/AIDS-related research must be documented in a letter from a high-ranking institutional official. This letter should also verify that facilities existed prior to the hurricane and include a description of the extent of the damage, destruction, or loss resulting from the hurricane. Also, the letter must confirm that the application does not request any funding that overlaps with FEMA, under a contract for insurance, or self-insurance payments. The letter must be co-signed by an institutional Signing Official.

6)  Certification of Title to Site: 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).

7)  Project timeline: To demonstrate how the project will be completed within the five-year budget and award period.

8)  Letters of Support: A maximum of 5 optional support letters may be attached.

SF424(R&R) Senior/Key Person Profile Expanded

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 scientific and technical skills. The team must include a PhD-level scientist with experience in managing non-human primate colonies and overseeing HIV/AIDS-related research. 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. Also, an individual with technical proficiency in engineering or architectural matters who will serve as a construction project manager - must be identified. This person's responsibility will include oversight of the design, implementation of the project, and communication between the scientific and technical staff at every step of the development of the application and subsequent execution of the project. A project role for this person should be specified as "Other" or "Other Professional" and a biosketch with relevant information about professional qualifications and expertise should be attached.

SF424C Budget Information for Construction Programs

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.

PHS 398 Cover Page Supplement

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

PHS Assignment Request Form

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

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 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.

5. Intergovernmental Review (E.O. 12372)

This initiative is 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.

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

Funds will be restricted, so that they cannot duplicate costs reimbursed by FEMA, under a contract for insurance or self-insurance. If during the period of the award, a claim is paid which provides such duplication, the grantee will be required to pay back the equivalent funds to the NIH.

Pre-award costs are allowable only as described the NIH GPS. For example, pre-award costs are allowable only for design and engineering fees.

Funds may be requested for design of the facility, its construction, purchases of fixed equipment and its installation, and allowable fees. Allowable costs 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 NFI.

F&A costs are NOT allowed. Other non-allowable costs include:

  • Bonus payments to contractors
  • Construction of shell space designed for completion at a future date
  • Equipment purchased through a conditional sales contract
  • Fund-raising expenses
  • Consultant fees not related to actual construction
  • Legal services not related to title certification
  • Land acquisition
  • Damage judgment suits
  • Landscaping and irrigation costs
  • Movable equipment
  • Fund-raising expenses
  • Interior and exterior decorating fees (e.g., purchase of artwork, sculpture, etc.).

Funds will be awarded in a single action using a five-year budget and project period.

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. Upon completion and occupancy, the facility will be monitored annually for 20 years in order to determine whether the facility is used for biomedical research-related activities.

If awarded, all funds will be initially 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) (15-30%),
  • 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); however, 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).

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

Important reminders:
All 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.

Post Submission Materials

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

Only the review criteria described below will be considered in the review process. As part of the NIH mission, all applications submitted to the NIH in support of biomedical and behavioral research are evaluated through the NIH peer review system.

Overall Impact

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).

Scored Review Criteria

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 meritorious 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, support or maintain biomedical or behavioral research? 

Is there sufficient justification for improving this animal core facility?  To what extent will the proposed change in the research environment facilitate the applicant institution's ability to conduct, expand, improve, support 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? 

How will the proposed construction activity facilitate the applicant institution's ability to restore and maintain non-human primate animal facilities for the benefit of HIV/AIDS-related research?

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

How effective is 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?

Is the PD/PI qualified to lead a multidisciplinary team of Key Personnel within a collaborative environment and to oversee the requested project from design to completion? Do the PD/PI and Key Personnel have the complementary expertise necessary to plan for and design a non-human primate facility to support HIV/AIDS research? Do Key Personnel demonstrate the relevant level of engineering expertise and skills to ensure that the proposed facility can meet the relevant codes and engineering standards to withstand severe weather?

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

How likely is the proposed activity to benefit research 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? 

How will the project restore the facility's capability to support HIV/AIDS-related research? How will research supported by NIH, other federal agencies, and nonprofit organizations benefit from this project? 

Need for the Project or Additional Space

How compelling are: 1) the identified need(s) 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? 

How compelling are the needs of HIV/AIDS-related research for the restoration of the function of the 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? 

Is the design consistent with the relevant codes to ensure welfare of non-human primates? Is the design based on the relevant engineering standards so that the completed structures will likely to withstand future hurricanes and storms? 

Additional Review Criteria

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

Additional Review Considerations

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 research.

2. Review and Selection Process

Applications will be evaluated by (an) appropriate Scientific Review Group(s), convened by an appropriate Scientific Review Group(s), 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 appropriate national Advisory Council or Board. The following will be considered in making funding decisions:

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

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, Grantees, and Activities. More information is provided at Award Conditions and Information for NIH Grants.

Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights law. This means that recipients of HHS funds must ensure equal access to their programs without regard to a person's race, color, national origin, disability, age and, in some circumstances, sex and religion. This includes ensuring your programs are accessible to persons with limited English proficiency.  HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator's scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research.

For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA. HHS provides general guidance to recipients of FFA on meeting their legal obligation to take reasonable steps to provide meaningful access to their programs by persons with limited English proficiency. Please see http://www.hhs.gov/ocr/civilrights/resources/laws/revisedlep.html. The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html; and http://www.hhs.gov/ocr/civilrights/understanding/index.html. Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html. Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at http://www.hhs.gov/ocr/office/about/rgn-hqaddresses.html or call 1-800-368-1019 or TDD 1-800-537-7697. Also note it is an HHS Departmental goal to ensure access to quality, culturally competent care, including long-term services and supports, for vulnerable populations. For further guidance on providing culturally and linguistically appropriate services, recipients should review the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care at http://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.

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

3. 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.

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.

Section VII. Agency Contacts

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

Application Submission Contacts

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

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading forms and application packages)
Contact Center Telephone: 800-518-4726
Email: support@grants.gov

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

Scientific/Research Contact(s)

Willie D. McCullough, Ph.D.
Office of Research Infrastructure Programs (ORIP)
Telephone: 301-435-0783
Email: mccullow@mail.nih.gov 

L. Jean Patterson, Ph.D.
Office of AIDS Research (OAR)
Telephone: 301-496-4077
Email: jean.patterson@nih.gov

Peer Review Contact(s)

Ross D. Shonat, Ph.D.
Center for Scientific Review (CSR)
Telephone: 301-435-2786
Email: ross.shonat@nih.gov

Financial/Grants Management Contact(s)

Esther Young
Office of Research Infrastructure Programs (ORIP)
Telephone: 301-401-7183
Email: esther.young@nih.gov 

Section VIII. Other Information

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.

Authority and Regulations

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.

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