Required Application Instructions

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

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

Biomedical and bio-behavioral investigators often rely on animal models to explore fundamentals of biology, to investigate physiological and pathological conditions, to build models of human diseases and to interrogate clinically-relevant procedures. This Program does not offer direct funding for research activities; however, it plays an essential role within the NIH-supported research enterprise by funding awards which improve physical infrastructure of animal research facilities. The major objective of this program is to upgrade and modernize facilities to support the conduct of biomedical and/or behavioral research. Enhancing physical conditions brings on many direct benefits, such as controllable and safe environments, ease of maintenance, and up-to-date standard of care.

Support can be requested to alter and renovate animal facilities and to purchase animal care equipment for the facilities. The proposed remodeling efforts must directly serve animals or be related to animal care. A related objective of this program is to assist institutions in complying with the USDA Animal Welfare Act and the DHHS policies related to the care and use of laboratory animals.

The program aids in correcting deficiencies of institutional animal facilities and animal care. For example, refurbishing of procedure rooms adjacent to the holding area is not allowed under this FOA, because it would not directly involve animal care. Types of remodeling efforts and equipment which are allowed under this FOA include, but are not limited to, purchasing and installing items which directly impact animal care; for example, heating and air-conditioning (HVAC) equipment serving the facility, cagewashes, autoclaves, microisolator cages, or socializing cage systems. Investigators are strongly encouraged to contact the Scientific/Research Contact listed in Section VII. Agency Contacts to discuss their planned projects before submitting applications.

It is expected that the PD/PI and key personnel of the project have the capability and position to manage the project having the relevant standing within the institutional administration structure, and knowledge and experience in animal care. In addition, an individual with technical proficiency in engineering and architectural matters must be listed among key personnel and his/her biosketch must be attached. This Facility Person will serve as a point of contact to the NIH technical staff. Specifically, if a project includes a remodeling aspect, after the award is issued but before the project can move forward, NIH will review design documents.

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

Higher Education Institutions

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

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

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

Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.

Foreign components, as defined in the NIH Grants Policy Statement, are not allowed.

Applicant Organizations

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

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

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

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

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director/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.

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

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

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

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

In addition, the NIH will not accept a resubmission (A1) application that is submitted later than 37 months after submission of the new (A0) application that it follows. The NIH will accept submission:

• To an RFA of an application that was submitted previously as an investigator-initiated application but not paid;
• Of an investigator-initiated application that was originally submitted to an RFA but not paid; or
• Of an application with a changed grant activity code.

Applicants must download the SF424 (R&R) application package associated with this funding opportunity using the Apply for Grant Electronically button in this FOA or following the directions provided at Grants.gov.

It is critical that applicants follow the 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.

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

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

The forms package associated with this FOA includes all applicable components, required and optional. Please note that some components marked optional in the application package are required for submission of applications for this FOA. Follow all instructions in the SF424 (R&R) Application Guide to ensure you complete all appropriate optional components.

Instructions for Application Submission

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

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

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

Is Application Subject to Review by State Executive Order 12372 Process: Applicants shuld enter "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. The following additional specific instructions apply:

Project Summary/Abstract: This section must not exceed one page. The abstract should briefly describe the scope of the planned project and its benefits to the animal research facility.

Project Narrative: The Project Narrative should include the following sections (assembled in this order): Specific Aims, Background, Significance and Need, Project Management and Institutional Commitment, and Design Considerations.The Project Narrative should be submitted in a single PDF attachment; the filename cannot have spaces or special characters, and a .pdf extension must be used.

Begin each section with a header (e.g., Specific Aims, Background, Significance and Need, etc.).

Specific Aims: This section must not exceed one page. State the specific goals set for the project and the proposed strategy to accomplish them. In particular, describe the area affected by the project, including its square footage and any equipment which is requested here. State how the project will contribute to the research infrastructure at the Institution and improve animal care.

Background: The Background section must not exceed two pages. Briefly describe all animal-research resources at your institution. Describe the facility which is to be modernized, in the context of the animal-model research conducted at the Institution.

Significance and Need: Present the current status of the facility in the context of the number of animals it houses, the number of users it serves, and the overall animal research program at the Institution. Describe the space which will be improved by the project: address current deficiencies and how the planned project will correct these deficiencies and benefit animal care. Describe how current and future scientific needs will be accommodated by the proposed improvements. Describe the modifications to the existing facility to accommodate the proposed functions and the requested equipment. Explain how the proposed project, if accomplished, will contribute to research activities, expand research capabilities, or modernize research infrastructure. You may refer to the data shown in Tables 1 - 4 (See "Other Attachments", below).

Project Management and Institutional Commitment: Describe the administrative structure and the oversight for the project: present the role that the PD/PI will play in coordinating and overseeing the activities of planning and conducting the project. Describe the ability of the PD/PI, the Project Manger (if other than PD/PI), and the Facility Person to work together.

Describe the ongoing institutional long-term plan for animal-model research and animal facilities. Describe the financial plan for operating and maintaining the facility. Attach a letter describing institutional financial support for this animal facility (See "Other Attachments", below). Describe the structure of user fees, if any.

Design Considerations: In this section, describe the architectural and engineering design of the project. Provide sufficient details about its implementation, including any technical challenges that will need to be overcome. The level of detail of the application's Line Drawings, data in Table 5 (See "Other Attachments", below), and the engineering and architectural criteria narrative must provide sufficient information for reviewers to determine the functionality of the overall design plans, and the safety and reliability of the final product. Discuss the facility's placement in the building that houses it, as relevant to the project.

In the narrative, justify all requested equipment as being relevant to the function of the animal facility and serving an identified user group. Also, describe all equipment in the context of the engineering aspects of the project: specification for installation in the context of mechanical, electrical and plumbing needs. You may refer to data in Table 6 (See "Other Attachments", below).

Provide Engineering Criteria as relevant to the project:

• 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.

Provide Architectural Criteria as relevant to the project:

• Width of corridors and doors and surface finishes;
• Quality of life issues (e.g., light levels, natural lighting, noise, vibration);
• Functional relationships and zoning of the renovated area.

Provide sufficient information to allow the evaluation of plans for Biological Safety Level-3/Animal Biological Safety Level-3 (BSL-3/ABSL-3) designs, if applicable.

Other Attachments: Include the following, each as a separate PDF attachment. NOTE: Each attachment must be given a file name using the headings below (e.g., budget_justification_form). Only those items specifically mentioned in "Other Attachments" will not count towards the pages limits of the Project Narrative.

Attach the following 4 tables: (1) Active NIH Grants, (2) Pending NIH Grants, (3) Active Other Grants, (4) Pending Other Grants listing active grants and pending applications which present research that would benefit from the proposed improvement. Each table must have the following columns: Status: Grant Number (for active grants), or Submitted or To-be-Paid for pending applications; PD/PI Name; Annual Amount of Funding; Start and End Dates; Animal-Model (e.g., species); Number of animals needed per year. In Tables 3 and 4, list all active and pending grants from other Federal agencies, private foundations, and other sources that will benefit from the proposed improvement. Use the same format as in Tables 1 and 2, but include in the Status column the name of the funding agency or organization (e.g., NSF, HHMI, or American Diabetes Association).

In Table 5, list the size (dimensions) and square footage of each component (e.g., room, alcove, cubicle, laboratory etc.) that will be directly affected by the project.

In Table 6, list all requested fixed equipment. 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 Section.

Attach Line Drawings: The line drawings must be included for all applications submitted to this FOA. Applications submitted that propose an alteration and renovation component without corresponding line drawings will be deemed incomplete and will not be reviewed.

Although the line drawings do not count toward the page limits, additional text must not be included in the line drawings to circumvent the page limits. Such additional text will be counted toward the page limit of the Project Narrative.

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

Do not include construction design documents in the application. If your application is selected to be funded, you'll be asked to send such documents for approval before proceeding with the project.

Provide the following information as relevant to the project:

• Indicate the location of the proposed renovation/upgrade area in the existing building;
• Including floor plans of existing and proposed facilities, af applicable;
• Give the net and gross square feet of space which will be affected by the project; in particuler, indicate dimensions, function, and the net and gross square feet for each room;
• Indicate the functional layout of the proposed facility showing the location of entries and exits, clearances;
• Indicate the location of equipment (including racks and cages) and illustrate safety clearances and workspace;
• Show traffic flow pattern of personnel, animals and equipment;
• Indicate egress routes;
• Describe directly in notes made directly on the plan or attached to the plan any changes in additions to the existing MEP system.

Attach Institutional Financial Commitment Letter (including plans for support of this facility)

Attach Budget Justification: Briefly describe the requested budget including design costs, costs of any alteration of existing structure, equipment and its installation costs. You must attach Vendor Quotes for each piece of the requested equipment. A justification must be provided for all items in the budget. Matching funds are not required, but if the applicant chooses to pursue a bigger project that requires combining funds from different sources, their availability has to be clearly documented in the application.

Attach 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 biomedical or behavioral research purposes for at least five years beginning on the date of beneficial occupancy of the remodeled space. Any lease agreement must cover a time period sufficient for the usage requirement and be a minimum of five years in length from the occupancy of the remodeled facility.

In a separate brief attachment, applicants must include information about their Institutional Occupational Health Program as it pertains to animal care staff.

Applicants must include the Institutional Animal Care and Use Committee (IACUC) and if accredited, the Association for Assessment and Accreditation of Laboratory Animal Care (AAALAC) summary reports, and/or sections of these reports that describe deficiencies of the facility and the animal care program.

A maximum of three letters of support may be attached in this section of the application.

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

In addition to PD/PI, a Facilities Person must be identified for this application. Please include a profile of this person in the Research & Related Senior/Key Personnel Form (following the PD/PI's profile) and, in particular, specify the project role as Facilities Person in the Other Project Category field. Also, attach a biographical sketch of this person. A Facilities Person will directly communicate with NIH technical staff about the design of the project. Typically, he/she is familiar with systems of biomedical research buildings and many times is an architect, engineer, or the construction project person. In addition, include information such as Profile and biographical sketch of the Director of the Animal Facility. Among the listed Key Personnel identify Project Manager and (if other than PD/PI) specify this person's role in the Other Project Role Category fields as Other or Other Professional . A Project Manager has full responsibility and the level of authority for completing the project.

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

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

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

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

Part I. Overview Information contains information about Key Dates. 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.

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.

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.

Not Applicable

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.

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.

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 by the Center for Scientific Review, NIH. Applications that are incomplete will not be reviewed.

Here we provide a list of documents with relevant information to the design of animal research facilities.

NIH Grants Policy Statement 10/12) Part II- Subpart B (construction grants) http://grants.nih.gov/grants/policy/nihgps_2012/nihgps_ch10.htm. Please refer to this document for a representative list of allowable and unallowable costs.

NIH Design Requirements Manual
http://orf.od.nih.gov/PoliciesAndGuidelines/BiomedicalandAnimalResearchFacilitiesDesignPoliciesandGuidelines/Pages/DesignRequirementsManualPDF.aspx

Biosafety in Microbiological and Biomedical Laboratories, CDC/NIH, 5th Edition, http://www.cdc.gov/biosafety/. Appendix A is particularly useful.

Information about the Select Agent Rule and related matters. http://www.selectagents.gov/

Guide for the Care and Use of Laboratory Animals, National Research Council, National Academy Press, Washington, D.C. http://grants.nih.gov/grants/olaw/Guide-for-the-Care-and-Use-of-Laboratory-Animals.pdf

Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-13-030.

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

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).

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

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

Does the applicant provide sufficient evidence of 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, or maintain biomedical or behavioral research?

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

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

How effective 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?

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 NIH-funded research projects (Table 1) benefit from the proposed modernization of the animal facility? How will research supported by other federal agencies and nonprofit organizations (Table 3) benefit from this project? How will this modernization project contribute to the well-being of research animals in the context of the federally mandated policies related to the care and use of laboratory animals?

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?

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?

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

For Resubmissions, the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.

Renewals

Not Applicable

Revisions

Not Applicable

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

Applications from Foreign Organizations

Not Applicable

Select Agent Research

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

Resource Sharing Plans

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

Budget and Period of Support

Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.

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

Applications will be assigned on the basis of established PHS referral guidelinesto the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications. Following initial peer review, recommended applications will receive a second level of review by the Council of Councils . The following will be considered in making funding decisions:

• Impact/priority 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.

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.

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

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

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

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

Any application awarded in response to this FOA will be subject to the DUNS, SAM Registration, and Transparency Act requirements as noted on the Award Conditions and Information for NIH Grants website.

Timeline:

All projects that include an alteration and renovation component must submit 100% complete construction design documents within four months following the receipt of the Notice of Award. The construction documents must be approved by NIH prior to beginning renovation. The PD/PI must plan and show how to complete the project within six months following NIH approval of construction documents; that is, one year from the receipt of the Notice of Award.

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

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.

Cooperative Agreement Terms and Conditions of Award

Not Applicable

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

When multiple years are involved, awardees will be required to submit the Non-Competing Continuation Grant Progress Report (PHS 2590 or RPPR) annually and financial statements as required in the NIH Grants Policy Statement.

A final progress report, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement. 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.

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

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)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)
Finding Help Online: http://grants.nih.gov/support/index.html
TTY: 301-451-5939
Email: [email protected]

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading forms and application packages)
Contact Center Telephone: 800-518-4726
Web ticketing system: https://grants-portal.psc.gov/ContactUs.aspx
Email: [email protected]

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone: 301-710-0267
TTY: 301-451-5936
Email: [email protected]

Willie D. McCullough, Ph.D.
Office of Research Infrastructure Programs (ORIP)
Telephone: 301-435-0766
Email: [email protected]

Direct inquiries regarding engineering or architectural issues:
Marlene Jefferson, AIA
Office of Research Infrastructure Programs (ORIP)
Telephone: 301- 594-6140
Email: [email protected]

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

Jenelle Wiggins
National Center for Advancing Translational Sciences (NCATS)
Telephone: 301-435-0843
Email: [email protected]

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

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284), 42 USC 283k, and under Federal Regulations 42 CFR Part 52b and 45 CFR Parts 74 and 92.