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

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

Purpose

The purpose of this FOA is to provide an opportunity for the Regional Biocontainment Laboratories (RBLs) established by the National Institute of Allergy and Infectious Diseases (NIAID) to request support for upgrades to established RBL facilities and building systems to facilitate the conduct of biomedical research on infectious diseases, including infectious disease outbreaks. This is a limited competition for one-time support designated for the RBLs based at the following institutions: University of Alabama at Birmingham; Tulane University; University of Tennessee; George Mason University; Duke University; Rutgers University; Tufts University; University of Pittsburgh; University of Chicago; University of Missouri; University of Louisville; and Colorado State University.

Background

In February 2002, NIAID, as the lead NIH Institute for biodefense research, initiated a systematic planning process for its biodefense research program. As a first step, NIAID convened the Blue Ribbon Panel on Bioterrorism and Its Implications for Biomedical Research (Panel) to determine key priorities and short- and long-term goals for biodefense research in the United States. The Panel noted a shortage of Biosafety level 3 (BSL-3) and 4 (BSL-4) laboratory space as a significant obstacle. In response, NIAID released funding announcements and ultimately made awards for the construction of two National Biocontainment Laboratories and 12 Regional Biocontainment Laboratories (RBLs). The RBL awards were nonrenewable and operational support was excluded. Since their inception, the RBLs have been an important resource. They assist national, state, and local public health efforts by providing safe and secure state-of-the-art BSL-3 laboratory space to the scientific community to advance research on biodefense pathogens and emerging infectious diseases.

Research Objectives

The objective of this FOA is to provide one-time funding support in Fiscal Year 2021 for upgrades to existing facilities and building systems at the 12 RBLs to facilitate the conduct of research that aims to prevent, prepare for, and respond to infectious diseases, including infectious disease outbreaks. Examples of activities that are covered under this FOA include but are not limited to:

Repair, renovation, and modernization of building systems to enhance functions and operations of existing research facilities, i.e., renovating space or updating the facility’s HVAC, plumbing or electrical systems;

Equipment connected to building systems that modernizes, streamlines, or improves efficiencies of the operations of the facility, i.e., specialized autoclaves, glass washers, hoods, changing stations, downdraft tables, and biosafety cabinets; and

Building automation systems related to functioning of the facility.

The following activities are considered non-responsive and will not be funded:

• Applications that propose construction as defined in the NIH Grants Policy Statement.
• Operational costs.
• Upgrades that are outside the footprint of the originally constructed RBL facility.
• Clinical trials: Clinical research may be supported; however, clinical trials are not to be initiated or conducted through this funding opportunity. See NOT-OD-15-015 for the NIH Definition of a Clinical Trial.

For more information see the NIAID Research Funding site Questions and Answers for RFA-AI-21-022 found at the following: https://www.niaid.nih.gov/grants-contracts/questions-answers-RFA-AI-21-022

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

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

The following organizations/institutions are eligible to apply:

• University of Alabama at Birmingham
• Tulane University
• University of Tennessee
• George Mason University
• Duke University
• Rutgers University
• Tufts University
• University of Pittsburgh
• University of Chicago
• University of Missouri
• University of Louisville
• Colorado State University

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

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

Applicant Organizations

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

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

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

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

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed project 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).

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

It is critical that applicants follow the the Research (R) Instructions in the SF424 (R&R) Application Guide, except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

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

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

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

The letter of intent should be sent to:

Lynn Rust Ph.D.
Telephone: 240-669-5069
Email: [email protected]

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.
• Project Narrative -- 12 pages

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.

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

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

Project Summary/Abstract: The abstract should briefly describe the scope of the planned facility upgrades and discussion of how the upgrades will support biomedical research to help prevent, prepare for, and respond to infectious disease outbreaks.

Project Narrative: The Project Narrative should describe the facility where the project is to be located, justify the upgrade needs, and present the proposed improvement plan with technical details necessary to demonstrate the feasibility of the project. Include the following sections (assembled in this order): Specific Aims, Significance and Need, Description of the Facility, Justification of the Project, Modernization Plan, and Project Management and Institutional Commitment.

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

Specific Aims: State the specific goals set for the project and the proposed strategy to accomplish them. In particular, describe the proposed facility and equipment upgrades. State how the project will contribute to the research infrastructure at the Institution and enhance the conduct of biodefense and emerging infectious diseases research.

Significance and Need: Present the current status of the facility. Describe the space that will be improved, noting any current deficiencies. Describe how the planned project will correct these deficiencies and anticipated benefit of such efforts. Explain how the proposed project, if accomplished, will contribute to biodefense and emerging infectious diseases research activities, and enhance research capabilities.

Description of the Facility: Include information about the location of the facility, areas of research supported, types of research services offered, and the research community that relies on services provided by the facility. The narrative should also describe the Institutional commitment to support long-term operations and maintenance of the facility. Deficiencies of the facility’s existing physical infrastructure that limit or threaten the provision of services it offers and research-related activities it supports, will serve as the basis for the justification of the upgrade needs.

Justification of the Project: Describe how the proposed improvements will remedy the infrastructure’s deficiencies, improve the facility’s operations, and modernize the facility. If the project includes the upgrade of animal laboratory space, planned improvements in animal management, maintenance, or care should be presented and connected (as applicable) to improvements of the accuracy of the models that will be used in research.

Current NIH research funding to investigators who rely on the facility is not a prerequisite. If applicable, the PD/PI should briefly describe NIH-funded research awards that will benefit from the project and explain the role of the facility in advancing NIH-supported areas of research. If NIH research funding is not available, the PD/PI should describe the institutional biomedical research community who uses the facility and their research projects, to demonstrate the shared use of the facility and its role in supporting the institutional research enterprise. To add to the justification, the PD/PI should also demonstrate how the project will benefit biomedical research programs over the long term.

Modernization Plan: Describe the equipment requested and demonstrate that the chosen model(s) when installed will optimally address current deficiencies and meet the research-driven demands. The location of the equipment must be marked on the floor plan (required to be uploaded in Other Attachments) to indicate that its installation and operations will meet architectural and engineering standards. Technical specification of the equipment together with its demands on building systems (HVAC, electrical, plumbing) should also be described to demonstrate the feasibility of the project. The use of green technologies offering savings in energy, water and other functional efficiencies is encouraged. Challenges associated with refurbishing or altering of space should be described along with their proposed solutions. There should also be an outline of the plans leading to the successful completion of the projects, including how the PD/PI will leverage their own expertise and leadership skills to work with other scientific and technical experts.

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 Manager (if other than PD/PI) and the other personnel associated with the RBL to work together.

Other Attachments: Include the following, each as a separate PDF attachment. Only those items specifically mentioned in "Other Attachments" will not count towards the page limits of the Project Narrative.

Timeline: The filename "Timeline.pdf" should be used and will be reflected in the final image bookmarking for easy access for reviewers. Include a timeline for the conduct of the project, including space preparations, adjustments to the building systems, equipment ordering, delivery, and installation; securing any permits, as applicable.

Floor Plan: The filename "Floor Plan.pdf" should be used and will be reflected in the final image bookmarking for easy access for reviewers. Include:

• Functional layout of the area, showing dimensions and the location of entries and exits, egress routes, clearances, and the location of fixed equipment.
• Changes or additions to existing mechanical, electrical, and plumbing systems; notes that annotate the changes may be directly included on the plan.
• Provide sufficient information to allow the evaluation of plans for Biological Safety Level-3/Animal Biological Safety Level-3 (BSL-3/ABSL-3) designs.

Budget Justification: The filename "Budget Justification.pdf" should be used and will be reflected in the final image bookmarking for easy access for reviewers. Include itemized valid manufacturer’s quotes and budget justification. Provide quotes from manufacturer(s) for all items of equipment requested. Also, describe and justify any costs associated with the installation of the equipment and the modification of space or building systems (as applicable) to ensure proper functioning of the equipment. Provide a justification for all other items in the budget.

Institutional Support: The filename "Institutional Support.pdf" should be used and will be reflected in the final image bookmarking for easy access for reviewers. Include a letter from a high-ranking institutional official (e.g., Dean, Provost, President) indicating institutional financial support for the operations of the shared facility and research activities conducted therein. If any term-limited software licenses are requested, a detailed financial commitment to support renewal of licenses in outward years must be included.

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 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:

This FOA does not cover construction or construction related costs. When completing "The Budget Information for Construction Programs (SF424C)" form applicants should NOT complete the following fields:

2. Land, structures, rights-of-way, appraisals, etc.

7. Site work

9. Construction

13. Contingencies

15. Project (program) income

All other fields should be completed.

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

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

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

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

Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies). Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date and time. If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Policy on Late Application Submission.

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

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

This initiative is subject to intergovernmental review.

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

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

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

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

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

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

See more tips for avoiding common errors.

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

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

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

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

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

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

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?

Need for the Project

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 of work to be performed; 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 Individuals Across the Lifespan

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

Vertebrate Animals

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

Biohazards

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

Resubmissions

Not Applicable

Renewals

Not Applicable

Revisions

Not Applicable

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

Applications from Foreign Organizations

Not Applicable

Select Agent Research

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

Resource Sharing Plans

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

Budget and Period of Support

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

Applications will be evaluated by (an) appropriate Scientific Review Group(s) convened by the National Institute of Allergy and Infectious Diseases, 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:

• Will receive a written critique.

Appeals of initial peer review will not be accepted for applications submitted in response to this FOA.

Applications will be assigned to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the National Advisory Allergy and Infectious Diseases Council. 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 proposed to the objectives and priorities of the particular program authorized by the Public Health Service Act
• Availability, by affiliation or other association, of other scientific or health personnel and facilities to the extent necessary to carry out effectively the program proposed for the facility, including the adequacy of an acceptable biohazard control and containment program when warranted
• The need for the facility and its total effects on similar or related facilities in the locale, and the need for appropriate geographic distribution of similar facilities
• The project 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. Refer to Part 1 for dates for peer review, advisory council review, and earliest start date.

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

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

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

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

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

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Recipients, 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 laws that prohibit discrimination on the basis of race, color, national origin, disability, age and, in some circumstances, religion, conscience, and sex. This includes ensuring programs are accessible to persons with limited English proficiency. The HHS Office for Civil Rights provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-providers/provider-obligations/index.html and http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html.

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

• Recipients of FFA must ensure that their programs are accessible to persons with limited English proficiency. HHS provides guidance to recipients of FFA on meeting their legal obligation to take reasonable steps to provide meaningful access to their programs by persons with limited English proficiency. Please see https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/fact-sheet-guidance/index.html and https://www.lep.gov. 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 https://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.
• 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.
• HHS funded health and education programs must be administered in an environment free of sexual harassment. Please see https://www.hhs.gov/civil-rights/for-individuals/sex-discrimination/index.html; https://www2.ed.gov/about/offices/list/ocr/docs/shguide.html; and https://www.eeoc.gov/eeoc/publications/upload/fs-sex.pdf. For information about NIH's commitment to supporting a safe and respectful work environment, who to contact with questions or concerns, and what NIH's expectations are for institutions and the individuals supported on NIH-funded awards, please see https://grants.nih.gov/grants/policy/harassment.htm.
• Recipients of FFA must also administer their programs in compliance with applicable federal religious nondiscrimination laws and applicable federal conscience protection and associated anti-discrimination laws. Collectively, these laws prohibit exclusion, adverse treatment, coercion, or other discrimination against persons or entities on the basis of their consciences, religious beliefs, or moral convictions. Please see https://www.hhs.gov/conscience/conscience-protections/index.html and https://www.hhs.gov/conscience/religious-freedom/index.html.

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

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

A final RPPR 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.

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

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

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

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

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

General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources)
Email: [email protected] (preferred method of contact)
Telephone: 301-945-7573

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

Nancy Boyd
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 240-292-4119
Email: [email protected]

Lynn Rust Ph.D.
National Institute of Allergy and Infectious Diseases (NIAID)
240 669 5069
[email protected]

Michael Fato
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 240-669-2968
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 Part 75.