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

This Funding Opportunity Announcement (FOA) invites applications to develop cutting edge assays that will enable complex immune monitoring from small volume samples derived from human subjects. The purpose of this FOA is to accelerate the development and validation of sample sparing assays that can be applied for studying the human immune system in health and disease. Development of sample sparing assays will lead to maximum use of the sampled material by significant reduction of sample volumes/amounts required or by simultaneous multi-parameter assessments of immune function. By expanding the spectrum of parameters that can be measured on small samples derived from human subjects, assays developed in response to this announcement will be valuable for advancing our fundamental understanding of the immune system and equally important for immune monitoring in healthy individuals as well as in disease conditions such as allergy, asthma, autoimmunity, acquired and primary immunodeficiency, transplantation, and infection. New sample sparing assays will have a major impact on clinical studies aimed to understand immune functions in young children with infectious diseases and/or immune mediated disorders; for example, food allergy, diabetes or primary immunodeficiency where sample availability is most limited.

The NIAID’s Division of Allergy, Immunology and Transplantation (DAIT) and Division of AIDS (DAIDS) support a wide range of research programs spanning basic immunology, translational and clinical research on HIV and immune-mediated diseases, including autoimmune and primary immunodeficiency diseases, allergic diseases, graft-versus host disease (GVHD) and allograft rejection in organ, tissue and cell transplantation. DAIT and DAIDS currently sponsor a wide variety of clinical trials that incorporate a strong emphasis on defining the underlying immunological mechanisms associated with the treatment and prevention of these diseases. Major constraints encountered in designing mechanism of action studies are related to limited quantity of biological specimens available for study and the paucity of robust, validated, miniaturized assays that can reliably and reproducibly assess immune function, disease state or effects of therapy. The restricted amounts of tissue, cells and fluids that can be collected from adult, pediatric or immunocompromised patients are often inadequate for the application of conventional assays that interrogate immune function. Novel, multi-parameter, sample sparing assays are needed to obtain maximal biologic information from limited amounts of biological materials.

Emerging scientific advances in various research fields such as nanotechnology, microfluidic multiplexing, mass cytometry, as well as high dimensional genomic, proteomic and transcriptional profiling, allow for simultaneous interrogation of an unprecedented number of parameters and provide opportunities for the development of novel, miniaturized, multi-parameter assays of immune function.

Combining these methods may best facilitate evaluation of a multiplicity of cell functions. For example, flow cytometry studies combined with assessments of cell function, such as cytokine secretion, mRNA profiling, or kinase activity, revealed a high degree of heterogeneity within cell populations. Contemporary sequencing methods enabled for the first time the study of heterogeneity within the adaptive arm of the immune system by interrogating antigen receptors on B- and T- cells. Metabolomic and proteomic approaches enabled measurement of hundreds of analytes in serum and plasma, adding an additional level of complexity.

The goal of this FOA is to support development of high resolution immune monitoring approaches that leverage contemporary and emerging technologies in studies utilizing limited biological specimens that can be accomplished for example by multiplex assays or developing new assays that can enable higher degree of sensitivity and data output. It is expected that assays developed in response to this FOA will add valuable tools for immune monitoring strategies leading to better understanding of immune responses in general, as well as for monitoring immunologic changes associated with disease prevention/remission/progression and responses to treatment. In addition it is anticipated the tools developed will facilitate development of improved clinical biomarkers of disease severity. The assays developed in this initiative will have broad application in programs/networks/consortia/clinical trials sponsored by DAIT (http://www.niaid.nih.gov/about/organization/dait/Pages/programsNetworks.aspx) and DAIDS (http://www.niaid.nih.gov/about/organization/daids/networks/pages/daidsnetworks.aspx) and will be made available to the scientific community through publication of manuscripts and data sharing through NIAID’s web portal (ImmPort, https://immport.niaid.nih.gov).

This FOA will support studies to develop novel assays for assessing immune function in health and disease using human biologic specimens that are available in limited quantities (e.g., blood, biologic fluids, tissue biopsies, etc.). This initiative is not aimed at the discovery of new immune signaling pathways nor the definition of new immune ligands and receptors, but rather at new ways to miniaturize or multiplex the measurement of biological markers of immune status and function. The sample sparing assays developed through this funding opportunity must address challenges, gaps or unmet needs in the study of human immune responses and provide clear advantages over existing assays. The assay development must predominately use human cells, tissues, or fluids, and validation with primary human cells, tissues or fluids is required when animal models are used. The ultimate goal of this FOA is to accelerate development of robust, reliable and multifunctional sample sparing assays for direct application in studies of the human immune system in healthy and diseased individuals. At the end of the award, the expectations are: 1) development of a new or significantly improved sample sparing assay, 2) assay validation studies in primary human cells or tissue, and 3) provision of Standard Operating Procedures (SOPs)/protocols and relevant data sets for the research community. Applications that include multi-parametric measurements and/or technologies that integrate assessments of distinct aspects of human immune function are strongly encouraged.

Development of alternative approaches to visualize data generated from the proposed assay is encouraged if existing visualization approaches are inadequate.

Sparing immune assays of interest may include, but are not limited to monitoring or assessments of the following:

• Antigen-specific immune responses
• Distinct immune cell populations
• T-cell and B-cell regulatory networks
• Innate immune responses
• Markers of T-cell turnover and homing to lymphoid tissue
• Cytokine and signaling networks
• Gene and protein expression and regulation
• Mucosal inflammatory and innate immune responses
• Persistent HIV reservoirs in tissues of infected individuals on fully suppressive antiretroviral therapy
• Assessing CSF samples from HIV infected adults and pediatric samples

Technologies of interest may include, but are not limited to:

• Multiplexed mass cytometry (CyToF) profiling
• Multiplexed fluorescence/mass microscopy techniques
• Multiplexed phenotypic imaging for various cell function studies
• Highly multiplexed flow cytometry approaches (quantum dots, semiconducting polymer dots, imaging flow cytometry)
• Microfluidic platforms
• Nanotechnology-based biosensing platforms
• New microarray technologies
• Next generation sequencing technologies

This FOA will NOT support:

• Any phase clinical trial
• Identification of new biomarkers
• Validation of biomarker candidates
• Studies focused exclusively on animal studies and animal disease models. Animals may be used in assay development phase but all assays must be validated using primary human samples
• Development of assays using established cell lines without validation in primary human samples
• Virus-induced cancers
• Studies that do not fall within NIAID mission

Steering Committee

All PDs/PIs will be required to form a Steering Committee after award to foster collaborations among awardees, accelerate assay development efforts and provide overall advice on future research direction.

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)

Nonprofits Other Than Institutions of Higher Education

• Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
• Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)

For-Profit Organizations

• Small Businesses
• For-Profit Organizations (Other than Small Businesses)

Governments

• State Governments
• County Governments
• City or Township Governments
• Special District Governments
• Indian/Native American Tribal Governments (Federally Recognized)
• Indian/Native American Tribal Governments (Other than Federally Recognized)
• Eligible Agencies of the Federal Government
• U.S. Territory or Possession

Other

• Independent School Districts
• Public Housing Authorities/Indian Housing Authorities
• Native American Tribal Organizations (other than Federally recognized tribal governments)
• Faith-based or Community-based Organizations
• Regional Organizations
• Non-domestic (non-U.S.) Entities (Foreign Institutions)

Non-domestic (non-U.S.) Entities (Foreign Institutions) are eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply.
Foreign components, as defined in the NIH Grants Policy Statement, are 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(s)/Principal Investigator(s) (PD(s)/PI(s)) 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.

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

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

Applicant organizations may submit more than one application, provided that each application is scientifically distinct.

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.

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(s)/PI(s)
• Names of other key personnel
• Participating institution(s)
• Number and title of this funding opportunity

The letter of intent should be sent to:

Maja Maric, Ph.D.
National Institute of Allergy and Infectious Diseases (NIAID)
6700B Rockledge Drive, Room 3266
Bethesda, MD 20892-7616
Telephone: 301-451-2634
Fax: 301-480-2408
Email: [email protected]

All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed.

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.

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.

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 PD(s)/PI(s) will be required to participate and budget accordingly for: an initial scientific meeting, arranged by NIAID staff, to be held soon after award in the Washington, D.C. metropolitan area; annual face-to-face scientific meetings to be held each year following the first year’s initial meeting; and quarterly teleconferences.

Include in the proposed budget costs for the initial scientific meeting and Annual Scientific Meetings (the Steering Committee Meeting will be held jointly with the Annual Scientific Meeting), including costs for travel, lodging and the venue for the PD(s)/PI(s) and relevant staff. Assume that each Annual Scientific Meeting will require two days and take place in the Washington, D.C. metropolitan area. Include travel costs for the PD(s)/PI(s) and one additional investigator or other relevant staff member.

In the proposed budget, include costs related to data management and submission to ImmPort.

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:

Specific Aims: List the Specific Aims of the proposed program. Describe the resources that will be provided to the research community.

Research Strategy: All applications should include the following information:

• A detailed description of the proposed plan for sample sparing assay(s) that includes an explanation of why the existing technology/methodology is inadequate;
• Description of how the proposed assay is superior to, or significantly extends, currently available technologies and addresses an unmet need;
• Details on the current development stage of the proposed technology;
• Details on how the sensitivity or specificity of detection is increased or the sample size required for testing is reduced;
• Preliminary data to demonstrate the feasibility of the approach;
• A description of the standardization/ validation approaches that will be used in the assay development phase;
• The benchmark technology that the new assay will be compared to;
• An indication of the potential of the new technology to be widely used in basic and clinical human subjects research; and
• Plans for validation of the assay in human samples, if preliminary data are generated in animal models/cell lines.

Applicants are expected to explain the significance of the specific technical approach with special emphasis on reproducibility and standardization. The use of Good Clinical Laboratory Practice (GCLP) standards in the assay development should be emphasized and is encouraged (https://www.daidscrss.com/LaboratoryManagementCenter/Pages/GCLP_Standards.aspx). Preliminary results should clearly indicate what the new assay is offering in terms of specificity, sensitivity or sample reduction.

Note: The following technical details about the data submission process to Immport are provided so that applicants can present plans for proper data transfer and management.

• Consent study participants using appropriate language that will allow the sharing of study results through ImmPort.
• Defined list of key data elements for the assay (https://immport.niaid.nih.gov/tutorials/MinimumInformationGuidelines.doc and https://immport.niaid.nih.gov/immportWeb/display.do?content=DataTemplates)
• De-identified study participant in the data and file names according to the ImmPort requirement (the web link to the document) before data submission (https://immport.niaid.nih.gov/tutorials/BISC-Subject-De-identification.pdf)

Milestones

The milestones section of the Research Strategy should include explicit, detailed, and quantitative yearly milestones that can be used by NIAID staff in assessing progress and recommending continued funding on an annual basis. This section should include planned timelines for executing tasks needed for completion of the work to be accomplished during the award. This section also should include a description of each stage of assay development, criteria for completing each stage and contingency plans if the milestones are not met. The milestones and Go/No-Go decision points may be captured in a variety of tools, such as in Gantt charts, time lines, selection algorithms and decision trees. The milestones and Go/No-Go decision points should identify and quantify both success and failure of proposed activities at each development decision point. Applicants are cautioned that milestones and Go/No-Go decisions points are not a restatement of the Specific Aims or overall application, but a quantitative description of what constitutes successful development.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) as provided in the SF424 (R&R) Application Guide, with the following modification:

• All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.

PD(s)/PI(s) are expected to share assay development and validation data along with developed SOPs with the general scientific community through NIAID’s Bioinformatics Information Support Contract (BISC). The BISC program will provide support for handling and housing datasets along with developed SOPs in ImmPort (https://immport.niaid.nih.gov/), a data sharing platform funded by the NIAID. BISC has templates for data collection from various assays and established procedures for data exchanges that can be adapted by NIAID supported research programs. BISC also is charged with developing additional standards for data collection, curation, and exchange to meet the specific needs of NIAID-supported research programs.

Appendix: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

When conducting clinical research, follow all instructions for completing Planned Enrollment Reports as described in the SF424 (R&R) Application Guide.

When conducting clinical research, follow all instructions for completing Cumulative Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide.

Foreign (non-U.S.) institutions must follow policies described in the NIH Grants Policy Statement, and procedures for foreign institutions described throughout the SF424 (R&R) Application Guide.

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. 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. If a Changed/Corrected application is submitted after the deadline, the application will be considered late.

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 not subject to intergovernmental review.

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

Pre-award costs are allowable only as described in the NIH Grants Policy Statement.

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 PD(s)/PI(s) 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. See Section III of this FOA for information on registration requirements.

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. 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 and responsiveness by components of participating organizations, NIH. Applications that are incomplete and/or nonresponsive will not be reviewed.

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 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.

Significance

Does the project address an important problem or a critical barrier to progress in the field? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field? Does the project address an unmet need for the development of sample sparing assays or improve an existing technology? Does the proposed assay have significant potential to achieve higher sensitivity or specificity over existing approaches for analyzing small biologic samples? Does the proposed assay introduce new multilevel analyses of cell function? Is the proposed technology broadly applicable?

Investigator(s)

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or New Investigators, or in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?

Innovation

Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed?

If the project involves human subjects and/or NIH-defined clinical research, are the plans to address 1) the protection of human subjects from research risks, and 2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of children, justified in terms of the scientific goals and research strategy proposed?

Does preliminary data demonstrate feasibility? Are animal models appropriately validated in human samples? Are assay standardization and reproducibility assessments included in the assay development plan?

Environment

Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?

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

Milestones

Given the critical nature of the milestones to measure the success of program and development of sample sparing technologies, are the proposed milestones well-defined with quantifiable measures that are appropriate for assessing success? Are the milestones appropriate, adequately described, feasible, quantifiable and achievable within the proposed time frame for the elements they support? Do the milestones provided incorporate Go/No-Go criteria appropriate for the described testing? Are the Milestones well-integrated into Gantt charts or other applicable descriptive mechanisms and achievement measured using Go/No-Go decision criteria? Do the proposed milestones lead to the desired product properties? Is it clear how the scientific and operational objectives will evolve as milestones are achieved? Given the potential benefits of the proposed research, do the milestones support the potential for the overall program to advance the proposed technology? Are the proposed efforts feasible within the proposed timeframes, and integrated with the overall milestones for the program?

Protections for Human Subjects

For research that involves human subjects but does not involve one of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or more of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.

Inclusion of Women, Minorities, and Children

When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of children to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.

Vertebrate Animals

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

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

Reviewers will assess whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions that exist in other countries and either are not readily available in the United States or augment existing U.S. resources.

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

Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: 1) Data Sharing Plan; 2) Sharing Model Organisms; and 3) Genome Wide Association Studies (GWAS).

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 for scientific and technical merit by (an) appropriate Scientific Review Group(s)convened by NIAID in accordance with NIH peer review policy and procedures, 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 highest scientific and technical merit (generally the top half of applications under review) will be discussed and assigned an overall impact score.
• Will receive a written critique.

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

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

• Scientific and technical merit of the proposed project as determined by scientific peer review.
• Availability of funds.
• Relevance of the proposed project to program priorities.

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.

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

The following special terms of award are in addition to, and not in lieu of, otherwise applicable OMB administrative guidelines, HHS grant administration regulations at 45 CFR Parts 74 and 92 (Part 92 is applicable when State and local Governments are eligible to apply), and other HHS, PHS, and NIH grant administration policies.

The administrative and funding instrument used for this program will be the cooperative agreement an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the awardees is anticipated during the performance of the activities. Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the award recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the awardees for the project as a whole, although specific tasks and activities may be shared among the awardees and the NIH as defined below.

The PD(s)/PI(s) will have the primary responsibility for:

• Defining the research plan and goals within the guidelines of this FOA;
• Setting Project milestones and timelines to achieve the proposed goals;
• Completion of yearly Milestones within the timeframe and budget proposed;
• Overseeing execution of the project;
• Performing the scientific activities of the research plan;
• Administratively managing the cooperative agreement; and
• Data submission to Immport.

In addition, the PD(s)/PI(s) will:

• Be required to form a Steering Committee after award to foster collaborations among awardees, accelerate assay development efforts and provide overall advice on future research direction;
• Participate in all Steering Committee activities with each PD/PI being a voting member of the Steering Committee and only one PD/PI serving as the Chair (see Steering Committee Responsibilities, below);
• Develop a succession plan that addresses potential changes in leadership of the award;
• Establish and implement mechanisms of quality control in data collection and management;
• Cooperate with NIH staff members in the periodic evaluation of the Program and its specific aspects;
• Develop and implement a plan for making the resources developed under this program available to the broad research community; and
• Deposit final data and assay SOPs to ImmPort.

NIH staff members have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:

An agency program official will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice. The assigned Program Official will also serve as the NIH Project Scientist. This stewardship role will include monitoring program progress and approving changes. The Government, via the Program Official, will have access to data generated under this Cooperative Agreement and may periodically review the data and progress reports. NIAID staff may use information obtained from the data for the preparation of internal reports on the activities of the study. However, awardees will retain custody of and have primary rights to all data developed under these awards. The NIAID may appoint three to five External Consultants to meet with the Steering Committee. This group will be updated on progress and give feedback to the Steering Committee and NIAID staff on adjustments and future directions for the research projects.

In addition, the NIH Project Scientist will:

• Evaluate yearly Milestones and provide guidance to investigators regarding study implementation and design;
• Participate as a non-voting member of the Steering Committee;
• Help coordinate program activities through the Steering Committee;
• Participate in the design of activities recommended by the Steering Committee;
• Advise in the selection of sources or resources (e.g., determining where a particular resource may be found);
• Assist in promoting and encouraging the sharing of unique research resources developed under this program;
• Advise in management and technical issues and performance;
• Help to maintain the overall scientific balance on the program commensurate with emerging research opportunities; and
• If applicable, assist awardees in refining and implementing the Sharing Unique Resources Plan after award.

Funding beyond the first year may be subject to downward negotiation depending on the progress made in meeting negotiated milestones.

Areas of Joint Responsibility include:

Steering Committee

The Steering Committee will serve as the governing board of this Program. Membership consists of the PD(s)/PI(s) for all awards made under this Program. Operational details include:

• Identifying and appointing as appropriate other non-federal members either by the Steering Committee membership or the NIAID;
• Each member has one vote;
• Meetings to include quarterly teleconferences and annual face-to-face meetings to discuss results and research plans as determined by the NIAID. Ad hoc meetings to be scheduled by the NIH Project Scientist;
• Meeting agendas to be developed jointly with the Steering Committee Chair and the NIH Project Scientist;
• Providing advice and recommendations regarding the redirection or replacement of project to the NIH Project Scientist and the PD(s)/PI(s). Requests for advice may be initiated by an individual PD/PI, a member of the Steering Committee, or the NIH Project Scientist. For a decision or course of action to be recommended by the Steering Committee, a majority of the votes must be cast in favor of the decision or course of action; and
• Providing advice on scientific opportunities, emerging needs and impediments related to success of the Program.

Dispute Resolution:

Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and the NIH may be brought to arbitration. An Arbitration Panel composed of three members will be convened. It will have three members: a designee of the Steering Committee chosen without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual awardee. This special arbitration procedure in no way affects the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulations 42 CFR Part 50, Subpart D and HHS regulations 45 CFR Part 16.

When multiple years are involved, awardees will be required to submit the annual Non-Competing Progress Report (PHS 2590 or RPPR) 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.

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)
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Contact CenterTelephone: 800-518-4726
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GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone: 301-710-0267
TTY 301-451-5936
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Kasia Bourcier, Ph.D.
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 240-627-3482
Email: [email protected]

Jim Lane, Ph.D.
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 240-627-3033
Email: [email protected]

Jeymohan Joseph, Ph.D.
National Institute of Mental Health (NIMH)
Telephone: 301-443-6100
Email: [email protected]

Maja Maric, Ph.D.
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 301-451-2634
Email: [email protected]

Shellie Wilburn
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 301-594-9676
Email: [email protected]

Rita Sisco
National Institute of Mental Health (NIMH)
Telephone: 301-443-2805
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) and under Federal Regulations 42 CFR Part 52 and 45 CFR Parts 74 and 92.