Department of Health
and Human Services (HHS)
and Human Services (HHS)
National Institute of Allergy and Infectious Diseases (NIAID)
Reissue of RFA-AI-14-027
None
93.855
The purpose of this Funding Opportunity Announcement (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 new, cutting-edge sample sparing assays will lead to maximum use of the human-derived specimens by significant reduction of sample volumes/amounts required or by simultaneous multi-parameter assessments of immune function.
March 27, 2019
30 days prior to the application due date
Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.
Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.
Not Applicable
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.
Purpose
The purpose of this Funding Opportunity Announcement (FOA) is to solicit applications to develop cutting-edge assays that will enable complex immune monitoring from small volume samples derived from human subjects. Studies are sought 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 biological specimens 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 the fundamental understanding of the immune system. Advances in this field will also be important for immune monitoring of healthy individuals and those with allergy, asthma, autoimmunity, primary immunodeficiency, transplantation, as well as in infectious diseases and vaccinology research.New sample sparing assays will have a major impact on clinical studies aimed at understanding immune functions in infants and young children where sample availability is most limited.
Background
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 technological advances such as microfluidic multiplexing, nanotechnology, 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, have revealed a high degree of heterogeneity within cell populations. In addition, for the first time, contemporary sequencing methods have enabled the study of heterogeneity within the adaptive arm of the immune system by interrogating antigen receptors on single B and/or T cells. Metabolomic and proteomic approaches have also enabled measurement of hundreds of analytes in serum and plasma, adding an additional level of complexity. Furthermore, development of microfluidic platforms has permitted studies on cell heterogeneity with significant cost reduction and enhanced precision.
Research Objectives and Scope
The goal of this FOA is to accelerate development of robust, reliable, reproducible and multifunctional sample sparing assays for direct application in studies of the human immune system in healthy and diseased individuals. This FOA will support studies to develop novel assays for assessing human immune function in health and disease using biologic specimens that are available in limited sample volumes (e.g., blood, biologic fluids, tissue biopsies, etc.). It is expected that assays developed in response to this FOA will add valuable tools for immune-monitoring strategies leading to a better understanding of immune responses in general, as well as immunologic changes associated with disease prevention/remission/progression and responses to treatment. In addition, it is anticipated the new tools will ultimately facilitate development of improved clinical biomarkers of disease heterogeneity/severity. 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/and multiplex the measurement of biological markers related to immune status and function. The sample sparing assays developed through this FOA are intended to 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. When animal models are used validation with primary human cells, tissues or fluids is required. At the end of the award, the expectations are: 1) development of a novel or significantly improved, robust sample sparing assay, 2) assay validation studies in primary human cells or tissue, and 3) submission of Standard Operating Procedures (SOPs)/protocols and relevant data sets for the research community through ImmPort.
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.
Sample sparing immune assays of interest may include, but are not limited to, monitoring or assessments of the following:
Technologies of interest may include, but are not limited to:
Applications proposing studies in the following areas will not be supported by this FOA and will not be reviewed:
Steering Committee
All PDs/PIs will be required to participate in a Steering Committee that will be formed after award to foster collaborations among awardees, accelerate assay development efforts and provide overall advice on future research directions. The steering committee will be composed at a minimum of PDs/PIs of each of the awards and a NIH Project Scientist serving as the representative of the NIH. The Steering Committee will also make recommendations regarding the use of the Infrastructure and Opportunities Fund.
Infrastructure and Opportunities Fund (IOF)
To capitalize on emerging opportunities consistent with the goals of the Development of Sample Sparing Assay (DSSA) program an Infrastructure and Opportunities Fund (IOF) will be made available to one institution chosen from successful applicants by NIH after award to manage for the entire DSSA program. This institution must agree to take responsibility for managing the IOF, and includes establishing an administrative structure, disbursement and tracking of funds, and reporting status. Examples of activities supported by the IOF may/could include collaborative and pilot/feasibility projects; resource development and sharing opportunities; translational projects; early stage investigator projects. IOF projects must be within the scope of this FOA and may be submitted by awardees or by outside investigators.
Renewal of RFA-AI-14-027
The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types.
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NIAID intends to commit $5M in FY 2020 to fund 8-10 awards and includes total costs of $0.5M annually to support an Infrastructure and Opportunities Fund (IOF).
For this funding opportunity, budgets may be requested up to $0.85M direct costs per year which includes a limit on the budget for the Infrastructure and Opportunity Fund of $0.5M direct costs per year, and a limit on the U24 research project of $0.35M direct costs per year.
The scope of the proposed project should determine the project period. The maximum period is five years.
Higher Education Institutions
The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:
Nonprofits Other Than Institutions of Higher Education
For-Profit Organizations
Governments
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.
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.
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.
The NIH will not accept duplicate or highly overlapping applications under review at the same time. This means that the NIH will not accept:
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.
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:
The letter of intent should be sent to:
Priti Mehrotra, Ph.D.
Telephone: 240-669-5375
Email: PMehrotra@niaid.nih.gov
Other Attachments: The following attachment is required for this FOA. The filename "IOF.pdf" should be used.
Applicants must provide: An Infrastructure and Opportunities Funds (IOF) Management Plan that describes how the IOF will operate to serve the DSSA program.
The IOF management plan must include:
All instructions in the SF424 (R&R) Application Guide must be followed.
Specific Aims: Describe the resources that will be provided to the research community.
Research Strategy: Include the following information:
Provide the following plans for data submission to ImmPort:
Milestones
The following modifications also apply:
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 Immunology Database and Analysis Portal (ImmPort). ImmPort is a contract supported by NIAID that provides support for handling and housing datasets along with developed SOPs in ImmPort (http://www.immport.org/immport-open/public/home/home), a data sharing platform. ImmPort has templates for data collection from various assays and established procedures for data exchanges that can be adapted by NIAID supported research programs. ImmPort also is charged with developing additional standards for data collection, curation, and exchange to meet the specific needs of NIAID-supported research programs.
If you answered Yes to the question Are Human Subjects Involved? on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or Delayed Onset Study record.
Study Record: PHS Human Subjects and Clinical Trials Information
All instructions in the SF424 (R&R) Application Guide must be followed.
Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start).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 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 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 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 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.
Only the review criteria described below will be considered in the review process. Applications submitted to the NIH in support of the NIH mission are evaluated for scientific and technical merit through the NIH peer review system.
Does the project address an important problem or a critical barrier to progress in the field? Is the prior research that serves as the key support for the proposed project rigorous? 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 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?
Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or those 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?
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?
Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Have the investigators included plans to address weaknesses in the rigor of prior research that serves as the key support for the proposed project ? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? 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? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?
Do the preliminary data demonstrate feasibility? Are animal models appropriately validated in human samples? Are assay standardization and reproducibility assessments included in the assay development plan?
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 individuals of all ages (including children and older adults), justified in terms of the scientific goals and research strategy proposed?
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?
Milestones
Given the critical nature of the milestones to measure the success of program and development of sample sparing technologies, are the proposed milestones and Go/No-Go criteria well-defined with quantifiable measures that are appropriate for assessing success? Are the milestones appropriate, adequately described, feasible and achievable within the proposed time frame for the elements they support?
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?
Is provision of the proposed IOF management services to the DSSA program described in sufficient detail? Is sufficient justification provided for the management methods proposed for the IOF? Are the personnel charged with managing the IOF appropriate?
For research that involves human subjects but does not involve one of the 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 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.
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 individuals of all ages (including children and older adults) 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.
The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.
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.
Not Applicable
For Renewals, the committee will consider the progress made in the last funding period.
Not Applicable
Not Applicable
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).
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) Genomic Data Sharing Plan (GDS).
For projects involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.
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 the National Institute of Allergy and Infectious Diseases, 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.
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 National Advisory Allergy and Infectious Diseases Council. The following will be considered in making funding decisions:
Information regarding the disposition of applications is available in the NIH Grants Policy Statement.
A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the grantee’s business official.
Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.
Any application awarded in response to this FOA will be subject to terms and conditions found on the Award Conditions and Information for NIH Grants website. This includes any recent legislation and policy applicable to awards that is highlighted on this website.
Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights law. This means that recipients of HHS funds must ensure equal access to their programs without regard to a person’s race, color, national origin, disability, age and, in some circumstances, sex and religion. This includes ensuring your programs are accessible to persons with limited English proficiency. HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research.
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.
For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA. HHS provides general guidance to recipients of FFA on meeting their legal obligation to take reasonable steps to provide meaningful access to their programs by persons with limited English proficiency. Please see https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/index.html. The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-individuals/section-1557/index.htmlhttps://www.hhs.gov/civil-rights/for-providers/laws-regulations-guidance/index.html. Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see https://www.hhs.gov/civil-rights/for-individuals/disability/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. Also note it is an HHS Departmental goal to ensure access to quality, culturally competent care, including long-term services and supports, for vulnerable populations. For further guidance on providing culturally and linguistically appropriate services, recipients should review the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care at http://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.
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, 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:
NIH staff members have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:
The NIH Project Scientist will:
Areas of Joint Responsibility include:
Steering Committee
Infrastructure and Opportunities Fund (IOF): The NIH Project Scientist and PD(s)/PI(s) from the funded projects will establish a Steering Committee. The DSSA program Steering Committee will oversee the Infrastructure and Opportunities Fund, consistent with the goals of the program. The Steering Committee will devise and implement procedures, practices, and subcommittees as needed, for the IOF solicitation, receipt, review, development, evaluation, and recommendation of feasibility, pilot, resource development, or collaborative projects or potential resource sharing opportunities and other collaborative needs. The Steering Committee will also assess additional professional and administrative staffing needs beyond the administrative support provided as part of the requirements to manage the IOF budget and activities (e.g. for review activities or IT needs as required) and provide assessment to the NIH Project Scientist. In addition, the Steering Committee will be responsible for an annual report of progress of projects, status of funds, and other activities funded by the IOF program, including outcomes of all completed projects.
Results and research plans will be discussed, as determined by NIAID.
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.
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.
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: GrantsInfo@nih.gov (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: support@grants.gov
Kasia Bourcier, Ph.D.
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 240-627-3482
Email: bourcierkd@niaid.nih.gov
Priti Mehrotra, Ph.D.
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 240-669-5375
Email: PMehtrotra@niaid.nih.gov
Kevin Lyons
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 240-627-3513
Email: lyonskd@niaid.nih.gov
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