EXPIRED
National Institutes of Health (NIH)
HLA and KIR Region Genomics in Immune-Mediated Diseases (U01)
U01 Research Project Cooperative Agreements
Reissue of RFA-AI-09-030
RFA-AI-14-012
RFA-AI-14-013, U19 Research Program Cooperative Agreements
93.855, 93.856, 93.853
This Funding Opportunity Announcement (FOA) invites applications from investigators to participate in the HLA and KIR Region Genomics in Immune Mediated Diseases Consortium (HLAGC), formerly the HLA Region Genomics in Immune-Mediated Diseases Consortium. This cooperative research group supports projects defining the association between variations in the human leukocyte antigen (HLA), also known as the Major Histocompatibility Complex (MHC), and natural killer cell immunoglobulin-like receptor (KIR) genetic regions and immune-mediated diseases, including outcomes following cell, tissue, and organ transplantation.
June 9, 2014
September 20, 2014
September 20, 2014
October 20, 2014, by 5:00 PM local time of applicant organization.
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
February 2015
May 2015
July 2015
October 21, 2014
Not Applicable
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) solicits applications from institutions to participate in the HLA and KIR Region Genomics in Immune-Mediated Diseases Consortium (HLAGC), formerly the HLA Region Genomics in Immune-Mediated Diseases Consortium. This cooperative research group supports studies to discover and characterize associations between polymorphisms in the human leukocyte antigen (HLA, also known as the Major Histocompatibility Complex or MHC), and natural killer cell immunoglobulin-like receptor (KIR) genomic regions and (1) immune-mediated diseases, including risk and phenotype, and (2) cell, tissue, and organ transplantation outcomes, including rejection, tolerance, or graft versus host disease (GVHD).
In addition to supporting HLA and KIR region association studies, a major goal of this program is the assemblage of high-quality, high-resolution genetic data with accompanying disease state and phenotype information. The data generated by the HLAGC will be submitted to the NIAID Bioinformatics Information Support Contract (BISC) database, ImmPort (Immunology Database and Analysis Portal, https://immport.niaid.nih.gov). Data from these studies will also be submitted to and maintained by dbMHC (http://www.ncbi.nlm.nih.gov/projects/gv/mhc) and dbGaP (http://www.ncbi.nlm.nih.gov/gap), publicly accessible databases of MHC genetics and phenotypes maintained by the National Center for Biomedical Information (NCBI), part of the National Institutes of Health National Library of Medicine (NLM).
The HLA genomic region is the most polymorphic and gene-dense region in the human genome. This four megabase region on chromosome 6 contains at least 150 coding genes, and includes the HLA Class I, II, and III gene families. The Class I and Class II genes encode molecules responsible for the presentation of endogenously and exogenously derived peptides to T cells. The Class III region contains genes encoding a variety of immune response mediators, including some complement components and cytokines. In addition to their role in peptide presentation, HLA Class I molecules act as ligands for KIR on natural killer (NK) cells. The interaction between HLA and KIR results in either inhibition or, less commonly, activation of NK cell cytotoxic activity. KIRs are encoded by a highly polymorphic gene cluster on chromosome 19, and have evolved to catalyze swift immune responses to a variety of threats. Specific combinations of KIR and HLA haplotypes have been linked to immune-mediated diseases and transplantation outcomes, suggesting that the study of these molecules in tandem may be especially valuable.
In 2005, the HLAGC was formed by NIAID, with co-sponsorship from NINDS. The primary goal of this program is to define associations between sequence variations in HLA and KIR genomic regions with susceptibility or resistance to immune-mediated diseases, including autoimmune diseases, primary immunodeficiencies, and outcomes of cell, tissue, and organ transplantation. Genome-wide association studies (GWAS) of these diseases consistently show the highest level of association within these regions. However, conventional GWAS techniques are inadequate when applied to this dense, highly polymorphic cluster of genes with similar functions. The HLA region also displays a high degree of linkage disequilibrium, complicating its study. For these reasons, it has been determined that a high-resolution approach specifically targeting the HLA and KIR regions is critical.
Previous studies carried out by members of the HLAGC have focused on autoimmune diseases (Multiple Sclerosis, Rheumatoid Arthritis, Juvenile Idiopathic Arthritis, Myasthenia Gravis, Systemic Lupus Erythematosus, Crohn’s Disease, Ulcerative Colitis, Behcet’s Disease, Systemic Sclerosis, Ankylosing Spondylitis, and Narcolepsy/Hypocretin Deficiency), primary immunodeficiencies (IgA deficiency and Common Variable Immune Deficiency), and hematopoietic stem cell and cord blood transplantation outcomes. The formation of this cooperative group has facilitated the exchange of reagents and technologies, fostered collaborations across diseases and disciplines, and revealed how common sequence variations within these regions may be linked to multiple diseases.
The goal of this FOA is to continue support of the HLAGC program to further identify, map, and characterize how genetic variants within these regions may influence disease phenotype, progression, and severity; predict health outcomes; and direct treatment strategies, with an emphasis on population diversity. In addition, high quality, high-resolution HLA and KIR region genomic and phenotype data produced from these projects will populate publicly accessible databases such as dbMHC and dbGaP.
This initiative will support prospective and/or retrospective studies investigating the role of the HLA and/or KIR genomic regions in immune-mediated diseases and transplantation outcome. Research projects must be focused on the correlation between sequence variations in the HLA and/or KIR genomic regions with disease risk, severity, progression, and response to therapy, or transplantation outcome. Studies investigating associations within these regions and disease susceptibility or transplantation outcome linked to race or ethnicity are especially encouraged. In addition, as the independent segregation of HLA and KIR genes results in diverse HLA-KIR combinations between individuals, studies of HLA-KIR region gene combinations are also encouraged. Studies may examine polymorphisms in the coding and/or non-coding regions with the HLA and KIR regions, as well as non-classical genes residing in these regions.
Potential areas of research include, but are not limited to, the following:
Applications including the following types of studies will be considered non-responsive and will not be reviewed:
Applicants are strongly encouraged to contact the Scientific Research/Contact well in advance of the application submission deadline to discuss the proposed research program.
Steering Committee:
Program Directors (PDs)/Principal Investigators (PIs) from U01 and U19 projects funded under this program will form a Steering Committee after award. The Steering Committee will serve as the main governing body for the cooperative group. Among other responsibilities, it will identify scientific opportunities, emerging needs and impediments; ensure the timely release of data through publications and/or release of data to public databases; develop guidelines for the publication of collaborative research project results, prepare cumulative progress reports as requested by the NIAID Program Officer; and establish collection standards in collaboration with BISC that will facilitate meta-analysis across studies and disease areas.
NIAID Bioinformatics Information Support (BISC):
The BISC program (http://www.niaid.nih.gov/about/organization/dait/Pages/bisc.aspx) will provide technical assistance, software development, and data submission support for HLAGC awardees. The primary goal of BISC is to advance the discovery and generation of new hypotheses for immune-mediated diseases by providing an integrated data repository, providing advanced computer support for handling scientific data, disseminating best practices in scientific data analysis, and building and supporting a platform for integrated research and data sharing, via the BISC Immunology Database and Analysis Portal (ImmPort, https://immport.niaid.nih.gov).
The data generated by the HLAGC will be submitted to the BISC database, ImmPort. ImmPort is designed to manage data integration and statistical analysis, and will serve as a central data repository for NIAID-supported research in immune-mediated diseases, including linkages with high resolution HLA genomic information. Each awardee will collect and ensure the consistency and quality of their data, with assistance from BISC, as needed. BISC will be responsible for data receipt, deposition, curation, archive and backup, recovery (as necessary), and subsequent data deposition into and interface with dbMHC or other appropriate public databases (e.g., dbSNP, GenBank). BISC will develop and disseminate software for all data submission and analysis, and establish customized graphical interfaces for frequent and interactive communication with project investigators. BISC will also provide statistical software tools for local interim analysis (as needed), and assist with technical support in the collection, submission, and exchange of data primarily through the statistical liaison of each U01 and U19 project. BISC will provide feedback to the statistical liaison regarding the quality of data submitted, and will accept data from the project(s) in a variety of formats (such as XML or tab-delimited text files), which will be determined in consultation with the Steering Committee and project statistical liaisons.
Cooperative Agreement: A support mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, NIH scientific or program staff will assist, guide, coordinate, or participate in project activities.
New
Renewal
The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types.
The following NIH components intend to commit the following amounts in FY 2015:
NIAID $3.0 million and NINDS $400,000 in direct costs, to fund 4-7 U01 and/or U19 awards
Application budgets are not limited but need to reflect the actual needs of the proposed project.
The total project period requested for this FOA may not exceed five years.
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
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
Other
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 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.
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 duplicate or highly overlapping applications under review at the same time. This means that the NIH will not accept:
In addition, the NIH will not accept a resubmission (A1) application that is submitted later than 37 months after submission of the new (A0) application that it follows. The NIH will accept submission:
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:
The letter of intent should be sent to:
Andrea Wurster, Ph.D.
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases
(NIAID)
Room 3259, MSC-7616
6700B Rockledge Drive
Bethesda, MD 20892-7616 (U.S. Postal Service or regular
mail)
Bethesda, MD 20817-7616 (for express/courier service;
non-USPS service)
Telephone: 301-451-2660
Email: wurstera@mail.nih.gov
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, with the following additional instruction.
Include the name and biosketch of a biostatistician who will serve as the project’s statistical expert with direct responsibility for analysis and to act as a liaison to BISC.
All instructions in the SF424 (R&R) Application Guide must be followed.
PD(s)/PI(s) are expected to commit substantial time and effort to ensure success of the program and must commit, at a minimum, 1.8 calendar months.
Applicants should include appropriate travel budgets to accommodate travel by the PD(s)/PI(s) and project biostatistician to the annual Steering Committee meeting in Bethesda, MD.
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, in priority order, the Specific Aims of the proposed project. Concisely describe the hypothesis or hypotheses to be tested.
Research Strategy: Within the research strategy, applicants must include the following:
Letters of Support: If the proposed study includes samples and clinical data from an ongoing clinical trial or not currently in the possession of the PD/PI, the application should include a letter of support from the person or institution controlling the samples indicating that the samples and associated clinical/phenotypic data will be made available to the applicant.
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:
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.
Include in the Appendix an informed consent document compatible with data sharing:
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.
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 the NIAID, 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?
Will the project significantly advance understanding of the role of HLA and/or KIR region genes in immune-mediated diseases or transplantation?
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?
Does the project biostatistician have the appropriate experience to serve as the project’s statistical expert and to act as the liaison to BISC?
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?
Are there sufficient preliminary data to support the
proposed research projects?
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?
Are milestones and timelines reasonable and appropriate? If applicable, is the study sufficiently powered? Are the statistical plan and interactions with BISC adequately described and appropriate? Does the applicant describe how phenotypic data will be captured, validated, and linked to later analyses? Is the selected study population(s) well described and justified? For prospective studies, does the applicant demonstrate the capability to recruit human subjects? Is there adequate evidence that the human samples from ongoing, completed, or prospective clinical trials or studies were appropriately retained for future use or that individuals are re-consented to allow for this use? Is support for clinical procedures to obtain samples that are not part of an associated clinical trial or study clearly described and strongly justified? Does the applicant provide compelling evidence that the genetic material and clinical data necessary for the proposed project will be available within an acceptable timeframe?
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.
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
For Renewals, the committee will consider the progress made in the last funding period. Was progress under any current HLA Region Genomics in Immune Mediated Diseases award satisfactory?
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
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 the 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:
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 l. The following will be considered in making funding decisions:
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 U.S. Office of Management and Budget (OMB)
administrative guidelines, U.S. Department of Health and Human Services (DHHS)
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:
NIH staff have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:
Areas of Joint Responsibility include:
Steering Committee
A Steering Committee will serve as the governing board of the HLAGC. All consortium investigators will be required to accept and implement common guidelines and procedures approved by the Steering Committee.
The Steering Committee will:
Additional details and responsibilities of the Steering Committee will be negotiated at the time of award or post-award.
In order to most efficiently utilize research resources and rapidly exchange scientific information to promote HLA and KIR genomics research and NIH objectives, it is anticipated that cooperation or opportunities to collaborate with other NIH funded programs will be initiated in future years and will be coordinated and facilitated by the NIH Program Officer(s).
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 Dispute Resolution. A Dispute Resolution 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 dispute resolution procedure does not alter the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulation 42 CFR Part 50, Subpart D and DHHS regulation 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.
The awardee is solely responsible for the timely acquisition
of all appropriate propriety rights, including intellectual property rights,
and all materials needed for the awardee to perform the project. Before,
during, and subsequent to the award, the U.S. Government is not required to
obtain for the awardee any propriety rights, including intellectual property
rights, or any materials needed by the awardee to perform the project.
The awardee is required to report to the U.S. Government all inventions made in
the performance of the project, as specified by 35 U.S.C. Sect. 202 (Bayh-Dole
Act).
We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.
eRA Commons Help Desk (Questions regarding eRA Commons
registration, submitting and tracking an application, documenting system
problems that threaten submission by the due date, post submission issues)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)
Finding Help Online: http://grants.nih.gov/support/index.html
TTY: 301-451-5939
Email: commons@od.nih.gov
Grants.gov
Customer Support (Questions
regarding Grants.gov registration and submission, downloading forms and
application packages)
Contact CenterTelephone: 800-518-4726
Web ticketing system: https://grants-portal.psc.gov/ContactUs.aspx
Email: support@grants.gov
GrantsInfo (Questions regarding application instructions and
process, finding NIH grant resources)
Telephone: 301-710-0267
TTY: 301-451-5936
Email: GrantsInfo@nih.gov
Jeffrey Rice, Ph.D.
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 240-627-3552
Email: ricejs@niaid.nih.gov
Ursula Utz, Ph.D.
National Institute of Neurologic Disorders and Stroke
(NINDS)
Telephone: 301-496-1431
Email: utzu@ninds.nih.gov
Andrea Wurster, PhD
National Institute of Allergy and Infectious Diseases
(NIAID)
Telephone: 301-451-2660
Email: wurstera@mail.nih.gov
Jay Colbert
National Institute of Allergy and Infectious Disease (NIAID)
Telephone: 240-669-2980
Email: colbertrj@niaid.nih.gov
Tijuanna Decoster
National Institute of Neurological Disorders and Stroke (NINDS)
Telephone: 301-496-9231
Email: decoster@mail.niih.gov
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.