National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Reissue of RFA-DK-13-017
December 17, 2018
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.
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.
This Funding Opportunity Announcement (FOA) requests Cooperative Agreement (U01) applications to support continuation of the Consortium on Modeling Autoimmune Interactions (CMAI), a founding program within the Human Islet Research Network (HIRN). The mission of HIRN is to advance Type 1 Diabetes (T1D) research, and CMAI’s role within HIRN is to establish the experimental systems needed to model pathogenic features of human T1D. In order to maximize scientific exchange and accelerate research in this area, it is expected that all information, data, biomaterials, models, protocols, reagents, resources and methods developed by CMAI investigators will be rapidly shared not only within CMAI, but also with other HIRN investigators, and with the research community at-large.
The NIDDK Human Islet Research Network (HIRN)
Starting in 2014, NIDDK established the Human Islet Research Network (HIRN), a team-science oriented program supporting collaborative research in type 1 diabetes (T1D). The mission of HIRN is to provide a research environment that will facilitate the exploration of beta cell loss in Type 1 diabetes, and that will inform new strategies to protect or replace functional beta cell mass in diabetic patients. The HIRN program is configured as a modular network of small research consortia, each defined by a specific set of research priorities. Within that network structure, the Consortium on Modeling Autoimmune Interactions (CMAI) is specifically charged with developing the reagents and model systems needed to propel advances in basic and translational research in human T1D. Accordingly, CMAI supports resource development projects that are primarily focused on the reagents and model systems needed for mechanistic study of human T1D. All HIRN research initiatives, including HIRN-CMAI, put a strong emphasis on human disease biology, the use of human cells and tissues, and on the development of reagents, tools and disease-modeling platforms that can lead to innovations in treatment strategies for T1D patients.
HIRN Consortium on Modeling Autoimmune Interactions (HIRN-CMAI)
Although our understanding of Type 1 Diabetes pathophysiology has advanced dramatically over the past several years, many important questions remain, including:
HIRN-CMAI Research Objectives and Scope
HIRN-CMAI consists of groups of investigators developing innovative approaches to model molecular and cellular features of human T1D biology. One goal of the program is to develop the tools needed to measure the sequence of immune events that lead to beta cell dysfunction and/or destruction. Of particular interest are studies that will develop platforms and reagents to test emerging therapies to inhibit or reverse human T1D.
HIRN-CMAI modeling projects should be designed to address both short-term and long-term translational goals. In addition, the potential pre-clinical utility of any tools or models to be developed should be a motivating factor in designing the aims. Focus areas for CMAI modeling projects may include, but are not limited to:
HIRN-CMAI projects should incorporate multidisciplinary approaches and teams with the necessary expertise in immunology, beta cell biology, and engineering to address fundamental challenges in T1D modeling. As needed for individual projects, investigative teams should have expertise and take advantage of recent advances in human stem cell biology, gene editing, cellular imaging, and in vivo model development as needed to successfully develop reproducible models from renewable human cell sources.
HIRN-CMAI Project Milestones
All projects will be milestone-driven with clear criteria for measuring progress that are objective and quantifiable. Annual milestones with corresponding timelines must be included in the application. Prior to funding an application, the Program Official will contact the applicant to discuss the proposed milestones, including plans to perform comparisons across models studied within the consortium-at-large, and any changes supported by NIH staff or the NIH review panel. Each year, the Program Official and the applicant will review progress against the specified milestones and negotiate approved milestones for the coming year to be incorporated into each subsequent annual Notice of Award.
Meetings of HIRN-CMAI
Program Director(s)/Principal Investigators(s) participating in HIRN-CMAI must participate in the annual HIRN Investigator's Scientific Retreat held in the spring, in CMAI teleconferences, and in any in-person HIRN-CMAI meetings that may be organized by the CMAI Steering Committee. All participants will be expected to abide by policies adopted by majority vote of the HIRN-CMAI Steering Committee.
Cells : The use of primary cells and organ explants in initial modeling studies with a clear plan for progressing to use of pluripotent stem cells, particularly iPSCs, is encouraged. The current NIH guidance on stem cell usage can be found at http://stemcells.nih.gov/policy/pages/2009guidelines.aspx
Collaborations : Collaborative interactions are a critical feature of this FOA, and of HIRN in general. The development of tools needed to interrogate islet autoimmunity in experimental in vivo systems will require extensive collaboration among immunologists, stem cell biologists, islet and diabetes experts, and animal modeling experts. Additional funds may be made available at a later time to support collaborative studies within HIRN between CMAI and the HIRN-Consortium on Beta Cell Death and Survival (CBDS) to validate or test any new therapeutics or biomarkers for T1D, with the HIRN-Consortium on Targeting and Regeneration (CTAR) to provide for in vivo testing of new approaches for modulating the human pancreatic microenvironment, or with the HIRN-Consortium on Human Islet Biomimetics (CHIB) to facilitate complementary studies investigating islet cell/immune interactions in microphysiologic systems.
Other Special Performance Requirements:
The HIRN-CMAI investigators may be asked to identify fixed and variable costs and establish procedures for negotiation of third party agreements or selection of subcontractors and develop processes to efficiently administer and manage same throughout the project.
Applications that include the following types of studies will be considered non-responsive and will not be reviewed:
The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types.
Need help determining whether you are doing a clinical trial?
NIDDK intends to commit $2.5 million per year in FY 2019 to fund 2-5 awards.
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
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:
Buttons to access the online ASSIST system or to download application forms 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.
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:
John Connaughton, Ph.D.
Chief, Scientific Review Branch
National Institute of Diabetes and Digestive and Kidney Disorders (NIDDK)
All instructions in the SF424 (R&R) Application Guide must be followed.
, with the following additional instructions:
Research Strategy: The applicant must:
The following modifications also apply:
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.
All instructions in the SF424 (R&R) Application Guide must be followed.
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.
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 Applying Electronically. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Guidelines for Applicants Experiencing System Issues. For assistance with application submission, contact the Application Submission Contacts in Section VII.
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.
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.
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?
Specific to this FOA: Is a strong justification/rationale provided for the goals of the project? Is there a potential translational benefit to be derived from the development and use of the proposed model or tool? Does the application focus on critical gaps to address important questions or obstacles in Type 1 diabetes research? Will successful completion of the research aims promote an understanding of Type 1 diabetes pathogenesis and/or advance the future development of diagnostics and interventions?
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?
Specific to this FOA : Is the Multi-PI leadership plan, if applicable, well-described, including plans for dispute resolution? Does the project leadership have experience working productively within a large consortium/center or other large collaborative program? Have project leadership and other key personnel demonstrated a track record of directing and conducting research activities related to creating and validating tools for T1D research, and do they have the expertise needed to create and validate in vitro and in vivo assays and models of type 1 diabetes?
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?
Specific to this FOA : Are the overall goals of the application conducive to generating significant multidisciplinary investigations that generate robust and reproducible tools and models for the T1D research community? Will any tools or novel models developed for studies of type 1 diabetes advance basic and translational science and/or future therapy development? Does the project utilize the current advances of cutting edge technologies?
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?
Specific to this FOA : Has the applicant included an adequate description and justification of the tools and/or model system to be developed? Are the technologies or experimental approaches state of the art or is there novel use of non-state of the art technology? Will the expected results lead to advances in understanding the pathophysiology of Type 1 Diabetes? Are the proposed approaches, tools, and technologies scientifically justified and adequate for the particular model system? Does the application identify major technical risks, and are the proposed efforts to mitigate or address the risks clearly defined and feasible?
Milestones. Are appropriate, clearly-defined quantitative milestones provided for each aim of the overall project? Are the milestones feasible, well-developed and quantitative with regard to the specific aims within each phase? Is the overall timeline feasible and appropriate? Are adequate criteria provided to assess milestone completion?
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?
Collaborative Research Opportunities
Does the project present an opportunity for research that would be enhanced by consortium interaction, collaboration and expertise?
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 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.
Individuals Across the Lifespan
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.
For Renewals, the committee will consider the progress made in the last funding period.
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.
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 convened by the NIDDK, 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.
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 http://www.hhs.gov/ocr/civilrights/resources/laws/revisedlep.html. The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html; and http://www.hhs.gov/ocr/civilrights/understanding/index.html. Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html. Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at http://www.hhs.gov/ocr/office/about/rgn-hqaddresses.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 Part 75, and other HHS PHS, and NIH grant administration policies.
The administrative and funding instrument used for this program will be the cooperative agreement U01, 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 PI(s)/PD(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:
Through the Awardee(s) and NIH staff, CMAI will cooperatively develop and implement processes to submit information and data to the HIRN-coordinating center, determine criteria and processes for quality control of information and data to be posted for the research community, refine scientific objectives, and implement research advances to facilitate the goals of the study, consistent with NIH policies and achieving the goals of the program as described in the Funding Opportunity Announcement.
Awardee(s), the CMAI Project Scientist, and the CMAI Program Official are expected to attend the annual HIRN Investigator’s retreats, and meetings of the CMAI steering committee. A team will be established through this program to enable multiple, but coordinated, approaches to advance this area of research. If a single award is made, then CMAI will be governed by the PI and the NIH Project Scientist.
If multiple U01s are funded, then CMAI Awardees agree to the governance of the study through a Steering Committee.
HIRN Trans-Network Committee (HIRN-TNC)
The HIRN-TNC will consist of: the PI/PD of the HIRN Coordinating Center and the Steering Committee Chairs and Project Scientists of the HIRN scientific topic consortia; the TNC is not a governing body and does not cast votes.
Expert Scientific Panel (ESP)
An independent panel of 2-5 External Experts will be appointed by the NIDDK and meet by teleconference with the CMAI Project Scientist and the CMAI Project Officer at least once a year. The CMAI-ESP will be updated on progress and give feedback to the NIH on adjustments and future directions for the CMAI research projects(s). On an annual basis, and following input from the ESP members, NIDDK staff will appoint an ESP Chair who will be required to attend the annual HIRN investigator's Scientific Retreat, to participate in the CMAI Steering Committee meetings as ex-officio, and to serve as the CMAI-ESP representative to the larger HIRN-ESP that will also meet once a year. The CMAI ESP Chair will be tasked with relaying the CMAI Steering Committee recommendations for new Opportunity Funds Initiatives to the HIRN-ESP. All CMAI-ESP members will also be invited to listen as ex-officio to CMAI Steering Committee meetings. Members of CMAI-ESP may be asked, on an ad hoc basis, to assist in the peer review of applications for new research applications that request “opportunity pool” funds. The HIRN-Coordinating Center will support costs for teleconferences between the ESP and the CMAI Steering Committee, provide teleconference technical support, maintain a record of minutes, and support costs for the CMAI ESP chair to participate in the annual HIRN Investigator's Scientific Retreat.
Dispute ResolutionDisagreements that may arise in scientific/technical matter or programmatic matters (within the scope of the award) between award recipients and the NIDDK may be brought to arbitration after first attempting to resolve the issue through the Steering Committee or its subcommittees, as appropriate. 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 dispute resolution procedures in no way affect the awardee's right to appeal an adverse action in accordance with PHS regulations at 42 CFR Part 50, Subpart D, and HHS regulations at 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)
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Email: GrantsInfo@nih.gov (preferred method of contact)
Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Guillermo Arreaza-Rubin, MD.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Ann A. Jerkins, Ph.D.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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