National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK )
This Funding Opportunity Announcement (FOA) solicits applications for the Consortium on Targeting and Regeneration (CTAR) that supports the development of innovative strategies to increase or protect functional human beta cell mass in patients with Type-1 Diabetes (T1D) through the controlled manipulation of beta cell replication, islet cell plasticity, and the reprogramming of pancreatic non-beta cells into beta-like cells, or through shielding the residual beta cell mass from the autoimmune environment. CTAR is part of the Human Islet Research Network (HIRN).
All types of non-AIDS applications allowed for this funding opportunity announcement are due on these dates.
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) solicits cooperative agreement applications for projects to develop strategies to target the human pancreatic environment in-vivo to deliver regulatory cells, molecules or gene constructs that can protect or replenish functional beta cell mass, or to engineer cellular or synthetic sentinel biomarkers that can safely monitor the islet tissue environment in individuals at risk of developing Type-1 Diabetes (T1D).
T1D is characterized by the development of an autoimmune response that leads to the specific destruction of the pancreatic beta-cells. While some progress has been made in recent years to partially protect residual beta cell mass in recently-diagnosed individuals and to measure disease progression in patients with T1D with sub-optimal sensitivity, strategies for initiating, maintaining and monitoring a full arrest of disease progression are still needed. In addition, in spite of the encouraging identification of molecules that may have an impact on beta cell replication, robust and safe therapeutic strategies to replenish beta cell mass in patients with T1D have yet to be developed.
The promising outcome of cadaveric islet transplantation has demonstrated that beta cell replacement can be therapeutic for the treatment of T1D. It has prompted the search for alternative and abundant sources of beta cells for replacement therapy, and much progress has been made in differentiating insulin-producing cells from stem/progenitor cells for possible clinical use. At the same time, our rapidly evolving knowledge in areas such as islet-cell plasticity, epigenetic control of cell identity, cellular reprogramming, genome editing and gene therapy, synthetic biology and engineering of therapeutic compounds with cell-specific properties could be leveraged to develop therapeutic alternatives to islet transplantation, such as the safe and controlled replenishment of functional beta cell mass using the remaining islet non-beta cells as a cell source, or the protection of residual beta cell mass following systemic delivery of islet-specific immunomodulatory agents or protective cell-engineering gene constructs.
This initiative proposes to fill technological and scientific gaps that currently prevent the development of innovative therapeutic strategies for preserving or replenishing functional beta cell mass in T1D, including in the following areas:
Research Opportunities and Scope
This Funding Opportunity Announcement encourages the development of innovative tools and strategies for the therapeutic targeting of relevant cell types residing within or around the human islet with the long-term goal of protecting or replenishing functional beta cell mass in patients with T1D, or for the non-invasive monitoring of the islet environment in individuals at risk of developing T1D or diagnosed with the disease. Contributions to this initiative could include, but are not limited to, the discovery, development or optimization of:
Next-generation medium- to high-throughput screening platforms using single (or a small number of) primary human islets for the discovery, validation or optimization of novel regulators of islet cell plasticity or beta cell mass, stress, survival, immunogenicity and/or function; emphasis should be on platforms or devices that could be easily manufactured, could be readily distributed to and adopted by the biomedical research and drug-discovery communities, and can provide dynamic readouts of islet function through the use of technologies such as high-content imaging or stable isotope labeling with amino acids in cell cultures (SILAC); next-generation xenotransplantation platforms for the functional validation of targeted therapeutic strategies using human islets in-vivo, that may include the reconstitution of components of the human autoimmune environment to assess the efficacy of immunomodulatory interventions.
Projects that are mostly focused on developing delivery vehicles or cell-targeting strategies need to demonstrate efficacy of delivery to the human islet environment in-vivo using biological or imaging-based readouts.
Projects that are exclusively focused on developing new imaging-based strategies for in-vivo monitoring of beta cell mass or function are not responsive to this FOA. However, the use of imaging-based reporter systems to validate in-vivo efficacy of new islet-targeting strategies is considered responsive.
The long-term outcome of the projects proposed in response to the current initiative should be the development of safe and highly-specific products or reagents that could be administered orally or systemically to patients with T1D, at risk of developing T1D or with severe insulin deficiency unrelated to T1D, and could have a reasonable chance of being used in the clinic in the foreseeable future. To demonstrate the translational potential of their approach, applicants will need to validate within the funding period of the grant the efficacy of the proposed therapeutic or diagnostic strategy in vivo using human cells or tissues (engraftment models), or large animal models that would be adequate for assessing efficacy and toxicity prior to first in man. Biological efficacy should be demonstrated following systemic, oral or surgical administration of the therapeutic or diagnostic agent in the relevant preclinical system.
Successful applicants will join the Consortium on Targeting And Regeneration (CTAR) that was created in 2014 to support the development of innovative strategies to increase functional human beta cell mass in vivo through the controlled manipulation of beta cell replication or islet plasticity, or the reprogramming of adult non-beta cells into beta-like cells, or the protection of residual beta cell mass from autoimmune destruction in T1D (http://grants.nih.gov/grants/guide/rfa-files/RFA-DK-13-015.html ). CTAR is one of the five consortia that constitute the Human Islet Research Network (HIRN), created in 2014 to support innovative and collaborative translational research to understand how human beta cells are lost in T1D, and to find innovative strategies to protect and replace functional beta cell mass in humans.
Successful applicants will be expected to work collaboratively with all of their CTAR and HIRN colleagues and to contribute to an environment of sharing and trust across the network. All methods, reagents, resources, biomaterials, protocols, data and models developed by CTAR investigators are expected to be made available to the research community, as appropriate and consistent with achieving the goals of the program. All participants will be expected to adhere to the sharing policies developed by the HIRN as a term of the award. CTAR Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) must participate in the annual HIRN Investigator Scientific Retreat, as well as in CTAR Steering Committee teleconferences to be held at least bi-annually. All participants will be obligated to abide by the policies adopted the majority vote of the CTAR Steering Committee and the HIRN Trans-Network Committee (see "Cooperative Agreement Terms and Conditions of Award, Section VI.2.).
The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types.
NIDDK intends to commit $2.5 million for FY 2019 to fund 3-5 awards.
The maximum project period is 4 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
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 Diseases (NIDDK)
All instructions in the SF424 (R&R) Application Guide must be followed.
In addition to describing the details of their research strategy, applicants should specifically document the following characteristics of their project:
Contribution to the HIRN effort:
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.
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.
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 the proposed project likely to lead to the development of safe and efficient therapeutic products or diagnostic tools that have a reasonable chance of being used in the clinic?
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?
Specific to this FOA: is the applicant proposing to fill an important technological gap in the field that could benefit the overall research community, or to develop a significantly novel approach to the diagnosis or treatment of T1D?
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: For projects that are focused on developing cell-targeting strategies, is the proposed approach to demonstrate efficacy and specificity of delivery to a human islet environment appropriate? For projects that are proposing to discover or to develop novel diagnostic or therapeutic strategies, is the proposed approach to validate the biological efficacy of the strategy using live human cells or tissues appropriate?
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?
Relevance to CTAR's and HIRN's missions:
Will the proposed research contribute positively and significantly to the overall scientific mission of CTAR and HIRN? 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 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.
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 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:
CTAR awardees agree to the governance of the CTAR through a Steering Committee.
HIRN Trans-Network Committee (HIRN-TNC)
The HIRN-TNC will consist of: the PD/PI of the HIRN-AH and the Steering Committee Chairs and Project Scientists of the HIRN scientific topic consortia (CHIB, CTAR, CMAI, CBDS and HPAC); the TNC is not a governing body and does not cast votes.
Expert Scientific Panel (ESP)
An independent panel of 2-3 External Experts will be appointed by the NIDDK and meet by teleconference with the CTAR Project Scientist and the CTAR Project Officer at least once a year. The CTAR-ESP will be updated on progress and give feedback to NIH on adjustments and future directions for the CTAR research projects. 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 Scientific Retreat, to participate to the CTAR Steering Committee meetings as ex-officio, and to serve as the CTAR-ESP representative to the larger HIRN-ESP that will also meet once a year. The CTAR ESP Chair will be tasked with relaying the CTAR Steering Committee recommendations for new Opportunity Funds Initiatives to the HIRN-ESP. All CTAR-ESP members will also be invited to listen as ex-officio to CTAR Steering Committee meetings. Members of the CTAR-ESP may be asked, on an ad hoc basis, in the peer review of applications for new research applications that request "opportunity pool" funds. The HIRN-AH will support costs for teleconferences between the ESP and the CTAR Steering Committee, will arrange the CTAR-ESP and HIRN-ESP teleconferences, maintain a record of minutes, and support costs for the CTAR-ESP chair to participate in the annual HIRN Investigator Scientific Retreat.
Disagreements 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.
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Olivier Blondel, Ph.D.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Najma Begum, 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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