The NIDCD Temporal Bone Registry is a national research resource for human auditory and vestibular research. Its fundamental purpose is to coordinate information about specimens of the human ear and to recruit potential temporal bone donors. The Registry coordinates specimen collection, information recording and data management of specimens, and provides public information, including an up-to-date website about human ear specimens for research. It is not a simple database or tissue bank for human ear specimens. Applications are encouraged that will enhance, promote, and support critical research on the human middle and inner ear that cannot be done in living humans. Use of temporal bone specimens also provides an opportunity for translation from critical animal models to human models for auditory and vestibular research. This initiative will support the Registry by cooperative agreement, to:
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.
Funding opportunities to establish and maintain resources for the research community can be critical for research progress. The NIH supports U24 Resource-Related Research Projects for research activities that are not hypothesis-driven, to provide data, materials, tools or services that are essential for timely, high-quality and cost-efficient progress in a scientific field.
In pursuit of its mission, NIDCD supports basic, translational, clinical and outcomes research on hearing and balance, in normal and diseased states, including basic cellular/molecular biology and genetics research in neuroplasticity, neurodevelopment, neurodegeneration, and studies aimed at detection, prevention, and treatment of otological and neurotological diseases and disorders.
The NIDCD National Temporal Bone, Hearing & Balance Pathology Resource Registry, known as the ‘Registry’, is an important scientific resource for the auditory and vestibular communities, whose fundamental purpose is to coordinate information regarding human temporal bones that are available to study, to recruit additional temporal bone donors, and to arrange and for the procurement of the donated specimens upon death of the donor. The human middle and inner ear is unusually hard to study as the ear is encased in the dense temporal bone of the skull; moreover, the soft tissues cannot be readily accessed by routine biopsy or other techniques on living subjects. Modern biological approaches to ear diseases and disorders require obtaining tissues as soon as possible after death, because adequate donor arrangements are needed for immediate Registry notification and harvest at death. Currently evolving technologies and methodologies need to be considered for handling database design, donor recruitment, tissue procurement, tissue placement, and information format and access for scientific researchers.
The Registry was established by NIDCD in 1992 to expand an earlier National Temporal Bone Banks program. The Registry is a resource activity to coordinate nationwide collection, usage, information, and public education about human temporal bone tissues for hearing and balance research. Since 2013 the Registry has been supported through the U24 cooperative resource activity code.
The U24 is appropriate for this funding opportunity in otopathology as a critical-need resource in the mission of NIDCD. In addition,the cooperative agreement mechanism enables NIDCD involvement to continue developing this resource for increased nationwide use. The 2015 NIDCD Workshop: "Synaptopathy and Noise-Induced Hearing Loss: Animal Studies and Implications for Human Hearing" emphasized the need for human temporal bone data to validate comparisons with discoveries from animal models, as well as to reveal structural correlates of genetic and physiological disorders of the human ear and consequences of therapeutic treatments including drugs and devices. Currently evolving technologies and methodologies need to be considered for handling database design, donor recruitment, tissue procurement, tissue placement, information format, and access for scientific researchers.
The goal of this FOA is to continue support for the Registry as it seeks to make temporal bone specimens and accompanying information available and responsive to the needs of auditory and vestibular research. Therefore, only recipient organizations previously funded under RFA-DC-14-002 are eligible to apply.
To this end, this FOA will support the Registry to:
continue to develop and maintain a growing database for access to detailed information about the location, condition, and other bioinformatics data about new and archival human temporal bone tissues around the country that are available as resources for auditory and vestibular research;
communicate with scientific and clinical researchers to disseminate information about the resources available;
maintain a well-organized nationwide network of on-call experts for timely post-mortem harvesting of temporal bone tissues;
develop a strategy for receipt of harvested tissue by nearby temporal bone laboratories;
develop new methods or techniques for donor recruitment and tissue procurement;
communicate with ‘pledges’ for tissue donation combined with relevant medical histories that will allow linking functional disorders to morphological, biochemical and genetic pathologies;
provide education/outreach to the scientific community and to the public about temporal bone donations.
The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types.
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.
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.
All instructions in the SF424 (R&R) Application Guide must be followed.
Need and uniqueness: A resource must meet a demonstrable and timely community need, so the potential impact on the scientific community should be described. Factors also could include known work that has used the Registry, its database or website, or other evidence for community usage or community interest for basic and clinical scientists. (Do not provide letters of support here; see below.) Include information about how further development of the Registry and its database will provide a complementary resource that does not duplicate other efforts to enhance research.
Access: Indicate how broad access to the Registry will be made available to all investigators, for clear purposes that are understood by the providers and the users. As a resource, the Registry must include cost-effective mechanisms for dissemination and advertisement of resources and services to the community of basic and clinical investigators, as well as to the general public.
Appropriate attention is needed to regulations on human subject protections and confidentiality of data collected. Plans must describe how the registry will coordinate donor recruitment and tissue procurement; how and where donated tissues and related data will be handled, evaluated, archived and protected; fair distribution of the donated tissues, and how to access the information will be allocated and protected.
Quality control: Measures must be described to monitor, control,document, and increase the quality of specimens and data, including such aspects as donor data, tissue harvesting and handling protocols, and database upgrades for the resource.
Outreach: Describe plans to maximize effective use of the Registry for outreach to research scientists and to the public. Describe in detail how donor recruitment will be enhanced to increase donations and to include the targeting of underrepresented populations or clinically informative populations.
Efficiency: Describe appropriate staffing plans and discuss measures for improving efficiency or offsetting some costs. Consider appropriate technology that will not become obsolete rapidly.
Overall, enhancements to consider must include features for increasing donor participation, imaging and informatics in the design and content of the database, and optimizing the scale and efficient use of existing resources for research.
Administration: Details must be provided for the role of any personnel receiving support from this award. The resource must be integrated with broad strategic interests of potential users on a national and international scale. Accordingly, a framework for a Steering Committee for the Registry must be proposed to provide technical and scientific expertise for guidance. Accordingly, a framework for a Steering Committee for the registry must be proposed to provide technical and scientific expertise for guidance. If a Steering Committee is already in place, please list the names, affiliations, and dates of service for current and former members. Do not name individuals who may be considered in the future for Steering Committee membership.
Milestones: Objective milestone indicators are needed to help guide the project, and to ensure that the resource is meeting the community's needs, is of high quality, and is accessible. Applications must include quantifiable metrics for ongoing improvement, and to gauge the impact of usage on the scientific field. Examples could include tracking growth of the collection information (new donors, new tissues, etc.), requests for services, successful use of the resource data, the number of users, publications citing uses, etc. The milestones must include realistic quantitative goals for resource usage to be reported at the end of each annual funding period.
Letters of Support: Limit letters of support to only those who are named in the application (e.g., collaborators, senior/key personnel and other significant contributors) and are expected to contribute in a substantive way to the execution of the proposed resource. Do NOT provide letters from potential or previous users (individuals, groups, or consortia) .
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
with the following additional instructions:
All instructions in the SF424 (R&R) Application Guide must be followed.
See Part 1. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov
Part I. Overview Information contains information about Key Dates and times. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission. When a submission date falls on a weekend or Federal holiday , the application deadline is automatically extended to the next business day.
Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies). Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date and time. If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Policy on Late Application Submission.
Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission.
Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.
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.
Important Update: See NOT-OD-18-228 for updated inclusion and human subjects review language for due dates on or after January 25, 2019.
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 there a strong scientific premise for the project? 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?
How well does the proposed resource meet a significant community need by contributing substantially to the quality of research on human temporal bones and the ear (otology, audiology, and other clinical and basic sciences involving the inner and middle ear, etc.)? Will the proposed services and outreach convincingly add major value to the research community? Is the resource likely to improve the public awareness of human ear disorders and the need for research and for temporal bone donors?
Does the proposed Resource address the needs of the research projects that it will serve? Is the scope of activities proposed for the resource appropriate to meet those needs? Will successful completion of the aims bring unique advantages or capabilities to the research resource?
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 PD(s)/PI(s) have a history of service-oriented efforts outside the needs of their own research to facilitate oversight of this resource? Are they uniquely positioned to provide the proposed resource, and to integrate their efforts with broader strategic interests of potential users on a national and international scale?
Are the PD(s)/PI(s) and other personnel well suited to their roles in the Registry? Do they have appropriate experience and training, and have they demonstrated experience and an ongoing record of accomplishments in managing archival research? Do the investigators demonstrate significant experience with coordinating collaborative basic or clinical research? If the Center is multi-PD/PI, do the investigators have complementary and integrated expertise and skills; are their leadership approach, governance, plans for conflict resolution, and organizational structure appropriate for the Registry? Does the applicant have experience overseeing selection and management of subawards, if needed?
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?
Does the PD(s) PI(s) have a history of service-oriented efforts outside the needs of their own research to facilitate oversight of this resource? Are they uniquely positioned to provide the proposed resource, and to integrate their efforts with broader strategic interests of potential users on a national and international scale?
Does the application propose novel organizational concepts, management strategies, or instrumentation] in coordinating the research resource the Registry will serve? Are the concepts, strategies, or instrumentation novel to one type of research program or applicable in a broad sense? Is a refinement, improvement, or new application of organizational concepts, management strategies or instrumentation proposed?
Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the 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?
How is quality control addressed and is it adequate? Evaluate the plans for how accessible the resources are to the scientific community. Will the resources be broadly accessible? Are the plans for resource sharing satisfactory, including protections for data? Are the plans for the administrative framework and Steering Committee appropriate for the resource? Are the personnel well justified?
Are the overall strategy, operational plan, and organizational structure well-reasoned and appropriate to accomplish the goals of the research resource the Registry will serve? Will the investigators promote strategies to ensure a robust and unbiased scientific approach across the resource, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the resource is in the early stages of operation, does the proposed strategy adequately establish feasibility and manage the risks associated with the activities of the resource? Are an appropriate plan for work-flow and a well-established timeline proposed? Have the investigators presented adequate plans to ensure consideration of relevant biological variables, such as sex, for studies of vertebrate animals or human subjects?
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?
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?
Will the institutional environment in which the Registry will operate contribute to the probability of success in facilitating the research community it serves? Are the institutional support, equipment and other physical resources available to the investigators adequate for the Registry proposed? Will the Registry benefit from unique features of the institutional environment, infrastructure, or personnel? Are resources available within the scientific environment to support electronic information handling?
Does the application have a plan in place for evaluation of the resource activity? Are the proposed milestone metrics appropriate for assessing the ongoing value of the proposed resources?
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.
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.
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.
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).
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 https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/index.html. The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html; and https://www.hhs.gov/civil-rights/for-providers/laws-regulations-guidance/index.html. Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see 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 https://www.hhs.gov/ocr/about-us/contact-us/index.html or call 1-800-368-1019 or TDD 1-800-537-7697. Also note it is an HHS Departmental goal to ensure access to quality, culturally competent care, including long-term services and supports, for vulnerable populations. For further guidance on providing culturally and linguistically appropriate services, recipients should review the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care at http://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.
The following special terms of award are in addition to, and not in lieu of, otherwise applicable 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 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, 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:
The NIDCD Project Coordinator:
Areas of Joint Responsibility include:
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.
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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