This FOA invites investigation of biological and clinical measures of TBI-related progressive neurodegeneration and neurocognitive decline associated with increased risk for dementia and /or traumatic encephalopathy syndrome (TES) (clinicopathologic diagnostic counterpart to the neuropathological diagnosis of Chronic Traumatic Encephalopathy (CTE)). Investigations should be based on existing, well-characterized populations of patients with a history of TBI that are enriched for increased risk of cognitive impairment or dementia and can continue to be followed longitudinally; additional subjects may be recruited as appropriate. The overall goal is to advance knowledge of the underlying pathophysiology and clinical characterization of the chronic effects of TBI that distinguish static-chronic TBI cognitive impairment from those that lead to progressive neurodegeneration associated with TES and dementia. A critical feature of this FOA includes the broad sharing of clinical, neuroimaging, physiological, and biospecimen data to further advance research in this area
February 25, 2019
March 15, 2019
April 15, 2019, by 5:00 PM local time of applicant organization.
No late applications will be accepted for this Funding Opportunity Announcement.
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.
In recent years, there has been a resurgence of both research and public interest in the long-term consequence of TBI, particularly as it relates to neurodegeneration, dementia and Chronic Traumatic Encephalopathy (CTE). Epidemiological data suggest that a history of traumatic brain injury (TBI) is a significant risk factor for Alzheimer’s Disease (AD) and Alzheimer’s Disease Related Dementias (ADRD) and that the relative risk may be mediated by injury severity and frequency with increased severity and multiple insults resulting in higher risk. Frequency and severity of injury also contribute to the heterogenous expression of chronic static TBI-induced neurocognitive and neuropsychiatric sequelae. For example, more severe injuries often result in long-term static neurocognitive impairments that contribute to overall disability. However, the lack of selective and sensitive tools to differentiate the chronic static TBI-induced sequelae from progressive neurocognitive dysfunction can confuse the risk of dementia following TBI. Similarly, while TBI likely incurs risk for multiple progressive neurodegenerative paths, neither the diagnostic tools nor biomarkers exist to distinguish the potential risk for any specific neurodegenerative path. To date, the best characterized association may be the relationship between frequency of brain injury with CTE, though diagnostics for CTE in living persons remain underdeveloped which hampers progress in this area. Advancing diagnostics of TBI-related neurodegeneration and associated cognitive impairment, including CTE, through the discovery and validation of novel and existing tools has the potential to improve understanding of TBI's contribution to risk for specific dementias which could lead to improved clinical care and patient stratification in future clinical trials.
In 2012, the National Institute for Neurological Disorders and Stroke (NINDS) held the Report on the Neuropathology of Chronic Traumatic Encephalopathy Workshop that outlined research strategies and resources needed to fill knowledge gaps for advancing understanding of CTE including identifying CTE in living individuals and neuropathology. Discussion of identifying CTE in living individuals suggest that there may be multiple disease progression trajectories that may reflect distinct pathological processes related both to “dosing” of brain injury (a combination of both frequency and severity of exposure to head impacts and/or explosive blast) and patient-specific vulnerabilities. A primary recommendation from this workshop was the need to develop diagnostics for CTE in living persons. They concluded that the development of diagnostics should include neuroimaging, biofluid biomarker, clinical outcome assessments (COAs), and genetic susceptibility investigations into individuals with possible and probable CTE. While this workshop focused on CTE, the knowledge gap for understanding the association between a history of TBI exposure and risk for dementia is parallel and similarly understudied.
In 2011, the National Alzheimer's Project Act (NAPA) allocated resources "to prevent and effectively treat Alzheimer's by 2025." Since then, the National Institute on Aging (NIA) and the National Institute of Neurological Disorders and Stroke (NINDS) have held multiple research summits to assess the needs and opportunities relevant to this goal for Alzheimer's Disease (AD) and Alzheimer's Disease Related Dementias (ADRD). In particular, the NINDS has convened expert panels in 2013 and again in 2016 that were tasked with recommending research priorities for advancing the state-of-the-science for all ADRDs, including those due to multiple neuropathological mechanisms (i.e., Multiple Etiology Dementias--MED, and Vascular Contributions to Cognitive Impairment and Dementia (VCID), Including Vascular Cognitive Impairment and Vascular Dementia). Recommendations for MED emphasized the need to describe quantitatively the clinical synergies between different etiologies and identify molecular pathways that accelerate cognitive dysfunction or that protect cognition that are agnostic to specific pathologies, i.e., that might act on mechanisms of cell death or synaptic dysfunction common to more than one neurodegenerative process. Recommendations for VCID emphasized investigations of the contributions of additional risk factors for AD, including diabetes/metabolic syndrome, obesity, lipid metabolism, hypertension, diet, exercise, sleep head injury, and aging, on cerebrovascular function.
Specific Research Objectives
Applications to this FOA will be expected to discover and develop biological and clinical measures of TBI-related progressive neurodegeneration and cognitive decline associated with increased risk for dementia including traumatic encephalopathy syndrome (TES) (clinicopathologic diagnostic counterpart to the neuropathological diagnosis of Chronic Traumatic Encephalopathy (CTE)). Results are expected to inform dementia risk prognoses for patients with history of TBI, using objective clinical and pathophysiologically relevant biological measures. Addressing this goal will require (1) enhanced, validated methods for assessing individual's lifetime exposure to TBI (across varying levels of frequency, severity, and time since injury), (2) accounting for chronic but non-progressive neurocognitive impairment following TBI, and (3) access to an existing longitudinal cohort with a history of TBI exposure and / or dementia cohort with measures of TBI-exposure history. Applicants to this FOA are expected to assess hypothesis-driven objective biological measures and clinical assessments of progressive neurodegeneration, neurocognitive impairment, and neuropsychiatric dysfunction that, in persons with a history of exposure to TBI, may catalyze pathological pathways associated with AD / ADRD and TES. Biological measures may include but are not limited to neuroimaging (such as CT, MRI and PET imaging), vascular reactivity, assessments of sleep, oculomotor and vestibular function, blood-based biomarkers, proteomics, transcriptomics, metabolomics, biofluid markers from samples of CSF and saliva, and known genetic markers of dementia risk.
To address the heterogeneity of post-TBI clinicopathology and extend the generalizability of results, applications to this FOA are expected to recruit both male and female participants with history of TBI across multiple injury severities. These individuals may include former athletes from a variety of sports but should not be limited to the recruitment of or enrich recruitment primarily with former American-rules Football players. To ensure maximal value of this project, a critical feature of this FOA includes the broad sharing of clinical, neuroimaging, physiological, and biospecimen data through the Federal Interagency TBI Research (FITBIR) database.
Areas of interest include but are not limited to:
Studies not responsive under this FOA include but are not limited to:
The study team should include expertise in TBI and expertise necessary to diagnose neurodegenerative disorders and recruit and follow a relevant study cohort. In addition, the multidisciplinary team should be able to collect and analyze high quality data such as MRI and PET, genetics, cognitive tests, CSF and blood biomarkers. The study must include relevant TBI Common Data Elements and comply with the data sharing policies of the FITBIR Informatics System as outlined in NOT-NS-17-029.
Common Data Element Use and Data Sharing
It is expected that applications will incorporate the NINDS Core TBI common data elements (CDEs), other appropriate CDEs in the NINDS TBI CDE set, and the Global Unique Identifier (GUID) server supported by NINDS and NIA. Studies are also expected to use NINDS CDEs for both outcome and non-outcome measures (including, but not limited to demographics, medical and injury history, history of abusive injury, family history, medications, neuroimaging, rehabilitation strategy, and standardized outcome assessments) as described by the NINDS CDE Project. Compiling the broad array of CDEs that may be necessary to accomplish the goals of this FOA may require searching across NINDS CDE Disease areas (e.g., TBI, Parkinson's Disease, Epilepsy, Headache, and Huntington's Disease). When appropriate biospecimen collection and processing should follow procedures outlined in the NINDS CDE program (see "Studies Involving Biospecimens" section below).
In order to advance the goal of widespread data sharing, investigators funded under this FOA are required to share all data collected in this FOA via FITBIR. FITBIR staff will work with investigators to assist with data harmonization to the NINDS CDE program and the FITBIR Data Dictionary that is based on the NINDS CDE program. For answers to frequently asked questions and how to contact FITBIR, please see: https://fitbir.nih.gov/content/contact-us.
As the research strategy is prepared, it is important to note that NINDS believes applications will be greatly strengthened if the rigorous design, execution, and interpretation of the proposed studies and supporting data are adequately described. NINDS encourages investigators, whenever possible, to address these elements directly in their applications. Investigators are urged to discuss these issues with Scientific/Research staff prior to submission of applications (see:NOT-NS-11-023andNOT-OD-15-103). The NINDS also expects that applications will conform to the principles outlined inLandis et al., 2012and show consideration for biological variables described inNOT-OD-15-102.
Imaging Based Studies
Applications proposing to include neuroimaging approaches are expected, where appropriate, to align with the NINDS neuroimaging CDEs. To optimize widespread data sharing, whenever possible, imaging sequencesshould align with existing large federally-funded TBI cohort studies (e.g., TRACK-TBI, NCAA/DoD CARE Consortium, Chronic Effects of Neurotrauma Consortium (CENC), Diagnostics, Imaging, and Genetics Network for the Objective Study and Evaluation of Chronic Traumatic Encephalopathy (DIAGNOSE CTE)).
Studies Involving Biospecimens
Applications proposing to collect biospecimens must use NINDS Biomarkers Repository BioSpecimen Exchange for Neurological Disorders (BioSEND) protocols and procedures, and all specimens collected and banked with BioSEND must come from individuals who have consented to banking and sharing broadly with academia and industry.
Note that costs for collection are NOT included as a component of the NINDS Biomarkers Repository award. Therefore, most costs for the biospecimen banking are borne by the grantees utilizing this resource (see NOT-NS-15-046) Applicants planning projects in which biospecimens will be collected are strongly advised to consult the NINDS Biomarkers Repository website for more information about samples banked at the repository (https://www.biosend.org). In addition, applicants are advised to consult with NINDS Biomarkers Repository staff to obtain a quote for biospecimen banking costs (email:firstname.lastname@example.org).
Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.
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?
NIH intends to fund up to 4 awards, corresponding to a total of $2,700,000, for fiscal year 2019.
Future year amounts will depend on annual appropriations.
Up to 5 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:
The application forms package specific to this opportunity must be accessed through ASSIST, Grants.gov Workspace or an institutional system-to-system solution. Links to apply using ASSIST or Grants.gov Workspace are available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.
Letter of Intent
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:Patrick SF Bellgowan, PHD
All instructions in the SF424 (R&R) Application Guide must be followed.
Budget considerations should include, but are not limited to:
Specific Aims: Provide the overall goals or hypothesis of the entire project and list separate Specific Aims to be accomplished, briefly outline the methods proposed, and summarize the expected outcomes.
Research Strategy: Describe the research strategy to accomplish the Specific Aims and how the research will advance knowledge of progressive TBI-related neurodegeneration and cognitive decline, how a history of TBI may catalyze pathological pathways associated with TES and dementia, inform prognostic models for dementia risk (including TES) in persons with a history of TBI, assess the relative risk for developing TBI-related neurodegeneration in individuals with a history of varying levels of exposure to TBI, and / or contribute to the development of diagnostic methods for TES. Describe access to relevant existing longitudinal cohort with a history of TBI and relevance of this cohort for achieving the purpose of this FOA. Provide alternative approaches to addressing the research aims if the proposed approaches fail. Operational definitions should be provided for measures of TBI exposure including injury frequency and severity (e.g., "concussion", "repetitive head impacts", and "multiple TBIs"), and time since injury. The method and criteria for assessing prior history of TBI should be well described and reproducible. It is expected that the NINDS TBI "Core" common data elements (CDEs) will be collected.
Investigations should be conducted in existing, well-characterized populations of patients with a history of TBI, enriched for increased risk of cognitive impairment or dementia, that have been and can continue to be followed longitudinally. While applications should be based on an existing cohort, additional subjects may be recruited as appropriate. Applications to this FOA are expected to recruit both male and female participants with history of TBI across multiple injury severities. These individuals may include former athletes from a variety of sports but should not be limited to, or enriched by, the recruitment of former American-rules Football players.
Applications should include multidisciplinary expertise and should detail a plan for supervising and coordinating the entire range of proposed activities. Applicants should include a timeline that includes recruitment goals and interim analyses.
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.
See Part 1. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov
Part I. Overview Information contains information about Key Dates and times. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission. When a submission date falls on a weekend or Federal holiday , the application deadline is automatically extended to the next business day.
Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies). Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date and time. If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Policy on Late Application Submission.
Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission.
Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.
This initiative is not subject to intergovernmental review.
All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement .
Pre-award costs are allowable only as described in the NIH Grants Policy Statement.
Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide. Paper applications will not be accepted.
Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.
For assistance with your electronic application or for more information on the electronic submission process, visit How to Apply – Application Guide. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Dealing with System Issues guidance. For assistance with application submission, contact the Application Submission Contacts in Section VII.
All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH. See Section III of this FOA for information on registration requirements.
The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in the SF424 (R&R) Application Guide.
See more tips for avoiding common errors.
Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review and responsiveness by NINDS, NIH. Applications that are incomplete, non-compliant and/or non-responsive will not be reviewed.
In order to expedite review, applicants are requested to notify the NINDS Referral Office by email email@example.com when the application has been submitted. Please include the FOA number and title, PD/PI name, and title of the application.
Only the review criteria described below will be considered in the review process. Applications submitted to the NIH in support of the NIH mission are evaluated for scientific and technical merit through the NIH peer review system.
Does the project address an important problem or a critical barrier to progress in the field? Is the prior research that serves as the key support for the proposed project rigorous? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?
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 investigative team have appropriate expertise in diagnoses of dementia, neurodegenerative disorders, and TBI? Does the application include a plan for the supervision and coordination of the range of proposed activities?
Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?
Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Have the investigators included plans to address weaknesses in the rigor of prior research that serves as the key support for the proposed project ? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?
Are the TBI exposure related operational definitions quantifiable? Does the study propose hypotheses for how TBI may incur increased risk for dementia and / or TES? Is the data management and curation plan, and description of data harmonization with the NINDS CDEs (e.g., clinical assessment & outcome measures, symptom lists, mechanism of injury, demographics, etc.) appropriate for submission to FITBIR? Does the application describe the method and criteria for assessing patients' prior history of TBI that is clear and reproducible? Is the timeline for recruitment and a plan for interim analyses feasible?
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?
Does the project propose to study an existing longitudinal cohort appropriate for achieving the purpose of this FOA? Does the cohort include a well-characterized population of patients with a history of TBI and an increased risk of cognitive impairment and/or dementia? Will the project assess multiple severities of TBI?
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?
For research that involves human subjects but does not involve one of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.
For research that involves human subjects and meets the criteria for one or more of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.
When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of individuals of all ages (including children and older adults) to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.
The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.
Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.
Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).
Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: (1) Data Sharing Plan; (2) Sharing Model Organisms; and (3) Genomic Data Sharing Plan (GDS).
For projects involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.
Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.
Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by the Center for Scientific Review, 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.
Applications will be assigned to the appropriate NIH Institute or Center.
Applications will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the NINDS National Advisory Council (NANDS). The following will be considered in making funding decisions:
Information regarding the disposition of applications is available in the NIH Grants Policy Statement.
A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the grantee’s business official.
Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.
Any application awarded in response to this FOA will be subject to terms and conditions found on the Award Conditions and Information for NIH Grants website. This includes any recent legislation and policy applicable to awards that is highlighted on this website.
Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights law. This means that recipients of HHS funds must ensure equal access to their programs without regard to a person’s race, color, national origin, disability, age and, in some circumstances, sex and religion. This includes ensuring your programs are accessible to persons with limited English proficiency. HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research.
In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements. FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award. An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a Federal agency previously entered and is currently in FAPIIS. The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgement about the applicant’s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 45 CFR Part 75.205 “Federal awarding agency review of risk posed by applicants.” This provision will apply to all NIH grants and cooperative agreements except fellowships.
For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA. HHS provides general guidance to recipients of FFA on meeting their legal obligation to take reasonable steps to provide meaningful access to their programs by persons with limited English proficiency. Please see https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/index.html. The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-individuals/section-1557/index.htmlhttps://www.hhs.gov/civil-rights/for-providers/laws-regulations-guidance/index.html. Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see https://www.hhs.gov/civil-rights/for-individuals/disability/index.html. Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at https://www.hhs.gov/ocr/about-us/contact-us/index.html or call 1-800-368-1019 or TDD 1-800-537-7697. Also note it is an HHS Departmental goal to ensure access to quality, culturally competent care, including long-term services and supports, for vulnerable populations. For further guidance on providing culturally and linguistically appropriate services, recipients should review the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care at http://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.
The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All awardees of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000. See the NIH Grants Policy Statement for additional information on this reporting requirement.
In accordance with the regulatory requirements provided at 45 CFR 75.113 and Appendix XII to 45 CFR Part 75, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM) about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period. The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (currently FAPIIS). This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313). As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available. Full reporting requirements and procedures are found in Appendix XII to 45 CFR Part 75 – Award Term and Conditions for Recipient Integrity and Performance Matters.
Finding Help Online: http://grants.nih.gov/support/ (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)
General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources)
Email: GrantsInfo@nih.gov (preferred method of contact)
Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Patrick S Frost Bellgowan, Ph.D.
National Institute of Neurological Disorders and Stroke (NINDS)
National Institute on Aging (NIA)
Samuel Edwards, Ph.D.
Center for Scientific Review
Tijuanna Decoster, Ph.D.
National Institute of Neurological Disorders and Stroke (NINDS)
National Institute on Aging (NIA)
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