Part 1. Overview Information

Key Dates

All applications are due by 5:00 PM local time of applicant organization.

Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.

It is critical that applicants follow the instructions in the Research (R) Instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this NOFO or in a Notice from NIH Guide for Grants and Contracts).

Conformance to all requirements (both in the Application Guide and the NOFO) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions.

Applications that do not comply with these instructions may be delayed or not accepted for review.

Part 2. Full Text of Announcement

Section I. Notice of Funding Opportunity Description

The COVID-19 pandemic continues to be a major public health concern and remains as the third leading cause of death in the United States according to the Centers for Disease Control and Prevention (CDC). Extraordinary advancements have been made regarding the surveillance of the SARS-CoV-2 virus variants and the development of vaccines and therapeutics for acute COVID-19 infection. Despite these advances, there is growing evidence that more than half of people infected with COVID-19 continue to experience a spectrum of symptoms beyond the acute phase, a condition now termed “Post-Acute Sequelae of SARS-CoV-2 Infection (PASC)” and also called “Long COVID”, “long-haul COVID”, and “post-acute COVID-19”. Acute COVID and PASC-related symptoms include cardiopulmonary, gastrointestinal, dermatologic, endocrine, psychiatric and/or neurological manifestations.  PASC symptoms can be mild to highly debilitating and are more likely in those who were hospitalized or had severe acute COVID symptoms. However, PASC can occur in people who did not require hospitalization or who were asymptomatic during the acute phase. There are world-wide initiatives to better characterize PASC symptoms and phenotypes, and to uncover its pathophysiology including large scale health surveys and review of large electronic health records as well as large prospective cohort studies that incorporate collection of biospecimens. These studies have identified multiple mechanisms that may play a role in PASC including an ongoing exacerbated inflammatory response, vascular and/or microvascular dysfunction, endothelial disruption, hypercoagulability, persistent viral reservoirs, SARS-CoV2-evoked autoimmunity, viral neurotropism and others. Substantial further work is needed to link these mechanisms to specific symptomatology and complications and to develop effective preventative measures and treatments. 

COVID-19, PASC and Neurological Complications: Neurological symptoms have a high incidence and prevalence among individuals with acute COVID-19 and PASC. Acute manifestations of SARS-CoV2 infection include encephalopathy, seizures, Guillain-Barre syndrome and stroke, especially in patients who are severely ill and require hospitalization and ICU care. In PASC, commonly reported neurological symptoms include “brain fog” characterized by difficulty with cognition, concentration and focus, neuropathic-like pain, headache, myalgia, fatigue, neurocognitive impairment, sleep disturbances, dysautonomia, dizziness, mood disorders and others. There is also growing evidence that COVID-19 may increase the risks of developing neurological conditions like Alzheimer’s disease, movement disorders, and epilepsy in the long term. Underlying pre-COVID vascular and immunological conditions appear to predispose the development of PASC which can worsen a pre-existing neurologic condition or trigger a new onset of neurological manifestations. Lack of understanding of the specific mechanisms underlying the development of neurological symptoms has been a major obstacle for the identification of effective treatments for PASC-related neurological complications.  

National Institute of Neurological Disorders and Stroke (NINDS)

The mission of NINDS is to seek fundamental knowledge about the brain and nervous system and to use that knowledge to reduce the burden of neurological disease for all people. The purpose of this Notice of Funding Opportunity (NOFO) is to invite exploratory and innovative research applications focused on the neurological manifestations of COVID-19 (neuro-COVID) and Post-Acute Sequelae of SARS-CoV-2 Infection (neuro-PASC) and on the effect of COVID-19 on pre-infection neurologic conditions. NINDS will accept applications investigating the pathophysiology and mechanisms of neuro-COVID and neuro-PASC as well as mechanistic clinical trials probing the biological or behavioral processes implicated neuro-COVID and/or neuro-PASC. NINDS will not accept clinical trials to develop therapeutic interventions, to test the safety and/or tolerability of an intervention, to demonstrate pharmacodynamic or neurodynamic effects to establish dosing or to demonstrate the efficacy or effectiveness of an intervention through this NOFO (see non-responsive criteria below). Applicants interested in evaluating treatments for clinical efficacy should apply through one of the NINDS NOFOs listed at the NINDS Funding-Opportunities to find the appropriate NIH or NINDS-specific NOFO for such clinical trials. This NOFO has restrictions on the types of Clinical Trials allowed (see non-responsive criteria below). For clinical trial applications that seek to answer specific questions about intervention or treatment safety, tolerability or efficacy, please refer to NINDS Funding-Opportunities to find the appropriate NIH or NINDS-specific NOFO for such clinical trials. In many cases, small interventional trials exploring an intervention are within scope of PAR-22-142 NINDS Exploratory Clinical Trials (U01 Clinical Trial Required). 

When appropriate, this NOFO strongly encourages applications that include a plan for stakeholder engagement. Stakeholder engagement in clinical studies involves patients, families, their representatives, health professionals, and the clinical research team working in active partnership at various levels across the continuum of clinical research. Continued respectful, equitable, and bidirectional knowledge transfer during stakeholder engagement can improve participant retention and adherence to the study protocol. Engagement can help build trust in communities that may be fearful of participating in clinical research because of stigmas and medical mistrust. 

NINDS is committed to reducing the disproportionate burden of neurological disease borne by underserved groups of society, including racial and ethnic minority, rural, and socioeconomically disadvantaged populations. Persons from racial and ethnic minority groups and people living in rural areas are disproportionately affected by COVID-19, including experiencing increased risk for infection, hospitalization, and death. Additionally, socioeconomically disadvantaged populations are more likely to be at risk for poorer health outcomes.  Therefore, ensuring appropriate inclusion of populations that experience health disparities is strongly encouraged, when applicable. 

NINDS strongly encourages applicants to consult with NINDS Program Officials to ensure the suitability of the application for this NOFO.

Examples of research activities include (but are not limited to) the following:

• Identification of mechanisms of central nervous system (CNS) and peripheral nervous system (PNS) manifestations of COVID-19 and PASC.
• Identification of persistent SARS-CoV-2 reservoirs and evidence of chronic immune dysregulation or viral re-activation in relation to neurologic symptomatology.
• Research on CNS or PNS-specific tissue-associated autoantibodies and correlation with neurologic clinical parameters including severity and duration of symptoms.
• Longitudinal correlation of specific inflammatory biomarkers and PASC-related neurological complications.
• Research evaluating brain endothelial dysfunction, coagulopathy and vasculopathy and the effects of potential protective agents on neurologic symptoms.
• Development and validation of biomarkers of mitochondrial dysfunction in PASC that may relate to neurologic symptoms.
• Research to better understand the neuropathobiology of COVID-19 and PASC in the context of SARS-CoV-2 variants.
• Understanding overlapping mechanisms of COVID-19/PASC and other chronic conditions with similar neurologic symptomatology, such as myalgic encephalomyelitis/chronic fatigue (ME/CFS) syndrome, Ebola, Lyme disease, HIV, Epstein-Barr virus, or connective tissue disorders.
• Studies to better understand the impact of SARS-CoV-2 on pre-existing neurological conditions such as multiple sclerosis, migraine, epilepsy, stroke, dementia, and traumatic brain injury. 
• Development and validation of animal models replicating neuro-PASC. 
• Neuropathological studies of COVID-19 and the contribution of tissue damage by SARS-CoV-2 to PASC-related neurological complications.

National Institute of Mental Health (NIMH)

The National Institute of Mental Health (NIMH) accepts research to transform the understanding and treatment of mental illness through basic and clinical research, paving the way for prevention, recovery, and cure. For this Notice of Funding Opportunity (NOFO), the NIMH is interested in supporting mental health research questions related to SARS-CoV-2 Infection and those arising from Post-Acute Sequelae of SARS-CoV-2 Infection (PASC). NIMH research areas of interest include 1) exploring mechanisms and pathophysiology of SARS-CoV-2 infection and PASC contributing to new and worsening mental illness outcomes, 2) identifying modifiable targets uniquely or robustly implicated in SARS-CoV-2 infection and PASC and relevant to new and worsening mental illness, and 3) conducting mechanistic trials probing the biological or behavioral processes of those targets that may be pursued in future mental health therapeutic development. Basic and translational research are relevant but note that for this NOFO, NIMH only allows mechanistic clinical trials (see NOT-MH-20-105 Consolidated Notice on NIMH Clinical Trial Policies and related announcement for intervention development). NIMH will not accept clinical trials to develop therapeutic interventions, to test the safety and/or tolerability of an intervention, to demonstrate pharmacodynamic or neurodynamic effects to establish dosing or to demonstrate the efficacy or effectiveness of an intervention through this NOFO (see non-responsive criteria below).  Applicants interested in evaluating treatments for clinical efficacy should apply through one of the NIMH NOFOs listed at the Support for Clinical Trials at NIMH web page, which includes links to the NIMH clinical trials NOFOs and Applicant FAQs. Applications that propose a clinical trial for the purpose of testing the safety and/or clinical efficacy of novel interventions are outside of the scope of NIMH research interests for this NOFO and will not be supported through this NOFO. Projects focused on broad neurological effects (including brain fog, general memory deficits, and general neural functioning) outside of the context of mental illness should be directed to NINDS. Projects focused on mental illness (including psychosis, depression, anxiety) should be directed to NIMH. For the purposes of this RFA, the NIMH has interest in:

• Research establishing experimental systems to model SARS-CoV-2 CNS infection contributing to mental illness specifically and/or mental health related outcomes.
• Studies of SARS-CoV-2-specific maternal immune responses and signaling in CNS development and function in offspring.
• Studies of the mechanisms of SARS-CoV-2 and PASC affecting brain endothelial cells, brain lymphatics and glial cells responsible for triggering cognitive and emotional deficits, including the impact of stress, hormonal influences as well as sex effects in experimental systems relevant to mental illness.
• Studies to understand the impact of SARS-CoV-2 on the neuro-immune milieu and the resulting disruption of neuronal circuits, function, or behavior relevant to mental health.
• Studies to identify mechanisms by which people with mental illness are at increased risk of SARS-CoV-2 infection and death.
• Mechanistic clinical trials (see NOT-MH-20-105) to probe the relevance of therapeutic targets uniquely or robustly implicated specific to COVID-19 and mental illness.
• Studies to clarify the role of SARS-CoV-2 CNS infection and mental illness in PASC.
• Studies elucidating the pathogenesis of the mental illness characteristic of PASC.
• Host and environmental factors and the associated biological pathways that mediate the intensity and duration of mental illness dimensions of PASC, and affect recovery.

NIMH strongly encourages applicants to consult with NIMH Program Officials when developing plans for an application. This early contact will provide an opportunity to clarify NIMH policies and guidelines and identify whether the proposed project is consistent with NIMH mission and program priorities. This is particularly important if there is doubt as to whether the submission is determined to be an NIH-defined clinical trial, and if found to be a clinical trial, whether it is a mechanistic clinical trial as defined by NIMH. Studies proposing to model SARS-CoV-2 CNS infection contributing to mental illness specifically and/or mental health related outcomes should align with the guidance provided in NOT-MH-19-053 Notice of NIMH’s Considerations Regarding the Use of Animal Neurobehavioral Approaches in Basic and Pre-clinical Studies.

 The National Institute on Aging (NIA) 

NIA encourages applications under this NOFO that address research questions central to NIA’s mission of improving the health and well-being of older adults through research.  Specific areas of interest include, but are not limited to: 

• Research on mechanisms underlying neurological and neurocognitive symptoms and sequelae of SARS-CoV-2 infection in older adults across the full range of illness severity (e.g., early alterations in sensory function, delirium, neuropsychiatric symptoms). 
• Studies to better understand the impact of SARS-CoV-2 on pre-existing age-related neurodegeneration, including AD/ADRD. 
• Studies of the role of brain barriers in preventing SARS-CoV-2 from gaining access to neural tissues in the context of aging and age-related neurodegeneration; mechanisms through which SARS-CoV-2 compromises brain barriers and propagates in the central nervous system (CNS).
• Research on genetic risk or protective factors that may alter cognitive function in older adults who have been afflicted with COVID-19.
• Neuropathological studies of COVID-19 and the contribution of brain tissue damage by SARS-CoV-2 to the morbidity and mortality of COVID-19 in older adults.     
• Drug discovery research and development of novel drugs, as well as re-purposing and repositioning existing drugs, for preventing and treating PASC in older adults, particularly drugs specific for COVID-19 related CNS targets and CNS mechanisms driving the viral-mediated pathophysiology, and research on blood-brain-barrier penetrant drug candidates to treat potential SARS-CoV-2 reservoirs in the CNS.
• Research to develop novel models for investigating concurrent aging and neurodegenerative processes in the context of SARS-CoV-2 infection.

Applications Not Responsive to this NOFO: 

Applications proposing the following will be considered non-responsive to this NOFO and will not be reviewed:

• Development of a therapeutic intervention.
• Testing the safety and/or tolerability of an intervention and/or demonstrating pharmacodynamic or neurodynamic effects to establish dosing.
• Demonstrating efficacy or effectiveness of an intervention.
• Exclusively qualitative research.
• Correlation of patient-reported symptoms and/or neuropsychological testing and neuroimaging that do not carry the potential to identify pathways for the development of treatments.
• Research targeting post-intensive care syndrome in which it is hard to distinguish what is due to PASC and what is due to critical illness.
• Research on SARS-CoV-2 virus and PASC unrelated to changes in mental and/or neurological health.
• Research focused solely on the acute phase of SARS-CoV-2 infection with no implications to PASC.
• Research of other virus or pathogens with no implications to SARS-CoV-2 infection or PASC.

See Section VIII. Other Information for award authorities and regulations.

Investigators proposing NIH-defined clinical trials may refer to the Research Methods Resources website for information about developing statistical methods and study designs.

Section II. Award Information

NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from this NOFO.

Section III. Eligibility Information

1. Eligible Applicants

Higher Education Institutions

• Public/State Controlled Institutions of Higher Education
• Private Institutions of Higher Education

The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:

• Hispanic-serving Institutions
• Historically Black Colleges and Universities (HBCUs)
• Tribally Controlled Colleges and Universities (TCCUs)
• Alaska Native and Native Hawaiian Serving Institutions
• Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)

Nonprofits Other Than Institutions of Higher Education

• Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
• Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)

For-Profit Organizations

• Small Businesses
• For-Profit Organizations (Other than Small Businesses)

Local Governments

• State Governments
• County Governments
• City or Township Governments
• Special District Governments
• Indian/Native American Tribal Governments (Federally Recognized)
• Indian/Native American Tribal Governments (Other than Federally Recognized)

Federal Government

• Eligible Agencies of the Federal Government
• U.S. Territory or Possession

Other

• Independent School Districts
• Public Housing Authorities/Indian Housing Authorities
• Native American Tribal Organizations (other than Federally recognized tribal governments)
• Faith-based or Community-based Organizations
• Regional Organizations

Collaborations among multiple investigators and key personnel with complementary expertise are encouraged.

Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.

Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.

Foreign components, as defined in the NIH Grants Policy Statement, are not allowed. 

Applicant Organizations

Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.

• System for Award Management (SAM) – Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
  • NATO Commercial and Government Entity (NCAGE) Code – Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.
  • Unique Entity Identifier (UEI) - A UEI is issued as part of the SAM.gov registration process. The same UEI must be used for all registrations, as well as on the grant application.
• eRA Commons - Once the unique organization identifier is established, organizations can register with eRA Commons in tandem with completing their Grants.gov registration; all registrations must be in place by time of submission. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
• Grants.gov – Applicants must have an active SAM registration in order to complete the Grants.gov registration.

Program Directors/Principal Investigators (PD(s)/PI(s))

All PD(s)/PI(s) must have an eRA Commons account. PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with their organization to develop an application for support. Individuals from diverse backgrounds, including underrepresented racial and ethnic groups, individuals with disabilities, and women are always encouraged to apply for NIH support. See, Reminder: Notice of NIH's Encouragement of Applications Supporting Individuals from Underrepresented Ethnic and Racial Groups as well as Individuals with Disabilities, NOT-OD-22-019.

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.

2. Cost Sharing

This NOFO does not require cost sharing as defined in the NIH Grants Policy Statement.

3. Additional Information on Eligibility

Number of Applications

Applicant organizations may submit more than one application, provided that each application is scientifically distinct.

The NIH will not accept duplicate or highly overlapping applications under review at the same time, per 2.3.7.4 Submission of Resubmission Application. This means that the NIH will not accept:

• A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.
• A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.
• An application that has substantial overlap with another application pending appeal of initial peer review (see 2.3.9.4 Similar, Essentially Identical, or Identical Applications)

Section IV. Application and Submission Information

1. Requesting an Application Package

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 NOFO. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in the Research (R) Instructions in the SF424 (R&R) Application Guide except where instructed in this notice of funding opportunity to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

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:

• Descriptive title of proposed activity
• Name(s), address(es), and telephone number(s) of the PD(s)/PI(s)
• Names of other key personnel
• Participating institution(s)
• Number and title of this funding opportunity

The letter of intent should be sent to:

Lumy Sawaki-Adams, MD, PhD
Telephone: 301-827-1457
Email: [email protected]

All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed.

The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an application to this NOFO.

All instructions in the SF424 (R&R) Application Guide must be followed.

All instructions in the SF424 (R&R) Application Guide must be followed.

All instructions in the SF424 (R&R) Application Guide must be followed.

All instructions in the SF424 (R&R) Application Guide must be followed.

R&R or Modular Budget

All instructions in the SF424 (R&R) Application Guide must be followed.

R&R Subaward Budget

All instructions in the SF424 (R&R) Application Guide must be followed.

All instructions in the SF424 (R&R) Application Guide must be followed.

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:

Significance: In addition to the topics outlined in the SF424 (R&R) Application Guide, describe how study of the proposed neuropathogenesis will advance the state of the art. Describe how understanding the proposed neuropathogenesis will contribute to the prevention and/or treatment of NeuroCOVID and/or NeuroPASC.

Investigator: In addition to the topics outlined in the SF424 (R&R) Application Guide, describe the expertise and/or experience of the PD/PI(s) demonstrating that s/he understands the current needs of patients with COVID-19, PASC and their related neurological complications. If proposing multi-PD/PI, describe how their expertise will be complementary and skills will be integrated in the context of NeuroCOVID and NeuroPASC as well as the leadership approach, governance, plans for conflict resolution, and organizational structure.

Innovation: In addition to the topics outlined in the SF424 (R&R) Application Guide, outline the unique nature of the proposed neuropathogenesis in the context of NeuroCOVID and NeuroPASC. Describe the pathways that can accelerate the translation to preventative measures and/or effective treatments.

Approach: In addition to the topics outlined in the SF424 (R&R) Application Guide, describe in detail the approach that will test the proposed neuropathogenesis in the context of NeuroCOVID and NeuroPASC. Outline how data will be obtained, analyzed, and interpreted with sufficient rigor to quantitatively assess project outcomes. Where appropriate, provide a strong and rigorous rationale for the design of neurologically-focused mechanistic clinical trials and describe how the design of projects considers potential sex and gender differences that may affect the questions asked and the analysis performed. Where appropriate, describe how the planned enrollment will appropriately represent the sex/gender, race, ethnicity and age of the population of individuals in the U.S. affected by COVID-19. Describe the use of the NIH Common Data Elements and, as applicable, other NIH resources to standardize the collection of clinical data. When appropriate, include a plan for stakeholder engagement.

Resource Sharing Plan:

Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R& R ) Application Guide.

Other Plan(s):

Note: Effective for due dates on or after January 25, 2023, the Data Management and Sharing Plan will be attached in the Other Plan(s) attachment in FORMS-H application forms packages.

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:

• All applicants planning research (funded or conducted in whole or in part by NIH) that results in the generation of scientific data are required to comply with the instructions for the Data Management and Sharing Plan. All applications, regardless of the amount of direct costs requested for any one year, must address a Data Management and Sharing Plan

Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

• No publications or other material, with the exception of blank questionnaires or blank surveys, may be included in the Appendix.

When involving human subjects research, clinical research, and/or NIH-defined clinical trials (and when applicable, clinical trials research experience) follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:

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.

Delayed Onset Study

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.

All instructions in the SF424 (R&R) Application Guide must be followed.

3. Unique Entity Identifier and System for Award Management (SAM)

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.

5. Intergovernmental Review (E.O. 12372)

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.

Important reminders:

All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile form. 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 NOFO for information on registration requirements.

The applicant organization must ensure that the unique entity identifier provided on the application is the same identifier 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 the appropriate IC. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.

Applicants are required to follow the instructions for post-submission materials, as described in the policy

Section V. Application Review Information

1. Criteria

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.

For this particular announcement, note the following:

The R21 exploratory/developmental grant supports investigation of novel scientific ideas or new model systems, tools, or technologies that have the potential for significant impact on biomedical or biobehavioral research. An R21 grant application need not have extensive background material or preliminary information. Accordingly, reviewers will emphasize the conceptual framework, the level of innovation, and the potential to significantly advance our knowledge or understanding. Appropriate justification for the proposed work can be provided through literature citations, data from other sources, or, when available, from investigator-generated data. Preliminary data are not required for R21 applications; however, they may be included if available.

A proposed Clinical Trial application may include study design, methods, and intervention that are not by themselves innovative but address important questions or unmet needs. Additionally, the results of the clinical trial may indicate that further clinical development of the intervention is unwarranted or lead to new avenues of scientific investigation.

Overall Impact

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).

Scored Review Criteria

Reviewers will consider each of the review criteria below in the determination of scientific merit and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.

Significance

Does the project address an important problem or a critical barrier to progress in the field? 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?

In addition, for applications involving clinical trials

Are the scientific rationale and need for a clinical trial to test the proposed hypothesis or intervention well supported by preliminary data, clinical and/or preclinical studies, or information in the literature or knowledge of biological mechanisms? For trials focusing on clinical or public health endpoints, is this clinical trial necessary for testing the safety, efficacy or effectiveness of an intervention that could lead to a change in clinical practice, community behaviors or health care policy? For trials focusing on mechanistic, behavioral, physiological, biochemical, or other biomedical endpoints, is this trial needed to advance scientific understanding?

Specific to this NOFO:

How well will the proposed study of pathobiology underlying COVID-19, PASC-related neurological complications or the effects on pre-existing neurologic conditions open new avenues for novel preventatives or treatments? How well will the proposed study advance the current state of the art for neuro-COVID and neuro-PASC?  

Investigator(s)

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?

In addition, for applications involving clinical trials

With regard to the proposed leadership for the project, do the PD/PI(s) and key personnel have the expertise, experience, and ability to organize, manage and implement the proposed clinical trial and meet milestones and timelines? Do they have appropriate expertise in study coordination, data management and statistics? For a multicenter trial, is the organizational structure appropriate and does the application identify a core of potential center investigators and staffing for a coordinating center?

Specific to this NOFO:

       Evaluate whether the key personnel have in-depth knowledge of the current needs of patients with COVID-19, PASC and their related neurological complications. 

Innovation

Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?

In addition, for applications involving clinical trials

Does the design/research plan include innovative elements, as appropriate, that enhance its sensitivity, potential for information or potential to advance scientific knowledge or clinical practice?

Specific to this NOFO:

How well does the   application describe and test novel neuropathogenesis in the context of neuro-COVID and/or neuro-PASC? How well does the study identify or explore scientifically compelling pathways that can ultimately accelerate translation to preventative measures and/or effective treatments?

Approach

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?

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?

In addition, for applications involving clinical trials

Does the application adequately address the following, if applicable

Study Design

Is the study design justified and appropriate to address primary and secondary outcome variable(s)/endpoints that will be clear, informative and relevant to the hypothesis being tested? Is the scientific rationale/premise of the study based on previously well-designed preclinical and/or clinical research? Given the methods used to assign participants and deliver interventions, is the study design adequately powered to answer the research question(s), test the proposed hypothesis/hypotheses, and provide interpretable results? Is the trial appropriately designed to conduct the research efficiently? Are the study populations (size, gender, age, demographic group), proposed intervention arms/dose, and duration of the trial, appropriate and well justified?

Are potential ethical issues adequately addressed? Is the process for obtaining informed consent or assent appropriate? Is the eligible population available? Are the plans for recruitment outreach, enrollment, retention, handling dropouts, missed visits, and losses to follow-up appropriate to ensure robust data collection? Are the planned recruitment timelines feasible and is the plan to monitor accrual adequate? Has the need for randomization (or not), masking (if appropriate), controls, and inclusion/exclusion criteria been addressed? Are differences addressed, if applicable, in the intervention effect due to sex/gender and race/ethnicity?

Are the plans to standardize, assure quality of, and monitor adherence to, the trial protocol and data collection or distribution guidelines appropriate? Is there a plan to obtain required study agent(s)? Does the application propose to use existing available resources, as applicable?

Data Management and Statistical Analysis

Are planned analyses and statistical approach appropriate for the proposed study design and methods used to assign participants and deliver interventions? Are the procedures for data management and quality control of data adequate at clinical site(s) or at center laboratories, as applicable? Have the methods for standardization of procedures for data management to assess the effect of the intervention and quality control been addressed? Is there a plan to complete data analysis within the proposed period of the award?

Specific to this NOFO:

How well described are the details of the neuropathogenesis in the context of neuro-COVID and neuro-PASC? How well proposed are the planned data collection, analysis, and statistical approach to fit the  study design? How well described are the methods for standardization for data collection and quality control?  If applicable, how strong and rigorous are the rationale for design of neurologically-focused mechanistic clinical trials? How well does the application take into consideration the potential of sex and gender differences for the analysis performed (if applicable)? How well described is the planned enrollment to ensure appropriate representation of the population affected by COVID-19 (if applicable)? How well described are the Common Data Elements? How well described is the plan for stakeholder engagement (If applicable)? 

Environment

Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment, and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?

In addition, for applications involving clinical trials

If proposed, are the administrative, data coordinating, enrollment and laboratory/testing centers, appropriate for the trial proposed?

Does the application adequately address the capability and ability to conduct the trial at the proposed site(s) or centers? Are the plans to add or drop enrollment centers, as needed, appropriate?

If international site(s) is/are proposed, does the application adequately address the complexity of executing the clinical trial?

If multi-sites/centers, is there evidence of the ability of the individual site or center to: (1) enroll the proposed numbers; (2) adhere to the protocol; (3) collect and transmit data in an accurate and timely fashion; and, (4) operate within the proposed organizational structure?

Additional Review Criteria

As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items.

Study Timeline

Specific to applications involving clinical trials

Is the study timeline described in detail, taking into account start-up activities, the anticipated rate of enrollment, and planned follow-up assessment? Is the projected timeline feasible and well justified? Does the project incorporate efficiencies and utilize existing resources (e.g., CTSAs, practice-based research networks, electronic medical records, administrative database, or patient registries) to increase the efficiency of participant enrollment and data collection, as appropriate?

Are potential challenges and corresponding solutions discussed (e.g., strategies that can be implemented in the event of enrollment shortfalls)?

Protections for Human Subjects

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.

Inclusion of Women, Minorities, and 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.

Vertebrate Animals

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 Animals Section.

Biohazards

Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.

Resubmissions

For Resubmissions, the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.

Renewals

Not Applicable.

Revisions

Not Applicable.

As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact score.

Applications from Foreign Organizations

Not Applicable.

Select Agent Research

Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).

Resource Sharing Plans

Reviewers will comment on whether the Resource Sharing Plan(s) (i.e., Sharing Model Organisms) or the rationale for not sharing the resources, is reasonable.

Authentication of Key Biological and/or Chemical Resources:

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.

Budget and Period of Support

Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by the Center for Scientific Review (CSR), in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.

As part of the scientific peer review, all applications will receive a written critique.

Applications may undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review) will be discussed and assigned an overall impact score.

Appeals of initial peer review will not be accepted for applications submitted in response to this NOFO.

Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this NOFO. Following initial peer review, recommended applications will receive a second level of review by the appropriate national Advisory Council or Board. The following will be considered in making funding decisions:

• Scientific and technical merit of the proposed project as determined by scientific peer review.
• Availability of funds.
• Relevance of the proposed project to program priorities.

3. Anticipated Announcement and Award Dates

After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons. Refer to Part 1 for dates for peer review, advisory council review, and earliest start date.

Information regarding the disposition of applications is available in the NIH Grants Policy Statement.

Section VI. Award Administration Information

1. Award Notices

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement.

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the recipient's business official.

Recipients must comply with any funding restrictions described in Section IV.6. 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 NOFO 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.

Individual awards are based on the application submitted to, and as approved by, the NIH and are subject to the IC-specific terms and conditions identified in the NoA.

ClinicalTrials.gov: If an award provides for one or more clinical trials. By law (Title VIII, Section 801 of Public Law 110-85), the "responsible party" must register and submit results information for certain “applicable clinical trials” on the ClinicalTrials.gov Protocol Registration and Results System Information Website (https://register.clinicaltrials.gov). NIH expects registration and results reporting of all trials whether required under the law or not. For more information, see https://grants.nih.gov/policy/clinical-trials/reporting/index.htm

Institutional Review Board or Independent Ethics Committee Approval: Recipient institutions must ensure that all protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in NIH-funded studies, the recipient must provide NIH copies of documents related to all major changes in the status of ongoing protocols.

Data and Safety Monitoring Requirements: The NIH policy for data and safety monitoring requires oversight and monitoring of all NIH-conducted or -supported human biomedical and behavioral intervention studies (clinical trials) to ensure the safety of participants and the validity and integrity of the data. Further information concerning these requirements is found at http://grants.nih.gov/grants/policy/hs/data_safety.htm and in the application instructions (SF424 (R&R) and PHS 398).

Investigational New Drug or Investigational Device Exemption Requirements: Consistent with federal regulations, clinical research projects involving the use of investigational therapeutics, vaccines, or other medical interventions (including licensed products and devices for a purpose other than that for which they were licensed) in humans under a research protocol must be performed under a Food and Drug Administration (FDA) investigational new drug (IND) or investigational device exemption (IDE).

2. Administrative and National Policy Requirements

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Recipients, and Activities, including of note, but not limited to:

• Federal wide Research Terms and Conditions
• Prohibition on Certain Telecommunications and Video Surveillance Services or Equipment
• Acknowledgment of Federal Funding

If a recipient is successful and receives a Notice of Award, in accepting the award, the recipient agrees that any activities under the award are subject to all provisions currently in effect or implemented during the period of the award, other Department regulations and policies in effect at the time of the award, and applicable statutory provisions.

Should the applicant organization successfully compete for an award, recipients of federal financial assistance (FFA) from HHS will be required to complete an HHS Assurance of Compliance form (HHS 690) in which the recipient agrees, as a condition of receiving the grant, to administer programs in compliance with federal civil rights laws that prohibit discrimination on the basis of race, color, national origin, age, sex and disability, and agreeing to comply with federal conscience laws, where applicable. This includes ensuring that entities take meaningful steps to provide meaningful access to persons with limited English proficiency; and ensuring effective communication with persons with disabilities. Where applicable, Title XI and Section 1557 prohibit discrimination on the basis of sexual orientation, and gender identity, The HHS Office for Civil Rights provides guidance on complying with civil rights laws enforced by HHS. See https://www.hhs.gov/civil-rights/for-providers/provider-obligations/index.html and https://www.hhs.gov/civil-rights/for-individuals/nondiscrimination/index.html.

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. 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 NOFO.

• For guidance on meeting the legal obligation to take reasonable steps to ensure meaningful access to programs or activities by limited English proficient individuals see https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/fact-sheet-guidance/index.html and https://www.lep.gov.

• For information on an institution’s specific legal obligations for serving qualified individuals with disabilities, including providing program access, reasonable modifications, and to provide effective communication, see https://www.hhs.gov/civil-rights/for-individuals/disability/index.html.

• HHS funded health and education programs must be administered in an environment free of sexual harassment, see https://www.hhs.gov/civil-rights/for-individuals/sex-discrimination/index.html. For information about NIH's commitment to supporting a safe and respectful work environment, who to contact with questions or concerns, and what NIH's expectations are for institutions and the individuals supported on NIH-funded awards, please see https://grants.nih.gov/grants/policy/harassment.htm.

• For guidance on administering programs in compliance with applicable federal religious nondiscrimination laws and applicable federal conscience protection and associated anti-discrimination laws see https://www.hhs.gov/conscience/conscience-protections/index.html and https://www.hhs.gov/conscience/religious-freedom/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.

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 and 2 CFR Part 200.206 “Federal awarding agency review of risk posed by applicants.” This provision will apply to all NIH grants and cooperative agreements except fellowships.”

Not Applicable

3. Data Management and Sharing

Note: The NIH Policy for Data Management and Sharing is effective for due dates on or after January 25, 2023.

Consistent with the NIH Policy for Data Management and Sharing, when data management and sharing is applicable to the award, recipients will be required to adhere to the Data Management and Sharing requirements as outlined in the NIH Grants Policy Statement. Upon the approval of a Data Management and Sharing Plan, it is required for recipients to implement the plan as described.

4. Reporting

When multiple years are involved, recipients will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement.

A final RPPR, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement. NIH NOFOs outline intended research goals and objectives. Post award, NIH will review and measure performance based on the details and outcomes that are shared within the RPPR, as described at 45 CFR Part 75.301 and 2 CFR Part 200.301.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for recipients of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All recipients 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.

Section VII. Agency Contacts

We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.

eRA Service Desk (Questions regarding ASSIST, eRA Commons, application errors and warnings, documenting system problems that threaten submission by the due date, and post-submission issues)

Finding Help Online: https://www.era.nih.gov/need-help (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: [email protected] (preferred method of contact)
Telephone: 301-480-7075

Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email: [email protected]

Lumy Sawaki-Adams, MD, PhD
National Institute of Neurological Disorders and Stroke (NINDS)
Telephone: 301-827-1457
Email: [email protected]

Barbara Karp, MD
National Institute of Neurological Disorders and Stroke (NINDS)
Telephone: 240-461-5127
Email: [email protected]

Luci Roberts, PhD
National Institute of Aging (NIA)
Telephone: 301-496-9350
Email: [email protected]

Collene Lawhorn, Ph.D.
National Institute of Mental Health (NIMH)
Telephone: 301-451-4262
Email: [email protected]

Center for Scientific Review (CSR)
Email: [email protected]

Chief Grants Management Officer
National Institute of Neurological Disorders and Stroke (NINDS)
Email: [email protected]

Kathleen Moy
National Institute on Aging (NIA)
Phone: 301.827.2856
E-mail: [email protected]

Rita Sisco
National Institute of Mental Health (NIMH)
Telephone: 301-443-2805
Email: [email protected]

Section VIII. Other Information

Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Part 75 and 2 CFR Part 200.