National Institutes of Health (NIH)
National Institute on Aging (NIA)
R01 Research Project Grant
See Notices of Special Interest associated with this funding opportunity
NOT-OD-23-012 Reminder: FORMS-H Grant Application Forms and Instructions Must be Used for Due Dates On or After January 25, 2023 - New Grant Application Instructions Now Available
NOT-OD-22-190 - Adjustments to NIH and AHRQ Grant Application Due Dates Between September 22 and September 30, 2022
The purpose of this Funding Opportunity Announcement (FOA) is to 1) invite applications that propose to develop and implement early to late stage clinical trials of promising pharmacological and non-pharmacological interventions for cognitive and neuropsychiatric changes associated with age-related cognitive decline and Alzheimer's disease (AD) and Alzheimer's disease-related Dementias (ADRD) across the spectrum from pre-symptomatic to more severe stages of disease, and 2) stimulate studies to enhance trial design and methods.
Not Applicable
| Application Due Dates | Review and Award Cycles | ||||
|---|---|---|---|---|---|
| New | Renewal / Resubmission / Revision (as allowed) | AIDS | Scientific Merit Review | Advisory Council Review | Earliest Start Date |
| March 04, 2022 | March 04, 2022 | Not Applicable | July 2022 | October 2022 | December 2022 |
| June 05, 2022 * | July 05, 2022 * | Not Applicable | November 2022 | January 2023 | April 2023 |
| October 05, 2022 * | November 05, 2022 * | Not Applicable | March 2023 | May 2023 | July 2023 |
| February 05, 2023 * | March 05, 2023 * | Not Applicable | July 2023 | October 2023 | December 2023 |
| June 05, 2023 * | July 05, 2023 * | Not Applicable | November 2023 | January 2024 | April 2024 |
| October 05, 2023 * | November 05, 2023 * | Not Applicable | March 2024 | May 2024 | July 2024 |
| February 05, 2024 * | March 05, 2024 * | Not Applicable | July 2024 | October 2024 | December 2024 |
| June 05, 2024 * | July 05, 2024 * | Not Applicable | November 2024 | January 2025 | April 2025 |
| October 05, 2024 * | November 05, 2024 * | Not Applicable | March 2025 | May 2025 | July 2025 |
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.
Not Applicable
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 FOA or in a Notice from NIH Guide for Grants and Contracts ).
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.
Background
The biggest risk factor for Alzheimer's disease (AD) is age, and AD is the most common cause of dementia in those aged 65 and older. Because of the aging of populations worldwide, this disorder, as well as AD-related dementias (ADRD), will reach epidemic proportions even in best-case scenarios, with an enormous human and economic burden. Dementia is one of the most persistent and devastating neurodegenerative diseases because it eventually leads to widespread brain and neuropsychological dysfunction, and the loss of the ability to interact with others and to function independently. It is estimated that over six million people in the United States have AD in its various stages, at an estimated cost to society of over $355 billion in 2021. It is projected that more than 13 million people and their families could be affected by AD by the middle of this century if no effective therapies are developed to prevent, slow, or arrest the progression of the disease.
Most older adults will experience some deterioration in cognitive function as they age. This age-related cognitive decline may presage AD or other neurodegenerative disorders, but even when it does not, it can have substantial impact on quality of life, character of personal relationships, and the capacity for making informed decisions about health care, retirement, and other issues faced daily by millions of adults.
Currently there are few interventions that have been approved by the Food and Drug Administration for the treatment of AD, and the approved treatments have only modest effects. The Alzheimer's Association's 2015 trajectory report estimated that a treatment delaying onset by five years, and beginning to show its effect in 2025, would decrease the total number of older Americans with Alzheimer's from 8.2 million to 5.8 million in 2030. Moreover, a treatment that had no effect on age of onset but only slowed disease progression would result in many fewer people living with AD/ADRD in its most advanced stages, which requires the highest level of care and incurs the greatest costs.
In response to this looming public health crisis in the United States and worldwide, a growing number of countries are increasing their investment in all aspects of AD research. On January 4, 2011, President Obama signed into law the National Alzheimer's Project Act (NAPA). As part of the Strategic Planning Process for the implementation of the National Alzheimer's Project Act, the National Institute on Aging (NIA) at the NIH, with support from the Foundation for the NIH (FNIH), organized and hosted three Alzheimer's Disease Research Summits entitled "Path to Treatment and Prevention," which were held in 2012, 2015, and 2018. The overarching goal of the summits was to formulate a strategy for a new integrated, multidisciplinary research agenda to enable the development of effective therapies (both disease-modifying and palliative) across the disease continuum for the cognitive as well as neuropsychiatric symptoms of Alzheimer's disease and to identify the resources, infrastructure, and public/private partnerships necessary to successfully implement this translational agenda.This Funding Opportunity Announcement (FOA) is consistent with the recommendations of the 2012, 2015, and 2018 AD research summits. Maintenance of cognitive health with age is also a growing public health imperative. The 2017 Cognitive Aging Summit III, held by the NIA in conjunction with the McKnight Brain Research Foundation (MBRF) and the Foundation for NIH (FNIH), included a focus on strategies to preserve and bolster cognitive function during aging. .
.
Research Objectives
This FOA invites research grant applications that enable the early- to late-stage testing of promising pharmacological and non-pharmacological interventions that target deleterious cognitive and neuropsychiatric changes associated with age-related cognitive decline and AD/ADRD across the spectrum from pre-symptomatic to more severe stages of disease.
A recent evidence review conducted by the Agency for Healthcare Research and Quality (AHRQ) on Care Interventions for People Living With Dementia and Their Caregivers underscored the need for rigorous, well-powered, replicable research addressing issues of intervention fidelity and efficacy, as well as potential intervention mechanisms. While this review was limited to dementia care and caregiver interventions, the issues identified have relevance to all non-pharmacological (including behavioral and social) clinical trials addressing issues related to AD care, treatment, and prevention. Two issues that were highlighted in the AHRQ report were the need to identify how and why interventions work (i.e., the mechanism of action of non-pharmacological (e.g. behavioral) interventions), and the need to ensure that complex interventions can be delivered with fidelity in real world settings. The NIH Stage Model is a conceptual framework for intervention development that directly addresses these two issues by: 1) offering a mechanisms-focused framework to intervention development and testing, with the goal of producing interventions defined by their principles and; 2) addressing issues related to ultimate implementation, such as determining ways to ensure that interventions can be delivered in the community with fidelity.
Early stage clinical trials of pharmacological interventions (Phase I/Phase II) and trials of non-pharmacological interventions (Stage I - III)
This FOA supports 1) early stage clinical testing of promising pharmacological and non-pharmacological interventions for cognitive and neuropsychiatric changes associated with age-related cognitive decline and AD/ADRD across the spectrum from pre-symptomatic to more severe stages of disease, and 2) studies to enhance trial design and methods. Investigators will be expected to collect DNA and other biosamples from these studies to enable subsequent interrogation of treatment responsiveness, as well as examination of predictors of decline in the groups receiving placebo.
This FOA encourages clinical trial applications including, but not limited to, the following focus areas:
-
- Studies to refine the intervention strategy. These studies could include work to determine appropriate dosage of drugs, duration of treatment, and the delivery system. For non-pharmacological interventions, such work might examine the intensity or duration of therapy required. This can also include modifying an intervention (consistent with its principles) to make it more scalable, and testing it to determine if it retains its potency. This can also include the modification and testing of interventions shown to be efficacious in a non-AD/ADRD population, for an AD/ADRD population. For all interventions, the potential synergistic effects of combined interventions could be explored.
- Studies to evaluate the safety and/or efficacy of the intervention(s).
- Studies that elucidate mechanism of action. In some cases, there may be interventions that have some level of demonstrated efficacy (e.g., exercise for age-related cognitive decline), but lack a real understanding of the mechanism of action. Work in this area could use a variety of approaches appropriate to the intervention in order to elucidate the mechanism of action, which could allow both the confirmation of engagement of the intervention target and the potential to optimize the intervention.
- Studies to define and refine the target population and ensure adequate enrollment, protocol adherence, and subject retention.
- Studies that address heterogeneity of response. This would include the identification of specific individuals according to genetic profiles, behavioral factors, and/or sociocultural or demographic factors who are more likely or less likely to benefit from the intervention(s). Mediators of the therapeutic intervention, such as continued educational opportunities and continued engagement in driving or financial decision-making, may facilitate real-life function and should be considered.
- Studies to establish/validate trial outcome measures. These measures may include clinical/neuropsychological/behavioral measures, neuroimaging measures, and other biological measures in blood and cerebrospinal fluid.
Examples of interventions for evaluation that are appropriate for this FOA include, but are not limited to, the following:
-
- Pharmacological interventions (small molecules/biologics) that target eradication or progression of disease;
- Pharmacological interventions (small molecules/biologics) that target disease symptomatology including neuropsychiatric symptoms;
- Repurposed drugs that have promise for AD/ADRD treatment such as chemotherapeutic agents or drugs for insulin dysregulation/diabetes;
- Neuromodulation;
- Assistive technology interventions;
- Novel cognitive training or cognitive engagement approaches;
- Aerobic exercise and/or other movement therapies, such as Tai Chi;
- Sleep enhancement;
- Mindfulness-based stress reduction;
- Nutritional supplementation or adoption of specific dietary programs; and/or
- Combinations of interventions including the mixture of pharmacological with non-pharmacological therapeutics.
For studies focused on behavioral adherence to lifestyle interventions, please see the following FOAs: RFA-AG-22-016; PAR-21-207.
Late stage clinical trials of pharmacological interventions (Phase II/III and III) and trials of non-pharmacological interventions (Stage IV):
This FOA supports pivotal late stage clinical trials testing pharmacological (small molecules and biologics) and non-pharmacological interventions, using a combination of biomarkers (fluid and imaging), cognitive measures, and functional measures as outcomes. These applications may include trials testing combinations of interventions that may act synergistically to produce a more robust and long-lasting response, as well as combinations of interventions that attempt to address multiple risk factors simultaneously (e.g., obesity, hypertension, diabetes, physical inactivity, anxiety, and depression). Investigators will be expected to collect DNA and other biosamples from these studies to enable subsequent interrogation of treatment responsiveness, as well as examination of predictors of decline in the groups receiving placebo.
Late stage pharmacological clinical trial applications that are appropriate for this FOA will have established proof of mechanism or target engagement at earlier stages of clinical development for the intervention(s) being tested. The intervention(s) being tested in late stage trials should also have adequate safety data for the populations under study. Late stage non-pharmacological clinical trial applications will have also established that there are tested and validated procedures in place to ensure that the intervention can be delivered with fidelity to its principles (mechanisms of action) by real world practitioners.
Studies designed to address heterogeneity of response are strongly encouraged. This would include the identification of specific individuals according to genetic profiles, behavioral factors, and/or sociocultural or demographic factors who are more likely or less likely to benefit from the intervention(s). Potential mediators of the therapeutic intervention, such as continued educational opportunities, social network exposure and engagement, and continued engagement in driving or financial decision-making, may facilitate effective real-life function and should be considered in interpreting therapeutic outcomes.
Examples of interventions for evaluation that are appropriate for this FOA include, but are not limited to, the following:
-
- Pharmacological interventions (small molecules/biologics) that target eradication or progression of disease;
- Pharmacological interventions (small molecules/biologics) that target disease symptomatology including neuropsychiatric symptoms;
- Repurposed drugs that have promise for AD/ADRD treatment such as chemotherapeutic agents or drugs for insulin dysregulation/diabetes;
- Neuromodulation;
- Assistive technology interventions;
- Novel cognitive training or cognitive engagement approaches;
- Aerobic exercise and/or other movement therapies, such as Tai Chi;
- Sleep enhancement;
- Mindfulness-based stress reduction;
- Nutritional supplementation or adoption of specific dietary programs; and/or
- Combinations of interventions including the mixture of pharmacological with non-pharmacological therapeutics, as well as combinations of non-pharmacological interventions.
Design, Analysis, and Sample Size for Studies to Evaluate Group-Based Interventions: Investigators who wish to evaluate the effect of an intervention on a health-related biomedical or behavioral outcome may propose a study in which (1) groups or clusters are assigned to study arms and individual observations are analyzed to evaluate the effect of the intervention, or (2) participants are assigned individually to study arms but receive at least some of their intervention in a real or virtual group or through a shared facilitator. Such studies may propose a parallel group- or cluster-randomized trial, an individually randomized group-treatment trial, a stepped-wedge design, or a quasi-experimental version of one of these designs. In these studies, special methods may be warranted for analysis and sample size estimation. Applicants should show that their methods are appropriate given their plans for assignment of participants and delivery of interventions. Additional information is available at https://researchmethodsresources.nih.gov/.
The National Institute on Aging (NIA) supports a central resource to NIA staff and extramural investigators to facilitate/support the conduct and management of clinical research. This resource, the Clinical Research Operations Management System (CROMS), is a comprehensive data management system to support the business functions, management, and oversight responsibilities of NIA grants that support the conduct of clinical research with human subjects. It is NIA’s policy that all successful applicants will interface, integrate, or adapt their information system(s) and processes to interact with existing and future components of the CROMS as necessary, including the use of CROMS data templates as specified.
See Section VIII. Other Information for award authorities and regulations.
Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.
Renewal
Resubmission
Revision
The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types. Only those application types listed here are allowed for this FOA.
Optional: Accepting applications that either propose or do not propose clinical trial(s).
Need help determining whether you are doing a clinical trial?
The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications.
The scope of the proposed project should determine the project period. The maximum project period is 5 years.
NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from this FOA.
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
- Non-domestic (non-U.S.) Entities (Foreign Institutions)
Non-domestic (non-U.S.) Entities (Foreign Institutions) are eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply.
Foreign components, as defined in the NIH Grants Policy Statement, are 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. SAM registrations prior to fall 2021 were updated to include a UEI. For applications due on or after January 25, 2022, the UEI must be provided on the application forms (e.g., FORMS-G); the same UEI must be used for all registrations, as well as on the grant application.
- Dun and Bradstreet Universal Numbering System (DUNS) Organization registrations prior to April 2022 require applicants to obtain a DUNS prior to registering in SAM. By April 2022, the federal government will stop using the DUNS number as an entity identifier and will transition to the Unique Entity Identifier (UEI) issued by SAM. Prior to April 2022, after obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.
- eRA Commons - Once the unique organization identifier (DUNS prior to April 2022; UEI after April 2022) is established, organizations can register with eRA Commons in tandem with completing their full SAM and Grants.gov registrations; 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 his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.
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 FOA does not require cost sharing as defined in the NIH Grants Policy Statement.
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)
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 FOA. 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 funding opportunity announcement 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.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 FOA.
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.
For applications proposing clinical trials, members of the investigative team should have an appropriate level of experience in the conduct of clinical trials, including the collection and storage of biosamples, and data analysis.
R&R or Modular 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.
All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:
Research Strategy:
For Early Stage Clinical Trials
Pharmacological Interventions
This FOA encourages the submission of applications for the clinical testing of novel candidate therapeutics (small molecule and biologics), as well as for repurposed drugs. Investigators are strongly encouraged to incorporate pharmacodynamic biomarkers in the design. Investigators are also expected to collect and store blood and other biosamples for future genomic and other 'omic' analyses aimed at interrogating treatment responsiveness and examining predictors of decline and progression. Additional guidance for this section is provided below, based on the clinical trial phase.
Phase I pharmacological clinical trials
Applications for therapeutic agents against known target(s) are expected to include information on the mechanism of action for the therapeutic agent, information regarding the target's role in disease pathogenesis and clinical relevance of the target, and information on the predicted optimal disease stage (e.g. pre-symptomatic, Mild Cognitive Impairment, mild, moderate or severe AD) to engage the target from preclinical development studies. Applicants proposing a multi-target therapeutic should summarize the available information on the pathogenic pathways that the agent engages and provide a strong clinically-relevant rationale for this approach.
If the molecular target of the therapeutic agent is not known, applications should summarize what is known about the agent's mechanism of action and whether the agent engages a disease-relevant pathophysiological process.
Finally, applications should contain a plan for future clinical development of the therapeutic agent, including details about the clinical indication (disease stage, target population), plan for use of biomarkers in the course of further clinical development (i.e., biomarkers for target engagement, responsiveness to treatment, and/or tracking of disease progression), and a clinical development timeline.
Phase II pharmacological clinical trials
Applications for Phase II clinical trials could be designed as proof of mechanism/target engagement/proof of concept studies. Applicants should also provide evidence of safety from earlier phase clinical trials and should include further evaluation of safety in the trial design. Finally, applications should contain a plan for future clinical development, i.e., later stage trials, if a positive signal were to be identified.
Early stage non-pharmacological interventions
This FOA encourages the submission of applications for the testing of novel non-pharmacological interventions,. Applications for clinical trials should include information on proof of mechanism for the intervention(s) being tested. The study design should align with the NIH Stage Model framework. Applications for clinical trials should also contain a plan for future clinical development, i.e., later stage trials, should a positive signal be identified. Investigators are encouraged to collect and store blood and other biosamples for future genomic and other 'omic' analyses aimed at interrogating treatment responsiveness and examining predictors of decline and progression.
For Late Stage Clinical Trials:
Phase II/III and phase III pharmacological clinical trials
Applications for late stage pharmacological clinical trials that are appropriate for this FOA will have established proof of mechanism or target engagement at earlier stages of clinical development for the intervention(s) being tested. The intervention(s) being tested in late stage clinical trials should also have adequate safety data for the populations under study. Investigators will be expected to collect DNA and other biosamples from these studies to enable subsequent interrogation of treatment responsiveness, as well as examination of predictors of decline in the groups receiving placebo.
Late stage non-pharmacological interventions
All applications for late stage non-pharmacological clinical trialsthat are appropriate for this FOA will have an established demonstration of efficacy. The intervention(s) being tested in late stage trials should also have adequate safety data for the populations under study. The study design should also align with the NIH Stage Model framework.
Late stage non-pharmacological clinical trial applications will have also established that there are tested and validated procedures in place to ensure that the intervention can be delivered with fidelity to its principles (mechanisms of action) by real world practitioners.
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.
-
For Early Stage Clinical Trials:
-
- All applications for early-stage clinical trials, regardless of the amount of direct costs requested for any one year, must address a Data Sharing Plan. Sharing of clinical trial data (participant level and summary level data, raw and processed) and biosamples is expected at the time of publication of the primary results or within 9 months of database lock, whichever comes first. The data sharing plan must address which data and biosamples will be shared, where data and biosamples will be stored, and how approved parties will access these resources. NOT-OD-21-015 provides guidance regarding allowable costs associated with data management and sharing. The data sharing plan must also specify where the data will be stored. Appropriate data repositories can be publicly supported or can be hosted by the home institution. Examples of NIA supported public repositories include The Alzheimer's Clinical Trials Consortium (ACTC) and The National Centralized Repository for Alzheimer's Disease and Related Dementias (NCRAD).
For Late Stage Clinical Trials:
-
- All applications, regardless of the amount of direct costs requested for any one year, must address a Data Sharing Plan. Generally, sharing of clinical trial data (participant level and summary level data, raw and processed) and biosamples is expected at the time of publication of the primary results or within 9 months of database lock, whichever comes first. For late-stage pivotal trials, post-randomization trial data and biosamples must be shared after the earlier of either regulatory approval of the tested treatment or 18 months after the completion or early termination of the trial per the Collaboration for Alzheimer's Prevention (CAP) data and sample sharing principles. Additionally, per CAP principles, late-stage trials must make screening and pre-randomization baseline data available to the scientific community within 12 months of enrollment completion. Moreover, emerging data from ongoing late-stage prevention trials must be made available as soon as possible without compromising trial integrity. The data sharing plan must address which data and biosamples will be shared, where data and biosamples will be stored, and how approved parties will access these resources. NOT-OD-21-015 provides guidance regarding allowable costs associated with data management and sharing. The data sharing plan must also specify where the data will be stored. Appropriate data repositories can be publicly supported or can be hosted by the home institution. Examples of NIA supported public repositories include The Alzheimer's Clinical Trials Consortium (ACTC) and The National Centralized Repository for Alzheimer's Disease and Related Dementias (NCRAD).
-
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.
Foreign Institutions
Foreign (non-U.S.) institutions must follow policies described in the NIH Grants Policy Statement, and procedures for foreign institutions described throughout the SF424 (R&R) Application Guide.
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 fieldof 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 FOA for information on registration requirements.
The applicant organization must ensure that the unique entity identifier (DUNS number or UEI as required) provided 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, NIH. Applications that are incomplete or non-compliant will not be reviewed.
Requests of $500,000 or more for direct costs in any year
Applicants requesting $500,000 or more in direct costs in any year (excluding consortium F&A) must contact a Scientific/ Research Contact at least 6 weeks before submitting the application and follow the Policy on the Acceptance for Review of Unsolicited Applications that Request $500,000 or More in Direct Costs as described in the SF424 (R&R) Application Guide.
Applicants are required to follow the instructions for post-submission materials, as described in the policy. Any instructions provided here are in addition to the instructions in the policy.
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.
In addition, for applications involving clinical trials: 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.
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?
Does the therapeutic target/mechanism of action for the intervention engage a disease-relevant pathophysiological process or processes? Will the intervention presented help overcome the critical barriers to progress in Alzheimer's clinical trials?
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?
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?
Does the investigator(s) have the experience/knowledge to plan the future clinical development, i.e., later stage trials, if a positive signal were to be identified?
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?
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?
Is the intervention novel for a clinical trial in Alzheimer's disease and related dementias; age-related cognitive decline? Is the proposed therapeutic target/mechanism of action novel or is the clinical indication (disease stage, target population) novel?
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?
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?
Are the mechanisms of action for the intervention included and well presented in regard to the target and the target's role in disease pathogenesis and clinical relevance of the target? Is there adequate information on the predicted optimal disease stage (pre-symptomatic, Mild Cognitive Impairments, mild, moderate, or severe AD/ADRD)? If there is a multi-target therapeutic approach, is it well justified and clinically-relevant in rationale? Is the future clinical development of the therapeutic agent discussed and is there potential? Is there evidence of safety? Are the pharmacodynamic biomarkers well-reasoned and appropriate to evaluate the success of the intervention? Will the investigator collect biosamples?
How adequate are the applicants' Data Sharing Plans?
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?
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?
Is the proposed trial population readily available and are there adequate resources for recruitment and retention? Will the project have the resources to collect and store blood and other biosamples?
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 Animal 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
For Renewals, the committee will consider the progress made in the last funding period.
Revisions
For Revisions, the committee will consider the appropriateness of the proposed expansion of the scope of the project. If the Revision application relates to a specific line of investigation presented in the original application that was not recommended for approval by the committee, then the committee will consider whether the responses to comments from the previous scientific review group are adequate and whether substantial changes are clearly evident.
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
Reviewers will assess whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions that exist in other countries and either are not readily available in the United States or augment existing U.S. resources.
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 following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: (1) Sharing Model Organisms; and (2) Genomic Data Sharing Plan (GDS).
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, 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.
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. 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.
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.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.
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:
- Federalwide 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 must administer their programs in compliance with federal civil rights laws that prohibit discrimination on the basis of race, color, national origin, disability, age and, in some circumstances, religion, conscience, and sex (including gender identify, sexual orientation, and pregnancy). This includes ensuring programs are accessible to persons with limited English proficiency and persons with disabilities. The HHS Office for Civil Rights provides guidance on complying with civil rights laws enforced by HHS. Please 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 FOA.
- Recipients of FFA must ensure that their programs are accessible to persons with limited English proficiency. 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 reasonable accommodations and making services accessible to them, see http://www.hhs.gov/ocr/civilrights/understanding/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 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. 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 FOAs 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.
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: 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)
Telephone: 301-637-3015
Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email: support@grants.gov
Laurie Ryan
National Institute on Aging (NIA)
Telephone: 301-496-9350
Email: ryanl@mail.nih.gov
Kristina McLinden
National Institute on Aging (NIA)
Telephone: 301-496-9350
Email: mclindenka@nih.gov
Luke E. Stoeckel, Ph.D.
National Institute on Aging (NIA)
Telephone: 202-570-9388
Email: luke.stoeckel@nih.gov
Examine your eRA Commons account for review assignment and contact information (information appears two weeks after the submission due date).
Jennifer Edwards
National Institute on Aging (NIA)
Telephone: 301-827-6689
Email: jennifer.edwards@nih.gov
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 Human Services (HHS)
Note: For help accessing PDF, RTF, MS Word, Excel, PowerPoint, Audio or Video files, see Help Downloading Files.