It is critical that applicants follow 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 the 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.

Part 1. Overview Information
Part 2. Full Text of the Announcement

Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information

Background and Purpose

Early detection of incident cognitive impairment, including dementia, is viewed as a healthcare priority in the United States. For example, detecting cognitive impairment is a required component of the Medicare Annual Wellness Visit. Assessment tools, as well as signs and symptoms of cognitive impairment and dementia, are made available by the NIA, the Department of Veterans Affairs, the Alzheimer's Association and others. However, and despite the existence of cognitive assessment tools that are widely accessible, cognitive impairment, even when dementia is present, is frequently under-recognized and underdiagnosed in primary care and other everyday clinical settings. The likely result, when cognitive complaints and other warning signs are evident but not pursued in primary care, is increased disease burden due to delayed or obviated treatment of reversible conditions, delayed recognition of iatrogenic causes such as anti-cholinergic agents and polypharmacy, delayed use of appropriate medical and support services, and forestalled critical planning. The purpose of this FOA is to create a research consortium to establish, test and validate paradigms for detecting cognitive impairment, including dementia, when a patient, relative, or care provider indicates concern, in primary care and other forms of everyday clinical practice. This includes addressing barriers that are specific to heath disparities populations in United States, because there is evidence that missed detection of cognitive impairment, including dementia, is even more prevalent among older African-Americans, Hispanics and other health disparities populations than among older whites.

One reason for the under-detection of cognitive impairment, including dementia, is that the existing detection tools have not been tested and standardized into user-friendly paradigms suitable for primary care in typical large and diverse populations in the United States. Adding to this, there has been a lack of development of implementation strategies for incorporation of detection of cognitive impairment into everyday clinical practice. Moreover, a challenge specific to heath disparities populations is the need for tools that are appropriate for the population being assessed. For example, few paradigms have been designed around factors, such as low literacy or stigma associated with dementia, which may impact detection of cognitive impairment in certain populations. Taken together, these factors represent a barrier to rigorously assessing the public health importance and impact of detecting cognitive impairment in older adults.

The scope of this FOA includes developing and testing paradigms for detecting cognitive impairment, including dementia, both in the general population as well as in health disparities populations. The NIH identifies the following types of health disparities populations in the United States and its territories: race/ethnicity (African Americans, Hispanic/Latinos, Asian Americans, American Indians/Alaska Natives, Native Hawaiians and other Pacific Islanders), low socioeconomic status, rural populations, and sexual and gender minorities (lesbian, gay, bisexual and transgender).

This FOA directly responds to Alzheimer's Disease-Related Dementias (ADRD) Milestones in the National Plan to Address Alzheimer's Disease for Multiple Etiology Dementias and Health Disparities. If successful, this program will increase detection of cognitive impairment, including dementia, in the United States. This is essential to enable next steps, e.g. differential diagnosis and improved medical management, with the goal of improving quality of life for people with cognitive impairment, including dementia, and their families.

Consortium

The Consortium for Detecting Cognitive Impairment, Including Dementia, will include awards funded under this FOA. This consortium will be a collaborative network of research programs that also perform cross-site validation of paradigms including tools and protocols, with an overall goal of increasing the frequency and improving the quality of patient evaluations for detecting cognitive impairment in primary care and other everyday clinical settings, as well as community screenings. Up to half of the funded consortium research will focus on paradigms specifically designed to address barriers to detecting cognitive impairment associated with health disparities.

Each project funded under this FOA will have developed a Team Management Plan for the research proposed within the specific aims, as well as a Cross-Consortium Coordinating Team (CCCT) management plan, for logistically driving coordination across the consortium. One proposed CCCT will be selected from among funded applications.

The Consortium Steering Committee will be made up of the contact PDs/PIs of funded applications and the NIH Scientific Project Officer(s), and will be responsible for leadership and scientific direction of the Consortium, including decision making during activities logistically organized by the CCCT. The Steering Committee will also be responsible for coordinating with other critical researchers and stakeholders, e.g. the FDA, CMS, etc. Membership of consortium subcommittees, which will make recommendations for consideration by the Consortium Steering Committee, will be determined by Consortium contact PDs/PIs in consultation with the NIH Scientific Project Officer(s). These committees include: (i) a Sharing Committee for publications involving more than a single consortium project, and for ensuring intra- and extra- consortium sharing of protocols, paradigms and data; (ii) a Clinical Data Committee for harmonization and establishing best practices for clinical data; (iii) a Data Analysis Committee including statistical analyses.

Funded projects must participate in all consortium meetings and activities, including quarterly calls to coordinate and synergize activities as well as in-person meetings: a kickoff meeting; an end of year one meeting; and annual in person meetings during each subsequent year.

The consortium established by this FOA uses the UG3/UH3 cooperative agreement mechanism. As such, there are two phases to the proposed research. The UG3 phase (1 or 2 years in length) is for paradigm development including harmonization and establishing common formats and interoperability among testers and sites that will facilitate very broad application, nation-wide, across all types of primary and other everyday care clinical settings. The UH3 phase (3 or 4 years in length; the overall project maximum length is 5 years) will focus on cohort and population testing, optimization and validation, with significant testing in primary care and other everyday clinical settings. Ideally, and to the extent possible, during the UH3 phase, paradigms from different studies funded in the consortium will undergo testing and validation via other funded studies. Applicants must be willing and able to carry out cross-site validation studies if and when the opportunity arises, and should budget for this expectation during the UH3 phase.

Consistent with the goals of this program, progress during both the UG3 and UH3 phases of the U award-based cooperative agreements under this FOA will be tracked with milestones agreed upon by the applicant and the NIH at the time of award. NIH's decisions on approval of transition from the UG3 phase to UH3 phase will be based on achieving milestones during the UG3 phase, and a Transition Report prepared by the applicant and submitted 4 months before the end of the final year of the UG3 phase. An External Advisory Committee will be appointed by the NIH and applicants must not nominate any members to this committee in their applications. The External Advisory Committee will provide input to the NIH, including on decisions regarding the UG3 to UH3 transition of each funded project in the Consortium. Milestones will be used to track progress in all years (i.e. during both the UG3 and UH3 phases), as well as for the completion of the first phase (UG3, paradigm development and feasibility) and transition into the second phase (UH3, testing and validation).

Examples of UG3 and UG3 to UH3 transition Milestones:

Participation in consortium calls by 1 month after Notice of Grant Award

Contact PD/PI participation in all in person consortium meetings

Engage in a broad range of stakeholders needed to meet the goals of this FOA

Evidence of a paradigm ready for testing and validation, including data collection methods and tools, analysis plans, and data sharing approaches

Documentation of feasibility of the protocol in the target population

Final UH3 protocol ready for implementation

Examples of progress that UH3 phase Milestones will track:

Further test, optimize, and validate paradigms in large cohorts and populations, including with significant testing in primary care and other everyday clinical practice settings.

Establish and prepare for next steps, during and beyond the UH3 phase, to move from the end of the project period to larger scale testing, further validation, and wide adoption into existing medical systems.

Research Project Objectives

Applicants are to propose to develop paradigms, i.e. clinical methodologies, for detecting incident cognitive impairment, including dementia, designed to be applicable to large and varied adult populations in the United States. Applications are to propose strategies for successful implementation in primary care and other everyday clinical settings. Paradigms should allow categorization of patients about whom a concern has been raised (by the patient themselves, a relative, or care provider) regarding cognitive impairment into one of the following two groups, with a rationale and recommendations for follow-up:

1. No objective cognitive impairment detected. This category includes individuals for whom the cause of the concern is unknown or appears to be a consequence of a condition that is not cognitive impairment (e.g. hearing loss). Appropriate recommendations could include measures such as periodic re-assessment, or referral for medical follow-up of the underlying condition that is not cognitive impairment;

Or

2. Detection of cognitive impairment. This category includes both individuals with cognitive impairment due to underlying medical condition(s) that may be managed in primary care, and in some instances may be reversible, as well as individuals with cognitive impairment detected that requires workup by a specialist. Appropriate recommendations could include for treatment in primary care if appropriate, follow-up clinical assessment, and/or referral to one or more specialists.

Paradigms should use and validate in large populations tools that are simple to implement, can be standardized and validated, and ideally take five minutes or less (but not longer than 10 minutes) to administer in a primary care clinical setting. A wide variety of paradigms and tools are in scope, for example: a questionnaire; a paper/pencil test for cognition/memory; a clinical decision support system/phenotypic association tree/principle component analysis of clinical data; behavioral symptoms; performance-based instruments of function and instrumental activities of daily living; or other clinical protocols. Proposed paradigms can include existing and already widely available tools, refined versions of existing tools and novel tools. A strategy for implementation into everyday clinical settings should be proposed and developed, with assessment of implementation cost, identification of the areas that are challenging for implementation, and with implementation measures such as for adoption, fidelity, penetration, and sustainability. The ideal outcome of this program is one or more paradigm(s) suitable for primary care and other everyday clinical settings to detect cognitive impairment, including dementia, with a rationale and structure for individual medical follow-up.

Other Characteristics of Responsive Applications

Projects should identify and evaluate the risks and consequences of over- or under-detection of cognitive impairment using the proposed paradigm(s).

Projects investigating health disparities should identify the major (hypothesized) barriers resulting in delay and/or lack detection of cognitive impairment in the specific health disparities population being addressed, and clearly indicate which of these barriers are addressed in the application.

Attention should be paid to consideration of when the paradigm(s) should and should not be used (e.g. settings, state of the patient).

Applicants should make their paradigm(s) available for others to test and provide input on optimization, and utilize both during the funding period (e.g., at a minimum, to other consortium members), and after, including how and with minimum burden.

Projects should include at least one paradigm that, in its fully developed form, does not require informant participation in the cognitive impairment detection protocol.

Projects should address potential longer term goals for establishing feasibility and effectiveness, and how the proposed research will facilitate those goals by establishing an essential foundation for future efforts. Specifically, applicants must provide descriptions of: (i) how the research will yield information critical for next steps, including for widespread implementation of developed paradigm(s); (ii) how, including via utilizing paradigm(s) developed under this FOA, together with other appropriate strategies, it will be possible to fully assess the need and the potential impact in the United States of routinely detecting cognitive impairment, including dementia, in everyday clinical settings, including in primary care.

Characteristics of Non-Responsive Applications

This FOA is only for studies related to humans; animal or other disease model studies are not responsive to this FOA.

Applications that are not focused on developing paradigm(s) for detecting cognitive impairment, including dementia in large human populations in the United States are not responsive.

Applications that do not indicate how they will make their paradigm(s) available for others to test and provide input on optimization, and utilize both during the funding period (e.g., at a minimum, to other consortium members), and after, including how and with minimum burden, are not responsive.

Applications that do not, in the UH3 phase, further test, optimize, and validate paradigms in large cohorts and populations, including with significant testing in primary care and other everyday clinical practice settings, are not responsive.

Applications that do not include a Cross-Consortium Coordinating Team (CCCT) plan are not complete.

Applications that focus on related topics that are not central to the goals of this FOA, such as determining the degree of cognitive impairment and whether the cognitive impairment detected does or does not meet criteria for dementia, and differentiating among different dementia disorders, are not responsive.

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

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

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:

o Hispanic-serving Institutions

o Historically Black Colleges and Universities (HBCUs)

o Tribally Controlled Colleges and Universities (TCCUs)

o Alaska Native and Native Hawaiian Serving Institutions

o 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)

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)
• 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) 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 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.

• Dun and Bradstreet Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number. 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.
• System for Award Management (SAM) (formerly CCR) 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.
• o 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.
• eRA Commons - Applicants must have an active DUNS number and SAM registration in order to complete the eRA Commons registration. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration. 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 DUNS number and 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.

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. 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 NOT-OD-11-101).

Buttons to access the online ASSIST system or to download application forms are available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

It is critical that applicants follow the Research (R) Instructions in the SF424 (R&R) Application Guide, including Supplemental Grant Application Instructions 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.

For information on Application Submission and Receipt, visit Frequently Asked Questions Application Guide, Electronic Submission of Grant Applications.

Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.

By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:

• 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:

Roderick Corriveau, PhD
Telephone: 301-496-5680
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 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.

Other Attachments: Applicants are required to include the following items in the Other Project Information section of the application: (i) Intellectual Property Strategy; (ii) Team Management Plan for the proposed research project; and (iii) a Cross-Consortium Coordinating Team (CCCT) Management Plan. These items must be uploaded as separate attachments in pdf format with filenames that correspond to the individual items (e.g. Intellectual Property Strategy.pdf, Team Management Plan.pdf, CCCT Management Team Plan.pdf). Applications lacking these required items will be deemed incomplete and will not be reviewed.

Intellectual Property Strategy: Applications must include an Intellectual property (IP) strategy that is no more than two pages in length. Applications that exceed this limit will be withdrawn. Applicants are encouraged to prepare this section of the application in consultation with their institution's technology transfer officials, as applicable.

The goal of this program initiative is to advance research towards the development of paradigms for detection of cognitive impairment, including dementia that will benefit the public. Accordingly, applicants should describe the copyright and IP landscape surrounding their paradigm(s). This should include any known constraints that could impede development (e.g., copyright considerations, certain restrictions under transfer or sharing agreements, applicants' previous or present IP filings and publications, similar technologies/paradigms that are under copyright, patent and/or are on the market, etc.) and how these issues could be addressed as appropriate and consistent with achieving the goals of the program. If the applicant proposes using a device or technology whose IP or copyright is not owned by the applicant's institution, the applicant should address any questions that may constrain or impede the ability to operate and move the technology forward consistent with achieving the goals of the program. Applicants should include a letter (see Letters of Support) from the entity that owns the IP indicating whether the entity will provide the device or technology, if there are any limits on the studies that can be performed with that device or technology, and agreement about public disclosure of results (including negative results), and whether there is an agreement already in place.

If copyright or patents pertinent to the paradigms developed under this application have been filed, the applicants should indicate the details such as filing dates, what types of patents are filed, application status, and associated United States Patent Office (USPTO) links, if applicable. Applicants should also discuss future copyright or IP filing plans. For a multiple-PD/PI, multiple-institution application, applicants should describe the infrastructure of each institution for bringing the technologies to practical application and for coordinating these efforts (e.g., licensing, managing IP) among the institutions both within and outside the consortium. Applicants must clarify how IP will be shared or otherwise be managed with other consortium members. All existing and planned copyright that impacts or may impact the proposed paradigm(s) must be disclosed and discussed.

Team Management Plan for the proposed research project: Each project funded under this FOA must have a Team Management Plan for the research proposed within the application's specific aims. The project Team Management Plan must not exceed two pages. Applications that exceed this limit will be withdrawn. NIH strongly encourages applicants to form multidisciplinary teams that consist of non-clinical and clinical scientists, cognitive, statistical, population-based clinical research, and other relevant academic/industry experts and, as applicable, health disparities disease experts. This multi-disciplinary team should have the expertise needed to execute the research strategy. The Team Management Plan should describe how team members will collaborate to accomplish the aims as proposed.

Cross-Consortium Coordinating Team (CCCT) Management Plan: Each application to this FOA must propose a Cross-Consortium Coordinating Team (CCCT). Once CCCT will be selected from among funded applications, and this CCCT will facilitate consortium-wide functions including driving cross-project coordination, including for consortium calls, scientific synergy and collaboration, and meetings and committees. This section must not exceed two pages. Applications that exceed this limit will be withdrawn. The CCCT, led by the CCCT point of contact, will be expected to enable and drive both logistic and scientific synergy. The CCCT strategy should include details regarding: communication, committees, meetings, harmonization, sharing of data and paradigms, and Consortium publications. The CCCT will be responsible for organizing in person meetings including a kickoff and annual meeting in Y1, and then annual meetings thereafter, for 6 meetings total over 5 years. The CCCT is also responsible for developing, with input from NIH, meeting agendas. Committees to be included, as a suggestion, are:

• Consortium Steering Committee (contact PDs/PIs of funded applications)
• Sharing Committee (publications, protocols, paradigms, data)
• Clinical Data Committee (data harmonization and best practices)
• Analysis Committee including statistical analyses

All instructions in the SF424 (R&R) Application Guide must be followed. The range of interdisciplinary expertise of included key personnel that will ensure success in the UG3 paradigm development phase, and will poise the team for making strong advances during the UH3 paradigm testing and validation phase, is to be clearly indicated in the biosketches. Expertise of key personnel should include, but is not limited to, clinical (including primary care), cognitive, statistical, population-based clinical research, and, as applicable, health disparities. It would be an asset to the consortium if key personnel have a history of collaborations within clinical research consortia, as well as experience sharing of de-identified clinical data and biospecimens for a broad range of biomedical research.

All instructions in the SF424 (R&R) Application Guide must be followed. The CCCT will be responsible for budgeting for in person meetings (venue, travel, accommodation, per diem for up to 12 individuals) and must budget for a kickoff and annual meeting in Y1, and then annual meetings thereafter, for 6 meetings total over 5 years.

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:

Specific Aims: State the aims and hypotheses to be tested for the UG3 and the UH3 phases.

Research Strategy: Organize the Research Strategy by Significance, Innovation, and Approach.

Significance: Describe the rationale and supporting data for the proposed paradigm(s), including proposed tool(s) and implementation protocol(s); describe the paradigm's potential to detect incident cognitive impairment in adults following a patient complaint (or a family member, caregiver, or health professional on their behalf). Describe the rationale and supporting data demonstrating the merit of the technical and clinical approaches used to develop paradigm(s), including the potential to participate in and drive cross-consortium collaborative studies in the UH3 phase, and the potential to attain the overall goal of increasing the frequency and improving the quality of detection of incident cognitive impairment, including dementia, in primary care and other everyday clinical settings in large and diverse populations in the United States.

Applications that propose heath disparities research must identify the specific disparities in detection of cognitive impairment, including dementia that are addressed. If an application targets more than one disparity (such as minority group, and low socio-economic status), the application must discuss the conceptual framework for each including how they may overlap.

Innovation: Describe the leading edge and innovative attributes the application brings to both the specific paradigm(s), including tool(s), proposed, their broad application including via sharing with minimum logistic, legal, and financial burden, as well as the overall technical advances and innovative strengths (including collaborative) that the application has to offer the consortium. For applications investigating health disparities, specify the major (hypothesized) barriers resulting in delay and/or lack of detection of cognitive impairment in the specific health disparities population being addressed, and clearly indicate which of these barriers are addressed in the application.

Approach: The approach must detail the strengths and appropriateness of paradigm(s), including tool(s), for detecting cognitive impairment, including dementia, in large and diverse populations seen in primary care and other everyday clinical settings, plus whether or not the paradigm(s) and measures are quantitative, robust, reproducible, and clearly linked to cognitive impairment. Describe how the paradigm(s) are simple to implement, can be standardized, and ideally take five minutes or less (but not longer than 10 minutes) to administer in primary care clinical settings. Applications must include at least one paradigm that, in its fully developed form, does not require informant participation in the cognitive impairment detection protocol.

Describe how proposed paradigm(s) allow categorization of patients about whom a concern has been raised (by the patient themselves, a relative, or care provider) regarding cognitive impairment, including dementia, into one of the following two groups, with a rationale and recommendations for follow-up:

1. No objective cognitive impairment detected. This category will include individuals for whom the cause of the concern is unknown or appears to be a consequence of a condition that is not cognitive impairment (e.g. hearing loss). Appropriate recommendations could include measures such as periodic re-assessment, or referral for medical follow-up of the underlying condition that is not cognitive impairment;

Or

2. Detection of cognitive impairment. This category will include both individuals with cognitive impairment due to underlying medical condition(s) that may be managed in primary care, and in some instances may be reversible, as well as individuals with cognitive impairment detected that requires workup by a specialist. Appropriate recommendations could include for treatment in primary care if appropriate, follow-up clinical assessment, and/or referral to one or more specialists.

For the UG3 phase (1 or 2 years: Year 1 and, if applicable, Year 2), detail how the proposed research will further develop and further establish feasibility of paradigms, i.e. clinical methodologies, for detecting incident cognitive impairment, including dementia, designed to be applicable to large and varied adult populations in the United States. Describe the approach for paradigm(s) development in the UG3 phase, including how assessments tools and methods will be harmonized among testers and across sites. Discuss the intended setting or settings for broad implementation of the paradigm(s), the characteristics of the individual who should perform the assessment, and the demographic characteristics of the people to be tested (such as age, sex, ethnicity). Describe how the proposed paradigm(s) meet the need for tools that are simple to use, standardized, and pose minimal burden to participants and clinicians in terms of administration time and ease of use.

For the UH3 phase (3 or 4 years: Year 2, if applicable, Years 3-4, and Year 5, if applicable) detail how the proposed research will test, validate and implement paradigm(s) in primary care and other everyday clinical settings. Describe the approach to UH3 activities, including cohort and population testing, optimization, and validation. Identify the target population(s), methods for ensuring male/female balance, approaches to cohort retention, data collection strategies, and planned clinical outcomes and analysis strategies. Describe how paradigms will be rigorously validated for accuracy, precision, sensitivity, reproducibility and quantitative results. Applicants should propose a validation approach suitable for detecting cognitive impairment and dementia in a real world setting of large and diverse populations seen in primary care and other everyday clinical settings in the United States; accordingly, the UH3 phase must include significant testing and validation in primary care and other everyday clinical settings. Assessment of validity must include determination of reliability and reproducibility across caregivers, geographical locations, and over time (appointment to appointment). Discuss potential biases and challenges with the proposed research and how they will be addressed. Applications should include a plan to identify and evaluate the risks and consequences of over- or under-detection of cognitive impairment using the proposed paradigm during the UH3 phase.

Describe how the project will establish best practices documents/publications for detection of cognitive impairment and dementia, including in health disparities populations if proposed, to meet the goal of making the information gained and paradigm(s) developed accessible to the broader research and clinical community. Specifically address how the paradigm(s) will be made available for others to test and provide input on optimization, and for others to utilize both during the funding period (e.g., at a minimum, to other consortium members), and after, including how and with minimum burden. Applicants must provide descriptions of: (i) how the research will yield information critical for next steps, including for widespread implementation of developed paradigm(s); (ii) how, including via utilizing paradigm(s) developed under this FOA, together with other appropriate strategies, it will be possible to fully assess the need and the potential impact in the United States of routinely detecting cognitive impairment, including dementia, in everyday clinical settings, including in primary care.

Milestone Plan: The Consortium established by this FOA uses the UG3/UH3 cooperative agreement mechanism; therefore, include a Milestone Plan under a separate heading in the Approach section. Propose milestones for each year of the project, including paradigm development and feasibility (UG3, 1 or 2 years), followed by testing and validation in large and diverse populations (UH3, 3 or 4 years; 5 years maximum for the entire project). Milestones must be unambiguous, objective, and scientifically justified. Milestones must be proposed for all years (during both the UG3 and UH3 phases), as well as for the completion of the first phase (UG3, paradigm development) and transition into the second phase (UH3, testing and validation). The final Milestone plan is subject to concurrence by the NIH.

Letters of Support: If an application plans to utilize the infrastructure or resources of existing projects, whether funded by the NINDS, other governmental, or nongovernmental entities, letters of support detailing the terms of collaboration and data sharing must be included, and must be from the appropriate authority/ies of the parent activity (e.g. institutional/foundation official, funding sponsor, and lead PI). Any conflicts in sharing with any known entities should be revealed and discussed. If the proposed study is ancillary to an ongoing parent project, the letter of support from the parent study PD/PI and business official must confirm that the proposed research does not interfere with the parent study, does not place undue burden on participants, and follows approved procedures and policies from the parent study. Letters of support from relevant stakeholders may also be included as evidence of necessary expertise (e.g. professional organizations or patient groups).

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, with the following modification:

• Applications funded under this FOA are expected to provide a specific plan for sharing paradigm(s), including tool(s), with Consortium collaborators during the UH3 phase, and very broadly with others at the conclusion of this 5 year program, consistent with achieving the goals of the program.

Appendix:

Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

Clinical Protocol Synopsis: The clinical protocol synopsis must not exceed six pages. Applications that exceed this limit will be withdrawn. The following information must be included:

• A list of participant eligibility criteria including the demographic characteristics of the people to be tested (such as age, sex, ethnicity), and how it will be determined whether or not a given individual will be selected for testing.
• Participant recruitment and retention plans, including a discussion of the availability of participants for the proposed study and the ability of enrollment sites to recruit and retain the proposed number of participants meeting the eligibility criteria, including women and minority participants as applicable. Data supporting recruitment and retention estimates must be provided. Evidence should be provided that relevant stakeholders (e.g., potential participants, referring and treating physicians, patient groups) have sufficient equipoise, consider the question to be important and the study acceptable.
• A brief description of all assessments including clinical, laboratory, physiological, behavioral, patient-centered, or other outcomes addressing the research paradigm. Do not include copies of the assessment tools.
• Description of statistical methods including sample size and power calculations, study outcome measures, plans for interim and final analyses, methods of bias control, and methods for handling missing data. Examples of the critical elements of a well-designed study are summarized on the NINDS website.
• Overview of efficient data management and methods for monitoring quality, methods for monitoring the quality and consistency of paradigm administration, and methods for ensuring participant confidentiality. Applicants are expected to incorporate data elements from the NINDS Common Data Elements (CDE) Project when appropriate in their data collection forms.
• Overview of informed consent process, and example consent language that describes sharing. Consent should allow sharing of de-identified clinical data and, if applicable, biospecimens, for broad biomedical research.

When conducting clinical research, follow all instructions for completing PHS Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide.

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

See Part 1. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov

Part I. Overview Information contains information about Key Dates and times. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission. When a submission date falls on a weekend or Federal holiday, the application deadline is automatically extended to the next business day.

Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies). Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date and time. If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Policy on Late Application Submission.

Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission.

Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.

This initiative is not subject to intergovernmental review.

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Pre-award costs are allowable only as described in the NIH Grants Policy Statement.

Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide. Paper applications will not be accepted.

Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.

For assistance with your electronic application or for more information on the electronic submission process, visit Applying Electronically. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Guidelines for Applicants Experiencing System Issues. For assistance with application submission, contact the Application Submission Contacts in Section VII.

Important reminders:

All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH. See Section III of this FOA for information on registration requirements.

The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in the SF424 (R&R) Application Guide.

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review and responsiveness by components of participating organizations, NIH. 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.

Only the review criteria described below will be considered in the review process. As part of the NIH mission, all applications submitted to the NIH in support of biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.

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).

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.

Does the project address an important problem or a critical barrier to progress in the field? Is there a strong scientific premise for the project? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field? Do the proposed paradigm(s), including tool(s) and approaches for detecting cognitive impairment, including dementia, have strong potential to address the unmet need to detect cognitive impairment and dementia in large and diverse populations seen in primary care practice and other everyday clinical settings across the United States, when a patient, relative, care provider, or health professional voices concern? If heath disparities research is proposed, does the application identify the major (hypothesized) barriers resulting in delay and/or lack of detection of cognitive impairment, including dementia, in the specific health disparities population being addressed, and clearly indicate which of these barriers are addressed in the application?

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or New Investigators, or 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 expertise of key personnel include clinical (including primary care), cognitive, statistical, population-based clinical research, and, if applicable, health disparities? Do key personnel have a history of collaborations within clinical research consortia, as well as experience sharing of de-identified clinical data and biospecimens for a broad range of biomedical research?

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

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Have the investigators 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?

Is the proposed paradigm(s) feasible and suitable for detecting cognitive impairment and dementia in a real world setting of large and diverse populations seen in primary care and other everyday clinical settings in the United States? Are the paradigm(s) and measures quantitative, robust, reproducible, and clearly linked to cognitive impairment? Are the proposed methods for validation of the paradigm(s) rigorous and will they adequately assess accuracy, precision, sensitivity, reproducibility and reliability of the results across caregivers, geographical locations, and over time (appointment to appointment)?

Do proposed paradigms allow categorization of patients about whom a concern has been raised (by the patient themselves, a relative, or care provider) regarding cognitive impairment into one of the following two groups, with a rationale and recommendations for follow-up?

1. No objective cognitive impairment detected. This category includes individuals for whom the cause of the concern is unknown or appears to be a consequence of a condition that is not cognitive impairment (e.g. hearing loss). Appropriate recommendations could include measures such as periodic re-assessment, or referral for medical follow-up of the underlying condition that is not cognitive impairment;

Or

2. Detection of cognitive impairment. This category includes both individuals with cognitive impairment due to underlying medical condition(s) that may be managed in primary care, and in some instances may be reversible, as well as individuals with cognitive impairment detected that requires workup by a specialist. Appropriate recommendations could include for treatment in primary care if appropriate, follow-up clinical assessment, and/or referral to one or more specialists.

Do proposed paradigm(s) use and validate in large populations tools that are simple to implement, can be standardized and validated, and ideally take five minutes or less (but not longer than 10 minutes) to administer in a primary care clinical setting?

For health disparities applications, is the proposed paradigm(s) culturally appropriate and sensitive for the target health disparities population and the known disparities for cognitive impairment and dementia? Does the proposed paradigm, including tool(s), address or adequately provide a solution to the disparity?

Are the proposed plans for making the paradigm(s) available for others to test, provide input on optimization, and utilize both during the funding period (e.g., at a minimum, to other consortium members), reasonable and practical?

Is a strategy for broad and harmonized implementation into everyday clinical settings proposed and developed, including with assessment of implementation cost, identification of the areas that are challenging for implementation, and with implementation measures such as for adoption, fidelity, penetration, and sustainability?

Does the application include a plan to identify and evaluate the risks and consequences of over- or under-detection of cognitive impairment using the proposed paradigm(s)?

Does the application include at least one paradigm that, in its fully developed form, does not require informant participation in the cognitive impairment detection protocol?

Does the application adequately describe how the applicants will establish best practices documents/publications for detection of cognitive impairment and dementia, including in health disparities populations if proposed, to meet the goal of making the information gained and paradigm(s) developed accessible to the broader research and clinical community?

Are the proposed milestones for the UG3 phase (paradigm development) and the UH3 phase (testing and validation, including with significant testing in primary care settings) feasible and likely to keep progress on target? Are the proposed milestones appropriate for determining go/no-go decisions for transitioning from the UG3 phase to the UH3 phase?

If the project involves human subjects and/or NIH-defined clinical research, are the plans to address 1) the protection of human subjects from research risks, and 2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of children, justified in terms of the scientific goals and research strategy proposed?

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

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.

Team Management Plan

Is the proposed Team Management Plan appropriate to support the research proposed within this application?

For research that involves human subjects but does not involve one of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or more of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.

When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of children to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

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

Not Applicable.

Not Applicable.

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.

Intellectual Property Strategy

Is the Intellectual Property Strategy clear, viable for broad sharing of paradigm(s) without undue burden of logistics or cost, and consistent with achieving the goals of the project and of the program supported by this FOA?

Cross-Consortium Coordinating Team (CCCT) Management Plan

Does the proposed CCCT Management Plan include a suitable strategy, as well as leadership with appropriate scientific and logistical expertise, to manage and coordinate research activities that include more than one funded award across the consortium? Does the CCCT propose a suitable and capable person as the primary point of contact for the CCCT? Is the CCCT Management Plan, overall, acceptable, or unacceptable?

Not Applicable

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

Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: (1) Data Sharing Plan; (2) Sharing Model Organisms; and (3) Genomic Data Sharing Plan (GDS).

For projects involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.

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

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by the NINDS, 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:

• 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.
• Will receive a written critique.

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

Applications will be assigned to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the National Advisory Neurological Disorders and Stroke Council. 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.

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.

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 grantee’s business official.

Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.

Any application awarded in response to this FOA will be subject to terms and conditions found on the Award Conditions and Information for NIH Grants website. This includes any recent legislation and policy applicable to awards that is highlighted on this website.

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, Grantees, and Activities. More information is provided at Award Conditions and Information for NIH Grants.

Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights law. This means that recipients of HHS funds must ensure equal access to their programs without regard to a person’s race, color, national origin, disability, age and, in some circumstances, sex and religion. This includes ensuring your programs are accessible to persons with limited English proficiency. HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research.

For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA. HHS provides general guidance to recipients of FFA on meeting their legal obligation to take reasonable steps to provide meaningful access to their programs by persons with limited English proficiency. Please see http://www.hhs.gov/ocr/civilrights/resources/laws/revisedlep.html. The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html; and http://www.hhs.gov/ocr/civilrights/understanding/index.html. Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html. Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at http://www.hhs.gov/ocr/office/about/rgn-hqaddresses.html or call 1-800-368-1019 or TDD 1-800-537-7697. Also note it is an HHS Departmental goal to ensure access to quality, culturally competent care, including long-term services and supports, for vulnerable populations. For further guidance on providing culturally and linguistically appropriate services, recipients should review the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care at http://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.

In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements. FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award. An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a Federal agency previously entered and is currently in FAPIIS. The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgement about the applicant s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 45 CFR Part 75.205 Federal awarding agency review of risk posed by applicants. This provision will apply to all NIH grants and cooperative agreements except fellowships.

Cooperative Agreement Terms and Conditions of Award

The following special terms of award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (DHHS) grant administration regulations at 45 CFR Parts 74 and 92 (Part 92 is applicable when State and local Governments are eligible to apply), and other HHS, PHS, and NIH grant administration policies.

The administrative and funding instrument used for this program will be the cooperative agreement, an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the awardees is anticipated during the performance of the activities. Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the award recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the awardees for the project as a whole, although specific tasks and activities may be shared among the awardees and the NIH as defined below.

The PD(s)/PI(s) will have the primary responsibility for:

• Adherence to all applicable NIH/NINDS policies including for data sharing and human subjects as appropriate and consistent with achieving the goals of the program;
• Determining experimental approaches, designing protocols, and conducting experiments;
• Submitting annual progress reports, other required reports, and meeting milestones during the funding period, in a format as agreed upon by NINDS program staff;
• Accepting and implementing any other common guidelines and procedures developed for the Consortium initiative and approved by NINDS program staff;
• Attending Consortium calls and actively participating in Consortium activities;
• Being willing to serve as a chair or member of the Consortium Steering Committee and other Consortium committees if elected;
• Attending in-person Consortium meetings organized by the CCCT with input from the NINDS, the Steering Committee, and the External Advisory Committee, and presenting up to date findings (including unpublished results) on ongoing projects;
• Awardees are expected to make new information and materials known to the research community not only in Consortium meetings but also in a timely manner through publications, web announcements, reports to NINDS program staff, and other mechanisms;
• Timely submission of all abstracts, manuscripts and reviews (co)authored by project investigators and supported in whole or in part under this Cooperative Agreement.
• The PD(s)/PI(s) and Project Leaders are requested to submit manuscripts to the NIH Project Scientist within two weeks of acceptance for publication so that an up-to-date summary of program accomplishments can be maintained;
• Publications and oral presentations of work conducted under this Cooperative Agreement are the responsibility of the PD(s)/PI(s) and appropriate Project Leaders and will require appropriate acknowledgement of NINDS support. Timely publication of major findings is required;
• This award is co-funded by the National Institute on Aging and the National Institute of Neurological Disorders and Stroke. All publications, posters, oral presentations at scientific meetings, seminars, and any other forum in which results of this co-funded research are presented must include a formal acknowledgement of the NINDS/NIA support, citing the NINDS grant number as identified on this award document.
• Establishment of informed consent such that when new clinical data (and biospecimens, if applicable) are collected, consent allow all enrolled individuals the opportunity to share via NINDS Repositories their de-identified data (and samples, if applicable) to researchers in academic, not for profit, and industry (for internal research use only, for profit use is not allowed). Assurance that the de-identified clinical data and samples, if applicable, will be securely stored and can be distributed to scientists for use in research and teaching only. Assurance that the de-identified data and samples, if applicable, will be available for use in any type of biomedical research, not only for research on the detection of cognitive impairment and dementia.

The NINDS Project Scientist will:

NIH staff have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below. NINDS program staff will have substantial scientific/programmatic involvement during the conduct of this activity through technical assistance, advice and coordination. However, the role of NINDS Project Scientist will be to facilitate and not to direct the activities. An NINDS Administrative Project Officer will be responsible for the normal programmatic stewardship of the award and will be named in the award notice. The NINDS Administrative Project Officer retains the option to recommend the withholding or reduction of support from any cooperative agreement that either substantially fails to achieve its goals agreed to at the time of award, fails to maintain state-of-the-art capabilities, or fails to comply with the Terms and Conditions of the award including biospecimen and data sharing requirements as appropriate and consistent with achieving the goals of the program.

Additionally, the NINDS Scientific Project Officer will:

• Contribute to the adjustment of research protocols or approaches as warranted;
• Serve as a liaison between the awardees, the NINDS Advisory Council and the larger scientific community;
• Serve on committees of the Consortium as appropriate;
• Assist in promoting the availability of data and resources developed in the course of this project to the scientific community at large;
• Assist awardees in the development, if needed, of policies for dealing with situations that require coordinated action;
• Retain the option to recommend the withholding or reduction of support from any cooperative agreement that either substantially fails to achieve its goals agreed to at the time of award, fails to maintain state-of-the-art capabilities, or fails to comply with the Terms and Conditions of the award including biospecimen and data sharing requirements as appropriate and consistent with achieving the goals of the program.

Areas of Joint Responsibilities include:

None

External Advisory Committee:

The NINDS will establish an independent External Advisory Committee to assist in determining the broad direction of the Consortium. The Advisory Committee will contain five members that are not NIH employees, and are not in the consortium. The External Advisory Committee’s role is to attend the Kickoff and Annual meetings and provide feedback and recommendations, formal or informal, regarding progress and issues. Formal input may be solicited only by the NINDS.

In particular, the External Advisory Committee will provide formal input on the UG3 to UH3 transition.

Dispute Resolution:

Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and the NIH may be brought to Dispute Resolution. A Dispute Resolution Panel will be convened, and will vote to resolve the dispute. The Dispute Resolution Panel will have three members (with one vote each): a designee of the award governing body chosen without NIH staff input, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two Panel members. This special dispute resolution procedure does not alter the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulation 42 CFR Part 50, Subpart D and DHHS regulation 45 CFR Part 16.

When multiple years are involved, awardees 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 progress report, 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.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All awardees of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000. See the NIH Grants Policy Statement for additional information on this reporting requirement.

In accordance with the regulatory requirements provided at 45 CFR 75.113 and Appendix XII to 45 CFR Part 75, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM) about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period. The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (currently FAPIIS). This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313). As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available. Full reporting requirements and procedures are found in Appendix XII to 45 CFR Part 75 Award Term and Conditions for Recipient Integrity and Performance Matters.

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 registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, 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)

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading forms and application packages)
Contact Center Telephone: 800-518-4726
Email: [email protected]

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Email: [email protected] (preferred method of contact)
Telephone: 301-945-7573

Roderick A. Corriveau, PhD
National Institute of Neurological Disorders and Stroke (NINDS)
Telephone: 301-496-5680
Email: [email protected]

Claudia Moy, PhD
National Institute of Neurological Disorders and Stroke (NINDS)
Telephone: 301-496-9135
Email: [email protected]

Chief, Scientific Review Branch
National Institute of Neurological Disorders and Stroke (NINDS)
Telephone: 301-496-9223
Email: [email protected]

Tijuanna E. DeCoster, PhD
National Institute of Neurological Disorders and Stroke (NINDS)
Telephone: 301-496-9231
Email: [email protected]

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.