Part 1. Overview Information

Key Dates

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 2. Full Text of Announcement

Section I. Funding Opportunity Description

Background

The Alzheimer's Disease Centers of Excellence Program was initiated in 1984 when Congress directed NIH and, in particular, NIA to foster further research related to AD. The NIA ADRC program is authorized by the Public Health Service Act, Section 445, and currently includes 31 NIA-designated ADRCs.

NACC was first established by NIA in 1999 to facilitate collaborative research across the growing ADRC program, making clinical and neuropathological data on all ADRC participants available to researchers in a central resource. NACC, with guidance from an NIA-appointed Clinical Task Force, facilitated the development of the Uniform Data Set and currently collects this information from 31 ADRCs across the country. Additionally, it has supported the development of a frontotemporal dementia (FTD) module and a dementia of Lewy bodies (DLB) module and is working with the Alzheimer's Biomarker Consortium for Down Syndrome (ABC-DS) to develop a Down Syndrome (DS) module, each to be collected and submitted voluntarily by ADRCs that have a focus in these areas. The Coordinating Center also has been instrumental in streamlining ADRC collaborations by supporting and managing interest groups and steering committees working to maximize the resources of the Centers to advance AD/ADRD research.

NACC has been and will continue to interact with multiple NIA-funded research resources, including multiple national AD/ADRD genetic projects such as the NIA Genetics of Alzheimer's Disease Data Storage Site (NIAGADS), the Alzheimer's Disease Genetics Consortium (ADGC), the National Centralized Repository for Alzheimer’s Disease and Related Dementias (NCRAD), and now the Standardized Centralized Alzheimer's and Related Dementias Neuroimaging (SCAN).

In 2017, NIA completed a strategic planning process for the AD Centers program that resulted in a set of 166 recommendations. Leading experts from academia, industry, and nonprofit foundations working in Alzheimer’s and other complex diseases were engaged to help ensure that the next generation of ADRCs is aligned with the key recommendations from the NIH AD and ADRD Research Summits. Their recommendations include:

• Recognize the heterogeneity and the multifactorial nature of the disease.
• Support extensive molecular profiling of existing cohorts and establish new cohorts to fill the gaps in large-scale human data needed to build predictive models of disease and wellness.
• Employ new research paradigms such as systems biology and systems pharmacology.
• Enable rapid and extensive sharing of data, disease models, and biological specimens.
• Develop computational tools and infrastructure for storage, integration, and analysis of large-scale biological and other patient-relevant data.
• Build new multidisciplinary translational teams, and create virtual and real spaces where these teams can operate.
• Support and enable open science.
• Develop new precompetitive public-private partnerships.
• Change academic, publishing, and funding incentives to promote collaborative, transparent, and reproducible research.
• Engage patients, caregivers, and citizens as direct partners in research.

These sets of recommendations enable NIA to strengthen the ability to capitalize on the unique resources available through the ADRC program, namely by leveraging the numerous strengths of the Centers network to provide large numbers of samples and standardized clinical data collection from well-characterized participants followed to autopsy, as well as a large pool of potential participants for future AD-related research. NACC, including the associated steering committees of the ADRC program, will be the primary drivers of successful implementation of these recommendations.

Purpose

This FOA invites applications for a National Alzheimer's Coordinating Center (NACC) whose purpose is to serve NIA as 1) a national data resource, collecting data from the ADRCs and their affiliated data and sample repositories; 2) a facilitator of current and future research on AD/ADRD; and 3) the central hub for organizing and enabling communication within and outside of the ADRC program, including annual meetings and steering committees.

The goals of the overall ADRC program are to serve as major sources of discovery regarding the nature of AD/ADRD and the development of more effective approaches to prevention, diagnosis, care, and therapy. The Centers contribute significantly to the development of shared resources that support dementia-relevant research, and they collaborate to coordinate their research efforts with other NIH-funded programs and investigators. They also provide substantial support to increase the number of researchers engaged in these fields through a variety of research and infrastructure activities.

Structure

NACC will include the following three teams: Administrative, Database and Computing, and Research and Consulting.

Administrative Team

NACC will financially and logistically support semiannual in-person meetings, including support for outside speakers.

NACC will support a wide variety of communication functions for the overall ADRC program, including the following:

• Serve as the point of contact for NIA, other NIA Centers, and the broader scientific community, including the Research Coordinating Center Network (RCCN).
• Provide a user-friendly web interface to serve the lay public as well as ADRCs and other investigators wishing to access ADRC clinical, neuropathological, neuroimaging, and biomarker data. The website should provide documentation such as coding guidebooks and data dictionaries as well as forms and instructions for ADRC personnel.
• Conduct outreach activities to raise awareness of availability of the data, including providing database training and support, and bring new users to the data.
• Track usage of the website and data resources, as well as follow up to junior investigator awards.
• Maintain and update, as needed, interest group and Core Leader listservs, and support core steering committee elections and processes.
• Maintain and regularly update the ADRC personnel directory.

Support the following additional administrative activities:

• Solicit and support the review process and funding for peer-reviewed Junior Investigator projects utilizing NACC data and affiliated resources.
• Support subcontracts with each of the ADRCs to enable availability of rapid multi-center/national effortsand ensure timely and efficient data submission.
• Ensure that copyrights for any assessment tools allow for broad sharing of the tools as well as the resulting data.
• Ensure that data use agreements and safeguards are in place to prevent inadvertent release of PII.
• Provide timely responses to inquiries from interested researchers.
• Provide administrative support for the NACC Steering Committee, External Advisory Committee, Clinical Task Force, and collaborative activities as described below.

Database and Computing Team

The Database and Computing Team will be responsible for ensuring the quality and accessibility of data, both for ADRC submission and for outside researcher access, as follows:

• Maintain high standards of data quality for all new and existing NACC data.
• Use modern database structures and functions, including streamlining of data submission and access processes, expanding version control, and developing automated processes for users.
• Provide high-security-compliant, high-capacity informatics infrastructure suitable for data integration, storage, management, and sharing and ensure that the data meet the FAIR principles: findable, accessible, interoperable, and reusable.
• Support collection and facilitate availability of digital biomarker data, as available and connected to other data on each participant.
• Support collection of standard set of imaging data as described by the ADC Imaging Steering Committee, and coordinate with SCAN to analyze and provide data from images collected across the ADRC (e.g., obtain segmented volumes for existing MRIs).
• Implement and utilize global unique identifiers (GUID) collection throughout the ADRC program, facilitate deidentified submission to NACC and integration into the NACC database, and coordinate with other related data and sample resources such as NIAGADS and NCRAD.
• Manage continuous improvements and expedite data distribution, e.g., quick access full data download for users.
• Provide advanced online query and data visualization capabilities, investigator training, and instructions for data access.
• Provide a plan for receiving and storing other imaging and biomarker assay data (in anticipation of future NIA, Clinical Task Force (CTF), or NACC Steering Committee directives).
• Augment the ability to include legacy and other non-UDS data (currently held at individual sites) from participants already included in the national database, particularly access to item-level data, and including at least a verbal learning test.
• Enhance and support linkages with administrative data sources.

As a national data resource, NACC must foster communication and collaborative activities within and across ADRCs and interact with other connected national resources, including:

• The National Centralized Repository for Alzheimer's Disease and Related Dementias (NCRAD) to allow samples from the ADRCs to be connected with the data at NACC.
• The National Institute on Aging Genetics of Alzheimer's Disease Data Storage Site (NIAGADS) and the Alzheimer's Disease Genetics Consortium (ADGC) to connect genetic information with other participant data.
• Standardized Centralized Alzheimer's Neuroimaging (SCAN), a new NIA U24. SCAN will be responsible for developing standardized magnetic resonance imaging (MRI) and positron emission tomography (PET) neuroimaging protocols at participating ADRCs, then harmonizing this neuroimaging data so that it can be shared and used by the scientific community. NACC will be responsible for the collection and management of new neuroimaging data by creating a repository, ensuring its integrity, and providing qualified investigators access to the neuroimaging data and any associated non-neuroimaging data.

Research and Consulting Team

• Promote and conduct research using NACC data.
• Develop statistical/research methodology important to the research field.
• Facilitate standardization of data collection and sharing processes throughout the ADRC program, where deemed appropriate by NIA and the NACC Steering Committee.
• Provide monthly and annual data summaries to individual ADRCs and to NIA; seek novel ways to communicate and display summary information.
• Plan to support data evaluations for future recommended changes to UDS or added data and data types to be collected.
• Provide in-depth consultation to researchers interested in utilizing the NACC data for research questions.
• Support planning and consultation for potential future ADRC applicants.

Section II. Award Information

Section III. Eligibility Information

1. Eligible Applicants

Higher Education Institutions

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

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

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

Nonprofits Other Than Institutions of Higher Education

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

For-Profit Organizations

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

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

• 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) 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.
• eRA Commons - Applicants must have an active DUNS number to register in eRA Commons.Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration, but 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 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.

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.

3. Additional Information on Eligibility

Number of Applications

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)

Section IV. Application and Submission Information

1. Requesting an Application Package

The application forms package specific to this opportunity must be accessed through ASSIST, Grants.gov Workspace or an institutional system-to-system solution. Links to apply using ASSIST or Grants.gov Workspace are available in Part 1 of this 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

Letter of Intent

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

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

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

The letter of intent should be sent to:

Nina Silverberg, Ph.D.
National Institute on Aging (NIA)
Telephone: 301-496-9350
Email: silverbergn@mail.nih.gov

Facilities & Other Resources:

• Describe the scientific environment that supports the electronic information handling.
• Describe the logistical and administrative assistance as well as operational support, including, but not limited to, website maintenance, meeting support, maintenance of documents and email listservs, and coordination of Steering Committees, that will maximize the utility of the Coordinating Center.
• Describe how the described resources can accommodate growth of the Coordinating Center and the ADRC program.

Other Attachments:

Submit the following as separate attachments:

• External Advisory Committee plan (membership to be determined after award in consultation with NIA).
• Leadership succession plan to assure continuity in the event of unexpected situations.
• List of expected collaborative activities that will be managed during the project period.
• Description of monthly reporting plan to NIA and to each ADRC including enrollment, submission statistics, and other data summaries. Additionally, describe an annual summary report across all ADRCs that evaluates the strengths, weaknesses, and completion of objectives for each collaborative activity.
• Description of the tracking and synthesis of progress and outcomes of ADRC and NACC activities.

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

NACC should provide sufficient resources to, at minimum:

• Support semiannual ADRC network meetings
• Provide at least 2 Junior Investigator awards per year
• Employ a database trainer and provide database training materials
• Conduct outreach to promote NACC and its resources, including a presence (booth) at major national and international meetings
• Secure Uniform Data Set (UDS) licensing, as needed
• Support data and sample collection at ADRCs as well as assuring secure transmission of de-identified data from ADRCs to NACC
• Support known and future collaborative relationships
• Travel for staff to include:
  • Semiannual ADC meetings
  • Site visits to conduct scientific review of Junior Investigator award applications
  • Large national and international meetings to promote the availability of NACC data

Specific Aims: Describe the specific aims of the NACC with respect to oversight and coordination of the ADRC program.

Research Strategy:

In a clearly labeled section entitled Administrative Plan :

Describe the administrative and organizational structure of the NACC Administrative and Leadership Team (NACC Admin Team). Include the unique features of the organizational structure that serve to facilitate accomplishment of the stated goals and objectives.

Describe how communications will be planned, implemented, and provided to ADRCs, collaborators, and outside researchers. Specifically address how the NACC Admin Team will communicate with ADRCs and NIA to ensure coordination and collaboration across the ADRC Program.

Highlight how the proposed staffing plan incorporates and leverages scientific and administrative expertise and experience to fulfill the goals.

In a clearly labeled section entitled "Database and Computing Plan":

Provide a plan for data submission, quality control, and data access and sharing for ADRCs as well as outside investigators, consistent with the goals of the program.

Describe internal and external data acquisition strategies to achieve harmonization of systems and procedures for data management, data quality, data analyses, and dissemination of data and data-related materials generated by the ADRCs. Within the plan, indicate the extent to which dedicated systems or procedures will be utilized to harmonize the acquisition, curation, management, inventory, and storage of data and connections with samples and genetic, imaging, and other data.

Describe how training on data collection and use, including adaptation to changes such as availability of point-of-contact primary data collection options, will be provided to all staff, including those at enrollment sites.

Describe quality control procedures for the data, including how to identify and resolve issues with quality control in a manner that maintains the integrity of the data.

In a clearly labeled section entitled "Research and Consulting Plan":

Describe the Research and Consulting Team staffing plan and processes that will facilitate interaction with current and future interested researchers both within and outside of the ADRC community.

Specific research to be conducted by NACC staff may be proposed, but is not required.

In a clearly labeled section entitled "Junior Investigator Award Plan":

Outline the processes that will be used to solicit, review, and select at least 2 Junior Investigator awards per year.

The following modifications also apply:

• The Resource Sharing Plan should cover all the activities of the Coordinating Center. Program staff may negotiate modifications to these plans prior to funding.

If you answered Yes to the question Are Human Subjects Involved? on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or Delayed Onset Study record.

Study Record: PHS Human Subjects and Clinical Trials Information

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

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start).All instructions in the SF424 (R&R) Application Guide must be followed.

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

4. Submission Dates and Times

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.

6. Funding Restrictions

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.

7. Other Submission Requirements and Information

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

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

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

Important reminders:

All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile 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.

Section V. Application Review Information

1. Criteria

Only the review criteria described below will be considered in the review process. Applications submitted to the NIH in support of the NIH mission are evaluated for scientific and technical merit through the NIH peer review system.

Significance

Does the proposed Coordinating Center address the needs of the centers that it will coordinate and serve? Is the scope of activities proposed appropriate to meet those needs? Will successful completion of the aims bring added value or unique advantages or capabilities to the scientific activities and accomplishments of the ADRC program?

Investigator(s)

Are the PD(s)/PI(s) and other key personnel well suited to their roles in the NACC? Do they have appropriate experience and training, and have they demonstrated experience and an ongoing record of accomplishments in managing AD/ADRD research? Do the investigators demonstrate significant experience with coordinating collaborative basic or clinical research? If the Coordinating Center is multi-PD/PI, do the investigators have complementary and integrated expertise and skills; are their leadership approach, governance, plans for conflict resolution, and organizational structure appropriate for the Coordinating Center? Does the applicant have experience overseeing selection and management of subawards, if needed?

Does the proposed team have the relevant experience and expertise in project management and coordination required for this Coordinating Center? Will the investigative team proposed be able to facilitate cooperation across a wide range of relevant research fields? Is there strong evidence of the availability of sufficient scientific expertise and of the ability to work with scientists to serve as the overall ADRC point of contact for a broad research community?

Innovation

Does the application propose novel organizational concepts, management strategies, or instrumentation in coordinating the research Centers the Coordinating Center will serve? Are the concepts, strategies, or instrumentation novel to one type of research program or applicable in a broad sense? Is a refinement, improvement, or new application of organizational concepts, management strategies, or instrumentation proposed?

Does the application support innovative approaches to data that will facilitate outside researchers' attempts to address unique and novel ideas?

Approach

Are the overall strategy, operational plan, and organizational structure well-reasoned and appropriate to accomplish the goals of the research centers the Coordinating Center will serve? Will the investigators promote strategies to ensure a robust and unbiased scientific approach across the centers, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the program is in the early stages of operation, does the proposed strategy adequately establish feasibility and manage the risks associated with the activities of the program? Are an appropriate plan for work-flow and a well-established timeline proposed? Have the investigators presented adequate plans to ensure consideration of relevant biological variables, such as sex, for studies of vertebrate animals or human subjects??

How will the organizational structures accomplish the specific aims of the Coordinating Center? How does the communication plan ensure coordination and collaboration across the ADRC program? How do the data systems promote harmonization of systems and procedures for data management and analysis? How well do the training plans enhance data sharing and data collection? What state-of-the-art quality control procedures are being used to maintain data, and will they maximize data use? How well does the staff promote interaction within its consulting plan? How adequate are the applicant's plans to solicit, review, and select Junior Investigator Awards?

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?

Environment

Will the institutional environment in which the NACC will operate contribute to the probability of success in facilitating the research program it serves? Are the institutional support, equipment, and other physical resources available to the investigators adequate for the Coordinating Center proposed? Will the NACC benefit from unique features of the institutional environment, infrastructure, or personnel? Are resources available within the scientific environment to support electronic information handling?

Protections for Human Subjects

For research that involves human subjects but does not involve one of thecategories 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

Not Applicable

Renewals

Not Applicable

Revisions

Not Applicable

Applications from Foreign Organizations

Not Applicable

Select Agent Research

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

Resource Sharing Plans

Reviewers will comment on whether the 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).

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 NIA, 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.

• Will receive a written critique.

• 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

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

Section VI. Award Administration Information

1. Award Notices

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.

2. Administrative and National Policy Requirements

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

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

For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA. HHS provides general guidance to recipients of FFA on meeting their legal obligation to take reasonable steps to provide meaningful access to their programs by persons with limited English proficiency. Please see https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/index.html. The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-individuals/section-1557/index.htmlhttps://www.hhs.gov/civil-rights/for-providers/laws-regulations-guidance/index.html. Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see https://www.hhs.gov/civil-rights/for-individuals/disability/index.html. Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at https://www.hhs.gov/ocr/about-us/contact-us/index.htmlor call 1-800-368-1019 or TDD 1-800-537-7697. Also note it is an HHS Departmental goal to ensure access to quality, culturally competent care, including long-term services and supports, for vulnerable populations. For further guidance on providing culturally and linguistically appropriate services, recipients should review the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care at http://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.

The following special terms of award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (DHHS) grant administration regulations at 45 CFR Part 75, and other HHS, PHS, and NIH grant administration policies.

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

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

The Program Director(s)/Principal Investigator(s) will have primary responsibility for defining the details of the projects within the guidelines of this FOA. The PD(s)/PI(s) will agree to accept the close coordination, cooperation, and participation of NIH staff (Project Scientist) in those aspects of scientific and technical management of the projects described below. Specifically, the PD(s)/PI(s) supported by this FOA will:

• Retain primary authority and responsibility for the project as a whole and development of the methods, procedures to accomplish the aims and objectives of the FOA, and preparation of publications.
• Provide, in addition to standard annual progress reports (see Section VI.3. Reporting), other relevant information to the NIH Project Scientist(s) or Program Officer, as well as coordinate and cooperate with NIH staff and other members of appropriate collaborating NIH programs.
• Work directly with the NIH Project Scientist(s) on the coordination of intra-program activities and the integration of ADRCs as well as other relevant NIH programs.
• Manage the coordination, collaboration, and organization of the ADRC program, in consultation with the Steering Committees comprised of elected ADRC staff and core leaders.
• Establish the agendas, in consultation with the Steering Committees, for joint meetings held twice annually.
• Create and participate in the appropriate coordinating meetings and/or working groups that will advance the aims of the Coordinating Center and maximize the use of the data resources stored at the Coordinating Center.
• Agree not to disclose confidential information obtained from other members of the ADRC program and extended research network.

Awardees will retain custody of and have primary rights to the data and software developed under these awards, subject to Government rights of access consistent with current DHHS, PHS, and NIH policies.

NIH staff have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:

One designated NIH Program Staff member, acting as the Project Scientist, will have substantial programmatic involvement that is above and beyond the normal stewardship role in awards. The role of the Project Scientist will be to facilitate and not to direct. This includes facilitating the partnership relationship between NIH, ADRCs, and the Coordinating Center. The Project Scientist's role includes helping to maintain the overall balance in the program commensurate with the functions and scope of NACC activities; facilitating communication and coordination between the NACC, ADRC Data Cores, and ADRC Directors; and ensuring that the activities of the awardee are consistent with the mission of NIA. Specifically, the NIH Project Scientist will:

• Provide technical assistance and advice to the NACC awardee as appropriate to achieve the aims of the cooperative agreement.
• Work directly with the awardee to facilitate their interactions with ADRCs and ADRC Steering Committees.
• Promote and help coordinate collaborative efforts that involve interactions with other members of the AD/ADRD and aging research communities, as well as with other NIH-sponsored programs, projects, and centers where appropriate.
• Assist in the interaction between the awardee and investigators at other institutions, as appropriate for the program.
• Assist in avoiding unwarranted duplication of effort.

To help carry out these duties, the Project Scientist may consult with non-NIH experts in the field.

The NIH Project Scientist will perform the initial analysis of awardee research strategy and will work with the Program Officer on any strategy renegotiations.

Additionally, an agency program official or IC program director will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice.

Areas of Joint Responsibility include:

The NIH Project Scientist(s) and the PD(s)/PI(s) of NACC will be jointly responsible for the coordination of intra-program activities and the integration of individual projects with other appropriate NIA and NIH programs. Joint responsibilities include:

• Developing working groups, coordinating committees, and/or trans-project and/or Center efforts as needed.
• Organizing and conducting regular meetings to share progress and foster collaborations with the ADRCs, by teleconference, videoconference, or face-to-face, as needed.
• Organizing workshops to promote outreach and database user training.
• Convening to assess progress, discuss data resources, establish priorities, consider policy recommendations, propose publication guidelines, and discuss strategies.
• Meeting in person, virtually, or by teleconference, with additional NACC staff and/or NIH staff, on a schedule to be determined.

The NIH Project Scientist may additionally form an External Scientific Panel (ESP) composed of senior non-federal scientists who are not directly involved in the activities of the NACC. The ESP would advise NIH on the progress of the Coordinating Center and ADRC Program, on the contributions of collaborations within the Program, and on the progress and effectiveness of the Program as a whole.

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 composed of three members will be convened. It will have three members: a designee of the Steering Committee chosen without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual awardee. This special dispute resolution procedure does not alter the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulation 42 CFR Part 50, Subpart D and DHHS regulation 45 CFR Part 16.

3. Reporting

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 agreementsare required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000. See the NIH Grants Policy Statement for additional information on this reporting requirement.

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

Section VII. Agency Contacts

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: 301-945-7573

Grants.gov Customer Support(Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email:support@grants.gov

Nina Silverberg
National Institute on Aging (NIA)
Telephone: 301-496-9350
Email: silverbergn@nih.gov

Ramesh Vemuri, Ph.D.
National Institute on Aging (NIA)
Telephone: 301-496-9666
Email: ramesh.vemuri@nih.gov

Jennifer Edwards
National Institute on Aging (NIA)
Telephone: 301-827-6689
Email: edwardsj@mail.nih.gov

Section VIII. Other Information