NIH’s new Application Submission System & Interface for Submission Tracking (ASSIST) is available for the electronic preparation and submission of multi-project applications through Grants.gov to NIH. Applications to this FOA must be submitted electronically; paper applications will not be accepted. ASSIST replaces the Grants.gov downloadable forms currently used with most NIH opportunities and provides many features to enable electronic multi-project application submission and improve data quality, including: pre-population of organization and PD/PI data, pre-submission validation of many agency business rules and the generation of data summaries in the application image used for review.

Required Application Instructions

It is critical that applicants follow the 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) and where instructions in the Application Guide are directly related to the Grants.gov downloadable forms currently used with most NIH opportunities. 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

Alzheimer's disease (AD) is estimated to affect millions of older people in the United States. Although it is occasionally identified in people in their forties and fifties, it is most frequently associated with advancing age. AD is the most frequent cause of institutionalization for long-term care. It destroys the active, productive life of its victims and devastates their families financially and emotionally. It has been estimated that the United States spends 180-215 billion dollars per year for the direct and indirect costs of care for people with AD. The risk of AD increases greatly with age and projections suggest that the numbers of people with AD will increase with the aging of the population unless effective interventions are found.

In the United States, the Executive and Legislative Branches of the Federal Government have both expressed concern about the enormity of the problem posed by AD, and in 2011, Congress passed the National Alzheimer s Project Act (NAPA). Congressional concern has focused on funding for research on the causes, diagnosis, treatment, and prevention of the disease, as well as on disparities and on the cost and coordination of care. In 1984, Congress directed the National Institutes of Health (NIH), and in particular the National Institute on Aging (NIA), to foster further research related to AD. The NIA Alzheimer's Disease Centers (ADCs) program is authorized by the Public Health Service Act, Section 445, and currently includes fifteen Alzheimer's Disease Research Centers (ADRCs) and twelve Alzheimer's Disease Core Centers (ADCCs).

The ADC program has moved into a new era, capitalizing on the extraordinary opportunities presented by leveraging the strengths of the network of centers to provide large numbers of biological samples and standardized clinical data collection from well-characterized participants as well as a large pool of potential participants for future AD-related research. At the same time, strong emphasis is placed on the unique contributions and new directions of each individual center. Additionally, renewed emphasis is placed on possibilities for utilizing the resources within and across the ADCs to advance and augment the fields of drug discovery and drug development for novel therapeutics for AD.

The principal aim of the ADCCs is to enhance the performance of innovative research on AD and related topics, including research that may lead to potential disease-modifying therapy or behavioral or other symptom treatments. Centers are requested to concentrate their attention on better defining normal aging and the transition from normal aging to mild cognitive impairment (MCI) to the earliest stages of dementia, whether AD itself or other related dementias associated with aging. Clinical and pathological information about the earliest cognitive changes is now beginning to make it possible to develop strategies to prevent the disease from developing or to slow its progression. Attention should also be paid to mixed dementias and overlapping neurodegenerative syndromes that often occur with AD, such as vascular dementia, Lewy Body disease, frontotemporal degeneration and Parkinson’s dementia, in order to better differentiate among them and to recognize commonalities. In addition, co-occurring conditions in other organ systems that may contribute to clinical dementia could be studied.

Centers provide an environment and core resources that will enhance cutting-edge research by bringing together biomedical, behavioral, and clinical investigators to study the etiology, pathogenesis, diagnosis, treatment, and prevention of AD, and to improve health-care delivery. Centers should also foster the development of new lines of research and provide a rich training environment for fellows and junior faculty to acquire research skills and experience in interdisciplinary AD research. The Centers provide investigators and research groups with data from well-characterized research participants, family information, and brain tissue and biological specimens. Centers should incorporate contemporary biochemical/molecular techniques and pursue research, when feasible, in genomics, epigenomics, proteomics and metabolomics. Centers are encouraged to develop in accordance with local talents, interests, and resources, but should also be responsive to national needs related to AD.

The ADCs provide a mechanism for fostering and coordinating the interdisciplinary cooperation of a group of established investigators conducting programs of research on AD and related dementing disorders of older people. The central focus may be translational research, clinical pathological research, basic research or a combination. Applicants are strongly encouraged to include efforts to address the needs of, and research on, ethnically and racially diverse people as well as other underserved populations.

As part of a network, centers should be poised to participate in cooperative efforts on a massive scale within a relatively short time frame. Applicants need to agree to collect a standard clinical data set (the Uniform Data Set, or UDS) that is common to all Centers and will be transmitted to the National Alzheimer’s Coordinating Center (NACC). To support the unique research needs of the center, most centers collect additional data to supplement those required by the UDS. Centers should demonstrate a readiness to provide biological samples and data, with proper consent from well characterized populations, to enable participation in large scale collaborative national or international research projects.

Centers should work together with other AD research groups in collaborative research activities and cooperate with other Federal, State, and Local agency-supported AD programs (such as the Alzheimer's Disease Cooperative Study (ADCS) and the Alzheimer's Disease Neuroimaging Initiative (ADNI)), as well as community organizations such as the Alzheimer’s Association in furthering mutual goals. Centers should also, whenever possible, cooperate with other NIA Centers such as Pepper, Shock, and RCMAR Centers (Resource Centers for Minority Aging Research), and Udall Centers sponsored by the National Institute of Neurological Disorders and Stroke (NINDS).

The use of NIH resources, such as those available from the chemical genomics center (http://www.ncats.nih.gov/research/reengineering/ncgc/ncgc.html) or the Biomedical Informatics Research Network (BIRN, http://www.nbirn.net/) is also encouraged. In addition, AD Centers should consider, where there are research questions in common that are consistent with the scientific goals of the center, collaboration with Centers for Drug Discovery or Clinical and Translational Science Award recipients (see http://www.ncats.nih.gov/research/cts/ctsa/ctsa.html).

The Center Grant may incorporate ancillary activities such as longitudinal studies and limited patient care necessary to support the primary research effort. The spectrum of activities should comprise a multi-disciplinary approach to research focused on understanding and treating AD and other neurodegenerative diseases, including distinguishing early stages from normal aging, investigating mixed dementias, as well as studying unique aspects and subtypes of these very complex and heterogeneous disease processes.

Alzheimer’s Centers are required to include the following six cores:

Administrative

The administrative core is responsible for managing and coordinating interaction among the Director, the core leaders, the principal investigators of research projects using the cores, other researchers at the applicant institution as well as outside institutions, appropriate institutional administrative personnel, the staff of the awarding agency, and the members of the community in which the Center is located.

Clinical

The Clinical Core has the responsibility of establishing and maintaining a clinical enterprise that provides valuable, well-documented resources for cutting edge clinical research for both center personnel and the wider scientific community.

Data Management and Statistics

The Data Management and Statistics Core both perform data management and provides statistical consultation and liaison with other cores and research projects. Data cores are important to facilitate not only local analyses but also collaborations between and among Centers and with NACC.

Neuropathology

The neuropathology core has the responsibility of providing post-mortem diagnosis on cases and normal control subjects enrolled in the clinical core and on other well-documented AD cases and controls.

Outreach and Recruitment (OR)

The Outreach and Recruitment Core has the responsibility for providing important liaison and outreach between the ADC and people with dementia, their caregivers and both the professional and local lay community so that information may be communicated bi-directionally.

Research Education Component (RL5)

The over-arching goal of the Research Education Component (REC) is to support educational activities that complement and/or enhance the training of a workforce to meet the nation’s biomedical, behavioral and clinical needs in Alzheimer's Disease-related research. The REC will support creative educational activities with a primary focus on providing research experiences and mentoring to promote the development of future research leaders in Alzheimer's disease related research, particularly leaders who can integrate clinical insights with knowledge of advances in the basic sciences to improve clinical interventions. Integrative science, taking advantage of the interdisciplinary expertise at the Center and throughout the network of centers is key to understanding, treating and providing appropriate care for people with dementia and their families.

Mentoring activities should be dedicated efforts at providing not only technical expertise, but advice, insight, and professional career skills to postdoctoral students and/or early-career faculty. Research experiences should provide relevant preparation for a workforce for conducting Alzheimer's Disease research.

Additional Cores

Other cores (such as a satellite clinic focusing on a special population) can be proposed if they contribute to the overall mission of the Center, are scientifically justified, support research affiliated with the Center, and fit within the budget guidelines.

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:

• 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

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.
  • 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.

Only one application per institution (normally identified by having a unique DUNS number or NIH IPF number) is allowed.

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).

Applicants can access the SF424 (R&R) application package associated with this funding opportunity using the Apply for Grant Electronically button in this FOA or following the directions provided at Grants.gov.

Most applicants will use NIH’s ASSIST system to prepare and submit applications through Grants.gov to NIH. Applications prepared and submitted using applicant systems capable of submitting electronic multi-project applications to Grants.gov will also be accepted.

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, including Supplemental Grant Application Instructions except where instructed in this funding opportunity announcement to do otherwise and where instructions in the Application Guide are directly related to the Grants.gov downloadable forms currently used with most NIH opportunities. 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:

Nina B. Silverberg, Ph.D.
Alzheimer’s Disease Centers Program
Dementias of Aging Branch
Division of Neuroscience
National Institute on Aging
7201 Wisconsin Ave., Suite 350
Bethesda, MD, 20892-9205 (20814 for express shipping)
Telephone: 301-496-9350
Fax: 301-496-1494
Email: silverbergn@mail.nih.gov

Component Types Available in ASSIST	Research Strategy/Program Plan Page Limits
Overall	12
Admin Core (Use this component type for the Administrative Core)	12
Core (Use this component type for the Clinical Core, Data Management and Statistical Core, Neuropathology Core, Outreach and Recruitment Core, Satellite Diagnostic and Treatment Clinic Core, and Additional Cores)	6
Research Education (Use this component type for the Research Education Component (RL5))	12

Additional page limits 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 a multi-component application.

The application should consist of the following components:

• Overall: required; one
• Administrative Core: required; one
• Clinical Core: required; one
• Data Management and Statistical Core: required; one
• Neuropathology Core: required; one
• Outreach and Recruitment Core: required; one
• Research Education Component: required; maximum, one
• Satellite Diagnostic and Treatment Clinic Core: optional; maximum, three
• Additional Cores: optional; maximum, three

Please enter in ASSIST using the order listed above.

When preparing your application in ASSIST, use Component Type Overall .

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

Complete entire form.

Note: Human Embryonic Stem Cell lines from other components should be repeated in cell line table in Overall component.

Follow standard instructions.

Facilities and Other Resources: Shared facilities and resources across cores should be described in the Facilities and Other Resources attachment.

Other Attachments: Renewal applications may present summary tables such as those provided in the annual Non-Competing Continuation Grant Progress Report detailing: Federally and non-federally funded grants that utilized resources from the Center, funding for therapeutic trials and other grants from industry, collaborations (including NACC, Alzheimer’s Association and others), and health disparities and diversity related grants

Enter primary site only. An Alzheimer's Disease Core Center (ADCC) will be an identifiable organizational unit formed by a single institution or a consortium of cooperating institutions.

A summary of Project/Performance Sites in the Overall section of the assembled application image in eRA Commons compiled from data collected in the other components will be generated upon submission.

Include only the Project Director/Principal Investigator (PD/PI) and any multi-PDs/PIs (if applicable to this FOA) for the entire application.

Program Director/Principal Investigator: The PD/PI should be a scientific leader experienced in the field of AD and/or other neurodegenerative disease research and should be able to coordinate, integrate, and provide guidance in the establishment of programs in AD research and allied areas.

A summary of Senior/Key Persons followed by their Biographical Sketches in the Overall section of the assembled application image in eRA Commons will be generated upon submission.

The only budget information included in the Overall component is the Estimated Project Funding section of the SF424 (R&R) Cover.

A budget summary in the Overall section of the assembled application image in eRA Commons compiled from detailed budget data collected in the other components will be generated upon submission.

Introduction to Application: For Resubmission applications, an Introduction to Application is required in the Overall component.

Specific Aims: Describe the aims of the overall center and outline how the different cores will contribute to these aims.

Research Strategy:

Significance: Focusing on the center as a whole address (i) the importance of the problem or critical barrier to progress in the field that the proposed center is focused on; (ii) how the resources of the proposed center will improve scientific knowledge, technical capability, and/or clinical practice; (iii) how the concepts, methods, technologies, treatments, services, or preventive interventions that drive this field will be changed if the proposed aims are achieved.

• Additionally, show how the center will:Enhance the performance of innovative research on AD and related topics;
• Contribute to the national network of Alzheimer’s Centers;
• Provide an environment and resources to enhance cutting edge research by bringing together investigators from various fields to study the etiology, pathogenesis, diagnosis, treatment and prevention of AD;
• Foster the development of new lines of research;
• Provide a supportive environment for trainees, postdoctoral fellows and junior faculty who are supported through different awards;
• Provide well-characterized participants, brain tissue and biological specimens;
• Advance and augment the fields of drug discovery and drug development for novel therapeutics for AD and/or other neurodegenerative diseases.

Renewal Applications: Describe any changes in research emphasis.

Innovation: Considering the center as a whole, show how the proposed research seeks to shift current research or clinical practice paradigms through use of novel concepts, approaches, methodologies, instrumentation, or interventions. Does the proposed work refine, or improve, or apply in a new way, the concepts, approaches, methodologies, instrumentation, or interventions proposed?

Approach: Include the major approaches and studies in the application showing how the approaches of cores complement each other or are inter-dependent. Describe the mechanisms that will ensure the coherence of the center and maintain a multidisciplinary focus.

Renewal Applications: Provide an overall summary that addresses the major scientific achievements in research on AD, normal aging and related topics carried out by Center personnel as well as by research utilizing Center resources in the last funding period. Identify the most significant findings that were facilitated or supported directly through Center resources. Include summaries of progress in achieving the major aims of the Center. Provide examples of how the presence of the ADC has brought new investigators into the field and has stimulated non-ADC funded research in the last funding period. Explain the Center’s role in generating new funding from grants as well as leveraging funds from donors and other private sources. Discuss the interrelation of the center to other activities in the applicant's institution (e.g., other relevant research projects) and the extent of institutional, departmental, and interdepartmental cooperation (charts and tables may be included). In addition, describe the administrative relations of the proposed ADC to the institution. Include relevant issues relating to institutional commitment and settings.

New applications should describe preliminary organizational work, experience with AD and other neurodegenerative disease research, potential for developing new and exciting research, and specific plans for implementation of the new program.

Protection of Human Subjects: In addition to the required content of the Protection of Human Subjects section, describe the procedures for obtaining informed consent for 1) research on cognitively-impaired human subjects who may not have the capacity to consent, specifically how proxy or surrogate consent will be obtained in the context of local and state law; 2) future participation in research studies if the participant becomes unable to consent (advanced directive for research); 3) placing data in the National Alzheimer s Coordinating Center’s Uniform Data Set and sharing data and specimens with other qualified scientists consistent with achieving the goals of this program; and 4) autopsy, specifying how and by whom and with whom the topic will be discussed, when and how often. Attention should be paid to obtaining advanced directives for research and obtaining autopsy permission from participants and families and informed consent for current and future use of biological samples by qualified investigators. Permission should be obtained for sharing of cells, DNA, and genetic and phenotypic information as well as for storage in repositories. See the Biospecimen Task Force guidelines on the NACC web site (https://www.alz.washington.edu/BiospecimenTaskForce.html) for further guidance on consent forms, as well as http://www.nia.nih.gov/research/dn/sharing-policy-and-guidance-research-genetics-alzheimers-disease for sample language regarding genetics that may be used in consent forms.

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:

Consistent with achieving the goals of this program, applicants should commit to cooperate fully and to share specimens with other research scientists both within and outside the Centers network as well as data concerning clinical core participants with the NIA-sponsored National Alzheimer’s Coordinating Center (NACC) where uniform data from all AD Centers is centrally stored. Any genetic specimens collected by the Center (blood samples and DNA) should be made available to the National Cell Repository for Alzheimer’s Disease (NCRAD) in accordance with agreed upon protocols and policies. Centers may also be requested to contribute other biological samples such as serum and cerebrospinal fluid, using agreed upon protocols, for trans-center studies examining biomarkers that might relate to risk, diagnosis or progression of AD. Therefore, consent forms should be written to allow for this possibility as well as for the possibility of eventual data sharing with the wider research community, while maintaining participants confidentiality. The Steering Committee of the NACC in conjunction with the ADC Directors and the NIA sets policies that allow the individual Centers to conduct unique research with participants while also sharing common data sets with NACC.

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.

When preparing your application in ASSIST, use Component Type Admin Core.

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

Complete only the following fields:

• Applicant Information
• Type of Applicant (optional)
• Descriptive Title of Applicant’s Project (Note: Project Title is Core A: Administrative Core)
• Proposed Project Start/Ending Dates

Enter Human Embryonic Stem Cells in each relevant component.

Human Subjects: Answer only the Are Human Subjects Involved? and 'Is the Project Exempt from Federal regulations? questions.

Vertebrate Animals: Answer only the Are Vertebrate Animals Used? question.

Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

Facilities and Other Resources: Provide a description of all resources for the core...

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

• In the Project Director/Principal Investigator section of the form, use Project Role of Other with Category of Core Lead and provide a valid eRA Commons ID in the Credential field.
• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
• Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.
• Core Leader (CL) should have demonstrated leadership and administrative skills. Specifically, the CL should be able to organize and administer the resources created by the core or project in such a way that they may be shared within the ADCC as well as with other interested scientists. Demonstrated leadership in training junior investigators is desirable.
• The Program Director/Principal Investigator of the proposed ADCC should also be the Administrative Core Leader; sufficient time should be devoted to the core to ensure that the aims are met and required functions are carried out efficiently. The PD/PI’s biographical sketch should present evidence of scientific expertise relevant to the themes of the ADCC and demonstrate the capacity for the leadership of an ADCC.
• The administrative requirements of the ADCC will necessitate the assistance of an administrator with business management expertise. It is important that such an individual be identified and be directly involved with the fiscal and administrative aspects of the ADCC application and grant. The administrator should be able to provide consultation in matters of fiscal administration and be familiar with NIH grant-related compliance policies.
• An Associate Director may be named who will be involved in the administrative and scientific efforts of the Center.

Budget forms appropriate for the specific component will be included in the application package.

A significant time commitment (2.4 person months) should be made by the CL.

If large items of equipment are requested, the application should document what is already available and provide clear justification in terms of use by core staff and how it relates to research projects dependent on the core. General-purpose equipment needs should be included and justified only after surveying the availability of such items within the institution.

Domestic and foreign travel of project personnel directly related to the core and scientific activities of the ADCC is allowable. Budgeting should include travel and lodging for 1) the semi-annual meetings of the Center Directors; 2) annual meetings of administrators, clinical core leaders, education core leaders, data managers, and neuropathology core leaders; and, 3) representatives of the Center to attend ad hoc meetings called by the ADCs or the NIA to discuss research findings and plan cooperative projects, to promulgate data sharing, and to discuss standardization of procedures among the ADCs. Include funds for travel of the PD/PI and other key personnel 1) to the semiannual meetings of the Center Directors; 2) for at least 2 ad hoc meetings on special topics; 3) for visits of Center investigators to other ADCs for the exchange of scientific ideas, planning of multi Center research projects and to receive training in specialized techniques; 4) for the Administrator to attend the Administrators meeting; and 5) for core leaders to attend meetings with core leaders from other ADCs.

Requests for pilot projects will be budgeted in the Administrative Core budget. A brief description of the first-year pilot research and detailed pilot budgets for the first year of Center funding will be requested as Just-in-Time information through the eRA Commons shortly before the award of successful applications. Future-year pilots should be submitted with the annual non-competing renewal applications. Facilities & Administrative costs will be provided in accordance with these budgets.

Pilot costs should be in the range of $25,000-$35,000 direct costs per year. Pilot projects may be awarded to investigators outside of the home institution. Funds for the pilot projects should be included under the other expenses within the administrative core budgets. These funds should not be listed as a separate line in the composite budget. Pilot grants are allowed for consortium arrangements

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

Introduction to Application: For Resubmission applications, an Introduction to Application is allowed for each component.

Specific Aims: Clearly state how the core will contribute to the goals of the ADC and outline interactions of the core with each of the other components of the center. Provide an overview of how the core will set the overall direction of the Center and ensure optimal utilization of Center resources.

Research Strategy: Organize the Research Strategy into sections on: Significance, Innovation and Approach.

Significance: Explain the role of the Administrative core in the center as a whole and as a resource for other ongoing activities in Alzheimer’s disease and other neurodegenerative diseases.

Approach: Describe how the center's administrative structure will facilitate the following:

• coordination and integration of Center components and activities; (for example, the clinical and data management cores with the neuropathology and education components);
• direction for future planning and optimal utilization of resources;
• support and advice for the Center Director in oversight of the activities of the Center;
• interaction with the scientific and lay communities to develop relevant goals for the Center;
• coordination and organization of external and internal advisory committee meetings;
• coordination and organization of pilot project advertisement, review, and submission of pilot projects to NIA for approval;
• assurance of compliance with human subjects, animal welfare, scientific integrity, data and sample sharing as appropriate, and financial policy requirements of NIH;
• interaction with other Centers, the Data Coordinating Center and other researchers to develop trans-ADC and outside research projects;
• timely and routine transmissions of appropriate Center data sets to the NACC;
• interaction and involvement with other research programs of the University including the provision of core resources for development of related research;
• coordination with NIA on media coverage of the latest research findings from the center.

Present plans to establish and operate Center advisory panels including:

• An External Advisory Committee (EAC) to conduct and provide annual evaluations of the programs of the ADC, research progress, the effectiveness of communications within the ADC, interactions with NACC, and any other activities for which outside expertise is required or desirable. EAC members should not be named in the application and should not be contacted for participation in the committee prior to award. The NIA program officer may be invited to attend EAC meetings as a non-voting member. A copy of the advisory committee report should be routinely sent to the NIA with the annual Non-Competing Continuation Grant Progress Report and should include a list of committee members after they have been appointed;
• An executive committee (composed of core leaders and the administrator) to assist the Director in making the scientific and administrative decisions relating to the Center utilizing advice and consultation, both from within the institution and from other institutions, to monitor and develop the scientific content and direction of the center;
• A review panel to assist in selecting pilot projects. Criteria for selecting committee members, how they will be identified, the operating procedures of the groups and the frequency of meetings should be described. Review should include a biostatistician as well as scientists from outside the Center. New applications should not select committee members prior to peer review of the Center application. Members from the External Advisory Committee may serve as reviewers for the pilot applications, provided their expertise is appropriate for the submitted applications.

Pilot Projects: A plan to support one to three pilot projects for basic or clinical biomedical, translational, and epidemiological, caregiving, educational or behavioral research should be included in the application. The announcement for pilot funding should include a description of data available through NACC, including their website. Use of this resource should be strongly encouraged. This funding mechanism is intended to allow an investigator the opportunity to develop preliminary data sufficient to provide the basis for an application for independent research support. They are designed for postdoctoral or junior faculty level investigators, but may be awarded to a more senior investigator who has experience in areas other than AD research, and who wants to work in the AD research field or who wants to try a new hypothesis, method, or approach that is not an extension of ongoing AD research. Any one investigator is eligible only once for pilot support, unless the additional proposed pilot project constitutes a real departure from his or her ongoing research. Pilot projects are typically limited to a nonrenewable single year of support. If described and well-justified, two years of support may be requested.

Examples of possible pilot projects are:

• A study based on data in the NACC data set to determine the feasibility of conducting larger studies in the future.
• A study proposed by a new investigator, with an interest in research in AD, before the study has developed to the point of being suitable to apply for individual grant support.
• Functional, mechanistic, or pre-clinical activities designed to move a basic discovery towards a translational endpoint in the near future.

No pilot project applications should be submitted with the Center application. Funds designated for pilots are restricted until the pilots receive NIA approval. Successful Center applicants should conduct a competition and submit the successful applications to NIA for the first year of pilot funding after receiving a notice of grant award; in subsequent years competition for pilot awards should be timed so successful applications can be submitted with the non-competing renewal application for NIA review.

New applications should describe preliminary organizational work, institutional experience with AD and other neurodegenerative disease research, potential for developing new and exciting research, and specific plans for implementation of the new program.

Renewal Applications only: Provide evidence of successful overall integration of cores to promote the theme(s) of the center as well as interaction within the academic and local and national communities. Provide evidence of productivity of funded pilot grants. Describe the most important contributions to research on AD, related dementias and aging utilizing core resources. Reports should include Core objectives and progress in meeting them. Basic functions of the cores should be briefly summarized. Any developmental work carried out by the core should also be presented.

Progress Report Publication List: Publications resulting from resources or developmental work carried out by the core should be listed.

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:

Applicants should commit to cooperate fully and to share specimens with other research scientists both within and outside the Centers network as well as data concerning clinical core participants with the NIA-sponsored National Alzheimer’s Coordinating Center (NACC) where uniform data from all AD Centers is centrally stored. Any genetic specimens collected by the Center (blood samples and DNA) should be made available to the National Cell Repository for Alzheimer’s Disease (NCRAD) in accordance with agreed upon protocols and policies. Centers may also be requested to contribute other biological samples such as serum and cerebrospinal fluid, using agreed upon protocols, for trans-center studies examining biomarkers that might relate to risk, diagnosis or progression of AD. Therefore, consent forms should be written to allow for this possibility as well as for the possibility of eventual data sharing with the wider research community, while maintaining participants confidentiality. The Steering Committee of the NACC in conjunction with the ADC Directors and the NIA sets policies that allow the individual Centers to conduct unique research with participants while also sharing common data sets with NACC.

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.

Not Applicable

Not Applicable

When preparing your application in ASSIST, use Component Type Core.

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

SF424 (R&R) Cover (Clinical Core)

Complete only the following fields:

• Applicant Information
• Type of Applicant (optional)
• Descriptive Title of Applicant’s Project (Note: Project Title is Core B: Clinical Core)
• Proposed Project Start/Ending Dates

PHS 398 Cover Page Supplement (Clinical Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Clinical Core)

Human Subjects: Answer only the Are Human Subjects Involved? and 'Is the Project Exempt from Federal regulations? questions.

Vertebrate Animals: Answer only the Are Vertebrate Animals Used? question.

Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components

Facilities and Other Resources: Provide a description of all resources for this core.

Project /Performance Site Location(s) (Clinical Core)

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

Clinical cores of ADCs are usually based in university medical center neurology or psychiatry department memory disorders clinics, but they may also, or instead, include special populations that might be available to some applicants such as an ethnic or minority population, a religious community or a community population living in elderly housing where the likelihood of being able to study the full spectrum from normal aging to mild cognitive impairment to AD would be possible

Research & Related Senior/Key Person Profile (Clinical Core)

• In the PD/PI section of the form, use Project Role of Other with Category of Core Leader and provide a valid eRA Commons ID in the Credential field.
• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
• Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component. ASSIST only allows a single biosketch for each person. Therefore the biosketches must be comprehensive, covering multiple roles if a single individual has multiple roles.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.
• The Clinical Core Leader is often a neurologist, but may be a neuropsychologist, psychiatrist, geriatrician or other clinician with expertise in diagnosing Alzheimer’s and other neurodegenerative diseases. The Clinical Core Leader should have a track record of research in some aspect of neurodegenerative disease, preferably including interactions with key personnel from other cores.

Budget (Clinical Core)

Budget forms appropriate for the specific component will be included in the application package.

If an optional satellite core is included, it should have a separate budget in a core component specific to the satellite core. If an existing satellite has been rolled into a clinical core, the budget for the satellite must still be identifiable within the budget justification of the clinical core budget.

Research patient care costs (both inpatient and outpatient expenses) will be considered in the context of other existing institutional clinical resources. Attempts should be made by the applicant institution to utilize existing clinical facilities. Costs relating to the clinical efforts of the ADCC may be funded through the ADCC, provided there is no overlap of funding. Only those research patient costs directly related to ADCC activities may be charged to the ADCC.

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

PHS 398 Research Plan (Clinical Core)

Introduction to Application: For Resubmission applications, an Introduction to Application is allowed for each component.

Specific Aims: Clearly state how the core will contribute to the goals of the ADC and outline interactions of the core with each of the other components of the center.

Describe the target population for which the core will provide well-characterized, longitudinally followed research participants for cutting edge research projects involving e.g., clinico-pathological correlations, comparison of disease states to normal aging (including those using biological samples or imaging), and drug/intervention studies.

Research Strategy: Organize the Research Strategy into sections on: Significance, Innovation and Approach.

Significance: Explain the role of the clinical core in the center as a whole and as a resource for other ongoing activities in Alzheimer’s disease and other neurodegenerative diseases. If the clinical core will include special populations, the applicant should describe the characteristics of the population and justify the added scientific value to research at the Center resulting from the inclusion of this group, so that peer reviewers can evaluate the comparative strengths and weaknesses of the proposed clinical core. If the application includes a satellite clinic as part of the clinical core, explain its significance.

Approach: State how the clinical core, in addition to participant recruitment, will provide: evaluation, and diagnosis, maintain a research volunteer registry that tracks number and reasons for those lost to follow-up, and conduct longitudinal follow up of participants. Describe interactions with other cores, including procedures for discussing autopsy consent.

Describe procedures related to collection, storage, and distribution of biological samples, that may include, but are not limited to, cell lines, cerebrospinal fluid (CSF), blood and plasma; particular attention should be paid to an ability to share these samples both within and outside the Center as well as best practices for collection and use of biospecimens detailed in documents available on the NACC website (https://www.alz.washington.edu/). Applicants should describe and follow agreed upon protocols for multi-center projects involving specimen collection.

Proposed developmental work should be described in the application.

Describe the types (with specific examples) of research projects and clinical trials that use or will use the core and what benefits will obtain to other research activities from the existence of the clinical core. While supporting clinical drug trials may be one function of a clinical core, it should not be the only major effort of the core.

Longitudinal data on preclinical stages of AD, MCI, possible and probable AD, other neurodegenerative disorders and normal aging should be collected and transmitted in a timely manner to the Data Management and Statistics Core. Cooperation, concurrence and collaboration with the Data Management and Statistics Core should continue from the initial specification of data content through data collection to database management and data analysis. A clear linkage between clinical and neuropathological data should be described. There should be a commitment to working across the center to increase the number of participants who agree to autopsy, especially of controls and persons with MCI or early in the course of AD. Applicants should state in this section of the application that they agree to collect and provide the Uniform Data Set (UDS) to NACC where it will be combined with data from other Centers and made available to scientists for collaborative studies. Participants should be enrolled in the Clinical Core with the intent of longitudinal follow-up. Information on the UDS is available from NACC.

Recent developments in biomarker research and improvements in evaluation of cognitive change in normal aging, and preclinical stages of mild cognitive impairment (MCI) and AD, present new opportunities for research on early stages of disease and diminish the necessity to enroll only symptomatic subjects. In those Centers with research interests related to the earliest stages of disease, Clinical Cores have the option to recruit cognitively normal but higher risk subjects for natural history and biomarker studies. This cohort would be distinct from the primary clinical core cohort, but evaluation and tracking of the cohort would be the responsibility of the clinical core. Retention and follow-up are of critical importance for this group of subjects just as for the regular Clinical Core subjects. Such subjects may be selected for age, ApoE status, family history or any other criteria that may predict higher risk of developing Alzheimer or neurodegenerative pathology. These subjects would be very valuable for primary and secondary prevention trials supported by other grants. Cognitively normal higher risk subjects would receive the baseline clinical and psychometric evaluation for the UDS that all subjects enrolled in the Clinical Core receive, and biospecimens would be collected, but these subjects would not necessarily be seen for an in-person UDS visit annually. Instead these cognitively normal subjects could be given a brief UDS compatible remotely administered (telephone or web-based) cognitive test(s) at their first and second annual follow-up, scheduled approximately one and two years after initial enrollment. However, if a clinically important decline in cognition is noted at one of the follow-up calls, the participant would be scheduled for a full, in-person clinical evaluation (including UDS) as soon as would be feasible. From that point forward the participant would be seen annually for an in-person evaluation and would become part of the regular clinical core cohort. If cognitive or functional decline does not trigger an in-person visit earlier, all participants in this "at risk" cohort would be brought back to the ADCC for a full evaluation in the third year after enrollment. In the cognitively normal participants, it would be critically important to obtain serial biological fluid biomarker measurements and, when possible, serial imaging following the baseline enrollment visit. If the natural history of biomarker change and correlation with clinical change can become well established, such biomarkers may eventually serve as intermediate endpoints for clinical trials or intervention.

New applications should describe preliminary organizational work, institutional experience with AD and other neurodegenerative disease research, potential for developing new and exciting research, and specific plans for implementation of the new program.

Renewal Applications only: Clearly summarize resource use in affiliated research projects (both funded by the center and externally funded) and the new insights obtained from these studies. Describe demographic information including numbers and kinds of participants recruited, diagnosis, percentage follow up and dropout rate and reasons for drop out, and diagnostic accuracy confirmation by autopsy. Describe the most important contributions to research on AD, related dementias and aging utilizing core resources. Reports should include Core objectives and progress in meeting them. Basic functions of the cores should be briefly summarized. Any developmental work carried out by the core should also be presented.

Progress Report Publication List: Publications resulting from resources or developmental work carried out by the core should be listed.

Inclusion of Women and Minorities: Summarize strategies, with reference to the OR core, to recruit and retain participants from diverse backgrounds including a description of how the plan fits with all of the proposed research that will make use of the core. The plan should demonstrate sensitivity to research design and biostatistical analysis. Procedures for communicating recruitment needs to the OR Core and for evaluating success should be outlined.

The inclusion of participants with different characteristics will assist investigators in providing answers to questions about AD diagnosis, treatment, and management strategies that are likely to be applicable to the broad U.S. population. Additionally, a more diverse participant pool will facilitate investigations of the neuropathology and genetics of AD as well as studies of care giving and family burden in diverse groups. Diversity of participants may be achieved in multiple ways. One option is to have a Satellite Clinic in locations that have higher populations of underserved individuals.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genomic Data Sharing (GDS)) as provided in the SF424 (R&R) Application Guide, with the following modification:

Consistent with achieving the goals of this program, , applicants are expected to cooperate fully and to share specimens with other research scientists both within and outside the Centers network as well as data concerning clinical core participants with the NIA-sponsored National Alzheimer’s Coordinating Center (NACC) where uniform data from all AD Centers is centrally stored. Any genetic specimens collected by the Center (blood samples and DNA) should be made available to the National Cell Repository for Alzheimer’s Disease (NCRAD) in accordance with agreed upon protocols and policies. Centers may also be requested to contribute other biological samples such as serum and cerebrospinal fluid, using agreed upon protocols, for trans-center studies examining biomarkers that might relate to risk, diagnosis or progression of AD. Therefore, consent forms should be written to allow for this possibility as well as for the possibility of eventual data sharing with the wider research community, while maintaining participants confidentiality. The Steering Committee of the NACC in conjunction with the ADC Directors and the NIA sets policies that allow the individual Centers to conduct unique research with participants while also sharing common data sets with NACC.

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.

Planned Enrollment Report (Clinical Core)

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

PHS 398 Cumulative Inclusion Enrollment Report (Clinical Core)

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

When preparing your application in ASSIST, use Component Type Core.

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

SF424 (R&R) Cover (Data Management and Statistical Core)

Complete only the following fields:

• Applicant Information
• Type of Applicant (optional)
• Descriptive Title of Applicant’s Project (Note: Project Title is Core C: Data Management and Statistical Core)
• Proposed Project Start/Ending Dates

PHS 398 Cover Page Supplement (Data Management and Statistical Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Data Management and Statistical Core)

Human Subjects: Answer only the Are Human Subjects Involved? and 'Is the Project Exempt from Federal regulations? questions.

Vertebrate Animals: Answer only the Are Vertebrate Animals Used? question.

Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

Facilities and Other Resources: Provide a description of all resources for this core..

Project /Performance Site Location(s) (Data Management and Statistical Core)

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

Research & Related Senior/Key Person Profile (Data Management and Statistical Core)

• In the PD/PI section of the form, use Project Role of Other with Category of Core Leader and provide a valid eRA Commons ID in the Credential field.
• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
• Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component. ASSIST only allows a single biosketch for each person. Therefore the biosketches must be comprehensive, covering multiple roles if a single individual has multiple roles.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.
• This Core Leader's biosketch should reflect awareness of and experience with database management practices, computing and statistics. The Core Leader may be primarily a data manager or a statistician. The Core Leader should have the time and the authority to work administratively with other cores.
• The core should include a) a systems manager for computing and database management who will be the architect of the database structure and responsible for its maintenance; b) a systems analyst with sufficient background to select and implement database management software, represent data structures, specify and organize data flow, construct detailed error-check programs, develop/implement data checking and cleaning procedures, and provide for data entry and access, as well as information distribution, through electronic means (e.g., the internet or intranet); and c) a statistician who can consult with researchers on design and analysis of their projects, if the Core Leader is not a statistician.

Budget (Data Management and Statistical Core)

Budget forms appropriate for the specific component will be included in the application package.

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

PHS 398 Research Plan (Data Management and Statistical Core)

Introduction to Application: For Resubmission applications, an Introduction to Application is allowed for each component.

Specific Aims: Clearly state how the core will contribute to the goals of the ADC and outline interactions of the core with each of the other components of the center.

Describe both database and statistical services that will be provided to the cores and pilots. Outline the process for contributing data to NACC and for making data available both within and outside of the center, consistent with achieving the goals of the program.

Research Strategy: Organize the Research Strategy into sections on: Significance, Innovation and Approach.

Significance: Explain the role of the Data Management and Statistical Core in the center as a whole and as a resource for other ongoing activities in Alzheimer’s disease and other neurodegenerative diseases.

Approach: Include a data management plan that covers at least:

• data flow schemes;
• data forms (electronic or hard copy; following core and affiliated project specified content);
• a Center-wide system of subject ID numbers that meets privacy standards;
• adequate filing systems for raw data within the cores and affiliated projects and within the data core itself;
• a mechanism to track data edits;
• longitudinal follow-up data storage/retrieval consistent with the protocols of the center.

The Data Management and Statistical Core should have the capacity to prepare the UDS for transmission to the NACC which in turn will make appropriate data sets available to qualified investigators for further research. The institution will be responsible for monitoring the data sharing policy. The Data Management and Statistical Core should be adequately funded and staffed to allow required tasks to be carried out. (New applicants may contact NACC to learn more about NACC procedures, the structure of the uniform data set, and the regular updates to the datasets required from all Centers; http://www.alz.washington.edu/).

Other possible functions of the core might include:

• Manage database issues related to scheduling and other participant tracking;
• Sample inventory and tracking, including requests;
• Develop, implement and maintain a tracking system for Outreach and Recruitment core activities recruitment, retention, calls to center, etc. and/or a volunteer database;
• Design, maintain, and track usage of the Center’s website;
• Develop improved mathematical models that might help e.g., identify mediation or improve understanding of the interactions of multiple variables on cognitive decline;
• Develop enhanced statistical techniques to improve trial design with a focus on issues relevant to detecting cognitive decline early in the disease process

Describe how the core staff will work with clinical and research personnel as well as with statisticians to assure that their data are in an appropriate form for storage, transmission and analysis.

Describe how core staff will have a working relationship with core data collectors and have their cooperation to reconcile errors and missing or incomplete data elements as discovered through error check programs or through hands-on inspection procedures.

Describe how the core staff will work cooperatively with the NACC staff and respond appropriately to data calls issued by NACC.

Demonstrate how the biostatistics consultation and liaison will:

• be involved in the design and analysis of studies using participant data and/or biomaterials from the Cores;
• work closely with the data manager to insure analysis files are produced that are consistent with the needs of the question at hand; and
• be available for consultation with pilot project applicants and awardees as well as with affiliated research project investigators.

New applications should describe preliminary organizational work, institutional experience with AD and other neurodegenerative disease research, potential for developing new and exciting research, and specific plans for implementation of the new program.

Renewal Applications only: Summarize progress and activities related to data collection, data management and statistical consulting activities. Describe the most important contributions to research on AD, related dementias and aging utilizing core resources. Reports should include Core objectives and progress in meeting them. Basic functions of the core should be briefly summarized. Include progress and interactions with NACC as well as descriptions of any novel data analysis or study design strategies that have been developed. Present evidence for meeting timetables for data transfer in the proper format to NACC. Any developmental work carried out by the core should also be presented.

Progress Report Publication List: Publications resulting from resources or developmental work carried out by the core should be listed.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genomic Data Sharing (GDS)) as provided in the SF424 (R&R) Application Guide, with the following modification:

Consistent with achieving the goals of this program, applicants are expected to cooperate fully and to share specimens with other research scientists both within and outside the Centers network as well as data concerning clinical core participants with the NIA-sponsored National Alzheimer’s Coordinating Center (NACC) where uniform data from all AD Centers is centrally stored. Any genetic specimens collected by the Center (blood samples and DNA) should be made available to the National Cell Repository for Alzheimer’s Disease (NCRAD) in accordance with agreed upon protocols and policies. Centers may also be requested to contribute other biological samples such as serum and cerebrospinal fluid, using agreed upon protocols, for trans-center studies examining biomarkers that might relate to risk, diagnosis or progression of AD. Therefore, consent forms should be written to allow for this possibility as well as for the possibility of eventual data sharing with the wider research community, while maintaining participants confidentiality. The Steering Committee of the NACC in conjunction with the ADC Directors and the NIA sets policies that allow the individual Centers to conduct unique research with participants while also sharing common data sets with NACC.

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

Planned Enrollment Report (Data Management and Statistical Core)

Not Applicable

PHS 398 Cumulative Inclusion Enrollment Report (Data Management and Statistical Core)

Not Applicable

When preparing your application in ASSIST, use Component Type 'Core.

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

SF424 (R&R) Cover (Neuropathology Core)

Complete only the following fields:

• Applicant Information
• Type of Applicant (optional)
• Descriptive Title of Applicant’s Project (Note: Project Title is Core D: Neuropathology Core)
• Proposed Project Start/Ending Dates

PHS 398 Cover Page Supplement (Neuropathology Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Neuropathology Core)

Human Subjects: Answer only the Are Human Subjects Involved? and 'Is the Project Exempt from Federal regulations? questions.

Vertebrate Animals: Answer only the Are Vertebrate Animals Used? question.

Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components

Facilities and Other Resources: Provide a description of all resources for this core.

Project /Performance Site Location(s) (Neuropathology Core)

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

Research & Related Senior/Key Person Profile (Neuropathology Core)

• In the PD/PI section of the form, use Project Role of Other with Category of Core Leader and provide a valid eRA Commons ID in the Credential field.
• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
• Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component. ASSIST only allows a single biosketch for each person. Therefore the biosketches must be comprehensive, covering multiple roles if a single individual has multiple roles.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.
• The Core Leader should have a track record of research in some aspect of neurodegenerative disease, preferably including interactions with key personnel from other cores. The Core Leader should have demonstrated knowledge of standard protocols as well as expertise in state of the art techniques for diagnosis of neuropathological specimens.

Budget (Neuropathology Core)

Budget forms appropriate for the specific component will be included in the application package.

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

PHS 398 Research Plan (Neuropathology Core)

Introduction to Application: For Resubmission applications, an Introduction to Application is allowed for each component.

Specific Aims: Clearly state how the core will contribute to the goals of the ADC and outline interactions of the core with each of the other components of the center.

Describe the state of the art diagnostic services, strategy for collecting well-prepared brain material, and distribution of samples for cutting edge research, locally as well as in cooperative research across Centers and with other researchers outside of Centers.

Research Strategy: Organize the Research Strategy into sections on: Significance, Innovation and Approach.

Significance: Explain the role of the Neuropathology core in the center as a whole and as a resource for other national and international research activities focused on Alzheimer s disease and other neurodegenerative diseases.

Approach: Describe procedures related to criteria for diagnosis, and the collection, storage, and distribution of brain tissue and other biological samples, including, but not limited to, cell lines, cerebrospinal fluid (CSF) and plasma. Specimen collection, data gathering and storage activities should be coordinated with those of the Clinical Core and the Data Management Core.

Describe procedures and processes to prevent catastrophic loss of stored specimens.

Describe how the core will provide a resource for research studies that include clinical-pathological correlations across Centers. To do so, ADCs should agree to follow standardized procedures whenever possible, so that cross-Center correlations are possible. (New applicants may go to the NACC to get the most recent best practice guidelines for biospecimens: https://www.alz.washington.edu/BiospecimenTaskForce.html).

Discuss the procedure for prioritizing the use of tissues and other biological samples stored at the Center and describe potential research projects that will use the samples.

Discuss procedures to provide coded samples to investigators that protect the identity of the participants.

Unless specific research questions require brains from people with late stage AD, emphasis should be placed on collection of brains from people who are cognitively normal, or who have MCI or early AD, in order to support specific research efforts of investigators affiliated with the local center and other scientists. If collection of special material is proposed (e.g., tissues from people with other dementia diagnoses) justification should be included. If proposing developmental work, describe the role of this work and its significance to the core, the center and other research activities.

The Neuropathology Core should provide the infrastructure necessary for applying novel technologies, techniques and/or information to increase the value of stored tissues and fluids, especially those that have longitudinal data available.

To facilitate data sharing and cross-Center comparisons of diagnosis, all Centers should use the neuropathological criteria for AD developed by the NIA-Alzheimer's Association Working Group. If tissue from other diseases is collected, list the clinical diagnostic criteria used. More detailed criteria for local research purposes should also be described. Pathology data should be included in the data set transmitted to NACC as defined by the UDS. (New applicants may get information from NACC about the pathology data set). Neuropathologists from the ADCs meet yearly to share ideas and discuss technical aspects of tissue sampling, development of standardized tissue processing for diverse research protocols, cataloging and data management, and banking and distribution of tissues and biological samples. The applicant should commit to sending a representative to this meeting. New applications should describe preliminary organizational work, institutional experience with AD and other neurodegenerative disease research, potential for developing new and exciting research, and specific plans for implementation of the new program. All applicants, but particularly new applications, or centers with primarily younger cognitively normal cohorts may wish to focus the neuropathology core primarily on biological sample collections, storage and distribution.

Renewal Applications only: Clearly summarize resource use in affiliated research projects and the new insights obtained from these studies, as well as type and quantity of tissue provided to investigators both funded by the Center and by other means. Describe the most important contributions to research on AD, related dementias and aging utilizing core resources. Reports should include Core objectives and progress in meeting them. Basic functions of the core should be briefly summarized. Any developmental work carried out by the core should also be presented.

Progress Report Publication List: Publications resulting from resources or developmental work carried out by the core should be listed.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genomic Data Sharing(GDS)) as provided in the SF424 (R&R) Application Guide, with the following modification:

Consistent with achieving the goals of this program, applicants are expected to cooperate fully and to share specimens with other research scientists both within and outside the Centers network as well as data concerning clinical core participants with the NIA-sponsored National Alzheimer’s Coordinating Center (NACC) where uniform data from all AD Centers is centrally stored. Any genetic specimens collected by the Center (blood samples and DNA) should be made available to the National Cell Repository for Alzheimer’s Disease (NCRAD) in accordance with agreed upon protocols and policies. Centers may also be requested to contribute other biological samples such as serum and cerebrospinal fluid, using agreed upon protocols, for trans-center studies examining biomarkers that might relate to risk, diagnosis or progression of AD. Therefore, consent forms should be written to allow for this possibility as well as for the possibility of eventual data sharing with the wider research community, while maintaining participants confidentiality. The Steering Committee of the NACC in conjunction with the ADC Directors and the NIA sets policies that allow the individual Centers to conduct unique research with participants while also sharing common data sets with NACC.

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

Planned Enrollment Report (Neuropathology Core)

Not Applicable

PHS 398 Cumulative Inclusion Enrollment Report (Neuropathology Core)

Not Applicable

When preparing your application in ASSIST, use Component Type Core.

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

SF424 (R&R) Cover (Outreach and Recruitment Core)

Complete only the following fields:

• Applicant Information
• Type of Applicant (optional)
• Descriptive Title of Applicant’s Project (Note: Project Title is Core E: Outreach and Recruitment Core)
• Proposed Project Start/Ending Dates

PHS 398 Cover Page Supplement (Outreach and Recruitment Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Outreach and Recruitment Core)

Human Subjects: Answer only the Are Human Subjects Involved? and 'Is the Project Exempt from Federal regulations? questions.

Vertebrate Animals: Answer only the Are Vertebrate Animals Used? question.

Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

Facilities and Other Resources: Provide a description of all resources for this core.

Project /Performance Site Location(s) (Outreach and Recruitment Core)

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

Research & Related Senior/Key Person Profile (Outreach and Recruitment Core)

• In the PD/PI section of the form, use Project Role of Other with Category of Core Leader and provide a valid eRA Commons ID in the Credential field.
• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
• Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component. ASSIST only allows a single biosketch for each person. Therefore the biosketches must be comprehensive, covering multiple roles if a single individual has multiple roles.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used
• The Core Leaders should have expertise in the primary area of focus of the education core, either recruitment/outreach or professional education/training, or both.

Budget (Outreach and Recruitment Core)

Budget forms appropriate for the specific component will be included in the application package.

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

PHS 398 Research Plan (Outreach and Recruitment Core)

Introduction to Application: For Resubmission applications, an Introduction to Application is allowed for each component.

Specific Aims: Clearly state how the Outreachand Recruitment (OR) core will contribute to the goals of the ADC and outline interactions of the core with each of the other components of the center.

Summarize the outreach and recruitment needs of the center as well as local academic and community settings. Outline recruitment plans in light of the needs of the research that will rely on the center.

Research Strategy: Organize the Research Strategy into sections on: Significance, Innovation and Approach.

Significance: Explain the role of the Outreach and Recruitment core in the center as a whole and as a community resource on Alzheimer’s Disease and related dementias.

Approach: Provide an assessment of the outreach and recruitment needs that are unique to the center as well as to the geographical area in the vicinity of the ADC, including identifying underserved groups. The assessment might include information about census data, community organizations, and an evaluation of the outreach and recruitment activities and needs of each research function of the center. Other proposed activities such as those outlined in section I of this FOA should be clearly described in the application.

Depending on the local needs as identified in an analysis of local needs, this core may focus on coordination with other cores for recruitment and retention of subjects for particular research protocols and clinical trials, with a special emphasis on underserved/underrepresented populations. An outreach plan should address the needs identified, including both strengths and barriers (e.g., parking/transportation).

The methods and techniques to be employed to disseminate information and the audience targeted to receive information should be defined including 1) descriptions of seminar or lecture series, or workshops; 2) outreach to specific communities to publicize research; 3) collaboration with other organizations such as state and local agencies, the Alzheimer’s Association, other community/service groups, sports teams, hospitals, religious organizations, business groups, local medical societies, etc.; and 4) descriptions of materials (e.g., videos and printed matter) to be developed by the Center.

Attention should be directed to issues of cultural sensitivity and, where appropriate, the information should be structured so that it can effectively reach diverse populations, including non-English-speaking people. Procedures by which the education and outreach activities are closely coordinated with the clinical core and satellite(s) (if appropriate) should be described, especially in recruitment of diverse populations. The outreach activities should also be prepared to support activities of the Centers group as a whole as well as recruitment for special NIA initiatives, such as subjects for genetic studies. Collaboration with other ADCs and the NIA Alzheimer’s Disease Education and Referral Center (ADEAR) in subject recruitment, education and coordinated dissemination of educational materials is expected. Collaboration and consultation with RCMARs regarding recruitment and retention of diverse elder populations are encouraged (http://www.rcmar.ucla.edu/).

Other major activities of the Outreach and Recruitment Core might include:

• Create and maintain community advisory groups;
• Evaluate the outreach programs which may include, e.g., number of participants, feedback forms, number of participants who sign up to receive information or be contacted by the center, etc.;
• Communicate the latest research findings both locally and generally to study participants, families and professionals. These efforts might include website maintenance, newsletters, brochures, seminars, workshops, media appearances, including TV, radio and print;
• Develop and maintain a local registry/database of potential study volunteers with and without cognitive impairment, regardless of how well-characterized. Recruitment may be coordinated with the Alzheimer’s Disease Cooperative Study group if the center serves as a performance site. New applications should describe preliminary organizational work, institutional experience with AD and other neurodegenerative disease research, potential for developing new and exciting research, and specific plans for implementation of the new program.

Renewal Applications only: Describe efforts to assist the clinical core and NIA special initiatives, such as the genetics initiative, in participant recruitment, especially any efforts directed to recruitment of people from diverse and underrepresented backgrounds. Provide information about educational activities that effectively impart knowledge to professionals and the lay public. Describe other outreach activities. Describe the most important contributions to research on AD, related dementias and aging utilizing core resources. Reports should include Core objectives and progress in meeting them. Basic functions of the core should be briefly summarized. Any developmental work carried out by the core should also be presented.

Progress Report Publication List: Publications resulting from resources or developmental work carried out by the core should be listed.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genomic Data Sharing (GDS)) as provided in the SF424 (R&R) Application Guide, with the following modification:

Consistent with achieving the goals of this program, applicants are expected to cooperate fully and to share specimens with other research scientists both within and outside the Centers network as well as data concerning clinical core participants with the NIA-sponsored National Alzheimer’s Coordinating Center (NACC) where uniform data from all AD Centers is centrally stored. Any genetic specimens collected by the Center (blood samples and DNA) should be made available to the National Cell Repository for Alzheimer’s Disease (NCRAD) in accordance with agreed upon protocols and policies. Centers may also be requested to contribute other biological samples such as serum and cerebrospinal fluid, using agreed upon protocols, for trans-center studies examining biomarkers that might relate to risk, diagnosis or progression of AD. Therefore, consent forms should be written to allow for this possibility as well as for the possibility of eventual data sharing with the wider research community, while maintaining participants confidentiality. The Steering Committee of the NACC in conjunction with the ADC Directors and the NIA sets policies that allow the individual Centers to conduct unique research with participants while also sharing common data sets with NACC.

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

Planned Enrollment Report (Outreach and Recruitment Core)

Not Applicable

PHS 398 Cumulative Inclusion Enrollment Report (Outreach and Recruitment Core)

Not Applicable

When preparing your application in ASSIST, use Component Type Research Education.

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

SF424 (R&R) Cover (Research Education Component (RL5))

Complete only the following fields:

• Applicant Information
• Type of Applicant (optional)
• Descriptive Title of Applicant’s Project (Note: Project Title is Core F: Research Education Component (RL5))
• Proposed Project Start/Ending Dates

PHS 398 Cover Page Supplement (Research Education Component (RL5)Follow all instructions provided in the SF424 (R&R) Application Guide.

Research & Related Other Project Information (Research Education Component (RL5))

Human Subjects: Answer only the Are Human Subjects Involved? and 'Is the Project Exempt from Federal regulations? questions.

Vertebrate Animals: Answer only the Are Vertebrate Animals Used? question.

Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

Facilities and Other Resources: Describe the educational environment, including the facilities, laboratories, participating departments, computer services, and any other resources to be used in the development and implementation of the proposed program. List all thematically related sources of support for research training and education following the format for Current and Pending Support.

Other Attachments. Provide a plan for the External Advisory Committee of the ADCC to monitor progress of the research education program.

Project /Performance Site Location(s) (Research Education Component (RL5))

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

Research & Related Senior/Key Person Profile (Research Education Component (RL5))

• In the PD/PI section of the form, use Project Role of Other with Category of REC Leader and provide a valid eRA Commons ID in the Credential field.
• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
• Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component. ASSIST only allows a single biosketch for each person. Therefore the biosketches must be comprehensive, covering multiple roles if a single individual has multiple roles.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used

Budget (Research Education Component (RL5))

Budget forms appropriate for the specific component will be included in the application package.

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

Include all personnel other than the PD(s)/PI(s) in the Other Personnel section, including clerical and administrative staff.

Use the section on Participant/Trainee Support Costs to include all allowable categories of funds requested to support participants in the program.

PHS 398 Research Plan (Research Education Component (RL5))

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

Introduction to Application: For Resubmission applications, an Introduction to Application is allowed for each component.

Specific Aims: Describe the contribution of the Research Education Component (REC) to the Center's overall goals. Describe how the proposed use of Research Education Component funds for research education activities will contribute to Center's goals for research education. Describe how the Research Education Component Leader(s) and other mentors will help implement the intended goals of the REC.

Research Strategy: Organize the Research Strategy into sections on:

Proposed Research Education Program. While the proposed research education program may complement ongoing research training and education occurring at the applicant institution, the proposed educational experiences must be distinct from those research training and research education programs currently receiving federal support. When research training programs are on-going in the same department, the applicant organization should clearly distinguish between the activities in the proposed research education program and the research training supported by the training program.

The research education program should include mentoring and research experiences. Outline the objectives of the program and the program activities that will be used to meet these objectives. Describe plans to accommodate differences in preparation among participants. Include information about mentored research experiences and other educational activities essential for the proposed program.

Describe the plan for recruiting, selecting, mentoring, and monitoring the progress of individuals who will receive REC support over the proposed Center award period, and describe the abilities that REC candidates will be expected to acquire. The plan should include use of the external advisory panel.

The research education plans for at least some of the junior faculty and research associates supported through the REC should provide for the development of combined competence in basic and clinical research. This should be accomplished either by enhancing the clinical research experience of basic scientists, developing basic research skills and experience of clinical investigators, or providing a combination of the two approaches. An emphasis on development of skills for translating basic findings into clinical research, and clinical findings into mechanistic studies, is encouraged. Regarding the goal of developing researchers with combined expertise in clinical and basic research (including aging research), Applicants should consider the previous training of the individual candidate in determining the nature and extent of research education activities for which REC support is requested.

Core Leader(s). Describe arrangements for administration of the program. Provide evidence that the Core Leader(s) is/are actively engaged in research and/or teaching in an area related to the mission of the NIA and the ADC Program, and can organize, administer, monitor, and evaluate the research education program. For programs proposing multiple Core Leaders, describe the complementary and integrated expertise of the Leaders, their leadership approach, and governance appropriate for the planned program.

Program Faculty. Researchers from diverse backgrounds, including racial and ethnic minorities, persons with disabilities, and women are encouraged to participate as program faculty. Faculty should have research expertise and experience relevant to the proposed program and demonstrate a history of, or the potential for, their intended roles.

Describe how the Program Faculty will serve as preceptors/mentors and provide guidance and expertise appropriate to the level of participants proposed in the application. Describe the complementary expertise and experiences of the proposed Program Faculty, including active research and other scholarly activities in which the faculty are engaged, as well as experience mentoring and training individuals at the proposed career stage(s). For any proposed Program Faculty lacking research training experience, describe a plan to ensure successful participant guidance by these individuals. Describe the criteria used to appoint and remove individuals as Program Faculty and to evaluate their participation.

Program Participants. Applications must describe the intended participants, and the eligibility criteria and/or specific educational background characteristics that are essential for participation in the proposed research education program. Identify the career levels for which the proposed program is planned.

Present brief descriptions of the research and training background, potential research experiences, and mentoring activities for up to five candidates in the first year. Describe the goals for each candidate's career progression by the end of the award period. REC support is intended primarily for US citizens and permanent residents, unless there is strong justification otherwise based on exceptional relevance to the NIH and NIA.

REC support is intended for junior faculty and research associates. At least some participants selected for support through the REC should hold a clinical doctoral degree. Research education support should be integrated with other sources of career support that they may be receiving (e.g., GEMSSTAR, fellowships, non-NIH career awards) in concerted programs for research education.

Recruitment Plan to Enhance Diversity: Fostering diversity in the scientific research workforce is a key component of the NIH strategy to identify, develop, support and maintain the quality of our scientific human capital (NOT-OD-15-053). Every facet of the United States scientific research enterprise from basic laboratory research to clinical and translational research to policy formation requires superior intellect, creativity and a wide range of skill sets and viewpoints. NIH’s ability to help ensure that the nation remains a global leader in scientific discovery and innovation is dependent upon a pool of highly talented scientists from diverse backgrounds who will help to further NIH's mission.

Research shows that diverse teams working together and capitalizing on innovative ideas and distinct perspectives outperform homogenous teams. Scientists and trainees from diverse backgrounds and life experiences bring different perspectives, creativity, and individual enterprise to address complex scientific problems. There are many benefits that flow from a diverse NIH-supported scientific workforce, including: fostering scientific innovation, enhancing global competitiveness, contributing to robust learning environments, improving the quality of the researchers, advancing the likelihood that underserved or health disparity populations participate in, and benefit from health research, and enhancing public trust.

In spite of tremendous advancements in scientific research, information, educational and research opportunities are not equally available to all. NIH encourages institutions to diversify their student and faculty populations to enhance the participation of individuals from groups identified as underrepresented in the biomedical, clinical, behavioral and social sciences, such as:

A, Individuals from racial and ethnic groups that have been shown by the National Science Foundation to be underrepresented in health-related sciences on a national basis (see data at http://www.nsf.gov/statistics/showpub.cfm?TopID=2&SubID=27 and the report Women, Minorities, and Persons with Disabilities in Science and Engineering). The following racial and ethnic groups have been shown to be underrepresented in biomedical research: Blacks or African Americans, Hispanics or Latinos, American Indians or Alaska Natives, Native Hawaiians and other Pacific Islanders.

B. Individuals with disabilities, who are defined as those with a physical or mental impairment that substantially limits one or more major life activities, as described in the Americans with Disabilities Act of 1990, as amended. See NSF data at, http://www.nsf.gov/statistics/wmpd/2013/pdf/tab7-5_updated_2014_10.pdf

C. Individuals from disadvantaged backgrounds, defined as:

1. Individuals who come from a family with an annual income below established low-income thresholds. These thresholds are based on family size, published by the U.S. Bureau of the Census; adjusted annually for changes in the Consumer Price Index; and adjusted by the Secretary for use in all health professions programs. The Secretary periodically publishes these income levels at http://aspe.hhs.gov/poverty/index.shtml.

2. Individuals who come from an educational environment such as that found in certain rural or inner-city environments that has demonstrably and directly inhibited the individual from obtaining the knowledge, skills, and abilities necessary to develop and participate in a research career.

The disadvantaged background category (C1 and C2) is applicable to programs focused on high school and undergraduate candidates.

Literature shows that women from the above backgrounds (categories A, B, and C) face particular challenges at the graduate level and beyond in scientific fields. (See, e.g., Inside the Double Bind, A Synthesis of Empirical Research on Undergraduate and Graduate Women of Color in Science, Technology, Engineering, and Mathematics http://her.hepg.org/content/t022245n7x4752v2/fulltext.pdf).

Applications must include a plan to enhance recruitment of a diverse participant pool and may wish to include data in support of past accomplishments. The plan should be appropriate and reasonable for the nature and duration of the proposed program.

Applications lacking a diversity recruitment plan will not be reviewed.

Plan for Instruction in the Responsible Conduct of Research. All applications must include a plan to fulfill NIH requirements for instruction in the Responsible Conduct of Research (RCR). The plan must address the five, required instructional components outlined in the NIH policy: 1) Format - the required format of instruction, i.e., face-to-face lectures, coursework, and/or real-time discussion groups (a plan with only on-line instruction is not acceptable); 2) Subject Matter - the breadth of subject matter, e.g., conflict of interest, authorship, data management, human subjects and animal use, laboratory safety, research misconduct, research ethics; 3) Faculty Participation - the role of the program faculty in the instruction; 4) Duration of Instruction - the number of contact hours of instruction, taking into consideration the duration of the program; and 5) Frequency of Instruction instruction must occur during each career stage and at least once every four years. See also NOT-OD-10-019. The plan should be appropriate and reasonable for the nature and duration of the proposed program.

Applications lacking a plan for instruction in responsible conduct of research will not be reviewed.

Evaluation Plan. Applications must include a plan for evaluating the activities supported by the research education program. The application must specify baseline metrics (e.g., numbers, educational levels, and demographic characteristics of participants), as well as measures to gauge the short or long-term success of the research education program in achieving its objectives. Wherever appropriate, applicants are encouraged to obtain feedback from participants to help identify weaknesses and to provide suggestions for improvements.

Letters of Support

A letter of institutional commitment must be attached as part of Letters of Support. Appropriate institutional commitment should include the provision of adequate staff, facilities, and educational resources that can contribute to the planned research education program.

Progress Report Publication List: Publications resulting from resources or developmental work carried out by the REC should be listed.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genomic Data Sharing (GDS)) as provided in the SF424 (R&R) Application Guide, with the following modification:

Dissemination Plan: A specific plan must be provided to disseminate nationally any findings resulting from or materials developed under the auspices of the research education program, e.g., sharing course curricula and related materials via web postings, presentations at scientific meetings, workshops.

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 .

Planned Enrollment Report (Research Education Component (RL5))

Not Applicable

PHS 398 Cumulative Inclusion Enrollment Report (Research Education Component (RL5))

Not Applicable

When preparing your application in ASSIST, use Component Type 'Core.

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

Satellite Diagnostic and Treatment Clinics (SDTCs) are designed to increase the heterogeneity of the research participant pool and to enhance the research capabilities of the ADC by extending the activities of the clinical core. Existing Centers should retain any satellites or any special recruitment activities within the clinical and education cores previously designated as a satellite and should describe these activities in a separate section of the application labeled as a separate core. New satellite clinics may be proposed if they fit within the overall budget requirements. Satellite clinics are not required to conduct research but should serve as vehicles for the recruitment, diagnosis and management of people with dementia and other research volunteers from rural and diverse and underserved communities, who are then offered the opportunity to participate in research protocols, clinical drug trials and autopsy. Effective satellites usually include multicultural staff members who have links to the community being involved. In addition, the satellite should have clearly delineated interactions with all of the other cores of the center.

SF424 (R&R) Cover (Satellite Diagnostic and Treatment Clinic Core)

Complete only the following fields:

• Applicant Information
• Type of Applicant (optional)
• Descriptive Title of Applicant’s Project (Note: If applicable, Project Title is Core G: Satellite Diagnostic and Treatment Clinic Core)
• Proposed Project Start/Ending Dates

PHS 398 Cover Page Supplement (Satellite Diagnostic and Treatment Clinic Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Satellite Diagnostic and Treatment Clinic Core)

Human Subjects: Answer only the Are Human Subjects Involved? and 'Is the Project Exempt from Federal regulations? questions.

Vertebrate Animals: Answer only the Are Vertebrate Animals Used? question.

Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components

Facilities and Other Resources: Provide a description of all resources for this core..

Project /Performance Site Location(s) (Satellite Diagnostic and Treatment Clinic Core)

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

Research & Related Senior/Key Person Profile (Satellite Diagnostic and Treatment Clinic Core)

• In the PD/PI section of the form, use Project Role of Other with Category of Core Leader and provide a valid eRA Commons ID in the Credential field.
• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
• Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component. ASSIST only allows a single biosketch for each person. Therefore the biosketches must be comprehensive, covering multiple roles if a single individual has multiple roles.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.
• The Core Leader for a Satellite should have experience in the relevant community as well as expertise in diagnosing Alzheimer’s and other neurodegenerative diseases. This person could be a neurologist, a neuropsychologist, psychiatrist, geriatrician or other clinician. This Core Leader should have a track record of research in some aspect of neurodegenerative disease, preferably including interactions with key personnel from other cores.

Budget (Satellite Diagnostic and Treatment Clinic Core)

Budget forms appropriate for the specific component will be included in the application package.

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

PHS 398 Research Plan (Satellite Diagnostic and Treatment Clinic Core)

Introduction to Application: For Resubmission applications, an Introduction to Application is allowed for each component.

Specific Aims: Clearly state how the core will contribute to the goals of the ADC and outline interactions of the core with each of the other components of the center.

Research Strategy: Organize the Research Strategy into sections on: Significance, Innovation and Approach.

Significance: Explain the role of the Satellite core in the center as a whole and as a community resource on Alzheimer’s Disease and related dementias.

Approach: Describe how the Satellite will serve any of the needs identified from the ORE core needs assessment, with a particular focus on underserved populations.

New applications should describe preliminary organizational work, institutional experience with AD and other neurodegenerative disease research, potential for developing new and exciting research, and specific plans for implementation of the new program.

For Renewal Applications: Place overall summaries of progress in the approach section of each core. Describe the most important contributions to research on AD, related dementias and aging utilizing core resources. Reports should include Core objectives and progress in meeting them. Basic functions of the core should be briefly summarized. Any developmental work carried out by the core should also be presented.

Progress Report Publication List: Publications resulting from resources or developmental work carried out by the core should be listed.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genomic Data Sharing (GDS)) as provided in the SF424 (R&R) Application Guide, with the following modification:

Consistent with achieving the goals of this program, applicants are expected to cooperate fully and to share specimens with other research scientists both within and outside the Centers network as well as data concerning clinical core participants with the NIA-sponsored National Alzheimer’s Coordinating Center (NACC) where uniform data from all AD Centers is centrally stored. Any genetic specimens collected by the Center (blood samples and DNA) should be made available to the National Cell Repository for Alzheimer’s Disease (NCRAD) in accordance with agreed upon protocols and policies. Centers may also be requested to contribute other biological samples such as serum and cerebrospinal fluid, using agreed upon protocols, for trans-center studies examining biomarkers that might relate to risk, diagnosis or progression of AD. Therefore, consent forms should be written to allow for this possibility as well as for the possibility of eventual data sharing with the wider research community, while maintaining participants confidentiality. The Steering Committee of the NACC in conjunction with the ADC Directors and the NIA sets policies that allow the individual Centers to conduct unique research with participants while also sharing common data sets with NACC.

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.

Planned Enrollment Report (Satellite Diagnostic and Treatment Clinic Core)

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

PHS 398 Cumulative Inclusion Enrollment Report (Satellite Diagnostic and Treatment Clinic Core)

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

When preparing your application in ASSIST, use Component Type Core.

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

The NIA will support additional cores that provide opportunities for scientific research beyond those attainable solely through support of the mandatory cores and other functions. However, any optional cores should fit within the budget restrictions outlined in the budget guidelines for the application. Support should not be requested for cores that only replace or centralize resources supported on individual project grants. In a Center grant application, it is not sufficient for the PD/PI merely to identify such centralized resources. Rather, it should be demonstrated exactly how each core would augment or enhance the present capabilities of investigators using center resources to make possible new activities at the home Center as well as other Centers.

Some examples of research support that core components could provide are:

• medicinal chemistry;
• microarray facilities;
• transgenic animal or cell preparation;
• tissue and/or cell culture facilities;
• complex instrumentation, e.g., electron microscopy, mass spectrometry, electrophysiology;
• imaging;
• genetics;
• caregiving; and
• proteomics, metabolomics.

SF424 (R&R) Cover (Additional Cores)

Complete only the following fields:

• Applicant Information
• Type of Applicant (optional)
• Descriptive Title of Applicant’s Project (Note: If applicable, should be identified with subsequent consecutive letters.)
• Proposed Project Start/Ending Dates

PHS 398 Cover Page Supplement (Additional Cores)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Additional Cores)

Human Subjects: Answer only the Are Human Subjects Involved? and 'Is the Project Exempt from Federal regulations? questions.

Vertebrate Animals: Answer only the Are Vertebrate Animals Used? question.

Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

Facilities and Other Resources: Provide a description of all resources for this core..

Project /Performance Site Location(s) (Additional Cores)

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

Research & Related Senior/Key Person Profile (Additional Cores)

• In the PD/PI section of the form, use Project Role of Other with Category of Core Leader and provide a valid eRA Commons ID in the Credential field.
• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
• Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component. ASSIST only allows a single biosketch for each person. Therefore the biosketches must be comprehensive, covering multiple roles if a single individual has multiple roles.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.

Budget (Additional Cores)

Budget forms appropriate for the specific component will be included in the application package.

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

PHS 398 Research Plan (Additional Cores)

Introduction to Application: For Resubmission applications, an Introduction to Application is allowed for each component.

Specific Aims: Clearly state how the core will contribute to the goals of the ADC and outline interactions of the core with each of the other cores of the center.

Demonstrate the augmentation or enhancement of capabilities of center resources to make possible new activities at the applicant center as well as other centers.

Research Strategy: Organize the Research Strategy into sections on: Significance, Innovation and Approach. There should be a detailed discussion of the project(s) that will use resources of additional cores.

New applications should describe preliminary organizational work, institutional experience with AD and other neurodegenerative disease research, potential for developing new and exciting research, and specific plans for implementation of the new program.

For Renewal Applications: Place overall summaries in the approach section of each core. Describe the most important contributions to research on AD, related dementias and aging utilizing core resources. Reports should include Core objectives and progress in meeting them. Basic functions of the core should be briefly summarized. Any developmental work carried out by the core should also be presented.

Progress Report Publication List: Publications resulting from resources or developmental work carried out by the core should be listed.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genomic Data Sharing (GDS)) as provided in the SF424 (R&R) Application Guide, with the following modification:

Consistent with achieving the goals of this program, applicants are expected to cooperate fully and to share specimens with other research scientists both within and outside the Centers network as well as data concerning clinical core participants with the NIA-sponsored National Alzheimer’s Coordinating Center (NACC) where uniform data from all AD Centers is centrally stored. Any genetic specimens collected by the Center (blood samples and DNA) should be made available to the National Cell Repository for Alzheimer’s Disease (NCRAD) in accordance with agreed upon protocols and policies. Centers may also be requested to contribute other biological samples such as serum and cerebrospinal fluid, using agreed upon protocols, for trans-center studies examining biomarkers that might relate to risk, diagnosis or progression of AD. Therefore, consent forms should be written to allow for this possibility as well as for the possibility of eventual data sharing with the wider research community, while maintaining participants confidentiality. The Steering Committee of the NACC in conjunction with the ADC Directors and the NIA sets policies that allow the individual Centers to conduct unique research with participants while also sharing common data sets with NACC.

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

Planned Enrollment Report (Additional Cores)

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

PHS 398 Cumulative Inclusion Enrollment Report (Additional Cores)

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

See Part I. Section III.1 for information regarding the requirements for obtaining a Dun and Bradstreet Universal Numbering System (DUNS) Number and for completing and maintaining an active System for Award Management (SAM) registration. Part I. Overview Information contains information about Key Dates. 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.

Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies) using ASSIST or other electronic submission systems. 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.

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.

For information on how your application will be automatically assembled for review and funding consideration after submission go to: http://grants.nih.gov/grants/ElectronicReceipt/files/Electronic_Multi-project_Application_Image_Assembly.pdf.

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.

Important reminders:

All PD(s)/PI(s) and component Project Leads 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.

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 (SAM). 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.

In order to expedite review, applicants are requested to notify the NIA Referral Office by email at Vemuri@mail.nih.gov when the application has been submitted. Please include the FOA number and title, PD/PI name, and title of the application.

In order to assure active collaboration with other Centers, the ADCC PD/PI and other staff should attend semi-annual meetings of the ADC PD/PIs and other ad hoc meetings arranged by the ADCs or the NIA to share research findings, participate in planning for cooperative research or help to refine and standardize operating procedures among the Centers.

Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-13-030.

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 center 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 center 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 core that by its nature is not innovative may be essential to advance a field.

Does the center address an important problem or a critical barrier to progress in the field? If the aims of the center 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?

How strong is the base of ongoing high quality research in AD and other related neurodegenerative disorders? Do the stated goals and plans demonstrate potential for contributing to cutting edge research on normal aging, MCI, AD and related disorders? How well is the center able to participate in coordinated national efforts for collaborative research (including establishing a network of investigators, sharing data and resources within the network, and holding jointly organized meetings)? Does the proposed ADC provide a supportive environment for trainees, postdoctoral fellows and junior faculty who are supported through different awards? Does the application document the research, both existing and planned, whether funded by the Center or not, that has, or will depend upon, resources provided by the requested cores?

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the center? 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?

How well do the investigators and staff provide creative scientific and administrative leadership of the Center and demonstrate a commitment to devote adequate time to the management of the ADCC program? Is there evidence of collaboration and interdisciplinary research among the investigators who will be associated with the ADCC? Does the group have stability? Are plans for recruitment of new personnel addressed? Are transition plans clearly described and feasible?

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?

How well do the proposed center and each component demonstrate the capacity to develop critical new knowledge and unique and innovative contributions to AD research locally, nationally and internationally?

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

If the centerinvolves 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?

How well does the proposed Center demonstrate appropriate organization and core management? Are the organizational plan and management structure adequate to meet Center goals? Are the procedures for internal communication and cooperation among the investigators adequate?

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?

How adequate are the relevant facilities for the proposed work? Does the geographic relationship between facilities seem reasonable to carry out the proposed work? How strong are the environment and core resources to enhance cutting-edge research by bringing together multidisciplinary investigators?

As applicable for the core 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.

Administrative Core

How strong is the administrative foundation to support the proposed activities and affiliated research projects?

How well does the proposed Center demonstrate appropriate organization and core management? Are the organizational plan and management structure adequate to meet Center goals? Are the procedures for internal communication and cooperation among the investigators adequate?

Clinical Core

Do the stated goals, plans and targeted population demonstrate potential for contributing to cutting edge research on normal aging, MCI, early AD and related disorders? If any special populations are proposed, are they clearly described and does their inclusion contribute substantially to the overall goals?

Does the application clearly describe how the clinical core, in addition to participant recruitment, will provide: evaluation, and diagnosis, maintain a research volunteer registry that tracks number and reasons for those lost to follow-up, and conduct longitudinal follow up of participants? Are procedures for sample collection, storage and evaluation clearly described? Are interactions and roles of other cores clearly described?

Data Management and Statistical Core

Are both database and statistical services sufficiently described? Is it clear how the core will contribute to the goals of the ADC as well as the national efforts of the ADC program?

Are the data management and statistical plans clearly described? How well will the staff foster working relationships with the data contributors and harmonize the data collection? Will data be available in a useful format for both planned and future analyses? Are appropriate safety procedures in place? Are the plans for timely transmission of UDS data to NACC appropriate and reasonable?

Neuropathology Core

Is it clear how the core will contribute to the goals of the ADC and provide a resource for other national and international research activities focused on Alzheimer’s disease and other neurodegenerative diseases?

Are the diagnostic methods and collection and distribution of samples clearly described? Will the identity of the participants be protected?

Outreach and Recruitment Core

Is it clear how the core will contribute to the goals of the ADC as well as the national efforts of the ADC program? Does the core serve as a community resource?

Is the needs assessment well described? Are the needs identified met by the proposed plan? Are interactions of this core with the other cores well described?

Research Education Component

Does the proposed program address a key audience and an important aspect or important need in research education? Is there convincing evidence in the application that the proposed program will significantly advance the stated goal of the program?

If applicable, is there evidence that the participating faculty have experience in mentoring students and teaching science? If applicable, are the faculty good role models for the participants by nature of their scientific accomplishments?

Taking into consideration the nature of the proposed research education program, does the applicant make a strong case for this program effectively reaching an audience in need of the program’s offerings? Where appropriate, is the proposed program developing or utilizing innovative approaches and latest best practices to improve the knowledge and/or skills of the intended audience?

Does the proposed program clearly state its goals and objectives, including the educational level of the audience to be reached, the content to be conveyed, and the intended outcome? Is there evidence that the program is based on a sound rationale, as well as sound educational concepts and principles? Is the plan for evaluation sound and likely to provide information on the effectiveness of the program? If the proposed program will recruit participants, are the planned recruitment, retention, and follow-up (if applicable) activities adequate to ensure a highly qualified participant pool?

Will the scientific and educational environment of the proposed program contribute to its intended goals? Is there a plan to take advantage of this environment to enhance the educational value of the program? Is there tangible evidence of institutional commitment? Is there evidence that the faculty have sufficient institutional support to create a sound educational environment for the participants? Where appropriate, is there evidence of collaboration and buy-in among participating programs, departments, and institutions?

Satellite Diagnostic and Treatment Clinic

Is it clear how the core will contribute to the goals of the ADC and meet the needs identified for the ADC? Does the core serve as a community resource?

Are the plans and procedures clearly described? Do they address needs identified for the center and the local community? Are interactions of this core with the other cores well described?

Additional Cores

Is it clear how the core will contribute to the goals of the ADC as well as the national and international research goals focused on Alzheimer’s disease and other neurodegenerative diseases?

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

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 core 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 five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia. 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.

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

For Renewals, the committee will consider the progress made in the last funding period.

Not Applicable

As applicable for the core 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.

Recruitment Plan to Enhance Diversity

Peer reviewers will separately evaluate the recruitment plan to enhance diversity after the overall score has been determined. Reviewers will examine the strategies to be used in the recruitment of individuals from underrepresented groups. The review panel’s evaluation will be included in the summary statement. Plans will be rated as acceptable or unacceptable, and the summary statement will provide the consensus of the review committee.

Training in the Responsible Conduct of Research

Taking into account the specific characteristics of the proposed research education program, the level of participant experience, the reviewers will evaluate the adequacy of the proposed RCR training in relation to the following five required components: 1) Format - the required format of instruction, i.e., face-to-face lectures, coursework, and/or real-time discussion groups (a plan with only on-line instruction is not acceptable); 2) Subject Matter - the breadth of subject matter, e.g., conflict of interest, authorship, data management, human subjects and animal use, laboratory safety, research misconduct, research ethics; 3) Faculty Participation - the role of the program faculty in the instruction; 4) Duration of Instruction - the number of contact hours of instruction, taking into consideration the duration of the program; and 5) Frequency of Instruction instruction must occur during each career stage and at least once every four years. See also: NOT-OD-10-019. The review panel’s evaluation will be included in the summary

statement. Plans will be rated as acceptable or unacceptable, and the summary statement will provide the consensus of the review committee.

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

The adequacy of plans to share brain tissue and biological specimens with other research scientists both within and outside the AD Centers network will be assessed. Any specimens that could be used for genetics research (e.g., blood, tissue) by the Center should be made available to the National Cell Repository for Alzheimer's Disease (NCRAD) in accordance with agreed upon protocols and policies.

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 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.

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 Council on Aging. 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.

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.

Awardee-selected projects that involve {clinical trials or studies involving greater than minimal risk to human subjects} require prior approval by NIH prior to initiation.

The awardee institution will provide NIH with written study protocols that address risks and protections for human subjects in accordance with NIH s Instructions for Preparing the Human Subjects Section of the Research Plan.

The awardee institution will provide NIH with specific plans for data and safety monitoring, and will notify the IRB and NIH of serious adverse events and unanticipated problems, consistent with NIH DSMP policies.

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.

Cooperative Agreement Terms and Conditions of Award

Not Applicable

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.

Continuation support will not be provided until the required forms are submitted and accepted. Programs that involve participants should report on education in the responsible conduct of research and complete a Training Diversity Report, in accordance with the RPPR Instruction Guide.

• The institution must submit a completed Statement of Appointment (PHS Form 2271) for each participant appointed full time for eight weeks or more or the equivalent. Grantees must submit the PHS 2271 data electronically using the xTrain system. More information on xTrain is available at xTrain (eRA Commons). An appointment or reappointment may begin any time during the budget period, but not before the budget period start date of the grant year.
• Participant Termination Notice: Within 30 days of the end of the total support period for each participant, the institution must submit a Termination Notice (PHS Form 416-7) via xTrain for each participant appointed full time for eight weeks or more, or the equivalent.

In carrying out its stewardship of human resource-related programs, the NIA will periodically evaluate REC programs, employing the measures identified below. In assessing the effectiveness of its research education investments, NIA may request information from databases, PD/PIs, and from participants themselves. Where necessary, PD/PIs and participants may be contacted after the completion of a research education experience for periodic updates on participants subsequent educational or employment history and professional activities.

In evaluating REC, the NIA expects to use the following evaluation measures:

• Aggregate number and demographic characteristics of participants
• Educational level of participants
• Evidence of new knowledge or skills acquired that promote the development of future research leaders in Alzheimer's disease related research
• Subsequent educational/career progress of participants, including, subsequent employment in a field related to Alzheimer's disease research
• Subsequent independent research grant support from NIH or another source

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.

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
Web ticketing system: https://grants-portal.psc.gov/ContactUs.aspx
Email: support@grants.gov

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Email: GrantsInfo@nih.gov (preferred method of contact)
Telephone: 301-710-0267

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

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

Traci Lafferty
National Institute on Aging (NIA)
Telephone: 301-496-8987
Email: laffertt@nia.nih.gov

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

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241, 284, and 285e-2) and under Federal Regulations 42 CFR Part 52 and 45 CFR Part 75.