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). 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

The National Institute on Aging (NIA) requests submission of a Renewal application for a limited competition for the National Cell Repository for Alzheimer’s Disease (NCRAD). NCRAD was established in 1990 to recruit, collect, maintain and distribute information and biological specimens on large numbers of genetically informative, phenotypically well-characterized families having multiple individuals affected with AD. Initial efforts were focused on the recruitment of early onset, autosomal dominant families. Subsequently, NCRAD expanded its focus to include late onset families as well as kindreds with familial non-AD dementia, such as the Fronto-temporal Disorders. In 2003, NCRAD became the repository for a large NIA-sponsored genetics initiative to expand the collection of families with late onset AD (LOAD Study). In addition, NCRAD has become a key sample repository for the NIA sponsored Alzheimer's Disease Centers, the Alzheimer Disease Genetic Consortium (ADGC) and the Alzheimer's Disease Sequencing Project (ADSP), which have led collaborative efforts among US dementia researchers. These consortia include the network of NIA-funded Alzheimer's Disease Centers and the National Alzheimer's Coordinating Center (NACC). NCRAD has developed working relationships with all of these entities and future success depends on keeping the relationships together. An important aspect of NCRAD function is to continue to coordinate with NACC and to provide infrastructural support for the ADGC, ADSP, and other NIA-funded genetic studies such as the Late Onset Alzheimer's Disease (LOAD) Family Study, Alzheimer's Disease Neuroimaging Initiative (ADNI), and other multiple- and single-site studies that involve the collection and banking of biospecimens for genetic research on Alzheimer's disease. In the next 5 years NCRAD should continue to work toward:

• Being a state-of-the-art sample repository for DNA, cell lines, plasma, serum, RNA, brain tissue, cerebrospinal fluid and peripheral blood mononuclear cells or fibroblasts that could be used to produce IPSCs;
• Providing overall project management of research and resource goals, the ability to receive and organize previously collected biosamples and new biospecimen collections when approved by NCRAD Executive Committee (NEC), and plans for working with a range of stakeholders including government, academic scientists, industry, and data-management experts such as National Alzheimer's Coordinating Center (NACC) and National Institutes on Aging Genetics of Alzheimer's Disease Data Storage Site (NIAGADs);
• Providing scientific and laboratory expertise. This will require the skills and flexibility to apply cutting-edge science to the development and use of biospecimen protocols and QA/QC assays. It will require coordination of the receipt, processing, storage, and distribution of biospecimens from a variety of projects;
• Having the ability to link clinical data with biosamples. Projects supported by NCRAD will include both academic and industry-based research. Data sharing and protocol standardization is expected to play a significant role in the success of this as a community research resource. A user-friendly, query-based website is an essential component of the overall activity.

It is expected in the next five-year funding period that NCRAD will expand its scope to ensure that the NIA will have a central biospecimen repository that will meet the needs of genetic research on Alzheimer's disease and related neurodegenerative diseases, such as Frontotemporal Disorders, Lewy Body disorders and Down Syndrome. NCRAD should be a state-of-the-art central biospecimen repository for samples (DNA, cell lines, plasma, serum, RNA, brain tissue) collected by other NIA-funded studies. NCRAD will distribute data and biospecimens to qualified investigators for use in research studies following government guidelines and regulations.

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

Eligibility is limited to applications from currently active NIA-funded U24 awards with established relationships with the National Alzheimer's Coordinating Center, the network of NIA-funded Alzheimer's Centers and the NIA-funded Alzheimer's Disease Genetics Consortium.

Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.
Foreign components, as defined in the NIH Grants Policy Statement, are not allowed.

Applicant Organizations

Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date’s 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 must download 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.

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. 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:

Tony Phelps, Ph.D.
National Institute on Aging (NIA)
Telephone: 301-496-9350
Fax: 301-496-1694
Email: phelpsc@mail.nih.gov

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

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

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

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

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

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

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

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

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

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

Specific Aims: Provide a succinct description of how the proposed work will continue to meet the overall scientific goals, the expected outcomes, and the impact of NCRAD, should those goals be achieved. Refer to the Funding Opportunity Description in Section I when formulating specific aims.

Research Strategy: Provide an overall description of the proposed organizational structure and project management plan and show how it will serve particular communities of researchers studying Alzheimer's disease.

Describe the strategy for effectively carrying out each specific aim including the establishment of an Executive Committee. Applicants should present an integrated plan that will be responsive to and flexible regarding the evolving needs of the scientific community especially the Alzheimer's Disease Genetics Consortium, the Alzheimer's Disease Sequencing Project and other major genetics projects.

Show how the plan to arrange coordinated receipt and distribution of biospecimens will facilitate research in Alzheimer's disease that is supported on independent projects. Refer to the funding Opportunity Description in Section I when developing the Research Strategy.

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:

• All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.

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

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). Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date. If a Changed/Corrected application is submitted after the deadline, the application will be considered late.

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

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

This initiative is not subject to intergovernmental review.

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

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

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

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

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

Important reminders:

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

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

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review, NIH. Applications that are incomplete or non-compliant will not be reviewed.

Applicants are required to follow our Post Submission Application Materials policy.

Important Update: See NOT-OD-16-006 for updated review language for applications for due dates on or after January 25, 2016.

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

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

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

Does the project address an important problem or a critical barrier to progress in the field? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

Is the proposed repository needed to achieve the goals of the research programs it proposes to serve? How responsive is the proposed structure likely to be to evolving needs in the community including the Alzheimer’s Disease Genetics Consortium, the Alzheimer’s Disease Sequencing Project, and other major genetics projects? Will coordinated receipt and distribution of biospecimens facilitate or expedite research that would be delayed or infeasible if conducted as independent projects? What advantages will the repository bring to the research programs it services?

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or New Investigators, or in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?

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

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

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

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

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

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

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

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following 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.

For Revisions, the committee will consider the appropriateness of the proposed expansion of the scope of the project. If the Revision application relates to a specific line of investigation presented in the original application that was not recommended for approval by the committee, then the committee will consider whether the responses to comments from the previous scientific review group are adequate and whether substantial changes are clearly evident.

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

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 Wide Association Studies (GWAS) /Genomic Data Sharing Plan.

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:

• Will receive a written critique.

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.

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

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

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

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

The awardee, as National Cell Repository for Alzheimer's Disease (NCRAD) PD/PI, will coordinate project activities:

• Scientifically and administratively at the awardee institution, and will have primary responsibility for performing all scientific and fee-for-service activities. The PI agrees to accept the close coordination, cooperation, and participation of the NIA Scientific Officer and NCRAD Executive Committee (NEC) in those aspects of scientific and technical management of the project as described below;
• Specifically, the PD/PI will:
• Develop guidelines and procedures related to cell bank operations and seek approval from NEC;
• Design protocols, oversee the provision of services and research resources to the scientific community, and work cooperatively to set project milestones, in consultation with NIA program staff and NEC;
• Receive biomaterials and data files from the Alzheimer's Disease Centers (ADCs) the National Alzheimer's Coordinating Center (NACC) and other scientists, ascertain that proper informed consent exists for all samples, develop a unique coding system for each sample that de-identifies patient data, and distribute biomaterials and data files to qualified researchers granted access by criteria set up by NEC and consistent with NIH data and biomaterials sharing policies. (see below);
• Provide free DNA extraction and banking for all NIA funded ADCs and other dementia related studies approved by NEC;
• Define a protocol detailing the requirements for sharing of genotypic data to a central databank from scientists using cells and DNA obtained from NCRAD;
• Maintain a log of Cell Bank usage that records the products and Services provided and the fees charged;
• For each non-competing renewal, submit progress reports in the standard format, as required by NIH. The progress report will describe the activities and accomplishments of the Cell Bank for the preceding award period, and the goals to be accomplished during the renewal period. The progress report will include the log of Cell Bank usage. The contents of the progress report will be used by the NIA program officer, along with other information, to determine the amount of funding the Cell Bank will receive for the renewal period;
• Organize and set the agenda for at least one meeting of NEC, with additional advisors as appropriate, each year along with teleconferences as needed. The awardee will have one vote on NEC and will accept any modification, deletion, or addition of Cell Bank activities approved by NEC .. The PI will be responsible for preparing within 30 days a concise summary of each NEC meeting or teleconference for distribution to participants;
• Attend and participate in ADC Director's meetings twice-yearly meetings.

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

The NIA Project Scientist will have substantial scientific involvement during the conduct of this activity through technical assistance, advice, and coordination above and beyond normal stewardship. This includes facilitating the partnership relationship between the NIA and the Cell Bank, helping to maintain the overall scientific balance in the program commensurate with emerging research opportunities, and ensuring that the activities of the Cell Bank are consistent with the scientific mission of the NIA Alzheimer's Disease Genetic Initiative. Access to research resources maintained in the Cell Bank will be determined by the NEC with input from NIA and consistent with NIH sharing policies (see below). The NIA Project Scientist shall be a voting member of NEC. The Program Official (see below) and other NIA staff involved with the genetics initiative may also attend meetings of NEC as observers but will not have voting privileges.

Specifically, the NIA Project Scientist will:

• Provide relevant scientific expertise and overall knowledge;
• Advise the NCRAD Director regarding recruitment of members and replacement of existing members of NEC should any choose to leave.
• Attend NEC meetings and assist in developing operating guidelines, quality control procedures, and consistent policies for dealing with recurrent situations that require coordinated action;
• Participate with other NEC members in the group process of setting priorities and milestones, deciding optimal approaches and protocol designs, and contributing to the adjustment of protocols or approaches as warranted;
• Serve as administrative liaison to NACC and the ADCs and help coordinate Cell Bank activities with those of the complimentary programs. The Scientific Officer will coordinate Cell Bank activities with the scientific mission and evolving goals of the NIA Alzheimer's Genetics Initiative, with input as required from NEC and other NIA staff. The Scientific Officer will also coordinate Cell Bank activities with other US and international efforts that focus on sharing research resources for genetic analyses of complex diseases.

The NIA Program Official is responsible for normal stewardship of the Cooperative agreement and will:

• Serve as program liaison between the Cell Bank and other NIA staff involved in the Genetics Initiative;
• Assist in promoting and encouraging the sharing of unique research resources for genetic studies of Alzheimer's disease and other dementias of aging by the scientific community at large;
• Retain the option to recommend re-allocating NIA support provided to the Cell Bank, as scientific goals evolve;
• Determine the amount of support that will be awarded to the Cell Bank as a non-competing renewal. The progress report received from the Cell Bank, along with other information, will be used to make this determination. The criteria used for this decision will include, but not be limited to, Cell Bank productivity e.g.. number of samples banked and distributed, customer satisfaction, and successful performance of the Cell bank in providing services to the genetic research community.

Scientific Oversight - NCRAD Executive Committee (NEC):

The NEC will meet at least once each year and will oversee Cell Bank Activities to assure that the needs of the broader scientific community for research resources necessary for the genetic analysis of Alzheimer's disease and other dementias of aging are being met. NEC will provide oversight of the Cell Bank, and scientific advice to NIA. NEC members will provide scientific and operational oversight concerning both long-term developments and distribution activities at the Cell Bank. NEC also will consult on the incorporation of emerging genomic and genetic tools and technologies into Cell Bank activities.

The NEC will consist of approximately 10 scientists including the Director of NACC and the NIA Scientific Officer. NEC members will be selected by the NCRAD Director after consultation with the NIA. Members will be selected for their broad expertise in relevant topics such as molecular biology, molecular genetics, genomics, pharmacogenomics, statistical genetics, epidemiology, bioinformatics, cell and DNA banking, and Alzheimer's genetics. One member of NEC will be appointed by the NCRAD Director/PI to chair NEC after consulting with NEC members and NIA.

Additional NEC members may be added with agreement between NEC and the NIA. The NIA Scientific Officer (voting member) and Program Official (non-voting member) will attend NEC meetings and will act as representatives of NIA. Other NIA staff involved with the Genetics Initiative may attend the NEC meetings to help facilitate specific discussions. The NIA Program Official will consider NEC opinions with regard to overall Cell Bank functioning and when making determinations for renewal funding.

Data Sharing:

Providing access to data and biomaterials collected in Alzheimer's genetic studies for qualified investigators in the wider scientific community is a guiding principle of the NIA Alzheimer's Genetics Initiative. To address the joint interests of the government in the availability of, and access to, the results of publicly funded research and in the opportunity for economic development based on these results, the NIA expects that the information to be shared will include clinical, diagnostic, and pedigree structure information, in addition to cell lines and DNA. Oversight for this process will be provided by the NEC and the NIA.

More specifically, it is expected that the Indiana Cell Bank will when requested: (1) establish cell lines, from which DNA will be extracted and stored; (2) provide data to qualified investigators related to the clinical phenotype, diagnostic criteria and pedigree structure for cell lines, DNA and other specimens from the Cell bank; and (3) set up mechanisms by which data and biomaterials can be made easily available to qualified investigators in the scientific community

Areas of Joint Responsibility include:

None. All responsibilities are divided between awardees and NIH staff as described above.

Dispute Resolution:

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

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

A final progress report, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement.

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

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: https://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 CenterTelephone: 800-518-4726
Email: support@grants.gov

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Email: GrantsInfo@nih.gov (preferred method of contact)
Telephone: 301-945-7573

Creighton H. Phelps, Ph.D.
National Institute on Aging (NIA)
Telephone: 301-496-9350
Email: phelpsc@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 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Part 75.