Part 1. Overview Information

Key Dates

All applications are due by 5:00 PM local time of applicant organization. 

Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.

No late applications will be accepted for this Notice of Funding Opportunity (NOFO).

It is critical that applicants follow the instructions in the Research (R) Instructions in the How to Apply - Application Guide, except where instructed to do otherwise (in this NOFO or in a Notice from NIH Guide for Grants and Contracts).

Conformance to all requirements (both in the How to Apply - Application Guide and the NOFO) is required and strictly enforced. Applicants must read and follow all application instructions in the How to Apply - Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the How to Apply - Application Guide, follow the program-specific instructions.

Applications that do not comply with these instructions may be delayed or not accepted for review.

Part 2. Full Text of Announcement

Section I. Notice of Funding Opportunity Description

Purpose

This is a non-competitive funding opportunity intended to fund a single award. Through this NOFO, NIA is announcing its intent to issue a single source cooperative agreement award to Indiana University Indianapolis for the National Centralized Repository for Alzheimer's Disease and Related Dementias (NCRAD).

Background

NCRAD is an essential infrastructure for NIA-funded Alzheimer's disease (AD) and AD-related dementias (ADRD) research, providing a biorepository that currently supports 74 studies (including 35 Alzheimer’s Disease Research Centers). This single source cooperative agreement will support the continuation of this central biospecimen repository for all NIA-funded dementia studies and its facilitation of sample sharing, as well as a biomarker assessment laboratory, which advances biomarker research with high quality control and harmonization with other laboratories. NCRAD is necessary to the continued support of multiple larger NIA infrastructure projects, including National Alzheimer’s Coordinating Center (NACC), Alzheimer's Disease Sequencing Project (ADSP) Functional Genomics Consortium, and NIA Center for Alzheimer’s and Related Dementia. 

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 (Late Onset Alzheimer's Disease (LOAD) Family Study). In addition, NCRAD has become a key repository for the NIA-sponsored Alzheimer's Disease Research Centers, the Alzheimer Disease Genetic Consortium (ADGC), and the ADSP, which have led collaborative efforts among U.S. dementia researchers. An important aspect of NCRAD’s function is the continued coordination with the National Alzheimer’s Coordinating Center (NACC) and infrastructural support for the ADGC, ADSP, and other NIA-funded studies such as the LOAD Family Study, Alzheimer's Disease Neuroimaging Initiative (ADNI), Alzheimer Biomarkers Consortium — Down Syndrome (ABC-DS) and the Alzheimer’s Gut Microbiome Project and other multiple- and single-site studies that involve the collection and banking of biospecimens for research on Alzheimer's disease and other dementias.

In 2018, NIA supported the expansion of the number of studies and types of samples NCRAD collected to address increasing needs in the AD research community. Additionally, NCRAD supports multiple new NIA-funded national efforts and should plan for continued increases in capacity to support future studies. Major goals for the next period will be to continue to expand collected samples, both in terms of participant demographics and types of studies, and increase the availability of samples through active promotion that assures their maximum utility by a wider research community.

Research Objectives

In the next 5 years NCRAD will continue to:

• Maintain and enhance the existing NCRAD infrastructure to continue to provide a centralized resource and repository for DNA, cell lines, plasma, serum, RNA, brain tissue, cerebrospinal fluid and peripheral blood mononuclear cells or fibroblasts, induced pluripotent stem cells (IPSCs), and other emerging biological samples and reagents.
• Provide overall biorepository management expertise, including procedure manual development, training videos, site training, sample kits, direct study support (calls and meetings), data reconciliation (as needed), and the ability to receive and track previously collected biosamples and new biospecimen collections. The applicant should include plans for working with a range of stakeholders, including government, academic scientists, industry, and large national projects, such as NACC and NIA Genetics of Alzheimer's Disease Data Storage Site (NIAGADS).
• Provide established and commercially available fluid based AD/ADRD biomarkers assays ensuring standardization of processes and delivery of reliable and consistent research biomarker results for samples banked at NCRAD.
• Support projects by supplying needed scientific and laboratory expertise. Apply cutting-edge science to the development and use of biospecimen protocols and QA/QC assays. Coordinate the receipt, processing, storage, and distribution of biospecimens from a variety of projects, and support the review and recommendation by NCRAD Biospecimen Review Committee (BRC) for approval by NIA.
• Assure linkages connecting 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.
• Maintain a user-friendly, query-based website as an essential component of the overall activity. Provide dynamic bidirectional interactions/links with other resources such as NACC and NIAGADS to ensure the connection of biological samples, clinical information, and data generated from the samples. Support a tracking system to monitor, collect, and report usage statistics regarding information requests, sample and data distribution, and website visits.
• Continue to provide, in consultation with NIA, terms and conditions of the Material Transfer Agreement (MTA) for biosample deposition in NCRAD that assures data are returned and made available to other researchers. Maintain a Standard Operating Procedure (SOP) to provide investigators with instructions to initiate and complete the MTA.

In the next five-year funding period, it is expected that NCRAD will continue to evaluate and adapt to the growing needs of a wide variety of research on Alzheimer's disease and related neurodegenerative diseases, such as Frontotemporal Degeneration, 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, stool, fibroblasts, peripheral blood mononuclear cells, iPSCs) 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.

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

Section II. Award Information

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

Section III. Eligibility Information

1. Eligible Applicants

Only the following applicant is eligible to apply for this single source funding: Indiana University Indianapolis. Please refer to Section I. Notice of Funding Opportunity Information for more details. 

Non-domestic (non-U.S.) Entities (Foreign Organizations) 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 How to Apply - 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. Failure to complete registrations in advance of a due date is not a valid reason for a late submission, please reference NIH Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications for additional information

• System for Award Management (SAM) – Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
  • NATO Commercial and Government Entity (NCAGE) Code – Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.
  • Unique Entity Identifier (UEI) - A UEI is issued as part of the SAM.gov registration process. The same UEI must be used for all registrations, as well as on the grant application.
• eRA Commons - Once the unique organization identifier is established, organizations can register with eRA Commons in tandem with completing their Grants.gov registrations; all registrations must be in place by time of submission. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
• Grants.gov – Applicants must have an active SAM registration in order to complete the Grants.gov registration.

Program Directors/Principal Investigators (PD(s)/PI(s))

All PD(s)/PI(s) must have an eRA Commons account.  PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.

Only the PD/PIs associated with the award issued under RFA-AG-21-005 to Indiana University Indianapolis is eligible to apply for this single source funding. Please refer to Section I. Notice of Funding Opportunity Information for more details.

2. Cost Sharing

This NOFO does not require cost sharing as defined in the NIH Grants Policy Statement NIH Grants Policy Statement Section 1.2 Definition of Terms.

3. Additional Information on Eligibility

Number of Applications

Only a single award will be issued to Indiana University Indianapolis under this single source funding opportunity. Please refer to Section I. Notice of Funding Opportunity Information for more details.

Section IV. Application and Submission Information

1. Requesting an Application Package

The application forms package specific to this opportunity must be accessed through ASSIST, Grants.gov Workspace or an institutional system-to-system solution. Links to apply using ASSIST or Grants.gov Workspace are available in Part 1 of this NOFO. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in the Research (R) Instructions in the How to Apply - Application Guide except where instructed in this notice of funding opportunity to do otherwise. Conformance to the requirements in the How to Apply - Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

Page Limitations

All page limitations described in the How to Apply – Application Guide and the Table of Page Limits must be followed.

The following section supplements the instructions found in the How to Apply – Application Guide and should be used for preparing an application to this NOFO.

SF424(R&R) Cover

All instructions in the How to Apply - Application Guide must be followed.

SF424(R&R) Project/Performance Site Locations

All instructions in the How to Apply - Application Guide must be followed.

SF424(R&R) Other Project Information

All instructions in the How to Apply - Application Guide must be followed.

Other Attachments:

Submit the following as separate attachments: 

1. Highlight the organization's procedures. Please name your file "Standard Operating Procedures.pdf".
2. Describe what samples are available and how collaborators will access the samples. Please name your file "Catalogs.pdf".
3. Provide a master list of acronyms. Please name your file "Acronym_Dictionary.pdf".
4. Describe a plan for raising awareness of this resource to maximize its use in the scientific community. Please name your file “Dissemination.pdf”.
5. Facility-derived training, continuing education, and certification programs for personnel. Please name your file “Personnel Training.pdf”

The filename provided for each “Other Attachment” will be the name used for the bookmark in the electronic application in eRA Commons.

SF424(R&R) Senior/Key Person Profile

All instructions in the How to Apply - Application Guide must be followed.

R&R Budget

All instructions in the How to Apply - Application Guide must be followed.

R&R Subaward Budget

All instructions in the How to Apply - Application Guide must be followed.

PHS 398 Cover Page Supplement

All instructions in the How to Apply - Application Guide must be followed.

PHS 398 Research Plan

All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions:

Applicants should refer to Section I. Notice of Funding Opportunity Description of this NOFO when formulating the specific aims and research strategy.

Specific Aims: 

• Provide a succinct description of how the proposed work will meet the overall scientific goals, the expected outcomes, and the impact of NCRAD, should those goals be achieved. 

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 and related dementias. 
• Provide an explicit strategy for assuring that the samples included in the repository reflect participants most at risk for the disease types collected.
• Describe the strategy for effectively carrying out each specific aim, including the plan and process for an Executive Committee. Theapplicant should present an integrated plan that will be responsive to and flexible regarding the evolving needs of the scientific community.
• Show how the plan to arrange coordinated receipt and distribution of biospecimens will facilitate research in Alzheimer's disease and related dementias that is supported by independent projects. 

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the How to Apply - Application Guide.

• All Standard Operating Procedures, laboratory manuals, and other procedural documents are expected to be made freely available, in order to allow harmonization across studies and in order to have full transparency regarding laboratory procedures, thus limiting the risk of batch effect in biomarkers research findings.

Other Plan(s): 

All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions:

• All applicants planning research (funded or conducted in whole or in part by NIH) that results in the generation of scientific data are required to comply with the instructions for the Data Management and Sharing Plan. All applications, regardless of the amount of direct costs requested for any one year, must address a Data Management and Sharing Plan.

Appendix: Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the How to Apply - Application Guide.

• No publications or other material, with the exception of blank questionnaires or blank surveys, may be included in the Appendix.

PHS Human Subjects and Clinical Trials Information

When involving human subjects research, clinical research, and/or NIH-defined clinical trials (and when applicable, clinical trials research experience) follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the How to Apply - Application Guide, with the following additional instructions:

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

Study Record: PHS Human Subjects and Clinical Trials Information

All instructions in the How to Apply - Application Guide must be followed.

Delayed Onset Study

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

PHS Assignment Request Form

All instructions in the How to Apply - Application Guide must be followed.

3. Unique Entity Identifier and System for Award Management (SAM)

See Part 2. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov

4. Submission Dates and Times

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

Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies). Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date and time.  If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications.

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 How to Apply – Application Guide.

5. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

6. Funding Restrictions

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

Pre-award costs are allowable only as described in the NIH Grants Policy Statement Section 7.9.1 Selected Items of Cost.

7. Other Submission Requirements and Information

Applications must be submitted electronically following the instructions described in the How to Apply - Application Guide. Paper applications will not be accepted.

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

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

Important reminders:

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

The applicant organization must ensure that the unique entity identifier provided on the application is the same identifier used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in the How to Apply - 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 National Institute on Aging, NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.

Recipients or subrecipients must submit any information related to violations of federal criminal law involving fraud, bribery, or gratuity violations potentially affecting the federal award. See Mandatory Disclosures, 2 CFR 200.113 and NIH Grants Policy Statement Section 4.1.35.

Send written disclosures to the NIH Chief Grants Management Officer listed on the Notice of Award for the IC that funded the award and to the HHS Office of Inspector Grant Self Disclosure Program at [email protected]. 

Post Submission Materials

Applicants are required to follow the instructions for post-submission materials, as described in the policy

Section V. Application Review Information

1. Criteria

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

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.

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.

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.

2. Review and Selection Process

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

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

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 NOFO. 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.

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 Section 2.5.1. Just-in-Time Procedures. This request is not a Notice of Award nor should it be construed to be an indicator of possible funding.

Prior to making an award, NIH reviews an applicant’s federal award history in SAM.gov to ensure sound business practices. An applicant can review and comment on any information in the Responsibility/Qualification records available in SAM.gov.  NIH will consider any comments by the applicant in the Responsibility/Qualification records in SAM.gov to ascertain the applicant’s integrity, business ethics, and performance record of managing Federal awards per 2 CFR Part 200.206 “Federal awarding agency review of risk posed by applicants.”  This provision will apply to all NIH grants and cooperative agreements except fellowships.

3. Anticipated Announcement and Award Dates

After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons. Refer to Part 1 for dates for peer review, advisory council review, and earliest start date.

Information regarding the disposition of applications is available in the NIH Grants Policy Statement Section 2.4.4 Disposition of Applications.

Section VI. Award Administration Information

1. Award Notices

A Notice of Award (NoA) is the official authorizing document notifying the applicant that an award has been made and that funds may be requested from the designated HHS payment system or office. The NoA is signed by the Grants Management Officer and emailed to the recipient’s business official.

In accepting the award, the recipient agrees that any activities under the award are subject to all provisions currently in effect or implemented during the period of the award, other Department regulations and policies in effect at the time of the award, and applicable statutory provisions.

Recipients must comply with any funding restrictions described in Section IV.6. Funding Restrictions. Any pre-award costs incurred before receipt of the NoA are at the applicant's own risk.  For more information on the Notice of Award, please refer to the NIH Grants Policy Statement Section 5. The Notice of Award and NIH Grants & Funding website, see Award Process.

Institutional Review Board or Independent Ethics Committee Approval: Recipient institutions must ensure that protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in NIH-funded studies, the recipient must provide NIH copies of documents related to all major changes in the status of ongoing protocols.

2. Administrative and National Policy Requirements

The following Federal wide and HHS-specific policy requirements apply to awards funded through NIH:

• The rules listed at 2 CFR Part 200, Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards.
• All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the terms and conditions in the Notice of Award (NoA). The NoA includes the requirements of this NOFO. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Recipients, and Activities.

All federal statutes and regulations relevant to federal financial assistance, including those highlighted in NIH Grants Policy Statement Section 4 Public Policy Requirements, Objectives and Other Appropriation Mandates.

Recipients are responsible for ensuring that their activities comply with all applicable federal regulations.  NIH may terminate awards under certain circumstances.  See 2 CFR Part 200.340 Termination and NIH Grants Policy Statement Section 8.5.2 Remedies for Noncompliance or Enforcement Actions: Suspension, Termination, and Withholding of Support. 

Pursuant to the Cybersecurity Act of 2015, Div. N, § 405, Pub. Law 114-113, 6 USC § 1533(d), the HHS Secretary has established a common set of voluntary, consensus-based, and industry-led guidelines, best practices, methodologies, procedures, and processes.

Successful recipients under this NOFO agree that:

When recipients, subrecipients, or third-party entities have:

1. ongoing and consistent access to HHS owned or operated information or operational technology systems; and
2. receive, maintain, transmit, store, access, exchange, process, or utilize personal identifiable information (PII) or personal health information (PHI) obtained from the awarding HHS agency for the purposes of executing the award.

Recipients shall develop plans and procedures, modeled after the NIST Cybersecurity framework, to protect HHS systems and data. Please refer to NIH Post-Award Monitoring and Reporting for additional information. 

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 (HHS) grant administration regulations at 2 CFR Part 200, 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 recipients 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 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 recipients for the project as a whole, although specific tasks and activities may be shared among the recipients and NIH as defined below.

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

The recipient, as National Centralized Repository for Alzheimer's Disease and Related Dementias (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 NCRAD operations and seek approval from the 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 the NEC.
• Receive biomaterials and data files from the Alzheimer's Disease Research Centers (ADRCs), 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 the NEC and consistent with NIH data and biomaterials sharing policies (see below).
• Provide free DNA extraction and banking for all NIA-funded ADRCs and other dementia-related studies approved by the NEC.
• Maintain a log of NCRAD usage that records the products and services provided and the fees charged.
• Organize and set the agenda for at least one meeting of the NEC, with additional advisors as appropriate, each year, along with teleconferences as needed. The awardee will have one vote on the NEC and will accept any modification, deletion, or addition of NCRAD activities approved by the 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 ADRC Directors' twice-yearly meetings.

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

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

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 NCRAD, helping to maintain the overall scientific balance in the program commensurate with emerging research opportunities, and ensuring that the activities of the repository are consistent with the scientific mission of the NIA Alzheimer's Disease Genetic Initiative. Access to research resources maintained in the repository 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 the NEC. The Program Official (see below) and other NIA staff involved with the genetics initiative may also attend meetings of the 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 PI regarding recruitment of members and replacement of existing members of the 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 ADRCs and help coordinate NCRAD activities with those complimentary programs. The NIA Project Scientist will coordinate NCRAD activities with the scientific mission and evolving goals of the NIA Alzheimer's Genetics Initiative, with input as required from the NEC and other NIA staff. The NIA Project Scientist will also coordinate NCRAD 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 NCRAD and other NIA staff involved in the Genetics Initiative.
• Assist in promoting and encouraging the sharing of unique research resources for genetic and biomarker studies of Alzheimer's disease and related dementias by the scientific community at large.
• Be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice.

Scientific Oversight - NCRAD Executive Committee (NEC):

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

Areas of Joint Responsibility include:

• Develop terms and conditions of MTAs, track their compliance, and collaborate to resolve instances of non-compliance.
• Create and maintain a succession plan that addresses the transfer of NCRAD activities and materials in the event of a change in the NCRAD award recipient.  

Dispute Resolution:

Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between recipients and NIH may be brought to Dispute Resolution. A Dispute Resolution Panel composed of three members will be convened: a designee of the NCRAD Executive Committee (NEC) 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 recipient. This special dispute resolution procedure does not alter the recipient's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulation 42 CFR Part 50, Subpart D and HHS regulation 45 CFR Part 16.

3. Data Management and Sharing

Consistent with the 2023 NIH Policy for Data Management and Sharing, when data management and sharing is applicable to the award, recipients will be required to adhere to the Data Management and Sharing requirements as outlined in the NIH Grants Policy Statement. Upon the approval of a Data Management and Sharing Plan, it is required for recipients to implement the plan as described.

4. Reporting

When multiple years are involved, recipients will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement Section 8.4.1 Reporting. To learn more about post-award monitoring and reporting, see the NIH Grants & Funding website, see Post-Award Monitoring and Reporting.

A final RPPR, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement Section 8.6 Closeout. NIH NOFOs outline intended research goals and objectives. Post award, NIH will review and measure performance based on the details and outcomes that are shared within the RPPR, as described at 2 CFR Part 200.301.

In carrying out its stewardship of this NOFO, the NIH or its Institutes and Centers may request information essential to an assessment of the effectiveness of this program from the participants (NCRAD, investigators depositing biospecimens, investigators requesting biospecimens and others as determined). Participants may be contacted during and after the completion of this award for periodic updates on publications, new collaborations, support from research grants or contracts, and other information helpful in evaluating the impact of the program. NIH and its ICs will use this information to determine overall success in building a state-of-the-art central biospecimen repository for samples (DNA, cell lines, plasma, serum, RNA, brain tissue, stool, fibroblasts, peripheral blood mononuclear cells, iPSCs) collected by other NIA-funded studies.

Section VII. Agency Contacts

We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.

eRA Service Desk (Questions regarding ASSIST, eRA Commons, application errors and warnings, documenting system problems that threaten submission by the due date, and post-submission issues)

Finding Help Online: https://www.era.nih.gov/need-help (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources)
Email: [email protected] (preferred method of contact)
Telephone: 301-480-7075

Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email: [email protected]

Cerise Elliott, Ph.D.
National Institute on Aging (NIA) 
Division of Neuroscience (DN)
Telephone: 301-496-9350
Email: [email protected] 

Examine your eRA Commons account for review assignment and contact information (information appears two weeks after the submission due date).

Robin Laney
National Institute on Aging (NIA)
Telephone: 301-496-1473
Email: [email protected]

Section VIII. Other Information

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 2 CFR Part 200.