Part 1. Overview Information

Key Dates

It is critical that applicants follow the instructions in the Research (R) Instructions in the SF424 (R&R) Application Guide,except where instructed to do otherwise (in this FOA or in a Notice from 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 2. Full Text of Announcement

Section I. Funding Opportunity Description

Background

The National Institute of Neurological Disorders and Stroke (NINDS) invites applications to serve as the NINDS Human Biospecimen and Data Repository for Neurological Disorders. The repository, the Biospecimen Exchange for Neurological Disorders (BioSEND) was established in 2015 to acquire, maintain, and distribute existing NINDS biospecimen collections for biomarker research in disorders such as Parkinson's Disease, Huntington's Disease, and Frontotemporal Dementia. Subsequently, the repository has expanded to support active clinical studies supported by NINDS in Parkinsonisms, Lewy Body Dementia, Epilepsy, Traumatic Brain Injury, Myalgic encephalomyelitis/Chronic Fatigue Syndrome, and Spinocerebellar Ataxia. To date the repository has distributed over 18,300 samples worldwide to both academic and industry researchers.

This open competition FOA requests applications from organizations to serve as an integrated and comprehensive biospecimen resource for the NINDS. The repository will manage the existing collection and expand the collection to bank well-annotated high-quality clinical biospecimens to foster discovery and validation of neurological biomarkers as well as complementary basic, translational, and clinical research. It is expected that biospecimen resources supported within this FOA will continue to be broadly distributed to both qualified academic and industry researchers worldwide following government guidelines and regulations

Scope

Activities required under this FOA include:

• Provide consistent, integrated, and well-coordinated infrastructure to support biobanking and distribution
• Maintain and distribute current biospecimen collection including DNA, RNA, plasma, serum, cerebrospinal fluid, urine, saliva, and other emerging biological sample types to scientific researchers.
• Provide study management expertise to NINDS clinical studies including design of biospecimen protocols and training for study staff in biospecimen collection and processing.
• Apply innovative cutting-edge advances in biorepository research and technology including quality assessment and quality control procedures
• Support the review and recommendation of biospecimen access requests by a NINDS Biospecimen and Resource Access Committee (BRAC)
• Coordinate with future biobanking projects so that an appropriate budget can be included by investigators as part of planned grant applications with input by appropriate NINDS Program Staff
• Data management including effective sharing of de-identified linked clinical data with biospecimens to researchers
• Maintain a user-friendly, query-based website to provide dynamic bidirectional interactions/links with study data management coordinating centers 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

A successful application will have strengths in four major areas of emphasis: 1) Biobanking; 2) Dedicated coordination with clinical research teams; 3) Data Management; and 4) Efficient and effective biospecimen distribution and outreach to the research community. Qualifications for applicants should include academic excellence in the fields of biobanking operations for complex clinical studies, neuroscience, data management and curation.

The administrative structure should be such that it provides leadership and program management to the entire project. Because this is a cooperative agreement, extensive collaboration and management input from the NINDS will occur, and milestones will be used to make go/no go funding decisions. This overall structure is intended to ensure that stakeholders including academic and industry scientists, and research subjects will be served by the resource. The repository is likely to expand to include biospecimens from other neurological disorders during the duration of this project. Receipt, processing, storage, and the national and international distribution of biospecimens will be required.

Applications that propose to develop non-human cell resources are non-responsive to this funding announcement.

Due to the unique requirements of this project, applicants are strongly encouraged to consult with NINDS Scientific/Research Staff early on during the planning for an application.

A webinar will be held prior to the receipt date to provide an overview of the initiative and to answer questions from potential applicants pertinent to preparing applications.

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 FOA.

Section III. Eligibility Information

1. Eligible Applicants

Higher Education Institutions

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

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

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

Nonprofits Other Than Institutions of Higher Education

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

For-Profit Organizations

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

Local 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)

Federal Governments

• 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) Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
  • NATO Commercial and Government Entity (NCAGE) Code Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.
• eRA Commons - Applicants must have an active DUNS number to register in eRA Commons. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration, but all registrations must be in place by time of submission. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
• Grants.gov Applicants must have an active DUNS number and SAM registration in order to complete the Grants.gov registration.

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

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

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.

2. Cost Sharing

This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.

3. Additional Information on Eligibility

Applicant organizations may submit more than one application, provided that each application is scientifically distinct.

The NIH will not accept duplicate or highly overlapping applications under review at the same time. This means that the NIH will not accept:

• A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.
• A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.
• An application that has substantial overlap with another application pending appeal of initial peer review (see NOT-OD-11-101)

Section IV. Application and Submission Information

1. Requesting an Application Package

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

2. Content and Form of Application Submission

Letter of Intent

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

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

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

The letter of intent should be sent to:

Christine Swanson-Fischer, Ph.D.
Telephone: 301-496-5680
Email: [email protected]

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

For this specific FOA, the Research Strategy section is limited to 30 pages.

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.

Highlight, how the Research Team has appropriate expertise (without duplicating information in the biosketches) in:

• Clinical neuroscience and biomarker research
• Characterization, quality control and assurance measures for clinical biospecimen resources
• Human Subjects including familiarity with HHS and NIH guidelines and regulations on informed consent and research resources as well as compliance with HIPAA
• Data Management and Web-based catalog design and IT support

R&R Budget

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

If appropriate, the applicant should budget for the intake of the existing repository collection.

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 meet the overall scientific goals, the expected outcomes, and the impact should those goals be achieved.

Goals should include:

• Providing leadership to the entire project. This requires 1) overall project management of the research and resource goals, 2) the ability to receive, process, and store new as well as existing biospecimen collections which dovetail with ongoing and future studies of interest to the NINDS, 3) strategies for inclusion of new biospecimen collections when approved by NINDS, and 4) plans for working with a range of stakeholders including government, academic scientists, industry, non-profit organizations, data-management experts, and the lay public.
• Providing scientific and laboratory expertise. This will require the skills and flexibility to apply cutting-edge and innovative science to the development and use of biobanking and assay protocols, QA/QC assays, and batch effect analyses. It will require coordination of the receipt, processing, storage, and distribution of biospecimens from a variety of projects.
• In terms of data management, the resource must be able to link clinical data with biosamples and coordinate IT efforts across projects and databases supporting biomarker banking, biomarker discovery and clinical assessments. Projects supported by this resource will include both academic and industry-based research. Data sharing and protocol standardization will play a significant role in the success of this resource. The sharing of raw and analyzed data, protocols, quality assurance, and other data generated by the research team is expected. A user-friendly, query-based website is an essential component of the overall activity.

Research Strategy: Propose plans that describe how valuable existing and new biospecimens from projects identified by NINDS will be managed by the repository. Plan should address how the proposed procedures and processes will ensure standardized banking and distribution of verified, high-quality, uncontaminated samples that will advance biomedical research. Address each of the following key areas:

Sub-section A. Biobanking Administration

Sub-section B. Biobanking Operations

Sub-section C. Data Management and Informatics

Specific guidelines and requirements for these sub-sections are described below.

Sub-section A. Biobanking Administration

Provide an overall description of the proposed organizational structure and project management plan. Describe the strategy for effectively carrying out each specific aim. Applicants must present an integrated plan that will be responsive to and flexible regarding the evolving needs of the scientific community. In particular:

• Address the management plan for the proposed project in the context of the overall organization of the proposed research resource.
• Describe the administrative structure of the project proposed, including an organizational chart, and planned meetings, proposed committees and user groups, and other activities which will involve NINDS and other stakeholders.
• Ensure capabilities of the Repository in terms of the current and future scale of operation.
• Summarize how collaborations or subcontracts, if proposed, will be managed.
• Highlight how the management plan will facilitate and maintain communication with clinical staff submitting specimens, patient advocacy groups, biomedical researchers who request samples, and NINDS.
• Provide education and training of investigators and clinical staff in biospecimen collection to ensure standardization and best practices.
• Coordinate transfer (if appropriate) and maintenance of the existing Repository collection. This collection contains approximately 316,000 sample aliquots from approximately 6,000 unique subjects, including: DNA, RNA, plasma, serum, whole blood, saliva, urine, and cerebrospinal fluid (CSF) along with phenotypic data. Supplementary information about the current Repository can be found at https://biosend.org/index.html.
• Coordinate future collections. In alignment with NOT-NS-15-016, it is expected that the costs for banking new collections will be included in those grant applications planning to deposit samples. Furthermore, the recipient of this award is expected to work directly with potential applicants to develop budgets for biosample banking in a timely fashion prior to submission. A brief discussion regarding how this will be coordinated by the awardee should be included, with the specifics of the costs for each sample collection included in the body of the application. NINDS will advise applicants of the importance of contacting the Repository prior to their grant submission so that they can appropriately gauge the budget they need to submit for banking samples. Appropriate estimation of costs is the Repository's responsibility.
• Receipt of extant sample collections from academics, non-profit organizations or industry may be submitted to the repository upon NINDS request. If any samples are to be stored under a subcontract, they shall not be distributed nor used for research by the subcontractor without prior NINDS authorization.
• Develop innovative biospecimen management strategies, as needed to ensure that the resource remains responsive to researchers' needs.
• Consideration of custodianship and ownership of samples. Once deposited, the original donor will have the right to remove samples from the repository. However, once samples have been distributed, it will not be possible to retrieve any such samples. Ideally, a master Material Transfer Agreement (MTA) should be utilized to cover all activities of this repository (i.e., it is expected that individual MTAs will not be negotiated for individual users). At any point during the project, as well as at the time of project termination, the NINDS has the right to transfer all samples to a site of NINDS discretion.
• Ensure commitment to the principles of free and open sharing of biospecimen research resources for neurological disorders.
• Develop and execute periodic innovative outreach approaches to promote repository resources to the scientific research community and increase the number of biospecimen users.
• Establish and maintain the Repository website, as well as any proposed social media presence.
• Organize and convene a Repository Scientific Liaison committee. This committee is required to provide unbiased scientific input to the research team regarding operational and mission related aspects of the resource. It may also participate in evaluation activities along with NINDS staff regarding repository accomplishments. The committee will be recommended by the applicant, but final approval and additional members may be recommended by the NINDS.

Sub-section B. Biobanking Operations

This sub-section should address all essential aspects of biobanking operations, including QA/QC and human biospecimen-related legal and ethical issues. Specific items to be covered include but are not limited to

• Receipt of biospecimens from the collection sites (including but not limited to whole blood (including for DNA and RNA extraction), serum, plasma, cerebrospinal fluid, urine, and saliva). It is expected that newly collected samples will be submitted to the repository within 24 hours of each subject visit. Applicants must demonstrate that they are able to follow existing standard operating procedures for sample handling. Therefore, the repository must describe an ability to coordinate shipping and to receive samples to accommodate this requirement, including on weekends and holidays if necessary
• Biospecimen reconciliation
• Processing and storing biospecimens at the repository (including preparing nucleic acid extraction, and sub-aliquoting, as well as generation of biospecimen reference pools as needed);
• Conducting QA/QC of the biospecimens before distributing them to investigators (including but not limited to)
  • DNA: quantity, yield, and purity
  • RNA: RNA Integrity Number (RIN), quantity, purity
  • Plasma: hemoglobin concentration, turbidity values
  • Serum: hemoglobin concentration, turbidity values
  • CSF: hemoglobin concentration to assess blood contamination
• Describe services available for screening of known variants, ancestral informative characterization, or other approaches for genotyping sample collections. Describe planned sample tracking methods (such as bar-coding and/or SNP genotyping)
• Describe plans for maintenance of the existing collection. These plans must describe safeguards against accidental loss of the collection including, storage of duplicates at an off-site location, freezer failure back-up and plan, and other contingencies. Describe safeguards to prevent temperature changes when freezers are accessed, alarm systems and procedures, backup power sources, and other safeguards if they exist. Lost samples may be re-collected at the expense of the awardee, depending on the circumstances, at the request of NINDS.
• Distributing biospecimens to qualified investigators and/or laboratories. The NINDS has established a Biospecimen Resource Access Committee (BRAC) for several extant collections, which will continue to function under NINDS direction. Other resources have separate approval processes. Describe in general how requests for samples will be acknowledged, how approvals will be sought (if appropriate), and how samples will be distributed. Describe safeguards against any loss or damage to samples during shipping (to the extent possible). These plans should include both US and international recipients following government guidelines and regulations.
• The ways of handling legal and ethical aspects related to human biospecimens. It is likely that most samples will not be subject to Human Subjects regulations, as most will be de-identified and HIPAA compliant. However, rare collections may have Human Subjects aspects. For this reason, include proposed procedures for evaluating and maintaining adherence to Health and Human Services and NIH guidelines and regulations on informed consent and research resources, including information technology security and the implications of the Health Insurance Portability and Accountability Act (HIPAA) regulations Privacy Rule. Describe plans for the Institutional Review Board (IRB) that will review the use of materials that are considered human subjects.
• Describe how details of laboratory standard operating procedures will be shared and publicized.
• Provide estimated times for regularly performed activities including timelines for processing from sample receipt to storage, sample request approval to shipping, protocol deviation to reporting to NINDS, and other activities. Where possible, integrate timelines for these activities into project milestones.
• Note on Innovative Aspects: In respective parts of this sub-section, highlight any proposed improved practices and innovative management strategies for biospecimen processing and QA/QC, specimen tracking, and/or other creative ways to accelerate research and standardization as well as advancing the utilization of the resource.

Sub-section C. Data Management and Informatics

The applicant must describe plans for maintaining a computerized data management system for cataloging, querying, and retrieval of biospecimen-related information. The data management plan must present a system that is effective for quality control, tracking of samples, order fulfillment, billing methods for cost reimbursement, shipment, and inventory tracking. Present plans for a back-up system to protect against accidental loss of valuable data. The design and development of the database should provide user-friendly accounting of the repository's holdings, and ensure data integrity, accuracy, and security. Such information should include but is not limited to: a global unique identifier (GUID), sample type, sample volume/weight/aliquot size, inventory data, and processing data, including QC for individual specimens (such as such as time between collection, shipping, freezing or other temperature changes, processing, needle bore, centrifugation, etc.)

Applicants must address their strategy to provide the following:

• A data management plan which will include solutions for inventory, catalog and other necessary information for researchers utilizing the repository
• A public web-based interface to promote the goals of the NINDS Human Biospecimen Repository and to provide tools and supporting information for the collection and use of these biospecimens including protocols, procedures, and policy guidance
• Data management strategies to facilitate ease of searching, identification, and requesting of biospecimens and associated data
• Assuring linkages connecting de-identified clinical data with biospecimens including implementation of Application Programming Interfaces (APIs) to support data exchange as needed
• A plan for monitoring of publications related to use of the resource. This will in part enable NINDS to partially gauge the scientific impact of the biorepository activities

Data management. Data management activities must dovetail with a variety of other data management resources in academic and industry settings. The data management capabilities must be 1) nimble in sharing inventory and cataloging data on a regular basis; 2) able to receive de-identified clinical and other sample associated data, to ensure that data follows the FAIR data principles (findable, accessible, interoperable, and reusuable); 3) able to track and notify submitters and requestors regarding sample status (via an electronic system); 4) able to fully share data with NINDS Program staff and their designees is expected in real time. Dedicated staff with IT and data management experience must be available for trouble-shooting any data management aspects of the project.

Integrating with Related Projects. Flexible, innovative, and novel problem solving approaches towards unique situations for various shareholders is essential. Present a general plan for how you will integrate with research projects and their data management approaches. There may be designated data form structure requirements for sharing data with other projects to facilitate this activity as appropriate. If none exists for certain special projects (ie, those with data generated via unique technologies), these must be created collaboratively.

Web-based Catalog. Describe plans for a Web-based electronic catalog, which must be made available for collections where such resources do not/will not exist. Note that for some active studies, a catalog will be hosted by the awardee; in others, by the clinical project itself via NINDS funding (such as is being done, for example, by the PDBP DMR). If hosted by the awardee, the catalog must outline the policies and procedures for governing the submission and requesting of samples. This should list the available samples with associated information, including a GUID, detailed phenotype and molecular genotype data, links to related genetic databases, pedigree structure when relevant and available, assay results, and all quality assurance information. Provide a strategy of tracking performance of the resource including metrics such as distribution, website traffic, publications citing the source, and other utilization of the resource. Novel approaches may be employed to support the implementation of a user-friendly web-based access portal.

Customer Service. Describe plans for customer service, including plans for a user-friendly customer service interface, such as a help-desk. This help-desk function should serve not only those with IT and data management related concerns, but the entire spectrum of Research and Resource activities. For example, this help-desk function would provide support for the following activities: protocol clarification, QC processes and results, sample submission, sample requests/ordering, and shipping questions. The customer service plan must include timelines regarding estimated responsiveness on any query. Applicants should also describe plans to incorporate end-user feedback into improvements in the repository.

Publicizing Repository Collections. Describe plans and innovative outreach approaches to publicize repository collections. Efforts may include publishing articles in relevant scientific journals that describe specific repository collections or the general purpose and operation of the repository, presentations at scientific meetings to represent the scientific activities and collaborations, or other activities. The aim of the activities should be to increase the use of repository collections, to promote awareness of repository services to the scientific community, and/or to aid in recruitment of additional samples for the repository collection when appropriate. Additionally, the public website should serve as a means to educate patients with neurological diseases and the other members of the lay public about what the repository does, whom it serves, how to participate, information about biomarker research, and news items regarding recent discoveries by users, among other items.

Additional Application Elements:

Milestones. Specific milestones must be presented that will need to be met in order to accomplish the aims. Annual milestones must be provided in the context of a study timeline. These milestones will provide clear indicators of a project's continued success or emergent difficulties. Milestones are goals that create go/no-go decision points in the project and must include clear and quantitative criteria for success. Milestones may include (but are not limited to):

• Acquisition of existing repository collection (if appropriate),
• Development of standardized operating procedures (SOPs) for collection, storage, shipping, and other handling of biospecimens
• Maintaining up-to-date innovative biobanking capabilities and practices
• Training of clinical site personnel in appropriate sample collection, processing, and shipping
• Timely processing of sample submissions
• Timely fulfillment BRAC approved sample requests and distribution to researchers
• Deployment of repository website to provide information about the existing collection, how to bank, SOPs and available biospecimens for distribution
• Development and implementation, as needed, of data management strategies for projects without existing infrastructure to host biospecimen catalog
• Formation of External Steering Committee
• Publicizing the availability of biospecimens and tracking publications relevant to samples banked and utilized
• Clear communication timelines with NINDS and other stakeholders.

Achievement of milestones will be evaluated by NINDS, and funding of non-competing award years will depend on milestone accomplishments.

Letters of Support: Statements of Institutional Commitment, if appropriate, should be included in this section. In addition, a letter from the applicant must be included and titled "Procedures related to materials obtained from human subjects" that provides documentation of the following:

• That the resource's offices that handle or process the samples and data for biomedical research are/would be in compliance with the Health Insurance Portability and Accountability Act (HIPAA).
• That the resource will not accept biospecimens from any human subject unless that subject or subject's representative has given signed, explicit consent and the consent follows the language required for broad distribution, banking and utilization as established by NINDS.

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.

The following modifications also apply:

• Consistent with achieving the goals of this repository, applications are required to describe a Data Sharing Plan. All data and biomaterials managed and produced by the repository are expected to be widely distributed to the national and international scientific community, consistent with achieving the goals of this program. The data sharing plan should minimally include the following elements:
  • 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.
• Consistent with NIH Genomic Data Sharing (GDS) policy, applicants must also provide a GDS plan for any sequencing data generated.
• Resource development involving partnerships with industry, small businesses or non-government organizations are encouraged under this FOA. The policy of the NIH is to make available to the public the results and accomplishments of the activities that it funds. To ensure that research resources are made accessible to the broader biomedical community, NIH expects applicants who respond to this funding opportunity to submit a plan for: (1) sharing the research resources generated through any grants awarded and (2) addressing how they will exercise intellectual property rights, should any be generated through an award, while making such research resources available to the broader scientific community consistent with this initiative.
• Applications which do not describe plans and resource capability to provide all the required functions and services will be considered incomplete to this FOA and applications will be withdrawn.

With the following modifications:

Applicants may include the following items (if available) in the Appendix:

• Standard Laboratory Protocols including quality assurance/quality controls processes and sample aliquoting procedures
• Screenshots of database views if relevant to data management capabilities
• Standard operating procedures for equipment monitoring and maintenance
• Facility-derived training, continuing education, and certification programs for personnel
• Examples of Master Material Transfer Agreements for deposition and distribution of biological resources

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 SF424 (R&R) 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 SF424 (R&R) Application Guide must be followed.

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

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

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

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

4. Submission Dates and Times

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

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

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

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

5. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

6. Funding Restrictions

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

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

7. Other Submission Requirements and Information

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

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

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

Important reminders:

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

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

See more tips for avoiding common errors.

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

Applicants are required to follow the instructions for post-submission materials, as described in the policy. Any instructions provided here are in addition to the instructions 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.

For this particular announcement, note the following:

Applications responsive to this FOA support the management, maintenance expansion, and distribution of human biospecimen resources that will play a significant role in advancing basic science and drug discovery efforts for neurological disorders supported by NINDS. Accordingly, since the biospecimens will be broadly distributed to the research community, reviewers will emphasize the technology capabilities, quality assurance standards and the level of innovation that will be applied to ensure the research value of this resource.

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.

Significance

Does the proposed [Center] address the needs of the research resource that it will serve?

Is the scope of activities proposed for the repository appropriate to meet those needs? Will successful completion of the aims bring unique advantages or capabilities to the research resource? What will be the effect of these research resources on other scientific activities that drive this field? Is there convincing evidence that the proposed plan for the biobanking resource will stimulate and facilitate neurological biomarker and clinically relevant research efforts by optimizing access to high-quality, well-characterized biospecimens and data? How well does the proposed repository address the needs of the scientific community?

Investigator(s)

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

Does the applicant/organization have demonstrated expertise in laboratory biorepository science, and hands-on leadership experience in operating a large-scale clinical biospecimen operation as well as providing efficient and equitable access to biospecimens?

To what extent do the PD(s)/PI(s) have experience in providing high-quality research resources and services for neurological disorders to the scientific community?

To what extent does the PD(s)/PI(s) have experience in Human Subjects research including understanding of HHS and NIH guidelines and regulations as well as compliance with HIPAA?

To what extent are the PD(s)/PI(s) committed to the principles of free and open sharing of research resources for neurological disorders?

Do the applicant and research team have experience in biomarker research, such as evaluation of batch effects, protocol development and standardization, and analyte quality control measures?

Does the applicant have experience in data management and web-based IT design and support, including a customer service component?

Does the applicant have a track record which would facilitate understanding and serving the needs of academic communities?

Innovation

Does the application propose novel organizational concepts or management strategies in coordinating the research resource the repository will serve? Are the concepts, strategies, or instrumentation novel to one type of research program or applicable in a broad sense? To what extent does the proposed repository employ novel concepts, approaches, or methods for the production and sharing of research resources, the integration of biorepository data into a central warehouse, the integration of that data with other public resources, and the implementation of a single user-friendly, web-based access portal?

Is there a high likelihood that the activities proposed will remain scientifically current to the greatest extent possible, given rapid advances in biospecimen science, molecular biology, and information technologies?

Is there evidence of innovative approaches to outreach to the scientific community?

Approach

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

Are plans for publicizing repository collections appropriate and likely to promote awareness of repository collections to the scientific community and/or aid in recruitment of additional biospecimen collections to the repository in a cost-effective manner?

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

Is the management plan well integrated and likely to facilitate achieving repository goals and objectives? Does the application inspire confidence regarding an ability to recognize the priorities of the scientific community relevant to neurological biomarkers and clinically relevant research?

Are repository collection acquisition plans appropriate well-reasoned, timely, and appropriate?

Are appropriate plans in place for training staff and assuring continuity of activities in the case of staff turnover?

If applicable, is the plan for transfer of existing collections clear and feasible?

Are plans for characterization of newly acquired specimens robust and likely to be broadly valuable? Are plans for quality control, data collection and analysis, and diagnostic verification likely to result in distribution of high-quality, well-characterized samples to the biomedical research community?

Does the proposed database provide a user-friendly accounting of the resource's holdings and ensure data integrity, accuracy, and secure cyberinfrastructure? Is the plan for a back-up facility appropriate? Are plans for customer service likely to facilitate acquisition of biospecimen resources by academic and industry researchers? Are plans for a web catalogue and query system presented and feasible? Is integration with other projects data management systems likely to be successful?

Does the application appropriately address evaluation of processes and implementation of improvement plans of the resource's procedures and programs when feedback is given via users or the NIH staff, and is this plan nimble and flexible?

Does the application requisitely address a need for broad sharing of protocols and standard operating procedures, and an approach for ensuring that these occur?

Does the application give adequate evidence of how protocols will be shared, including via web-based and other methods?

Are reasonable, appropriate, and timely methods described to track and monitor repository use, both submitting and accessing, and the outcomes of such use, including data and publications?

Does the application provide an adequate strategy to address any intellectual property issues?

Is an appropriate budget estimate provided regarding costs of accepting existing sample collections and banking future samples of various types for individual researchers who choose to submit samples? Is the estimate specific enough to judge the reasonableness of the costs for these banking activities prospectively?

Does the application provide appropriate milestones that will need to be met to accomplish the work set out above in a five-year time frame?

Is an appropriate budget estimate provided regarding costs of accepting existing sample collections and banking future samples of various types for individual researchers who choose to submit samples? Is the estimate specific enough to judge the reasonableness of the costs for these banking activities prospectively?

Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: (1) Data Sharing Plan; (2) Sharing Model Organisms; and (3) Genomic Data Sharing Plan (GDS). Does the sharing plan provided factor in existing resources and is it responsive to the broad sharing as desired in this FOA?

Environment

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

Is there an appropriate alternative off-site location been identified for storing duplicate samples in case of natural or man-made disaster?

Is the plan in case of equipment or other failure which might jeopardize samples reasonable and feasible? Are personnel available in case of equipment failure or other malfunction at all times?

Is there adequate server capacity to support a variety of activities including biospecimen data management, clinical data management, data query, file protocol sharing, genomics and other data banking and management?

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.

Protections for Human Subjects

For research that involves human subjects but does not involve one of the 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 categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.

Inclusion of Women, Minorities, and Individuals Across the Lifespan

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

Vertebrate Animals

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

Biohazards

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

Resubmissions

Not Applicable

Renewals

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

Revisions

Not Applicable

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

Applications from Foreign Organizations

Not Applicable

Select Agent Research

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

Authentication of Key Biological and/or Chemical Resources:

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

Budget and Period of Support

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

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened bythe National Institute of Neurological Disorders and Stroke (NINDS)}, in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.

As part of the scientific peer review, all applications will receive a written critique.

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.

Applications will be assigned to the National Institute of Neurological Disorders and Stroke (NINDS). Applications will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the National Advisory Neurological Disorders and Stroke (NANDS) Council . The following will be considered in making funding decisions:

• Scientific and technical merit of the proposed project as determined by scientific peer review.
• Availability of funds.
• Relevance of the proposed project to program priorities.
• Commitment of the PD(s)/PI(s) to broad data and sample sharing and the long-term scientific mission, goals, and objectives of the NINDS.
• Consideration of the plans to make biomaterials and data broadly available in a rapid manner to the scientific research community.

3. Anticipated Announcement and Award Dates

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

Section VI. Award Administration Information

1. Award Notices

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the grantee’s business official.

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

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

Institutional Review Board or Independent Ethics Committee Approval: Grantee 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 awardee must provide NIH copies of documents related to all major changes in the status of ongoing protocols.

2. Administrative and National Policy Requirements

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities. More information is provided at Award Conditions and Information for NIH Grants.

Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights laws that prohibit discrimination on the basis of race, color, national origin, disability, age and, in some circumstances, religion, conscience, and sex. This includes ensuring programs are accessible to persons with limited English proficiency. The HHS Office for Civil Rights provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-providers/provider-obligations/index.html and http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html.

HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research. For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA.

• Recipients of FFA must ensure that their programs are accessible to persons with limited English proficiency. HHS provides guidance to recipients of FFA on meeting their legal obligation to take reasonable steps to provide meaningful access to their programs by persons with limited English proficiency. Please see https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/fact-sheet-guidance/index.html and https://www.lep.gov. For further guidance on providing culturally and linguistically appropriate services, recipients should review the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care at https://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.

• Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html.

• HHS funded health and education programs must be administered in an environment free of sexual harassment. Please see https://www.hhs.gov/civil-rights/for-individuals/sex-discrimination/index.html; https://www2.ed.gov/about/offices/list/ocr/docs/shguide.html; and https://www.eeoc.gov/eeoc/publications/upload/fs-sex.pdf. For information about NIH's commitment to supporting a safe and respectful work environment, who to contact with questions or concerns, and what NIH's expectations are for institutions and the individuals supported on NIH-funded awards, please see https://grants.nih.gov/grants/policy/harassment.htm.

• Recipients of FFA must also administer their programs in compliance with applicable federal religious nondiscrimination laws and applicable federal conscience protection and associated anti-discrimination laws. Collectively, these laws prohibit exclusion, adverse treatment, coercion, or other discrimination against persons or entities on the basis of their consciences, religious beliefs, or moral convictions. Please see https://www.hhs.gov/conscience/conscience-protections/index.html and https://www.hhs.gov/conscience/religious-freedom/index.html.

Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at https://www.hhs.gov/ocr/about-us/contact-us/index.html or call 1-800-368-1019 or TDD 1-800-537-7697.

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

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:

• Planning, organizing, coordinating and administering the described project activities.
• Performing all activities within the scope of the research strategy specified in the application including setting project milestones. The awardee agrees to accept close coordination, cooperation, and participation of NIH staff in those aspects of scientific and technical management of the study as stated in these terms and conditions.
• Organizing Scientific Advisory Committee meetings for the Repository.
• Providing written reports as requested to NINDS Program staff as well as weekly supplementary status reports.
• Accept and implement any other common guidelines and procedures developed for clinical biospecimen banking and tracking, research and public outreach, and approved by NINDS program staff.
• Coordinate with other projects at NINDS, including sharing of data with affiliated data management resources as appropriate and consistent with achieving the goals of the program.
• Participating in group activities including resource supported Scientific Advisory Committee calls and subcommittees as needed.
• Attend in-person meetings for projects and studies the repository is supporting up to five times per year (ie, yearly for individual projects) and present up to date findings (including unpublished results) on ongoing activities at these meetings.
• Participate in individual project steering committee calls, an average of one per project per month, or about five a month.
• Preparing abstracts, presentations, and publications and collaborating in making the public and scientific community aware of this resource.
• Awardees will retain custody of and have primary rights to the software that is developed under this award, subject to Government rights of access consistent with HHS, PHS, and NIH policies.

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

• Serving as a liaison to help coordinate activities of the awardee, including acting as a liaison to other NIH Institutes/Centers sponsored biobanks and databases as needed and as an information resource for the awardees.
• Contribute to the adjustment of research protocols, project milestones or approaches as warranted.
• Substantial involvement in coordinating the activities of the awardee with other NIH-sponsored biobanks and databases as necessary.
• Participation in Repository Scientific Advisory Committee meetings.
• Assisting awardees in the development, if needed of policies for dealing with situations that require coordinated action.
• Providing advice in the management and technical performance of the award.
• Assisting in promoting the availability of data and resources developed in the course of this project to the scientific community at large.

Additionally, an NINDS Program Official will be responsible for:

• Normal scientific and programmatic stewardship of the award and will be named in the award notice.
• Monitoring the project on a regular basis. Monitoring may include regular communication with the PI and awardee staff, periodic site visits or meetings for discussion with the awardee research team, fiscal reviews, and other relevant stewardship matters.
• Formally evaluating the project on a yearly basis. The yearly evaluation will be based on the non-competing application and recommendations of the NINDS Project Scientist.

NINDS reserves the right to terminate or curtail the resource (or an individual component of the resource) in the event of inadequate progress, data reporting, or insufficient use of this resource.

Areas of Joint Responsibility include:

• Clarifying, negotiating, and finalizing the milestones and timelines.
• During the course of the award period, the awardee(s) may be invited to meet with NINDS Project Scientist, and other uninvolved experts in Bethesda, MD, to review scientific progress, the use of the resource, and/or relevant NIH or HHS policies relevant to the resource.
• Existing policies on distribution and appropriate use of repository samples, as outlined in the NINDS Human Biospecimen and Data Repository Material Transfer Agreement and other established NIH/NINDS policies, will be maintained in the new project period. Changes to existing policies may be developed jointly by the awardee and NINDS staff and must be in compliance with relevant HHS, PHS, and NIH policies.
• The government retains ownership of all cell lines and data associated with the samples in the current repository collection and those developed under this project. NINDS and the awardee will jointly develop a plan to transfer repository cell lines and data to a new repository operator in the event that the awardee does not successfully compete for a subsequent project period.

NINDS Human Biospecimen and Data Repository Scientific Advisory Committee

The NINDS Human Biospecimen and Data Repository Scientific Advisory Committee will meet annually, along with teleconferences as needed, to review progress, advancements, innovations and external demand for the Repository and identify areas within the Repository Program that could benefit from additional reporting, technology development, resources provided or infrastructure. Members of the Scientific Advisory Committee will be selected by the PI after consultation with NINDS. NINDS will reserve the option to add ad hoc and permanent members during the course of the project.

Dispute Resolution:

Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and the NIH may be brought to Dispute Resolution. A Dispute Resolution Panel composed of three members will be convened. The three members will be: a designee of the awardee, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two. This special dispute resolution procedure does not alter the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulation 42 CFR Part 50, Subpart D and DHHS regulation 45 CFR Part 16.

3. Reporting

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.

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

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

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: http://grants.nih.gov/support/ (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources)
Email: [email protected] (preferred method of contact)
Telephone: 301-945-7573

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

Christine Swanson-Fischer, PhD
National Institute of Neurological Disorders and Stroke (NINDS)
Telephone: 301-496-5680
Email: [email protected]

Daniel Miller, PhD
National Institute of Neurological Disorders and Stroke (NINDS)
Telephone: 301-496-5680
Email:[email protected]

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

Chief Grants Management Officer
National Institute of Neurological Disorders and Stroke (NINDS)
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 45 CFR Part 75.