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.

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.

There are several options available to submit your application through Grants.gov to NIH and Department of Health and Human Services partners. You must use one of these submission options to access the application forms for this opportunity.

1. Use the NIH ASSIST system to prepare, submit and track your application online.
2. Use an institutional system-to-system (S2S) solution to prepare and submit your application to Grants.gov and eRA Commons to track your application. Check with your institutional officials regarding availability.
3. Use Grants.gov Workspace to prepare and submit your application and eRA Commons to track your application.

Part 2. Full Text of Announcement

Section I. Notice of 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 Amyotrophic Lateral Sclerosis, Chronic Traumatic Encephalopathy, Chronic Subdural Hematoma, Epilepsy, Leukodystropies, Lewy Body Dementia, Multiple System Atrophy, Myalgic Encephalomyelitis/Chronic Fatigue Syndrome, Myotonic Dystrophy, Parkinson's Disease Dementia, Progressive Supranuclear Palsy, Spinocerebellar Ataxia, and Traumatic Brain Injury. To date the repository has distributed over 54,353 sample aliquots worldwide to both academic and industry researchers.

This open competition NOFO 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 NOFO will continue to be broadly distributed to both qualified academic and industry researchers worldwide following government guidelines and regulations

Scope

Activities required under this NOFO 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.
• Provide support for community based research to enable remote collections and/or clinical laboratory tests to studies banking with the repository.
• 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 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.
• Facilitate 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 an electronic biobanking management 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) Biospecimen tracking; 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, and 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 Not Responsive to this NOFO

• Applications that propose to develop non-human cell and/or biospecimen resources.
• Applications that propose to develop human cell resources including fibroblast, induced pluripotent stem cells, or post-mortem brain tissue. 
• Applications that do not include a plan for broad distribution of biospecimens.

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.

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

Higher Education Institutions - Includes all types

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

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

Foreign Organizations/Foreign Collaborations

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 not 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.

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 their organization to develop an application for 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 How to Apply - Application Guide.

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

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, per NIH Grants Policy Statement Section 2.3.7.4 Submission of Resubmission Application. 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 NIH Grants Policy Statement 2.3.9.4 Similar, Essentially Identical, or Identical Applications).

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 (in this NOFO, in a policy notice, or other notice from NIH Guide for Grants and Contracts). 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.

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

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.

SF424(R&R) Senior/Key Person Profile

All instructions in the How to Apply - 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
• Protocol development and standardization
• 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 How to Apply - Application Guide must be followed.

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

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:

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 must 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. Standardization of protocols is required.
• Sample 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. The sharing of raw and analyzed data, protocols, quality assurance, and other data generated by the research team is required. 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 must 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:

Subsection A. Biobanking Administration

Subsection B. Biobanking Operations

Subsection C. Biospecimen and Related Data Tracking and Informatics

Specific guidelines and requirements for these subsections are described below.

Subsection 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:

• Summarize how collaborations or subcontracts, if proposed, will be managed. 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.
• Describe the administrative structure of the project proposed, including an organizational chart, 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. Ensure adequate staffing needs for banking study coordinating, laboratory procedures, IT support, etc.
• Provide education and training of investigators and clinical staff in biospecimen collection to ensure standardization and best practices.
• Provide support for community based research to enable remote collections and/or clinical tests for banking studies interested in these services. Include a brief description regarding how this will be coordinated with the recipient and subcontracts, as appropriate, including types of possible specimen collections, storage and shipment to the repository, and QA/QC tracking procedures for remote collections.
• Develop innovative biospecimen management strategies, as needed to ensure that the resource remains responsive to researchers' needs.
• Coordinate transfer (if appropriate) and maintenance of the existing Repository collection. This collection contains approximately 450,000 sample aliquots from approximately 6,000 unique subjects, including: DNA, RNA, plasma, serum, whole blood, peripheral blood mononuclear cells (PBMCs), saliva, urine, cerebrospinal fluid (CSF), tears, stool, tissue/skin biopsy, and subdural hematoma fluid along with phenotypic data. Supplementary information about the current Repository can be found at https://biosend.org/index.html. Please contact Scientific/Research Contacts listed in Section VII. Agency Contacts for questions about collection transfer.
• 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. 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 recipient 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.
• 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. 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.
• 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.
• Establish and maintain the Repository website as well as any proposed social media presence.
• Organize and convene a Scientific Advisory 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 provide recommendations on sample destruction to ensure optimal use of storage space. The committee will be recommended by the applicant, but final approval and additional members may be recommended by the NINDS.
• Establish a policy and decision process including input from the Scientific Advisory Committee for reviewing existing collection and providing recommendations for sample destruction as needed.
• Establish a process to improve the resource's procedures and programs when feedback is given via users or the NIH staff that is nimble and flexible.

Subsection B. Biobanking Operations

This subsection must 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, saliva, and stool). It is expected that newly collected samples will be submitted to the repository within 24 hours of each subject visit. Applicants 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 recipient, depending on the circumstances, at the request of NINDS.
• Distributing biospecimens to qualified investigators and/or laboratories. The NINDS has established Biospecimen Resource Access Committees (BRACs) for existing and new 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 must include both US and international recipients following government guidelines and regulations.
• Describe procedures for distributing blinded biospecimens. Biospecimens distributed to approved investigators must be distributed in a blinded fashion to promote rigorous science. Applicants should include information about how proper blinding will be achieved, while providing adequate information for approved investigators to run biosample assays. Unblinding keys will be provided to approved investigators following approval of blinded data submission by the Repository and NINDS staff and return of bioassay data to the appropriate data repository. The applicant will be responsible for providing the unblinding key.
• Legal and ethical aspects related to human biospecimens. Most samples will not be subject to Human Subjects regulations, as most will be de-identified and Health Insurance Portability and Accountability Act (HIPAA) compliant. However, rare collections may have Human Subjects aspects or require personally identifiable information (PII) for specific collection protocols (e.g. remote collections). For this reason, include proposed procedures for evaluating and maintaining adherence to Health and Human Services (HHS) and NIH guidelines and regulations on informed consent and research resources, including information technology security and the implications of the 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 and collection protocols 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 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 subsection, 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.

Subsection C. Biospecimen and Related Data Tracking and Informatics

The applicant must describe plans for maintaining a computerized system for cataloging, querying, and retrieval of biospecimen-related information that can dovetail with a variety of other data management resources in academic and industry settings. The design and development of the system should provide nimble, user-friendly accounting of the repository's inventory, and ensure data integrity, accuracy, and security following the FAIR data principles (findable, accessible, interoperable, and reusable). 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 time between collection, shipping, freezing or other temperature changes, processing, needle bore, centrifugation, etc.)

Applicants must address the following in their strategy:

• Solutions for effective quality control, tracking of samples, order fulfillment, billing methods for cost reimbursement, shipment, and inventory tracking, including a back-up system to protect against accidental loss of valuable data.
• 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, policy guidance, procedures for governing the submission and requesting of samples and location of associated clinical, and genetic and phenotypic data for available biospecimens.
• 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 recipient, but in others, the catalog will be hosted by the clinical project itself via NINDS funding (such as is being done, for example, by the PDBP DMR). If hosted by the recipient, the catalog must list the available samples with associated information, including a GUID, minimal clinical and phenotypic data, assay results, and all quality assurance information.
• Web-based systems must be able to track and notify submitters and requestors regarding sample status (via an electronic system) and to fully share data with NINDS Program staff and their designees in real time.
• A strategy for tracking performance 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. 
• 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 publications related to use of the resource. This will in part enable NINDS to partially gauge the scientific impact of the biorepository activities.
• Dedicated staff with IT and data management experience must be available for troubleshooting.

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.

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 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:

Sustainability Plan. A plan for future sustainability must be presented to ensure longevity of the repository should future federal funding no longer be available. The sustainability plan must address how to maintain the storage of extant samples and plans to continue broad distribution of samples to academic and industry researchers worldwide within a framework that maintains public trust. The plan may also include (but not limited to): plans to destroy samples (where appropriate) with guidance from the External Steering Committee, methods to engage with stakeholders, and a timeline to reduce support from federal funds. If a cost-recovery model is used, charges for samples should only be used to recover reasonable costs associated with the operation of the repository and not to generate undue profit. Applicants are recommended to review existing resources such as the International Society for Biological and Environmental Repositories (ISBER) Best Practices for Repositories or the National Cancer Institute’s report on Critical Financial Challenges for Biobanking to aid in development of the sustainability plan.

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 of 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 a Scientific Advisory Committee
• Publicizing the availability of biospecimens and tracking publications relevant to samples banked and utilized
• Clear communication timelines with NINDS and other stakeholders.
• Policy and procedures for review of existing collection for recommendations for sample destruction, as needed.

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 How to Apply - Application Guide.

• Consistent with achieving the goals of this repository, applications are required to describe a Resource 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 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, 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 NOFO. 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 NOFO and applications will be withdrawn. 

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 components of participating organizations, 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 grantdisclosures@oig.hhs.gov. 

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.

For this particular announcement, note the following:

Applications responsive to this NOFO 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.

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.

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.

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 Neurological Disorders and Stroke 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.

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.

By applying for or accepting federal funds from HHS, recipients certify compliance with all federal antidiscrimination laws and these requirements and that complying with those laws is a material condition of receiving federal funding streams. Recipients are responsible for ensuring subrecipients, contractors, and partners also comply.

Applicants and recipients are strongly encouraged to refer to the NIH Director’s Statement of Priorities, entitled “Advancing NIH’s Mission Through a Unified Strategy.” 

Recipients are responsible for ensuring that their activities comply with all applicable federal regulations. Pursuant to 2 CFR 200.340, by accepting an NIH award, the recipient agrees that continued funding for the award is contingent upon the availability of appropriated funds, recipient satisfactory performance, compliance with the Terms and Conditions of the award, and may also otherwise be terminated, to the extent authorized by law, if the agency determines that the award no longer effectuates the program goals or agency priorities, in line with 2 CFR 200.340(a)(4).

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:

• 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 recipient 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 fo 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 (i.e., 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 per year.
• Preparing abstracts, presentations, and publications and collaborating in making the public and scientific community aware of this resource.
• Recipients 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 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:

The Project Scientist will:

• Serving as a liaison to help coordinate activities of the recipient, including acting as a liaison to other NIH Institutes/Centers sponsored biobanks and databases as needed and as an information resource for the recipients.
• Contribute to the adjustment of research protocols, project milestones, or approaches as warranted.
• Substantial involvement in coordinating the activities of the recipient with other NIH-sponsored biobanks and databases as necessary.
• Participation in Scientific Advisory Committee meetings.
• Assisting recipients 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 agency program official or IC program director 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 recipient staff, periodic staff visits, or meetings for discussion with the recipient 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 timeline.
• During the course of the award period, the recipient(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 recipient 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 recipient will jointly develop a plan to transfer repository cell lines and data to a new repository operator in the event that the recipient 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, infrastructure, or sample destruction as needed. 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. NIH advisory or steering committee members will share one combined vote in support of the project. 

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 Steering Committee chosen without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual 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.

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.

Grants.gov Support Center - Questions regarding Grants.gov registration and services (e.g., Workspace, subscriptions).

NINDS-BRAC@ninds.nih.gov

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

Email: NOFOReviewContact@csr.nih.gov
 

Chief Grants Management Officer
National Institute of Neurological Disorders and Stroke (NINDS)
Email: ChiefGrantsManagementOfficer@ninds.nih.gov

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.