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.



Table of Contents
Part 1. Overview Information
Key Dates
Part 2. Full Text of Announcement
Section I. Notice of Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information

Part 2. Full Text of Announcement

Section I. Notice of Funding Opportunity Description

Background

Under the 2009 American Recovery and Reinvestment Act (ARRA), the National Institute of Neurological Disorders and Stroke (NINDS) supported three consortium efforts to develop human induced pluripotent stem cell (iPSC) resources for familial forms of adult-onset neurodegenerative diseases. From this and subsequent efforts, the NINDS Repository now offers cell lines from 427 subjects, including 270 human fibroblast lines and 187 human iPSC lines from healthy control subjects, individuals with neurological disorders including Huntington's disease, Amyotrophic Lateral Sclerosis, Frontotemporal Degeneration, Spinal Muscular Atrophy, Spinal-Bulbar Muscular Atrophy, Spinocerebellar Ataxia, Dystonia, Parkinson's Disease, Lewy Body Dementia, Myotonic Dystrophy, Ataxia-Telangiectasia, Alzheimer's Disease, and Mild Cognitive Impairment. To date, the NINDS Repository has distributed over 1,700 fibroblast lines and over 2,700 iPSC lines worldwide to both academic and industry researchers.

Given the rapid advancements in technologies for both iPSC derivation and genome editing and the continued demand for human fibroblast lines representing both rare and common forms of neurological disorders this NOFO supports further advancements, expansion, and standardizations in iPSC lines and source cell resources for basic research and drug discovery efforts in neurological disorders supported by the NINDS. It is expected that the existing and new resources developed under this NOFO will continue to be broadly distributed to both academic and industry researchers worldwide.

Scope

Activities required under this NOFO include:

• Maintenance and distribution of current fibroblast, peripheral blood mononuclear cell (PBMC), and iPSC lines available through the NINDS Repository;
• De novo derivation, quality assessment, and distribution of new iPSC lines using a standardized non-integrating protocol for derivation. Quality assessment standards should include, but are not limited to those outlined in NOT-NS-24-019;
• Establishment of master and distribution banks for iPSC lines which meet banking standards established by NINDS (see NOT-NS-24-019);
• Limited expansion, quality assessment, and distribution of fibroblast lines wherein patient consents allow for banking with a repository and broad distribution of these lines;
• De novo generation, quality assessment, and distribution of fibroblast lines. Quality assessment of fibroblast lines should include karyotyping at the distribution phase to ensure normal karyotypes;
• Generation and maintenance of a peripheral blood mononuclear cell source for future iPSC derivation efforts. Extensive de-identified clinical data must accompany each sample and a global unique identifier (GUID) will be used to link the clinical data with the cell resource;
• Generation, quality assessment, and distribution of isogenic iPSC lines through genome editing using standardized protocols. The parent and corresponding genome-edited lines must undergo standardized quality assessments including whole genome sequencing;
• Data management including a catalog of all cell sources available through the NINDS Repository, as well as routine tracking and reporting of submissions, requests, and distribution.

A successful application will have strengths in four major areas of emphasis: 1) iPSC technology and genome editing; 2) project management; 3) resource creation, maintenance, and operation; and 4) data management. Qualifications for applicants should include academic excellence in the field of induced pluripotent stem cell derivation, quality assessment, and genomic editing.

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 resource and research activities will also require the continued collection and maintenance of existing NINDS Repository human cell lines and data. Other disorders are likely to be added during the duration of the project. Receipt, processing, storage, and the national and international distribution of iPSC and fibroblast cell lines will be required.

Applications Not Responsive to this NOFO

• Applications that propose to develop non-human cell resources.
• Applications that propose to develop human cell resources other than fibroblasts, PBMCs, and iPSCs. Demonstration of capabilities to generate differentiated cell lines in the future, if warranted by NINDS, would NOT be considered unresponsive.
• Applications that do not include a plan for broad distribution of cell lines, including a catalog of all cell sources available through the NINDS Repository, as well as routine tracking and reporting of submissions, requests, and distribution.
• Applications that do not include quality assessment standards outlined in NOT-NS-24-019.

Non-responsive applications will be withdrawn and will not be reviewed.

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

• 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 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. Individuals from diverse backgrounds, including underrepresented racial and ethnic groups, individuals with disabilities, and women are always encouraged to apply for NIH support. See, Reminder: Notice of NIH's Encouragement of Applications Supporting Individuals from Underrepresented Ethnic and Racial Groups as well as Individuals with Disabilities, NOT-OD-22-019.

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. 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.

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:

Rebecca Price, PhD
National Institute of Neurological Disorders and Stroke
Telephone: 301-827-3587  
Email: rebecca.price@nih.gov

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:

• Characterization, quality control, and assurance measures for iPSC and source cell 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 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 NHCDR 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:

Research Strategy      

Acquisition, Characterization, Quality Control and Assurance Measures, De Novo Derivation, Genome Editing, Maintenance and Storage and Distribution for NINDS Repository human induced pluripotent stem cells (iPSCs), human peripheral blood mononuclear cells (PBMCs), and human fibroblasts.

Propose plans that describe how valuable existing and new samples from projects identified by NINDS will be supported by the Repository. Plans 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:

• Acquisition. Describe, in general terms, procedures for accessioning biomaterials and corresponding clinical data for the development of human cell sources including from researchers and clinicians who are not familiar with biomaterial collection for cell source derivation. Note that cell lines will be identified by NINDS for inclusion after the award is made. Presented plans must include: 1) the de novo generation of 15-25 iPSC lines per year; 2) the generation of 15-25 fibroblast lines per year, either through de novo establishment from skin biopsies or through limited expansion of NINDS approved lines; and 3) the banking of 40-50 peripheral blood mononuclear cell (PBMC) samples per year. All iPSC, fibroblast and PBMC sources developed through this resource will be approved by the NINDS Scientific Program Director prior to commencement of work.
• It is anticipated that PBMC samples will be received within 24 hours of each subject visit. 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.
• Characterization, quality control and assurance measures. Describe methods for the development, expansion, and characterization of a master bank and distribution lot for iPSC and fibroblast cell resources. Describe any sample-specific characterization and sample-type specific quality assurance procedures planned. Describe genotyping services available for both routine screening of known variants for certain sample types, and whole genome sequencing, ancestral informative characterization, or other approaches for genotyping sample collections. For cell lines where genomic modification will be performed, both the parent and modified lines will undergo whole genome sequence characterization. Describe planned sample tracking methods (such as bar-coding or SNP genotyping).
• Control lines. Describe methods for providing appropriate and high-quality controls for disease iPSC lines. Planned strategies should go beyond developing controls by matching age and sex.
• De novo derivation of iPSC and fibroblast cell sources. Describe strategies to be used for the de novo derivation of iPSC and fibroblast cell resources including the handling and quality assessment of the starting sample types (e.g., skin biopsies, PBMCs, other cell sources). Propose detailed plans for characterization, quality assessment, preparation, storage, and distribution of various cell sources. Plans should describe how the proposed methods and processes will ensure the distribution of high-quality, well-characterized samples to the biomedical research community for appropriate uses. Plans should also describe how innovation in derivation methods, sample handling, or characterization will be incorporated over the time course of this award. Given the significant variation in expertise at sites that will contribute samples, describe any expectations and training plans for local processing and handling of various sample types at the collection sites.
• Genome Editing. Describe strategies for genome editing that will enable the development of isogenic lines carrying novel mutations or corrections of known mutations. Strategies should include the quality assessment of these lines, including whole genome sequencing of the parent line and corresponding lines that have been genetically modified.
• Maintenance and Storage. Describe plans for maintenance of the existing collection and for re-expansion of samples when needed. Describe safeguards against accidental loss of the collection, including storage of duplicates at a remote site, freezer failure back-up plan, and other contingencies. Describe safeguards to prevent temperature changes when freezers are accessed, alarm systems and procedures, and other safeguards against sample loss. If samples are to be stored under a subcontract, they shall not be distributed or used by the subcontractor without prior NINDS written authorization. Lost samples may be re-collected at the expense of the recipient , at the request of NINDS.
• Distribution of human iPSC and fibroblast lines. Describe the approach for receiving requests for samples from various requestors, how requests 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 and strategies to prevent samples not being collected by the recipient upon arrival (to the extent possible). Note: these plans should include both US and international recipients. It is anticipated that world-wide distribution will include 600-800 cell lines per year.
• Describe innovation in cell banking that may accelerate research and standardization of resources through the development and distribution of cell source derivatives such as, but not limited to iPSC-derived neural precursor cell sources. In the description include standardization and quality assessments that will be applied to cell source derivatives to ensure the distribution of a standardized product.

Additionally, applicants must :

• Describe how the details of laboratory standard operating procedures and best practices for sample collection will be shared and publicized.
• Describe plans for the Institutional Review Board (IRB) that will review the use of materials that are considered Human Subjects.
• Describe timelines for: processing from sample receipt to storage, sample request to shipping, protocol deviation to reporting to NINDS, and other activities. Where possible, integrate timelines for these activities into project milestones.

Data Repository:

The applicant must describe plans for maintaining a computerized   system that facilitates retrieval of sample information about NINDS Repository iPSCs, PBMCs, and fibroblast cell lines. The research strategy must present a system that is effective for quality control, tracking of samples, fulfilling orders, billing for cost reimbursement, shipping, and maintaining inventories.  

Applicants must address their strategy to provide the following: 

• A system (and back-up system to protect against accidental loss of valuable data)  that includes inventory, catalog, and other necessary information for researchers to access fibroblast and iPSC lines and related de-identified clinical information. The system should be updated on a regular basis.
• A user-friendly public web-based interface with the research community to promote the goals of the NINDS Human Cell Resource and Data Repository and to provide tools and information for the collection and use of these cell lines, including ordering samples, and ensures data integrity, accuracy, and security.
• Data management strategies to facilitate easy searching, identification, and requesting of cell lines and their associated data.
• Manage data associated with the human cell lines including integration of de-identified clinical data from other databases or resources (ensuring that the relevant data is findable, accessible, interoperable, and reusable), including NINDS Common Data Elements (CDEs).
• Ensure that updated specimens data is accessible to NINDS Program staff and their designees as appropriate.
• Dedicated staff with IT and data management experience must be available for troubleshooting any data management aspects of the project. 
• A plan to incorporate improvements to the inventory, catalog, and web-based interface following user or NIH staff feedback that demonstrates nimbleness and flexibility of the system.

Web-based Catalog. Describe plans for a web-based electronic catalog that lists the available cell lines with associated information about them, including a NINDS GUID, detailed phenotype and molecular genotype data, cell culture history, cell lines and DNA available from family members, pedigree diagrams, and chromosome ideograms, and links to related genetic databases. This catalog will be hosted by the recipient , as well as other databases that increase the visibility of the cell lines available. Catalog information must include a list and explanation of the policies governing the submission and requesting of samples. 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.

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 will serve not only IT and data management related concerns, but the entire collection project. For example, this help-desk function would provide support to biomedical researchers who submit samples, submit data, search for samples, have technical questions regarding the submission, or who need assistance with decisions on ordering. The customer service plan must include timelines regarding turn-around time on any query.

Publicizing Repository Collections. Describe plans to publicize repository collections. Efforts may include publishing notices and 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 repository, and/or other activities. The aim of the activities is 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. These activities must be directed towards scientists and towards the public being served, i.e., those with neurological disorders and their friends and families.

Additional Application Elements:

Applicants must also address each of the following key 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 should include timely processing of sample submissions and requests, and 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 accomplishment.

• Describe the research communities served in terms of providing access to iPSC, fibroblast or PBMC lines, and any unique skills, tools, or experience relevant to the proposed work that are not already detailed in the Biosketch. Describe particular abilities in technology advancements and standardization in iPSC resource development, development and characterization of genetically modified iPSC lines, and iPSC derivatives.
• Cost-Recovery program. Outline an overall cost-recovery program that provides a plan for a charge-back fee for collection kits and shipping for prospective collections and distribution of samples. Ideally, this charge-back plan should take into consideration the importance to the NINDS of serving the community and promoting broad sharing, and therefore, should neither be onerous nor provide a disincentive for use of the collection.
• Intellectual Property Rights. Provide a strategy for resource management that addresses the need/requirement for licensing agreements that enable the broad distribution of NINDS repository cell resources to both academic and industry investigators. These licensing agreements must address and provide reasonable solutions for any intellectual property rights that limit the use of the NINDS cell repository cell resources and create egregious demands on the intended cell source recipient or their institution.

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 Repository's offices that handle or process the samples and data for biomedical research are in compliance with the Health Insurance Portability and Accountability Act (HIPAA).
• That the Repository 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.

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.

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 development, maintenance and distribution of human cell resources including iPSCs and fibroblasts that will play a significant role in advancing basic science and drug discovery efforts for neurological disorders supported by NINDS. Accordingly, since the cell lines developed 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 cell 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 the 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.

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

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 NOFO . 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.

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.
• If a recipient receives an award, the recipient must follow all applicable nondiscrimination laws. The recipient agrees to this when registering in SAM.gov. The recipient must also submit an Assurance of Compliance (HHS-690). To learn more, see the Laws and Regulations Enforced by the HHS Office for Civil Rights website. 
  • HHS recognizes that NIH 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 NOFO.

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

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

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 NINDS Human Cell and Data Repository.
• Providing written reports as requested to NINDS Program staff as well as biweekly supplementary status reports.
• Participating in group activities including resource supported Scientific Advisory Committee calls and subcommittees as needed.
• 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:

• 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 .
• Substantial involvement in coordinating the activities of the recipient  with other NIH-sponsored biobanks and databases as necessary.
• Participation in NINDS Human Cell and Data Repository 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 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 recipient  staff, periodic site 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.

Areas of Joint Responsibility include:

• Clarifying, negotiating, and finalizing the milestones and timelines.
• 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 Cell 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 Cell and Data Repository (NHCDR) Scientific Advisory Committee

The NINDS Human Cell and Data Repository Scientific Advisory Committee will meet annually, along with teleconferences as needed, to review progress, advancements, innovations and external demand for the NINDS Human Cell and Data Repository and identify areas within the Cell and Data 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 NHCDR PI after consultation with NINDS.

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)

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

General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources)
Email: GrantsInfo@nih.gov (preferred method of contact)
Telephone: 301-480-7075

Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email: support@grants.gov

Rebecca Price , PhD
National Institute of Neurological Disorders and Stroke (NINDS)
Telephone: 301-827-3587 
Email:rebecca.price@nih.gov 

Christine Swanson-Fischer, PhD
National Institute of Neurological Disorders and Stroke (NINDS)
Telephone: 301-827-3587 
Email:christine.swanson-fischer@nih.gov

Chief, Scientific Review Branch
National Institute of Neurological Disorders and Stroke (NINDS)
Telephone: 301-496-9223
Email: nindsreview.nih.gov@mail.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.