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 Multi-Project (M) Instructions in the How to Apply - Application Guide, except where instructed to do otherwise (in this NOFO or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the NOFO) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

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.
   
   



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

This is a non-competitive funding opportunity intended, if the application is meritorious, to fund a single award to the Coriell Institute for Medical Research for the NIGMS Human Genetic Cell Repository (HGCR). Coriell Institute for Medical Research has unique capabilities for this competition including maintaining the repository and current stock of samples, expertise in human genetics, cell culture, development of induced pluripotent stem cells (iPSCs), molecular biology and bioinformatics, and a demonstrated track record of managing a complex resource. The purpose of the NIGMS HGCR is to provide well-characterized, high-quality human cell lines and DNA samples for use in research. The repository currently contains more than 11,900 cell lines, primarily fibroblasts and transformed lymphoblasts, over 5,900 DNA samples, and over 85 iPSC lines. Repository samples represent a variety of disease states, chromosomal abnormalities, apparently healthy individuals, and many distinct human populations.

The repository acquires cell samples from individuals affected by genetic disorders and from unaffected individuals to create cell lines and then distributes those cell lines and extracted DNA to researchers. The repository facilitates research by enabling investigators to formulate and test hypotheses using high-quality human cells and DNA that are uncontaminated, well-documented, well-characterized, and for which donors have given appropriate consent for use in research.

Scope

The work to be supported by this NOFO includes several interrelated functions:

• Maintaining and distributing the cell lines currently in the repository's collection, acquiring new cell samples, and establishing and characterizing permanent cell lines from these samples.
• Maintaining the current stock of DNA samples and the preparation, storage, and distribution of purified, high-quality DNA samples from additional selected cell lines in the repository.
• Providing additional genetic services and distributing other reagents as determined by the recipient and NIGMS staff.
• Enhancing and maintaining a comprehensive computerized database containing detailed information on every cell line and DNA sample and providing a user-friendly and web-accessible catalog.
• Disseminating information about the repository's collections.
• Engaging with the global biobanking community to provide guidance on biobanking best practices.
• Ensuring that distributed samples have appropriate donor consent for use in research.
• Sustainability planning to assure long-term access of the resources to the biomedical research community.

Performance of these functions at a high level requires repository staff to have recognized expertise in human genetics, cell culture, development of induced pluripotent stem cells (iPSCs), molecular biology and bioinformatics, as well as a demonstrated track record managing a complex resource, including ethical and legal considerations, customer service and outreach.

Plan for Enhancing Diverse Perspectives (PEDP)

NIGMS recognizes that diverse teams working together and capitalizing on innovative ideas and distinct perspectives outperform homogeneous teams. There are many benefits that flow from a diverse scientific workforce, including: fostering scientific innovation, enhancing global competitiveness, contributing to robust learning environments, improving the quality of the research, advancing the likelihood that underserved populations participate in and benefit from research, and enhancing public trust.

To support the best science, NIGMS encourages inclusivity in research. Examples of structures that promote diverse perspectives include but are not limited to:

• Transdisciplinary research projects and collaborations among human and clinical geneticists, data scientists, bioethicists, and experts in biological repositories.
• Engagement from different types of institutions and organizations (e.g., research-intensive, undergraduate-focused, minority-serving, community-based).
• Individual applications and partnerships that enhance geographic and regional heterogeneity.
• Investigators and teams composed of researchers at different career stages.
• Participation of individuals from diverse backgrounds, including groups historically underrepresented in the biomedical, behavioral, and clinical research workforce (see NOT-OD-20-031), such as underrepresented racial and ethnic groups, those with disabilities, those from disadvantaged backgrounds, and women.
• Project-based opportunities to enhance the research environment to benefit early- and mid-career investigators.

This NOFO requires a Plan for Enhancing Diverse Perspectives (PEDP) as described in NOT-MH-21-310, submitted as Other Project Information as an attachment (see Section IV). Applicants are strongly encouraged to read the NOFO instructions carefully and view the available PEDP guidance material. The PEDP will be assessed as part of the scientific and technical peer review evaluation, as well as considered among programmatic matters with respect to funding decisions.

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

Section II. Award Information

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

Section III. Eligibility Information

1. Eligible Applicants

Only the following applicant may apply for this single source funding: Coriell Institute for Medical Research. Please refer to Section I. Notice of Funding Opportunity Information for more details.

Non-domestic (non-U.S.) Entities (Foreign Organization) 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 registration; all registrations must be in place by time of submission. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
• Grants.gov Applicants must have an active SAM registration in order to complete the Grants.gov registration.

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

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

Only the PI/PDs associated with the award issued under announcement, RFA-GM-19-002, to Coriell Institute for Medical Research is eligible to apply for this single source funding. Please refer to Section I. Notice of Funding Opportunity Information for more details.

2. Cost Sharing

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

3. Additional Information on Eligibility

Number of Applications

Only a single award will be issued to Coriell Institute for Medical Research under this single source funding opportunity, pending submission of a meritorious application. Please refer to Section I. Notice of Funding Opportunity Information for more details.

Section IV. Application and Submission Information

1. Requesting an Application Package

The application forms package specific to this opportunity must be accessed through ASSIST or an institutional system-to-system solution. A button to apply using ASSIST is available in Part 1 of this NOFO. See the administrative office for instructions if planning to use an institutional system-to-system solution.

2. Content and Form of Application Submission

It is critical that applicants follow the Multi-Project (M) Instructions in the How to Apply - Application Guide, except where instructed in this notice of funding opportunity to do otherwise and where instructions in the Application Guide are directly related to the Grants.gov downloadable forms currently used with most NIH opportunities. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

Page Limitations

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

Instructions for the Submission of Multi-Component Applications

The following section supplements the instructions found in How to Apply- Application Guide and should be used for preparing a multi-component application.

Overall Component

When preparing the application, use Component Type Overall .

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

SF424(R&R) Cover (Overall)

Complete entire form.

PHS 398 Cover Page Supplement (Overall)

Note: Human Embryonic Stem Cell lines from other components should be repeated in cell line table in Overall component.

Research & Related Other Project Information (Overall)

Follow standard instructions.

Other Attachments: The application must include the following attachment.

Plan for Enhancing Diverse Perspectives (PEDP) (1-page maximum): All applications must include a summary of strategies to advance the scientific and technical merit of the proposed project through expanded inclusivity. The PEDP should provide a holistic and integrated view of how enhancing diverse perspectives is viewed and supported throughout the application and can incorporate elements with relevance to any review criteria (significance, investigator(s), innovation, approach, and environment) as appropriate. Where possible, applicants should align their description with these required elements within the research strategy section. The PEDP will vary depending on the scientific aims, expertise required, the environment and performance site(s), as well as how the project aims are structured. The PEDP should include a timeline and milestones for relevant components that will be considered as part of the review. Examples of items that advance inclusivity in research and may be part of the PEDP can include, but are not limited to:

• Discussion of engagement with different types of institutions and organizations (e.g., research-intensive, undergraduate-focused, minority-serving, community-based).
• Description of any planned partnerships that may enhance geographic and regional diversity.
• Plan to enhance recruiting of women and individuals from groups historically under-represented in the biomedical, behavioral, and clinical research workforce.
• Proposed monitoring activities to identify and measure PEDP progress benchmarks.
• Plan to utilize the project infrastructure (i.e., research and structure) to support career-enhancing research opportunities for diverse junior, early- and mid-career researchers.
• Description of any training and/or mentoring opportunities available to encourage participation of students, postdoctoral researchers and co-investigators from diverse backgrounds.
• Plan to develop transdisciplinary collaboration(s) that require unique expertise and/or solicit diverse perspectives to address research question(s).
• Publication plan that enumerates planned manuscripts and proposed lead authorship.
• Outreach and planned engagement activities to enhance recruitment of individuals from diverse groups as research participants including those from under-represented backgrounds.

For further information on the PEDP, please see https://braininitiative.nih.gov/vision/plan-enhancing-diverse-perspectives/pedp-key-elements-and-examples?search-term=pedp.

This attachment should be titled Plan for Enhancing Diverse Perspectives.

Project/Performance Site Locations (Overall)

Enter primary site only.

A summary of Project/Performance Sites in the Overall section of the assembled application image in eRA Commons compiled from data collected in the other components will be generated upon submission.

Research and Related Senior/Key Person Profile (Overall)

Include only the Project Director/Principal Investigator (PD/PI) and any multi-PDs/PIs (if applicable to this NOFO) for the entire application.

A summary of Senior/Key Persons followed by their Biographical Sketches in the Overall section of the assembled application image in eRA Commons will be generated upon submission.

Budget (Overall)

The only budget information included in the Overall component is the Estimated Project Funding section of the SF424 (R&R) Cover.

A budget summary in the Overall section of the assembled application image in eRA Commons compiled from detailed budget data collected in the other components will be generated upon submission.

PHS 398 Research Plan (Overall)

Introduction to Application: For Resubmissions, an Introduction to Application is required in the Overall component.

Specific Aims: Provide a succinct description of how the proposed work will meet the overall scientific goals of the research resource and the expected outcomes and impact should those goals be achieved. The specific aims should support the purpose of serving the biomedical research community through acquisition, maintenance, and distribution of high-quality human cell samples and extracted DNA to researchers with qualified biomedical research needs, as assessed by Coriell Institute for Medical Research in possible consultation with NIGMS staff.

Research Strategy: Provide an overall description of the proposed repository and its organizational structure. Describe plans for effectively carrying out each of the described core functions of the repository. The applicant must present an integrated plan that will be responsive to the evolving needs of the biomedical research community. The applicant must also address each of the following key elements:

• Milestones: Present specific milestones that will need to be met in order to accomplish the work set out in a five-year period.
• Experience in Operating a Biobank: Describe the research community(ies) served during previous experience operating a biobank and describe any unique experience(s) not already detailed in the biosketch(es) that will facilitate and enable the proposed work.
• Cost-recovery Program: Outline a cost-recovery program that provides a plan for a charge-back fee for distribution of cell lines and DNA samples. In the past 7 years, costs of carrying out the core functions of the NIGMS HGCR have averaged approximately $6.2 million per year. Cost-recovery will cover an increasing amount of the total costs across the 5-year period. The cost-recovery program presented should be designed to contribute approximately 70% of overall costs from the program's income in years 1 and 2, 75% in years 3 and 4, and 80% in year 5. NIGMS funding is expected to decrease correspondingly as program income increases. The calculated costs must take into account all the expenses associated with each component activity.
• Representation: Describe how new diseases and conditions will be prioritized for addition to the resource and how the resource will work to ensure that current and new acquisitions align with characteristics of the US population.
• Informed consent and ethical issues: Explain how the resource will ensure that all current and future samples available to researchers will have the appropriate consent for use. Also explain how other ethical issues will be approached and resolved.
• Outreach: The NIGMS HGCR is expected to serve as a resource for the biomedical research community. Explain how the resource will provide outreach and leadership to the community on biobanking best practices and maintain a connection to the global biobanking community.

Resource Sharing Plan:
Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide.

Generally, Resource Sharing Plans are expected, but they are not applicable for this NOFO.

Other Plan(s):

Note: Effective for due dates on or after January 25, 2023, the Data Management and Sharing Plan will be attached in the Other Plan(s) attachment in FORMS-H application forms packages. If required, the Data Management and Sharing (DMS) Plan must be provided in the Overall component.

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

• A Data Management and Sharing Plan is not applicable for this NOFO.

Appendix:

Only limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in How to Apply- Application Guide; any instructions provided here are in addition to the Application Guide instructions.

PHS Human Subjects and Clinical Trials Information (Overall)

When involving human subjects research, clinical research, and/or NIH-defined clinical trials follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:

If you answered Yes to the question Are Human Subjects Involved? on the R&R Other Project Information form, there must be at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record within the application. The study record(s) must be included in the component(s) where the work is being done, unless the same study spans multiple components. To avoid the creation of duplicate study records, a single study record with sufficient information for all involved components must be included in the Overall component when the same study spans multiple components.

Study Record: PHS Human Subjects and Clinical Trials Information

All instructions in the SF424 (R&R) 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 (Overall)

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

Scientific and Administrative Management Core

When preparing your application, use Component Type Admin Core.

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

SF424 (R&R) Cover (Scientific and Administrative Management Core)

Complete only the following fields:

• Applicant Information
• Type of Applicant (optional)
• Descriptive Title of Applicant’s Project
• Proposed Project Start/Ending Dates

PHS 398 Cover Page Supplement (Scientific and Administrative Management Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Scientific and Administrative Management Core)

Human Subjects: Answer only the Are Human Subjects Involved? and 'Is the Project Exempt from Federal regulations? questions.

Vertebrate Animals: Answer only the Are Vertebrate Animals Used? question.

Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

Project /Performance Site Location(s) (Scientific and Administrative Management Core)

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

Research & Related Senior/Key Person Profile (Scientific and Administrative Management Core)

• In the Project Director/Principal Investigator section of the form, use Project Role of Other with Category of Core Lead and provide a valid eRA Commons ID in the Credential field.
• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
• Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.

Budget (Scientific and Administrative Management Core)

Budget forms appropriate for the specific component will be included in the application package.

PEDP implementation costs: Budget request may include allowable costs associated with PEDP implementation (as outlined in the Grants Policy Statement).

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

PHS 398 Research Plan (Scientific and Administrative Management Core)

Introduction to Application: For Resubmission applications, an Introduction to Application is allowed for each component.

Specific Aims: State concisely the goals and objectives of the proposed Scientific and Administrative Management Core.

Research Strategy: Applicant must address each of the following key areas:

• Administrative Structure: Describe the proposed administrative structure of the project, including PD(s)/PI(s), key personnel, an Executive Committee, a Scientific Advisory Committee, and key resource cores.
• Executive Committee: An internal Executive Committee is required. The Executive Committee should include the Program Directors/Principal Investigators (PD(s)/PI(s)) and leads of the individual Cores, as well as other senior personnel of the Coriell Institute for Medical Research, as appropriate. The Executive Committee will oversee progress and performance of the NIGMS HGCR and identify definitive solutions to problems that arise, consistent with the needs to protect human subjects and to provide high-quality resources to the scientific community. Describe the composition of the committee, the roles, responsibilities, and expertise of committee members, and the frequency of committee meetings.
• Scientific Advisory Committee: An external Scientific Advisory Committee that provides advice about operational, scientific and ethical aspects of the resource is required. List the membership and qualifications of the committee members and any additional scientific expertise that will be sought. Describe the issues upon which the committee’s expertise will be sought, the frequency and format of committee meetings, and procedures for implementing its recommendations.
• Human Subjects: Describe procedures for evaluating and maintaining adherence to Federal, 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 Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule. An Institutional Review Board (IRB) is required. Describe the qualifications that will be sought for members of the IRB, how it will operate, and the institutional structures that will be in place to ensure that the IRB will have adequate independence to maximally assure the protection of human subjects. Explain how the research resource will ensure that newly acquired samples are accompanied by informed consent for retention, distribution and research use of cells, DNA, and/or derived iPSCs. Explain the resource's plans for ensuring that historical samples have appropriate consents and what will be done if they do not.
• Sustainability Planning: Describe the long-term plans for ensuring continuous, long-term access to the resource.

Resource Sharing Plan: Generally, Resource Sharing Plans are expected, but they are not applicable for this NOFO.

Appendix: Only limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions.

PHS Human Subjects and Clinical Trials Information (Scientific and Administrative Management Core)

When involving human subjects research, clinical research, and/or NIH-defined clinical trials follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:

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

Study Record: PHS Human Subjects and Clinical Trials Information

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

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

Database and Web-based Catalog Core

When preparing your application, use Component Type Core.

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

SF424 (R&R) Cover (Database and Web-based Catalog Core)

Complete only the following fields:

• Applicant Information
• Type of Applicant (optional)
• Descriptive Title of Applicant’s Project
• Proposed Project Start/Ending Dates

PHS 398 Cover Page Supplement (Database and Web-based Catalog Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Database and Web-based Catalog Core)

Human Subjects: Answer only the Are Human Subjects Involved? and 'Is the Project Exempt from Federal regulations? questions.

Vertebrate Animals: Answer only the Are Vertebrate Animals Used? question.

Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

Project /Performance Site Location(s) (Database and Web-based Catalog Core)

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

Research & Related Senior/Key Person Profile (Database and Web-based Catalog Core)

• In the Project Director/Principal Investigator section of the form, use Project Role of Other with Category of Core Lead and provide a valid eRA Commons ID in the Credential field.
• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
• Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.

Budget (Database and Web-based Catalog Core)

Budget forms appropriate for the specific component will be included in the application package.

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

PHS 398 Research Plan (Database and Web-based Catalog Core)

Introduction to Application: For Resubmission applications, an Introduction to Application is allowed for each component.

Specific Aims: State concisely the goals and objectives of the proposed Database and Web-based Catalog Core.

Research Strategy: Applicant must address each of the following key areas:

• Database: Describe the expertise of staff in bioinformatics and database administration. Describe plans for maintaining a computerized data management system that facilitates retrieval of information about cell lines and DNA samples. Describe plans to protect against accidental loss of data and to ensure data integrity, accuracy, and security.
• Web-based Catalog: Describe plans for an accessible web-based electronic catalog that lists the available cell lines and DNA samples and provides essential information on pedigrees, genetics, phenotypes, and availability of samples from relatives. The catalog must also explain the policies governing the purchase and submission of samples. The web-based catalog should also provide support for technical questions and assistance with decisions on ordering cell lines or DNA.
• Publicizing Repository Collections: Describe plans to promote awareness and use of the repository and the recruitment of additional cell lines for the collection.

Resource Sharing Plan: Generally, Resource Sharing Plans are expected, but they are not applicable for this NOFO.

Appendix: Only limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions.

PHS Human Subjects and Clinical Trials Information (Database and Web-based Catalog Core)

When involving human subjects research, clinical research, and/or NIH-defined clinical trials follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:

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

Study Record: PHS Human Subjects and Clinical Trials Information

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

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

Resource Core

When preparing your application, use Component Type Resource Core.

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

SF424 (R&R) Cover (Resource Core)

Complete only the following fields:

• Applicant Information
• Type of Applicant (optional)
• Descriptive Title of Applicant’s Project
• Proposed Project Start/Ending Date

PHS 398 Cover Page Supplement (Resource Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Resource Core)

Human Subjects: Answer only the Are Human Subjects Involved? and 'Is the Project Exempt from Federal regulations? questions.

Vertebrate Animals: Answer only the Are Vertebrate Animals Used? question.

Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other component

Project /Performance Site Location(s) (Resource Core)

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

Research & Related Senior/Key Person Profile (Resource Core)

• In the Project Director/Principal Investigator section of the form, use Project Role of Other with Category of Core Lead and provide a valid eRA Commons ID in the Credential field.
• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
• Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.

Budget (Resource Core)

Budget forms appropriate for the specific component will be included in the application package.

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

PHS 398 Research Plan (Resource Core)

Introduction to Application: For Resubmission applications, an Introduction to Application is allowed for each component.

Specific Aims: State concisely the goals and objectives of the proposed Resource Core.

Research Strategy: The applicant should plan on acquisition of 200 to 300 unique cell samples per year. Distribution plans should assume shipment of approximately 5,000 cell lines per year and approximately 40,000 DNA samples per year, comparable to current repository activity.

In describing the operation of the Resource Core, include the following key topics:

• Acquisition:
  • Describe procedures for acquisition of cell samples and cell lines from clinicians.
  • Describe procedures for direct recruitment of samples from individuals/patients and/or patient advocacy groups.
  • Describe procedures for ensuring appropriate informed consent is obtained for all samples.
  • Describe how the range of humans represented by the samples in the HGCR will be defined and increased.
• Establishment and Characterization:
  • Describe methods for establishment, characterization and expansion of newly acquired cell lines, including any cell line-specific characterization methods.
  • Describe the scientific expertise of the project staff in human genetics, cell culture, molecular biology, biochemistry, iPSC derivation, and cytogenetics.
• Preparation, Maintenance, and Distribution:
  • Describe plans for maintenance of the existing and future collection and for re-expansion of cell lines when needed.
  • Describe procedures that ensure the correct identity of samples and for the purity, quality, and stability of DNA extractions.
  • Describe procedures for diagnostic verification.
  • Describe plans to prevent accidental loss of items in the repository. If samples are stored under a subaward, they must not be distributed or used by the subawardee.
• On-demand Genetic Services:
  • Describe plans for providing on-demand services related to cell cultures and DNA samples, including submission of requests for novel services and their prioritization for fulfillment.
  • Describe formulation of kits for specialized activities, such as proficiency testing or certification.
  • Describe how new services required to remain relevant to the needs of biomedical research or proficiency testing will be identified and established.

Resource Sharing Plan: Generally, Resource Sharing Plans are expected, but they are not applicable for this NOFO.

Appendix: Only limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions.

PHS Human Subjects and Clinical Trials Information (Resource Core)

When involving human subjects research, clinical research, and/or NIH-defined clinical trials follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:

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

Study Record: PHS Human Subjects and Clinical Trials Information

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

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

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

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

4. Submission Dates and Times

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

Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies) using ASSIST or other electronic submission systems. 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 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.

For information on how applications will be automatically assembled for review and funding consideration after submission, refer to: http://grants.nih.gov/grants/ElectronicReceipt/files/Electronic_Multi-project_Application_Image_Assembly.pdf.

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) and component Project Leads 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.

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 How To Apply- Application Guide.

Upon receipt, the application will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review and NIGMS. An application that is incomplete and/or non-compliant will not be reviewed.

The application must include a PEDP submitted as an Other Attachment on the SF424(R&R) Other Project Information form. An application that fails to include a PEDP will be considered incomplete and will be withdrawn without review.

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 NIH in support of the NIH mission are evaluated for scientific and technical merit through the NIH peer review system.

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

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

Significance

Evaluate the likelihood that the proposed resource will achieve the goal of serving the biomedical research community through acquisition, maintenance, and distribution of high-quality human cell samples and DNA isolated from these cells to qualified biomedical researchers.

Evaluate the plans for prioritizing new disease entities to be added to the repository and for improving representation of the US population.

Evaluate the extent to which the efforts described in the PEDP will further the significance of the project.

Investigator(s)

Evaluate whether the investigator(s) have the demonstrated background, training, and expertise in operating and managing an established biorepository and providing customer service. Assess the quality of the leadership approach, governance and organizational structure of the resource.

Evaluate the extent to which the efforts described in the PEDP will strengthen and enhance the expertise required for the project.

Innovation

Assess the likelihood that new technologies will be adopted as appropriate to assure high-quality preparation and characterization of cell lines and DNA and that relevant information about those samples will be easily accessible to biomedical researchers. Evaluate whether the application has exhibited evidence that the resource will remain current with rapid advances in derivation of cell lines, cell culture, molecular biology, and information technology.

Evaluate the extent to which the efforts described in the PEDP will meaningfully contribute to innovation.

Approach

Evaluate the overall strategy, operational plan, and organizational structure for accomplishing the goals of the research resource. Evaluate the strategies to ensure a robust and unbiased scientific approach across the resource.

Evaluate plans to address potential problems, alternative strategies, and benchmarks for success.

Evaluate whether milestones are well-developed and feasible for the proposed project period.

Evaluate whether the application includes adequate plans to address relevant biological variables, such as sex or age, in the design, analysis, and reporting.

Evaluate the plans to address: 1) the protection of human subjects from research risks, and 2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of individuals of all ages (including children and older adults), justified in terms of the scientific goals and research strategy proposed.

Evaluate the plans for ensuring informed consent for all new samples and for ensuring existing samples either have appropriate consent or adequate plans are in place for dealing with those that do not.

Evaluate whether the proposed outreach activities are likely to achieve the goals of maintaining a productive connection to the global biobanking community and providing leadership on best practices.

Evaluate the feasibility of the plan for achieving an increase in cost-recovery over the project period.

Evaluate whether the timeline and milestones associated with the PEDP are well-developed and feasible.

Environment

Evaluate whether the institutional support, equipment and other physical resources available to the investigators are adequate for the repository and will support electronic information handling.

Evaluate whether adequate structures and procedures are in place to ensure compliance with Federal, Health and Human Services (HHS), and NIH guidelines and regulations related to informed consent, information technology security, and the implications of the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule.

Evaluate to what extent features of the environment described in the PEDP (e.g., collaborative arrangements, geographic diversity, institutional support) will contribute to the success of the project.

Additional Review Criteria

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.

During the review process, "Merit Descriptors" will first be provided in individual reviewers' critiques for the Scientific and Administrative Management, Database and Web-based Catalog, and Resource Cores and the review panel will then assign a Merit Descriptor after discussion. The three potential Merit Descriptors are outstanding, acceptable, or unacceptable.

Scientific and Administrative Management Core

The review panel will evaluate:

• Whether the proposed administrative structure is sufficient to accomplish the goals of the Scientific and Administrative Management Core.
• How effectively the composition and proposed activities of the Executive Committee and Scientific Advisory Committee will aid in achieving repository goals.
• How well the resource will manage informed consent, privacy and human subjects protections, including the HIPAA Privacy Rule.
• Whether the IRB will have adequate qualifications and independence to maximally assure the protection of human subjects.
• For future acquisitions, how well the resource will solicit and implement the donor’s preferences for retention, distribution, and research use of samples.
• Whether the sustainability plan will ensure continuous access to the biorepository during the proposed project period and whether it is sufficiently robust to future changes in biomedical research needs and financial exigencies.

Database and Web-based Catalog Core

The review panel will evaluate:

• Whether the application provides adequate plans to protect against accidental loss of data and to ensure data integrity, accuracy, and security.
• Whether the proposed web-based catalog will provide outside researchers with needed information on the holdings of the repository, policies on purchase or submission of samples, and on associated, essential data, such as pedigrees, genetics, phenotypes, and availability of samples from relatives. If there are critical data elements or functionalities missing, elaborate.
• Whether the efforts towards publicizing the repository collections are likely to increase use and awareness of the repository, knowledge of the available services, and recruitment of additional cell lines into the repository collections.

Resource Core

The review panel will evaluate:

• Whether the plans for acquisition and distribution are likely to achieve the goals of adding 200 to 300 new samples per year and providing approximately 5,000 cells lines and 40,000 DNA samples per year to researchers.
• Whether the methods and expertise in establishment and characterization of cell lines meet the needs of the resource.
• How effectively the plans for maintenance, identity authentication, and distribution of samples will ensure that high-quality, correct samples are distributed, that associated clinical data are accurate, and that accidental loss of samples is prevented.
• How well the plans for on-demand genetic services provide timely, flexible and accurate services to the biomedical research community and maintain the value and relevance of the repository to evolving research needs.

Protections for Human Subjects

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

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

Inclusion of Women, Minorities, and Individuals Across the Lifespan

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

Vertebrate Animals

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following three points: (1) a complete description of all proposed procedures including the species, strains, ages, sex, and total numbers of animals to be used; (2) justifications that the species is appropriate for the proposed research and why the research goals cannot be accomplished using an alternative non-animal model; and (3) interventions including analgesia, anesthesia, sedation, palliative care, and humane endpoints that will be used to limit any unavoidable discomfort, distress, pain and injury in the conduct of scientifically valuable research. Methods of euthanasia and justification for selected methods, if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals, is also required but is found in a separate section of the application. For additional information on review of the Vertebrate Animals Section, please refer to the Worksheet for Review of the Vertebrate Animals Section.

Biohazards

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

Resubmissions

For Resubmissions, the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the application.

Renewals

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

Revisions

Not Applicable

Additional Review Considerations

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

Applications from Foreign Organizations

Not Applicable

Select Agent Research

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

Resource Sharing Plans

Reviewers will comment on whether the Resource Sharing Plan(s) (e.g., Sharing Model Organisms) or the rationale for not sharing the resources, is reasonable.

Authentication of Key Biological and/or Chemical Resources:

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

Budget and Period of Support

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

2. Review and Selection Process

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

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

Applications will be assigned on the basis of established PHS referral guidelines 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 appropriate national Advisory Council or Board. 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.

3. Anticipated Announcement and Award Dates

After the peer review of the application is completed, the PD/PI will be able to access their 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

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement.

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

Recipients must comply with any funding restrictions described in Section IV.6. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.

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

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

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Recipients, and Activities, including of note, but not limited to:

• Federal-wide Standard Terms and Conditions for Research Grants
• Prohibition on Certain Telecommunications and Video Surveillance Services or Equipment
• Acknowledgment of Federal Funding

If a recipient is successful and receives a Notice of Award, 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.

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 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.

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

The following special terms of award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (DHHS) grant administration regulations at 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 recipient is anticipated during the performance of the activities. Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the award recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the recipient for the project as a whole, although specific tasks and activities may be shared among the recipient and the NIH as defined below.

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

• Planning, organizing, and administering the described work.
• Organizing and chairing Scientific Advisory Committee meetings for the NIGMS HGCR.
• Documenting progress in annual RPPRs to NIGMS and providing to the NIGMS Program Official supplementary reports upon request.
• Recipient will retain custody of and have primary rights to the software that is developed under this award, subject to Government rights of access consistent with 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:

NIGMS will assign a staff member to serve as Project Coordinator. The Project Coordinator will have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:

• Substantial involvement in coordinating the activities of the recipient with other NIH-sponsored biobanks, as necessary.
• Participation as a voting member in Executive Committee meetings.
• Participation in Scientific Advisory Committee meetings.
• Serving as a resource with respect to other ongoing NIH activities that may be relevant to this effort and providing expert advice to the recipient on specific scientific or policy issues.
• Reviewing research resource design and initiatives to ensure that they are within the scope of this effort; and
• Facilitate, not direct, activities.

Additionally, a NIGMS Program Official will be responsible for:

• Normal programmatic stewardship of the award, including participating in funding recommendations, and will be named in the award notice.
• Monitoring the project on a regular basis. Monitoring may include: regular communication with the PD/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.

NIGMS 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:

• During the course of the award period, the recipient may be invited to meet with NIH or NIGMS staff, and/or other interested parties in Bethesda, MD, or virtually convened, 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 current repository Material Transfer Agreement and other information posted at https://catalog.coriell.org/1/NIGMS, will be maintained in the new project period. Changes to existing policies may be developed jointly by the recipient and NIGMS staff and must be in compliance with relevant HHS, PHS, and NIH policies.
• The government retains ownership of all cell lines, DNA samples, and data associated with the samples in the current repository collection and those developed under this project. NIGMS and the recipient will jointly develop a plan to transfer repository cell lines, DNA samples, and data to a new repository operator in the event that the recipient does not successfully compete for a subsequent project period.

Dispute Resolution:

• Disagreements between award recipients and the NIH that arise regarding matters related to the scientific direction of the funded program may be brought to Dispute Resolution. A Dispute Resolution Panel composed of three members will be convened. The panel will consist of a designee of the recipient, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two. This special dispute resolution procedure does not alter the recipient’s right to appeal an adverse action that is otherwise appealable in accordance with PHS regulation 42 CFR Part 50, Subpart D and DHHS regulation 45 CFR Part 16.

3. 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.

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.

The overall evaluation of the program will be based on metrics that may include, but are not limited to, the following: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. 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.

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

In accordance with the regulatory requirements provided at 2 CFR Part 200.113 and Appendix XII to 2 CFR Part 200, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM) about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period. The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (currently FAPIIS). This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313). As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available. Full reporting requirements and procedures are found in Appendix XII to 2 CFR Part 200 Award Term and Condition for Recipient Integrity and Performance Matters.

5. Evaluation

In carrying out stewardship of grant programs, NIGMS will periodically evaluate the NIGMS Human Genetic Cell Repository, employing the representative measures identified below. In assessing the effectiveness of research resource investments, NIGMS may use information from progress reports and public databases, PD/PIs, and from participants themselves. Where necessary, PD/PIs and participants may be appropriately contacted after the completion of the grant period for updates on participants subsequent outcomes.

The overall evaluation of the program will be based on metrics that may include, but are not limited to, the following:

• Measures of resource utilization, such as:
  • Information about the size and characteristics of the userbase
  • Downloads and uploads of digital resources
  • Degree of dissemination of software, specimen, or reagent resources
  • Publications citing use of the resource
• Indicators of research community outreach and engagement, such as:
  • Availability of user training materials
  • Evidence of activities to publicize services provided
  • Enhanced recruitment of researchers from underrepresented groups in biomedical research

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

Ronald Adkins, Ph.D.
National Institute of General Medical Sciences (NIGMS)
Email: ronald.adkins@nih.gov

NIGMS Review
Email: NIGMSReview@mail.nih.gov

Lan Nguyen
National Institute of General Medical Sciences (NIGMS)
Email: nguyenLa@mail.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.