Department of Health and Human Services
Part 1. Overview Information

 

Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

National Institute of General Medical Sciences (NIGMS)

Funding Opportunity Title

The NIGMS Human Genetic Cell Repository (U42 - Clinical Trial Not Allowed)

Activity Code

U42 Animal (Mammalian and Nonmammalian) Model, and Animal and Biological Materials Resource Cooperative Agreements

Announcement Type

Reissue of RFA-GM-15-005

Related Notices

None

Funding Opportunity Announcement (FOA) Number

RFA-GM-19-002

Companion Funding Opportunity

None

Number of Applications

Only one application per institution is allowed, as defined in Section III. 3. Additional Information on Eligibility.

Catalog of Federal Domestic Assistance (CFDA) Number(s)

93.859

Funding Opportunity Purpose

The purpose of this FOA is to support the NIGMS Human Genetic Cell Repository (HGCR). The repository will maintain the current collection of cell cultures and DNA samples and will acquire, characterize, and expand high-quality cell samples, and distribute cell lines and DNA isolated from them to qualified biomedical researchers.

Key Dates

 

Posted Date

May 7, 2019

Open Date (Earliest Submission Date)

June 9, 2019

Letter of Intent Due Date(s)

Not Applicable

Application Due Date(s)

July 9, 2019, by 5:00 PM local time of applicant organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on this date. 

No late applications will be accepted for this Funding Opportunity Announcement.

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.

AIDS Application Due Date(s)

Not Applicable

Scientific Merit Review

October/November 2019

Advisory Council Review

January 2020

Earliest Start Date

March 1, 2020

Expiration Date

July 10, 2019

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the Multi-Project (M) Instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.


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. Table of Contents

    Part 1. Overview Information
    Part 2. Full Text of the Announcement

    Section I. 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. Funding Opportunity Description

    The NIGMS Human Genetic Cell Repository (HGCR) provides well-characterized, high-quality human cell lines and DNA samples for use in biomedical research.  The repository, established by NIGMS in 1972, currently contains more than 11,400 cell lines, primarily fibroblasts and transformed lymphoblasts, and over 5,800 DNA samples. Currently, the NIGMS HGCR catalog also contains more than 50 induced pluripotent stem cell (iPSC) lines. Repository samples represent a variety of disease states, chromosomal abnormalities, apparently healthy individuals, and many distinct human populations.

    The repository's primary function is to serve the biomedical research community by stimulating and facilitating research.  The repository acquires cell samples from individuals affected by genetic disorders and from normal control individuals and establishes and distributes cell lines and DNA to researchers.  It also offers certain on-demand custom services related to providing cell cultures and DNA samples.  The repository is expected to stimulate research by encouraging investigators, through the easy availability of high-quality material, to try a new technique or to test a new hypothesis with human cells that could otherwise not be done due to a lack of access to an appropriate patient population.  The repository is expected to continue to facilitate research by providing high-quality, uncontaminated, well-characterized, and clinically and molecularly well-documented cell lines and high-quality DNA samples to investigators at academic, non-profit, and for-profit institutions throughout the United States and abroad.

    It is anticipated that, in the next five-year funding period, the repository will continue to perform essentially the same functions with several additions. The additions include:

    • Sustainability planning - what are the long-term plans for achieving sustainable community access to the HGCR?  Sustainability in the context of this resource refers to continuing, long-term access to the resource.
    • Outreach - The NIGMS HGCR is expected to serve as a resource for the biomedical research community. Beyond providing samples, the HGCR should provide leadership to the community on biobanking best practices and maintaining a connection to the global biobanking community.

    The successful applicant/organization must have a demonstrated track record of running an established biobank; recognized expertise in human genetics, cell culture, growth of iPSCs, and molecular biology; and experience in managing a complex resource, including customer service and outreach.

    Scope

    The work to be supported by this cooperative agreement includes six separate but interrelated functions:

    1.  The maintenance and distribution of the approximately 11,400 cell lines currently in the repository's collection, the acquisition of new cell samples, and the establishment and characterization of permanent cell lines from these samples.

    2.  The maintenance of the current stock of DNA samples for approximately 5,800 cell lines and the preparation, storage, and distribution of purified, high-quality DNA samples from additional selected cell lines in the repository.

    3.  The provision of additional genetic services and distribution of other reagents as determined by the awardee and NIGMS staff.

    4.  The enhancement and maintenance of a comprehensive computerized database providing detailed information on each cell line and DNA sample, and the provision of a Web-based electronic catalog that continues, at a minimum, to list in an easily accessible format cell lines and DNA samples and as much information about them as is currently available.

    5.  The publicizing of the repository's collections through dissemination of information by a variety of means, including publication of descriptions of the collections in relevant journals, paid advertisements, and other activities.

    6. The dissemination of biobanking best practices and knowledge through outreach and engagement with the global biobanking community.

    Carrying out the necessary functions requires the repository staff to have extensive and state-of-the-art knowledge of human genetics including molecular, biochemical, and cytogenetic developments, as well as an understanding of genetic applications of bioinformatics.  To accomplish this, the repository staff must also have a strong record of being able to interact with the biomedical research community.

    The NIGMS HGCR is known for the high quality of its performance. Assurance of the integrity and identification of the cell lines at all stages of their processing, the quality of the DNA preparations, the availability of complete and accurate information about the cell lines and DNA samples, and a high level of quality control in all aspects of repository operations are the responsibility of the awardee.

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

    Section II. Award Information
    Funding Instrument

    Cooperative Agreement: A support mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, NIH scientific or program staff will assist, guide, coordinate, or participate in project activities. See Section VI.2 for additional information about the substantial involvement for this FOA.  

    Application Types Allowed

    New

    Renewal

    The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types.

    Clinical Trial?

    Not Allowed: Only accepting applications that do not propose clinical trials  

    Need help determining whether you are doing a clinical trial?

    Funds Available and Anticipated Number of Awards

    NIGMS intends to commit $2 million total costs in FY 2020 to fund one award.

    Award Budget

    Application budgets are limited to $2 million total costs exclusive of estimated cost-recovery. 

    Award Project Period

    The maximum project period is 5 years. 

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

    Section III. Eligibility Information
    1. Eligible Applicants
    Eligible Organizations

    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:

    o   Hispanic-serving Institutions

    o   Historically Black Colleges and Universities (HBCUs)

    o   Tribally Controlled Colleges and Universities (TCCUs)

    o   Alaska Native and Native Hawaiian Serving Institutions

    o   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)

    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)
    • Eligible Agencies of the Federal Government
    • U.S. Territory or Possession

    Other

    • Independent School Districts
    • Public Housing Authorities/Indian Housing Authorities
    • Native American Tribal Organizations (other than Federally recognized tribal governments)
    • Faith-based or Community-based Organizations
    • Regional Organizations
    Foreign Institutions

    Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.
    Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.

    Foreign components, as defined in the NIH Grants Policy Statement, are not allowed.

    Required Registrations

    Applicant Organizations

    Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.

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

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

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

    Eligible Individuals (Program Director/Principal Investigator)

    Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.

    For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide.

    2. Cost Sharing

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

    3. Additional Information on Eligibility
    Number of Applications

    Only one application per institution (normally identified by having a unique DUNS number or NIH IPF number) is allowed.

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

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

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

    2. Content and Form of Application Submission

    It is critical that applicants follow the Multi-Project (M) Instructions in the SF424 (R&R) Application Guide, except where instructed in this funding opportunity announcement 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

    Available Component Types

    Research Strategy/Program Plan Page Limits

    Overall

    6

    Admin Core (Use for Scientific and Administrative Management Core)

    6

    Core (Use for Database and Web-based Catalog Core)

    6

    Resource Management (use for Resource Core)

    12

    Additional page limits described in the SF424 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 the SF424 (R&R) Application Guide, and should be used for preparing a multi-component application.

    The application should consist of the following components:

    • Overall: Required
    • Administrative Core (Use for Scientific and Administrative Management Core): Required
    • Resource Management (use for Resource Core): Required
    • Core (Use for Database and Web-based Catalog Core): Required
    Overall Component

    When preparing your 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.

    Project/Performance Site Location(s) (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 & Related Senior/Key Person Profile (Overall)

    Include only the Project Director/Principal Investigator (PD/PI) and any multi-PDs/PIs (if applicable to this FOA) 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)

    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 DNA isolated from them to qualified biomedical researchers.

    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.  Applicants must present an integrated plan that will be responsive to the evolving needs of the biomedical research community.  Applicants must also address each of the following key elements:

    1. Milestones. Present specific milestones that will need to be met in order to accomplish the work set out in a five-year period.

    2. Experience in operating a biobank. Describe the research community(ies) served during previous experience operating a biobank and describe any unique experiences not already detailed in the biosketch that will facilitate and enable the proposed work.

    3. Cost-recovery Program.  Outline an overall cost-recovery program that provides a plan for a charge-back fee for distribution of cell lines and DNA samples.  In the past 8 years, cost for carrying out the core functions of the NIGMS HGCR have averaged approximately $5 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 60% of overall costs from program income in years 1 and 2, 65% in years 3 and 4, and 68% in year 5. The calculated costs must take into account all of the expenses associated with each component activity.  

    4. Outreach. The NIGMS HGCR is expected to serve as a resource for the biomedical research community. Beyond providing samples, the HGCR should provide outreach and leadership to the community on biobanking best practices and maintaining a connection to the global biobanking community.

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

    That the resource's offices that handle or process the cell lines for biomedical research are in compliance with the Health Insurance Portability and Accountability Act (HIPAA).

    That the resource will not accept specimens for the resource's use from any human subject unless that subject or subject's representative has given signed, explicit consent.

    All letters of support should then be concatenated into one attachment for uploading.

    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, with the following modification:

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

    Appendix:

    Only limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

    PHS Human Subjects and Clinical Trials Information (Overall)

    When involving NIH-defined human subjects research, clinical research, and/or 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 SF424 (R&R) Application Guide must be followed

    PHS Assignment Request Form (Overall)

    All instructions in the SF424 (R&R) 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 ‘Project 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.

    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)

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

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

    1. 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.

    2. Scientific Expertise.  Explain how the scientific expertise of the project staff in human genetics, including state-of-the-art cell culture, molecular, biochemical, and cytogenetic knowledge will facilitate the project goals.  Describe the ability of project staff to interact with clinicians and researchers.  Explain how the expertise of staff in bioinformatics is well matched to the project plan.  Describe the team's expertise deriving and growing iPSC.

    3. Executive Committee.  An internal Executive Committee is required.  Describe the composition of the committee; the roles, responsibilities, and expertise of committee members; and the frequency of committee meetings.

    4. Scientific Advisory Committee.  An external Scientific Advisory Committee is required to provide advice about operational aspects of the repository.  This may include recommendations about sample acquisition, cell line characterization, and DNA sample preparation.  The Scientific Advisory Committee may also participate in quality control by assisting project staff in review of clinical documentation associated with cell samples before distribution of samples to the scientific community.  Describe the proposed composition of the committee, the frequency and format of committee meetings, and any proposed role for the committee in evaluating the effectiveness of the repository operation in attaining its goals.  Describe the relevant expertise that will be sought for the Advisory Committee.  If an existing advisory committee exists, the members should be listed.

    5. Human Subjects. Describe procedures for evaluating and maintaining adherence to Health and Human Services and NIH guidelines and regulations on informed consent and research resources, including information technology security and the implications of the Health Insurance Portability and Accountability Act (HIPAA) regulations Privacy Rule.  Describe plans for the Institutional Review Board (IRB) that will review the use of materials that are considered human subjects.

    6. Management and Integration.  Describe the management plan for the proposed project in the context of the overall organization of the proposed research resource.  Describe how the management plan will facilitate the research resource goals and milestones.  Describe appropriate structures that would oversee procurement, protocols for collection and storage, distribution procedures, maintenance, and quality control of cell lines and DNA.  Describe how integration of separate research resource components will form an efficient pipeline from request of cell lines and DNA samples to their distribution to biomedical researchers.  Describe procedures for implementing recommendations made by the advisory committee.  Describe how collaborations or subcontracts, if proposed, will be managed.  Describe how the management plan will facilitate and maintain communication with clinicians submitting specimens, patient advocacy groups, biomedical researchers who request samples, and NIGMS.  Coordination of the proposed awardee's activities with those of other biobanking efforts at the awardee site, if any, must be described.

    7. Sustainability Planning. Describe the long-term plans for achieving sustainable community access to the HGCR.  Sustainability in the context of this resource refers to continuing, long-term access to the resource.

    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, with the following modification:

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

    Appendix:

    Only limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.  

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

    When involving NIH-defined human subjects research, clinical research, and/or 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 in ASSIST, use Component Type ‘Resource Management.’

    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 Dates

    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 components.

    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 ‘Project 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)

    Specific Aims: State concisely the goals and objectives of the proposed Resource Core, which consists of the following three subsections:

    1. Acquisition, Establishment, Characterization, Maintenance, and Distribution of Cell Lines

    2. Preparation, Storage, and Distribution of DNA from Cell Lines

    3. On-demand Genetic Services 

    Research Strategy: Present plans to maintain the current collection of the NIGMS HGCR.  The repository currently contains over 14,000 cell lines, including human fibroblast and lymphoblast cell lines and a collection of approximately 50 iPSC lines.  The repository contains over 5,800 DNA samples derived from cell lines in the collection.  Further information about the repository is available on the NIGMS HGCR webpage and a full description of the cell and DNA samples available from the repository can be found here.

    Present plans for acquisition of 200 to 300 unique cell samples per year and for distribution of cell lines and DNA samples.  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.  Present plans to provide on-demand service related to cell cultures and DNA samples.

    1. Acquisition, Establishment, Characterization, Maintenance, and Distribution of Cell Lines. Propose detailed plans that describe how valuable new cell lines will be added to repository and how new cell lines and the existing cell line collection will be maintained.  Plans should address how the proposed procedures and processes will ensure distribution of verified, high-quality, uncontaminated cell lines to advance biomedical research.  Address each of the following key areas:

    • ·    Acquisition and Establishment.  Describe procedures for acquisition of cell samples and cell lines from clinicians.  Describe procedures and processes for direct recruitment of samples from individuals. Describe plans to increase diversity of samples submitted and distributed by the HGCR.  Describe procedures for confidentiality and informed consent.  Describe processes for receipt and establishment of cell lines and for establishment of cell lines from patient samples.
    • ·    Characterization.  Describe methods for characterization and expansion of newly acquired cell lines.  Describe any cell line-specific characterization methods.
    • ·    Maintenance.  Describe plans for maintenance of the existing collection and for re-expansion of cell lines when needed.  Describe plans for cell line request application and fulfillment, including shipping, and for distribution to qualified biomedical researchers.  Describe quality control, data collection and analysis, and diagnostic verification.  Describe plans to maintain a suitable off-site facility for storage of each cell line as a safeguard against accidental loss of this valuable collection.  If the cell cultures are stored under a subcontract, they shall not be distributed or used by the subcontractor.

    2. Preparation, Storage, and Distribution of DNA from Cell Lines.  Propose detailed plans for preparation, storage and distribution of DNA samples derived from cell lines in the repository collection.  Describe quality control methods that ensure the purity and stability of the DNA.  Describe methods that will be used to compare each DNA sample prepared to that of the cell line from which it was derived. Describe how the proposed methods and processes will ensure the distribution of high-quality, verified DNA samples to the biomedical research community for appropriate uses.  Describe methods to safeguard against accidental loss of this valuable collection.

    3. On-demand Genetic Services.  Describe plans for providing on-demand services related to cell cultures and DNA samples including but not limited to:

    • ·    Formulation of kits for activities such as proficiency testing protocols.
    • ·    Extraction of RNA fractions from cell lines.
    • ·    Custom services as requested by the biomedical research community.
    • ·    Additional services as indicated by scientific developments.

    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, with the following modification:

    • ·    Generally, Resource Sharing Plans are expected, but they are not applicable for this FOA.

    Appendix: Only limited items are allowed in the Appendix.. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

    PHS Human Subjects and Clinical Trials Information (Resource Core)

    When involving NIH-defined human subjects research, clinical research, and/or 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 in ASSIST, 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 ‘Project 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)

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

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

    1. Database.  Describe plans for maintaining a computerized data management system that facilitates retrieval of information about cell lines and DNA samples in the NIGMS HGCR.  The plan must present a system that is effective for quality control, tracking of samples, fulfilling orders, billing, shipping, and maintaining inventories.  Present plans to maintain a back-up system to protect against accidental loss of valuable data.  The design and development of the database should be such that it provides a user-friendly accounting of the repository's holdings and ensures data integrity, accuracy, and security.

    2. Web-based Catalog.  Describe plans for an easily accessible web-based electronic catalog that lists the available cell lines and DNA samples with associated information about them, including detailed phenotype and molecular genotype data, cell culture history, cell lines and DNA available from family members, pedigree diagrams, and chromosome ideograms; and that contains links to related genetic databases.  The catalog must also list and explain the policies governing the purchase and submission of samples.

    3. Customer Service.  Describe plans for customer service, including plans for a user-friendly customer service interface. The plan should describe capabilities of the interface for searching for cell lines and DNA samples, easy access for biomedical researchers who have technical questions regarding the search, or who need assistance with decisions on ordering cell lines or DNA.

    4. Publicizing Repository Collections.  Describe plans to publicize repository collections of cell lines and DNA samples.  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 and exhibits at scientific meetings to represent the repository, or other activities.  The aim of the activities should be to increase the use of repository collections, to promote awareness of repository services to the biomedical research community, and/or to aid in recruitment of additional cell lines for the repository collection.

    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, with the following modification:

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

    Appendix: Only limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.   

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

    When involving NIH-defined human subjects research, clinical research, and/or 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 Policy on Late Application Submission.

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

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

    5. Intergovernmental Review (E.O. 12372)

    This initiative is not subject to intergovernmental review.

    6. Funding Restrictions

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

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

    7. Other Submission Requirements and Information

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

    For information on how your application will be automatically assembled for review and funding consideration after submission go 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 Component of the SF424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH.

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

    See more tips for avoiding common errors.

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

    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.

    Overall Impact - Overall

    Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the resource 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 resource proposed).

    Scored Review Criteria - Overall

    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 resource that by its nature is not innovative may be essential to advance a field.

    Significance

    Does the proposed Repository address the needs of the research resource that it will administer? Is the scope of activities proposed for the Repository appropriate to meet those needs? Will successful completion of the aims bring unique advantages or capabilities to the research resource?

    Is there convincing evidence that the proposed plan for managing the resource will stimulate and facilitate research efforts by optimizing access to high-quality, well-characterized cell lines and DNA? 

    Investigator(s)

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

    Does the applicant/organization have a demonstrated track record of running an established biobank that includes recognized scientific expertise and knowledge of managing such a resource, including a customer service component?  Does the management plan for the proposed resource support achievement of the proposed goals and milestones?

    Innovation

    Does the application propose novel organizational concepts, management strategies, or instrumentation in coordinating the research resource the Repository will serve? Are the concepts, strategies, or instrumentation novel to one type of research program or applicable in a broad sense? Is a refinement, improvement, or new application of organizational concepts, management strategies or instrumentation proposed?  

    Is there evidence that new technologies will be adopted as appropriate to assure high-quality characterization of cell lines and preparation of DNA and to assure that relevant information about available cell lines and DNA will be easily accessible by biomedical researchers?  Is there a high likelihood that the activities proposed will be nimble enough to stay current to the greatest extent possible, given rapid advances in derivation of cell lines and in cell culture, molecular biology, and information technologies? 

    Approach

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

    If the resource involves human subjects and/or NIH-defined clinical research, are the plans to address:

    1) the protection of human subjects from research risks, and

    2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of individuals of all ages (including children and older adults), justified in terms of the scientific goals and research strategy proposed? 

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

    Are plans for outreach appropriate? Does the plan adequately describe how best practices in biobanking will be disseminated to the global biobanking community?

    Environment

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

    Is there evidence that the environment is conducive to operating a facility of the complexity and scope of the NIGMS repository?

    Additional Review Criteria - Overall

    As applicable for the resource 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, Resource, and Database and Web-based Catalog Cores and the review panel will then assign a Merit Descriptor after discussion.  The three potential Merit Descriptors are Outstanding, Acceptable, or Unacceptable. .    

    Review Criteria for the Scientific and Administrative Management Core

    The Scientific and Administrative Management Core will receive a merit descriptor (outstanding, acceptable, or unacceptable) that reflects the following:

    Is the proposed administrative structure likely to function effectively in achieving the aims of the repository?  Is the management plan well integrated and likely to facilitate achieving repository goals and objectives?

    Does the scientific staff have appropriate expertise in cell culture, human genetics, molecular biology, biochemistry, cytogenetics, and bioinformatics?  Does the team have adequate knowledge and experience with iPSC? Is the infrastructure adequate to support the use and maintenance of cultured iPSC?

    Is there evidence that the scientific staff will interact productively with clinicians and researchers?

    Are plans for composition and use of Executive and Scientific Advisory Committees in operation of the repository likely to aid in achieving repository goals and objectives?

    Are plans for managing informed consent, privacy and human subjects issues well described? Are confidentiality and informed consent adequately addressed? Has the applicant considered Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule and its implications for the resource's operation?

    Are the design of quality control, data collection, and analysis appropriate? 

    Are the plans to recruit additional cell lines for the repository appropriate?  Are recruitment plans to increase diversity of samples appropriate? 

    Are plans for sustainability well described?

    Review Criteria for the Resource Core

    The Resource Core will receive a merit descriptor (outstanding, acceptable, or unacceptable) that reflects the following:

    Are plans presented for acquisition of the additional cell lines likely to achieve the specified number of additional cell lines (200 to 300 per year)?  Are plans for distribution of cell lines and DNA samples likely to be able to efficiently fulfill anticipated demand (shipment of approximately 5,000 cell lines and 40,000 DNA samples per year)?

    Are plans for characterization and expansion of newly acquired cell lines robust and effective?  Are effective cell-line specific characterization methods described where appropriate? Is the plan for maintaining the existing collection likely to effectively safeguard the collection and result in timely re-expansion of lines when needed?

    Are plans for quality control, data collection and analysis, and diagnostic verification likely to result in distribution of high-quality, well-characterized cell lines to the biomedical research community?  Are effective plans proposed to safeguard the collection, including provision of off-site storage facilities?

    Are plans for preparation, storage, and distribution of DNA samples from cell lines likely to ensure easy availability of high-quality DNA samples for the biomedical research community?  Are quality control methods and methods for verifying the origin of DNA samples from the relevant cell line likely to ensure distribution of high-quality, verified DNA samples?  Are effective methods proposed to safeguard against accidental loss of DNA samples?

    Are plans for providing on-demand genetic services appropriate?  Are repository staff and environment likely to provide adequate flexibility and expertise to meet changing scientific needs for on-demand genetic services?

    Review Criteria for the Database and Web-based Catalog Core

    The Database and Web-based Catalog Core will receive a merit descriptor (outstanding, acceptable, or unacceptable) that reflects the following:

    Is the proposed database likely to be effective in assuring quality control, sample tracking, order fulfillment, and inventory maintenance?  Are appropriate back-up plans presented?  Will the database effectively support assurance of data integrity, accuracy and security?

    Are plans for the web-based catalog and customer service components likely to result in a user-friendly interface that provides easy access for biomedical researchers who seek cell lines or DNA samples?

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

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

    Vertebrate Animals

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

    Biohazards

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

    Resubmissions

    Not Applicable

    Renewals

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

    Revisions

    Not Applicable

    Additional Review Considerations - Overall

    As applicable for the resource 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 following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: 1) Data Sharing Plan; 2) Sharing Model Organisms; and 3) Genomic Data Sharing Plan .


    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 NIGMS 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:

    • 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.
    • Will receive a written critique.

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

    Applications will be assigned  to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the National Advisory General Medical Sciences 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.  
    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 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 grantee’s business official.

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

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

    2. Administrative and National Policy Requirements

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

    Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights law. This means that recipients of HHS funds must ensure equal access to their programs without regard to a person’s race, color, national origin, disability, age and, in some circumstances, sex and religion. This includes ensuring your programs are accessible to persons with limited English proficiency.  HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research.

    For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA. HHS provides general guidance to recipients of FFA on meeting their legal obligation to take reasonable steps to provide meaningful access to their programs by persons with limited English proficiency. Please see https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/index.html. The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-individuals/section-1557/index.html; and https://www.hhs.gov/civil-rights/for-providers/laws-regulations-guidance/index.html. Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see https://www.hhs.gov/civil-rights/for-individuals/disability/index.html. Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at https://www.hhs.gov/ocr/about-us/contact-us/index.html or call 1-800-368-1019 or TDD 1-800-537-7697. Also note it is an HHS Departmental goal to ensure access to quality, culturally competent care, including long-term services and supports, for vulnerable populations. For further guidance on providing culturally and linguistically appropriate services, recipients should review the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care at http://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.

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

    Cooperative Agreement Terms and Conditions of Award

    The following special terms of award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (DHHS) grant administration regulations at 45 CFR Part 75, and other HHS, PHS, and NIH grant administration policies.

    The administrative and funding instrument used for this program will be the cooperative agreement, an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the awardees is anticipated during the performance of the activities. Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the award recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the awardees for the project as a whole, although specific tasks and activities may be shared among the awardees and the NIH as defined below.

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

    • Planning, organizing, 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.
    • Awardees will retain custody of and have primary rights to the software that is developed under this award, subject to Government rights of access consistent with 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 Scientist. The Project Scientist 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 awardee 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 awardee on specific scientific or policy issues.
    • Reviewing research resource design and initiatives to ensure that they are within the scope of this effort.

    Additionally, an NIGMS 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 PD/PI and awardee staff, periodic site visits or meetings for discussion with the awardee research team, fiscal reviews, and other relevant stewardship matters.
    • Formally evaluating the project on a yearly basis.  The yearly evaluation will be based on the non-competing application and recommendations of the NIGMS Project Scientist.

    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 awardee(s) may be invited to meet with NIH or NIGMS staff, and/or 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 current repository Material Transfer Agreement and other information posted at http://ccr.coriell.org/Sections/Collections/NIGMS/?SsId=8, will be maintained in the new project period.  Changes to existing policies may be developed jointly by the awardee 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 awardee will jointly develop a plan to transfer repository cell lines, DNA samples, and data to a new repository operator in the event that the awardee does not successfully compete for a subsequent project period.

    Dispute Resolution:

    Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and the NIH may be brought to Dispute Resolution. A Dispute Resolution Panel composed of three members will be convened. It will have three members: a designee of the awardee, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two. This special dispute resolution procedure in no way affects the awardee's right to appeal an adverse action in accordance with PHS regulations at 42 CFR Part 50, Subpart D and DHHS regulations at 45 CFR Part 16.

    3. Reporting

    When multiple years are involved, awardees will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement.

    A final RPPR, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement.

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

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

    Section VII. Agency Contacts

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

    Application Submission Contacts

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

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

    General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources)
    Email: GrantsInfo@nih.gov (preferred method of contact)
    Telephone: 301-945-7573

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

    Scientific/Research Contact(s)

    Amanda Melillo, Ph.D.
    National Institute of General Medical Sciences (NIGMS)
    Email: melilloaa@mail.nih.gov

    Peer Review Contact(s)

    Stephanie Constant, Ph.D.
    National Institute of General Medical Sciences (NIGMS)
    Email: stephanie.constant@nih.gov

    Financial/Grants Management Contact(s)

    Ms. 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.

    Authority and Regulations

    Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Part 75.    

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