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 How to Apply - Application Guide and the NOFO) is required and strictly enforced. Applicants must read and follow all application instructions in the How to Apply - Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the How to Apply - Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

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

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



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

This Notice of Funding Opportunity (NOFO) invites applications for the continued support and advancement of a human organ and tissue resource. The overarching purpose of research funding by the Office of Research Infrastructure Programs (ORIP) is to reduce the burden on society of the morbidity and mortality of diverse conditions and diseases and to understand normal human tissue and organ function. This NOFO, issued by ORIP in partnership with several categorical NIH Institutes and Centers with interest in specific organs and diseases, focuses on providing a resource for biomedical research that facilitates the procurement and preservation of human tissues and organs as well as the distribution of these biospecimens to qualified researchers.

The overall goal of the research resource is to provide a wide variety of human tissues and organs, diseased and normal, young and aged, to investigators for laboratory studies depending on researcher needs. Such samples include tissues from the nervous, pulmonary, cardiovascular, lymphoid, endocrine, renal, digestive, and reproductive systems, as well as from eyes, skin, bone, cartilage, synovium, and muscle. Diverse human biospecimens facilitate critical investigations across the gamut of human diseases and medical conditions. Depending on the studies to which the biospecimens are applied, these samples enable human tissue research on both noninfectious and infectious diseases. The biospecimens facilitate research on diseases that are public health priorities and on rare diseases, such as genetic disorders.

The successful applicant/organization must have a demonstrated track record of running an established human tissue and organ research resource for providing diverse human biospecimens to researchers, including knowledge of managing such a resource, recognized relevant expertise, attention to rigor and reproducibility, adequate implementation of quality control protocols, and effective customer service. The resource is currently funded as a cooperative agreement (U42) to provide normal and diseased of young and aged human tissues and organs for biomedical research. The research resource for human organs and tissues supports the procurement, preservation, and distribution of human tissue and organs for basic and clinical research at research centers, academic institutions, the NIH, and other federal agencies.

Additional Information

The U42 application is a multi-component application, with an Overall Component that describes the entire application and provides an overview of how each of the other components fit together, and a  Management (major) and Resource (major) Component..

Multiple PDs/PIs for the Overall grant are allowed. Typically, one or more of the PDs/PIs of the Overall application also serve as the Core Lead(s) of the Management and Resource Component. 

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

Section II. Award Information

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

Section III. Eligibility Information

1. Eligible Applicants

Higher Education Institutions

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

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

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

Nonprofits Other Than Institutions of Higher Education

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

For-Profit Organizations

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

Local Governments

• State Governments
• County Governments
• City or Township Governments
• Special District Governments
• Indian/Native American Tribal Governments (Federally Recognized)
• Indian/Native American Tribal Governments (Other than Federally Recognized)

Federal Governments

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

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.

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

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

2. Cost Sharing

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

3. Additional Information on Eligibility

Number of Applications

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

The NIH will not accept duplicate or highly overlapping applications under review at the same time per NIH Grants Policy Statement Section 2.3.7.4 Submission of Resubmission Application. This means that the NIH will not accept:

• A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.
• A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.
• An application that has substantial overlap with another application pending appeal of initial peer review (see NIH Grants Policy Statement 2.3.9.4 Similar, Essentially Identical, or Identical Applications).

Section IV. Application and Submission Information

1. Requesting an Application Package

The application forms package specific to this opportunity must be accessed through ASSIST 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 How to Apply - Application Guide are directly related to the Grants.gov downloadable forms currently used with most NIH opportunities. Conformance to the requirements in the How to Apply - Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

Page Limitations

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

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.

Revision applications must include an Overall component and the components that are affected by the revision. Therefore, the component requirements listed below may not apply to the revision application.

The application should consist of the following components:

• Overall: required
• Management Section: required, maximum of 1
• Resource Section: required, maximum of 1

Overall Component

When preparing the application, use Component Type ‘Overall’.

All instructions in the How to Apply - 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 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)

Specific Aims: State concisely the goals of the proposed human tissue and organ research resource and summarize the expected outcome(s), including the impact that the results of the proposed resource will exert on the research field(s) involved.

Research Strategy: Applicants must provide an overall description of the proposed resource and management/organizational structure, its specimens, and the topics of research. The overall description must include a summary of the purpose and history of the human organ and tissue resource and the research communities it serves. Furthermore, the overall description must describe how the human organ and tissue resource has been or will be operated, including the interactions that occurred among tissue and organ banks, hospitals, research facilities, organ and tissue repositories, and the researchers served by this resource. A past and/or expected users table may be included in this section. In addition, the overall description must delineate what associated metadata, demographics to clinical phenotype, or health records are available or linked to the biospecimens. Applicants must also describe how they plan to address any recommendations of an advisory board/committee – including external advisors.

Letters of Support: Statements of Institutional Commitment, Letters of Support from past and potential future users of the resources and services, Letters of Collaborations, and other similar documents, if appropriate, should be included in this section (rather than in the Management Section and Resource Section).

Resource Sharing Plan:
Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the How to Apply - Application Guide.

• All applications, regardless of the amount of direct costs requested for any one year, should address a Resource Sharing Plan.

Other Plan(s): 

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

All applicants planning research (funded or conducted in whole or in part by NIH) that results in the generation of scientific data are required to comply with the instructions for the Data Management and Sharing Plan. All applications, regardless of the amount of direct costs requested for any one year, must address a Data Management and Sharing Plan.

• U42-supported research that results in the generation of scientific data will occur as a result of the Pilot Research Program component. Accordingly, the Pilot Research Program must be addressed in the Data Management and Sharing Plan.  Because the pilot research projects to be funded are not known at the time of application submission, address the following in the Data Management and Sharing Plan: most common expected data types to be generated by pilot research projects (e.g., based on the last grant cycle); tools and standards for those expected data types; likely data repositories to be used; accessibility of the new scientific data that are likely to be generated; timelines for data sharing to be required of Pilot Research Program awardees; factors likely to affect subsequent access, distribution, or reuse of the most common expected data; and any technical limitations that may affect the sharing of the most common expected data types to be generated by the Pilot Research Program.
• Genomic data sharing for any component that will generate genome-wide genetic data must be addressed in the Data Management and Sharing Plan.
• Data sharing for research projects that (i) will be funded by other NIH Institute and Center grants and (ii) will be supported with U42 resources (e.g., tissues, biospecimens, etc.) will be addressed in the Data Management and Sharing Plans of the other grant applications and do not need to be addressed in the Data Management and Sharing Plan for this application.

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 How to Apply - 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 How to Apply - Application Guide, with the following additional instructions:

If you answered “Yes” to the question “Are Human Subjects Involved?” on the R&R Other Project Information form, 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 How to Apply - Application Guide must be followed.

Delayed Onset Study

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

PHS Assignment Request Form (Overall)

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

Management Section

When preparing your application, use Component Type ‘Management Section.’

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

Note: The Data Management and Sharing Plan as applicable to this section should be attached in the Other Plan(s) attachment in the Overall component.

SF424 (R&R) Cover (Management Section)

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 (Management Section)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Management Section)

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) (Management Section)

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 (Management Section)

• 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 (Management Section)

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 (Management Section)

Specific Aims: State concisely the goals and administrative structure of the proposed Management Section.

Research Strategy: This section must describe the proposed administrative structure of the project, including PD(s)/PI(s), collaborators, the Advisory Board/Committee, other functional committees or special interest groups, and other research support resources. The applicant must describe how these units function to support and maintain the research resource plan of the human organ and tissue resource, as well as how communication will be maintained among tissue and organ banks, hospitals, research facilities, organ and tissue repositories, participating Federal agencies (i.e., ORIP/NIH and other NIH Institutes and Centers), and the biomedical research community. Appropriate structures that would oversee procurement, protocols for collection and storage, distribution procedures, and quality control of specimens should be described. Each PD/PI must devote at least 1.2 person-months of effort to the project each year. The applicant should describe an appropriate structure for an advisory board/committee. The following key areas should also be included in the management section:

i. Enhancing the capacity and evaluating processes of the human organ and tissue resource to engage biomedical researchers and address the tissue and organ requests.

ii. Evaluating and continually improving service, delivery, and communication with the biomedical research community.

iii. Addressing the shared commitment and linkages with tissue and organ banks, hospitals, research facilities, and tissue and organ procurement organizations affiliated with the applicant’s human tissue and organ research resource in the formulation and continued development of the research resource.

iv. Enhancing the capacity to utilize technologies and improving the quality of the resource’s approaches and protocols to access, procure, preserve, store, and distribute specimens.

v. Evaluating and continually maintaining biohazard safety.

vi. Evaluating and maintaining adherence to Health and Human Services and NIH guidelines and regulations on informed consent and research resources, and the implications of the Health Insurance Portability and Accountability Act (HIPAA) regulations Privacy Rule.

vii. Communicating with the government and public on recent research advances and the current research being done by the community of investigators who use the resource.

viii. Addressing the evaluation of the resource's processes and the implementation of plans to continually improve the resource's procedures and programs.

ix. Addressing pathologic review of specimens and quality control protocols.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the How to Apply- Application Guide, with the following modification:

All applications, regardless of the amount of direct costs requested for any one year, should address a Resource Sharing Plan.

Resource Sharing Plans should be consolidated in the Overall Component.

Appendix:

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

PHS Human Subjects and Clinical Trials Information (Management Section)

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 How to Apply- Application Guide, with the following additional instructions:

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

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

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

Resource Section

When preparing your application, use Component Type ‘Resource Section.’

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

Note: The Data Management and Sharing Plan as applicable to this section should be attached in the Other Plan(s) attachment in the Overall component.

SF424 (R&R) Cover (Resource Section)

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 Section)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Resource Section)

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 Section)

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 Section)

• 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 Section)

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 Section)

Specific Aims: State concisely the goals of the proposed Resource Section and summarize the expected outcome(s), including the impact that the results of the proposed Resource Section will exert on the ability of investigators at research centers, academic institutions, the NIH and other federal agencies to advance scientific knowledge across broad areas of biomedical research.

Research Strategy: If applicable, a detailed summary of previous efforts should be included in this section as background to document the development and progress of the proposed resource.

A. Research Resource Design and Plan (Required)

i. Structure and Approach
The applicant must propose detailed plans describing the design and development of the resource for human organs and tissues, to include current capacities of the research resource, procedures for the procurement, shipping, preparation, preservation, confidentiality and informed consent, biohazards and pathogen screening, tissue and organ request application and fulfillment, redundancy, disaster recovery, and distribution of all types of specimens that will be handled by the resource center. The applicant must describe pathologic review, quality control, data collection and analysis, diagnostic verification, and how data will be stored and managed in a database. The design and development of the database should be such that it provides a user-friendly accounting of the resource’s holdings, including all human tissue and organ specimens for human subjects research, and ensures data integrity, accuracy, and security. The applicant must maintain a core of remote site collection centers.

ii. Customer Service
The applicant must describe the current status of, and future plans for, customer service and public relations. This description must include a plan for a user-friendly customer service interface. This plan needs to provide access for biomedical researchers who search for tissue and organ specimens, who have technical questions regarding the search or specification of tissue or organ specimens, or who need assistance with decisions on ordering or obtaining tissue and organ specimens. Moreover, the applicant must outline the current status of, and plans for, communication and enhancement of public relations of the research resource with government and private research facilities.

iii. Milestones
The application must present specific milestones that will need to be met in order to accomplish the work set out above in a 5-year time frame. The application must also include proposed metrics for tracking and evaluating program success and impact.

iv. Integration Plan
The applicant must describe the integration plan for the proposed project, and how it will facilitate the proposed goals and milestones. The application should describe the organization of the proposed research resource, including integration of the separate components to form an efficient pipeline from request of specimens to the specimens’ distribution to biomedical researchers. The integration plan should also describe the key personnel, the expert advisory committee, and reporting relationships. Recruitment and training of personnel should be discussed. The plan should also describe how the various components of the proposed research resource effort will be integrated, and how collaborations or subcontracts, if proposed, will be managed. Coordination of the proposed awardee’s activities with those of the other components of the human tissue and organ research resources, as well as with other national and international programs aimed at producing human tissue and organ specimens, must be described.

v. Sustainability Plan
The applicant must provide an overview table that shows how resource operations are currently funded, including support from: the current U42 cooperative agreement, Program Income (from different categories of users based on their funding), and other sources if applicable. The applicant must also describe a stepwise approach for how Program Income is projected to contribute to reductions in the costs of tissue procurement, distribution, and other services. All proposed costs and projected cost reductions requested above must be given in terms of the direct, indirect, and total costs, i.e., the fully loaded costs (including overhead). The calculated costs must take into account all of the expenses associated with each component activity, including those attributable to informatics infrastructure, quality control, management, and data release.

B. Evaluation (Required)
Procedures must be described for the evaluation of core functioning (e.g., by an advisory board/committee) and for implementing recommendations resulting from such evaluations. In addition, upon completion of a program evaluation and assessment, NIH will determine whether to (1) continue the resource as currently configured, (b) continue the resource with modifications, or (c) discontinue the resource.

C. Pilot Award Program (Optional)
The applicant may include a Pilot Award Program that solicits applications from investigators for a limited number of human biospecimens at no cost to support pilot research studies. If a Pilot Award Program is included, applications for pilot awards must be competitive and awards should be prioritized for underrepresented populations in the U.S. biomedical research enterprise (see NOT-OD-20-031), early stage investigators, and/or established preclinical investigators who have not previously used human biospecimens in their investigations but wish to do so to facilitate translational research. If a Pilot Award Program is incorporated into the Resource Section, briefly describe the following: nature of support provided to pilot program awardees; expectations of awardees; application criteria and format; scientific review committee composition; review criteria and decision process; application cycle (i.e., timing of applications and awards); expected number of awards per year and distribution of awardees' primary sources of funding; strategy for tracking impact of pilot awards; and outreach efforts to solicit applications and promote the program. The applicant also must describe how a Pilot Award Program would be supported, including levels of support from the parent award and other sources of funding

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the How to Apply- Application Guide, with the following modification:

All applications, regardless of the amount of direct costs requested for any one year, should address a Resource Sharing Plan.

Resource Sharing Plans should be consolidated in the Overall Component.

Appendix:

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

PHS Human Subjects and Clinical Trials Information (Resource Section)

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 How to Apply- Application Guide, with the following additional instructions:

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

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

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

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

See Part 2. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov

4. Submission Dates and Times

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

Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies) 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. 

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 the Office of Research Infrastructure Programs, NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.

Recipients or subrecipients must submit any information related to violations of federal criminal law involving fraud, bribery, or gratuity violations potentially affecting the federal award. See Mandatory Disclosures, 2 CFR 200.113 and NIH Grants Policy Statement Section 4.1.35.

Send written disclosures to the NIH Chief Grants Management Officer listed on the Notice of Award for the IC that funded the award and to the HHS Office of Inspector Grant Self Disclosure Program at [email protected].

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

Does the proposed Center address the needs of the research resource that it will serve? Is the scope of activities proposed for the Center appropriate to meet those needs? Will successful completion of the aims bring unique advantages or capabilities to the research resource? If the aims of the project are achieved, will scientific knowledge, technical capability, and/or clinical practice be improved? Will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

Investigator(s)

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

Innovation

Does the application propose novel organizational concepts, management strategies, or instrumentation in coordinating the research resource the Center 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?

Approach

Are the overall strategy, operational plan, and organizational structure well-reasoned and appropriate to accomplish the goals of the research resource the Center will serve? Will the investigators promote strategies to ensure a robust and unbiased scientific approach across the 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 relevant biological variables, such as sex, for studies of vertebrate animals or human subjects?

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

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

Environment

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

Review Criteria for the Management Section

Reviewers will consider each of the review criteria below in the determination of scientific merit and provide a component score for the Management Section. An application does not need to be strong in all categories to be judged likely to have major scientific impact.

• To what extent will the goals and administrative structure of the proposed Management Section facilitate the operation of the resource to meet the needs of the research community it serves?
• To what extent does the proposed administrative structure function to support and maintain the research resource plan of the human organ and tissue resource? To what extent will the proposed administrative structure maintain communication across tissue and organ banks, hospitals, research facilities, organ and tissue repositories, participating Federal agencies, and the biomedical research community?
• Does the PD/PI demonstrate effective scientific and administrative leadership, as demonstrated by program development as well as promotion of effective interactions and relationships with researchers, tissue and organ banks, hospitals, research facilities, and tissue and organ repositories?
• Does the applicant/organization have a demonstrated track record of running an established human tissue and organ research resource that includes recognized expertise and knowledge of managing such a resource, including the management of needed customer service functions?
• To what extent does the application describe appropriate structures that would oversee procurement, protocols for collection and storage, distribution procedures, and quality control of specimens?
• Is the structure for an advisory board/committee adequately described and appropriate?
• Do the capacity and evaluating processes of the human organ and tissue resource engage biomedical researchers and address the tissue and organ requests?
• Does the applicant address shared commitment and linkages with tissue and organ banks, hospitals, research facilities, and tissue and organ procurement organizations?
• How well does the human organ and tissue resource utilize technologies to improve the quality of the resource's approaches and protocols to access, procure, preserve, store, and distribute specimens?
• Has the applicant considered the HIPAA Privacy Rule and its implications for the resource's operations?
• How well does the application address the evaluation of mechanisms, a continuous process to improve programs, and the implementation of improvement plans for the resource's procedures and programs?
• Does the application adequately address pathologic review of specimens and quality control protocols?

Review Criteria for the Resource Section

Reviewers will consider each of the review criteria below in the determination of scientific merit and provide a component score for the Resource Section. An application does not need to be strong in all categories to be judged likely to have major scientific impact.

• Are there detailed plans describing the design and development of the human organ and tissue resource, including current capacities of the research resource as described in the Research Plan?
• How well developed are the proposed approaches and protocols to access, procure, preserve, and distribute specimens and for addressing redundancy and disaster recovery?
• Are the designs of the pathologic review, quality control, data collection and analysis, and diagnostic verification systems adequate?
• To what extent are confidentiality and informed consent, biohazards, and pathogen screening adequately addressed?
• How well does the proposed database provide a user-friendly accounting of the resource's holdings, including all human tissue and organ specimens for human subjects research? How well does the proposed database ensure data integrity, accuracy, and security?
• Does the applicant maintain a core of remote-site collection centers?
• How well does the application describe plans for customer service and public relations with government, public, and private research facilities?
• Does the application provide specific milestones that will need to be met to accomplish the work set out above in a five-year time frame?
• Will the integration plan for the proposed resource facilitate achievement of the proposed goals and milestones?
• Does the application propose metrics that will be effective for tracking and evaluating program success and impact?
• To what extent are recruitment and training of personnel adequate?
• Does the applicant provide an adequate plan describing how Program Income contributes to the sustainability of the resource?
• To what extent are appropriate procedures described for the evaluation of core functioning and for implementing recommendations from such evaluations?
• If a Pilot Award Program is proposed, to what extent will it serve the goals of the human organ and tissue resource and benefit from the resource's services and expertise? Are the proposed number of biospecimens and extent of other services provided to successful applicants appropriate for pilot research studies involving human biospecimens?
• If included, is the Pilot Award Program designed for one or more of the following goals: to promote diversity in the U.S. biomedical research enterprise; to support pilot research by early-stage investigators; and/or to support pilot research by preclinical investigators who have not previously used human biospecimens but wish to do so in order to move their research in a translational direction?
• If appropriate, how well designed is the approach of the Pilot Award Program in terms of program promotion and outreach, application solicitation, merit review, application cycle (i.e., timing of applications and awards), expected number of recipients, expectations of recipients, strategy for tracking program impact, and approach for funding the program?

Additional Review Criteria - Overall

As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items.

Protections for Human Subjects

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

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

Inclusion of Women, Minorities, and Individuals Across the Lifespan

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

Vertebrate Animals

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following 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

Not Applicable

Renewals

Not Applicable

Revisions

Not Applicable

Additional Review Considerations - Overall

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 Center for Scientific Review, NIH, in accordance with NIH peer review policies and practices, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.

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

Applications may undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review) will be discussed and assigned an overall impact score.

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

Applications will be assigned 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.

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement Section 2.5.1. Just-in-Time Procedures. This request is not a Notice of Award nor should it be construed to be an indicator of possible funding.

Prior to making an award, NIH reviews an applicant’s federal award history in SAM.gov to ensure sound business practices. An applicant can review and comment on any information in the Responsibility/Qualification records available in SAM.gov.  NIH will consider any comments by the applicant in the Responsibility/Qualification records in SAM.gov to ascertain the applicant’s integrity, business ethics, and performance record of managing Federal awards per 2 CFR Part 200.206 “Federal awarding agency review of risk posed by applicants.”  This provision will apply to all NIH grants and cooperative agreements except fellowships.

3. Anticipated Announcement and Award Dates

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

A Notice of Award (NoA) is the official authorizing document notifying the applicant that an award has been made and that funds may be requested from the designated HHS payment system or office. The NoA is signed by the Grants Management Officer and emailed to the recipient’s business official.

In accepting the award, the recipient agrees that any activities under the award are subject to all provisions currently in effect or implemented during the period of the award, other Department regulations and policies in effect at the time of the award, and applicable statutory provisions.

Recipients must comply with any funding restrictions described in Section IV.6. Funding Restrictions. Any pre-award costs incurred before receipt of the NoA are at the applicant's own risk.  For more information on the Notice of Award, please refer to the NIH Grants Policy Statement Section 5. The Notice of Award and NIH Grants & Funding website, see Award Process.

Institutional Review Board or Independent Ethics Committee Approval: 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.

Prior Approval of Pilot Projects

Recipient-selected projects that involve {clinical trials or studies involving greater than minimal risk to human subjects} require prior approval by NIH prior to initiation.

• The recipient institution will comply with the NIH Guidance on Changes That Involve Human Subjects in Active Awards and That Will Require Prior NIH Approval.
• The recipient institution will provide NIH with specific plans for data and safety monitoring, and will notify the IRB and NIH of serious adverse events and unanticipated problems, consistent with NIH DSMP policies.

2. Administrative and National Policy Requirements

The following Federal wide and HHS-specific policy requirements apply to awards funded through NIH:

• The rules listed at 2 CFR Part 200, Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards.
• All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the terms and conditions in the Notice of Award (NoA). The NoA includes the requirements of this NOFO. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Recipients, and Activities.
• If a recipient receives an award, the recipient must follow all applicable nondiscrimination laws. The recipient agrees to this when registering in SAM.gov. The recipient must also submit an Assurance of Compliance (HHS-690). To learn more, see the Laws and Regulations Enforced by the HHS Office for Civil Rights website.
  • HHS recognizes that NIH research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research. For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this NOFO.

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

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

The following special terms of award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (HHS) grant administration regulations at 2 CFR Part 200, and other HHS, PHS, and NIH grant administration policies.

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

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

• Organizing and chairing annual site visit activities.
• Monitoring the successful completion of milestones within the time frame and budget proposed.
• Ensuring that results obtained from the resource are analyzed and published in a timely manner.
• Participating in the activities of the Advisory/Steering Committee as a voting member.
• Cooperating with the ORIP programmatic, technical, and administrative staff.

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

The role of the ORIP/NIH Project Scientist in the cooperative agreement is to support and encourage the recipient's activities by substantial involvement as a partner and facilitator in the process without assuming responsibilities that remain with the PDs/PIs. The ORIP Project Scientist will work closely with the PD/PI and other Program member scientists to facilitate collaborations and to leverage the resources available to the Program. The Project Scientist will have substantial programmatic involvement that is above and beyond the stewardship role in awards, as described below:

• Substantial involvement in coordinating the activities of the recipient with the human tissue and organ research resource researchers and other NIH sponsored research networks.
• Participation in the Advisory/Steering Committee and subcommittee 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 and/or analytic issues.
• Reviewing research resource design and initiatives, data abstraction, and survey instruments to ensure that they are within the scope of this effort and within the scope of peer review.

An ORIP Project Collaborator (Program Official plus substantial scientific and/or programmatic involvement) will be responsible for:

• Scientific and programmatic stewardship of the award and will be named in the award notice.
• Management of the program.
• Monitor the progress with the PD(s)/PI(s) on a regular basis. Monitoring may include regular communication with the PD/PI and his/her staff, periodic site visits or meetings for discussion with the recipient research team, observation of field data collection and management techniques, fiscal reviews, review scientific reports and articles, and other relevant stewardship matters.
• Identify other NIH staff who have appropriate experience and expertise to utilize or collaborate with the Research Resource for Human Organs and Tissues and review of scientific reports and articles.

Additionally, an agency program official or IC program director will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the notice of award.  ORIP reserves the right to phase-out or curtail the study (or an individual component of the award) 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(s) will be invited to meet with ORIP, other PDs/PIs, and/or other uninvolved experts in Bethesda, MD, to review scientific progress.
• The human organ and tissue research resource center and NIH staff members will jointly develop methods to make this resource accessible to other investigators. This joint development may occur through trans-NIH events and meetings, publications on the Internet and in print, and other mechanisms, as deemed appropriate.

Dispute Resolution:

Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between recipients and NIH may be brought to Dispute Resolution. A Dispute Resolution Panel composed of three members will be convened: a designee of the Steering Committee chosen without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual recipient. This special dispute resolution procedure does not alter the recipient's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulation 42 CFR Part 50, Subpart D and HHS regulation 45 CFR Part 16.

3. Data Management and Sharing

Consistent with the 2023 NIH Policy for Data Management and Sharing, when data management and sharing is applicable to the award, recipients will be required to adhere to the Data Management and Sharing requirements as outlined in the NIH Grants Policy Statement. Upon the approval of a Data Management and Sharing Plan, it is required for recipients to implement the plan as described. 

• When multiple years are involved, recipients will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement Section 8.4.1 Reporting. To learn more about post-award monitoring and reporting, see the NIH Grants & Funding website, see Post-Award Monitoring and Reporting.

A final RPPR, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement Section 8.6 Closeout. NIH NOFOs outline intended research goals and objectives. Post award, NIH will review and measure performance based on the details and outcomes that are shared within the RPPR, as described at 2 CFR Part 200.301.

Section VII. Agency Contacts

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

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

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

General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources)
Email: [email protected] (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: [email protected]

Stephanie Murphy, V.M.D., Ph.D.
Office of Research Infrastructure Programs (ORIP), OD
Telephone: 301-451-7818
Email: [email protected]

Yong Chen, Ph.D.
Office of Research Infrastructure Programs (ORIP), OD
Telephone: 301-594-1187
Email: [email protected]

Heiyoung Park, PhD
NIAMS - NATIONAL INSTITUTE OF ARTHRITIS AND MUSCULOSKELETAL AND SKIN DISEASES
Phone: 301-594-5032
E-mail: [email protected]

Yan Zhou, Ph.D.
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 240-627-3208
Email: [email protected]

Kristin M Abraham, Ph.D.
NIDDK - NATIONAL INSTITUTE OF DIABETES AND DIGESTIVE AND KIDNEY DISEASES
Phone: (301) 451-8048
E-mail: [email protected]

Paekgyu Lee
NEI - NATIONAL EYE INSTITUTE
Phone: (301) 435-8164
E-mail: [email protected]

Maqsood Wani, Ph.D.
Center for Scientific Review (CSR)
Telephone: 301-435-2270
Email: [email protected]

Donna James
National Heart, Lung, and Blood Institute (NHLBI)
Telephone: 301-827-8063
Email: [email protected]

Erik Edgerton
NIAMS - NATIONAL INSTITUTE OF ARTHRITIS AND MUSCULOSKELETAL AND SKIN DISEASES
Phone: 301-594-7760
E-mail: [email protected]

Ann Devine
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 240-669-2988
Email: [email protected]

Christina Coriz
NIDDK - NATIONAL INSTITUTE OF DIABETES AND DIGESTIVE AND KIDNEY DISEASES
Phone: 301-594-8848
E-mail: [email protected]

Karen Robinson Smith
NEI - NATIONAL EYE INSTITUTE
Phone: 301-435-8178
E-mail: [email protected]

Section VIII. Other Information

Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 2 CFR Part 200.