Research Resource for Human Organs and Tissues (U42 Clinical Trial Not Allowed)

Research Resource for Human Organs and Tissues (U42 Clinical Trial Not Allowed) is sponsored by National Institutes of Health. This program supports the development and maintenance of resources for human organs and tissues for research purposes. This could be relevant for offices involved in facilitating health research.

Expired PAR-24-258: Research Resource for Human Organs and Tissues (U42 Clinical Trial Not Allowed) This notice has expired. For NIH, in limited situations, applications may be accepted on a case-by-case basis for a short period after expiration to accommodate NIH late or continuous submission policies . Contact the eRA Service Desk for any submission issues.

Check the NIH Guide for active opportunities and notices. Department of Health and Human Services Part 1.

Overview Information Participating Organization(s) National Institutes of Health ( NIH ) Components of Participating Organizations Division of Program Coordination, Planning and Strategic Initiatives, Office of Research Infrastructure Programs ( ORIP ) National Eye Institute ( NEI ) National Institute of Allergy and Infectious Diseases ( NIAID ) National Institute of Arthritis and Musculoskeletal and Skin Diseases ( NIAMS ) National Institute of Diabetes and Digestive and Kidney Diseases ( NIDDK ) National Institute on Deafness and Other Communication Disorders ( NIDCD ), July 3, 2025 - Participation added ( NOT-DC-25-030 ) National Heart, Lung, and Blood Institute ( NHLBI ), July 17, 2025 - Participation added ( NOT-HL-25-029 ) Funding Opportunity Title Research Resource for Human Organs and Tissues (U42 Clinical Trial Not Allowed) U42 Animal (Mammalian and Nonmammalian) Model, and Animal and Biological Materials Resource Cooperative Agreements August 08, 2025 - Notice of Early Termination of PAR-24-258: Research Resource for Human Organs and Tissues (U42 Clinical Trial Not Allowed).

See Notice NOT-OD-25-144 . July 17, 2025 - Notice of NHLBI Participation in PAR-24-258, "Research Resource for Human Organs and Tissues (U42 Clinical Trial Not Allowed)". See Notice NOT-HL-25-029 .

July 3, 2025 - Notice of Participation in PAR-24-258, "Research Resource for Human Organs and Tissues (U42 Clinical Trial Not Allowed)". See Notice NOT-DC-25-030 . March 31, 2025 - This funding opportunity was updated to align with agency priorities.

Carefully reread the full funding opportunity and make any needed adjustments to your application prior to submission. December 17, 2024 - Notice of Change to PAR-24-258: Research Resource for Human Organs and Tissues (U42 Clinical Trial Not Allowed). See Notice NOT-OD-25-046 .

April 4, 2024 - Overview of Grant Application and Review Changes for Due Dates on or after January 25, 2025. See Notice NOT-OD-24-084 . August 31, 2022 - Implementation Changes for Genomic Data Sharing Plans Included with Applications Due on or after January 25, 2023.

See Notice NOT-OD-22-198 . August 5, 2022 - Implementation Details for the NIH Data Management and Sharing Policy. See Notice NOT-OD-22-189 .

Funding Opportunity Number (FON) Companion Notice of Funding Opportunity See Section III. 3. Additional Information on Eligibility .

Assistance Listing Number(s) 93. 351, 93. 855, 93.

867, 93. 847, 93. 846, 93.

173, 93. 837, 93. 838, 93.

839, 93. 840, 93. 233 Notice of Funding Opportunity Purpose The purpose of this Notice of Funding Opportunity (NOFO) is to support a Human Tissue and Organ Research Resource program to enable the continued availability of human tissues and organs to biomedical researchers.

The overall goal of the research resource is to provide a wide variety of human tissues and organs, both diseased and normal, to investigators. The research resource is expected to facilitate the procurement and preservation of human tissues and organs as well as the distribution of these materials to qualified biomedical researchers.

Open Date (Earliest Submission Date) Letter of Intent Due Date(s) Renewal / Resubmission / Revision (as allowed) AIDS - New/Renewal/Resubmission/Revision, as allowed 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.

New Date August 08, 2025 per NOT-OD-25-144 (Prior Date September 26, 2025). Any due dates beyond the new expiration date are no longer available. Required Application Instructions 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. Part 1. Overview Information 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.

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 Cooperative Agreement: A financial assistance 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 NOFO. Application Types Allowed The OER Glossary and the How to Apply - Application Guide provides details on these application types. Only those application types listed here are allowed for this NOFO.

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 One award will be made contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications.

The Direct Costs requested cannot exceed $720,000. Requested Direct Costs need to reflect the actual needs of the proposed project. The scope of the proposed resource should determine the project period.

The maximum 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 NOFO. Section III.

Eligibility Information Higher Education Institutions Public/State Controlled Institutions of Higher Education Private Institutions of Higher Education Nonprofits Other Than Institutions of Higher Education Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education) Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education) For-Profit Organizations (Other than Small Businesses) 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 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 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.

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.

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

Component Type for Submission 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: Management Section: required, maximum of 1 Resource Section: required, maximum of 1 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) 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) 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.

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).

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.

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. 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.

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.

When preparing your application, use Component Type ‘Core. ’ 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: 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. 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.

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. When preparing your application, use Component Type ‘Core.

’ 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: 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