RFA-OD-25-011-Full-Announcement.html

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)

Funding Opportunity Title

Animal and Biological Material Resource Centers (P40 Clinical Trial Not Allowed)

Activity Code

P40 Animal (Mammalian and Nonmammalian) Model, and Animal and Biological Material Resource Grants

Announcement Type

Reissue of

RFA-OD-23-001

Related Notices

Check for any recent Notices of NIH Policy Changes that may impact application requirements.

Funding Opportunity Number (FON)

RFA-OD-25-011

Companion Notice of Funding Opportunity

None

Number of Applications

See Section III. 3. Additional Information on Eligibility.

Assistance Listing Number(s)

93.351

Notice of Funding Opportunity Purpose

This Notice of Funding Opportunity (NOFO) encourages grant applications for Animal and Biological Material Resource Centers. These Centers provide support for special colonies of laboratory animals and associated services, as well as other resources such as informatics tools, reagents, cultures (cells, tissues, and organs) and genetic stocks that serve the biomedical research community in a variety of research areas on a local, regional, and national basis. The goal of projects supported by this NOFO is to provide research resources that facilitate optimization and enhancement of scientific rigor, transparency, and experimental reproducibility of biomedical research. Proposed Animal and Biological Material Resource Centers must have broad application to multiple NIH Institutes or Centers (ICs) to align with the ORIP’s NIH-wide mission (https://orip.nih.gov/about-orip). This funding opportunity is designed to support both continuation of existing resources and to develop new ones when appropriate. Of special interest of the announcement is a requirement of the Center’s close coordination with efforts to develop new approach methodologies (NAMs) that complement traditional animal-based research. These include cell culture, organoids, computational models, and microphysiological systems. Applied Research Component should include studies to generate comparative data to increase applicability of NAMs and promote integration of the most predictive human disease models. Prior to preparing an application, all applicants are strongly encouraged to consult with Scientific/Research staff to be advised on appropriateness of the intended resource plans for this program, competitiveness of a potential application, and ORIP's program priorities.

Funding Opportunity Goal(s)

The Office of Research Infrastructure Programs (ORIP) is a program office in the Division of Program Coordination, Planning, and Strategic Initiatives (DPCPSI) dedicated to supporting research infrastructure and related research resource programs. ORIP consists of the Division of Comparative Medicine (DCM) and the Division of Construction and Instruments (DCI).

Key Dates

Posted Date

December 04, 2025

Open Date (Earliest Submission Date)

January 18, 2026

February 18, 2026

February 18, 2026

May 11, 2026

December 2026

May 27, 2026

May 27, 2026

September 09, 2026

April 2027

September 21, 2026

September 21, 2026

January 11, 2027

July 2027

January 26, 2027

January 26, 2027

May 10, 2027

December 2027

May 28, 2027

May 28, 2027

September 08, 2027

April 2028

September 28, 2027

September 28, 2027

January 10, 2028

July 2028

January 31, 2028

January 31, 2028

May 09, 2028

December 2028

May 30, 2028

May 30, 2028

September 11, 2028

April 2029

September 26, 2028

September 26, 2028

January 09, 2029

July 2029

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.

Expiration Date

January 10, 2029

Due Dates for E.O. 12372

Not Applicable

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.

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

Objective ORIP uses the P40 mechanism to support Animal and Biological Material Resource Centers in a variety of areas of biomedical science. Animal and Biological Material Resource Centers create, collect, develop, characterize, preserve, and distribute special colonies of high-quality and well-characterized laboratory animals and animal-related models. Special colonies of research animals are defined as animals that add value for biomedical research but are not generally available to investigators. Collecting, generating, and distributing such animals render these resources more accessible to the research community and eliminate costly redundant efforts. Other types of Animal and Biological Material Resource Centers provide informatics tools, data, analytical expertise, biological materials, or services that support research projects and that will enhance and expand an animal model system. Centers should emphasize use of broadly applicable, interdisciplinary validation tools to increase predictability of animal models, such as approaches to compare and determine relatedness and usefulness of a disease associated network/pathway/physiological process between an animal model and a human patient. Applications that heavily focus on building and maintaining genomic or phenotyping databases for individual animal species will not be considered for funding.

Of special interest of the announcement is a requirement of the Center’s close coordination with efforts to develop new approach methodologies (NAMs) that complement traditional animal-based research. These include cell culture, organoids, computational models, and microphysiological systems. NAMs enable research to be done more quickly, by more researchers, at a more affordable cost. Importantly, these advances are opening doors to complementary and more effective non-animal-based approaches for a variety of applications. The development of NAMs holds tremendous promise for increasing the tools available to achieve the NIH mission and potentially reduce and refine the future use of animals in some areas of research in the future. The Centers should promote integration with NAMs.

It is important that the community fully understand the strengths and limitations of these Centers, as well as areas of opportunity given the current state of science, that in turn will improve selection, design, and relevance of animal models.

Details concerning current Division of Comparative Medicine (DCM) Animal and Biological Material Resource Centers can be found at the following link: https://orip.nih.gov/resource-directory.

All applicants are strongly encouraged to consult with DCM Program staff on the appropriateness of the intended resource, competitiveness of a potential application, and whether the proposed application meets the goals and mission of the DCM/ORIP and is broad enough to serve the needs of the biomedical research community.

Examples of projects that WILL NOT be supported under this NOFO include those that:

Animal and Biological Material Resource Centers should have the following characteristics:

1) There should be a demonstrated need for the resource in the wider biomedical research community. Evidence of the depth and breadth of impact on a scientific community must be provided. Examples could include up to 15 letters of support from institutions, individuals, groups, or consortia; website usage; a statement from a scientific society; and/or a published white paper. Applications exceeding the 15 letters limit will be administratively withdrawn without review. Support letters from the institution submitting the P40 application are not counted towards this limit/cap.

2) The Centers should serve the needs of investigators in a variety of research areas where work is sponsored by multiple NIH ICs.

3) The Centers must be available and utilized by investigators on a national basis.

4) The Centers must ensure the quality and welfare of distributed animals and describe how their activities assist and promote optimization and enhancement of scientific rigor, transparency and experimental reproducibility of biomedical research.

5) The Centers must have an Applied Research Component to generate new approaches or to enhance existing ones that will improve the resources and services provided to the community. Hypothesis driven R21- or R01-like research is not considered applied research. Applied Research Component should include studies to generate comparative data to increase applicability of NAMs and promote integration of the most predictive human disease models. The Applied Research Component may comprise no more than 15 percent of the direct costs associated with the P40 grant.

6) The Centers must have a Curation and Informatics component to support development and maintenance of in-house data management systems, curate stocks of animals and biomaterials, and maintain a searchable web portal with an integrated client friendly request/ordering system and outreach presentations.

7) The Institution submitting the P40 application must be committed to the Center being proposed. Evidence of such support must be provided. The application should include a letter of support from the Institution.

8) A critical component of improving scientific reproducibility of the research is to develop approaches for unique identification of research resources in public databases, including publications. The Center should register catalogs of their resources with current resource tagging and identification initiatives, such as FORCE 11 (https://www.force11.org/group/resource-identification-initiative). The Center should also work with the investigators to encourage the use of a resource identification system in their publications and reports.

9) The Centers required to develop approaches to maintain critical resources in reliable and cost-effective ways. Long-term preservation of the genetic stock of animal models is needed to ensure efficiency, rigor, and reproducibility in biomedical research. Cryopreservation of the germplasm should be considered when it is appropriate. In addition, the Center should have a disaster preparedness plan to minimize total loss of resources in the event of a catastrophic disaster, such as loss of power or potable water, fire, flooding, data breach, pandemic or public health emergency.

10) The Center is required to develop an active program for monitoring and collecting information for reporting purposes and evaluating the impact of their ongoing activities and services provided to the biomedical community. Examples should include tracking user information (such as Institute affiliation and location), sources of funds, associated grant numbers for purchases made with Government funds, and/or outcomes of the studies using obtained animal models and biomaterials. Such information should also be included in progress reports to the NIH.

Additional Information The P40 application is a multi-component application, with an Overall Component that is the aggregate of the Resource (major), Curation and Informatics (minor), and Applied Research (minor) Components.

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 Resource Component and can serve as the Project Lead(s) of the Curation and Informatics Component and/or Applied Research Component. The applied research is typically conducted at the applicant institution and not subcontracted.

It is required that Animal and Biological Material Resource Center grants will generate Program Income which will support efforts to enhance the volume of its operations. In general, this means that Renewal (a.k.a. Type 2) applications should recover in the initial year of the proposed grant cycle a greater percentage of operating costs from Program Income than for the last year of the previous grant cycle. Furthermore, each additional year in the proposed grant cycle should reasonably expect to recover a greater percentage of operating costs from Program Income than the average of the previous 5-year project period. Costs specifically associated with the establishment, improvement, or expansion of animal or material distributions and long-term resource maintenance should be recovered from users through a charge schedule acceptable to the NIH. Significant growth of Animal and Biological Material Resource Centers should result from Program Income and not from an ever-increasing P40 award. Note that the Center's use of Program Income is governed by the NIH Grants Policy statement, Section 8.3.2: (http://grants.nih.gov/grants/policy/policy.htm).

An important function of the Animal and Biological Material Resource Center is developing and maintaining the Center’s in-house data management systems in a format that may facilitate its integration with other animal resource databases and community standards for information accessibility and interoperability, and providing adequate staff for curation of newly acquired stocks for collection and animal resource distribution management. These activities will contribute to the implementation of the NIH Strategic Plan for Data Science, which describes actions aimed at modernizing the biomedical research data ecosystem. Biomedical repositories should accept submission of relevant data from the community and generate its own data to store, organize, validate, archive, preserve, and distribute information in compliance with the FAIR (Findable, Accessible, Interoperable, and Reusable) Data Principles. Center should develop plans in accordance with the new NIH Policy for Data Management and Sharing (NOT-OD-22-189) to better position itself for the updated data requirements. In addition, improving access to the Resource Center’s databases as well as developing metrics to evaluate the usage, utility, and impact of a given repository will improve the ability of the center to meet the needs of the biomedical research community.

Most Centers cannot afford to accept all possible donor deposits if the future demand for these materials cannot justify the expense associated with quality control, expansion and archiving of animals and biological materials. For this and additional reasons, Centers must have an External Advisory Board of experts and users who will be responsible for review and evaluation of the Center’s progress, guidance to the PDs/PIs on which potential new animals and biological materials should be accepted for archiving and future distribution, as well as analysis of the Center’s long-term sustainability, biomedical research relevance, and its ability to provide timely and relevant products and services to the research community. The assessments and recommendations should be provided annually to the PDs/PIs as well as NIH Program. The External Advisory Board must be composed of a minimum of 4 members (outside of the PI parent Institution) and must meet a minimum of once per year (the required expertise of the members should be stated, but names of the candidates should not be listed in the application). If a specific External Advisory Board member receives a salary from the P40 grant, s/he should be a non-voting member. Tele- or videoconferencing is encouraged to decrease costs unless the budgeted expense of face-to-face meetings is justified in the application.

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

Section II. Award Information

Funding Instrument

Grant: A financial assistance mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.

Application Types Allowed

New

Renewal

Resubmission

Revision

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.

Clinical Trial?

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

Need help determining whether you are doing a clinical trial?

Funds Available and Anticipated Number of Awards

The National Institutes of Health (NIH) intends to commit $1.3 M in FY 2023-2025 to fund at least two awards per fiscal year.

Award Budget

Application budgets are not limited but need to reflect the actual needs of the proposed project.

For Renewal (a.k.a. Type 2) applications including Renewal Resubmission applications, no more than a 5 percent increase of direct cost based on a previous non-competing year with the highest direct cost in the prior five-year funding cycle will be accepted. Those calculations do not include the budget for adding a new Curation and Informatics component (up to $300,000 of additional total cost per year) unless the renewal application already had a Curation and Informatics component added via a revision application or existing from the previous project period. In these cases, the 5 percent increase cap for direct cost includes this component.

Award Project Period

The scope of the proposed project should determine the project period. The maximum project period is 5 years.

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

Section III. Eligibility Information

1. Eligible Applicants

Eligible Organizations

Nonprofits Other Than Institutions of Higher Education

For-Profit Organizations

Local Governments

Federal Governments

Eligible Agencies of the Federal Government

U.S. Territory or Possession

Foreign Organizations/International Collaborations

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.

Required Registrations

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.

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.

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 (in this NOFO, in a policy notice, or other notice from NIH Guide for Grants and Contracts) 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.

Required

Required

Required

Required

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 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) Introduction to Application: For Resubmission and Revision applications, an Introduction to Application is required in the Overall component.

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

Research Strategy: Follow the instructions in the SF424 (R&R) Application Guide. In addition, generally describe and justify the need for the Overall Center in the research community, including possible alternatives. Describe how the activities of the Center will enhance reproducible use of the animal models and biological materials it will provide. Describe how the Center will serve the needs of investigators in a variety of research areas where work is sponsored by multiple NIH ICs. Describe how Center activities will assist and promote optimization and enhancement of scientific rigor, transparency and experimental reproducibility of biomedical research. Describe how the Center will coordinate its activities with the development of NAMs, assist in generation of comparative data for decision-making process, contribute to assessing the value and limitations of NAMs and for establishing confidence in NAMs applications. Describe how the Center will be made available to investigators on a national basis. Regarding the plans for the operation and maintenance of the Overall Center, describe how the resources generated by this project will be made available rapidly and efficiently to the NIH-supported research community. Describe how the Center will provide transparency and reproducibility for the information, services, products, and models to be shared. Describe the institutional support for the Overall Center, including plans for long-term continuity. Describe how the Center would be continued beyond this potential grant award. Describe Center efforts for monitoring and collecting information on the impact of their ongoing activities on biomedical research. Such information should also be included in their progress reports to the NIH.

Letters of Support: Letters of Support should be included in the Overall Component (rather than in the Resource or Applied Research Component). Include a Letter of Support from any institution providing space, resources, or financial support other than Program Income from distribution of resources or services.

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.

Other Plan(s):

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

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

Appendix: Only limited 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.

Resource When preparing your application, use Component Type ‘Core.' All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions, as noted.

SF424(R&R) Cover (Resource) Complete only the following fields:

PHS 398 Cover Page Supplement (Resource) Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Resource) 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) 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)

Budget (Resource) 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) Introduction to Application: For Resubmission and Revision applications, an Introduction to Application is allowed for each component.

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

Research Strategy: Follow the instructions in the SF424 (R&R) Application Guide.

In addition, describe in detail the resources the Center will create, develop, characterize, preserve, and distribute. Describe what quality control procedures will characterize the resources to be provided. Describe in detail how requests for the resources will be handled, including periodic assessments of performance, including milestones and timelines. Describe plans for protocol/methods dissemination to the greater research community, if appropriate.

Describe the Center’s support structure regarding coordination of the Center’s mission; monitoring the timelines for achieving milestones; coordinating and integrating Center activities; implementing a plan for regular evaluation of scientific progress; working with the applicant institution to enhance the visibility and effectiveness of the Center; and ensuring appropriate prioritization of activities, including needed course corrections and problem identification and resolution.

Provide a table that shows how the Center is currently funded, including support from any current P40 grant, Program or Center Income, and other sources such as institutional funds, if applicable. Provide a financial plan, including how the Resource will progress toward recovering increasing support from Program Income. Different Centers have grown at various rates and have accumulated different resources. Therefore, Centers may be at various stages regarding the amount of Program Income that can be generated, which depends on the size and marketability of the resource. The sum of the direct costs requested plus Program Income and Institutional commitment, if applicable, should equal the costs associated with all the functions of the Center. Support for the Center from sources other than the grant and Program Income is not required. The requirement for support in addition to that provided by the grant can be waived by the DCM Director in exceptional circumstances.

Describe the planned meeting format for the Center's External Advisory Board, frequency of meetings, and functions. For Renewal applications, applicants must name and briefly describe the qualifications of their Board members. For New applications, describe the types of expertise that would be sought. New Grantees should contact their potential Board members after their grant is awarded. Potential members of the Board should not be contacted, named, or selected until an award has been made. This stipulation will allow a wider pool of potential reviewers of the applications.

Marketing Plan: The Center should present an effective marketing program, aimed at increasing the awareness of the scientific community regarding its program. It is also incumbent on the Centers to assist the wider community to effectively access and use animals, biomaterials and informatics resources created by the program. The development of new marketing methods based upon evaluation of researcher interest via surveys and methods to analyze interactions with the user interface is highly encouraged. Describe approaches for development of additional methods to raise visibility of resources available from the Center, including social media, targeted publications, and development and implementation of a resource tagging system.

Community Outreach: The Center will also develop a plan to provide community training to enhance the use and utility of the resource. Seminars, presentations, posters or workshops can be an element of this effort. The Center should implement mechanisms that solicit regular feedback and opinion from the user community, including comment boxes and online flash-surveys, and then regularly analyze the results. The Center will also track and report to NIH users’ numbers, web hits and traffic as well as assist in other tracking metrics.

Describe a disaster plan to minimize total loss of resources in the event of a catastrophic disaster, such as loss of power, fire, flooding, data breach, pandemic or public health emergency.

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

Resource Sharing Plans should be consolidated in the Overall Component.

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

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

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

Study Record: PHS Human Subjects and Clinical Trials Information All instructions in the SF424 (R&R) Application Guide must be followed Delayed Onset Study Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start). All instructions in the SF424 (R&R) Application Guide must be followed.

Curation and Informatics When preparing your application, use Component Type ‘Admin Core.’

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

SF424(R&R) Cover (Curation and Informatics) Complete only the following fields:

PHS 398 Cover Page Supplement (Curation and Informatics) Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Curation and Informatics) 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) (Curation and Informatics) 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 (Curation and Informatics)

Budget (Curation and Informatics) Budget forms appropriate for the specific component will be included in the application package.

PHS 398 Research Plan (Curation and Informatics) Introduction to Application: For Resubmission and Revision applications, an Introduction to Application is allowed for each component.

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

Research Strategy: Follow the instructions in the SF424 (R&R) Application Guide.

In addition, describe how the Curation and Informatics component will generate or support the generation of new information, services, products, models, and NAMs that will improve the Resource. Describe how refinement, improvement, or new application of theoretical concepts, approaches, methodologies, instrumentation, or interventions will be achieved. Describe how the scientific rationale for the Curation and Informatics components will develop new approaches and apply them to the functions of the overall Resource.

The applicant should describe the Center’s in-house data management systems, how they will facilitate integration with other animal resource databases and community standards for information accessibility and interoperability, and how they will provide adequate staff for curation of newly acquired stocks for collection and resource distribution management.

The plan must discuss the following key areas:

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

Resource Sharing Plans should be consolidated in the Overall Component.

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

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

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

Study Record: PHS Human Subjects and Clinical Trials Information All instructions in the SF424 (R&R) Application Guide must be followed Delayed Onset Study Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start). All instructions in the SF424 (R&R) Application Guide must be followed.

Applied Research When preparing your application, use Component Type ‘Project.' All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions, as noted.

SF424(R&R) Cover (Applied Research) Complete only the following fields:

PHS 398 Cover Page Supplement (Applied Research) Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Applied Research) 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.