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)

Activity Code

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

Announcement Type

Reissue of PAR-11-001

Related Notices
  • June 4, 2014 - Notice NOT-14-074 supersedes instructions in Section III.3 regarding applications that are essentially the same.
Funding Opportunity Announcement (FOA) Number

PAR-14-005

Companion Funding Opportunity

None

Number of Applications

See Section III. 3. Additional Information on Eligibility.

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

93.351

Funding Opportunity Purpose

This FOA encourages grant applications for national Animal Model, and Animal and Biological Material Resource Centers. These Centers provide support for special colonies of laboratory animals, as well as other resources such as reagents, cultures (cells, tissues, and organs) and genetic stocks that serve the biomedical research community.  The resource centers for Animal and Biological Materials collect, maintain, characterize, and distribute defined strains of animals and/or related biological materials to biomedical investigators in a variety of research areas on a local, regional, national and international basis. This funding opportunity is designed to both support continuation of existing resources, and to develop new ones when appropriate.  Prior to preparing an application, all applicants are strongly encouraged to consult with Program staff to be advised on appropriateness of the intended resource plans for this program, competitiveness of a potential application and ORIP's program priorities.

Key Dates
Posted Date

November 21, 2013

Open Date (Earliest Submission Date)

December 25, 2013

Letter of Intent Due Date(s)

Not Applicable

Application Due Date(s)

Standard dates apply, 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.

AIDS Application Due Date(s)

Standard AIDS dates apply or Month(s) Day(s), Year(s), 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.

Scientific Merit Review

Standard dates apply

Advisory Council Review

Standard dates apply

Earliest Start Date

Standard dates apply

Expiration Date

January 8, 2017

Due Dates for E.O. 12372

Not Applicable

** ELECTRONIC APPLICATION SUBMISSION REQUIRED**

NIH’s new Application Submission System & Interface for Submission Tracking (ASSIST) is available for the electronic preparation and submission of multi-project applications through Grants.gov to NIH. Applications to this FOA must be submitted electronically; paper applications will not be accepted. ASSIST replaces the Grants.gov downloadable forms currently used with most NIH opportunities and provides many features to enable electronic multi-project application submission and improve data quality, including: pre-population of organization and PD/PI data, pre-submission validation of many agency business rules and the generation of data summaries in the application image used for review.

Required Application Instructions

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

You will be sent to ASSIST to prepare and submit your application. Problems accessing or using ASSIST should be directed to the eRA Commons Help Desk.
Table of Contents

Part 1. Overview Information
Part 2. Full Text of the Announcement
Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information

Part 2. Full Text of Announcement
Section I. Funding Opportunity Description
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, develop, characterize, preserve, and distribute special colonies of high-quality laboratory animals and animal-related models.  Special colonies of research animals are defined as animals that are valuable for biomedical research, but are not generally available to investigators.  Other types of Animal and Biological Material Resource Centers provide data, biological materials, tools, or services that support research projects that will improve and expand an animal model system that will make the model more useful and more accessible to the research community.  Details concerning current Division of Comparative Medicine (DCM) Animal and Biological Material Resource Centers can be found at the following links: http://dpcpsi.nih.gov/orip/cm/index.aspx and http://projectreporter.nih.gov/reporter.cfm.  All applicants are strongly encouraged to consult with DCM Program staff to be advised on the appropriateness of the intended resource plans for this program, competitiveness of a potential application and DCM's program priorities.

Support for all Animal and Biological Material Resource Centers is limited to those that span the interests of two or more categorical NIH Institutes/Centers/Offices (ICOs).  Applications proposing studies that are related predominantly to the interest of one ICO and only peripherally to the interests of other ICOs will not be reviewed.  An example of an inappropriate request is a resource that exclusively maintains and distributes animal or biological materials for cancer or other specific disease research.

Animal and Biological Material Resource Centers must also have the following characteristics:

1)  There must be demonstrated need for the resource in the biomedical research community. Evidence of the depth and breadth of impact on a scientific community must be provided.  Examples could include up to 20 letters of support from institutions, individuals, groups, or consortia; database or website usage; a statement from a scientific society; and/or a published white paper;

2)  Animal and Biological Material Resource Centers must serve the needs of investigators in a variety of research areas where work is sponsored by multiple NIH ICOs.  If the user community is very narrow or limited to the research area supported by one NIH ICO, support for the animal resource should be sought from the appropriate NIH ICO;

3)  Animal and Biological Material Resource Centers must be available to investigators on a local, regional, and national basis;

4)  The resource must have an Applied Research Component to generate new information that will improve the resource.  Hypothesis driven R21- or R01-like research is not considered applied research.  The Applied Research Component may comprise no more than 10 percent of the direct costs associated with the P40 grant; and 

5)  The Institution submitting the P40 application must be committed to the Center Resource being proposed.  The form of this commitment (space, resources, plans for long-term continuity) must be described in one of the included Letters of Support.

Additional Information

The P40 application is a multi-component application, with an Overall Component that is the aggregate of the major Resource Component and the minor Applied Research Component.  Each of these Components is described in the three respective Research Strategy sections (Section IV Applciation and Submission Information) and the three respective review Criteria sections (Section V Applicaiton and Review Information) of this FOA.

Multiple PDs/PIs for the Overall grant are allowed, but justification is required in the application.  Typically, one or more of the PDs/PIs of the Overall application also serves as the Core Lead(s) of the Resource Component and can serve as the Project Lead(s) of the Applied Research Component.  The applied research is typically conducted at the applicant institution and not subcontracted.

It is expected that Animal and Biological Material Resource Center grants will progress toward self-sufficiency. In general this means that Renewal (a.k.a. competing continuation or 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.  In addition, each of the up to 4 following years in the proposed grant cycle should reasonably expect to recover a greater percentage of operating costs from Program Income than the previous year.  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 mostly 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: (http://grants.nih.gov/grants/policy/policy.htm).  

For Renewal (a.k.a. competing continuation or Type 2) applications, no more than a 5 percent (direct cost) increase from the last non-competing year will be accepted.

Most P40 resource Centers cannot afford to accept all possible donor deposits if the future demand for these materials cannot justify the expense associated with quality control, expanding, and archiving the material.  For this and additional reasons, P40 Centers must have an External Advisory Board of experts and users who advise the PDs/PIs on which potential new materials should be accepted for archival and future distribution.  The External Advisory Board must be comprised of a minimum of 4 members, and must meet a minimum of once per year.  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.

Section II. Award Information
Funding Instrument

Grant: A support 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 SF424 (R&R) Application Guide provide details on these application types.

Funds Available and Anticipated Number of Awards

The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications.

Award Budget

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

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 in response to this FOA.

Section III. Eligibility Information
1. Eligible Applicants
Eligible Organizations

Higher Education Institutions

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

Nonprofits Other Than Institutions of Higher Education

Governments

Other

Foreign Institutions

Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.
Foreign components, as defined in the NIH Grants Policy Statement, are allowed.

Required Registrations

Applicant Organizations

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

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

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

Eligible Individuals (Program Director/Principal Investigator)

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

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

2. Cost Sharing

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

3. Additional Information on Eligibility
Number of Applications

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

NIH will not accept any application that is essentially the same as one already reviewed within the past thirty-seven months (as described in the NIH Grants Policy Statement), except for submission:

Section IV. Application and Submission Information
1. Requesting an Application Package

Applicants can access the SF424 (R&R) application package associated with this funding opportunity using the “Apply for Grant Electronically” button in this FOA or following the directions provided at Grants.gov.

Most applicants will use NIH’s ASSIST system to prepare and submit applications through Grants.gov to NIH. Applications prepared and submitted using applicant systems capable of submitting electronic multi-project applications to Grants.gov will also be accepted.

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, except where instructed in this funding opportunity announcement to do otherwise and where instructions in the Application Guide are directly related to the Grants.gov downloadable forms currently used with most NIH opportunities. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

For information on Application Submission and Receipt, visit Frequently Asked Questions – Application Guide, Electronic Submission of Grant Applications.

Page Limitations

Component Types Available in ASSIST

Research Strategy/Program Plan Page Limits

Overall

6

Core (use for Resource component)

12

Project (use for Applied Research component)

6

Additional page limits described in the SF424 Application Guide and the Table of Page Limits must be followed.

Instructions for the Submission of Multi-Component Applications

The following section supplements the instructions found in the SF424 (R&R) Application Guide, and should be used for preparing a multi-component application.

The application should consist of the following components:

Overall Component

When preparing your application in ASSIST, use Component Type ‘Overall’.

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

SF424 (R&R) Cover (Overall)

Complete entire form.

PHS 398 Cover Page Supplement  (Overall)

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

Research & Related Other Project Information (Overall)

Follow standard instructions.

Project/Performance Site Location(s) (Overall)

Enter primary site only.

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

Research & Related Senior/Key Person Profile (Overall)

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

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

Budget (Overall)

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

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

PHS 398 Research Plan          (Overall)

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

Specific Aims: Follow the instructions in the SF424 (R&R) Application Guide.

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 Center will serve the needs of investigators in a variety of research areas where work is sponsored by categorical NIH ICOs.  Describe how the Center will be made available to investigators on a local, regional, and 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 Resource will provide transparency and replicatability for the information, services, products, and models to be shared.  Describe the institutional support for the Overall Center, including space, resources, and plans for long-term continuity.  Describe how the Resource would be continued beyond this potential grant award.

Letters of Support:  Up to 20 Letters of Support can 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 or 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 (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) as provided in the SF424 (R&R) Application Guide, with the following modifications:

Appendix: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.Surveys may be submitted in the Appendix as necessary.  P40 applicants can provide a Table that summarizes the survey of potential users (and actual users for competing renewal applications) of the Center, and the users’ source of support from the various ICOs of NIH, as well as non-NIH sources. 

Resource

When preparing your application in ASSIST, use Component Type ‘Core.'

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

SF424 (R&R) Cover (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.

Project /Performance Site Location(s) (Resource)

List all performance sites that apply to the specific component.

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

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 the current P40 grant, Program Income, and other sources such as institutional funds, if applicable.  Provide a financial plan, including how the Resource will progress toward becoming self-sufficient. Different Centers have grown at various rates and have accumulated different resources. Therefore, Centers may be at various stages in regard to 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 Center's External Advisory Board's planned meeting format, frequency of meeting, 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.

Resource Sharing Plan: Resource Sharing Plans should be consolidated in the Overall Component.

Appendix: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.   

Planned Enrollment Report  (Resource)

When conducting clinical research, follow all instructions for completing Planned Enrollment Reports as described in the SF424 (R&R) Application Guide. 

PHS 398 Cumulative Inclusion Enrollment Report (Resource)

When conducting clinical research, follow all instructions for completing Cumulative Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide. 

Applied Research

When preparing your application in ASSIST, 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.

Project /Performance Site Location(s) (Applied Research)

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 (Applied Research)

Budget (Applied Research)

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          (Applied Research)

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

Specific Aims: Follow the instructions in the SF424 (R&R) Application Guide.

Research Strategy:  Follow the instructions in the SF424 (R&R) Application Guide.  In addition, describe how the Applied Research Component will generate new information, services, products, and models that will improve the Resource. Describe how a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions will be achieved. Describe how the scientific rationale for the Applied Research will develop or apply new methodologies to the functions of the Resource Component.  Describe how the Resource and Applied Research Components synergize beyond what could be achieved through a traditional research project.

Resource Sharing Plan: Resource Sharing Plans should be consolidated in the Overall component.

Appendix: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.   

Planned Enrollment Report  (Applied Research)

When conducting clinical research, follow all instructions for completing Planned Enrollment Reports as described in the SF424 (R&R) Application Guide. 

PHS 398 Cumulative Inclusion Enrollment Report (Applied Research)

When conducting clinical research, follow all instructions for completing Cumulative Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide.

3. Submission Dates and Times

Part I. Overview Information contains information about Key Dates. 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.

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.

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

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

4. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

5. 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.

6. Other Submission Requirements and Information

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

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

Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.

For assistance with your electronic application or for more information on the electronic submission process, visit Applying Electronically.

Important reminders:
All PD(s)/PI(s) and component Project Leads must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH.

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

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review, NIH. Applications that are incomplete will not be reviewed.

Requests of $500,000 or more for direct costs in any year

Applicants requesting $500,000 or more in direct costs in any year (excluding consortium F&A) must contact NIH program staff at least 6 weeks before submitting the application and follow the Policy on the Acceptance for Review of Unsolicited Applications that Request $500,000 or More in Direct Costs as described in the SF424 (R&R) Application Guide.

Post Submission Materials

Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-13-030.

Section V. Application Review Information
1. Criteria

Only the review criteria described below will be considered in the review process. As part of the NIH mission, all applications submitted to the NIH in support of biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.

The P40 application is a multi-Component application, with an Overall Component that is the aggregate of the Resource Component and the Applied Research Component.  Standard numerical scoring will be applied to the Center's Overall Impact, Significance, Investigators, Innovation, Approach and Environment.  Scores should emphasize the Resource Component and the resource aspect of the Center.  In addition "Merit Descriptors" will be provided in individual Reviewer’s critiques for individual elements of the Resource and Applied Research Components indicated below.  The three potential Merit Descriptors are outstanding, acceptable, or unacceptable. 

Overall Impact - Overall Center

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

Scored Review Criteria - Overall Component

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

Significance

Does the Overall Center address an important problem or a critical barrier to progress in the field? If the aims of the Center are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

Is there a demonstrated need for the Overall Center in the research community?  Could the need have been easily satisfied in other ways? Will the Center support progress in the field? Does the Center serve the needs of investigators in a variety of research areas where work is sponsored by categorical NIH ICOs? Will the Center be available to investigators on a local, regional, and national basis? Is there appropriate institutional support for the Overall Center, and are plans for continuity appropriate for the scientific field’s needs? 

Investigator(s)

Are the PD(s)/PI(s) of the Overall Center, Core Lead(s) of the Resource, Project Lead(s) of the Applied Research Component, collaborators, and other researchers well suited to the Overall Center? If Early Stage Investigators or New Investigators, or in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?

Are the PD(s)/PI(s), Core Lead(s), and Project Lead(s) appropriately trained and well suited to manage a national resource? Is the work proposed appropriate to the scientific and managerial experience level of the PDs/PI(s) and other researchers? To what extent have collaborations been established or consultants identified to provide the appropriate depth and breadth of scientific and managerial expertise necessary?

Innovation

Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?

Are the design of the Overall Center and the method of providing information, services, products and models innovative? Are there innovative features in the planned Overall Center's interactions with users of the resource, and within the internal and external decision making processes? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the Overall Center? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? 

If the Center involves clinical research, are the plans for 1) protection of human subjects from research risks, and 2) inclusion of minorities and members of both sexes/genders, as well as the inclusion of children, justified in terms of the scientific goals and research strategy proposed?

Are the plans for the operation and maintenance of the Overall Center adequately developed and described? Will the resources generated by this project be made available rapidly and efficiently to the NIH-supported research community?

Are appropriate plans in place for assurance of quality control? Are appropriate procedures in place for handling requests for the resources, and for the adequate distribution of the resources? Are the timeline and milestones clear and feasible? Are the plans for transparent protocol/methods dissemination to the greater research community appropriate? Is outside scientific expertise available to advise on governance, management, and function of the Resource? Are the Center's External Advisory Board's planned meeting format, frequency of meeting, proposed expertise, and functions adequate? Are there reasonable plans for the Resource to become self-sufficient? Does the financial plan for each of years 2 through 5 of the proposed support period include appropriate Program Income?  Is it likely that the financial plan will meet the stated objectives, and move the Center toward self-sufficiency?

Environment

Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?

Is there evidence of institutional support for the Overall Center? Is the form of this commitment (space, resources, plans for long-term continuity) appropriate? Is continuation of the Resource beyond this award anticipated and planned for? If so, is an adequate plan to transition to other sources of support presented?

Scored Review Criteria for the Resource Component

The Resource Component will receive a merit descriptor (outstanding, acceptable, unacceptable) that reflects:

Scored Review Criteria for the Applied Research Component

The Applied Research Component will receive a merit descriptor (outstanding, acceptable, unacceptable) that reflects:

Additional Review Criteria - Overall, Resource, and Applied Research Components

As applicable for the Overall Center and 2 components being 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 six 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 six 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 Children 

When the proposed Overall Center and 2 Components involves clinical research, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children. 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 five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

Biohazards

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

Resubmissions

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

Renewals

For Renewals, the committee will consider the progress made in the last funding period. The progress should be evaluated for accomplishment of objectives for the Overall Center. Was there a demonstrated need for the Center in the research community? Could the need have been easily satisfied in other ways? Did the Center support progress in the field? Did the Center serve the needs of investigators in a variety of research areas where work is sponsored by categorical NIH ICOs? Was the Center available to investigators on a local, regional, and national basis? 

Have investigators clearly and concisely described the previous specific aims, and whether they were achieved? Were resources generated by this project made available rapidly and efficiently to the NIH-supported research community? Were appropriate plans in place for assurance of quality control? Were appropriate procedures in place for handling requests for the resources, and for the adequate distribution of the resources? Was there progress toward financial self-sufficiency via Program Income in the last grant cycle?

Revisions

For Revisions (competitive supplement requests), the committee will consider the appropriateness of the proposed expansion of the scope of the project. If the Revision application relates to a specific line of investigation presented in the original application that was not recommended for approval by the committee, then the committee will consider whether the responses to comments from the previous scientific review group are adequate and whether substantial changes are clearly evident.

Additional Review Considerations - Overall, Resource, and Applied Research Components

As applicable for the Center and 2 components proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact score.

Applications from Foreign Organizations

Not Applicable

Select Agent Research

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

Resource Sharing Plans

Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: 1) Data Sharing Plan; 2) Sharing Model Organisms; and 3) Genome Wide Association Studies (GWAS).

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

As part of the scientific peer review, all applications:

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. Following initial peer review, recommended applications will receive a second level of review by the NIH Council of Councils. The following will be considered in making funding decisions:

3. Anticipated Announcement and Award Dates

After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons

Information regarding the disposition of applications is available in the NIH Grants Policy Statement.

Section VI. Award Administration Information
1. Award Notices

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

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

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

Any application awarded in response to this FOA will be subject to the DUNS, SAM Registration, and Transparency Act requirements as noted on the Award Conditions and Information for NIH Grants website.

2. Administrative and National Policy Requirements

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

Cooperative Agreement Terms and Conditions of Award

Not Applicable

3. Reporting

When multiple years are involved, awardees will be required to submit the Non-Competing Continuation Grant Progress Report (PHS 2590 or RPPR) annually and financial statements as required in the NIH Grants Policy Statement.

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

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

Section VII. Agency Contacts

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

Application Submission Contacts

eRA Commons Help Desk (Questions regarding eRA Commons registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, post submission issues)
Phone: 301-402-7469 or 866-504-9552 (Toll Free)
Web ticketing system: https://public.era.nih.gov/commonshelp
TTY: 301-451-5939
Email: commons@od.nih.gov

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading forms and application packages)
Contact Center Phone: 800-518-4726

Web ticketing system: https://grants-portal.psc.gov/ContactUs.aspx
Email: support@grants.gov

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone 301-435-0714
TTY: 301-451-5936
Email: GrantsInfo@nih.gov

Scientific/Research Contact(s)

Oleg Mirochnitchenko, Ph.D.
Division of Comparative Medicine (DCM)
Office of Research Infrastructure Programs (ORIP) Division of Program Coordination, Planning, and Strategic Initiatives (DPCPSI)
Telephone:  301-435-0748
Email:  oleg.mirochnitchenko@nih.gov

Peer Review Contact(s)

Maribeth Champoux, Ph.D.
Center for Scientific Review (CSR)
Telephone: 301-594-3163
Email: champoum@csr.nih.gov

Financial/Grants Management Contact(s)

Ruthann Rand
Office of Grants Management and Scientific Review National Center for Advancing Translational Sciences (NCATS) Office of Research Infrastructure Programs (ORIP) Division of Program Coordination, Planning, and Strategic Initiatives (DPCPSI)
Phone: (301) 451-4238
Email:  randrudy@mail.nih.gov

Section VIII. Other Information

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

Authority and Regulations

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Parts 74 and 92.


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