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.

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

This Funding Opportunity Announcement (FOA) requests cooperative agreement applications (U42) from the institutions currently participating in the ORIP-supported Chimpanzee Biomedical Research Program (now designated the Chimpanzee Biomedical Resource Program, CBRP) or institutions currently funded to support NIH-owned and NIH-supported/institution-owned chimpanzees. The existing CBRP was established in 1986. The recipient organizations have a responsibility to maintain colonies of chimpanzees that are, have been, or will be used in NIH-sponsored research: providing for the complex social, behavioral, and medical needs of the aging research chimpanzee population.

The demonstrated capabilities and the highly specialized facilities of the current ORIP-supported institutions housing NIH-owned or -supported animals make them uniquely qualified to compete for this continuation support. The efforts at funded sites will be coordinated and managed under the Chimpanzee Management Plan (CMP) based in the Division of Comparative Medicine of ORIP. The Program Director of the CMP will be the ORIP Project Scientist for these awards. Each Program Director/Principal Investigator (PD/PI) will be expected to participate in efforts to develop and implement progressive policies in areas such as animal allocation, environmental enrichment, uniform record keeping, and data collection and distribution.

The overall objectives of this program are: 1) to continue to maintain high quality animals, facilities and expertise for biomedical and behavioral researchers, 2) to house chimpanzees in social and complex living environments consistent with their species-specific needs, while advancing biomedical research aimed at improving human and the captive chimpanzee's health, 3) to continue to provide quality health care to the NIH owned and supported chimpanzee population that addresses both individual animal and colony health through annual physical examinations and supportive resource relevant clinical investigations, and 4) to structure the chimpanzee resource according to research priority.

The program should include resource-relevant research to improve the health of the animals, with special emphasis on studies to enhance the quality of life and usefulness of the chimpanzee to the biomedical community. Included in the program should be the means for providing animals, tissues/biological fluids, cell lines, expert advice, and research support to the biomedical research community. The provision of these resources will be governed by the NIH policies found in NOT-OD-15-097. This Notice informs the community that proposes to use chimpanzees in research about the Chimpanzee Research Use (CRU) reporting system. The CRU reporting system is the work flow and record keeping mechanism for the Chimpanzee Research Use Panel (CRUP, http://dpcpsi.nih.gov/council/crup) process for all funding mechanisms (extramural grants, contracts, intramural protocols, and 3rd party requests for use of chimpanzees). The CRUP is the panel that determines if a proposed research protocol adheres to the guidelines derived from the Institute of Medicine (IOM) report Chimpanzees in Biomedical and Behavioral Research: Assessing the Necessity (2011). Awardees should coordinate with the CMP when any research use of chimpanzees is being considered.

ORIP may need to periodically relocate chimpanzees (between current facilities) to enhance research activities or to accommodate retiring animals. Applicants should plan for excess capacity in terms of special facility features/programs for aging animals and estimate what group sizes that may be accommodated. The National Academy of Sciences Report on "Chimpanzees in Research: Strategies for their Ethical Care, Management, and Use" (1997) recommended a 5 year moratorium for chimpanzee breeding activities. This is consistent with the ORIP recommendation made in 1995, 2000, and 2007 for the CBRP colonies, by the Chimpanzee Management Plan (ChiMP) working group. A moratorium on breeding activities within the ORIP-supported CBRP colonies will remain in effect for the duration of the Project Period (September 1, 2016 to August 31, 2021), unless notified in writing by ORIP staff.

Each institution with CBRP colonies will categorically identify and manage its chimpanzee population relative to their accessibility or non-availability for further research, thus providing a systematic and defined program of lifetime or near-lifetime management of these valuable animals.

Animals will be categorized within the system by each institution in an effort to optimize efficiency and efficacy of the chimpanzee resource. Animals should be maintained at their home institution, whenever possible, to preserve the social group stability, high level of animal husbandry, and quality health care currently being provided. Animals in all categories will be housed and maintained at levels that meet or exceed all federal regulations and guidelines, including the USDA Animal Welfare Act, the Guide for the Care and Use of Laboratory Animals, and the recommendations of the Council of Councils Working Group on the Use of Chimpanzees in NIH-Supported Research.

The animals will be categorized according to research-use priority as Research Status, Available Status, or Restricted Access Status. Research Status animals are currently participating in biomedical studies or were previously placed into the research colony but are not currently in a study. These animals are available to allow institutions, with biomedical research protocols approved by NIH, the opportunity to utilize these animal resources for the purpose of advancing the nation’s public health. A complete health history and viral status may be made available to research institutions, upon request, along with information concerning current health status. There will be a maximum of 50 animals, across all facilities, in this category. Animals listed as Research Status can eventually be moved into Restricted Access Status, or can remain in Research status indefinitely. Once a chimpanzee leaves the Research Status (death or movement to another category) there will be no replacement of this animal in the research colony; i.e., the maximum allowable number of animals in the research colony will begin to decrease.

Available Status animals are considered suitable for use in biomedical studies. Because human health research may require access to animal models with specific non-life threatening health problems, any animal in Available Status (regardless of non-life threatening health status) can be entered into Research Status and into needed studies that are approved by NIH. Available Status animals can be maintained at this level indefinitely, 1) until moved into Research Status, 2) until the research colony is closed or, 3) until moved to Restricted Access Status.

Restricted Access Status animals are no longer deemed suitable for use in most research due to infectious status, advanced age, or presence of chronic severe illness. This status will be determined by the facility staff currently caring for the animal. Under extraordinary circumstances, Restricted Access Status animals (prior to retirement) could be accessed for limited research. This access will be contingent upon approval by the Chimpanzee Research Use Panel. As space becomes available, animals in Restricted Access Status may become eligible for retirement and be moved into the Federal Sanctuary system. This transfer will be contingent upon several factors that will be determined and evaluated by representatives of the sanctuary and the donating facility. The factors may include: general health status, specific infection history and current status, status of the animal within its social group, and behavioral characteristics. There may currently be no animals that fit the Restricted Access Status criteria since these animals are currently relocated to the federal sanctuary system as space becomes available. Once the colony of 50 Research Status animals is completed, all remaining chimpanzees will move into the Restricted Access Status and await movement into the Federal Sanctuary system.

Awardees are expected to establish a Program Management Committee, constituted with appropriate representation from the participating CBRP institutions, NIH program staff, and the scientific community. The Program Management Committee will be the vehicle for providing overall guidance for developing standards and policies and meeting the program requisites described in this announcement. These standards and policies should reflect support of the recommendations contained in the publications, "Chimpanzees in Research: Strategies for their Ethical Care, Management, and Use" (1997) and more recently the Institute of Medicine report, Chimpanzees in Biomedical and Behavioral Research: Assessing the Necessity (2011).

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.

Eligibility is limited to applications from organizations previously funded through the prior CBRP FOA, RFA-RR-10-008."

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

Applicant Organizations

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

• Dun and Bradstreet Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number. After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.
• System for Award Management (SAM) (formerly CCR) 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.
• eRA Commons - Applicants must have an active DUNS number and SAM registration in order to complete the eRA Commons registration. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
• Grants.gov Applicants must have an active DUNS number and SAM registration in order to complete the Grants.gov registration.

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

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

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.

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

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.  This means that the NIH will not accept:

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

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.

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, including Supplemental Grant Application Instructions 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.

Component Types Available in ASSIST	Research Strategy/Program Plan Page Limits
Overall	6
Core (Resource Management, Behavioral Management, Resource-Related Research)	12

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

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

The application should consist of the following components:

• Overall: required
• Resource Management: required
• Behavioral Management: required
• Resource-Related Research: required

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.

Complete entire form.

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

Follow standard instructions.

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.

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.

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.

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

Specific Aims: State the goals of the proposed CBRP center and summarize the care program and how the expected increase in geriatric related problems will impact the way in which the CBRP cares for the chimpanzee population.

Research Strategy: Briefly describe the purpose and history of the overall CBRP center. Describe how the CBRP, with institutional support and the Program Management Committee, will be prepared to serve the needs of the research community in the future as well as provide for the possibility of retirement-from-research of chimpanzees as they age and retirement space becomes available. The plan must discuss how decisions are or will be made to categorize a chimpanzee as available for research at some level or unavailable for research.

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:

• All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.
• The CBRP Sharing Plan for the entire application should be consolidated in this section.

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.

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.

Complete only the following fields:

• Applicant Information
• Type of Applicant (optional)
• Descriptive Title of Applicant’s Project
• Proposed Project Start/Ending Dates

Enter Human Embryonic Stem Cells in each relevant component.

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.

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.

• In the Project Director/Principal Investigator section of the form, use Project Role of Other with Category of Core Lead and provide a valid eRA Commons ID in the Credential field.
• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
• Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.

Budget 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.

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

Specific Aims: Describe concisely the plans and administrative structure of the proposed Resource Management Core.

Research Strategy: This should include detailed information about the Program Management Committee and its interactions with the CBRP, clinical management, husbandry management, training, veterinary pathology, and electronic record systems. The specific characteristics of each animal chosen for the research colony should be indicated in that animal's medical records. A plan should be included for assisting potential users (when their research proposal is approved by NIH) in verifying that the optimal number of chimpanzees proposed is statistically or scientifically justified and that these animals are present at the facility. If sufficient animals do not exist at a single facility to satisfy an approved research protocol, the plan should be to determine if collaborative efforts between facilities will satisfy the needs.

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

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

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

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 (Behavioral Management)

Complete only the following fields:

• Applicant Information
• Type of Applicant (optional)
• Descriptive Title of Applicant’s Project
• Proposed Project Start/Ending Dates

PHS 398 Cover Page Supplement (Behavioral Management)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Behavioral Management)

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) (Behavioral Management)

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 (Behavioral Management)

• In the Project Director/Principal Investigator section of the form, use Project Role of Other with Category of Core Lead and provide a valid eRA Commons ID in the Credential field.
• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
• Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.

Budget (Behavioral Management)

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 (Behavioral Management)

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

Specific Aims: Describe concisely the plans and administrative structure of the proposed Behavioral Management Core.

Research Strategy: This should include approaches to: 1) enhance the quality and utility of captive chimpanzees as biomedical and behavioral research resources; 2) refine the techniques used to manage captive chimpanzees to promote and maintain appropriate animal behavior; and 3) assess the effects of aging processes on the behavioral, cognitive, and physiological responses of the animals in the captive population. A description of any unique "team" expertise that results from the synergy of expertise of individual members of the behavioral team should be included.

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: 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 (Behavioral Management)

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 (Behavioral Management)

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

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-Related Research)

Complete only the following fields:

• Applicant Information
• Type of Applicant (optional)
• Descriptive Title of Applicant’s Project
• Proposed Project Start/Ending Dates

PHS 398 Cover Page Supplement (Resource-Related Research)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Resource-Related 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. 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-Related 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 (Resource-Related Research)

• In the Project Director/Principal Investigator section of the form, use Project Role of Other with Category of Core Lead and provide a valid eRA Commons ID in the Credential field.
• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
• Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.

Budget (Resource-Related 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 (Resource-Related Research)

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

Specific Aims: Describe concisely the plans and administrative structure of the proposed Resource-Related Research Core.

Research Strategy: This section should include research that is directed at improving individual animal's or colony health. Examples would include training approaches to improve care by minimizing stress in animals undergoing procedures, methods of monitoring stress in animals/colonies and methods of monitoring or treating viral or other microbial infections that may adversely affect animals. Any unique research capabilities should be clearly described. Proposed research must adhere to U.S. Fish and Wildlife Service final rule that designates all chimpanzees, both wild and captive, as endangered. If research outcomes will benefit other species, including human, please indicate.

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: 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-Related 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 (Resource-Related Research)

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

See Part I. Section III.1 for information regarding the requirements for obtaining a Dun and Bradstreet Universal Numbering System (DUNS) Number and for completing and maintaining an active System for Award Management (SAM) registration. 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.

This initiative is not subject to intergovernmental review.

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.

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: https://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. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Guidelines for Applicants Experiencing System Issues.

Important reminders:

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

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

See more tips for avoiding common errors.

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

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

Important Update: See NOT-OD-16-006 for updated review language for applications for due dates on or after January 25, 2016.

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 U42 application is a multicomponent application, with an Overall component that is the aggregate of the Resource Management Core, Behavioral Management Core, and the Resource-Related Research Core. During the review process, reviewers will first consider each of the review criteria listed for each of the Cores and provide an overall impact score for each Core. Once the Cores are completed, scoring will be assigned for the Overall application.

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

Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.

Does the CBRP address an important problem or a critical barrier to progress in the field? If the aims of the CBRP 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?

Does the application propose ways to position or restructure the resource to maintain effectiveness in light of changing policies regarding the research use of chimpanzees maintained at the CBRP?

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the CBRP? 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/PI and the Core Heads appropriately experienced to adapt, if needed, to managing an increasingly geriatric population of nonhuman primates?

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 there innovative features to improvement of the husbandry, behavioral (including enrichment activities), and medical care of this chimpanzee population?

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the CBRP? 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 CBRP involves human subjects and/or NIH-defined clinical research, are the plans to address 1) the protection of human subjects from research risks, and 2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of children, justified in terms of the scientific goals and research strategy proposed?

Does the application propose to effectively use the expertise of the Program Management Committee to adjust to the changing policies that will have an impact on how or if chimpanzees are used in research projects?

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?

There is an anticipated decrease in the use of chimpanzees in research. Will the institutional support remain adequate as the amount of research that uses the chimpanzee population decreases?

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

• Is there evidence that the CBRP is knowledgeable of NIH policies regarding chimpanzee-related research?
• Is it clear how NIH policy guidelines will be accommodated at the CBRP center?
• Are the criteria used for classification of chimpanzees based on research availability clearly defined?
• Is the Program Management Committee appropriately constituted to provide assistance in evaluating and managing an increasingly geriatric chimpanzee colony?
• Is there a plan for regular communication with the Program Management Committee?
• Is the overall plan for clinical care, husbandry, training, pathology, and record-keeping adequate?

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

• Are procedures to identify, evaluate, and treat problematic behaviors clearly documented?
• Are the facilities appropriate to adequately deal with animals with problematic social behavioral characteristics?
• Are the professional and care staff prepared to deal with anticipated behavioral issues or changing colony dynamics that may be associated with an increasing percentage of geriatric animals?
• Is the enrichment strategy adequate for this specific animal population?
• Is an adequate quality-of-life program in place?

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

• Are the research projects clearly and specifically designed to improve or monitor chimpanzee health or welfare?
• Are there any potential benefits to other species resulting from research outcomes? If so, are these benefits clearly stated?
• Are the facilities and staff adequate to conduct the proposed research?

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

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.

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

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.

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.

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.

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

Not Applicable

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

Not Applicable

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).

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

Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s), convened by 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:

• Will receive a written critique.

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

Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. 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:

• Scientific and technical merit of the proposed project as determined by scientific peer review.
• Availability of funds.
• Relevance of the proposed project to program priorities.

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.

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

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

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

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

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

The following special terms of award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (DHHS) grant administration regulations at 45 CFR Parts 74 and 92 (Part 92 is applicable when State and local Governments are eligible to apply), and other HHS, PHS, and NIH grant administration policies.

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

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

• Leading the project as a whole, and agree to accept close assistance, advice, and coordination, and to collaborate with the ORIP Project Scientist and other awardees.
• Planning, direction, and execution of the proposed program; determining experimental approaches; designing protocols; setting milestones and conducting experiments/evaluations.
• Participating in group activities, including the Program Management Committee, to share design and analysis techniques and promote comparability across centers wherever possible.
• Ensuring active participation of partner sites and collaborators in group activities, if applicable.
• Implementing Program Management Committee recommendations for designing, implementing, evaluating, and disseminating disease modeling projects and best practices for animal care and maintenance, as appropriate and feasible.
• Adhering to the general NIH policies regarding sharing of resources and data release, as well as the specific data and resource-sharing policies proposed in the application, as appropriate and as modified by any negotiation prior to award.
• Submitting periodic progress reports in a standard format, as agreed upon by the Program Management Committee.
• Attending and participating in Program Management Committee meetings as appropriate.

Awardees will retain custody of and have primary rights to the data and software developed under these awards, subject to Government rights of access consistent with current DHHS, PHS, and NIH policies.

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

The Project Scientist is a scientist of the ORIP/DPCPSI staff who will have substantial scientific and programmatic involvement during the conduct of this activity through technical assistance, advice, and coordination. However, the role of the Project Scientist will be to facilitate and not to direct the activities. It is anticipated that decisions in all activities will be reached by consensus of the CBRP program staff which will include input by ORIP program staff. The Project Scientist will participate as a member of the Program Management Committee and will have one vote. The Project Scientist will have the following substantial involvement:

• Participating with the other Program Management Committee members in the group process of setting research or retirement priorities, deciding optimal research approaches and protocol designs, and contributing to the adjustment of research protocols or approaches as warranted. The Project Scientist will assist and facilitate the group process and not direct it.
• Serving as a liaison, helping to coordinate activities among and for the awardees, including acting as a liaison to the NIH and other federal agencies, and as an information resource for the awardees about other resource relevant activities. The Project Scientist will also coordinate the efforts of the program with other groups involved in similar activities.
• Attending all Program Management Committee meetings as a voting member and assisting in developing operating guidelines, quality control procedures, and consistent policies for dealing with situations that require coordinated action.
• Reporting periodically on the progress of the program to the ORIP and DCM Directors.
• Assisting awardees in the development, if needed, of policies for dealing with situations that require coordinated action.
• Providing advice in the management and technical performance of the award.
• Assisting in promoting the availability of the data and related resources developed in the course of this program to the scientific and other relevant communities at large.
• Participating in data analyses, interpretations, and, where warranted, co-authorship of the publication of results of studies conducted through the program.

Additionally, an NIH ORIP/DPCPSI Program Official will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice. The Program Official may withhold or reduce support from any awardee that fails to achieve its goals or comply with the Terms and Conditions of Award. The assigned Program Official may also serve as an NIH Project Scientist.

Other ORIP/DPCPSI staff may assist the awardees as designated by the Program Official.

Areas of Joint Responsibility include:

As experts in this scientific field, the awardees will maintain the dominant role and prime responsibility for the planned activities, although specific tasks and activities in carrying out the activity will be shared among the awardee and the ORIP Project Scientist. The ORIP Project Scientist is better positioned to monitor the success of the effort than any individual awardee. A close interaction among the participating investigators will be required, as well as significant involvement from the NIH, to categorize and assure research availability of the chimpanzee population as well as monitoring the population for animals that may need to move into retirement. Substantial NIH staff involvement is required to assure that this population of chimpanzees continues to serve as an important biomedical research model as needed and is made available to multiple user communities. The NIH staff will play an important role in deciding when an animal will be eligible for approved protocols and when an animal may need to be phased out of eligibility for research and become eligible for retirement from research. The fact that this particular animal model is very expensive to maintain and its use is a high profile and sensitive issue to some non-research communities warrants closer oversight and guidance from the NIH than other similar resources. It is anticipated that one ORIP Project Scientist and a Program Management Committee of five or more experts with diverse but relevant backgrounds will be necessary to carry out the program.

The awardees and the Project Scientist will meet with the Program Management Committee at least one time per year in person and monthly (or as needed) on conference calls to share information on research and retirement assignments for the chimpanzee population. To address particular issues, the Program Management Committee may establish working groups as needed, which will include representatives from the CBRP program and the NIH and possibly other experts.

Dispute Resolution:

Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and the NIH may be brought to Dispute Resolution. A Dispute Resolution Panel will be convened. It will have three members: a designee of the Program Management Committee chosen without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual awardee. This special dispute resolution procedure in no way affects the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulations 42 CFR Part 50, Subpart D and HHS regulations 45 CFR Part 16.

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

A final 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.

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

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

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

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

Harold L. Watson, Ph.D.
Office of Research Infrastructure Programs (ORIP)
Telephone: 301-435-0884
Email: watsonh@mail.nih.gov

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

Jenelle Wiggins
Office of Research Infrastructure Programs (ORIP)
National Center for Advancing Translational Sciences (NCATS)
Telephone: 301-435-0843
Email: Jenelle.Wiggins@nih.gov

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

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