Native American Research Centers for Health (NARCH) Planning Grants (R34) is sponsored by National Institutes of Health. Supports the planning and development of research infrastructure and community-based health interventions within American Indian and Alaska Native communities.

PAR-25-441: Native American Research Centers for Health (NARCH) Planning Grants (R34 - Clinical Trial Not Allowed) Department of Health and Human Services Part 1.

Overview Information Participating Organization(s) National Institutes of Health ( NIH ) Components of Participating Organizations National Institute of General Medical Sciences ( NIGMS ) Funding Opportunity Title Native American Research Centers for Health (NARCH) Planning Grants (R34 - Clinical Trial Not Allowed) April 4, 2024 - Overview of Grant Application and Review Changes for Due Dates on or after January 25, 2025.

See Notice NOT-OD-24-084 . August 31, 2022 - Implementation Changes for Genomic Data Sharing Plans Included with Applications Due on or after January 25, 2023. See Notice NOT-OD-22-198 .

August 5, 2022 - Implementation Details for the NIH Data Management and Sharing Policy. See Notice NOT-OD-22-189 . Funding Opportunity Number (FON) Companion Funding Opportunity Eligible applicant organizations may submit only one application per due date; see Section III.

3 Additional Information on Eligibility.

Assistance Listing Number(s) Funding Opportunity Purpose The purpose of the Native American Research Centers for Health (NARCH) Planning Grants program is to support federally-recognized American Indian/Alaska Native Tribes, Tribal colleges and universities, Tribal health programs, or Tribal organizations (collectively, federally-recognized Tribes and Tribal entities) to plan and conduct preparatory work for developing competitive NARCH applications.

Funding Opportunity Goal(s) To ensure the vitality and continued productivity of the research enterprise, NIGMS provides leadership in supporting the training of future scientists and developing research capacity throughout the country. Open Date (Earliest Submission Date) The following table includes NIH standard due dates marked with an asterisk.

Renewal / Resubmission / Revision (as allowed) AIDS - New/Renewal/Resubmission/Revision, as allowed All applications are due by 5:00 PM local time of applicant organization. Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.

Required Application Instructions It is critical that applicants follow the instructions in the Research (R) Instructions in the How to Apply - Application Guide , except where instructed to do otherwise (in this NOFO or in a Notice from NIH Guide for Grants and Contracts ). Conformance to all requirements (both in the Application Guide and the NOFO) 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.

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

Use the NIH ASSIST system to prepare, submit and track your application online. Use an institutional system-to-system (S2S) solution to prepare and submit your application to Grants. gov and eRA Commons to track your application.

Check with your institutional officials regarding availability. Workspace to prepare and submit your application and eRA Commons to track your application. Part 1.

Overview Information Part 2. Full Text of Announcement Section I. Notice of Funding Opportunity Description Section II.

Award Information Section III. Eligibility Information Section IV. Application and Submission Information Section V.

Application Review Information Section VI. Award Administration Information Section VII. Agency Contacts Section VIII.

Other Information Part 2. Full Text of Announcement Section I. Notice of Funding Opportunity Description The NARCH program was launched in 2000 to promote Tribal health research prioritized and led by eligible federally-recognized Tribal entities, with the goal of ultimately improving Tribal health.

The program is one of the federal government’s primary funding sources that support Tribal health research. NARCH supports health related research, research capacity building, research career development, and infrastructure enhancement projects led by eligible federally-recognized Tribes or Tribal entities.

To enhance the program’s efficacy in meeting its goals, NIGMS completed a comprehensive NARCH program evaluation culminating in a formal Tribal Consultation in 2021.

This Notice of Funding Opportunity (NOFO) addresses a specific recommendation received through the Consultation: to increase participation of eligible federally-recognized Tribes or Tribal entities in the NARCH S06 program (referred to as NARCH applications or awards in this NOFO) by providing support for potential applicants to conduct planning and preparatory work needed to develop competitive NARCH applications.

The NARCH Planning Grant awards are aimed at expanding the reach of the NARCH program to eligible Tribal entities. A NARCH Planning Grant supports Tribal entities who do not currently have a NARCH award to conduct preparatory work for the development of a competitive NARCH application. An applicant organization may partner with other eligible Tribal entities as well as additional non-Tribal organizations.

When in partnership with non-Tribal organizations, 75% or more of requested funds must be allocated to the eligible federally-recognized Tribes or Tribal entities. See Section III. Eligibility Information for details.

The NARCH Planning Grant application should include: A plan to formulate overall goals for a future NARCH application, including, but not limited to: Assessment of administrative capacity needs to support a future NARCH award, and Determining the types of allowable components (Research Project, Pilot Project Program, Career Enhancement Projects, or Research Infrastructure Enhancement Projects) that will be appropriate for a future NARCH application.

Activities to lay the groundwork for potential components of the future NARCH application and strategies to address needs, including but not limited to: defining research questions; assessing research workforce and infrastructure needs for required and optional components. Efforts to identify collaborators, consultants, and advisors to strengthen the application, if necessary.

All activities to be supported in the NARCH Planning Grant must contribute coherently and synergistically to the goal of developing a competitive NARCH application. The recipient organization(s) is expected to submit a NARCH S06 application within one year of the end date of the NARCH Planning Grant award. A NARCH Planning Grant is not renewable.

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

Award Information Grant: A financial assistance mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity. Application Types Allowed The OER Glossary and the How to Apply Application Guide provide details on these application types. Only those application types listed here are allowed for this NOFO.

Not Allowed: Only accepting applications that do not propose clinical trials. Need help determining whether you are doing a clinical trial? Funds Available and Anticipated Number of Awards The number of awards is contingent upon NIH appropriations and the number of meritorious applications.

Application budgets must not exceed $225,000 in annual direct costs, excluding consortium facilities and administrative (F&A) costs. For applications that include partner organizations that are not eligible Tribal entities, the requested direct costs of subcontracts to these organizations, combined, must be 25% or less of the application’s overall direct cost budget, excluding consortium F&A. The project period is limited to 2 years.

NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from this NOFO. Section III. Eligibility Information The applicant organization must meet one of the following criteria: A federally recognized AI/AN Tribe, as defined under 25 U.S.C.

1603(14); or A Tribal college or university, a Tribal health program, or a Tribal organization as defined under 25 U.S.C. 1603 (24), (25), and (26), respectively; or A consortium of two or more of those Tribal entities.

Additionally, eligibility is limited to federally-recognized Tribes or Tribal entities that are not currently supported by a NARCH S06 award and, at the time of submission, are not supported by an active NARCH Planning Grant award. Active awards include those in no-cost extension.

Foreign Organizations/ International Collaborations NIH will no longer issue awards (new, renewal, or non-competing continuation) to domestic or foreign entities that involve foreign subawards/subcontracts. All NIH-funded research involving foreign subawards/subcontracts must be submitted in response to a NOFO that is specifically designated for funded international collaborations. This new requirement was effective, May 1, 2025.

Applications involving foreign subawards/subcontracts submitted in response to this NOFO will be deemed noncompliant and will not be considered for funding.

This policy applies to all monetary international collaborations resulting in foreign subawards/subcontracts, however, it does not preclude unfunded international collaborations or foreign components , funding for foreign consultants, or procurement of unique equipment or supplies from foreign vendors.

Specifically, an application may include foreign components only if one or more federally-recognized Tribes with ancestral catchment areas crossing the U. S. border will participate in the proposed NARCH planning grant application.

Non-domestic (non-U.S.) Entities (Foreign Organizations) 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.

Applicant organizations must complete and maintain the following registrations as described in the How to Apply- Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible.

Failure to complete registrations in advance of a due date is not a valid reason for a late submission, please reference the NIH Grants Policy Statement Section 2. 3. 9.

2 Electronically Submitted Applications for additional information. System for Award Management (SAM) – Applicants must complete and maintain an active registration, which requires renewal at least annually . The renewal process may require as much time as the initial registration.

SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code. NATO Commercial and Government Entity (NCAGE) Code – Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM. Unique Entity Identifier (UEI) - A UEI is issued as part of the SAM.

gov registration process. The same UEI must be used for all registrations, as well as on the grant application. eRA Commons - Once the unique organization identifier is established, organizations can register with eRA Commons in tandem with completing their Grants.

gov registrations; all registrations must be in place by time of submission. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application. Grants.

gov – Applicants must have an active SAM registration in order to complete the Grants. gov registration. Program Directors/Principal Investigators (PD(s)/PI(s)) All PD(s)/PI(s) must have an eRA Commons account.

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

Eligible Individuals (Program Director/Principal Investigator) Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with their organization to develop an application for support.

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

The PD(s)/PI(s) of a NARCH Planning Grant assumes overall scientific and administrative leadership of the project, including oversight responsibilities of research activities involving human subjects. The PD/PI or the contact PD/PI of a multi-PI (MPI) application must have a primary appointment with the applicant organization.

Non-contact PDs/PIs' primary appointments may be with the applicant organization or a partner organization that is an eligible Tribal entity. PDs/PIs employed at eligible Tribal entities through special employment arrangements, such as interorganizational personnel agreements among federally-recognized Tribes, are allowable. This NOFO does not require cost sharing as defined in the NIH Grants Policy Statement Section 1.

2 Definition of Terms . 3. Additional Information on Eligibility Applicant organizations may submit more than one application, provided that each application is scientifically distinct.

The NIH will not accept duplicate or highly overlapping applications under review at the same time, per NIH Grants Policy Statement Section 2. 3. 7.

4 Submission of Resubmission Application . This means that the NIH will not accept: A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application. A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.

An application that has substantial overlap with another application pending appeal of initial peer review (see NIH Grants Policy Statement 2. 3. 9.

4 Similar, Essentially Identical, or Identical Applications ). Each eligible Tribal entity may submit only one application per due date. Section IV.

Application and Submission Information 1. Requesting an Application Package The application forms package specific to this opportunity must be accessed through ASSIST, Grants. gov Workspace or an institutional system-to-system solution.

Links to apply using ASSIST or Grants. gov Workspace are available in Part 1 of this NOFO. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

2. Content and Form of Application Submission It is critical that applicants follow the instructions in the Research (R) Instructions in the How to Apply - Application Guide except where instructed in this notice of funding opportunity to do otherwise. 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. All page limitations described in the How to Apply- Application Guide and the Table of Page Limits must be followed. Instructions for Application Submission The following section supplements the instructions found in the How to Apply- Application Guide and should be used for preparing an application to this NOFO.

All instructions in the How to Apply - Application Guide must be followed. SF424(R&R) Project/Performance Site Locations All instructions in the How to Apply- Application Guide must be followed. SF424(R&R) Other Project Information All instructions in the How to Apply- Application Guide must be followed.

Other Attachments: The application must include the following attachment from the applicant organization: Letter of Vision and Commitment: A letter from a senior organizational official such as a Tribal council leader or president of a Tribal college/university that describes the organization’s vision and commitment to develop and sustain a workforce and infrastructure that would enable health research.

The file should be named “Letter of Vision and Commitment”. Applications missing this attachment will not be accepted for review. SF424(R&R) Senior/Key Person Profile All instructions in the How to Apply- Application Guide must be followed.

All instructions in the How to Apply- Application Guide must be followed. A modular budget is required. All instructions in the How to Apply-Application Guide must be followed.

For applications that include partner organizations that are not eligible Tribal entities, the requested direct costs of subcontracts to these organizations combined must be 25% or less of the application’s overall direct cost budget, excluding consortium F&A. PHS 398 Cover Page Supplement All instructions in the How to Apply- Application Guide must be followed.

All instructions in the How to Apply- Application Guide must be followed, with the following additional instructions: Research Strategy: The Research Strategy should articulate the applicant organization’s needs for a NARCH Planning Grant award and how it will carry out the activities proposed that will aid in the development of a subsequent NARCH application.

The Research Strategy should address the following elements: Plans to ensure the work proposed in the eventual NARCH application will be culturally appropriate and reflect community needs, interests and values. Any community engagement activities that will be employed in the planning process should be described.

Any proposed activities that are new/novel to the applicant organization and/or its communities should be briefly described under "Innovation." Plans for assessing the needs for new or strengthened administrative capabilities with descriptions of the areas to be assessed and approaches to be taken.

Strategies to identify components, among Research Projects, Pilot Project Program, Career Enhancement Projects, and Research Infrastructure Enhancement Projects, to be included in the future NARCH application.

Plans to assess the workforce and infrastructure needs of components identified for the future NARCH application, including the required Administrative Core, and the development of strategies to build capacities to address these needs. If partner organizations are proposed, a description of their roles in and contributions to the planning activities that will contribute to the success of the proposed work and future NARCH application.

If external collaborators, consultants, and advisors are anticipated for the eventual NARCH application, a plan for identifying individuals with expertise should be described, along with a plan to engage them in the development of the future NARCH application. Plans for consultants to help with activities related to the planning process, such as administrative capacity building needs assessments.

If Research Projects or a Pilot Project Program will be a likely component(s) in the future NARCH application, a description of activities to define the research question(s) and plan how to administer the projects to answer the questions. Plans for developing a data management and sharing plan, if applicable, for the eventual NARCH application that reflects appropriate cultural and data sovereignty considerations.

If it is anticipated that the eventual NARCH application will involve Human Subjects Research, describe plans for identifying or developing needed infrastructure such as Institutional Review Boards. The application should include a timeline for all the proposed major activities.

Letters of Support: Tribal Resolutions or Tribal Letters of Support for the application should be included in this section and should include the grant application title. Resource Sharing Plan : Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the How to Apply- Application Guide.

All instructions in the How to Apply-Application Guide must be followed, with the following additional instructions: A Data Management and Sharing Plan is not applicable for this NOFO. Appendix: Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the How to Apply- Application Guide.

No publications or other material, with the exception of blank questionnaires or blank surveys, may be included in the Appendix.

PHS Human Subjects and Clinical Trials Information When involving human subjects research, clinical research, and/or NIH-defined clinical trials (and when applicable, clinical trials research experience) follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the How to Apply- Application Guide, with the following additional instructions: If you answered “Yes” to the question “Are Human Subjects Involved?

” on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or Delayed Onset Study record. Study Record: PHS Human Subjects and Clinical Trials Information All instructions in the How to Apply- Application Guide must be followed.

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

3. Unique Entity Identifier and System for Award Management (SAM) See Part 2. Section III.

1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants. gov 4. Submission Dates and Times Part I.

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

Organizations must submit applications to Grants. gov (the online portal to find and apply for grants across all Federal agencies). Applicants must then complete the submission process by tracking the status of the application in the eRA Commons , NIH’s electronic system for grants administration.

NIH and Grants. gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.

gov on or before the application due date and time. If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Grants Policy Statement Section 2.

3. 9. 2 Electronically Submitted Applications .

Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission. Information on the submission process and a definition of on-time submission are provided in the How to Apply-Application Guide. 5.

Intergovernmental Review (E. O. 12372) 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 Section 7. 9.

1 Selected Items of Cost. 7. Other Submission Requirements and Information Applications must be submitted electronically following the instructions described in the How to Apply Application Guide.

Paper applications will not be accepted. Applicants must complete all required registrations before the application due date. Section III.

Eligibility Information contains information about registration. For assistance with your electronic application or for more information on the electronic submission process, visit How to Apply – Application Guide . If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Dealing with System Issues guidance.

For assistance with application submission, contact the Application Submission Contacts in Section VII. All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile form . Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH.

See Section III of this NOFO for information on registration requirements. The applicant organization must ensure that the unique entity identifier provided on the application is the same identifier used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in the How to Apply Application Guide.

See more tips for avoiding common errors. Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review and NIGMS. Applications that are incomplete or non-compliant will not be reviewed.

Recipients or subrecipients must submit any information related to violations of federal criminal law involving fraud, bribery, or gratuity violations potentially affecting the federal award. See Mandatory Disclosures, 2 CFR 200. 113 and NIH Grants Policy Statement Section 4.

1. 35 . Send written disclosures to the NIH Chief Grants Management Officer listed on the Notice of Award for the IC that funded the award and to the HHS Office of Inspector Grant Self Disclosure Program at [email protected] .

Post Submission Materials Applicants are required to follow the instructions for post-submission materials, as described in the policy Section V. Application Review Information Only the review criteria described below will be considered in the review process. Applications submitted to the NIH in support of the NIH mission are evaluated for scientific and technical merit through the NIH peer review system.

For this particular NOFO, note the following: The purpose of the Native American Research Centers for Health (NARCH) Planning Grants program is to support Federally-recognized Tribes, Tribal colleges and universities, Tribal health programs, or Tribal organizations (collectively, eligible Tribal entities ) to plan and conduct preparatory work for developing competitive NARCH applications.

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following scored review criteria and additional review criteria (as applicable for the project proposed). An application does not need to be strong in all categories to be judged likely to have a major scientific impact.

Reviewers will consider Factors 1, 2 and 3 in the determination of scientific merit, and in providing an overall impact score. In addition, Factors 1 and 2 will each receive a separate factor score. Factor 1.

Importance of the Research (Significance and Innovation) Evaluate how implementation of the proposed planning activities contribute to the submission of a successful NARCH application. Evaluate the rationale for NARCH planning grant. Evaluate the extent to which innovation influences the importance of undertaking the proposed research.

Note that while technical or conceptual innovation can influence the importance of the proposed research, a project that is not applying novel concepts or approaches may be of critical importance for the field. Evaluate whether the proposed work applies novel concepts, methods or technologies or uses existing concepts, methods, technologies in novel ways, to enhance the overall impact of the project. Factor 2.

Rigor and Feasibility (Approach) Evaluate the plans to determine the direction of a future NARCH application and formulate its goals. Evaluate whether the the proposed activities help to define culturally appropriate and impactful research questions or capacity building for a future NARCH award.

Evaluate the extent to which the plans to assess the needs of administrative capacity, the workforce and infrastructure, including approaches to be taken, contribute to a successful eventual NARCH application.

If partner organizations, collaborators, or consultants might be recruited for the eventual NARCH application, assess how suitable the plans are to identify the expertise needed and to develop strategies to recruit the external collaborators, consultants, and/or advisors For applications involving human subjects or vertebrate animals, also evaluate: the rigor of the intervention or study manipulation (if applicable to the study design).

whether outcome variables are justified. whether the results will be generalizable or, in the case of a rare disease/special group, relevant to the particular subgroup. whether the study population appropriately models the target population.

For applications involving human subjects, including clinical trials, assess the adequacy of inclusion plans as appropriate for the scientific goals of the research. Considerations of appropriateness may include disease/condition/behavior incidence, prevalence, or population burden, population representation, and/or current state of the science.

Evaluate whether the proposed approach is sound and achievable, including plans to address problems or new challenges that emerge during the planning phase.

Evaluate the feasibility of the proposed timeline for all major activities For applications involving human subjects, including clinical trials, evaluate the adequacy and feasibility of the plan to recruit and retain a study population that appropriately models the target population. Additionally, evaluate the likelihood of successfully achieving the proposed enrollment based on age, race, ethnicity, and sex.

For clinical trial applications, evaluate whether the study timeline and milestones are feasible. Factor 3. Expertise and Resources (Investigator(s) and Environment) Evaluate whether the investigator(s) have demonstrated background, training, and expertise, as appropriate for their career stage, to conduct the proposed work.

For Multiple Principal Investigator (MPI) applications, assess the quality of the leadership plan to facilitate coordination and collaboration. Evaluate whether the institutional resources are appropriate to ensure the successful execution of the proposed work.

Additional Review Criteria As applicable for the project proposed, reviewers will consider the following additional items while determining scientific and technical merit, but will not give criterion scores for these items, and should consider them in providing an overall impact score.

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

For research that involves human subjects and meets the criteria for one or more of the categories of research that are exempt under 45 CFR Part 46, 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 research includes Vertebrate Animals, evaluate the involvement of live vertebrate animals according to the following criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals.

For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animals Section . When the proposed research includes Biohazards, evaluate whether specific materials or procedures that will be used are significantly hazardous to research personnel and/or the environment, and whether adequate protection is proposed.

As applicable, evaluate the full application as now presented. As applicable, evaluate the progress made in the last funding period. As applicable, evaluate the appropriateness of the proposed expansion of the scope of the project.

Additional Review Considerations As applicable for the proposed application, 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.

Authentication of Key Biological and/or Chemical Resources For projects involving key biological and/or chemical resources, evaluate the brief plans proposed for identifying and ensuring the validity of those resources. Budget and