FDA OMHHE Racial & Ethnic Minority Acceleration Consortium for Health Equity (REACH) (RFA-FD-23-010)

FDA OMHHE Racial & Ethnic Minority Acceleration Consortium for Health Equity (REACH) (RFA-FD-23-010) is sponsored by U.S. Department of Health and Human Services, Food and Drug Administration (FDA) Office of Minority Health and Health Equity (OMHHE). This cooperative agreement program aims to form a consortium of multiple funded organizations working in parallel to strengthen and accelerate work that advances minority health and health equity.

Expired RFA-FD-23-010: FDA OMHHE Health Equity Innovation Award: Racial & Ethnic Minority Acceleration Consortium for Health Equity (REACH) (U01) Clinical Trials Optional This notice has expired. Check the NIH Guide for active opportunities and notices. Department of Health and Human Services Part 1.

Overview Information Participating Organization(s) U.S. Food and Drug Administration ( FDA ) NOTE: The policies, guidelines, terms, and conditions stated in this announcement may differ from those used by the NIH. Where this Funding Opportunity Announcement (FOA) provides specific written guidance that may differ from the general guidance provided in the grant application form, please follow the instructions given in this FOA.

The FDA does not follow the NIH Page Limitation Guidelines or the NIH Review Criteria. Applicants are encouraged to consult with FDA Agency Contacts for additional information regarding page limits and the FDA Objective Review Process.

of Participating Organizations Office of the Commissioner ( OC ) Funding Opportunity Title FDA OMHHE Health Equity Innovation Award: Racial & Ethnic Minority Acceleration Consortium for Health Equity (REACH) (U01) Research Project Cooperative Agreements Funding Opportunity Announcement (FOA) Number Companion Funding Opportunity Additional Information on Eligibility .

Assistance Listing Number(s) Funding Opportunity Purpose This Funding Opportunity Announcement (FOA) is for FDA Office of Minority Health and Health Equity's (OMHHE) Health Equity Innovation Award: Racial & Ethnic Minority Acceleration Consortium for Health Equity (REACH).

The consortium will consist of multiple cooperative agreement (U01) recipients that will strengthen and advance minority health and health equity focused research, outreach, and communications as well as support training and mentoring of diverse students, fellows, and/or researchers. Open Date (Earliest Submission Date) Letter of Intent Due Date(s) April 6, 2023, by 11:59 PM Eastern Time.

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. Applicants should be aware that on-time submission means that an application is submitted error free (of both Grants. gov and eRA Commons errors) by 11:59 PM Eastern Time on the application due date.

applications will not be accepted for this FOA. AIDS Application Due Date(s) It is critical that applicants follow the Research (R) Instructions (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 ). 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 I.

Funding Opportunity Description Section II. Award Information Section III. Eligibility Information Section IV.

Application and Submission Section V. Application Review Information Section VI. Award Administration Information Section VII.

Agency Contacts Section VIII. Other Information Part 2. Full Text of Announcement I.

Funding Opportunity Description This Funding Opportunity Announcement (FOA) is for FDA Office of Minority Health and Health Equity's (OMHHE) Health Equity Innovation Award: Racial & Ethnic Minority Acceleration Consortium for Health Equity (REACH), which solicits applications from diverse institutions, to participate in a consortium.

The consortium will consist of multiple cooperative agreement (U01) recipients that will strengthen and advance minority health and health equity focused research, outreach, and communications as well as support training and mentoring of diverse students, fellows, and/or researchers. The following studies are encouraged under this FOA.

Proposals that support the following three health equity pillars: (1) Equity of Voices, (2) Equitable Data Efforts, and (3) Equity in Clinical Trials.

REACH supports research projects that enhance EQUITY of voices by: amplifying FDA’s communication with groups and organizations to ensure diverse communities are informed about FDA’s efforts; increasing understanding of racial and ethnic minority patient perspectives, preferences, and unmet needs; and advancing FDA engagement with racial and ethnic minority Example areas of interest include, but are not limited to: Developing and sustaining relationships with groups and organizations that serve racial and ethnic minority populations to enhance education about health disparities, health equity, including equity in clinical Studies that advance understanding of how to mitigate spread of misinformation and disinformation about science and medicine for racial and ethnic minority populations.

Leveraging novel and big data sources to understand diverse patient perspectives, preferences, and unmet needs. Supporting expansion of culturally and linguistically appropriate Support training and mentoring of diverse students, fellows, REACH supports research projects that enhance EQUITABLE data efforts by increasing data available on diverse groups including, but not limited to, ethnicity, race, age, disability, and geography.

Examples areas of interest include, but are not limited to: Increasing availability of disaggregated demographic data , including, but not limited to, ethnicity, race, age, disability, and geography. Increasing evidence to support evaluation of outcomes of FDA-regulated products by demographic data, including, but not limited to, ethnicity, race, age, disability, and geography.

Leveraging Real World Data (RWD), novel data sources and artificial intelligence/machine learning options that contribute to the continued evaluation of the safety and efficacy of FDA-approved products.

Leveraging data to understand incidence and prevalence of diseases, diagnosing patterns, disease progression, genotype (if available), race, ethnicity, insurance status, socio-economic status, and geographic Increasing training and mentoring for diverse students, fellows, investigators, and researchers.

EQUITY in clinical trials REACH supports research projects that advance EQUITY in clinical trials by supporting efforts to increase the participation of underrepresented racial and ethnic minority populations in clinical trials. Examples of EQUITY in clinical trials research areas of interest include, but are not limited to: Support innovative models of clinical trial enrollment for racial and ethnic minority populations.

Increasing training and mentoring for diverse clinical trial/study investigators, fellows and other researchers. Administrative and Governance Structure: REACH will include multiple U01 recipients. FDA OMHHE will provide oversight for REACH collaborative activities as well as work in partnership with the funded REACH organizations.

REACH Organizational Structure: Each REACH institution must include Research Projects (minimum 1,) and an Administrative Core. The Administrative Core will support the coordination of efforts across their REACH organization(s) research projects and activities with FDA OMHHE. The Administrative Core will also work to advance integration into the broader REACH network to promote synergistic research efforts.

This Administrative Core will be responsible for coordination, management, decision-making, and periodic evaluations within their individual REACH organization, involvement of institutional and programmatic resources, and shared publications.

The Administrative Core is expected to create and implement administrative and leadership mechanisms that will foster effective interactions with REACH investigators and FDA OMHHE, as well as support synergistic research efforts within the broader REACH network. Research Projects will be projects that are well integrated to support advancing health equity for racial and ethnic minority populations.

Research projects should be organized around advancing communications, research, trainings and collaborations on diseases and conditions that impact racial and ethnic minority populations. 1. Initial REACH Award: FDA OMHHE provides funding at initiation of the cooperative agreement award for each REACH organization to establish its Administrative Core base and organization structure, and pilot 1.

Funding for year 1 will support administrative base and pilot projects/trainings, as well as post-award research projects/trainings. 2. Funding for year 2 will support the Administrative Core as well as additional post-award projects/trainings.

Post-Award Research Projects/Trainings: As needs arise, post-award research projects will be initiated in collaboration with the REACH organization. See Section VIII. Other Information for award authorities and regulations.

Section II. Award Information Cooperative Agreement: A support mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, FDA scientific or program staff will assist, guide, coordinate, or participate in project activities.

See Section VI. 2 for additional information about the substantial involvement for Application Types Allowed and the SF424 (R&R) Application Guide provide details on these application types. Only those application types listed here are allowed for this FOA.

Optional: Accepting applications that either propose or do not propose clinical trial(s) help determining whether you are doing a clinical trial? Funds Available and Anticipated Number of Awards The number of awards is contingent upon FDA appropriations and the submission of a sufficient number of meritorious applications.

Award(s) will provide one (1) year of support and include future recommended support for one (1) additional year contingent upon annual appropriations, availability of funding and satisfactory recipient performance. FDA OMHHE intends to fund up to $3,000,000 in FY 2023 in support of this cooperative agreement program.

It is anticipated that up to (6) awards will be made, not to exceed $500,000 in total costs (direct plus indirect) per award. Awards pursuant to this FOA may be funded incrementally throughout the budget period to: 1) support projects proposed in the application but not funded at the time of Initial Award; 2) continue support for successful projects funded at the time of Initial Award; or 3) support new projects/trainings.

Application budgets need to reflect the actual needs of the proposed project. and should not exceed the following in total costs (direct Base funding for year 1 will support Administrative Core and pilot projects/trainings. Base funding for year 2 will support Administrative Core The scope of the proposed project should determine the project period.

The maximum project period is two (2) years. Grants Policy Statement will apply to the applications submitted and awards made from this FOA.

Higher Education Institutions Public/State Controlled Institutions of Higher Education Private Institutions of Higher Education The following types of Higher Education Institutions are always encouraged to apply for FDA support as Public or Private Institutions of Higher Education: Hispanic-serving Institutions (HSIs) Historically Black Colleges and Universities (HBCUs) Tribally Controlled Colleges and Universities (TCCUs) Alaska Native and Native Hawaiian Serving Institutions Asian American Native American Pacific Islander Serving Nonprofits Other Than Institutions of Higher Education Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Nonprofits without 501(c)(3) IRS Status (Other than Institutions For-Profit Organizations (Other than Small Businesses) Indian/Native American Tribal Governments (Federally Recognized) Indian/Native American Tribal Governments (Other than Federally Recognized) U.S. Territory or Possession Independent School Districts Public Housing Authorities/Indian Housing Authorities Native American Tribal Organizations (other than Federally recognized tribal governments) Faith-based or Community-based Organizations Non-domestic (non-U.S.) Entities (Foreign Institutions) are Non-domestic (non-U.S.) components of U.S. Organizations are not eligible Foreign components, as defined in the HHS Grants Policy Statement , are not allowed.

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.

Failure to complete registrations in advance of a due date is not a valid reason for a late submission. Award Management (SAM) Applicants must complete and maintain an active 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. 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. Commons - Once the unique organization identifier is established, organizations can register with eRA Commons in tandem with completing their full SAM and 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. Applicants must have an active SAM registration in order to complete the 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 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 diverse backgrounds, including underrepresented racial and ethnic groups, individuals with disabilities, and women are always encouraged to apply for FDA 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 This FOA does not require cost sharing as defined in the HHS 3. Additional Information on Eligibility Applicant organizations may submit more than one application, provided that each application is scientifically distinct.

The FDA will not accept duplicate or highly overlapping applications under review at the same time. This means that the FDA will A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application. IV.

Application and Submission Information 1. Requesting an Application 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 FOA. 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 Research (R) Instructions (R&R) Application Guide , except where instructed in this funding opportunity announcement 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 Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows FDA staff to estimate the potential review workload and By the date listed in Part 1.

Overview prospective applicants are asked to submit a letter of intent that includes the Descriptive title of proposed activity Name(s), email address(es), and telephone number(s) of the Names of other key personnel Participating institution(s) Number and title of this funding opportunity The letter of intent should be sent to: Food and Drug Administration Office of Acquisitions and Grants Services All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed, with the following exceptions or additional requirements: For this specific FOA, the Research Strategy section is Instructions for Application Submission The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an All instructions in the SF424 (R&R) Application Guide SF424(R&R) Project/Performance Site Locations All instructions in the SF424 (R&R) Application Guide SF424(R&R) Other Project Information All instructions in the SF424 (R&R) Application Guide SF424(R&R) Senior/Key Person Profile All instructions in the SF424 (R&R) Application Guide All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions: Applications requesting multiple years of support must complete and submit a separate detailed budget breakdown and narrative justification for each year of financial support requested.

If an applicant is requesting indirect costs as part of their budget, a copy of the most recent Federal indirect cost rate or F&A agreement must be provided as part of the application submission. This agreement should be attached to the RESEARCH & RELATED Other Project Information Component as line #12 'Other Attachments'.

If the applicant organization has never established an indirect cost rate and/or does not have a negotiated Federal indirect cost rate agreement, a de minimis indirect cost rate of 10 percent (10%) of modified total direct costs (MTDC) will be allowed.

MTDC means all direct salaries and wages, applicable fringe benefits, materials and supplies, services, travel, and subaward and subcontracts up to the first $25,000 of each subaward or subcontract. MTDC excludes equipment, capital expenditures, charges for patient care, rental costs, tuition remission, scholarships and fellowships, participant support costs and the portion of each subaward and subcontract in excess of $25,000.

Indirect/F&A costs under grants to foreign and international organizations will be funded at a fixed rate of 8 percent of modified total direct costs (MTDC), exclusive of tuition and related fees, direct expenditures for equipment, and subawards in excess of $25,000. (With the exception of the American University of Beirut and the World Health Organization, which are eligible for full F&A cost reimbursement).

Awards to domestic organizations with a foreign or international consortium participant may include 8 percent of MTDC, exclusive of tuition and related fees, direct expenditures for equipment, and subawards in excess of $25,000.

All instructions in the SF424 (R&R) Application Guide PHS 398 Cover Page Supplement All instructions in the SF424 (R&R) Application Guide All instructions in the SF424 (R&R) Application Guide 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: Generally, Resource Sharing Plans are expected, but they are not Only limited Appendix materials are allowed.

Follow all instructions for the Appendix as described in the SF424 (R&R) Application PHS Human Subjects and Clinical Trials Information When involving human subjects research, clinical research, and/or clinical trials (and when applicable, clinical trials research experience) follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions: If you answered Yes to the question Are Human Subjects Involved?

on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or Delayed Record: PHS Human Subjects and Clinical Trials Information All instructions in the SF424 (R&R) Application Guide Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start).

All instructions in the SF424 (R&R) Application Guide PHS Assignment Request Form All instructions in the SF424 (R&R) Application Guide 3. Unique Entity Identifier and System for Award Management (SAM) See Part 1. 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 Part I. Overview Information 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. 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 , FDA’s electronic system for grants administration. eRA Commons 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 will not be accepted for this FOA.

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 FDA awards are subject to the terms and conditions, cost principles, and other considerations described in the HHS Grants Policy Statement and 45 CFR 75, currently in effect or implemented during the period of the award, other Department regulations and policies in effect at the time of the award, and applicable statutory Pre-award costs are allowable only as described in the HHS Grants Policy Statement .

Additional funding restrictions may be part of the Notice of Requirements and Information Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide. Paper applications will not be accepted. 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 Apply Application Guide .

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 FDA.

See Section III of this FOA 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 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 assigned Grants Management Specialist and responsiveness by components of participating organizations , FDA. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.

Post Submission Materials Post-submission materials are those submitted after submission of the grant application but prior to objective review. They are not intended to correct oversights or errors discovered after submission of the application. FDA accepts limited information between the time of initial submission of the application and the time of objective review.

Applicants must contact the assigned Grants Management Specialist to receive approval, prior to submitting any post submission materials. Acceptance and/or rejection of any post submission materials is at the sole discretion of the FDA. Any inquiries regarding post submission materials should be directed to the assigned Grants Management Specialist.

V. Application Review Information Reviewers will consider each of the review criteria below in the determination of scientific/technical merit. Significance and Innovation (25 Do the projects address an important issue or a critical barrier to progress in the field?

Is the prior research that serves as the key support for the proposed project rigorous? If the aims of the projects are achieved, how will scientific knowledge, technical capability, communication resources, trainings, regulatory science and/or health equity 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 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 If the project involves human subjects and/or FDA-defined clinical research, are there plans to address: 1) the protection of human subjects 2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of individuals of all ages (including children and older adults), justified in terms of the scientific goals and research strategy Investigator(s) (25 Points) Are the PD(s)/PI(s), collaborators, and other researchers well suited for the project?

If Early-Stage Investigators or those 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? Will the scientific environment in which the work will be done contribute to the probability of success?

Is 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 Have the investigators included plans to address weaknesses in the rigor of prior research that serves as the key support for the proposed project?

Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? 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?

Have the investigators presented adequate plans to address relevant biological, social, and other structural variables as applicable? Health Disparity Impact (25 Recipients must develop a disparity impact statement.

The disparity impact statement provides the contextual and measurement framework for implementation, ongoing monitoring, and the determination of project impact to promote minority health and addess health disparities experienced by racial and ethnic minority populations. Additionally, the disparity impact statement should address plans for equity in clinical trials and/or equitable data efforts, and/or equity in voices.

For example, does the project address, identify and mitigate barriers to enrollment for underrepresented populations in clinical trials (e.g., racial, ethnic minorities); and/or leverage big data, novel data sources and artificial intelligence/machine learning options to contribute to informing the continued evaluation of the safety and efficacy of FDA-approved products (therapeutics, diagnostics, and vaccines) for racial and ethnic minority populations; and/or support research to leverage novel data sources to understand diverse patient perspectives, preferences, and unmet When the proposed project involves human subjects and/or clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals to determine if it is justified in terms of the scientific goals and research strategy Are the overall strategy and administrative and organizational structure well-reasoned and appropriate to coordinate efforts with FDA OMHHE across the REACH organization research projects and activities and supportive to advance integration into the broader REACH network?

Does the approach support organization, management, decision-making, and periodic evaluations? Does the approach support the involvement of institutional and programmatic resources, and shared publications?

Is the overall strategy conducive towards creating and implementing administrative and leadership mechanisms that will foster effective interactions with FDA OMHHE, REACH investigators and other REACH network PDs/PIs and institutions to promote synergistic research efforts?

Additional Review Considerations As applicable for the project proposed, reviewers will evaluate the following additional items but will not give separate scores for these items and should not consider them in providing an overall 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, 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 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 Inclusion of Women, Minorities, and Individuals Across the Lifespan When the proposed project involves human subjects and/or 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 individuals of all ages (including children and older adults) 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 The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment 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.

Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. 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 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 Model Organisms; and (3) Genomic Data