Animal and Veterinary Innovation Centers (U18) is a grant program from the FDA's Center for Veterinary Medicine (CVM) that funds long-term cooperative research partnerships with academic institutions to address critical animal health and food safety priorities.

Funded research areas include interventions to prevent or eliminate Highly Pathogenic Avian Influenza (HPAI) in animals, intentional genomic alterations supporting agricultural resilience and food security, and veterinary products for minor species or underserved medical needs. Initial awards provide up to ,250,000, with applications due by June 11, 2028.

Eligible applicants include public and private academic research institutions partnering with nonprofits or other research organizations. This funding opportunity (PAR-24-251) was updated in March 2025 to align with current agency priorities.

PAR-24-251: Animal and Veterinary Innovation Centers This funding opportunity was updated to align with agency priorities. Carefully reread the full funding opportunity and make any needed adjustments to your application prior to submission. 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 Notice of Funding Opportunity (NOFO) may differ from those used by the NIH. Where this NOFO provides specific written guidance that may differ from the general guidance provided in the grant application form, please follow the instructions given in this NOFO.

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 of Participating Organizations Center for Veterinary Medicine ( CVM ) Funding Opportunity Title Animal and Veterinary Innovation Centers (U18) Research Demonstration Cooperative Agreements March 31, 2025 - This funding opportunity was updated to align with agency priorities.

Carefully reread the full funding opportunity and make any needed adjustments to your application prior to submission. April 04, 2024 - Overview of Grant Application and Review Changes for Due Dates on or after January 25, 2025. See Notice NOT-OD-24-084 June 26, 2024 - Notice of Change to Funding Opportunity: PAR-24-251 Animal and Veterinary Innovation Centers (U18).

See Notice NOT-FD-24-009 Funding Opportunity Number (FON) Companion Notice of Funding Additional Information on Eligibility .

Assistance Listing Number(s) Funding Opportunity Purpose The purpose of this Funding Opportunity Announcement (FOA) is to solicit applications for inclusion as Animal and Veterinary Innovation Centers, which are intended to form long-term partnerships to address priority areas for FDA's Center for Veterinary Medicine (CVM).

This includes CVM developing cooperative agreement(s) with academic research institutions (public and private) to: 1. Drive research that supports the development of interventions to prevent, control, or eliminate Highly Pathogenic Avian Influenza (HPAI) virus in animals, or interventions that reduce the circulation of the virus in the ecosystem.

Work may also include other emerging zoonotic disease threats or One Health issues in future years. 2. Drive research that supports the development of intentional genomic alternations in animals and the advancement of regulatory science in this field, with a focus on intentional genomic alternations that support agricultural resilience, food security, animal health, or public health.

3. Drive research that supports the development of products for minor species, minor uses in major species (dogs, cats, horses, cattle, pigs, chickens, and turkeys) and other unmet veterinary medical needs in major species that create a significant animal or public health burden. Open Date (Earliest Submission Date) Letter of Intent Due Date(s) Not applicable for 2024.

For future years due 30 days before application due date Technical Review Session(s) will be held: Dates in bold and italics reflect changes per NOT-FD-24-009 All applications are due by 11:59 PM local time of applicant organization.

All types of non-AIDS applications allowed for this notice of funding opportunity are due on 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. Late applications will not be accepted for this FOA.

AIDS Application Due Date(s) August 2024, June of each subsequent year It is critical that applicants follow the Research (R) Instructions in How to Apply - Application Guide , except where instructed to do otherwise (in this NOFO or in a Notice from the Guide for Grants and Contracts ). Conformance to all requirements (both in to Apply - Application Guide and the NOFO) is required and strictly enforced.

Applicants must read and follow all application instructions in the How to Apply - Application Guide as well as any program-specific instructions noted in Section IV . When the program-specific instructions deviate from those in the How to Apply - Application Guide , follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

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 the Announcement 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 Section I. Notice of Funding Opportunity Description The Food and Drug Administration (FDA), Center for Veterinary Medicine (CVM) regulates animal food and animal drugs. To help meet the growing needs to develop and regulate new animal drug products, CVM and Veterinary Innovation Agenda (AVIA), which communicated CVM's plans to address critical unmet needs impacting animal and human health.

In support of the AVIA, CVM is announcing the establishment of Animal and Veterinary Innovation Centers (AVICs) comprised of academic research institutions (public and private). These Centers are intended to have a long-standing relationship with CVM and must have strong institutional support to advance CVM priorities in a specific topic area listed below.

To become an AVIC, applications are sought for cooperative agreements to address research needs identified by CVM. These applications must have detailed, multi-year research plans to address one or more of the priority areas listed below. This includes clear proposals for how these critical animal, human, or environmental health concerns will be addressed.

The focus should be on research and related efforts that seek to answer regulatory science questions about new products or technologies or that potentially support the development and approval of FDA-regulated animal and veterinary products.

The Agency's goal is that these Innovation Centers will contribute research and work that will result in more FDA-regulated products coming to market - particularly products that are innovative or address high-impact needs such as food security, agricultural resilience, unmet animal health needs, or public Areas of specific interest related to the funding 1.

Animal therapeutic interventions for Highly Pathogenic Avian Influenza (HPAI), including those with a One Health approach. Applications in this area can include novel non-vaccine strategies to decrease the impact of HPAI on affected animal species or other novel interventions to prevent, control, or treat HPAI virus in animals.

This may include research to characterize genomic targets for disease resistance as well as gene editing to decrease the susceptibility of animals to HPAI.

This work can improve animal health, public health, improve food security, and increase the safety of the human and animal Relevant research may also address broader interventions that support animal health, human health, and food safety as related to HPAI virus such as on-farm interventions that might reduce the presence of HPAI virus in milk or the circulation of the virus in the ecosystem.

It could include novel strategies to design, pilot, or build innovative data systems (e.g., data trusts) that use a One Health approach to help collect, aggregate and analyze data that could support the food safety system. Work to address other emerging zoonotic disease threats or One Health issues can also be included in years past 2024, though the immediate focus for the first funding cycle is HPAI virus. 2.

Research to address development and regulatory science needs genomic alterations (IGAs) in animals . FDA defines IGAs in animals to include changes made to an animal's genome using modern molecular technologies (e.g., recombinant DNA-based genetic engineering, CRISPR-Cas genome editing).

This research is intended to spur innovation and generate regulatory science answers and smart improvements to FDA's regulatory approach for IGAs in animals.

Needs include genome editing research to determine the frequency of and factors that influence unintended alterations (including plasmid integration), consistency between genome editing events in different strains and breeds, and the reproducibility and reliability of editing and characterization assays.

Potential goals include generating data demonstrating the consistency of inherited IGAs across generations or between separate editing events, or data comparing the efficiency and risk for unintended alterations when using different editing methodologies (e.g., different delivery methods, nucleases [standard Cas9, high-efficiency versions]).

Additional needs include research into standardized molecular characterization and evaluation of genome editing, as well as adaption of tools for the genomes of commonly edited animal species (e.g., swine and cattle). 3.

Research that supports the development and regulatory needs of products for minor uses in major species (dogs, cats, horses, cattle, pigs, chickens, and turkeys), minor species, and other unmet veterinary medical needs in major species that create a significant animal or public health burden, influence animal production, or have environmental benefits, such as those described in FDA’s Animal and Veterinary Innovation Agenda .

See also Minor Use/Minor a. Products to address unmet needs for minor uses in major species include, but are not limited to, products for blackhead disease (histomoniasis) in turkeys. A minor use, as determined by the FDA, is the intended use of a new animal drug in a major species for an indication that occurs infrequently or in limited geographical areas and in only a small number of animals annually in the United States.

The Minor Use/Minor Species Designations List on the FDA website shows the intended uses that FDA has previously deemed as minor uses in major species. b. Products to address unmet needs for minor species include, but are not limited to, products for honey bees, fish, and small c.

Products to address other unmet veterinary medical needs, such as those that create a significant animal health burden in major species, include, but are not limited to, products for cancer, cardiac disease, chronic renal failure, and pain control in food- producing animals. Products to address the unmet needs described above (a, b, and c) can include those with novel mechanisms of action or novel technologies.

Given the national importance of food-producing species, preference among applications related to minor use and minor species will be given to applications in this area. VIII. Other Information for award authorities and regulations.

Section II. Award Information Cooperative Agreement: A financial assistance 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 Application Types Allowed 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 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 up to four (4) additional year(s) contingent upon annual appropriations, availability of funding and satisfactory recipient performance. FDA intends to fund an estimate of up to 8 awards, corresponding to a total of approximately $3,000,000, for fiscal year 2024.

Future year amounts and number of awards will depend on annual Application budgets need to reflect the actual needs of the proposed project and should not exceed the following in total costs (direct and indirect costs): The scope of the proposed project should determine the project period.

The maximum project period is HHS grants policies as described Grants Policy Statement will apply to the applications submitted and awards made from this NOFO.

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 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 Institutions Non-domestic (non-U.S.) Entities (Foreign Organizations) 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 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 HHS Grants Policy Statement for additional information. Award Management (SAM) Applicants must complete and maintain an active registration, 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. 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. - Once the unique organization identifier is established, organizations can register with eRA Commons in tandem with completing their Grants.

gov registration; all registrations must be in place by time of submission. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an Applicants must have an active SAM registration in order to complete the Grants. gov 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 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 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 . This NOFO does not require cost sharing as defined in the HHS Grants 3.

Additional Information 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 per 2. 3.

7. 4 Submission of Resubmission Application . This means that the FDA 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 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 Grants Policy Statement 2. 3. 9.

4 Similar, Essentially Identical, or Identical Applications ). Section IV. Application and Submission Information 1.

Requesting an Application Package The application forms package specific to this opportunity must be accessed through ASSIST, 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 2. Content and Form of Application It is critical that applicants follow the Research (R) Instructions to Apply - Application Guide , except where instructed in this notice of funding opportunity to do otherwise.

Conformance to the requirements to Apply - Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted 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 IC staff to estimate the potential review workload and By the date listed in Part 1.

Overview Information , prospective applicants are asked to submit a letter of intent that includes the following information: Descriptive title of proposed activity Name(s), address(es), and telephone number(s) of the PD(s)/PI(s) Names of other key personnel Participating institution(s) Number and title of this funding opportunity The letter of intent should be sent to: All page limitations described in the How to Apply Application Guide of Page Limits must be followed.

For this specific NOFO, the Research Strategy section is 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 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. 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, 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'. All instructions in the How to Apply - Application Guide must be followed. 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 1. The research plan should address one of the scientific questions and/or priorities discussed under part 2 of this notice, considering the associated animal health, human health, environmental health, or regulatory 2.

Collaboration with other entities is encouraged and plans for interactions with other potential Innovation Centers should be included, 3. Prospective applicants should reach out to the science/research contact about budget and scope before submission. This can ensure alignment of potential applications with programmatic needs.

All instructions in the How to Apply - Application Guide must be followed, with the following additional All applicants planning research (funded or conducted in whole or in part by the FDA) that results in the generation of scientific data are required to comply with the instructions for the Data Management and Sharing Plan.

All applications, regardless of the amount of direct costs requested for any one year, must address a Data Management and Sharing Plan. Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the How to Apply - Application Guide .

PHS Human Subjects and Clinical Trials Information Trials involving human subjects are not allowed for this funding 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 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 Grants. gov 4.

Submission Dates and Times 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.

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 , FDA’s electronic system for grants administration. FDA 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 FDA Policy on Late 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. This initiative is not subject to intergovernmental All FDA awards are subject to the terms and conditions, cost principles, and other considerations described in the HHS Grants Policy Statement .

Pre-award costs are allowable only as described in the HHS Grants Policy Statement . Allowable costs include but are not limited to: 1. Employee salaries, wages, and fringe benefits.

2. Rental, purchasing, calibration, and installation of 4. Registration Fees for relevant conferences or trainings.

5. Purchase of IT equipment, software, support. Specific programs may be requested to support reporting data.

6. Shipping and mailing of equipment, supplies and samples. 7.

Travel - Funds can be requested in the budget to travel to meetings with FDA program staff about the progress of the project, or to attend applicable conferences or trainings. Limited to $10,000 direct costs per year. 8.

Laboratory and office supplies. 9. Publication fees, if publication relates to work conducted as part of the grant.

2. New building construction. Additional funding restrictions may be part of the Notice of 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, 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 with System Issues guidance. For assistance with application submission, contact the Application Submission Contacts in Section 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 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 . for avoiding common errors.

Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the assigned FDA Grants Management Specialist and responsiveness by components of participating organizations. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.

In order to expedite review, applicants are requested to notify the peer review contact by email at [email protected] when the application has been submitted. Please include the FON and title, PD/PI name, and title of the application. 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, Grants Policy Statement . Send written disclosures to the FDA 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 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 Section V.

Application Review Information Only the review criteria described below will be considered Applications submitted to the FDA in support of the HHS mission are evaluated for scientific and technical merit through the FDA peer review 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 review criteria and additional review criteria (as applicable for the project 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 project address an important problem 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 project 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? What tangible impact will be made to animal/human/environmental health or regulatory science? Will this project result in new therapies being made available or other significant advances?

Does this application address not only a specific short-term project, but demonstrate sufficient long-term significance to be established as an Investigator(s) (15 points) Are the PD(s)/PI(s), collaborators, and other researchers well suited to 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 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? Is the work reflective of new technologies or innovations and their impact on public health and regulatory science?

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? 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 variables, such as sex, for studies in vertebrate animals?

Is there IACUC oversight of research involving vertebrate animals? Are there existing or planned collaborations that will help drive the project forward? Is the work to be accomplished of reasonable scope to be accomplished in the planned study period?

Is there a clear multi-year strategy to address the topic areas described in this NOFO? Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment, and other physical resources available to the investigators adequate for the project proposed?

Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements? Is there ongoing research in this area at the institution that increases the likelihood of success? Does the institution have the proper support to justify long-term presence as an Innovation Center?

Additional Review Criteria 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 The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following three points: (1) a complete description of all proposed procedures including the species, strains, ages, sex, and total numbers of animals to be used; (2) justifications that the species is appropriate for the proposed research and why the research goals cannot be accomplished using an alternative non-animal model; and (3) interventions including analgesia, anesthesia, sedation, palliative care, and humane endpoints that will be used to limit any unavoidable discomfort, distress, pain and injury in the conduct of scientifically valuable research.

Methods of euthanasia and justification for selected