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 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.
- Use Grants.gov Workspace to prepare and submit your application and eRA Commons to track your application.
- Applicant should identify and characterize specific antimicrobial use data gaps or challenges to data collection in one or more population(s) of animal species or species subsector(s), including domestic livestock (e.g., beef cattle, dairy cattle, swine), poultry (e.g., layer chickens, broiler chickens, turkeys), companion animals (e.g., dogs, cats, horses), or other minor species (e.g., fish, sheep, goats).
- Applicant shall collect and report detailed summary information on available antimicrobial drug use data and contextual information (e.g., antimicrobial drug name or identifier, dosing information, or indication for use) from the identified animal population(s) (e.g., animal demographic information, population numbers, or weights at time of treatment) using methodologies that are standard or appropriate to that sector.
- Applicant shall collect data in a manner that protects disclosure of nonpublic information, such as raw data containing identifying information or other confidential business information.
- Applicant shall characterize the extent to which the collected data are representative of the animal species sector or animal species subsector in the United States.
- Applicant shall produce annual summary reports of the quantitative and qualitative antimicrobial use data collected (which does not include raw data), such as detailed descriptions of the data collection methodology, analysis of trends, and information that provides essential context to interpretation of the data (e.g., information about data source/record type, type of veterinary setting, epidemiological information)
- Applicant shall also make annual summary data available to the public, such as, for use to inform antimicrobial stewardship programs or to inform policymakers.
- Applicant shall contribute summary antimicrobial use data and technical support to public-private partnerships/collaborations for long-term data collection that are under development in the United States, including through contributing data to national data repository or dashboard, as those resources or infrastructure become available.
- Characterize and address data gaps and specific challenges to the collection of antimicrobial use data from an identified animal population, sector, or subsector.
- Propose methods and strategies for data collection and standardization of antimicrobial use data from across diverse data sources from the identified animal population, sector, or subsector;
- Propose methods and strategies to ensure data confidentiality and maintain anonymization of identifying data extracted from records (e.g., producer treatment records, veterinary prescription records);
- Summarize the collected antimicrobial use data using standardized formats that are appropriate to the studied animal population, sector, or subsector, including analyses of trends and contextual information pertinent to accurate interpretation of the data;
- Make collected antimicrobial use data and summary information, such as analysis of trends, available to the public using a variety of appropriate outlets, such as peer-reviewed scientific literature or public-facing dashboards;
- Collaborate with and contribute to public-private partnership efforts working towards development of a national data repository or dashboard(s) across animal or veterinary sectors to collect and report antimicrobial use data, including collaboration with animal health organizations, veterinary practices, animal producer groups, universities, and federal or state partners who are involved in those efforts; and
- Propose methodologies to provide aggregated and anonymized antimicrobial use data which will be made available for input to a national database repository or dashboard in future years, as resources or national infrastructure are developed.
- Public/State Controlled Institutions of Higher Education
- 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 (AANAPISIs)
- Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
- Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)
- Small Businesses
- For-Profit Organizations (Other than Small Businesses)
- State Governments
- County Governments
- City or Township Governments
- Special District Governments
- Indian/Native American Tribal Governments (Federally Recognized)
- Indian/Native American Tribal Governments (Other than Federally Recognized)
- Eligible Agencies of the Federal Government
- 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
- Regional Organizations
-
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 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 application.
- Grants.gov Applicants must have an active SAM registration in order to complete the Grants.gov registration.
- 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 HHS Grants Policy Statement).
- 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
- All applicants planning research (funded or conducted in whole or in part by 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.
- Scientific and technical merit of the proposed project as determined by objective review.
- Availability of funds.
- Relevance of the proposed project to program priorities.
- For guidance on meeting the legal obligation to take reasonable steps to ensure meaningful access to programs or activities by limited English proficient individuals see https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/fact-sheet-guidance/index.html and https://www.lep.gov.
- For information on an institution’s specific legal obligations for serving qualified individuals with disabilities, including reasonable accommodations and making services accessible to them, see http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html.
- HHS funded health and education programs must be administered in an environment free of sexual harassment, see https://www.hhs.gov/civil-rights/for-individuals/sex-discrimination/index.html. For information about FDA'S commitment to supporting a safe and respectful work environment, who to contact with questions or concerns, and what FDA's expectations are for institutions and the individuals supported on FDA-funded awards, please see https://grants.nih.gov/grants/policy/harassment.htm.
- For guidance on administering programs in compliance with applicable federal conscience protection and associated anti-discrimination laws see https://www.hhs.gov/conscience/conscience-protections/index.html and https://www.hhs.gov/conscience/religious-freedom/index.html.
Part 1. Overview Information
Part 2. Full Text of the 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
Background:
Antimicrobial resistance is recognized as a growing global health threat requiring coordinated antimicrobial use stewardship actions across multiple sectors, including human, animal, and environmental health. Insights into what drugs are being used, how much of the drugs are being used, and how they are being used are vital to guiding stewardship efforts and furthering our understanding of the relationship between antimicrobial drug use and resistance. However, the accessibility of antimicrobial use data in animals is limited and therefore, it remains a key data gap for veterinary and animal production settings within the United States.
Antimicrobial use data includes the collection and analysis of information about the amount of antimicrobial prescribing, authorizing, administering, and delivering for administration in a defined animal species or population. Antimicrobial use data is ideally collected as close to the point of actual administration to the animal or population of animals as possible, along with information about appropriate contextual information for the use of those drugs.
In 2018, FDA CVM released 'Supporting Antimicrobial Stewardship in Veterinary Settings: Goals for Fiscal Years 2019-2023.' This plan outlined CVM's intended focus on supporting antimicrobial stewardship along three key goals: 1) align antimicrobial drug product use with the principles of antimicrobial stewardship, 2) foster stewardship of antimicrobials in veterinary settings, and 3) enhance monitoring of antimicrobial resistance and antimicrobial drug use in animals. In 2023, FDA CVM released its next 5-Year Plan for Fiscal Years 2023-2028 outlining ongoing and additional actions related to these three key goals in supporting antimicrobial stewardship in veterinary settings.
As part of its strategy to address the third goal of enhanced monitoring of antimicrobial drug use data in animals, FDA CVM funded four cooperative agreements for antimicrobial use data collection in food-producing animals (two (2) grants funded since 2016) and in companion animals (two (2) grants funded since 2020). These pilot data collection efforts were intended to provide baseline information on antimicrobial use practices in animals and important information on methodologies to help optimize long-term strategies for collecting and reporting such data. Some of these groups published a series of papers in a 2020 describing the first few years of data collection (in one issue of the journal, Zoonoses and Public Health), and other publications are reported in the scientific literature since then, and are also listed on the FDA CVM website.
In 2021, FDA CVM asked the Reagan Udall Foundation for FDA to seek input from a variety of affected stakeholders on a draft framework exploring public-private partnerships to track antimicrobial use data in food producing animals in the United States. The Foundation conducted this outreach under a cooperative agreement with the FDA, the results of which are summarized in a report outlining the draft framework. The report includes information about antimicrobial use data standardization and protection of data confidentiality; it also summarizes stakeholder input and public comments about potential objectives, membership, organizational structure, and financing for a potential public-private partnership. The report describes a potential framework, supported in part by public and private resources, that includes a Data Repository Coordinator, Data Partners, and a Steering Committee.
Antimicrobial use data collection projects funded under this Notice of Funding Opportunity would function to collect data in a manner similar to that envisioned for the "data partners" outlined in the report referenced above. Grantees would be expected to contribute to the development of data collection frameworks, including providing data and expertise as resources and public-private partnership framework becomes available.
Problem Statement:
Antimicrobial use data in animals is critical to foster antimicrobial stewardship in veterinary settings. A key data gap is the limited availability of antimicrobial use data in animals. Development of a long-term strategy is needed to successfully implement a functional and efficient infrastructure for ongoing collection of antimicrobial use data from across diverse veterinary and animal production sectors.
Purpose:
Building upon prior antimicrobial use data collection efforts, including exploration of a potential framework for establishing public-private partnership to collect and analyze antimicrobial use data, the purpose of the funded studies is to:
1) Gather, summarize, and report information about antimicrobial use in domestic animals from diverse veterinary or animal production sectors; and
2) Contribute to and support long-term data collection efforts that are under development within the United States, including potential public-private partnership frameworks and national data repositories or dashboards intended to securely store, analyze, and report antimicrobial use data.
Goals and Objectives:
Project Activities:
For FY 2024, proposals to collect antimicrobial use data from domestic livestock or poultry sectors will be prioritized. In FY 2025, proposals to collect antimicrobial use data collection from companion animal or minor species sectors will be prioritized.
FDA is requesting proposals describing the following activities and detailed information about how applicants intend to accomplish them:
See Section VIII. Other Information for award authorities and regulations.
FDA grants policies as described in the HHS Grants Policy Statement will apply to the applications submitted and awards made from this NOFO.
Higher Education Institutions
The following types of Higher Education Institutions are always encouraged to apply for FDA support as Public or Private Institutions of Higher Education:
Nonprofits Other Than Institutions of Higher Education
For-Profit Organizations
Local Governments
Federal Governments
Other
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 HHS Grants Policy Statement, are not allowed.
Applicant Organizations
Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. Failure to complete registrations in advance of a due date is not a valid reason for a late submission, please reference HHS Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications for additional information.
Program Directors/Principal Investigators (PD(s)/PI(s))
All PD(s)/PI(s) must have an eRA Commons account. PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.
Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with their 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 (R&R) Application Guide.
This NOFO does not require cost sharing as defined in the HHS Grants Policy Statement Section 1.2 Definition of Terms.
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 HHS Grants Policy Statement. This means that the FDA will not accept:
For Fiscal Year 2024, FDA intends to fund up to three (3) awards.
For Fiscal Year 2025, FDA intends to an additional two (2) awards
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.
It is critical that applicants follow 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.
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 plan the review.
By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:
The letter of intent should be sent to:
Katherine Huebner via katherine.huebner@fda.hhs.gov
or
GRANTS MANAGEMENT STAFF CONTACT NAME
Email: zahara.graves@fda.hhs.gov
All page limitations described in the How to Apply Application Guide and the Table of Page Limits must be followed.
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 SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:
Resource Sharing Plan:
Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide
Note: Effective for due dates on or after January 25, 2023, the Data Management and Sharing Plan will be attached in the Other Plan(s) attachment in FORMS-H application forms packages.
All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:
Appendix:
Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.
When involving human subjects research, clinical research, and/or FDA-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 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 Onset Study record.
Study Record: PHS Human Subjects and Clinical Trials Information
All instructions in the SF424 (R&R) Application Guide must be followed.
Delayed Onset Study
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 must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
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
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 HHS Grants Policy Statement .
Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission.
Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.
This initiative is not subject to intergovernmental review.
All 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
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 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.
Important reminders:
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 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 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
Only the review criteria described below will be considered in the review process.
Applications submitted to the FDA in support of the HHS mission are evaluated for scientific and technical merit through the FDA peer review system.
Reviewers will consider each of the review criteria below in the determination of scientific/technical merit.
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?
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 for the project?
Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?
Are the 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 or human subjects?
If the project involves human subjects and/or FDA-defined clinical research, are the plans to address
1) the protection of human subjects from research risks, and
2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of individuals of all ages (including children and older adults), justified in terms of the scientific goals and research strategy proposed?
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?
As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items.
For FY 2024, proposals to collect antimicrobial use data collection in domestic livestock or poultry sectors will be prioritized.
In FY 2025, proposals to collect antimicrobial use data collection in companion animal or minor species will be prioritized.
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 Subjects.
When the proposed project involves human subjects and/or FDA-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of 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 in Clinical Research.
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 methods, if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals, is also required but is found in a separate section of the application. For additional information on review of the Vertebrate Animals Section, please refer to the Worksheet for Review of the Vertebrate Animals Section.
Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.
For Resubmissions, the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.
For Renewals, the committee will consider the progress made in the last funding period.
For Revisions, the committee will consider the appropriateness of the proposed expansion of the scope of the project. If the Revision application relates to a specific line of investigation presented in the original application that was not recommended for approval by the committee, then the committee will consider whether the responses to comments from the previous scientific review group are adequate and whether substantial changes are clearly evident.
As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact score.
Reviewers will assess whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions that exist in other countries and either are not readily available in the United States or augment existing U.S. resources.
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 Resource Sharing Plan(s) (e.g., Sharing Model Organisms) or the rationale for not sharing the resources, is reasonable.
For projects involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.
Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.
Applications will be evaluated for scientific and technical merit by (an) appropriate Objective Review Committee using the stated review criteria.
As part of the Objective Review, all applications:
Will receive a written critique.
Appeals of initial peer review will not be accepted for applications submitted in response to this NOFO.
Applications will compete for available funds with all other recommended applications submitted in response to this NOFO. The following will be considered in making funding decisions:
After the peer review of the application is completed, the PD/PI will be able to access their Summary Statement (written critique) via the eRA Commons. Refer to Part 1 for dates for peer review, advisory council review, and earliest start date.
Information regarding the disposition of applications is available in the HHS Grants Policy Statement.
If the application is under consideration for funding, FDA will request "just-in-time" information from the applicant as described in the HHS Grants Policy Statement.
A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the recipient’s business official.
Recipients must comply with any funding restrictions described in Section IV.6. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.
Any application awarded in response to this NOFO will be subject to terms and conditions found on the Award Conditions and Information for FDA Grants website. This includes any recent legislation and policy applicable to awards that is highlighted on this website.
All FDA grant and cooperative agreement awards include the HHS Grants Policy Statement as part of the NoA.
If a recipient is successful and receives a Notice of Award, in accepting the award, the recipient agrees that any activities under the award are subject to all provisions 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 provisions.
Should the applicant organization successfully compete for an award, recipients of federal financial assistance (FFA) from HHS will be required to complete an HHS Assurance of Compliance form (HHS 690) in which the recipient agrees, as a condition of receiving the grant, to administer programs in compliance with federal civil rights laws that prohibit discrimination on the basis of race, color, national origin, age, sex and disability, and agreeing to comply with federal conscience laws, where applicable. This includes ensuring that entities take meaningful steps to provide meaningful access to persons with limited English proficiency; and ensuring effective communication with persons with disabilities. Where applicable, Title XI and Section 1557 prohibit discrimination on the basis of sexual orientation, and gender identity, The HHS Office for Civil Rights provides guidance on complying with civil rights laws enforced by HHS. See https://www.hhs.gov/civil-rights/for-providers/provider-obligations/index.html and https://www.hhs.gov/civil-rights/for-individuals/nondiscrimination/index.html.
HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research. For additional guidance regarding how the provisions apply to FDA grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this NOFO.
Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at https://www.hhs.gov/ocr/about-us/contact-us/index.html or call 1-800-368-1019 or TDD 1-800-537-7697.
In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), FDA awards will be subject to the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements. FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award. An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a Federal agency previously entered and is currently in FAPIIS. The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgement about the applicant s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 45 CFR Part 75.205 and 2 CFR Part 200.206 Federal awarding agency review of risk posed by applicants. This provision will apply to all FDA grants and cooperative agreements except fellowships.
Although the funding vehicle is a cooperative agreement, FDA merely plans to select from among the various data collection plans submitted in response to the funding opportunity announcement. Because FDA will not be substantially involved in the data collection, FDA is not conducting or sponsoring an information collection and, as a result, the project does not need OMB review and approval under the Paperwork Reduction Act.
Due to these special circumstances (the use of a cooperative agreement funding vehicle but without FDA substantial involvement in the project activities), the typical terms and conditions used in a cooperative agreement are inappropriate for the project. The terms and conditions must be modified to avoid triggering the need for OMB clearance. The HHS Grants Policy Statement is available at: http://www.hhs.gov/sites/default/files/grants/grants/policies-regulations/hhsgps107.pdf.
This text represents FDA oversight of the publication of the resulting summary data, not FDA oversight of the collection of the data:
SPECIAL TERMS AND CONDITIONS
DELINEATION OF SUBSTANTIVE INVOLVEMENT
1. The awardees will not represent to respondents that the information is being collected for, or in association with, FDA.
2. FDA will assist and approve (as deemed appropriate) the substance of publications, co-authorship of publications and data release.
PRINCIPAL INVESTIGATOR RESPONSIBILITIES
Additionally, PD/PIs will:
1. Participate in regular telephone conference calls with FDA-CVM staff.
2. Cooperate with other awardees in the development and design of testing protocols as well as define common procedures for quality control, data analysis, and interpretation.
3. Participate in site visits or meetings as requested by the FDA.
4. Any publication or oral presentation of project results must undergo FDA-CVM review and approval process. This process can take 30-90 days.
Note: The HHS Policy for Data Management and Sharing is effective for due dates on or after January 25, 2023.
Consistent with the HHS Policy for Data Management and Sharing, when data management and sharing is applicable to the award, recipients will be required to adhere to the Data Management and Sharing requirements as outlined in the HHS Grants Policy Statement. Upon the approval of a Data Management and Sharing Plan, it is required for recipients to implement the plan as described.
Consistent with the 2023 FDA Policy for Data Management and Sharing, when data management and sharing is applicable to the award, recipients will be required to adhere to the Data Management and Sharing
When multiple years are involved, recipients will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the HHS Grants Policy Statement.
A final RPPR, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the HHS Grants Policy Statement. FDA NOFOs outline intended research goals and objectives. Post award, FDA will review and measure performance based on the details and outcomes that are shared within the RPPR, as described at 2 CFR Part 200.301.
The Federal Funding Accountability and Transparency Act of 2006 as amended (FFATA), includes a requirement for recipients of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All recipients of applicable FDA grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over the threshold. See the HHS Grants Policy Statement for additional information on this reporting requirement.
In accordance with the regulatory requirements provided at 2 CFR Part 200.113 and Appendix XII to 2 CFR Part 200, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM) about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period. The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (currently FAPIIS). This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313). As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available. Full reporting requirements and procedures are found in Appendix XII to 2 CFR Part 200 Award Term and Condition for Recipient Integrity and Performance Matters.
We encourage inquiries concerning this funding opportunity
and welcome the opportunity to answer questions from potential applicants.
eRA Service Desk (Questions regarding ASSIST, eRA Commons, application errors and warnings, documenting system problems that threaten submission by the due date, and post-submission issues)
Finding Help Online: https://www.era.nih.gov/need-help
(preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)
Grants.gov Customer Support (Questions regarding
Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email: support@grants.gov
Katherine Huebner, VMD, MS
Center for Veterinary Medicine (CVM)
Telephone: 240-402-4347
Email: Katherine.Huebner@fda.hhs.gov
Zahara Graves
Office of Acquisitions & Grants Services (OAGS)
Food and Drug Administration
Email: Zahara.Graves@fda.hhs.gov
Zahara Graves
Office of Acquisitions & Grants Services (OAGS)
Food and Drug Administration
Email: Zahara.Graves@fda.hhs.gov
All awards are subject to the terms and conditions, cost principles, and other considerations described in the HHS Grants Policy Statement.
Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 2 CFR Part 200.
and Human Services (HHS)
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