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 How 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.
- Use Grants.gov Workspace to prepare and submit your application and eRA Commons to track your application.
- Higher Education Institutions
- 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)
-
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 Grants Policy Statement 2.3.9.4 Similar, Essentially Identical, or Identical Applications).
- 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 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.
- Will receive a written critique.
- Scientific and technical merit of the proposed project as determined by scientific peer review.
- Availability of funds.
- Relevance of the proposed project to program priorities.
- The rules listed at 2 CFR Part 200, Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards.
- All FDA grant and cooperative agreement awards include the HHS Grants Policy Statement as part of the terms and conditions in the Notice of Award (NoA). The NoA includes the requirements of this NOFO.
- If a recipient receives an award, the recipient must follow all applicable nondiscrimination laws. The recipient agrees to this when registering in SAM.gov. The recipient must also submit an Assurance of Compliance (HHS-690). To learn more, see the Laws and Regulations Enforced by the HHS Office for Civil Rights website.
- HHS recognizes that FDA 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.
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
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 released an Animal 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 health.
Areas of specific interest related to the funding announcement include:
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 food supply.
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 related to intentional 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 Species | FDA.
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 ruminants.
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.
See Section VIII. Other Information for award authorities and regulations.
HHS grants policies as described in the HHS Grants Policy Statement will apply to the applications submitted and awards made from this NOFO.
The following types of Higher Education Institutions are always encouraged to apply for FDA support as Public or Private Institutions of Higher Education:
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 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.
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 How to Apply - Application Guide.
This NOFO does not require cost sharing as defined in the HHS Grants Policy Statement.
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:
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 How to Apply - 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:
Kimberly Pendleton
Email: kimberly.pendleton@fda.hhs.gov
All page limitations described in the How to Apply Application Guide and the Table of Page Limits must be followed.
For this specific NOFO, the Research Strategy section is limited to 30 pages.
The following section supplements the instructions found in the How to Apply Application Guide and should be used for preparing an application to this NOFO.
All instructions in the How to Apply - Application Guide must be followed.
All instructions in the How to Apply - Application Guide must be followed.
All instructions in the How to Apply - Application Guide must be followed.
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.
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:
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 impacts.
2. Collaboration with other entities is encouraged and plans for interactions with other potential Innovation Centers should be included, where applicable.
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.
Resource Sharing Plan:
All instructions in the How to Apply - 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 How to Apply - Application Guide .
Trials involving human subjects are not allowed for this funding opportunity.
All instructions in the How to Apply - 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 FDA Policy on Late Application Submission.
Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission.
Information on the submission process and a definition of on-time submission are provided in the How to Apply Application Guide.
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.
Allowable costs include but are not limited to:
1. Employee salaries, wages, and fringe benefits.
2. Rental, purchasing, calibration, and installation of equipment.
3. Indirect costs.
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.
Non-allowable costs:
1. Vehicle purchases.
2. New building construction.
Additional funding restrictions may be part of the Notice of Award.
Applications must be submitted electronically following the instructions described in the How to Apply - Application Guide. Paper applications will not be accepted.
Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.
For assistance with your electronic application or for more information on the electronic submission process, visit How to Apply - Application Guide. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Dealing with System Issues guidance. For assistance with application submission, contact the Application Submission Contacts in Section VII.
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 How to Apply - Application Guide.
See more tips for avoiding common errors.
Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the 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 kimberly.pendleton@fda.hhs.gov 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, 2 CFR 200.113 and HHS 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 grantdisclosures@oig.hhs.gov.
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 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 Innovation Center?
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? 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?
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.
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.
Not Applicable
Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).
Reviewers will comment on whether the 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 Scientific Review Group(s) convened by the FDA, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.
As part of the scientific peer review, all applications:
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:
Successful applicants will be notified of additional information that may be required or other actions leading to an award. The decision not to award a grant, or to award a grant at a particular funding level, is discretionary and is not subject to appeal to any FDA or HHS official or board.
Information regarding the disposition of applications is available in the HHS Grants Policy Statement.
A Notice of Award (NoA) is the official authorizing document notifying the applicant that an award has been made and that funds may be requested from the designated HHS payment system or office. The NoA is signed by the Grants Management Officer and emailed to the recipient’s business official.
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.
Recipients must comply with any funding restrictions described in Section IV.6. Funding Restrictions. Any pre-award costs incurred before receipt of the NoA are at the applicant's own 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 federal statutes and regulations relevant to federal financial assistance, including those highlighted in the HHS Grants Policy Statement.
Recipients are responsible for ensuring that their activities comply with all applicable federal regulations. FDA may terminate awards under certain circumstances. See the HHS Grants Policy Statement.
Cooperative Agreement Terms and Conditions of Award
The administrative and funding instrument used for this program will be the cooperative agreement, an assistance mechanism (rather than an acquisition mechanism), in which substantial FDA programmatic involvement with the awardees is anticipated during the performance of the activities. Under the cooperative agreement, FDA's purpose is to support and stimulate the recipient's activities by involvement in and otherwise working jointly with the award recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the awardees for the project, although specific tasks and activities may be shared among the awardees and FDA as defined below.
Substantive involvement may include, but is not limited to, the following:
(1) General guidance on activities
(2) Site visits from FDA staff
(3) Facilitating cooperation and joint advancement of priorities among multiple grant recipients.
The following conditions of the award will apply to all funded applicants and must be maintained throughout the cooperative agreement.
Principal Investigator Rights and Responsibilities
The PD(s)/PI(s) will have the primary responsibility for the scientific, technical, and programmatic aspects of the cooperative agreement and for day-to-day management of the project or program. The PD(s)/PI(s) will maintain general oversight for ensuring compliance with the financial and administrative aspects of the award, as well as ensuring that all staff have sufficient clearance and/or background checks to work on this project or program. This individual will work closely with designated officials within the recipient organization to create and maintain necessary documentation, including both technical and administrative reports; prepare justifications; appropriately acknowledge Federal support in publications, announcements, news programs, and other media; and ensure compliance with other Federal and organizational requirements.
Additional conditions:
1. Cooperate with other Innovation Centers and identify common procedures, as applicable.
2. Participate in site visits or attend meetings as requested by the FDA. A portion of the budget may be reserved for such travel.
3. The awardees will provide FDA any samples if requested by FDA.
4. The awardees will provide FDA any data obtained from work under the cooperative agreement as requested. Data will be posted to appropriate or available data repositories as requested by FDA.
5. FDA may also request data be made available through speaking engagements and publications, presentations at scientific symposia and seminars, while making sure that confidentiality and privacy of the data is protected.
6. Any publication or oral presentation of the results of funded work must undergo FDA review and approval process. This process can take 30-90 days.
7. The grantee must provide quarterly reports as requested, to include status and budget updates.
FDA Responsibilities:
An FDA Project Officer (PO) will have substantial programmatic involvement as described below. The PO is the official responsible for monitoring the programmatic, scientific, and/or technical aspects of assigned applications and grants. The PO’s responsibilities include, but are not limited to, post-award monitoring of project/program performance, including review of progress reports and making site visits; and other activities complementary to those of the Grants Management Officer (GMO). The PO and the GMO work as a team in many of these activities.
FDA will provide technical monitoring and/or direction of the work, including monitoring of data analysis, interpretation of analytical findings and their significance.
FDA will assist and approve (as deemed appropriate) the substance of publications, co-authorship of publications and data release.
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 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.
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.
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
Megan Miller
Center for Veterinary Medicine
Telephone: 301-796-2483
Email: megan.miller@fda.hhs.gov
Kimberly Pendleton
Office of Acquisitions & Grants Services (OAGS)
Food and Drug Administration
Telephone: 240-402-7610
Email: kimberly.pendleton@fda.hhs.gov
Kimberly Pendleton
Office of Acquisitions & Grants Services (OAGS)
Food and Drug Administration
Telephone: 240-402-7610
Email: kimberly.pendleton@fda.hhs.gov
Recently issued policy notices may affect your application submission. A full list of policy notices published by the Guide for Grants and Contracts. 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 of the Public Health Service Act as amended (42 USC 241), section 573(b) of the Federal Food, Drug, and Cosmetic Act (21 USC 360ccc-2(b)) and under Federal Regulations 42 CFR Part 52, 45 CFR Part 75, and 2 CFR Part 200.
and Human Services (HHS)
