Required Application Instructions
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.
- A study to evaluate the stability of a MUMS drug;
- A study to validate analytical methods associated with the manufacture of a MUMS drug;
- A study to determine the homogeneity/segregation of an animal feed bearing or containing a MUMS drug;
- A study to validate analytical methods for an animal feed bearing or containing a MUMS drug.
- Public/State Controlled Institutions of Higher Education
- Private Institutions of Higher Education
- 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)
- 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
- Non-domestic (non-U.S.) Entities (Foreign Organizations)
- The applicant must be an organization, or a party working as the organization's research partner, in the process of developing, or supporting the development of, a designated new animal drug intended for minor use in a major species or intended for use in a minor species (MUMS). Section I. Funding Opportunity Description provides details regarding minor use.
- The organization seeking FDA approval of the new animal drug under investigation must have already opened an Investigational New Animal Drug (INAD) file and must already hold a MUMS "designation" granted by FDA/CVM's Office of Minor Use and Minor Species Animal Drug Development (OMUMS) for that drug for a specified intended use prior to applying. The Minor Use/Minor Species Designations List on the FDA website shows the drugs and their intended uses that currently have designation status.
- Applicants must propose studies intended to provide new animal drug safety and/or effectiveness data that could be used to satisfy the requirements for FDA approval of the drug for a MUMS-designated intended use. See Studies eligible for funding below.
-
FDA/CVM’s Office of New Animal Drug Evaluation (ONADE) must have
already reviewed and concurred with the protocol for the proposed study before
the applicant can apply.
- The study protocol must be submitted under an active INAD file and must support the development of the MUMS-designated drug product toward FDA approval or conditional approval.
- Studies involving products already approved by FDA for veterinary use that are intended to evaluate new MUMS indications are also subject to the above INAD requirements.
- The applicant must be in compliance with INAD and designation regulations at the time of application submission, as applicable. The applicant must remain in compliance throughout the proposed project period if the FDA awards the applicant a grant.
- Qualified safety and effectiveness testing includes studies that support target animal safety or effectiveness, environmental safety, human food safety, and certain manufacturing studies, as well as the analytical method validation studies described below, when a grant will either result in, or substantially contribute to, the FDA approval or conditional approval of a MUMS-designated drug for a designated use.
- The following manufacturing studies, as part of the qualified safety and effectiveness studies, are eligible for funding, if FDA/CVM/ONADE has reviewed and concurred with the study protocol prior to application submission: 1) a study to evaluate the stability of a MUMS drug, 2) a study to validate analytical methods associated with the manufacture of a MUMS drug, 3) a study to determine the homogeneity/segregation of an animal feed bearing or containing a MUMS drug, and 4) a study to validate analytical methods for an animal feed bearing or containing a MUMS drug.
- A separate study to validate an analytical method prior to the conduct of an in-life human food safety study is eligible for funding if FDA/CVM/ONADE has already reviewed and concurred with the study protocol prior to application submission.
- 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.
- o 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.
- o 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 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
- Applicants requesting multiple years of support must complete and submit a separate detailed budget breakdown and narrative justification for each year of financial support requested.
- If an applicant is requesting indirect costs as part of their budget, a copy of the most recent Federal indirect cost rate or F&A agreement must be provided as part of the application submission. This agreement should be attached to the RESEARCH & RELATED Other Project Information Component as line #12 'Other Attachments'.
- If the applicant organization has never established an indirect cost rate and/or does not have a negotiated Federal indirect cost rate agreement, a de minimis indirect cost rate of 10 percent (10%) of modified total direct costs (MTDC) will be allowed. MTDC means all direct salaries and wages, applicable fringe benefits, materials and supplies, services, travel, and subaward and subcontracts up to the first $25,000 of each subaward or subcontract. MTDC excludes equipment, capital expenditures, charges for patient care, rental costs, tuition remission, scholarships and fellowships, participant support costs and the portion of each subaward and subcontract in excess of $25,000.
- Indirect/F&A costs under grants to foreign and international organizations will be funded at a fixed rate of 8 percent of modified total direct costs (MTDC), exclusive of tuition and related fees, direct expenditures for equipment, and subawards in excess of $25,000. (With the exception of the American University of Beirut and the World Health Organization, which are eligible for full F&A cost reimbursement). Awards to domestic organizations with a foreign or international consortium participant may include 8 percent of MTDC, exclusive of tuition and related fees, direct expenditures for equipment, and subawards in excess of $25,000.
- Specific Aims is limited to 1 page.
- Research Strategy, including tables, graphs, figures, diagrams, and charts, is limited to 12 pages. This 12-page limit does not apply to the study protocol concurred-upon by FDA/CVM/ONADE; the study protocol should be a separate attachment in the Appendix (see below).
- The Significance section of the Research Strategy (PHS 398 Research Plan) should explain how the proposed study will contribute to FDA approval or conditional approval of the designated new animal drug product for the designated intended use. The applicant should state or reference the specific designated intended use of the drug that the proposed study supports. The Minor Use/Minor Species Designations List on the FDA website shows the drugs and their intended uses that currently have designation status.
- Attach as Appendix 1: A copy of the study protocol that FDA/CVM Office of New Animal Drug Evaluation (ONADE) reviewed and concurred with. The applicant should not alter the protocol from the version that FDA/CVM/ONADE concurred with. Protocol changes could result in ineligibility of a grant application. It is not necessary to include the protocol forms in the grant application (e.g., blank data capture forms, etc.).
- Attach as Appendix 2: A copy of the protocol concurrence letter or a reference to the letter with the submission identifier from the applicable FDA/CVM/ONADE review division.
- Attach as Appendix 3: A letter from the entity sponsoring the designated new animal drug under investigation documenting the relationship between the sponsor and the party submitting the grant application if the applicant is a party other than the animal drug sponsor of the designated new animal drug. The animal drug sponsor should also submit this letter to their INAD file.
- Attach as Appendix 4: A letter from the supplier of the product under investigation, stating that the product is available to the applicant in the form and quantity needed to conduct the proposed study. If negotiations regarding the supply of the study product are underway but have not been finalized at the time of application, a letter indicating such must be provided in the application. Verification of adequate supply of study product will be necessary before an award is made.
- A Data Management and Sharing Plan is not applicable for this NOFO.
- Will receive a written critique.
- Scientific and technical merit of the proposed project as determined by scientific objective review.
- Availability of funds.
- Relevance of the proposed project to program priorities.
- Policies and procedures
- List of grant expenditures
- Accounting records
- Supporting documents (e.g., invoices, receipts, paystubs, timesheets, contracts, etc.)
- Financial statements
- Audit reports
- Other related documentation
- Reasonable steps must be taken to ensure that the project provides meaningful access to persons with limited English proficiency. For guidance on meeting the legal obligation to take reasonable steps to ensure meaningful access to the 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 the specific legal obligations for serving qualified individuals with disabilities, including providing program access, reasonable modifications, and taking appropriate steps to provide effective communication, 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 guidance on administering the project in compliance with applicable federal religious nondiscrimination laws and 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
The Food and Drug Administration’s (FDA) Center for Veterinary Medicine’s (CVM) Office of Minor Use and Minor Species Animal Drug Development (OMUMS) was created after The Minor Use and Minor Species Animal Health Act of 2004 (MUMS act) was signed into law. The MUMS act helps make more medications legally available to veterinarians and animal owners to treat minor animal species and minor uses in major animal species (MUMS drugs). Major species of animals are: horses, dogs, cats, cattle, swine, turkeys, and chickens. All other animal species (except humans) are minor species. A minor use is the intended use of a new animal drug in a major species for an indication that occurs infrequently and in only a small number of animals or in limited geographical areas and in only a small number of animals annually in the United States.
To determine whether any particular use in a major species is a minor use, the FDA has established a specific small number of animals for each of the seven major animal species as follows: Horses-50,000 annually; Dogs-80,000 annually; Cats-150,000 annually; Cattle-310,000 annually; Swine-1,450,000 annually; Turkeys-14,000,000 annually; and Chickens-72,000,000 annually. Additional information about minor use and minor species is available on the FDA’s website for OMUMS.
The FDA is authorized to provide grants to assist in defraying the costs of qualified safety and effectiveness testing that could be used to satisfy the requirements for FDA approval of MUMS-designated drugs. The entity seeking FDA approval of the new animal drug under investigation must have opened an Investigational New Animal Drug (INAD) file with FDA/CVM and must hold a minor use or minor species "designation" granted by FDA/CVM/OMUMS for that drug for a specified intended use prior to application submission; the entity requests designation status through a formal request to their INAD file.
FDA/CVM’s Office of New Animal Drug Evaluation (ONADE) must have already concurred with the proposed study protocol.
Qualified safety and effectiveness testing eligible for funding includes studies that support target animal safety or effectiveness, environmental safety, human food safety, and certain manufacturing studies, as well as the analytical method validation studies described below. The following manufacturing studies, as part of the qualified safety and effectiveness studies, are eligible for funding if FDA/CVM/ONADE has already reviewed and concurred with the study protocol:
A separate study to validate an analytical method prior to the conduct of an in-life human food safety study is also eligible for funding if FDA/CVM/ONADE has already reviewed and concurred with the study protocol.
Applicants must explain how the proposed study will contribute to FDA approval or conditional approval of the product in the application’s Significance section of the Research Strategy (PHS 398 Research Plan).
All funded studies are subject to the requirements of the Federal Food, Drug and Cosmetic Act (21 U.S.C. 331 et seq.), regulations issued under it, and applicable Department of Health and Human Services (HHS) statutes and regulations.
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.
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:
o Hispanic-serving Institutions
o Historically Black Colleges and Universities (HBCUs)
o Tribally Controlled Colleges and Universities (TCCUs)
o Alaska Native and Native Hawaiian Serving Institutions
o Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)
Nonprofits Other Than Institutions of Higher Education
For-Profit Organizations
Local Governments
Other
Additional Information on Eligibility: 1) The organization (or applicant) seeking approval of the new animal drug under investigation must have already opened an Investigational New Animal Drug (INAD) file with FDA/CVM and must already hold a minor use or minor species (MUMS) "designation" granted by FDA/CVM's Office of Minor Use and Minor Species Animal Drug Development (OMUMS) for that drug prior to application submission; and 2) FDA/CVM’s Office of New Animal Drug Evaluation (ONADE) must have already reviewed and concurred with the protocol for the proposed study before the applicant applies.
To be eligible for this funding opportunity:
Studies eligible for funding:
Applicants are strongly encouraged to contact FDA to resolve any unanswered questions about eligibility criteria or the application process itself before applying. Please direct all questions of a technical or scientific nature to the OMUMS program staff and all questions of an administrative or financial nature to the grants management staff. See Section VII. Agency Contacts.
Non-domestic (non-U.S.) Entities (Foreign Organizations) are
eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are eligible to
apply.
Foreign components, as defined
in the HHS Grants Policy Statement, are 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 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 HHS Grants Policy Statement. This means that the FDA will not accept:
The FDA will not accept any application that is essentially the same as one currently pending initial objective review unless the applicant withdraws the pending application. When a previously objectively reviewed, unfunded application, and originally submitted as an investigator-initiated application, is submitted again in response to this funding opportunity, it should be prepared as a NEW application.
Resubmission applications are not permitted in response to this NOFO.
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:
Terrin Brown
Office of Acquisitions & Grants Services (OAGS)
Food and Drug Administration
Email: [email protected]
All page limitations described in the How to Apply Application Guide and the Table of Page Limits must be followed with the following exceptions or additional requirements:
Specific Aims - One (1) page;
For this specific NOFO, the Research Strategy section is limited to 12 pages. This 12-page limit does not apply to the study protocol that FDA/CVM/ONADE has already concurred with; that protocol should be attached separately to the application in the Appendix.
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:
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:
The grant application should include the following information attached in the Appendix:
Resource Sharing Plan:
Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the How to Apply - Application Guide.
Appendix:
Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the How to Apply - Application Guide . Attach required documents to the Appendix as described above under PHS Research Plan
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 How to Apply - Application Guide , with the following additional instructions:
If you answered Yes to the question Are Human Subjects Involved? on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or Delayed Onset Study record.
Study Record: PHS Human Subjects and Clinical Trials Information
All instructions in the How to Apply - Application Guide must be followed.
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 How to Apply - Application Guide must be followed.
All instructions in the How to Apply - Application Guide must be followed.
Foreign (non-U.S.) organizations must follow policies described in the HHS Grants Policy Statement, and procedures for foreign organizations.
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 . Late applications will not be accepted for this NOFO.
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
Funds may be restricted until a grantee either negotiates an Animal Welfare Assurance with the NIH Office of Laboratory Animal Welfare (OLAW) or establishes an Interinstitutional Assurance with an institution having a PHS-approved Animal Welfare Assurance before conducting any study involving animal subjects.
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 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 Grants Management Specialist and responsiveness by components of participating organizations, FDA. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.
Applicants are required to follow the instructions for post-submission materials, as described in the policy. Any instructions provided here are in addition to the instructions in the policy.
Only the review criteria described below will be considered in the review process.
Applications submitted to the FDA in support of the FDA's 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 merit and give a separate score for each.
Does the proposed study address an aspect of new animal drug safety or effectiveness that will substantially contribute to the FDA approval or conditional approval of the designated drug product?
Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? 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?
Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Does the application adequately describe the rationale, design, facilities, proposed conduct, proposed evaluation, and justification for financial support of the proposed study, including the ability of the applicant to complete the proposed study within the proposed budget and time limits? Are potential problems, alternative strategies, and benchmarks for success presented?
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 the requested budget and duration reasonable relative to the proposed research? Does the budget adequately describe the costs associated with meeting the aims of the project? Are Senior/Key Persons and other required personnel identified in the budget? Is the level of effort for Senior/Key Personnel adequate to conduct the aims of the project? Are consultants identified and their service costs adequately described in the attached budget justification? If the budget includes subaward/consortium costs, are those costs sufficiently detailed?
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.
Not Applicable
Not Applicable
Not Applicable
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.
Applications will be evaluated for scientific and technical merit by (an) appropriate Objective Review Committee convened by the FDA, using the stated review criteria.
As part of the scientific objective review, all applications:
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.
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.
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 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.
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 System for Award Management (SAM.gov) requirements. SAM.gov requires Federal agencies to review and consider information about an applicant in the designated integrity and performance system (currently SAM.gov) prior to making an award. An applicant can review and comment on any information in the responsibility/qualification records available in SAM.gov. FDA will consider any comments by the applicant, in addition to the information available in the responsibility/qualification records in SAM.gov, 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 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.
Reporting Requirements
All FDA grants require both Financial and Performance reporting.
Financial Reporting:
Financial Expenditure Reports
A required Federal Financial Report (FFR) must be submitted annually. All annual FFRs must be submitted electronically using the Payment Management System (PMS). This includes all initial FFRs being prepared for submission and any revised FFRs being submitted or re-submitted to FDA. Paper expenditure/FFR reports will not be accepted.
Annual FFRs must be submitted for each budget period no later than 90 days after the end of the calendar quarter in which the budget period ended. The reporting period for an annual FFR will be that of the budget period for the particular grant; however, the actual submission date is based on the calendar quarter.
Performance Progress Reporting:
When multiple years (more than one budget period) are involved, recipients will be required to submit the Research Performance Progress Report (RPPR) annually as required in the Notice of Award. Annual RPPRs must be submitted using the RPPR module in eRA Commons. The annual RPPR must include a detailed budget. Annual RPPRs are due no later than 60 days prior to the start of the next budget period.
Failure to submit timely reports may affect future funding. Additional Financial and Performance Progress reports may be required. Any additional reporting requirements will be listed under Section IV Special Terms and Condition of the Notice of Award.
Salary Caps:
None of the funds in this award shall be used to pay the salary of an individual at a rate in excess of the current Executive Level II of the Federal Executive Pay Scale.
Certificates of Confidentiality 42 U.S.C. 241(d)
Recipients are responsible for complying with all requirements to protect the confidentiality of identifiable, sensitive information that is collected or used in biomedical, behavioral, clinical, or other research (including research on mental health and research on the use and effect of alcohol and other psychoactive drugs) funded wholly or in part by the Federal Government. See 42 U.S.C. 241(d). All research funded by FDA, in whole or in part, that is within the scope of these requirements is deemed to be issued a Certificate of Confidentiality through these Terms and Conditions. Certificates issued in this manner will not be issued as a separate document.
Recipients are expected to ensure that any investigator or institution not funded by FDA who receives a copy of identifiable, sensitive information protected by these requirements, understand they are also subject to the requirements of 42 U.S.C. 241(d). Recipients are also responsible for ensuring that any subrecipient that receives funds to carry out part of the FDA award involving a copy of identifiable, sensitive information protected by these requirements understand they are also subject to subsection 42 U.S.C. 241(d).
Acknowledgment of Federal Support:
When issuing statements, press releases, publications, requests for proposal, bid solicitations and other documents such as toolkits, resource guides, websites, and presentations (hereafter statements ) describing the projects or programs funded in whole or in part with FDA federal funds, the recipient must clearly state:
1. the percentage and dollar amount of the total costs of the program or project funded with federal money; and,
2. the percentage and dollar amount of the total costs of the project or program funded by non-governmental sources.
When issuing statements resulting from activities supported by FDA financial assistance, the recipient entity must include an acknowledgement of federal assistance using one of the following statements.
If the FDA Grant or Cooperative Agreement is NOT funded with other non-governmental sources:
This [project/publication/program/website, etc.] [is/was] supported by the Food and Drug Administration (FDA) of the U.S. Department of Health and Human Services (HHS) as part of a financial assistance award [FAIN] totaling $XX with 100 percent funded by FDA]/HHS. The contents are those of the author(s) and do not necessarily represent the official views of, nor an endorsement, by FDA/HHS, or the U.S. Government.
If the FDA Grant or Cooperative Agreement IS partially funded with other nongovernmental sources:
This [project/publication/program/website, etc.] [is/was] supported by the Food and Drug Administration (FDA) of the U.S. Department of Health and Human Services (HHS) as part of a financial assistance award [FAIN] totaling $XX with XX percentage funded by FDA/HHS and $XX amount and XX percentage funded by non-government source(s). The contents are those of the author(s) and do not necessarily represent the official views of, nor an endorsement, by FDA/HHS, or the U.S. Government.
The federal award total must reflect total costs (direct and indirect) for all authorized funds (including supplements and carryover) for the total competitive segment up to the time of the public statement. Any amendments by the recipient to the acknowledgement statement must be coordinated with FDA. If the recipient plans to issue a press release concerning the outcome of activities supported by FDA financial assistance, it should notify FDA in advance to allow for coordination.
Additional prior approval requirements pertaining to Acknowledgement of Federal Support, publications, press statements, etc. may be required, and if applicable, will be listed under Special Terms and Condition of the Notice of Award.
Prior Approval:
All prior approval requests must be submitted using the Prior Approval module in eRA Commons. Any requests involving budgetary issues must include a new proposed budget and a narrative justification of the requested changes. If there are any questions regarding the need or requirement for prior approval for any activity or cost, the recipient is to contact the assigned Grants Management Specialist prior to expenditure of funds.
For grant awards not covered under Expanded Authorities, Carryover and No Cost Extension (NCE) requests will require prior approval. All Carryover and NCE requests should be submitted using the Prior Approval module in eRA Commons.
The following activities require prior approval from FDA on all awards:
1. Change in Recipient Organization
2. Significant Rebudgeting
3. Change in Scope or Objectives
4. Deviation from Terms and Conditions of Award
5. Change in Key Personnel which includes replacement of the PD/PI or other key personnel as specified on the NoA.
6. Disengagement from the project for more than three months, or a 25 percent reduction in time devoted to the project, by the approved PD/PI. No individual may be committed to more than 100% professional time and effort. In the event that an individual's commitment exceeds 100%, the recipient must make adjustments to reduce effort. For FDA-sponsored projects, significant reductions in effort (i.e., in excess of 25% of the originally proposed level of effort) for the PD/PI and key personnel named on named on this Notice of Award must receive written prior approval from FDA.
Audits and Monitoring:
Audit Requirements:
1. Recipients of Federal funds are subject to annual audit requirements as specified in 45 CFR 75.501 (eCFR :: 45 CFR 75.501 -- Audit requirements.). Recipients should refer to this regulation for the current annual Federal fund expenditure threshold level which requires audit.
2. Foreign recipients are subject to the same audit requirements as for-profit organizations (specified in 45 CFR 75.501(h) through 75.501(k).
3. For-profit and foreign entities can email their audit reports to [email protected] or mail them to the following address:
U.S. Department of Health and Human Services
Audit Resolution Division, Room 549D
Attention: Robin Aldridge, Director
200 Independence Avenue, SW
Washington, DC 20201
Monitoring:
Recipients are responsible for managing the day-to-day operations of grant-supported activities using their established controls and policies, as long as they are consistent with Federal, DHHS and FDA requirements. However, to fulfill their role in regard to the stewardship of Federal funds, FDA monitors our grants to identify potential problems and areas where technical assistance might be necessary. This active monitoring is accomplished through review of reports and correspondence from the recipient, audit reports, site visits, and other information available to FDA.
1. Desk review: FDA grants monitoring specialists will periodically reach out to recipients to request information for the completion of desk reviews. Requested information may include:
2. Site visits: FDA will conduct site visits when necessary and will notify the recipient with reasonable advance notice of any such visit(s).
3. Foreign entities: All Foreign entities are subject to the same monitoring requirements as domestic entities. Foreign entities covered under immunity Executive Orders will provide supporting documents for monitoring requirements unless such an action is a violation of the Executive Orders. Recipients may discuss with the FDA to come up with an alternate approach to satisfy the award monitoring requirements.
All recipients will make reasonable efforts to resolve issues found, including audit findings. Successful resolutions to issues are important as they are part of the grant performance review. All recipients are responsible for submitting all requested information in an expeditious manner. Failure to submit timely reports and/or respond to inquiries from FDA may affect future funding or enforcement actions, including withholding, or conversion to a reimbursement payment method.
All recipients will make reasonable efforts to resolve issues found, including audit findings. Successful resolutions to issues are important as they are part of the grant performance review. All recipients are responsible for submitting all requested information in an expeditious manner. Failure to submit timely reports and/or respond to inquiries from FDA may affect future funding or enforcement actions, including withholding, or conversion to a reimbursement payment method.
Financial Conflict of Interest (FCOI):
This award is subject to the Financial Conflict of Interest (FCOI) regulation at 42 CFR Part 50 Subpart F.
Closeout Requirements (when applicable):
A Final Research Performance Progress Report (FRPPR), Final Invention Statement (FIS) HHS-568 (if applicable), Tangible Personal Property Report SF-428 (if applicable), and Statement of Disposition of Equipment (if applicable) must be submitted within 120 days after the expiration date of the project period. All closeout documents must be submitted electronically in eRA Commons.
The Final Federal Financial Report (FFFR) SF-425 must be submitted in the Payment Management System (PMS) within 120 days after the expiration date of the project period. Recipients have 90 days after the project period end date to liquidate all obligations in PMS. All obligations must be liquidated prior to the submission of the Final FFR. The Final FFR must indicate the exact balance of unobligated funds and may not reflect unliquidated obligations. There must be no discrepancies between the Final FFR expenditure data and FFR cash transaction data in the Payment Management System (PMS). The expended funds reported on the Final FFR must exactly match the disbursements and the charge advances in PMS. It is the recipient's responsibility to reconcile reports submitted to PMS and to the FDA.
Program Income:
The recipient is required to report any Program Income generated during the Project Period of this grant. Except for royalty income generated from patents and inventions, the amount and disposition of Program Income must be identified on lines 10 (l), (m), (n), and (o) of the recipient s Federal Financial Report (FFR) SF-425.
Examples of Program Income include (but are not limited to): fees for services performed during the grant or sub-grant period, proceeds from sale of tangible personal or real property, usage or rental fees, patent or copyright royalties, and proceeds from the sale of products and technology developed under the grant.
Any Program Income generated during the Project Period of this grant by the recipient or sub-recipient will be treated as identified below.
Treatment of Program Income:
Additional Costs
Prohibition on certain telecommunications and video surveillance services or equipment:
(a) As described in CFR 200.216, recipients and subrecipients are prohibited to obligate or spend grant funds (to include direct and indirect expenditures as well as cost share and program) to:
(1) Procure or obtain,
(2) Extend or renew a contract to procure or obtain; or
(3) Enter into contract (or extend or renew contract) to procure or obtain equipment, services, or systems that use covered telecommunications equipment or services as a substantial or essential component of any system, or as critical technology as part of any system. As described in Pub. L. 115-232, section 889, covered telecommunications equipment is telecommunications equipment produced by Huawei Technologies Company or ZTE Corporation (or any subsidiary or affiliate of such entities).
i. For the purpose of public safety, security of government facilities, physical security surveillance of critical infrastructure, and other national security purposes, video surveillance and telecommunications equipment produced by Hytera Communications Corporation, Hangzhou Hikvision Digital Technology Company, or Dahua Technology Company (or any subsidiary or affiliate of such entities).
ii. Telecommunications or video surveillance services provided by such entities or using such equipment.
iii. Telecommunications or video surveillance equipment or services produced or provided by an entity that the Secretary of Defense, in consultation with the Director of the National Intelligence or the Director of the Federal Bureau of Investigation, reasonably believes to be an entity owned or controlled by, or otherwise, connected to the government of a covered foreign country.
Other:
The award is subject to the requirements of 2 CFR Part 25 for institutions to maintain an active registration in the System of Award Management (SAM). Should a consortium/subaward be issued under the award, a requirement for active registration in SAM must be included.
In accordance with the regulatory requirements provided at 45 CFR 75.113 and Appendix XII to 45 CFR Part 75, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts with cumulative total value greater than $10,000,000 must report and maintain information 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 the Federal Awardee Performance and Integrity Information System (FAPIIS)). Full reporting requirements and procedures are found in Appendix XII to 45 CFR Part 75.
The project must be administered in compliance with federal civil rights laws that prohibit discrimination on the basis of race, color, national origin, disability, age and, in some circumstances, religion, conscience, and sex (including gender identity, sexual orientation, and pregnancy). This includes taking reasonable steps to provide meaningful access to persons with limited English proficiency and providing programs that are accessible to and usable by persons with disabilities. The HHS Office for Civil Rights provides guidance on complying with civil rights laws enforced by HHS.
Please 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
USE OF ANIMALS IN RESEARCH
NOTICE: VERTEBRATE ANIMALS: Under governing regulations, no Federal funds administered by the Department of Health and Human Services may be expended for research involving animals or identifiable data, as defined by the Office of Laboratory Animal Welfare (OLAW), without an Assurance to comply with the requirements of Humane Care and Use of Laboratory Animals. The restriction against using Federal funds for this purpose applies to all performance sites or suppliers of identifiable data, whether domestic or foreign, that does not have an Animal Welfare-approved assurance. The awardee is responsible for determining whether or not performance sites are 'engaged' in vertebrate animal research as defined by OLAW and must ensure the compliance of all performance sites. Refer to the OLAW website at http://grants1.nih.gov/grants/olaw/olaw.htm for details and guidance.
By accepting an award the grantee certifies that 1) its Institutional Animal Care and Use Committee(s) (IACUC) has addressed the specific issue of "engagement" in vertebrate animal research by its own organization as well as any other performance sites; 2) any performance site determined to be "engaged" in vertebrate animal research will have an OLAW-approved Assurance in place, or be explicitly listed as an affiliated institution on another institution's Assurance document, before it performs any vertebrate animal research; 3) the grantee will provide FDA with the name and address of each performance site requiring an assurance, and notify FDA if additional sites requiring assurances are identified post-award; 4) the grantee will provide FDA with the name and address of each performance site that the grantee's IACUC has determined is not "engaged" in vertebrate animal research; and 5) the grantee will provide FDA with Assurance numbers as they are approved for performance sites.
If the applicant organization does not have an Animal Welfare Assurance and the animal work will be conducted at an institution with an Assurance, the grantee must obtain an Inter-institutional Assurance from OLAW. Animal Welfare Assurances must be submitted to OLAW no later than 30 days from award. Failure to submit the Animal Welfare Assurance to OLAW within the required timeframe or to otherwise comply with the above requirements can result in suspension and/or termination of this award, withholding of support, audit disallowances, and/or other appropriate action.
Not Applicable
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.
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 (Responsibility/Qualification in SAM.gov, formerly 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: [email protected]
Dr. Janah Maresca
Office of Minor Use and Minor Species Animal Drug Development (OMUMS)
Center for Veterinary Medicine (CVM)
Food and Drug Administration
Telephone: 301-796-5079
Email: [email protected]
Terrin Brown
Office of Acquisitions & Grants Services (OAGS)
Food and Drug Administration
Email: [email protected]
Recently issued trans-FDA policy notices may affect your application submission. A full list of policy notices published by FDA is provided in 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 Section 573(b) of the Food, Drug and Cosmetic Act (21 U.S.C. 360ccc-2(b)) and under Federal Regulations 42 CFR Part 52 and 45 CFR Part 75.
and Human Services (HHS)
