Minor Use Minor Species Development of Drugs (R01) is sponsored by U.S. Food and Drug Administration (FDA) Center for Veterinary Medicine (CVM). This grant supports the development and potential approval or conditional approval of new animal drugs intended to treat uncommon diseases (minor uses) in major species (horses, dogs, cats, cattle, pigs, turkeys, and chickens) or to treat minor species.

PAR-24-216: Minor Use Minor Species Development of Drugs (R01) This funding opportunity was updated to align with agency priorities. Carefully reread the full funding opportunity and make any needed adjustments to your application prior to submission. Department of Health and Human Services Part 1.

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

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

of Participating Organizations Center for Veterinary Medicine (CVM) Funding Opportunity Title Minor Use Minor Species Development of March 31, 2025 - This funding opportunity was updated to align with agency priorities. Carefully reread the full funding opportunity and make any needed adjustments to your application prior to submission.

April 04, 2024 - Overview of Grant Application and Review Changes for Due Dates on or after January 25, 2025. See Notice NOT-OD-24-084 Funding Opportunity Number (FON) Companion Notice of Funding Additional Information on Eligibility .

Assistance Listing Number(s) Funding Opportunity Purpose Opportunity (NOFO) is issued by the Food and Drug Administration (FDA), Center for Veterinary Medicine (CVM), and solicits Research Project (R01) grant applications from institutions or organizations that propose to develop or support the development of designated new animal drugs intended for minor uses in major species or for use in minor species (MUMS).

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 Only entities developing drugs for veterinary use or parties working as research partners with such entities are eligible for The organization (or applicant) seeking 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's Office of Minor Use and Minor Species Animal Drug Development (OMUMS) for that drug for a specified intended use, in accordance with the provisions of section 573 of the Food, Drug and Cosmetic Act (21 U.S.C.

360ccc-2) and 21 CFR part 516. FDA/CVM's Office of New Animal Drug Evaluation (ONADE) must have reviewed and concurred with the proposed study protocol before an applicant can submit a grant application.

Open Date (Earliest Submission Date) May 24, 2024 (for July 26, 2024 application due date); November 29, 2024 (for January 31, 2025 application due May 23, 2025 (for July 25, 2025 application due date); November 28, 2025) (for January 30, 2026 application due May 22, 2026 (for July 24, 2026 application due date); November 27, 2026 (for January 29, 2027 application due Letter of Intent Due Date(s) June 21, 2024 (for July 26, 2024 application due date; December 27, 2024 (for January 31, 2025 application due June 20, 2025 (for July 25, 2025 application due date); December 26, 2025 (for January 30, 2026 application due June 19, 2026 (for July 24, 2026 application due date); December 25, 2026 (for January 29, 2027 application due All applications are due by 11:59 PM Eastern Time.

Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date. Applicants should be aware that on-time submission means that an application is submitted error free (of both Grants. gov and eRA Commons errors) by 11:59 PM Eastern Time on the application due date.

applications will not be accepted for this NOFO. AIDS Application Due Date(s) 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. Workspace to prepare and submit your application and eRA Commons to track your application.

Part 1. Overview Information Part 2. Full Text of the Announcement I.

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

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

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

Notice of Funding Opportunity Description 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 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.

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 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 See Section VIII. Other Information for award authorities and regulations. Section II.

Award Information Grant: A financial assistance mechanism providing money, property, or both to an eligible entity to carry out an approved project or Application Types Allowed Apply - Application Guide provide details on these application types. Only those application types listed here are allowed for this NOFO.

Funds Available and Anticipated Number of Awards The number of awards is contingent upon FDA appropriations and the submission of a sufficient number of meritorious applications. The nature and scope of the proposed research will vary from application to application; it is anticipated that the size and duration of each award will also vary.

Although the financial plans of the FDA are to provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds.

Application budgets need to reflect the actual needs of the proposed project and should not exceed the following in total costs (direct YR 03: $250,000 (long-term toxicological study only The length of support of award project periods will depend on the nature of the study but is one (1) year from date of award for most studies. Applicants should explain in the Budget Justification if more than one year of support is needed.

For those studies with an expected duration of more than one year, a second, or in some cases, a third year of noncompetitive continuation of support will depend on the following factors: (1) performance during the preceding year, (2) compliance with the regulatory requirements of an Investigational New Animal Drug File (INAD) and those associated with (3) availability of Federal funds.

The maximum project period is 3 years (long-term Grants Policy Statement will apply to the applications submitted and awards made from this NOFO. Section III.

Eligibility Information Higher Education Institutions Public/State Controlled Institutions of Higher Education Private Institutions of Higher Education The following types of Higher Education Institutions are always encouraged to apply for FDA support as Public or Private Institutions of Higher Education: Hispanic-serving Institutions Historically Black Colleges and Universities (HBCUs) Tribally Controlled Colleges and Universities (TCCUs) Alaska Native and Native Hawaiian Serving Institutions Asian American Native American Pacific Islander Serving Nonprofits Other Than Institutions of Higher Education Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Nonprofits without 501(c)(3) IRS Status (Other than Institutions For-Profit Organizations (Other than Small Businesses) City or Township Governments Special District Governments Indian/Native American Tribal Governments (Federally Recognized) Indian/Native American Tribal Governments (Other than Federally Independent School Districts Public Housing Authorities/Indian Housing Authorities Native American Tribal Organizations (other than Federally recognized tribal governments) Faith-based or Community-based Organizations Non-domestic (non-U.S.) Entities (Foreign Organizations) 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 Program-Specific Eligibility Requirement To be eligible for this funding opportunity: 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 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 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. 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 Non-domestic (non-U.S.) components of U.S. Organizations are eligible to Foreign components, as defined in the HHS Grants Policy Statement , are allowed. Applicant organizations must complete and maintain the following registrations as described in the How to Apply - Application Guide to be eligible to apply for or receive an award.

All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. Failure to complete registrations in advance of a due date is not a valid reason for a late submission, please Grants Policy Statement for additional information.

Award Management (SAM) Applicants must complete and maintain an active requires renewal at least annually . The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.

Commercial and Government Entity (NCAGE) Code Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM. Unique Entity Identifier (UEI)- A UEI is issued as part of the SAM. gov registration process.

The same UEI must be used for all registrations, as well as on the grant application. Commons - Once the unique organization identifier is established, organizations can register with eRA Commons in tandem with completing their 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. Applicants must have an active SAM registration in order to complete the Directors/Principal Investigators (PD(s)/PI(s)) All PD(s)/PI(s) must have an eRA Commons account.

PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.

Eligible Individuals (Program Director/Principal Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with their organization to develop an application for support.

For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the How to Apply - Application Guide . This NOFO does not require cost sharing as defined in the HHS Grants Policy Statement .

Information on Eligibility Applicant organizations may submit more than one application, provided that each application is scientifically distinct. The FDA will not accept duplicate or highly overlapping applications under review at the same time per HHS Grants Policy Statement .

This means that the FDA will not accept: A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new application. An application that has substantial overlap with another application pending appeal of initial peer review (see HHS Grants Policy Statement ).

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 Application and Submission Information 1. Requesting an Application Package The application forms package specific to this opportunity must be accessed through ASSIST, Grants. gov Workspace or an institutional system-to-system solution.

Links to apply using ASSIST or Grants. gov Workspace are available in Part 1 of this NOFO. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

It is critical that applicants follow the Research (R) Instructions to Apply - Application Guide , except where instructed in this notice of funding opportunity to do otherwise. Conformance to the requirements 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 Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and By the date listed in Part 1.

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

Instructions for Application Submission The following section supplements the instructions found in the How to Apply Application Guide and should be used for preparing an application to All instructions in the How to Apply - Application Guide must be followed. SF424(R&R) Project/Performance Site Locations All instructions in the How to Apply - Application Guide must be followed.

SF424(R&R) Other Project Information All instructions in the How to Apply - Application Guide must be followed. SF424(R&R) Senior/Key Person Profile All instructions in the How to Apply - Application Guide must be followed.

All instructions in the How to Apply - Application Guide must be followed, with the following additional 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 Indirect/F&A costs under grants to foreign and international organizations will be funded at a fixed rate of 8 percent of modified total direct costs (MTDC), exclusive of tuition and related fees, direct expenditures for equipment, and subawards in excess of $25,000.

(With the exception of the American University of Beirut and the World Health Organization, which are eligible for full F&A cost reimbursement). Awards to domestic organizations with a foreign or international consortium participant may include 8 percent of MTDC, exclusive of tuition and related fees, direct expenditures for equipment, and subawards in excess of $25,000.

All instructions in the How to Apply - Application Guide must be followed. PHS 398 Cover Page Supplement All instructions in the How to Apply - Application Guide must be followed. All instructions in the How to Apply - Application Guide must be followed, with the following additional 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.

Use/Minor Species Designations List on the FDA website shows the drugs and their intended uses that currently have designation status. The grant application should include the following information attached in the 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.).

2 : A copy of the protocol concurrence letter or a reference to the letter with the submission identifier from the applicable FDA/CVM/ONADE 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. 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. Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the How to Apply - Application Guide .

A Data Management and Sharing Plan is not applicable for this NOFO. 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 PHS Human Subjects and Clinical Trials Information 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 Record: PHS Human Subjects and Clinical Trials Information All instructions in the How to Apply - Application Guide must be followed. 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. PHS Assignment Request Form All instructions in the How to Apply - Application Guide must be followed. Foreign (non-U.S.) organizations must follow policies Grants Policy Statement , and procedures for foreign organizations.

3. Unique Entity Identifier and System for Award See Part 1. Section III.

1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants. gov 4. Submission Dates and Times Part I.

Overview Information contains information about Key Dates and times. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission. When a submission date falls on a weekend or Federal holiday , the application deadline is automatically extended to the next 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.

are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission. Information on the submission process and a definition of on-time submission are provided in the How to Apply Application Guide . 5.

Intergovernmental Review (E. O. This initiative is not subject to intergovernmental All FDA awards are subject to the terms and conditions, cost principles, and other considerations described in the HHS Grants Policy Statement .

Pre-award costs are allowable only as described in the HHS 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 7.

Other Submission Requirements and Information Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide. Paper applications will not be accepted. Applicants must complete all required registrations before the application due date.

Section III. Eligibility Information contains information about registration. For assistance with your electronic application or for more information on the electronic submission process, Apply - Application Guide .

If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Dealing with System Issues guidance. For assistance with application submission, contact the Application Submission Contacts in Section VII . All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile form .

Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to FDA. See Section III of this NOFO for information on registration requirements. The applicant organization must ensure that the unique entity identifier provided on the application