Minor Use Minor Species Development of Drugs: Research Project Grant

Grants to USA, Canada, and International Nonprofits,
For-Profits, IHEs, and Agencies to Develop Drugs for Animals

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Agency Type:

Federal

Funding Source:

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US Food and Drug Administration (FDA), Center for Veterinary Medicine (CVM)

LOI Date:

12/01/20

Deadline Date:

01/15/21 11:59 PM ET

Description:

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Grants to USA, Canada, and International nonprofit organizations, for-profits, IHEs, and government agencies to develop new drugs for animals that may be used in minor species or for minor uses in major species. Applicants are advised that the required registrations may take up to six weeks to complete.

This Funding Opportunity Announcement (FOA) 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 new animal drugs intended for minor use in major species or for use in minor species.

The FDA is authorized to provide grants to assist in defraying the costs of qualified safety and effectiveness testing.

The Food & Drug Administration’s (FDA) Center for Veterinary Medicine’s (CVM) Office of Minor Use & 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.

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.

FDA/CVM’s Office of New Animal Drug Evaluation (ONADE) must have accepted the proposed study protocol prior to application submission.
The following manufacturing studies, as part of the qualified safety and effectiveness studies, are eligible for funding if FDA/CVM/ONADE has accepted the study protocol prior to application submission:

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 accepted the study protocol prior to application submission.
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.

GrantWatch ID#:

GrantWatch ID#: 172152

Estimated Total Program Funding:

$500,000

Number of Grants:

It is anticipated that up to 10 awards will be made. The number of awards is contingent upon FDA appropriations and the submission of a sufficient number of meritorious applications. Award(s) will provide one (1) year of support and include future recommended support for two (2) additional year(s) contingent upon annual appropriations, availability of funding and satisfactory awardee performance.

Estimated Size of Grant:

There are two levels of funding available. The FDA will award grants up to $100,000 per year for up to 2 years (level one), or up to $150,000 per year for up to 3 years in certain cases (level two). Please note the dollar limitation will apply to total costs, not direct costs. Applications for the smaller level one grants ($100,000) may be for any routine safety or effectiveness study supportive of new animal drug approval or conditional approval of the designated product for the designated intended use. Study proposals for larger level two grants ($150,000) must be for necessary studies that are of unusual complexity, duration, or size. A third year of funding is available only for long-term toxicological studies.

Application budgets need to reflect the actual needs of the proposed project and should not exceed the following in total costs (direct and indirect):

Level One:
- Year 01: $100,000
- Year 02: $100,000

Level Two:
- Year 01: $150,000
- Year 02: $150,000
- Year 03: $150,000 (long-term toxicological study only)

Term of Contract:

The length of support of award project periods will depend on the nature of the study, but is one-year from date of award for most studies. 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 designation, and (3) Availability of Federal funds.

The maximum project period is 3 years.

A third year of funding is available only for long-term toxicological studies.

Earliest Start Date:
- February 2019 for the August 27, 2018 Deadline
- June 2019 for the January 18, 2019 Deadline
- February 2020 for the August 16, 2019 Deadline
- June 2020 for the January 17, 2020 Deadline
- February 2021 for the August 14, 2020 Deadline
- June 2021 for the January 15, 2021 Deadline

Eligibility:

City or township governments
County governments
For profit organizations other than small businesses
Independent school districts
Indian housing authorities
Native American tribal governments (Federally recognized)
Native American tribal organizations (other than Federally funded tribal governments)
Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education
Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education
Private institutions of higher education
Public and State controlled institutions of higher education
Public housing authorities
See RFP and/or Grant Guidelines for full eligibility
Small businesses
Special district governments
State governments

Additional Eligibility Criteria:

Additional Information on Eligibility: 1) The applicant seeking approval of the new animal drug under investigation 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 prior to application submission; and 2) FDA/CVM’s Office of New Animal Drug Evaluation (ONADE) must accept the protocol for the proposed study prior to application submission.

The following types of Higher Education Institutions are always encouraged to apply for FDA support as Public or Private Institutions of Higher Education:
- Hispanic-serving Institutions
- Historically Black Colleges and Universities (HBCUs)
- Tribally Controlled Colleges and Universities (TCCUs)
- Alaska Native and Native Hawaiian Serving Institutions
- Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)

Foreign Institutions:
- Non-domestic (non-U.S.) Entities (Foreign Institutions) 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.

Eligible Individuals (Program Director/Principal Investigator):
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 his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for FDA support.

For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide.

Pre-proposal Conference:

A technical session will be held for prospective applicants in July 2018; any future dates will be based on receipt of letters of intent. The conference call information will be provided to prospective applicants that submit a letter of intent. The technical session will provide an overview of the submission requirements and allow prospective applicants an opportunity to ask questions regarding the application process. Participation in the technical session is optional, but strongly encouraged.

Pre-Application Information:

Timeline:
Application Due Date(s):
- August 27, 2018; Open Date: June 27, 2018, Letter of Intent Due Date: July 2, 2018; Scientific Merit Review: November 2018
- January 18, 2019; Open Date: November 16, 2018, Letter of Intent Due Date: December 3, 2018; Scientific Merit Review: April 2019
- August 16, 2019; Open Date: June 14, 2019, Letter of Intent Due Date: July 1, 2019; Scientific Merit Review: November 2019
- January 17, 2020; Open Date: November 15, 2019, Letter of Intent Due Date: December 2, 2019; Scientific Merit Review: April 2020
- August 14, 2020; Open Date: June 19, 2020, Letter of Intent Due Date: July 1, 2020; Scientific Merit Review: November 2020
- January 15, 2021; Open Date: November 13, 2020, Letter of Intent Due Date: December 1, 2020; Scientific Merit Review: April 2021

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.

Late applications will not be accepted for this FOA.

An application for a given study can only be submitted for one level of funding.

Letter of Intent: 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 FDA staff to estimate the potential review workload and plan the 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.
1. Use the NIH ASSIST system to prepare, submit and track your application online.
2. 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.
3. Use Grants.gov Workspace to prepare and submit your application and eRA Commons to track your application.

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. eRA Commons 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. Late applications will not be accepted for this FOA.

Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission.

Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. Failure to complete registrations in advance of a due date is not a valid reason for a late submission.
- Dun and Bradstreet Universal Numbering System (DUNS)
- System for Award Management (SAM) (formerly CCR)
- eRA Commons
- Grants.gov

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.

This FOA does not require cost sharing as defined in the HHS Grants Policy Statement.

Additional information about minor use and minor species is available on the FDA’s website for OMUMS: http://www.fda.gov/AnimalVeterinary/DevelopmentApprovalProcess/MinorUseMinorSpecies/default.htm

Frequently Asked Questions:
https://grants.nih.gov/grants/ElectronicReceipt/faq_full.htm

View this opportunity on Grants.gov:
https://www.grants.gov/web/grants/view-opportunity.html?oppId=306175

For a list of application documents, see the Package tab (press Preview) on the Grants.gov page above.

Contact Information:

Before starting your grant application, please review the funding source's website listed below for updates/changes/addendums/conferences/LOIs.

Apply online using ASSIST:
https://public.era.nih.gov/assist/public/login.era?TARGET=https%3A%2F%2Fpublic.era.nih.gov%2Fassist%2F

The letter of intent should be sent to:
Bryce Jones
Grants Management Specialist
E-mail: bryce.jones@fda.hhs.gov
Phone: 240-402-2111

Application Submission Contacts:
- eRA Service Desk - for questions regarding ASSIST, eRA Commons registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, post submission issues):
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)
Finding Help Online: https://grants.nih.gov/support/index.html

- Grants.gov Customer Support - For questions regarding Grants.gov registration and submission, downloading forms and application packages:
Contact CenterTelephone: 800-518-4726
Email: support@grants.gov

Scientific/Research Contact(s):
Dr. Stuart Jeffrey
Office of Minor Use Minor Species Animal Drug Development (OMUMS)
Center for Veterinary Medicine (CVM)
Food and Drug Administration (FDA)
7500 Standish Place (HFV-50)
Rockville, MD 20855
Telephone: 240-402-0568
Email: stuart.jeffrey@fda.hhs.gov

Objective Review Contact(s):
Rene Vasquez
Grants Management Specialist
Office of Acquisition & Grants Services (OAGS)
Food and Drug Administration
Telephone:301-796-3546
Email: rene.vasquez@fda.hhs.gov

CFDA Number:

93.103

Funding or Pin Number:

PAR-18-827

URL for Full Text (RFP):

See the full text of this grant

Geographic Focus:

USA: Alabama; Alaska; Arizona; Arkansas; California; Colorado; Connecticut; Delaware; Florida; Georgia; Hawaii; Idaho; Illinois; Indiana; Iowa; Kansas; Kentucky; Louisiana; Maine; Maryland; Massachusetts; Michigan; Minnesota; Mississippi; Missouri; Montana; Nebraska; Nevada; New Hampshire; New Jersey; New Mexico; New York City; New York; North Carolina; North Dakota; Ohio; Oklahoma; Oregon; Pennsylvania; Rhode Island; South Carolina; South Dakota; Tennessee; Texas; Utah; Vermont; Virginia; Washington, DC; Washington; West Virginia; Wisconsin; Wyoming

USA Territories: American Samoa (USA) Guam (USA) Puerto Rico (USA) Virgin Islands (USA) Northern Mariana Islands (USA)

USA Compact Free Associations: The Federated States of Micronesia (USA) Marshall Islands (USA) Republic of Palau (USA)

Canada: Alberta; British Columbia; Manitoba; New Brunswick; Newfoundland and Labrador; Northwest Territories; Nova Scotia; Nunavut; Ontario; Prince Edward Island; Quebec; Saskatchewan; Yukon;

Israel

International country outside of the USA, Israel and Canada.

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