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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

Agency Type:

Federal

Funding Source:

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

LOI Date:

12/03/18

Deadline Date:

01/18/19 11:59 PM ET

Description:

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Grants to USA, Canada, and International nonprofits, 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 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.

Purpose/Research Objectives

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.

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-70,000 annually; Cats-120,000 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 for designated new animal drugs to assist in defraying the costs of qualified safety and effectiveness testing. The entity seeking approval of the new animal drug under investigation 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 accomplishes this through a formal request to their Investigational New Animal Drug File (INAD).

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.

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.

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 in each FY.

Estimated Size of Grant:

It is anticipated that grants will not to exceed $150,000 in total costs (direct plus indirect), per award.

There are two levels of funding available. Grants will be awarded up to $100,000 per year for up to 2 years, or up to $150,000 per year for up to 3 years in certain cases. Please note the dollar limitation will apply to total costs, not direct costs. Applications for the smaller 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 the larger grants ($150,000) must be for necessary studies that are of unusual complexity, duration, or size.

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)

Note regarding indirect costs: 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.

Term of Contract:

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.

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 (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.

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
  • Single entities
  • Small businesses
  • Special district governments
  • State governments

Additional Eligibility Criteria:

Eligible Organizations:

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 Institutions (AANAPISIs)

Nonprofits Other Than 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)

For-Profit Organizations:
-Small Businesses
-For-Profit Organizations (Other than Small Businesses)

Governments:
-State Governments
-County Governments
-City or Township Governments
-Special District Governments
-Indian/Native American Tribal Governments (Federally Recognized)
-Indian/Native American Tribal Governments (Other than Federally Recognized)
-Eligible Agencies of the Federal Government
-U.S. Territory or Possession

Other:
-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 Institutions)

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.

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.

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.

Program-Specific Eligibility Requirements/Eligible Studies:

To be eligible for this funding opportunity:

-The applicant must be a company, or a party working as the company's research partner, in the process of developing, or supporting the development of, a new animal drug intended for minor use in a major species or intended for use in a minor species. Details regarding minor use are found under Part 2. Section I. Funding Opportunity Description.

-The organization developing the new animal drug being studied for FDA approval must have already opened an Investigational New Animal Drug File (INAD) and must have the drug designated for a particular use for a particular species by the FDA Center for Veterinary Medicine’s Office of Minor Use & Minor Species Animal Drug Development (OMUMS) prior to submitting an application. Designation is accomplished by the submission of a formal request to the animal drug sponsor's INAD for review by FDA/CVM/OMUMS. The Minor Use/Minor Species Designations List on the FDA website shows the drugs that are currently designated.

-Applicants must propose studies intended to provide new animal drug safety and/or effectiveness data for a designated intended use. See Studies eligible for funding below.

-The protocol for the proposed study must be accepted by FDA/CVM’s Office of New Animal Drug Evaluation (ONADE) prior to the submission of the grant application.

The study protocol must be under an active INAD file and must support the development of the designated drug product toward FDA approval or conditional approval.

The INAD submission number of the proposed study should appear in the cover letter of the application along with the title of the project.

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.

Pre-Application Information:

Open Date (Earliest Submission Date):

June 27, 2018 (for August 27, 2018 application due date);
November 16, 2018 (for January 18, 2019 application due date);
June 14, 2019 (for August 16, 2019 application due date);
November 15, 2019 (for January 17, 2020 application due date);
June 19, 2020 (for August 14, 2020 application due date);
November 13, 2020 (for January 15, 2021 application due date)

Please note that this FOA has multiple open periods. Each open date has a corresponding due date listed below.

Letter of Intent Due Date(s):

July 2, 2018 (for August 27, 2018 application due date);
December 3, 2018 (for January 18, 2019 application due date);
July 1, 2018 (for August 16, 2019 application due date);
December 2, 2019 (for January 17, 2020 application due date);
July 1, 2020 (for August 14, 2020 application due date);
December 1, 2020 (for January 15, 2021 application due date)

Application Due Date(s):

August 27, 2018;
January 18, 2019;
August 16, 2019;
January 17, 2020;
August 14, 2020;
January 15, 2021

Scientific Merit Review:

November 2018
April 2019
November 2019
April 2020
November 2020
April 2021

Earliest Start Date:

February 2019
June 2019
February 2020
June 2020
February 2021
June 2021

Expiration Date: January 16, 2021

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.

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.

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.

FDA/CVM's Office of New Animal Drug Evaluation (ONADE) must have reviewed and accepted the proposed study protocol before an applicant can submit a grant application.

Applicants are strongly encouraged to contact FDA to resolve any unanswered questions about eligibility criteria or the application process itself before submitting their application.

Required Registrations:

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.

-Dun and Bradstreet Universal Numbering System (DUNS)
-System for Award Management (SAM) (formerly CCR)
-NATO Commercial and Government Entity (NCAGE) Code
-eRA Commons - Applicants must have an active DUNS number and SAM registration in order to complete the eRA Commons registration.
-Grants.gov – Applicants must have an active DUNS number and SAM registration in order to complete the Grants.gov registration.

Frequently Asked Questions:
https://grants.nih.gov/grants/guide/url_redirect.htm?id=41137

Grants guide: https://grants.nih.gov/grants/guide/

eRA Commons: http://public.era.nih.gov/commons/

View this opportunity on Grants.gov: https://www.grants.gov/view-opportunity.html?dpp=1&oppId=306175

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

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

CFDA Number:

93.103

Funding or Pin Number:

PAR-18-827

URL for Full Text (RFP):

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.