Notice of Change to PAR-18-827 "Minor Use Minor Species Development of Drugs (R01)"

Notice Number: NOT-FD-19-012

Key Dates
Release Date: May 22, 2019

Related Announcements
PAR-18-827

Issued by
FOOD AND DRUG ADMINISTRATION (FDA)

Purpose

The purpose of this Notice is to change the following subsections of PAR-18-827: 1) “Purpose/Research Objectives” under Section 1. Funding Opportunity Description; and 2) “Funds Available” and “Awards Budget” under Section II. Award Information.

Reads Prior To This Notice:

Purpose/Research Objectives

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.

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. 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.

CVM intends to fund up to $500,000 yearly, for fiscal year (FY) 2019, FY2020 and FY 2021 in support of this grant program.

It is anticipated that up to 10 awards will be made, not to exceed $150,000 in total costs (direct plus indirect), per award.

Award Budget

There are two levels of funding available. Grants will be awarded up to $100,000 per year of up to 2 years, or up to $150,000 per year for up to 3 years in certain cases. Please note the dollar amount 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 unusual complexity, duration, or size. A third year of funding is available only for long-term toxicological studies.

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

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.

FDA grants policies as described in the HHS Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.

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)

Now Reads After This Notice:

Purpose/Research Objectives

There is one level of funding available. The FDA will award grants up to $250,000 per year for up to 2 years, or up to $250,000 for up to 3 years in certain cases. Please note the dollar limitation will apply to total costs, not direct costs. Applications may be for any safety or effectiveness study supportive of new animal drug approval or conditional approval of the designated product for the designated intended use. A third year of funding is available only for long-term toxicological studies.

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. Award(s) will provide one (1) year of support and include future recommended support for up to two (2) additional year(s) contingent upon annual appropriations, availability of funding and satisfactory awardee performance.

FDA/CVM intends to fund up to $1,500,000 yearly, for fiscal years 2020 and 2021 in support of this grant program.

FDA/CVM anticipates making up to 10 awards, not to exceed $250,000 in total costs (direct plus indirect), per award.

Award Budget

There is one level of funding available. FDA/CVM will award grants up to $250,000 per year for up to 2 years, or up to $250,000 for up to 3 years in certain cases. Please note the dollar limitation will apply to total costs, not direct costs. Applications may be for any safety or effectiveness study supportive of new animal drug approval or conditional approval of the designated product for the designated intended use. A third year of funding is available only for long-term toxicological studies. The nature and scope of the proposed research will vary from application to application; 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.

FDA grants policies as described in the HHS Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.

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

Year 01: $250,000

Year 02: $250,000

Year 03: $250,000 (long-term toxicological study only)

Inquiries

Please direct all inquiries to:

Rene Vasquez
Office of Acquisitions & Grants Services (OAGS)
Food and Drug Administration
Email:Rene.Vasquez@fda.hhs.gov