Notice of Correction to RFA-FD-12-003 Minor Use Minor Species Development of Drugs; Research Project Grant (R01)

Notice Number: NOT-FD-13-014

Release Date: June 7, 2013

RFA-FD-12-003

U.S. Food and Drug Administration (FDA)

FDA is modifying some of the dates and text in RFA-FD-12-003, which was published January 6, 2012. Our changes are BOLDED.

Part 1. Overview Information

FOA Purpose section replaced with:

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/organizations that propose to develop, or support the development of new animal drugs intended for minor use in major species or intended for use in minor species. Only new animal drug products that have been designated by CVM’s Office of Minor Use & Minor Species Animal Drug Development (OMUMS), in accordance with the provisions of section 573 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360ccc-2) and 21 CFR Part 516, are eligible for grants.

FDA is authorized to provide grants for designated new animal drugs to assist in defraying the costs of qualified safety and effectiveness testing when a grant will either result in, or substantially contribute to, approval or conditional approval of a designated MUMS drug for a designated intended use. The protocol for the proposed study must be accepted by CVM prior to application submission. Applicants must include an explanation of how the proposed study will help gain product approval or conditional approval in the application’s Background and Significance section. 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

Open Date(s) (Earliest Submission Date)

January 13, 2012; June 01, 2012; October 12, 2012; June 07, 2013; October 11, 2013; June 20, 2014; November 21, 2014. (Earliest dates an application may be submitted to Grants.gov).

Application Due Date(s) replaced dates

February 17, 2012; July 20, 2012; December 07, 2012; August 16, 2013; January 03, 2014; August 15, 2014; January 16, 2015 by 5:00 PM eastern standard time.

Scientific Merit Review replaced dates

April 4, 2012; September 12, 2012; January 30, 2013; October 11, 2013; February 28, 2014; October 10, 2014; March 13, 2015

Earliest Start Date(s) Delete entire block

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

Replaced paragraph

The primary goal of FDA s OMUMS grant program is to support the development of new animal drugs intended for minor use for major species or intended for use for minor species.

Only new animal drugs that have been designated by OMUMS, in accordance with the provisions of section 573 of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360ccc-2) and 21 CFR Part 516, are eligible for grants.

FDA is authorized to provide grants for designated new animal drugs to assist in defraying the costs of qualified safety and effectiveness testing when a grant will either result in, or substantially contribute to, approval or conditional approval of a designated MUMS drug for a designated intended use. The protocol for the proposed study must be accepted by CVM prior to application submission. Applicants must include an explanation of how the proposed study will help gain approval or conditional approval of the designated product for a designated intended use in the application’s Background and Significance section. 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. For specific information about the mission of each FDA Center, see About FDA at www.fda.gov.

Section II. Award Information-

ADDED sentence

Award Budget

Indirect costs are limited to 15% of direct costs.

Section V. Application Review Information

Criteria Replaced section

To be eligible for this funding opportunity, (1) the new animal drug being studied must be designated for a particular use for a particular species by the Center for Veterinary Medicine s Office of Minor Use & Minor Species Animal Drug Development (OMUMS) prior to application, as shown on the Minor Use/Minor Species Designations List on the FDA website; (2) applicants must propose studies intended to provide new animal drug safety and/or effectiveness data for a designated intended use; and (3) the protocol for the proposed study must be accepted by CVM prior to the submission of the grant application.

Applicants are strongly encouraged to contact FDA to resolve any unanswered questions about criteria before submitting their application. 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 Agency Contacts, Section VII of this document).

For this particular announcement, note the following:

Responsive applications will be reviewed and evaluated for scientific and technical merit by a panel of experts. A score will be assigned to each application based on the scientific/technical review criteria. Consultation with the proper FDA review division may also occur during this phase of the review to determine whether a proposed study will provide acceptable data that could contribute to the goals of the program. Funding decisions will be made by the Commissioner of Food and Drugs or her designee.

There must be an explanation in the Background and Significance section of the application regarding how the proposed study will contribute to approval or conditional approval of the designated new animal drug product for a designated intended use.

The Study protocol proposed in the grant application must be under an active Investigational New Animal Drug (INAD) file and must support the development of the designated drug product towards approval or conditional approval to qualify the application for scientific and technical review. Additional INAD information is described as follows:

• The protocol for the proposed study must be determined to be acceptable by the applicable FDA INAD review division prior to submission of the grant application, and a copy of the protocol must be included in the grant application. (Page limits, font size, and margins should comply with the Application Guide, https://grants.nih.gov/grants/funding/424/SF424_RR_Guide_General_Adobe_VerB.pdf)
• The number assigned to the INAD that includes the proposed study should appear in the cover letter of the application with the title of the project.
• A copy of the letter or a reference to the letter, from the applicable FDA INAD review division, accepting the protocol must be included in the grant application.
• If the party submitting the grant application is not the sponsor of the INAD providing for the designated new animal drug under investigation, a letter from the sponsor of the designated new animal drug documenting the relationship between the sponsor and the party submitting the grant application must be filed in the sponsor’s INAD and included in the grant application.
• Studies involving already approved products, intended to evaluate new MUMS indications, are also subject to these INAD requirements.

The requested budget must be within the dollar limits outlined, up to $75,000 in total costs per year for up to 3 years for any safety or effectiveness study supportive of new animal drug approval or conditional approval, or up to $125,000 in total costs per year for up to 3 years for studies that are of necessity of unusual complexity, duration, or size. Indirect costs are limited to 15% of direct costs. The length of support will depend on the nature of the study. For those studies with an expected duration of more than one (1) 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 INAD; and (3) availability of Federal funds. Note: A third (3rd) year of funding is available only for long-term toxicological studies.

Any application received that requests support over the maximum amount allowable for that particular study will be considered non-responsive. Applications requesting more than $75,000 must document the necessity for a study of unusual complexity, duration, or size.

In an appendix to the application, there must be evidence that the product to be studied is available to the applicant in the form and quantity needed for the study proposed. A current letter from the supplier as an appendix will be acceptable. 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.

Section VII. Agency Contacts

Contact person updated

Financial/Grants Management Contact(s)

Oluyemisi (Yemisi) Akinneye
Division of Acquisition Support and Grants
Office of Acquisition and Grants Services (HFA-500) Food and Drug Administration
5630 Fishers Lane, Room 2037
Rockville, Maryland 20857
Telephone: (301) 827-0079
Email: [email protected]
All other aspects of the FOA remain unchanged.

Oluyemisi (Yemisi) Akinneye
Division of Acquisition Support and Grants
Office of Acquisition and Grants Services (HFA-500) Food and Drug Administration
5630 Fishers Lane, Room 2037
Rockville, Maryland 20857
Telephone: (301) 827-0079
Email: [email protected]