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HHS/FDA

RIN: 0910-AG58

Publication ID: Spring 2011

Title: New Animal Drugs for Minor Use and Minor Species
Abstract: The Minor Use and Minor Species Animal Health Act of 2004 (MUMS Act) amended the Federal Food, Drug, and Cosmetic Act (the Act) to establish new regulatory procedures that provide incentives intended to make more drugs legally available to veterinarians and animal owners for the treatment of minor animal species and uncommon diseases in major animal species. FDA published the final rule to implement the designation portion of these regulations (21 CFR part 516) on July 26, 2007 (72 FR 41010). These regulations describe the standards and procedures for designation of minor use or minor species new animal drugs. Such designation establishes eligibility for the incentives provided by the MUMS Act. FDA is issuing this direct final rule to amend its regulations regarding new animal drugs for minor use and minor species (MUMS) in part 516 to update language and clarify the intent of the regulations consistent with the preambles to the proposed and final rules. In section 516.3(b), FDA is amending the definition of "same dosage form" to make it clearer that the six dosage form categories listed in the regulations under numbers (i) through (vi) are the "categories" of dosage forms that the preamble to the proposed rule referenced as follows: "The second test of sameness which the statute establishes to determine eligibility of an animal drug for designation is 'same dosage form.' The Agency proposes to use the long-established dosage form categories listed in title 21 of the Code of Federal Regulations to implement this statutory requirement." (70 FR 56394 at 56398). To accomplish this clarification, the amendment will add the word "categories" after the phrase "dosage forms" and remove the "s" from "forms" in the first sentence of the definition. Section 516.20(b)(2) requires that requests for MUMS designation include "the generic and trade name, if any, of the drug" intended to be designated and FDA is amending this language to replace the terms "generic" and "trade" with the terms "established" and "proprietary", respectively, because the latter are the terms used in the Act. See section 502(e) of the act (21 U.S.C. section 352(e)). FDA is also revising this language to clarify that "drug" in the context of paragraph (b)(2) refers to the "active pharmaceutical ingredient (API)" name rather than to a formulated drug product name. The purpose of the information required in this provision of the regulation is to permit the Agency to determine whether a drug is eligible for designation on the basis that it is not the "same drug" as a drug that is already designated, conditionally approved, or approved (see section 573(a)(2)(B) of the Act) and, since the definition of "same drug" in section 516.3(b) requires a knowledge of the drug's "active moiety" in order to make this determination, a request for MUMS designation needs to include the API name. This is because the API name includes the active moiety and the drug product name normally does not. FDA is also clarifying the relationship between established and proprietary names in this context with the use of parentheses.
Agency: Department of Health and Human Services(HHS)	Priority: Substantive, Nonsignificant
RIN Status: Previously published in the Unified Agenda	Agenda Stage of Rulemaking: Completed Actions
Major: No	Unfunded Mandates: No
CFR Citation: 21 CFR 516
Legal Authority: 21 USC 360ccc-1 21 USC 360ccc-2 21 USC 371(a)

Legal Deadline: None

Timetable:

Action	Date	FR Cite
NPRM	11/15/2010	75 FR 69614
Direct Final Rule	11/15/2010	75 FR 69586
NPRM Comment Period End	01/31/2011
Confirmation of Effective Date	03/02/2011	76 FR 11331

Regulatory Flexibility Analysis Required: No	Government Levels Affected: None
Small Entities Affected: No	Federalism: No
Included in the Regulatory Plan: No
RIN Data Printed in the FR: No
Agency Contact: Margaret Oeller Director, Office of Minor Use and Minor Species Animal Drug Development Department of Health and Human Services Food and Drug Administration HFV-2, Center for Veterinary Medicine, Room N375, MPN-2, HFV-50, 7500 Standish Place, Rockville, MD 20855 Phone:240 402-0566 Email: margaret.oeller@fda.hhs.gov