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HHS/FDA

RIN: 0910-AF60

Publication ID: Fall 2005

Title: Designation of New Animal Drugs for Minor Use and Minor Species
Abstract: This proposed rule is being issued in response to the Minor Use and Minor Species (MUMS) Animal Health Act of 2004. The proposed rule implements section 573 of the MUMS Act which sets forth the functional requirements for drug sponsors requesting MUMS designation for proposed new animal drugs. MUMS designation of a new animal drug will allow drug sponsors to be granted seven years of exclusive marketing rights for these limited demand new animal drugs once the drugs are approved or conditionally approved. This regulation will define content and format requirements for designation, requests changing designation ownership, and annual reporting requirements. This rule will also describe the criteria CVM will use for granting or denying these requests. Specific sections of the rule will be dedicated to documentation of MUMS status in a request, granting MUMS designation, and revocation of MUMS designation. This is a voluntary program for animal drug sponsors. While we do not have estimates of the impact on the animal drug industry, we expect that this rule will have a net beneficial impact on the industry with those firms participating who hope to profit as a result of the market exclusivity provided by the MUMS Act. A large number of these drug companies are classified as small businesses.
Agency: Department of Health and Human Services(HHS)	Priority: Other Significant
RIN Status: Previously published in the Unified Agenda	Agenda Stage of Rulemaking: Proposed Rule Stage
Major: No	Unfunded Mandates: No
CFR Citation: 21 CFR 514.1(d)(1)(i)
Legal Authority: 21 USC 360ccc-2

Legal Deadline: Action Source Description Date Final  Statutory    08/02/2006  NPRM  Statutory    08/02/2005

Timetable: Action Date FR Cite NPRM  09/27/2005  70 FR 56394    NPRM Comment Period End  12/12/2005     Final Rule  02/00/2006

Regulatory Flexibility Analysis Required: No	Government Levels Affected: None
Small Entities Affected: Businesses	Federalism: No
Included in the Regulatory Plan: No
Agency Contact: Bernadette Dunham Director, Office of Minor Use and Minor Species Animal Drug Development Department of Health and Human Services Food and Drug Administration HFV-101, Center for Veterinary Medicine (HFV-50, MPN-4), Room 180, 7519 Standish Place, Rockville, MD 20855 Phone:240 276-9000 Fax:240 276-9001 Email: bernadette.dunham@fda.hhs.gov