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HHS/FDA

RIN: 0910-AF60

Publication ID: Spring 2006

Title: Designation of New Animal Drugs for Minor Uses or Minor Species
Abstract: The proposed rule was published on September 27, 2005, in response to the Minor Use and Minor Species (MUMS) Animal Health Act of 2004. The proposed rule would implement section 573 of the MUMS Act which sets forth the requirements for drug sponsors requesting MUMS designation for proposed new animal drugs. MUMS designation of a new animal drug allows 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 would define content and format requirements for designation, requests changing designation ownership, and annual reporting requirements. This rule would also describe the criteria CVM will use for granting or denying these requests. Specific sections of the rule are dedicated to documentation of MUMS status in a request, granting MUMS designation, and revocation of MUMS designation. FDA intends to finalize this proposal after reviewing any comments received. 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: Final Rule Stage
Major: No	Unfunded Mandates: No
CFR Citation: 21 CFR 516
Legal Authority: 21 USC 360ccc-2

Legal Deadline:

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

Timetable:

Action	Date	FR Cite
NPRM	09/27/2005	70 FR 56394
NPRM Comment Period End	12/12/2005
Final Rule	10/00/2006

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