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HHS/FDA

RIN: 0910-AF67

Publication ID: Spring 2006

Title: Index of Legally Marketed Unapproved New Animal Drugs for 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 572 of the MUMS Act which provides for a public index listing of legally-marketed unapproved new animal drugs for minor species of animals (species other than cattle, horses, swine, chickens, turkeys, dogs, and cats). The drugs in this index will only be indicated for use in non-food minor species or for use in early non-food life stages to food-producing minor species. This proposed rule, will, among other things, specify the procedures for requesting eligibility for indexing and for requesting addition to the index as well as the reporting requirements for index holders. This rule will also describe the criteria requestors will use for assembling a qualified expert panel to evaluate for FDA the target animal safety and effectiveness of a new animal drug proposed for indexing.
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 516
Legal Authority: 21 USC 360 ccc-1

Legal Deadline:

Action	Source	Description	Date
NPRM	Statutory		02/02/2006
Final	Statutory		08/02/2007

Timetable:

Action	Date	FR Cite
NPRM	05/00/2006
NPRM Comment Period End	08/00/2006

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