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U.S. Department of Health and Human Services

Animal & Veterinary

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Rulemaking and Guidances: January 2010 to April 2010

For the complete Federal Register Notices, go to www.gpoaccess.gov/fr/advanced.html


New Animal Drug Applications; Confirmation of Effective Date. Direct final Rule.
Docket No. FDA-2009-N-0436

FDA is confirming the effective date of March 8, 2010, for the final rule that appeared in the Federal Register of October 23, 2009 (74 FR 54749). The direct final rule amends the regulations regarding new animal drug applications (NADAs). Specifically, this direct final rule is being issued to provide that NADAs shall be submitted in the described form, as appropriate for the particular submission. Currently, the regulation requires that all NADAs contain the same informational sections and does not explicitly provide the appropriate flexibility needed to address the development of all types of new animal drug products. This amendment will allow the agency to appropriately review safety and effectiveness data submitted to support the approval of new animal drug products. This document confirms the effective date of the direct final rule. The effective date is confirmed as March 8, 2010.

New Animal Drugs; Removal of Obsolete and Redundant Regulations. Final Rule.
Docket No. FDA-2003-N-0446, (formerly Docket No. 2003N-0324).

FDA is removing portions of a regulation that required drug sponsors to submit data regarding the sub-therapeutic use of certain antibiotic, nitrofuran, and sulfonamide drugs administered in animal feed, because these regulations have been determined to be obsolete or redundant. The portions of the regulation being removed are provisions listing certain feed use combinations for oxytetracycline and neomycin in the tables contained in that regulation. This rule does not finalize the provisions of the proposed rule regarding removing the remainder of the regulation. This rule is effective April 30, 2010.

Final Guidance

Guidance for Industry on Anesthetics for Companion Animals; Notice of Availability.
Docket No. FDA-2008-D-0623

FDA is announcing the availability of Guidance for Industry #192 entitled ‘‘Anesthetics for Companion Animals.’’ This guidance makes recommendations for the development of anesthetic new animal drug products for companion animals. The guidance discusses the contents of the target animal safety, effectiveness, and labeling technical sections of a new animal drug application (NADA) for general anesthetics. Notice published March 26, 2010.