Health and Human Services Department, Food and Drug Administration
The Food and Drug Administration (FDA) is announcing its periodic reassessment for defining the small numbers of animals for minor use in major species.
Document Headings Document headings vary by document type but may contain the following: the agency or agencies that issued and signed a document the number of the CFR title and the number of each part the document amends, proposes to amend, or is directly related to the agency docket number / agency internal file number the RIN which identifies each regulatory action listed in the Unified Agenda of Federal Regulatory and Deregulatory Actions See the Document Drafting Handbook for more details. Department of Health and Human Services Food and Drug Administration [Docket No. FDA-2008-N-0176 (Formerly Docket No. 2008N-0011)] AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing its periodic reassessment for defining the small numbers of animals for minor use in major species. DATES: Submit either electronic or written comments at any time. ADDRESSES: Submit electronic comments to http://www.regulations.gov/​ . Submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Margaret Oeller, Center for Veterinary Medicine (HVF-50), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 240-402-0566, email: margaret.oeller@fda.hhs.gov . SUPPLEMENTARY INFORMATION: I. Background The Minor Use and Minor Species Animal Health Act of 2004 ( Pub. L. 108-282 ) (the MUMS Act), defines the term minor use to mean the intended use of a new animal drug in a major species for an indication that occurs infrequently and in only a small number of animals annually, or in limited geographical areas and in only a small number of animals annually ( 21 U.S.C. 321(pp) ). As provided by the MUMS Act, major species of animals are dogs, cats, horses, cattle, pigs, turkeys, and chickens ( 21 U.S.C. 321(nn) . This statutory definition of minor use creates the need for FDA to establish a smal…
Citation: 79 FR 28736
