-
Start Preamble
AGENCY:
Food and Drug Administration, HHS.
ACTION:
Final rule.
SUMMARY:
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental new animal drug application (NADA) filed by Novartis Animal Health US, Inc. The supplemental NADA provides for approval of a new concentration of a Type A medicated article.
DATES:
This rule is effective April 23, 2012.
Start Further InfoFOR FURTHER INFORMATION CONTACT:
Cindy L. Burnsteel, Center for Veterinary Medicine (HFV-130), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 240-276-8341, email: cindy.burnsteel@fda.hhs.gov.
End Further Info End Preamble Start Supplemental InformationSUPPLEMENTARY INFORMATION:
Novartis Animal Health US, Inc. (Novartis), 3200 Northline Ave., Suite 300, Greensboro, NC 27408, filed a supplement to NADA 139-472 for DENAGARD (tiamulin hydrogen fumarate) Type A medicated articles for use of a new product formulation in medicated swine feed. The supplemental NADA is approved as of January 6, 2012, and the regulations in 21 CFR 558.4 and 558.600 are amended to reflect the approval.
The Agency has determined under 21 CFR 25.33 that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required.
This rule does not meet the definition of “rule” in 5 U.S.C. 804(3)(A) because it is a rule of “particular applicability.” Therefore, it is not subject to the congressional review requirements in 5 U.S.C. 801-808.
Start List of SubjectsList of Subjects in 21 CFR Part 558
- Animal drugs
- Animal feeds
Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs and redelegated to the Center for Veterinary Medicine, 21 CFR part 558 is amended as follows:
Start PartPART 558—NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS
End Part Start Amendment Part1. The authority citation for 21 CFR part 558 continues to read as follows:
End Amendment Part Start Amendment Part2. In paragraph (d) of § 558.4, in the “Category II” table, revise the entries for “Tiamulin” to read as follows:
End Amendment PartRequirement of a medicated feed mill license.* * * * *(d) * * *
Start Printed Page 24139Category II
Drug Assay limits percent 1 Type A Type B maximum (100x) Assay limits percent 1 Type B/C 2 * * * * * * * Tiamulin hydrogen fumarate 90-115 10 g/lb 90-115/70-130 * * * * * * * 1 Percent of labeled amount. 2 Values given represent ranges for either Type B or Type C medicated feeds. For those drugs that have two range limit, the first set is for a Type B medicated feed and the second set is for a Type C medicated feed. These values (ranges) have been assigned in order to provide for the possibility of dilution of a Type B medicated feed with lower assay limits to make a Type C medicated feed. * * * * *3. In § 558.600, revise paragraph (a) and the heading of the first column in the table in paragraph (e)(1) to read as follows:
End Amendment PartTiamulin.(a) Specifications. Type A article containing 363.2 grams of tiamulin hydrogen fumarate per pound.
* * * * *(e) * * *
(1) * * *
Tiamulin hydrogen fumarate in grams per ton * * * * * * * * * * * * * * * * * * * * * * * *Dated: April 17, 2012.
Steven D. Vaughn,
Director, Office of New Animal Drug Evaluation, Center for Veterinary Medicine.
[FR Doc. 2012-9708 Filed 4-20-12; 8:45 am]
BILLING CODE 4160-01-P
Document Information
- Effective Date:
- 4/23/2012
- Published:
- 04/23/2012
- Department:
- Food and Drug Administration
- Entry Type:
- Rule
- Action:
- Final rule.
- Document Number:
- 2012-9708
- Dates:
- This rule is effective April 23, 2012.
- Pages:
- 24138-24139 (2 pages)
- Docket Numbers:
- Docket No. FDA-2012-N-0002
- Topics:
- Animal drugs, Animal feeds
- PDF File:
- 2012-9708.pdf
- Supporting Documents:
- » Freedom of Information Summary ANADA 200-543 Cefpodoxime Proxetil
- » Freedom of Information Summary ANADA 200-491, Loxicom (meloxicam)
- » Freedom of Information Summary ANADA 200-485, Meloxicam Injection (meloxicam)
- » Freedom of Information Summary NADA 200-496 96% Solution Growing chickens, turkeys and laying hens
- » Freedom of Information Summary NADA 200-534 Melengestrol acetate plus monensin USP plus tylosin phosphate
- » Freedom of Information Summary NADA 141-068 BAYTRIL 100 Injectable Solution
- » Freedom of Information Summary NADA 141-346 OroCAM
- » Freedom of Information Summary NADA 141-344 VERAFLOX Suspension for Cats
- » Freedom of Information Summary ANADA 200-466 SPARMECTIN Plus Clorsulon
- » Freedom of Information Summary NADA 141-342 ALFAXAN
- CFR: (2)
- 21 CFR 558.4
- 21 CFR 558.600