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Food and Drug Administration, HHS.
Final rule; technical amendment.
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor's name from Mylan Bertek Pharmaceuticals, Inc., to UDL Laboratories, Inc.
This rule is effective July 5, 2007.Start Further Info
FOR FURTHER INFORMATION CONTACT:
David R. Newkirk, Center for Veterinary Medicine (HFV-100), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301-827-6967, e-mail: firstname.lastname@example.org.End Further Info End Preamble Start Supplemental Information
Mylan Bertek Pharmaceuticals, Inc., 12720 Dairy Ashford, Sugar Land, TX 77478, has informed FDA that it has changed its name to UDL Laboratories, Inc., and is using a new drug labeler code. Accordingly, the agency is amending the regulations in 21 CFR 510.600(c) to reflect these changes. A conforming change is being made in 21 CFR 524.2620 for this sponsor's sole product.
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 Subjects
List of Subjects
- Administrative practice and procedure
- Animal drugs
- Reporting and recordkeeping requirements
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,End Amendment Part Start Part
PART 510—NEW ANIMAL DRUGSEnd Part Start Amendment Part
1. The authority citation forEnd Amendment Part Start Amendment Part
2. In § 510.600, in the table in paragraph (c)(1), remove the entry for “Mylan Bertek Pharmaceuticals, Inc.” and alphabetically add a new entry for “UDL Laboratories, Inc.”; and in the table in paragraph (c)(2) remove the entry for “062749” and numerically add a new entry for “051079” to read as follows:End Amendment Part
(c) * * *
(1) * * *
|Firm name and address||Drug labeler code|
|* * * * *|
|UDL Laboratories, Inc., 12720 Dairy Ashford, Sugar Land, TX 77478||051079|
|* * * * *|
(2) * * *
|Drug labeler code||Firm name and address|
|* * * * *|
|051079||UDL Laboratories, Inc., 12720 Dairy Ashford, Sugar Land, TX 77478|
|* * * * *|
PART 524—OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGSEnd Part Start Amendment Part
3. The authority citation forEnd Amendment Part
4. In paragraph (a)(2) of § 524.2620, remove “062794” and add in its place “051079”.End Amendment Part Start Signature
Dated: June 21, 2007.
Deputy Director, Center for Veterinary Medicine.
[FR Doc. E7-13010 Filed 7-3-07; 8:45 am]
BILLING CODE 4160-01-S