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 for four approved new animal drug applications (NADAs) from Anthony Products, Co. to Cross Vetpharm Group, Ltd.
This rule is effective June 20, 2003.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: email@example.com.End Further Info End Preamble Start Supplemental Information
Anthony Products, Co., 5600 Peck Rd., Arcadia, CA 91006, has informed FDA that it has transferred ownership of, and all rights and interest in, the following four approved NADAs to Cross Vetpharm Group, Ltd., Broomhill Rd., Tallaght, Dublin 24, Ireland.
|NADA Number||Trade Name||21 CFR Section|
|049-187||PHEN-BUTA (phenylbutazone) Vet Tablets; Phenylbutazone Tablets (Dogs)||520.1720a|
|122-447||FURA-SEPTIN (nitrofurazone) Soluble Dressing||524.1580b|
|140-582||BIOCYL 50; BIOCYL 100 (oxytetracycline)||522.1662a|
Accordingly, the agency is amending the regulations in §§ 522.1662a, 522.1680, and 524.1580b (21 CFR 522.1662a, 522.1680, and 524.1580b) to reflect the transfer of ownership. No amendment of 21 CFR 520.1720a is necessary as each sponsor owns additional phenylbutazone products.
In addition, § 522.1662a is being revised to reflect current format. This action is being taken to improve consistency between sections of the regulations.
This rule does not meet the definition of “rule” in 5 U.S.C. 804(3)(A) because Start Printed Page 36913it 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 in 21 CFR Parts 522 and 524
- Animal drugs
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 parts 522 and 524 are amended as follows:End Amendment Part Start Part
PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGSEnd Part Start Amendment Part
1. The authority citation for 21 CFR part 522 continues to read as follows:End Amendment Part
2. Section 522.1662a Oxytetracycline hydrochloride injection is amended in paragraph (k)(2) by removing “000864” and by adding in its place “061623”.End Amendment Part Start Amendment Part
3. Section 522.1680 is amended in paragraph (b) by removing “000864” and by numerically adding “061623”; in paragraph (c) by removing the footnote; in paragraphs (c)(1)(i) and (c)(1)(ii) in the table headings by removing “ml” and by adding in its place “mL”; and by revising paragraphs (a) and (c)(3) to read as follows:End Amendment Part
(a) Specifications. Each milliliter (mL) of solution contains 20 USP units oxytocin.
(c) * * *
(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.Start Part
PART 524-OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGSEnd Part Start Amendment Part
4. The authority citation for 21 CFR part 524 continues to read as follows:End Amendment Part
5. Section 524.1580b Nitrofurazone ointment is amended in paragraph (b) by removing “000864,”.End Amendment Part Start Signature
Dated: June 3, 2003.
Steven D. Vaughn,
Director, Office of New Animal Drug Evaluation, Center for Veterinary Medicine.
[FR Doc. 03-15618 Filed 6-19-03; 8:45 am]
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