Rules and Regulations. Final rule; technical amendment

545 words·~2 min read·/register/2003/06/20/03-15618·

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BILLING CODE 4191-02-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Parts 522 and 524 Dosage Form New Animal Drugs; Change of Sponsor; Technical Amendment AGENCY: Food and Drug Administration, HHS. ACTION: Final rule; technical amendment. SUMMARY: 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. DATES: This rule is effective June 20, 2003. 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: *dnewkirk@cvm.fda.gov.* SUPPLEMENTARY 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 130-136 Oxytocin Injection 522.1680 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 it is a rule of “particular applicability.” Therefore, it is not subject to the congressional review requirements in 5 U.S.C. 801-808. 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: PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS 1. The authority citation for 21 CFR part 522 continues to read as follows: Authority: 21 U.S.C. 360b. § 522.1662a [Amended] 2. Section 522.1662a *Oxytetracycline hydrochloride injection* is amended in paragraph (k)(2) by removing “000864” and by adding in its place “061623”. 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: § 522.1680 Oxytocin injection.

(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. PART 524-OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS 4. The authority citation for 21 CFR part 524 continues to read as follows: Authority: 21 U.S.C. 360b. § 524.1580b [Amended] 5. Section 524.1580b *Nitrofurazone ointment* is amended in paragraph

(b)by removing “000864,”. 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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