Rules and Regulations. Final rule

799 words·~4 min read·/register/2004/08/05/04-17878

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BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Parts 510, 522, and 524 New Animal Drugs; Change of Sponsor AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. SUMMARY: The Food and Drug Administration

(FDA)is amending the animal drug regulations to reflect a change of sponsor for one new animal drug application

(NADA)from Chemdex, Inc., to Sparhawk Laboratories, Inc., and one NADA and two abbreviated new animal drug applications (ANADAs) from Veterinary Laboratories, Inc., to Sparhawk Laboratories, Inc. DATES: This rule is effective August 5, 2004. 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: *david.newkirk@fda.gov* . SUPPLEMENTARY INFORMATION: Chemdex, Inc., 12340 Santa Fe Trail Dr., Lenexa, KS 66215, has informed FDA that it has transferred ownership of, and all rights and interest in, the following approved NADA to Sparhawk Laboratories, Inc., 12340 Santa Fe Trail Dr., Lenexa, KS 66215: Application No. 21 CFR Section Trade Name NADA 138-255 522.1183 Iron Hydrogenated Dextran Injection Veterinary Laboratories, Inc., 12340 Santa Fe Trail Dr., Lenexa, KS 66215, has informed FDA that it has transferred ownership of, and all rights and interest in, the following approved NADA and two approved ANADAs to Sparhawk Laboratories, Inc., 12340 Santa Fe Trail Dr., Lenexa, KS 66215: Application No. 21 CFR Section Trade Name NADA 138-657 524.1580b Nitrofurazone Ointment ANADA 200-315 522.1260 Lincomycin Injection 25; Lincomycin Injection 100; Lincomycin Injection 300 ANADA 200-324 522.540 Dexamethasone Injection 2 milligrams/milliliters Accordingly, the agency is amending the regulations in 21 CFR 522.540, 522.1183, 522.1260, and 524.1580b to reflect the transfer of ownership. Following these changes of sponsorship, Chemdex, Inc., and Veterinary Laboratories, Inc., are no longer the sponsor of an approved application. Accordingly, the agency is amending 21 CFR 510.600(c) to remove the entries for Chemdex, Inc., and Veterinary Laboratories, Inc. 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 21 CFR Part 510 Administrative practice and procedure, Animal drugs, Labeling, Reporting and recordkeeping requirements. 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 510, 522, and 524 are amended as follows: PART 510—NEW ANIMAL DRUGS 1. The authority citation for 21 CFR part 510 continues to read as follows: Authority: 21 U.S.C. 321, 331, 351, 352, 353, 360b, 371, 379e. 2. Section 510.600 is amended in the table in paragraph (c)(1) by removing the entries for “Chemdex, Inc.” and “Veterinary Laboratories, Inc.” and by alphabetically adding an entry for “Sparhawk Laboratories, Inc.”; and in the table in paragraph (c)(2) by removing the entries for “017287” and “000857” and by numerically adding an entry for “058005” to read as follows: § 510.600 Names, addresses, and drug labeler codes of sponsors of approved applications.

(c)* * *

(1)* * * Firm name and address Drug labeler code * * * * * Sparhawk Laboratories, Inc., 12340 Santa Fe Trail Dr., Lenexa, KS 66215 058005 * * * * *

(2)* * * Drug labeler code Firm name and address * * * * * 058005 Sparhawk Laboratories, Inc., 12340 Santa Fe Trail Dr., Lenexa, KS 66215 * * * * * PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS 3. The authority citation for 21 CFR part 522 continues to read as follows: Authority: 21 U.S.C. 360b. § 522.540 [Amended] 4. Section 522.540 is amended in paragraph (a)(2)(ii) by removing “000857” and by adding in its place “058005”. § 522.1183 [Amended] 5. Section 522.1183 is amended in paragraph (e)(1) by removing “017287” and by adding in its place “058005”. § 522.1260 [Amended] 6. Section 522.1260 is amended in paragraph (b)(2) by removing “000857” and by adding in its place “058005”. PART 524—OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS 7. The authority citation for 21 CFR part 524 continues to read as follows: Authority: 21 U.S.C. 360b. 8. Section 524.1580b is amended by revising paragraph

(b)to read as follows: § 524.1580b Nitrofurazone ointment.

(b)*Sponsor* . For use on dogs, cats, or horses, see Nos. 000010, 000069, 023851, 050749, 051259, 058005, and 061623 in § 510.600(c) of this chapter. For use on dogs and horses, see No. 017135 in § 510.600(c) of this chapter. For use on horses, see No. 017153 in § 510.600(c) of this chapter. Dated: June 23, 2004. Steven D. Vaughn, Director, Office of New Animal Drug Evaluation, Center for Veterinary Medicine. [FR Doc. 04-17878 Filed 8-4-04; 8:45 am]

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