Rules and Regulations. Final rule

1,139 words·~5 min read·/register/2003/01/31/03-2295

A research copy — for the controlling text, always check the official state or federal source. Not legal advice.

BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Parts 510, 520, 522, 524, 526, and 558 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 25 approved new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) from Bimeda, Inc., to Cross Vetpharm Group Ltd. DATES: This rule is effective January 31, 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: Bimeda, Inc., 291 Forest Prairie Rd., LeSueur, MN 56058, has informed FDA that it has transferred ownership of, and all rights and interest in, the following 25 approved NADAs and ANADAs to Cross Vetpharm Group Ltd., Broomhill Rd., Tallaght, Dublin 24, Ireland. NADA Number Trade Name 010-092 GALLIMYCIN 50 010-346 COMBUTHAL Powder 012-123 ERYTHRO-100, -200; GALLIMYCIN Injectable 035-157 GALLIMYCIN 100; GALLIMYCIN 500 035-455 ERYTHRO-36 Dry; GALLIMYCIN-36 Dry 035-456 GALLIMYCIN-36 Sterile 038-241 ERYTHRO (High Lev)/Zoalene Plus Arsanilic Acid 038-242 ERYTHRO (Low Lev)/Amp Plus Etho 038-624 PRO-GALLIMYCIN-10 038-661 SPECTAM Water Soluble Concentrate 041-955 Erythromycin Medicated Premix 044-756 TEVCODYNE 055-059 TEVCOCIN Tablets 093-515 SPECTAM Tablets 095-218 Dexamethasone Tablets, 0.25 mg 100-128 Supersweet Medipak TYLAN 10 101-690 ERYTHRO-100 Injection 107-506 CARBAM Tablets 118-032 CARBAM PALATABS 118-979 BUTATRON Gel 120-615 SUSTAIN III Bolus 126-504 Nitrofurazone Ointment 200-050 Neomycin 325 Soluble Powder 200-103 Penicillin G Potassium, USP 200-144 Oxytetracycline HCl Soluble Powder; TETROXY Accordingly, the agency is amending the regulations in 21 CFR 520.390a, 520.540b, 520.622a, 520.823, 520.1484, 520.1660d, 520.1696b, 520.1720a, 520.1720d, 520.2123a, 520.2123b, 520.2260b, 522.820, 522.2444b, 524.1580b, 526.820, 558.248, and 558.625 to reflect the transfer of ownership. Following this change of sponsorship, Bimeda, Inc., is no longer the sponsor of any approved application. Accordingly, 21 CFR 510.600(c) is being amended to remove the entries for Bimeda, 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 520, 522, 524, and 526 Animal drugs. 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 parts 510, 520, 522, 524, 526, and 558 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. § 510.600 [Amended] 2. Section 510.600 *Names, addresses, and drug labeler codes of sponsors of approved applications* is amended in the table in paragraph (c)(1) by removing the entry for “Bimeda, Inc.” and in the table in paragraph (c)(2) by removing the entry for “061133”. PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGS 3. The authority citation for 21 CFR part 520 continues to read as follows: Authority: 21 U.S.C. 360b. § 520.390a [Amended] 4. Section 520.390a *Chloramphenicol tablets* is amended in paragraph (b)(2) by removing “061133” and by adding in its place “061623”. § 520.540b [Amended] 5. Section 520.540b *Dexamethasone tablets and boluses* is amended in paragraph (b)(2) by removing “061133” and by adding in its place “061623”. § 520.622a [Amended] 6. Section 520.622a *Diethylcarbamazine citrate tablets* is amended in paragraph (a)(3) by removing “061133” and by adding in its place “061623”. § 520.823 [Amended] 7. Section 520.823 *Erythromycin phosphate* is amended in paragraphs

(b)by removing “061133” and by adding in its place “061623”. § 520.1484 [Amended] 8. Section 520.1484 *Neomycin sulfate soluble powder* is amended in paragraph (b)(2) by removing “061133” and by adding in its place “061623”. § 520.1660d [Amended] 9. Section 520.1660d *Oxytetracycline hydrochloride soluble powder* is amended in paragraph (b)(7) by removing “061133” and by adding in its place “061623”. § 520.1696b [Amended] 10. Section 520.1696b *Penicillin G potassium in drinking water* is amended in paragraph

(b)by removing “061133” and by adding in its place “061623”. § 520.1720a [Amended] 11. Section 520.1720a *Phenylbutazone tablets and boluses* is amended in paragraph (b)(3) by removing “061133” and by adding in its place “061623”. § 520.1720d [Amended] 12. Section 520.1720d *Phenylbutazone gel* is amended in paragraph

(b)by removing “061133” and by adding in its place “No. 061623”. § 520.2123a [Amended] 13. Section 520.2123a *Spectinomycin dihydrochloride pentahydrate tablets* is amended in paragraph

(b)by removing “061133” and by adding in its place “061623”. § 520.2123b [Amended] 14. Section 520.2123b *Spectinomycin dihydrochloride pentahydrate soluble powder* is amended in paragraph

(b)by removing “061133” and by adding in its place “061623”. § 520.2260b [Amended] 15. Section 520.2260b *Sulfamethazine sustained-release boluses* is amended in paragraphs (c)(1) and (e)(1) by removing “061133” and by adding in its place “061623”. PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS 16. The authority citation for 21 CFR part 522 continues to read as follows: Authority: 21 U.S.C. 360b. § 522.820 [Amended] 17. Section 522.820 *Erythromycin injection* is amended in paragraph

(a)by removing “061133” and by adding in its place “No. 061623”. § 522.2444b [Amended] 18. Section 522.2444b *Sodium thiopental, sodium pentobarbital for injection* is amended in paragraph

(b)by removing “061133” and by adding in its place “061623”. PART 524—OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS 19. The authority citation for 21 CFR part 524 continues to read as follows: Authority: 21 U.S.C. 360b. § 524.1580b [Amended] 20. Section 524.1580b *Nitrofurazone ointment* is amended in paragraph

(b)by removing “061133” and by adding in its place “061623”. PART 526—INTRAMAMMARY DOSAGE FORM NEW ANIMAL DRUGS 21. The authority citation for 21 CFR part 526 continues to read as follows: Authority: 21 U.S.C. 360b. § 526.820 [Amended] 22. Section 526.820 *Erythromycin* is amended in paragraph

(b)by removing “061133” and by adding in its place “061623”. PART 558—NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS 23. The authority citation for 21 CFR part 558 continues to read as follows: Authority: 21 U.S.C. 360b, 371. § 558.248 [Amended] 24. Section 558.248 *Erythromycin thiocyanate* is amended in paragraphs (a)(1) and (a)(2) by removing “061133” and by adding in its place “061623”; and in the table in paragraph (d)(1) in the “Sponsor” column by removing “061133” wherever it appears and by adding in its place “061623”. § 558.625 [Amended] 25. Section 558.625 *Tylosin* is amended in the table in paragraph (b)(39) by removing “061133” and by adding in its place “061623”. Dated: January 6, 2003. Steven D. Vaughn, Director, Office of New Animal Drug Evaluation, Center for Veterinary Medicine. [FR Doc. 03-2295 Filed 1-30-03; 8:45 am]

Connectionstraces to 4

Traces to 4 documents

CFR