Rules and Regulations. Final rule

697 words·~3 min read·/register/2010/09/14/2010-22808·

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BILLING CODE P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Parts 510, 520, and 558 [Docket No. FDA-2010-N-0002] Animal Drugs, Feeds, and Related Products; Withdrawal of Approval of New Animal Drug Applications; Chloramphenicol; Lincomycin; Pyrantel Tartrate; and Tylosin Phosphate and Sulfamethazine AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. SUMMARY: The Food and Drug Administration

(FDA)is amending the animal drug regulations by removing those portions that reflect approval of four new animal drug applications (NADAs). In a notice published elsewhere in this issue of the **Federal Register** , FDA is withdrawing approval of these NADAs. DATES: This rule is effective September 24, 2010. FOR FURTHER INFORMATION CONTACT: John Bartkowiak, Center for Veterinary Medicine (HFV-212), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240-276-9079; email: *john.bartkowiak@fda.hhs.gov* . SUPPLEMENTARY INFORMATION: John J. Ferrante, 11 Fairway Lane, Trumbull, CT 06611; International Nutrition, Inc., 7706 “I” Plaza, Omaha, NE 68127; and Feed Service Co., Inc., 303 Lundin Blvd., P.O. Box 698, Mankato, MN 56001 have requested that FDA withdraw approval of the four NADAs listed in the following paragraph because they are no longer manufactured or marketed: In a notice published elsewhere in this issue of the **Federal Register** , FDA gave notice that approval of NADA 65-137, 121-337, 132-923, and 138-342, and all supplements and amendments thereto, is withdrawn, effective September 24, 2010. As provided in the regulatory text of this document, the animal drug regulations are amended to reflect these withdrawals of approval. Following these changes of sponsorship, Feed Service Co., Inc., and John J. Ferrante are no longer the sponsor of an approved application. Accordingly, 21 CFR 510.600(c) is being amended to remove the entries for these firms. 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 Part 520 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, 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. In § 510.600, in the table in paragraph (c)(1), remove the entries for “Feed Service Co., Inc.” and “John J. Ferrante”; and in the table in paragraph (c)(2), remove the entries for “030841” and “058034”. 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. 4. In § 520.390b, revise paragraph

(b)to read as follows: § 520.390b Chloramphenicol capsules.

(b)*Sponsors* . See Nos. 000069 and 050057 in § 510.600(c) of this chapter for use as in paragraph

(d)of this section. PART 558—NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS 5. The authority citation for 21 CFR part 558 continues to read as follows: Authority: 21 U.S.C. 360b, 371. 6. In § 558.325, revise paragraphs

(a)and (c)(3)(ii); and in the table in paragraphs (d)(2)(ii) and (d)(2)(iii), in the “Sponsor” column, remove “043733” to read as follows: § 558.325 Lincomycin.

(a)*Approvals* . Type A articles and Type B feeds approved for sponsors in § 510.600(c) of this chapter for specific uses as in paragraph

(d)of this section as follows:

(1)No. 000009 for 20 and 50 grams per pound.

(2)No. 051311 for 2.5 and 8 grams per pound.

(c)* * *

(3)* * *

(ii)No. 051311:“CAUTION: Not to be fed to swine that weigh more than 250 lb.” § 558.485 [Amended] 7. In paragraph (b)(3) of § 558.485, remove “043733”. § 558.630 [Amended] 8. In paragraph (b)(5) of § 558.630, remove “030841”. Dated: September 1, 2010. Bernadette Dunham, Director, Center for Veterinary Medicine. [FR Doc. 2010-22808 Filed 9-13-10; 8:45 am]

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