[Federal Register: March 18, 1999 (Volume 64, Number 52)] [Rules and Regulations] [Page 13341-13342] From the Federal Register Online via GPO Access [wais.access.gpo.gov] [DOCID:fr18mr99-12] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Parts 520, 556, and 558 Animal Drugs, Feeds, and Related Products; Lincomycin AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of three supplemental new animal drug applications (NADA's) filed by Pharmacia & Upjohn Co. The supplemental NADA's provide new tolerances and withdrawal times for use of lincomycin, and codification of an acceptable daily intake (ADI). EFFECTIVE DATE: March 18, 1999. FOR FURTHER INFORMATION CONTACT: William T. Flynn, Center for Veterinary Medicine (HFV-133), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301-827-7570. SUPPLEMENTARY INFORMATION: Pharmacia & Upjohn Co., 7000 Portage Rd., Kalamazoo, MI 49001-0199, filed supplemental NADA's 34-025, 97-505, and 111-636. NADA 34-025 provides for use of Lincocin sterile solution and Lincomix injectable (lincomycin hydrochloride) for dogs, cats, and swine. NADA 97-505 provides for use of Lincomix 20/50 Type A medicated articles and Lincomix 10 Type B medicated feed (lincomycin hydrochloride) for swine and broiler chickens. NADA 111-636 provides for use of Lincomix soluble powder (lincomycin hydrochloride) for swine and broiler chicken drinking water. The supplemental NADA's provide for establishing a zero withdrawal period for lincomycin oral products, establishing residue tolerances of 0.6 parts per million (ppm) in swine liver and 0.1 ppm in swine muscle, and establishing an ADI of 25 micrograms per kilogram of body weight per day. The supplemental NADA's are approved as of August 25, 1998, and the regulations in 21 CFR 520.1263c(d)(1)(i)(C), 556.360, and 558.325(c)(2)(ii)(b), (c)(2)(iii)(b), and (c)(2)(iv)(b) are amended to reflect the approval. The basis of approval is discussed in each freedom of information summary. Since these approvals involve revised tolerances for residues of lincomycin in edible tissues of swine, Sec. 556.360 is amended to reflect the revised tolerance for lincomycin residues in swine tissues. In addition to revising the tolerance for lincomycin residues in swine tissues, FDA is further amending the tolerance regulation to codify the ADI for total residues of lincomycin. The ADI is the amount of total drug residue that can be safely consumed by humans every day. In accordance with the freedom of information provisions of 21 CFR part 20 and 514.11(e)(2)(ii), a summary of safety and effectiveness data and information submitted to support approval of this application may be seen in the Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852, between 9 a.m. and 4 p.m., Monday through Friday. Under section 512(c)(2)(F)(iii) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360b(c)(2)(F)(iii)), the supplemental approval for food-producing animals for Lincocin sterile solution and Lincomix injectable (NADA 34-025) qualifies for 3 years of marketing exclusivity beginning August 25, 1998, because the supplemental application contains substantial evidence of the effectiveness of the drug involved, studies of animal safety or, in the case of food-producing animals, human food safety studies (other than bioequivalence or residue studies) required for approval and conducted or sponsored by the applicant. The 3 years of marketing exclusivity applies only to the new tolerance for lincomycin in swine liver for which the supplemental NADA was approved. The agency has determined under 21 CFR 25.33(a)(1) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required. List of Subjects 21 CFR Part 520 Animal drugs. 21 CFR Part 556 Animal drugs, Foods. 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 520, 556, and 558 are amended as follows: PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS 1. The authority citation for 21 CFR part 520 continues to read as follows: Authority: 21 U.S.C. 360b. Sec. 520.1263c [Amended] 2. Section 520.1263c Lincomycin hydrochloride soluble powder is amended in paragraph (d)(1)(i)(C) by removing the last sentence. [[Page 13342]] PART 556--TOLERANCES FOR RESIDUES OF NEW ANIMAL DRUGS IN FOOD 3. The authority citation for 21 CFR part 556 continues to read as follows: Authority: 21 U.S.C. 342, 360b, 371. 4. Section 556.360 is revised to read as follows: Sec. 556.360 Lincomycin. (a) Acceptable daily intake (ADI). The ADI for total residues of lincomycin is 25 micrograms per kilogram of body weight per day. (b) Chickens. A tolerance for residues of lincomycin in chickens is not required. (c) Swine. Tolerances for lincomycin of 0.6 part per million in liver and 0.1 part per million in muscle are established. 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. Sec. 558.325 [Amended] 6. Section 558.325 Lincomycin is amended by redesignating paragraph (c) as paragraph (d), by reserving paragraph (c), in newly redesignated paragraph (d)(2)(ii)(b) by removing ``; feed containing 100 grams per ton lincomycin hydrochloride should be withdrawn 6 days before slaughter'', and in newly redesignated paragraphs (d)(2)(iii)(b) and (d)(2)(iv)(b) by removing ``; withdraw 6 days before slaughter''. Dated: March 2, 1999. Margaret Ann Miller, Acting Director, Office of New Animal Drug Evaluation, Center for Veterinary Medicine. [FR Doc. 99-6530 Filed 3-17-99; 8:45 am] BILLING CODE 4160-01-F