[Federal Register Volume 62, Number 223 (Wednesday, November 19, 1997)] [Rules and Regulations] [Pages 61627-61628] From the Federal Register Online via the Government Publishing Office [www.gpo.gov] [FR Doc No: 97-30405] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 558 New Animal Drugs for Use in Animal Feeds; Chlortetracycline 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 a supplemental new animal drug application (NADA) filed by Hoffmann-La Roche, Inc. The supplemental NADA provides for changing the withdrawal time to zero following certain uses of chlortetracycline (CTC) in Type C cattle feeds (including free-choice feeds). EFFECTIVE DATE: November 19, 1997. FOR FURTHER INFORMATION CONTACT: Jack Caldwell, Center for Veterinary Medicine (HFV-126), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301-594-1638. SUPPLEMENTARY INFORMATION: Hoffmann-La Roche, Inc., 340 Kingsland St., Nutley, NJ 07110-1199, filed supplemental NADA 48-761 that provides for decreasing the withdrawal times for all National Academy of Sciences/ National Research Council drug efficacy study implementation (NAS/NRC DESI) approved uses of CTC Type C medicated feeds (including free- choice feeds) for beef and nonlactating dairy cattle and for control of anaplasmosis and other claims to a zero withdrawal time. The supplemental NADA is approved as of September 23, 1997, and the regulations are amended in Sec. 558.128(d)(1) and (d)(2) (21 CFR 558.128(d)(1) and (d)(2)) to reflect the approval. The basis of approval is discussed in the freedom of information summary. Also, in the revision of Sec. 558.128 published in the Federal Register of [[Page 61628]] July 9, 1996 (61 FR 35949), FDA provided for approval of five supplemental NADA's to reflect compliance with the results of the NAS/ NRC DESI review of the products and FDA's conclusions based on that study. In that document, FDA failed to reflect that Hoffmann-La Roche is the sponsor of the product codified in Sec. 558.128(d)(2) (see 53 FR 31316, August 18, 1988). The sponsor was the subject of a change of sponsor from American Cyanamid published in the Federal Register of April 24, 1996 (61 FR 18081). At this time, the paragraph is amended to reflect the correct sponsor. In accordance with the freedom of information provisions of 21 CFR part 20 and 514.11(e)(2)(ii), a summary of human food safety data and information submitted to support approval of this supplement may be seen in the Dockets Management Branch (HFA-305), Food and Drug Administration, 12420 Parklawn Dr., rm. 1-23, Rockville, MD 20857, between 9 a.m. and 4 p.m., Monday through Friday. FDA 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 in 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 part 558 is amended as follows: PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS 1. The authority citation for 21 CFR part 558 continues to read as follows: Authority: 21 U.S.C. 360b, 371. Sec. 558.128 [Amended] 2. Section 558.128 Chlortetracycline is amended in the table in paragraph (d)(1) in entry (xi) in the column ``Limitations'' by adding after the existing text the sentence ``For sponsor 000004 zero withdrawal time.'', in entry (xii) for indication 1., in the column ``Limitations'' by adding after the phrase ``for sponsor 048573;'' the phrase ``zero withdrawal for sponsor 000004;'', in entry (xvii) for indication 1., in the column ``Limitations'' by adding after the existing text the sentence ``For sponsor 000004 zero withdrawal time.'', and in paragraph (d)(2) by adding after the number ``(2)'' the phrase ``For sponsor 000004:'' and removing the phrase ``discontinue use 4 days prior to slaughter''. Dated: November 3, 1997. Robert C. Livingston, Director, Office of New Animal Drug Evaluation, Center for Veterinary Medicine. [FR Doc. 97-30405 Filed 11-18-97; 8:45 am] BILLING CODE 4160-01-F