[Federal Register: May 3, 1999 (Volume 64, Number 84)] [Rules and Regulations] [Page 23539-23540] From the Federal Register Online via GPO Access [wais.access.gpo.gov] [DOCID:fr03my99-5] ======================================================================= ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 558 New Animal Drugs for Use in Animal Feeds; Chlortetracycline Hydrochloride 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 PennField Oil Co. The supplemental NADA provides for a revised withdrawal period of 1-day following feeding of Type B and Type C chlortetracycle feeds to cattle. EFFECTIVE DATE: May 3, 1999 FOR FURTHER INFORMATION CONTACT: Dianne T. McRae, Center for Veterinary Medicine (HFV-102), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301-827-0212. SUPPLEMENTARY INFORMATION: PennField Oil Co., 14040 Industrial Rd., Omaha, NE 68144, is the sponsor of NADA 138-935 that provides for feeding Type B and Type C chlortetracycline medicated feeds to poultry cattle, swine, and sheep. The firm has filed a supplemental NADA that provides for a revised withdrawal period of 1-day in cattle. The supplemental NADA is approved as of March 24, 1999, and the regulations are amended in 21 CFR 558.128 to reflect the approval. The basis for approval is discussed in the freedom of information summary. 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. The agency has determined under 21 CFR 25.33(a)(3) 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 entries (xi) and (xvii) by revising the entry under the ``Limitations'' column, and in entry (xii) by revising the entry under the ``Indications for use'' column to read as follows: (d)(1) * * * -------------------------------------------------------------------------------------------------------------------------------------------------------- Chlortetracycline amount Combination Indications for use Limitations Sponsor -------------------------------------------------------------------------------------------------------------------------------------------------------- * * * * * * * (xi) * * * * * * * * * Withdraw 48 h prior to slaughter. * * * For sponsor 000004 zero withdrawal time. For sponsor 053389 1 d withdrawal time. (xii) * * * * * * 1. Calves, beef and nonlactating * * * * * * dairy cattle; treatment of bacterial enteritis caused by E. coli and bacterial pneumonia caused by P. multocida organisms susceptible to chlortetracycline. For sponsor 053389 1 d withdrawal time. 2. * * * * * * * * * * (xvii) * * * * * * * * * Withdraw 48 h prior to slaughter. * * * For sponsor 000004 zero withdrawal time. For sponsor 053389 1 d withdrawal time. * * * * * * * -------------------------------------------------------------------------------------------------------------------------------------------------------- [[Page 23540]] * * * * * Dated: April 22, 1999. Margaret Ann Miller, Acting Director, Office of New Animal Drug Evaluation, Center for Veterinary Medicine. [FR Doc. 99-10983 Filed 4-30-99; 8:45 am] BILLING CODE 4160-01-F