[Federal Register Volume 62, Number 162 (Thursday, August 21, 1997)] [Rules and Regulations] [Pages 44409-44410] From the Federal Register Online via the Government Publishing Office [www.gpo.gov] [FR Doc No: 97-22264] ======================================================================= ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 522 Implantation or Injectable Dosage Form New Animal Drugs; Doramectin 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 Pfizer, Inc. The supplemental NADA provides for use of doramectin in cattle to control infections and to protect from reinfection with Cooperia punctata and Dictyocaulus viviparus for 28 days after treatment. This supplemental NADA also amends the wording of the claim for protection against infection or reinfection with Ostertagia ostertagi for 21 days and incorporates the claim into the new indication statement. EFFECTIVE DATE: August 21, 1997. FOR FURTHER INFORMATION CONTACT: Thomas Letonja, Center for Veterinary Medicine (HFV-135), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301-594-1643. SUPPLEMENTARY INFORMATION: Pfizer, Inc., 235 East 42d St., New York, NY 10017-5755, is sponsor of NADA 141-061 that provides for the use of Dectomax1% injectable solution (doramectin) for treatment and control of certain gastrointestinal roundworms, lungworms, eyeworms, grubs, lice, and mange mites of cattle, and protection against infection or reinfection with O. ostertagi for up to 21 days. The firm filed a supplemental NADA that provides for added use in cattle to control infections and to protect from reinfection with C. punctata and D. viviparus for 28 days after treatment. The supplemental NADA also amends the wording of the claim for ``* * * protection against infection or reinfection with Ostertagia ostertagi for 21 days'' and incorporates the claim into the new indication statement. The supplemental NADA is approved as of July 18, 1997, and the regulations are amended in 21 CFR 522.770(d)(2) to reflect the approval. The basis of 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 data and information submitted to support approval of this application may be seen in the Dockets Management Branch (HFA-305), Food and Drug Administration, 12420 Parklawn Dr., rm. 1-23, Rockville, MD 20857, from 9 a.m. to 4 p.m., Monday through Friday. Under section 512(c)(2)(F)(iii) of the Federal Food, Drug, and Cosmetic Act, this supplemental approval for food-producing animals qualifies for 3 years of marketing exclusivity beginning July 18, 1997, because the supplement 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 of the supplement and conducted or sponsored by the applicant. Exclusivity applies only to the added indication to control infections and to protect cattle from reinfection with C. punctata and D. viviparus for 28 days after treatment. The agency has determined under 21 CFR 25.24(d)(1)(i) 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. [[Page 44410]] List of Subjects in 21 CFR Part 522 Animal drugs. 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 522 is amended as follows: PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS 1. The authority citation for 21 CFR part 522 continues to read as follows: Authority: Sec. 512 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360b). 2. Section 522.770 is amended by revising paragraph (d)(2) to read as follows: Sec. 522.770 Doramectin. * * * * * (d) * * * (2) Indications for use. For treatment and control of gastrointestinal roundworms, lungworms, eyeworms, grubs, lice, and mange mites. To effectively control infections and to protect cattle from reinfection with Ostertagia ostertagi for 21 days, and Cooperia punctata and Dictyocaulus viviparus for 28 days after treatment. * * * * * Dated: August 1, 1997. Stephen F. Sundlof, Director, Center for Veterinary Medicine. [FR Doc. 97-22264 Filed 8-20-97; 8:45 am] BILLING CODE 4160-01-F