[Federal Register Volume 62, Number 225 (Friday, November 21, 1997)] [Rules and Regulations] [Pages 62242-62243] From the Federal Register Online via the Government Publishing Office [www.gpo.gov] [FR Doc No: 97-30562] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Parts 522 and 556 Animal Drugs, Feeds, and Related Products; 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 intramuscular use of doramectin in swine for the treatment and control of certain infections of nematode and arthropod parasites. EFFECTIVE DATE: November 21, 1997. FOR FURTHER INFORMATION CONTACT: Estella Z. Jones, 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, which provides for the subcutaneous and intramuscular use of Dectomax1 percent injectable solution (doramectin) for treatment and control of certain gastrointestinal roundworms, lungworms, eyeworms, grubs, lice, and mange mites of cattle, and to 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. The firm filed a supplemental NADA that provides for intramuscular use of doramectin in swine for the treatment and control of certain infections of gastrointestinal roundworms, lungworms, kidney worms, sucking lice, and mange mites. The supplemental NADA is approved as of September 18, 1997, and the regulations are amended in 21 CFR 522.770(d) to reflect the approval. The basis of approval is discussed in the freedom of information summary. In addition, a tolerance for residues of doramectin in edible swine tissues has not been previously established. Section 556.225 (21 CFR 556.225) is amended to provide for a tolerance for residues of doramectin in swine tissues. 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 supplemental application 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. Under section 512(c)(2)(F)(iii) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360b(c)(2)(F)(iii)), this supplemental approval for food-producing animals qualifies for 3 years of marketing exclusivity beginning September 18, 1997, because the supplement contains substantial evidence of the effectiveness of the drug involved, any 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 supplemental application and conducted or sponsored by the applicant. Exclusivity applies only to the added indication for the treatment and control of gastrointestinal roundworms, lungworms, kidneyworms, sucking lice, and mange mites in swine. The agency has carefully considered the potential environmental effects of this action. FDA has concluded that the action will not have a significant impact on the human environment, and that an environmental impact statement is not required. The agency's finding of no significant impact and the evidence supporting that finding, contained in an environmental assessment, may be seen in the Dockets Management Branch (address above) between 9 a.m. and 4 p.m., Monday through Friday. List of Subjects 21 CFR Part 522 Animal drugs. 21 CFR Part 556 Animal drugs, Foods. 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 522 and 556 are 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: 21 U.S.C. 360b. 2. Section 522.770 is amended by revising the heading of paragraph (d) and redesignating paragraphs (d)(1), (d)(2), and (d)(3) as paragraphs (d)(1)(i), (d)(1)(ii), and (d)(1)(iii), respectively, and by adding new paragraph (d)(2) to read as follows: Sec. 522.770 Doramectin. * * * * * (d) Conditions of use--(1) Cattle. (i) Amount. * * * * * * * * (2) Swine. (i) Amount. 300 micrograms per kilogram (10 milligrams per 75 pounds). (ii) Indications for use. For treatment and control of gastrointestinal roundworms, lungworms, kidney worms, sucking lice, and mange mites. [[Page 62243]] (iii) Limitations. Administer as a single intramuscular injection. Do not slaughter swine within 24 days of treatment. Consult your veterinarian for assistance in the diagnosis, treatment, and control of parasitism. 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 556.225 is revised to read as follows: Sec. 556.225 Doramectin. A tolerance of 0.1 part per million (ppm) is established for parent doramectin (marker residue) in liver (target tissue) of cattle and 0.16 ppm in liver of swine. Dated: October 22, 1997. Stephen F. Sundlof, Director, Center for Veterinary Medicine. [FR Doc. 97-30562 Filed 11-20-97; 8:45 am] BILLING CODE 4160-01-F