[Federal Register Volume 64, Number 53 (Friday, March 19, 1999)]
[Rules and Regulations]
[Pages 13508-13509]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-6670]


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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.

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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,

[[Page 13509]]

Inc. The supplemental NADA provides for extended use of doramectin in 
cattle for persistent control of nematodes including Haemonchus placei 
for 14 days after treatment.

EFFECTIVE DATE: March 19, 1999.
FOR FURTHER INFORMATION CONTACT: Estella Z. Jones, Center for 
Veterinary Medicine (HFV-135), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-827-7575.

SUPPLEMENTARY INFORMATION: Pfizer, Inc., 235 East 42d St., New York, NY 
10017-5755, filed supplemental NADA 141-061 that provides for 
subcutaneous and intramuscular use of Dectomax (doramectin) 1 
percent injectable solution in cattle to control infections and to 
protect from reinfection with H. placei for 14 days after treatment. 
The persistent use is in addition to the approved use in cattle for 
treatment and control of various gastrointestinal roundworms, 
lungworms, eyeworms, grubs, sucking lice, and mange mites, and to 
control infections and to protect from reinfection with Cooperia 
oncophora for 14 days, Ostertagia ostertagi for 21 days, and Cooperia 
punctata, Oesophagostomum radiatum, and Dictyocaulus viviparus for 28 
days after treatment.
     Supplemental NADA 141-061 is approved as of February 1, 1999, and 
the regulations are amended in 21 CFR 522.770(d)(1)(ii) 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 the supplemental 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)), this supplemental approval 
for food-producing animals qualifies for 3 years of marketing 
exclusivity beginning February 1, 1999, 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 use of doramectin injection to control 
infections and to protect cattle from reinfection with H. placei for 14 
days after treatment.
     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 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: 21 U.S.C. 360b.


Sec. 522.770   [Amended]

     2. Section 522.770 Doramectin is amended in paragraph (d)(1)(ii) 
by adding after ``Cooperia oncophora'' the phrase ``and Haemonchus 
placei''.

    Dated: February 26, 1999.
Margaret Ann Miller,
Acting Director, Office of New Animal Drug Evaluation, Center for 
Veterinary Medicine.
[FR Doc. 99-6670 Filed 3-18-99; 8:45 am]
BILLING CODE 4160-01-F