[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]


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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, 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 
Dectomax 1% 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