[Federal Register Volume 63, Number 237 (Thursday, December 10, 1998)]
[Rules and Regulations]
[Pages 68183-68184]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-32740]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 522, 524, and 556


Animal Drugs, Feeds, and Related Products; 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 two supplemental new animal 
drug applications (NADA's) filed by Pfizer, Inc. The supplemental 
NADA's provide for added use of doramectin in cattle for injectable use 
for additional persistent efficacy for treatment and control of certain 
gastrointestinal roundworms and lungworms and for topical use for 
treatment and control of horn flies.

EFFECTIVE DATE: December 10, 1998.
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 Cooperia oncophora for 14 days and 
Oesophagostomum radiatum for 28 days after treatment. The new 
persistent use is in addition to the currently 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 Ostertagia 
ostertagi for 21 days and C. punctata and Dictyocaulus viviparus for 28 
days after treatment.
    Pfizer, Inc., also filed supplemental NADA 141-095 that provides 
for topical use of Dectomax (doramectin) 0.5 percent pour-on 
in beef and nonlactating dairy cattle to treat and control horn flies 
(Haematobia irritans) in addition to its use for treatment and control 
of gastrointestinal roundworms, lungworms, eyeworms, grubs, biting and 
sucking lice, and mange mites, and to control infections and to protect 
from reinfection with C. oncophora and Dictyocaulus viviparus for 21 
days, and O. ostertagi, C. punctata, and O. radiatum for 28 days after 
treatment.
    The supplemental NADA's are approved as of October 25, 1998, and 
the regulations are amended in 21 CFR 522.770(d)(1)(ii) and 
524.770(d)(2) to reflect the approvals. The basis of approval is 
discussed in the freedom of information summaries.
    In addition, a tolerance for doramectin and its residues in cattle 
muscle has not been previously established. Also, the acceptable daily 
intake (ADI) for doramectin has not been previously codified. At this 
time, the regulations are amended in 21 CFR 556.225 to provide for a 
tolerance for doramectin residues in cattle muscle and an ADI.
    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.
    Under section 512(c)(2)(F)(iii) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 360b(c)(2)(F)(iii)), these supplemental 
approvals for food-producing animals qualify for 3 years of marketing 
exclusivity beginning October 25, 1998, because the supplements contain 
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 applications 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 C. oncophora for 
14 days and O. radiatum for 28 days after treatment, and for doramectin 
topical for the treatment and control of horn flies (H. irritans).
    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

21 CFR Parts 522 and 524

     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, 
524, 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 paragraph (d)(1)(ii) to 
read as follows:

Sec. 522.770  Doramectin.

 * * * * *
    (d) *  *  *
    (1) *  *  *
    (ii) Indications for use. For treatment and control of 
gastrointestinal roundworms, lungworms, eyeworms, grubs, sucking lice, 
and mange mites. To control infections and to protect from reinfection 
with Cooperia oncophora for 14 days, Ostertagia ostertagi for 21 days, 
and C. punctata, Oesophagostomum radiatum, and Dictyocaulus viviparus 
for 28 days after treatment.
 * * * * *

PART 524--OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS

    3. The authority citation for 21 CFR part 524 continues to read as 
follows:

    Authority: 21 U.S.C. 360b.

    4. Section 524.770 is amended by revising paragraph (d)(2) to read 
as follows:

Sec. 524.770  Doramectin.

 * * * * *
    (d) * * *
    (2) Indications for use. For treatment and control of 
gastrointestinal roundworms, lungworms, eyeworms, grubs, biting and 
sucking lice, horn flies, and mange mites, and to control infections 
and to protect from reinfection with Cooperia oncophora and 
Dictyocaulus viviparus for 21 days, and Ostertagia ostertagia, C. 
punctata, and Oesophagostomum radiatum for 28 days after treatment.
 * * * * *

[[Page 68184]]

PART 556--TOLERANCES FOR RESIDUES OF NEW ANIMAL DRUGS IN FOOD

    5. The authority citation for 21 CFR part 556 continues to read as 
follows:

    Authority: 21 U.S.C. 342, 360b, 371.

    6. Section 556.225 is revised to read as follows:


Sec. 556.225  Doramectin.

    (a) Acceptable daily intake (ADI). The ADI for total residues of 
doramectin is 0.75 microgram per kilogram of body weight per day.
    (b) Tolerances--(1) Cattle. A tolerance of 100 parts per billion is 
established for parent doramectin (marker residue) in liver (target 
tissue) and of 30 parts per billion for parent doramectin in muscle.
    (2) Swine. A tolerance is established for parent doramectin (marker 
residue) in liver (target tissue) of 160 parts per billion.

    Dated: December 2, 1998.
Andrew J. Beaulieu,
Acting Director, Office of New Animal Drug Evaluation, Center for 
Veterinary Medicine.
[FR Doc. 98-32740 Filed 12-9-98; 8:45 am]
BILLING CODE 4160-01-F