[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]


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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.

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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 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 Dectomax<Register> 1 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