[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 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
