[Federal Register Volume 61, Number 199 (Friday, October 11, 1996)]
[Rules and Regulations]
[Pages 53320-53321]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-26212]
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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 new animal drug application
(NADA) filed by Pfizer, Inc. The NADA provides for subcutaneous and
intramuscular use of doramectin for treatment and control of
gastrointestinal roundworms, lungworms, eyeworms, grubs, lice, and
mange mites in cattle.
EFFECTIVE DATE: October 11, 1996.
FOR FURTHER INFORMATION CONTACT: Melanie R. Berson, 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 use of
Dectomax 1 percent injectable solution (doramectin) for
treatment and control of gastrointestinal roundworms, lungworms,
eyeworms, grubs, lice, and mange mites in cattle. The NADA is approved
as of July 30, 1996, and the regulations are amended in part 522 (21
CFR part 522) by adding new Sec. 522.770 to reflect the approval. The
basis of approval is discussed in the freedom of information summary.
In addition, part 556 (21 CFR part 556) is amended by adding new
Sec. 556.225 to provide for tolerances for residues of doramectin in
edible cattle tissues.
Under section 512(c)(2)(F)(i) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 360b(c)(2)(F)(i)), this approval qualifies for
5 years of marketing exclusivity beginning July 30, 1996, because no
active ingredient (including any ester or salt of the active
ingredient) has been previously approved in any other application filed
under section 512(b)(1) of the act.
[[Page 53321]]
In accordance with the freedom of information provisions of part 20
(21 CFR part 20) and Sec. 514.11(e)(2)(ii) (21 CFR 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, 12420
Parklawn Dr., rm. 1-23, Rockville, MD 20857, between 9 a.m. and 4 p.m.,
Monday through Friday.
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: Sec. 512 of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 360b).
2. New Sec. 522.770 is added to read as follows:
Sec. 522.770 Doramectin.
(a) Specifications. Each milliliter of sterile aqueous solution
contains 10 milligrams of doramectin.
(b) Sponsor. See No. 000069 in Sec. 510.600 (c) of this chapter.
(c) Related tolerances. See Sec. 556.225 of this chapter.
(d) Conditions of use. Cattle--(1) Amount. 200 micrograms per
kilogram (10 milligrams per 110 pounds).
(2) Indications for use. For treatment and control of
gastrointestinal roundworms, lungworms, eyeworms, grubs, lice, and
mange mites, and protection against infection or reinfection with
Ostertagia ostertagia for up to 21 days.
(3) Limitations. Administer as a single subcutaneous or
intramuscular injection. Do not slaughter cattle within 35 days of
treatment. Not for use in female dairy cattle 20 months of age or
older. Do not use in calves to be processed for veal.
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: Secs. 402, 512, 701 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 342, 360b, 371).
4. New Sec. 556.225 is added to subpart B to read as follows:
Sec. 556.225 Doramectin.
A tolerance of 0.1 part per million is established for parent
doramectin (marker residue) in liver (target tissue) of cattle.
Dated: September 23, 1996.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 96-26212 Filed 10-10-96; 8:45 am]
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