65FR36616 Ophthalmic and Topical Dosage Form New Animal Drugs; Moxidectin
robop...@us.govnews.org
Posting-number: Volume 65, Issue 112, Page 36616
[Federal Register: June 9, 2000 (Volume 65, Number 112)]
[Rules and Regulations]
[Page 36616-36617]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr09jn00-6]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 524 and 556
Ophthalmic and Topical Dosage Form New Animal Drugs; Moxidectin
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
-----------------------------------------------------------------------
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 Fort Dodge Animal Health, Division of
American Home Products Corp. The supplemental NADA provides for topical
use of a 0.5 percent moxidectin solution on dairy cattle of breeding
age for treatment and control of infections and infestations of certain
internal and external parasites. FDA is also amending the regulations
to establish a tolerance for moxidectin residues in milk.
DATES: This rule is effective June 9, 2000.
FOR FURTHER INFORMATION CONTACT: Steven D. Vaughn, Center for
Veterinary Medicine (HFV-130), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 301-827-7584.
SUPPLEMENTARY INFORMATION: Fort Dodge Animal Health, Division of
American Home Products Corp., 800 Fifth St. NW., Fort Dodge, IA 50501,
filed supplemental NADA 141-099 that provides for use of
Cydectin<Register> (moxidectin) 0.5 percent pouron for dairy cattle at
500 micrograms moxidectin per kilogram of body weight for treatment and
control of infections and infestations of certain gastrointestinal
roundworms, lungworms, cattle grubs, mites, lice, and horn flies. The
supplemental NADA is approved as of November 2, 1999, and the
regulations are amended in 21 CFR 524.1451 to reflect the approval. The
basis for approval is discussed in the freedom of information summary.
In addition, the regulations are amended in 21 CFR 556.426 to add a
tolerance for residues of moxidectin in milk and, editorially, to
reflect current format.
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)(ii) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 360b(c)(2)(F)(ii)), this approval qualifies for
3 years of marketing exclusivity beginning November 2, 1999, because
the application 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
application and conducted or sponsored by the applicant.
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.
This rule does not meet the definition of ``rule'' in 5 U.S.C.
804(3)(A) because it is a rule of ``particular applicability.''
Therefore, it is not subject to the congressional review requirements
in 5 U.S.C. 801-808.
List of Subjects
21 CFR Part 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 524 and
556 are amended as follows:
[[Page 36617]]
PART 524--OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS
1. The authority citation for 21 CFR part 524 continues to read as
follows:
Authority: 21 U.S.C. 360b.
Sec. 524.1451 [Amended]
2. Section 524.1451 Moxidectin is amended in the first sentence of
paragraph (d)(2) by removing the phrase ``Beef and non-lactating dairy
cattle'' and by adding in its place the phrase ``Beef and dairy
cattle'', and in paragraph (d)(3) by removing the first and second
sentences.
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 556.426 is revised to read as follows:
Sec. 556.426 Moxidectin.
(a) Acceptable daily intake (ADI). The ADI for total residues of
moxidectin is 4 micrograms per kilogram of body weight per day.
(b) Tolerances. The tolerance for parent moxidectin (the marker
residue) in edible tissues of cattle is 200 parts per billion (ppb) in
liver (the target tissue) and 50 ppb in muscle. The tolerance for
parent moxidectin is 50 ppb in milk.
Dated: May 29, 2000.
Claire M. Lathers,
Director, Office of New Animal Drug Evaluation, Center for Veterinary
Medicine.
[FR Doc. 00-14463 Filed 6-8-00; 8:45 am]
BILLING CODE 4160-01-F