[Federal Register Volume 75, Number 91 (Wednesday, May 12, 2010)]
[Rules and Regulations]
[Pages 26647-26648]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-11244]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 524
[Docket No. FDA-2010-N-0002]
Ophthalmic and Topical Dosage Form New Animal Drugs; Ivermectin
Topical Solution
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule, technical amendment.
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SUMMARY: The Food and Drug Administration (FDA) is amending the animal
drug regulations to reflect approval of an abbreviated new animal drug
application (ANADA) filed by First Priority, Inc. The supplemental
ANADA adds claims for persistent effectiveness against various species
of external and internal parasites when cattle are treated with a
topical solution of ivermectin.
DATES: This rule is effective May 12, 2010.
FOR FURTHER INFORMATION CONTACT: John K. Harshman, Center for
Veterinary Medicine (HFV-170), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 240-276-8197, e-mail:
[email protected].
SUPPLEMENTARY INFORMATION: First Priority, Inc., 1590 Todd Farm Dr.,
Elgin, IL 60123, filed a supplement to ANADA 200-340 for PRIVERMECTIN
(ivermectin), a topical solution used on cattle to control infestations
of certain species of external and internal parasites. The supplemental
ANADA
[[Page 26648]]
adds claims for persistent effectiveness against various species of
external and internal parasites that were approved for the pioneer
product with 3 years of marketing exclusivity (69 FR 501, January 6,
2004). The supplemental ANADA is approved as of March 26, 2010, and 21
CFR 524.1193 is amended to reflect the approval.
In addition, FDA has noticed the regulations do not accurately
reflect approved indications for generic products. At this time, the
regulations are being revised to reflect which generic products have
approved labeling for the durations of persistent effectiveness
approved for the pioneer product. FDA is also adding a parasite species
that was inadvertently omitted in the previously cited January 6, 2004,
final rule. These actions are being taken to improve the accuracy of
the regulations.
In accordance with the freedom of information provisions of 21 CFR
part 20 and 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 Division of Dockets Management
(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.
The agency has determined under 21 CFR 25.33 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.
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 in 21 CFR Part 524
Animal drugs.
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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 part 524 is
amended as follows:
PART 524--OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS
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1. The authority citation for 21 CFR part 524 continues to read as
follows:
Authority: 21 U.S.C. 360b.
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2. In Sec. 524.1193, revise paragraphs (b) and (e)(2) to read as
follows:
Sec. 524.1193 Ivermectin topical solution.
* * * * *
(b) Sponsors. See sponsors in Sec. 510.600(c) of this chapter for
use as in paragraph (e) of this section.
(1) Nos. 050604, 055529, 058829 for use as in paragraphs (e)(1),
(e)(2)(i), (e)(2)(iii), and (e)(3) of this section.
(2) Nos. 054925, 059130, 061623, and 066916 for use as in
paragraphs (e)(1), (e)(2)(i), (e)(2)(ii), and (e)(3) of this section.
* * * * *
(e) * * *
(2) Indications for use--(i) It is used for the treatment and
control of: Gastrointestinal roundworms (adults and fourth-stage
larvae) Ostertagia ostertagi (including inhibited stage), Haemonchus
placei, Trichostrongylus axei, T. colubriformis, Cooperia oncophora, C.
punctata, C. surnabada, Oesophagostomum radiatum; (adults)
Strongyloides papillosus, Trichuris spp.; lungworms (adults and fourth-
stage larvae) Dictyocaulus viviparus; cattle grubs (parasitic stages)
Hypoderma bovis, H. lineatum; mites Sarcoptes scabiei var. bovis; lice
Linognathus vituli, Haematopinus eurysternus, Damalinia bovis,
Solenoptes capillatus; and horn flies Haematobia irritans.
(ii) It controls infections and prevents reinfection with O.
ostertagi, O. radiatum, H. placei, T. axei, C. punctata, and C.
oncophora for 14 days after treatment.
(iii) It controls infections and prevents reinfection with O.
radiatum and D. viviparus for 28 days after treatment, C. punctata and
T. axei for 21 days after treatment, O. ostertagi, H. placei, C.
oncophora, and C. surnabada for 14 days after treatment, and D. bovis
for 56 days after treatment.
* * * * *
Dated: May 6, 2010.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2010-11244 Filed 5-11-10; 8:45 am]
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