[Federal Register: November 7, 2007 (Volume 72, Number 215)]
[Rules and Regulations]
[Page 62771]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr07no07-5]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 522
Implantation or Injectable Dosage Form New Animal Drugs;
Ivermectin
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 abbreviated new
animal drug application (ANADA) filed by Norbrook Laboratories, Ltd.
The supplemental ANADA adds claims for persistent effectiveness against
various species of external and internal parasites when cattle are
treated with a one percent ivermectin solution by subcutaneous
injection.
DATES: This rule is effective November 7, 2007.
FOR FURTHER INFORMATION CONTACT: John K. Harshman, Center for
Veterinary Medicine (HFV-104), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 301-827-0169, e-mail:
john.harshman@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Norbrook Laboratories, Ltd., Station Works,
Newry BT35 6JP, Northern Ireland, filed a supplement to ANADA 200-437
that provides for use of NOROMECTIN (ivermectin) Injection for Cattle
and Swine. The supplemental ANADA adds claims for persistent
effectiveness against various species of external and internal
parasites of cattle. The supplemental ANADA is approved as of October
5, 2007, and the regulations are amended in 21 CFR 522.1192 to reflect
the approval.
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(a)(1) 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 522
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 522 is
amended as follows:
PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS
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1. The authority citation for 21 CFR part 522 continues to read as
follows:
Authority: 21 U.S.C. 360b.
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2. In Sec. 522.1192, revise paragraph (b)(2) and add paragraph (b)(3)
to read as follows:
Sec. 522.1192 Ivermectin.
* * * * *
(b) * * *
(2) No. 055529 for use of the product described in paragraph (a)(2)
of this section as in paragraphs (e)(2)(i), (e)(2)(ii)(A),
(e)(2)(ii)(C), (e)(2)(iii), (e)(3), (e)(4) and (e)(5) of this section.
(3) No. 059130 for use of the product described in paragraph (a)(2)
of this section as in paragraphs (e)(2)(i), (e)(2)(ii)(A),
(e)(2)(ii)(B), (e)(2)(iii), (e)(3), (e)(4), and (e)(5) of this section.
* * * * *
Dated: October 26, 2007.
Bernadette Dunham,
Deputy Director, Center for Veterinary Medicine.
[FR Doc. E7-21839 Filed 11-6-07; 8:45 am]
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