Federal Register / Vol. 73, No.

16 / Thursday, January 24, 2008 / Rules and Regulations 4077

[FR Doc. E8–1012 Filed 1–23–08; 8:45 am] 1061, Rockville, MD 20852, between 9 Drug labeler Firm name and address
BILLING CODE 4910–13–P a.m. and 4 p.m., Monday through code
Friday.
* * * * *
FDA has determined under 21 CFR 043806 Novopharm Ltd., 30
DEPARTMENT OF HEALTH AND 25.33(a)(1) that this action is of a type Novopharm Ct., Toronto,
HUMAN SERVICES that does not individually or Ontario, Canada M1B
cumulatively have a significant effect on 2K9
Food and Drug Administration the human environment. Therefore, * * * * *
neither an environmental assessment
21 CFR Parts 510 and 520 nor an environmental impact statement PART 520—ORAL DOSAGE FORM
is required. NEW ANIMAL DRUGS
Oral Dosage Form New Animal Drugs;
Clindamycin This rule does not meet the definition
of ‘‘rule’’ in 5 U.S.C. 804(3)(A) because ■ 3. The authority citation for 21 CFR
AGENCY: Food and Drug Administration, it is a rule of ‘‘particular applicability.’’ part 520 continues to read as follows:
HHS. Therefore, it is not subject to the Authority: 21 U.S.C. 360b.
ACTION: Final rule. congressional review requirements in 5
■ 4. In § 520.446, add paragraphs (a)(3)
U.S.C. 801–808.
SUMMARY: The Food and Drug and (b)(3) to read as follows:
Administration (FDA) is amending the List of Subjects
§ 520.446 Clindamycin capsules and
animal drug regulations to reflect 21 CFR Part 510 tablets.
approval of an abbreviated new animal
drug application (ANADA) filed by Administrative practice and (a) * * *
Novopharm Ltd. The ANADA provides procedure, Animal drugs, Labeling, (3) Each capsule contains the
for the veterinary prescription use of Reporting and recordkeeping equivalent of 25, 75, or 150 mg
clindamycin hydrochloride oral requirements. clindamycin as the hydrochloride salt.
capsules in dogs for the treatment of (b) * * *
various infections due to susceptible 21 CFR Part 520 (3) No. 043806 for use of tablets
bacterial pathogens. described in paragraph (a)(3) of this
Animal drugs. section.
DATES: This rule is effective January 24,
■ Therefore, under the Federal Food, * * * * *
2008.
Drug, and Cosmetic Act and under
FOR FURTHER INFORMATION CONTACT: John Dated: January 14, 2008.
authority delegated to the Commissioner
K. Harshman, Center for Veterinary of Food and Drugs and redelegated to Bernadette Dunham,
Medicine (HFV–104), Food and Drug the Center for Veterinary Medicine, 21 Director, Center for Veterinary Medicine.
Administration, 7500 Standish Pl., CFR parts 510 and 520 are amended as [FR Doc. E8–1199 Filed 1–23–08; 8:45 am]
Rockville, MD 20855, 240–276–9808, e- follows: BILLING CODE 4160–01–S
mail: john.harshman@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: PART 510—NEW ANIMAL DRUGS
Novopharm Ltd., 30 Novopharm Ct., DEPARTMENT OF STATE
Toronto, Ontario, Canada M1B 2K9, ■ 1. The authority citation for 21 CFR
filed ANADA 200–383 that provides for part 510 continues to read as follows: 22 CFR Part 51
the veterinary prescription use of Authority: 21 U.S.C. 321, 331, 351, 352,
CLINDAROBE (clindamycin RIN 1400–AC28
353, 360b, 371, 379e.
hydrochloride) Capsules in dogs for the [Public Notice: 6071]
treatment of various infections due to ■ 2. Section 510.600 is amended in the
susceptible bacterial pathogens. table in paragraph (c)(1) by Passports; Correction
Novopharm Ltd.’s CLINDAROBE alphabetically adding a new entry for
Capsules is approved as a generic copy ‘‘Novopharm Ltd.’’ and in the table in AGENCY: Department of State.
of Pharmacia & Upjohn Co.’s paragraph (c)(2) by numerically adding ACTION: Final rule; correction.
ANTIROBE Capsules, approved under a new entry for ‘‘043806’’ to read as
follows: SUMMARY: This document contains a
NADA 120–161. The ANADA is
approved as of December 19, 2007, and correction to the revised Passport rule
§ 510.600 Names, addresses, and drug published in the Federal Register on
21 CFR 520.446 is amended to reflect labeler codes of sponsors of approved
the approval. November 19, 2007, 72 FR 64930.
applications.
In addition, Novopharm Ltd. has not DATES: Effective on February 1, 2008.
* * * * *
been previously listed in the animal FOR FURTHER INFORMATION CONTACT:
drug regulations as a sponsor of an (c) * * *
Consuelo Pachon, Office of Legal Affairs
approved application. At this time, 21 (1) * * * and Law Enforcement Liaison, Bureau
CFR 510.600(c) is being amended to add of Consular Affairs, 2100 Pennsylvania
entries for the firm. Drug labeler
Firm name and address code Avenue, NW., Suite 3000, Washington,
In accordance with the freedom of DC., telephone number 202–663–2431.
information provisions of 21 CFR part * * * * *
20 and 21 CFR 514.11(e)(2)(ii), a Background
Novopharm Ltd., 30 043806
summary of safety and effectiveness Novopharm Ct., Toronto, The rule reorganizes, restructures, and
data and information submitted to Ontario, Canada M1B updates the passport regulations in
jlentini on PROD1PC65 with RULES

support approval of this application 2K9 order to make them easier for users to
may be seen in the Division of Dockets * * * * * access the information, to better reflect
Management (HFA–305), Food and Drug current practice and changes in
Administration, 5630 Fishers Lane, rm. (2) * * *

VerDate Aug<31>2005 19:26 Jan 23, 2008 Jkt 214001 PO 00000 Frm 00027 Fmt 4700 Sfmt 4700 E:\FR\FM\24JAR1.SGM 24JAR1