Oral Dosage Form New Animal Drugs; Clindamycin Solution, 19796 [E7-7472]

Download as PDF 19796 Federal Register / Vol. 72, No. 76 / Friday, April 20, 2007 / Rules and Regulations pressure indicator at the end of the discharge line to confirm that the container has not discharged. (2) The discharge line terminates inside the airplane. As part of a predeparture check, visually inspect the pressure indicator for the container for loss of pressure within the container. (b) The certificate holder also must ensure that only non-corrosive extinguishing agents are used in systems where the pressure discharge line terminates inside the airplane. PART 135—OPERATING REQUIREMENTS: COMMUTER AND ON DEMAND OPERATIONS AND RULES GOVERNING PERSONS ON BOARD SUCH AIRCRAFT 3. The authority citation for part 135 continues to read as follows: I Authority: 49 U.S.C. 106(g), 41706, 44113, 44101, 44701–44702, 44705, 44709, 44711– 44713, 44715–44717, 44722. 4. Amend § 135.169 by revising paragraph (a) to read as follows: I § 135.169 Additional airworthiness requirements. (a) Except for commuter category airplanes, no person may operate a large airplane unless it meets the additional airworthiness requirements of §§ 121.215 through 121.283 and 121.307 of this chapter. * * * * * Marion C. Blakey, Administrator. [FR Doc. 07–1937 Filed 4–19–07; 8:45 am] BILLING CODE 4910–13–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 520 Oral Dosage Form New Animal Drugs; Clindamycin Solution AGENCY: Food and Drug Administration, HHS. cprice-sewell on PRODPC61 with RULES ACTION: Final rule. 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 ANADA provides for the veterinary prescription use of clindamycin hydrochloride oral solution in dogs and cats for the treatment of various infections due to susceptible bacterial pathogens. VerDate Aug<31>2005 15:15 Apr 19, 2007 Jkt 211001 DATES: This rule is effective April 20, 2007. John K. Harshman, Center for Veterinary Medicine (HFV–104), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301–827–0169, email: john.harshman@fda.hhs.gov. SUPPLEMENTARY INFORMATION: First Priority, Inc., 1585 Todd Farm Dr., Elgin, IL 60123, filed ANADA 200–398 for the veterinary prescription use of Clindamycin Hydrochloride Oral Drops in dogs and cats for the treatment of various infections due to susceptible bacterial pathogens. First Priority, Inc.’s Clindamycin Hydrochloride Oral Drops is approved as a generic copy of ANTIROBE AQUADROPS Liquid, sponsored by Pharmacia & Upjohn Co., a Division of Pfizer, Inc., under NADA 135–940. The ANADA is approved as of March 19, 2007, and 21 CFR 520.447 is amended 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. FDA 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 520 Animal drugs. I 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 520 is amended as follows: PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGS 1. The authority citation for 21 CFR part 520 continues to read as follows: I Authority: 21 U.S.C. 360b. 2. In § 520.447 revise paragraph (b) to read as follows: I Frm 00014 Clindamycin Solution. * FOR FURTHER INFORMATION CONTACT: PO 00000 § 520.447 Fmt 4700 Sfmt 4700 * * * * (b) Sponsors. See Nos. 000009, 051311, 058829, and 059130 in § 510.600(c) of this chapter. * * * * * Dated: April 9, 2007. Bernadette Dunham, Deputy Director, Center for Veterinary Medicine. [FR Doc. E7–7472 Filed 4–19–07; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 522 Oral Dosage Form New Animal Drugs; Dexmedetomidine; Technical Amendment AGENCY: Food and Drug Administration, HHS. Final rule; technical amendment. ACTION: SUMMARY: The Food and Drug Administration (FDA) is amending a final rule that appeared in the Federal Register of January 4, 2007 (72 FR 263), revising the animal drug regulations to reflect approval of an original new animal drug application (NADA). The document incorrectly listed the amount of drug per milliliter of dexmedetomidine hydrochloride injectable solution. This action is being taken to improve the accuracy of the regulations. DATES: This rule is effective April 20, 2007. FOR FURTHER INFORMATION CONTACT: George K. Haibel, Center for Veterinary Medicine (HFV–6), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240–267–9019, e-mail: george.haibel@fda.hhs.gov. SUPPLEMENTARY INFORMATION: FDA has discovered that an error has been incorporated into the agency’s regulations for 21 CFR part 522. This document corrects that error. Publication of this document constitutes final action under the Administrative Procedure Act (5 U.S.C. 553). FDA has determined that notice and public comment are unnecessary because this amendment is nonsubstantive. List of Subjects in 21 CFR Part 522 Animal drugs. I Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner E:\FR\FM\20APR1.SGM 20APR1

Agencies

[Federal Register Volume 72, Number 76 (Friday, April 20, 2007)]
[Rules and Regulations]
[Page 19796]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-7472]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 520


Oral Dosage Form New Animal Drugs; Clindamycin Solution

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 an abbreviated new animal drug 
application (ANADA) filed by First Priority, Inc. The ANADA provides 
for the veterinary prescription use of clindamycin hydrochloride oral 
solution in dogs and cats for the treatment of various infections due 
to susceptible bacterial pathogens.

DATES:  This rule is effective April 20, 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: First Priority, Inc., 1585 Todd Farm Dr., 
Elgin, IL 60123, filed ANADA 200-398 for the veterinary prescription 
use of Clindamycin Hydrochloride Oral Drops in dogs and cats for the 
treatment of various infections due to susceptible bacterial pathogens. 
First Priority, Inc.'s Clindamycin Hydrochloride Oral Drops is approved 
as a generic copy of ANTIROBE AQUADROPS Liquid, sponsored by Pharmacia 
& Upjohn Co., a Division of Pfizer, Inc., under NADA 135-940. The ANADA 
is approved as of March 19, 2007, and 21 CFR 520.447 is amended 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.
    FDA 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 520

    Animal drugs.

0
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 520 is 
amended as follows:

PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS

0
1. The authority citation for 21 CFR part 520 continues to read as 
follows:

    Authority:  21 U.S.C. 360b.

0
2. In Sec.  520.447 revise paragraph (b) to read as follows:


Sec.  520.447   Clindamycin Solution.

* * * * *
    (b) Sponsors. See Nos. 000009, 051311, 058829, and 059130 in Sec.  
510.600(c) of this chapter.
* * * * *

    Dated: April 9, 2007.
Bernadette Dunham,
Deputy Director, Center for Veterinary Medicine.
[FR Doc. E7-7472 Filed 4-19-07; 8:45 am]
BILLING CODE 4160-01-S

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