Certain Other Dosage Form New Animal Drugs; Sevoflurane, 1021 [2010-47]

Download as PDF 1021 Federal Register / Vol. 75, No. 5 / Friday, January 8, 2010 / Rules and Regulations Supplement No. 1 to Part 738 [Corrected] On page 68145, in Supplement No. 1 to Part 738, the table is reprinted to read as set forth below: SUPPLEMENT NO. 1 TO PART 738—COMMERCE COUNTRY CHART [Reason for control] Chemical & biological weapons Countries CB CB Nuclear nonproliferation Missile Tech National Security Firearms convention Regional Stability Anti-terrorism Crime control CB NP 1 2 * Albania 2 3 ... X X * Croatia 3 ...... X 3See NS NS MT RS RS FC CC CC CC AT AT 1 2 1 2 1 1 2 1 1 2 3 1 2 X X X X X X * * X * * 2See 3 NP * X ........ * * * * * * * * * * X * * * §742.4(a) for special provisions that apply to exports and reexports to these countries of certain thermal imaging cameras. §742.6(a)(3) for special provisions that apply to military commodities that are subject to ECCN OA919. [FR Doc. C1–2009–30484 Filed 1–7–10; 8:45 am] BILLING CODE 1505–01–D DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 529 [Docket No. FDA–2009–N–0665] Certain Other Dosage Form New Animal Drugs; Sevoflurane AGENCY: Food and Drug Administration, HHS. ACTION: pwalker on DSK8KYBLC1PROD with RULES * 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 Halocarbon Products Corp. The ANADA provides for the use of sevoflurane inhalant anesthetic in dogs. DATES: This rule is effective January 8, 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, email: john.harshman@fda.hhs.gov. SUPPLEMENTARY INFORMATION: Halocarbon Products Corp., 887 Kinderkamack Rd., River Edge, NJ 07661, filed ANADA 200–467 that provides for use of Sevoflurane, an inhalant anesthetic, in dogs. Halocarbon VerDate Nov<24>2008 16:10 Jan 07, 2010 Jkt 220001 Products Corp.’s Sevoflurane is approved as a generic copy of SEVOFLO (sevoflurane), sponsored by Abbott Laboratories, under NADA 141–103. The ANADA is approved as of November 27, 2009, and the regulations are amended in § 529.2150 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 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 529 Animal drugs. Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs and redelegated to PO 00000 Frm 00005 Fmt 4700 Sfmt 4700 the Center for Veterinary Medicine, 21 CFR part 529 is amended as follows: PART 529—CERTAIN OTHER DOSAGE FORM NEW ANIMAL DRUGS 1. The authority citation for 21 CFR part 529 continues to read as follows: Authority: 21 U.S.C. 360b. § 529.2150 [Amended] 2. In paragraph (b) of § 529.2150, remove ‘‘Nos. 000074 and 060307’’ and in its place add ‘‘Nos. 000074, 012164, and 060307’’. Dated: January 4, 2010. Bernadette Dunham, Director, Center for Veterinary Medicine. [FR Doc. 2010–47 Filed 1–7–10; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration 50 CFR Part 648 [Docket No. 0907241164–91415–02] RIN 0648–AY09 Magnuson-Stevens Fishery Conservation and Management Act Provisions; Fisheries of the Northeastern United States AGENCY: National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce. E:\FR\FM\08JAR1.SGM 08JAR1

Agencies

[Federal Register Volume 75, Number 5 (Friday, January 8, 2010)]
[Rules and Regulations]
[Page 1021]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-47]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 529

[Docket No. FDA-2009-N-0665]


Certain Other Dosage Form New Animal Drugs; Sevoflurane

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 an abbreviated new animal drug 
application (ANADA) filed by Halocarbon Products Corp. The ANADA 
provides for the use of sevoflurane inhalant anesthetic in dogs.

DATES: This rule is effective January 8, 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: 
john.harshman@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: Halocarbon Products Corp., 887 Kinderkamack 
Rd., River Edge, NJ 07661, filed ANADA 200-467 that provides for use of 
Sevoflurane, an inhalant anesthetic, in dogs. Halocarbon Products 
Corp.'s Sevoflurane is approved as a generic copy of SEVOFLO 
(sevoflurane), sponsored by Abbott Laboratories, under NADA 141-103. 
The ANADA is approved as of November 27, 2009, and the regulations are 
amended in Sec.  529.2150 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 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 529

    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 529 is 
amended as follows:

PART 529--CERTAIN OTHER DOSAGE FORM NEW ANIMAL DRUGS

0
1. The authority citation for 21 CFR part 529 continues to read as 
follows:

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


Sec.  529.2150  [Amended]

0
2. In paragraph (b) of Sec.  529.2150, remove ``Nos. 000074 and 
060307'' and in its place add ``Nos. 000074, 012164, and 060307''.

    Dated: January 4, 2010.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2010-47 Filed 1-7-10; 8:45 am]
BILLING CODE 4160-01-S

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