Implantation or Injectable Dosage Form New Animal Drugs; Mepivacaine, 39547 [E6-10970]

Download as PDF Federal Register / Vol. 71, No. 134 / Thursday, July 13, 2006 / Rules and Regulations DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 522 Implantation or Injectable Dosage Form New Animal Drugs; Mepivacaine AGENCY: Food and Drug Administration, HHS. Final rule, technical amendment. ACTION: 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 The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental new animal drug application (NADA) filed by Pharmacia & Upjohn Co. The supplemental NADA provides for revised food safety labeling for mepivacaine injectable solution used in horses for local anesthesia. DATES: This rule is effective July 13, 2006. FOR FURTHER INFORMATION CONTACT: Melanie R. Berson, Center for Veterinary Medicine (HFV–110), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301–827–7543, email: melanie.berson@fda.hhs.gov. SUPPLEMENTARY INFORMATION: Pharmacia & Upjohn Co., a Division of Pfizer, Inc., 235 East 42d St., New York, NY 10017, filed a supplement to NADA 100 703 for CARBOCAINE-V (mepivacaine hydrochloride) Sterile Aqueous Solution. The supplemental NADA provides for revised food safety labeling for mepivacaine injectable solution used in horses for local anesthesia. The application is approved as of June 2, 2006, and the regulations are amended in § 522.1372 (21 CFR 522.1372) to reflect the approval. In addition, FDA has found that the April 1, 2005, edition of parts 500 to 599 of title 21 of the Code of Federal Regulations (CFR) does not accurately reflect the approved conditions of use for mepivacaine solution used in horses. These conditions of use were inadvertently deleted as a publication error. At this time, the regulations are being amended in § 522.1372 to correct this error and to format portions of this section to reflect a current format. This action is being taken to improve the accuracy of the regulations. Approval of this supplemental NADA did not require review of additional safety or effectiveness data or information. Therefore, a freedom of information summary is not required. The agency has determined under § 25.33(d)(1) that this action is of a type that does not individually or wwhite on PROD1PC61 with RULES SUMMARY: VerDate Aug<31>2005 17:17 Jul 12, 2006 Jkt 208001 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 the Center for Veterinary Medicine, 21 CFR part 522 is amended as follows: I PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS 1. The authority citation for 21 CFR part 522 continues to read as follows: I Authority: 21 U.S.C. 360b. 2. Revise § 522.1372 to read as follows: I § 522.1372 Mepivacaine. (a) Specifications. Each milliliter (mL) of solution contains 20 milligrams mepivacaine hydrochloride. (b) Sponsor. See No. 000009 in § 510.600(c) of this chapter. (c) Conditions of use in horses—(1) Amount. For nerve block, 3 to 5 mL; for epidural anesthesia, 5 to 20 mL; for intra-articular anesthesia, 10 to 15 mL; for infiltration, as required; for anesthesia of the laryngeal mucosa prior to ventriculectomy, by topical spray, 25 to 40 mL, by infiltration, 20 to 50 mL. (2) Indications for use. For use as a local anesthetic for infiltration, nerve block, intra-articular and epidural anesthesia, and topical and/or infiltration anesthesia of the laryngeal mucosa prior to ventriculectomy. (3) Limitations. Not for use in horses intended for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Dated: June 30, 2006. Steven D. Vaughn, Director, Office of New Animal Drug Evaluation, Center for Veterinary Medicine. [FR Doc. E6–10970 Filed 7–12–06; 8:45 am] BILLING CODE 4160–01–S PO 00000 Frm 00035 Fmt 4700 Sfmt 4700 39547 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 522 Implantation or Injectable Dosage Form New Animal Drugs; Furosemide 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 a supplemental new animal drug application (NADA) filed by Intervet Inc. The supplemental NADA provides for the revision of a food safety warning on labeling of furosemide injectable solution for use in horses. DATES: This rule is effective July 13, 2006. FOR FURTHER INFORMATION CONTACT: Melanie R. Berson, Center for Veterinary Medicine (HFV–110), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301–827–7540, email: melanie.berson@fda.hhs.gov. SUPPLEMENTARY INFORMATION: Intervet Inc., P.O. Box 318, 29160 Intervet Lane, Millsboro, DE 19966, filed a supplement to NADA 34–478 for SALIX (furosemide) Injection 5%. The supplemental NADA provides for the revision of a food safety warning on labeling of furosemide injectable solution for use in horses. The supplemental application is approved as of June 20, 2006, and the regulations are amended in 21 CFR 522.1010 to reflect the approval. Approval of this supplemental NADA did not require review of additional safety or effectiveness data or information. Therefore, a freedom of information summary is not required. The agency has determined under 21 CFR 25.33(a)(1) that these actions are of a type that do 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. I Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner E:\FR\FM\13JYR1.SGM 13JYR1

Agencies

[Federal Register Volume 71, Number 134 (Thursday, July 13, 2006)]
[Rules and Regulations]
[Page 39547]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-10970]



[[Page 39547]]

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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; 
Mepivacaine

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule, technical amendment.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is amending the animal 
drug regulations to reflect approval of a supplemental new animal drug 
application (NADA) filed by Pharmacia & Upjohn Co. The supplemental 
NADA provides for revised food safety labeling for mepivacaine 
injectable solution used in horses for local anesthesia.

DATES: This rule is effective July 13, 2006.

FOR FURTHER INFORMATION CONTACT: Melanie R. Berson, Center for 
Veterinary Medicine (HFV-110), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-827-7543, e-mail: 
melanie.berson@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: Pharmacia & Upjohn Co., a Division of 
Pfizer, Inc., 235 East 42d St., New York, NY 10017, filed a supplement 
to NADA 100 703 for CARBOCAINE-V (mepivacaine hydrochloride) Sterile 
Aqueous Solution. The supplemental NADA provides for revised food 
safety labeling for mepivacaine injectable solution used in horses for 
local anesthesia. The application is approved as of June 2, 2006, and 
the regulations are amended in Sec.  522.1372 (21 CFR 522.1372) to 
reflect the approval.
    In addition, FDA has found that the April 1, 2005, edition of parts 
500 to 599 of title 21 of the Code of Federal Regulations (CFR) does 
not accurately reflect the approved conditions of use for mepivacaine 
solution used in horses. These conditions of use were inadvertently 
deleted as a publication error. At this time, the regulations are being 
amended in Sec.  522.1372 to correct this error and to format portions 
of this section to reflect a current format. This action is being taken 
to improve the accuracy of the regulations.
    Approval of this supplemental NADA did not require review of 
additional safety or effectiveness data or information. Therefore, a 
freedom of information summary is not required.
    The agency has determined under Sec.  25.33(d)(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.

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 522 is 
amended as follows:

PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS

0
1. The authority citation for 21 CFR part 522 continues to read as 
follows:

    Authority: 21 U.S.C. 360b.
0
2. Revise Sec.  522.1372 to read as follows:


Sec.  522.1372  Mepivacaine.

    (a) Specifications. Each milliliter (mL) of solution contains 20 
milligrams mepivacaine hydrochloride.
    (b) Sponsor. See No. 000009 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use in horses--(1) Amount. For nerve block, 3 to 
5 mL; for epidural anesthesia, 5 to 20 mL; for intra-articular 
anesthesia, 10 to 15 mL; for infiltration, as required; for anesthesia 
of the laryngeal mucosa prior to ventriculectomy, by topical spray, 25 
to 40 mL, by infiltration, 20 to 50 mL.
    (2) Indications for use. For use as a local anesthetic for 
infiltration, nerve block, intra-articular and epidural anesthesia, and 
topical and/or infiltration anesthesia of the laryngeal mucosa prior to 
ventriculectomy.
    (3) Limitations. Not for use in horses intended for human 
consumption. Federal law restricts this drug to use by or on the order 
of a licensed veterinarian.

    Dated: June 30, 2006.
Steven D. Vaughn,
Director, Office of New Animal Drug Evaluation, Center for Veterinary 
Medicine.
[FR Doc. E6-10970 Filed 7-12-06; 8:45 am]
BILLING CODE 4160-01-S

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