2010-29326. Intramammary Dosage Form New Animal Drugs; Cloxacillin Benzathine

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 supplementary new animal drug application (NADA) filed by Boehringer Ingelheim Vetmedica, Inc. The supplement provides for minor revisions to labeling.

DATES:

This rule is effective November 22, 2010.

FOR FURTHER INFORMATION CONTACT:

Cindy L. Burnsteel, Center for Veterinary Medicine (HFV-130), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 240-276-8341, e-mail: [e-mail].

SUPPLEMENTARY INFORMATION:

Boehringer Ingelheim Vetmedica, Inc., 2621 North Belt Highway, St. Joseph, MO 64506-2002 has filed a supplement to NADA 55-058 for DRY-CLOX (cloxacillin benzathine) Intramammary Infusion for dry dairy cattle. The supplemental NADA provides for various minor revisions to labeling. The supplemental application is approved as of October 21, 2010, and the regulations in § 526.464a (21 CFR 526.464a) are amended to reflect the approval.

In addition, FDA has noticed that certain portions of § 526.464a were inadvertently removed when the regulations were amended to reflect a change of sponsorship (75 FR 10165, March 5, 2010). At this time, the regulations are being amended to reflect fully the approved conditions of use of this new animal drug product. This change is being made to improve the accuracy of the animal drug 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 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 526

• 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 526 is amended as follows:

PART 526—INTRAMAMMARY DOSAGE FORM NEW ANIMAL DRUGS

1. The authority citation for 21 CFR part 526 continues to read as follows:

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

2. Revise the heading for part 526 to read as set forth above.

3. In § 526.464a, revise paragraph (c) to read as follows:

§ 526.464a

Cloxacillin benzathine.

* * * * *

(c) Sponsor. See No. 000010 in § 510.600(c) of this chapter for use in dairy cows.

(1) Amount. Administer aseptically into each quarter immediately after last milking.

(2) Indications for use. For the treatment of mastitis caused by Staphylococcus aureus and Streptococcus agalactiae including penicillin resistant strains in dairy cows during the dry period.

(3) Limitations. For use in dry cows only. Not to be used within 30 days of calving. Animals infused with this product must not be slaughtered for food use for 30 days after the latest infusion. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Dated: November 16, 2010.

Elizabeth Rettie,

Deputy Director, Office of New Animal Drug Evaluation, Center for Veterinary Medicine.