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New Animal Drugs; Dexmedetomidine; Lasalocid; Melengestrol; Monensin; and Tylosin; Correction

---
identifier: "/us/fr/2013-13331"
source: "fr"
legal_status: "authoritative_unofficial"
title: "New Animal Drugs; Dexmedetomidine; Lasalocid; Melengestrol; Monensin; and Tylosin; Correction"
title_number: 0
title_name: "Federal Register"
section_number: "2013-13331"
section_name: "New Animal Drugs; Dexmedetomidine; Lasalocid; Melengestrol; Monensin; and Tylosin; Correction"
positive_law: false
currency: "2013-06-05"
last_updated: "2013-06-05"
format_version: "1.1.0"
generator: "[email protected]"
agency: "Health and Human Services Department"
document_number: "2013-13331"
document_type: "rule"
publication_date: "2013-06-05"
agencies:
  - "Health and Human Services Department"
  - "Food and Drug Administration"
cfr_references:
  - "21 CFR Part 522"
fr_citation: "78 FR 33698"
fr_volume: 78
docket_ids:
  - "Docket No. FDA-2013-N-0002"
effective_date: "2013-06-05"
fr_action: "Correcting amendments."
---

#  Dexmedetomidine.

**AGENCY:**

Food and Drug Administration, HHS.

**ACTION:**

Correcting amendments.

**SUMMARY:**

The Food and Drug Administration (FDA) is correcting a document amending the animal drug regulations to reflect approval actions for new animal drug applications and abbreviated new animal drug applications during March 2013 that appeared in the *Federal Register* of April 30, 2013. FDA is correcting the approved strengths of dexmedetomidine hydrochloride injectable solution. This correction is being made to improve the accuracy of the animal drug regulations.

**DATES:**

This rule is effective June 5, 2013.

**FOR FURTHER INFORMATION CONTACT:**

George K. Haibel, Center for Veterinary Medicine (HFV-6), Food and Drug  Administration, 7519 Standish Pl., Rockville, MD 20855, 240-276-9019, * [email protected].*

**SUPPLEMENTARY INFORMATION:**

The Food and Drug Administration (FDA) is correcting a document amending the animal drug regulations to reflect approval actions for new animal drug applications and abbreviated new animal drug applications during March 2013 that appeared in the *Federal Register* of April 30, 2013 (78 FR 25182). FDA is correcting the approved strengths of dexmedetomidine hydrochloride injectable solution. This correction is being made to improve the accuracy of the animal drug regulations.

**List of Subjects in 21 CFR Part 522**

Animal drugs.

Therefore, 21 CFR part 522 is corrected by making the following correcting amendment.

**21 CFR Part 522**

**PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS**

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

**Authority:**

21 U.S.C. 360b.

**21 CFR Part 522**

2. In § 522.558, revise paragraph (a) to read as follows:

§ 522.558

(a) *Specifications.* Each milliliter of solution contains 0.1 or 0.5 milligrams dexmedetomidine hydrochloride.

Dated: May 31, 2013.

Bernadette Dunham,

Director, Center for Veterinary Medicine.