Legal Status
Legal Status
Rule
Oral Dosage Form New Animal Drugs; Dexmedetomidine; Technical Amendment
A Rule by the Food and Drug Administration on
Document Details
Information about this document as published in the Federal Register.
- Printed version:
- Publication Date:
- 04/20/2007
- Agencies:
- Food and Drug Administration
- Dates:
- This rule is effective April 20, 2007.
- Effective Date:
- 04/20/2007
- Document Type:
- Rule
- Document Citation:
- 72 FR 19796
- Page:
- 19796-19797 (2 pages)
- CFR:
- 21 CFR 522
- Document Number:
- E7-7594
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Published Document
This document has been published in the Federal Register. Use the PDF linked in the document sidebar for the official electronic format.
AGENCY:
Food and Drug Administration, HHS.
ACTION:
Final rule; technical amendment.
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.
Start Further InfoFOR 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.
End Further Info End Preamble Start Supplemental InformationSUPPLEMENTARY 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.
Start List of SubjectsList of Subjects in 21 CFR Part 522
End List of Subjects Start Amendment PartTherefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner
End Amendment Part Start PartPART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS
End Part Start Amendment Part1. The authority citation for
End Amendment Part Start AuthorityAuthority: 21 U.S.C. 360b.
End Authority Start Amendment Part2. In § 522.558, paragraph (a) is revised to read as follows:
End Amendment Part(a) Specifications. Each milliliter of solution contains 0.5 milligram (mg) of dexmedetomidine hydrochloride.
Dated: April 13, 2007.
Bernadette Dunham,
Deputy Director, Center for Veterinary Medicine.
[FR Doc. E7-7594 Filed 4-19-07; 8:45 am]
BILLING CODE 4160-01-S