Certain Other Dosage Form New Animal Drugs; Detomidine; Correction, 16533 [2011-6791]

Download as PDF Federal Register / Vol. 76, No. 57 / Thursday, March 24, 2011 / Rules and Regulations entry for ‘‘060307’’ and in numerical sequence, add an entry for ‘‘066794’’ to read as follows: DEPARTMENT OF HEALTH AND HUMAN SERVICES § 510.600 Names, addresses, and drug labeler codes of sponsors of approved applications. 21 CFR Part 529 * * * (c) * * * (1) * * * * Food and Drug Administration Drug labeler code Firm name and address Food and Drug Administration, HHS. ACTION: Correcting amendment. The Food and Drug Administration (FDA) published a document in the Federal Register of 066794 April 23, 2010 (75 FR 21162), that amended the animal drug regulations to reflect approval of an original new * * * * * animal drug application (NADA). FDA is correcting a paragraph describing (2) * * * limitations to the approved conditions of use for detomidine hydrochloride Drug oromucosal gel in horses. This labeler Firm name and address correction is being made to improve the code accuracy of the animal drug regulations. DATES: This rule is effective March 24, * * * * * 2011. 066794 .... Piramal Critical Care, Inc., 3850 FOR FURTHER INFORMATION CONTACT: Schelden Circle, Bethlehem, George K. Haibel, Center for Veterinary PA 18017. Medicine (HFV–6), Food and Drug Administration, 7519 Standish Pl., * * * * * Rockville, MD 20855, 240–276–9019, email: George.Haibel@fda.hhs.gov. PART 529—CERTAIN OTHER DOSAGE SUPPLEMENTARY INFORMATION: FDA FORM NEW ANIMAL DRUGS published a document in the Federal Register of April 23, 2010 (75 FR ■ 3. The authority citation for 21 CFR 21162), that amended the animal drug part 529 continues to read as follows: regulations to reflect approval of an original NADA. FDA is correcting a Authority: 21 U.S.C. 360b. paragraph describing limitations to the § 529.1186 [Corrected] approved conditions of use for detomidine hydrochloride oromucosal ■ 4. In paragraph (b) of § 529.1186, gel in horses. This correction is being remove ‘‘060307, and 065085’’ and in its made to improve the accuracy of the place add ‘‘065085, and 066794’’. animal drug regulations. * * * * Piramal Critical Care, Inc., 3850 Schelden Circle, Bethlehem, PA 18017 .............................. § 529.2150 * SUMMARY: List of Subjects in 21 CFR Part 529 [Corrected] 5. In paragraph (b) of § 529.2150, remove ‘‘060307’’ and in its place add ‘‘066794’’. ■ Dated: March 17, 2011. Leslie Kux, Acting Assistant Commissioner for Policy. [FR Doc. 2011–6795 Filed 3–23–11; 8:45 am] BILLING CODE 4160–01–P Animal drugs. Accordingly, 21 CFR part 529 is corrected by making the following correcting amendment: PART 529—CERTAIN OTHER DOSAGE FORM NEW ANIMAL DRUGS 1. The authority citation for part 529 continues to read as follows: ■ jdjones on DSK8KYBLC1PROD with RULES Authority: 21 U.S.C. 360b. 2. In § 529.536, amend paragraph (c)(3) by adding a sentence after the first sentence to read as follows: ■ § 529.536 * VerDate Mar<15>2010 14:49 Mar 23, 2011 Jkt 223001 Detomidine. * * (c) * * * PO 00000 Frm 00009 Dated: March 17, 2011. Leslie Kux, Acting Assistant Commissioner for Policy. BILLING CODE 4160–01–P Certain Other Dosage Form New Animal Drugs; Detomidine; Correction AGENCY: (3) * * * Do not use in horses intended for human consumption. [FR Doc. 2011–6791 Filed 3–23–11; 8:45 am] [Docket No. FDA–2010–N–0002] * 16533 * Fmt 4700 * Sfmt 4700 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 558 [Docket No. FDA–2010–N–0002] Animal Drugs, Feeds, and Related Products; Withdrawal of Approval of New Animal Drug Applications; Aklomide; Levamisole Hydrochloride; Nitromide and Sulfanitran; Roxarsone; Correction AGENCY: Food and Drug Administration, HHS. ACTION: Correcting amendment. The Food and Drug Administration (FDA) published a document in the Federal Register of October 26, 2010 (75 FR 65565) amending the animal drug regulations. The October 26, 2010, final rule amended the regulations by removing those portions that reflect approval of eight new animal drug applications. The final rule inadvertently failed to add conforming amendments in § 558.530. FDA is correcting the animal drug regulations by removing cross references for use of the withdrawn drugs in combination drug medicated feed. This correction is being made to improve the accuracy of the animal drug regulations. DATES: This rule is effective March 24, 2011. 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, e-mail: george.haibel@fda.hhs.gov. SUPPLEMENTARY INFORMATION: The Food and Drug Administration (FDA) published a document in the Federal Register of October 26, 2010 (75 FR 65565) amending the animal drug regulations. The October 26, 2010, final rule amended the regulations by removing those portions that reflect approval of eight new animal drug applications. The final rule inadvertently failed to add conforming amendments in § 558.530. FDA is correcting the animal drug regulations by removing cross references for use of the withdrawn drugs in combination SUMMARY: E:\FR\FM\24MRR1.SGM 24MRR1

Agencies

[Federal Register Volume 76, Number 57 (Thursday, March 24, 2011)]
[Rules and Regulations]
[Page 16533]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-6791]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 529

[Docket No. FDA-2010-N-0002]


Certain Other Dosage Form New Animal Drugs; Detomidine; 
Correction

AGENCY: Food and Drug Administration, HHS.

ACTION: Correcting amendment.

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

SUMMARY: The Food and Drug Administration (FDA) published a document in 
the Federal Register of April 23, 2010 (75 FR 21162), that amended the 
animal drug regulations to reflect approval of an original new animal 
drug application (NADA). FDA is correcting a paragraph describing 
limitations to the approved conditions of use for detomidine 
hydrochloride oromucosal gel in horses. This correction is being made 
to improve the accuracy of the animal drug regulations.

DATES: This rule is effective March 24, 2011.

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, e-mail: 
George.Haibel@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: FDA published a document in the Federal 
Register of April 23, 2010 (75 FR 21162), that amended the animal drug 
regulations to reflect approval of an original NADA. FDA is correcting 
a paragraph describing limitations to the approved conditions of use 
for detomidine hydrochloride oromucosal gel in horses. This correction 
is being made to improve the accuracy of the animal drug regulations.

List of Subjects in 21 CFR Part 529

    Animal drugs.

    Accordingly, 21 CFR part 529 is corrected by making the following 
correcting amendment:

PART 529--CERTAIN OTHER DOSAGE FORM NEW ANIMAL DRUGS

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

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


0
2. In Sec.  529.536, amend paragraph (c)(3) by adding a sentence after 
the first sentence to read as follows:


Sec.  529.536  Detomidine.

* * * * *
    (c) * * *
    (3) * * * Do not use in horses intended for human consumption.

    Dated: March 17, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-6791 Filed 3-23-11; 8:45 am]
BILLING CODE 4160-01-P

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