Animal Drugs, Feeds, and Related Products; Withdrawal of Approval of New Animal Drug Applications; Aklomide; Levamisole Hydrochloride; Nitromide and Sulfanitran; Roxarsone; Correction, 16533-16534 [2011-6790]

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 16534 Federal Register / Vol. 76, No. 57 / Thursday, March 24, 2011 / Rules and Regulations drug medicated feed. This correction is being made to improve the accuracy of the animal drug regulations. List of Subjects in 21 CFR Part 558 Animal drugs, Animal feeds. Accordingly, 21 CFR part 558 is corrected by making the following correcting amendment: PART 558—NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS 1. The authority citation for 21 CFR part 558 continues to read as follows: ■ [Corrected] 1. The authority citation for 21 CFR part 558 continues to read as follows: ■ 2. In § 558.530, remove and reserve paragraphs (d)(4)(i) and (d)(4)(xvii). ■ Authority: 21 U.S.C. 360b, 371. Dated: March 17, 2011. Leslie Kux, Acting Assistant Commissioner for Policy. § 558.4 BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Dated: March 17, 2011. Leslie Kux, Acting Assistant Commissioner for Policy. Food and Drug Administration 21 CFR Part 558 [FR Doc. 2011–6789 Filed 3–23–11; 8:45 am] [Docket No. FDA–2010–N–0002] BILLING CODE 4160–01–P New Animal Drugs for Use in Animal Feeds; Florfenicol; Correction Food and Drug Administration, Stanley F. Mires, Chief Counsel, Legislative. [FR Doc. 2011–6911 Filed 3–23–11; 8:45 am] POSTAL SERVICE 39 CFR Parts 111 and 121 Correcting amendments. The Food and Drug Administration (FDA) published a document in the Federal Register of June 17, 2010 (75 FR 34361) revising the animal drug regulations to reflect approval of a supplemental new animal drug application (NADA). That document contained an incorrect table entry describing the maximum florfenicol concentration in Type B medicated swine feeds. 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, email: george.haibel@fda.hhs.gov. SUPPLEMENTARY INFORMATION: The Food and Drug Administration (FDA) published a document in the Federal Register of June 17, 2010 (75 FR 34361) revising the animal drug regulations to SUMMARY: jdjones on DSK8KYBLC1PROD with RULES on February 28, 2011, the Postal Service provided a new option for mailers to combine Standard Mail flats and Periodicals flats, when bundled and placed on pallets. Mailers using this option would have combined differentclass mailpieces within the same bundle (comail), or combined separate sameclass bundles (of different classes) on the same pallet (copalletize) to maximize presorting or to qualify for deeper destination entry discounts. All mailpieces prepared under this option were required to be bundled and placed on pallets. In consideration of concerns expressed by members of the mailing community, the Postal Service has elected to withdraw this final rule and will publish these standards as a proposed rule concurrently. The Postal Service also withdraws the revision to 39 CFR part 121.2 whereby we added a new item ‘‘c’’ to describe the USPS processing of Periodicals mailpieces included in combined mailings of Standard Mail flats and Periodicals flats, and specifying that Periodicals mailpieces included in these mailings will be assigned the service standards applicable to Standard Mail pieces. BILLING CODE 7710–12–P HHS. ACTION: [Corrected] 2. In paragraph (d) of § 558.4, in the ‘‘Category II’’ table, in the ‘‘Type B maximum (100x)’’ column, in the entry for ‘‘Florfenicol’’, remove ‘‘Swine feed: n/a’’, ‘‘Catfish feed: n/a’’, and ‘‘Salmonid feed: n/a’’ and in their places add ‘‘9.1 g/lb (2.0%)’’. ■ [FR Doc. 2011–6790 Filed 3–23–11; 8:45 am] AGENCY: List of Subjects in 21 CFR Part 558 Animal drugs, Animal feeds. Accordingly, 21 CFR part 558 is corrected by making the following correcting amendments: PART 558—NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS Authority: 21 U.S.C. 360b, 371. § 558.530 reflect approval of a supplemental new animal drug application (NADA). That document contained an incorrect table entry describing the maximum florfenicol concentration in Type B medicated swine feeds. This correction is being made to improve the accuracy of the animal drug regulations. VerDate Mar<15>2010 14:49 Mar 23, 2011 Jkt 223001 ENVIRONMENTAL PROTECTION AGENCY Combined Mailings of Standard Mail and Periodicals Flats 40 CFR Part 261 Postal Service.TM Final rule; withdrawal. AGENCY: ACTION: The Postal Service is withdrawing a final rule that would have provided a new option for mailers to combine mailings of Standard Mail ® flats and Periodicals flats within the same bundle, when placed on pallets, and to combine bundles of Standard Mail flats and bundles of Periodicals flats on the same pallet. The Postal Service also withdraws the Code of Federal Regulations revision to reflect that Standard Mail service standards apply to all Periodicals flats pieces entered in such combined mailings. DATES: The final rule published on February 28, 2011 (76 FR 10757), is withdrawn effective March 24, 2011. FOR FURTHER INFORMATION CONTACT: Jonathan Leon at 202–268–7443, or Kevin Gunther at 202–268–7208. SUPPLEMENTARY INFORMATION: In a final rule published in the Federal Register SUMMARY: PO 00000 Frm 00010 Fmt 4700 Sfmt 4700 [EPA–R03–RCRA–2010–0132; FRL–9285–7] Hazardous Waste Management System Identification and Listing of Hazardous Waste; Final Exclusion Environmental Protection Agency. ACTION: Final rule. AGENCY: The Environmental Protection Agency (EPA, also the Agency or we in this preamble) today is granting a petition submitted by Babcock & Wilcox Nuclear Operations Group, Inc., the current owner, and to BWX Technologies, Inc., as predecessor in interest to the current owner, identified collectively hereafter in this preamble as ‘‘B&W NOG,’’ to exclude (or delist) on a one-time basis from the lists of hazardous waste, a certain solid waste generated at its Mt. Athos facility near Lynchburg, Virginia. After careful analysis, we have concluded that the petitioned waste is SUMMARY: E:\FR\FM\24MRR1.SGM 24MRR1

Agencies

[Federal Register Volume 76, Number 57 (Thursday, March 24, 2011)]
[Rules and Regulations]
[Pages 16533-16534]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-6790]


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

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.

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

SUMMARY: 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 Sec.  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 Sec.  558.530. FDA 
is correcting the animal drug regulations by removing cross references 
for use of the withdrawn drugs in combination

[[Page 16534]]

drug medicated feed. This correction is being made to improve the 
accuracy of the animal drug regulations.

List of Subjects in 21 CFR Part 558

    Animal drugs, Animal feeds.

    Accordingly, 21 CFR part 558 is corrected by making the following 
correcting amendment:

PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS

0
1. The authority citation for 21 CFR part 558 continues to read as 
follows:

    Authority: 21 U.S.C. 360b, 371.


Sec.  558.530  [Corrected]

0
2. In Sec.  558.530, remove and reserve paragraphs (d)(4)(i) and 
(d)(4)(xvii).

    Dated: March 17, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-6790 Filed 3-23-11; 8:45 am]
BILLING CODE 4160-01-P
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