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
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*
*
(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,
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*
*
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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
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VerDate Mar<15>2010
14:49 Mar 23, 2011
Jkt 223001
Detomidine.
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*
(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]
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16533
*
Fmt 4700
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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
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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
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[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