New Animal Drugs; Change of Sponsor's Name and Address; Corrections, 16532-16533 [2011-6795]
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16532
Federal Register / Vol. 76, No. 57 / Thursday, March 24, 2011 / Rules and Regulations
Regulatory Procedures
List of Subjects in 20 CFR Part 404
We follow Administrative Procedure
Act (APA) rulemaking procedures
specified in 5 U.S.C. 553 when we
develop regulations. Section 702(a)(5) of
the Social Security Act, 42 U.S.C.
902(a)(5). The APA provides exceptions
to its notice and public comment
procedures when an agency finds there
is good cause for dispensing with such
procedures because they are
impracticable, unnecessary, or contrary
to the public interest. 5 U.S.C. 553(b)(B).
The change we are making in this rule
only corrects an error in a crossreference. Because the change we are
making is only a minor technical
correction to a rule to correct an
outdated cross-reference, we have
determined that the opportunity for
prior comment is unnecessary.
Therefore, we are issuing this rule as a
final rule.
In addition, we find that there is good
cause for dispensing with the 30-day
delay in the effective date of a
substantive rule provided by 5 U.S.C.
553(d)(3). For the reasons already
discussed, because this change is a
minor technical correction to a rule, a
delay in the effective date is
unnecessary.
Administrative practice and
procedure, Blind, Disability benefits,
Old-Age, Survivors, and Disability
Insurance, Reporting and recordkeeping
requirements, Social Security.
Executive Order 12866, as
Supplemented by Executive Order
13563
1. The authority citation for subpart P
of part 404 continues to read as follows:
■
Authority: Secs. 202, 205(a)–(b), and (d)–
(h), 216(i), 221(a), (i), and (j), 222(c), 223,
225, and 702(a)(5) of the Social Security Act
(42 U.S.C. 402, 405(a)–(b), and (d)–(h), 416(i),
421(a), (i), and (j), 422(c), 423, 425, and
902(a)(5)); sec. 211(b), Pub. L. 104–193, 110
Stat. 2105, 2189; sec. 202, Pub. L. 108–203,
118 Stat. 509 (42 U.S.C. 902 note).
2. Amend appendix 1 to subpart P of
part 404 by revising section 111.09C of
part B to read as follows:
■
APPENDIX 1 TO SUBPART P OF PART
404—LISTING OF IMPAIRMENTS
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*
111.00 [Neurological]
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*
*
*
*
111.09 * * *
C. Impairment of hearing as described
under the criteria in 102.10 or 102.11.
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List of Subjects
*
[FR Doc. 2011–6983 Filed 3–23–11; 8:45 am]
Paperwork Reduction Act
21 CFR Part 510
BILLING CODE 4191–02–P
We certify that this final rule will not
have a significant economic impact on
a substantial number of small entities
because it affects only individuals.
Therefore, a regulatory flexibility
analysis was not required under the
Regulatory Flexibility Act, as amended.
jdjones on DSK8KYBLC1PROD with RULES
PART 404—FEDERAL OLD-AGE,
SURVIVORS AND DISABILITY
INSURANCE (1950– )
Part B
Regulatory Flexibility Act
Administrative practice and
procedure, Animal drugs, Labeling,
Reporting and Recordkeeping
requirements.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 510 and 529
[Docket No. FDA–2010–N–0002]
This rule does not create any new or
affect any existing collections, and
therefore, does not require Office of
Management and Budget approval
under the Paperwork Reduction Act.
(Catalog of Federal Domestic Assistance
Program Nos. 96.001, Social Security—
Disability Insurance; 96.002, Social
Security—Retirement Insurance; 96.004,
Social Security—Survivors Insurance; and
96.006, Supplemental Security Income)
14:49 Mar 23, 2011
For the reasons set out in the
preamble, we are amending subpart P of
part 404 of chapter III of title 20 of the
Code of Federal Regulations as set forth
below:
*
We consulted with the Office of
Management and Budget (OMB) and
determined that this final rule does not
meet the requirements for a significant
regulatory action under Executive Order
12866, as supplemented by Executive
Order 13563. Therefore, it was not
subject to OMB review.
VerDate Mar<15>2010
Michael J. Astrue,
Commissioner of Social Security.
April 20, 2010 (75 FR 20522) amending
the animal drug regulations to reflect
changes to a sponsor’s name and
address. That document contained
errors in the regulatory text. FDA is
correcting the tables listing sponsors of
approved animal drug applications
(NADAs) by adding a change to the
sponsor’s drug labeler code (DLC).
Cross-references to the sponsor’s DLC
are amended in two sections of the Code
of Federal Regulations (CFR) containing
the conditions of use approved animal
drug products. These corrections are
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 April 20, 2010 (75 FR 20522)
amending the animal drug regulations to
reflect changes to a sponsor’s name and
address. That document contained
errors in the regulatory text. FDA is
correcting the tables listing sponsors of
approved animal drug applications
(NADAs) by adding a change to the
sponsor’s drug labeler code (DLC).
Cross-references to the sponsor’s DLC
are amended in two sections of the Code
of Federal Regulations (CFR) containing
the conditions of use approved animal
drug products. These corrections are
being made to improve the accuracy of
the animal drug regulations.
Jkt 223001
New Animal Drugs; Change of
Sponsor’s Name and Address;
Corrections
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Correcting amendments.
The Food and Drug
Administration (FDA) published a
document in the Federal Register of
SUMMARY:
PO 00000
Frm 00008
Fmt 4700
Sfmt 4700
21 CFR Part 529
Animal drugs.
Accordingly, 21 CFR parts 510 and
529 are corrected by making the
following correcting amendments:
PART 510—NEW ANIMAL DRUGS
1. The authority citation for 21 CFR
part 510 continues to read as follows:
■
Authority: 21 U.S.C. 321, 331, 351, 352,
353, 360b, 371, 379e.
2. In § 510.600, in the table in
paragraph (c)(1), revise the entry for
‘‘Piramal Critical Care, Inc.’’; and in the
table in paragraph (c)(2), remove the
■
E:\FR\FM\24MRR1.SGM
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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
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*
*
*
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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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.,
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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.
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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
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Fmt 4700
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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]
[Pages 16532-16533]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-6795]
=======================================================================
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 510 and 529
[Docket No. FDA-2010-N-0002]
New Animal Drugs; Change of Sponsor's Name and Address;
Corrections
AGENCY: Food and Drug Administration, HHS.
ACTION: Correcting amendments.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) published a document in
the Federal Register of April 20, 2010 (75 FR 20522) amending the
animal drug regulations to reflect changes to a sponsor's name and
address. That document contained errors in the regulatory text. FDA is
correcting the tables listing sponsors of approved animal drug
applications (NADAs) by adding a change to the sponsor's drug labeler
code (DLC). Cross-references to the sponsor's DLC are amended in two
sections of the Code of Federal Regulations (CFR) containing the
conditions of use approved animal drug products. These corrections are
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 April 20, 2010 (75 FR
20522) amending the animal drug regulations to reflect changes to a
sponsor's name and address. That document contained errors in the
regulatory text. FDA is correcting the tables listing sponsors of
approved animal drug applications (NADAs) by adding a change to the
sponsor's drug labeler code (DLC). Cross-references to the sponsor's
DLC are amended in two sections of the Code of Federal Regulations
(CFR) containing the conditions of use approved animal drug products.
These corrections are being made to improve the accuracy of the animal
drug regulations.
List of Subjects
21 CFR Part 510
Administrative practice and procedure, Animal drugs, Labeling,
Reporting and Recordkeeping requirements.
21 CFR Part 529
Animal drugs.
Accordingly, 21 CFR parts 510 and 529 are corrected by making the
following correcting amendments:
PART 510--NEW ANIMAL DRUGS
0
1. The authority citation for 21 CFR part 510 continues to read as
follows:
Authority: 21 U.S.C. 321, 331, 351, 352, 353, 360b, 371, 379e.
0
2. In Sec. 510.600, in the table in paragraph (c)(1), revise the entry
for ``Piramal Critical Care, Inc.''; and in the table in paragraph
(c)(2), remove the
[[Page 16533]]
entry for ``060307'' and in numerical sequence, add an entry for
``066794'' to read as follows:
Sec. 510.600 Names, addresses, and drug labeler codes of sponsors of
approved applications.
* * * * *
(c) * * *
(1) * * *
------------------------------------------------------------------------
Drug
Firm name and address labeler
code
------------------------------------------------------------------------
* * * * *
Piramal Critical Care, Inc., 3850 Schelden Circle, 066794
Bethlehem, PA 18017.......................................
* * * * *
------------------------------------------------------------------------
(2) * * *
------------------------------------------------------------------------
Drug labeler code Firm name and address
------------------------------------------------------------------------
* * * * *
066794............................ Piramal Critical Care, Inc., 3850
Schelden Circle, Bethlehem, PA
18017.
* * * * *
------------------------------------------------------------------------
PART 529--CERTAIN OTHER DOSAGE FORM NEW ANIMAL DRUGS
0
3. The authority citation for 21 CFR part 529 continues to read as
follows:
Authority: 21 U.S.C. 360b.
Sec. 529.1186 [Corrected]
0
4. In paragraph (b) of Sec. 529.1186, remove ``060307, and 065085''
and in its place add ``065085, and 066794''.
Sec. 529.2150 [Corrected]
0
5. In paragraph (b) of Sec. 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
