New Animal Drugs; Change of Sponsor; Chlortetracycline Powder, 5700 [2012-2633]
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5700
Federal Register / Vol. 77, No. 24 / Monday, February 6, 2012 / Rules and Regulations
the Center for Veterinary Medicine, 21
CFR parts 510 and 520 are amended as
follows:
DEPARTMENT OF THE TREASURY
PART 510—NEW ANIMAL DRUGS
26 CFR Part 1
1. The authority citation for 21 CFR
part 510 continues to read as follows:
[TD 9572]
Authority: 21 U.S.C. 321, 331, 351, 352,
353, 360b, 371, 379e.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Dividend Equivalents From Sources
Within the United States
Internal Revenue Service
Food and Drug Administration
21 CFR Parts 510 and 520
■
[Docket No. FDA–2011–N–0003]
New Animal Drugs; Change of
Sponsor; Chlortetracycline Powder
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Final rule.
The Food and Drug
Administration (FDA) is amending the
animal drug regulations to reflect a
change of sponsor for an abbreviated
new animal drug application (ANADA)
for chlortetracycline soluble powder
from Teva Animal Health, Inc., to Quo
Vademus, LLC.
DATES: This rule is effective February 6,
2012.
FOR FURTHER INFORMATION CONTACT:
Steven D. Vaughn, Center for Veterinary
Medicine (HFV–100), Food and Drug
Administration, 7520 Standish Pl.,
Rockville, MD 20855, (240) 276–8300,
email: steven.vaughn@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Teva
Animal Health, Inc., 3915 South 48th
Street Ter., St. Joseph, MO 64503, has
informed FDA that it has transferred
ownership of, and all rights and interest
in, ANADA 200–236 for
Chlortetracycline HCL Soluble Powder
to Quo Vademus, LLC, 277 Faison
McGowan Rd., Kenansville, NC 28349.
Accordingly, the Agency is amending
the regulations in 21 CFR 520.441 to
reflect the transfer of ownership.
Quo Vademus, LLC, is not currently
listed in the animal drug regulations as
a sponsor of an approved application.
Accordingly, 21 CFR 510.600 is being
amended to add entries for this sponsor.
This rule does not meet the definition
of ‘‘rule’’ in 5 U.S.C. 804(3)(A) because
it is a rule of ‘‘particular applicability.’’
Therefore, it is not subject to the
congressional review requirements in
5 U.S.C. 801–808.
SUMMARY:
List of Subjects
tkelley on DSK3SPTVN1PROD with RULES
Jkt 226001
*
*
*
(c) * * *
(1) * * *
*
*
*
*
In rule document 2012–01234
beginning on page 3108 of the issue of
Monday, January 23, 2012 make the
following correction:
On page 3108, in the second column,
in the heading, immediately below ‘‘26
CFR Part 1’’, ‘‘[TD 9572]’’ should
appear.
BILLING CODE 1505–01–D
*
Drug labeler
code
*
*
076475
*
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*
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 52
[EPA–R01–OAR–2011–0346, FRL–9627–8]
Quo Vademus, LLC, 277
Faison McGowan Rd.,
Kenansville, NC 28349 .....
*
Correction
[FR Doc. C1–2012–1234 Filed 2–3–12; 8:45 am]
Firm name and address
*
(2) * * *
Approval and Promulgation of
Implementation Plans; New
Hampshire: Prevention of Significant
Deterioration; Greenhouse Gas
Permitting Authority and Tailoring Rule
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
Drug labeler
code
Firm name and address
*
*
EPA is approving revisions to
the New Hampshire State
Implementation Plan (SIP), submitted
by the New Hampshire Department of
Environmental Services (NH DES) to
EPA on February 7, 2011. The SIP
revision modifies New Hampshire’s
Prevention of Significant Deterioration
(PSD) program to establish appropriate
emission thresholds for determining
which new stationary sources and
modification projects become subject to
New Hampshire’s PSD permitting
requirements for their greenhouse gas
(GHG) emissions. EPA proposed
approval of these regulatory revisions
on June 14, 2011, and received no
comments. This action affects major
stationary sources in New Hampshire
that have GHG emissions above the
thresholds established in the PSD
regulations.
SUMMARY:
*
076475 ........
*
*
*
*
Quo Vademus, LLC, 277
Faison McGowan Rd.,
Kenansville, NC 28349
*
*
*
PART 520—ORAL DOSAGE FORM
NEW ANIMAL DRUGS
3. The authority citation for 21 CFR
part 520 continues to read as follows:
■
§ 520.441
[Amended]
4. In paragraph (b)(4) of § 520.441,
remove ‘‘059130’’ and in its place add
‘‘076475’’.
■
21 CFR Part 520
Animal drugs.
Therefore, under the Federal Food,
Drug, and Cosmetic Act and under
authority delegated to the Commissioner
of Food and Drugs and redelegated to
20:15 Feb 03, 2012
§ 510.600 Names, addresses, and drug
labeler codes of sponsors of approved
applications.
Authority: 21 U.S.C. 360b.
21 CFR Part 510
Administrative practice and
procedure, Animal drugs, Labeling,
Reporting and recordkeeping
requirements.
VerDate Mar<15>2010
2. In § 510.600, in the table in
paragraph (c)(1), alphabetically add a
new entry for ‘‘Quo Vademus, LLC’’;
and in the table in paragraph (c)(2), in
numerical sequence add a new entry for
‘‘076475’’ to read as follows:
■
RIN 1545–BK53
Dated: February 1, 2012.
William T. Flynn,
Acting Director, Center for Veterinary
Medicine.
[FR Doc. 2012–2633 Filed 2–3–12; 8:45 am]
BILLING CODE 4160–01–P
PO 00000
Frm 00020
Fmt 4700
Sfmt 4700
Effective Date: This rule will be
effective on March 7, 2012.
ADDRESSES: EPA has established a
docket for this action under Docket
Identification No. EPA–R01–OAR–
DATES:
E:\FR\FM\06FER1.SGM
06FER1
]]>Agencies
[Federal Register Volume 77, Number 24 (Monday, February 6, 2012)]
[Rules and Regulations]
[Page 5700]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-2633]
[[Page 5700]]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 510 and 520
[Docket No. FDA-2011-N-0003]
New Animal Drugs; Change of Sponsor; Chlortetracycline Powder
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is amending the animal
drug regulations to reflect a change of sponsor for an abbreviated new
animal drug application (ANADA) for chlortetracycline soluble powder
from Teva Animal Health, Inc., to Quo Vademus, LLC.
DATES: This rule is effective February 6, 2012.
FOR FURTHER INFORMATION CONTACT: Steven D. Vaughn, Center for
Veterinary Medicine (HFV-100), Food and Drug Administration, 7520
Standish Pl., Rockville, MD 20855, (240) 276-8300, email:
steven.vaughn@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Teva Animal Health, Inc., 3915 South 48th
Street Ter., St. Joseph, MO 64503, has informed FDA that it has
transferred ownership of, and all rights and interest in, ANADA 200-236
for Chlortetracycline HCL Soluble Powder to Quo Vademus, LLC, 277
Faison McGowan Rd., Kenansville, NC 28349. Accordingly, the Agency is
amending the regulations in 21 CFR 520.441 to reflect the transfer of
ownership.
Quo Vademus, LLC, is not currently listed in the animal drug
regulations as a sponsor of an approved application. Accordingly, 21
CFR 510.600 is being amended to add entries for this sponsor.
This rule does not meet the definition of ``rule'' in 5 U.S.C.
804(3)(A) because it is a rule of ``particular applicability.''
Therefore, it is not subject to the congressional review requirements
in 5 U.S.C. 801-808.
List of Subjects
21 CFR Part 510
Administrative practice and procedure, Animal drugs, Labeling,
Reporting and recordkeeping requirements.
21 CFR Part 520
Animal drugs.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs and
redelegated to the Center for Veterinary Medicine, 21 CFR parts 510 and
520 are amended as follows:
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), alphabetically
add a new entry for ``Quo Vademus, LLC''; and in the table in paragraph
(c)(2), in numerical sequence add a new entry for ``076475'' to read as
follows:
Sec. 510.600 Names, addresses, and drug labeler codes of sponsors of
approved applications.
* * * * *
(c) * * *
(1) * * *
------------------------------------------------------------------------
Drug labeler
Firm name and address code
------------------------------------------------------------------------
* * * * *
Quo Vademus, LLC, 277 Faison McGowan Rd., Kenansville, 076475
NC 28349...............................................
* * * * *
------------------------------------------------------------------------
(2) * * *
------------------------------------------------------------------------
Drug labeler code Firm name and address
------------------------------------------------------------------------
* * * * *
076475.............................. Quo Vademus, LLC, 277 Faison
McGowan Rd., Kenansville, NC
28349
* * * * *
------------------------------------------------------------------------
PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS
0
3. The authority citation for 21 CFR part 520 continues to read as
follows:
Authority: 21 U.S.C. 360b.
Sec. 520.441 [Amended]
0
4. In paragraph (b)(4) of Sec. 520.441, remove ``059130'' and in its
place add ``076475''.
Dated: February 1, 2012.
William T. Flynn,
Acting Director, Center for Veterinary Medicine.
[FR Doc. 2012-2633 Filed 2-3-12; 8:45 am]
BILLING CODE 4160-01-P
