New Animal Drugs; Change of Sponsor's Name and Address, 72679 [2010-29693]
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Federal Register / Vol. 75, No. 227 / Friday, November 26, 2010 / Rules and Regulations
72679
COORDINATION OF RETIREMENT AND EFFECTIVE DATES TABLE—Continued
Existing approved
standard
Requirement to be
retired or replaced
Proposed
standard
New requirement
to be implemented
Date for concurrent retirement and implementation
R2.1
PER–004–1 ....................
PER–002–0 ....................
R3
R4
R4
PER–005–1
R3
1st day of 1st calendar quarter after regulatory approval.
PER–004–1 ....................
PER–004–1 ....................
R2
R1
PER–004–2
R1
1st day of 1st calendar quarter after regulatory approval.
N/A ..................................
R5
N/A
PER–005–1
R2
R3.1
1st day of 1st calendar quarter 36 months after
regulatory approval.
List of Subjects in 21 CFR Part 510
Administrative practice and
procedure, Animal drugs, Labeling,
Reporting and recordkeeping
requirements.
■ 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 part 510 is amended as follows:
[FR Doc. 2010–29717 Filed 11–24–10; 8:45 am]
BILLING CODE 6717–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 510
[Docket No. FDA–2010–N–0002]
■
AGENCY:
1. The authority citation for 21 CFR
part 510 continues to read as follows:
Food and Drug Administration,
HHS.
ACTION:
BILLING CODE 4160–01–P
DEPARTMENT OF THE INTERIOR
Bureau of Ocean Energy Management,
Regulation and Enforcement
Final rule.
The Food and Drug
Administration (FDA) is amending the
animal drug regulations to reflect a
change of sponsor’s name from Belcher
Pharmaceuticals, Inc., to Belcher
Pharmaceuticals, LLC. The sponsor’s
mailing address will also be changed.
DATES: This rule is effective November
26, 2010.
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: Belcher
Pharmaceuticals, Inc., 12393 Belcher
Rd., suite 420, Largo, FL 33773 has
informed FDA that it has changed its
name and address to Belcher
Pharmaceuticals, LLC, 6911 Bryan Dairy
Rd., Largo, FL 33777. Accordingly, the
Agency is amending the regulations in
21 CFR 510.600 to reflect this change.
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.
VerDate Mar<15>2010
18:10 Nov 24, 2010
Jkt 223001
30 CFR Part 285
[Docket ID: BOEM–2010–0045]
Authority: 21 U.S.C. 321, 331, 351, 352,
353, 360b, 371, 379e.
RIN 1010–AD71
2. In § 510.600, in the table in
paragraph (c)(1), revise the entry for
‘‘Belcher Pharmaceuticals, Inc.’’; and in
the table in paragraph (c)(2), revise the
entry for ‘‘062250’’ to read as follows:
Renewable Energy Alternate Uses of
Existing Facilities on the Outer
Continental Shelf—Acquire a Lease
Noncompetitively
■
SUMMARY:
srobinson on DSKHWCL6B1PROD with RULES
[FR Doc. 2010–29693 Filed 11–24–10; 8:45 am]
PART 510—NEW ANIMAL DRUGS
New Animal Drugs; Change of
Sponsor’s Name and Address
Dated: November 19, 2010.
Elizabeth Rettie,
Deputy Director, Office of New Animal Drug
Evaluation, Center for Veterinary Medicine.
Bureau of Ocean Energy
Management, Regulation and
Enforcement (BOEMRE), Interior.
ACTION: Direct Final rule.
AGENCY:
§ 510.600 Names, addresses, and drug
labeler codes of sponsors of approved
applications.
*
*
*
(c) * * *
(1) * * *
*
*
Drug labeler code
Firm name and address
*
*
*
*
*
Belcher Pharmaceuticals, LLC,
062250
6911 Bryan Dairy Rd., Largo,
FL 33777.
*
*
*
*
*
(2) * * *
Drug labeler code
Firm name and address
*
*
*
*
*
062250 .... Belcher Pharmaceuticals, LLC,
6911 Bryan Dairy Rd., Largo,
FL 33777.
PO 00000
*
*
Frm 00027
BOEMRE is revising
regulations that pertain to
noncompetitive acquisition of an Outer
Continental Shelf (OCS) renewable
energy lease. We are taking this action
because the current regulations covering
noncompetitive leasing of an OCS
renewable energy lease and an
unsolicited request for an OCS
renewable energy lease are inconsistent.
This rulemaking will make the two
processes consistent with each other by
eliminating an extra step in the
noncompetitive leasing process.
DATES: Effective Date: This rule becomes
effective on January 25, 2011 unless
BOEMRE publishes a notice
withdrawing this rule before that date.
Comment Due Date: Submit
comments on the direct final rule by
December 27, 2010.
FOR FURTHER INFORMATION CONTACT:
Timothy Redding at (703) 787–1219.
SUMMARY:
*
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*
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*
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]]>Agencies
[Federal Register Volume 75, Number 227 (Friday, November 26, 2010)]
[Rules and Regulations]
[Page 72679]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-29693]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 510
[Docket No. FDA-2010-N-0002]
New Animal Drugs; Change of Sponsor's Name and Address
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's name from Belcher
Pharmaceuticals, Inc., to Belcher Pharmaceuticals, LLC. The sponsor's
mailing address will also be changed.
DATES: This rule is effective November 26, 2010.
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, e-mail:
steven.vaughn@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Belcher Pharmaceuticals, Inc., 12393 Belcher
Rd., suite 420, Largo, FL 33773 has informed FDA that it has changed
its name and address to Belcher Pharmaceuticals, LLC, 6911 Bryan Dairy
Rd., Largo, FL 33777. Accordingly, the Agency is amending the
regulations in 21 CFR 510.600 to reflect this change.
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 in 21 CFR Part 510
Administrative practice and procedure, Animal drugs, Labeling,
Reporting and recordkeeping requirements.
0
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 part 510 is
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), revise the entry
for ``Belcher Pharmaceuticals, Inc.''; and in the table in paragraph
(c)(2), revise the entry for ``062250'' to read as follows:
Sec. 510.600 Names, addresses, and drug labeler codes of sponsors of
approved applications.
* * * * *
(c) * * *
(1) * * *
------------------------------------------------------------------------
Firm name and address Drug labeler code
------------------------------------------------------------------------
* * * * *
Belcher Pharmaceuticals, LLC, 6911 Bryan 062250
Dairy Rd., Largo, FL 33777.
* * * * *
------------------------------------------------------------------------
(2) * * *
------------------------------------------------------------------------
Drug labeler code Firm name and address
------------------------------------------------------------------------
* * * * *
062250............................ Belcher Pharmaceuticals, LLC, 6911
Bryan Dairy Rd., Largo, FL 33777.
* * * * *
------------------------------------------------------------------------
Dated: November 19, 2010.
Elizabeth Rettie,
Deputy Director, Office of New Animal Drug Evaluation, Center for
Veterinary Medicine.
[FR Doc. 2010-29693 Filed 11-24-10; 8:45 am]
BILLING CODE 4160-01-P
