New Animal Drugs; Change of Sponsor's Address, 39278 [2011-16845]
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39278
Federal Register / Vol. 76, No. 129 / Wednesday, July 6, 2011 / Rules and Regulations
367. An applicant must apply to receive
all business proprietary information on
the record of the segment of a
proceeding in question, but may waive
service of business proprietary
information it does not wish to receive
from other parties to the proceeding. An
applicant must serve an APO
application on the other parties by the
most expeditious manner possible at the
same time that it files the application
with the Department.
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[FR Doc. 2011–16352 Filed 7–5–11; 8:45 am]
BILLING CODE 3510–DS–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
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:
DEPARTMENT OF THE TREASURY
PART 510—NEW ANIMAL DRUGS
[TD 9533]
■
1. The authority citation for 21 CFR
part 510 continues to read as follows:
RIN 1545–BK28
Authority: 21 U.S.C. 321, 331, 351, 352,
353, 360b, 371, 379e.
Modification of Treasury Regulations
Pursuant to Section 939A of the DoddFrank Wall Street Reform and
Consumer Protection Act
2. In § 510.600, in the table in
paragraph (c)(1), revise the entry for
‘‘Huvepharma AD’’; and in the table in
paragraph (c)(2), revise the entry for
‘‘016592’’ to read as follows:
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21 CFR Part 510
[Docket No. FDA–2011–N–0003]
*
*
(c) * * *
(1) * * *
New Animal Drugs; Change of
Sponsor’s Address
AGENCY:
*
*
Drug
labeler
code
Firm name and address
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 address for Huvepharma AD,
a sponsor of approved new animal drug
applications.
DATES: This rule is effective July 6,
2011.
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:
Huvepharma AD, 33 James Boucher
Blvd., Sophia 1407, Bulgaria, has
informed FDA that it has changed its
address to 5th Floor, 3A Nikolay Haitov
Str., 1113 Sofia, Bulgaria. 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.
mstockstill on DSK4VPTVN1PROD with RULES
SUMMARY:
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Huvepharma AD, 5th Floor, 3A
Nikolay Haitov Str., 1113 Sofia,
Bulgaria .....................................
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17:43 Jul 05, 2011
Jkt 223001
016592
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(2) * * *
Drug labeler code
Firm name and address
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016592 .... Huvepharma AD, 5th Floor, 3A
Nikolay Haitov Str., 1113
Sofia, Bulgaria.
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Dated: June 24, 2011.
Elizabeth Rettie,
Deputy Director, Office of New Animal Drug
Evaluation, Center for Veterinary Medicine.
[FR Doc. 2011–16845 Filed 7–5–11; 8:45 am]
BILLING CODE 4160–01–P
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
VerDate Mar<15>2010
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PO 00000
Frm 00034
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26 CFR Parts 1 and 48
Internal Revenue Service (IRS),
Treasury.
ACTION: Final and temporary
regulations.
AGENCY:
This document contains
temporary regulations that remove any
reference to, or requirement of reliance
on, ‘‘credit ratings’’ in regulations under
the Internal Revenue Code (Code) and
provides substitute standards of creditworthiness where appropriate. This
action is required by the Dodd-Frank
Wall Street Reform and Consumer
Protection Act, which requires Federal
agencies to remove any reference to, or
requirement of reliance on, credit
ratings from their regulations and to
substitute such standard of creditworthiness as the agency deems
appropriate for such regulations. These
regulations affect persons subject to
various provisions of the Code. The text
of these temporary regulations also
serves as the text of the proposed
regulations set forth in the notice of
proposed rulemaking on this subject in
the Proposed Rules section of this issue
of the Federal Register.
DATES: Effective Date: These regulations
are effective on July 6, 2011.
Applicability Dates: For dates of
applicability, see §§ 1.150–1T(a)(4),
1.171–1T(f), 1.197–2T(b)(7), 1.249–
1T(f)(3), 1.475(a)–4T(d)(4), 1.860G–
2T(g)(3), 1.1001–3T(d), (e), and (g), and
48.4101–1T(l)(5).
FOR FURTHER INFORMATION CONTACT:
Arturo Estrada, (202) 622–3900 (not a
toll-free number).
SUPPLEMENTARY INFORMATION:
SUMMARY:
§ 510.600 Names, addresses, and drug
labeler codes of sponsors of approved
applications.
Food and Drug Administration
Internal Revenue Service
Background
Section 939A(a) of the Dodd-Frank
Wall Street Reform and Consumer
Protection Act, Public Law 111–203
(124 Stat. 1376 (2010)), (the ‘‘DoddFrank Act’’), requires each Federal
agency to review its regulations that
require the use of an assessment of
credit-worthiness of a security or money
market instrument, and to review any
references or requirements in those
regulations regarding credit ratings.
Section 939A(b) directs each agency to
E:\FR\FM\06JYR1.SGM
06JYR1
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[Federal Register Volume 76, Number 129 (Wednesday, July 6, 2011)]
[Rules and Regulations]
[Page 39278]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-16845]
=======================================================================
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 510
[Docket No. FDA-2011-N-0003]
New Animal Drugs; Change of Sponsor's 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 address for Huvepharma AD, a
sponsor of approved new animal drug applications.
DATES: This rule is effective July 6, 2011.
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: Huvepharma AD, 33 James Boucher Blvd.,
Sophia 1407, Bulgaria, has informed FDA that it has changed its address
to 5th Floor, 3A Nikolay Haitov Str., 1113 Sofia, Bulgaria.
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.
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 ``Huvepharma AD''; and in the table in paragraph (c)(2), revise the
entry for ``016592'' 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
------------------------------------------------------------------------
* * * * *
Huvepharma AD, 5th Floor, 3A Nikolay Haitov Str., 1113 Sofia, 016592
Bulgaria....................................................
* * * * *
------------------------------------------------------------------------
(2) * * *
------------------------------------------------------------------------
Drug labeler code Firm name and address
------------------------------------------------------------------------
* * * * *
016592............................ Huvepharma AD, 5th Floor, 3A Nikolay
Haitov Str., 1113 Sofia, Bulgaria.
* * * * *
------------------------------------------------------------------------
Dated: June 24, 2011.
Elizabeth Rettie,
Deputy Director, Office of New Animal Drug Evaluation, Center for
Veterinary Medicine.
[FR Doc. 2011-16845 Filed 7-5-11; 8:45 am]
BILLING CODE 4160-01-P
