New Animal Drugs; Change of Sponsor's Address, 79955-79956 [2010-31952]
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79955
Federal Register / Vol. 75, No. 244 / Tuesday, December 21, 2010 / Rules and Regulations
The AMOC approval letter must specifically
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Directive 2008–0072, dated April 18, 2008,
for related information.
Material Incorporated by Reference
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Issued in Renton, Washington, on
December 10, 2010.
Ali Bahrami,
Manager, Transport Airplane Directorate,
Aircraft Certification Service.
changed its address to 556 Morris Ave.,
Summit, NJ 07901. 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.
[FR Doc. 2010–31896 Filed 12–20–10; 8:45 am]
BILLING CODE 4910–13–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
List of Subjects in 21 CFR Part 510
Administrative practice and
procedure, Animal drugs, Labeling,
Reporting and recordkeeping
requirements.
Food and Drug Administration
21 CFR Part 510
[Docket No. FDA–2010–N–0002]
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
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:
■
New Animal Drugs; Change of
Sponsor’s Address
Final rule.
PART 510—NEW ANIMAL DRUGS
The Food and Drug
Administration (FDA) is amending the
animal drug regulations to reflect a
change of address for Intervet, Inc., a
sponsor of approved new animal drug
applications.
SUMMARY:
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.
This rule is effective December
21, 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: Intervet,
Inc., 56 Livingston Ave., Roseland, NJ
07068 has informed FDA that it has
DATES:
2. In § 510.600, in the table in
paragraph (c)(1), revise the entry for
‘‘Intervet, Inc.’’; and in the table in
paragraph (c)(2), revise the entry for
‘‘000061’’ to read as follows:
■
§ 510.600 Names, addresses, and drug
labeler codes of sponsors of approved
applications.
*
*
*
(c) * * *
(1) * * *
Firm name and address
*
*
Drug labeler code
*
*
*
*
Intervet, Inc., 556 Morris Ave., Summit, NJ 07901 .................................................
*
*
*
*
*
*
*
000061
*
*
*
(2) * * *
Drug labeler code
Firm name and address
*
*
*
*
000061 .....................................................................................................................
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Intervet, Inc., 556 Morris Ave., Summit, NJ 07901.
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79956
Federal Register / Vol. 75, No. 244 / Tuesday, December 21, 2010 / Rules and Regulations
Dated: December 9, 2010.
Steven D. Vaughn,
Director, Office of New Animal Drug
Evaluation, Center for Veterinary Medicine.
[FR Doc. 2010–31952 Filed 12–20–10; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HOMELAND
SECURITY
Coast Guard
33 CFR Part 53
[USCG–2009–0239]
RIN 1625–AB33
Protection for Whistleblowers in the
Coast Guard
Coast Guard, DHS.
Direct final rule; request for
comments.
AGENCY:
ACTION:
By this direct final rule, the
Coast Guard is amending its ‘‘Coast
Guard Whistleblower Protection’’
regulations to conform to statutory
protections for all members of the
Armed Forces. The revised regulations
broaden the protection already afforded
uniformed members of the Coast Guard
by: Providing that uniformed Coast
Guard members may make protected
communications to other persons and
organizations in additiPn to Members of
Congress or an Inspector General, and
expanding the subject matter of
protected communications to include
information that the member reasonably
believes constitutes evidence of sexual
harassment and discrimination, among
other subjects. Additionally, changes to
the regulations update the
responsibilities of the Inspector General
of the Department of Homeland Security
to conform to relevant statutory
provisions.
DATES: This rule is effective April 20,
2011, unless an adverse comment or
notice of intent to submit an adverse
comment is either submitted to our
online docket via https://
www.regulations.gov on or before
February 22, 2011, or reaches the Docket
Management Facility by that date. If an
adverse comment or notice of intent to
submit an adverse comment is received
by February 22, 2011, we will withdraw
this direct final rule and publish a
timely notice of withdrawal in the
Federal Register.
ADDRESSES: You may submit comments
identified by docket number USCG–
2009–0239 using any one of the
following methods:
(1) Federal eRulemaking Portal:
https://www.regulations.gov.
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(2) Fax: 202–493–2251.
(3) Mail: Docket Management Facility
(M–30), U.S. Department of
Transportation, West Building Ground
Floor, Room W12–140, 1200 New Jersey
Avenue SE., Washington, DC 20590–
0001.
(4) Hand delivery: Same as mail
address above, between 9 a.m. and
5 p.m., Monday through Friday, except
Federal holidays. The telephone number
is 202–366–9329.
To avoid duplication, please use only
one of these four methods. See the
‘‘Public Participation and Request for
Comments’’ portion of the
SUPPLEMENTARY INFORMATION section
below for instructions on submitting
comments.
FOR FURTHER INFORMATION CONTACT: If
you have questions on this rule, e-mail
or call Commander Michael Cavallaro,
U.S. Coast Guard Office of General Law,
telephone 202–372–3777, e-mail
Michael.S.Cavallaro@uscg.mil. If you
have questions on viewing or submitting
material to the docket, call Renee V.
Wright, Program Manager, Docket
Operations, telephone 202–366–9826.
SUPPLEMENTARY INFORMATION:
Table of Contents
I. Public Participation and Request for
Comments
A. Submitting Comments
B. Viewing Comments and Documents
C. Privacy Act
D. Public Meeting
II. Abbreviations
III. Regulatory Information
IV. Background
V. Discussion of the Rule
VI. Regulatory Analysis
A. Regulatory Planning and Review
B. Small Entities
C. Collection of Information
D. Federalism
E. Unfunded Mandates Reform Act
F. Taking of Private Property
G. Civil Justice Reform
H. Protection of Children
I. Indian Tribal Governments
J. Energy Effects
K. Technical Standards
L. Environment
I. Public Participation and Request for
Comments
We encourage you to participate in
this rulemaking by submitting
comments and related materials. All
comments received will be posted,
without change, to https://
www.regulations.gov and will include
any personal information you have
provided.
A. Submitting Comments
If you submit comments, please
include the docket number for this
rulemaking (USCG–2009–0239),
PO 00000
Frm 00010
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indicate the specific section of this
document to which each comment
applies, and provide a reason for each
suggestion or recommendation. You
may submit your comments and
material online, or by fax, mail or hand
delivery, but please use only one of
these means. We recommend that you
include your name and a mailing
address, an e-mail address, or a phone
number in the body of your document
so that we can contact you if we have
questions regarding your submission.
To submit your comment online, go to
https://www.regulations.gov, and type
‘‘USCG–2009–0239’’ in the ‘‘Keyword’’
box. If you submit your comments by
mail or hand delivery, submit them in
an unbound format, no larger than 81⁄2
by 11 inches, suitable for copying and
electronic filing. If you submit them by
mail and would like to know that they
reached the Facility, please enclose a
stamped, self-addressed postcard or
envelope. We will consider all
comments and material received during
the comment period.
B. Viewing Comments and Documents
To view comments, as well as
documents mentioned in this preamble
as being available in the docket, go to
https://www.regulations.gov, click on the
‘‘read comments’’ box, which will then
become highlighted in blue. In the
‘‘Keyword’’ box type ‘‘USCG–2009–0239’’
and click ‘‘Search.’’ Click the ‘‘Open
Docket Folder’’ in the ‘‘Actions’’ column.
If you do not have access to the internet,
you may also view the docket online by
visiting the Docket Management Facility
in Room W12–140 on the ground floor
of the Department of Transportation
West Building, 1200 New Jersey
Avenue, SE., Washington, DC 20590,
between 9 a.m. and 5 p.m., Monday
through Friday, except Federal holidays.
We have an agreement with the
Department of Transportation to use the
Docket Management Facility.
C. Privacy Act
Anyone can search the electronic
form of comments received into any of
our dockets by the name of the
individual submitting the comment (or
signing the comment, if submitted on
behalf of an association, business, labor
union, etc.). You may review a Privacy
Act notice regarding our public dockets
in the January 17, 2008 issue of the
Federal Register (73 FR 3316).
D. Public Meeting
We do not now plan to hold a public
meeting for this rulemaking. But you
may submit a request for one to the
docket using one of the methods
specified under ADDRESSES. In your
E:\FR\FM\21DER1.SGM
21DER1
]]>Agencies
[Federal Register Volume 75, Number 244 (Tuesday, December 21, 2010)]
[Rules and Regulations]
[Pages 79955-79956]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-31952]
=======================================================================
-----------------------------------------------------------------------
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 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 Intervet, Inc., a
sponsor of approved new animal drug applications.
DATES: This rule is effective December 21, 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: Intervet, Inc., 56 Livingston Ave.,
Roseland, NJ 07068 has informed FDA that it has changed its address to
556 Morris Ave., Summit, NJ 07901. 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 ``Intervet, Inc.''; and in the table in paragraph (c)(2), revise
the entry for ``000061'' 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
----------------------------------------------------------------------------------------------------------------
* * * * * * *
Intervet, Inc., 556 Morris Ave., Summit, NJ 07901..... 000061
* * * * * * *
----------------------------------------------------------------------------------------------------------------
(2) * * *
----------------------------------------------------------------------------------------------------------------
Drug labeler code Firm name and address
----------------------------------------------------------------------------------------------------------------
* * * * * * *
000061................................................ Intervet, Inc., 556 Morris Ave., Summit, NJ 07901.
* * * * * * *
----------------------------------------------------------------------------------------------------------------
[[Page 79956]]
Dated: December 9, 2010.
Steven D. Vaughn,
Director, Office of New Animal Drug Evaluation, Center for Veterinary
Medicine.
[FR Doc. 2010-31952 Filed 12-20-10; 8:45 am]
BILLING CODE 4160-01-P
