New Animal Drugs; Change of Sponsor's Address, 30970-30971 [E7-10771]
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30970
Federal Register / Vol. 72, No. 107 / Tuesday, June 5, 2007 / Rules and Regulations
TABLE 1.—AFM TEMPORARY AMENDMENTS
Use
Bombardier
temporary
amendment—
For model—
DHC–8–400 airplanes ........................................................................
DHC–8–401 airplanes ........................................................................
DHC–8–402 airplanes ........................................................................
Note 1: This may be done by inserting a
copy of the applicable temporary amendment
into the applicable AFM. When the
applicable temporary amendment has been
included in general revisions of the AFM, the
general revisions may be inserted into the
AFM, provided the relevant information in
the general revisions is identical to that in
the temporary amendment.
Alternative Methods of Compliance
(AMOCs)
(g)(1) The Manager, New York Aircraft
Certification Office, FAA, has the authority to
approve AMOCs for this AD, if requested in
accordance with the procedures found in 14
CFR 39.19.
Dated—
Issue—
13
13
13
1
1
1
(2) To request a different method of
compliance or a different compliance time
for this AD, follow the procedures in 14 CFR
39.19. Before using any approved AMOC on
any airplane to which the AMOC applies,
notify your appropriate principal inspector
(PI) in the FAA Flight Standards District
Office (FSDO), or lacking a PI, your local
FSDO.
Related Information
(h) Canadian airworthiness directive CF–
2006–08, dated April 26, 2006, also addresses
the subject of this AD.
Material Incorporated by Reference
(i) You must use the temporary
amendments specified in Table 2 of this AD,
as applicable, to perform the actions that are
To Bombardier Dash
8 Q400 Airplane
Flight Manual—
July 14, 2005 .............
July 14, 2005 .............
July 14, 2005 .............
PSM 1–84–1A.
PSM 1–84–1A.
PSM 1–84–1A.
required by this AD, unless the AD specifies
otherwise. The Director of the Federal
Register approved the incorporation by
reference of these documents in accordance
with 5 U.S.C. 552(a) and 1 CFR part 51.
Contact Bombardier, Inc., Bombardier
Regional Aircraft Division, 123 Garratt
Boulevard, Downsview, Ontario M3K 1Y5,
Canada, for a copy of this service
information. You may review copies at the
FAA, Transport Airplane Directorate, 1601
Lind Avenue, SW., Renton, Washington; or at
the National Archives and Records
Administration (NARA). For information on
the availability of this material at NARA, call
202–741–6030, or go to: https://
www.archives.gov/federal-register/cfr/ibrlocations.html.
TABLE 2.—MATERIAL INCORPORATED BY REFERENCE
Bombardier temporary amendment—
13 .............................................................................................................
13 .............................................................................................................
13 .............................................................................................................
Issued in Renton, Washington, on May 25,
2007.
Ali Bahrami,
Manager, Transport Airplane Directorate,
Aircraft Certification Service.
[FR Doc. E7–10678 Filed 6–4–07; 8:45 am]
BILLING CODE 4910–13–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 510
New Animal Drugs; Change of
Sponsor’s Address
AGENCY:
Food and Drug Administration,
HHS.
cprice-sewell on PROD1PC71 with RULES
ACTION:
Final rule.
15:27 Jun 04, 2007
1
1
1
To Bombardier Dash 8 Q400
Airplane Flight Manual—
July 14, 2005 ..............
July 14, 2005 ..............
July 14, 2005 ..............
Model 400 PSM 1–84–1A.
Model 401 PSM 1–84–1A.
Model 402 PSM 1–84–1A.
FOR FURTHER INFORMATION CONTACT:
David R. Newkirk, Center for Veterinary
Medicine (HFV–100), Food and Drug
Administration, 7500 Standish Pl.,
Rockville, MD 20855, 301–827–6967, email: david.newkirk@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Watson
Laboratories, Inc., 620 North 51st Ave.,
Phoenix, AZ 85043–4705 has informed
FDA of a change of address to 311
Bonnie Circle, Corona, CA 92880.
Accordingly, the agency is amending
the regulations in 21 CFR 510.600(c) to
reflect the 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
SUMMARY: The Food and Drug
Administration (FDA) is amending the
animal drug regulations to reflect a
change of sponsor address for Watson
Laboratories, Inc.
DATES: This rule is effective June 5,
2007.
VerDate Aug<31>2005
Dated—
Issue—
Jkt 211001
Administrative practice and
procedure, Animal drugs, Labeling,
Reporting and recordkeeping
requirements.
I Therefore, under the Federal Food,
Drug, and Cosmetic Act and under
authority delegated to the Commissioner
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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
1. The authority citation for 21 CFR
part 510 continues to read as follows:
I
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
‘‘Watson Laboratories, Inc.’’; and in the
table in paragraph (c)(2) revise the entry
for ‘‘000402’’ to read as follows:
I
§ 510.600 Names, addresses, and drug
labeler codes of sponsors of approved
applications.
*
*
*
(c) * * *
(1) * * *
*
*
Firm name and address
*
*
*
*
Watson Laboratories, Inc., 311
Bonnie Circle, Corona, CA
92880.
E:\FR\FM\05JNR1.SGM
05JNR1
Drug labeler
code
*
000402
Federal Register / Vol. 72, No. 107 / Tuesday, June 5, 2007 / Rules and Regulations
Drug labeler
code
Firm name and address
*
*
*
*
*
(2) * * *
Drug labeler
code
Firm name and address
Dated: May 24, 2007.
Bernadette Dunham,
Deputy Director, Center for Veterinary
Medicine.
[FR Doc. E7–10771 Filed 6–4–07; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF STATE
22 CFR Part 9
[Public Notice 5822]
RIN 1400–AB91
National Security Information
Regulations
State Department.
Final rule.
AGENCY:
SUMMARY: This rule makes final the
Department’s proposed rule published
on January 3, 2007. The rule revises the
Department’s regulations governing the
classification and declassification of
national security information that is
under the control of the Department in
order to reflect changes in the
provisions of a new executive order on
national security information and
consequent changes in the Department’s
procedures since the last revision of the
Department’s regulations on this
subject. The Department received one
non-substantive comment and proposes
no changes to the proposed rule. The
proposed rule is therefore adopted as
final.
Effective Date: This rule is
effective June 5, 2007.
ADDRESSES: Persons having questions
with respect to these regulations should
address such questions to: Margaret P.
Grafeld, Director, Office of Information
Programs and Services, U.S. Department
of State, SA–2, 515 22nd St., NW.,
Washington, DC 20522–6001. Tel: 202–
261–8300; FAX: 202–261–8590. Persons
with access to the Internet may also
view this notice by going to the
regulations.gov Web site at https://
www.regulations. gov/index.cfm.
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DATES:
VerDate Aug<31>2005
15:27 Jun 04, 2007
Jkt 211001
Margaret P. Grafeld, Director, Office of
Information Programs and Services, U.S.
Department of State, SA–2, 515 22nd
St., NW., Washington, DC 20522–6001.
Tel: 202–261–8300; FAX: 202–261–
8590.
The
Department’s proposed rule was
published as Public Notice 5658 at 72
FR 59–62 on January 3, 2007, with a 90day public comment period. The
Department received one nonsubstantive comment discussed under
Analysis of Comments. Since the last
comprehensive revision of the
Department’s national security
information regulations, a new
governing executive order, E.O. 12958,
has been issued and modified several
times, most substantially by E.O. 13292
of March 25, 2003. In addition, the
Information Security Oversight Office
has issued a new classified national
security information directive
containing interpretive guidance. Both
the order and the directive effected
significant changes in the procedures for
classifying and declassifying national
security information. The final
regulations of the Department take
account of these changes and reflect
changes in the Department’s procedures
designed to implement them.
Analysis of Comments: The proposed
rule was published for comments on
January 3, 2007. The comment period
closed April 3, 2007. The one public
comment received by the Department
related to the language in Sec. 9.2
pertaining to the objective of the
classification program. The comment
suggested the inclusion in Sec. 9.2 of
additional language from the preamble
of E.O. 12958. The Department
concluded that such additional
elaboration of program objective was
duplicative of the order and
unnecessary.
SUPPLEMENTARY INFORMATION:
*
*
*
*
*
000402 ....... Watson Laboratories, Inc., 311
Bonnie Circle, Corona, CA
92880.
*
*
*
*
*
ACTION:
FOR FURTHER INFORMATION CONTACT:
Regulatory Findings
Administrative Procedure Act. The
Department is publishing this regulation
as a final rule, after it was published as
a proposed rule on January 3, 2007.
Regulatory Flexibility Act. The
Department, in accordance with the
Regulatory Flexibility Act (5 U.S.C.
605(b)), has reviewed this rule and, by
approving it, certifies that this rule will
not have significant economic impact on
a substantial number of small entities.
Unfunded Mandates Act of 1995. This
rule will not result in the expenditure
by State, local, and tribal governments,
in the aggregate, or by the private sector,
of $100 million or more in any year, and
it will not significantly or uniquely
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30971
affect small governments. Therefore, no
actions are deemed necessary under the
provisions of the Unfounded Mandates
Reform Act of 1995.
Small Business Regulatory
Enforcement Fairness Act of 1996. This
rule is not a major rule as defined by
section 804 of the Small Business
Regulatory Enforcement Act of 1996.
This rule will not result in an annual
effect on the economy of $100 million
or more; a major increase in costs or
prices; or significant adverse effects on
competition, employment, investment,
productivity, innovation, or on the
ability of United States-based
companies to compete with foreign
based companies in domestic and
import markets.
Executive Order 12866. The
Department does not consider this rule
to be a ‘‘significant regulatory action’’
under Executive Order (E.O.) 12866,
section 3(f), Regulatory Planning and
Review. In addition, the Department is
exempt from Executive Order 12866
except to the extent that it is
promulgating regulations in conjunction
with a domestic agency that are
significant regulatory actions. The
Department has nevertheless reviewed
the regulation to ensure its consistency
with the regulatory philosophy and
principles set forth in that Executive
Order.
Executive Order 12988—Civil Justice
Reform. The Department has reviewed
this regulation in light of sections 3(a)
and 3(b) (2) of Executive Order 12988 to
eliminate ambiguity, minimize
litigation, establish clear legal
standards, and reduce burden.
Executive Orders 12372 and 13132.
This regulation will not have substantial
direct effects on the States, on the
relationship between the national
government and the States, or on the
distribution of power and
responsibilities among the various
levels of government. Therefore, in
accordance with section 6 of Executive
Order 13132, it is determined that this
rule does not have sufficient federalism
implications to require consultations or
warrant the preparation of a federalism
summary impact statement. The
regulations implementing Executive
Order 12372 regarding
intergovernmental consultation on
Federal programs and activities do not
apply to this regulation.
National Environmental Policy Act.
The Department has analyzed this
regulation for the purpose of the
National Environmental Policy Act of
1969 (42 U.S.C. 4321–4347) and has
determined that it will not have any
effect on the quality of the environment.
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]]>Agencies
[Federal Register Volume 72, Number 107 (Tuesday, June 5, 2007)]
[Rules and Regulations]
[Pages 30970-30971]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-10771]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 510
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 sponsor address for Watson
Laboratories, Inc.
DATES: This rule is effective June 5, 2007.
FOR FURTHER INFORMATION CONTACT: David R. Newkirk, Center for
Veterinary Medicine (HFV-100), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 301-827-6967, e-mail:
david.newkirk@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Watson Laboratories, Inc., 620 North 51st
Ave., Phoenix, AZ 85043-4705 has informed FDA of a change of address to
311 Bonnie Circle, Corona, CA 92880. Accordingly, the agency is
amending the regulations in 21 CFR 510.600(c) to reflect the 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 ``Watson Laboratories, Inc.''; and in the table in paragraph (c)(2)
revise the entry for ``000402'' 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
------------------------------------------------------------------------
* * * * *
Watson Laboratories, Inc., 311 Bonnie Circle, 000402
Corona, CA 92880.
[[Page 30971]]
* * * * *
------------------------------------------------------------------------
(2) * * *
------------------------------------------------------------------------
Drug labeler code Firm name and address
------------------------------------------------------------------------
* * * * *
000402.................. Watson Laboratories, Inc., 311 Bonnie Circle,
Corona, CA 92880.
* * * * *
------------------------------------------------------------------------
Dated: May 24, 2007.
Bernadette Dunham,
Deputy Director, Center for Veterinary Medicine.
[FR Doc. E7-10771 Filed 6-4-07; 8:45 am]
BILLING CODE 4160-01-S
