Oral Dosage Form New Animal Drugs; Change of Sponsor; Griseofulvin Powder; Levamisole Hydrochloride Powder; Oxytetracycline Powder, 28252-28253 [2012-11382]
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28252
Federal Register / Vol. 77, No. 93 / Monday, May 14, 2012 / Rules and Regulations
SUPPLEMENT NO. 4 TO PART 744—ENTITY LIST—Continued
Country
Entity
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License requirement
License review policy
Federal Register citation
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PAKISTAN
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Jalaluddin Haqqani, a.k.a., the following
seven aliases:
—General Jalaluddin;
—Haqqani Sahib;
—Maulama Jalaluddin;
—Maulawi Haqqani;
—Molvi Sahib;
—Mulawi Jalaluddin; and
—Mullah Jalaluddin.
Miram Shah, Pakistan.
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For all items subject to
the EAR. (See § 744.11
of the EAR).
Presumption of denial ......
77 FR 25055,
4/27/12.
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UNITED ARAB
EMIRATES
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Al Maskah Used Car and Spare Parts,
Maliha Road, Industrial Area 6,
Sharjah, U.A.E.
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Feroz Khan, a.k.a., the following three
aliases:
—Haaje Khan;
—Haaji Khan; and
—Firoz.
Maliha Road, Industrial Area 6,
Sharjah, U.A.E.
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Dated: May 8, 2012.
Bernard Kritzer,
Director, Office of Exporter Services.
[FR Doc. 2012–11555 Filed 5–11–12; 8:45 am]
BILLING CODE 3510–33–P
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Presumption of denial ......
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Food and Drug Administration
21 CFR Part 520
emcdonald on DSK29S0YB1PROD with RULES
[Docket No. FDA–2012–N–0002]
Oral Dosage Form New Animal Drugs;
Change of Sponsor; Griseofulvin
Powder; Levamisole Hydrochloride
Powder; Oxytetracycline Powder
AGENCY:
Food and Drug Administration,
HHS.
VerDate Mar<15>2010
14:45 May 11, 2012
Jkt 226001
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77 FR 25055, 4/27/12.
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Presumption of denial ......
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
77 FR 25055, 4/27/12.
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For all items subject to
the EAR. (See § 744.11
of the EAR).
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Presumption of denial ......
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For all items subject to
the EAR. (See § 744.11
of the EAR).
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Zurmat General Trading,
Office No. 205, Platinum Business
Center, Baghdad Street, Al-Nahda 2,
Al-Qusais, Dubai, U.A.E.; and P.O.
Box No. 171452, Dubai, U.A.E.; and
1st Street, Industrial Area 4th,
Sharjah, U.A.E. (Behind the Toyota
Showroom), and P.O. Box 35470,
Sharjah, U.A.E.
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For all items subject to
the EAR. (See § 744.11
of the EAR).
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77 FR 25055,
4/27/12.
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ACTION:
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Final rule.
The Food and Drug
Administration (FDA) is amending the
animal drug regulations to reflect a
change of sponsor for five abbreviated
new animal drug applications
(ANADAs) for griseofulvin powder,
levamisole hydrochloride soluble
powder, and oxytetracycline
hydrochloride soluble powder from
Teva Animal Health, Inc., to Cross
Vetpharm Group, Ltd.
DATES: This rule is effective May 14,
2012.
SUMMARY:
E:\FR\FM\14MYR1.SGM
14MYR1
Federal Register / Vol. 77, No. 93 / Monday, May 14, 2012 / Rules and Regulations
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,
steven.vaughn@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Teva
Animal Health, Inc., 3915 South 48th St.
Ter., St. Joseph, MO 64503, has
informed FDA that it has transferred
ownership of, and all rights and interest
in, ANADA 200–391 for Griseofulvin
Powder, ANADAs 200–146 and 200–247
for Oxytetracycline Hydrochloride
Soluble Powder, and ANADAs 200–313
and 200–386 for Levamisole
Hydrochloride Soluble Pig Wormer and
Drench Powder to Cross Vetpharm
Group Ltd., Broomhill Rd., Tallaght,
Dublin 24, Ireland. Accordingly, the
agency is amending the regulations in
part 520 (21 CFR part 520) to reflect the
transfer of ownership and a current
format.
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 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 part 520 is amended as follows:
PART 520—ORAL DOSAGE FORM
NEW ANIMAL DRUGS
1. The authority citation for 21 CFR
part 520 continues to read as follows:
■
Authority: 21 U.S.C. 360b.
§ 520.1100
[Amended]
2. In paragraph (b)(2) of § 520.1100,
remove ‘‘059130’’ and in its place add
‘‘061623’’.
■ 3. In § 520.1242, revise the section
heading to read as follows:
■
§ 520.1242
Levamisole.
4. In § 520.1242a, revise the section
heading to read as set forth below, and
in paragraph (b)(4) remove ‘‘059130’’
and in its place add ‘‘061623’’.
■
emcdonald on DSK29S0YB1PROD with RULES
§ 520.1242a
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Levamisole powder.
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§ 520.1660d
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[Amended]
5. In § 520.1660d, in paragraphs (b)(5),
(d)(1)(ii)(A)(3), (d)(1)(ii)(B)(3),
(d)(1)(ii)(C)(3), and (d)(1)(iii)(C), remove
‘‘059130’’ and in its place add
‘‘061623’’.
■
VerDate Mar<15>2010
14:45 May 11, 2012
Jkt 226001
Dated: May 7, 2012.
Elizabeth Rettie,
Deputy Director, Office of New Animal Drug
Evaluation, Center for Veterinary Medicine.
[FR Doc. 2012–11382 Filed 5–11–12; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HOMELAND
SECURITY
Coast Guard
33 CFR Part 165
[Docket No. USCG–2011–1172]
RIN 1625–AA00
Safety Zone; America’s Cup World
Series, East Passage, Narragansett
Bay, RI
Coast Guard, DHS.
Final rule.
AGENCY:
ACTION:
The Coast Guard is
establishing two temporary safety zones
in the navigable waters of the East
Passage, Narragansett Bay, Rhode
Island, during the America’s Cup World
Series (ACWS) sailing vessel racing
event.
SUMMARY:
This rule is effective June 13,
2012 until 5:00 p.m. on July 1, 2012.
ADDRESSES: Comments and material
received from the public, as well as
documents mentioned in this preamble
as being available in the docket, are part
of docket USCG–2011–1172 and are
available online by going to https://
www.regulations.gov, inserting USCG–
2011–1172 in the ‘‘Keyword’’ box, and
then clicking ‘‘Search.’’ This material is
also available for inspection or copying
at the 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, between 9 a.m.
and 5 p.m., Monday through Friday,
except Federal holidays.
FOR FURTHER INFORMATION CONTACT: If
you have questions on this rule, call or
email Mr. Edward G. LeBlanc,
Waterways Management Division at
Coast Guard Sector Southeastern New
England, telephone 401–435–2351,
email Edward.G.LeBlanc@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:
DATES:
Regulatory Information
On February 10, 2012, we published
a notice of proposed rulemaking
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28253
(NPRM) entitled ‘‘Safety Zones;
America’s Cup World Series, East
Passage, Narragansett Bay, RI’’ in the
Federal Register (77 FR 7025). We
received one comment on the proposed
rule.
Basis and Purpose
The legal basis for this rule is 33
U.S.C. 1231; 46 U.S.C. chapter 701,
3306, 3703; 50 U.S.C. 191, 195; 33 CFR
1.05–1, 6.04–1, 6.04–6, 160.5; Public
Law 107–295, 116 Stat. 2064; and
Department of Homeland Security
Delegation No. 0170.1, which
collectively authorize the Coast Guard
to define safety zones.
This rule is necessary to provide for
the safety of life and navigation for both
participants and spectators involved
with the America’s Cup World Series in
the vicinity of Newport, RI.
Discussion of Comments and Changes
One comment was received,
supporting this rule. The commenter
believed the safety zones established by
this rule will improve navigation safety
for all mariners and facilitate a safe
America’s Cup World Series event. No
changes were made to the language
contained in the NPRM.
Regulatory Analyses
We developed this rule after
considering numerous statutes and
executive orders related to rulemaking.
Below we summarize our analyses
based on 13 of these statutes or
executive orders.
Executive Order 12866 and Executive
Order 13563
This rule is not a significant
regulatory action under section 3(f) of
Executive Order 12866, Regulatory
Planning and Review, as supplemented
by Executive Order 13563, and does not
require an assessment of potential costs
and benefits under section 6(a)(3) of that
Order. The Office of Management and
Budget has not reviewed it under that
Order.
We expect the economic impact of
this rule to be minimal. Although this
regulation may have some impact on the
public, the potential impact will be
minimized for the following reasons:
Vessels will only be restricted from the
East Passage of Narragansett Bay by the
designated safety zone for a maximum
of six hours per day for a maximum of
10 days; there is an alternate route, the
West Passage of Narragansett Bay, that
does not add substantial transit time, is
already routinely used by mariners, and
will not be affected by these safety
zones; many vessels, especially
recreational vessels, may transit in all
E:\FR\FM\14MYR1.SGM
14MYR1
]]>Agencies
[Federal Register Volume 77, Number 93 (Monday, May 14, 2012)]
[Rules and Regulations]
[Pages 28252-28253]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-11382]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 520
[Docket No. FDA-2012-N-0002]
Oral Dosage Form New Animal Drugs; Change of Sponsor;
Griseofulvin Powder; Levamisole Hydrochloride Powder; Oxytetracycline
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 five abbreviated
new animal drug applications (ANADAs) for griseofulvin powder,
levamisole hydrochloride soluble powder, and oxytetracycline
hydrochloride soluble powder from Teva Animal Health, Inc., to Cross
Vetpharm Group, Ltd.
DATES: This rule is effective May 14, 2012.
[[Page 28253]]
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,
steven.vaughn@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Teva Animal Health, Inc., 3915 South 48th
St. Ter., St. Joseph, MO 64503, has informed FDA that it has
transferred ownership of, and all rights and interest in, ANADA 200-391
for Griseofulvin Powder, ANADAs 200-146 and 200-247 for Oxytetracycline
Hydrochloride Soluble Powder, and ANADAs 200-313 and 200-386 for
Levamisole Hydrochloride Soluble Pig Wormer and Drench Powder to Cross
Vetpharm Group Ltd., Broomhill Rd., Tallaght, Dublin 24, Ireland.
Accordingly, the agency is amending the regulations in part 520 (21 CFR
part 520) to reflect the transfer of ownership and a current format.
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 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 part 520 is
amended as follows:
PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS
0
1. The authority citation for 21 CFR part 520 continues to read as
follows:
Authority: 21 U.S.C. 360b.
Sec. 520.1100 [Amended]
0
2. In paragraph (b)(2) of Sec. 520.1100, remove ``059130'' and in its
place add ``061623''.
0
3. In Sec. 520.1242, revise the section heading to read as follows:
Sec. 520.1242 Levamisole.
0
4. In Sec. 520.1242a, revise the section heading to read as set forth
below, and in paragraph (b)(4) remove ``059130'' and in its place add
``061623''.
Sec. 520.1242a Levamisole powder.
* * * * *
Sec. 520.1660d [Amended]
0
5. In Sec. 520.1660d, in paragraphs (b)(5), (d)(1)(ii)(A)(3),
(d)(1)(ii)(B)(3), (d)(1)(ii)(C)(3), and (d)(1)(iii)(C), remove
``059130'' and in its place add ``061623''.
Dated: May 7, 2012.
Elizabeth Rettie,
Deputy Director, Office of New Animal Drug Evaluation, Center for
Veterinary Medicine.
[FR Doc. 2012-11382 Filed 5-11-12; 8:45 am]
BILLING CODE 4160-01-P
