Animal Drugs, Feeds, and Related Products; Withdrawal of Approval of a New Animal Drug Application; Buquinolate; Coumaphos, 24394 [2010-10564]
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24394
Federal Register / Vol. 75, No. 86 / Wednesday, May 5, 2010 / Rules and Regulations
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 556 and 558
[Docket No. FDA–2010–N–0002]
Animal Drugs, Feeds, and Related
Products; Withdrawal of Approval of a
New Animal Drug Application;
Buquinolate; Coumaphos
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Final rule.
List of Subjects
The Food and Drug
Administration (FDA) is amending the
animal drug regulations by removing
those portions that reflect approval of
two new animal drug applications
(NADAs). In a notice published
elsewhere in this issue of the Federal
Register, FDA is withdrawing approval
of these NADAs.
DATES: This rule is effective May 17,
2010.
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SUMMARY:
FOR FURTHER INFORMATION CONTACT: John
Bartkowiak, Center for Veterinary
Medicine (HFV–212), Food and Drug
Administration, 7519 Standish Pl.,
Rockville, MD 20855, 240–276–9079, email: john.bartkowiak@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Purina
Mills, Inc., P.O. Box 66812, St. Louis,
MO 63166–6812 has requested that FDA
withdraw approval of NADA 42–117 for
Purina 6 Day Worm-Kill Concentrate
(coumaphos) because the product is no
longer manufactured or marketed.
In addition, Pharmacia & Upjohn Co.,
a Division of Pfizer, Inc., 235 East 42d
St., New York, NY 10017 has requested
that FDA withdraw approval of NADA
45–738 for use of LINCOMIX
(lincomycin) and BONAID (buquinolate)
single-ingredient Type A medicated
articles to make two-way, combination
drug Type C medicated broiler feed
because buquinolate is no longer
manufactured or marketed.
In a notice published elsewhere in
this issue of the Federal Register, FDA
gave notice that approval of NADA 42–
117 and NADA 45–738, and all
supplements and amendments thereto,
is withdrawn, effective May 17, 2010.
As provided in the regulatory text of
this document, the animal drug
regulations are amended to reflect these
withdrawals of approval.
In 1995, the approval of NADA 34 716
for BONAID Type A medicated article
was voluntarily withdrawn (60 FR
37651, July 21, 1995) and approved
conditions of use for buquinolate and all
its approved combinations in 21 CFR
VerDate Mar<15>2010
14:33 May 04, 2010
558.105, including combination with
lincomycin under NADA 45–738, were
removed (60 FR 39847, July 21, 1995).
At this time, the tolerances for residues
of buquinolate in edible products of
chickens and its listing as a Category I
drug in 21 CFR 558.4 are being
removed.
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.
Jkt 220001
21 CFR Part 556
Animal drugs, Foods.
21 CFR Part 558
Animal drugs, Animal feeds.
Therefore, under the Federal Food,
Drug, and Cosmetic Act and under the
authority delegated to the Commissioner
of Food and Drugs and redelegated to
the Center for Veterinary Medicine, 21
CFR parts 556 and 558 are amended as
follows:
■
PART 556—TOLERANCES FOR
RESIDUES OF NEW ANIMAL DRUGS
IN FOOD
1. The authority citation for 21 CFR
part 556 continues to read as follows:
■
Authority: 21 U.S.C. 342, 360b, 371.
§ 556.90
■
[Removed]
2. Remove § 556.90.
PART 558—NEW ANIMAL DRUGS FOR
USE IN ANIMAL FEEDS
3. The authority citation for 21 CFR
part 558 continues to read as follows:
■
[Amended]
4. In § 558.4, in paragraph (d), in the
‘‘Category I’’ table, remove the entry for
‘‘Buquinolate’’.
■
§ 558.185
[Amended]
5. In § 558.185, remove paragraph
(b)(2) and redesignate paragraph (b)(3)
as paragraph (b)(2).
■
Dated: April 30, 2010.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2010–10564 Filed 5–4–10; 8:45 am]
BILLING CODE 4160–01–S
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Frm 00022
Fmt 4700
Sfmt 4700
Office of Foreign Assets Control
31 CFR Part 551
Somalia Sanctions Regulations
AGENCY: Office of Foreign Assets
Control, Treasury.
ACTION: Final Rule.
SUMMARY: The Department of the
Treasury’s Office of Foreign Assets
Control (‘‘OFAC’’) is issuing regulations
with respect to Somalia to implement
Executive Order 13536 of April 12,
2010. OFAC intends to supplement this
part 551 with a more comprehensive set
of regulations, which may include
additional interpretive and definitional
guidance and additional general
licenses and statements of licensing
policy.
DATES:
Effective Date: May 5, 2010.
FOR FURTHER INFORMATION CONTACT:
Assistant Director for Compliance,
Outreach & Implementation, tel.: 202/
622–2490, Assistant Director for
Licensing, tel.: 202/622–2480, Assistant
Director for Policy, tel.: 202/622–4855,
Office of Foreign Assets Control, or
Chief Counsel (Foreign Assets Control),
tel.: 202/622–2410, Office of the General
Counsel, Department of the Treasury
(not toll free numbers).
SUPPLEMENTARY INFORMATION:
Electronic and Facsimile Availability
This document and additional
information concerning OFAC are
available from OFAC’s Web site
(https://www.treas.gov/ofac). Certain
general information pertaining to
OFAC’s sanctions programs also is
available via facsimile through a 24hour fax-on-demand service, tel.: 202/
622–0077.
Background
Authority: 21 U.S.C. 360b, 371.
§ 558.4
DEPARTMENT OF THE TREASURY
On April 12, 2010, the President,
invoking the authority of, inter alia, the
International Emergency Economic
Powers Act (50 U.S.C. 1701–1706), the
National Emergencies Act (50 U.S.C.
1601 et seq.), and section 5 of the
United Nations Participation Act (22
U.S.C. 287c), issued Executive Order
13536 (75 FR 19869, April 15, 2010)
(‘‘E.O. 13536’’), effective at 12:01 a.m.
eastern daylight time on April 13, 2010.
The Department of the Treasury’s
Office of Foreign Assets Control is
issuing the Somalia Sanctions
Regulations, 31 CFR part 551 (the
‘‘Regulations’’), to implement E.O.
13536, pursuant to authorities delegated
to the Secretary of the Treasury in E.O.
E:\FR\FM\05MYR1.SGM
05MYR1
]]>Agencies
[Federal Register Volume 75, Number 86 (Wednesday, May 5, 2010)]
[Rules and Regulations]
[Page 24394]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-10564]
[[Page 24394]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 556 and 558
[Docket No. FDA-2010-N-0002]
Animal Drugs, Feeds, and Related Products; Withdrawal of Approval
of a New Animal Drug Application; Buquinolate; Coumaphos
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is amending the animal
drug regulations by removing those portions that reflect approval of
two new animal drug applications (NADAs). In a notice published
elsewhere in this issue of the Federal Register, FDA is withdrawing
approval of these NADAs.
DATES: This rule is effective May 17, 2010.
FOR FURTHER INFORMATION CONTACT: John Bartkowiak, Center for Veterinary
Medicine (HFV-212), Food and Drug Administration, 7519 Standish Pl.,
Rockville, MD 20855, 240-276-9079, e-mail: john.bartkowiak@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Purina Mills, Inc., P.O. Box 66812, St.
Louis, MO 63166-6812 has requested that FDA withdraw approval of NADA
42-117 for Purina 6 Day Worm-Kill Concentrate (coumaphos) because the
product is no longer manufactured or marketed.
In addition, Pharmacia & Upjohn Co., a Division of Pfizer, Inc.,
235 East 42d St., New York, NY 10017 has requested that FDA withdraw
approval of NADA 45-738 for use of LINCOMIX (lincomycin) and BONAID
(buquinolate) single-ingredient Type A medicated articles to make two-
way, combination drug Type C medicated broiler feed because buquinolate
is no longer manufactured or marketed.
In a notice published elsewhere in this issue of the Federal
Register, FDA gave notice that approval of NADA 42-117 and NADA 45-738,
and all supplements and amendments thereto, is withdrawn, effective May
17, 2010. As provided in the regulatory text of this document, the
animal drug regulations are amended to reflect these withdrawals of
approval.
In 1995, the approval of NADA 34 716 for BONAID Type A medicated
article was voluntarily withdrawn (60 FR 37651, July 21, 1995) and
approved conditions of use for buquinolate and all its approved
combinations in 21 CFR 558.105, including combination with lincomycin
under NADA 45-738, were removed (60 FR 39847, July 21, 1995). At this
time, the tolerances for residues of buquinolate in edible products of
chickens and its listing as a Category I drug in 21 CFR 558.4 are being
removed.
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
21 CFR Part 556
Animal drugs, Foods.
21 CFR Part 558
Animal drugs, Animal feeds.
0
Therefore, under the Federal Food, Drug, and Cosmetic Act and under the
authority delegated to the Commissioner of Food and Drugs and
redelegated to the Center for Veterinary Medicine, 21 CFR parts 556 and
558 are amended as follows:
PART 556--TOLERANCES FOR RESIDUES OF NEW ANIMAL DRUGS IN FOOD
0
1. The authority citation for 21 CFR part 556 continues to read as
follows:
Authority: 21 U.S.C. 342, 360b, 371.
Sec. 556.90 [Removed]
0
2. Remove Sec. 556.90.
PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS
0
3. The authority citation for 21 CFR part 558 continues to read as
follows:
Authority: 21 U.S.C. 360b, 371.
Sec. 558.4 [Amended]
0
4. In Sec. 558.4, in paragraph (d), in the ``Category I'' table,
remove the entry for ``Buquinolate''.
Sec. 558.185 [Amended]
0
5. In Sec. 558.185, remove paragraph (b)(2) and redesignate paragraph
(b)(3) as paragraph (b)(2).
Dated: April 30, 2010.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2010-10564 Filed 5-4-10; 8:45 am]
BILLING CODE 4160-01-S
