Microbiology Devices; Reclassification of Herpes Simplex Virus Types 1 and 2 Serological Assays; Confirmation of Effective Date, 59611 [2010-23638]
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Federal Register / Vol. 75, No. 187 / Tuesday, September 28, 2010 / Rules and Regulations
adding new § 522.930 to reflect the
approval.
In accordance with the freedom of
information provisions of 21 CFR part
20 and 21 CFR 514.11(e)(2)(ii), a
summary of safety and effectiveness
data and information submitted to
support approval of this application
may be seen in the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852, between 9
a.m. and 4 p.m., Monday through
Friday.
The agency has determined under 21
CFR 25.33 that this action is of a type
that does not individually or
cumulatively have a significant effect on
the human environment. Therefore,
neither an environmental assessment
nor an environmental impact statement
is required.
Under section 512(c)(2)(F)(ii) of the
Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 360b(c)(2)(F)(ii)), this
approval qualifies for 3 years of
marketing exclusivity beginning on the
date of approval.
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 522
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 522 is amended as follows:
■
PART 522—IMPLANTATION OR
INJECTABLE DOSAGE FORM NEW
ANIMAL DRUGS
1. The authority citation for 21 CFR
part 522 continues to read as follows:
■
Authority: 21 U.S.C. 360b.
■
2. Add § 522.930 to read as follows:
WReier-Aviles on DSKGBLS3C1PROD with RULES
§ 522.930
Firocoxib.
(a) Specifications. Each milliliter of
solution contains 20 milligrams (mg)
firocoxib.
(b) Sponsors. See No. 050604 in
§ 510.600(c) of this chapter.
(c) Conditions of use in horses—(1)
Amount. Administer 0.04 mg/pound (lb)
(0.09 mg/kilogram (kg)) of body weight
(BW) intravenously, once daily, for up
to 5 days. If further treatment is needed,
firocoxib oral paste can be administered
at a dosage of 0.045 mg/lb (0.1 mg/kg)
of BW for up to an additional 9 days of
treatment.
VerDate Mar<15>2010
15:19 Sep 27, 2010
Jkt 220001
(2) Indications for use. For the control
of pain and inflammation associated
with osteoarthritis.
(3) Limitations. Do not use in horses
intended for human consumption.
Federal law restricts this drug to use by
or on the order of a licensed
veterinarian.
Dated: September 21, 2010.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
59611
and under authority delegated to the
Commissioner of Food and Drugs, 21
CFR part 866 is amended. Accordingly,
the amendments issued thereby are
effective.
Dated: September 16, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010–23638 Filed 9–27–10; 8:45 am]
BILLING CODE 4160–01–S
[FR Doc. 2010–24254 Filed 9–27–10; 8:45 am]
DEPARTMENT OF THE TREASURY
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Office of Foreign Assets Control
31 CFR Part 560
Food and Drug Administration
Iranian Transactions Regulations
21 CFR Part 866
AGENCY:
Office of Foreign Assets
Control, Treasury.
ACTION: Final rule.
[Docket No. FDA–2009–N–0344]
Microbiology Devices; Reclassification
of Herpes Simplex Virus Types 1 and
2 Serological Assays; Confirmation of
Effective Date
AGENCY:
Food and Drug Administration,
HHS.
Direct final rule; confirmation of
effective date.
ACTION:
The Food and Drug
Administration (FDA) is confirming the
effective date of December 7, 2009, for
the direct final rule that appeared in the
Federal Register of August 25, 2009 (74
FR 42773). The direct final rule corrects
the regulation classifying herpes
simplex virus (HSV) serological assays
by removing the reference to HSV
serological assays other than type 1 and
type 2. This document confirms the
effective date of the direct final rule.
DATES: Effective date confirmed:
December 7, 2009.
FOR FURTHER INFORMATION CONTACT:
Scott McFarland, Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, rm. 5543, Silver Spring,
MD 20993–0002, 301–796–6217.
SUPPLEMENTARY INFORMATION: In the
Federal Register of August 25, 2009 (74
FR 42773), FDA solicited comments
concerning the direct final rule for a 44day period ending October 8, 2009. FDA
stated that the effective date of the
direct final rule would be on December
7, 2009, 60 days after the end of the
comment period, unless any significant
adverse comment was submitted to FDA
during the comment period. FDA did
not receive any significant adverse
comments.
■ Authority: Therefore, under the
Federal Food, Drug, and Cosmetic Act
SUMMARY:
PO 00000
Frm 00007
Fmt 4700
Sfmt 4700
The Department of the
Treasury’s Office of Foreign Assets
Control (‘‘OFAC’’) is amending the
Iranian Transactions Regulations in the
Code of Federal Regulations to remove
general licenses authorizing the
importation into the United States of,
and dealings in, certain foodstuffs and
carpets of Iranian origin and related
services, and to implement the import
and export prohibitions in section 103
of the Comprehensive Iran Sanctions,
Accountability, and Divestment Act of
2010.
DATES: Effective Date: September 29,
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:
SUMMARY:
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 24-hour fax-ondemand service, tel.: 202/622–0077.
Background
On July 1, 2010, the President signed
into law the Comprehensive Iran
Sanctions, Accountability, and
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]]>Agencies
[Federal Register Volume 75, Number 187 (Tuesday, September 28, 2010)]
[Rules and Regulations]
[Page 59611]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-23638]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 866
[Docket No. FDA-2009-N-0344]
Microbiology Devices; Reclassification of Herpes Simplex Virus
Types 1 and 2 Serological Assays; Confirmation of Effective Date
AGENCY: Food and Drug Administration, HHS.
ACTION: Direct final rule; confirmation of effective date.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is confirming the
effective date of December 7, 2009, for the direct final rule that
appeared in the Federal Register of August 25, 2009 (74 FR 42773). The
direct final rule corrects the regulation classifying herpes simplex
virus (HSV) serological assays by removing the reference to HSV
serological assays other than type 1 and type 2. This document confirms
the effective date of the direct final rule.
DATES: Effective date confirmed: December 7, 2009.
FOR FURTHER INFORMATION CONTACT: Scott McFarland, Center for Devices
and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, rm. 5543, Silver Spring, MD 20993-0002, 301-
796-6217.
SUPPLEMENTARY INFORMATION: In the Federal Register of August 25, 2009
(74 FR 42773), FDA solicited comments concerning the direct final rule
for a 44-day period ending October 8, 2009. FDA stated that the
effective date of the direct final rule would be on December 7, 2009,
60 days after the end of the comment period, unless any significant
adverse comment was submitted to FDA during the comment period. FDA did
not receive any significant adverse comments.
0
Authority: Therefore, under the Federal Food, Drug, and Cosmetic Act
and under authority delegated to the Commissioner of Food and Drugs, 21
CFR part 866 is amended. Accordingly, the amendments issued thereby are
effective.
Dated: September 16, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-23638 Filed 9-27-10; 8:45 am]
BILLING CODE 4160-01-S
