Federal Register / Vol. 75, No. 187 / Tuesday, September 28, 2010 / Rules and Regulations 59611 

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: 

§ 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. 

(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. 

[FR Doc. 2010–24254 Filed 9–27–10; 8:45 am] 

BILLING CODE 4160–01–S 

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. 

■ 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 

DEPARTMENT OF THE TREASURY 

Office of Foreign Assets Control 

31 CFR Part 560 

Iranian Transactions 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 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: 

Electronic and Facsimile Availability 

This document and additional 

information concerning OFAC are 

available from OFAC’s Web site (http:// 

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 

WReier-Aviles on DSKGBLS3C1PROD with RULES