59610 Federal Register / Vol. 75, No. 187 / Tuesday, September 28, 2010 / Rules and Regulations 

2 Although the Commission no longer has the 

authority to promulgate regulations implementing 

the smokeless tobacco labels or to approve related 

rotational plans, the Commission continues to have 

authority to bring enforcement actions with respect 

to violations of 15 U.S.C. 4402 under 15 U.S.C. 

4404(a). 

2010). The regulations themselves, 

however, remain in place. 

The Commission has now concluded 

that, in light of the amendments to the 

Smokeless Tobacco Act, the regulations 

in 16 CFR Part 307 no longer serve any 

purpose and actually conflict with the 

new statutory provisions. As noted 

above, the Family Smoking Prevention 

Act revised the language of the 

smokeless tobacco health warning 

statements and adopted new 

requirements for the format, size, and 

location of those statements on 

smokeless tobacco packaging and in ads 

for smokeless tobacco products. These 

requirements supersede those adopted 

by the Commission pursuant to the 1986 

statute. Accordingly, the Commission 

concludes that its regulations 

implementing the Smokeless Tobacco 

Act should be removed. Indeed, 

retention of these regulations could 

generate confusion if some smokeless 

tobacco manufacturers and importers 

mistakenly believe that they reflect 

current legal requirements. 

Under 5 U.S.C. 553(b)(B), an agency 

may promulgate a rule without prior 

notice and an opportunity for public 

comment if the agency finds for good 

cause that this procedure is 

unnecessary. Nat’l Customs Brokers & 

Forwarders Ass’n v. United States, 59 

F.3d 1219, 1223-1224 (Fed. Cir. 1995). 

In rescinding 16 CFR Part 307, the 

Commission finds that public comment 

is unnecessary because the FTC is 

rescinding its regulations in response to 

the transfer of its underlying regulatory 

authority to the Secretary of DHHS. 

Since the FTC has no discretion in that 

matter, there is no reason or need for 

public comment on this regulatory 

action. The Family Smoking Prevention 

Act amended 15 U.S.C. 4402 by 

repealing the Commission’s authority to 

promulgate rules implementing the 

smokeless tobacco labels and related 

rotational plans. That Act provides the 

Secretary of DHHS the authority to 

promulgate rules regarding the 

smokeless tobacco labels and the 

authority to approve related rotational 

plans. Therefore, as of June 22, 2010, the 

effective date of Congress’s 

amendments, the Commission’s rules 

under 16 CFR Part 307 were no longer 

authorized by statute. Although 15 

U.S.C. 4404(b) continues to refer to 

‘‘[r]egulations issued by the Federal 

Trade Commission under [15 U.S.C. 

4402],’’ it is clear from the amendments 

to 15 U.S.C. 4402 that the Commission 

no longer has the authority to 

promulgate such regulations. Moreover, 

the Commission’s rules under 16 CFR 

Part 307, if left intact, would conflict 

with the unambiguously expressed 

intent of Congress to provide the 

Secretary with the authority to 

promulgate such regulations and to 

approve the related rotational plans. 

Therefore, immediate rescission of the 

outdated rules will help avoid 

confusion as to which agency has 

proper authority to promulgate these 

rules and to approve related rotational 

plans.2 For all of these reasons, the 

Commission finds that public notice 

and comment are not necessary in 

rescinding 16 CFR Part 307. 

In addition, the Commission finds 

that, under 5 U.S.C. 553(d)(1), the 

rescission may take effect immediately 

upon publication of this notice in the 

Federal Register. The removal of the 

regulations is exempt from the usual 30- 

day notice requirement as it merely 

‘‘relieves a restriction’’ from FTC 

requirements. 5 U.S.C. 553(d)(1); see 

also Indep. U.S. Tanker Owners Comm. 

v. Skinner, 884 F.2d 587, 591 (D.C. Cir. 

1989). The 30-day notice requirement 

does not apply under these 

circumstances, in which the Family 

Smoking Prevention Act has required 

the submission of rotational warning 

plans to DHHS since June 22, 2010. 

Therefore, affected companies do not 

need time to prepare for or take any 

action with regard to the rescission. See 

Daniel Int’l Corp. v. Occupational Safety 

& Health Review Com., 656 F.2d 925, 

931 (4th Cir. 1981) (‘‘The purpose of the 

30-day notice requirement in § 553(d) is 

to ‘afford persons affected a reasonable 

time to prepare for the effective date of 

a rule or rules or to take any other action 

which the issuance of rules may 

prompt.’ Administrative Procedure Act 

Legislative History, 79th Cong., 2d Sess. 

201 (1946)’’). 

III. Paperwork Reduction Act 

The Commission’s regulations 

implementing the Smokeless Tobacco 

Act impose reporting requirements that 

constitute a ‘‘collection of information’’ 

under the Paperwork Reduction Act, 44 

U.S.C. 3501 et seq. Accordingly, 

removal of these regulations will 

eliminate any burden on the public 

previously imposed by those 

requirements. 

IV. Regulatory Flexibility Act 

Because the Commission has 

determined that it may remove these 

regulations without public comment, 

the Commission is also not required to 

publish any initial or final regulatory 

flexibility analysis under the Regulatory 

Flexibility Act as part of such action. 

See 5 U.S.C. 603(a), 604(b). 

List of Subjects in 16 CFR Part 307 

Advertising, Labeling Smokeless 

Tobacco, Tobacco, Trade Practices. 

■ Accordingly, for the reasons set forth 

above, and under the authority of 15 

U.S.C. 4402 and 5 U.S.C. 553(d)(1), the 

Commission amends Title 16, Code of 

Federal Regulations, by removing and 

reserving part 307. 

PART 307—REMOVED AND 

RESERVED 

By direction of the Commission. 

Donald S. Clark, 

Secretary. 

[FR Doc. 2010–24220 Filed 9–27–10; 8:45 am] 

BILLING CODE 6750–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 522 

[Docket No. FDA–2010–N–0002] 

Implantation and Injectable Dosage 

Form New Animal Drugs; Firocoxib 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Final rule. 

SUMMARY: The Food and Drug 

Administration (FDA) is amending the 

animal drug regulations to reflect 

approval of an original new animal drug 

application (NADA) filed by Merial Ltd. 

The NADA provides for the veterinary 

prescription use of firocoxib injectable 

solution in horses for the control of pain 

and inflammation associated with 

osteoarthritis. 

DATES: This rule is effective September 

28, 2010. 

FOR FURTHER INFORMATION CONTACT: 

Melanie R. Berson, Center for Veterinary 

Medicine (HFV–110), Food and Drug 

Administration, 7500 Standish Pl., 

Rockville, MD 20855, 240–276–8337, 

email: melanie.berson@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: Merial 

Ltd., 3239 Satellite Blvd., Bldg. 500, 

Duluth, GA 30096–4640 filed NADA 

141–313 that provides for veterinary 

prescription use of EQUIOXX (firocoxib) 

Injection in horses for the control of 

pain and inflammation associated with 

osteoarthritis. The NADA is approved as 

of August 20, 2010, and the regulations 

are amended in 21 CFR part 522 by 

WReier-Aviles on DSKGBLS3C1PROD with RULES

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