Federal Register / Vol. 75, No. 187 / Tuesday, September 28, 2010 / Rules and Regulations 59609 

1 The regulations were amended in 1991 to 

include provisions for the rotation and display of 

the statutory warnings on utilitarian items. 56 FR 

11654 (Mar. 20, 1991). 

Authority: 49 U.S.C. 106(g); 40103, 40113, 

40120; E.O. 10854, 24 FR 9565, 3 CFR, 1959– 

1963 Comp., p. 389. 

§ 71.1 [Amended] 

■ 2. The incorporation by reference in 

14 CFR 71.1 of Federal Aviation 

Administration Order 7400.9U, 

Airspace Designations and Reporting 

Points, dated August 18, 2010, effective 

September 15, 2010, is amended as 

follows: 

Paragraph 5000 Class D Airspace. 

* * * * * 

AEA MD D Patuxent River, MD 

[AMENDED] 

Patuxent River NAS (Trapnell Field), MD 

(Lat. 38°17′10′′ N., long. 76°24′42′′ W.) 

Chesapeake Ranch Airpark, MD 

(Lat. 38°21′40′′ N., long. 76°24′19′′ W.) 

That airspace extending upward from the 

surface to and including 2,500 feet MSL 

within a 4.5-mile radius of Patuxent River 

NAS (Trapnell Field) and within a .5-mile 

radius of Chesapeake Ranch Airpark 

excluding that airspace within Restricted 

Areas R–4005 and R–4007 when active. This 

Class D airspace area is effective during the 

specific dates and times established in 

advance by a Notice to Airmen. The effective 

date and time will thereafter be continuously 

published in the Airport Facility Directory. 

* * * * * 

Paragraph 6002 Class E Airspace 

Designated as Surface Areas. 

* * * * * 

AEA MD E2 Patuxent River, MD [NEW] 

Patuxent River NAS (Trapnell Field), MD 

(Lat. 38°17′10′′N., long. 76°24′42′′ W.) 

Patuxent VORTAC 

(Lat. 38°17′16′′ N., long. 76°24′01′′ W.) 

Patuxent River NDB 

(Lat. 38°17′09′′ N., long. 76°24′11′′ W.) 

Chesapeake Ranch Airpark, MD 

(Lat. 38°21′40′′ N., long. 76°24′19′′ W.) 

That airspace extending upward from the 

surface within a 4.5-mile radius of Patuxent 

River NAS (Trapnell Field) and within 1.8 

miles each side of the Patuxent VORTAC 

045° radial extending from the 4.5-mile 

radius of Patuxent River NAS to 6.1 miles 

northeast of the VORTAC; and within 1.8 

miles north of and 2.0 miles south of the 

Patuxent VORTAC 235° radial extending 

from the 4.5-mile radius to 6.6 miles 

southwest of the VORTAC; and within 1.8 

miles each side of the Patuxent VORTAC 

140° radial extending from the 4.5-mile 

radius to 10.5 miles southeast of the 

VORTAC; and within a .5-mile radius of 

Chesapeake Ranch Airpark, excluding that 

airspace within Restricted Areas R–4005 and 

R–4007 when active. This Class E airspace 

area is effective during those times when the 

Class D airspace is not in effect. 

* * * * * 

Paragraph 6004 Class E Airspace Areas 

Designated as an Extension to a Class D 

Surface Area. 

* * * * * 

AEA MD E4 Patuxent River, MD 

[AMENDED] 

Patuxent River NAS (Trapnell Field), MD 

(Lat. 38°17′10′′ N., long. 76°24′42′′ W.) 

Patuxent VORTAC 

(Lat. 38°17′16′′ N., long. 76°24′01′′ W.) 

Patuxent River NDB 

(Lat. 38°17′09′′ N., long. 76°24′11′′ W.) 

That airspace extending upward from the 

surface within 1.8 miles each side of the 

Patuxent VORTAC 045° radial extending 

from the 4.5-mile radius of Patuxent River 

NAS (Trapnell Field) to 6.1 miles northeast 

of the VORTAC; and within 1.8 miles north 

of and 2.0 miles south of the Patuxent 

VORTAC 235° radial extending from the 4.5- 

mile radius to 6.6 miles southwest of the 

VORTAC; and within 1.8 miles each side of 

the Patuxent VORTAC 140° radial extending 

from the 4.5-mile radius to 10.5 miles 

southeast of the VORTAC, excluding that 

airspace within Restricted Areas R–4005 and 

R–4007 when active. This Class E airspace 

area is effective during specific dates and 

times established in advance by a Notice to 

Airmen. The effective date and time will 

thereafter be continuously published in the 

Airport Facility Directory. 

Issued in College Park, Georgia, on 

September 17, 2010. 

Myron A. Jenkins, 

Acting Manager, Operations Support Group, 

Eastern Service Center, Air Traffic 

Organization. 

[FR Doc. 2010–24110 Filed 9–27–10; 8:45 am] 

BILLING CODE 4910–13–P 

FEDERAL TRADE COMMISSION 

16 CFR Part 307 

[RIN 3084-AB23] 

Rescission of Regulations Under the 

Comprehensive Smokeless Tobacco 

Health Education Act of 1986 

AGENCY: Federal Trade Commission. 

ACTION: Final rule. 

SUMMARY: The Federal Trade 

Commission (‘‘FTC’’ or ‘‘Commission’’) is 

rescinding its smokeless tobacco 

regulations. Recent legislation 

transferred the FTC’s authority for those 

regulations to the Secretary of the 

Department of Health and Human 

Services (‘‘DHHS’’). DHHS will now 

review and approve rotational warning 

plans for these products. 

EFFECTIVE DATE: September 28, 2010. 

ADDRESSES: Copies of this document are 

available from: Public Reference Branch, 

Room 130, Federal Trade Commission, 

600 Pennsylvania Avenue, N.W., 

Washington, DC 20580. Copies of this 

document are also available on the 

Internet at the Commission’s website: 

(http://www.ftc.gov). 

FOR FURTHER INFORMATION CONTACT: 

Shira Modell, (202) 326-3116, Attorney, 

Division of Advertising Practices, 

Bureau of Consumer Protection, Federal 

Trade Commission, 600 Pennsylvania 

Avenue, N.W., Washington, D.C., 20580. 

SUPPLEMENTARY INFORMATION: 

I. Background 

The Comprehensive Smokeless 

Tobacco Health Education Act of 1986 

(‘‘Smokeless Tobacco Act’’), Pub. L. 99- 

252, 100 Stat. 30 (1986), required 

manufacturers, importers, and packagers 

of smokeless tobacco products to 

display on a rotating basis one of three 

statutory health warnings on product 

packages and in most advertising (other 

than billboards). The Smokeless 

Tobacco Act also directed the FTC to 

issue implementing regulations 

governing the format and display of the 

health warnings, and to review and 

approve (if appropriate) plans 

specifying how smokeless tobacco 

companies planned to comply with the 

rotational warning requirements 

specified in the Smokeless Tobacco Act 

and the implementing regulations. 15 

U.S.C. 4402 (1986) (amended 2009). The 

Commission issued its smokeless 

tobacco regulations, 16 CFR Part 307, on 

November 4, 1986.1 51 FR 40015. 

II. Basis for Removal of Regulations 

On June 22, 2009, President Obama 

signed into law the Family Smoking 

Prevention and Tobacco Control Act, 

Pub. L. No. 111-31, 123 Stat. 1776 

(2009) (‘‘Family Smoking Prevention 

Act’’). The Family Smoking Prevention 

Act, among other things, amended the 

Smokeless Tobacco Act to change the 

language of the existing three statutory 

health warnings and add a fourth 

warning, and to require new size, 

format, and display requirements for the 

statutory health warnings. Family 

Smoking Prevention Act, § 204. The 

Family Smoking Prevention Act also 

gave the Secretary of DHHS authority to 

change the warning statements and the 

size, format, and display requirements 

of those warnings, and transferred 

authority over the review and approval 

of rotational warning plans from the 

Commission to the Secretary. Family 

Smoking Prevention Act, § 205. These 

amendments to the Smokeless Tobacco 

Act became effective on June 22, 2010. 

Earlier this year, the Commission 

terminated its regulatory review of the 

smokeless tobacco regulations, citing 

the enactment of the Family Smoking 

Prevention Act. 75 FR 3665 (Jan. 22, 

WReier-Aviles on DSKGBLS3C1PROD with RULES

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 

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