Federal Register / Vol. 74, No. 122 / Friday, June 26, 2009 / Rules and Regulations 30463 

collection of information requirements 

subject to review and approval by the 

Office of Management and Budget 

(‘‘OMB’’) under the Paperwork 

Reduction Act of 1995. Collection 

activities are currently approved by the 

OMB under control number 0625–0037. 

Notwithstanding any other provision 

of the law, no person is required to 

respond to, nor shall any person be 

subject to a penalty for failure to comply 

with a collection of information unless 

it displays a currently valid OMB 

control number. 

Executive Order 12866. It has been 

determined that this rulemaking is not 

significant for purposes of Executive 

Order 12866. 

Signing Authority. With respect to the 

responsibility of the Department of the 

Treasury in issuing these joint 

regulations of the Commerce and 

Treasury Departments, it is noted that 

the Secretary of the Treasury retains the 

sole authority to approve regulation 

relating to certain customs revenue 

functions pursuant to 19 CFR 0.1(a)(1). 

Accordingly, this document is being 

signed by the Secretary of the Treasury 

(or his/her delegate), and by the 

Commissioner of CBP, who is signing 

this document as the delegate of the 

Secretary of the Department of 

Homeland Security. 

List of Subjects in 15 CFR Part 301 

Administrative practice and 

procedure, Customs duties and 

inspection, Educational facilities, 

Imports, Nonprofit organizations, 

Scientific equipment. 

Amendments to the Regulations 

■ For the reasons set forth in the 

preamble, part 301 of title 15 of the CFR 

(15 CFR Part 301) is amended as 

follows: 

PART 301—[AMENDED] 

■ 1. The authority citation for part 301 

is amended to read as follows: 

Authority: Sec. 6(c), Pub. L. 89–651, 80 

Stat. 897, 899; Sec. 2402, Pub. L. 106–36, 113 

Stat. 127, 168; 19 U.S.C. 1514(c)(3)); and 

Presidential Proclamation 7011, signed on 

June 30, 1997. 

§ 301.1 [Amended] 

■ 2. Section 301.1 is amended by 

removing ‘‘Secretary of the Treasury 

(U.S. Customs Service)’’ in paragraph 

(c)(2) and adding ‘‘Customs and Border 

Protection’’ in its place. 

§ 301.2 [Amended] 

■ 3. Section 301.2 is amended as 

follows: 

■ a. Paragraph (b) is amended by 

removing ‘‘Customs means the U.S. 

Customs Service and ‘The 

Commissioner’ means Commissioner of 

the U.S. Customs Service’’ and adding 

‘‘The Commissioner means 

Commissioner of Customs and Border 

Protection’’ in its place; 

■ b. Paragraph (c) is amended by 

removing ‘‘Customs Port’’ and adding 

‘‘CBP Port’’ in its place; 

■ c. The third sentence of paragraph (j) 

is amended by removing ‘‘automatic 

sampling equipment sold for use with a 

variety of mass spectrometers’’ and 

adding ‘‘a vacuum evaporator sold for 

use with an electron microscope’’ in its 

place; 

■ d. Paragraph (o) is amended by 

removing ‘‘mass spectrometer’’ and ‘‘xray spectrometer’’. 

§ 301.3 [Amended] 

■ 4. Section 301.3 is amended as 

follows: 

■ a. The first sentence of paragraph (b) 

is amended by removing ‘‘20230, or’’ 

and adding ‘‘20230, the Web site at 

http://ia.ita.doc.gov/sips/index.html, 

or’’ in its place; 

■ b. Paragraph (c) is amended by 

removing the words ‘‘U.S. Customs 

Service, Department of the Treasury,’’ 

and adding ‘‘U.S. Customs and Border 

Protection’’ in its place. 

■ 5. Section 301.8 is amended as 

follows: 

■ a. Paragraph (a)(4) is revised; 

■ b. The second sentence of paragraph 

(c) is amended by removing ‘‘, within 90 

days after notice of liquidation’’. 

The revision reads as follows: 

§ 301.8 Instructions for entering 

instruments through U.S. Customs and 

Border Protection under subheading 

9810.00.60, HTSUS. 

* * * * * 

(a) * * * 

(4) If a claim for duty-free entry under 

subheading 9810.00.60, HTSUS is made 

but is not accompanied by a copy of the 

properly stamped form, a deposit of the 

estimated duty is required. Before the 

entry is liquidated, the applicant must 

file with the CBP Port a properly 

stamped copy of the application form. 

In the event that the CBP Port does not 

receive a copy of the properly stamped 

application form before liquidation, the 

instrument shall be classified and 

liquidated in the ordinary course, 

without regard for subheading 

9810.00.60, HTSUS. 

* * * * * 

§§ 301.1, 301.2, 301.4, 301.5, 301.8, 301.9, 

301.10 [Amended] 

■ 6. In addition to the amendments set 

forth above, 15 CFR Part 301 is amended 

by removing ‘‘U.S. Customs Service’’, 

‘‘U.S. Customs’’, or ‘‘Customs’’ and 

adding ‘‘Customs and Border 

Protection’’ in its place in the following 

places: 

■ a. Second sentence in § 301.1(d); 

■ b. Fourth sentence in § 301.2(k); 

■ c. Section 301.4 heading, and first 

sentence of § 301.4(a) introductory text; 

■ d. Second sentence in § 301.5(d)(1)(ii); 

■ e. Section 301.8 heading, § 301.8(a)(3), 

(b) heading and first and second 

sentences, and (d) first and second 

sentences; 

■ f. Section § 301.9(b) and § 301.9(c); 

and 

■ g. Second sentence in § 301.10(a). 

§§ 301.7, 301.8, 301.9 [Amended] 

■ 7. In addition to the amendments set 

forth above, 15 CFR Part 301 is amended 

by removing ‘‘Customs Port’’ and adding 

‘‘CBP Port’’ in its place in the following 

places: 

■ a. First sentence in § 301.7(b); and 

■ b. Third sentence of § 301.9(a) 

introductory text. 

Ronald K. Lorentzen, 

Acting Assistant Secretary for Import 

Administration, Department of Commerce. 

Jayson P. Ahern, 

Acting Commissioner, U.S. Customs and 

Border Protection, Department of Homeland 

Security. 

Timothy Skud, 

Deputy Assistant Secretary, Department of 

the Treasury. 

[FR Doc. E9–14884 Filed 6–25–09; 8:45 am] 

BILLING CODE 3510–DS–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 520 

[Docket No. FDA–2009–N–0665] 

Oral Dosage Form New Animal Drugs; 

Trilostane 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Final rule. 

SUMMARY: The Food and Drug 

Administration (FDA) is amending the 

animal drug regulations to reflect the 

supplemental approval of a new animal 

drug application (NADA) filed by 

Dechra, Ltd. The supplemental NADA 

provides for the addition of a 10- 

milligram capsule size of trilostane, 

used in dogs for treatment of 

hyperadrenocorticism. 

DATES: This rule is effective June 26, 

2009. 

30464 Federal Register / Vol. 74, No. 122 / Friday, June 26, 2009 / Rules and Regulations 

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, 

e-mail: melanie.berson@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: Dechra, 

Ltd., Dechra House, Jamage Industrial 

Estate, Talke Pits, Stoke-on-Trent, 

Staffordshire, ST7 1XW, United 

Kingdom, filed a supplement to NADA 

141–291 that provides for use of 

VETORYL (trilostane) Capsules in dogs 

for treatment of pituitary-dependent 

hyperadrenocorticism and for treatment 

of hyperadrenocorticism due to 

adrenocortical tumors. The supplement 

provides for the use of a 10-milligram 

capsule size. The supplemental NADA 

is approved as of June 5, 2009, and the 

regulations are amended in 21 CFR 

520.2598 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. 

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 520 

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 520 is amended as follows: 

PART 520—ORAL DOSAGE FORM 

NEW ANIMAL DRUGS 

■ 1. The authority citation for 21 CFR 

part 520 continues to read as follows: 

Authority: 21 U.S.C. 360b. 

§ 520.2598 [Amended] 

■ 2. In paragraph (a) of § 520.2598 

remove ‘‘30 or 60 milligrams’’ and in its 

place add ‘‘10, 30, or 60 milligrams’’. 

Dated: June 19, 2009. 

Steven D. Vaughn, 

Director, Office of New Animal Drug 

Evaluation, Center for Veterinary Medicine. 

[FR Doc. E9–15152 Filed 6–25–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HOMELAND 

SECURITY 

Coast Guard 

33 CFR Part 165 

[Docket No. USCG–2009–0405] 

RIN 1625–AA00 

Safety Zone; Harborfest 2009, Parade 

of Sail, Elizabeth River, Norfolk, VA 

AGENCY: Coast Guard, DHS. 

ACTION: Temporary final rule. 

SUMMARY: The Coast Guard is 

establishing a mobile safety zone on the 

Elizabeth River in the vicinity of 

Sewell’s Point, Virginia, to Town Point 

Park, Norfolk, Virginia, in support of the 

Parade of Sail event taking place in 

conjunction with Harborfest 2009. This 

action is intended to restrict vessel 

traffic on the Elizabeth River to protect 

mariners from the hazards associated 

with marine parade events. 

DATES: This rule is effective from 10 

a.m. July 3, 2009 through 3 p.m. on July 

5, 2009. 

ADDRESSES: Documents indicated in this 

preamble as being available in the 

docket are part of docket USCG–2009– 

0405 and are available online by going 

to http://www.regulations.gov, selecting 

the Advanced Docket Search option on 

the right side of the screen, inserting 

USCG–2009–0405 in the Docket ID box, 

pressing Enter, and then clicking on the 

item in the Docket ID column. They are 

also available for inspection or copying 

at the following location: the Docket 

Management Facility (M–30), U.S. 

Department of Transportation, West 

Building Ground Floor, Room W12–140, 

1200 New Jersey Avenue, SE., 

Washington, DC 20590, between 9 a.m. 

and 5 p.m., Monday through Friday, 

except Federal holidays. 

FOR FURTHER INFORMATION CONTACT: If 

you have questions on this temporary 

rule, call or e-mail LT Tiffany Duffy, 

Chief, Waterways Management Division, 

Coast Guard; telephone 757–668–5580, 

e-mail Tiffany.A.Duffy@uscg.mil. If you 

have questions on viewing the docket, 

call Renee V. Wright, Program Manager, 

Docket Operations, telephone 202–366– 

9826. 

SUPPLEMENTARY INFORMATION: 

Regulatory Information 

The Coast Guard is issuing this 

temporary final rule without prior 

notice and opportunity to comment 

pursuant to authority under section 4(a) 

of the Administrative Procedure Act 

(APA) (5 U.S.C. 553(b)). This provision 

authorizes an agency to issue a rule 

without prior notice and opportunity to 

comment when the agency for good 

cause finds that those procedures are 

‘‘impracticable, unnecessary, or contrary 

to the public interest.’’ Under 5 U.S.C. 

553(b)(B), the Coast Guard finds that 

good cause exists for not publishing a 

notice of proposed rulemaking (NPRM) 

with respect to this rule because any 

delay encountered in this regulation’s 

effective date by publishing a NPRM 

would be contrary to public interest 

since immediate action is needed to 

provide for the safety of life and 

property on navigable waters. 

Additionally, this temporary safety zone 

will be enforced for approximately 4 

hours on Friday, July 3, 2009 and for 

approximately 4 hours on Sunday, July 

5, 2009 while the Parade of Sail arrives 

at and departs Town Point Park. This 

safety zone should have a minimal 

impact on vessel transits because 

mariners are not precluded from using 

any portion of the waterway except the 

safety zone area. 

Under 5 U.S.C. 553(d)(3), the Coast 

Guard finds that good cause exists for 

making this rule effective less than 30 

days after publication in the Federal 

Register as any delay encountered in 

this regulation’s effective date by 

publishing a NPRM would be contrary 

to public interest since immediate 

action is needed to provide for the 

safety of life and property on navigable 

waters. 

Background and Purpose 

During the period of July 3 through 

July 5, 2009, the City of Norfolk and 

Norfolk Festevents Ltd. will sponsor 

Harborfest 2009, which includes the 

Parade of Sail event. This event will 

include a parade of more than twenty 

ships from around the world departing 

from Sewell’s Point, Virginia enroute to 

Town Point Park, Norfolk, Virginia on 

July 3, 2009. Due to the need for vessel 

control during the event, vessel traffic 

will be temporarily restricted to provide 

for the safety of spectators and transiting 

vessels. The Coast Guard anticipates 

numerous spectator craft for these 

scheduled events. Operators should 

expect significant vessel congestion 

along the parade route and viewing 

areas. The purpose of this regulation is 

to promote maritime safety and protect 

participants and the boating public in