36604 Federal Register / Vol. 74, No. 141 / Friday, July 24, 2009 / Rules and Regulations 

$14,192 for other administrative 

expenses. In comparison, budgeted 

expenses for these items in 2008 were 

$5,000 for compliance activities, 

$61,000 for salaries, $18,000 for 

research, and $49,254 for other 

administrative expenses. 

Decreases in management and 

administrative expenses are the result of 

management services, office rental fees 

and utilities being shared by the 

Committee and the California Date 

Administrative Committee (CDAC). In 

2008, the Committee and the CDAC 

agreed to share management and 

administrative costs in order to 

streamline expenses for both programs. 

Additionally, the Committee 

recommended not renewing its budget 

for research in 2009 given that there 

were no pending research proposals at 

the time the budget was reviewed. 

Prior to arriving at this budget, the 

Committee considered alternative 

expenditure and assessment rate levels, 

but ultimately decided that the 

recommended levels were reasonable to 

properly administer the order. The 

assessment rate recommended by the 

Committee was derived by the following 

formula: Anticipated 2009 expenses 

($77,692) plus the desired 2009 ending 

reserve ($88,534), minus the 2009 

beginning reserve ($100,226) plus 

anticipated interest income ($1,000), 

divided by the estimated 2009 

shipments (6.5 million 18-pound lugs). 

This rate should provide sufficient 

funds in combination with interest and 

reserve funds to meet the anticipated 

expenses of $77,692 and result in a 

December 2009 ending reserve of 

$88,534. This figure is about $10,800 

over the Committee’s 2009 expenses. 

Section 925.41 of the order permits the 

Committee to maintain approximately 

one fiscal period’s expenses in reserve. 

The Committee plans to continue using 

reserve funds to help meet its expenses 

and bring the reserve to a level lower 

than its expenses. 

To calculate the percentage of grower 

revenue represented by the assessment 

rate for 2008, the assessment rate of 

$0.02 per 18-pound lug is divided by 

the estimated average grower price 

(according to the NASS). This results in 

estimated assessment revenue for the 

2008 season as a percentage of grower 

revenue of .245 percent ($0.02 divided 

by $8.16 per 18-pound lug). NASS data 

for 2009 is not yet available. However, 

applying the same calculations above 

using the average grower price for 2006– 

08 would result in estimated assessment 

revenue as a percentage of total grower 

revenue of .13 percent for the 2009 

season ($0.01 divided by $7.77 per 18- 

pound lug). Thus, the assessment 

revenue should be well below 1 percent 

of estimated grower revenue in 2009. 

This rule continues in effect the 

action that decreased the assessment 

obligation imposed on handlers. 

Assessments are applied uniformly on 

all handlers, and some of the costs may 

be passed on to producers. However, 

decreasing the assessment rate reduces 

the burden on handlers, and may reduce 

the burden on producers. In addition, 

the Committee’s meeting was widely 

publicized throughout the grape 

production area and all interested 

persons were invited to attend the 

meeting and participate in Committee 

deliberations on all issues. Like all 

Committee meetings, the November 14, 

2008, meeting was a public meeting and 

all entities, both large and small, were 

able to express views on this issue. 

This action imposes no additional 

reporting or recordkeeping requirements 

on either small or large California grape 

handlers. As with all Federal marketing 

order programs, reports and forms are 

periodically reviewed to reduce 

information requirements and 

duplication by industry and public 

sector agencies. 

USDA has not identified any relevant 

Federal rules that duplicate, overlap, or 

conflict with this rule. 

Comments on the interim final rule 

were required to be received on or 

before April 27, 2009. No comments 

were received. Therefore, for the reasons 

given in the interim final rule, we are 

adopting the interim final rule as a final 

rule, without change. 

To view the interim final rule, go to 

http://www.regulations.gov/fdmspublic/ 

component/ 

main?main=DocketDetail&d=AMS-FV08-0107. 

This action also affirms information 

contained in the interim final rule 

concerning Executive Orders 12866 and 

12988, the Paperwork Reduction Act (44 

U.S.C. Chapter 35), and the E-Gov Act 

(44 U.S.C. 101). 

After consideration of all relevant 

material presented, it is found that 

finalizing the interim final rule, without 

change, as published in the Federal 

Register (74 FR 8141, February 24, 

2009) will tend to effectuate the 

declared policy of the Act. 

List of Subjects in 7 CFR Part 925 

Grapes, Marketing agreements, 

Reporting and recordkeeping 

requirements. 

PART 925—GRAPES GROWN IN A 

DESIGNATED AREA OF 

SOUTHEASTERN CALIFORNIA— 

[AMENDED] 

■ Accordingly, the interim final rule 

amending 7 CFR part 925, which was 

published at 74 FR 8141 on February 24, 

2009, is adopted as a final rule, without 

change. 

Dated: July 20, 2009. 

Rayne Pegg, 

Administrator, Agricultural Marketing 

Service. 

[FR Doc. E9–17602 Filed 7–23–09; 8:45 am] 

BILLING CODE 3410–02–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 314 

[Docket No. FDA–2009–N–0316] 

New Drug Applications and 

Abbreviated New Drug Applications; 

Technical Amendment 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Final rule; technical 

amendment. 

SUMMARY: The Food and Drug 

Administration (FDA) is amending its 

new drug application (NDA) and 

abbreviated new drug application 

(ANDA) regulations to correct the 

address for the Orange Book Staff in the 

Office of Generic Drugs. This action is 

being taken to ensure accuracy and 

clarity in the agency’s regulations. 

DATES: This rule is effective July 24, 

2009. 

FOR FURTHER INFORMATION CONTACT: 

Olivia A. Pritzlaff, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, Bldg. 51, rm. 

6308, 10903 New Hampshire Ave., 

Silver Spring, MD 20993–0002, 301– 

796–3506. 

SUPPLEMENTARY INFORMATION: FDA is 

amending its regulations in part 314 (21 

CFR part 314) to correct the address for 

Orange Book Staff in the Office of 

Generic Drugs in §§ 314.52(a)(2), 

314.53(f), and 314.95(a)(2). 

List of Subjects in 21 CFR Part 314 

Administrative practice and 

procedure, Confidential business 

information, Drugs, Reporting and 

recordkeeping requirements. 

■ Therefore, under the Federal Food, 

Drug, and Cosmetic Act and under 


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Federal Register / Vol. 74, No. 141 / Friday, July 24, 2009 / Rules and Regulations 36605 

authority delegated to the Commissioner 

of Food and Drugs, 21 CFR part 314 is 

amended as follows: 

PART 314—APPLICATIONS FOR FDA 

APPROVAL TO MARKET A NEW DRUG 

■ 1. The authority citation for 21 CFR 

part 314 continues to read as follows: 

Authority: 21 U.S.C. 321, 331, 351, 352, 

353, 355, 356, 356a, 356b, 356c, 371, 374, 

379e. 

§ 314.52 [Amended] 

■ 2. Section 314.52 is amended in 

paragraph (a)(2) by removing ‘‘at the 

address identified on FDA’s Web site 

(http://www.fda.gov/cder/ogd)’’ and by 

adding in its place ‘‘7500 Standish Pl., 

Rockville, MD 20855’’. 

§ 314.53 [Amended] 

■ 3. Section 314.53 is amended in 

paragraph (f) by removing ‘‘at the 

address identified on FDA’s Web site 

(http://www.fda.gov/cder/ogd)’’ and by 

adding in its place ‘‘7500 Standish Pl., 

Rockville, MD 20855’’. 

§ 314.95 [Amended] 

■ 4. Section 314.95 is amended in 

paragraph (a)(2) by removing ‘‘at the 

address identified on FDA’s Web site 

(http://www.fda.gov/cder/ogd)’’ and by 

adding in its place ‘‘7500 Standish Pl., 

Rockville, MD 20855’’. 

Dated: July 17, 2009. 

Jeffrey Shuren, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. E9–17680 Filed 7–23–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HOMELAND 

SECURITY 

Coast Guard 

33 CFR Part 100 

[Docket No. USCG–2009–0659] 

RIN 1625–AA08 

Special Local Regulations for Marine 

Events; Port Huron to Mackinac Island 

Sail Race 

AGENCY: Coast Guard, DHS. 

ACTION: Temporary final rule. 

SUMMARY: The Coast Guard will enforce 

a special local regulation for the annual 

Port Huron to Mackinac Island Sail 

Race. This action is necessary to safely 

control vessel movements in the vicinity 

of the race starting point and provide for 

the safety of the general boating public 

and commercial shipping. During this 

period, no person or vessel may enter 

the regulated area without the 

permission of the Coast Guard Patrol 

Commander (‘‘PATCOM’’). 

DATES: This rule is effective from 9 a.m. 

through 4 p.m. on July 25, 2009. 

ADDRESSES: Documents indicated in this 

preamble as being available in the 

docket are part of docket USCG–2009– 

0659 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–2009–0659 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 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 concerning this 

temporary rule, call or e-mail Mr. Frank 

Jennings, Jr., Enforcement Branch, Ninth 

Coast Guard District, 1240 East 9th 

Street, Cleveland, OH, via e-mail at: 

frank.t.jennings@uscg.mil or by phone 

at: (216) 902–6094. 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 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 the 

special local regulation pertaining to 

this annual race was previously 

published in the Code of Federal 

Regulations, but inadvertently removed 

during the most recent revision to 33 

CFR 100.901. Because this is an annual 

race, held in the same location, local 

maritime interests are already familiar 

with the provisions of these regulations. 

Based on the late discovery of the 

missing permanent rule, the hazards 

associated with marine regattas within 

Port Huron and the short amount of 

time until the event, delaying 

publication of this regulation would be 

contrary to the public interest. 

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. The special local regulation 

pertaining to this annual race was 

previously published in the Code of 

Federal Regulations, but inadvertently 

removed during the most recent revision 

to 33 CFR 100.901. Because this is an 

annual race, held in the same location, 

local maritime interests are already 

familiar with the provisions of these 

regulations. Delaying this rule would be 

contrary to the public interest of 

ensuring the safety of spectators and 

vessels during this operation and 

immediate action is necessary to 

prevent possible loss of life or property. 

Background and Purpose 

Special local regulations are necessary 

to safely control vessel movements in 

the vicinity of the race starting point 

and provide for the safety of the general 

boating public and commercial 

shipping. The Captain of the Port 

Detroit has determined that the start of 

the Port Huron to Mackinac Island Sail 

Race does pose significant risks to 

public safety and property. The likely 

combination of congested waterways, 

vessels engaged in a regatta, and fast 

currents could easily result in serious 

injuries or fatalities. 

Discussion of Rule 

The Coast Guard will enforce special 

local regulations for the annual Port 

Huron to Mackinac Sail Race from 9 

a.m. until 4 p.m. on July 25, 2009. The 

special local regulations apply to the 

waters of the Black River, St. Clair River 

and lower Lake Huron from: 

Latitude Longitude 

42°58.8′ N ............ 082°26′ W, to 

42°58.4′ N ............ 082°24.8′ W, thence 

northward along the 

International Boundary 

to 

43°02.8′ N ............ 082°23.8′ W, to 

43°02.8′ N ............ 082°26.8′ W, thence 

southward along the 

U.S. shoreline to 

42°58.9′ N ............ 082°26′ W, thence to 

42°58.8′ N ............ 082°26′ W. 

[DATUM: NAD 1983]. 

In order to ensure the safety of 

spectators and participating vessels, the 

special local regulations will be in effect 

for the day of the start of the event. The 

Coast Guard will patrol the race area 

under the direction of a designated 

Coast Guard Patrol Commander 


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