This section of the FEDERAL REGISTER

contains regulatory documents having general

applicability and legal effect, most of which

are keyed to and codified in the Code of

Federal Regulations, which is published under

50 titles pursuant to 44 U.S.C. 1510.

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new books are listed in the first FEDERAL

REGISTER issue of each week.

Rules and Regulations Federal Register

36603 

Vol. 74, No. 141 

Friday, July 24, 2009 

DEPARTMENT OF AGRICULTURE 

Agricultural Marketing Service 

7 CFR Part 925 

[Doc. No. AMS–FV–08–0107; FV09–925–2 

FIR] 

Grapes Grown in a Designated Area of 

Southeastern California; Decreased 

Assessment Rate 

AGENCY: Agricultural Marketing Service, 

USDA. 

ACTION: Affirmation of interim final rule 

as final rule. 

SUMMARY: The Department of 

Agriculture (USDA) is adopting, as a 

final rule, without change, an interim 

final rule that decreased the assessment 

rate established for the California Desert 

Grape Administrative Committee 

(Committee), for the 2009 and 

subsequent fiscal periods from $0.02 to 

$0.01 per 18-pound lug of grapes 

handled. The Committee locally 

administers the marketing order for 

grapes grown in a designated area of 

southeastern California (order). The 

interim final rule was necessary to align 

the Committee’s expected revenue with 

decreases in its proposed budget for the 

2009 fiscal period, which began on 

January 1. 

DATES: Effective Date: Effective July 27, 

2009. 

FOR FURTHER INFORMATION CONTACT: 

Jennifer Robinson, Marketing Specialist, 

or Kurt J. Kimmel, Regional Manager, 

California Marketing Field Office, 

Marketing Order Administration 

Branch, Fruit and Vegetable Programs, 

AMS, USDA; Telephone: (559) 487– 

5901, Fax: (559) 487–5906, or e-mail: 

Jen.Robinson@ams.usda.gov or 

Kurt.Kimmel@ams.usda.gov. 

Small businesses may obtain 

information on complying with this and 

other marketing order regulations by 

viewing a guide at the following Web 

site: http://www.ams.usda.gov/

AMSv1.0/ams.fetchTemplateData.do?

template=TemplateN&page=Marketing

OrdersSmallBusinessGuide; or by 

contacting Jay Guerber, Marketing Order 

Administration Branch, Fruit and 

Vegetable Programs, AMS, USDA, 1400 

Independence Avenue, SW., STOP 

0237, Washington, DC 20250–0237; 

Telephone: (202) 720–2491, Fax: (202) 

720–8938, or E-mail: 

Jay.Guerber@ams.usda.gov. 

SUPPLEMENTARY INFORMATION: This rule 

is issued under Marketing Order No. 

925, as amended (7 CFR part 925), 

regulating the handling of grapes grown 

in a designated area of southeastern 

California, hereinafter referred to as the 

‘‘order.’’ The order is effective under the 

Agricultural Marketing Agreement Act 

of 1937, as amended (7 U.S.C. 601–674), 

hereinafter referred to as the ‘‘Act.’’ 

The Department of Agriculture 

(USDA) is issuing this rule in 

conformance with Executive Order 

12866. 

Under the order, California desert 

grape handlers are subject to 

assessments, which provide funds to 

administer the order. Assessment rates 

issued under the order are intended to 

be applicable to all assessable desert 

grapes for the entire fiscal period, and 

continue indefinitely until amended, 

suspended, or terminated. The 

Committee’s fiscal period begins on 

January 1, and ends on December 31. 

In an interim final rule published in 

the Federal Register on February 24, 

2009, and effective on February 25, 2009 

(74 FR 8141, Doc. No. AMS–FV–08– 

0107; FV08–932–2 IFR), § 925.215 was 

amended by decreasing the assessment 

rate established for the Committee for 

the 2009 and subsequent fiscal periods 

from $0.02 to $0.01 per 18-pound lug or 

equivalent of desert grapes. The 

decrease in the per-unit assessment rate 

was possible due to significant 

decreases in budgeted management and 

administrative expenses for 2009. 

Final Regulatory Flexibility Analysis 

Pursuant to requirements set forth in 

the Regulatory Flexibility Act (RFA) (5 

U.S.C. 601–612), the Agricultural 

Marketing Service (AMS) has 

considered the economic impact of this 

rule on small entities. Accordingly, 

AMS has prepared this final regulatory 

flexibility analysis. 

The purpose of the RFA is to fit 

regulatory actions to the scale of 

business subject to such actions in order 

that small businesses will not be unduly 

or disproportionately burdened. 

Marketing orders issued pursuant to the 

Act, and the rules issued thereunder, are 

unique in that they are brought about 

through group action of essentially 

small entities acting on their own 

behalf. 

There are approximately 14 handlers 

of southeastern California grapes who 

are subject to regulation under the order 

and about 50 grape producers in the 

production area. Small agricultural 

service firms are defined by the Small 

Business Administration (13 CFR 

121.201) as those having annual receipts 

of less than $7,000,000, and small 

agricultural producers are defined as 

those whose annual receipts are less 

than $750,000. Nine of the 14 handlers 

subject to regulation have annual grape 

sales of less than $7 million. Based on 

data from the National Agricultural 

Statistics Service (NASS) and the 

Committee, the average crop value for 

2008 is about $53,040,000. Dividing this 

figure by the number of producers (50) 

yields an average annual producer 

revenue estimate of about $1,060,800, 

which is above the SBA threshold of 

$750,000. Based on the foregoing, it may 

be concluded that a majority of grape 

handlers and none of the producers may 

be classified as small entities. 

This rule continues in effect the 

action that decreased the assessment 

rate established for the Committee and 

collected from handlers for the 2009 and 

subsequent fiscal periods from $0.02 to 

$0.01 per 18-pound lug of grapes. The 

Committee unanimously recommended 

expenditures of $77,692 and an 

assessment rate of $0.01 per 18-pound 

lug of grapes for the 2009 fiscal period. 

The assessment rate of $0.01 is one-half 

of the rate currently in effect. The 

number of assessable grapes is estimated 

at 6.5 million 18-pound lug of grapes. 

Thus, the $0.01 rate should provide 

$65,000 in assessment income. Income 

derived from handler assessments, along 

with interest income and funds from the 

Committee’s authorized reserve will be 

adequate to cover budgeted expenses. 

The major expenditures 

recommended by the Committee for the 

2009 fiscal period include $10,500 for 

compliance activities, $53,000 for 

salaries and payroll expenses, and 


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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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