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.

The Code of Federal Regulations is sold by

the Superintendent of Documents. Prices of

new books are listed in the first FEDERAL

REGISTER issue of each week.

Rules and Regulations Federal Register

48713 

Vol. 76, No. 153 

Tuesday, August 9, 2011 

DEPARTMENT OF AGRICULTURE 

Agricultural Marketing Service 

7 CFR Part 946 

[Doc. No. AMS–FV–11–0024; FV11–946–3 

FIR] 

Irish Potatoes Grown in Washington; 

Modifications of the Rules and 

Regulations 

AGENCY: Agricultural Marketing Service, 

USDA. 

ACTION: Affirmation of interim rule as 

final rule. 

SUMMARY: The Department of 

Agriculture is adopting, as a final rule, 

without change, an interim rule that 

extended the one-year suspension of the 

minimum quality, maturity, pack, 

marking, and inspection requirements 

prescribed for russet potato varieties 

under the Washington potato marketing 

order for the 2011–2012 and subsequent 

fiscal periods. The interim rule also 

extended the reporting requirement for 

russet potato handlers for the purpose of 

obtaining information necessary for 

administering the marketing order. This 

change is expected to reduce overall 

industry expenses and increase net 

returns to producers and handlers while 

allowing the industry the opportunity to 

continue exploring alternative 

marketing strategies. 

DATES: Effective August 10, 2011. 

FOR FURTHER INFORMATION CONTACT: 

Teresa Hutchinson or Gary Olson, 

Northwest Marketing Field Office, 

Marketing Order Administration 

Branch, Fruit and Vegetable Programs, 

AMS, USDA, Telephone: (503) 326– 

2724, Fax: (503) 326–7440, or E-mail: 

Teresa.Hutchinson@ams.usda.gov or 

GaryD.Olson@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/ 

MarketingOrdersSmallBusinessGuide; 

or by contacting Laurel May, 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: 

Laurel.May@ams.usda.gov. 

SUPPLEMENTARY INFORMATION: This rule 

is issued under Marketing Order No. 

946, as amended (7 CFR part 946), 

regulating the handling of Irish potatoes 

grown in Washington, 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. 

The handling of potatoes grown in 

Washington is regulated by 7 CFR part 

946. This rule continues in effect the 

interim rule that extended the one-year 

suspension of the order’s handling 

regulation for russet potato varieties for 

the 2011–2012 and subsequent fiscal 

periods. This change also extended the 

reporting requirement for russet potato 

handlers to obtain information 

necessary for the collection of 

assessments and statistical data. This 

change allows the Washington potato 

industry to continue marketing russet 

potatoes without regard to the minimum 

quality, maturity, pack, marking, and 

inspection requirements prescribed 

under the Washington potato marketing 

order. 

In an interim rule published in the 

Federal Register on May 13, 2011, and 

effective on July 1, 2011, (76 FR 27850, 

Doc. No. AMS–FV–11–0024, FV11–946– 

3 IR), the introductory text of §§ 946.143 

and 946.336 were amended by removing 

text referring to the temporary 

suspension and replacing it with text 

referring to a permanent suspension. 

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 

action 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 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 43 handlers of Washington 

potatoes subject to regulation under the 

order (inclusive of the 33 russet potato 

handlers) and approximately 267 

producers in the regulated 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 having 

annual receipts of less than $750,000. 

During the 2009–2010 fiscal period, 

the Committee reports that 9,765,131 

hundredweight of Washington potatoes 

were shipped into the fresh market. 

Based on average f.o.b. prices estimated 

by the USDA’s Economic Research 

Service and Committee data on 

individual handler shipments, the 

Committee estimates that 42, or 

approximately 98 percent of the 

handlers, had annual receipts of less 

than $7,000,000. 

In addition, based on information 

provided by the National Agricultural 

Statistics Service, the average producer 

price for Washington potatoes for 2010 

was $7.55 per hundredweight. The 

average gross annual producer revenue 

for each of the 267 Washington potato 

producers is therefore calculated to be 

approximately $276,130. In view of the 

foregoing, the majority of Washington 

potato producers and handlers may be 

classified as small entities. 

This rule continues in effect the 

action that extended the one-year 

suspension of the handling regulation 

for russet potato varieties for the 2011– 

2012 and subsequent fiscal periods. 

This rule also continues in effect the 

action that extended the reporting 

requirement for russet potato handlers 

to obtain information necessary to 

administer the order. This change is 

expected to reduce overall industry 

expenses while providing the industry 

with the opportunity to continue 

exploring alternative marketing 

strategies. This rule amends the 


jlentini on DSK4TPTVN1PROD with RULES
48714 Federal Register / Vol. 76, No. 153 / Tuesday, August 9, 2011 / Rules and Regulations 

introductory text in §§ 946.143 and 

946.336. Authority for the change in the 

order’s rules and regulations is provided 

for in §§ 946.70 and 946.52, 

respectively. 

This action is not expected to increase 

costs associated with the order 

requirements. Rather, this action 

represents a cost savings for handlers 

and has the potential to increase 

industry returns. This change extends 

the one-year suspension of minimum 

quality, maturity, pack, marking, and 

inspection requirements indefinitely. 

Though inspections will not be 

mandated for russet potatoes handled 

under the order, handlers may at their 

discretion choose to have their potatoes 

inspected. Handlers are thus able to 

control costs—which are generally 

passed on to producers—based on the 

demands of their customers. The 

opportunities and benefits of this rule 

are equally available to all Washington 

potato handlers and growers, regardless 

of their size. 

In accordance with the Paperwork 

Reduction Act of 1995 (44 U.S.C. 

Chapter 35), the order’s information 

collection requirements have been 

previously approved by the Office of 

Management and Budget (OMB) and 

assigned OMB No. 0581–0178 

(Vegetable and Specialty Crop 

Marketing Orders). No changes in those 

requirements as a result of this action 

are necessary. Should any changes 

become necessary, they would be 

submitted to OMB for approval. 

This change continues the monthly 

reporting requirement for russet potato 

handlers. The reports provide the 

Committee with information necessary 

to track shipments and collect 

assessments. 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. In addition, USDA has 

not identified any relevant Federal rules 

that duplicate, overlap or conflict with 

this rule. 

Further, the Committee’s meeting was 

widely publicized throughout the 

Washington potato industry and all 

interested persons were invited to 

participate in Committee deliberations. 

Like all Committee meetings, the 

January 26, 2011, meeting was a public 

meeting, and all entities, both large and 

small, were able to express views on 

this issue. 

Comments on the interim rule were 

required to be received on or before July 

12, 2011. No comments were received. 

Therefore, for the reasons given in the 

interim rule, we are adopting the 

interim rule as a final rule, without 

change. 

To view the interim rule, go to: 

http: 

//www.regulations.gov/ 

#!documentDetail;D=AMS-FV-11-0024- 

0001. 

This action also affirms information 

contained in the interim 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 rule, without 

change, as published in the Federal 

Register (76 FR 27850, May 13, 2011) 

will tend to effectuate the declared 

policy of the Act. 

List of Subjects in 7 CFR Part 946 

Marketing agreements, Potatoes, 

Reporting and recordkeeping 

requirements. 

Accordingly, the interim rule that 

amended 7 CFR 946.143 and 946.336 

and that was published at 76 FR 27850 

on May 13, 2011, is adopted as a final 

rule, without change. 

Dated: August 3, 2011. 

David R. Shipman, 

Acting Administrator, Agricultural Marketing 

Service. 

[FR Doc. 2011–20124 Filed 8–8–11; 8:45 am] 

BILLING CODE 3410–02–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Parts 520, 522, and 524 

[Docket No. FDA–2011–N–0003] 

New Animal Drugs; Change of 

Sponsor; Moxidectin 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Final rule. 

SUMMARY: The Food and Drug 

Administration (FDA) is amending the 

animal drug regulations to reflect a 

change of sponsor for three approved 

new animal drug applications (NADAs) 

for dosage form products containing 

moxidectin from Fort Dodge Animal 

Health, Division of Wyeth, a wholly 

owned subsidiary of Pfizer, Inc., to 

Boehringer Ingelheim Vetmedica, Inc. 

DATES: This rule is effective August 9, 

2011. 

FOR FURTHER INFORMATION CONTACT: 

Steven D. Vaughn, Center for Veterinary 

Medicine (HFV–100), Food and Drug 

Administration, 7520 Standish Pl., 

Rockville, MD 20855, 240–276–8300, email: steven.vaughn@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: Fort 

Dodge Animal Health, Division of 

Wyeth, a wholly owned subsidiary of 

Pfizer, Inc., 235 East 42d St., New York, 

NY 10017 has informed FDA that it has 

transferred ownership of, and all rights 

and interest in, the following three 

approved NADAs for dosage form 

products containing moxidectin to 

Boehringer Ingelheim Vetmedica, Inc., 

2621 North Belt Highway, St. Joseph, 

MO 64506–2002: NADA 141–099, 

NADA 141–220, and NADA 141–247. 

Accordingly, the Agency is amending 

the regulations in 21 CFR parts 520, 522, 

and 524 to reflect the transfer of 

ownership. 

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 Parts 520, 

522, and 524 

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 parts 520, 522, and 524 are 

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. 

■ 2. In § 520.1454, revise paragraphs (b) 

and (d) to read as follows: 

§ 520.1454 Moxidectin solution. 

* * * * * 

(b) Sponsor. See No. 000010 in 

§ 510.600(c) of this chapter. 

* * * * * 

(d) Special considerations. See 

§ 500.25 of this chapter. 

* * * * * 

PART 522—IMPLANTATION OR 

INJECTABLE DOSAGE FORM NEW 

ANIMAL DRUGS 

■ 3. The authority citation for 21 CFR 

part 522 continues to read as follows: 

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

■ 4. In § 522.1450, redesignate 

paragraph (d) as paragraph (e); add new 

paragraph (d); and revise paragraph (b) 


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