Federal Register / Vol. 74, No. 39 / Monday, March 2, 2009 / Rules and Regulations 9047 

FR 73995, December 5, 2008), with a 

change, will tend to effectuate the 

declared policy of the Act. 

List of Subjects in 7 CFR Part 984 

Walnuts, Marketing agreements, Nuts, 

Reporting and recordkeeping 

requirements. 

■ Accordingly, the interim final rule 

amending 7 CFR part 984, which was 

published at 73 FR 73995 on December 

5, 2008, is adopted as a final rule with 

the following change: 

PART 984—WALNUTS GROWN IN 

CALIFORNIA 

■ 1. The authority citation for 7 CFR 

part 984 continues to read as follows: 

Authority: 7 U.S.C. 601–674. 

■ 2. In § 984.437 paragraphs (a) and (b) 

are revised to read as follows: 

§ 984.347 Methods for proposing names of 

additional candidates to be included on 

walnut growers’ nomination ballots. 

(a) With regard to Board grower 

member positions specified in 

§ 984.35(a)(5) and (b)(6), any ten or more 

such growers who marketed an 

aggregate of 500 or more tons of walnuts 

through handlers who did not handle 

35% or more of the crop during the 

marketing year preceding the year in 

which Board nominations are held, may 

petition the Board to include on the 

nomination ballot the name of an 

eligible candidate for this position, and 

the name of an eligible candidate to 

serve as his or her alternate. The names 

of the eligible candidates proposed 

pursuant to this paragraph shall be 

included on the ballot together with the 

names of any incumbents who are 

willing to continue serving on the 

Board. 

(b) Any ten or more growers eligible 

to serve in the grower member positions 

specified in § 984.35(a)(3) and (4) or 

§ 984.35(b)(4) and (5) and who marketed 

an aggregate of 500 or more tons of 

walnuts through handlers who did not 

handle 35% or more of the crop during 

the marketing year preceding the year in 

which Board nominations are held, may 

petition the Board to include on the 

nomination ballot for a district the name 

of an eligible candidate for the 

applicable position, and the name of an 

eligible candidate to serve as his or her 

alternate. The names of the eligible 

candidates proposed pursuant to this 

paragraph shall be included on the 

ballot together with the names of any 

incumbents who are willing to continue 

serving on the Board. 

* * * * * 

Dated: February 24, 2009. 

Robert C. Keeney, 

Acting Associate Administrator. 

[FR Doc. E9–4291 Filed 2–27–09; 8:45 am] 

BILLING CODE 3410–02–P 

DEPARTMENT OF AGRICULTURE 

Agricultural Marketing Service 

7 CFR Part 1220 

[Doc. No. AMS–LS–08–0074] 

Soybean Promotion, Research, and 

Information Program: Amend 

Procedures To Request a Referendum 

AGENCY: Agricultural Marketing Service, 

USDA. 

ACTION: Final rule. 

SUMMARY: This final rule amends the 

procedures to request a referendum 

under the Soybean Promotion, Research, 

and Consumer Information program, 

commonly known as the soybean 

checkoff program, by updating the 

number of soybean producers in the 

United States. The number of soybean 

producers, based on information 

provided by the Department of 

Agriculture (USDA), Farm Service 

Agency (FSA), is 589,182. 

Additionally, this rule amends the 

regulations pursuant to administrative 

changes to Web site addresses and office 

locations made for the USDA’s 

Agricultural Marketing Service (AMS). 

DATES: Effective Date: March 3, 2009. 

FOR FURTHER INFORMATION CONTACT: 

Kenneth R. Payne, Chief, Marketing 

Programs Branch, Livestock and Seed 

Program, AMS, USDA, Room 2628–S, 

STOP 0251, 1400 Independence 

Avenue, SW., Washington, DC 20250– 

0251; Telephone 202/720–1115; Fax 

202/720–1125; or e-mail to 

Kenneth.Payne@usda.gov. 

SUPPLEMENTARY INFORMATION: 

Executive Order 12866 

The Office of Management and Budget 

(OMB) has waived the review process 

required by Executive Order 12866 for 

this action. 

Executive Order 12988 

This final rule has been reviewed 

under Executive Order 12988, Civil 

Justice Reform. This final rule is not 

intended to have a retroactive effect. 

The final rule would not preempt any 

other Federal or State laws, regulations, 

or policies. 

The Soybean Promotion, Research, 

and Consumer Information Act (Act) 

provides that administrative 

proceedings must be exhausted before 

parties may file suit in court. Under 

section 1971 of the Act, a person subject 

to the Soybean Promotion and Research 

Order (Order) may file a petition with 

USDA stating that the Order, any 

provision of the Order, or any obligation 

imposed in connection with the Order, 

is not in accordance with the law and 

requesting a modification of the Order 

or an exemption from the Order. The 

petitioner is afforded the opportunity 

for a hearing on the petition. After a 

hearing, USDA would rule on the 

petition. The Act provides that district 

courts of the United States in any 

district in which such person is an 

inhabitant, or has their principal place 

of business, has jurisdiction to review 

USDA’s ruling on the petition, if a 

complaint for this purpose is filed 

within 20 days after the date of the entry 

of the ruling. 

Further, section 1974 of the Act 

provides, with certain exceptions, that 

nothing in the Act may be construed to 

preempt or supersede any other program 

relating to soybean promotion, research, 

consumer information, or industry 

information organized under the laws of 

the United States or any State. One 

exception in the Act concerns 

assessments collected by Qualified State 

Soybean Boards (QSSBs). The exception 

provides that to ensure adequate 

funding of the operations of QSSBs 

under the Act, no State law or 

regulation may limit or have the effect 

of limiting the full amount of 

assessments that a QSSB in that State 

may collect, and which is authorized to 

be credited under the Act. Another 

exception concerns certain referenda 

conducted during specified periods by a 

State relating to the continuation of a 

QSSB or State soybean assessment. 

Regulatory Flexibility Act 

AMS has determined that this final 

rule will not have a significant impact 

on a substantial number of small 

entities, as defined by the Regulatory 

Flexibility Act (RFA) (5 U.S.C. 601– 

612). The purpose of the RFA is to fit 

regulatory actions to the scale of 

businesses subject to such actions so 

that small businesses will not be 

disproportionately burdened. 

For the purpose of the Request for 

Referendum, the Secretary will use the 

most recent number of soybean 

producers identified by USDA’s FSA. 

The latest number of soybean producers 

identified by FSA is 589,182 and was 

obtained using information from 2006 

and 2007 acreage reports. The data were 

sorted in such a manner as to include 

all producers that were engaged in the 

production of soybeans in at least one 


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9048 Federal Register / Vol. 74, No. 39 / Monday, March 2, 2009 / Rules and Regulations 

of the 2 years and exclude counting a 

producer more than once if that 

producer engaged in production during 

both years. Therefore, the number of 

soybean producers, as presented in the 

proposed rule, who would be eligible to 

participate in the Request for 

Referendum will be changed from 

663,880 to 589,182. The majority of 

producers subject to the Order are small 

businesses under the criteria established 

by the Small Business Administration 

(SBA) [13 CFR 121.201]. SBA defines 

small agricultural producers as those 

having annual receipts of less than 

$750,000. 

Further, the information collection 

requirements are minimal. Requesting 

form LS–51–1 to participate in a 

Request for Referendum may be done by 

mail, in-person, by facsimile, or via the 

Internet and would not impose a 

significant economic burden on 

participants. Finally, this final rule will 

amend, as described in the proposed 

rule, the regulations pursuant to 

administrative changes to Web site 

addresses and office locations for the 

AMS. 

Paperwork Reduction Act 

In accordance with the Paperwork 

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

Chapter 35), the reporting and 

recordkeeping requirements included in 

7 CFR part 1220 were previously 

approved by OMB and were assigned 

control number 0581–0093. 

Background 

The Act (7 U.S.C. 6301–6311) 

provides for the establishment of a 

coordinated program of promotion and 

research designed to strengthen the 

soybean industry’s position in the 

marketplace, and to maintain and 

expand domestic and foreign markets 

and uses for soybeans and soybean 

products. The program is financed by an 

assessment of 0.5 of 1 percent of the net 

market price of soybeans sold by 

producers. The final rule establishing a 

Soybean Promotion, Research, and 

Consumer Information program was 

published in the July 9, 1991 issue of 

the Federal Register (56 FR 31043) and 

assessments began on September 1, 

1991. 

The Act required that an initial 

referendum be conducted no earlier 

than 18 months and not later than 36 

months after the issuance of the Order 

to determine whether the Order should 

be continued. The initial referendum 

was conducted on February 9, 1994. On 

April 1, 1994, the Secretary announced 

that of the 85,606 valid ballots cast, 

46,060 (53.8 percent) were in favor of 

continuing the Order and the remaining 

39,546 votes (46.2 percent) were against 

continuing the Order. The Act required 

approval by a simple majority for the 

Order to continue. 

The Act also required that within 18 

months after the Secretary announced 

the results of the initial referendum, the 

Secretary would conduct a poll among 

producers to determine if producers 

favored a referendum on the 

continuance of the payment of refunds 

under the Order. On December 5, 2008, 

USDA published a proposed rule in the 

Federal Register (73 FR 74080) to 

amend the procedures for soybean 

producers to request a referendum on 

the Order. 

A July 25, 1995, nationwide poll of 

soybean producers did not generate 

sufficient support for a refund 

referendum to be held. A refund 

referendum would have been held if at 

least 20 percent (not in excess of onefifth of which may be producers in any 

one State) of the 381,000 producers 

(76,200) nationwide requested it. Only 

48,782 soybean producers participated 

in the poll. Consequently, refunds were 

discontinued on October 1, 1995. 

The Act also specifies that the 

Secretary shall, 5 years after the conduct 

of the initial referendum and every 5 

years thereafter, provide soybean 

producers an opportunity to request a 

referendum on the Order. Additionally, 

the Act specifies that these subsequent 

polls require that at least 10 percent (not 

in excess of one-fifth in any one State) 

of all producers must request a 

referendum in order to trigger the 

conduct of a referendum. If a 

referendum is requested, it will be held 

within 1 year of that determination. 

On October 1, 1999, through 

November 16, 1999, a nationwide 

Request for Referendum was conducted 

to determine if there was sufficient 

interest among soybean producers to 

vote on whether to continue the soybean 

checkoff program. Ten percent of the 

600,813 soybean producers nationwide 

(not in excess of one-fifth of which may 

be producers in any one State) needed 

to participate in the Request for 

Referendum to trigger a referendum. 

Only 17,970 eligible soybean producers 

completed valid requests. 

Five years later, another Request for 

Referendum was conducted May 1, 

2004, through May 28, 2004. As in the 

prior Request for Referendum, the 

purpose was to determine if there was 

sufficient interest among soybean 

producers to vote on whether to 

continue the soybean checkoff Program. 

To be eligible to participate in the 

Request for Referendum, producers or 

the producer entity that they are 

authorized to represent had to certify 

and provide supporting documentation 

showing that they or the producer entity 

they represent paid an assessment 

sometime during the representative 

period between January 1, 2002 and 

December 31, 2003. Of the total 663,880 

soybean producers eligible to 

participate, 3,206 valid Requests for 

Referendum were completed. This 

number did not meet the requisite 

number of 66,388; therefore, a 

referendum was not conducted. 

In accordance with the Act, another 

Request for Referendum will be 

conducted in 2009. In the proposed 

rule, data provided by USDA’s FSA was 

presented that would amend the 

number of soybean producers in 

preparation for this upcoming Request 

for Referendum. Presently, section 

1220.616 of the Order states that the 

number of soybean producers in the 

United States is 663,880. This final rule 

amends the number of eligible 

producers based on information from 

acreage reports provided by FSA which 

identifies 589,182 soybean producers for 

crop years 2006 and 2007. The data 

were sorted in such a manner as to 

include all producers that were engaged 

in the production of soybeans in at least 

one of the 2 years and exclude counting 

a producer more than once if that 

producer engaged in production during 

both years. Using the last two crop years 

for which complete data is available 

ensures that all eligible producers are 

counted, as some producers use 

soybeans in rotation with other crops 

and do not plant soybeans every year or 

the market for some producers in a 

particular crop year may not have been 

conducive to growing soybeans. This 

methodology is consistent with that 

used during the last amendment to 

section 1220.616 in 2004. 

In addition to the changes presented 

in the proposed rule relating to the 

number of eligible soybean producers, 

AMS also proposed amendments to 

sections 1220.622 and 1220.628 to 

update Web site addresses and office 

locations as a result of internal changes 

within the agency. 

Discussion of Comments 

In the December 5, 2008, proposed 

rule in the Federal Register (73 FR 

74080), interested persons were 

provided the opportunity to comment 

on the changes to section 1220.616 of 

the regulations. The comment period 

ended December 22, 2008. 

USDA received one comment raising 

a number of issues concerning the 2009 

Request for Referendum, including the 

timing of the poll. The comment, 

however, did not address the proposed 

changes to section 1220.616. The 2009 


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Federal Register / Vol. 74, No. 39 / Monday, March 2, 2009 / Rules and Regulations 9049 

Request for Referendum will be 

conducted in accordance with the Act 

and applicable regulations. Pursuant to 

5 U.S.C. 553, good cause is found for not 

postponing the effective date of the 

action until 30 days after publication in 

the Federal Register in order to conduct 

the Request for Referendum within the 

timeframes that appear in the Act. 

List of Subjects in 7 CFR Part 1220 

Administrative practice and 

procedure, Advertising, Agricultural 

research, Marketing agreements, 

Reporting and recordkeeping 

requirements, Soybeans and soybean 

products. 

■ For the reasons set forth in the 

preamble, 7 CFR part 1220 is amended 

as follows: 

PART 1220—SOYBEAN PROMOTION, 

RESEARCH, AND CONSUMER 

INFORMATION 

■ 1. The authority citation for part 1220 

continues to read as follows: 

Authority: 7 U.S.C. 6301–6311 and 7 

U.S.C. 7401. 

Subpart F—Procedures to Request a 

Referendum 

■ 2. In § 1220.616, paragraph (d) is 

revised to read as follows: 

§ 1220.616 General. 

* * * * * 

(d) For purposes of paragraphs (b) and 

(c) of this section, the number of 

soybean producers in the United States 

is determined to be 589,182. 

§ 1220.622 [Amended] 

■ 3. In § 1220.622, paragraph (b) the 

Web site ‘‘http://www.ams.usda.gov/lsg/ 

mpb/rp-soy.htm’’ is removed and a new 

Web site ‘‘http://www.ams.usda.gov/ 

lsmarketing programs’’ is added in its 

place. 

■ 4. In § 1220.628, paragraph (a) is 

revised to read as follows: 

§ 1220.628 Results of the request for 

referendum. 

(a) The Administrator, FSA, shall 

submit to the Administrator, AMS, the 

reports from all State FSA offices. The 

Administrator, AMS shall tabulate the 

results of the Request for Referendum. 

USDA will issue an official press release 

announcing the results of the Request 

for Referendum and publish the same 

results in the Federal Register. In 

addition, USDA will post the official 

results at the following Web site: 

‘‘http://www.ams.usda.gov/ 

lsmarketingprograms’’. 

Subsequently, State reports and 

related papers shall be available for 

public inspection upon request during 

normal business hours in the Marketing 

Programs Branch office, Livestock and 

Seed Program, AMS, USDA, Room 

2628–S, STOP 0251, 1400 Independence 

Avenue, SW., Washington, DC. 

* * * * * 

Dated: February 24, 2009. 

Robert C. Keeney, 

Acting Associate Administrator. 

[FR Doc. E9–4292 Filed 2–27–09; 8:45 am] 

BILLING CODE 3410–02–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 522 

[Docket No. FDA–2009–N–0665] 

Implantation or Injectable Dosage 

Form New Animal Drugs; Ivermectin 

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 a supplemental abbreviated 

new animal drug application (ANADA) 

filed by IVX Animal Health, Inc. The 

supplemental ANADA adds claims for 

persistent effectiveness against various 

species of external and internal 

parasites when cattle are treated with a 

1-percent ivermectin solution by 

subcutaneous injection. 

DATES: This rule is effective March 2, 

2009. 

FOR FURTHER INFORMATION CONTACT: John 

K. Harshman, Center for Veterinary 

Medicine (HFV–104), Food and Drug 

Administration, 7500 Standish Pl., 

Rockville, MD 20855, 240–276–8197, 

e-mail: john.harshman@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: IVX 

Animal Health, Inc., 3915 South 48th 

Street Ter., St. Joseph, MO 64503, filed 

a supplement to ANADA 200–228 that 

provides for use of PHOENECTIN 

(ivermectin) Injection 1% for the 

treatment and control of parasites in 

cattle. The supplemental ANADA adds 

claims for persistent effectiveness 

against various species of external and 

internal parasites of cattle. The 

supplemental ANADA is approved as of 

January 23, 2009, and the regulations 

are amended in 21 CFR 522.1192 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(a)(1) 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 522 

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 522 is amended as follows: 

PART 522—IMPLANTATION OR 

INJECTABLE DOSAGE FORM NEW 

ANIMAL DRUGS 

■ 1. The authority citation for 21 CFR 

part 522 continues to read as follows: 

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

§ 522.1192 [Amended] 

■ 2. In § 522.1192, in paragraph (b)(2), 

remove ‘‘No. 055529’’ and in its place 

add ‘‘Nos. 055529 and 059130’’; and 

remove paragraph (b)(3). 

Dated: February 18, 2009. 

Steven D. Vaughn, 

Director, Office of New Animal Drug 

Evaluation, Center for Veterinary Medicine. 

[FR Doc. E9–4304 Filed 2–27–09; 8:45 am] 

BILLING CODE 4160–01–S 


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