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 


erowe on PROD1PC63 with RULES