34236 Federal Register / Vol. 74, No. 134 / Wednesday, July 15, 2009 / Rules and Regulations 

§ 510.600 Names, addresses, and drug 

labeler codes of sponsors of approved 

applications. 

* * * * * 

(c) * * * 

(1) * * * 

Firm name and address Drug labeler 

code 

* * * * * 

Cephazone Pharma, LLC, 

250 East Bonita Ave., 

Pomona, CA 91767 

068330 

* * * * * 

(2) * * * 

Drug labeler 

code Firm name and address 

* * * * * 

068330 Cephazone Pharma, LLC, 

250 East Bonita Ave., 

Pomona, CA 91767 

* * * * * 

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 § 522.313c, revise paragraph (b) 

to read as follows: 

§ 522.313c Ceftiofur sodium 

* * * * * 

(b) Sponsors. See Nos. 000009 and 

068330 in § 510.600(c) of this chapter. 

* * * * * 

Dated: July 8, 2009. 

Bernadette Dunham, 

Director, Center for Veterinary Medicine. 

[FR Doc. E9–16734 Filed 7–14–09; 8:45 am] 

BILLING CODE 4160–01–S 

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; Flunixin 

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 an original abbreviated new 

animal drug application (ANADA) filed 

by Norbrook Laboratories, Ltd. The 

ANADA provides for the use of flunixin 

meglumine injectable solution in swine. 

DATES: This rule is effective July 15, 

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: Norbrook 

Laboratories, Ltd., Station Works, 

Newry BT35 6JP, Northern Ireland, filed 

ANADA 200–476 that provides for use 

of Flunixin Injection -S in swine for 

various bacterial infections. Norbrook 

Laboratories, Ltd.’s Flunixin Injection -S 

is approved as a generic copy of 

BANAMINE–S (flunixin meglumine) 

injectable solution, sponsored by 

Schering-Plough Animal Health Corp. 

under NADA 101–479. The ANADA is 

approved as of June 22, 2009, and the 

regulations are amended in 21 CFR 

522.970 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 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. 

■ 2. In § 522.970, revise paragraphs 

(b)(1) and (b)(4) to read as follows: 

§ 522.970 Flunixin. 

* * * * * 

(b) * * * 

(1) See Nos. 000061 and 055529 for 

use as in paragraph (e) of this section. 

* * * * * 

(4) See Nos. 059130 and 061623 for 

use as in paragraphs (e)(1) and (e)(2) of 

this section. 

* * * * * 

Dated: July 8, 2009. 

Bernadette Dunham, 

Director, Center for Veterinary Medicine. 

[FR Doc. E9–16735 Filed 7–14–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 558 

[Docket No. FDA–2009–N–0665] 

New Animal Drugs for Use in Animal 

Feeds; Lasalocid; Roxarsone 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Final rule; technical 

amendment. 

SUMMARY: The Food and Drug 

Administration (FDA) is amending the 

animal drug regulations to reflect 

approval of an original new animal drug 

application (NADA) filed by Alpharma 

Inc. The NADA provides for use of 

single-ingredient Type A medicated 

articles containing lasalocid and 

roxarsone to formulate two-way 

combination drug Type C medicated 

feeds for use in growing turkeys. 

DATES: This rule is effective July 15, 

2009. 

FOR FURTHER INFORMATION CONTACT: 

Timothy Schell, Center for Veterinary 

Medicine (HFV–128), Food and Drug 

Administration, 7500 Standish Pl., 

Rockville, MD 20855, 240–276–8116, 

e-mail: timothy.schell@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: Alpharma 

Inc., 440 Rte. 22, Bridgewater, NJ 08807, 

filed NADA 141–293 that provides for 

use of AVATEC (lasalocid sodium) and 

3-NITRO (roxarsone) single-ingredient 

Type A medicated articles to formulate 

two-way combination drug Type C 

medicated feeds for use in growing 

turkeys. The NADA is approved as of 

May 22, 2009, and the regulations are 

amended in 21 CFR 558.311 and 

§ 558.530 (21 CFR 558.530) to reflect the 

approval. 


srobinson on DSKHWCL6B1PROD with RULES
Federal Register / Vol. 74, No. 134 / Wednesday, July 15, 2009 / Rules and Regulations 34237 

In addition, FDA is amending 

§ 558.530 to remove an incorrect human 

food safety warning and to revise an 

animal safety limitation for use of 

roxarsone in chicken and turkey feeds. 

The food safety warning restricting use 

of roxarsone in poultry producing eggs 

for human consumption was codified in 

error during a change from text to table 

format in 2005 (70 FR 41958; July 21, 

2005). The animal safety warning is 

revised to reflect recommendations of 

the National Academy of SciencesNational Research Council (NAS-NRC) 

Drug Efficacy Study in 1970 (35 FR 

14273; September 10, 1970), following 

their evaluation of the product. NASNRC’s recommended warning was 

restated, but not codified, at the time of 

Drug Efficacy Study Implementation’s 

finalization of NADA 7–891 for a 

roxarsone Type A medicated article in 

1981 (46 FR 52330; October 27, 1981). 

The revised warning for medicated feed 

use agrees with the warning that is 

codified for roxarsone oral dosage forms 

in 21 CFR part 520. 

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 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 558 

Animal drugs, Animal feeds. 

■ 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 558 is amended as follows: 

PART 558—NEW ANIMAL DRUGS FOR 

USE IN ANIMAL FEEDS 

■ 1. The authority citation for 21 CFR 

part 558 continues to read as follows: 

Authority: 21 U.S.C. 360b, 371. 

■ 2. In § 558.311, in the table in 

paragraph (e)(1)(xv), alphabetically add 

a new entry for ‘‘Roxarsone 22.7 to 

45.4’’ to read as follows: 

§ 558.311 Lasalocid. 

* * * * * 

(e) * * * 

(1) * * * 

Lasalocid sodium activity 

in grams per ton 

Combination in 

grams per ton Indications for use Limitations Sponsor 

(xv) 68 (0.0075 pct) to 

113 (0.0125 pct). 

* * * * **

* * * * * * * 

Roxarsone 22.7 to 

45.4 

Growing turkeys: For prevention of 

coccidiosis caused by E. 

meleagrimitis, E. gallopavonis, and E. 

adenoeides, increased rate of weight 

gain, improved feed efficiency, and 

improved pigmentation. 

Feed continuously as the sole ration. 

Roxarsone provided by No. 046573 in 

§ 510.600(c) in this chapter. 

046573 

* * * * * * * 

§ 558.530 [Amended] 

■ 3. Amend § 558.530 as follows: 

a. In the table in paragraph (d)(1)(i), 

in the ‘‘Limitations’’ column, remove 

the phrase ‘‘do not feed to chickens 

producing eggs for human 

consumption;’’ and remove the phrase 

‘‘may result in leg weakness’’ and in its 

place add the phrase ‘‘may result in 

weakness or paralysis of the legs’’ and 

b. In the table in paragraph (d)(2)(i), 

in the ‘‘Limitations’’ column, remove 

the phrase ‘‘do not feed to turkeys 

producing eggs for human 

consumption;’’ and remove the phrase 

‘‘may result in leg weakness’’ and in its 

place add the phrase ‘‘may result in 

weakness or paralysis of the legs’’. 

Dated: July 9, 2009. 

Bernadette Dunham, 

Director, Center for Veterinary Medicine. 

[FR Doc. E9–16733 Filed 7–14–09; 8:45 am] 

BILLING CODE 4160–01–S 

PENSION BENEFIT GUARANTY 

CORPORATION 

29 CFR Part 4022 

Benefits Payable in Terminated SingleEmployer Plans; Interest Assumptions 

for Valuing and Paying Benefits 

AGENCY: Pension Benefit Guaranty 

Corporation. 

ACTION: Final rule. 

SUMMARY: Pension Benefit Guaranty 

Corporation’s regulation on Benefits 

Payable in Terminated Single-Employer 

Plans prescribes interest assumptions 

for valuing and paying certain benefits 

under terminating singleπemployer 

plans. This final rule amends the benefit 

payments regulation to adopt interest 

assumptions for plans with valuation 

dates in August 2009. Interest 

assumptions are also published on 

PBGC’s Web site (http://www.pbgc.gov). 

DATES: Effective August 1, 2009. 

FOR FURTHER INFORMATION CONTACT: 

Catherine B. Klion, Manager, Regulatory 

and Policy Division, Legislative and 

Regulatory Department, Pension Benefit 

Guaranty Corporation, 1200 K Street, 

NW., Washington, DC 20005, 202–326– 

4024. (TTY/TDD users may call the 

Federal relay service toll-free at 1–800– 

877–8339 and ask to be connected to 

202–326–4024.) 

SUPPLEMENTARY INFORMATION: PBGC’s 

regulations prescribe actuarial 

assumptions—including interest 

assumptions—for valuing and paying 

plan benefits of terminating singleemployer plans covered by title IV of 

the Employee Retirement Income 

Security Act of 1974. The interest 

assumptions are intended to reflect 

current conditions in the financial and 

annuity markets. 


srobinson on DSKHWCL6B1PROD with RULES