Federal Register / Vol. 74, No. 134 / Wednesday, July 15, 2009 / Rules and Regulations 34235 

between other countries, if that person 

has reached his or her 60th birthday 

unless there is another pilot in the flight 

deck crew who has not yet attained 60 

years of age. 

(e) No pilot may: 

(1) Serve as a pilot in operations 

under this part if that person has 

reached his or her 65th birthday. 

(2) Serve as a pilot in command in 

operations under this part between the 

United States and another country, or in 

operations between other countries, if 

that person has reached his or her 60th 

birthday unless there is another pilot in 

the flight deck crew who has not yet 

attained 60 years of age. 

■ 8. Amend § 121.411 by revising 

paragraph (e) to read as follows: 

§ 121.411 Qualifications: Check airmen 

(airplane) and check airmen (simulator). 

* * * * * 

(e) Check airmen who have reached 

their 65th birthday or who do not hold 

an appropriate medical certificate may 

function as check airmen, but may not 

serve as pilot flightcrew members in 

operations under this part. 

* * * * * 

9. Amend § 121.412 by revising 

paragraph (e) to read as follows: 

§ 121.412 Qualifications: Flight instructors 

(airplane) and flight instructors (simulator). 

* * * * * 

(e) Flight instructors who have 

reached their 65th birthday or who do 

not hold an appropriate medical 

certificate may function as flight 

instructors, but may not serve as pilot 

flightcrew members in operations under 

this part. 

* * * * * 

■ 10. Amend § 121.440 by adding 

paragraphs (d), (e), and (f) to read as 

follows: 

§ 121.440 Line checks. 

* * * 

(d) No certificate holder may use the 

services of any person as a pilot in 

operations under this part unless the 

certificate holder evaluates every 6 

months the performance, through a line 

check, of each pilot of the certificate 

holder who has attained 60 years of age. 

Notwithstanding the foregoing, a 

certificate holder is not required to 

conduct for a 6-month period a line 

check under this paragraph of a pilot 

serving as a second-in-command if the 

pilot has undergone a regularly 

scheduled simulator evaluation during 

that period. 

(e) No pilot who has attained 60 years 

of age may serve as a pilot in operations 

under this part unless the certificate 

holder has evaluated the pilot’s 

performance every 6 months, through a 

line check. Notwithstanding the 

foregoing, a certificate holder is not 

required to conduct for a 6-month 

period a line check under this paragraph 

of a pilot serving as a second-incommand if the pilot has undergone a 

regularly scheduled simulator 

evaluation during that period. 

(f) The training program provisions of 

§ 121.401(b) do not apply to pilots who 

have attained 60 years of age and serve 

in operations under this part. 

Issued in Washington, DC, on July 8, 2009. 

J. Randolph Babbitt, 

Administrator. 

[FR Doc. E9–16777 Filed 7–14–09; 8:45 am] 

BILLING CODE 4910–13–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Parts 510 and 522 

[Docket No. FDA–2009–N–0665] 

New Animal Drugs; Ceftiofur Sodium 

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 Cephazone Pharma, LLC. The 

ANADA provides for the use of ceftiofur 

sodium powder for injection as a 

solution in dogs, horses, cattle, swine, 

day old chickens, turkey poults, sheep, 

and goats as therapy for various 

bacterial infections. 

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: 

Cephazone Pharma, LLC, 250 East 

Bonita Ave., Pomona, CA 91767, filed 

ANADA 200–420 that provides for use 

of Ceftiofur Sodium Sterile Powder, as 

an injectable solution, in dogs, horses, 

cattle, swine, day-old chickens, turkey 

poults, sheep, and goats as therapy for 

various bacterial infections. Cephazone 

Pharma, LLC’s Ceftiofur Sodium Sterile 

Powder is approved as a generic copy of 

NAXCEL (ceftiofur sodium) Sterile 

Powder for Injection, sponsored by 

Pharmacia & Upjohn Co., a Division of 

Pfizer, Inc., under NADA 140–338. The 

ANADA is approved as of May 27, 2009, 

and the regulations are amended in 21 

CFR 522.313c to reflect the approval. 

In addition, Cephazone Pharma, LLC, 

has not been previously listed in the 

animal drug regulations as a sponsor of 

an approved application. Accordingly, 

21 CFR 510.600(c) is being amended to 

add entries for this firm. 

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 

21 CFR Part 510 

Administrative practice and 

procedure, Animal drugs, Labeling, 

Reporting and recordkeeping 

requirements. 

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 parts 510 and 522 are amended as 

follows: 

PART 510—NEW ANIMAL DRUGS 

■ 1. The authority citation for 21 CFR 

part 510 continues to read as follows: 

Authority: 21 U.S.C. 321, 331, 351, 352, 

353, 360b, 371, 379e. 

■ 2. In § 510.600, in the table in 

paragraph (c)(1) alphabetically add an 

entry for ‘‘Cephazone Pharma, LLC’’; 

and in the table in paragraph (c)(2) 

numerically add an entry for ‘‘068330’’ 

to read as follows: 


srobinson on DSKHWCL6B1PROD with RULES
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