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contains regulatory documents having general

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are keyed to and codified in the Code of

Federal Regulations, which is published under

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Rules and Regulations Federal Register

21767 

Vol. 74, No. 89 

Monday, May 11, 2009 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Parts 510 and 520 

[Docket No. FDA–2009–N–0665] 

New Animal Drugs; Trilostane 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Final rule. 

SUMMARY: The Food and Drug 

Administration (FDA) is amending the 

animal drug regulations to reflect the 

original approval of a new animal drug 

application (NADA) filed by Dechra, 

Ltd. The NADA provides for the 

veterinary prescription use of trilostane 

capsules in dogs for treatment of 

pituitary-dependent 

hyperadrenocorticism and for treatment 

of hyperadrenocorticism due to 

adrenocortical tumor. 

DATES: This rule is effective May 11, 

2009. 

FOR FURTHER INFORMATION CONTACT: 

Melanie R. Berson, Center for Veterinary 

Medicine (HFV–110), Food and Drug 

Administration, 7500 Standish Pl., 

Rockville, MD 20855, 240–276–8337, email: melanie.berson@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: Dechra, 

Ltd., Dechra House, Jamage Industrial 

Estate, Talke Pits, Stoke-on-Trent, 

Staffordshire, ST7 1XW, United 

Kingdom, filed NADA 141–291 that 

provides for veterinary prescription use 

of VETORYL (trilostane) Capsules in 

dogs for treatment of pituitarydependent hyperadrenocorticism and 

for treatment of hyperadrenocorticism 

due to adrenocortical tumor. The NADA 

is approved as of December 5, 2008, and 

the regulations are amended in 21 CFR 

part 520 to reflect the approval. 

In addition, Dechra, Ltd. is not 

currently 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 sponsor. 

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. 

Under section 512(c)(2)(F)(i) of the 

Federal Food, Drug, and Cosmetic Act 

(the act) (21 U.S.C. 360b(c)(2)(F)(i)), this 

approval qualifies for 5 years of 

marketing exclusivity beginning on the 

date of approval. 

Under section 573(c) of the act (21 

U.S.C. 360ccc–2), the approval of 

trilostane capsules for treatment of 

hyperadrenocorticism due to 

adrenocortical tumor in dogs qualifies 

for 7 years of exclusive marketing rights 

beginning on the date of approval 

because the new animal drug has been 

declared a designated new animal drug 

by FDA under section 573(a) of the act. 

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 520 

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 520 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 ‘‘Dechra, Ltd.’’; and in the table 

in paragraph (c)(2), numerically add an 

entry for ‘‘043264’’ to read as follows: 

§ 510.600 Names, addresses, and drug 

labeler codes of sponsors of approved 

applications. 

* * * * * 

(c) * * * 

(1) * * * 

Firm name and address Drug labeler 

code 

* * * * * 

Dechra, Ltd., Dechra 

House, Jamage Industrial 

Estate, Talke Pits, Stokeon-Trent, Staffordshire, 

ST7 1XW, United Kingdom 

043264 

* * * * * 

(2) * * * 

Drug labeler 

code Firm name and address 

* * * * * 

043264 Dechra, Ltd., Dechra 

House, Jamage Industrial 

Estate, Talke Pits, Stokeon-Trent, Staffordshire, 

ST7 1XW, United Kingdom 

* * * * * 

PART 520—ORAL DOSAGE FORM 

NEW ANIMAL DRUGS 

■ 3. The authority citation for 21 CFR 

part 520 continues to read as follows: 

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

■ 4. Add § 520.2598 to read as follows: 

§ 520.2598 Trilostane. 

(a) Specifications. Each capsule 

contains 30 or 60 milligrams (mg) 

trilostane. 

(b) Sponsor. See No. 043264 in 

§ 510.600 of this chapter. 

(c) Conditions of use in dogs—(1) 

Amount. The starting dose is 1.0 to 3.0 

21768 Federal Register / Vol. 74, No. 89 / Monday, May 11, 2009 / Rules and Regulations 

milligrams per pound (2.2 to 6.7 

milligrams per kilogram) once a day. 

(2) Indications for use. For treatment 

of pituitary-dependent 

hyperadrenocorticism. For treatment of 

hyperadrenocorticism due to 

adrenocortical tumor. 

(3) Limitations. Federal law restricts 

this drug to use by or on the order of 

a licensed veterinarian. 

Dated: May 5, 2009. 

Bernadette Dunham, 

Director, Center for Veterinary Medicine. 

[FR Doc. E9–10927 Filed 5–8–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Parts 510 and 520 

[Docket No. FDA–2009–N–0665] 

New Animal Drugs; Carprofen 

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 the 

original approval of an abbreviated new 

animal drug application (ANADA) filed 

by Norbrook Laboratories, Ltd. The 

ANADA provides for the veterinary 

prescription use of carprofen caplets in 

dogs. 

DATES: This rule is effective May 11, 

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, email: john.harshman@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: Norbrook 

Laboratories, Ltd., Station Works, 

Newry BT35 6JP, Northern Ireland, filed 

ANADA 200–498 that provides for 

veterinary prescription use of 

NOROCARP (carprofen) Caplets in dogs 

for the relief of pain and inflammation 

associated with osteoarthritis and for 

the control of postoperative pain 

associated with soft tissue and 

orthopedic surgeries. The ANADA is 

approved as of November 25, 2008, and 

the regulations are amended in 21 CFR 

520.309 to reflect the approval. 

In addition, FDA has found that a 

sponsor of another generic carprofen 

caplet product is not currently 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 IMPAX 

Laboratories, Inc. 

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. 

FDA 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 520 

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 520 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 a 

new entry for ‘‘IMPAX Laboratories, 

Inc.’’; and in the table in paragraph 

(c)(2) numerically add a new entry for 

‘‘000115’’ to read as follows: 

§ 510.600 Names, addresses, and drug 

labeler codes of sponsors of approved 

applications. 

* * * * * 

(c) * * * 

(1) * * * 

Firm name and address Drug labeler 

code 

* * * * * 

IMPAX Laboratories, Inc., 

30831 Huntwood Ave., 

Hayward, CA 94544 

000115 

* * * * * 

(2) * * * 

Drug labeler 

code Firm name and address 

* * * * * 

000115 IMPAX Laboratories, Inc., 

30831 Huntwood Ave., 

Hayward, CA 94544 

* * * * * 

PART 520—ORAL DOSAGE FORM 

NEW ANIMAL DRUGS 

■ 3. The authority citation for 21 CFR 

part 520 continues to read as follows: 

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

§ 520.309 [Amended] 

■ 4. In paragraph (b)(2) of § 520.309, 

remove ‘‘000115 and 062250’’ and add 

in its place ‘‘000115, 055529, and 

062250’’. 

Dated: May 6, 2009. 

Bernadette Dunham, 

Director, Center for Veterinary Medicine. 

[FR Doc. E9–10925 Filed 5–8–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF THE INTERIOR 

Office of Surface Mining Reclamation 

and Enforcement 

30 CFR Part 938 

[PA–148–FOR; OSM–2008–0014] 

Pennsylvania Regulatory Program 

AGENCY: Office of Surface Mining 

Reclamation and Enforcement (OSM), 

Interior. 

ACTION: Final rule: clarification. 

SUMMARY: We recently approved an 

amendment to the Pennsylvania 

regulatory program (the Pennsylvania 

program) under the Surface Mining 

Control and Reclamation Act of 1977 

(SMCRA or the Act). The changes 

related to blasting for the development 

of shafts for underground mines and 

other changes to the blasting regulations 

in the Pennsylvania program. After our 

approval of the amendment, the 

Pennsylvania Department of 

Environmental Protection (PADEP) 

requested a clarification of our findings 

in support of that approval. Therefore,