Federal Register / Vol. 75, No. 171 / Friday, September 3, 2010 / Rules and Regulations 54017 

§ 510.600 Names, addresses, and drug 

labeler codes of sponsors of approved 

applications. 

* * * * * 

(c) * * * 

(1) * * * 

Firm name and address Drug labeler 

code 

* * * * * 

Alpharma LLC, 400 Crossing Blvd., Bridgewater, 

NJ 08807. 

046573 

* * * * * 

(2) * * * 

Drug labeler 

code Firm name and address 

* * * * * 

046573 Alpharma LLC, 400 Crossing Blvd., Bridgewater, 

NJ 08807. 

* * * * * 

Dated: August 31, 2010. 

Elizabeth Rettie, 

Deputy Director, Office of New Animal Drug 

Evaluation, Center for Veterinary Medicine. 

[FR Doc. 2010–22044 Filed 9–2–10; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Parts 510 and 522 

[Docket No. FDA–2010–N–0002] 

New Animal Drugs; Change of 

Sponsor; Penicillin G Benzathine and 

Penicillin G Procaine Suspension; 

Penicillin G Procaine Aqueous 

Suspension 

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 a 

change of sponsor for two new animal 

drug applications (NADAs) from G. C. 

Hanford Manufacturing Co. to Norbrook 

Laboratories, Ltd. 

DATES: This rule is effective September 

3, 2010. 

FOR FURTHER INFORMATION CONTACT: 

David R. Newkirk, Center for Veterinary 

Medicine (HFV–100), Food and Drug 

Administration, 7500 Standish Pl., 

Rockville, MD 20855, 240–276–8307, 

e-mail: david.newkirk@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: G. C. 

Hanford Manufacturing Co., P.O. Box 

1017, Syracuse, NY 13201, has informed 

FDA that it has transferred ownership 

of, and all rights and interest in, NADA 

65–493 for Penicillin G Procaine 

Aqueous Suspension and NADA 65–500 

for Penicillin G Benzathine and 

Penicillin G Procaine Suspension, to 

Norbrook Laboratories, Ltd., Station 

Works, Newry BT35 6JP, Northern 

Ireland. Accordingly, the agency is 

amending the regulations in 21 CFR 

522.1696a and 522.1696b to reflect the 

transfer of ownership. In addition, FDA has noticed that ‘‘G. 

C. Hanford’’ and ‘‘GTC Biotherapeutics, 

Inc.’’ are not spelled correctly in the 

listing of sponsors of approved NADAs. 

At this time, the table in 21 CFR 

510.600(c)(1) is amended. This action is 

being taken to improve the accuracy of 

the regulations. 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. 

§ 510.600 [Amended] 

■ 2. In § 510.600, in the table in 

paragraph (c)(1), in the entry for ‘‘G. C. 

Biotherapeutics, Inc.’’, remove ‘‘G. C.’’ 

and in its place add ‘‘GTC’’; and in the 

entry for ‘‘GTC Hanford Manufacturing 

Co.’’, remove ‘‘GTC’’ and in its place add 

‘‘G. C.’’. 

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 § 522.1696a, revise paragraphs 

(b)(1), (b)(2), (d)(2)(ii)(A), and (d)(2)(iii) 

to read as follows: 

§ 522.1696a Penicillin G benzathine and 

penicillin G procaine suspension. 

* * * * * 

(b) * * * 

(1) Nos. 000856, 049185, 055529, and 

061623 for use as in paragraph (d)(1) of 

this section. 

(2) Nos. 055529, 059130, and 061623 

for use as in paragraphs (d)(2)(i), 

(d)(2)(ii)(A), and (d)(2)(iii) of this 

section. 

* * * * * 

(d) * * * 

(2) * * * 

(ii) * * * 

(A) Treatment of bacterial pneumonia 

(Streptococcus spp., Actinomyces 

pyogenes, Staphylococcus aureus); 

upper respiratory infections such as 

rhinitis or pharyngitis (A. pyogenes); 

blackleg (Clostridium chauvoei). 

* * * * * 

(iii) Limitations. Limit treatment to 

two doses. Not for use within 30 days 

of slaughter. For Nos. 049185, 055529, 

059130, and 061623: A withdrawal 

period has not been established for this 

product in preruminating calves. Do not 

use in calves to be processed for veal. 

■ 5. In § 522.1696b, revise paragraphs 

(b)(1), (b)(2), (d)(2)(i)(A), and 

(d)(2)(iii)(B) to read as follows: 

§ 522.1696b Penicillin G procaine aqueous 

suspension. 

* * * * * 

(b) * * * 

(1) Nos. 053501, 055529, and 059130 

for use as in paragraph (d) of this 

section. 

(2) No. 061623 for use as in paragraph 

(d)(2) of this section. 

* * * * * 

(d) * * * 

(2) * * * 

(i) * * * 

(A) For Nos. 053501, 055529, 059130, 

and 061623: Continue treatment at least 

48 hours after symptoms disappear. 

* * * * * 

(iii) * * * 

(B) For Nos. 055529 and 059130: 

Continue treatment at least 1 day after 

symptoms disappear (usually 2 or 3 

days). 

Dated: August 31, 2010. 

Elizabeth Rettie, 

Deputy Director, Office of New Animal Drug 

Evaluation, Center for Veterinary Medicine. 

[FR Doc. 2010–22042 Filed 9–2–10; 8:45 am] 

BILLING CODE 4160–01–S 


erowe on DSK5CLS3C1PROD with RULES