Document ID: FDA-2010-N-0002-0057
Agency: fda
Document Type: Rule
Title: New Animal Drugs; Change of Sponsor: Penicillin G Benzathine and Penicillin G Procaine Suspension; Penicillin G Procaine Aqueous Suspension
Posted Date: 2010-09-03T04:00Z

[Federal Register: September 3, 2010 (Volume 75, Number 171)]
[Rules and Regulations]               
[Page 54017]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr03se10-3]                         

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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.

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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.

0
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

0
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.

Sec.  510.600  [Amended]

0
2. In Sec.  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

0
3. The authority citation for 21 CFR part 522 continues to read as 
follows:

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

0
4. In Sec.  522.1696a, revise paragraphs (b)(1), (b)(2), (d)(2)(ii)(A), 
and (d)(2)(iii) to read as follows:

Sec.  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.

0
5. In Sec.  522.1696b, revise paragraphs (b)(1), (b)(2), (d)(2)(i)(A), 
and (d)(2)(iii)(B) to read as follows:

Sec.  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