Oral Dosage Form New Animal Drugs; Change of Sponsor; Chlortetracycline; Sulfamethazine, 49649 [2011-20404]

Agencies

• Food and Drug Administration
• DEPARTMENT OF HEALTH AND HUMAN SERVICES

[Federal Register Volume 76, Number 155 (Thursday, August 11, 2011)]
[Rules and Regulations]
[Page 49649]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-20404]



========================================================================
Rules and Regulations
                                                Federal Register
________________________________________________________________________

This section of the FEDERAL REGISTER contains regulatory documents 
having general applicability and legal effect, most of which are keyed 
to and codified in the Code of Federal Regulations, which is published 
under 50 titles pursuant to 44 U.S.C. 1510.

The Code of Federal Regulations is sold by the Superintendent of Documents. 
Prices of new books are listed in the first FEDERAL REGISTER issue of each 
week.

========================================================================


Federal Register / Vol. 76, No. 155 / Thursday, August 11, 2011 / 
Rules and Regulations

[[Page 49649]]



DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 520

[Docket No. FDA-2011-N-0003]


Oral Dosage Form New Animal Drugs; Change of Sponsor; 
Chlortetracycline; Sulfamethazine

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is amending the animal 
drug regulations to reflect a change of sponsor for five new animal 
drug applications (NADAs) from Fort Dodge Animal Health, Division of 
Wyeth Holdings Corp., a wholly owned subsidiary of Pfizer, Inc., to 
Boehringer Ingelheim Vetmedica, Inc.

DATES: This rule is effective August 11, 2011.

FOR FURTHER INFORMATION CONTACT: Steven D. Vaughn, Center for 
Veterinary Medicine (HFV-100), Food and Drug Administration, 7520 
Standish Pl., Rockville, MD 20855, 240-276-8300, e-mail: 
steven.vaughn@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: Fort Dodge Animal Health, Division of Wyeth 
Holdings Corp., a wholly owned subsidiary of Pfizer, Inc., 235 East 42d 
St., New York, NY 10017 has informed FDA that it has transferred 
ownership of, and all rights and interest in, five approved NADAs 
(NADAs 055-012, 055-018, 055-039, 065-071, and 065-440) to Boehringer 
Ingelheim Vetmedica, Inc., 2621 North Belt Highway, St. Joseph, MO 
64506-2002. Accordingly, the Agency is amending the regulations in 21 
CFR part 520 to reflect the transfer of ownership.
    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 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 part 520 is 
amended as follows:

PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS

0
1. The authority citation for 21 CFR part 520 continues to read as 
follows:

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

0
2. Revise Sec.  520.445 to read as follows:


Sec.  520.445  Chlortetracycline and sulfamethazine powder.

    (a) Specifications. Each pound of soluble powder contains 
chlortetracycline bisulfate equivalent to 102.4 grams (g) of 
chlortetracycline hydrochloride and sulfamethazine bisulfate equivalent 
to 102.4 g of sulfamethazine.
    (b) Sponsor. See No. 000010 in Sec.  510.600(c) of this chapter.
    (c) Related tolerances. See Sec. Sec.  556.150 and 556.670 of this 
chapter.
    (d) Conditions of use in swine. Administer in drinking water as 
follows:
    (1) Amount. 250 milligrams (mg) of chlortetracycline and 250 mg of 
sulfamethazine per gallon.
    (2) Indications for use. For the prevention and treatment of 
bacterial enteritis; as an aid in the reduction of the incidence of 
cervical abscesses; and as an aid in the maintenance of weight gains in 
the presence of bacterial enteritis and atrophic rhinitis.
    (3) Limitations. Use as the sole source of chlortetracycline and 
sulfonamide. Not to be used for more than 28 consecutive days. Withdraw 
15 days before slaughter.


Sec.  520.445a  [Removed]

0
3. Remove Sec.  520.445a.


Sec.  520.445b  [Redesignated as Sec.  520.441]

0
4. Redesignate Sec.  520.445b as Sec.  520.441.

0
5. Amend newly redesignated Sec.  520.441 by revising paragraphs 
(b)(2), (b)(3), and the last sentence of paragraph (d)(4)(iii)(C) to 
read as follows:


Sec.  520.441  Chlortetracycline powder.

* * * * *
    (b) * * *
    (2) Nos. 046573 and 000010 for use as in paragraph (d) of this 
section.
    (3) No. 000010 for use as in paragraphs (d)(4)(i)(A), (d)(4)(i)(B), 
and (d)(4)(ii) through (d)(4)(iv) of this section.
* * * * *
    (d) * * *
    (4) * * *
    (iii) * * *
    (C) * * * For Nos. 000010 and 021930, do not slaughter animals for 
food within 5 days of treatment. For No. 000010, do not slaughter 
animals for food within 24 hours of treatment.
* * * * *


Sec.  520.445c  [Redesignated as Sec.  520.443]

0
6. Redesignate Sec.  520.445c as Sec.  520.443.
0
7. Amend newly redesignated Sec.  520.443 as follows:
0
a. Revise paragraphs (a) and (b);
0
b. Remove paragraph (d);
0
c. Redesignate paragraph (e) as paragraph (d); and
0
d. Revise the heading for newly redesignated paragraph (d) introductory 
text.
    The revisions read as follows:


Sec.  520.443  Chlortetracycline tablets and boluses.

    (a) Specifications. Each tablet/bolus contains 25, 250, or 500 
milligrams (mg) chlortetracycline hydrochloride.
    (b) Sponsor. See No. 000010 in Sec.  510.600(c) of this chapter.
* * * * *
    (d) Conditions of use in calves--* * *
* * * * *

    Dated: August 4, 2011.
Elizabeth Rettie,
Deputy Director, Office of New Animal Drug Evaluation, Center for 
Veterinary Medicine.
[FR Doc. 2011-20404 Filed 8-10-11; 8:45 am]
BILLING CODE 4160-01-P