Document ID: FDA-2012-N-0002-0002
Agency: fda
Document Type: Rule
Title: Oral Dosage Form New Animal Drugs: Lincomycin Hydrochloride Soluble Powder; Penicillin G Potassium in Drinking Water; Tetracycline Powder; Change of Sponsor
Posted Date: 2012-04-09T04:00Z

[Federal Register Volume 77, Number 68 (Monday, April 9, 2012)]
[Rules and Regulations]
[Pages 20987-20988]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-8322]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 520

[Docket No. FDA-2012-N-0002]

Oral Dosage Form New Animal Drugs; Change of Sponsor; Lincomycin 
Hydrochloride Soluble Powder; Penicillin G Potassium in Drinking Water; 
Tetracycline Powder

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 three abbreviated 
new animal drug applications (ANADAs) for lincomycin hydrochloride; 
penicillin G potassium, USP; and tetracycline hydrochloride soluble 
powders administered in drinking water from Teva Animal Health, Inc., 
to Quo Vademus, LLC.

DATES: This rule is effective April 9, 2012.

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, email: 
steven.vaughn@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: Teva Animal Health, Inc., 3915 South 48th 
Street Ter., St. Joseph, MO 64503, has informed FDA that it has 
transferred ownership of, and all rights and interest in, ANADA 200-136 
for Tetracycline Hydrochloride Soluble Powder 324; ANADA 200-303 for 
Lincomycin Hydrochloride Soluble Powder; and ANADA 200-347 for 
Penicillin G Potassium, USP, all soluble powders administered in 
drinking water to Quo Vademus, LLC, 277 Faison West McGowan Rd., 
Kenansville, NC 28349. Accordingly, the Agency is amending the 
regulations in part 520 (21 CFR part 520) to reflect the transfer of 
ownership and a current format.
    In addition FDA has noticed two errors in Sec.  520.1696 Penicillin 
oral dosage forms. At this time, Sec.  520.1696a is being removed 
because no sponsor is listed, and an obsolete drug labeler code is 
being removed from Sec.  520.1696d.

[[Page 20988]]

These actions are 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 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. In Sec.  520.1263, revise the section heading to read as follows:

Sec.  520.1263  Lincomycin.

* * * * *

0
3. In Sec.  520.1263c, revise the section heading and paragraph (b) to 
read as follows:

Sec.  520.1263c  Lincomycin powder.

* * * * *
    (b) Sponsors. See Nos. 000009, 046573, 054925, 061623, and 076475 
in Sec.  510.600(c) of this chapter for use as in paragraph (d) of this 
section.
* * * * *

0
4. In Sec.  520.1696, revise the section heading to read as follows:

Sec.  520.1696  Penicillin.

* * * * *

Sec.  520.1696a  [Removed and Reserved]

0
5. Remove and reserve Sec.  520.1696a.

0
6. In Sec.  520.1696b, revise the section heading, paragraphs (a) and 
(b), and the heading for paragraph (c) to read as follows:

Sec.  520.1696b  Penicillin G powder.

    (a) Specifications. Each gram of powder contains penicillin G 
potassium equivalent to 1.54 million units of penicillin G.
    (b) Sponsors. See Nos. 010515, 046573, 053501, 059320, 061623 and 
076475 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use in turkeys--
* * * * *

0
7. In Sec.  520.1696c, revise the section heading and remove and 
reserve paragraph (c) to read as follows:

Sec.  520.1696c  Penicillin V powder.

* * * * *

0
8. In Sec.  520.1696d, revise the section heading and paragraph (b) and 
remove and reserve paragraph (c) to read as follows:

Sec.  520.1696d  Penicillin V tablets.

* * * * *
    (b) Sponsors. See Nos. 050604 and 053501 in Sec.  510.600(c) of 
this chapter.
* * * * *

0
9. In Sec.  520.2345, revise the section heading to read as follows:

Sec.  520.2345  Tetracycline.

* * * * *

0
10. In Sec.  520.2345d, revise paragraph (b)(4) to read as follows:

Sec.  520.2345d  Tetracycline powder.

* * * * *
    (b) * * *
    (4) Nos. 054925, 057561, 061623, and 076475: 324 grams per pound as 
in paragraph (d) of this section.
* * * * *

    Dated: March 27, 2012.
William T. Flynn,
Acting Director, Center for Veterinary Medicine.
[FR Doc. 2012-8322 Filed 4-6-12; 8:45 am]
BILLING CODE 4160-01-P