Document ID: FDA-2010-N-0002-0063
Agency: fda
Document Type: Rule
Title: Animal Drugs, Feeds, and Related Products; Withdrawals of Approvals of New Animal Drug Applications: Chloramphenicol; Lincomycin;Pyrantel Tartrate; and Tylosin Phosphate and Sulfamethazine
Posted Date: 2010-09-14T04:00Z

[Federal Register: September 14, 2010 (Volume 75, Number 177)]
[Rules and Regulations]               
[Page 55676-55677]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr14se10-3]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 510, 520, and 558

[Docket No. FDA-2010-N-0002]

 
Animal Drugs, Feeds, and Related Products; Withdrawal of Approval 
of New Animal Drug Applications; Chloramphenicol; Lincomycin; Pyrantel 
Tartrate; and Tylosin Phosphate and Sulfamethazine

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA) is amending the animal 
drug regulations by removing those portions that reflect approval of 
four new animal drug applications (NADAs). In a notice published 
elsewhere in this issue of the Federal Register, FDA is withdrawing 
approval of these NADAs.

DATES:  This rule is effective September 24, 2010.

FOR FURTHER INFORMATION CONTACT:  John Bartkowiak, Center for 
Veterinary Medicine (HFV-212), Food and Drug Administration, 7519 
Standish Pl., Rockville, MD 20855, 240-276-9079; email: 
john.bartkowiak@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: John J. Ferrante, 11 Fairway Lane, Trumbull, 
CT 06611; International Nutrition, Inc., 7706 ``I'' Plaza, Omaha, NE 
68127; and Feed Service Co., Inc., 303 Lundin Blvd., P.O. Box 698, 
Mankato, MN 56001 have requested that FDA withdraw approval of the four 
NADAs listed in the following paragraph because they are no longer 
manufactured or marketed:
    In a notice published elsewhere in this issue of the Federal 
Register, FDA gave notice that approval of NADA 65-137, 121-337, 132-
923, and 138-342, and all supplements and amendments thereto, is 
withdrawn, effective September 24, 2010. As provided in the regulatory 
text of this document, the animal drug regulations are amended to 
reflect these withdrawals of approval.
    Following these changes of sponsorship, Feed Service Co., Inc., and 
John J. Ferrante are no longer the sponsor of an approved application. 
Accordingly, 21 CFR 510.600(c) is being amended to remove the entries 
for these firms.
    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.

21 CFR Part 558

    Animal drugs, Animal feeds.

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, 
520, and 558 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.

510.600  [Amended]

0
2. In Sec.  510.600, in the table in paragraph (c)(1), remove the 
entries for ``Feed Service Co., Inc.'' and ``John J. Ferrante''; and in 
the table in paragraph (c)(2), remove the entries for ``030841'' and 
``058034''.

PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS

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

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

0
4. In Sec.  520.390b, revise paragraph (b) to read as follows:

Sec.  520.390b  Chloramphenicol capsules.

* * * * *
    (b) Sponsors. See Nos. 000069 and 050057 in Sec.  510.600(c) of 
this chapter for use as in paragraph (d) of this section.
* * * * *

PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS

0
5. The authority citation for 21 CFR part 558 continues to read as 
follows:

    Authority: 21 U.S.C. 360b, 371.

0
6. In Sec.  558.325, revise paragraphs (a) and (c)(3)(ii); and in the 
table in paragraphs (d)(2)(ii) and (d)(2)(iii), in the ``Sponsor'' 
column, remove ``043733'' to read as follows:

[[Page 55677]]

Sec.  558.325   Lincomycin.

    (a) Approvals. Type A articles and Type B feeds approved for 
sponsors in Sec.  510.600(c) of this chapter for specific uses as in 
paragraph (d) of this section as follows:
    (1) No. 000009 for 20 and 50 grams per pound.
    (2) No. 051311 for 2.5 and 8 grams per pound.
* * * * *
    (c) * * *
    (3) * * *
    (ii) No. 051311:``CAUTION: Not to be fed to swine that weigh more 
than 250 lb.''
* * * * *

Sec.  558.485  [Amended]

0
7. In paragraph (b)(3) of Sec.  558.485, remove ``043733''.

Sec.  558.630  [Amended]

0
8. In paragraph (b)(5) of Sec.  558.630, remove ``030841''.

    Dated: September 1, 2010.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2010-22808 Filed 9-13-10; 8:45 am]
BILLING CODE 4160-01-S