[Federal Register Volume 75, Number 177 (Tuesday, September 14, 2010)]
[Rules and Regulations]
[Pages 55676-55677]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-22808]
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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:
[email protected].
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withdrawn, effective September 24, 2010.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.
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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
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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]
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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
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3. The authority citation for 21 CFR part 520 continues to read as
follows:
Authority: 21 U.S.C. 360b.
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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
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5. The authority citation for 21 CFR part 558 continues to read as
follows:
Authority: 21 U.S.C. 360b, 371.
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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]
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7. In paragraph (b)(3) of Sec. 558.485, remove ``043733''.
Sec. 558.630 [Amended]
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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