[Federal Register Volume 72, Number 75 (Thursday, April 19, 2007)]
[Rules and Regulations]
[Pages 19665-19666]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-7460]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 510 and 558


New Animal Drugs For Use in Animal Feed; Withdrawal of Approval 
of NADAs; Pyrantel; Tylosin; Tylosin and Sulfamethazine

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA) is withdrawing approval 
of three new animal drug applications (NADAs) for intermediate premixes 
used to manufacture Type C medicated feeds. In a notice published 
elsewhere in this issue of the Federal Register, FDA is withdrawing 
approval of the NADAs.

DATES: This rule is effective April 30, 2007.

FOR FURTHER INFORMATION CONTACT: Pamela K. Esposito, Center for 
Veterinary Medicine (HFV-212), Food and Drug Administration, 7519 
Standish Pl., Rockville, MD 20855, 240-276-9067, e-mail: 
[email protected].

SUPPLEMENTARY INFORMATION: Custom Feed Services Corp., 2100 N. 13th 
St., Norfolk, NE 68701, has requested that FDA withdraw approval of 
NADA 121-200 for Tylosin 10 Premix (tylosin), NADA 129-159 for TYLAN 40 
Sulfa-G (tylosin and sulfamethazine), and NADA 137-484 for Swine Guard-
BN (pyrantel). All are intermediate premixes used to manufacture Type C 
medicated feeds. This action is requested because the products are no 
longer manufactured or marketed.
    In a final rule published elsewhere in this issue of the Federal 
Register, FDA gives notice that approval of NADA

[[Page 19666]]

121-200, NADA 129-159, and NADA 137-484 and all supplements and 
amendments thereto, is withdrawn, effective April 30, 2007.
    Following the withdrawal of approval of these NADAs, Custom Feed 
Services Corp. is no longer a sponsor of an approved application. 
Therefore, 21 CFR 510.600(c) is amended to remove entries for this 
firm. As provided in the regulatory text of this document, the animal 
drug regulations are amended to reflect the withdrawal of approval.
    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 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 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.


Sec.  510.600  [Amended]

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2. In Sec.  510.600, in the table in paragraph (c)(1), remove the entry 
for ``Custom Feed Services Corp.''; and in the table in paragraph 
(c)(2) remove the entry for ``017473''.

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

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

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


Sec.  558.485  [Amended]

0
4. In Sec.  558.485, in paragraph (b)(3), remove ``017473''.


Sec.  558.625  [Amended]

0
5. In Sec.  558.625, remove and reserve paragraph (b)(68).


Sec.  558.630  [Amended]

0
6. In Sec.  558.630, in paragraph (b)(10), remove ``017473''.

    Dated: April 9, 2007.
Bernadette Dunham,
Deputy Director, Center for Veterinary Medicine.
[FR Doc. E7-7460 Filed 4-18-07; 8:45 am]
BILLING CODE 4160-01-S