[Federal Register: April 19, 2007 (Volume 72, Number 75)]
[Rules and Regulations]
[Page 19665-19666]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr19ap07-3]
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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:
pamela.esposito@fda.hhs.gov.
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amendments thereto, is withdrawn, effective April 30, 2007.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
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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.
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
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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]
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4. In Sec. 558.485, in paragraph (b)(3), remove ``017473''.
Sec. 558.625 [Amended]
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5. In Sec. 558.625, remove and reserve paragraph (b)(68).
Sec. 558.630 [Amended]
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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