Withdrawal of Approval of New Animal Drug Applications; Roxarsone, 78716 [2013-30838]

Download as PDF 78716 Federal Register / Vol. 78, No. 249 / Friday, December 27, 2013 / Rules and Regulations AIRAC date State City Airport FDC No. FDC date Subject 1/9/14 ........... CA Los Angeles ............ Los Angeles Intl ...................... 3/9143 11/15/13 1/9/14 ........... CA Los Angeles ............ Los Angeles Intl ...................... 3/9144 11/22/13 [FR Doc. 2013–30482 Filed 12–26–13; 8:45 am] BILLING CODE 4910–13–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 520 [Docket No. FDA–2013–N–0002] Withdrawal of Approval of New Animal Drug Applications; Roxarsone AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect the withdrawal approval of five new animal drug applications (NADAs) for roxarsone oral dosage form products at the sponsor’s request because the products are no longer manufactured or marketed. DATES: Withdrawal of approval is effective January 6, 2014. 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, john.bartkowiak@fda.hhs.gov. SUPPLEMENTARY INFORMATION: Zoetis Inc., 333 Portage St., Kalamazoo, MI 49007 has requested that FDA withdraw approval of the following five NADAs for roxarsone oral dosage form products, used to make medicated drinking water for chickens, turkeys, and swine, because the products are no longer manufactured or marketed: SUMMARY: 008–274, and 093–025, and all supplements and amendments thereto, is withdrawn, effective January 6, 2014. As provided in the regulatory text of this document, the animal drug regulations are amended to reflect these voluntary withdrawals 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 in 21 CFR Part 520 Animal drugs. Therefore, under the Federal Food, Drug, and Cosmetic Act and under the 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 1. The authority citation for 21 CFR part 520 continues to read as follows: ■ Authority: 21 U.S.C. 360b. §§ 520.2087, 520.2088, and 520.2089 [Removed] 2. Remove §§ 520.2087, 520.2088, and 520.2089. Proprietary name 005–414 ............. REN–O–SAL (roxarsone) Tablets. Zuco Poultry Tablets. Korum Improved Formula. Pig Scour Tablets. 3–NITRO (roxarsone) Soluble. Dated: December 20, 2013. Bernadette Dunham, Director, Center for Veterinary Medicine. [FR Doc. 2013–30838 Filed 12–26–13; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration tkelley on DSK3SPTVN1PROD with RULES [Docket No. FDA–2013–N–0002] 006–019 006–081 008–274 093–025 ............. ............. ............. ............. Elsewhere in this issue of the Federal Register, FDA gave notice that approval of NADAs 005–414, 006–019, 006–081, VerDate Mar<15>2010 18:49 Dec 26, 2013 Jkt 232001 Rwy 24R Rwy 24R applications (NADAs) for roxarsone oral dosage form products at the sponsor’s request because the products are no longer manufactured or marketed. Withdrawal of approval is effective January 6, 2014. DATES: John Bartkowiak, Center for Veterinary Medicine (HFV–212), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240–276–9079, john.bartkowiak@fda.hhs.gov. FOR FURTHER INFORMATION CONTACT: Zoetis Inc., 333 Portage St., Kalamazoo, MI 49007 has requested that FDA withdraw approval of the following five NADAs for roxarsone oral dosage form products, used to make medicated drinking water for chickens, turkeys, and swine, because the products are no longer manufactured or marketed: SUPPLEMENTARY INFORMATION: NADA 005–414 006–019 006–081 008–274 093–025 ............. ............. ............. ............. ............. Proprietary name REN–O–SAL Tablets. Zuco Poultry Tablets. Korum Improved Formula. Pig Scour Tablets. 3–NITRO Soluble. ■ 21 CFR Part 520 NADA ILS or LOC Rwy 24R, ILS 24R (CAT II), ILS Rwy (CAT III), Amdt 24A. ILS or LOC Rwy 24R, ILS 24R (CAT II), ILS Rwy (CAT III), Amdt 24A. Withdrawal of Approval of New Animal Drug Applications; Roxarsone AGENCY: Food and Drug Administration, HHS. ACTION: Notice of withdrawal. PO 00000 Frm 00024 Fmt 4700 Sfmt 9990 Dated: December 20, 2013. Bernadette Dunham, Director, Center for Veterinary Medicine. [FR Doc. 2013–30837 Filed 12–26–13; 8:45 am] The Food and Drug Administration (FDA) is withdrawing approval of five new animal drug SUMMARY: Therefore, under authority delegated to the Commissioner of Food and Drugs and redelegated to the Center for Veterinary Medicine, and in accordance with § 514.116 Notice of withdrawal of approval of application (21 CFR 514.116), notice is given that approval of NADAs 005–414, 006–019, 006–081, 008–274, and 093–025, and all supplements and amendments thereto, is hereby withdrawn, effective January 6, 2014. Elsewhere in this issue of the Federal Register, FDA is amending the animal drug regulations to reflect the voluntary withdrawal of approval of these applications. BILLING CODE 4160–01–P E:\FR\FM\27DER1.SGM 27DER1

Agencies

[Federal Register Volume 78, Number 249 (Friday, December 27, 2013)]
[Rules and Regulations]
[Page 78716]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-30838]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 520

[Docket No. FDA-2013-N-0002]


Withdrawal of Approval of New Animal Drug Applications; Roxarsone

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 to reflect the withdrawal approval of five new animal 
drug applications (NADAs) for roxarsone oral dosage form products at 
the sponsor's request because the products are no longer manufactured 
or marketed.

DATES: Withdrawal of approval is effective January 6, 2014.

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, john.bartkowiak@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: Zoetis Inc., 333 Portage St., Kalamazoo, MI 
49007 has requested that FDA withdraw approval of the following five 
NADAs for roxarsone oral dosage form products, used to make medicated 
drinking water for chickens, turkeys, and swine, because the products 
are no longer manufactured or marketed:

------------------------------------------------------------------------
               NADA                           Proprietary name
------------------------------------------------------------------------
005-414..........................  REN-O-SAL (roxarsone) Tablets.
006-019..........................  Zuco Poultry Tablets.
006-081..........................  Korum Improved Formula.
008-274..........................  Pig Scour Tablets.
093-025..........................  3-NITRO (roxarsone) Soluble.
------------------------------------------------------------------------

    Elsewhere in this issue of the Federal Register, FDA gave notice 
that approval of NADAs 005-414, 006-019, 006-081, 008-274, and 093-025, 
and all supplements and amendments thereto, is withdrawn, effective 
January 6, 2014. As provided in the regulatory text of this document, 
the animal drug regulations are amended to reflect these voluntary 
withdrawals 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 in 21 CFR Part 520

    Animal drugs.
    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
the 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.


Sec. Sec.  520.2087, 520.2088, and 520.2089  [Removed]

0
2. Remove Sec. Sec.  520.2087, 520.2088, and 520.2089.

    Dated: December 20, 2013.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2013-30838 Filed 12-26-13; 8:45 am]
BILLING CODE 4160-01-P