Withdrawal of Approval of New Animal Drug Applications; Arsanilic Acid, 70496 [2013-28256]

Download as PDF 70496 Federal Register / Vol. 78, No. 228 / Tuesday, November 26, 2013 / Rules and Regulations Columbia/Mount Pleasant, TN, Maury County, Takeoff Minimums and Obstacle DP, Amdt 3 Millington, TN, Millington Rgnl Jetport, RNAV (GPS) RWY 4, Amdt 1 Oak Harbor, WA, AJ Eisenberg, RNAV (GPS) RWY 7, Amdt 2D Milwaukee, WI, General Mitchell Intl, RNAV (RNP) Y RWY 7R, Orig Milwaukee, WI, General Mitchell Intl, RNAV (RNP) Y RWY 25L, Orig Spencer, WV, Boggs Field, RNAV (GPS) RWY 10, Amdt 2 [FR Doc. 2013–27947 Filed 11–25–13; 8:45 am] 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 558 Animal drugs, Animal feeds. 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 part 558 is amended as follows: BILLING CODE 4910–13–P PART 558—NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS DEPARTMENT OF HEALTH AND HUMAN SERVICES 1. The authority citation for 21 CFR part 558 continues to read as follows: ■ Food and Drug Administration Authority: 21 U.S.C. 360b, 371. 21 CFR Part 558 § 558.62 [Docket No. FDA–2013–N–0002] ■ Withdrawal of Approval of New Animal Drug Applications; Arsanilic Acid 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 of approval of a new animal drug application (NADA) for an arsanilic acid Type A medicated article at the sponsor’s request because the product is no longer manufactured or marketed. SUMMARY: Withdrawal of approval is effective December 6, 2013. [Amended] 2. In § 558.62, remove and reserve paragraphs (a)(1), (a)(2), (c)(1)(i), and (c)(1)(ii); and in paragraphs (c)(1)(iii), (c)(1)(iv), (c)(1)(v), (c)(1)(vi), and (c)(1)(vii), in the ‘‘Arsanilic acid in grams per ton’’ column, add ‘‘90’’. Dated: November 20, 2013. Bernadette Dunham, Director, Center for Veterinary Medicine. [FR Doc. 2013–28256 Filed 11–25–13; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HOMELAND SECURITY Coast Guard DATES: rmajette on DSK2TPTVN1PROD with RULES FOR FURTHER INFORMATION CONTACT: 33 CFR Part 117 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: Fleming Laboratories, Inc., P.O. Box 34384, Charlotte, NC 28234 has requested that FDA withdraw approval of NADA 008– 019 for PRO–GEN (arsanilic acid) Type A medicated article because the product, used to manufacture Type B and Type C medicated feeds, is no longer manufactured or marketed. Elsewhere in this issue of the Federal Register, FDA gave notice that approval of NADA 008–019, and all supplements and amendments thereto, is withdrawn, effective December 6, 2013. 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 VerDate Mar<15>2010 14:32 Nov 25, 2013 Jkt 232001 [Docket No. USCG–2013–0947] Drawbridge Operation Regulation; Old River, Between Victoria Island and Byron Tract, CA Coast Guard, DHS. Notice of deviation from drawbridge regulation. AGENCY: ACTION: The Coast Guard has issued a temporary deviation from the operating schedule that governs the State Highway 4 Drawbridge across Old River, mile 14.8 between Victoria Island and Byron Tract, CA. The deviation is necessary to allow the bridge owner to make critical repairs to the bridge gears. This deviation allows the bridge to remain in the closed-to-navigation position during the deviation period. DATES: This deviation is effective without actual notice from November 26, 2013 until December 6, 2013. For the purposes of enforcement, actual notice will be used from the date the deviation SUMMARY: PO 00000 Frm 00012 Fmt 4700 Sfmt 4700 was signed, November 15, 2013, until December 6, 2013. ADDRESSES: The docket for this deviation, [USCG–2013–0947], is available at http://www.regulations.gov. Type the docket number in the ‘‘SEARCH’’ box and click ‘‘SEARCH.’’ Click on Open Docket Folder on the line associated with this deviation. You may also visit the Docket Management Facility in Room W12–140 on the ground floor of the Department of Transportation West Building, 1200 New Jersey Avenue SE., Washington, DC 20590, between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. FOR FURTHER INFORMATION CONTACT: If you have questions on this temporary deviation, call or email David H. Sulouff, Chief, Bridge Section, Eleventh Coast Guard District; telephone 510– 437–3516, email David.H.Sulouff@ uscg.mil. If you have questions on viewing the docket, call Barbara Hairston, Program Manager, Docket Operations, telephone 202–366–9826. SUPPLEMENTARY INFORMATION: California Department of Transportation has requested a temporary change to the operation of the State Highway 4 Drawbridge, mile 14.8, over Old River, between Victoria Island and Byron Tract, CA. The drawbridge navigation span provides 12 feet vertical clearance above Mean High Water in the closedto-navigation position. Pursuant to 33 CFR 117.183, the draw opens on signal from May 1 through October 31 from 6 a.m. to 10 p.m. and from November 1 through April 30 from 9 a.m. to 5 p.m. and at other times, opening the draw on signal if at least four hours advance notice is given to the drawtender at the Rio Vista drawbridge across the Sacramento River, mile 12.8. Navigation on the waterway is recreational and commercial. The drawspan will be secured in the closed-to-navigation position from 6 p.m. on November 8, 2013 to 6 p.m. on December 6, 2013, to allow the bridge owner to repair the gears inside the main bridge gearbox, critical components of the drawbridge. This temporary deviation has been coordinated with the waterway users. No objections to the proposed temporary deviation were raised. Vessels able to pass through the bridge in the closed positions may do so at anytime. The bridge will not be able to open for emergencies. An alternative route around Victoria Island may be used for vessels unable to pass through the bridge in the closed position. The Coast Guard will also inform the users of the waterways through our Local and E:\FR\FM\26NOR1.SGM 26NOR1

Agencies

[Federal Register Volume 78, Number 228 (Tuesday, November 26, 2013)]
[Rules and Regulations]
[Page 70496]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-28256]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 558

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


Withdrawal of Approval of New Animal Drug Applications; Arsanilic 
Acid

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 of approval of a new animal 
drug application (NADA) for an arsanilic acid Type A medicated article 
at the sponsor's request because the product is no longer manufactured 
or marketed.

DATES: Withdrawal of approval is effective December 6, 2013.

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: Fleming Laboratories, Inc., P.O. Box 34384, 
Charlotte, NC 28234 has requested that FDA withdraw approval of NADA 
008-019 for PRO-GEN (arsanilic acid) Type A medicated article because 
the product, used to manufacture Type B and Type C medicated feeds, is 
no longer manufactured or marketed.
    Elsewhere in this issue of the Federal Register, FDA gave notice 
that approval of NADA 008-019, and all supplements and amendments 
thereto, is withdrawn, effective December 6, 2013. 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 558

    Animal drugs, Animal feeds.

    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 part 558 is 
amended as follows:

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

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

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


Sec.  558.62  [Amended]

0
2. In Sec.  558.62, remove and reserve paragraphs (a)(1), (a)(2), 
(c)(1)(i), and (c)(1)(ii); and in paragraphs (c)(1)(iii), (c)(1)(iv), 
(c)(1)(v), (c)(1)(vi), and (c)(1)(vii), in the ``Arsanilic acid in 
grams per ton'' column, add ``90''.

    Dated: November 20, 2013.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2013-28256 Filed 11-25-13; 8:45 am]
BILLING CODE 4160-01-P