New Animal Drugs; Withdrawal of Approval of New Animal Drug Application, 8982-8983 [2019-04222]

Download as PDF 8982 Federal Register / Vol. 84, No. 49 / Wednesday, March 13, 2019 / Rules and Regulations Salinomycin in grams/ton Combination in grams/ton Indications for use Limitations (iv) 40 to 60 ..... Bacitracin methylenedisalicylate, 100 to 200. Broiler chickens: For the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti, and E. mivati, and as an aid in the control of necrotic enteritis caused or complicated by Clostridium spp. or other organisms susceptible to bacitracin. (v) 40 to 60 ...... Bacitracin zinc, 10 to 50. Broiler chickens: For the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti, and E. mivati, and for increased rate of weight gain. (vi) 40 to 60 ..... Bambermycins, 1 to 3. Broiler chickens: For the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti, and E. mivati, and for improved feed efficiency. Feed continuously as sole ration. To control necrotic enteritis, start medication at first clinical signs of disease; vary dosage based on the severity of infection; administer continuously for 5 to 7 days or as long as clinical signs persist, then reduce bacitracin to prevention level (50 grams per ton). Do not feed to laying chickens. May be fatal if fed to adult turkeys or to horses. Salinomycin as provided by No. 016592; bacitracin methylenedisalicylate as provided by No. 054771 in § 510.600(c) in this chapter. Feed continuously as sole ration. Not approved for use with pellet binders. Do not feed to layers. May be fatal if accidentally fed to adult turkeys or horses. Bacitracin zinc as provided by No. 054771 in § 510.600(c) of this chapter. Feed continuously as sole ration. Do not feed to laying chickens. Not approved for use with pellet binders. May be fatal if accidentally fed to adult turkeys or horses. Salinomycin and bambermycins as provided by No. 016592 in § 510.600(c) in this chapter. Sponsor 054771 016592 054771 016592 (2) Game birds— Salinomycin in grams/ton Combination in grams per ton Indications for use Limitations Sponsor (i) 50 ................ ................................. Quail: For the prevention of coccidiosis caused by E. dispersa and E. lettyae. ........................ (ii) [Reserved] .. ................................. ................................................................... Feed continuously as sole ration. Not approved for use with pellet binders. Do not feed to laying hens producing eggs for human consumption. May be fatal if accidentally fed to adult turkeys or horses. ................................................................... (3) Salinomycin may also be used in combination with: (i) Chlortetracycline as in § 558.128. (ii) Lincomycin as in § 558.325. (iii) Oxytetracycline as in § 558.450. (iv) Virginiamycin as in § 558.635. Dated: March 5, 2019. Lowell J. Schiller, Acting Associate Commissioner for Policy. 87. In § 558.625, revise paragraphs (b)(1) through (4) to read as follows: DEPARTMENT OF HEALTH AND HUMAN SERVICES § 558.625 Food and Drug Administration ■ Tylosin. amozie on DSK9F9SC42PROD with RULES * * * * * (b) * * * (1) No. 016592: Type A medicated articles containing 40 or 100 grams per pound (g/lb). (2) No. 054771: Type A medicated article containing 40 g/lb. (3) No. 058198: Type A medicated articles containing 10, 40, or 100 g/lb. (4) No. 066104: Type A medicated articles containing 20 or 40 g/lb. * * * * * VerDate Sep<11>2014 16:11 Mar 12, 2019 Jkt 247001 [FR Doc. 2019–04226 Filed 3–12–19; 8:45 am] BILLING CODE 4164–01–P 21 CFR Part 520 [Docket No. FDA–2018–N–0002] New Animal Drugs; Withdrawal of Approval of New Animal Drug Application AGENCY: Food and Drug Administration, HHS. ACTION: Notification of withdrawal. The Food and Drug Administration (FDA) is withdrawing SUMMARY: PO 00000 Frm 00030 Fmt 4700 Sfmt 4700 ........................ approval of a new animal drug application (NADA) and an abbreviated new animal drug application (ANADA) at the sponsors’ request because these products are no longer manufactured or marketed. DATES: Withdrawal of approval is effective March 25, 2019. FOR FURTHER INFORMATION CONTACT: Sujaya Dessai, Center for Veterinary Medicine (HFV–212), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240–402–5761, sujaya.dessai@fda.hhs.gov. SUPPLEMENTARY INFORMATION: Elanco US Inc., 2500 Innovation Way, Greenfield, IN 46140, has requested that FDA withdraw approval of NADA 140–939 for use of RUMENSIN (monensin) and TYLAN (tylosin phosphate) Type A medicated articles in the manufacture of combination drug Type C medicated cattle feeds because the product is no longer manufactured or marketed. E:\FR\FM\13MRR1.SGM 13MRR1 Federal Register / Vol. 84, No. 49 / Wednesday, March 13, 2019 / Rules and Regulations Also, Sergeant’s Pet Care Products, Inc., 10077 S 134th St., Omaha, NE 68138 has requested that FDA withdraw approval of ANADA 200–600 for WORMX (pyrantel pamoate) Flavored Tablets because the product is no longer manufactured or marketed. 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 NADA 140–939 and ANADA 200– 600, and all supplements and amendments thereto, is hereby withdrawn, effective March 25, 2019. 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. Dated: March 4, 2019. Lowell J. Schiller, Acting Associate Commissioner for Policy. BILLING CODE 4164–01–P DEPARTMENT OF TRANSPORTATION Saint Lawrence Seaway Development Corporation 33 CFR Part 401 RIN 2135–AA45 Seaway Regulations and Rules: Periodic Update, Various Categories Saint Lawrence Seaway Development Corporation, DOT. ACTION: Final rule. AGENCY: The Saint Lawrence Seaway Development Corporation (SLSDC) and the St. Lawrence Seaway Management Corporation (SLSMC) of Canada, under international agreement, jointly publish and presently administer the St. Lawrence Seaway Regulations and Rules (Practices and Procedures in Canada) in their respective jurisdictions. Under agreement with the SLSMC, the SLSDC is amending the joint regulations by updating the Seaway Regulations and Rules in various categories. The changes update the following sections of the Regulations and Rules: Seaway Navigation; and, Information and Reports. These amendments are merely editorial or for clarification of existing requirements. The joint regulations will become effective in Canada on March 30, 2019. For consistency, because these are joint regulations under international agreement, and to avoid confusion amozie on DSK9F9SC42PROD with RULES VerDate Sep<11>2014 16:11 Mar 12, 2019 Jkt 247001 This rule is effective on March 30, 2019. DATES: Docket: For access to the docket to read background documents or comments received, go to https:// www.Regulations.gov; or in person at the Docket Management Facility; U.S. Department of Transportation, 1200 New Jersey Avenue SE, West Building Ground Floor, Room W12–140, Washington, DC 20590–001, between 9 a.m. and 5 p.m., Monday through Friday, except Federal Holidays. ADDRESSES: FOR FURTHER INFORMATION CONTACT: Carrie Mann Lavigne, Chief Counsel, Saint Lawrence Seaway Development Corporation, 180 Andrews Street, Massena, New York 13662; 315/764– 3200. The Saint Lawrence Seaway Development Corporation (SLSDC) and the St. Lawrence Seaway Management Corporation (SLSMC) of Canada, under international agreement, jointly publish and presently administer the St. Lawrence Seaway Regulations and Rules (Practices and Procedures in Canada) in their respective jurisdictions. Under agreement with the SLSMC, the SLSDC is amending the joint regulations by updating the Regulations and Rules in various categories. The changes update the following sections of the Regulations and Rules: Seaway Navigation; and, Information and Reports. These changes are to clarify existing requirements in the regulations. Regulatory Notices: Privacy Act: Anyone is able to search the electronic form of all comments received into any of our dockets by the name of the individual submitting the comment (or signing the comment, if submitted on behalf of an association, business, labor union, etc.). You may review DOT’s complete Privacy Act Statement in the Federal Register published on April 11, 2000 (Volume 65, Number 70; Pages 19477–78) or you may visit https:// www.Regulations.gov. The joint regulations will become effective in Canada on March 30, 2019. SUPPLEMENTARY INFORMATION: [FR Doc. 2019–04222 Filed 3–12–19; 8:45 am] SUMMARY: among users of the Seaway, the SLSDC finds that there is good cause to make the U.S. version of the amendments effective on the same date. Regulatory Evaluation This regulation involves a foreign affairs function of the United States and therefore, Executive Order 12866 does not apply and evaluation under the Department of Transportation’s Regulatory Policies and Procedures is not required. PO 00000 Frm 00031 Fmt 4700 Sfmt 4700 8983 Regulatory Flexibility Act Determination I certify that this regulation will not have a significant economic impact on a substantial number of small entities. The St. Lawrence Seaway Regulations and Rules primarily relate to commercial users of the Seaway, the vast majority of who are foreign vessel operators. Therefore, any resulting costs will be borne mostly by foreign vessels. Environmental Impact This regulation does not require an environmental impact statement under the National Environmental Policy Act (49 U.S.C. 4321, et seq.) because it is not a major federal action significantly affecting the quality of the human environment. Federalism The Corporation has analyzed this rule under the principles and criteria in Executive Order 13132, dated August 4, 1999, and have determined that this proposal does not have sufficient federalism implications to warrant a Federalism Assessment. Unfunded Mandates The Corporation has analyzed this rule under Title II of the Unfunded Mandates Reform Act of 1995 (Pub. L. 104–4, 109 Stat. 48) and determined that it does not impose unfunded mandates on State, local, and tribal governments and the private sector requiring a written statement of economic and regulatory alternatives. Paperwork Reduction Act This regulation has been analyzed under the Paperwork Reduction Act of 1995 and does not contain new or modified information collection requirements subject to the Office of Management and Budget review. List of Subjects in 33 CFR Part 401 Hazardous materials transportation, Navigation (water), Penalties, Radio, Reporting and recordkeeping requirements, Vessels, Waterways. Accordingly, the Saint Lawrence Seaway Development Corporation is amending 33 CFR part 401 as follows: PART 401—SEAWAY REGULATIONS AND RULES Subpart A—Regulations 1. The authority citation for subpart A of part 401 continues to read as follows: ■ Authority: 33 U.S.C. 983(a) and 984(a) (4), as amended; 49 CFR 1.52, unless otherwise noted. E:\FR\FM\13MRR1.SGM 13MRR1

Agencies

[Federal Register Volume 84, Number 49 (Wednesday, March 13, 2019)]
[Rules and Regulations]
[Pages 8982-8983]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-04222]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 520

[Docket No. FDA-2018-N-0002]


New Animal Drugs; Withdrawal of Approval of New Animal Drug 
Application

AGENCY: Food and Drug Administration, HHS.

ACTION: Notification of withdrawal.

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SUMMARY: The Food and Drug Administration (FDA) is withdrawing approval 
of a new animal drug application (NADA) and an abbreviated new animal 
drug application (ANADA) at the sponsors' request because these 
products are no longer manufactured or marketed.

DATES: Withdrawal of approval is effective March 25, 2019.

FOR FURTHER INFORMATION CONTACT: Sujaya Dessai, Center for Veterinary 
Medicine (HFV-212), Food and Drug Administration, 7519 Standish Pl., 
Rockville, MD 20855, 240-402-5761, sujaya.dessai@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: Elanco US Inc., 2500 Innovation Way, 
Greenfield, IN 46140, has requested that FDA withdraw approval of NADA 
140-939 for use of RUMENSIN (monensin) and TYLAN (tylosin phosphate) 
Type A medicated articles in the manufacture of combination drug Type C 
medicated cattle feeds because the product is no longer manufactured or 
marketed.

[[Page 8983]]

    Also, Sergeant's Pet Care Products, Inc., 10077 S 134th St., Omaha, 
NE 68138 has requested that FDA withdraw approval of ANADA 200-600 for 
WORMX (pyrantel pamoate) Flavored Tablets because the product is no 
longer manufactured or marketed.
    Therefore, under authority delegated to the Commissioner of Food 
and Drugs and redelegated to the Center for Veterinary Medicine, and in 
accordance with Sec.  514.116 Notice of withdrawal of approval of 
application (21 CFR 514.116), notice is given that approval of NADA 
140-939 and ANADA 200-600, and all supplements and amendments thereto, 
is hereby withdrawn, effective March 25, 2019.
    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.

    Dated: March 4, 2019.
Lowell J. Schiller,
Acting Associate Commissioner for Policy.
[FR Doc. 2019-04222 Filed 3-12-19; 8:45 am]
BILLING CODE 4164-01-P
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