Oral Dosage Form New Animal Drugs; Withdrawal of Approval of New Animal Drug Application; Oxytetracycline, 74021 [2014-29248]

Download as PDF Federal Register / Vol. 79, No. 240 / Monday, December 15, 2014 / Rules and Regulations (b) Sponsors. See sponsors in § 510.600(c) of this chapter for use as in paragraph (c) of this section. (1) No. 053599 for use of in 2 mg/mL solution as in paragraph (c)(1) of this section. (2) No. 053923 for use of in 5 mg/mL solution as in paragraph (c)(2) of this section. (c) Conditions of use—(1) Dogs—(i) Amount. Administer 0.05 mg per pound (0.11 mg per kilogram) of body weight by intravenous injection. (ii) Indications for use. To reverse the effects of xylazine in dogs. (iii) Limitations. Not for use in foodproducing animals. Federal law restricts this drug to use by or on the order of a licensed veterinarian. (2) Deer and elk—(i) Amount. Administer 0.2 to 0.3 mg per kilogram of body weight by intravenous injection. (ii) Indications for use. A s an antagonist to xylazine sedation in free ranging or confined members of the family Cervidae (deer and elk). (iii) Limitations. Do not use in domestic food-producing animals. Do not use for 30 days before or during hunting season. Federal law restricts this drug to use by or on the order of a licensed veterinarian. PART 558—NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS 20. The authority citation for 21 CFR part 558 continues to read as follows: ■ Authority: 21 U.S.C. 360b, 371. § 558.76 [Amended] 21. In § 558.76, in paragraph (d)(1)(x), in the entry for ‘‘Quail’’, in the ‘‘Limitations’’ column, remove the first sentence. ■ § 558.105 [Removed] 22. Remove reserved § 558.105. ■ 23. In § 558.355, add paragraph (f)(1)(xxxi) to read as follows: ■ § 558.355 Monensin. tkelley on DSK3SPTVN1PROD with RULES * * * * * (f) * * * (1) * * * (xxxi) Amount per ton. Monensin, 90 to 110 grams; plus virginiamycin, 20 grams. (a) Indications for use. Broiler chickens: As an aid in the prevention of coccidiosis caused by E. necatrix, E. tenella, E. acervulina, E. brunetti, E. mivati, and E. maxima; and for prevention of necrotic enteritis caused by Clostridium perfringens susceptible to virginiamycin. (b) Limitations. Feed continuously as sole ration. Do not feed to laying chickens. See paragraph (d) of this VerDate Sep<11>2014 17:02 Dec 12, 2014 Jkt 235001 section. As monensin provided by No. 000986; virginiamycin as provided by No. 066104 in § 510.600(c) of this chapter. * * * * * Dated: December 9, 2014. Bernadette Dunham, Director, Center for Veterinary Medicine. [FR Doc. 2014–29249 Filed 12–12–14; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 74021 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 ANADA 200–305, and all supplements and amendments thereto, is hereby withdrawn, effective December 26, 2014. Elsewhere in this issue of the Federal Register, FDA is amending the animal drug regulations to reflect the voluntary withdrawal of approval of this application. Dated: December 9, 2014. Bernadette Dunham, Director, Center for Veterinary Medicine. [FR Doc. 2014–29248 Filed 12–12–14; 8:45 am] 21 CFR Part 520 BILLING CODE 4164–01–P [Docket No. FDA–2014–N–0002] Oral Dosage Form New Animal Drugs; Withdrawal of Approval of New Animal Drug Application; Oxytetracycline AGENCY: Food and Drug Administration, HHS. Notification of withdrawal of approval. ACTION: The Food and Drug Administration (FDA) is withdrawing approval of an abbreviated new animal drug application (ANADA) for an oxytetracycline soluble powder used to make medicated drinking water for livestock and poultry. This action is being taken at the sponsor’s request because this product is no longer manufactured or marketed. DATES: Withdrawal of approval is effective December 26, 2014. FOR FURTHER INFORMATION CONTACT: Sujaya Dessai, Center for Veterinary Medicine (HFV–212), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240–276–9075, sujaya.dessai@fda.hhs.gov. SUPPLEMENTARY INFORMATION: ´ Vetoquinol N.-A., Inc., 2000 chemin Georges, Lavaltrie (PQ), Canada, J5T 3S5 has requested that FDA withdraw approval of ANADA 200–305 for Oxytetracycline Hydrochloride Soluble Powder because the product is no longer manufactured or marketed. Note this ANADA was identified as being affected by guidance for industry (GFI) #213, ‘‘New Animal Drugs and New Animal Drug Combination Products Administered in or on Medicated Feed or Drinking Water of Food-Producing Animals: Recommendations for Drug Sponsors for Voluntarily Aligning Product Use Conditions with GFI #209’’, December 2013. Therefore, under authority delegated to the Commissioner of Food and Drugs and redelegated to the Center for SUMMARY: PO 00000 Frm 00007 Fmt 4700 Sfmt 4700 PENSION BENEFIT GUARANTY CORPORATION 29 CFR Parts 4022 and 4044 Allocation of Assets in SingleEmployer Plans; Benefits Payable in Terminated Single-Employer Plans; Interest Assumptions for Valuing and Paying Benefits Pension Benefit Guaranty Corporation. ACTION: Final rule. AGENCY: This final rule amends the Pension Benefit Guaranty Corporation’s regulations on Benefits Payable in Terminated Single-Employer Plans and Allocation of Assets in Single-Employer Plans to prescribe interest assumptions under the benefit payments regulation for valuation dates in January 2015 and interest assumptions under the asset allocation regulation for valuation dates in the first quarter of 2015. The interest assumptions are used for valuing and paying benefits under terminating single-employer plans covered by the pension insurance system administered by PBGC. DATES: Effective January 1, 2015. FOR FURTHER INFORMATION CONTACT: Catherine B. Klion (Klion.Catherine@ PBGC.gov), Assistant General Counsel for Regulatory Affairs, Pension Benefit Guaranty Corporation, 1200 K Street NW., Washington, DC 20005, 202–326– 4024. (TTY/TDD users may call the Federal relay service toll free at 1–800– 877–8339 and ask to be connected to 202–326–4024.) SUPPLEMENTARY INFORMATION: PBGC’s regulations on Allocation of Assets in Single-Employer Plans (29 CFR part 4044) and Benefits Payable in Terminated Single-Employer Plans (29 CFR part 4022) prescribe actuarial SUMMARY: E:\FR\FM\15DER1.SGM 15DER1

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[Federal Register Volume 79, Number 240 (Monday, December 15, 2014)]
[Unknown Section]
[Page 74021]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-29248]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 520

[Docket No. FDA-2014-N-0002]


Oral Dosage Form New Animal Drugs; Withdrawal of Approval of New 
Animal Drug Application; Oxytetracycline

AGENCY: Food and Drug Administration, HHS.

ACTION: Notification of withdrawal of approval.

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SUMMARY: The Food and Drug Administration (FDA) is withdrawing approval 
of an abbreviated new animal drug application (ANADA) for an 
oxytetracycline soluble powder used to make medicated drinking water 
for livestock and poultry. This action is being taken at the sponsor's 
request because this product is no longer manufactured or marketed.

DATES: Withdrawal of approval is effective December 26, 2014.

FOR FURTHER INFORMATION CONTACT: Sujaya Dessai, Center for Veterinary 
Medicine (HFV-212), Food and Drug Administration, 7519 Standish Pl., 
Rockville, MD 20855, 240-276-9075, sujaya.dessai@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: V[eacute]toquinol N.-A., Inc., 2000 chemin 
Georges, Lavaltrie (PQ), Canada, J5T 3S5 has requested that FDA 
withdraw approval of ANADA 200-305 for Oxytetracycline Hydrochloride 
Soluble Powder because the product is no longer manufactured or 
marketed. Note this ANADA was identified as being affected by guidance 
for industry (GFI) #213, ``New Animal Drugs and New Animal Drug 
Combination Products Administered in or on Medicated Feed or Drinking 
Water of Food-Producing Animals: Recommendations for Drug Sponsors for 
Voluntarily Aligning Product Use Conditions with GFI #209'', December 
2013.
    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 ANADA 
200-305, and all supplements and amendments thereto, is hereby 
withdrawn, effective December 26, 2014.
    Elsewhere in this issue of the Federal Register, FDA is amending 
the animal drug regulations to reflect the voluntary withdrawal of 
approval of this application.

    Dated: December 9, 2014.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2014-29248 Filed 12-12-14; 8:45 am]
BILLING CODE 4164-01-P