Federal Register / Vol. 79, No. 240 / Monday, December 15, 2014 / Rules and Regulations 74021 

(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. 

* * * * * 

(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 

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 

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. 

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: 

Ve ́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 § 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 

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 

AGENCY: Pension Benefit Guaranty 

Corporation. 

ACTION: Final rule. 

SUMMARY: 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 


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