74018 Federal Register / Vol. 79, No. 240 / Monday, December 15, 2014 / Rules and Regulations 

R–2933 Cape Canaveral, FL [Amended] 

By removing the current boundaries and 

adding the following: 

Boundaries. Beginning at lat. 28°39′21′′ N., 

long. 80°42′39′′ W.; to lat. 28°41′33′′ N., long. 

80°35′25′′ W.; thence 3 NM from and parallel 

to the shoreline; to lat. 28°24′31′′ N., long. 

80°29′52′′ W.; to lat. 28°25′01′′ N., long. 

80°37′59′′ W.; to lat. 28°34′01′′ N., long. 

80°39′29′′ W.; to the point of beginning. 

R–2934 Cape Canaveral, FL [Amended] 

By removing the current boundaries and 

adding the following: 

Boundaries. Beginning at lat. 28°49′11′′ N., 

long. 80°50′44′′ W.; to lat. 28°51′16′′ N., long. 

80°47′14′′ W.; to lat. 28°51′16′′ N., long. 

80°42′29′′ W.; thence 3 NM from and parallel 

to the shoreline; to lat. 28°41′33′′ N., long. 

80°35′25′′ W.; to lat. 28°39′21′′ N., long. 

80°42′39′′ W.; to lat. 28°34′01′′ N., long. 

80°39′29′′ W.; to lat. 28°25′01′′ N., long. 

80°37′59′′ W.; to lat. 28°25′01′′ N., long. 

80°41′44′′ W.; to lat. 28°31′21′′ N., long. 

80°43′49′′ W.; to lat. 28°38′01′′ N., long. 

80°47′01′′ W.; to the point of beginning, 

excluding that airspace below 1,200 feet AGL 

west of a line from lat. 28°31′21′′ N., long. 

80°43′49′′ W.; to lat. 28°28′41′′ N., long. 

80°40′29′′ W.; to lat. 28°25′01′′ N., long. 

80°40′29′′ W. 

R–2935 Cape Canaveral, FL [Amended] 

By removing the current boundaries and 

adding the following: 

Boundaries. Beginning at lat. 28°47′21′′ N., 

long. 81°04′59′′ W.; to lat. 28°58′02′′ N., long. 

80°46′58′′ W.; thence 3 NM from and parallel 

to the shoreline; to lat. 28°51′16′′ N., long. 

80°42′29′′ W.; to lat. 28°51′16′′ N., long. 

80°47′14′′ W.; to lat. 28°49′11′′ N., long. 

80°50′44′′ W.; to lat. 28°38′01′′ N., long. 

80°47′01′′ W.; to lat. 28°31′21′′ N., long. 

80°43′49′′ W.; to lat. 28°25′01′′ N., long. 

80°41′44′′ W.; to lat. 28°24′31′′ N., long. 

80°29′52′′ W.; thence 3 NM from and parallel 

to the shoreline; to lat. 28°19′01′′ N., long. 

80°33′00′′ W.; to lat. 28°19′01′′ N., long. 

80°46′29′′ W.; to the point of beginning. 

Issued in Washington, DC, on December 9, 

2014. 

Gary A. Norek, 

Manager, Airspace Policy and Regulations 

Group. 

[FR Doc. 2014–29268 Filed 12–12–14; 8:45 am] 

BILLING CODE 4910–13–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Parts 510, 520, 522, and 558 

[Docket No. FDA–2014–N–0002] 

New Animal Drugs; Approval of New 

Animal Drug Applications; Change of 

Sponsor; Withdrawal of Approval of 

New Animal Drug Applications 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Final rule, technical 

amendment. 

SUMMARY: The Food and Drug 

Administration (FDA) is amending the 

animal drug regulations to reflect 

approval actions for new animal drug 

applications (NADAs) and abbreviated 

new animal drug applications 

(ANADAs) during September and 

October 2014. FDA is also informing the 

public of the availability of summaries 

of the basis of approval and of 

environmental review documents, 

where applicable. The animal drug 

regulations are also being amended to 

reflect a change of sponsorship of six 

NADAs and four ANADAs, the 

voluntary withdrawal of approval of an 

ANADA, and a correcting amendment. 

DATES: This rule is effective December 

15, 2014, except for the amendment to 

21 CFR 520.1660d, which is effective 

December 26, 2014. 

FOR FURTHER INFORMATION CONTACT: 

George K. Haibel, Center for Veterinary 

Medicine (HFV–6), Food and Drug 

Administration, 7519 Standish Pl., 

Rockville, MD 20855, 240–276–9019, 

george.haibel@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: FDA is 

amending the animal drug regulations to 

reflect approval actions for NADAs and 

ANADAs during September and October 

2014, as listed in table 1. In addition, 

FDA is informing the public of the 

availability, where applicable, of 

documentation of environmental review 

required under the National 

Environmental Policy Act (NEPA) and, 

for actions requiring review of safety or 

effectiveness data, summaries of the 

basis of approval (FOI Summaries) 

under the Freedom of Information Act 

(FOIA). These public documents may be 

seen in the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, Rm. 

1061, Rockville, MD 20852, between 9 

a.m. and 4 p.m., Monday through 

Friday. Persons with access to the 

Internet may obtain these documents at 

the CVM FOIA Electronic Reading 

Room: http://www.fda.gov/AboutFDA/

CentersOffices/OfficeofFoods/CVM/

CVMFOIAElectronicReadingRoom/

default.htm. Marketing exclusivity and 

patent information may be accessed in 

FDA’s publication, Approved Animal 

Drug Products Online (Green Book) at: 

http://www.fda.gov/AnimalVeterinary/

Products/ApprovedAnimalDrug 

Products/default.htm. 

In addition, Lloyd, Inc., 604 W. 

Thomas Ave., Shenandoah, IA 51601, 

has transferred ownership of, and all 

rights and interest in, the following 

approved applications to Akorn Animal 

Health, Inc., 1925 West Field Ct., Suite 

300, Lake Forest, IL 60045. 

File No. Product name 21 CFR cite 

139–236 .................................... ANASED (xylazine hydrochloride) Injectable Solution ................................................................. 522.2662 

140–866 .................................... YOBINE (yohimbine hydrochloride) Injectable Solution .............................................................. 522.2670 

140–994 .................................... TOLAZINE (tolazine hydrochloride) Injectable Solution .............................................................. 522.2474 

200–055 .................................... VETAKET (ketamine hydrochloride) Injectable Solution ............................................................. 522.1222 

200–332 .................................... BUTORPHIC (butorphanol tartrate) Injectable Solution .............................................................. 522.246 

Bioniche Animal Health USA, Inc., 

119 Rowe Rd., Athens, GA 30601, has 

transferred ownership of, and all rights 

and interest in, the following approved 

applications to Ve ́toquinol USA, Inc., 

4250 N. Sylvania Ave., Fort Worth, TX 

76137. 

File No. Product name 21 CFR cite 

141–431 .................................... FOLLTROPIN (follicle stimulating hormone) Injection ................................................................. 522.1002 

200–266 .................................... BUTEQUINE (phenylbutazone) Paste ......................................................................................... 520.1720c 

200–432 .................................... NEXHA (hyaluronate sodium) Injection ....................................................................................... 522.1145 


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Federal Register / Vol. 79, No. 240 / Monday, December 15, 2014 / Rules and Regulations 74019 

In addition, Veterinary Service, Inc. 

4100 Bangs Ave., Modesto, CA 95356, 

has transferred ownership of, and all 

rights and interest in, NADA 065–252 

for STREP–SOL (streptomycin sulfate) 

Oral Solution to Huvepharma AD, 5th 

Floor, 3A Nikolay Haitov Str., 1113 

Sofia, Bulgaria. 

Also, Elanco Animal Health, Inc., A 

Division of Eli Lilly & Co., Lilly 

Corporate Center, Indianapolis, IN 

46285, has transferred ownership of, 

and all rights and interest in, NADA 

141–272 for RECONCILE (fluoxetine 

hydrochloride) Chewable Tablets to 

Nexcyon Pharmaceuticals, Inc., 644 

West Washington Ave., Madison, WI 

53703. 

At this time, the regulations are being 

amended to reflect these changes of 

sponsorship. Following these changes of 

sponsorship, Akorn Animal Health, Inc., 

Nexcyon Pharmaceuticals, Inc., and 

Ve ́toquinol USA, Inc. will now be the 

sponsors of an approved application 

while Bioniche Animal Health USA, 

Inc. and Veterinary Service, Inc. will no 

longer be the sponsors of an approved 

application. Accordingly, 21 CFR 

510.600(c) is being amended to reflect 

these changes. 

FDA is also amending the regulations 

at 21 CFR 558.76 to remove a limitation 

on the concentrations of bacitracin 

methylene disalicyclate Type A 

medicated articles that can be used to 

manufacture medicated feed for quail. 

In addition, FDA is removing reserved 

21 CFR 558.105 for which there is no 

entry. These actions are being taken to 

improve the accuracy of the regulations. 

Also, 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. 

Elsewhere in this issue of the Federal 

Register, FDA gave notice that approval 

of ANADA 200–305, and all 

supplements and amendments thereto, 

is withdrawn, effective December 26, 

2014. As provided in the regulatory text 

of this document, the animal drug 

regulations are amended to reflect this 

voluntary withdrawal 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. 

TABLE 1—ORIGINAL AND SUPPLEMENTAL NADAS AND ANADAS APPROVED DURING SEPTEMBER AND OCTOBER 2014 

NADA/ 

ANADA Sponsor New animal drug product name Action 21 CFR sections 

FOIA 

summary 

NEPA 

review 

141–244 ...... Zoetis Inc., 333 Portage 

St., Kalamazoo, MI 

49007.

DRAXXIN (tulathromycin) 

Injectable Solution.

Supplemental approval for 

treatment of bovine respiratory disease (BRD) 

in suckling calves, dairy 

calves, and veal calves.

522.2630 yes ............... CE1 2

141–430×3 ... Phibro Animal Health 

Corp., GlenPointe Centre East, 3d Floor, 300 

Frank W. Burr Blvd., 

suite 21, Teaneck, NJ 

07666.

STAFAC (virginiamycin) 

plus COBAN (monensin) 

combination drug Type 

C medicated feeds.

Original approval for prevention of coccidiosis 

and necrotic enteritis in 

broiler chickens.

558.355 yes ............... CE1 4

200–522 ...... Putney, Inc., One Monument Sq., suite 400, 

Portland, ME 04101.

Carprofen Sterile 

Injectable Solution.

Original approval as a generic copy of NADA 

141–199.

522.304 yes .............. CE1 5

200–540 ...... Putney, Inc., One Monument Sq., suite 400, 

Portland, ME 04101.

Meloxicam (meloxicam) 

Solution for Injection.

Original approval as a generic copy of NADA 

141–219.

522.1367 yes .............. CE1 5

200–581 ...... Cross Vetpharm Group 

Ltd., Broomhill Rd., 

Tallaght, Dublin 24, Ireland.

FLUNAZINE (flunixin 

meglumine) Equine 

Paste.

Original approval as a generic copy of NADA 

137–409.

520.970 yes ............... CE1 5

1The Agency has determined that this action is categorically excluded (CE) from the requirement to submit an environmental assessment or 

an environmental impact statement because it is of a type that does not have a significant effect on the human environment. 2 CE granted under 21 CFR 25.33(d)(5). 

3This application is affected by 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. 4 CE granted under 21 CFR 25.33(a)(2). 

5 CE granted under 21 CFR 25.33(a)(1). 

List of Subjects 

21 CFR Part 510 

Administrative practice and 

procedure, Animal drugs, Labeling, 

Reporting and recordkeeping 

requirements. 

21 CFR Parts 520 and 522 

Animal drugs. 

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 parts 510, 520, 522, and 558 are 

amended as follows: 

PART 510—NEW ANIMAL DRUGS 

■ 1. The authority citation for 21 CFR 

part 510 continues to read as follows: 

Authority: 21 U.S.C. 321, 331, 351, 352, 

353, 360b, 371, 379e. 

■ 2. In § 510.600, in the table in 

paragraph (c)(1), remove the entries for 

‘‘Bioniche Animal Health USA, Inc.’’ 

and ‘‘Veterinary Service, Inc.’’ and 


tkelley on DSK3SPTVN1PROD with RULES
74020 Federal Register / Vol. 79, No. 240 / Monday, December 15, 2014 / Rules and Regulations 

alphabetically add entries for ‘‘Akorn 

Animal Health, Inc.’’, ‘‘Nexcyon 

Pharmaceuticals, Inc.’’, and ‘‘Ve ́toquinol 

USA, Inc.’’; and in the table in 

paragraph (c)(2), remove the entries for 

‘‘033008’’ and ‘‘064847’’ and 

numerically add entries for ‘‘017030’’, 

‘‘050929’’, and ‘‘053599’’ to read as 

follows: 

§ 510.600 Names, addresses, and drug 

labeler codes of sponsors of approved 

applications. 

* * * * * 

(c) * * * 

(1) * * * 

Firm name and address Drug labeler 

code 

* * * * * 

Akorn Animal Health, Inc., 

1925 West Field Ct., suite 

300, Lake Forest, IL 60045 053599 

* * * * * 

Nexcyon Pharmaceuticals, 

Inc., 644 West Washington 

Ave., Madison, WI 53719 .. 050929 

* * * * * 

Ve ́toquinol USA, Inc., 4250 

N. Sylvania Ave., Fort 

Worth, TX 76137 ............... 017030 

* * * * * 

(2) * * * 

Drug labeler 

code Firm name and address 

* * * * * 

017030 ........ Ve ́toquinol USA, Inc., 4250 N. 

Sylvania Ave., Fort Worth, 

TX 76137. 

* * * * * 

050929 ........ Nexcyon Pharmaceuticals, 

Inc., 644 West Washington 

Ave., Madison, WI 53719. 

* * * * * 

053599 ........ Akorn Animal Health, Inc., 

1925 West Field Ct., suite 

300, Lake Forest, IL 60045. 

* * * * * 

PART 520—ORAL DOSAGE FORM 

NEW ANIMAL DRUGS 

■ 3. The authority citation for 21 CFR 

part 520 continues to read as follows: 

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

■ 4. In § 520.970, revise paragraphs (b) 

and (c)(1) to read as follows: 

§ 520.970 Flunixin. 

* * * * * 

(b) Sponsors. See sponsors in 

§ 510.600(c) of this chapter for use as in 

paragraph (c) of this section. 

(1) No. 000061 for use of products 

described in paragraph (a). 

(2) No. 061623 for use of the product 

described in paragraph (a)(2). 

(c) * * * 

(1) Amount. 0.5 mg per pound of body 

weight per day for up to 5 days. 

* * * * * 

§ 520.980 [Amended] 

5. In paragraph (b) of § 520.980, 

remove ‘‘000986’’ and in its place add 

‘‘050929’’. 

§ 520.1660d [Amended] 

■ 6. In § 520.1660d, remove paragraph 

(b)(8); and in paragraphs (d)(1)(ii)(A)(3), 

(d)(1)(ii)(B)(3), (d)(1)(ii)(C)(3), and 

(d)(1)(iii)(C), remove ‘‘059320,’’. 

§ 520.1720c [Amended] 

■ 7. In paragraph (b)(2) of § 520.1720c, 

remove ‘‘064847’’ and in its place add 

‘‘017030’’. 

§ 520.2158 [Amended] 

■ 8. In paragraph (b) of § 520.2158, 

remove ‘‘033008’’ and in its place add 

‘‘016592’’. 

PART 522—IMPLANTATION OR 

INJECTABLE DOSAGE FORM NEW 

ANIMAL DRUGS 

■ 9. The authority citation for 21 CFR 

part 522 continues to read as follows: 

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

§ 522.246 [Amended] 

■ 10. In paragraph (b)(3) of § 522.246, 

remove ‘‘061690’’ and in its place add 

‘‘053599’’. 

■ 11. In § 522.304, revise paragraph (b) 

to read as follows: 

§ 522.304 Carprofen. 

* * * * * 

(b) Sponsors. See Nos. 026637, 

054771, and 055529 in § 510.600(c) of 

this chapter. 

* * * * * 

§ 522.1002 [Amended] 

■ 12. In paragraph (c)(2) of § 522.1002, 

remove ‘‘064847’’ and in its place add 

‘‘017030’’. 

§ 522.1145 [Amended] 

■ 13. In paragraph (e)(2)(ii) of 

§ 522.1145, remove ‘‘064847’’ and in its 

place add ‘‘017030’’. 

■ 14. In § 522.1222, revise paragraph (b) 

to read as follows: 

§ 522.1222 Ketamine. 

* * * * * 

(b) Sponsors. See Nos. 000859, 

026637, 053599, 054628, 054771, and 

063286 in § 510.600(c) of this chapter. 

* * * * * 

■ 15. In § 522.1367, revise paragraph (b) 

to read as follows: 

§ 522.1367 Meloxicam. 

* * * * * 

(b) Sponsors. See Nos. 000010, 

016729, 026637, and 055529 in 

§ 510.600(c) of this chapter. 

* * * * * 

§ 522.2474 [Amended] 

■ 16. In paragraph (b) of § 522.2474, 

remove ‘‘061690’’ and in its place add 

‘‘053599’’. 

■ 17. In § 522.2630, revise paragraph 

(d)(1) to read as follows: 

§ 522.2630 Tulathromycin. 

* * * * * 

(d) * * * 

(1) Cattle—(i) Amount. 2.5 mg per 

kilogram (/kg) body weight as a single 

subcutaneous injection in the neck. 

(ii) Indications for use—(A) Beef and 

non-lactating dairy cattle; suckling 

calves, dairy calves, and veal calves: For 

the treatment of bovine respiratory 

disease (BRD) associated with 

Mannheimia haemolytica, Pasteurella 

multocida, Histophilus somni, and 

Mycoplasma bovis; 

(B) Beef and non-lactating dairy 

cattle: For the control of respiratory 

disease in cattle at high risk of 

developing BRD associated with M. 

haemolytica, P. multocida, H. somni, 

and M. bovis. For the treatment of 

infectious bovine keratoconjunctivitis 

associated with Moraxella bovis. For the 

treatment of bovine foot rot (interdigital 

necrobacillosis) associated with 

Fusobacterium necrophorum and 

Porphyromonas levii. 

(iii) Limitations. Cattle intended for 

human consumption must not be 

slaughtered within 18 days from the last 

treatment. Do not use in female dairy 

cattle 20 months of age or older. Federal 

law restricts this drug to use by or on 

the order of a licensed veterinarian. 

* * * * * 

§ 522.2662 [Amended] 

■ 18. In paragraph (b)(4) of § 522.2662, 

remove ‘‘061690’’ and in its place add 

‘‘053599’’. 

■ 19. Revise § 522.2670 to read as 

follows: 

§ 522.2670 Yohimbine. 

(a) Specifications. Each milliliter (mL) 

of solution contains 2 or 5 milligrams 

(mg) of yohimbine (as hydrochloride). 


tkelley on DSK3SPTVN1PROD with RULES
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 


tkelley on DSK3SPTVN1PROD with RULES