This section of the FEDERAL REGISTER

contains regulatory documents having general

applicability and legal effect, most of which

are keyed to and codified in the Code of

Federal Regulations, which is published under

50 titles pursuant to 44 U.S.C. 1510.

The Code of Federal Regulations is sold by

the Superintendent of Documents. Prices of

new books are listed in the first FEDERAL

REGISTER issue of each week.

Rules and Regulations Federal Register

18773 

Vol. 80, No. 67 

Wednesday, April 8, 2015 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Parts 510, 520, 522, 524, 529, 

and 558 

[Docket No. FDA–2015–N–0002] 

New Animal Drugs; Approval of New 

Animal Drug Applications; Withdrawal 

of Approval of New Animal Drug 

Applications; Change of Sponsor; 

Change of Sponsor’s Name; Change of 

Sponsor’s Address 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Final rule; technical 

amendments. 

SUMMARY: The Food and Drug 

Administration (FDA) is amending the 

animal drug regulations to reflect 

application-related actions for new 

animal drug applications (NADAs) and 

abbreviated new animal drug 

applications (ANADAs) during January 

and February 2015. 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 several nonsubstantive changes. These technical 

amendments are being made to improve 

the accuracy of the regulations. 

DATES: This rule is effective April 8, 

2015, except for the amendment to 21 

CFR 522.1004, which is effective April 

20, 2015. 

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 January and February 

2015, 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/ 

ApprovedAnimalDrugProducts/ 

default.htm. 

TABLE 1—ORIGINAL AND SUPPLEMENTAL NADAS AND ANADAS APPROVED DURING JANUARY AND FEBRUARY 2015 

NADA/ANADA Sponsor New animal drug 

product name Action 21 CFR sections FOIA summary NEPA review 

141–435 ........ Piedmont Animal 

Health, 204 Muirs 

Chapel Rd., Suite 

200, Greensboro, NC 

27410.

ADVANTUS 

(imidacloprid) 

Chewable Tablets.

Original approval for 

the treatment of flea 

infestations on dogs 

and puppies.

520.1156 yes ................. CE1 2

141–418 ........ Luitpold Pharmaceuticals, Inc., Animal Health Division, 

Shirley, NY 11967.

BETAVET 

(betamethasone sodium phosphate and 

betamethasone acetate) Injectable Suspension.

Original approval for 

the control of pain 

and inflammation associated with osteoarthritis in horses.

522.167 yes ................. CE1 2

200–527 ........ Putney, Inc., One 

Monument Sq., suite 

400, Portland, ME 

04101.

Enrofloxacin Antibacterial Injectable 

Solution.

Original approval as a 

generic copy of 

NADA 140–913.

522.812 yes ................. CE1 3

200–576 ........ Akorn Animal Health, 

Inc., 1925 West Field 

Ct., suite 300, Lake 

Forest, IL 60045.

Gentamicin Sulfate 

Ophthalmic Solution.

Original approval as a 

generic copy of 

NADA 099–008.

524.1044a yes ................. CE1 3


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18774 Federal Register / Vol. 80, No. 67 / Wednesday, April 8, 2015 / Rules and Regulations 

TABLE 1—ORIGINAL AND SUPPLEMENTAL NADAS AND ANADAS APPROVED DURING JANUARY AND FEBRUARY 2015— 

Continued 

NADA/ANADA Sponsor New animal drug 

product name Action 21 CFR sections FOIA summary NEPA review 

141–280 4 ...... Intervet, Inc., 556 Morris Ave., Summit, NJ 

07901.

ZILMAX (zilpaterol hydrochloride) plus 

RUMENSIN 

(monensin) plus 

TYLAN (tylosin phosphate) plus MGA 

(melengestrol acetate) Type A medicated articles.

Supplemental approval 

to provide for component feeding of combination drug Type C 

medicated feeds to 

heifers fed in confinement for slaughter.

558.665 yes ................. CE1 5

141–406 ........ Merial, Inc., 3239 Satellite Blvd., Bldg. 

500, Duluth, GA 

30096–4640.

NEXGARD (afoxolaner) 

Chewable Tablets.

Supplemental approval 

for the treatment and 

control of an additional tick species in 

dogs and puppies.

520.43 yes ................. CE1 2

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)(1). 

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

4This application is 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. 5 CE granted under 21 CFR 25.33(a)(2). 

In addition during January and 

February 2015, ownership of, and all 

rights and interest in, the following 

approved applications have been 

transferred as follows: 

NADA/ANADA Previous sponsor New animal drug product name New sponsor 21 CFR 

Section 

141–098 ........ Abbott Laboratories, North Chicago, IL 60064.PROPOFLO (propofol) Injectable 

Suspension.

Zoetis Inc., 333 Portage St., Kalamazoo, MI 49007.522.2005 

141–103 ........ Abbott Laboratories, North Chicago, IL 60064.SEVOFLO (sevoflurane) Inhalation 

Anesthetic.

Zoetis Inc., 333 Portage St., Kalamazoo, MI 49007.529.2150 

141–346 ........ Abbott Laboratories, North Chicago, IL 60064.OROCAM (meloxicam) Oral Spray Zoetis Inc., 333 Portage St., Kalamazoo, MI 49007.529.1350 

141–434 ........ Abbott Laboratories, North Chicago, IL 60064.SIMBADOL (buprenorphine) 

Injectable Solution.

Zoetis Inc., 333 Portage St., Kalamazoo, MI 49007.522.230 

200–070 ........ Abbott Laboratories, North Chicago, IL 60064.ISOFLO (isoflurane) Inhalation Anesthetic.Zoetis Inc., 333 Portage St., Kalamazoo, MI 49007.529.1186 

048–480 ........ ADM Alliance Nutrition., Inc., 1000 

North 30th St., Quincy, IL 

62305–3115.

CHLORATET 90 and 100 (chlortetracycline) Type A medicated 

articles.

Pharmgate LLC, 161 North Franklin Turnpike, suite 2C, Ramsey, 

NJ 07446.

558.128 

065–256 ........ ADM Alliance Nutrition., Inc., 1000 

North 30th St., Quincy, IL 

62305–3115.

CHLORTET-SOLUBLE-O (chlortetracycline) Powder.Pharmgate LLC, 161 North Franklin Turnpike, suite 2C, Ramsey, 

NJ 07446.

520.441 

200–197 ........ Contemporary Products, Inc., 3788 

Elm Springs Rd., Springdale, AR 

72764–6067.

Streptomycin Oral Solution ............ Huvepharma AD, 5th Floor, 3A 

Nikolay Haitov Str., 1113 Sofia, 

Bulgaria.

520.2158 

141–084 ........ Novartis Animal Health US, Inc., 

3200 Northline Ave., suite 300, 

Greensboro, NC 27408.

SENTINEL (milbemycin oxime and 

lufenuron) FLAVOR TABS.

Virbac AH, Inc., 3200 Meacham 

Blvd., Ft. Worth, TX 76137.

522.1143 

141–204 ........ Novartis Animal Health US, Inc., 

3200 Northline Ave., suite 300, 

Greensboro, NC 27408.

SENTINEL (milbemycin oxime and 

lufenuron) FLAVOR TABS and 

CAPSTAR (nitenpyram) Tablets 

Flea Management Program.

Virbac AH, Inc., 3200 Meacham 

Blvd., Ft. Worth, TX 76137.

520.1510 

141–333 ........ Novartis Animal Health US, Inc., 

3200 Northline Ave., suite 300, 

Greensboro, NC 27408.

SENTINEL SPECTRUM 

(milbemycin oxime/lufenuron/

praziquantel) Tablets.

Virbac AH, Inc., 3200 Meacham 

Blvd., Ft. Worth, TX 76137.

520.1447 

141–067 ........ OPK Biotech, LLC, 11 and 39 Hurley St., Cambridge, MA.OXYGLOBIN (hemoglobin 

glutamer-200 (bovine)).

Hemoglobin Oxygen Therapeutics, 

LLC, 674 Souder Rd., 

Souderton, PA 18964.

522.1125 


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At this time, the regulations are being 

amended to reflect these changes of 

sponsorship. 

In addition, Paladin Labs (USA), Inc., 

160 Greentree Dr., Suite 101, Dover, DE 

19904 has requested that FDA withdraw 

approval of NADA 141–075 for 

ANTIZOL–VET (fomepizole) Injection. 

Elsewhere in this issue of the Federal 

Register, FDA gave notice that approval 

of NADA 141–075, and all supplements 

and amendments thereto, is withdrawn, 

effective April 20, 2015. As provided in 

the regulatory text of this document, the 

animal drug regulations are being 

amended to reflect this voluntary 

withdrawal of approval. 

Following these changes of 

sponsorship and withdrawal of 

approval, Hemoglobin Oxygen 

Therapeutics, LLC is now the sponsor of 

an approved application while OPK 

Biotech, LLC and Paladin Labs (USA), 

Inc., are no longer the sponsor of an 

approved application. Also, Merial Ltd., 

3239 Satellite Blvd., Bldg. 500, Duluth, 

GA 30096–4640, has informed FDA that 

it has changed its name to Merial, Inc., 

and Intervet, Inc., 556 Morris Ave., 

Summit, NJ 07901, has informed FDA 

that it has changed its address to 2 

Giralda Farms, Madison, NJ 07940. 

Accordingly, § 510.600 (21 CFR 

510.600) is being amended to reflect 

these changes. 

In addition, FDA is amending the 

tables in § 510.600(c) to remove listings 

for International Nutrition, Inc.; 

NutriBasics Co.; Seeco Inc.; Southern 

Micro-Blenders, Inc.; and Wellmark 

International because these firms are no 

longer the sponsor of an approved 

application. These technical 

amendments are being made to improve 

the accuracy of the regulations. 

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 

21 CFR Part 510 

Administrative practice and 

procedure, Animal drugs, Labeling, 

Reporting and recordkeeping 

requirements. 

21 CFR Parts 520, 522, 524, and 529 

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, 524, 529, 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. Amend § 510.600 as follows: 

■ a. In the table in paragraph (c)(1), 

remove the entries for ‘‘Contemporary 

Products, Inc.’’, ‘‘International 

Nutrition, Inc.’’, ‘‘NutriBasics Co.’’, 

‘‘OPK Biotech, LLC’’, ‘‘Paladin Labs 

(USA), Inc.’’, ‘‘Seeco Inc.’’, ‘‘Southern 

Micro-Blenders, Inc.’’, and ‘‘Wellmark 

International’’; 

■ b. In the table in paragraph (c)(1), 

revise the entries for ‘‘Intervet, Inc.’’ and 

‘‘Merial Ltd.’’; and add an entry, in 

alphabetical order, for ‘‘Hemoglobin 

Oxygen Therapeutics, LLC’’; 

■ c. In the table in paragraph (c)(2), 

remove the entries for ‘‘011536’’, 

‘‘043733’’, ‘‘046129’’, and ‘‘055462’’; 

and 

■ d. In the table in paragraph (c)(2), 

revise the entries for ‘‘000061’’, 

‘‘050604’’, and ‘‘063075’’. 

The additions and revisions 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 

* * * * * 

Hemoglobin Oxygen Therapeutics, LLC, 674 Souder 

Rd., Souderton, PA 18964 063075 

* * * * * 

Intervet, Inc., 2 Giralda 

Farms, Madison, NJ 07940 000061 

* * * * * 

Merial, Inc., 3239 Satellite 

Blvd., Bldg. 500, Duluth, 

GA 30096–4640 ................ 050604 

* * * * * 

(2) * * * 

Drug labeler 

code Firm name and address 

* * * * * 

000061 ......... Intervet, Inc., 2 Giralda 

Farms, Madison, NJ 07940. 

Drug labeler 

code Firm name and address 

* * * * * 

050604 ......... Merial, Inc., 3239 Satellite 

Blvd., Bldg. 500, Duluth, 

GA 30096–4640. 

* * * * * 

063075 ......... Hemoglobin Oxygen Therapeutics, LLC, 674 Souder 

Rd., Souderton, PA 18964. 

* * * * * 

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 § 520.43, revise paragraph (c)(2) 

to read as follows: 

§ 520.43 Afoxolaner. 

* * * * * 

(c) * * * 

(2) Indications for use. Kills adult 

fleas; for the treatment and prevention 

of flea infestations (Ctenocephalides 

felis); for the treatment and control of 

black-legged tick (Ixodes scapularis), 

American dog tick (Dermacentor 

variabilis), lone star tick (Amblyomma 

americanum), and brown dog tick 

(Rhipicephalus sanguineus) infestations 

in dogs and puppies 8 weeks of age and 

older, weighing 4 lb of body weight or 

greater, for 1 month. 

* * * * * 

§ 520.441 [Amended] 

■ 5. In § 520.441, in paragraph (b)(4), 

remove ‘‘012286’’ and in its place add 

‘‘069254’’. 

■ 6. Add § 520.1156 to read as follows: 

§ 520.1156 Imidacloprid. 

(a) Specifications. Each chewable 

tablet contains 7.5 or 37.5 milligrams 

(mg) imidacloprid. 

(b) Sponsor. See No. 000859 in 

§ 510.600(c) of this chapter. 

(c) Conditions of use in dogs—(1) 

Amount. Administer daily one 7.5-mg 

chewable tablet to dogs weighing 4 to 22 

pounds (lb) or one 37.5-mg chewable 

table to dogs weighing 23 to 110 lb. 

(2) Indications for use. Kills adult 

fleas and is indicated for the treatment 

of flea infestations on dogs and puppies 

10 weeks of age and older and weighing 

4 lb or greater. 

(3) Limitations. Do not give to puppies 

younger than 10 weeks of age or to dogs 

weighing less than 4 lb. Do not give 

more than one tablet a day. 


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§ 520.1443 [Amended] 

■ 7. In § 520.1443, in paragraph (b), 

remove ‘‘058198’’ and in its place add 

‘‘051311’’. 

§ 520.1447 [Amended] 

■ 8. In § 520.1447, in paragraph (b), 

remove ‘‘058198’’ and in its place add 

‘‘051311’’. 

■ 9. In § 520.1510, in paragraph 

(d)(1)(ii)(B), remove ‘‘§ 520.1446(d)(1) of 

this chapter’’ and in its place add 

‘‘§ 520.1443(d)(1)’’; and revise the 

section heading and paragraph (b) to 

read as follows: 

§ 520.1510 Nitenpyram. 

* * * * * 

(b) Sponsors. See sponsor numbers in 

§ 510.600(c) of this chapter: 

(1) No. 058198 for use as in 

paragraphs (d)(1)(i)(A), (d)(1)(ii)(A), and 

(d)(2) of this section. 

(2) No. 051311 for use as in 

paragraphs (d)(1)(i)(B) and (d)(1)(ii)(B) 

of this section. 

* * * * * 

§ 520.2158 [Amended] 

■ 10. In § 520.2158, in paragraph (b), 

remove ‘‘Nos. 016592 and 055462’’ and 

in its place add ‘‘No. 016592’’. 

PART 522—IMPLANTATION OR 

INJECTABLE DOSAGE FORM NEW 

ANIMAL DRUGS 

■ 11. The authority citation for 21 CFR 

part 522 continues to read as follows: 

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

■ 12. Add § 522.167 to read as follows: 

§ 522.167 Betamethasone sodium 

phosphate and betamethasone acetate. 

(a) Specifications. Each milliliter (mL) 

of suspension contains 6 milligrams 

(mg) betamethasone (3.15 mg 

betamethasone sodium phosphate and 

2.85 mg betamethasone acetate). 

(b) Sponsor. See No. 010797 in 

§ 510.600(c) of this chapter. 

(c) Conditions of use in horses—(1) 

Amount. Administer 1.5 mL (9 mg total 

betamethasone) per joint by intraarticular injection. May be administered 

concurrently in up to two joints per 

horse. 

(2) Indications for use. For the control 

of pain and inflammation associated 

with osteoarthritis in horses. 

(3) Limitations. Do not use in horses 

intended for human consumption. 

Federal law restricts this drug to use by 

or on the order of a licensed 

veterinarian. 

§ 522.230 [Amended] 

■ 13. In § 522.230, in paragraph (b), 

remove ‘‘000044’’ and in its place add 

‘‘054771’’. 

■ 14. In § 522.812, add paragraph (b)(3) 

to read as follows: 

§ 522.812 Enrofloxacin. 

* * * * * 

(b) * * * 

(3) No. 026637 for use of product 

described in paragraph (a)(1) as in 

paragraph (e)(1) of this section. 

* * * * * 

§ 522.1004 [Removed] 

■ 15. Remove § 522.1004. 

■ 16. In § 522.2005, remove paragraph 

(b)(3); and revise paragraph (b)(2) to 

read as follows: 

§ 522.2005 Propofol. 

* * * * * 

(b) * * * 

(2) No. 054771 for use as in paragraph 

(c) of this section. 

* * * * * 

PART 524—OPHTHALMIC AND 

TOPICAL DOSAGE FORM NEW 

ANIMAL DRUGS 

■ 17. The authority citation for 21 CFR 

part 524 continues to read as follows: 

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

■ 18. Revise § 524.1044a to read as 

follows: 

§ 524.1044a Gentamicin ophthalmic 

solution. 

(a) Specifications. Each milliliter of 

solution contains gentamicin sulfate 

equivalent to 3 milligrams of 

gentamicin. 

(b) Sponsors. See Nos. 000061 and 

059399 in § 510.600(c) of this chapter. 

(c) Conditions of use in dogs and 

cats—(1) Amount. Administer 1 or 2 

drops into the conjunctival sac 2 to 4 

times a day. 

(2) Indications for use. For the topical 

treatment of infections of the 

conjunctiva caused by susceptible 

bacteria. 

(3) Limitations. Federal law restricts 

this drug to use by or on the order of 

a licensed veterinarian. 

PART 529—CERTAIN OTHER DOSAGE 

FORM NEW ANIMAL DRUGS 

■ 19. The authority citation for 21 CFR 

part 529 continues to read as follows: 

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

§ 529.1186 [Amended] 

■ 20. In § 529.1186, in paragraph (b), 

remove ‘‘000044’’ and add ‘‘054771,’’ 

after ‘‘012164,’’. 

§ 529.1350 [Amended] 

■ 21. In § 529.1350, in paragraph (b), 

remove ‘‘000074’’ and in its place add 

‘‘054771’’. 

§ 529.2150 [Amended] 

■ 22. In § 529.2150, in paragraph (b), 

remove ‘‘000044’’ and add ‘‘054771,’’ 

after ‘‘012164,’’. 

PART 558—NEW ANIMAL DRUGS FOR 

USE IN ANIMAL FEEDS 

■ 23. The authority citation for 21 CFR 

part 558 continues to read as follows: 

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

§ 558.128 [Amended] 

■ 24. Amend § 558.128 as follows: 

■ a. In paragraph (b)(2), remove ‘‘No. 

012286’’ and in its place add ‘‘No. 

069254’’; 

■ b. In paragraph (e)(3)(iv), in the 

‘‘Limitations’’ column, remove 

‘‘012286’’ and in its place add 

‘‘069254’’; and 

■ c. In the tables in paragraphs (e)(1), 

(e)(2), (e)(3), and (e)(4), in the ‘‘Sponsor’’ 

column, remove ‘‘012286,’’ wherever it 

occurs. 

■ 25. In § 558.665, add paragraph (e)(9) 

to read as follows: 

§ 558.665 Zilpaterol. 

* * * * * 

(e) * * * 


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Zilpaterol in 

grams/ton Combination in grams/ton Indications for use Limitations Sponsor 

*******

(9) 6.8 to 24 ....... Monensin 10 to 40, plus 

tylosin 8 to 10, plus 

melengestrol acetate to 

provide 0.25 to 0.5 mg/

head/day.

Heifers fed in confinement for slaughter: For 

increased rate of weight gain, improved 

feed efficiency, and increased carcass 

leanness in cattle fed in confinement for 

slaughter during the last 20 to 40 days on 

feed; for prevention and control of coccidiosis due to Eimeria bovis and E. 

zuernii; and for reduction of incidence of 

liver abscesses caused by Fusobacterium 

necrophorum and Arcanobacterium 

(Actinomyces) pyogenes; and for suppression of estrus (heat).

Feed continuously to heifers 

during the last 20 to 40 

days on feed to provide 60 

mg zilpaterol hydrochloride 

per head per day. See 

§§ 558.342(d), 558.355(d), 

and 558.625(c). Monensin 

and tylosin as provided by 

No. 000986; melengestrol 

acetate as provided by No. 

054771 in § 510.600(c) of 

this chapter. Withdrawal 

period: 3 days.

000061 

Dated: April 3, 2015. 

Bernadette Dunham, 

Director, Center for Veterinary Medicine. 

[FR Doc. 2015–08025 Filed 4–7–15; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 522 

[Docket No. FDA–2015–N–0002] 

Implantation or Injectable Dosage 

Form New Animal Drugs; Withdrawal 

of Approval of New Animal Drug 

Application; Fomepizole 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notification of withdrawal. 

SUMMARY: The Food and Drug 

Administration (FDA) is withdrawing 

approval of a new animal drug 

application (NADA) for a fomepizole 

injectable solution used as an antidote 

for ethylene glycol poisoning in dogs. 

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 April 20, 2015. 

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: Paladin 

Labs (USA), Inc., 160 Greentree Dr., 

suite 101, Dover, DE 19904 has 

requested that FDA withdraw approval 

of NADA 141–075 for ANTIZOL–VET 

(fomepizole) Injection 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 141–075, and all supplements 

and amendments thereto, is hereby 

withdrawn. 

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: April 3, 2015. 

Bernadette Dunham, 

Director, Center for Veterinary Medicine. 

[FR Doc. 2015–08024 Filed 4–7–15; 8:45 am] 

BILLING CODE 4164–01–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Parts 260 and 261 

[EPA–HQ–RCRA–2015–0118; FRL_9923–12– 

OSWER] 

Response to Vacaturs of the 

Comparable Fuels Rule and the 

Gasification Rule 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: The Environmental Protection 

Agency (EPA) is revising regulations 

associated with the comparable fuels 

exclusion and the gasification 

exclusion, originally issued by EPA 

under the Resource Conservation and 

Recovery Act (RCRA). These revisions 

implement vacaturs ordered by the 

United States Court of Appeals for the 

District of Columbia Circuit (D.C. 

Circuit), on June 27, 2014. 

DATES: Effective April 8, 2015. 

ADDRESSES: EPA has established a 

docket for this action under Docket ID 

No. EPA–HQ–RCRA–2015–0118. All 

documents in the docket are listed in 

the www.regulations.gov index. 

Although listed in the index, some 

information is not publicly available, 

e.g., Confidential Business Information 

(CBI) or other information whose 

disclosure is restricted by statute. 

Certain other material, such as 

copyrighted material, is not placed on 

the internet and will be publicly 

available only in hard copy form. 

Publicly available docket materials are 

available either electronically through 

www.regulations.gov or in hard copy at 

the EPA Docket Center, EPA/DC, WJC 

West Building, Room 3334, 1301 

Constitution Ave. NW., Washington, 

DC. The Public Reading Room is open 

from 8:30 a.m. to 4:30 p.m. Monday 

through Friday, excluding legal 

holidays. The telephone number for the 

Public Reading Room is (202) 566–1744 

and the telephone number for the RCRA 

Docket is (202) 566–0270. 

FOR FURTHER INFORMATION CONTACT: 

Office of Resource Conservation and 

Recovery, Materials Recovery and Waste 

Management Division, MC 5304P, 

Environmental Protection Agency, 1200 

Pennsylvania Ave. NW., Washington, 

DC 20460, Tracy Atagi, at (703) 308– 

8672, (atagi.tracy@epa.gov) or Frank 

Behan, at (703) 308–8476, behan.frank@

epa.gov. 

SUPPLEMENTARY INFORMATION: 

Preamble Outline 

I. General Information 

II. Statutory Authority 

III. Which regulations is EPA removing? 

IV. Background on the Comparable Fuels 

Rule and the Gasification Rule 

V. When will the final rule become effective? 

VI. State Authorization 

VII. Statutory and Executive Order (EO) 

Reviews 


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