13226 Federal Register / Vol. 80, No. 49 / Friday, March 13, 2015 / Rules and Regulations 

We are issuing the SECG consistent 

with our good guidance practices 

regulation (21 CFR 10.115(c)(2)). The 

SECG represents our current thinking on 

nutrition labeling of standard menu 

items in restaurants and similar retail 

food establishments. It does not create 

or confer any rights for or on any person 

and does not operate to bind FDA or the 

public. An alternative approach may be 

used if such approach satisfies the 

requirements of the applicable statutes 

and regulations. 

II. Paperwork Reduction Act of 1995 

This SECG refers to collections of 

information described in FDA’s final 

rule that published in the Federal 

Register of December 1, 2014 (79 FR 

71156), and that will be effective on 

December 1, 2015. As stated in the final 

rule, these collections of information are 

subject to review by the Office of 

Management and Budget (OMB) under 

the Paperwork Reduction Act of 1995 

(the PRA) (44 U.S.C. 3501–3520). In 

compliance with the PRA (44 U.S.C. 

3507(d)), the Agency has submitted the 

information collection provisions of the 

final rule to OMB for review. FDA will 

publish a document in the Federal 

Register announcing OMB’s decision to 

approve, modify, or disapprove the 

information collection provisions in this 

final rule. An Agency may not conduct 

or sponsor, and a person is not required 

to respond to, a collection of 

information unless it displays a 

currently valid OMB control number. 

III. Comments 

Interested persons may submit either 

electronic comments regarding the 

SECG to http://www.regulations.gov or 

written comments to the Division of 

Dockets Management (see ADDRESSES). It 

is only necessary to send one set of 

comments. Identify comments with the 

docket number found in brackets in the 

heading of this document. Received 

comments may be seen in the Division 

of Dockets Management between 9 a.m. 

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

will be posted to the docket at http://

www.regulations.gov. 

IV. Electronic Access 

Persons with access to the Internet 

may obtain the SECG at either http://

www.fda.gov/Food/Guidance

Regulation/GuidanceDocuments

RegulatoryInformation/default.htm or 

http://www.regulations.gov. Use the 

FDA Web site listed in the previous 

sentence to find the most current 

version of the guidance. 

Dated: March 6, 2015. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2015–05590 Filed 3–12–15; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Parts 510, 520, 522, 524, 556, 

and 558 

[Docket No. FDA–2014–N–0002] 

New Animal Drugs; Approval of New 

Animal Drug Applications; Change of 

Sponsor 

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 

approval actions for new animal drug 

applications (NADAs) and abbreviated 

new animal drug applications 

(ANADAs) during November and 

December 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 eight 

NADAs and nine ANADAs, and to make 

correcting amendments for a drug 

labeler code. 

DATES: This rule is effective March 13, 

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 November and 

December 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/

ApprovedAnimalDrugProducts/

default.htm. 

In addition, Pennfield Oil Co., 14040 

Industrial Rd., Omaha, NE 68144, has 

transferred ownership of, and all rights 

and interest in, the following approved 

applications to Pharmgate LLC, 161 

North Franklin Turnpike, Suite 2C, 

Ramsey, NJ 07446: 

File No. Product name 21 CFR Cite 

065–480 ........ Chlortetracycline Soluble Powder .................................................................................................. 520.441. 

138–934 ........ PENNCHLOR SP (chlortetracycline, sulfamethazine, penicillin) Type A medicated articles ....... 558.145. 

138–935 ........ PENNCHLOR (chlortetracycline) Type A medicated articles ........................................................ 558.128. 

138–938 ........ PENNOX (oxytetracycline) Type A medicated articles ................................................................. 558.450. 

138–939 ........ NEO–OXY (neomycin sulfate and oxytetracycline) Type A medicated articles ........................... 558.455. 

140–680 ........ TYLAN (tylosin phosphate) Type A medicated articles ................................................................ 558.625. 

140–681 ........ TYLAN Sulfa-G (tylosin phosphate and sulfamethazine) Type A medicated articles .................. 558.630. 

141–137 ........ PENITRACIN (bacitracin methylenedisalicylate) 50 Type A medicated article ............................ Not codified. 

200–026 ........ PENNOX 343 (oxytetracycline) ..................................................................................................... 520.1660d. 

200–154 ........ PENNOX 200 (oxytetracycline) ..................................................................................................... 558.450. 

200–295 ........ PENNCHLOR 64 (chlortetracycline) .............................................................................................. 558.128. 

200–314 ........ PENNCHLOR S (chlortetracycline) ............................................................................................... 558.140. 

200–354 ........ PENNCHLOR (chlortetracycline)/COBAN (monensin) .................................................................. 558.355. 

200–356 ........ PENNCHLOR (chlortetracycline)/DENAGARD (tiamulin) ............................................................. 558.600. 


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Federal Register / Vol. 80, No. 49 / Friday, March 13, 2015 / Rules and Regulations 13227 

File No. Product name 21 CFR Cite 

200–357 ........ PENNCHLOR (chlortetracycline)/BIO–COX (salinomycin) ........................................................... 558.550. 

200–358 ........ PENNCHLOR (chlortetracycline)/BMD (bacitracin MD) ................................................................ 558.76. 

200–359 ........ PENNCHLOR (chlortetracycline)/DECCOX (decoquinate) ........................................................... 558.195. 

At this time, the regulations are being 

amended to reflect these changes of 

sponsorship. Following these changes of 

sponsorship, Pharmgate LLC will now 

be the sponsor of an approved 

application while Pennfield Oil Co. will 

no longer be the sponsor of an approved 

application. Also, Hikma 

Pharmaceuticals LLC, P.O. Box 182400, 

Bayader Wadi Seer, Amman, Jordan 

11118, has informed FDA that it has 

changed its name to Hikma 

International Pharmaceuticals LLC. 

Accordingly, § 510.600 (21 CFR 

510.600) is being amended to reflect 

these changes. In addition, FDA is 

amending § 510.600 and several sections 

of part 520 to reflect a correct drug 

labeler code for Akorn Animal Health, 

Inc. FDA is also amending the 

regulations in 21 CFR parts 520, 522, 

556, and 558 to redesignate several 

sections to reflect alphabetical order and 

to make minor technical amendments. 

These corrections and technical 

amendments are being made to improve 

the accuracy of the animal drug 

regulations. 

TABLE 1—ORIGINAL AND SUPPLEMENTAL NADAS AND ANADAS APPROVED DURING NOVEMBER AND DECEMBER 2014 

NADA/ 

ANADA Sponsor New animal drug product name Action 21 CFR Sections 

FOIA 

Summary 

NEPA 

Review 

200–575 .... Putney, Inc., One 

Monument Sq., suite 

400, Portland, ME 

04101.

Carprofen Chewable 

Tablets.

Original approval as a generic 

copy of NADA 141–111.

520.309 yes CE1 2

141–232 .... Zoetis Inc., 333 Portage St., Kalamazoo, 

MI 49007.

SIMPLICEF 

(cefpodoxime 

proxetil) Chewable 

Tablets.

Supplemental approval of 

chewable tablet dosage form for 

dogs.

520.370 yes CE1 3

200–512 .... Zoetis Inc., 333 Portage St., Kalamazoo, 

MI 49007.

TRIAMULOX (tiamulin 

hydrogen fumarate) 

Liquid Concentrate.

Original approval as a generic 

copy of NADA 140–916.

520.2455 yes CE1 2

200–573 .... Putney, Inc., One 

Monument Sq., suite 

400, Portland, ME 

04101.

Dexmedetomidine HCl 

(dexmedetomidine hydrochloride).

Injectable Solution ......

Original approval as a generic 

copy of NADA 141–267.

522.558 yes CE1 2

141–068 .... Bayer HealthCare LLC, 

Animal Health Division, P.O. Box 390, 

Shawnee Mission, 

KS 66201.

BAYTRIL 100 

(enrofloxacin).

Injectable Solution ......

Supplemental approval adding administration by intramuscular injection in swine and an indication for control of colibacillosis in 

groups or pens of weaned pigs.

522.812 yes CE1 4

141–349 .... Zoetis Inc., 333 Portage St., Kalamazoo, 

MI 49007.

DRAXXIN 25 ...............

(tulathromycin) ............

Injectable Solution ......

Supplemental approval for treatment of bovine respiratory disease (BRD) in suckling calves, 

dairy calves, and veal calves.

522.2630 yes CE1 4

141–437 .... Novartis Animal Health 

US, Inc., 3200 

Northline Ave., suite 

300, Greensboro, 

NC 27408.

OSURNIA ....................

(florfenicol, terbinafine, 

betamethasone acetate) Otic Gel.

Original approval for the treatment 

of otitis externa in dogs.

524.955 yes CE1 3

034–267 .... Intervet, Inc., 556 Morris Ave., Summit, NJ 

07901.

GENTOCIN 

DURAFILM.

(gentamicin sulfate and 

betamethasone).

Ophthalmic Solution ....

Supplemental approval of additional safety information.524.1044i yes CE1 3

141–034 .... Huvepharma AD, 5th 

Floor, 3A Nikolay 

Haytov Str., 1113 

Sophia, Bulgaria.

GAINPRO ...................

(bambermycins) ..........

Type A medicated article.

Supplemental approval of a freechoice Type C medicated loose 

mineral feed without selenium 

for pasture cattle.

558.95 yes CE1 2

200–510 5 .. Pharmgate LLC, 161 

North Franklin Turnpike, suite 2C, 

Ramsey, NJ 07446.

DERACIN ....................

(chlortetracycline) ........

Type A medicated articles.

Original approval as a generic 

copy of NADA 048–761.

558.128 yes CE1 2

141–258 .... Intervet, Inc., 556 Morris Ave., Summit, NJ 

07901.

ZILMAX (zilpaterol hydrochloride) Type A 

medicated article.

Supplemental approval to provide 

for component feeding of Type 

C medicated feeds.

558.665 yes CE1 2


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TABLE 1—ORIGINAL AND SUPPLEMENTAL NADAS AND ANADAS APPROVED DURING NOVEMBER AND DECEMBER 2014— 

Continued 

NADA/ 

ANADA Sponsor New animal drug product name Action 21 CFR Sections 

FOIA 

Summary 

NEPA 

Review 

141–276 5 .. Intervet, Inc., 556 Morris Ave., Summit, NJ 

07901.

ZILMAX (zilpaterol hydrochloride) plus 

RUMENSIN 

(monensin) plus 

TYLAN (tylosin 

phosphate) Type C 

medicated feeds.

Supplemental approval to provide 

for component feeding of combination drug Type C medicated 

feeds.

558.665 yes CE1 6

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(a)(1). 

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

4 CE granted under 21 CFR 25.33(d)(5). 

5This 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. 6 CE granted under 21 CFR 25.33(a)(2). 

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, and 524 

Animal drugs. 

21 CFR Part 556 

Animal drugs, Foods. 

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, 556, 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), in 

the entry for ‘‘Akorn Animal Health, 

Inc.’’, in the ’’Drug labeler code’’ 

column, remove ‘‘053599’’, and in its 

place add ‘‘059399’’; 

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

the entry for ‘‘Hikma Pharmaceuticals 

LLC’’, in the ‘‘Firm name and address’’ 

column, remove ‘‘Hikma 

Pharmaceuticals LLC’’, and in its place 

add ‘‘Hikma International 

Pharmaceuticals LLC’’; 

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

remove the entry for ‘‘Pennfield Oil Co.’’ 

and add an entry, in alphabetical order, 

for ‘‘Pharmgate LLC’’; 

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

remove the entries for ‘‘000008’’, 

‘‘048164’’, and ‘‘053599’’ and add 

entries, in numerical order, for 

‘‘059399’’ and ‘‘069254’’; and 

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

the entry for ‘‘059115’’, in the ‘‘Firm 

name and address’’ column, remove 

‘‘Hikma Pharmaceuticals LLC’’, and in 

its place add ‘‘Hikma International 

Pharmaceuticals LLC’’. 

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 

*******

Pharmgate LLC, 161 North Franklin Turnpike, suite 2C, Ramsey, NJ 07446 .................................................................................... 069254 

* * * * * * * 

(2) * * * 

Drug labeler 

code Firm name and address 

*******

059399 ......... Akorn Animal Health, Inc., 1925 West Field Ct., suite 300, Lake Forest, IL 60045 

*******

069254 ......... Pharmgate LLC, 161 North Franklin Turnpike, suite 2C, Ramsey, NJ 07446 


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Federal Register / Vol. 80, No. 49 / Friday, March 13, 2015 / Rules and Regulations 13229 

Drug labeler 

code Firm name and address 

*******

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. 

§§ 520.310 and 520.312 [Redesignated as 

§§ 520.301 and 520.302] 

■ 4. Redesignate §§ 520.310 and 520.312 

as §§ 520.301 and 520.302, respectively. 

§ 520.309 [Redesignated as § 520.304 and 

Amended] 

■ 5. Redesignate § 520.309 as § 520.304 

and revise newly redesignated § 520.304 

by adding paragraph (b)(3) to read as 

follows: 

§ 520.304 Carprofen. 

* * * * * 

(b) * * * 

(3) No. 026637 for use of product 

described in paragraph (a)(2) of this 

section as in paragraph (d) of this 

section. 

* * * * * 

■ 6. In § 520.370, revise paragraphs (a) 

and (b) and in paragraph (c)(2), remove 

‘‘intermedius’’ and in its place add 

‘‘pseudintermedius’’ to read as follows: 

§ 520.370 Cefpodoxime tablets. 

(a) Specifications. (1) Each tablet 

contains cefpodoxime proxetil 

equivalent to 100 or 200 milligrams (mg) 

cefpodoxime. 

(2) Each chewable tablet contains 

cefpodoxime proxetil equivalent to 100 

or 200 mg cefpodoxime. 

(b) Sponsors. See sponsors in 

§ 510.600(c) of this chapter for uses as 

follows: 

(1) No. 026637 for use of product in 

paragraph (a)(1) of this section as in 

paragraph (c) of this section. 

(2) No. 054771 for use of products in 

paragraph (a) of this section as in 

paragraph (c) of this section. 

* * * * * 

§ 520.441 [Amended] 

■ 7. In § 520.441, in paragraph (b)(1), 

remove ‘‘048164’’ and in its place add 

‘‘069254’’. 

■ 8. Amend § 520.1660d as follows: 

■ a. In paragraph (b)(6), remove 

‘‘048164’’ and in its place add 

‘‘069254’’. 

■ b. In paragraphs (d)(1)(ii)(A)(3), 

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

the last sentence. 

The revisions read as follows: 

§ 520.1660d Oxytetracycline powder. 

* * * * * 

(d) * * * 

(1) * * * 

(ii) * * * 

(A) * * * 

(3) * * * Zero-day withdrawal for 

those products sponsored by Nos. 

054771, 057561, 061133, and 069254. 

(B) * * * 

(3) * * * Zero-day withdrawal for 

those products sponsored by Nos. 

054771, 057561, 061133, and 069254. 

(C) * * * 

(3) * * * Zero-day withdrawal for 

those products sponsored by Nos. 

054771, 057561, 061133, and 069254. 

* * * * * 

■ 9. In § 520.2455, revise paragraphs 

(b)(3) and (c) to read as follows: 

§ 520.2455 Tiamulin. 

* * * * * 

(b) * * * 

(3) No. 054771 for the product 

described in paragraph (a)(3) of this 

section. 

(c) Related tolerances. See § 556.732 

of this chapter. 

* * * * * 

PART 522—IMPLANTATION OR 

INJECTABLE DOSAGE FORM NEW 

ANIMAL DRUGS 

■ 10. The authority citation for 21 CFR 

part 522 continues to read as follows: 

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

§ 522.246 [Amended] 

■ 11. In § 522.246, in paragraph (b)(3), 

remove ‘‘053599’’ and in its place add 

‘‘059399’’. 

■ 12. In § 522.558, revise paragraphs (a) 

and (b) to read as follows: 

§ 522.558 Dexmedetomidine. 

(a) Specifications. Each milliliter of 

solution contains: 

(1) 0.1 milligrams (mg) 

dexmedetomidine hydrochloride; or 

(2) 0.5 mg dexmedetomidine 

hydrochloride. 

(b) Sponsors. See sponsors in in 

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

paragraph (c) of this section: 

(1) No. 026637 for use of product 

described in paragraph (a)(2) of this 

section; 

(2) No. 052483 for use of products 

described in paragraph (a) of this 

section. 

* * * * * 

■ 13. Amend § 522.812 as follows: 

■ a. Revise paragraph (b)(2); 

■ b. Remove paragraph (e)(3)(i); 

■ c. Redesignate paragraphs (e)(3)(ii) 

and (e)(3)(iii) as paragraphs (e)(3)(i) and 

(e)(3)(ii), respectively; and 

■ d. Revise newly redesignated 

paragraph (e)(3)(i). 

The revisions read as follows: 

§ 522.812 Enrofloxacin. 

* * * * * 

(b) * * * 

(2) No. 055529 for use of product 

described in paragraph (a)(1) of this 

section as in paragraph (e)(1) of this 

section, and use of product described in 

paragraph (a)(2) of this section as in 

paragraphs (e)(2)(i)(B), (e)(2)(ii)(B), 

(e)(2)(iii), (e)(3)(i)(B), and (e)(3)(ii) of 

this section. 

* * * * * 

(e) * * * 

(3) * * * 

(i) Amounts and indications for use. 

(A) Administer, either by intramuscular 

or subcutaneous (behind the ear) 

injection, a single dose of 7.5 mg/kg of 

body weight for the treatment and 

control of swine respiratory disease 

(SRD) associated with Actinobacillus 

pleuropneumoniae, Pasteurella 

multocida, Haemophilus parasuis, 

Streptococcus suis, Bordetella 

bronchiseptica, and Mycoplasma 

hyopneumoniae. 

(B) Administer, by subcutaneous 

(behind the ear) injection, a single dose 

of 7.5 mg/kg of body weight for the 

treatment and control of swine 

respiratory disease (SRD) associated 

with Actinobacillus pleuropneumoniae, 

Pasteurella multocida, Haemophilus 

parasuis, and Streptococcus suis. 

(C) Administer, either by 

intramuscular or subcutaneous (behind 

the ear) injection, a single dose of 7.5 

mg/kg of body weight for the control of 

colibacillosis in groups or pens of 

weaned pigs where colibacillosis 

associated with Escherichia coli has 

been diagnosed. 

* * * * * 

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

to read as follows: 

§ 522.1222 Ketamine. 

* * * * * 


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(b) Sponsors. See Nos. 000859, 

026637, 054628, 054771, 059399, and 

063286 in § 510.600(c) of this chapter. 

* * * * * 

§ 522.2474 [Amended] 

■ 15. In § 522.2474, in paragraph (b), 

remove ‘‘053599’’ and in its place add 

‘‘059399’’. 

■ 16. In § 522.2630, revise paragraphs 

(b)(1), (b)(2), (d)(1)(ii)(A), (d)(1)(ii)(B), 

and (d)(1)(iii) to read as follows: 

§ 522.2630 Tulathromycin. 

* * * * * 

(b) * * * 

(1) Product described as in paragraph 

(a)(1) of this section for use as in 

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

(d)(1)(iii)(A), and (d)(2) of this section. 

(2) Product described as in paragraph 

(a)(2) of this section for use as in 

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

(d)(1)(iii)(B), and (d)(2) of this section. 

* * * * * 

(d) * * * 

(1) * * * 

(ii) * * * 

(A) Beef and non-lactating dairy 

cattle. For the treatment of bovine 

respiratory disease (BRD) associated 

with Mannheimia haemolytica, 

Pasteurella multocida, Histophilus 

somni, and Mycoplasma bovis. 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 

(IBK) associated with Moraxella bovis. 

For the treatment of bovine foot rot 

(interdigital necrobacillosis) associated 

with Fusobacterium necrophorum and 

Porphyromonas levii. 

(B) 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. 

(iii) Limitations. (A) 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. 

(B) Calves intended for human 

consumption must not be slaughtered 

within 22 days from the last treatment. 

Not for use in ruminating cattle. Federal 

law restricts this drug to use by or on 

the order of a licensed veterinarian. 

* * * * * 

§ 522.2662 [Amended] 

■ 17. In § 522.2662, in paragraph (b)(4), 

remove ‘‘053599’’ and in its place add 

‘‘059399’’. 

§ 522.2670 [Amended] 

■ 18. In § 522.2670, in paragraph (b)(1), 

remove ‘‘053599’’ and in its place add 

‘‘059399’’. 

PART 524—OPHTHALMIC AND 

TOPICAL DOSAGE FORM NEW 

ANIMAL DRUGS 

■ 19. The authority citation for 21 CFR 

part 524 continues to read as follows: 

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

■ 20. Add § 524.955 to read as follows: 

§ 524.955 Florfenicol, terbinafine, and 

betamethasone acetate otic gel. 

(a) Specifications. Each milliliter of 

gel contains 10 milligrams (mg) 

florfenicol, 10 mg terbinafine, and 1 mg 

betamethasone acetate. 

(b) Sponsor. See No. 058198 in 

§ 510.600(c) of this chapter. 

(c) Conditions of use in dogs—(1) 

Amount. Administer one dose (1 tube) 

per affected ear(s) and repeat 

administration in 7 days. 

(2) Indications for use. For the 

treatment of otitis externa in dogs 

associated with susceptible strains of 

bacteria (Staphylococcus 

pseudintermedius) and yeast 

(Malassezia pachydermatis). 

(3) Limitations. Federal law restricts 

this drug to use by or on the order of 

a licensed veterinarian. 

■ 21. In § 524.1044i, revise paragraph 

(c)(2) to read as follows: 

§ 524.1044i Gentamicin and 

betamethasone ophthalmic solution. 

* * * * * 

(c) * * * 

(2) Indications for use. For treatment 

of external eye infections and 

inflammation. 

* * * * * 

PART 556—TOLERANCES FOR 

RESIDUES OF NEW ANIMAL DRUGS 

IN FOOD 

■ 22. The authority citation for 21 CFR 

part 556 continues to read as follows: 

Authority: 21 U.S.C. 342, 360b, 371. 

§ 556.738 [Redesignated as § 556.732] 

■ 23. Redesignate § 556.738 as 

§ 556.732. 

PART 558—NEW ANIMAL DRUGS FOR 

USE IN ANIMAL FEEDS 

■ 24. The authority citation for 21 CFR 

part 558 continues to read as follows: 

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

§ 558.76 [Amended] 

■ 25. In § 558.76, in paragraph (d)(1)(iv), 

in the ‘‘Limitations’’ and ‘‘Sponsor’’ 

columns, remove ‘‘048164’’ and in its 

place add ‘‘069254’’. 

■ 26. In § 558.95, add paragraph 

(d)(4)(v) to read as follows: 

§ 558.95 Bambermycins. 

* * * * * 

(d) * * * 

(4) * * * 

(v) Used as a free-choice Type C 

medicated loose mineral feed for 

pasture cattle (slaughter, stocker, and 

feeder cattle; and dairy and beef 

replacement heifers) as follows: 

(A) Specifications. 

Ingredient International feed 

No. Percent 

Deflorinated phosphate (20.5% calcium, 18.5% phosphorus) ........................................................................ 6–01–080 42.50 

Sodium chloride (salt) ...................................................................................................................................... 6–04–152 20.10 

Calcium carbonate (38% calcium) ................................................................................................................... 6–01–069 15.45 

Corn distillers dried grains w/solubles ............................................................................................................. 5–28–236 9.57 

Magnesium oxide ............................................................................................................................................. 6–02–756 5.15 

Vitamin and trace mineral premix * .................................................................................................................. ............................ 3.72 

Mineral oil ........................................................................................................................................................ ............................ 1.00 

Yeast (primary dehydrated yeast) ................................................................................................................... 7–05–533 0.75 

Bambermycins Type A article (10 g/lb) ........................................................................................................... ............................ 0.60 

Iron oxide ......................................................................................................................................................... 6–02–431 0.50 

Magnesium sulfate (67%) ................................................................................................................................ 6–02–758 0.32 

Copper sulfate ................................................................................................................................................. 6–01–720 0.18 


tkelley on DSK3SPTVN1PROD with RULES
Federal Register / Vol. 80, No. 49 / Friday, March 13, 2015 / Rules and Regulations 13231 

Ingredient International feed 

No. Percent 

Potassium sulfate (0.33%) ............................................................................................................................... 6–06–098 0.16 

* Content of vitamin/trace mineral premix may be varied. However, they should be comparable to those used for other free-choice feeds. Formulation modifications require FDA approval prior to marketing. Ethylenediamine dihydroiodide (EDDI) should comply with FDA Compliance Policy Guides Sec. 651.100 (CPG 7125.18). 

(B) Amount per ton. 120 grams. 

(C) Indications for use. For increased 

rate of weight gain. 

(D) Limitations. For free-choice 

feeding to pasture cattle (slaughter, 

stocker, and feeder cattle; and dairy and 

beef replacement heifers). Feed a nonmedicated commercial mineral product 

for 6 weeks to stabilize consumption 

between 2.66 and 10.66 ounces per head 

per day. Feed continuously to provide 

10 to 40 milligrams bambermycins per 

head per day. Daily bambermycins 

intakes in excess of 20 mg/head/day 

have not been shown to be more 

effective than 20 mg/head/day. 

* * * * * 

■ 27. Amend § 558.128 as follows: 

■ a. In paragraph (b)(1), remove ‘‘Nos. 

054771, 048164, and 066104’’ and in its 

place add ‘‘Nos. 054771, 066104, and 

069254’’; 

■ b. In paragraphs (e)(4)(ii) and (iv), in 

the ‘‘Limitations’’ column, remove 

‘‘048164’’ wherever it occurs and in its 

place add ‘‘069254’’; 

■ c. In paragraphs (e)(1)(i), (ii), and (iii), 

(e)(2)(i), (ii), (iii), and (iv), (e)(3)(i), (ii), 

(iii), and (iv), (e)(4)(i), (ii), (iv), (vii), and 

(viii), and (e)(5)(i) and (ii), in the 

‘‘Sponsor’’ column, remove ‘‘048164’’ 

wherever it occurs and in its place in 

numerical order add ‘‘069254’’; and 

■ d. Revise paragraphs (e)(1)(iv), 

(e)(4)(v), and (e)(4)(ix). 

The revisions read as follows: 

§ 558.128 Chlortetracycline. 

* * * * * 

(e) * * * 

(1) * * * 

Chlortetracycline amount Indications for use Limitations Sponsor 

*******

(iv) 500 g/ton ..................... Chickens: For the reduction of mortality 

due to E. coli infections susceptible to 

chlortetracycline.

1. Feed for 5 d. To sponsor No. 054771 under NADA 

048–761 and No. 069254 under ANADA 200–510: 

zero withdrawal time.

054771, 

069254. 

2. Feed for 5 d; withdraw 24 h prior to slaughter; do 

not feed to chickens producing eggs for human consumption.

012286, 

054771, 

066104, 

069254. 

* * * * * (4) * * * 

Chlortetracycline amount Indications for use Limitations Sponsor 

*******

(v) 500 to 4,000 g/ton ........ Calves, beef and nonlactating dairy cattle; 

treatment of bacterial enteritis caused by 

E. coli and bacterial pneumonia caused 

by P. multocida susceptible to chlortetracycline.

Feed continuously for not more than 5 days to provide 

10 mg/lb body weight per day. To sponsor No. 

054771 under NADA 046–699: 24-h withdrawal time.

To sponsor No. 054771 under NADA 048–761 and 

No. 069254 under ANADA 200–510: Zero withdrawal time.

054771 

069254 

* * * * * * * 

(ix) 350 mg/head/day ......... 1. Beef cattle: For control of bacterial pneumonia associated with shipping fever 

complex caused by Pasteurella spp. susceptible to chlortetracycline.

Withdraw 48 h prior to slaughter. To sponsor No. 

054771 under NADA 046–699: 48-h withdrawal 

time. To sponsor No. 054771 under NADA 048–761 

and No. 069254 under ANADA 200–510: Zero withdrawal time.

012286, 

054771, 

066104, 

069254. 

2. Beef cattle (under 700 lb): For control of 

active infection of anaplasmosis caused 

by A. marginale susceptible to chlortetracycline.

Withdraw 48 h prior to slaughter. To sponsor No. 

054771 under NADA 046–699: 48-h withdrawal 

time. To sponsor No. 054771 under NADA 048–761 

and No. 069254 under ANADA 200–510: zero withdrawal time.

012286, 

054771, 

066104, 

069254. 

* * * * * 

§ 558.140 [Amended] 

■ 28. In § 558.140, in paragraph (b)(1), 

remove ‘‘048164’’ and in its place add 

‘‘069254’’. 

§ 558.145 [Amended] 

■ 29. In § 558.145, in paragraph (a)(2), 

remove ‘‘048164’’ and in its place add 

‘‘069254’’. 

§ 558.195 [Amended] 

■ 30. In § 558.195, in paragraph 

(e)(2)(iv), in the ‘‘Limitations’’ and 

‘‘Sponsor’’ columns, remove ‘‘048164’’ 

and in its place add ‘‘069254’’. 

§ 558.355 [Amended] 

■ 31. In § 558.355, in paragraph 

(f)(1)(xiv)(b), remove ‘‘048164’’ and in 

its place add ‘‘069254’’. 


tkelley on DSK3SPTVN1PROD with RULES
13232 Federal Register / Vol. 80, No. 49 / Friday, March 13, 2015 / Rules and Regulations 

§ 558.450 [Amended] 

■ 32. Amend § 558.450 as follows: 

■ a. In paragraph (a)(2), remove 

‘‘048164’’ and in its place add 

‘‘069254’’; 

■ b. In paragraphs (d)(2)(iii), (d)(2)(iv), 

and (d)(4)(ii), in the ‘‘Limitations’’ 

column, remove ‘‘048164’’ wherever it 

occurs and in its place add ‘‘069254’’; 

and 

■ c. In paragraphs (d)(1)(i), (ii), (iii), and 

(iv), (d)(2)(i), (ii), (iii), and (iv), (d)(3)(i) 

and (ii), (d)(4)(i), (ii), (iii), (iv), and (v), 

and (d)(5)(i), (ii), and (iii), in the 

‘‘Sponsor’’ column, remove ‘‘048164’’ 

and in its place add ‘‘069254’’. 

§ 558.455 [Amended] 

■ 33. Amend § 558.455 as follows: 

■ a. In paragraph (b), remove ‘‘Nos. 

048164 and 066104’’ and in its place 

add ‘‘Nos. 066104 and 069254’’; and 

■ b. In paragraphs (e)(1)(i), (ii), (iii), and 

(iv), (e)(2)(i), (ii), (iii), and (iv), (e)(3)(i) 

and (ii), and (e)(4)(i), (ii), (iii), (iv), (v), 

and (vi), in the ‘‘Sponsor’’ column, 

remove ‘‘048164’’ and in its place in 

numerical order add ‘‘069254’’. 

§ 558.550 [Amended] 

■ 34. In § 558.550, in paragraphs (b)(3) 

and (d)(1)(xvi)(c), remove ‘‘048164’’ and 

in its place add ‘‘069254’’. 

§ 558.600 [Redesignated as § 558.612 and 

Amended] 

■ 35. Redesignate § 558.600 as § 558.612 

and amend newly redesignated 

§ 558.612 as follows: 

■ a. In paragraph (c), remove 

‘‘§ 556.738’’ and in its place add 

‘‘§ 556.732’’; and 

■ b. In paragraph (e)(1)(iii), in the 

‘‘Limitations’’ and ‘‘Sponsor’’ columns, 

remove ‘‘048164’’ and in its place in 

numerical order add ‘‘069254’’. 

§ 558.615 [Redesignated as § 558.600] 

■ 36. Redesignate § 558.615 as 

§ 558.600. 

§ 558.625 [Amended] 

■ 37. In § 558.625, in paragraph (b)(5), 

remove ‘‘048164’’ and in its place add 

‘‘069254’’. 

§ 558.630 [Amended] 

■ 38. In § 558.630, in paragraph (b)(2), 

remove ‘‘No. 054771’’ and in its place 

add ‘‘Nos. 054771 and 069254’’. 

■ 39. Amend § 558.665 as follows: 

■ a. Revise paragraphs (d)(1) and (e)(1); 

■ b. Redesignate paragraph (d)(2) as 

paragraph (d)(4); and 

■ c. Add paragraphs (d)(2), (d)(3), (e)(7), 

and (e)(8). 

The revisions and additions read as 

follows: 

§ 558.665 Zilpaterol. 

* * * * * 

(d) * * * 

(1) Labeling shall bear the following 

caution statements: ‘‘Zilpaterol 

hydrochloride is not for use in animals 

intended for breeding. Do not allow 

horses or other equines access to feed 

containing zilpaterol. Do not use in veal 

calves.’’ 

(2) Labeling of Type A medicated 

articles and Type B medicated feeds 

used to manufacture complete Type C 

medicated feeds shall bear the caution 

statements in paragraph (d)(3) of this 

section. 

(3) Labeling of complete Type C 

medicated feeds shall bear the following 

caution statements: ‘‘Not to be fed to 

cattle in excess of 90 mg zilpaterol/

head/day in complete feed. If pen 

consumption of complete feed exceeds 

26.5 lb/head/day (90 percent dry matter 

basis), zilpaterol should not be fed in 

complete feed.’’ 

* * * * * 

(e) * * * 

Zilpaterol in grams/ton Combination grams/

ton Indications for use Limitations Sponsor 

(1) 6.8 ........................ ................................... Cattle 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.

Feed continuously as the sole ration during the last 20 to 40 days 

on feed to provide 60 to 90 mg/

head/day. Withdrawal period: 3 

days.

000061 

* * * * * * * 

(7) 6.8 to 24 .............. ................................... Cattle 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.

Feed continuously to cattle during 

the last 20 to 40 days on feed to 

provide 60 mg zilpaterol hydrochloride per head per day. Withdrawal period: 3 days.

000061 

(8) 6.8 to 24 .............. Monensin 10 to 40, 

plus tylosin 8 to 10.

Cattle 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.

Feed continuously to cattle during 

the last 20 to 40 days on feed to 

provide 60 mg zilpaterol hydrochloride per head per day. See 

paragraphs §§ 558.355(d) and 

558.625(c). Monensin and 

tylosin as provided by No. 

000986 in § 510.600(c) of this 

chapter. Withdrawal period: 3 

days.

000061 

Dated: March 9, 2015. 

Bernadette Dunham, 

Director, Center for Veterinary Medicine. 

[FR Doc. 2015–05644 Filed 3–12–15; 8:45 am] 

BILLING CODE 4164–01–P 


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