64114 Federal Register / Vol. 79, No. 208 / Tuesday, October 28, 2014 / Rules and Regulations 

funded. The Council may thereafter 

revise this list. 

[FR Doc. 2014–25610 Filed 10–24–14; 4:15 pm] 

BILLING CODE 3510–22–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

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

556 

[Docket No. FDA–2014–N–0002] 

New Animal Drugs; Alfaxalone; 

Dinoprost; Ivermectin and Clorsulon; 

Nitrofurazone; Trenbolone and 

Estradiol Benzoate; Trimethoprim and 

Sulfadiazine; Tylosin; Change of 

Sponsor 

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 August 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 two NADAs and one 

ANADA, and to reflect a revised food 

safety warning. 

DATES: This rule is effective October 28, 

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 August 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, Macleod 

Pharmaceuticals, Inc., 2600 Canton Ct., 

Fort Collins, CO 80525 has transferred 

ownership of, and all rights and interest 

in ANADA 200–033 for UNIPRIM 

(trimethoprim and sulfadiazine) Powder 

to Neogen Corp. (Neogen), 944 Nandino 

Blvd., Lexington, KY 40511. In 2004, 

Hess & Clark, Inc., transferred 

ownership of, and all rights and interest 

in NADA 011–154 for NFZ Puffer 

(nitrofurazone soluble powder) and 

NADA 140–851 for NFZ Wound 

Dressing (nitrofurazone ointment) to 

Neogen. At this time, the regulations are 

being amended to reflect these transfers. 

Following these changes of 

sponsorship, Macleod Pharmaceuticals, 

Inc., and Hess & Clark, Inc., will no 

longer be the sponsor of an approved 

application. Accordingly, 21 CFR 

510.600(c) is being amended to remove 

the entries for these firms. 

Also, the animal drug regulations are 

being amended in 21 CFR 522.690 to 

revise a human food safety warning for 

dinoprost tromethamine injectable 

solution. This amendment is 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. 

TABLE 1—ORIGINAL AND SUPPLEMENTAL NADAS AND ANADAS APPROVED DURING AUGUST 2014 

NADA/

ANADA Sponsor New animal drug product name Action 21 CFR Sections 

FOIA 

Summary NEPA Review 

140–833 ...... Merial Ltd., 3239 Satellite Blvd., Bldg. 500, 

Duluth, GA 30096– 

4640.

IVOMEC Plus 

(ivermectin and 

clorsulon) Injection 

for Cattle.

Supplemental approval 

reducing the 

preslaughter withdrawal period from 49 

days to 21 days.

522.1193 ........

556.344 ..........

yes ................. CE.1 2

141–043 ...... Zoetis Inc., 333 Portage 

St., Kalamazoo, MI 

49007.

SYNOVEX CHOICE 

(trenbolone and estradiol implant).

Supplemental approval 

for increased rate of 

weight gain and improved feed efficiency 

in heifers fed in confinement for slaughter.

522.2478 ........ yes ................. EA/FONSI.3

141–342 ...... Jurox Pty. Ltd., 85 Gardiner Rd., Rutherford, 

NSW 2320, Australia.

ALFAXAN (alfaxalone) 

Injectable Anesthetic 

for Dogs and Cats.

Supplemental approval 

adding a label statement that alfaxalone 

is a Class IV controlled substance.

522.52 ............ no ................... CE.1 4


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Federal Register / Vol. 79, No. 208 / Tuesday, October 28, 2014 / Rules and Regulations 64115 

TABLE 1—ORIGINAL AND SUPPLEMENTAL NADAS AND ANADAS APPROVED DURING AUGUST 2014—Continued 

NADA/

ANADA Sponsor New animal drug product name Action 21 CFR Sections 

FOIA 

Summary NEPA Review 

141–348 ...... Zoetis Inc., 333 Portage 

St., Kalamazoo, MI 

49007.

SYNOVEX ONE FEEDLOT (trenbolone and 

estradiol extended release implant).

SYNOVEX ONE 

GRASS (trenbolone 

and estradiol extended release implant).

Original approval for increased rate of 

weight gain and improved feed efficiency 

for up to 200 days in 

steers and heifers fed 

in confinement for 

slaughter.

Original approval for increased rate of 

weight gain for up to 

200 days in pasture 

steers and heifers 

(slaughter, stocker, 

and feeder).

522.2478 ........ yes ................. EA/FONSI.1 3

200–455 5 .... Cross Vetpharm Group 

Ltd. Broomhill Rd., 

Tallaght,.

Dublin 24, Ireland .........

TYLOMED–WS (tylosin 

tartrate) Soluble Powder.

Supplemental approval 

of a change to veterinary prescription (Rx) 

marketing status to 

conform with reference (pioneer) 

product.

520.2640 ........ no ................... CE.1 6

1The Agency has determined under 21 CFR 25.33 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 individually or cumulatively have a significant effect on the human environment. 2 CE granted under 21 CFR 25.33(a). 

3The Agency has carefully considered an environmental assessment (EA) of the potential environmental impact of this action and has made a 

finding of no significant impact (FONSI). 4 CE granted under 21 CFR 25.33(d)(1). 

5This application was listed 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. 6 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, 522, and 524 

Animal drugs. 

21 CFR Part 556 

Animal drugs, Foods. 

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, and 556 

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 

‘‘Macleod Pharmaceuticals, Inc.’’ and 

‘‘Hess & Clark, Inc.’’ and alphabetically 

add an entry for ‘‘Neogen Corp.’’; and in 

the table in paragraph (c)(2), remove the 

entries for ‘‘058711’’ and ‘‘050749’’ and 

numerically add an entry for ‘‘059051’’ 

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 

*******

Neogen Corp., 944 Nandino Blvd., Lexington, KY 40511 .................................................................................................................. 059051 

* * * * * * * 

(2) * * * 

Drug labeler 

code Firm name and address 

*******

059051 Neogen Corp., 944 Nandino Blvd., Lexington, KY 40511 


asabaliauskas on DSK5VPTVN1PROD with RULES
64116 Federal Register / Vol. 79, No. 208 / Tuesday, October 28, 2014 / Rules and Regulations 

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. 

§ 520.2613 [Amended] 

■ 4. In paragraph (b) of § 520.2613, 

remove ‘‘058711’’ and in its place add 

‘‘059051’’. 

■ 5. In § 520.2640, revise paragraphs (b), 

(d), and (e)(2)(ii) to read as follows: 

§ 520.2640 Tylosin. 

* * * * * 

(b) Sponsors—(1) No. 000986 for use 

as in paragraph (e) of this section. 

(2) Nos. 016592 and 061623 for use as 

in paragraphs (e)(1)(i)(A), (e)(1)(ii), 

(e)(2), (e)(3), and (e)(4) of this section. 

* * * * * 

(d) Special considerations. Federal 

law restricts this drug to use by or on 

the order of a licensed veterinarian. 

(e) * * * 

(2) * * * 

(ii) Indications for use. For the 

reduction in severity of effects of 

infectious sinusitis associated with 

Mycoplasma gallisepticum. 

* * * * * 

PART 522—IMPLANTATION OR 

INJECTABLE DOSAGE FORM NEW 

ANIMAL DRUGS 

■ 6. The authority citation for 21 CFR 

part 522 continues to read as follows: 

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

■ 7. In § 522.52, in paragraph (c)(3), add 

a second sentence to read as follows: 

§ 522.52 Alfaxalone. 

* * * * * 

(c) * * * 

(3) * * * Alfaxalone is a Class IV 

controlled substance. 

■ 8. In § 522.690, revise paragraph 

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

§ 522.690 Dinoprost. 

* * * * * 

(d) * * * 

(1) * * * 

(iii) Limitations. Do not use in horses 

intended for human consumption. 

* * * * * 

■ 9. In § 522.1193, revise paragraph 

(e)(3) to read as follows: 

§ 522.1193 Ivermectin and clorsulon. 

* * * * * 

(e) * * * 

(3) Limitations. For No. 050604: Do 

not treat cattle within 21 days of 

slaughter. For Nos. 055529 and 058005: 

Do not treat cattle within 49 days of 

slaughter. Because a withdrawal time in 

milk has not been established, do not 

use in female dairy cattle of breeding 

age. A withdrawal period has not been 

established for preruminating calves. Do 

not use in calves to be processed for 

veal. 

■ 10. In § 522.2478, revise paragraphs 

(a), (d)(1)(i) introductory text, (d)(1)(ii) 

introductory text, and (d)(2); and add 

paragraphs (d)(1)(iii) and (d)(3) to read 

as follows: 

§ 522.2478 Trenbolone acetate and 

estradiol benzoate. 

(a) Specifications—(1) Each implant 

consists of: 

(i) 8 pellets, each pellet containing 25 

milligrams (mg) trenbolone acetate and 

3.5 mg estradiol benzoate. 

(ii) 4 pellets, each pellet containing 25 

mg trenbolone acetate and 3.5 mg 

estradiol benzoate. 

(2) Each extended release implant 

consists of: 

(i) 8 pellets with a porous polymer 

film coating, each pellet containing 25 

mg trenbolone acetate and 3.5 mg 

estradiol benzoate. 

(ii) 6 pellets with a porous polymer 

film coating, each pellet containing 25 

mg trenbolone acetate and 3.5 mg 

estradiol benzoate. 

* * * * * 

(d) * * * 

(1) * * * 

(i) For an implant as described in 

paragraph (a)(1)(i) of this section: 

* * * * * 

(ii) For an implant as described in 

paragraph (a)(1)(ii) of this section: 

* * * * * 

(iii) For an implant as described in 

paragraph (a)(2)(i) of this section: 

(A) Amount. 200 mg trenbolone 

acetate and 28 mg estradiol benzoate in 

an extended release implant. 

(B) Indications for use. For increased 

rate of weight gain and improved feed 

efficiency for up to 200 days. 

(C) Limitations. Implant 

subcutaneously in ear only. Safety and 

effectiveness have not been established 

in veal calves. A withdrawal period has 

not been established for this product in 

preruminating calves. Do not use in 

calves to be processed for veal. 

(2) Heifers fed in confinement for 

slaughter—(i) For an implant as 

described in paragraph (a)(1)(i) of this 

section: 

(A) Amount. 200 mg trenbolone 

acetate and 28 mg estradiol benzoate. 

(B) Indications for use. For increased 

rate of weight gain. 

(C) Limitations. Implant 

subcutaneously in ear only. Not for use 

in dairy or beef replacement heifers. 

Safety and effectiveness have not been 

established in veal calves. A withdrawal 

period has not been established for this 

product in preruminating calves. Do not 

use in calves to be processed for veal. 

(ii) For an implant as described in 

paragraph (a)(1)(ii) of this section: 

(A) Amount. 100 mg trenbolone 

acetate and 14 mg estradiol benzoate. 

(B) Indications for use. For increased 

rate of weight gain and improved feed 

efficiency. 

(C) Limitations. Implant 

subcutaneously in ear only. Not for use 

in dairy or beef replacement heifers. 

Safety and effectiveness have not been 

established in veal calves. A withdrawal 

period has not been established for this 

product in preruminating calves. Do not 

use in calves to be processed for veal. 

(iii) For an implant as described in 

paragraph (a)(2)(i) of this section: 

(A) Amount. 200 mg trenbolone 

acetate and 28 mg estradiol benzoate in 

an extended release implant. 

(B) Indications for use. For increased 

rate of weight gain and improved feed 

efficiency for up to 200 days. 

(C) Limitations. Implant 

subcutaneously in ear only. Not for use 

in dairy or beef replacement heifers. 

Safety and effectiveness have not been 

established in veal calves. A withdrawal 

period has not been established for this 

product in preruminating calves. Do not 

use in calves to be processed for veal. 

(3) Pasture steers and heifers 

(slaughter, stocker, and feeder)—(i) For 

an implant as described in paragraph 

(a)(2)(ii) of this section: 

(A) Amount. 150 mg trenbolone 

acetate and 21 mg estradiol benzoate in 

an extended release implant. 

(B) Indications for use. For increased 

rate of weight gain for up to 200 days. 

(C) Limitations. Implant 

subcutaneously in ear only. Not for use 

in dairy or beef replacement heifers. 


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Federal Register / Vol. 79, No. 208 / Tuesday, October 28, 2014 / Rules and Regulations 64117 

Safety and effectiveness have not been 

established in veal calves. A withdrawal 

period has not been established for this 

product in preruminating calves. Do not 

use in calves to be processed for veal. 

(ii) [Reserved] 

PART 524—OPHTHALMIC AND 

TOPICAL DOSAGE FORM NEW 

ANIMAL DRUGS 

■ 11. The authority citation for 21 CFR 

part 524 continues to read as follows: 

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

§ 524.1580a [Amended] 

■ 12. In paragraph (b)(1) of § 524.1580a, 

remove ‘‘Nos. 050749, 054628, 054925, 

058005, and 061623’’ and add in its 

place ‘‘Nos. 054628, 054925, 058005, 

059051, and 061623’’. 

§ 524.1580b [Amended] 

■ 13. In paragraph (b) of § 524.1580b, 

remove ‘‘No. 054628’’ and in its place 

add ‘‘Nos. 054628 and 059051’’. 

PART 556—TOLERANCES FOR 

RESIDUES OF NEW ANIMAL DRUGS 

IN FOOD 

■ 14. The authority citation for 21 CFR 

part 556 continues to read as follows: 

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

■ 15. In § 556.344, revise paragraphs (a), 

(b)(1)(i), and (b)(2)(ii); and add 

paragraph (c) to read as follows: 

§ 556.344 Ivermectin. 

(a) Acceptable Daily Intake (ADI). The 

ADI for total residues of ivermectin is 5 

micrograms per kilogram of body weight 

per day. 

(b) * * * 

(1) * * * 

(i) Cattle. 1.6 parts per million. 

(2) * * * 

(ii) Cattle. 650 parts per billion. 

(c) Related conditions of use. See 

§§ 520.1192, 520.1195, 520.1197, 

522.1192, 522.1193, 524.1193, and 

558.300 of this chapter. 

Dated: October 23, 2014. 

Bernadette Dunham, 

Director, Center for Veterinary Medicine. 

[FR Doc. 2014–25588 Filed 10–27–14; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HOMELAND 

SECURITY 

Coast Guard 

33 CFR Part 165 

[Docket Number USCG–2014–0747] 

RIN 1625–AA00 

Safety Zone; Allegheny River; Mile 

45.7; Kittanning, PA 

AGENCY: Coast Guard, DHS. 

ACTION: Temporary final rule. 

SUMMARY: The Coast Guard is 

establishing a temporary safety zone on 

the Allegheny River at mile 45.7. This 

safety zone is needed to protect vessels 

transiting the area and event spectators 

from the hazards associated with a 

barge-based fireworks display. Entry 

into this zone is prohibited unless 

specifically authorized by the Captain of 

the Port (COTP) Pittsburgh or a 

designated representative. 

DATES: This rule is effective from 8:30 

p.m. until 10:00 p.m. on November 21, 

2014. 

ADDRESSES: Documents mentioned in 

this preamble are part of docket USCG– 

2014–0747. To view documents 

mentioned in this preamble as being 

available in the docket, go to http://

www.regulations.gov, type the docket 

number in the ‘‘SEARCH’’ box and click 

‘‘SEARCH.’’ Click on Open Docket 

Folder on the line associated with this 

rulemaking. You may also visit the 

Docket Management Facility in Room 

W12–140 on the ground floor of the 

Department of Transportation West 

Building, 1200 New Jersey Avenue SE., 

Washington, DC 20590, between 9 a.m. 

and 5 p.m., Monday through Friday, 

except Federal holidays. 

FOR FURTHER INFORMATION CONTACT: If 

you have questions on this rule, call or 

email Jennifer Haggins, Marine Safety 

Unit Pittsburgh, U.S. Coast Guard, at 

telephone 412–644–5808, email 

Jennifer.L.Haggins@uscg.mil. If you have 

questions on viewing or submitting 

material to the docket, call Cheryl F. 

Collins, Program Manager, Docket 

Operations, telephone (202) 366–9826. 

SUPPLEMENTARY INFORMATION: 

Table of Acronyms 

DHS Department of Homeland Security 

FR Federal Register 

NPRM Notice of Proposed Rulemaking 

A. Regulatory History and Information 

The Coast Guard is issuing this 

temporary final rule without prior 

notice and opportunity to comment 

pursuant to authority under section 4(a) 

of the Administrative Procedure Act 

(APA) (5 U.S.C. 553(b)). This provision 

authorizes an agency to issue a rule 

without prior notice and opportunity to 

comment when the agency for good 

cause finds that those procedures are 

‘‘impracticable, unnecessary, or contrary 

to the public interest.’’ Under 5 U.S.C. 

553(b)(B), the Coast Guard finds that 

good cause exists for not using the 

NPRM process. Upon receiving notice of 

this display and after full review of the 

event information and location, the 

Coast Guard determined that a safety 

zone is necessary. Delaying this rule by 

completing the full NPRM process 

would unnecessarily delay the safety 

zone and be contrary to public interest 

because the safety zone is needed to 

protect transiting vessels, spectators, 

and the personnel involved in the 

display from the hazards associated 

with fireworks displays taking place 

over the waterway. Completing the full 

NPRM process could also unnecessarily 

delay the locally advertised and 

planned event and possibly interfere 

with contractual obligations. 

Under 5 U.S.C. 553(d)(3), the Coast 

Guard finds that good cause exists for 

making this temporary rule effective less 

than 30 days after publication in the 

Federal Register for the same reasons 

discussed in the preceding paragraph, 

waiting for a 30 day notice period to run 

would be impracticable and contrary to 

the public interest. 

B. Basis and Purpose 

On November 21, 2014, as a part of 

Light Up Night, Downtown Kittanning 

Inc. will sponsor a barge-based 

fireworks display. The display will take 

place in the vicinity of mile 45.7 on the 

Allegheny River. This event presents 

safety hazards for spectators and vessels 

navigating in the area, and therefore a 

safety zone is needed to protect persons 

and property from the hazards 

associated with a fireworks display over 

the waterway. 

The legal basis and authorities for this 

rule are found in 33 U.S.C. 1231; 46 

U.S.C. Chapter 701, 3306, 3703; 50 

U.S.C. 191, 195; 33 CFR 1.05–1, 6.04–1, 

6.04–6, and 160.5; Public Law 107–295, 

116 Stat. 2064; and Department of 

Homeland Security Delegation No. 

0170.1, which collectively authorize the 

Coast Guard to establish and define 

regulatory safety zones. 

C. Discussion of the Final Rule 

The Coast Guard is establishing a 

safety zone for all waters of the 

Allegheny River, mile 45.7, extending 

the entire width of the river. Entry into 

this zone is prohibited to all vessels and 


asabaliauskas on DSK5VPTVN1PROD with RULES