43482 Federal Register / Vol. 82, No. 179 / Monday, September 18, 2017 / Rules and Regulations 

(iv) Replace Fig. 11 with paragraph 

(b)(5)(v), ‘‘Fig. 12’’. 

(v) Fig. 12: Suffocation Hazard 

Warning. 

(vi) Replace Fig. 12 with paragraph 

(b)(5)(vii), ‘‘Fig. 13’’. 

(vii) Fig. 13: Instruction Warning 

Statements. 

(6) In section 9.2.2 of ASTM F2167– 

17, replace the reference to ‘‘Fig. 12’’ 

with ‘‘Fig. 13.’’ 

Alberta E. Mills, 

Acting Secretary, Consumer Product Safety 

Commission. 

[FR Doc. 2017–19255 Filed 9–15–17; 8:45 am] 

BILLING CODE 6355–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

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

558 

[Docket No. FDA–2017–N–0002] 

New Animal Drugs; Approval of New 

Animal Drug Applications; Change of 

Sponsor’s Address 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Final rule; technical 

amendments. 

SUMMARY: The Food and Drug 

Administration (FDA or we) is 

amending the animal drug regulations to 

reflect application-related actions for a 

new animal drug application (NADA) 

and abbreviated new animal drug 

applications (ANADAs) during March 

and April 2017. 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 a sponsor’s address 

and to make technical amendments to 

improve the accuracy of the regulations. 

DATES: This rule is effective September 

18, 2017. 


sradovich on DSKBBY8HB2PROD with RULESER18SE17.003</GPH> ER18SE17.004</GPH>
Federal Register / Vol. 82, No. 179 / Monday, September 18, 2017 / Rules and Regulations 43483 

FOR FURTHER INFORMATION CONTACT: 

George K. Haibel, Center for Veterinary 

Medicine (HFV–6), Food and Drug 

Administration, 7500 Standish Pl., 

Rockville, MD 20855, 240–402–5689, 

george.haibel@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Approval Actions 

FDA is amending the animal drug 

regulations to reflect approval actions 

for a NADA and ANADAs during March 

and April 2017, 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 Dockets Management Staff 

Office (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: https://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: 

https://www.fda.gov/AnimalVeterinary/ 

Products/ 

ApprovedAnimalDrugProducts/ 

default.htm. 

TABLE 1—ORIGINAL AND SUPPLEMENTAL NADAS AND ANADAS APPROVED DURING MARCH AND APRIL 2017 

Approval date File No. Sponsor Product name Species Effect of the action Public documents 

April 24, 2017 ... 141–269 Intervet, Inc., 2 

Giralda 

Farms, Madison, NJ 

07940.

REVALOR–XH 

(trenbolone 

acetate and 

estradiol extended-release implant).

Cattle ....... Supplemental approval of a new 

implant for increased rate of 

weight gain and improved 

feed efficiency for up to 200 

days after implantation in beef 

heifers fed in confinement for 

slaughter.

FOI Summary, EA/FONSI.1

April 19, 2017 ... 200–593 Accord 

Healthcare, 

Inc., 1009 

Slater Rd., 

Suite 210–B, 

Durham, NC 

27703.

Carprofen Injection.Dogs ........ Original approval as a generic 

copy of NADA 141–199.

FOI Summary. 

April 28, 2017 ... 200–595 Norbrook Laboratories, 

Ltd., Station 

Works, Newry 

BT35 6JP, 

Northern Ireland.

CARPRIEVE 

(carprofen) 

Chewable 

Tablets.

Dogs ........ Original approval as a generic 

copy of NADA 141–111.

FOI Summary. 

1The 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). 

II. Technical Amendments 

Pharmgate LLC, 1015 Ashes Dr., suite 

102, Wilmington, NC 28405, has 

informed FDA that it has changed its 

address to 1800 Sir Tyler Dr., 

Wilmington, NC 28405. Accordingly, we 

are amending § 510.600(c) to reflect this 

change. 

We are making several technical 

amendments in part 558, which was 

amended on December 27, 2016 (81 FR 

94991), and February 24, 2017 (82 FR 

11510), as part of the FDA Center for 

Veterinary Medicine’s (CVM’s) 

Judicious Use Initiative. We are also 

making several technical amendments 

to the regulations for dosage form drugs. 

These actions are being taken to 

improve the accuracy of the regulations. 

III. Legal Authority 

This final rule is issued under section 

512(i) of the Federal Food, Drug, and 

Cosmetic Act (the FD&C Act) (21 U.S.C. 

360b(i)), which requires Federal 

Register publication of ‘‘notice[s] . . . 

effective as a regulation,’’ of the 

conditions of use of approved new 

animal drugs. This rule sets forth 

technical amendments to the regulations 

to codify recent actions on approved 

new animal drug applications and 

corrections to improve the accuracy of 

the regulations, and as such does not 

impose any burden on regulated 

entities. 

Although denominated a rule 

pursuant to the FD&C Act, this 

document 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. Likewise, this is not a 

rule subject to Executive Order 12866, 

which defines a rule as ‘‘an agency 

statement of general applicability and 

future effect, which the agency intends 

to have the force and effect of law, that 

is designed to implement, interpret, or 

prescribe law or policy or to describe 

the procedure or practice requirements 

of an agency.’’ 

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 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, and 558 

are amended as follows: 

PART 510—NEW ANIMAL DRUGS 

■ 1. The authority citation for part 510 

continues to read as follows: 


sradovich on DSKBBY8HB2PROD with RULES
43484 Federal Register / Vol. 82, No. 179 / Monday, September 18, 2017 / Rules and Regulations 

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

353, 360b, 371, 379e. 

■ 2. In § 510.600, in the table in 

paragraph (c)(1), revise the entry for 

‘‘Pharmgate LLC’’; and in the table in 

paragraph (c)(2), revise the entry for 

‘‘069254’’ 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 

* * * * * 

Pharmgate LLC, 1800 Sir Tyler 

Dr., Wilmington, NC 28405 ....... 069254 

* * * * * 

(2) * * * 

Drug 

labeler 

code 

Firm name and address 

* * * * * 

069254 Pharmgate LLC, 1800 Sir Tyler 

Dr., Wilmington, NC 28405 

* * * * * 

PART 520—ORAL DOSAGE FORM 

NEW ANIMAL DRUGS 

■ 3. The authority citation for part 520 

continues to read as follows: 

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

§ 520.88g [Amended] 

■ 4. In § 520.88g, in paragraphs (c)(1)(ii) 

and (c)(2)(ii), in the first sentence, 

remove ‘‘nonbeta-lactamase’’ and in its 

place add ‘‘non-beta-lactamase’’. 

■ 5. In § 520.304, remove paragraph 

(b)(3) and revise paragraphs (b)(1) and 

(2) to read as follows: 

§ 520.304 Carprofen. 

* * * * * 

(b) * * * 

(1) Nos. 054771, 026637, 055529, and 

062250 for use of products described in 

paragraph (a) as in paragraph (d) of this 

section. 

(2) No. 000859 for use of product 

described in paragraph (a)(1) as in 

paragraph (d) of this section. 

* * * * * 

PART 522—IMPLANTATION OR 

INJECTABLE DOSAGE FORM NEW 

ANIMAL DRUGS 

■ 6. The authority citation for part 522 

continues to read as follows: 

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

■ 7. In § 522.304, revise paragraph (b) to 

read as follows: 

§ 522.304 Carprofen. 

* * * * * 

(b) Sponsors. See Nos. 016729, 

026637, 054771, and 055529 in 

§ 510.600(c) of this chapter. 

* * * * * 

■ 8. In § 522.970, revise paragraph 

(b)(1); remove paragraphs (b)(3), 

(e)(2)(ii)(B), and (e)(2)(iii); and add two 

sentences after the italic heading of 

paragraph (e)(2)(ii), to read as follows: 

§ 522.970 Flunixin. 

* * * * * 

(b) * * * 

(1) See Nos. 000061, 000859, 055529, 

057561, and 061623 for use as in 

paragraph (e) of this section. 

* * * * * 

(e) * * * 

(2) * * * 

(ii) Limitations. Approved only for 

intravenous administration in cattle. 

Intramuscular administration has 

resulted in violative residues in the 

edible tissues of cattle sent to slaughter. 

* * * 

* * * * * 

■ 9. In § 522.1002, revise paragraph 

(b)(1) to read as follows: 

§ 522.1002 Follicle stimulating hormone. 

* * * * * 

(b)(1) Specifications—(i) Single pack. 

Each package contains 2 vials. One vial 

contains 700 international units (IU) 

porcine-pituitary-derived follicle 

stimulating hormone (FSH) equivalent 

to 400 milligrams NIH–FSH–P1, as a dry 

powder. The other vial contains 20 

milliliters (mL) of bacteriostatic sodium 

chloride injection. When constituted, 

each milliliter of solution contains 35 IU 

FSH. 

(ii) Dual pack. Each package contains 

2 vials. Each vial contains 700 

international units (IU) porcinepituitary-derived FSH equivalent to 400 

milligrams NIH–FSH–P1, as a dry 

powder. Constitute with 20 mL 

bacteriostatic sodium chloride injection, 

using strict aseptic technique. When 

constituted, each milliliter of solution 

contains 35 IU FSH. 

* * * * * 

■ 10. In § 522.1660a, revise the first 

sentence of paragraph (e)(1)(ii) to read 

as follows: 

§ 522.1660a Oxytetracycline solution, 200 

milligrams/milliliter. 

* * * * * 

(e) * * * 

(1) * * * 

(ii) Limitations. Exceeding the highest 

recommended level of drug per pound 

of bodyweight per day, administering 

more than the recommended number of 

treatments, and/or exceeding 10 mL 

intramuscularly or subcutaneously per 

injection site in adult beef and dairy 

cattle may result in antibiotic residues 

beyond the withdrawal time. * * * 

* * * * * 

■ 11. In § 522.2477, revise paragraph 

(b)(2) and the first sentence in 

paragraphs (d)(1)(iii), (d)(2)(iii), 

(d)(3)(iii), and (d)(4)(iii); and add 

paragraph (d)(5) to read as follows: 

§ 522.2477 Trenbolone acetate and 

estradiol. 

* * * * * 

(b) * * * 

(2) No. 000061 for use as in 

paragraphs (d)(1)(i)(A), (d)(1)(i)(C), 

(d)(1)(i)(D), (d)(1)(i)(G), (d)(1)(ii), 

(d)(1)(iii), (d)(2)(i)(A), (d)(2)(i)(C), 

(d)(2)(i)(D), (d)(2)(ii), (d)(2)(iii), 

(d)(3)(i)(A), (d)(3)(ii), (d)(3)(iii), (d)(4), 

and (d)(5) of this section. 

* * * * * 

(d) * * * 

(1) * * * 

(iii) Limitations. Administer implant 

subcutaneously in the ear only. * * * 

(2) * * * 

(iii) Limitations. Administer implant 

subcutaneously in the ear only. * * * 

(3) * * * 

(iii) Limitations. Administer implant 

subcutaneously in the ear only. * * * 

(4) * * * 

(iii) Limitations. Administer implant 

subcutaneously in the ear only. * * * 

(5) Beef heifers fed in confinement for 

slaughter—(i) Amount. Each extendedrelease implant contains 200 mg 

trenbolone acetate and 20 mg estradiol 

(one implant consisting of 6 coated and 

4 uncoated pellets, each pellet 

containing 20 mg trenbolone acetate and 

2 mg estradiol). 

(ii) Indications for use. For increased 

rate of weight gain and improved feed 

efficiency for up to 200 days after 

implantation. 

(iii) Limitations. Administer implant 

subcutaneously in the ear only. Do not 

use in lactating dairy cows or in animals 

intended for subsequent breeding. Use 

in these cattle may cause drug residues 

in milk and/or in calves born to these 

cows. Do not use in calves to be 

processed for veal. A withdrawal period 

has not been established for this product 

in pre-ruminating calves. Effectiveness 


sradovich on DSKBBY8HB2PROD with RULES
Federal Register / Vol. 82, No. 179 / Monday, September 18, 2017 / Rules and Regulations 43485 

and animal safety in veal calves have 

not been established. Not approved for 

repeated implantation (reimplantation) 

with this or any other cattle ear implant 

during the production phase(s) 

identified on labeling (beef heifers fed 

in confinement for slaughter) unless 

otherwise indicated on labeling because 

safety and effectiveness have not been 

evaluated. 

PART 524—OPHTHALMIC AND 

TOPICAL DOSAGE FORM NEW 

ANIMAL DRUGS 

■ 12. The authority citation for part 524 

continues to read as follows: 

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

■ 13. In § 524.998, add paragraph (c)(2) 

to read as follows: 

§ 524.998 Fluralaner. 

* * * * * 

(c) * * * 

(2) Cats—(i) Amount. Administer 

topically as a single dose every 12 

weeks according to the label dosage 

schedule to provide a minimum dose of 

18.2 mg/lb (40 mg/kg) body weight. May 

be administered every 8 weeks in case 

of potential exposure to D. variabilis 

ticks. 

(ii) Indications for use. Kills adult 

fleas; for the treatment and prevention 

of flea infestations (C. felis) and the 

treatment and control of I. scapularis 

(black-legged tick) infestations for 12 

weeks in cats and kittens 6 months of 

age and older, and weighing 2.6 lb or 

greater; for the treatment and control of 

D. variabilis (American dog tick) 

infestations for 8 weeks in cats and 

kittens 6 months of age and older, and 

weighing 2.6 lb or greater. 

(iii) Limitations. 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 

■ 14. The authority citation for part 558 

continues to read as follows: 

Authority: 21 U.S.C. 354, 360b, 360ccc, 

360ccc–1, 371. 

■ 15. In § 558.4, in paragraph (d), in the 

‘‘Category II’’ table, revise the row 

entries for ‘‘Neomycin’’ and 

‘‘Oxytetracycline’’ to read as follows: 

§ 558.4 Requirement of a medicated feed 

mill license. 

* * * * * 

(d) * * * 

CATEGORY II 

Drug 

Assay limits 

percent Type 

A1

Type B maximum 

(100x) 

Assay limits 

percent Type 

B/C 2

*******

Neomycin ...................................................................... 80–120 20 g/lb (4.4%) ............................................................... 70–125 

Oxytetracycline .............................................................. 80–120 20 g/lb (4.4%) ............................................................... 65–135 

* * * * * * * 

1Percent of labeled amount. 

2Values given represent ranges for either Type B or Type C medicated feeds. For those drugs that have two range limit, the first set is for a 

Type B medicated feed and the second set is for a Type C medicated feed. These values (ranges) have been assigned in order to provide for 

the possibility of dilution of a Type B medicated feed with lower assay limits to make a Type C medicated feed. 

* * * * * 

§ 558.128 [Amended] 

■ 16. In § 558.128, in paragraphs 

(e)(4)(iii) and (xii) and (e)(5)(ii) and (iii), 

in the ‘‘Sponsor’’ column, add ‘‘069254’’ 

after ‘‘054771’’; in paragraphs (e)(4)(xi) 

and (xiii), in the ‘‘Limitations’’ column, 

remove the third sentence ‘‘Withdraw 

24 hours prior to slaughter.’’; and in 

paragraph (e)(6)(v), remove ‘‘Sponsor. 

See No. 054771’’ and in its place add 

‘‘Sponsors. See Nos. 054771 and 

069254’’. 

§ 558.625 [Amended] 

■ 17. Amend § 558.625 as follows: 

■ a. In paragraphs (e)(1)(vii) and (ix), in 

the ‘‘Tylosin grams/ton’’ column, 

remove ‘‘40 to 100’’ and in its place add 

‘‘40 or 100’’; 

■ b. In paragraph (e)(2)(ii), in the 

‘‘Limitations’’ column, add ‘‘See 

§§ 558.311(d) and 558.342(d) in this 

chapter.’’ after the last sentence; 

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

‘‘Limitations ’’ column, add ‘‘See 

§ 558.342(d) in this chapter.’’ after the 

last sentence; 

■ d. In paragraph (e)(2)(vi), in the 

‘‘Limitations’’ column, remove ‘‘See 

§ 558.355(d) in this chapter’’ and in its 

place add ‘‘See §§ 558.311(d) and 

558.355(d) in this chapter.’’; 

■ e. In paragraph (e)(2)(vii), in the 

‘‘Limitations’’ column, remove ‘‘See 

§ 558.355(d) in this chapter’’ and in its 

place add ‘‘See §§ 558.342(d) and 

558.355(d) in this chapter.’’; 

■ f. In paragraphs (e)(2)(viii), (ix), and 

(x), in the ‘‘Limitations’’ column, 

remove ‘‘See § 558.355(d) in this 

chapter’’ and in its place add ‘‘See 

§§ 558.355(d) and 558.500(d) in this 

chapter.’’ 

■ g. In paragraph (e)(2)(xi) in the 

‘‘Limitations’’ column, remove ‘‘See 

§ 558.355(d) in this chapter.’’ and in its 

place add ‘‘See §§ 558.342(d), 

558.355(d), and 558.500(d) in this 

chapter.’’; 

■ h. In paragraphs (e)(2)(xii) and (xiii), 

in the ‘‘Limitations’’ column, remove 

‘‘See § 558.355(d) in this chapter.’’ and 

in its place add ‘‘See §§ 558.355(d) and 

558.665(d) in this chapter.’’; and 

■ i. In paragraphs (e)(2)(xiv) and (xv), in 

the ‘‘Limitations’’ column, remove ‘‘See 

§ 558.355(d) in this chapter.’’ and in its 

place add ‘‘See §§ 558.342(d), 

558.355(d) and 558.665(d) in this 

chapter.’’ 

Dated: September 7, 2017. 

Anna K. Abram, 

Deputy Commissioner for Policy, Planning, 

Legislation, and Analysis. 

[FR Doc. 2017–19602 Filed 9–15–17; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HOMELAND 

SECURITY 

Coast Guard 

33 CFR Part 100 

[Docket No. USCG–2017–0864] 

RIN 1625–AA08 

Regattas and Marine Parades; Great 

Lakes Annual Marine Events 

AGENCY: Coast Guard, DHS. 

ACTION: Notice of enforcement of 

regulation. 


sradovich on DSKBBY8HB2PROD with RULES