17942 Federal Register / Vol. 87, No. 60 / Tuesday, March 29, 2022 / Rules and Regulations 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Parts 510, 516, 520, 522, 524, 

529, 556, and 558 

[Docket No. FDA–2021–N–0002] 

New Animal Drugs; Approval of New 

Animal Drug Applications; Change of 

Sponsor 

AGENCY: Food and Drug Administration, 

Department of Health and Human 

Services (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 

new animal drug applications (NADAs) 

and abbreviated new animal drug 

applications (ANADAs) during October, 

November, and December 2021. FDA is 

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 improve the accuracy of the 

regulations. 

DATES: This rule is effective March 29, 

2022. 

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. Approvals 

FDA is amending the animal drug 

regulations to reflect approval actions 

for NADAs and ANADAs during 

October, November, and December 

2021, 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 office of the Dockets 

Management Staff (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, 240–402–7500. Persons 

with access to the internet may obtain 

these documents at the CVM FOIA 

Electronic Reading Room: https://

www.fda.gov/about-fda/centerveterinary-medicine/cvm-foiaelectronic-reading-room. Marketing 

exclusivity and patent information may 

be accessed in FDA’s publication, 

Approved Animal Drug Products Online 

(Green Book) at: https://www.fda.gov/ 

animal-veterinary/products/approvedanimal-drug-products-green-book. 

FDA has verified the website 

addresses as of the date this document 

publishes in the Federal Register, but 

websites are subject to change over time. 

TABLE 1—ORIGINAL AND SUPPLEMENTAL NADAS AND ANADAS APPROVED DURING OCTOBER, NOVEMBER, AND

DECEMBER 2021 

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

documents 

October 1, 2021 ..... 200–691 Virbac AH, Inc., P.O. Box 

162059, Fort Worth, TX 

76161.

RAC 45 CATTLE 

(ractopamine hydrochloride Type A medicated article).

Cattle .............. Original approval as a generic copy of 

NADA 141–221.

FOI Summary. 

October 20, 2021 ... 200–604 Dechra Veterinary Products LLC, 7015 College 

Blvd., Suite 525, Overland Park, KS 66211.

Amoxicillin and 

Clavulanate Potassium 

for Oral Suspension.

Dogs and cats Original approval as a generic copy of 

NADA 055–101.

FOI Summary. 

October 28, 2021 ... 200–588 Sparhawk Laboratories, 

Inc., 12340 Santa Fe 

Trail Dr., Lenexa, KS 

66215.

Florfenicol Injection 

(florfenicol) Injectable 

Solution.

Cattle .............. Original approval as a generic copy of 

NADA 141–063.

FOI Summary. 

October 29, 2021 ... 200–628 Sparhawk Laboratories, 

Inc., 12340 Santa Fe 

Trail Dr., Lenexa, KS 

66215.

Enrofloxacin 100 

(enrofloxacin) Injectable 

Solution.

Cattle and 

swine.

Original approval as a generic copy of 

NADA 141–068.

FOI Summary. 

October 29, 2021 ... 141–348 Zoetis Inc., 333 Portage 

St., Kalamazoo, MI 

49007.

SYNOVEX ONE Grower 

(trenbolone acetate and 

estradiol benzoate extended-release implants).

Cattle .............. Supplemental approval adding cattle 

fed in confinement for slaughter.

FOI Summary. 

November 1, 2021 .. 200–711 Ceva Sante Animale, 10 

Avenue de la 

Ballastie`re, 33500 

Libourne, France.

TULAVEN 100 

(tulathromycin injection) 

Injectable Solution.

Cattle and 

swine.

Original approval as a generic copy of 

NADA 141–244.

FOI Summary. 

November 3, 2021 .. 200–712 Ceva Sante Animale, 10 

Avenue de la 

Ballastie`re, 33500 

Libourne, France.

TULAVEN 25 

(tulathromycin injection) 

Injectable Solution.

Cattle and 

swine.

Original approval as a generic copy of 

NADA 141–349.

FOI Summary. 

November 3, 2021 .. 141–508 Elanco US Inc., 2500 Innovation Way, Greenfield, IN 46140.EXPERIOR (lubabegron) 

Type A medicated article.

Cattle .............. Supplemental approval adding tolerances for residues in edible tissues 

of cattle.

FOI Summary. 

November 12, 2021 200–668 Virbac AH, Inc., P.O. Box 

162059, Fort Worth, TX 

76161.

TULISSIN 25 

(tulathromycin injection) 

Injectable Solution.

Cattle and 

swine.

Original approval as a generic copy of 

NADA 141–349.

FOI Summary. 

November 15, 2021 200–253 Bimeda Animal Health 

Ltd., 1B The Herbert 

Building, The Park, 

Carrickmines, Dublin 

18, Ireland.

PROSTAMATE (dinoprost 

tromethamine injection) 

Injectable Solution.

Cattle .............. Supplemental approval for use with 

gonadorelin or with progesterone 

intravaginal inserts.

FOI Summary. 

November 15, 2021 200–669 Virbac AH, Inc., P.O. Box 

162059, Fort Worth, TX 

76161.

TULISSIN 100 

(tulathromycin injection) 

Injectable Solution.

Cattle and 

swine.

Original approval as a generic copy of 

NADA 141–244.

FOI Summary. 


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TABLE 1—ORIGINAL AND SUPPLEMENTAL NADAS AND ANADAS APPROVED DURING OCTOBER, NOVEMBER, AND

DECEMBER 2021—Continued 

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

documents 

November 22, 2021 200–695 Virbac AH, Inc., P.O. Box 

162059, Fort Worth, TX 

76161.

TIA 12.5% (tiamulin hydrogen fumarate) Liquid 

Concentrate.

Swine ............. Original approval as a generic copy of 

NADA 140–916.

FOI Summary. 

November 24, 2021 200–714 Aurora Pharmaceutical, 

Inc, 1196 Highway 3 

South, Northfield, MN 

55057–3009.

BARRIER for Cats 

(imidacloprid and 

moxidectin) Topical Solution.

Cats ................ Original approval as a generic copy of 

NADA 141–254.

FOI Summary. 

December 10, 2021 200–705 Elanco US Inc., 2500 Innovation Way, Greenfield, IN 46140.ZOASHIELD (zoalene) 

Type A medicated article and BMD (bacitracin 

methylenedisalicylate) 

Type A medicated article.

Chickens and 

turkeys.

Original approval as a generic copy of 

NADA 141–085.

FOI Summary. 

December 21, 2021 141–552 Jaguar Animal Health, 

200 Pine St., suite 600, 

San Francisco, CA 

94104.

CANALEVIA–CA1 

(crofelemer delayed-release tablets).

Dogs ............... Conditional approval for treatment of 

chemotherapy-induced diarrhea.

FOI Summary. 

December 23, 2021 141–521 Zoetis Inc., 333 Portage 

St., Kalamazoo, MI 

49007.

SIMPARICA TRIO 

(sarolaner, moxidectin, 

and pyrantel chewable 

tablets) Chewable Tablet.

Dogs ............... Supplemental approval for the prevention of Borrelia burgdorferi infection 

as a direct result of killing Ixodes 

scapularis vector ticks and for the 

treatment and control of L4 and immature adult Ancylostoma caninum.

FOI Summary. 

II. Change of Sponsor 

Elanco US Inc., 2500 Innovation Way, 

Greenfield, IN 46140 has informed FDA 

that it has transferred ownership of, and 

all rights and interest in, the NADAs 

and ANADAs listed below to Dechra, 

Ltd., Snaygill Industrial Estate, Keighley 

Rd., Skipton, North Yorkshire, BD23 

2RW, United Kingdom: 

File No. Product name 

047–955 .......................................... ROMPUN (xylazine hydrochloride) Injectable (20 mg). 

047–956 .......................................... ROMPUN (xylazine hydrochloride) Injectable (100 mg). 

200–322 .......................................... Butorphanol Tartrate Injection. 

200–408 .......................................... Butorphanol Tartrate Injection. 

Thorn Bioscience LLC, 1044 East 

Chestnut St., Louisville, KY 40204 has 

informed FDA that it has transferred 

ownership of, and all rights and interest 

in, NADA 141–319 for SUCROMATE 

Equine (deslorelin acetate injection) to 

Dechra, Ltd., Snaygill Industrial Estate, 

Keighley Rd., Skipton, North Yorkshire, 

BD23 2RW, United Kingdom. 

As provided in the regulatory text, the 

animal drug regulations are amended to 

reflect these changes of sponsorship. 

III. Technical Amendments 

FDA is making the following 

amendments to improve the accuracy of 

the animal drug regulations: 

• 21 CFR 510.600 is amended to add 

Jaguar Animal Health and remove Thorn 

Bioscience LLC from the list of sponsors 

of approved applications. 

• 21 CFR 520.88h is amended to 

correct indications for use in cats of an 

oral suspension containing amoxicillin 

and clavulanate. 

• 21 CFR 520.2455 is amended to 

correct a spelling error in the limitations 

for use of tiamulin in drinking water of 

swine. 

• 21 CFR 522.230 is amended to add 

the caution that buprenorphine 

injectable solution is a Schedule III 

opioid under the Controlled Substances 

Act. 

• 21 CFR 522.690 is amended to 

reflect revised indications for use of 

dinoprost tromethamine injectable 

solution in mares. 

• 21 CFR 522.1940 is amended to 

reflect the approved classes of cattle and 

limitations for use of progesterone and 

estradiol benzoate ear implants. 

• 21 CFR 522.2343 is amended to 

reflect the approved classes of cattle and 

limitations for use of testosterone 

propionate and estradiol benzoate ear 

implants. 

• 21 CFR 556.240 is amended to 

reflect the use of revised food 

consumption values in establishing 

permitted concentrations of residues of 

estradiol and related esters in edible 

tissues of cattle. The basis for this action 

is explained in the FOI Summary for 

supplemental NADA 141–348, approved 

October 29, 2021. The section is also 

amended to reflect a cross reference for 

testosterone propionate and estradiol 

benzoate implants, recently 

redesignated as 21 CFR 522.2343. 

• 21 CFR 558.254 is amended to 

reflect the approved conditions of use 

for famphur in feed. 

• 21 CFR 558.355 is amended to 

reflect use of medicated feeds 

containing monensin alone or in 

combination with bacitracin 

methylenedisalicylate in revised classes 

of chickens. 

• 21 CFR 558.555 is amended to 

correct a spelling error in the permitted 

combination use of semduramicin in 

medicated feed. 

• 21 CFR 558.633 is amended to 

revise expiration dates for use of 

pelleted or crumbled tylvalosin 

medicated swine feeds. 

• 21 CFR 558.680 is amended to 

reflect the correct sponsor of an 

application for use of Type C medicated 

turkey feeds containing zoalene. 

IV. Legal Authority 

This final rule is issued under section 

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

Cosmetic Act (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 


lotter on DSK11XQN23PROD with RULES1
17944 Federal Register / Vol. 87, No. 60 / Tuesday, March 29, 2022 / Rules and Regulations 

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 Part 516 

Administrative practice and 

procedure, Animal drugs, Confidential 

business information, Reporting and 

recordkeeping requirements. 

21 CFR Parts 520, 522, 524, and 529 

Animal drugs. 

21 CFR Part 556 

Animal drugs, Dairy products, Foods, 

Meat and meat products. 

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, 21 CFR parts 510, 

516, 520, 522, 524, 529, 556, and 558 are 

amended as follows: 

PART 510—NEW ANIMAL DRUGS 

■ 1. The authority citation for part 510 

continues to read as follows: 

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

353, 360b, 371, 379e. 

■ 2. In § 510.600: 

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

in alphabetical order an entry for 

‘‘Jaguar Animal Health’’ and remove the 

entry for ‘‘Thorn Bioscience LLC’’; and 

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

remove the entry for ‘‘051330’’ and add 

in numerical order an entry for 

‘‘086149’’. 

The additions 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 

*******

Jaguar Animal Health, 200 Pine St., Suite 600, San Francisco, CA 94104 ....................................................................................... 086149 

*******

(2) * * * 

Drug labeler 

code Firm name and address 

*******

086149 .............. Jaguar Animal Health, 200 Pine St., Suite 600, 

San Francisco, CA 94104. 

*******

PART 516—NEW ANIMAL DRUGS FOR 

MINOR USE AND MINOR SPECIES 

■ 3. The authority citation for part 516 

continues to read as follows: 

Authority 21 U.S.C. 360ccc, 360ccc–2, 

371. 

■ 4. Add § 516.498 to subpart C to read 

as follows: 

§ 516.498 Crofelemer. 

(a) Specifications. Each delayedrelease tablet contains 125 milligrams 

(mg) crofelemer. 

(b) Sponsor. See No. 086149 in 

§ 510.600(c) of this chapter. 

(c) Conditions of use—(1) Amount. 

Administer 1 tablet orally twice daily 

for 3 days for dogs weighing ≤140 

pounds. Administer 2 tablets orally 

twice daily for 3 days for dogs weighing 

>140 pounds. 

(2) Indications for use. For the 

treatment of chemotherapy-induced 

diarrhea in dogs. 

(3) Limitations. Federal law restricts 

this drug to use by or on the order of 

a licensed veterinarian. It is a violation 

of Federal law to use this product other 

than as directed in the labeling. 

PART 520—ORAL DOSAGE FORM 

NEW ANIMAL DRUGS 

■ 5. The authority citation for part 520 

continues to read as follows: 

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

■ 6. Revise § 520.88h to read as follows: 

§ 520.88h Amoxicillin trihydrate and 

clavulanate potassium for oral suspension. 

(a) Specifications. When constituted, 

each milliliter (mL) of suspension 

contains amoxicillin trihydrate 

equivalent to 50 milligrams (mg) 

amoxicillin and clavulanate potassium 

equivalent to 12.5 mg clavulanic acid. 

(b) Sponsors. See Nos. 017033, 

054771, and 069043 in § 510.600(c) of 

this chapter. 

(c) Conditions of use—(1) Dogs—(i) 

Amount. 6.25 mg/lb (1 mL/10 lb of body 

weight) twice a day. Skin and soft tissue 

infections such as abscesses, cellulitis, 

wounds, superficial/juvenile pyoderma, 

and periodontal infections should be 

treated for 5 to 7 days or for 48 hours 

after all signs have subsided. If no 


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Federal Register / Vol. 87, No. 60 / Tuesday, March 29, 2022 / Rules and Regulations 17945 

response is seen after 5 days of 

treatment, therapy should be 

discontinued and the case reevaluated. 

Deep pyoderma may require treatment 

for 21 days; the maximum duration of 

treatment should not exceed 30 days. 

(ii) Indications for use. Treatment of 

skin and soft tissue infections such as 

wounds, abscesses, cellulitis, 

superficial/juvenile and deep pyoderma 

due to susceptible strains of the 

following organisms: Beta-lactamaseproducing Staphylococcus aureus, nonbeta-lactamase-producing 

Staphylococcus aureus, Staphylococcus 

spp., Streptococcus spp., and 

Escherichia coli. Treatment of 

periodontal infections due to 

susceptible strains of both aerobic and 

anaerobic bacteria. 

(iii) Limitations. Federal law restricts 

this drug to use by or on the order of 

a licensed veterinarian. 

(2) Cats—(i) Amount. 62.5 mg (1 mL) 

twice daily. Skin and soft tissue 

infections such as abscesses and 

cellulitis/dermatitis should be treated 

for 5 to 7 days or 48 hours after all 

symptoms have subsided, not to exceed 

30 days. If no response is seen after 3 

days of treatment, therapy should be 

discontinued and the case reevaluated. 

Urinary tract infections may require 

treatment for 10 to 14 days or longer. 

The maximum duration of treatment 

should not exceed 30 days. 

(ii) Indications for use. Treatment of 

skin and soft tissue infections, such as 

wounds, abscesses, and cellulitis/ 

dermatitis due to susceptible strains of 

the following organisms: Betalactamase-producing Staphylococcus 

aureus, non-beta-lactamase-producing 

Staphylococcus aureus, Staphylococcus 

spp., Streptococcus spp., Escherichia 

coli, Pasteurella multocida, and 

Pasteurella spp. Urinary tract infections 

(cystitis) due to susceptible strains of E. 

coli. 

(iii) Limitations. Federal law restricts 

this drug to use by or on the order of 

a licensed veterinarian. 

■ 7. In § 520.2090, revise paragraph 

(c)(2) to read as follows: 

§ 520.2090 Sarolaner, moxidectin, and 

pyrantel. 

* * * * * 

(c) * * * 

(2) Indications for use. For the 

prevention of heartworm disease caused 

by Dirofilaria immitis and for the 

treatment and control of roundworm 

(immature adult and adult Toxocara 

canis and adult Toxascaris leonina) and 

hookworm (L4, immature adult, and 

adult Ancylostoma caninum and adult 

Uncinaria stenocephala) infections. 

Kills adult fleas (Ctenocephalides felis) 

and is indicated for the treatment and 

prevention of flea infestations, and the 

treatment and control of tick 

infestations with Amblyomma 

americanum (lone star tick), 

Amblyomma maculatum (Gulf Coast 

tick), Dermacentor variabilis (American 

dog tick), Ixodes scapularis (blacklegged tick), and Rhipicephalus 

sanguineus (brown dog tick) for 1 

month in dogs and puppies 8 weeks of 

age and older, and weighing 2.8 pounds 

or greater. For the prevention of Borrelia 

burgdorferi infections as a direct result 

of killing Ixodes scapularis vector ticks. 

* * * * * 

■ 8. In § 520.2455: 

■ a. Revise paragraphs (b)(1) through 

(4); and 

■ b. In paragraph (d)(2), remove 

‘‘semduramycin’’ and in its place add 

‘‘semduramicin.’’ 

The revisions read as follows: 

§ 520.2455 Tiamulin. 

* * * * * 

(b) * * * 

(1) No. 058198 for products described 

in paragraph (a) of this section. 

(2) No. 066104 for product described 

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

(3) Nos. 016592, 051311, and 061133 

for product described in paragraph (a)(2) 

of this section. 

(4) No. 054771 for product described 

in paragraph (a)(3) of this section. 

* * * * * 

PART 522—IMPLANTATION OR 

INJECTABLE DOSAGE FORM NEW 

ANIMAL DRUGS 

■ 9. The authority citation for part 522 

continues to read as follows: 

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

■ 10. In § 522.246, revise paragraphs 

(b)(2) and (3) to read as follows: 

§ 522.246 Butorphanol. 

* * * * * 

(b) * * * 

(2) No. 043264 for use of the product 

described in paragraph (a)(2) of this 

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

section. 

(3) Nos. 000061, 043264, and 059399 

for use of the product described in 

paragraph (a)(3) of this section as in 

paragraph (d)(3) of this section. 

* * * * * 

§ 522.533 [Amended] 

■ 11. In § 522.533, in paragraph (b)(2), 

remove ‘‘051330’’ and in its place add 

‘‘043264’’. 

■ 12. In § 522.690: 

■ a. Revise paragraphs (a) and (b); 

■ b. Revise paragraph (d)(1) 

introductory text and paragraph 

(d)(1)(i); 

■ c. Add paragraph (d)(2) introductory 

text; 

■ d. Revise paragraph (d)(2)(ii); 

■ e. Add paragraph (d)(3) introductory 

text; 

■ f. Revise paragraph (d)(3)(ii); and 

■ g. Remove paragraph (d)(4). 

The revisions and additions read as 

follows: 

§ 522.690 Dinoprost. 

(a) Specifications. Each milliliter (mL) 

of solution contains dinoprost 

tromethamine equivalent to: 

(1) 5 milligrams (mg) dinoprost; or 

(2) 12.5 mg dinoprost. 

(b) Sponsors. See sponsors in 

§ 510.600(c) of this chapter as follows: 

(1) Nos. 054771 and 061133 for use of 

product described in paragraph (a)(1) as 

in paragraph (d) of this section. 

(2) No. 054771 for use of product 

described in paragraph (a)(2) as in 

paragraph (d)(1) of this section. 

* * * * * 

(d) * * * 

(1) Cattle. Administer products 

described in paragraph (a) of this 

section as follows: 

(i) Amount. 25 mg as an intramuscular 

injection of the 5 mg/mL product or as 

an intramuscular or subcutaneous 

injection of the 12.5 mg/mL product. 

* * * * * 

(2) * * * Administer product 

described in paragraph (a)(1) of this 

section as follows: 

* * * * * 

(ii) Indications for use. (A) For 

controlling the timing of estrus in 

estrous cycling mares. 

(B) For difficult-to-breed mares 

(clinically anestrous mares that have a 

corpus luteum). 

* * * * * 

(3) * * * Administer product 

described in paragraph (a)(1) of this 

section as follows: 

* * * * * 

(ii) Indications for use. For parturition 

induction in swine. 

■ 13. In § 522.812, revise paragraph 

(b)(2) to read as follows: 

§ 522.812 Enrofloxacin. 

* * * * * 

(b) * * * 

(2) Nos. 055529, 058005, 058198, and 

061133 for use of product described in 

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

paragraphs (e)(2) and (3) of this section. 

* * * * * 

§ 522.955 [Amended] 

■ 14. In § 522.955, in paragraph (b)(3), 

remove ‘‘No. 086050’’ and in its place 


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17946 Federal Register / Vol. 87, No. 60 / Tuesday, March 29, 2022 / Rules and Regulations 

add ‘‘Nos. 058005 and 086050’’; and in 

paragraph (d)(1)(ii)(C), remove ‘‘No. 

000061’’ and in its place add ‘‘Nos. 

000061, 058005, and 086050’’. 

■ 15. In § 522.1077, revise paragraph 

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

§ 522.1077 Gonadorelin. 

* * * * * 

(d) * * * 

(1) * * * 

(iv) Dinoprost injection for use as in 

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

provided by Nos. 054771 and 061133 in 

§ 510.600(c) of this chapter. 

* * * * * 

■ 16. In § 522.1940, revise the paragraph 

(c)(1) heading, paragraph (c)(1)(iii), the 

paragraph (c)(2) heading, and paragraph 

(c)(2)(iii) to read as follows: 

§ 522.1940 Progesterone and estradiol 

benzoate. 

* * * * * 

(c) * * * 

(1) Suckling beef calves at least 45 

days old and up to 400 lb of body 

weight—* * * 

* * * * * 

(iii) Limitations. For subcutaneous ear 

implantation, one dose per animal. Do 

not use in beef calves less than 45 days 

of age, dairy calves, and veal calves 

because effectiveness and safety have 

not been established. Do not use in 

animals intended for subsequent 

breeding, or in dairy cows. A 

withdrawal period has not been 

established for this product in 

preruminating calves. Do not use in 

calves to be processed for veal. 

(2) Growing beef steers weighing 400 

lb or more—* * * 

* * * * * 

(iii) Limitations. For subcutaneous ear 

implantation, one dose per animal. Do 

not use in beef calves less than 45 days 

of age, dairy calves, and veal calves 

because effectiveness and safety have 

not been established. Do not use in 

animals intended for subsequent 

breeding, or in dairy cows. A 

withdrawal period has not been 

established for this product in 

preruminating calves. Do not use in 

calves to be processed for veal. 

* * * * * 

■ 17. In § 522.2343, revise paragraph (c) 

introductory text and paragraph (c)(3) to 

read as follows: 

§ 522.2343 Testosterone propionate and 

estradiol benzoate. 

* * * * * 

(c) Conditions of use. For 

implantation in growing beef heifers 

weighing 400 lb or more as follows: 

* * * * * 

(3) Limitations. For subcutaneous ear 

implantation, one dose per animal. Not 

for use in dairy or beef replacement 

heifers. Do not use in beef calves less 

than 2 months of age, dairy calves, and 

veal calves because safety and 

effectiveness have not been established. 

A withdrawal period has not been 

established for this product in 

preruminating calves. Do not use in 

calves to be processed for veal. 

■ 18. In § 522.2478, redesignate 

paragraph (d)(3) as paragraph (d)(4); add 

new paragraph (d)(3); and revise newly 

redesignated paragraph (d)(4) heading 

and paragraph (d)(4)(i)(C) to read as 

follows: 

§ 522.2478 Trenbolone acetate and 

estradiol benzoate. 

* * * * * 

(d) * * * 

(3) Growing beef steers and heifers fed 

in confinement for slaughter. (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 pellets 

subcutaneously in ear only. Not 

approved for repeated implantation 

(reimplantation) with this or any other 

cattle ear implant within each separate 

production phase. Safety and 

effectiveness following reimplantation 

have not been evaluated. Do not use in 

beef calves less than 2 months of age, 

dairy calves, and veal calves because 

effectiveness and safety have not been 

established. Do not use in beef calves 

less than 2 months of age, dairy calves, 

and veal calves. A withdrawal period 

has not been established for this product 

in pre-ruminating calves. Do not use in 

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. 

(ii) [Reserved] 

(4) Growing beef steers and heifers on 

pasture (stocker, feeder, and slaughter). 

(i) * * * 

(C) Limitations. Implant pellets 

subcutaneously in ear only. Not 

approved for repeated implantation 

(reimplantation) with this or any other 

cattle ear implant within each separate 

production phase. Safety and 

effectiveness following reimplantation 

have not been evaluated. Do not use in 

beef calves less than 2 months of age, 

dairy calves, and veal calves because 

effectiveness and safety have not been 

established. Do not use in beef calves 

less than 2 months of age, dairy calves, 

and veal calves. A withdrawal period 

has not been established for this product 

in preruminating calves. Do not use in 

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. 

* * * * * 

■ 19. In 522.2630, revise paragraphs 

(b)(1) and (2) to read as follows: 

§ 522.2630 Tulathromycin. 

* * * * * 

(b) * * * 

(1) Nos. 013744, 051311, 054771, 

058198, and 061133 for use of product 

described in paragraph (a)(1) as in 

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

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

(2) Nos. 013744, 051311, and 054771 

for use of product described in 

paragraph (a)(2) as in paragraphs 

(d)(1)(i), (d)(1)(ii)(B), (d)(1)(iii)(B), and 

(d)(2) of this section. 

* * * * * 

■ 20. In § 522.2662, revise paragraph 

(b)(3) to read as follows: 

§ 522.2662 Xylazine. 

* * * * * 

(b) * * * 

(3) Nos. 043264 and 061651 for use of 

product described in paragraph (a)(1) of 

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

section; and product described in 

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

paragraphs (d)(2), (d)(3)(i), (d)(3)(ii)(A), 

and (d)(3)(iii) of this section. 

* * * * * 

PART 524—OPHTHALMIC AND 

TOPICAL DOSAGE FORM NEW 

ANIMAL DRUGS 

■ 21. The authority citation for part 524 

continues to read as follows: 

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

■ 22. In § 524.1146, revise paragraphs 

(b)(2) and (3) to read as follows: 

§ 524.1146 Imidacloprid and moxidectin. 

* * * * * 

(b) * * * 

(2) Nos. 051072, 017030, 058198, and 

061651 for use of product described in 

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

paragraph (d)(2) of this section. 

(3) Nos. 051072 and 058198 for use of 

product described in paragraph (a)(2) of 

this section as in paragraph (d)(3) of this 

section. 

* * * * * 

PART 529—CERTAIN OTHER DOSAGE 

FORM NEW ANIMAL DRUGS 

■ 23. The authority citation for part 529 

continues to read as follows: 

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


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■ 24. In § 529.1940, revise the last 

sentence in paragraph (e)(1)(iii) to read 

as follows: 

§ 529.1940 Progesterone intravaginal 

inserts. 

* * * * * 

(e) * * * 

(1) * * * 

(iii) * * * Dinoprost injection for use 

as in paragraphs (e)(1)(ii)(A) and (B) of 

this section as in § 522.690 of this 

chapter, provided by Nos. 054771 and 

061133 in § 510.600(c) of this chapter. 

* * * * * 

PART 556—TOLERANCES FOR 

RESIDUES OF NEW ANIMAL DRUGS 

IN FOOD 

■ 25. The authority citation for part 556 

continues to read as follows: 

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

■ 26. In 556.240, revise paragraphs 

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

§ 556.240 Estradiol and related esters. 

* * * * * 

(b) * * * 

(1) Cattle. (i) Muscle: 0.2 ppb. 

(ii) Liver: 0.6 ppb. 

(iii) Kidney: 1.2 ppb. 

(iv) Fat: 1.2 ppb. 

* * * * * 

(c) Related conditions of use. See 

§§ 522.840, 522.850, 522.1940, 

522.2343, 522.2477, and 522.2478 of 

this chapter. 

■ 27. In § 556.370, revise paragraph (b) 

to read as follows: 

§ 556.370 Lubabegron. 

* * * * * 

(b) Tolerances. The tolerances for 

lubabegron (marker residue) are: 

(1) Cattle. (i) Liver (target tissue): 10 

ppb. 

(ii) Muscle: 3 ppb. 

(iii) Kidney: 20 ppb. 

(2) [Reserved] 

* * * * * 

PART 558—NEW ANIMAL DRUGS FOR 

USE IN ANIMAL FEEDS 

■ 28. The authority citation for part 558 

continues to read as follows: 

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

360ccc–1, 371. 

■ 29. In § 558.254, revise paragraph (e) 

to read as follows: 

§ 558.254 Famphur. 

* * * * * 

(e) Conditions of use. It is used in 

cattle feed as follows: 

Famphur amount Indications for use Limitations Sponsor 

(1) To provide 1.1 milligrams 

per pound (mg/lb) body 

weight per day.

Beef cattle and nonlactating dairy cattle: For control of 

grubs and as an aid in control of sucking lice.

Feed for 30 days. Withdraw from dry dairy cows and heifers 

21 days prior to freshening. Withdraw 4 days prior to 

slaughter.

000061 

(2) To provide 2.3 mg/lb body 

weight per day.

Beef cattle and nonlactating dairy cattle: For control of 

grubs.

Feed for 10 days. Withdraw from dry dairy cows and heifers 

21 days prior to freshening. Withdraw 4 days prior to 

slaughter.

000061 

■ 30. In § 558.355, revise paragraphs 

(d)(8)(vi) and (f)(1)(ii), (iv), and (vi) to 

read as follows: 

§ 558.355 Monensin. 

* * * * * 

(d) * * * 

(8) * * * 

(vi) Not for replacement chickens 

intended to become broiler breeding 

chickens. 

* * * * * 

(f) * * * 

(1) * * * 

Monensin in grams/ 

ton 

Combination in grams/ 

ton Indications for use Limitations Sponsor 

*******

(ii) 90 to 110 ........... Layer replacement chickens: As an aid in the prevention of coccidiosis caused by E. necatrix, E. 

tenella, E. acervulina, E. brunetti, E. mivati, and 

E. maxima.

Feed continuously as the sole ration. Do not feed 

to chickens over 16 weeks of age. Do not feed 

to laying chickens.

058198 

*******

(iv) 90 to 110 .......... Bacitracin 

methylenedisalicylate, 

4 to 50.

Layer replacement chickens: As an aid in the prevention of coccidiosis caused by E. necatrix, E. 

tenella, E. acervulina, E. brunetti, E. mivati, and 

E. maxima, and for increased rate of weight gain 

and improved feed efficiency.

Feed continuously as sole ration. Do not feed to 

chickens over 16 weeks of age. Do not feed to 

laying chickens. Monensin sodium provided by 

No. 058198, bacitracin methylenedisalicylate 

provided by No. 054771 in § 510.600(c) of this 

chapter.

054771 

*******

(vi) 90 to 110 .......... Bacitracin 

methylenedisalicylate, 

50.

Broiler and layer replacement chickens: As an aid 

in the prevention of coccidiosis caused by E. 

necatrix, E. tenella, E. acervulina, E. brunetti, E. 

mivati, and E. maxima, and for improved feed 

efficiency, and as an aid in the prevention of necrotic enteritis caused or complicated by Clostridium spp. or other organisms susceptible to 

bacitracin.

Feed continuously as sole ration. Do not feed to 

chickens over 16 weeks of age. Do not feed to 

laying chickens. Monensin sodium provided by 

No. 058198, bacitracin methylenedisalicylate 

provided by No. 054771 in § 510.600(c) of this 

chapter.

054771 

*******

* * * * * 

■ 31. In § 558.500, revise paragraphs (b) 

and (e)(2)(i), (iii), and (vi) to read as 

follows: 

§ 558.500 Ractopamine. 

* * * * * 

(b) Sponsors. See sponsor numbers in 

§ 510.600(c) of this chapter. 

(1) No. 058198: Type A medicated 

articles containing 9 or 45.4 grams per 

pound (g/lb) ractopamine 

hydrochloride. 


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17948 Federal Register / Vol. 87, No. 60 / Tuesday, March 29, 2022 / Rules and Regulations 

(2) Nos. 016592, 051311, and 054771: 

Type A medicated articles containing 

45.4 g/lb ractopamine hydrochloride. 

* * * * * 

(e) * * * 

(2) * * * 

Ractopamine in grams/ton Combination 

in grams/ton Indications for use Limitations Sponsor 

(i) 8.2 to 24.6 ................... Cattle fed in confinement for slaughter: For increased rate of weight gain and improved feed efficiency during the last 28 to 42 days on feed.Feed continuously as sole ration during the last 28 

to 42 days on feed. Not for animals intended for 

breeding.

016592 

051311 

054771 

058198 

*******

(iii) 9.8 to 24.6 ................. Cattle fed in confinement for slaughter: For increased rate of weight gain, improved feed efficiency, and increased carcass leanness during 

the last 28 to 42 days on feed.

Feed continuously as sole ration during the last 28 

to 42 days on feed. Not for animals intended for 

breeding.

016592 

051311 

054771 

058198 

*******

(vi) Not to exceed 800; to 

provide 70 to 400 mg/ 

head/day.

........................... Cattle fed in confinement for slaughter: For increased rate of weight gain and improved feed efficiency during the last 28 to 42 days on feed.Top dress ractopamine at a minimum of 1.0 lb/ 

head/day of medicated feed continuously during 

the last 28 to 42 days on feed. Not for animals intended for breeding..

016592 

051311 

054771 

058198 

*******

* * * * * 

§ 558.555 [Amended] 

■ 32. In § 558.555, in paragraph (f), 

remove ‘‘Semduramycin’’ and in its 

place add ‘‘Semduramicin’’. 

■ 33. In § 558.633, revise paragraph 

(d)(3) to read as follows: 

§ 558.633 Tylvalosin. 

* * * * * 

(d) * * * 

(3) Pelleted Type C medicated feeds 

must bear an expiration date of 30 days 

after the date of manufacture. Crumbled 

Type C medicated feeds must bear an 

expiration date of 7 days after the date 

of manufacture. 

* * * * * 

■ 34. In § 558.680, revise paragraphs 

(d)(1)(iii), (iv), (vii), and (viii) and (d)(2) 

to read as follows: 

§ 558.680 Zoalene. 

* * * * * 

(d) * * * 

(1) * * * 

Zoalene in 

grams/ton 

Combination in 

grams/ton Indications for use Limitations Sponsor 

*******

(iii) 36.3 to 113.5 ............. Bacitracin 

methylenedisalicylate, 50.

Replacement chickens: For development of active 

immunity to coccidiosis; and as an aid in the control of necrotic enteritis caused or complicated by 

Clostridium spp. or other organisms susceptible 

to bacitracin.

Feed continuously as the sole ration as in the 

subtable in item (i). Grower ration not to be fed to 

birds over 14 weeks of age. Bacitracin 

methylenedisalicylate as provided by No. 054771 

in § 510.600(c) of this chapter.

054771 

058198 

(iv) 36.3 to 113.5 ............. Bacitracin 

methylenedisalicylate, 100 

to 200.

Replacement chickens: For development of active 

immunity to coccidiosis; and as an aid in the control of necrotic enteritis caused or complicated by 

Clostridium spp. or other organisms susceptible 

to bacitracin.

Feed continuously as sole ration as in the subtable 

in item (i). To control necrotic enteritis, start medication at first clinical signs of disease; vary bacitracin dosage based on the severity of infection; 

administer continuously for 5 to 7 days or as long 

as clinical signs persist, then reduce bacitracin to 

prevention level (50 g/ton). Bacitracin 

methylenedisalicylate as provided by No. 054771 

in § 510.600(c) of this chapter.

054771 

058198 

*******

(vii) 113.5 ......................... Bacitracin 

methylenedisalicylate, 50.

Broiler chickens: For prevention and control of coccidiosis; and as an aid in the prevention of necrotic enteritis caused or complicated by Clostridium spp. or other organisms susceptible to 

bacitracin.

Feed continuously as the sole ration. Bacitracin 

methylenedisalicylate as provided by No. 054771 

in § 510.600(c) of this chapter.

054771 

058198 

(viii) 113.5 ........................ Bacitracin 

methylenedisalicylate,.

100 to 200 .........

Broiler chickens: For prevention and control of coccidiosis; and as an aid in the control of necrotic 

enteritis caused or complicated by Clostridium 

spp. or other organisms susceptible to bacitracin.

Feed continuously as sole ration. To control necrotic enteritis, start medication at first clinical signs 

of disease; vary bacitracin dosage based on the 

severity of infection; administer continuously for 5 

to 7 days or as long as clinical signs persist, then 

reduce bacitracin to prevention level (50 g/ton). 

Bacitracin methylenedisalicylate as provided by 

No. 054771 in § 510.600(c) of this chapter.

054771 

058198 

*******

(2) Turkeys— 


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Federal Register / Vol. 87, No. 60 / Tuesday, March 29, 2022 / Rules and Regulations 17949 

Zoalene in grams/ton Combination in grams/ 

ton Indications for use Limitations Sponsor 

(i) 113.5 to 170.3 ........ Growing turkeys: For prevention and control of 

coccidiosis.

Feed continuously as sole ration. For turkeys 

grown for meat purposes only. Not to be fed to 

laying birds.

054771 

058198 

(ii) 113.5 to 170.3 ....... Bacitracin 

methylenedisalicylate, 

4 to 50.

Growing turkeys: For prevention and control of 

coccidiosis; and for increased rate of weight 

gain and improved feed efficiency.

Feed continuously as sole ration until 14 to 16 

weeks of age. For turkeys grown for meat purposes only. Not to be fed to laying birds.

054771 

058198 

* * * * * 

Dated: March 21, 2022. 

Andi Lipstein Fristedt, 

Deputy Commissioner for Policy, Legislation, 

and International Affairs, U.S. Food and Drug 

Administration. 

[FR Doc. 2022–06395 Filed 3–28–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 822 

[Docket No. FDA–2021–N–0246] 

Medical Devices; Technical 

Amendments 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Final rule; technical 

amendments. 

SUMMARY: The Food and Drug 

Administration (FDA, the Agency, or 

we) is amending its medical device 

regulations to update mailing address 

information and to reduce (from three to 

one) the number of copies of certain 

documents that need to be submitted to 

FDA. The rule does not impose any new 

regulatory requirements on affected 

parties. This action is editorial in nature 

and is intended to improve the accuracy 

of the Agency’s regulations, and to 

remove a submission requirement that is 

no longer necessary. 

DATES: This rule is effective March 29, 

2022. 

FOR FURTHER INFORMATION CONTACT: 

Madhusoodana Nambiar, Office of 

Policy, Center for Devices and 

Radiological Health, 10903 New 

Hampshire Ave., Bldg. 66, Rm. 5519, 

Silver Spring, MD 20993–0002, 301– 

796–5837. 

SUPPLEMENTARY INFORMATION: 

I. Background 

The FDA Center for Devices and 

Radiological Health (CDRH) has 

reorganized to create an agile 

infrastructure that can adapt to future 

organizational, regulatory, and scientific 

needs (84 FR 22854, May 20, 2019; 85 

FR 18439, April 2, 2020). The newly 

formed Office of Product Evaluation and 

Quality (OPEQ) combined the former 

Office of Compliance, the Office of 

Device Evaluation, the Office of 

Surveillance and Biometrics, and the 

Office of In Vitro Diagnostics and 

Radiological Health, with a focus on a 

Total Product Lifecycle (TPLC) 

approach to medical device oversight. 

Within OPEQ there are Offices of Health 

Technology that focus on the TPLC 

review of specific types of medical 

devices as well as cross-cutting offices 

focusing on specific policy and 

programmatic needs including the 

Office of Regulatory Programs and the 

Office of Clinical Evidence and 

Analysis. As part of this technical 

amendment, we are making a change to 

correctly identify the address for 

obtaining particular information. We are 

also amending the requirement for the 

submission of multiple copies of certain 

documents to a single copy, as FDA’s 

receipt of multiple copies is no longer 

necessary. The changes published in 

this notice are non-substantive and 

editorial in nature. 

II. Description of the Technical 

Amendments 

One regulation specified in this notice 

is being revised to make a nonsubstantive editorial change to update 

particular mailing address information. 

For the other two regulations specified 

in this notice, we are removing the 

requirements for submission of multiple 

copies of certain postmarket 

surveillance-related documents, to 

instead require submission of only one 

copy, because the requirement for 

multiple copies is no longer necessary. 

The rule does not impose any new 

regulatory requirements on affected 

parties. The amendments are editorial in 

nature and should not be construed as 

modifying any substantive standards or 

requirements. 

III. Notice and Public Comment 

Publication of this document 

constitutes final action under the 

Administrative Procedure Act (APA). 

The APA generally exempts ‘‘rules of 

agency organization, procedure, or 

practice’’ from the requirements of 

notice and comment rulemaking. (5 

U.S.C. 553(b)(A)). Rules are also 

generally exempt from such 

requirements when an Agency ‘‘for good 

cause finds (and incorporates the 

finding and a brief statement of reasons 

therefor in the rules issued) that notice 

and public procedure thereon are 

impracticable, unnecessary, or contrary 

to the public interest’’ (5 U.S.C. 

553(b)(B)). 

FDA has determined that this 

rulemaking meets the APA’s notice and 

comment exemption requirements. All 

the revisions FDA publishes through 

this notice make technical or nonsubstantive changes. Some of these 

revisions pertain solely to the CDRH 

reorganization, and constitute ‘‘rules of 

agency organization, procedure, or 

practice’’ not subject to the 

requirements of notice and comment 

under 5 U.S.C. 553(b)(A). The balance of 

these revisions reduces (from three to 

one) the number of copies of certain 

documents that need to be submitted to 

FDA. Such technical, non-substantive 

change is ‘‘a routine determination, 

insignificant in nature and impact, and 

inconsequential to the industry and to 

the public.’’ (Mack Trucks, Inc. v. EPA, 

682 F.3d 87, 94 (D.C. Cir. 2012)) 

(quotation marks and citation omitted). 

FDA accordingly for good cause finds 

that notice and public procedure 

thereon are unnecessary for this 

reduction in the number of copies of 

certain documents that must be 

submitted. 

The APA allows an effective date less 

than 30 days after publication as 

‘‘provided by the agency for good cause 

found and published with the rule’’ (5 

U.S.C. 553(d)(3)). An effective date 30 or 

more days from the date of publication 

is unnecessary in this case because the 

amendments do not impose any new 

regulatory requirements on affected 

parties, and affected parties do not need 

time to ‘‘adjust to the new regulation’’ 

before the rule takes effect (Am. 

Federation of Government Emp., AFL– 

CIO v. Block, 655 F.2d 1153, 1156 (D.C. 

Cir. 1981)). Therefore, FDA finds good 

cause for the amendments to become 

effective on the date of publication of 

this action. 

List of Subjects in 21 CFR Part 822 

Medical devices, Reporting and 

recordkeeping requirements. 


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