New Animal Drugs; Approval of New Animal Drug Applications; Changes of Sponsorship; Change of Sponsor's Name and Address
| Citation | 86 FR 14815 |
| Record Number | 2021-05203 |
| Published date | 19 March 2021 |
| Section | Rules and Regulations |
| Court | Food And Drug Administration |
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Federal Register / Vol. 86, No. 52 / Friday, March 19, 2021 / Rules and Regulations
humanitarian reasons or for other
purposes in the national interest, permit
the processing of travelers to the United
States not engaged in ‘‘essential travel.’’
Alejandro N. Mayorkas,
Secretary, U.S. Department of Homeland
Security.
[FR Doc. 2021–05877 Filed 3–18–21; 8:45 am]
BILLING CODE 9112–FP–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 510, 520, 522, 524, 529,
556, and 558
[Docket No. FDA–2020–N–0002]
New Animal Drugs; Approval of New
Animal Drug Applications; Changes of
Sponsorship; Change of Sponsor’s
Name and Address
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 July,
August, and September 2020. 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 and
readability of the regulations.
DATES
: This rule is effective March 19,
2021.
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 July,
August, and September 2020, 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/center-
veterinary-medicine/cvm-foia-
electronic-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/approved-
animal-drug-products-green-book.
T
ABLE
1—O
RIGINAL AND
S
UPPLEMENTAL
NADA
S AND
ANADA
S
A
PPROVED
D
URING
J
ULY
, A
UGUST
,
AND
S
EPTEMBER
2020
Approval date File No. Sponsor Product name Species Effect of the action Public
documents
July 9, 2020 .......... 141–532 Intervet, Inc., 2 Giralda
Farms, Madison, NJ
07940.
BRAVECTO 1-MONTH
(furalaner) Chews for
Dogs.
Dogs ............... Original approval for the treatment and
prevention of flea infestations, and
the treatment and control of tick in-
festations for 1 month in dogs and
puppies.
FOI Summary.
July 27, 2020 ........ 141–538 Ceva Sante Animale, 10
Avenue de la
Ballastie
`re, 33500
Libourne, France.
CARDALIS
(spironolactone and
benazepril hydro-
chloride chewable tab-
lets).
Dogs ............... Original approval with concurrent ther-
apy (e.g., furosemide, etc.) for the
management of clinical signs of mild,
moderate, or severe congestive heart
failure in dogs due to atrioventricular
valvular insufficiency (AVVI).
FOI Summary.
July 29, 2020 ........ 200–687 Cronus Pharma Speciali-
ties India Private Ltd.,
Sy No-99/1, GMR
Hyderabad Aviation
SEZ Ltd., Mamidipalli
Village, Shamshabad
Mandal, Ranga Reddy,
Hyderabad, Telangana,
501218, India.
Carprofen Chewable Tab-
lets. Dogs ............... Original approval as a generic copy of
NADA 141–111. FOI Summary.
August 4, 2020 ..... 200–681 Dechra Veterinary Prod-
ucts LLC, 7015 College
Blvd., Suite 525, Over-
land Park, KS 66211.
Carprofen Tablets ............ Dogs ............... Original approval as a generic copy of
NADA 140–035. FOI Summary.
September 9, 2020 141–529 Pharmgate LLC, 1800 Sir
Tyler Dr., Wilmington,
NC 28405.
MAXIBAN (naracin and
nicarbazin) plus
PENNITRACIN MD
(bacitracin
methylenedisalicylate)
Type C medicated
feeds.
Chickens ........ Original approval for increased rate of
weight gain, improved feed effi-
ciency, and for the prevention of coc-
cidiosis in broiler chickens.
FOI Summary.
September 18,
2020. 200–690 Pharmasone LLC, 1800
Sir Tyler Dr., Wil-
mington, NC 28405.
ZOASHIELD 25%
(zoalene Type A medi-
cated article).
Chickens, tur-
keys. Original approval as a generic copy of
NADA 141–218. FOI Summary.
September 28,
2020. 200–069 Bimeda Animal Health
Ltd., 1B The Herbert
Building, The Park,
Carrickmines, Dublin
18, Ireland.
OVACYST (gonadorelin)
Injectable Solution. Cattle .............. Supplemental approval for fixed-time
artificial insemination (FTAI) in beef
cows and lactating dairy cows.
FOI Summary.
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T
ABLE
1—O
RIGINAL AND
S
UPPLEMENTAL
NADA
S AND
ANADA
S
A
PPROVED
D
URING
J
ULY
, A
UGUST
,
AND
—Continued
S
EPTEMBER
2020
Approval date File No. Sponsor Product name Species Effect of the action Public
documents
September 29,
2020. 200–528 Pharmgate, Inc, 1800 Sir
Tyler Dr., Wilmington,
NC 28405.
SAVALAN 60
(salinomycin sodium)
Type A medicated arti-
cle.
Chickens, quail Original approval as a generic copy of
NADA 011–116. FOI Summary.
II. Changes 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, NADA 141–
437 for OSNURIA (betamethasone
acetate, florfenicol, terbinafine) Otic Gel
to Dechra, Ltd., Snaygill Industrial
Estate, Keighley Rd., Skipton, North
Yorkshire, BD23 2RW, United Kingdom.
Pharmasone LLC, 1800 Sir Tyler Dr.,
Wilmington, NC 28405 has informed
FDA that it has transferred ownership
of, and all rights and interest in,
ANADA 200–690 for ZOASHIELD 25%
(zoalene Type A medicated article) to
Elanco US Inc., 2500 Innovation Way,
Greenfield, IN 46140.
Also, Bayer HealthCare LLC, Animal
Health Division, P.O. Box 390, Shawnee
Mission, KS 66201 has informed FDA
that it has transferred ownership of, and
all rights and interest in, the 39 NADAs
and 17 ANADAs listed below to Elanco
US Inc., 2500 Innovation Way,
Greenfield, IN 46140:
File No. Product name
034–641 ............ TIGUVON (fenthion) Pour-On Cattle Insecticide.
040–001 ............ MELDANE 2 (coumaphos) Type A Medicated Article.
045–416 ............ TEVCODYNE (phenylbutazone) Injectable.
047–138 ............ SPOTTON (fenthion) 20% Ready-to-Use Cattle Insecticide.
047–955 ............ ROMPUN (xylazine hydrochloride) Injectable (20 mg).
047–956 ............ ROMPUN (xylazine hydrochloride) Injectable (100 mg).
091–818 ............ Phenylbutazone Tablets, USP 1 gram.
093–329 ............ HAVASPAN (sulfamethazine) Prolonged Release Bolus; SULFASPAN (sulfamethazine) Prolonged Release Bolus.
093–483 ............ SPECTAM (spectinomycin hydrochloride) Injectable Solution.
107–345 ............ RINTAL (febantel) Paste.
107–346 ............ RINTAL (febantel) Suspension.
111–529 ............ EQUIMATE (fluprostenol sodium).
111–607 ............ DRONCIT (praziquantel) 5.68% Injectable Solution.
111–798 ............ DRONCIT (praziquantel) Canine Cestocide Tablets; DRONCIT (praziquantel) Feline Cestocide Tablets.
116–089 ............ VELTRIM (clotrimazole) 1% Dermatologic Cream.
132–336 ............ PROBAN (cythioate) Oral Liquid.
132–337 ............ PROBAN (cythioate) Tablets.
132–533 ............ STYQUIN (butamisole hydrochloride) Parenteral 1.1%.
132–789 ............ PRO–SPOT (fenthion) Solution.
133–953 ............ VERCOM (febantel and praziquantel) Paste Anthelmintic.
140–441 ............ BAYTRIL (enrofloxacin) Antibacterial Tablets; BAYTRIL TASTE TABS (enrofloxacin) Antibacterial Tablets.
140–912 ............ RINTAL (febantel) Tabs Anthelmintic Tablets.
140–913 ............ BAYTRIL (enrofloxacin) Antibacterial Injectable Solution.
141–007 ............ DRONTAL Plus (febantel, praziquantel, pyrantel pamoate) Taste Tablets.
141–008 ............ DRONTAL (praziquantel and pyrantel pamoate) Tablets.
141–068 ............ BAYTRIL 100 (enrofloxacin) Injectable Solution.
141–099 ............ CYDECTIN (moxidectin) Pour-On for Beef and Dairy Cattle.
141–176 ............ BAYTRIL (enrofloxacin and silver sulfadiazine) Otic Emulsion.
141–208 ............ ADVANTAGE DUO (imidacloprid and ivermectin) Topical Solution.
141–220 ............ CYDECTIN (moxidectin) Injectable Solution.
141–247 ............ CYDECTIN (moxidectin) Oral Drench for Sheep.
141–251 ............ ADVANTAGE MULTI (imidacloprid and moxidectin) Topical Solution for Dogs.
141–254 ............ ADVANTAGE MULTI (imidacloprid and moxidectin) Topical Solution for Cats.
141–275 ............ PROFENDER (emodepside and praziquantel) Topical Solution.
141–344 ............ VERAFLOX (pradofloxacin) Oral Suspension for Cats.
141–417 ............ CORAXIS (moxidectin) Topical Solution.
141–435 ............ ADVANTUS (imidacloprid) Tablets.
141–440 ............ CLARO (florfenicol, mometasone furoate, terbinafine) Otic Solution.
141–527 ............ BAYTRIL 100 (enrofloxacin) CA1.
200–042 ............ Ketamine Hydrochloride Injection, USP.
200–124 ............ Flunixin Meglumine Injection.
200–126 ............ Phenylbutazone 20% Injection.
200–137 ............ GENTAMAX 100 (gentamicin sulfate) Solution.
200–181 ............ AMIMAX E (amikacin sulfate) Solution.
200–202 ............ PHOENECTIN (ivermectin) Liquid for Horses.
200–230 ............ Guaifenesin Injection.
200–246 ............ ANTHELBAN V (pyrantel pamoate) Equine Anthelmintic Suspension.
200–286 ............ PHOENECTIN (ivermectin) Paste 1.87%.
200–293 ............ Furosemide Injection 5%.
200–319 ............ Acepromazine Maleate Injection.
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File No. Product name
200–322 ............ Butorphanol Tartrate Injection.
200–360 ............ TIAGARD (tiamulin) Liquid Concentrate.
200–408 ............ Butorphanol Tartrate Injection.
200–555 ............ QUELLIN (carprofen) Tablets.
200–582 ............ LONCOR 300 (florfenicol) Injectable Solution.
200–608 ............ BAYTRIL (enrofloxacin) Soft Chewable Tablets.
Following these changes of
sponsorship, neither Bayer HealthCare
LLC nor Pharmasone LLC are the
sponsor of an approved application.
Accordingly, they will be removed from
the list of sponsors of approved
applications in 21 CFR 510.600(c). 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,
consistency, and readability of the
animal drug regulations:
•21 CFR 520.905a is amended to
reflect the approved conditions of use
for fenbendazole suspension in laying
hens.
•21 CFR 522.1182 is amended to
reflect the 2016 change of sponsorship
of an injectable ferric hydroxide product
in young piglets.
•21 CFR 522.1193 is amended to
reflect the approved withdrawal period
for a clorsulon injectable solution
product.
•21 CFR 522.1696a is amended to
reflect an associated limitation for a
penicillin G benzathine and penicillin G
procaine injectable suspension product.
•21 CFR 522.1890 is amended to
reflect the current format for titling
regulations for injectable dosage form
new animal drugs.
•Entries in parts 556 and 558 (21
CFR parts 556 and 558) for a coumaphos
Type A medicated article are being
added. These sections were withdrawn
in error (85 FR 18114, April 1, 2020).
•Part 558 is amended to reflect
current naming and organization for
specifications and application sponsors.
•21 CFR 558.261 is amended to
reflect an approved incorporation level
of florfenicol in medicated feed for fish.
•21 CFR 558.311 for lasalocid in
medicated feed is amended to reflect a
current tabular organization by species.
•21 CFR 558.355 is amended to
provide accurate cross references for
approved uses to special considerations
and label statements for monensin
medicated feeds.
•21 CFR 558.450 is amended to add
two indications for use of
oxytetracycline in medicated feed for
fish that were removed during the
recent codification of a supplemental
approval (84 FR 12491 at 12502, April
2, 2019).
•Part 558 is amended by removing
21 CFR 558.465, which is redundant
with 21 CFR 558.464. The cross
reference for poloxalene in part 556 is
amended to reflect this action.
•Part 558 is amended by adding 21
CFR 558.470 to reflect the approved
conditions of use of a polyoxyethylene
medicated feed block, which previously
had been removed from 21 CFR part 520
without being added to part 558.
•Typographical errors are being
corrected wherever they have been
found.
IV. Legal Authority
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. This 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 the
conditions of use of an approved or
conditionally approved new animal
drug and the name and address of the
drug’s sponsor in a ‘‘notice, which upon
publication shall be effective as a
regulation.’’ A notice published
pursuant to section 512(i) is not subject
to the notice-and-comment rulemaking
requirements of the Administrative
Procedure Act, 5 U.S.C. 551 et seq. See
section 512(i) of the FD&C Act; 21 CFR
10.40(e)(3); S. Rep. 90–1308, at 5 (1968).
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, 524, and 529
Animal drugs.
21 CFR Part 556
Animal drugs, Food.
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,
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.
§ 510.600 [Amended]
■2. In § 510.600, in the table in
paragraph (c)(1), remove the entry for
‘‘Bayer HealthCare LLC’’ and in the
table in paragraph (c)(2), remove the
entry for ‘‘000859’’.
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.
■4. In § 520.304, add paragraph (a)(3),
revise paragraphs (b)(1) and (2), and add
paragraph (b)(3) to read as follows:
§ 520.304 Carprofen.
(a) * * *
(3) Each chewable tablet contains 25,
37.5, 50, 75, or 100 mg carprofen.
(b) * * *
(1) Nos. 017033, 054771, 055529, and
062250 for use of product described in
paragraphs (a)(1) and (2) of this section
as in paragraph (c) of this section.
(2) No. 058198 for use of product
described in paragraph (a)(1) of this
section as in paragraph (c) of this
section.
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(3) No. 069043 for use of product
described in paragraph (a)(3) of this
section as in paragraph (c) of this
section.
* * * * *
■5. In § 520.530, revise paragraph (b) to
read as follows:
§ 520.530 Cythioate oral liquid.
* * * * *
(b) Sponsor. See Nos. 054771 and
058198 in § 510.600 of this chapter.
* * * * *
■6. In § 520.531, revise paragraph (b)(1)
to read as follows:
§ 520.531 Cythioate tablets.
* * * * *
(b) * * *
(1) No. 058198 for use of 30- and 90-
mg tablets.
* * * * *
■7. In § 520.812, revise paragraph (b)(1)
to read as follows:
§ 520.812 Enrofloxacin.
* * * * *
(b) * * *
(1) No. 058198 for use of products
described in paragraphs (a)(1)(i) and
(a)(2) and (3) of this section.
* * * * *
■8. In § 520.903a, revise paragraph (b)
to read as follows:
§ 520.903a Febantel paste.
* * * * *
(b) Sponsor. See No. 058198 in
§ 510.600(c) of this chapter.
* * * * *
■9. In § 520.903b, revise paragraph (b)
to read as follows:
§ 520.903b Febantel suspension.
* * * * *
(b) Sponsor. See No. 058198 in
§ 510.600(c) of this chapter.
* * * * *
■10. In § 520.903c, revise paragraph (b)
to read as follows:
§ 520.903c Febantel and praziquantel
paste.
* * * * *
(b) Sponsor. See No. 058198 in
§ 510.600(c) of this chapter.
* * * * *
■11. In § 520.903d, revise paragraph (b)
to read as follows:
§ 520.903d Febantel tablets.
* * * * *
(b) Sponsor. See No. 058198 in
§ 510.600(c) of this chapter.
* * * * *
■12. In § 520.905a, revise paragraph
(e)(5)(ii), remove paragraph (e)(5)(iii),
and revise paragraph (e)(6)(ii) to read as
follows:
§ 520.905a Fenbendazole suspension.
* * * * *
(e) * * *
(5) * * *
(ii) Indications for use. For the
treatment and control of adult Ascaridia
galli in broiler chickens and
replacement chickens, and for the
treatment and control of adult A. galli
and Heterakis gallinarum in breeding
chickens and laying hens.
(6) * * *
(ii) Indications for use. For the
treatment and control of: Lungworms:
Adult Metastrongylus apri, Adult
Metastrongylus pudendotectus;
Gastrointestinal worms: Adult and
larvae (L3, L4 stages, liver, lung,
intestinal forms) large roundworms
(Ascaris suum), Adult nodular worms
(Oesophagostomum dentatum, O.
quadrispinulatum), Adult small
stomach worms (Hyostrongylus
rubidus), Adult and larvae (L2, L3, L4
stages—intestinal mucosal forms)
whipworms (Trichuris suis); and Kidney
worms: Adult and larvae Stephanurus
dentatus.
* * * * *
■13. Revise § 520.998 to read as
follows:
§ 520.998 Fluralaner.
(a) Specifications. (1) Each chewable
tablet contains 112.5, 250, 500, 1,000, or
1,400 milligrams (mg) fluralaner.
(2) Each chewable tablet contains 45,
100, 200, 400, or 560 mg fluralaner.
(b) Sponsor. See No. 000061 in
§ 510.600(c) of this chapter.
(c) Conditions of use in dogs—(1)
Amount. Administer orally as a single
dose with food:
(i) Chewable tablets described in
paragraph (a)(1) of this section.
Administer every 12 weeks, an
appropriate combination of tablets to
provide a minimum dose of 11.4 mg per
pound (lb) (25 mg per kilogram (kg))
body weight. May be administered every
8 weeks in case of potential exposure to
Amblyomma americanum ticks.
(ii) Chewable tablets described in
paragraph (a)(2) of this section.
Administer monthly, an appropriate
combination of tablets to provide a
minimum dose of 4.5 mg/lb (10 mg/kg)
body weight.
(2) Indications for use—(i) Chewable
tablets described in paragraph (a)(1) of
this section. Kills adult fleas; for the
treatment and prevention of flea
infestations (Ctenocephalides felis), and
the treatment and control of tick
infestations [Ixodes scapularis (black-
legged tick), Dermacentor variabilis
(American dog tick), and Rhipicephalus
sanguineus (brown dog tick)] for 12
weeks in dogs and puppies 6 months of
age and older, and weighing 4.4 lbs or
greater; and for the treatment and
control of Amblyomma americanum
(lone star tick) infestations for 8 weeks
in dogs and puppies 6 months of age
and older, and weighing 4.4 lbs or
greater.
(ii) Chewable tablets described in
paragraph (a)(2) of this section. Kills
adult fleas; for the treatment and
prevention of flea infestations (C. felis),
and the treatment and control of tick
infestations [I. scapularis (black-legged
tick), D. variabilis (American dog tick),
and R. sanguineus (brown dog tick)] for
1 month in dogs and puppies 8 weeks
of age and older, and weighing 4.4 lbs
or greater; and for the treatment and
control of A. americanum (lone star
tick) infestations for 1 month in dogs
and puppies 6 months of age and older,
and weighing 4.4 lbs or greater.
(3) Limitations. Federal law restricts
this drug to use by or on the order of
a licensed veterinarian.
■14. In § 520.1156, revise paragraph (b)
to read as follows:
§ 520.1156 Imidacloprid.
* * * * *
(b) Sponsor. See No. 058198 in
§ 510.600(c) of this chapter.
* * * * *
■15. In § 520.1192, revise paragraph
(b)(2) to read as follows:
§ 520.1192 Ivermectin paste.
* * * * *
(b) * * *
(2) Nos. 051311, 054925, 058198, and
061133 for use of a 1.87 percent paste
for use as in paragraph (e)(1) of this
section.
* * * * *
■16. In § 520.1195, revise paragraph
(b)(1) to read as follows:
§ 520.1195 Ivermectin liquid.
* * * * *
(b) * * *
(1) Nos. 000010, 054925, 058005, and
058198 for use of product described in
paragraph (a)(1) of this section as in
paragraphs (e)(1)(i), (e)(1)(ii)(A), and
(e)(1)(iii) of this section.
* * * * *
■17. In § 520.1454, revise paragraph (b)
to read as follows:
§ 520.1454 Moxidectin solution.
* * * * *
(b) Sponsor. See No. 058198 in
§ 510.600(c) of this chapter.
* * * * *
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■18. In § 520.1720a, add paragraph
(b)(5) to read as follows:
§ 520.1720a Phenylbutazone tablets and
boluses.
* * * * *
(b) * * *
(5) No. 058198 for use of 1-g tablets
in horses.
* * * * *
■19. In § 520.1860, revise paragraph (b)
to read as follows:
§ 520.1860 Pradofloxacin.
* * * * *
(b) Sponsor. See No. 058198 in
§ 510.600(c) of this chapter.
* * * * *
■20. In § 520.1870, revise paragraph (b)
to read as follows:
§ 520.1870 Praziquantel tablets.
* * * * *
(b) Sponsors. See sponsors in
§ 510.600(c) of this chapter.
(1) No. 058198 for use of product
described in paragraph (a)(1) of this
section as in paragraph (c)(1) of this
section and for use of product described
in paragraph (a)(2) of this section as in
paragraph (c)(2) of this section.
(2) No. 069043 for use of product
described in paragraph (a)(1) of this
section as in paragraphs (c)(1) of this
section.
* * * * *
■21. In § 520.1871, revise paragraph
(b)(1) to read as follows:
§ 520.1871 Praziquantel and pyrantel.
* * * * *
(b) * * *
(1) See No. 058198 for use of tablets
described in paragraph (a)(1) of this
section for use as in paragraph (d)(1) of
this section.
* * * * *
■22. In § 520.1872, revise paragraph (b)
to read as follows:
§ 520.1872 Praziquantel, pyrantel pamoate,
and febantel tablets.
* * * * *
(b) Sponsor. See No. 058198 in
§ 510.600(c) of this chapter.
* * * * *
■23. In § 520.2043, revise paragraph
(b)(2) to read as follows:
§ 520.2043 Pyrantel pamoate suspension.
* * * * *
(b) * * *
(2) Nos. 054771, 058198, and 058829
for use of the products described in
paragraph (a)(2) of this section as in
paragraph (d)(2) of this section.
* * * * *
■24. Add § 520.2138 to read as follows:
§ 520.2138 Spironolactone and benazepril.
(a) Specifications. Each chewable
tablet contains 20 milligrams (mg)
spironolactone and 2.5 mg benazepril
hydrochloride, 40 mg spironolactone
and 5 mg benazepril hydrochloride, or
80 mg spironolactone and 10 mg
benazepril hydrochloride.
(b) Sponsor. See No. 013744 in
§ 510.600(c) of this chapter.
(c) Conditions of use in dogs—(1)
Amount. Administer orally once daily,
with food, at a dose of 0.9 mg per pound
(lb) (2 mg per kilogram (kg))
spironolactone and 0.11 mg/lb (0.25 mg/
kg) benazepril hydrochloride, according
to dog body weight using a suitable
combination of whole and/or half
tablets.
(2) Indications for use. With
concurrent therapy (e.g., furosemide,
etc.) for the management of clinical
signs of mild, moderate, or severe
congestive heart failure in dogs due to
atrioventricular valvular insufficiency
(AVVI).
(3) Limitations. Federal law restricts
this drug to use by or on the order of
a licensed veterinarian.
■25. In § 520.2260b, add a heading for
paragraph (b), revise paragraph (b)(1),
add a heading for paragraph (e), and
revise paragraph (e)(1) to read as
follows:
§ 520.2260b Sulfamethazine sustained-
release boluses.
* * * * *
(b) 22.5-gram bolus—(1) Sponsor. See
No. 058198 in § 510.600(c) of this
chapter for use of a 22.5-gram
sulfamethazine prolonged-release bolus.
* * * * *
(e) 22.5-gram bolus—(1) Sponsor. See
No. 058198 in § 510.600(c) of this
chapter for use of a 22.5-gram
sulfamethazine sustained release bolus.
* * * * *
■26. In § 520.2455, revise paragraphs
(b)(1) and (2) to read as follows:
§ 520.2455 Tiamulin.
* * * * *
(b) * * *
(1) No. 058198 for products described
in paragraphs (a)(1) and (3) of this
section.
(2) No. 066104 for the product
described in paragraph (a)(1) of this
section.
* * * * *
PART 522—IMPLANTATION OR
INJECTABLE DOSAGE FORM NEW
ANIMAL DRUGS
■27. The authority citation for part 522
continues to read as follows:
Authority: 21 U.S.C. 360b.
■28. In § 522.23, revise paragraph (b) to
read as follows:
§ 522.23 Acepromazine.
* * * * *
(b) Sponsors. See Nos. 000010 and
058198 in § 510.600(c) of this chapter.
* * * * *
■29. In § 522.234, revise paragraph (b)
to read as follows:
§ 522.234 Butamisole.
* * * * *
(b) Sponsors. See Nos. 054771 and
058198 in § 510.600(c) of this chapter.
* * * * *
■30. In § 522.246, revise paragraphs
(b)(2) and (3) to read as follows:
§ 522.246 Butorphanol.
* * * * *
(b) * * *
(2) No. 058198 for use of the product
described in paragraph (a)(2) of this
section as in paragraph (d)(2) of this
section.
(3) Nos. 000061, 058198, and 059399
for use of the product described in
paragraph (a)(3) of this section as in
paragraph (d)(3) of this section.
* * * * *
■31. In § 522.812, revise paragraphs
(b)(1) and (2) to read as follows:
§ 522.812 Enrofloxacin.
* * * * *
(b) * * *
(1) Nos. 017033, 055529, and 058198
for use of product described in
paragraph (a)(1) of this section as in
paragraph (e)(1) of this section; and
(2) Nos. 055529, 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.
* * * * *
■32. In § 522.955, revise paragraph
(b)(2) to read as follows:
§ 522.955 Florfenicol.
* * * * *
(b) * * *
(2) Nos. 000061 and 058198 for use of
product described in paragraph (a)(2) of
this section as in paragraph (d)(1)(ii) of
this section.
* * * * *
■33. In § 522.970, revise paragraph
(b)(1) to read as follows:
§ 522.970 Flunixin.
* * * * *
(b) * * *
(1) See Nos. 000061, 016592, 055529,
058198, and 061133 for use as in
paragraph (e) of this section.
* * * * *
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■34. In § 522.995, revise paragraph (b)
to read as follows:
§ 522.995 Fluprostenol.
* * * * *
(b) Sponsor. See No. 058198 in
§ 510.600(c) of this chapter.
* * * * *
■35. In § 522.1010, revise paragraph
(b)(3) to read as follows:
§ 522.1010 Furosemide.
* * * * *
(b) * * *
(3) No. 058198 as described in
paragraph (a)(2) of this section for use
as in paragraphs (d)(1), (d)(2)(i), and
(d)(3) of this section.
* * * * *
■36. In § 522.1077:
■a. Revise paragraph (b)(3);
■b. Remove paragraph (b)(4); and
■c. Redesignate paragraph (b)(5) as
paragraph (b)(4).
The revision reads as follows:
§ 522.1077 Gonadorelin.
* * * * *
(b) * * *
(3) Nos. 000010 and 061133 for use of
the 50-mg/mL product described in
paragraph (a)(3) of this section as in
paragraphs (e)(1)(i) and (v) of this
section.
* * * * *
■37. In § 522.1086, revise paragraph (b)
to read as follows:
§ 522.1086 Guaifenesin solution.
* * * * *
(b) Sponsors. See Nos. 037990 and
058198 in § 510.600(c) of this chapter.
* * * * *
■38. In § 522.1182, revise paragraph
(b)(1) introductory text to read as
follows:
§ 522.1182 Iron injection.
* * * * *
(b) * * *
(1) Nos. 016592 and 042552 for use of
product described in paragraph (a)(1)(i)
of this section as follows:
* * * * *
■39. In § 522.1193, revise paragraph
(e)(3)(i) to read as follows:
§ 522.1193 Ivermectin and clorsulon.
* * * * *
(e) * * *
(3) * * *
(i) Nos. 000010, 055529, and 061133:
Do not treat cattle within 21 days of
slaughter. No. 058005: Do not treat
cattle within 49 days of slaughter.
* * * * *
■40. In § 522.1222, revise paragraph (b)
to read as follows:
§ 522.1222 Ketamine.
* * * * *
(b) Sponsors. See Nos. 017033,
054771, 058198, 059399, 063286, and
069043 in § 510.600(c) of this chapter.
* * * * *
■41. In § 522.1450, revise paragraph (b)
to read as follows:
§ 522.1450 Moxidectin solution.
* * * * *
(b) Sponsor. See No. 058198 in
§ 510.600(c) of this chapter.
* * * * *
■42. In § 522.1696a, revise paragraph
(d)(2)(iii) to read as follows:
§ 522.1696a Penicillin G benzathine and
penicillin G procaine suspension.
* * * * *
(d) * * *
(2) * * *
(iii) Limitations. Not for use within 30
days of slaughter. For Nos. 000859 and
016592: A withdrawal period has not
been established for this product in pre-
ruminating calves. Do not use in calves
to be processed for veal.
■43. In § 522.1720, revise paragraph
(b)(2) to read as follows:
§ 522.1720 Phenylbutazone.
* * * * *
(b) * * *
(2) Nos. 000061, 054771, 058198, and
061133 for use of product described in
paragraph (a)(2) of this section as in
paragraph (c) of this section.
* * * * *
■44. In § 522.1870, revise paragraph (b)
to read as follows:
§ 522.1870 Praziquantel.
* * * * *
(b) Sponsors. See Nos. 058198 and
061133 in § 510.600(c) of this chapter.
* * * * *
■45. In § 522.1890, revise the section
heading to read as follows:
§ 522.1890 Prednisone suspension.
■46. Revise § 522.2120 to read as
follows:
§ 522.2120 Spectinomycin hydrochloride.
(a) Specifications. Each milliliter of
solution contains 100 milligrams (mg)
spectinomycin hydrochloride (as
spectinomycin dihydrochloride
pentahydrate).
(b) Sponsors. See sponsors in
§ 510.600(c) of this chapter:
(1) Nos. 016592 and 054771 for use as
in paragraph (d)(1) of this section; and
(2) No. 058198 for use as in paragraph
(d)(2) of this section.
(c) Related tolerances. See § 556.600
of this chapter.
(d) Conditions of use. It is
administered as follows:
(1) Turkeys (1- to 3-day-old poults)
and chickens (newly hatched chicks)—
(i) Amounts and indications for use. (A)
Administer 5 mg per poult
subcutaneously as an aid in the control
of chronic respiratory disease (CRD)
associated with Escherichia coli in 1- to
3-day-old turkey poults.
(B) Administer 10 mg per poult as a
single subcutaneous injection in the
nape of the neck as an aid in the control
of airsacculitis associated with
Mycoplasma meleagridis sensitive to
spectinomycin in 1- to 3-day-old turkey
poults.
(C) Administer 2.5 to 5 mg per chick
as an aid in the control of mortality and
to lessen severity of infections caused
by M. synoviae, Salmonella
typhimurium, S. infantis, and E. coli.
(ii) Limitations. For use only in 1- to
3-day-old turkey poults and newly
hatched chicks.
(2) Dogs—(i) Amount. Administer 2.5
to 5.0 mg per pound of body weight by
intramuscular injection twice daily.
Treatment may be continued for 4 days.
(ii) Indications for use. For treatment
of infections caused by gram-negative
and gram-positive organisms susceptible
to spectinomycin.
(iii) Limitations. Federal law restricts
this drug to use by or on the order of
a licensed veterinarian.
■47. In § 522.2662, revise paragraph
(b)(3) to read as follows:
§ 522.2662 Xylazine.
* * * * *
(b) * * *
(3) Nos. 058198 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
■48. The authority citation for part 524
continues to read as follows:
Authority: 21 U.S.C. 360b.
■49. In § 524.450, revise paragraph (b)
to read as follows:
§ 524.450 Clotrimazole.
* * * * *
(b) Sponsor. See No. 058198 in
§ 510.600(c) of this chapter.
* * * * *
■50. In § 524.775, revise paragraph (b)
to read as follows:
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§ 524.775 Emodepside and praziquantel.
* * * * *
(b) Sponsor. See No. 058198 in
§ 510.600(c) of this chapter.
* * * * *
■51. In § 524.802, revise paragraph (b)
to read as follows:
§ 524.802 Enrofloxacin and silver
sulfadiazine otic emulsion.
* * * * *
(b) Sponsor. See No. 058198 in
§ 510.600(c) of this chapter.
* * * * *
■52. In § 524.920, revise paragraphs
(b)(1) through (3) to read as follows:
§ 524.920 Fenthion.
* * * * *
(b) * * *
(1) No. 058198 for use of product
described in paragraph (a)(1)(i) of this
section as in paragraph (d)(1) of this
section.
(2) No. 058198 for use of product
described in paragraph (a)(1)(ii) of this
section as in paragraph (d)(2) of this
section.
(3) No. 058198 for use of products
described in paragraph (a)(2) of this
section as in paragraph (d)(3) of this
section.
* * * * *
■53. In § 524.955, revise paragraph (b)
to read as follows:
§ 524.955 Florfenicol, terbinafine, and
betamethasone acetate otic gel.
* * * * *
(b) Sponsor. See No. 043264 in
§ 510.600(c) of this chapter.
* * * * *
■54. In § 524.957, revise paragraph (b)
to read as follows:
§ 524.957 Florfenicol, terbinafine, and
mometasone otic solution.
* * * * *
(b) Sponsor. See No. 058198 in
§ 510.600(c) of this chapter.
* * * * *
■55. In § 524.1140, revise paragraph (b)
to read as follows:
§ 524.1140 Imidacloprid and ivermectin.
* * * * *
(b) Sponsor. See No. 058198 in
§ 510.600(c) of this chapter.
* * * * *
■56. In § 524.1146, revise paragraphs
(b)(1) through (3) to read as follows:
§ 524.1146 Imidacloprid and moxidectin.
* * * * *
(b) * * *
(1) Nos. 017030 and 058198 for use of
product described in paragraph (a)(1) of
this section as in paragraph (d)(1) of this
section.
(2) Nos. 017030 and 058198 for use of
product described in paragraph (a)(2) of
this section as in paragraph (d)(2) of this
section.
(3) No. 058198 for use of product
described in paragraph (a)(2) of this
section as in paragraph (d)(3) of this
section.
* * * * *
■57. In § 524.1450, revise paragraphs
(b)(1) and (2) to read as follows:
§ 524.1450 Moxidectin.
* * * * *
(b) * * *
(1) No. 058198 for use of product
described in paragraph (a)(1) of this
section as in paragraph (d)(1) of this
section; and
(2) No. 058198 for use of product
described in paragraph (a)(2) of this
section as in paragraph (d)(2) of this
section.
* * * * *
PART 529—CERTAIN OTHER DOSAGE
FORM NEW ANIMAL DRUGS
■58. The authority citation for part 529
continues to read as follows:
Authority: 21 U.S.C. 360b.
■59. In § 529.56, revise paragraph (b) to
read as follows:
§ 529.56 Amikacin.
* * * * *
(b) Sponsors. See Nos. 054771 and
058198 in § 510.600(c) of this chapter.
* * * * *
■60. In § 529.1044a, revise paragraph
(b) to read as follows:
§ 529.1044a Gentamicin solution for
infusion.
* * * * *
(b) Sponsors. See Nos. 000061,
016592, 054628, 054771, 058005,
058198, and 061133 in § 510.600(c) of
this chapter.
* * * * *
PART 556—TOLERANCES FOR
RESIDUES OF NEW ANIMAL DRUGS
IN FOOD
■61. The authority citation for part 556
continues to read as follows:
Authority: 21 U.S.C. 342, 360b, 371.
■62. Add § 556.168 to read as follows:
§ 556.168 Coumaphos.
(a) [Reserved]
(b) Tolerances. The tolerances for
coumaphos (measured as coumaphos
and its oxygen analog, O,O-diethyl O-3-
chloro-4-methyl-2-oxo-2 H-1-
benzopyran-7-yl phosphate) are:
(1) Chickens. (i) Edible tissues
(excluding eggs): 1 ppm.
(ii) Eggs: 0.1 ppm.
(2) [Reserved]
(c) Related conditions of use. See
§ 558.185 of this chapter.
■63. In § 556.517, revise paragraph (c)
to read as follows:
§ 556.517 Poloxalene.
* * * * *
(c) Related conditions of use. See
§§ 520.1840 and 558.464 of this chapter.
PART 558—NEW ANIMAL DRUGS FOR
USE IN ANIMAL FEEDS
■64. The authority citation for part 558
continues to read as follows:
Authority: 21 U.S.C. 354, 360b, 360ccc,
360ccc–1, 371.
■65. In § 558.55:
■a. Revise paragraph (a);
■b. Redesignate paragraphs (b) and (d)
as paragraphs (d) and (e); and
■c. Add new paragraph (b).
The revision and addition read as
follows:
§ 558.55 Amprolium.
(a) Specifications. Type A medicated
article containing 25 percent
amprolium.
(b) Sponsor. No. 016592 in
§ 510.600(c) of this chapter.
* * * * *
■66. In § 558.58:
■a. Revise paragraph (b); and
■b. Redesignate paragraphs (c) and (d)
as paragraphs (d) and (c).
The revision reads as follows:
§ 558.58 Amprolium and ethopabate.
* * * * *
(b) Sponsor. See No. 016592 in
§ 510.600(c) of this chapter.
* * * * *
■67. In § 558.68, revise paragraph (a) to
read as follows:
§ 558.68 Avilamycin.
(a) Specifications. Each pound of
Type A medicated article contains 45.4
or 90.7 grams of avilamycin.
* * * * *
■68. In § 558.76:
■a. Revise paragraph (b);
■b. Remove paragraph (c); and
■c. Redesignate paragraphs (d) and (e)
as paragraphs (c) and (d).
The revision reads as follows:
§ 558.76 Bacitracin methylenedisalicylate.
* * * * *
(b) Sponsors. See sponsors in
§ 510.600(c) of this chapter as follows:
(1) No. 054771 for use of products in
paragraph (a)(1) of this section as in
paragraph (d) of this section.
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(2) No. 069254 for use of product in
paragraph (a)(2) of this section as in
paragraph (d) of this section.
* * * * *
■69. In § 558.78, revise paragraph (b) to
read as follows:
§ 558.78 Bacitracin zinc.
* * * * *
(b) Sponsor. See No. 054771 in
§ 510.600(c) of this chapter.
* * * * *
■70. In § 558.95:
■a. Revise paragraph (a);
■b. Redesignate paragraphs (b) and (d)
as paragraphs (d) and (e);
■c. Add new paragraph (b);
■d. Add a heading for newly
redesignated paragraph (e)(5); and
■e. Revise newly redesignated
paragraph (e)(5)(iii).
The revisions and additions read as
follows:
§ 558.95 Bambermycins.
(a) Specifications. Type A medicated
articles containing 2, 4, or 10 grams
bambermycins per pound.
(b) Sponsors. See sponsors in
§ 510.600(c) of this chapter as follows:
(1) No. 016592: 2, 4, and 10 grams per
pound for use as in paragraphs (e)(1)
through (4) of this section.
(2) No. 012286: 2 grams for use as in
paragraph (e)(2) of this section and 0.4
and 2 grams per pound for use as in
paragraph (e)(3) of this section.
* * * * *
(e) * * *
(5) Combinations. ***
(iii) Clopidol as in § 558.175.
* * * * *
■71. In § 558.128, revise paragraph (b)
introductory text to read as follows:
§ 558.128 Chlortetracycline.
* * * * *
(b) Sponsors. See sponsors in
§ 510.600(c) of this chapter as follows:
* * * * *
■72. In § 558.140, revise paragraph (b)
introductory text to read as follows:
§ 558.140 Chlortetracycline and
sulfamethazine.
* * * * *
(b) Sponsors. See sponsors in
§ 510.600(c) of this chapter as follows:
* * * * *
■73. In § 558.175:
■a. Revise paragraph (d)(3); and
■b. Remove paragraph (e).
The revision reads as follows:
§ 558.175 Clopidol.
* * * * *
(d) * * *
(3) Combinations. Clopidol may also
be used in combination with:
(i) Chlortetracycline as in § 558.128.
(ii) Lincomycin as in § 558.325.
■74. Add § 558.185 to read as follows:
§ 558.185 Coumaphos.
(a) Specifications. Type A medicated
articles containing 1.12, 2.0, 11.2, or 50
percent coumaphos.
(b) Sponsor. See No. 058198 in
§ 510.600(c) of this chapter.
(c) Related tolerances. See § 556.168
of this chapter.
(d) Special considerations. (1)
Labeling shall bear the following
warning: The active ingredient
coumaphos is a cholinesterase inhibitor.
Do not use this product on animals
simultaneously or within a few days
before or after treatment with, or
exposure to, cholinesterase-inhibiting
drugs, pesticides, or chemicals.
(2) See § 500.25 of this chapter.
(e) Conditions of use in laying
chickens.
Coumaphos in
grams per ton Indications for use Limitations Sponsor
(1) 27.2 (0.003 per-
cent). Laying chickens: For control of capillary
worm (Capillaria obsignata) and as an
aid in control of common round worm
(Ascaridia galli) and cecal worm
(Heterakis gallinae).
Feed continuously as the sole ration for 14 days. If reinfection occurs, treatment
may be repeated, but not sooner than 3 weeks after the end of the previous treat-
ment. Do not feed to chickens within 10 days of vaccination or other conditions of
stress..
058198
(2) 36.3 (0.004 per-
cent). Replacement pullets: For control of cap-
illary worm (Capillaria obsignata) and
as an aid in control of common round
worm (Ascaridia galli) and cecal worm
(Heterakis gallinae).
Feed continuously as the sole ration for from 10 to 14 days. Do not feed to chick-
ens under 8 weeks of age or within 10 days of vaccination or other conditions of
stress. If birds are maintained on contaminated litter or exposed to infected birds,
a second 10- to 14-day treatment is recommended, but not sooner than 3 weeks
after the end of the previous treatment. If reinfection occurs after production be-
gins, repeat treatment as recommended for laying flocks..
058198
■75. In § 558.195, revise paragraph (b)
to read as follows:
§ 558.195 Decoquinate.
* * * * *
(b) Sponsor. See No. 054771 in
§ 510.600(c) of this chapter.
* * * * *
■76. In § 558.258, revise paragraph (b)
to read as follows:
§ 558.258 Fenbendazole.
* * * * *
(b) Sponsor. See No. 000061 in
§ 510.600(c) of this chapter.
* * * * *
■77. In § 558.261, revise paragraph
(e)(2)(ii) to read as follows:
§ 558.261 Florfenicol.
* * * * *
(e) * * *
(2) * * *
Florfenicol in
grams/ton of feed Indications for use Limitations
*******
(ii) 182 to 2,724 ..... Freshwater-reared salmonids: For the control
of mortality due to coldwater disease associ-
ated with Flavobacterium psychrophilum and
furunculosis associated with Aeromonas
salmonicida.
Feed as a sole ration for 10 consecutive days to deliver 10 to 15 mg florfenicol per kg of fish.
Feed containing florfenicol shall not be fed for more than 10 days. Following administration,
fish should be reevaluated by a licensed veterinarian before initiating a further course of
therapy. The effects of florfenicol on reproductive performance have not been determined.
Feeds containing florfenicol must be withdrawn 15 days prior to slaughter.
*******
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■78. In § 558.295, revise paragraph (a)
to read as follows:
§ 558.295 Iodinated casein.
(a) Specifications. Type A medicated
article containing iodinated casein.
* * * * *
■79. In § 558.305, revise paragraph (b)
to read as follows:
§ 558.305 Laidlomycin.
* * * * *
(b) Sponsor. See No. 054771 in
§ 510.600(c) of this chapter.
* * * * *
■80. In § 558.311:
■a. Revise paragraphs (a), (b), and
(d)(7);
■b. Add a heading and introductory
text for paragraph (e);
■c. Revise paragraph (e)(1);
■d. Redesignate paragraphs (e)(2)
through (5) as paragraphs (e)(5) through
(8);
■e. Add new paragraphs (e)(2) through
(4); and
■f. In the table in newly redesignated
paragraph (e)(6)(i), revise the last row.
The revisions and additions read as
follows:
§ 558.311 Lasalocid.
(a) Specifications. Each pound of
Type A medicated article contains 68
grams (15 percent), 90.7 grams (20
percent), or 150 grams (33.1 percent)
lasalocid as lasalocid sodium activity. A
minimum of 90 percent of lasalocid
activity is derived from lasalocid A.
(b) Sponsor. See No. 054771 in
§ 510.600(c) of this chapter.
* * * * *
(d) * * *
(7) Each use in a free-choice Type C
cattle feed as in paragraphs (e)(3)(vi)
through (e)(3)(viii) of this section must
be the subject of an approved NADA or
supplemental NADA as provided in
§ 510.455 of this chapter.
(e) Conditions of use. It is used as
follows:
(1) The conditions of use for chickens
are:
Lasalocid in
grams/ton Combination in
grams/ton Indications for use Limitations Sponsor
(i) 68 to 113 .......... ......................................................... Broiler or fryer chickens: For prevention of
coccidiosis caused by Eimeria tenella, E.
necatrix, E. acervulina, E. brunetti, E.
mivati, and E. maxima..
Feed continuously as the sole ration ............ 054771
(ii) 68 .................... Bacitracin methylenedisalicylate, 10
to 50. Broiler chickens: For prevention of coccidi-
osis caused by Eimeria tenella, E.
necatrix, E. acervulina, E. brunetti, E.
mivati, and E. maxima; and for increased
rate of weight gain and improved feed ef-
ficiency..
Feed continuously as the sole ration. Baci-
tracin methylenedisalicylate provided by
No. 054771 in §510.600(c) of this chapter.
054771
(iii) 68 to 113 ........ Bacitracin methylenedisalicylate, 4
to 50. Broiler chickens: For prevention of coccidi-
osis caused by Eimeria tenella, E.
necatrix, E. acervulina, E. brunetti, E.
mivati, and E. maxima; and for improved
feed efficiency..
Feed continuously as the sole ration. Baci-
tracin methylenedisalicylate provided by
No. 054771 in §510.600(c) of this chapter.
054771
(iv) 68 to 113 ........ Bacitracin zinc, 4 to 50 ................... Broiler chickens. For prevention of coccidi-
osis caused by Eimeria tenella, E.
necatrix, E. acervulina, E. brunetti, E.
mivati, and E. maxima; and for increased
rate of weight gain and improved feed ef-
ficiency..
Feed continuously as the sole ration. Baci-
tracin zinc provided by No. 054771 in
§510.600(c) of this chapter.
054771
(v) 68 to 113 ......... Bambermycins, 1 to 2 ..................... Broiler chickens: For prevention of coccidi-
osis caused by Eimeria tenella, E.
necatrix, E. acervulina, E. brunetti, E.
mivati, and E. maxima; and for increased
rate of weight gain and improved feed ef-
ficiency..
Feed continuously as sole ration.
Bambermycins provided by No. 016592 in
§510.600(c) of this chapter.
016592
(2) The conditions of use for turkeys
are:
Lasalocid in
grams/ton Combination in
grams/ton Indications for use Limitations Sponsor
(i) 68 to 113 .......... ......................................................... Growing turkeys; For prevention of coccidi-
osis caused by Eimeria meleagrimitis, E.
gallopavonis, and E. adenoeides..
Feed continuously as sole ration .................. 054771
(ii) 68 to 113 ......... Bacitracin methylenedisalicylate, 4
to 50. Growing turkeys: For prevention of coccidi-
osis caused by E. meleagrimitis, E.
gallopavonis, and E. adenoeides; and for
increased rate of weight gain and im-
proved feed efficiency..
Feed continuously as the sole ration. Baci-
tracin methylenedisalicylate as provided
by No. 054771 in §510.600(c) in this
chapter.
054771
(iii) 68 to 113 ........ Bacitracin zinc, 4 to 50 ................... Growing turkeys: For prevention of coccidi-
osis caused by E. meleagrimitis, E.
gallopavonis, and E. adenoeides; and for
increased rate of weight gain and im-
proved feed efficiency..
Feed continuously as the sole ration. Baci-
tracin zinc as provided by No. 054771 in
§510.600(c) in this chapter.
054771
(3) The conditions of use for cattle
are—
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2
To provide 150 gm lasalocid per ton, use 1.652
lb (0.083%) of a lasalocid liquid Type A medicated
article containing 90.7 g/lb. If using a dry lasalocid
Type A medicated article containing 68 g/lb, use,
use 2.206 lbs per ton (0.111%), replacing molasses.
If using a dry lasalocid Type A medicated article
containing 90.7 g/lb, use 1.652 lbs per ton (0.083%),
adding molasses.
Lasalocid amount Indications for use Limitations Sponsor
(i) 10 to 30 grams/ton of feed ............. Cattle fed in confinement for slaughter: For
improved feed efficiency.. Feed continuously in complete feed to provide not less than
100 milligrams (mg) nor more than 360 mg of lasalocid so-
dium activity per head per day.
054771
(ii) 25 to 30 grams/ton of feed ............ Cattle fed in confinement for slaughter: For
improved feed efficiency and increased rate
of weight gain..
Feed continuously in complete feed to provide not less than
250 mg nor more than 360 mg of lasalocid sodium activity
per head per day.
054771
(iii) Not less than 60 mg or more than
300 mg of lasalocid per head per
day.
Pasture cattle (slaughter, stocker, feeder cat-
tle, and dairy and beef replacement heif-
ers): For increased rate of weight gain..
Feed continuously at a rate of not less than 60 mg or more
than 300 mg of lasalocid per head per day when on pas-
ture. The drug must be contained in at least 1 pound of
feed. Daily intakes of lasalocid in excess of 200 mg/head/
day have not been shown to be more effective than 200
mg/head/day.
054771
(iv) 1 mg lasalocid per 2.2 pounds (lb)
body weight per day. Cattle up to 800 lb: For control of coccidiosis
caused by Eimeria bovis and E. zuernii..Hand feed continuously at a rate of 1 mg of lasalocid per 2.2
lb body weight per day to provide not more than 360 mg of
lasalocid per head per day.
054771
(v) 1 mg lasalocid per 2.2 lb body
weight per day. Replacement calves: For control of coccidiosis
caused by E. bovis and E. zuernii..In milk replacer powder, hand feed at a rate of 1 mg of
lasalocid per 2.2 lb body weight per day. A withdrawal pe-
riod has not been established for lasalocid in pre-rumi-
nating calves. Do not use in calves to be processed for
veal.
054771
(vi) 1,440 grams/ton ............................ Pasture cattle (slaughter, stocker, feeder cat-
tle, and dairy and beef replacement heif-
ers): For increased rate of weight gain..
As a free-choice Type C medicated loose mineral, feed con-
tinuously at a rate of not less than 60 mg nor more than
200 mg of lasalocid per head per day.
012286
(vii) 1,440 grams/ton ........................... Pasture cattle (slaughter, stocker, feeder cat-
tle, and dairy and beef replacement heif-
ers): For increased rate of weight gain..
As a free-choice Type C medicated mineral block, feed con-
tinuously at a rate of not less than 60 mg nor more than
200 mg of lasalocid per head per day.
017800
(viii) 300 grams/ton ............................. Pasture cattle (slaughter, stocker, feeder cat-
tle, and dairy and beef replacement heif-
ers): for increased rate of weight gain..
As a free-choice Type C medicated protein block, feed con-
tinuously at a rate of not less than 60 mg nor more than
200 mg of lasalocid per head per day.
067949
(4) The conditions of use for minor
species are:
Lasalocid in
grams/ton Indications for use Limitations Sponsor
(i) 20 to 30 .......................................... Sheep maintained in confinement: For preven-
tion of coccidiosis caused by Eimeria ovina,
E. crandallis, E. ovinoidalis (E.
ninakohlyakimovae), E. parva, and E.
intricata..
Feed continuously in complete feed to provide not less than
15 milligrams (mg) nor more than 70 mg of lasalocid so-
dium activity per head per day depending on body weight.
054771
(ii) 113 ................................................. Chukar partridges: For prevention of coccidi-
osis caused by E. legionensis..Feed continuously as sole ration up to 8 weeks of age ........... 054771
(iii) 113 ................................................ Rabbits: For prevention of coccidiosis caused
by E. stiedae..Feed continuously as sole ration up to 6 1/2 weeks of age .... 054771
* * * * *
(6) * * * (i) * * *
Ingredient Percent
International
feed No.
*******
Lasalocid liquid Type A medicated article (90.7 g/lb)
2
........................................................................................... 0.083 ........................
* * * * *
■81. In § 558.325, revise paragraphs (b)
and (e)(1)(ix) to read as follows:
§ 558.325 Lincomycin.
* * * * *
(b) Sponsor. See No. 054771 in
§ 510.600(c) of this chapter.
* * * * *
(e) * * *
(1) * * *
Lincomycin
grams/ton Combination in
grams/ton Indications for use Limitations Sponsors
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Lincomycin
grams/ton Combination in
grams/ton Indications for use Limitations Sponsors
*******
(ix) 2 ..................... Salinomycin, 40
to 60. Broiler chickens: For the control of
necrotic enteritis caused or com-
plicated by Clostridium spp. or
other organisms susceptible to
lincomycin, and for the preven-
tion of coccidiosis caused by
Eimeria tenella, E. necatrix, E.
acervulina, E maxima, E.
brunetti, and E. mivati.
Feed as the sole ration to broiler chickens. Do not feed to laying hens
producing eggs for human consumption. Not approved for use with
pellet binders. May be fatal if accidentally fed to adult turkeys or
horses. Not for use in laying hens, breeding chickens, or turkeys. Do
not allow rabbits, hamsters, guinea pigs, horses, or ruminants ac-
cess to feeds containing lincomycin. Ingestion by these species may
result in severe gastrointestinal effects. Salinomycin as provided by
No. 054771 in §510.600 of this chapter.
05477
*******
* * * * *
■82. In § 558.342, revise paragraph (b)
to read as follows:
§ 558.342 Melengestrol.
* * * * *
(b) Sponsor. See sponsors in
§ 510.600(c) of this chapter for use as in
paragraph (e) of this section.
* * * * *
■83. In § 558.355, revise paragraphs (b)
introductory text, (d)(9)(i) and (ii), and
(d)(10)(i) and (ii) to read as follows:
§ 558.355 Monensin.
* * * * *
(b) Sponsors. See sponsors in
§ 510.600(c) of this chapter as follows:
* * * * *
(d) * * *
(9) * * *
(i) Cattle (as described in paragraphs
(f)(3)(i) through (iii), (vi), and (vii) and
(f)(4)(i) through (vi) of this section). See
paragraphs (d)(6) and (d)(7)(i) through
(v), (vii), and (viii) of this section.
(ii) Dairy cows (as described in
paragraphs (f)(3)(iv) and (v) of this
section). See paragraphs (d)(6) and
(d)(7)(i) through (iv), (vii), (viii), and (ix)
of this section.
* * * * *
(10) * * *
(i) Cattle (as described in paragraphs
(f)(3)(i) through (iii), (vi), and (vii) and
(f)(4)(i) through (vi) of this section). See
paragraphs (d)(6) and (d)(7)(i), (v), (vii),
and (viii) of this section. Paragraph
(d)(7)(vii) of this section does not apply
to free-choice Type C medicated feeds
as defined in § 510.455 of this chapter.
(ii) Dairy cows (as described in
paragraphs (f)(3)(iv) and (v) of this
section). See paragraphs (d)(6) and
(d)(7)(i), (vii), (viii), and (ix) of this
section. Paragraph (d)(7)(vii) of this
section does not apply to free-choice
Type C medicated feeds as defined in
§ 510.455 of this chapter.
* * * * *
■84. In § 558.363, revise paragraph (a)
to read as follows:
§ 558.363 Narasin.
(a) Specifications. Type A medicated
articles containing 36, 45, 54, 72, or 90
grams narasin per pound.
* * * * *
■85. In § 558.364, revise paragraph
(d)(1)(ii) to read as follows:
§ 558.364 Naracin and nicarbazin.
* * * * *
(d) * * *
(1) * * *
Narasin and
nicarbazin
grams/ton
Combination in
grams/ton Indications for use Limitations Sponsor
*******
(ii) 27 to 45 of
each drug. Bacitracin
methylenedisal-
icylate, 4 to 50.
Broiler chickens: For the prevention
of coccidiosis caused by Eimeria
necatrix, E. tenella, E.
acervulina, E. brunetti, E. mivati,
and E. maxima, and for in-
creased rate of weight gain and
improved feed efficiency.
Feed continuously as sole ration. Do not feed to laying hens. Do not
allow turkeys, horses, or other equines access to formulations con-
taining narasin. Ingestion of narasin by these species has been fatal.
For No. 054771: Withdraw 5 days before slaughter. For No. 069254:
Zero withdrawal period. Bacitracin methylenedisalicylate as provided
by Nos. 054771 and 069254 in §510.600(c) of this chapter.
058198
069254
*******
* * * * *
■86. In § 558.366, revise paragraph (b)
to read as follows:
§ 558.366 Nicarbazin.
* * * * *
(b) Sponsors. See Nos. 058198,
060728, and 066104 in § 510.600(c) of
this chapter.
* * * * *
■87. In § 558.450, revise paragraph
(e)(5)(iv) to read as follows:
§ 558.450 Oxytetracycline.
* * * * *
(e) * * *
(5) * * *
Oxytetracycline
amount Indications for use Limitations Sponsor
*******
(iv) 3.75 g/100 lb of
fish/day. 1. Freshwater-reared salmonids: For con-
trol of mortality due to coldwater dis-
ease associated with Flavobacterium
psychrophilum.
Administer in mixed ration for 10 days. Do not liberate fish or slaughter fish for food
for 21 days following the last administration of medicated feed.. 066104
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Oxytetracycline
amount Indications for use Limitations Sponsor
2. Freshwater-reared Oncorhynchus
mykiss: For control of mortality due to
columnaris disease associated with
Flavobacterium columnare.
Administer in mixed ration for 10 days. Do not liberate fish or slaughter fish for food
for 21 days following the last administration of medicated feed.. 066104
3. Freshwater-reared salmonids weighing
up to 55 grams: For marking the skel-
etal tissue.
Feed for 10 days. Immediate release is permitted following last feeding of medi-
cated feed.. 066104
*******
§ 558.465 [Removed]
■88. Remove § 558.465.
■89. Add § 558.470 to read as follows:
§ 558.470 Polyoxyethylene.
(a) Specifications. Each molasses-
based block contains 2.2 percent
polyoxyethylene (23) lauryl ether.
(b) Sponsor. See No. 067949 in
§ 510.600(c) of this chapter.
(c) [Reserved]
(d) Conditions of use—(1) Amount. 2
grams of polyoxyethylene (23) lauryl
ether per 100 kilograms of body weight
per day (1 pound of block per 500
kilogram (1,100 pound) animal per day).
Initially, provide one block per five
head of cattle. Start treatment 10 to 14
days before exposure to bloat-producing
pastures.
(2) Indications for use. For reduction
of the incidence of bloat (alfalfa and
clover) in pastured cattle.
(3) Limitations. Administer free-
choice to beef cattle and nonlactating
dairy cattle only. Do not allow cattle
access to other sources of salt while
being fed this product. Do not feed this
product to animals without adequate
forage/roughage consumption.
■90. In § 558.485, revise paragraph (b)
introductory text to read as follows:
§ 558.485 Pyrantel.
* * * * *
(b) Sponsors. See sponsors in
§ 510.600(c) of this chapter for use as
follows:
* * * * *
■91. In § 558.500, revise paragraph (b)
to read as follows:
§ 558.500 Ractopamine.
* * * * *
(b) Sponsor. See Nos. 054771 and
058198 in § 510.600(c) of this chapter.
* * * * *
■92. In § 558.515:
■a. Revise paragraph (a);
■b. Redesignate paragraphs (b), (d), and
(e) as paragraphs (d), (e), and (f); and
■c. Add new paragraph (b).
The revision and addition read as
follows:
§ 558.515 Robenidine.
(a) Specifications. Type A medicated
articles containing 30 grams per pound.
(b) Sponsor. See No. 054771 in
§ 510.600(c) of this chapter.
* * * * *
■93. In § 558.550:
■a. Revise paragraphs (a), (b), (e)(1)(i),
and (e)(2)(i);
■b. Add a heading for paragraph (e)(3);
■c. Redesignate paragraphs (e)(3)(i)
through (iv) as paragraphs (e)(3)(ii)
through (v); and
■d. Add new paragraph (e)(3)(i).
The revisions and additions read as
follows:
§ 558.550 Salinomycin.
(a) Specifications. Type A medicated
articles containing:
(1) 30 grams of salinomycin sodium
activity per pound; or
(2) 60 grams of salinomycin sodium
activity per pound.
(b) Sponsors. See sponsors in
§ 510.600(c) of this chapter as follows:
(1) No. 016592 for product described
in paragraph (a)(1) of this section.
(2) Nos. 016592 and 069254 for
product described in paragraph (a)(2) of
this section.
* * * * *
(e) * * *
(1) * * *
Salinomycin in
grams/ton Combination in
grams/ton Indications for use Limitations Sponsor
(i) 40 to 60 ............ ............................ Broiler, roaster, and replacement
(breeder and layer) chickens: For
the prevention of coccidiosis
caused by Eimeria tenella, E.
necatrix, E. acervulina, E. maxi-
ma, E. brunetti, and E. mivati.
Feed continuously as sole ration. Do not feed to birds producing eggs
for human consumption. May be fatal if accidentally fed to adult tur-
keys or horses..
016592
069254
*******
(2) * * *
Salinomycin in
grams/ton Combination in
grams/ton Indications for use Limitations Sponsor
(i) 50 ..................... ............................ Quail: For the prevention of coc-
cidiosis caused by Eimeria.
dispersa and E. lettyae.
Feed continuously as sole ration. Do not feed to birds producing eggs
for human consumption. May be fatal if accidentally fed to adult tur-
keys or horses..
016592
069254
*******
(3) Combinations. ***
(i) Avilamycin as in § 558.68.
* * * * *
■94. In § 558.555, revise paragraph (b)
to read as follows:
§ 558.555 Semduramicin.
* * * * *
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(b) Sponsor. See No. 066104 in
§ 510.600(c) of this chapter for use of
product described in paragraph (a)(1) of
this section as in paragraph (d) of this
section; for use of product described in
paragraph (a)(2) of this section as in
paragraph (e) of this section.
* * * * *
■95. In § 558.575, revise paragraph (b)
introductory text to read as follows:
§ 558.575 Sulfadimethoxine and
ormetoprim.
* * * * *
(b) Sponsors. See sponsors in
§ 510.600(c) of this chapter as follows:
* * * * *
■96. In § 558.600, revise paragraphs (a)
and (d) to read as follows:
§ 558.600 Thiabendazole.
(a) Specifications. Dry Type A
medicated articles containing 22, 44.1,
66.1, or 88.2 percent thiabendazole.
* * * * *
(d) Special considerations. (1) The
66.1 percent Type A medicated article is
solely for the manufacture of cane
molasses liquid Type B feed, which is
mixed in dry feeds.
(2) The 88.2 percent Type A
medicated article is used solely for the
manufacture of an aqueous slurry for
adding to a Type C dry cattle feed.
(3) Do not use in Type B or Type C
medicated feed containing bentonite.
* * * * *
■97. In § 558.612, revise paragraph (b)
to read as follows:
§ 558.612 Tiamulin.
* * * * *
(b) Sponsor. See No. 058198 in
§ 510.600(c) of this chapter.
* * * * *
■98. In § 558.618, revise paragraph (b)
to read as follows:
§ 558.618 Tilmicosin.
* * * * *
(b) Sponsor. See Nos. 016592 and
058198 in § 510.600(c) of this chapter.
* * * * *
■99. In § 558.680, revise paragraphs (b),
(d)(1)(i) and (v), and (d)(2)(i) to read as
follows:
§ 558.680 Zoalene.
* * * * *
(b) Sponsors. See Nos. 054771 and
058198 in § 510.600(c) of this chapter.
* * * * *
(d) * * *
(1) * * *
Zoalene in
grams/ton Combination in
grams per ton Indications for use Limitations Sponsor
(i) 36.3 to 113.5 ..... .............................. Replacement chickens: For devel-
opment of active immunity to
coccidiosis.
Feed continuously as sole ration. Grower ration not to be fed to birds
over 14 weeks of age. Starter ration not to be fed to laying birds. 054771
058198
Growing conditions Starter ration
grams per ton Grower ration
grams per ton
Severe exposure ........................... 113.5 (0.0125%) ......................................................... 75.4–113.5 (0.0083%–0.0125%)
Light to moderate exposure .......... 75.4–113.5 (0.0083%–0.0125%) ................................ 36.3–75.4 (0.004%–0.0083%)
Zoalene in
grams/ton Combination in
grams per ton Indications for use Limitations Sponsor
*******
(v) 113.5 ................. .............................. Broiler chickens: For prevention
and control of coccidiosis. Feed continuously as sole ration. Not to be fed to laying birds 054771
058198
*******
(2) * * *
Zoalene in
grams/ton Combination in
grams per 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
*******
* * * * *
Dated: March 4, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2021–05203 Filed 3–18–21; 8:45 a.m.]
BILLING CODE 4164–01–P
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 52
[EPA–R05–OAR–2016–0321; FRL–10021–
50–Region 5]
Air Plan Approval; Michigan; Partial
Approval and Partial Disapproval of
the Detroit SO2 Nonattainment Area
Plan
AGENCY
: Environmental Protection
Agency (EPA).
ACTION
: Final rule.
SUMMARY
: The Environmental Protection
Agency (EPA) is partially approving and
partially disapproving a revision to the
Michigan State Implementation Plan
(SIP) for attaining the 2010 1-hour
primary sulfur dioxide (SO
2
) national
ambient air quality standard (NAAQS or
‘‘standard’’) for the Detroit SO
2
nonattainment area (NAA). This SIP
revision (hereinafter called the ‘‘Detroit
SO
2
plan’’ or ‘‘plan’’) includes
Michigan’s attainment demonstration
and other elements required under the
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