New Animal Drugs; Approval of New Animal Drug Applications; Changes of Sponsor Address, 61682-61687 [2021-24075]
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Federal Register / Vol. 86, No. 213 / Monday, November 8, 2021 / Rules and Regulations
principal inspector or responsible Flight
Standards Office, as appropriate. If sending
information directly to the manager of the
certification office, send it to the attention of
the person identified in paragraph (k)(1) of
this AD. Information may be emailed to: 9ANM-Seattle-ACO-AMOC-Requests@faa.gov.
(2) Before using any approved AMOC,
notify your appropriate principal inspector,
or lacking a principal inspector, the manager
of the responsible Flight Standards Office.
(3) An AMOC that provides an acceptable
level of safety may be used for any repair,
modification, or alteration required by this
AD if it is approved by The Boeing Company
Organization Designation Authorization
(ODA) that has been authorized by the
Manager, Seattle ACO Branch, FAA, to make
those findings. To be approved, the repair
method, modification deviation, or alteration
deviation must meet the certification basis of
the airplane, and the approval must
specifically refer to this AD.
(4) AMOCs approved for AD 2005–05–18
are approved as AMOCs for the
corresponding provisions of Boeing Alert
Service Bulletin 737–53A1251, Revision 2,
dated January 20, 2021, that are required by
paragraph (g) of this AD.
(5) Except as specified by paragraph (h) of
this AD: For service information that
contains steps that are labeled as Required
for Compliance (RC), the provisions of
paragraphs (j)(5)(i) and (ii) of this AD apply.
(i) The steps labeled as RC, including
substeps under an RC step and any figures
identified in an RC step, must be done to
comply with the AD. If a step or substep is
labeled ‘‘RC Exempt,’’ then the RC
requirement is removed from that step or
substep. An AMOC is required for any
deviations to RC steps, including substeps
and identified figures.
(ii) Steps not labeled as RC may be
deviated from using accepted methods in
accordance with the operator’s maintenance
or inspection program without obtaining
approval of an AMOC, provided the RC steps,
including substeps and identified figures, can
still be done as specified, and the airplane
can be put back in an airworthy condition.
(IBR) of the service information listed in this
paragraph under 5 U.S.C. 552(a) and 1 CFR
part 51.
(2) You must use this service information
as applicable to do the actions required by
this AD, unless the AD specifies otherwise.
(i) Boeing Alert Service Bulletin 737–
53A1251, Revision 2, dated January 20, 2021.
(ii) [Reserved]
(3) For service information identified in
this AD, contact Boeing Commercial
Airplanes, Attention: Contractual & Data
Services (C&DS), 2600 Westminster Blvd.,
MC 110–SK57, Seal Beach, CA 90740–5600;
telephone 562–797–1717; internet https://
www.myboeingfleet.com.
(4) You may view this service information
at the FAA, Airworthiness Products Section,
Operational Safety Branch, 2200 South 216th
St., Des Moines, WA. For information on the
availability of this material at the FAA, call
206–231–3195.
(5) You may view this service information
that is incorporated by reference at the
National Archives and Records
Administration (NARA). For information on
the availability of this material at NARA,
email fr.inspection@nara.gov, or go to:
https://www.archives.gov/federal-register/cfr/
ibr-locations.html.
(k) Related Information
(1) For more information about this AD,
contact Wayne Lockett, Aerospace Engineer,
Airframe Section, FAA, Seattle ACO Branch,
2200 South 216th St., Des Moines, WA
98198; phone and fax: 206–231–3524; email:
wayne.lockett@faa.gov.
(2) Service information identified in this
AD that is not incorporated by reference is
available at the addresses specified in
paragraphs (l)(3) and (4) of this AD.
New Animal Drugs; Approval of New
Animal Drug Applications; Changes of
Sponsor Address
(l) Material Incorporated by Reference
(1) The Director of the Federal Register
approved the incorporation by reference
Issued on October 8, 2021.
Gaetano A. Sciortino,
Deputy Director for Strategic Initiatives,
Compliance & Airworthiness Division,
Aircraft Certification Service.
[FR Doc. 2021–24225 Filed 11–5–21; 8:45 am]
BILLING CODE 4910–13–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 510, 520, 522, 524, 556,
and 558
[Docket No. FDA–2021–N–0002]
Food and Drug Administration,
(HHS).
ACTION: Final rule; technical
amendments.
AGENCY:
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)
SUMMARY:
and abbreviated new animal drug
applications (ANADAs) during April,
May, and June 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 and readability of
the regulations.
This rule is effective November
8, 2021.
DATES:
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 April,
May, and June 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/approved-animal-drugproducts-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.
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TABLE 1—ORIGINAL AND SUPPLEMENTAL NADAS AND ANADAS APPROVED DURING APRIL, MAY, AND JUNE 2021
Approval date
File No.
April 5, 2021 .........
200–697
I
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Sponsor
I
Accord Healthcare, Inc.,
1009 Slater Rd., Suite
210–B, Durham, NC
27703.
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Product name
Enrofloxacin Injectable
Solution 2.27%.
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Species
Dogs ...............
Effect of the action
Original approval as a generic copy of
NADA 140–913.
I
I
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Public
documents
FOI Summary.
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TABLE 1—ORIGINAL AND SUPPLEMENTAL NADAS AND ANADAS APPROVED DURING APRIL, MAY, AND JUNE 2021—
Continued
Species
Effect of the action
Public
documents
CREDELIO CAT
(lotilaner) Chewable
Tablets.
Cats ................
FOI Summary.
Cronus Pharma Specialties India Private Ltd.,
Sy No-99/1, M/s GMR
Hyderabad Aviation
SEZ Ltd., Mamidipalli
Village, Shamshabad
Mandal, Ranga Reddy,
Hyderabad, Telangana,
501218, India.
Intervet, Inc., 2 Giralda
Farms, Madison, NJ
07940.
Amoxicillin and
Clavulanate Potassium
Tablets.
Dogs and cats
Supplemental approval for treatment
and control of black-legged tick infestations for one month in cats and kittens.
Original approval as a generic copy of
NADA 055–099.
SAFE–GUARD
(fenbendazole) Type C
free-choice medicated
feed blocks.
Cattle ..............
FOI Summary.
141–452
Zoetis Inc., 333 Portage
St., Kalamazoo, MI
49007.
SIMPARICA (sarolaner)
Chewables.
Dogs ...............
May 26, 2021 ........
140–269
Do .....................................
KETOFEN (ketoprofen)
Injectable Solution.
Cattle ..............
June 1, 2021 .........
141–543
Do .....................................
Cattle ..............
June 10, 2021 .......
200–700
June 10, 2021 .......
200–701
Chanelle Pharmaceuticals
Manufacturing Ltd.,
Loughrea, County Galway, Ireland.
Do .....................................
Cats ................
Original approval as a generic copy of
NADA 141–254.
FOI Summary.
June 14, 2021 .......
128–620
Intervet, Inc., 2 Giralda
Farms, Madison, NJ
07940.
DRAXXIN KP
(tulathromycin and
ketoprofen) Injectable
Solution.
PARASEDGE Multi for
Dogs (imidacloprid and
moxidectin) Topical Solution.
PARASEDGE Multi for
Cats (imidacloprid and
moxidectin) Topical Solution.
SAFE–GUARD
(fenbendazole) Suspension.
Supplemental approval providing for a
tolerance and tissue withdrawal periods in accordance with a repartitioning of the acceptable daily intake
(ADI); and the addition of indications
for 4th-stage larval forms of certain
endoparasites.
Supplemental approval for the prevention of Borrelia burgdorferi infection
as a direct result of killing Ixodes
scapularis vector ticks.
Supplemental approval for control of
pyrexia associated with bovine respiratory disease (BRD) and establishing a tolerance for residues of
ketoprofen in edible tissues of cattle.
Original approval for the treatment of
bovine respiratory disease (BRD)
and control of pyrexia associated
with BRD in certain classes of cattle.
Original approval as a generic copy of
NADA 141–234.
........................
FOI Summary.
June 14, 2021 .......
200–704
June 28, 2021 .......
200–706
Felix Pharmaceuticals
PVT Ltd., 25–28 North
Wall Quay, Dublin, 1,
Ireland.
Do .....................................
Supplemental approval to establish a
milk discard time in cattle and a goat
tissue tolerance in accordance with
repartitioning of the ADI.
Original approval as a generic copy of
NADA 141–203.
Approval date
File No.
Sponsor
Product name
April 12, 2021 .......
141–528
Elanco US Inc., 2500 Innovation Way, Greenfield, IN 46140.
April 23, 2021 .......
200–702
April 26, 2021 .......
139–189
May 18, 2021 ........
Dogs ...............
Deracoxib Chewable Tablets.
Dogs ...............
Carprofen Chewable Tablets.
Dogs ...............
II. Change of Sponsor’s Address
Alexion Pharmaceuticals, Inc., 100
College St., New Haven, CT 06510 has
informed FDA that it has changed its
address to 121 Seaport Blvd., Boston,
MA 02210.
Purina Animal Nutrition LLC, 1080
County Road F West, Shoreview, MN
55126–2910 has informed FDA that it
has changed its address to 4001
Lexington Ave., North Arden Hills, MN
55126–2910.
• 21 CFR part 522 is amended to
organize sections for injectable
pentobarbital drugs by their titles in
alphabetic sequence.
• 21 CFR 558.128 is amended to add
introductory text identifying the
paragraph for medicated cattle feeds
containing chlortetracycline.
• 21 CFR 558.355 is amended to add
introductory text identifying the
paragraph for medicated cattle feeds
containing monensin.
III. Technical Amendments
FDA is making the following
amendment to improve the accuracy of
the animal drug regulations:
• 21 CFR 520.304 is amended to
reflect the currently approved strengths
of carprofen chewable tablets.
IV. Legal Authority
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Original approval as a generic copy of
NADA 141–111.
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
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FOI Summary.
FOI Summary.
FOI Summary.
FOI Summary.
FOI Summary.
FOI Summary.
FOI Summary.
conditions of use of approved new
animal drugs. This rule sets forth
technical amendments to the regulations
to codify recent actions on approved
new animal drug applications and
corrections to improve the accuracy of
the regulations, and as such does not
impose any burden on regulated
entities.
Although denominated a rule
pursuant to the FD&C Act, this
document does not meet the definition
of ‘‘rule’’ in 5 U.S.C. 804(3)(A) because
it is a ‘‘rule of particular applicability.’’
Therefore, it is not subject to the
congressional review requirements in 5
U.S.C. 801–808. Likewise, this is not a
rule subject to Executive Order 12866,
which defines a rule as ‘‘an agency
statement of general applicability and
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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 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, 556, and 558 are
amended as follows:
PART 510—NEW ANIMAL DRUGS
§ 510.600 Names, addresses, and drug
labeler codes of sponsors of approved
applications.
1. The authority citation for part 510
continues to read as follows:
*
■
21 CFR Parts 520, 522, and 524
Authority: 21 U.S.C. 321, 331, 351, 352,
353, 360b, 371, 379e.
Animal drugs.
2. In § 510.600:
■ a. In the table in paragraph (c)(1),
revise the entries for ‘‘Alexion
Pharmaceuticals, Inc.’’ and ‘‘Purina
Animal Nutrition LLC;’’ and
■ b. In the table in paragraph (c)(2),
revise the entries for ‘‘017800’’ and
‘‘069334’’.
The revisions read as follows:
■
*
*
(c) * * *
(1) * * *
*
*
Drug labeler
code
Firm name and address
*
*
*
*
*
*
Alexion Pharmaceuticals, Inc., 121 Seaport Blvd., Boston, MA 02210 ..............................................................................................
*
*
*
*
*
*
*
Purina Animal Nutrition LLC, 4001 Lexington Ave., North Arden Hills, MN 55126–2910 ..................................................................
*
*
*
*
*
*
069334
017800
*
*
(2) * * *
Drug labeler
code
Firm name and address
*
017800 ..............
*
*
*
*
Purina Animal Nutrition LLC, 4001 Lexington Ave., North Arden Hills, MN 55126–2910.
*
*
*
069334 ..............
*
*
*
Alexion Pharmaceuticals, Inc., 121 Seaport Blvd., Boston, MA 02210.
*
*
*
*
*
*
*
*
*
(2) Nos. 058198 and 086101 for use of
product described in paragraph (a)(2) as
in paragraph (c) of this section.
*
*
*
*
*
PART 520—ORAL DOSAGE FORM
NEW ANIMAL DRUGS
3. The authority citation for part 520
continues to read as follows:
■
■
6. In § 520.538, remove paragraph (c)
and redesignate paragraph (d) as new
paragraph (c); and revise paragraph (b)
to read as follows:
§ 520.88g Amoxicillin trihydrate and
clavulanate potassium tablets.
§ 520.538
■
Authority: 21 U.S.C. 360b.
4. In § 520.88g, revise paragraph (b)(2)
to read as follows:
*
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*
*
*
*
*
(b) * * *
(2) Nos. 026637 and 069043 for use of
tablets as in paragraph (c) of this
section.
*
*
*
*
*
■ 5. In § 520.304, revise paragraph (b)(2)
to read as follows:
§ 520.304
*
*
*
(b) * * *
VerDate Sep<11>2014
*
*
*
*
*
*
(b) Sponsors. See Nos. 013744,
058198, and 086101 in § 510.600(c) of
this chapter.
*
*
*
*
*
7. In § 520.905a, revise paragraphs
(e)(2), (3), and (4) to read as follows:
■
§ 520.905a
Carprofen.
*
*
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Fenbendazole suspension.
*
*
(e) * * *
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(2) Beef and dairy cattle—(i) Amount.
Administer orally 2.3 mg/lb of body
weight (5 mg/kg).
(ii) Indications for use. For the
treatment and control of: Lungworms:
Adult (Dictyocaulus viviparus);
Stomach worms: Adult brown stomach
worms (Ostertagia ostertagi); adult and
fourth-stage larvae barberpole worms
(Haemonchus contortus and H. placei);
adult and fourth-stage larvae small
stomach worms (Trichostrongylus axei);
Intestinal worms (adult and fourth-stage
larvae): Hookworms (Bunostomum
phlebotomum), thread-necked intestinal
worms (Nematodirus helvetianus), small
intestinal worms (Cooperia punctata
and C. oncophora), bankrupt worms
(Trichostrongylus colubriformis), and
nodular worms (Oesophagostomum
radiatum).
(iii) Limitations. Milk taken from
cows during treatment and for 48 hours
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after the last treatment must not be used
for human consumption. Cattle must not
be slaughtered for human consumption
within 8 days following last treatment
with this drug product. Not for 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.
(3) Beef cattle—(i) Amount.
Administer orally 4.6 mg/lb of body
weight (10 mg/kg).
(ii) Indications for use. For the
treatment and control of stomach worms
(fourth-stage inhibited larvae/type II
ostertagiasis), Ostertagia ostertagi, and
tapeworms, Moniezia benedeni.
(iii) Limitations. Cattle must not be
slaughtered for human consumption
within 8 days following last treatment
with this drug product. Not for 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. Federal law
restricts this drug to use by or on the
order of a licensed veterinarian.
(4) Goats—(i) Amount. Administer
orally 2.3 mg/lb of body weight (5 mg/
kg).
(ii) Indications for use. For the
treatment and control of stomach worms
(adults) Haemonchus contortus and
Teladorsagia circumcincta.
(iii) Limitations. Goats must not be
slaughtered for human consumption
within 6 days following last treatment
with this drug product. Because a milk
discard time has not been established,
do not use in lactating goats.
*
*
*
*
*
§ 520.905e
[Removed]
8. Remove § 520.905e.
9. In § 520.1286, revise paragraph
(c)(2)(ii) to read as follows:
■
■
§ 520.1286
Lotilaner.
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*
*
*
*
*
(c) * * *
(2) * * *
(ii) Indications for use. Kills adult
fleas, and for the treatment and
prevention of flea infestations
(Ctenocephalides felis) for 1 month in
cats and kittens 8 weeks of age and
older, and weighing 2.0 pounds or
greater; and for the treatment and
control of Ixodes scapularis (blacklegged tick) for 1 month in cats and
kittens 6 months of age and older, and
weighing 2.0 pounds or greater.
*
*
*
*
*
■ 10. In § 520.2086, in paragraph (c)(2),
add a sentence at the end of the
paragraph to read as follows:
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§ 520.2086
Sarolaner.
*
*
*
*
*
(c) * * *
(2) * * * For the prevention of
Borrelia burgdorferi infections as a
direct result of killing Ixodes scapularis
vector ticks.
*
*
*
*
*
PART 522—IMPLANTATION OR
INJECTABLE DOSAGE FORM NEW
ANIMAL DRUGS
11. The authority citation for part 522
continues to read as follows:
■
Authority: 21 U.S.C. 360b.
12. In § 522.812, revise paragraphs
(b)(1) and (e)(1)(i) to read as follows:
■
§ 522.812
Enrofloxacin.
*
*
*
*
*
(b) * * *
(1) Nos. 016729, 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
*
*
*
*
*
(e) * * *
(1) * * *
(i) Amount. 2.5 mg per kilogram (/kg)
of body weight (1.13 mg per pound) as
a single, intramuscular, initial dose
followed by use of tablets twice daily for
2 to 3 days beyond cessation of clinical
signs to a maximum of 30 days.
*
*
*
*
*
■ 13. Revise § 522.1225 to read as
follows:
§ 522.1225
Ketoprofen.
(a) Specifications. Each milliliter of
solution contains 100 milligrams (mg)
ketoprofen.
(b) Sponsors. See sponsors in
§ 510.600(c) of this chapter.
(1) No. 054771 for use as in
paragraphs (d)(1) and (d)(2) of this
section.
(2) No. 061133 for use as in paragraph
(d)(1) of this section.
(c) Related tolerances. See § 556.345
of this chapter.
(d) Conditions of use—(1) Horses—(i)
Amount. Administer by intravenous
injection 1.0 mg per pound (/lb) of body
weight once daily for up to 5 days.
(ii) Indications for use. For alleviation
of inflammation and pain associated
with musculoskeletal disorders in
horses.
(iii) Limitations. Do not use in horses
intended for human consumption.
Federal law restricts this drug to use by
or on the order of a licensed
veterinarian.
(2) Cattle—(i) Amount. Administer by
subcutaneous injection 3 mg per
kilogram (1.36 mg/lb) of body weight
once daily for up to 3 days.
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(ii) Indications for use. For the control
of pyrexia associated with bovine
respiratory disease (BRD) in beef heifers,
beef steers, beef calves 2 months of age
and older, beef bulls, replacement dairy
heifers, and dairy bulls.
(iii) Limitations. Not for use in
reproducing animals over 1 year of age.
Cattle must not be slaughtered for
human consumption within 48 hours
following last treatment with this drug
product. Not for use in female dairy
cattle 1 year of age or older, including
dry dairy cows; use in these cattle may
cause drug residues in milk and/or in
calves born to these cows or heifers. Not
for 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. Federal law restricts
this drug to use by or on the order of
a licensed veterinarian.
§ § 522.1697, 522.1698, and 522.1704
[Redesignated]
14. Redesignate §§ 522.1697,
522.1698, and 522.1704 as §§ 522.1700,
522.1702, and 522.1703.
■ 15. Add § 522.2632 to read as follows:
■
§ 522.2632
Tulathromycin and ketoprofen.
(a) Specifications. Each milliliter of
solution contains 100 milligrams (mg)
tulathromycin and 120 milligrams (mg)
ketoprofen.
(b) Sponsor. See No. 054771 in
§ 510.600(c) of this chapter.
(c) Related tolerances. See §§ 556.345
and 556.745 of this chapter.
(d) Conditions of use—(1) Cattle—(i)
Amount. Administer as a single
subcutaneous injection 2.5 mg
tulathromycin and 3 mg ketoprofen per
kilogram (1.1 mL/100 lb) of body
weight.
(ii) Indications for use. For the
treatment of bovine respiratory disease
(BRD) associated with Mannheimia
haemolytica, Pasteurella multocida,
Histophilus somni, and Mycoplasma
bovis, and control of pyrexia associated
with BRD in beef steers, beef heifers,
beef calves 2 months of age and older,
beef bulls, dairy bulls, and replacement
dairy heifers.
(iii) Limitations. Not for use in
reproducing animals over 1 year of age.
Cattle must not be slaughtered for
human consumption within 18 days
following last treatment with this drug
product. Not for use in female dairy
cattle 1 year of age or older, including
dry dairy cows; use in these cattle may
cause drug residues in milk and/or in
calves born to these cows or heifers. Not
for use in beef calves less than 2 months
of age, dairy calves, and veal calves. A
withdrawal period has not been
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established for this product in preruminating calves. Federal law restricts
this drug to use by or on the order of
a licensed veterinarian.
(2) [Reserved]
PART 556—TOLERANCES FOR
RESIDUES OF NEW ANIMAL DRUGS
IN FOOD
(c) Related conditions of use. See
§§ 522.2630 and 522.2632 of this
chapter.
18. The authority citation for part 556
continues to read as follows:
PART 558—NEW ANIMAL DRUGS FOR
USE IN ANIMAL FEEDS
■
Authority: 21 U.S.C. 342, 360b, 371.
PART 524—OPHTHALMIC AND
TOPICAL DOSAGE FORM NEW
ANIMAL DRUGS
19. In § 556.275, revise paragraph (c)
to read as follows:
■
16. The authority citation for part 524
continues to read as follows:
■
Authority: 21 U.S.C. 360b.
17. In § 524.1146, revise paragraphs
(b)(1) and (2) to read as follows:
■
§ 556.275
Imidacloprid and moxidectin.
*
*
*
*
*
(b) * * *
(1) Nos. 017030, 058198, and 061651
for use of product described in
paragraph (a)(1) of this section as in
paragraph (d)(1) of this section.
(2) Nos. 017030, 058198, and 061651
for use of product described in
paragraph (a)(2) of this section as in
paragraph (d)(2) of this section.
*
*
*
*
*
*
*
*
*
(c) Related conditions of use. See
§§ 520.905a, 520.905b, 520.905c,
520.905d, and 558.258 of this chapter.
■ 20. Add § 556.345 to read as follows:
*
*
Ketoprofen.
Tulathromycin.
*
*
23. In § 558.128, revise paragraph
(e)(4) introductory text to read as
follows:
■
§ 558.128
Chlortetracycline.
*
(a) Acceptable daily intake (ADI). The
ADI for total residue of ketoprofen is 5
mg/kg of body weight per day.
(b) Tolerances. The tolerances for
ketoprofen (marker residue) are:
(1) Cattle. (i) Kidney (target tissue):
0.36 ppm.
(ii) [Reserved]
(c) Related conditions of use. See
§§ 522.1225 and 522.2632 of this
chapter.
■ 21. In § 556.745, revise paragraph (c)
to read as follows:
§ 556.745
*
*
*
*
*
(e) * * *
(4) Cattle. It is used as follows:
*
*
*
*
*
■ 24. In § 558.258, revise paragraph
(e)(3)(iii) to read as follows:
§ 558.258
Fenbendazole.
*
*
*
*
*
(e) * * *
(3) * * *
(iii) Free-choice medicated feeds—(A)
Proprietary formulas (§ 510.455(e)(2) of
this chapter). The following feeds can be
manufactured only per an approved
proprietary formula and specifications:
Amount fenbendazole
Indications for use
Limitations
(1) 750 mg/lb of protein block
(to provide 5 mg/kg body
weight (2.27 mg/lb)).
Beef cattle: For the treatment and control of: Lungworms:
adult (Dictyocaulus viviparus); Stomach worms: Adult
brown stomach worms (Ostertagia ostertagi), adult and
fourth-stage larvae barberpole worms (Haemonchus
contortus), fourth-stage larvae barberpole worms (H.
placei), and adult and fourth-stage larvae small stomach worms (Trichostrongylus axei); Intestinal worms
(adult and fourth-stage larvae): Hookworms
(Bunostomum phlebotomum), thread-necked intestinal
worms (Nematodirus helvetianus), small intestinal
worms (Cooperia punctata and C. oncophora), bankrupt
worms (Trichostrongylus colubriformis), and nodular
worms (Oesophagostomum radiatum).
Beef cattle: For the treatment and control of: Lungworms:
adult (Dictyocaulus viviparus); Stomach worms: Adult
brown stomach worms (Ostertagia ostertagi), adult and
fourth-stage larvae barberpole worms (Haemonchus
contortus), fourth-stage larvae barberpole worms (H.
placei), and adult and fourth-stage larvae small stomach worms (Trichostrongylus axei); Intestinal worms
(adult and fourth-stage larvae): Hookworms
(Bunostomum phlebotomum), thread-necked intestinal
worms (Nematodirus helvetianus), small intestinal
worms (Cooperia punctata and C. oncophora), bankrupt
worms (Trichostrongylus colubriformis), and nodular
worms (Oesophagostomum radiatum).
Feed free choice at a rate of 0.1 pound of block per 100
pounds of body weight per day for 3 days to deliver a
total of 2.27 mg fenbendazole per pound of body
weight. Cattle must not be slaughtered for human consumption within 16 days following last treatment with
this drug product. Not for use in female dairy cattle 20
months of age or older, including dry dairy cows. Use
in these cattle may cause drug residues in milk and/or
in calves born to these cows or heifers. Not for 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.
000061
Feed free choice at a rate of 0.1 pound of block per 100
pounds of body weight per day for 3 days to deliver a
total of 2.27 mg fenbendazole per pound of body
weight. Cattle must not be slaughtered for human consumption within 11 days following last treatment with
this drug product. Not for use in female dairy cattle 20
months of age or older, including dry dairy cows. Use
in these cattle may cause drug residues in milk and/or
in calves born to these cows or heifers. Not for 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.
000061
(2) 750 mg/lb of molasses
block (to provide 5 mg/kg
body weight (2.27 mg/lb)).
lotter on DSK11XQN23PROD with RULES1
Authority: 21 U.S.C. 354, 360b, 360ccc,
360ccc–1, 371.
Fenbendazole.
*
§ 556.345
§ 524.1146
22. The authority citation for part 558
continues to read as follows:
■
(B) Published formulas
(§ 510.455(e)(1) of this chapter). The
following feeds can be manufactured
only per one of the formulas and
specifications published below:
(1) Amount. 5 mg/kg body weight
(2.27 mg/lb), including the following
formulations:
Ingredient 1
Percent
(i) Free-choice, dry Type C feed:
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08NOR1
International
feed No.
61687
Federal Register / Vol. 86, No. 213 / Monday, November 8, 2021 / Rules and Regulations
Ingredient 1
Percent
Salt (sodium chloride) .......................................................................................................................................
Monosodium phosphate ...................................................................................................................................
Dried cane molasses ........................................................................................................................................
Zinc sulfate .......................................................................................................................................................
Copper sulfate ..................................................................................................................................................
Fenbendazole 20% Type A article ...................................................................................................................
(ii) Free-choice, dry Type C feed:
Salt (sodium chloride) .......................................................................................................................................
Dicalcium phosphate (18.5% P) .......................................................................................................................
Calcium carbonate (38% Ca) ...........................................................................................................................
Magnesium oxide (56% Mg) ............................................................................................................................
Zinc sulfate .......................................................................................................................................................
Mineral oil .........................................................................................................................................................
Dried cane molasses (46% sugars) .................................................................................................................
Potassium iodide ..............................................................................................................................................
Fenbendazole 20% Type A article ...................................................................................................................
(iii) Free-choice, liquid Type C feed:
Cane molasses 2 ...............................................................................................................................................
Water ................................................................................................................................................................
Urea solution, 55% ...........................................................................................................................................
Phosphoric acid 75% (feed grade) ...................................................................................................................
Xantham gum ...................................................................................................................................................
Trace minerals ..................................................................................................................................................
Vitamin premix ..................................................................................................................................................
Fenbendazole 20% Type A article ...................................................................................................................
International
feed No.
59.00
31.16
3.12
0.76
0.45
5.51
6–04–152
6–04–288
4–04–695
6–05–556
6–01–720
n/a
35.93
32.44
15.93
10.14
1.47
1.00
0.98
0.01
2.10
6–04–152
6–00–080
6–01–069
6–02–756
6–05–556
8–03–123
4–04–695
6–03–759
n/a
80.902
9.36
7.05
2.00
0.20
0.20
0.01
0.278
4–13–251
n/a
5–05–707
6–03–707
8–15–818
n/a
n/a
n/a
1 The content of any added vitamin and trace mineral may be varied; however, they should be comparable to those used by the manufacturer
for other free-choice cattle feeds. Formulation modifications require FDA approval prior to marketing. Selenium is not approved for the freechoice formulations described in paragraph (e)(3)(iii) of this section. Free-choice cattle feeds containing selenium must comply with published
regulations (see 21 CFR 573.920).
2 The percentage of cane molasses and water in the formulation may be adjusted as needed in order to bring the brix value of the molasses to
the industry standard of 79.5 brix.
(2) Indications for use. As in
paragraph (e)(3)(i) of this section.
(3) Limitations. Feed a total of 5 mg
of fenbendazole per kg (2.27 mg/lb) of
body weight to cattle over a 3- to 6-day
period. Retreatment may be needed after
4 to 6 weeks. Cattle must not be
slaughtered within 13 days following
last treatment. For dairy cattle the milk
discard time is zero hours. A
withdrawal period has not been
established for this product in preruminating calves. Do not use in calves
to be processed for veal.
*
*
*
*
*
25. In § 558.355, add a heading to
paragraph (f)(3) to read as follows:
■
§ 558.355
Monensin.
*
*
(f) * * *
(3) Cattle—
*
*
*
lotter on DSK11XQN23PROD with RULES1
*
*
*
*
*
Dated: October 28, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2021–24075 Filed 11–5–21; 8:45 am]
BILLING CODE 4164–01–P
VerDate Sep<11>2014
16:24 Nov 05, 2021
Jkt 256001
and is finalizing the rule without
change.
DEPARTMENT OF JUSTICE
28 CFR Part 16
This final rule is effective
December 8, 2021.
DATES:
[CPCLO Order No. 010–2021]
FOR FURTHER INFORMATION CONTACT:
Privacy Act of 1974; Implementation
United States Department of
Justice.
ACTION: Final rule.
AGENCY:
The United States Department
of Justice (DOJ or Department) is
finalizing without changes its Privacy
Act exemption regulations for the
system of records titled, Department of
Justice Information Technology,
Information System, and Network
Activity and Access Records, JUSTICE/
DOJ–002, which were published as a
notice of proposed rulemaking (NPRM)
(July 22, 2021). Specifically, the
Department’s regulations will exempt
the records maintained in JUSTICE/
DOJ–002 from one or more provisions of
the Privacy Act. The exemptions are
necessary to avoid interference with the
efforts of DOJ and others to prevent the
unauthorized access, use, disclosure,
disruption, modification, or destruction
of DOJ information and information
systems, and to protect information on
DOJ classified networks. The
Department received no comments
during the notice-and-comment period
SUMMARY:
PO 00000
Frm 00023
Fmt 4700
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Nickolous Ward, DOJ Chief Information
Security Officer, (202) 514–3101, 145 N
Street NE, Washington, DC 20530.
SUPPLEMENTARY INFORMATION: In
accordance with the Federal
Information Security Modernization Act
of 2014, among other authorities, DOJ is
responsible for complying with
information security policies and
procedures requiring information
security protections commensurate with
the risk and magnitude of harm
resulting from the unauthorized access,
use, disclosure, disruption,
modification, or destruction of DOJ
information and information systems.
See, e.g., 44 U.S.C. 3554 (2018).
Consistent with these requirements, DOJ
must ensure that it maintains accurate
audit and activity records of the
observable occurrences on its
information systems and networks (also
referred to as ‘‘events’’) that are
significant and relevant to the security
of DOJ information and information
systems. These audit and activity
records may include, but are not limited
to, information that establishes what
type of event occurred, when the event
occurred, where the event occurred, the
E:\FR\FM\08NOR1.SGM
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]]>Agencies
[Federal Register Volume 86, Number 213 (Monday, November 8, 2021)]
[Rules and Regulations]
[Pages 61682-61687]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-24075]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 510, 520, 522, 524, 556, and 558
[Docket No. FDA-2021-N-0002]
New Animal Drugs; Approval of New Animal Drug Applications;
Changes of Sponsor Address
AGENCY: Food and Drug Administration, (HHS).
ACTION: Final rule; technical amendments.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or we) is amending the
animal drug regulations to reflect application-related actions for new
animal drug applications (NADAs) and abbreviated new animal drug
applications (ANADAs) during April, May, and June 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
and readability of the regulations.
DATES: This rule is effective November 8, 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,
[email protected].
SUPPLEMENTARY INFORMATION:
I. Approvals
FDA is amending the animal drug regulations to reflect approval
actions for NADAs and ANADAs during April, May, and June 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/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.
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 April, May, and June 2021
--------------------------------------------------------------------------------------------------------------------------------------------------------
Approval date File No. Sponsor Product name Species Effect of the action Public documents
--------------------------------------------------------------------------------------------------------------------------------------------------------
April 5, 2021............. 200-697 Accord Healthcare, Enrofloxacin Dogs.................. Original approval as FOI Summary.
Inc., 1009 Slater Injectable Solution a generic copy of
Rd., Suite 210-B, 2.27%. NADA 140-913.
Durham, NC 27703.
[[Page 61683]]
April 12, 2021............ 141-528 Elanco US Inc., 2500 CREDELIO CAT Cats.................. Supplemental approval FOI Summary.
Innovation Way, (lotilaner) Chewable for treatment and
Greenfield, IN 46140. Tablets. control of black-
legged tick
infestations for one
month in cats and
kittens.
April 23, 2021............ 200-702 Cronus Pharma Amoxicillin and Dogs and cats......... Original approval as FOI Summary.
Specialties India Clavulanate a generic copy of
Private Ltd., Sy No- Potassium Tablets. NADA 055-099.
99/1, M/s GMR
Hyderabad Aviation
SEZ Ltd.,
Mamidipalli Village,
Shamshabad Mandal,
Ranga Reddy,
Hyderabad,
Telangana, 501218,
India.
April 26, 2021............ 139-189 Intervet, Inc., 2 SAFE-GUARD Cattle................ Supplemental approval FOI Summary.
Giralda Farms, (fenbendazole) Type providing for a
Madison, NJ 07940. C free-choice tolerance and tissue
medicated feed withdrawal periods
blocks. in accordance with a
repartitioning of
the acceptable daily
intake (ADI); and
the addition of
indications for
4th[dash]stage
larval forms of
certain
endoparasites.
May 18, 2021.............. 141-452 Zoetis Inc., 333 SIMPARICA (sarolaner) Dogs.................. Supplemental approval FOI Summary.
Portage St., Chewables. for the prevention
Kalamazoo, MI 49007. of Borrelia
burgdorferi
infection as a
direct result of
killing Ixodes
scapularis vector
ticks.
May 26, 2021.............. 140-269 Do................... KETOFEN (ketoprofen) Cattle................ Supplemental approval FOI Summary.
Injectable Solution. for control of
pyrexia associated
with bovine
respiratory disease
(BRD) and
establishing a
tolerance for
residues of
ketoprofen in edible
tissues of cattle.
June 1, 2021.............. 141-543 Do................... DRAXXIN KP Cattle................ Original approval for FOI Summary.
(tulathromycin and the treatment of
ketoprofen) bovine respiratory
Injectable Solution. disease (BRD) and
control of pyrexia
associated with BRD
in certain classes
of cattle.
June 10, 2021............. 200-700 Chanelle PARASEDGE Multi for Dogs.................. Original approval as FOI Summary.
Pharmaceuticals Dogs (imidacloprid a generic copy of
Manufacturing Ltd., and moxidectin) NADA 141-234.
Loughrea, County Topical Solution.
Galway, Ireland.
June 10, 2021............. 200-701 Do................... PARASEDGE Multi for Cats.................. Original approval as FOI Summary.
Cats (imidacloprid a generic copy of
and moxidectin) NADA 141-254.
Topical Solution.
June 14, 2021............. 128-620 Intervet, Inc., 2 SAFE-GUARD ...................... Supplemental approval FOI Summary.
Giralda Farms, (fenbendazole) to establish a milk
Madison, NJ 07940. Suspension. discard time in
cattle and a goat
tissue tolerance in
accordance with
repartitioning of
the ADI.
June 14, 2021............. 200-704 Felix Pharmaceuticals Deracoxib Chewable Dogs.................. Original approval as FOI Summary.
PVT Ltd., 25-28 Tablets. a generic copy of
North Wall Quay, NADA 141-203.
Dublin, 1, Ireland.
June 28, 2021............. 200-706 Do................... Carprofen Chewable Dogs.................. Original approval as FOI Summary.
Tablets. a generic copy of
NADA 141-111.
--------------------------------------------------------------------------------------------------------------------------------------------------------
II. Change of Sponsor's Address
Alexion Pharmaceuticals, Inc., 100 College St., New Haven, CT 06510
has informed FDA that it has changed its address to 121 Seaport Blvd.,
Boston, MA 02210.
Purina Animal Nutrition LLC, 1080 County Road F West, Shoreview, MN
55126-2910 has informed FDA that it has changed its address to 4001
Lexington Ave., North Arden Hills, MN 55126-2910.
III. Technical Amendments
FDA is making the following amendment to improve the accuracy of
the animal drug regulations:
21 CFR 520.304 is amended to reflect the currently
approved strengths of carprofen chewable tablets.
21 CFR part 522 is amended to organize sections for
injectable pentobarbital drugs by their titles in alphabetic sequence.
21 CFR 558.128 is amended to add introductory text
identifying the paragraph for medicated cattle feeds containing
chlortetracycline.
21 CFR 558.355 is amended to add introductory text
identifying the paragraph for medicated cattle feeds containing
monensin.
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 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
[[Page 61684]]
future effect, which the agency intends to have the force and effect of
law, that is designed to implement, interpret, or prescribe law or
policy or to describe the procedure or practice requirements of an
agency.''
List of Subjects
21 CFR Part 510
Administrative practice and procedure, Animal drugs, Labeling,
Reporting and recordkeeping requirements.
21 CFR Parts 520, 522, and 524
Animal drugs.
21 CFR Part 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, 556, and 558 are amended as follows:
PART 510--NEW ANIMAL DRUGS
0
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.
0
2. In Sec. 510.600:
0
a. In the table in paragraph (c)(1), revise the entries for ``Alexion
Pharmaceuticals, Inc.'' and ``Purina Animal Nutrition LLC;'' and
0
b. In the table in paragraph (c)(2), revise the entries for ``017800''
and ``069334''.
The revisions read as follows:
Sec. 510.600 Names, addresses, and drug labeler codes of sponsors of
approved applications.
* * * * *
(c) * * *
(1) * * *
------------------------------------------------------------------------
Drug labeler
Firm name and address code
------------------------------------------------------------------------
* * * * * * *
Alexion Pharmaceuticals, Inc., 121 Seaport Blvd., 069334
Boston, MA 02210.......................................
* * * * * * *
Purina Animal Nutrition LLC, 4001 Lexington Ave., North 017800
Arden Hills, MN 55126-2910.............................
* * * * * * *
------------------------------------------------------------------------
(2) * * *
------------------------------------------------------------------------
Drug labeler code Firm name and address
------------------------------------------------------------------------
* * * * * * *
017800................... Purina Animal Nutrition LLC, 4001 Lexington
Ave., North Arden Hills, MN 55126-2910.
* * * * * * *
069334................... Alexion Pharmaceuticals, Inc., 121 Seaport
Blvd., Boston, MA 02210.
* * * * * * *
------------------------------------------------------------------------
PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS
0
3. The authority citation for part 520 continues to read as follows:
Authority: 21 U.S.C. 360b.
0
4. In Sec. 520.88g, revise paragraph (b)(2) to read as follows:
Sec. 520.88g Amoxicillin trihydrate and clavulanate potassium
tablets.
* * * * *
(b) * * *
(2) Nos. 026637 and 069043 for use of tablets as in paragraph (c)
of this section.
* * * * *
0
5. In Sec. 520.304, revise paragraph (b)(2) to read as follows:
Sec. 520.304 Carprofen.
* * * * *
(b) * * *
(2) Nos. 058198 and 086101 for use of product described in
paragraph (a)(2) as in paragraph (c) of this section.
* * * * *
0
6. In Sec. 520.538, remove paragraph (c) and redesignate paragraph (d)
as new paragraph (c); and revise paragraph (b) to read as follows:
Sec. 520.538 Deracoxib.
* * * * *
(b) Sponsors. See Nos. 013744, 058198, and 086101 in Sec.
510.600(c) of this chapter.
* * * * *
0
7. In Sec. 520.905a, revise paragraphs (e)(2), (3), and (4) to read as
follows:
Sec. 520.905a Fenbendazole suspension.
* * * * *
(e) * * *
(2) Beef and dairy cattle--(i) Amount. Administer orally 2.3 mg/lb
of body weight (5 mg/kg).
(ii) Indications for use. For the treatment and control of:
Lungworms: Adult (Dictyocaulus viviparus); Stomach worms: Adult brown
stomach worms (Ostertagia ostertagi); adult and fourth-stage larvae
barberpole worms (Haemonchus contortus and H. placei); adult and
fourth-stage larvae small stomach worms (Trichostrongylus axei);
Intestinal worms (adult and fourth-stage larvae): Hookworms (Bunostomum
phlebotomum), thread-necked intestinal worms (Nematodirus helvetianus),
small intestinal worms (Cooperia punctata and C. oncophora), bankrupt
worms (Trichostrongylus colubriformis), and nodular worms
(Oesophagostomum radiatum).
(iii) Limitations. Milk taken from cows during treatment and for 48
hours
[[Page 61685]]
after the last treatment must not be used for human consumption. Cattle
must not be slaughtered for human consumption within 8 days following
last treatment with this drug product. Not for 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.
(3) Beef cattle--(i) Amount. Administer orally 4.6 mg/lb of body
weight (10 mg/kg).
(ii) Indications for use. For the treatment and control of stomach
worms (fourth-stage inhibited larvae/type II ostertagiasis), Ostertagia
ostertagi, and tapeworms, Moniezia benedeni.
(iii) Limitations. Cattle must not be slaughtered for human
consumption within 8 days following last treatment with this drug
product. Not for 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. Federal law restricts this
drug to use by or on the order of a licensed veterinarian.
(4) Goats--(i) Amount. Administer orally 2.3 mg/lb of body weight
(5 mg/kg).
(ii) Indications for use. For the treatment and control of stomach
worms (adults) Haemonchus contortus and Teladorsagia circumcincta.
(iii) Limitations. Goats must not be slaughtered for human
consumption within 6 days following last treatment with this drug
product. Because a milk discard time has not been established, do not
use in lactating goats.
* * * * *
Sec. 520.905e [Removed]
0
8. Remove Sec. 520.905e.
0
9. In Sec. 520.1286, revise paragraph (c)(2)(ii) to read as follows:
Sec. 520.1286 Lotilaner.
* * * * *
(c) * * *
(2) * * *
(ii) Indications for use. Kills adult fleas, and for the treatment
and prevention of flea infestations (Ctenocephalides felis) for 1 month
in cats and kittens 8 weeks of age and older, and weighing 2.0 pounds
or greater; and for the treatment and control of Ixodes scapularis
(black-legged tick) for 1 month in cats and kittens 6 months of age and
older, and weighing 2.0 pounds or greater.
* * * * *
0
10. In Sec. 520.2086, in paragraph (c)(2), add a sentence at the end
of the paragraph to read as follows:
Sec. 520.2086 Sarolaner.
* * * * *
(c) * * *
(2) * * * For the prevention of Borrelia burgdorferi infections as
a direct result of killing Ixodes scapularis vector ticks.
* * * * *
PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS
0
11. The authority citation for part 522 continues to read as follows:
Authority: 21 U.S.C. 360b.
0
12. In Sec. 522.812, revise paragraphs (b)(1) and (e)(1)(i) to read as
follows:
Sec. 522.812 Enrofloxacin.
* * * * *
(b) * * *
(1) Nos. 016729, 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
* * * * *
(e) * * *
(1) * * *
(i) Amount. 2.5 mg per kilogram (/kg) of body weight (1.13 mg per
pound) as a single, intramuscular, initial dose followed by use of
tablets twice daily for 2 to 3 days beyond cessation of clinical signs
to a maximum of 30 days.
* * * * *
0
13. Revise Sec. 522.1225 to read as follows:
Sec. 522.1225 Ketoprofen.
(a) Specifications. Each milliliter of solution contains 100
milligrams (mg) ketoprofen.
(b) Sponsors. See sponsors in Sec. 510.600(c) of this chapter.
(1) No. 054771 for use as in paragraphs (d)(1) and (d)(2) of this
section.
(2) No. 061133 for use as in paragraph (d)(1) of this section.
(c) Related tolerances. See Sec. 556.345 of this chapter.
(d) Conditions of use--(1) Horses--(i) Amount. Administer by
intravenous injection 1.0 mg per pound (/lb) of body weight once daily
for up to 5 days.
(ii) Indications for use. For alleviation of inflammation and pain
associated with musculoskeletal disorders in horses.
(iii) Limitations. Do not use in horses intended for human
consumption. Federal law restricts this drug to use by or on the order
of a licensed veterinarian.
(2) Cattle--(i) Amount. Administer by subcutaneous injection 3 mg
per kilogram (1.36 mg/lb) of body weight once daily for up to 3 days.
(ii) Indications for use. For the control of pyrexia associated
with bovine respiratory disease (BRD) in beef heifers, beef steers,
beef calves 2 months of age and older, beef bulls, replacement dairy
heifers, and dairy bulls.
(iii) Limitations. Not for use in reproducing animals over 1 year
of age. Cattle must not be slaughtered for human consumption within 48
hours following last treatment with this drug product. Not for use in
female dairy cattle 1 year of age or older, including dry dairy cows;
use in these cattle may cause drug residues in milk and/or in calves
born to these cows or heifers. Not for 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. Federal
law restricts this drug to use by or on the order of a licensed
veterinarian.
Sec. Sec. 522.1697, 522.1698, and 522.1704 [Redesignated]
0
14. Redesignate Sec. Sec. 522.1697, 522.1698, and 522.1704 as
Sec. Sec. 522.1700, 522.1702, and 522.1703.
0
15. Add Sec. 522.2632 to read as follows:
Sec. 522.2632 Tulathromycin and ketoprofen.
(a) Specifications. Each milliliter of solution contains 100
milligrams (mg) tulathromycin and 120 milligrams (mg) ketoprofen.
(b) Sponsor. See No. 054771 in Sec. 510.600(c) of this chapter.
(c) Related tolerances. See Sec. Sec. 556.345 and 556.745 of this
chapter.
(d) Conditions of use--(1) Cattle--(i) Amount. Administer as a
single subcutaneous injection 2.5 mg tulathromycin and 3 mg ketoprofen
per kilogram (1.1 mL/100 lb) of body weight.
(ii) Indications for use. For the treatment of bovine respiratory
disease (BRD) associated with Mannheimia haemolytica, Pasteurella
multocida, Histophilus somni, and Mycoplasma bovis, and control of
pyrexia associated with BRD in beef steers, beef heifers, beef calves 2
months of age and older, beef bulls, dairy bulls, and replacement dairy
heifers.
(iii) Limitations. Not for use in reproducing animals over 1 year
of age. Cattle must not be slaughtered for human consumption within 18
days following last treatment with this drug product. Not for use in
female dairy cattle 1 year of age or older, including dry dairy cows;
use in these cattle may cause drug residues in milk and/or in calves
born to these cows or heifers. Not for use in beef calves less than 2
months of age, dairy calves, and veal calves. A withdrawal period has
not been
[[Page 61686]]
established for this product in pre-ruminating calves. Federal law
restricts this drug to use by or on the order of a licensed
veterinarian.
(2) [Reserved]
PART 524--OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS
0
16. The authority citation for part 524 continues to read as follows:
Authority: 21 U.S.C. 360b.
0
17. In Sec. 524.1146, revise paragraphs (b)(1) and (2) to read as
follows:
Sec. 524.1146 Imidacloprid and moxidectin.
* * * * *
(b) * * *
(1) Nos. 017030, 058198, and 061651 for use of product described in
paragraph (a)(1) of this section as in paragraph (d)(1) of this
section.
(2) Nos. 017030, 058198, and 061651 for use of product described in
paragraph (a)(2) of this section as in paragraph (d)(2) of this
section.
* * * * *
PART 556--TOLERANCES FOR RESIDUES OF NEW ANIMAL DRUGS IN FOOD
0
18. The authority citation for part 556 continues to read as follows:
Authority: 21 U.S.C. 342, 360b, 371.
0
19. In Sec. 556.275, revise paragraph (c) to read as follows:
Sec. 556.275 Fenbendazole.
* * * * *
(c) Related conditions of use. See Sec. Sec. 520.905a, 520.905b,
520.905c, 520.905d, and 558.258 of this chapter.
0
20. Add Sec. 556.345 to read as follows:
Sec. 556.345 Ketoprofen.
(a) Acceptable daily intake (ADI). The ADI for total residue of
ketoprofen is 5 [micro]g/kg of body weight per day.
(b) Tolerances. The tolerances for ketoprofen (marker residue) are:
(1) Cattle. (i) Kidney (target tissue): 0.36 ppm.
(ii) [Reserved]
(c) Related conditions of use. See Sec. Sec. 522.1225 and 522.2632
of this chapter.
0
21. In Sec. 556.745, revise paragraph (c) to read as follows:
Sec. 556.745 Tulathromycin.
* * * * *
(c) Related conditions of use. See Sec. Sec. 522.2630 and 522.2632
of this chapter.
PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS
0
22. The authority citation for part 558 continues to read as follows:
Authority: 21 U.S.C. 354, 360b, 360ccc, 360ccc-1, 371.
0
23. In Sec. 558.128, revise paragraph (e)(4) introductory text to read
as follows:
Sec. 558.128 Chlortetracycline.
* * * * *
(e) * * *
(4) Cattle. It is used as follows:
* * * * *
0
24. In Sec. 558.258, revise paragraph (e)(3)(iii) to read as follows:
Sec. 558.258 Fenbendazole.
* * * * *
(e) * * *
(3) * * *
(iii) Free-choice medicated feeds--(A) Proprietary formulas (Sec.
510.455(e)(2) of this chapter). The following feeds can be manufactured
only per an approved proprietary formula and specifications:
----------------------------------------------------------------------------------------------------------------
Amount fenbendazole Indications for use Limitations Sponsor
----------------------------------------------------------------------------------------------------------------
(1) 750 mg/lb of protein block (to Beef cattle: For the Feed free choice at a rate of 000061
provide 5 mg/kg body weight (2.27 mg/ treatment and control of: 0.1 pound of block per 100
lb)). Lungworms: adult pounds of body weight per
(Dictyocaulus viviparus); day for 3 days to deliver a
Stomach worms: Adult brown total of 2.27 mg
stomach worms (Ostertagia fenbendazole per pound of
ostertagi), adult and fourth- body weight. Cattle must not
stage larvae barberpole be slaughtered for human
worms (Haemonchus consumption within 16 days
contortus), fourth-stage following last treatment
larvae barberpole worms (H. with this drug product. Not
placei), and adult and for use in female dairy
fourth-stage larvae small cattle 20 months of age or
stomach worms older, including dry dairy
(Trichostrongylus axei); cows. Use in these cattle
Intestinal worms (adult and may cause drug residues in
fourth-stage larvae): milk and/or in calves born
Hookworms (Bunostomum to these cows or heifers.
phlebotomum), thread-necked Not for use in beef calves
intestinal worms less than 2 months of age,
(Nematodirus helvetianus), dairy calves, and veal
small intestinal worms calves. A withdrawal period
(Cooperia punctata and C. has not been established for
oncophora), bankrupt worms this product in pre-
(Trichostrongylus ruminating calves.
colubriformis), and nodular
worms (Oesophagostomum
radiatum).
(2) 750 mg/lb of molasses block (to Beef cattle: For the Feed free choice at a rate of 000061
provide 5 mg/kg body weight (2.27 mg/ treatment and control of: 0.1 pound of block per 100
lb)). Lungworms: adult pounds of body weight per
(Dictyocaulus viviparus); day for 3 days to deliver a
Stomach worms: Adult brown total of 2.27 mg
stomach worms (Ostertagia fenbendazole per pound of
ostertagi), adult and fourth- body weight. Cattle must not
stage larvae barberpole be slaughtered for human
worms (Haemonchus consumption within 11 days
contortus), fourth-stage following last treatment
larvae barberpole worms (H. with this drug product. Not
placei), and adult and for use in female dairy
fourth-stage larvae small cattle 20 months of age or
stomach worms older, including dry dairy
(Trichostrongylus axei); cows. Use in these cattle
Intestinal worms (adult and may cause drug residues in
fourth-stage larvae): milk and/or in calves born
Hookworms (Bunostomum to these cows or heifers.
phlebotomum), thread-necked Not for use in beef calves
intestinal worms less than 2 months of age,
(Nematodirus helvetianus), dairy calves, and veal
small intestinal worms calves. A withdrawal period
(Cooperia punctata and C. has not been established for
oncophora), bankrupt worms this product in pre-
(Trichostrongylus ruminating calves.
colubriformis), and nodular
worms (Oesophagostomum
radiatum).
----------------------------------------------------------------------------------------------------------------
(B) Published formulas (Sec. 510.455(e)(1) of this chapter). The
following feeds can be manufactured only per one of the formulas and
specifications published below:
(1) Amount. 5 mg/kg body weight (2.27 mg/lb), including the
following formulations:
------------------------------------------------------------------------
International
Ingredient \1\ Percent feed No.
------------------------------------------------------------------------
(i) Free-choice, dry Type C feed:
[[Page 61687]]
Salt (sodium chloride).............. 59.00 6-04-152
Monosodium phosphate................ 31.16 6-04-288
Dried cane molasses................. 3.12 4-04-695
Zinc sulfate........................ 0.76 6-05-556
Copper sulfate...................... 0.45 6-01-720
Fenbendazole 20% Type A article..... 5.51 n/a
(ii) Free-choice, dry Type C feed:
Salt (sodium chloride).............. 35.93 6-04-152
Dicalcium phosphate (18.5% P)....... 32.44 6-00-080
Calcium carbonate (38% Ca).......... 15.93 6-01-069
Magnesium oxide (56% Mg)............ 10.14 6-02-756
Zinc sulfate........................ 1.47 6-05-556
Mineral oil......................... 1.00 8-03-123
Dried cane molasses (46% sugars).... 0.98 4-04-695
Potassium iodide.................... 0.01 6-03-759
Fenbendazole 20% Type A article..... 2.10 n/a
(iii) Free-choice, liquid Type C feed:
Cane molasses \2\................... 80.902 4-13-251
Water............................... 9.36 n/a
Urea solution, 55%.................. 7.05 5-05-707
Phosphoric acid 75% (feed grade).... 2.00 6-03-707
Xantham gum......................... 0.20 8-15-818
Trace minerals...................... 0.20 n/a
Vitamin premix...................... 0.01 n/a
Fenbendazole 20% Type A article..... 0.278 n/a
------------------------------------------------------------------------
\1\ The content of any added vitamin and trace mineral may be varied;
however, they should be comparable to those used by the manufacturer
for other free-choice cattle feeds. Formulation modifications require
FDA approval prior to marketing. Selenium is not approved for the free-
choice formulations described in paragraph (e)(3)(iii) of this
section. Free-choice cattle feeds containing selenium must comply with
published regulations (see 21 CFR 573.920).
\2\ The percentage of cane molasses and water in the formulation may be
adjusted as needed in order to bring the brix value of the molasses to
the industry standard of 79.5 brix.
(2) Indications for use. As in paragraph (e)(3)(i) of this section.
(3) Limitations. Feed a total of 5 mg of fenbendazole per kg (2.27
mg/lb) of body weight to cattle over a 3- to 6-day period. Retreatment
may be needed after 4 to 6 weeks. Cattle must not be slaughtered within
13 days following last treatment. For dairy cattle the milk discard
time is zero hours. A withdrawal period has not been established for
this product in pre-ruminating calves. Do not use in calves to be
processed for veal.
* * * * *
0
25. In Sec. 558.355, add a heading to paragraph (f)(3) to read as
follows:
Sec. 558.355 Monensin.
* * * * *
(f) * * *
(3) Cattle--
* * * * *
Dated: October 28, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2021-24075 Filed 11-5-21; 8:45 am]
BILLING CODE 4164-01-P
