New Animal Drugs; Approval of New Animal Drug Applications; Changes of Sponsor Address
| Published date | 08 November 2021 |
| Citation | 86 FR 61682 |
| Record Number | 2021-24075 |
| Section | Rules and Regulations |
| Court | Food And Drug Administration |
Federal Register, Volume 86 Issue 213 (Monday, November 8, 2021)
[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]
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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.
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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.
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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
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\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
