New Animal Drugs; Approval of New Animal Drug Applications; Change of Sponsor's Name and Address, 53309-53313 [2019-21514]
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Federal Register / Vol. 84, No. 194 / Monday, October 7, 2019 / Rules and Regulations
ACTION:
summaries of the basis of approval and
of environmental review documents,
where applicable. The animal drug
regulations are also being amended to
make technical amendments to improve
the accuracy of the regulations.
DATES: This rule is effective October 7,
2019.
FOR FURTHER INFORMATION CONTACT:
George K. Haibel, Center for Veterinary
Medicine (CVM) (HFV–6), Food and
Drug Administration, 7500 Standish Pl.,
Rockville, MD 20855, 240–402–5689,
george.haibel@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
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 2019. FDA is informing
the public of the availability of
I. Approval Actions
FDA is amending the animal drug
regulations to reflect approval actions
for NADAs and ANADAs during April,
May, and June 2019, 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,
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 510, 520, 522, 526, 529,
556, and 558
[Docket No. FDA–2019–N–0002]
New Animal Drugs; Approval of New
Animal Drug Applications; Change of
Sponsor’s Name and Address
AGENCY:
Food and Drug Administration,
HHS.
Final rule; technical
amendments.
SUMMARY:
53309
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. Persons with access to
the internet may obtain these
documents at the CVM FOIA Electronic
Reading Room: https://www.fda.gov/
AboutFDA/CentersOffices/
OfficeofFoods/CVM/
CVMFOIAElectronicReadingRoom/
default.htm. Marketing exclusivity and
patent information may be accessed in
FDA’s publication, Approved Animal
Drug Products Online (Green Book) at:
https://www.fda.gov/AnimalVeterinary/
Products/
ApprovedAnimalDrugProducts/
default.htm.
TABLE 1—ORIGINAL AND SUPPLEMENTAL NADAS AND ANADAS APPROVED DURING APRIL, MAY, AND JUNE 2019
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Approval date
File No.
Product name
Species
Effect of the action
PARASITE-S (formalin) Aqueous
Formaldehyde Solution.
EXCENEL RTU EZ
(ceftiofur hydrochloride) Sterile
Suspension.
DERACIN (chlortetracycline) plus
DENAGARD
(tiamulin hydrogen
fumarate) Type C
medicated swine
feeds.
ENROMED 100
(enrofloxacin) Antimicrobial Injectable
Solution.
Freshwaterreared finfish.
Supplemental approval for the control of
mortality in freshwater-reared finfish due to
saprolegniasis associated with fungi in the
family Saprolegniaceae.
Supplemental approval providing for an increase in the maximum injection site volume in swine.
FOI Summary.
Swine ..............
Original approval as a generic copy of NADA
141–011.
FOI Summary.
Cattle and
swine.
Original approval as a generic copy of NADA
141–068.
FOI Summary.
EXPERIOR
(lubabegron),
RUMENSIN
(monensin), and
TYLAN (tylosin
phosphate) Type C
medicated feeds.
Cattle ...............
Original approval for beef steers and heifers
fed in confinement for slaughter during the
last 14 to 91 days on feed for reduction of
ammonia gas emissions per pound of live
weight and hot carcass weight; for reduction of incidence of liver abscesses associated with Fusobacterium necrophorum and
Arcanobacterium pyogenes; and for either
improved feed efficiency or prevention and
control of coccidiosis due to Eimeria bovis
and E. zuernii.
Original approval for beef steers and heifers
fed in confinement for slaughter during the
last 14 to 91 days on feed for reduction of
ammonia gas emissions per pound of live
weight and hot carcass weight; and for either improved feed efficiency or prevention
and control of coccidiosis due to Eimeria
bovis and E. zuernii.
Original approval as a generic copy of NADA
113–232.
FOI Summary.
April 11, 2019 ..
140–989
Syndel USA, 1441 W.
Smith Rd., Ferndale, WA 98248.
May 6, 2019 .....
141–288
Zoetis Inc., 333 Portage St., Kalamazoo, MI 49007.
May 7, 2019 .....
200–633
Pharmgate LLC, 1800
Sir Tyler Dr., Wilmington, NC 28405.
May 16, 2019 ...
200–598
May 21, 2019 ...
141–512
Bimeda Animal Health
Ltd., 1B The Herbert Building, The
Park, Carrickmines,
Dublin, 18, Ireland.
Elanco US Inc. 2500
Innovation Way,
Greenfield, IN
46140.
May 21, 2019 ...
141–514
Elanco US Inc. 2500
Innovation Way,
Greenfield, IN
46140.
EXPERIOR
(lubabegron) and
RUMENSIN
(monensin) Type C
medicated feeds.
Cattle ...............
May 30, 2019 ...
200–573
Bimeda Animal Health
Ltd., 1B The Herbert Building, The
Park, Carrickmines,
Dublin, 18, Ireland.
OXYMED LA (oxytetracycline injection).
Cattle and
swine.
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FOI Summary.
FOI Summary.
FOI Summary.
53310
Federal Register / Vol. 84, No. 194 / Monday, October 7, 2019 / Rules and Regulations
II. Change of Sponsor’s Names and
Addresses
Medicis Dermatologics, Inc., 8125
North Hayden Rd., Scottsdale, AZ 85258
has informed FDA that it has changed
its name and address to Bausch Health
US, LLC, 400 Somerset Corporate Blvd.,
Bridgewater, NJ 08807. Accordingly, we
are amending § 510.600(c) to reflect
these changes.
III. Technical Amendments
A section describing tolerances of
hetacillin residues (21 CFR 556.316) has
been added to subpart B of part 556.
This section cross-references the sole
hetacillin product approved for use in
food-producing animals, an
intramammary infusion for use in
lactating dairy cows (21 CFR 526.1130).
This new section codifies FDA’s finding
at the time of product approval that,
because hetacillin is rapidly hydrolyzed
to ampicillin, existing ampicillin
tolerances provide appropriate
tolerances for hetacillin in edible tissues
of cattle (38 FR 31172, November 12,
1973). This amendment is being made to
make the regulations more
comprehensive.
FDA is also revising the regulations to
reflect the approved conditions of use of
sulfaquinoxaline soluble powder as a
veterinary prescription product for oral
administration to cattle as a drench.
Finally, we are also revising the
regulations for use of monensin in
medicated goat feed to reflect the
approved incorporation level. These
actions are being taken to improve the
accuracy of the regulations.
21 CFR Parts 520, 522, 526, and 529
IV. Legal Authority
This final rule is issued under section
512(i) of the Federal Food, Drug, and
Cosmetic Act (the FD&C Act) (21 U.S.C.
360b(i)), which requires Federal
Register publication of ‘‘notice[s] . . .
effective as a regulation,’’ of the
conditions of use of approved new
animal drugs. This rule sets forth
technical amendments to the regulations
to codify recent actions on approved
new animal drug applications and
corrections to improve the accuracy of
the regulations, and as such does not
impose any burden on regulated
entities.
Although denominated a rule
pursuant to the FD&C Act, this
document does not meet the definition
of ‘‘rule’’ in 5 U.S.C. 804(3)(A) because
it is a ‘‘rule of particular applicability.’’
Therefore, it is not subject to the
congressional review requirements in 5
U.S.C. 801–808. Likewise, this is not a
rule subject to Executive Order 12866,
which defines a rule as ‘‘an agency
statement of general applicability and
future effect, which the agency intends
to have the force and effect of law, that
is designed to implement, interpret, or
prescribe law or policy or to describe
the procedure or practice requirements
of an agency.’’
List of Subjects
Animal drugs.
21 CFR Part 556
Animal drugs, Foods.
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, 526, 529, 556, and 558 are
amended as follows:
PART 510—NEW ANIMAL DRUGS
1. The authority citation for part 510
continues to read as follows:
■
Authority: 21 U.S.C. 321, 331, 351, 352,
353, 360b, 371, 379e.
2. In § 510.600, in the table in
paragraph (c)(1), remove the entry for
‘‘Medicis Dermatologics, Inc.’’ and add
an entry in alphabetic order for ‘‘Bausch
Health US, LLC’’; and in the table in
paragraph (c)(2), revise the entry for
‘‘099207’’.
The addition and revision read as
follows:
■
§ 510.600 Names, addresses, and drug
labeler codes of sponsors of approved
applications.
21 CFR Part 510
Administrative practice and
procedure, Animal drugs, Labeling,
Reporting and recordkeeping
requirements.
*
*
*
(c) * * *
(1) * * *
*
*
Drug labeler
code
Firm name and address
*
*
*
*
*
*
Bausch Health US, LLC, 400 Somerset Corporate Blvd., Bridgewater, NJ 08807 ............................................................................
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*
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*
*
*
*
099207
*
(2) * * *
Drug labeler code
Firm name and address
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*
*
*
099207 .........................................................................
PART 520—ORAL DOSAGE FORM
NEW ANIMAL DRUGS
3. The authority citation for part 520
continues to read as follows:
■
04:48 Oct 05, 2019
§ 520.812
§ 520.2325b
[Amended]
4. In § 520.812, in paragraph (a)(1)(i),
remove ‘‘2.7’’ and in its place add
‘‘22.7’’.
■
5. In § 520.2325b, revise paragraph
(d)(3) to read as follows:
■
Authority: 21 U.S.C. 360b.
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Bausch Health US, LLC, 400 Somerset Corporate Blvd., Bridgewater, NJ 08807.
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Sulfaquinoxaline drench.
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(d) * * *
(3) Limitations. Not for use in
lactating dairy cattle. A withdrawal
period has not been established for this
product in preruminating calves. Do not
use in calves to be processed for veal.
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Federal Register / Vol. 84, No. 194 / Monday, October 7, 2019 / Rules and Regulations
Federal law restricts this drug to use by
or on the order of a licensed
veterinarian.
PART 522—IMPLANTATION OR
INJECTABLE DOSAGE FORM NEW
ANIMAL DRUGS
(2) Nos. 000859, 055529, and 061133
for use of product described in
paragraph (a)(2) as in paragraphs (e)(2)
and (3) of this section.
*
*
*
*
*
PART 526—INTRAMAMMARY DOSAGE
FORM NEW ANIMAL DRUGS
6. The authority citation for part 522
continues to read as follows:
■
9. The authority citation for part 526
continues to read as follows:
■
Authority: 21 U.S.C. 360b.
7. In § 522.313b, revise paragraphs
(a)(2) and (e)(1)(iii) to read as follows:
Authority: 21 U.S.C. 360b.
■
§ 522.313b
Ceftiofur hydrochloride.
(a) * * *
(2) Ceftiofur hydrochloride equivalent
to 50 mg ceftiofur equivalents in the
inactive vehicles polyoxyethylene
sorbitan monooleate (polysorbate 80) in
a caprylic/capric triglyceride
suspension; or
*
*
*
*
*
(e) * * *
(1) * * *
(iii) Limitations. For products
described in paragraphs (a)(1) and (3) of
this section: Treated swine must not be
slaughtered for 4 days following the last
treatment. For products described in
paragraph (a)(2) of this section: Treated
swine must not be slaughtered for 6
days following the last treatment when
injection site volumes are greater than 5
mL up to the maximum injection site
volume of 15 mL. Treated swine must
not be slaughtered for 4 days when
injection site volumes are less than or
equal to 5 mL.
*
*
*
*
*
■ 8. In § 522.812, revise paragraphs
(b)(1) and (2) to read as follows:
§ 522.812
10. In § 526.1130, revise the section
heading, redesignate paragraph (c) as
paragraph (d), and add new paragraph
(c).
The revision and addition read as
follows:
■
Enrofloxacin.
*
*
*
*
*
(b) * * *
(1) Nos. 000859, 026637, and 055529
for use of product described in
paragraph (a)(1) as in paragraph (e)(1);
and
§ 526.1130
saprolegniasis associated with fungi in
the family Saprolegniaceae.
(2) * * *
(iv) For the control of mortality in
freshwater-reared finfish due to
saprolegniasis associated with fungi in
the family Saprolegniaceae: In tanks and
raceways, administer 150 mL/L (ppm)
for 60 minutes per day on alternate days
for three treatments.
*
*
*
*
*
PART 556—TOLERANCES FOR
RESIDUES OF NEW ANIMAL DRUGS
IN FOOD
13. The authority citation for part 556
continues to read as follows:
■
Hetacillin.
Authority: 21 U.S.C. 342, 360b, 371.
*
*
*
*
*
(c) Related tolerances. See § 556.316
of this chapter.
*
*
*
*
*
PART 529—CERTAIN OTHER DOSAGE
FORM NEW ANIMAL DRUGS
11. The authority citation for part 529
continues to read as follows:
■
Authority: 21 U.S.C. 360b.
12. In § 529.1030, revise paragraph (b)
and add paragraphs (d)(1)(iv) and
(d)(2)(iv) to read as follows:
■
§ 529.1030
Formalin.
*
*
*
*
(b) Sponsors. See sponsors in
§ 510.600(c) of this chapter for uses as
in paragraph (d) of this section.
(1) No. 050378 for use as in paragraph
(d) of this section.
(2) Nos. 049968 and 067188 for use as
in paragraphs (d)(1)(i), (ii), and (iii),
(d)(2)(i), (ii), and (iii), and (d)(3) of this
section.
(d) * * *
(1) * * *
(iv) Freshwater-reared finfish. For the
control of mortality due to
■
14. Add § 556.316 to read as follows:
§ 556.316
Hetacillin.
(a) [Reserved]
(b) Tolerances. The tolerances for
ampicillin (marker residue for
hetacillin) are:
(1) Cattle. Edible tissues: 0.01 ppm.
(2) [Reserved]
(c) Related conditions of use. See
§ 526.1130 of this chapter.
PART 558—NEW ANIMAL DRUGS FOR
USE IN ANIMAL FEEDS
*
15. The authority citation for part 558
continues to read as follows:
■
Authority: 21 U.S.C. 354, 360b, 360ccc,
360ccc–1, 371.
16. In § 558.4, in paragraph (d), in the
‘‘Category II’’ table, revise the row entry
for ‘‘Tilmicosin’’ to read as follows:
■
§ 558.4 Requirement of a medicated feed
mill license.
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(d) * * *
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CATEGORY II
Assay limits
percent 1 Type
A
Drug
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Tilmicosin .......................
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37.9 g/lb (8.35%) ..................................................
90–110
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17. In § 558.330, revise paragraph (d)
to read as follows:
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§ 558.330
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Type B maximum (100x)
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Cattle Type B feed: 85–115
Cattle Type C feed: 80–110
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(d) Conditions of use—(1) It is used in
cattle feed as follows:
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Federal Register / Vol. 84, No. 194 / Monday, October 7, 2019 / Rules and Regulations
Lubabegron fumarate in
grams/ton
Combination in
grams/ton
Indications for use
Limitations
(i) 1.25 to 4.54
........................
Beef steers and heifers fed in
confinement for slaughter:
For reduction of ammonia
gas emissions per pound of
live weight and hot carcass
weight during the last 14 to
91 days on feed.
(ii) 1.25 to 4.54
Monensin, 5 to
40.
Beef steers and heifers fed in
confinement for slaughter:
For reduction of ammonia
gas emissions per pound of
live weight and hot carcass
weight and for improved
feed efficiency during the
last 14 to 91 days on feed.
(iii) 1.25 to
4.54.
Monensin, 10
to 40.
Beef steers and heifers fed in
confinement for slaughter:
For reduction of ammonia
gas emissions per pound of
live weight and hot carcass
weight; and for prevention
and control of coccidiosis
due to Eimeria bovis and E.
zuernii during the last 14 to
91 days on feed.
Feed continuously as the sole ration to provide 13 to 90 mg
lubabegron/head/day during the last 14 to 91 days on
feed. A decrease in dry matter intake may be noticed in
some animals receiving lubabegron. Not approved for use
in breeding animals because safety and effectiveness
have not been evaluated in these animals. Do not allow
horses or other equines access to feed containing
lubabegron.
Feed continuously as the sole ration to provide 13 to 90 mg
lubabegron/head/day and 50 to 480 mg monensin/head/
day during the last 14 to 91 days on feed. No additional
improvement in feed efficiency has been shown from
feeding monensin at levels greater than 30 g/ton (360 mg
monensin/head/day. A decrease in dry matter intake may
be noticed in some animals receiving lubabegron.
Lubabegron has not been approved for use in breeding
animals because safety and effectiveness have not been
evaluated in these animals. Do not allow horses or other
equines access to feed containing lubabegron and
monensin. Ingestion of monensin by horses has been
fatal. Monensin medicated cattle and goat feeds are safe
for use in cattle and goats only. Consumption by unapproved species may result in toxic reactions. Feeding undiluted or mixing errors resulting in high concentrations of
monensin has been fatal to cattle and could be fatal to
goats. Must be thoroughly mixed in feeds before use. Do
not exceed the levels of monensin recommended in the
feeding directions, as reduced average daily gains may
result. If feed refusals containing monensin are fed to
other groups of cattle, the concentration of monensin in
the refusals and amount of refusals fed should be taken
into consideration to prevent monensin overdosing. A
withdrawal period has not been established for this product for preruminating calves. Do not use in calves to be
processed for veal.
Feed continuously as the sole ration to provide 13 to 90 mg
lubabegron/head/day and 0.14 to 0.42 mg monensin/lb
body weight per day, depending upon severity of coccidiosis challenge, during the last 14 to 91 days on feed. A
decrease in dry matter intake may be noticed in some
animals receiving lubabegron. Lubabegron has not been
approved for use in breeding animals because safety and
effectiveness have not been evaluated in these animals.
Do not allow horses or other equines access to feed containing lubabegron and monensin. Ingestion of monensin
by horses has been fatal. Monensin medicated cattle and
goat feeds are safe for use in cattle and goats only. Consumption by unapproved species may result in toxic reactions. Feeding undiluted or mixing errors resulting in high
concentrations of monensin has been fatal to cattle and
could be fatal to goats. Must be thoroughly mixed in
feeds before use. Do not exceed the levels of monensin
recommended in the feeding directions, as reduced average daily gains may result. If feed refusals containing
monensin are fed to other groups of cattle, the concentration of monensin in the refusals and amount of refusals
fed should be taken into consideration to prevent
monensin overdosing. A withdrawal period has not been
established for this product for preruminating calves. Do
not use in calves to be processed for veal.
(2) Lubabegron may also be used in
combination with:
(i) Tylosin as in § 558.625.
(ii) [Reserved]
■ 18. In § 558.355, in paragraph (f)(6)(i),
in the ‘‘Monensin in grams/ton’’
column, remove ‘‘5 to 40’’ and in its
place add ‘‘20’’; and redesignate
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paragraphs (f)(7)(iv) through (xi) as
paragraphs (f)(7)(v) through (xii) and
add new paragraph (f)(7)(iv).
The addition reads as follows:
§ 558.355
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PO 00000
Monensin.
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(f) * * *
Frm 00010
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058198
058198
058198
(7) * * *
(iv) Lubabegron as in § 558.330.
*
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*
■ 19. In § 558.625, redesignate
paragraphs (e)(2)(vii) through (xv) as
paragraphs (e)(2)(ix) through (xvii), and
add new paragraphs (e)(2)(vii) and (viii).
The additions read as follows:
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Federal Register / Vol. 84, No. 194 / Monday, October 7, 2019 / Rules and Regulations
§ 558.625
*
*
Tylosin.
*
*
Tylosin grams/
ton
Combination in
grams/ton
Indications for use
Limitations
*
(vii) 8 to 10 .....
*
Monensin, 5 to
40 plus
lubabegron
fumarate,
1.25 to 4.54.
*
Beef steers and heifers fed in
confinement for slaughter:
For reduction of ammonia
gas emissions per pound of
live weight and hot carcass
weight; for reduction of incidence of liver abscesses
associated with
Fusobacterium
necrophorum and
Arcanobacterium pyogenes,
and for improved feed efficiency during the last 14 to
91 days on feed.
(viii) 8 to 10 ....
Monensin, 10
to 40 plus
lubabegron
fumarate,
1.25 to 4.54.
Beef steers and heifers fed in
confinement for slaughter:
For reduction of ammonia
gas emissions per pound of
live weight and hot carcass
weight, for reduction of incidence of liver abscesses
associated with
Fusobacterium
necrophorum and
Arcanobacterium pyogenes,
and for prevention and control of coccidiosis due to
Eimeria bovis and E.
zuernii during the last 14 to
91 days on feed.
*
*
*
Feed continuously as sole ration to provide 13 to 90 mg
lubabegron/head/day, 50 to 480 mg monensin/head/day,
and 60 to 90 mg tylosin/head/day during the last 14 to 91
days on feed. No additional improvement in feed efficiency has been shown from feeding monensin at levels
greater than 30 g/ton (360 mg monensin/head/day. A decrease in dry matter intake may be noticed in some animals receiving lubabegron. Lubabegron has not been approved for use in breeding animals because safety and
effectiveness have not been evaluated in these animals.
Do not allow horses or other equines access to feed containing lubabegron and monensin. Ingestion of monensin
by horses has been fatal. Monensin medicated cattle and
goat feeds are safe for use in cattle and goats only. Consumption by unapproved species may result in toxic reactions. Feeding undiluted or mixing errors resulting in high
concentrations of monensin has been fatal to cattle and
could be fatal to goats. Must be thoroughly mixed in
feeds before use. Do not exceed the levels of monensin
recommended in the feeding directions, as reduced average daily gains may result. If feed refusals containing
monensin are fed to other groups of cattle, the concentration of monensin in the refusals and amount of refusals
fed should be taken into consideration to prevent
monensin overdosing. A withdrawal period has not been
established for this product for preruminating calves. Do
not use in calves to be processed for veal.
Feed continuously as sole ration to provide 13 to 90 mg
lubabegron/head/day, 0.14 to 0.42 mg monensin/lb body
weight per day, depending upon severity of coccidiosis
challenge, up to 480 mg/head/day, and 60 to 90 mg
tylosin/head/day during the last 14 to 91 days on feed. A
decrease in dry matter intake may be noticed in some
animals receiving lubabegron. Lubabegron has not been
approved for use in breeding animals because safety and
effectiveness have not been evaluated in these animals.
Do not allow horses or other equines access to feed containing lubabegron and monensin. Ingestion of monensin
by horses has been fatal. Monensin medicated cattle and
goat feeds are safe for use in cattle and goats only. Consumption by unapproved species may result in toxic reactions. Feeding undiluted or mixing errors resulting in high
concentrations of monensin has been fatal to cattle and
could be fatal to goats. Must be thoroughly mixed in
feeds before use. Do not exceed the levels of monensin
recommended in the feeding directions, as reduced average daily gains may result. If feed refusals containing
monensin are fed to other groups of cattle, the concentration of monensin in the refusals and amount of refusals
fed should be taken into consideration to prevent
monensin overdosing. A withdrawal period has not been
established for this product for preruminating calves. Do
not use in calves to be processed for veal.
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(e) * * *
(2) * * *
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Sponsor
*
*
Dated: September 27, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–21514 Filed 10–4–19; 8:45 am]
BILLING CODE 4164–01–P
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]]>Agencies
[Federal Register Volume 84, Number 194 (Monday, October 7, 2019)]
[Rules and Regulations]
[Pages 53309-53313]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-21514]
[[Page 53309]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 510, 520, 522, 526, 529, 556, and 558
[Docket No. FDA-2019-N-0002]
New Animal Drugs; Approval of New Animal Drug Applications;
Change of Sponsor's Name and 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 2019. 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 make technical
amendments to improve the accuracy of the regulations.
DATES: This rule is effective October 7, 2019.
FOR FURTHER INFORMATION CONTACT: George K. Haibel, Center for
Veterinary Medicine (CVM) (HFV-6), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 240-402-5689,
[email protected].
SUPPLEMENTARY INFORMATION:
I. Approval Actions
FDA is amending the animal drug regulations to reflect approval
actions for NADAs and ANADAs during April, May, and June 2019, 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. Persons with access
to the internet may obtain these documents at the CVM FOIA Electronic
Reading Room: https://www.fda.gov/AboutFDA/CentersOffices/OfficeofFoods/CVM/CVMFOIAElectronicReadingRoom/default.htm. Marketing
exclusivity and patent information may be accessed in FDA's
publication, Approved Animal Drug Products Online (Green Book) at:
https://www.fda.gov/AnimalVeterinary/Products/ApprovedAnimalDrugProducts/default.htm.
Table 1--Original and Supplemental NADAs and ANADAs Approved During April, May, and June 2019
--------------------------------------------------------------------------------------------------------------------------------------------------------
Approval date File No. Sponsor Product name Species Effect of the action Public documents
--------------------------------------------------------------------------------------------------------------------------------------------------------
April 11, 2019........ 140-989 Syndel USA, 1441 W. PARASITE-S Freshwater-reared Supplemental approval for FOI Summary.
Smith Rd., (formalin) Aqueous finfish. the control of mortality
Ferndale, WA 98248. Formaldehyde in freshwater-reared
Solution. finfish due to
saprolegniasis
associated with fungi in
the family
Saprolegniaceae.
May 6, 2019........... 141-288 Zoetis Inc., 333 EXCENEL RTU EZ Cattle and swine..... Supplemental approval FOI Summary.
Portage St., (ceftiofur providing for an
Kalamazoo, MI 49007. hydrochloride) increase in the maximum
Sterile Suspension. injection site volume in
swine.
May 7, 2019........... 200-633 Pharmgate LLC, 1800 DERACIN Swine................ Original approval as a FOI Summary.
Sir Tyler Dr., (chlortetracycline) generic copy of NADA 141-
Wilmington, NC plus DENAGARD 011.
28405. (tiamulin hydrogen
fumarate) Type C
medicated swine
feeds.
May 16, 2019.......... 200-598 Bimeda Animal Health ENROMED 100 Cattle and swine..... Original approval as a FOI Summary.
Ltd., 1B The (enrofloxacin) generic copy of NADA 141-
Herbert Building, Antimicrobial 068.
The Park, Injectable Solution.
Carrickmines,
Dublin, 18, Ireland.
May 21, 2019.......... 141-512 Elanco US Inc. 2500 EXPERIOR Cattle............... Original approval for FOI Summary.
Innovation Way, (lubabegron), beef steers and heifers
Greenfield, IN RUMENSIN fed in confinement for
46140. (monensin), and slaughter during the
TYLAN (tylosin last 14 to 91 days on
phosphate) Type C feed for reduction of
medicated feeds. ammonia gas emissions
per pound of live weight
and hot carcass weight;
for reduction of
incidence of liver
abscesses associated
with Fusobacterium
necrophorum and
Arcanobacterium
pyogenes; and for either
improved feed efficiency
or prevention and
control of coccidiosis
due to Eimeria bovis and
E. zuernii.
May 21, 2019.......... 141-514 Elanco US Inc. 2500 EXPERIOR Cattle............... Original approval for FOI Summary.
Innovation Way, (lubabegron) and beef steers and heifers
Greenfield, IN RUMENSIN (monensin) fed in confinement for
46140. Type C medicated slaughter during the
feeds. last 14 to 91 days on
feed for reduction of
ammonia gas emissions
per pound of live weight
and hot carcass weight;
and for either improved
feed efficiency or
prevention and control
of coccidiosis due to
Eimeria bovis and E.
zuernii.
May 30, 2019.......... 200-573 Bimeda Animal Health OXYMED LA Cattle and swine..... Original approval as a FOI Summary.
Ltd., 1B The (oxytetracycline generic copy of NADA 113-
Herbert Building, injection). 232.
The Park,
Carrickmines,
Dublin, 18, Ireland.
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[[Page 53310]]
II. Change of Sponsor's Names and Addresses
Medicis Dermatologics, Inc., 8125 North Hayden Rd., Scottsdale, AZ
85258 has informed FDA that it has changed its name and address to
Bausch Health US, LLC, 400 Somerset Corporate Blvd., Bridgewater, NJ
08807. Accordingly, we are amending Sec. 510.600(c) to reflect these
changes.
III. Technical Amendments
A section describing tolerances of hetacillin residues (21 CFR
556.316) has been added to subpart B of part 556. This section cross-
references the sole hetacillin product approved for use in food-
producing animals, an intramammary infusion for use in lactating dairy
cows (21 CFR 526.1130). This new section codifies FDA's finding at the
time of product approval that, because hetacillin is rapidly hydrolyzed
to ampicillin, existing ampicillin tolerances provide appropriate
tolerances for hetacillin in edible tissues of cattle (38 FR 31172,
November 12, 1973). This amendment is being made to make the
regulations more comprehensive.
FDA is also revising the regulations to reflect the approved
conditions of use of sulfaquinoxaline soluble powder as a veterinary
prescription product for oral administration to cattle as a drench.
Finally, we are also revising the regulations for use of monensin in
medicated goat feed to reflect the approved incorporation level. These
actions are being taken to improve the accuracy of the regulations.
IV. Legal Authority
This final rule is issued under section 512(i) of the Federal Food,
Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360b(i)), which
requires Federal Register publication of ``notice[s] . . . effective as
a regulation,'' of the conditions of use of approved new animal drugs.
This rule sets forth technical amendments to the regulations to codify
recent actions on approved new animal drug applications and corrections
to improve the accuracy of the regulations, and as such does not impose
any burden on regulated entities.
Although denominated a rule pursuant to the FD&C Act, this document
does not meet the definition of ``rule'' in 5 U.S.C. 804(3)(A) because
it is a ``rule of particular applicability.'' Therefore, it is not
subject to the congressional review requirements in 5 U.S.C. 801-808.
Likewise, this is not a rule subject to Executive Order 12866, which
defines a rule as ``an agency statement of general applicability and
future effect, which the agency intends to have the force and effect of
law, that is designed to implement, interpret, or prescribe law or
policy or to describe the procedure or practice requirements of an
agency.''
List of Subjects
21 CFR Part 510
Administrative practice and procedure, Animal drugs, Labeling,
Reporting and recordkeeping requirements.
21 CFR Parts 520, 522, 526, and 529
Animal drugs.
21 CFR Part 556
Animal drugs, Foods.
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, 526, 529, 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, in the table in paragraph (c)(1), remove the entry
for ``Medicis Dermatologics, Inc.'' and add an entry in alphabetic
order for ``Bausch Health US, LLC''; and in the table in paragraph
(c)(2), revise the entry for ``099207''.
The addition and revision 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
------------------------------------------------------------------------
* * * * * * *
Bausch Health US, LLC, 400 Somerset Corporate Blvd., 099207
Bridgewater, NJ 08807..................................
* * * * * * *
------------------------------------------------------------------------
(2) * * *
------------------------------------------------------------------------
Drug labeler code Firm name and address
------------------------------------------------------------------------
* * * * * * *
099207....................... Bausch Health US, LLC, 400 Somerset
Corporate Blvd., Bridgewater, NJ 08807.
------------------------------------------------------------------------
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.
Sec. 520.812 [Amended]
0
4. In Sec. 520.812, in paragraph (a)(1)(i), remove ``2.7'' and in its
place add ``22.7''.
0
5. In Sec. 520.2325b, revise paragraph (d)(3) to read as follows:
Sec. 520.2325b Sulfaquinoxaline drench.
* * * * *
(d) * * *
(3) Limitations. Not for use in lactating dairy cattle. A
withdrawal period has not been established for this product in
preruminating calves. Do not use in calves to be processed for veal.
[[Page 53311]]
Federal law restricts this drug to use by or on the order of a licensed
veterinarian.
PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS
0
6. The authority citation for part 522 continues to read as follows:
Authority: 21 U.S.C. 360b.
0
7. In Sec. 522.313b, revise paragraphs (a)(2) and (e)(1)(iii) to read
as follows:
Sec. 522.313b Ceftiofur hydrochloride.
(a) * * *
(2) Ceftiofur hydrochloride equivalent to 50 mg ceftiofur
equivalents in the inactive vehicles polyoxyethylene sorbitan
monooleate (polysorbate 80) in a caprylic/capric triglyceride
suspension; or
* * * * *
(e) * * *
(1) * * *
(iii) Limitations. For products described in paragraphs (a)(1) and
(3) of this section: Treated swine must not be slaughtered for 4 days
following the last treatment. For products described in paragraph
(a)(2) of this section: Treated swine must not be slaughtered for 6
days following the last treatment when injection site volumes are
greater than 5 mL up to the maximum injection site volume of 15 mL.
Treated swine must not be slaughtered for 4 days when injection site
volumes are less than or equal to 5 mL.
* * * * *
0
8. In Sec. 522.812, revise paragraphs (b)(1) and (2) to read as
follows:
Sec. 522.812 Enrofloxacin.
* * * * *
(b) * * *
(1) Nos. 000859, 026637, and 055529 for use of product described in
paragraph (a)(1) as in paragraph (e)(1); and
(2) Nos. 000859, 055529, and 061133 for use of product described in
paragraph (a)(2) as in paragraphs (e)(2) and (3) of this section.
* * * * *
PART 526--INTRAMAMMARY DOSAGE FORM NEW ANIMAL DRUGS
0
9. The authority citation for part 526 continues to read as follows:
Authority: 21 U.S.C. 360b.
0
10. In Sec. 526.1130, revise the section heading, redesignate
paragraph (c) as paragraph (d), and add new paragraph (c).
The revision and addition read as follows:
Sec. 526.1130 Hetacillin.
* * * * *
(c) Related tolerances. See Sec. 556.316 of this chapter.
* * * * *
PART 529--CERTAIN OTHER DOSAGE FORM NEW ANIMAL DRUGS
0
11. The authority citation for part 529 continues to read as follows:
Authority: 21 U.S.C. 360b.
0
12. In Sec. 529.1030, revise paragraph (b) and add paragraphs
(d)(1)(iv) and (d)(2)(iv) to read as follows:
Sec. 529.1030 Formalin.
* * * * *
(b) Sponsors. See sponsors in Sec. 510.600(c) of this chapter for
uses as in paragraph (d) of this section.
(1) No. 050378 for use as in paragraph (d) of this section.
(2) Nos. 049968 and 067188 for use as in paragraphs (d)(1)(i),
(ii), and (iii), (d)(2)(i), (ii), and (iii), and (d)(3) of this
section.
(d) * * *
(1) * * *
(iv) Freshwater-reared finfish. For the control of mortality due to
saprolegniasis associated with fungi in the family Saprolegniaceae.
(2) * * *
(iv) For the control of mortality in freshwater-reared finfish due
to saprolegniasis associated with fungi in the family Saprolegniaceae:
In tanks and raceways, administer 150 [mu]L/L (ppm) for 60 minutes per
day on alternate days for three treatments.
* * * * *
PART 556--TOLERANCES FOR RESIDUES OF NEW ANIMAL DRUGS IN FOOD
0
13. The authority citation for part 556 continues to read as follows:
Authority: 21 U.S.C. 342, 360b, 371.
0
14. Add Sec. 556.316 to read as follows:
Sec. 556.316 Hetacillin.
(a) [Reserved]
(b) Tolerances. The tolerances for ampicillin (marker residue for
hetacillin) are:
(1) Cattle. Edible tissues: 0.01 ppm.
(2) [Reserved]
(c) Related conditions of use. See Sec. 526.1130 of this chapter.
PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS
0
15. The authority citation for part 558 continues to read as follows:
Authority: 21 U.S.C. 354, 360b, 360ccc, 360ccc-1, 371.
0
16. In Sec. 558.4, in paragraph (d), in the ``Category II'' table,
revise the row entry for ``Tilmicosin'' to read as follows:
Sec. 558.4 Requirement of a medicated feed mill license.
* * * * *
(d) * * *
Category II
----------------------------------------------------------------------------------------------------------------
Assay limits
Drug percent \1\ Type B maximum (100x) Assay limits percent \1\
Type A Type B/C \2\
----------------------------------------------------------------------------------------------------------------
* * * * * * *
Tilmicosin.......................... 90-110 37.9 g/lb (8.35%)........... Swine Type B/C feed: 85-115
Cattle Type B feed: 85-115
Cattle Type C feed: 80-110
* * * * * * *
----------------------------------------------------------------------------------------------------------------
* * * * *
0
17. In Sec. 558.330, revise paragraph (d) to read as follows:
Sec. 558.330 Lubabegron.
* * * * *
(d) Conditions of use--(1) It is used in cattle feed as follows:
[[Page 53312]]
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Combination in grams/
Lubabegron fumarate in grams/ton ton Indications for use Limitations Sponsor
--------------------------------------------------------------------------------------------------------------------------------------------------------
(i) 1.25 to 4.54................... ...................... Beef steers and heifers fed Feed continuously as the sole ration to 058198
in confinement for provide 13 to 90 mg lubabegron/head/day
slaughter: For reduction during the last 14 to 91 days on feed. A
of ammonia gas emissions decrease in dry matter intake may be noticed
per pound of live weight in some animals receiving lubabegron. Not
and hot carcass weight approved for use in breeding animals because
during the last 14 to 91 safety and effectiveness have not been
days on feed. evaluated in these animals. Do not allow
horses or other equines access to feed
containing lubabegron.
(ii) 1.25 to 4.54.................. Monensin, 5 to 40..... Beef steers and heifers fed Feed continuously as the sole ration to 058198
in confinement for provide 13 to 90 mg lubabegron/head/day and
slaughter: For reduction 50 to 480 mg monensin/head/day during the
of ammonia gas emissions last 14 to 91 days on feed. No additional
per pound of live weight improvement in feed efficiency has been shown
and hot carcass weight and from feeding monensin at levels greater than
for improved feed 30 g/ton (360 mg monensin/head/day. A
efficiency during the last decrease in dry matter intake may be noticed
14 to 91 days on feed. in some animals receiving lubabegron.
Lubabegron has not been approved for use in
breeding animals because safety and
effectiveness have not been evaluated in
these animals. Do not allow horses or other
equines access to feed containing lubabegron
and monensin. Ingestion of monensin by horses
has been fatal. Monensin medicated cattle and
goat feeds are safe for use in cattle and
goats only. Consumption by unapproved species
may result in toxic reactions. Feeding
undiluted or mixing errors resulting in high
concentrations of monensin has been fatal to
cattle and could be fatal to goats. Must be
thoroughly mixed in feeds before use. Do not
exceed the levels of monensin recommended in
the feeding directions, as reduced average
daily gains may result. If feed refusals
containing monensin are fed to other groups
of cattle, the concentration of monensin in
the refusals and amount of refusals fed
should be taken into consideration to prevent
monensin overdosing. A withdrawal period has
not been established for this product for
preruminating calves. Do not use in calves to
be processed for veal.
(iii) 1.25 to 4.54................. Monensin, 10 to 40.... Beef steers and heifers fed Feed continuously as the sole ration to 058198
in confinement for provide 13 to 90 mg lubabegron/head/day and
slaughter: For reduction 0.14 to 0.42 mg monensin/lb body weight per
of ammonia gas emissions day, depending upon severity of coccidiosis
per pound of live weight challenge, during the last 14 to 91 days on
and hot carcass weight; feed. A decrease in dry matter intake may be
and for prevention and noticed in some animals receiving lubabegron.
control of coccidiosis due Lubabegron has not been approved for use in
to Eimeria bovis and E. breeding animals because safety and
zuernii during the last 14 effectiveness have not been evaluated in
to 91 days on feed. these animals. Do not allow horses or other
equines access to feed containing lubabegron
and monensin. Ingestion of monensin by horses
has been fatal. Monensin medicated cattle and
goat feeds are safe for use in cattle and
goats only. Consumption by unapproved species
may result in toxic reactions. Feeding
undiluted or mixing errors resulting in high
concentrations of monensin has been fatal to
cattle and could be fatal to goats. Must be
thoroughly mixed in feeds before use. Do not
exceed the levels of monensin recommended in
the feeding directions, as reduced average
daily gains may result. If feed refusals
containing monensin are fed to other groups
of cattle, the concentration of monensin in
the refusals and amount of refusals fed
should be taken into consideration to prevent
monensin overdosing. A withdrawal period has
not been established for this product for
preruminating calves. Do not use in calves to
be processed for veal.
--------------------------------------------------------------------------------------------------------------------------------------------------------
(2) Lubabegron may also be used in combination with:
(i) Tylosin as in Sec. 558.625.
(ii) [Reserved]
0
18. In Sec. 558.355, in paragraph (f)(6)(i), in the ``Monensin in
grams/ton'' column, remove ``5 to 40'' and in its place add ``20''; and
redesignate paragraphs (f)(7)(iv) through (xi) as paragraphs (f)(7)(v)
through (xii) and add new paragraph (f)(7)(iv).
The addition reads as follows:
Sec. 558.355 Monensin.
* * * * *
(f) * * *
(7) * * *
(iv) Lubabegron as in Sec. 558.330.
* * * * *
0
19. In Sec. 558.625, redesignate paragraphs (e)(2)(vii) through (xv)
as paragraphs (e)(2)(ix) through (xvii), and add new paragraphs
(e)(2)(vii) and (viii).
The additions read as follows:
[[Page 53313]]
Sec. 558.625 Tylosin.
* * * * *
(e) * * *
(2) * * *
--------------------------------------------------------------------------------------------------------------------------------------------------------
Combination in grams/
Tylosin grams/ton ton Indications for use Limitations Sponsor
--------------------------------------------------------------------------------------------------------------------------------------------------------
* * * * * * *
(vii) 8 to 10...................... Monensin, 5 to 40 plus Beef steers and heifers fed Feed continuously as sole ration to provide 13 058198
lubabegron fumarate, in confinement for to 90 mg lubabegron/head/day, 50 to 480 mg
1.25 to 4.54. slaughter: For reduction monensin/head/day, and 60 to 90 mg tylosin/
of ammonia gas emissions head/day during the last 14 to 91 days on
per pound of live weight feed. No additional improvement in feed
and hot carcass weight; efficiency has been shown from feeding
for reduction of incidence monensin at levels greater than 30 g/ton (360
of liver abscesses mg monensin/head/day. A decrease in dry
associated with matter intake may be noticed in some animals
Fusobacterium necrophorum receiving lubabegron. Lubabegron has not been
and Arcanobacterium approved for use in breeding animals because
pyogenes, and for improved safety and effectiveness have not been
feed efficiency during the evaluated in these animals. Do not allow
last 14 to 91 days on feed. horses or other equines access to feed
containing lubabegron and monensin. Ingestion
of monensin by horses has been fatal.
Monensin medicated cattle and goat feeds are
safe for use in cattle and goats only.
Consumption by unapproved species may result
in toxic reactions. Feeding undiluted or
mixing errors resulting in high
concentrations of monensin has been fatal to
cattle and could be fatal to goats. Must be
thoroughly mixed in feeds before use. Do not
exceed the levels of monensin recommended in
the feeding directions, as reduced average
daily gains may result. If feed refusals
containing monensin are fed to other groups
of cattle, the concentration of monensin in
the refusals and amount of refusals fed
should be taken into consideration to prevent
monensin overdosing. A withdrawal period has
not been established for this product for
preruminating calves. Do not use in calves to
be processed for veal.
(viii) 8 to 10..................... Monensin, 10 to 40 Beef steers and heifers fed Feed continuously as sole ration to provide 13 058198
plus lubabegron in confinement for to 90 mg lubabegron/head/day, 0.14 to 0.42 mg
fumarate, 1.25 to slaughter: For reduction monensin/lb body weight per day, depending
4.54. of ammonia gas emissions upon severity of coccidiosis challenge, up to
per pound of live weight 480 mg/head/day, and 60 to 90 mg tylosin/head/
and hot carcass weight, day during the last 14 to 91 days on feed. A
for reduction of incidence decrease in dry matter intake may be noticed
of liver abscesses in some animals receiving lubabegron.
associated with Lubabegron has not been approved for use in
Fusobacterium necrophorum breeding animals because safety and
and Arcanobacterium effectiveness have not been evaluated in
pyogenes, and for these animals. Do not allow horses or other
prevention and control of equines access to feed containing lubabegron
coccidiosis due to Eimeria and monensin. Ingestion of monensin by horses
bovis and E. zuernii has been fatal. Monensin medicated cattle and
during the last 14 to 91 goat feeds are safe for use in cattle and
days on feed. goats only. Consumption by unapproved species
may result in toxic reactions. Feeding
undiluted or mixing errors resulting in high
concentrations of monensin has been fatal to
cattle and could be fatal to goats. Must be
thoroughly mixed in feeds before use. Do not
exceed the levels of monensin recommended in
the feeding directions, as reduced average
daily gains may result. If feed refusals
containing monensin are fed to other groups
of cattle, the concentration of monensin in
the refusals and amount of refusals fed
should be taken into consideration to prevent
monensin overdosing. A withdrawal period has
not been established for this product for
preruminating calves. Do not use in calves to
be processed for veal.
* * * * * * *
--------------------------------------------------------------------------------------------------------------------------------------------------------
Dated: September 27, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-21514 Filed 10-4-19; 8:45 am]
BILLING CODE 4164-01-P
