New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Applications; Changes of Sponsorship; Change of a Sponsor's Name and Address, 13632-13637 [2018-06358]
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§ 134.1112
Federal Register / Vol. 83, No. 62 / Friday, March 30, 2018 / Rules and Regulations
The decision.
(a) Timing. The Judge shall decide a
CVE Appeal, insofar as practicable,
within 60 calendar days after close of
the record.
(b) Contents. Following closure of the
record, the Judge will issue a decision
containing findings of fact and
conclusions of law, reasons for such
findings and conclusions, and any relief
ordered.
(c) Basis for decision. Decisions under
this subpart will be based primarily on
the evidence in the CVE case file,
arguments made on appeal, and any
response(s) thereto. However, the Judge,
in his/her sole discretion, may consider
issues beyond those raised in the
pleadings and the denial or cancellation
letter.
(d) Finality. The decision is the final
agency decision and becomes effective
upon issuance. Where OHA dismisses
an appeal of a D/CVE denial or
cancellation, the D/CVE determination
remains in effect.
(e) Service. OHA will serve a copy of
all written decisions on each party, or,
if represented by counsel, on its
counsel.
(f) Effect. If the Judge grants the
appeal and finds the appellant eligible
for inclusion in the CVE database, the
D/CVE must immediately reinstate or
include the appellant, as the case may
be, in the CVE database.
(g) Reconsideration. A decision of the
Judge may be reconsidered. Any party
that has appeared in the proceeding, or
the Secretary of VA or his or her
designee, may request reconsideration
by filing with OHA and serving a
petition for reconsideration on all
parties to the CVE Appeal within twenty
(20) calendar days after service of the
written decision, upon a clear showing
of an error of fact or law material to the
decision. The Judge also may reconsider
a decision on his or her own initiative.
Dated: March 14, 2018.
Linda E. McMahon,
Administrator.
[FR Doc. 2018–06034 Filed 3–29–18; 8:45 am]
BILLING CODE 8025–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 510, 520, 522, 524, 556,
and 558
[Docket No. FDA–2017–N–0002]
New Animal Drugs; Approval of New
Animal Drug Applications; Withdrawal
of Approval of New Animal Drug
Applications; Changes of
Sponsorship; Change of a Sponsor’s
Name and Address
AGENCY:
This rule is effective March 30,
2018, except for amendatory
instructions 3 to 21 CFR 510.600, 9 to
21 CFR 522.300, 10 to 21 CFR 522.540,
and 11 to 21 CFR 522.1081, which are
effective April 9, 2018.
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:
DATES:
Food and Drug Administration,
HHS.
Final rule; technical
amendments.
ACTION:
The Food and Drug
Administration (FDA or we) is
amending the animal drug regulations to
reflect application-related actions for
new animal drug applications (NADAs)
and abbreviated new animal drug
applications (ANADAs) during July,
August, and September 2017. 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 reflect the withdrawal of
approval of applications, changes of
sponsorship of applications, and a
change of a sponsor’s name and address,
and to make technical amendments to
improve the accuracy of the regulations.
SUMMARY:
I. Approval Actions
FDA is amending the animal drug
regulations to reflect approval actions
for NADAs and ANADAs during July,
August, and September 2017, 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 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/ApprovedAnimal
DrugProducts/default.htm.
TABLE 1—ORIGINAL AND SUPPLEMENTAL NADAS AND ANADAS APPROVED DURING JULY, AUGUST, AND SEPTEMBER
2017
Approval date
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July 21, 2017 ....
VerDate Sep<11>2014
File No.
141–450
18:02 Mar 29, 2018
Sponsor
Intervet, Inc., 2
Giralda Farms,
Madison, NJ
07940.
Jkt 244001
PO 00000
Product name
Species
Effect of the action
Public
documents
BANAMINE
Transdermal
(flunixin
transdermal
solution) Solution.
Cattle ...........
Original approval for the control of
pyrexia associated with bovine respiratory disease and the control of
pain associated with foot rot in
steers, beef heifers, beef cows, beef
bulls intended for slaughter, and replacement dairy heifers under 20
months of age.
FOI Summary;
EA/FONSI.1
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13633
TABLE 1—ORIGINAL AND SUPPLEMENTAL NADAS AND ANADAS APPROVED DURING JULY, AUGUST, AND SEPTEMBER
2017—Continued
Approval date
File No.
Product name
Sponsor
Species
Effect of the action
Public
documents
Supplemental approval for control of
swine respiratory disease (SRD) associated
with
Bordetella
bronchiseptica,
Haemophilus
parasuis, Pasteurella multocida, and
Streptococcus suis in groups of
swine in buildings experiencing an
outbreak of SRD.
Original approval as a generic copy of
NADA 131–310.
FOI Summary.
FOI Summary.
July 19, 2017 ....
141–336
ECO LLC, 344
Nassau St.,
Princeton, NJ
08540.
AIVLOSIN
(tylvalosin tartrate) Water
Soluble Granules.
Swine ..........
July 14, 2017 ....
200–620
ALTREN
(altrenogest)
Solution.
Horses .........
July 14, 2017 ....
200–621
SWINEMATE
(altrenogest)
Solution.
Swine ..........
Original approval as a generic copy of
NADA 141–222.
September 15,
2017.
141–250
Aurora Pharmaceutical, LLC,
1196 Highway 3
South, Northfield,
MN 55057–3009.
Aurora Pharmaceutical, LLC,
1196 Highway 3
South, Northfield,
MN 55057–3009.
Zoetis Inc., 333
Portage St.,
Kalamazoo, MI
49007.
Cattle ...........
Supplemental approval of revised representative labeling making technical
amendments.
September 28,
2017.
141–333
Chlortetracycline
and lasalocid
Type B and
Type C medicated feeds.
SENTINEL
SPECTRUM
(milbemycin
oxime/
lufenuron/
praziquantel).
Dogs ............
Supplemental approval for the treatment and control of the adult tapeworm Dipylidium caninum.
Virbac AH, Inc.,
3200 Meacham
Blvd., Ft. Worth,
TX 76137.
FOI Summary.
FOI Summary.
1 The Agency has carefully considered an environmental assessment (EA) of the potential environmental impact of this action and has made a
finding of no significant impact (FONSI).
II. Change of Sponsorship
66061–1304 has informed FDA that it
has transferred ownership of, and all
rights and interest in, the following
SmartVet USA, Inc., 22201 West
Innovation Dr., suite 170A, Olathe, KS
application to Sparhawk Laboratories,
Inc., 12340 Santa Fe Trail Dr., Lenexa,
KS 66215:
File No.
Product name
21 CFR
Section
200–348 ....................................................
ECOMECTIN (ivermectin) Topical Solution .................................................................
524.1193
Following this withdrawal of approval,
SmartVet USA, Inc. is no longer the
sponsor of an approved application.
Accordingly, it will be removed from
the list of sponsors of approved
applications in § 510.600(c) (21 CFR
510.600(c)).
Strategic Veterinary Pharmaceuticals,
Inc., 100 NW. Airport Rd., St. Joseph,
MO 64503 has informed FDA that it has
transferred ownership of, and all rights
and interest in, the following
application to Cross Vetpharm Group
Ltd., Broomhill Rd., Tallaght, Dublin 24,
Ireland:
File No.
Product name
21 CFR
Section
109–305 ....................................................
Oxytocin Injection .........................................................................................................
522.1680
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The animal drug regulations are being
amended to reflect these changes of
sponsorship.
III. Withdrawals of Approval
The following sponsors requested that
FDA withdraw approval of the NADAs
listed in the following table because the
products are no longer manufactured or
marketed:
21 CFR
Section
File No.
Sponsor
Product name
047–055 .........................
Watson Laboratories, Inc., 311 Bonnie Circle,
Corona, CA 92880.
Watson Laboratories, Inc., 311 Bonnie Circle,
Corona, CA 92880.
Chorionic Gonadotropin Powder for Injection ......
522.1081
Dexamethasone Sodium Phosphate Injection .....
522.540
104–606 .........................
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21 CFR
Section
File No.
Sponsor
Product name
139–633 .........................
Wildlife Laboratories, Inc., 1230 W. Ash St.,
Suite D, Windsor, CO 80550.
WILDNIL (carfentanil citrate) Injection .................
Following this withdrawal of
approval, Watson Laboratories, Inc. is
no longer the sponsor of an approved
application. Accordingly, it will be
removed from the list of sponsors of
approved applications in § 510.600(c).
Elsewhere in this issue of the Federal
Register, FDA gave notice that approval
of NADAs 047–055, 104–606, and 139–
633, and all supplements and
amendments thereto, is withdrawn,
effective April 9, 2018. As provided in
the regulatory text of this document, the
animal drug regulations are amended to
reflect these actions.
IV. Technical Amendments
Western Chemical, Inc., 1269
Lattimore Rd., Ferndale, WA 98248 has
informed FDA that it has changed its
name and address to Syndel USA, 1441
W. Smith Rd., Ferndale, WA 98248.
ADM Alliance Nutrition, Inc., 1000
North 30th St., Quincy, IL 62305–3115
has informed FDA that it has changed
its name to ADM Animal Nutrition, Inc.
Accordingly, we are amending
§ 510.600(c) to reflect these changes.
We are also making technical
amendments to update the scientific
name of a pathogenic bacterium, to
accurately list the concentrations of
ingredients in a combination new
animal drug, and to correctly list the
assay limits and maximum drug
concentration in Type B medicated
feeds for a combination new animal
drug used in feed. These actions are
being taken to improve the accuracy of
the regulations.
V. 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
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
522.300
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
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 entries for
‘‘ADM Alliance Nutrition, Inc.’’,
‘‘SmartVet USA, Inc.’’ and ‘‘Western
Chemical, Inc.’’, and add entries for
‘‘ADM Animal Nutrition, Inc.’’ and
‘‘Syndel USA’’ in alphabetical order;
and in the table in paragraph (c)(2),
remove the entry for ‘‘086001’’ and
revise the entries for ‘‘012286’’ and
‘‘050378’’ to 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
*
*
*
*
*
*
ADM Animal Nutrition, Inc., 1000 North 30th St., Quincy, IL 62305–3115 .........................................................................................
*
*
*
*
*
*
*
Syndel USA, 1441 W. Smith Rd., Ferndale, WA 98248 .....................................................................................................................
*
*
*
*
*
*
*
012286
050378
*
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(2) * * *
Drug labeler code
Firm name and address
*
*
*
012286 ...........................................................................................
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*
*
*
*
ADM Animal Nutrition, Inc., 1000 North 30th St., Quincy, IL 62305–3115.
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Drug labeler code
Firm name and address
*
*
*
050378 ...........................................................................................
*
*
*
*
§ 522.300
3. Effective April 9, 2018,’’ in
§ 510.600, in the table in paragraph
(c)(1), remove the entry for ‘‘Watson
Laboratories, Inc.’’; and in the table in
paragraph (c)(2), remove the entry for
‘‘000402’’.
■
*
[Removed]
9. Effective April 9, 2018, remove
§ 522.300.
■ 10. Effective April 9, 2018, in
§ 522.540, revise paragraphs (b)(2) and
(c)(2) to read as follows:
■
PART 520—ORAL DOSAGE FORM
NEW ANIMAL DRUGS
§ 522.540
Dexamethasone solution.
*
4. The authority citation for part 520
continues to read as follows:
■
Authority: 21 U.S.C. 360b.
§ 520.48
*
*
*
Syndel USA, 1441 W. Smith Rd., Ferndale, WA 98248.
[Amended]
*
*
*
*
(b) * * *
(2) Sponsor. See No. 061623 in
§ 510.600(c) of this chapter.
*
*
*
*
*
(c) * * *
(2) Sponsor. See No. 061623 in
§ 510.600(c) of this chapter.
*
*
*
*
*
5. In § 520.48, in paragraph (b),
remove ‘‘000061 and 061623’’ and in its
place add ‘‘000061, 051072, and
061623’’.
§ 522.1081
§ 520.1447
■
■
[Amended]
6. In § 520.1447, in paragraph
(d)(1)(ii), remove ‘‘(Taenia pisiformis,
Echinococcus multilocularis, and E.
granulosus)’’ and in its place add
‘‘(Dipylidium caninum, Taenia
pisiformis, Echinococcus multilocularis,
and E. granulosus)’’.
■
[Amended]
11. Effective April 9, 2018, in
§ 522.1081, in paragraph (b)(1), remove
‘‘Nos. 000402 and 054771’’ and in its
place add ‘‘No. 054771’’.
*
*
*
respiratory disease and the control of
pain associated with foot rot in steers,
beef heifers, beef cows, beef bulls
intended for slaughter, and replacement
dairy heifers under 20 months of age.
(3) Limitations. Federal law restricts
this drug to use by or on the order of
a licensed veterinarian. Cattle must not
be slaughtered for human consumption
within 8 days of the last treatment. 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
suckling beef calves, dairy calves, and
veal calves. A withdrawal period has
not been established for this product in
pre-ruminating calves.
■ 16. In § 524.1132, revise paragraph (a)
to read as follows:
§ 524.1132 Hydrocortisone, miconazole,
and gentamicin otic suspension.
7. In § 520.2645, revise paragraphs
(d)(1) and (2) to read as follows:
12. In § 522.1662a, in paragraph
(h)(3)(ii), remove ‘‘Spherophorus
necrophorus’’ and in its place add
‘‘Fusobacterium necrophorum’’.
(a) Specifications. Each milliliter (mL)
of suspension contains 1.11 milligrams
(mg) hydrocortisone aceponate, 17.4 mg
miconazole nitrate, and 1.5 mg
gentamicin (as gentamicin sulfate).
*
*
*
*
*
§ 522.1680
§ 524.1193
§ 520.2645
■
■
Tylvalosin.
*
*
*
*
(d) * * *
(1) Amount. Administer 50 parts per
million (ppm) tylvalosin continuously
in drinking water for 5 consecutive
days.
(2) Indications for use. For control of
porcine proliferative enteropathy (PPE)
associated with Lawsonia intracellularis
infection in groups of swine in
buildings experiencing an outbreak of
PPE; and for control of swine respiratory
disease (SRD) associated with Bordetella
bronchiseptica, Haemophilus parasuis,
Pasteurella multocida, and
Streptococcus suis in groups of swine in
buildings experiencing an outbreak of
SRD.
*
*
*
*
*
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*
PART 522—IMPLANTATION OR
INJECTABLE DOSAGE FORM NEW
ANIMAL DRUGS
8. The authority citation for part 522
continues to read as follows:
■
Authority: 21 U.S.C. 360b.
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§ 522.1662a
[Amended]
■
[Amended]
13. In § 522.1680, in paragraph (b),
remove ‘‘054628,’’.
PART 524—OPHTHALMIC AND
TOPICAL DOSAGE FORM NEW
ANIMAL DRUGS
14. The authority citation for part 524
continues to read as follows:
■
Authority: 21 U.S.C. 360b.
■
PART 556—TOLERANCES FOR
RESIDUES OF NEW ANIMAL DRUGS
IN FOOD
18. The authority citation for part 556
continues to read as follows:
■
15. Add § 524.970 to read as follows:
§ 524.970
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Authority: 21 U.S.C. 342, 360b, 371.
§ 556.286
Flunixin.
(a) Specifications. Each milliliter of
solution contains 50 milligrams (mg)
flunixin (equivalent to 83 mg flunixin
meglumine).
(b) Sponsor. See No. 000061 in
§ 510.600(c) of this chapter.
(c) Related tolerances. See § 556.286
of this chapter.
(d) Conditions of use—(1) Amount.
Apply only once at a dose of 3.3 mg
flunixin per kg body weight (1.5 mg/lb;
3 mL per 100 lbs) topically in a narrow
strip along the dorsal midline from the
withers to the tailhead.
(2) Indications for use. For the control
of pyrexia associated with bovine
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[Amended]
17. In § 524.1193, in paragraph (b)(2),
remove ‘‘086001’’ and in its place add
‘‘058005’’.
■
[Amended]
19. In § 556.286, in paragraph (c),
remove ‘‘§§ 522.956 and 522.970’’ and
in its place add ‘‘§§ 522.956, 522.970,
and 524.970’’.
■
PART 558—NEW ANIMAL DRUGS FOR
USE IN ANIMAL FEEDS
20. The authority citation for part 558
continues to read as follows:
■
Authority: 21 U.S.C. 354, 360b, 360ccc,
360ccc–1, 371.
21. In § 558.4, in paragraph (d), in the
‘‘Category II’’ table, revise the row
entries for ‘‘Neomycin’’ through
‘‘Pyrantel tartrate’’ to read as follows:
■
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§ 558.4 Requirement of a medicated feed
mill license.
*
*
*
*
(d) * * *
*
CATEGORY II
Assay limits
percent 1
Type A 1
Drug
*
*
*
Neomycin ...................................................................
Oxytetracycline ...........................................................
Neomycin sulfate ........................................................
Nicarbazin (granular) ..................................................
Narasin .......................................................................
Nicarbazin (powder) ...................................................
Novobiocin ..................................................................
Pyrantel tartrate ..........................................................
*
*
80–120
80–120
80–120
90–110
90–110
98–106
85–115
90–110
*
Type B maximum
(100×)
Assay limits
percent 1
Type B/C 2
*
*
*
20 g/lb (4.4%) ............................................................
20 g/lb (4.4%) ............................................................
100 g/lb (22.0%) ........................................................
5.675 g/lb (1.25%) .....................................................
5.675 g/lb (1.25%) .....................................................
5.675 g/lb (1.25%) .....................................................
17.5 g/lb (3.85%) .......................................................
36 g/lb (7.9%) ............................................................
*
*
*
70–125
65–135
70–125
85–115/75–125
85–115/75–125
85–115/80–120
80–120
75–125
*
*
1 Percent
of labeled amount.
2 Values given represent ranges for either Type B or Type C medicated feeds. For those drugs that have two range limits, the first set is for a
Type B medicated feed and the second set is for a Type C medicated feed. These values (ranges) have been assigned in order to provide for
the possibility of dilution of a Type B medicated feed with lower assay limits to make a Type C medicated feed.
*
§ 558.128
■
*
*
*
*
*
22. In § 558.128, revise paragraphs
(e)(3)(vi), (e)(4)(ix), and (e)(4)(xxvi) to
read as follows:
Chlortetracycline
amount
*
(vi) 10 mg/lb of body
weight.
Combination in
grams/ton
*
Tiamulin hydrogen
fumarate, 35.
Chlortetracycline.
*
*
(e) * * *
(3) * * *
*
*
Indications for use
Limitations
*
*
*
*
For control of swine dysentery associ- Feed chlortetracycline at approximately
ated with Brachyspira (formerly
400 g/ton of feed, varying with body
Serpulina
or
Treponema)
weight and food consumption, to prohyodysenteriae susceptible to tiamulin
vide 10 mg/lb of body weight. Feed
and for treatment of swine bacterial
continuously as the sole ration for 14
enteritis caused by E. coli and Saldays. Withdraw medicated feed 2
monella choleraesuis sensitive to
days before slaughter. Tiamulin as
chlortetracycline and treatment of bacprovided by Nos. 058198 or 069254 in
terial pneumonia caused by P.
§ 510.600(c) of this chapter.
multocida sensitive to chlortetracycline.
Sponsor
*
058198
069254
(4) * * *
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Chlortetracycline
amount
Combination in
grams/ton
Indications for use
Limitations
*
(ix) 500 to 4,000 to
provide 10 mg/lb of
body weight daily.
*
Lasalocid, 30 to 600
*
*
Pasture cattle (slaughter, stocker, feeder
cattle, dairy and beef replacement
heifers): For treatment of bacterial enteritis caused by E. coli and bacterial
pneumonia caused by P. multocida
organisms susceptible to chlortetracycline; and for increased rate of
weight gain.
*
*
Feed continuously on a hand-fed basis
for not more than 5 days to provide
10 mg chlortetracycline per lb. body
weight per day and not less than 60
mg or more than 300 mg lasalocid per
head per day in at least 1 pound of
feed. Daily lasalocid intakes in excess
of 200 mg/head/day in pasture cattle
have not been shown to be more effective than 200 mg lasalocid/head/
day. Do not allow horses or other
equines access to feeds containing
lasalocid. No withdrawal period is required. A withdrawal period has not
been established for this product in
pre-ruminating calves. Do not use in
calves to be processed for veal. See
§ 558.311(d) of this chapter. Lasalocid
as provided by No. 054771 in
§ 510.600(c) of this chapter.
*
*
(xxvi) 500 to 4,000 to
provide 10 mg/
head/day.
*
Lasalocid, 30 to
181.8.
*
*
Cattle weighing up to 800 pounds: For
the treatment of bacterial enteritis
caused by E. coli and bacterial pneumonia caused by P. multocida susceptible to chlortetracycline; and for
the control of coccidiosis caused by
Eimeria bovis and E. zuernii.
*
*
Hand feed continuously for not more
than 5 days at a rate of 10 mg chlortetracycline and 1 mg lasalocid per
2.2 lb. body weight daily to cattle with
a maximum of 360 mg of lasalocid per
head per day. Do not allow horses or
other equines access to feeds containing lasalocid. No withdrawal period
is required. A withdrawal period has
not been established for this product
in pre-ruminating calves. Do not use
in calves to be processed for veal.
See § 558.311(d) of this chapter.
Lasalocid as provided by No. 054771
in § 510.600(c) of this chapter.
*
*
*
*
*
Dated: March 21, 2018.
Leslie Kux,
Associate Commissioner for Policy.
*
23. In § 558.325, revise paragraph
(d)(2) to read as follows:
■
§ 558.325
[FR Doc. 2018–06358 Filed 3–29–18; 8:45 am]
Lincomycin.
BILLING CODE 4164–01–P
*
*
*
*
*
(d) * * *
(2) The expiration date of VFDs for
lincomycin medicated feeds must not
exceed 6 months from the date of
issuance. VFDs for lincomycin shall not
be refilled.
*
*
*
*
*
§ 558.575
[Amended]
24. In § 558.575, in paragraph (e)(2)(ii)
remove ‘‘and bacterial infections due to
H. galmaxima,’’.
■
amozie on DSK30RV082PROD with RULES
The Food and Drug
Administration (FDA) is withdrawing
approval of three new animal drug
applications (NADAs). This action is
being taken at the sponsors’ request
because these products are no longer
manufactured or marketed.
DATES:
Food and Drug Administration
FOR FURTHER INFORMATION CONTACT:
21 CFR Part 522
[Docket No. FDA–2017–N–0002]
New Animal Drugs; Withdrawal of
Approval of New Animal Drug
Applications
AGENCY:
Food and Drug Administration,
HHS.
Notification of withdrawal.
Withdrawal of approval is
effective April 9, 2018.
Sujaya Dessai, Center for Veterinary
Medicine (HFV–212), Food and Drug
Administration, 7519 Standish Pl.,
Rockville, MD 20855, 240–402–5761,
sujaya.dessai@fda.hhs.gov.
During
July and August 2017, the following
sponsors requested that FDA withdraw
approval of the NADAs listed in the
following table because the products are
no longer manufactured or marketed:
SUPPLEMENTARY INFORMATION:
Sponsor
Product name
047–055 .........................
Watson Laboratories, Inc., 311 Bonnie Circle,
Corona, CA 92880.
Chorionic Gonadotropin Powder for Injection ......
Jkt 244001
054771
SUMMARY:
File No.
18:02 Mar 29, 2018
054771
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
ACTION:
VerDate Sep<11>2014
Sponsor
PO 00000
Frm 00013
Fmt 4700
Sfmt 4700
E:\FR\FM\30MRR1.SGM
30MRR1
21 CFR
section
522.1081
]]>Agencies
[Federal Register Volume 83, Number 62 (Friday, March 30, 2018)]
[Rules and Regulations]
[Pages 13632-13637]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-06358]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 510, 520, 522, 524, 556, and 558
[Docket No. FDA-2017-N-0002]
New Animal Drugs; Approval of New Animal Drug Applications;
Withdrawal of Approval of New Animal Drug Applications; Changes of
Sponsorship; Change of a 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 July, August, and September 2017. 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 reflect the
withdrawal of approval of applications, changes of sponsorship of
applications, and a change of a sponsor's name and address, and to make
technical amendments to improve the accuracy of the regulations.
DATES: This rule is effective March 30, 2018, except for amendatory
instructions 3 to 21 CFR 510.600, 9 to 21 CFR 522.300, 10 to 21 CFR
522.540, and 11 to 21 CFR 522.1081, which are effective April 9, 2018.
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. Approval Actions
FDA is amending the animal drug regulations to reflect approval
actions for NADAs and ANADAs during July, August, and September 2017,
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
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 July, August, and September 2017
--------------------------------------------------------------------------------------------------------------------------------------------------------
Approval date File No. Sponsor Product name Species Effect of the action Public documents
--------------------------------------------------------------------------------------------------------------------------------------------------------
July 21, 2017........... 141-450 Intervet, Inc., 2 BANAMINE Transdermal Cattle.............. Original approval for FOI Summary; EA/
Giralda Farms, (flunixin transdermal the control of pyrexia FONSI.\1\
Madison, NJ 07940. solution) Solution. associated with bovine
respiratory disease
and the control of
pain associated with
foot rot in steers,
beef heifers, beef
cows, beef bulls
intended for
slaughter, and
replacement dairy
heifers under 20
months of age.
[[Page 13633]]
July 19, 2017........... 141-336 ECO LLC, 344 Nassau AIVLOSIN (tylvalosin Swine............... Supplemental approval FOI Summary.
St., Princeton, NJ tartrate) Water Soluble for control of swine
08540. Granules. respiratory disease
(SRD) associated with
Bordetella
bronchiseptica,
Haemophilus parasuis,
Pasteurella multocida,
and Streptococcus suis
in groups of swine in
buildings experiencing
an outbreak of SRD.
July 14, 2017........... 200-620 Aurora ALTREN (altrenogest) Horses.............. Original approval as a FOI Summary.
Pharmaceutical, Solution. generic copy of NADA
LLC, 1196 Highway 131-310.
3 South,
Northfield, MN
55057-3009.
July 14, 2017........... 200-621 Aurora SWINEMATE (altrenogest) Swine............... Original approval as a FOI Summary.
Pharmaceutical, Solution. generic copy of NADA
LLC, 1196 Highway 141-222.
3 South,
Northfield, MN
55057-3009.
September 15, 2017...... 141-250 Zoetis Inc., 333 Chlortetracycline and Cattle.............. Supplemental approval .....................
Portage St., lasalocid Type B and of revised
Kalamazoo, MI Type C medicated feeds. representative
49007. labeling making
technical amendments.
September 28, 2017...... 141-333 Virbac AH, Inc., SENTINEL SPECTRUM Dogs................ Supplemental approval FOI Summary.
3200 Meacham (milbemycin oxime/ for the treatment and
Blvd., Ft. Worth, lufenuron/praziquantel). control of the adult
TX 76137. tapeworm Dipylidium
caninum.
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ The Agency has carefully considered an environmental assessment (EA) of the potential environmental impact of this action and has made a finding of
no significant impact (FONSI).
II. Change of Sponsorship
SmartVet USA, Inc., 22201 West Innovation Dr., suite 170A, Olathe,
KS 66061-1304 has informed FDA that it has transferred ownership of,
and all rights and interest in, the following application to Sparhawk
Laboratories, Inc., 12340 Santa Fe Trail Dr., Lenexa, KS 66215:
------------------------------------------------------------------------
File No. Product name 21 CFR Section
------------------------------------------------------------------------
200-348........................ ECOMECTIN (ivermectin) 524.1193
Topical Solution.
------------------------------------------------------------------------
Following this withdrawal of approval, SmartVet USA, Inc. is no longer
the sponsor of an approved application. Accordingly, it will be removed
from the list of sponsors of approved applications in Sec. 510.600(c)
(21 CFR 510.600(c)).
Strategic Veterinary Pharmaceuticals, Inc., 100 NW. Airport Rd.,
St. Joseph, MO 64503 has informed FDA that it has transferred ownership
of, and all rights and interest in, the following application to Cross
Vetpharm Group Ltd., Broomhill Rd., Tallaght, Dublin 24, Ireland:
------------------------------------------------------------------------
File No. Product name 21 CFR Section
------------------------------------------------------------------------
109-305........................ Oxytocin Injection.... 522.1680
------------------------------------------------------------------------
The animal drug regulations are being amended to reflect these changes
of sponsorship.
III. Withdrawals of Approval
The following sponsors requested that FDA withdraw approval of the
NADAs listed in the following table because the products are no longer
manufactured or marketed:
----------------------------------------------------------------------------------------------------------------
File No. Sponsor Product name 21 CFR Section
----------------------------------------------------------------------------------------------------------------
047-055............................. Watson Laboratories, Inc., Chorionic Gonadotropin 522.1081
311 Bonnie Circle, Corona, Powder for Injection.
CA 92880.
104-606............................. Watson Laboratories, Inc., Dexamethasone Sodium 522.540
311 Bonnie Circle, Corona, Phosphate Injection.
CA 92880.
[[Page 13634]]
139-633............................. Wildlife Laboratories, Inc., WILDNIL (carfentanil 522.300
1230 W. Ash St., Suite D, citrate) Injection.
Windsor, CO 80550.
----------------------------------------------------------------------------------------------------------------
Following this withdrawal of approval, Watson Laboratories, Inc. is
no longer the sponsor of an approved application. Accordingly, it will
be removed from the list of sponsors of approved applications in Sec.
510.600(c).
Elsewhere in this issue of the Federal Register, FDA gave notice
that approval of NADAs 047-055, 104-606, and 139-633, and all
supplements and amendments thereto, is withdrawn, effective April 9,
2018. As provided in the regulatory text of this document, the animal
drug regulations are amended to reflect these actions.
IV. Technical Amendments
Western Chemical, Inc., 1269 Lattimore Rd., Ferndale, WA 98248 has
informed FDA that it has changed its name and address to Syndel USA,
1441 W. Smith Rd., Ferndale, WA 98248. ADM Alliance Nutrition, Inc.,
1000 North 30th St., Quincy, IL 62305-3115 has informed FDA that it has
changed its name to ADM Animal Nutrition, Inc. Accordingly, we are
amending Sec. 510.600(c) to reflect these changes.
We are also making technical amendments to update the scientific
name of a pathogenic bacterium, to accurately list the concentrations
of ingredients in a combination new animal drug, and to correctly list
the assay limits and maximum drug concentration in Type B medicated
feeds for a combination new animal drug used in feed. These actions are
being taken to improve the accuracy of the regulations.
V. 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
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, in the table in paragraph (c)(1), remove the
entries for ``ADM Alliance Nutrition, Inc.'', ``SmartVet USA, Inc.''
and ``Western Chemical, Inc.'', and add entries for ``ADM Animal
Nutrition, Inc.'' and ``Syndel USA'' in alphabetical order; and in the
table in paragraph (c)(2), remove the entry for ``086001'' and revise
the entries for ``012286'' and ``050378'' to 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
------------------------------------------------------------------------
* * * * * * *
ADM Animal Nutrition, Inc., 1000 North 30th St., Quincy, 012286
IL 62305-3115..........................................
* * * * * * *
Syndel USA, 1441 W. Smith Rd., Ferndale, WA 98248....... 050378
* * * * * * *
------------------------------------------------------------------------
(2) * * *
--------------------------------------------------------------------------------------------------------------------------------------------------------
Drug labeler code Firm name and address
--------------------------------------------------------------------------------------------------------------------------------------------------------
* * * * * * *
012286..................................... ADM Animal Nutrition, Inc., 1000 North 30th St., Quincy, IL 62305-3115.
[[Page 13635]]
* * * * * * *
050378..................................... Syndel USA, 1441 W. Smith Rd., Ferndale, WA 98248.
* * * * * * *
--------------------------------------------------------------------------------------------------------------------------------------------------------
0
3. Effective April 9, 2018,'' in Sec. 510.600, in the table in
paragraph (c)(1), remove the entry for ``Watson Laboratories, Inc.'';
and in the table in paragraph (c)(2), remove the entry for ``000402''.
PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS
0
4. The authority citation for part 520 continues to read as follows:
Authority: 21 U.S.C. 360b.
Sec. 520.48 [Amended]
0
5. In Sec. 520.48, in paragraph (b), remove ``000061 and 061623'' and
in its place add ``000061, 051072, and 061623''.
Sec. 520.1447 [Amended]
0
6. In Sec. 520.1447, in paragraph (d)(1)(ii), remove ``(Taenia
pisiformis, Echinococcus multilocularis, and E. granulosus)'' and in
its place add ``(Dipylidium caninum, Taenia pisiformis, Echinococcus
multilocularis, and E. granulosus)''.
0
7. In Sec. 520.2645, revise paragraphs (d)(1) and (2) to read as
follows:
Sec. 520.2645 Tylvalosin.
* * * * *
(d) * * *
(1) Amount. Administer 50 parts per million (ppm) tylvalosin
continuously in drinking water for 5 consecutive days.
(2) Indications for use. For control of porcine proliferative
enteropathy (PPE) associated with Lawsonia intracellularis infection in
groups of swine in buildings experiencing an outbreak of PPE; and for
control of swine respiratory disease (SRD) associated with Bordetella
bronchiseptica, Haemophilus parasuis, Pasteurella multocida, and
Streptococcus suis in groups of swine in buildings experiencing an
outbreak of SRD.
* * * * *
PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS
0
8. The authority citation for part 522 continues to read as follows:
Authority: 21 U.S.C. 360b.
Sec. 522.300 [Removed]
0
9. Effective April 9, 2018, remove Sec. 522.300.
0
10. Effective April 9, 2018, in Sec. 522.540, revise paragraphs (b)(2)
and (c)(2) to read as follows:
Sec. 522.540 Dexamethasone solution.
* * * * *
(b) * * *
(2) Sponsor. See No. 061623 in Sec. 510.600(c) of this chapter.
* * * * *
(c) * * *
(2) Sponsor. See No. 061623 in Sec. 510.600(c) of this chapter.
* * * * *
Sec. 522.1081 [Amended]
0
11. Effective April 9, 2018, in Sec. 522.1081, in paragraph (b)(1),
remove ``Nos. 000402 and 054771'' and in its place add ``No. 054771''.
Sec. 522.1662a [Amended]
0
12. In Sec. 522.1662a, in paragraph (h)(3)(ii), remove ``Spherophorus
necrophorus'' and in its place add ``Fusobacterium necrophorum''.
Sec. 522.1680 [Amended]
0
13. In Sec. 522.1680, in paragraph (b), remove ``054628,''.
PART 524--OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS
0
14. The authority citation for part 524 continues to read as follows:
Authority: 21 U.S.C. 360b.
0
15. Add Sec. 524.970 to read as follows:
Sec. 524.970 Flunixin.
(a) Specifications. Each milliliter of solution contains 50
milligrams (mg) flunixin (equivalent to 83 mg flunixin meglumine).
(b) Sponsor. See No. 000061 in Sec. 510.600(c) of this chapter.
(c) Related tolerances. See Sec. 556.286 of this chapter.
(d) Conditions of use--(1) Amount. Apply only once at a dose of 3.3
mg flunixin per kg body weight (1.5 mg/lb; 3 mL per 100 lbs) topically
in a narrow strip along the dorsal midline from the withers to the
tailhead.
(2) Indications for use. For the control of pyrexia associated with
bovine respiratory disease and the control of pain associated with foot
rot in steers, beef heifers, beef cows, beef bulls intended for
slaughter, and replacement dairy heifers under 20 months of age.
(3) Limitations. Federal law restricts this drug to use by or on
the order of a licensed veterinarian. Cattle must not be slaughtered
for human consumption within 8 days of the last treatment. 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 suckling beef
calves, dairy calves, and veal calves. A withdrawal period has not been
established for this product in pre-ruminating calves.
0
16. In Sec. 524.1132, revise paragraph (a) to read as follows:
Sec. 524.1132 Hydrocortisone, miconazole, and gentamicin otic
suspension.
(a) Specifications. Each milliliter (mL) of suspension contains
1.11 milligrams (mg) hydrocortisone aceponate, 17.4 mg miconazole
nitrate, and 1.5 mg gentamicin (as gentamicin sulfate).
* * * * *
Sec. 524.1193 [Amended]
0
17. In Sec. 524.1193, in paragraph (b)(2), remove ``086001'' and in
its place add ``058005''.
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.
Sec. 556.286 [Amended]
0
19. In Sec. 556.286, in paragraph (c), remove ``Sec. Sec. 522.956 and
522.970'' and in its place add ``Sec. Sec. 522.956, 522.970, and
524.970''.
PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS
0
20. The authority citation for part 558 continues to read as follows:
Authority: 21 U.S.C. 354, 360b, 360ccc, 360ccc-1, 371.
0
21. In Sec. 558.4, in paragraph (d), in the ``Category II'' table,
revise the row entries for ``Neomycin'' through ``Pyrantel tartrate''
to read as follows:
[[Page 13636]]
Sec. 558.4 Requirement of a medicated feed mill license.
* * * * *
(d) * * *
Category II
----------------------------------------------------------------------------------------------------------------
Assay limits Assay limits
Drug percent \1\ Type B maximum (100x) percent \1\ Type
Type A \1\ B/C \2\
----------------------------------------------------------------------------------------------------------------
* * * * * * *
Neomycin.................................... 80-120 20 g/lb (4.4%)................. 70-125
Oxytetracycline............................. 80-120 20 g/lb (4.4%)................. 65-135
Neomycin sulfate............................ 80-120 100 g/lb (22.0%)............... 70-125
Nicarbazin (granular)....................... 90-110 5.675 g/lb (1.25%)............. 85-115/75-125
Narasin..................................... 90-110 5.675 g/lb (1.25%)............. 85-115/75-125
Nicarbazin (powder)......................... 98-106 5.675 g/lb (1.25%)............. 85-115/80-120
Novobiocin.................................. 85-115 17.5 g/lb (3.85%).............. 80-120
Pyrantel tartrate........................... 90-110 36 g/lb (7.9%)................. 75-125
* * * * * * *
----------------------------------------------------------------------------------------------------------------
\1\ Percent of labeled amount.
\2\ Values given represent ranges for either Type B or Type C medicated feeds. For those drugs that have two
range limits, the first set is for a Type B medicated feed and the second set is for a Type C medicated feed.
These values (ranges) have been assigned in order to provide for the possibility of dilution of a Type B
medicated feed with lower assay limits to make a Type C medicated feed.
* * * * *
0
22. In Sec. 558.128, revise paragraphs (e)(3)(vi), (e)(4)(ix), and
(e)(4)(xxvi) to read as follows:
Sec. 558.128 Chlortetracycline.
* * * * *
(e) * * *
(3) * * *
----------------------------------------------------------------------------------------------------------------
Combination in
Chlortetracycline amount grams/ton Indications for use Limitations Sponsor
----------------------------------------------------------------------------------------------------------------
* * * * * * *
(vi) 10 mg/lb of body weight... Tiamulin hydrogen For control of swine Feed chlortetracycline 058198
fumarate, 35. dysentery associated at approximately 400 069254
with Brachyspira g/ton of feed,
(formerly Serpulina varying with body
or Treponema) weight and food
hyodysenteriae consumption, to
susceptible to provide 10 mg/lb of
tiamulin and for body weight. Feed
treatment of swine continuously as the
bacterial enteritis sole ration for 14
caused by E. coli and days. Withdraw
Salmonella medicated feed 2 days
choleraesuis before slaughter.
sensitive to Tiamulin as provided
chlortetracycline and by Nos. 058198 or
treatment of 069254 in Sec.
bacterial pneumonia 510.600(c) of this
caused by P. chapter.
multocida sensitive
to chlortetracycline.
----------------------------------------------------------------------------------------------------------------
(4) * * *
----------------------------------------------------------------------------------------------------------------
Combination in
Chlortetracycline amount grams/ton Indications for use Limitations Sponsor
----------------------------------------------------------------------------------------------------------------
[[Page 13637]]
* * * * * * *
(ix) 500 to 4,000 to provide 10 Lasalocid, 30 to Pasture cattle Feed continuously on a 054771
mg/lb of body weight daily. 600. (slaughter, stocker, hand-fed basis for
feeder cattle, dairy not more than 5 days
and beef replacement to provide 10 mg
heifers): For chlortetracycline per
treatment of lb. body weight per
bacterial enteritis day and not less than
caused by E. coli and 60 mg or more than
bacterial pneumonia 300 mg lasalocid per
caused by P. head per day in at
multocida organisms least 1 pound of
susceptible to feed. Daily lasalocid
chlortetracycline; intakes in excess of
and for increased 200 mg/head/day in
rate of weight gain. pasture cattle have
not been shown to be
more effective than
200 mg lasalocid/head/
day. Do not allow
horses or other
equines access to
feeds containing
lasalocid. No
withdrawal period is
required. A
withdrawal period has
not been established
for this product in
pre-ruminating
calves. Do not use in
calves to be
processed for veal.
See Sec. 558.311(d)
of this chapter.
Lasalocid as provided
by No. 054771 in Sec.
510.600(c) of this
chapter.
* * * * * * *
(xxvi) 500 to 4,000 to provide Lasalocid, 30 to Cattle weighing up to Hand feed continuously 054771
10 mg/head/day. 181.8. 800 pounds: For the for not more than 5
treatment of days at a rate of 10
bacterial enteritis mg chlortetracycline
caused by E. coli and and 1 mg lasalocid
bacterial pneumonia per 2.2 lb. body
caused by P. weight daily to
multocida susceptible cattle with a maximum
to chlortetracycline; of 360 mg of
and for the control lasalocid per head
of coccidiosis caused per day. Do not allow
by Eimeria bovis and horses or other
E. zuernii. equines access to
feeds containing
lasalocid. No
withdrawal period is
required. A
withdrawal period has
not been established
for this product in
pre-ruminating
calves. Do not use in
calves to be
processed for veal.
See Sec. 558.311(d)
of this chapter.
Lasalocid as provided
by No. 054771 in Sec.
510.600(c) of this
chapter.
----------------------------------------------------------------------------------------------------------------
* * * * *
0
23. In Sec. 558.325, revise paragraph (d)(2) to read as follows:
Sec. 558.325 Lincomycin.
* * * * *
(d) * * *
(2) The expiration date of VFDs for lincomycin medicated feeds must
not exceed 6 months from the date of issuance. VFDs for lincomycin
shall not be refilled.
* * * * *
Sec. 558.575 [Amended]
0
24. In Sec. 558.575, in paragraph (e)(2)(ii) remove ``and bacterial
infections due to H. galmaxima,''.
Dated: March 21, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-06358 Filed 3-29-18; 8:45 am]
BILLING CODE 4164-01-P
