New Animal Drugs; Withdrawal of Approval of New Animal Drug Applications, 13637-13638 [2018-06357]
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13637
Federal Register / Vol. 83, No. 62 / Friday, March 30, 2018 / Rules and Regulations
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,’’.
■
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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
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21 CFR
section
522.1081
13638
Federal Register / Vol. 83, No. 62 / Friday, March 30, 2018 / Rules and Regulations
21 CFR
section
File No.
Sponsor
Product name
104–606 .........................
Watson Laboratories, Inc., 311 Bonnie Circle,
Corona, CA 92880.
Wildlife Laboratories, Inc., 1230 W. Ash St., suite
D, Windsor, CO 80550.
Dexamethasone Sodium Phosphate Injection .....
522.540
WILDNIL (carfentanil citrate) Injection .................
522.300
139–633 .........................
Therefore, under authority delegated
to the Commissioner of Food and Drugs,
and in accordance with § 514.116 Notice
of withdrawal of approval of application
(21 CFR 514.116), notice is given that
approval of NADAs 047–055, 104–606,
and 139–633, and all supplements and
amendments thereto, is hereby
withdrawn, effective April 9, 2018.
Elsewhere in this issue of the Federal
Register, FDA is amending the animal
drug regulations to reflect the voluntary
withdrawal of approval of these
applications.
Dated: March 21, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–06357 Filed 3–29–18; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HOMELAND
SECURITY
Coast Guard
33 CFR Part 100
[Docket No. USCG–2018–0235]
RIN 1625–AA08
Special Local Regulation; Wyandotte
Rowing Regatta; Detroit River, Trenton
Channel; Wyandotte, MI
Coast Guard, DHS.
Temporary final rule.
AGENCY:
ACTION:
The Coast Guard is
establishing a special local regulation
for certain waters of the Detroit River,
Trenton Channel, Wyandotte, MI. This
action is necessary and is intended to
ensure safety of life on navigable waters
to be used for a rowing event
immediately prior to, during, and
immediately after this event.
DATES: This temporary final rule is
effective from 8 a.m. until 11 a.m. on
April 21, 2018.
ADDRESSES: To view documents
mentioned in this preamble as being
available in the docket, go to https://
www.regulations.gov, type USCG–2018–
0235 in the ‘‘SEARCH’’ box and click
‘‘SEARCH.’’ Click on Open Docket
Folder on the line associated with this
rule.
FOR FURTHER INFORMATION CONTACT: If
you have questions on this temporary
amozie on DSK30RV082PROD with RULES
SUMMARY:
VerDate Sep<11>2014
18:02 Mar 29, 2018
Jkt 244001
rule, call or email Tracy Girard,
Prevention Department, Sector Detroit,
Coast Guard; telephone 313–568–9564,
or email Tracy.M.Girard@uscg.mil.
SUPPLEMENTARY INFORMATION:
safety and property. Therefore, the
COTP is establishing a Special Local
Regulation around the event location to
help minimize risks to safety of life and
property during this event.
I. Table of Abbreviations
IV. Discussion of the Rule
This rule establishes a temporary
special local regulation from 8 a.m. until
11 a.m. on April 21, 2018. In light of the
aforementioned hazards, the COTP has
determined that a special local
regulation is necessary to protect
spectators, vessels, and participants.
The special local regulation will
encompass the following waterway: All
waters of the Detroit River, Trenton
Channel between the following two
lines going from bank-to-bank: The first
line is drawn directly across the channel
from position 42°11.0′ N, 083°09.4′ W
(NAD 83); the second line, to the north,
is drawn directly across the channel
from position 42°11.7′ N, 083°08.9′ W
(NAD 83).
An on-scene representative of the
COTP may permit vessels to transit the
area when no race activity is occurring.
The on-scene representative may be
present on any Coast Guard, state, or
local law enforcement vessel assigned to
patrol the event. Vessel operators
desiring to transit through the regulated
area must contact the Coast Guard Patrol
Commander to obtain permission to do
so. The COTP or his designated onscene representative may be contacted
via VHF Channel 16 or at 313–568–
9560.
The COTP or his designated on-scene
representative will notify the public of
the enforcement of this rule by all
appropriate means, including a
Broadcast Notice to Mariners and Local
Notice to Mariners.
CFR Code of Federal Regulations
DHS Department of Homeland Security
FR Federal Register
NPRM Notice of Proposed Rulemaking
§ Section
COTP Captain of the Port
U.S.C. United States Code
II. Background Information and
Regulatory History
The Coast Guard is issuing this
temporary rule without prior notice and
opportunity to comment pursuant to
authority under section 4(a) of the
Administrative Procedure Act (APA) (5
U.S.C. 553(b)). This provision
authorizes an agency to issue a rule
without prior notice and opportunity to
comment when the agency for good
cause finds that those procedures are
‘‘impracticable, unnecessary, or contrary
to the public interest.’’ Under 5 U.S.C.
553(b)(B), the Coast Guard finds that
good cause exists for not publishing a
notice of proposed rulemaking (NPRM)
with respect to this rule because doing
so would be impracticable. The Coast
Guard did not receive the final details
of this rowing event until there was
insufficient time remaining before the
event to publish an NPRM. Thus,
delaying the effective date of this rule to
wait for a comment period to run would
be impracticable because it would
inhibit the Coast Guard’s ability to
protect participants, mariners and
vessels from the hazards associated with
this event. We are issuing this rule
under 5 U.S.C. 553(d)(3), as the Coast
Guard finds that good cause exists for
making it effective less than 30 days
after publication in the Federal Register
for the same reason noted above.
III. Legal Authority and Need for Rule
The Coast Guard is issuing this rule
under authority in 33 U.S.C. 1233. The
Captain of the Port Detroit (COTP) has
determined that the likely combination
of recreation vessels, commercial
vessels, and an unknown number of
spectators in close proximity to a youth
rowing regatta along the water pose
extra and unusual hazards to public
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V. Regulatory Analyses
We developed this rule after
considering numerous statutes and
Executive orders related to rulemaking.
Below we summarize our analyses
based on a number of these statutes and
Executive orders, and we discuss First
Amendment rights of protestors.
A. Regulatory Planning and Review
Executive Orders 12866 and 13563
direct agencies to assess the costs and
benefits of available regulatory
alternatives and, if regulation is
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[Federal Register Volume 83, Number 62 (Friday, March 30, 2018)]
[Rules and Regulations]
[Pages 13637-13638]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-06357]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
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.
ACTION: Notification of withdrawal.
-----------------------------------------------------------------------
SUMMARY: 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: Withdrawal of approval is effective April 9, 2018.
FOR FURTHER INFORMATION CONTACT: Sujaya Dessai, Center for Veterinary
Medicine (HFV-212), Food and Drug Administration, 7519 Standish Pl.,
Rockville, MD 20855, 240-402-5761, [email protected].
SUPPLEMENTARY INFORMATION: 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:
----------------------------------------------------------------------------------------------------------------
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.
[[Page 13638]]
104-606............................. Watson Laboratories, Inc., Dexamethasone Sodium 522.540
311 Bonnie Circle, Corona, Phosphate Injection.
CA 92880.
139-633............................. Wildlife Laboratories, Inc., WILDNIL (carfentanil 522.300
1230 W. Ash St., suite D, citrate) Injection.
Windsor, CO 80550.
----------------------------------------------------------------------------------------------------------------
Therefore, under authority delegated to the Commissioner of Food
and Drugs, and in accordance with Sec. 514.116 Notice of withdrawal of
approval of application (21 CFR 514.116), notice is given that approval
of NADAs 047-055, 104-606, and 139-633, and all supplements and
amendments thereto, is hereby withdrawn, effective April 9, 2018.
Elsewhere in this issue of the Federal Register, FDA is amending
the animal drug regulations to reflect the voluntary withdrawal of
approval of these applications.
Dated: March 21, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-06357 Filed 3-29-18; 8:45 am]
BILLING CODE 4164-01-P
