Implantation or Injectable Dosage Form New Animal Drugs; Withdrawal of Approval of New Animal Drug Application; Fomepizole, 18777 [2015-08024]
Download as PDF
<![CDATA[
18777
Federal Register / Vol. 80, No. 67 / Wednesday, April 8, 2015 / Rules and Regulations
Zilpaterol in
grams/ton
Combination in grams/ton
*
(9) 6.8 to 24 .......
*
Monensin 10 to 40, plus
tylosin 8 to 10, plus
melengestrol acetate to
provide 0.25 to 0.5 mg/
head/day.
Dated: April 3, 2015.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
Limitations
*
*
*
Heifers fed in confinement for slaughter: For
increased rate of weight gain, improved
feed efficiency, and increased carcass
leanness in cattle fed in confinement for
slaughter during the last 20 to 40 days on
feed; for prevention and control of coccidiosis due to Eimeria bovis and E.
zuernii; and for reduction of incidence of
liver abscesses caused by Fusobacterium
necrophorum
and
Arcanobacterium
(Actinomyces) pyogenes; and for suppression of estrus (heat).
*
Feed continuously to heifers
during the last 20 to 40
days on feed to provide 60
mg zilpaterol hydrochloride
per head per day. See
§§ 558.342(d), 558.355(d),
and 558.625(c). Monensin
and tylosin as provided by
No. 000986; melengestrol
acetate as provided by No.
054771 in § 510.600(c) of
this chapter. Withdrawal
period: 3 days.
Therefore, under authority delegated
to the Commissioner of Food and Drugs
and redelegated to the Center for
Veterinary Medicine, and in accordance
with § 514.116 Notice of withdrawal of
approval of application (21 CFR
514.116), notice is given that approval
of NADA 141–075, and all supplements
and amendments thereto, is hereby
withdrawn.
Elsewhere in this issue of the Federal
Register, FDA is amending the animal
drug regulations to reflect the voluntary
withdrawal of approval of this
application.
[FR Doc. 2015–08025 Filed 4–7–15; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 522
[Docket No. FDA–2015–N–0002]
Implantation or Injectable Dosage
Form New Animal Drugs; Withdrawal
of Approval of New Animal Drug
Application; Fomepizole
AGENCY:
Indications for use
Food and Drug Administration,
Dated: April 3, 2015.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2015–08024 Filed 4–7–15; 8:45 am]
BILLING CODE 4164–01–P
HHS.
ACTION:
Notification of withdrawal.
The Food and Drug
Administration (FDA) is withdrawing
approval of a new animal drug
application (NADA) for a fomepizole
injectable solution used as an antidote
for ethylene glycol poisoning in dogs.
This action is being taken at the
sponsor’s request because this product
is no longer manufactured or marketed.
DATES: Withdrawal of approval is
effective April 20, 2015.
FOR FURTHER INFORMATION CONTACT:
Sujaya Dessai, Center for Veterinary
Medicine (HFV–212), Food and Drug
Administration, 7519 Standish Pl.,
Rockville, MD 20855, 240–276–9075,
sujaya.dessai@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Paladin
Labs (USA), Inc., 160 Greentree Dr.,
suite 101, Dover, DE 19904 has
requested that FDA withdraw approval
of NADA 141–075 for ANTIZOL–VET
(fomepizole) Injection because the
product is no longer manufactured or
marketed.
asabaliauskas on DSK5VPTVN1PROD with RULES
SUMMARY:
VerDate Sep<11>2014
16:24 Apr 07, 2015
Jkt 235001
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Parts 260 and 261
[EPA–HQ–RCRA–2015–0118; FRL_9923–12–
OSWER]
Response to Vacaturs of the
Comparable Fuels Rule and the
Gasification Rule
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
The Environmental Protection
Agency (EPA) is revising regulations
associated with the comparable fuels
exclusion and the gasification
exclusion, originally issued by EPA
under the Resource Conservation and
Recovery Act (RCRA). These revisions
implement vacaturs ordered by the
United States Court of Appeals for the
District of Columbia Circuit (D.C.
Circuit), on June 27, 2014.
DATES: Effective April 8, 2015.
SUMMARY:
PO 00000
Frm 00005
Fmt 4700
Sfmt 4700
Sponsor
*
000061
EPA has established a
docket for this action under Docket ID
No. EPA–HQ–RCRA–2015–0118. All
documents in the docket are listed in
the www.regulations.gov index.
Although listed in the index, some
information is not publicly available,
e.g., Confidential Business Information
(CBI) or other information whose
disclosure is restricted by statute.
Certain other material, such as
copyrighted material, is not placed on
the internet and will be publicly
available only in hard copy form.
Publicly available docket materials are
available either electronically through
www.regulations.gov or in hard copy at
the EPA Docket Center, EPA/DC, WJC
West Building, Room 3334, 1301
Constitution Ave. NW., Washington,
DC. The Public Reading Room is open
from 8:30 a.m. to 4:30 p.m. Monday
through Friday, excluding legal
holidays. The telephone number for the
Public Reading Room is (202) 566–1744
and the telephone number for the RCRA
Docket is (202) 566–0270.
ADDRESSES:
FOR FURTHER INFORMATION CONTACT:
Office of Resource Conservation and
Recovery, Materials Recovery and Waste
Management Division, MC 5304P,
Environmental Protection Agency, 1200
Pennsylvania Ave. NW., Washington,
DC 20460, Tracy Atagi, at (703) 308–
8672, (atagi.tracy@epa.gov) or Frank
Behan, at (703) 308–8476, behan.frank@
epa.gov.
SUPPLEMENTARY INFORMATION:
Preamble Outline
I. General Information
II. Statutory Authority
III. Which regulations is EPA removing?
IV. Background on the Comparable Fuels
Rule and the Gasification Rule
V. When will the final rule become effective?
VI. State Authorization
VII. Statutory and Executive Order (EO)
Reviews
E:\FR\FM\08APR1.SGM
08APR1
]]>Agencies
[Federal Register Volume 80, Number 67 (Wednesday, April 8, 2015)]
[Rules and Regulations]
[Page 18777]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2015-08024]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 522
[Docket No. FDA-2015-N-0002]
Implantation or Injectable Dosage Form New Animal Drugs;
Withdrawal of Approval of New Animal Drug Application; Fomepizole
AGENCY: Food and Drug Administration, HHS.
ACTION: Notification of withdrawal.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is withdrawing approval
of a new animal drug application (NADA) for a fomepizole injectable
solution used as an antidote for ethylene glycol poisoning in dogs.
This action is being taken at the sponsor's request because this
product is no longer manufactured or marketed.
DATES: Withdrawal of approval is effective April 20, 2015.
FOR FURTHER INFORMATION CONTACT: Sujaya Dessai, Center for Veterinary
Medicine (HFV-212), Food and Drug Administration, 7519 Standish Pl.,
Rockville, MD 20855, 240-276-9075, sujaya.dessai@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Paladin Labs (USA), Inc., 160 Greentree Dr.,
suite 101, Dover, DE 19904 has requested that FDA withdraw approval of
NADA 141-075 for ANTIZOL-VET (fomepizole) Injection because the product
is no longer manufactured or marketed.
Therefore, under authority delegated to the Commissioner of Food
and Drugs and redelegated to the Center for Veterinary Medicine, and in
accordance with Sec. 514.116 Notice of withdrawal of approval of
application (21 CFR 514.116), notice is given that approval of NADA
141-075, and all supplements and amendments thereto, is hereby
withdrawn.
Elsewhere in this issue of the Federal Register, FDA is amending
the animal drug regulations to reflect the voluntary withdrawal of
approval of this application.
Dated: April 3, 2015.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2015-08024 Filed 4-7-15; 8:45 am]
BILLING CODE 4164-01-P
