Oral Dosage Form New Animal Drugs; Withdrawal of Approval of New Animal Drug Application; Oxytetracycline, 74021 [2014-29248]
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Federal Register / Vol. 79, No. 240 / Monday, December 15, 2014 / Rules and Regulations
(b) Sponsors. See sponsors in
§ 510.600(c) of this chapter for use as in
paragraph (c) of this section.
(1) No. 053599 for use of in 2 mg/mL
solution as in paragraph (c)(1) of this
section.
(2) No. 053923 for use of in 5 mg/mL
solution as in paragraph (c)(2) of this
section.
(c) Conditions of use—(1) Dogs—(i)
Amount. Administer 0.05 mg per pound
(0.11 mg per kilogram) of body weight
by intravenous injection.
(ii) Indications for use. To reverse the
effects of xylazine in dogs.
(iii) Limitations. Not for use in foodproducing animals. Federal law restricts
this drug to use by or on the order of
a licensed veterinarian.
(2) Deer and elk—(i) Amount.
Administer 0.2 to 0.3 mg per kilogram
of body weight by intravenous injection.
(ii) Indications for use. A s an
antagonist to xylazine sedation in free
ranging or confined members of the
family Cervidae (deer and elk).
(iii) Limitations. Do not use in
domestic food-producing animals. Do
not use for 30 days before or during
hunting season. Federal law restricts
this drug to use by or on the order of
a licensed veterinarian.
PART 558—NEW ANIMAL DRUGS FOR
USE IN ANIMAL FEEDS
20. The authority citation for 21 CFR
part 558 continues to read as follows:
■
Authority: 21 U.S.C. 360b, 371.
§ 558.76
[Amended]
21. In § 558.76, in paragraph (d)(1)(x),
in the entry for ‘‘Quail’’, in the
‘‘Limitations’’ column, remove the first
sentence.
■
§ 558.105
[Removed]
22. Remove reserved § 558.105.
■ 23. In § 558.355, add paragraph
(f)(1)(xxxi) to read as follows:
■
§ 558.355
Monensin.
tkelley on DSK3SPTVN1PROD with RULES
*
*
*
*
*
(f) * * *
(1) * * *
(xxxi) Amount per ton. Monensin, 90
to 110 grams; plus virginiamycin, 20
grams.
(a) Indications for use. Broiler
chickens: As an aid in the prevention of
coccidiosis caused by E. necatrix, E.
tenella, E. acervulina, E. brunetti, E.
mivati, and E. maxima; and for
prevention of necrotic enteritis caused
by Clostridium perfringens susceptible
to virginiamycin.
(b) Limitations. Feed continuously as
sole ration. Do not feed to laying
chickens. See paragraph (d) of this
VerDate Sep<11>2014
17:02 Dec 12, 2014
Jkt 235001
section. As monensin provided by No.
000986; virginiamycin as provided by
No. 066104 in § 510.600(c) of this
chapter.
*
*
*
*
*
Dated: December 9, 2014.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2014–29249 Filed 12–12–14; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
74021
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 ANADA 200–305, and all
supplements and amendments thereto,
is hereby withdrawn, effective
December 26, 2014.
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: December 9, 2014.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2014–29248 Filed 12–12–14; 8:45 am]
21 CFR Part 520
BILLING CODE 4164–01–P
[Docket No. FDA–2014–N–0002]
Oral Dosage Form New Animal Drugs;
Withdrawal of Approval of New Animal
Drug Application; Oxytetracycline
AGENCY:
Food and Drug Administration,
HHS.
Notification of withdrawal of
approval.
ACTION:
The Food and Drug
Administration (FDA) is withdrawing
approval of an abbreviated new animal
drug application (ANADA) for an
oxytetracycline soluble powder used to
make medicated drinking water for
livestock and poultry. 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 December 26, 2014.
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:
´
Vetoquinol N.-A., Inc., 2000 chemin
Georges, Lavaltrie (PQ), Canada, J5T 3S5
has requested that FDA withdraw
approval of ANADA 200–305 for
Oxytetracycline Hydrochloride Soluble
Powder because the product is no longer
manufactured or marketed. Note this
ANADA was identified as being affected
by guidance for industry (GFI) #213,
‘‘New Animal Drugs and New Animal
Drug Combination Products
Administered in or on Medicated Feed
or Drinking Water of Food-Producing
Animals: Recommendations for Drug
Sponsors for Voluntarily Aligning
Product Use Conditions with GFI #209’’,
December 2013.
Therefore, under authority delegated
to the Commissioner of Food and Drugs
and redelegated to the Center for
SUMMARY:
PO 00000
Frm 00007
Fmt 4700
Sfmt 4700
PENSION BENEFIT GUARANTY
CORPORATION
29 CFR Parts 4022 and 4044
Allocation of Assets in SingleEmployer Plans; Benefits Payable in
Terminated Single-Employer Plans;
Interest Assumptions for Valuing and
Paying Benefits
Pension Benefit Guaranty
Corporation.
ACTION: Final rule.
AGENCY:
This final rule amends the
Pension Benefit Guaranty Corporation’s
regulations on Benefits Payable in
Terminated Single-Employer Plans and
Allocation of Assets in Single-Employer
Plans to prescribe interest assumptions
under the benefit payments regulation
for valuation dates in January 2015 and
interest assumptions under the asset
allocation regulation for valuation dates
in the first quarter of 2015. The interest
assumptions are used for valuing and
paying benefits under terminating
single-employer plans covered by the
pension insurance system administered
by PBGC.
DATES: Effective January 1, 2015.
FOR FURTHER INFORMATION CONTACT:
Catherine B. Klion (Klion.Catherine@
PBGC.gov), Assistant General Counsel
for Regulatory Affairs, Pension Benefit
Guaranty Corporation, 1200 K Street
NW., Washington, DC 20005, 202–326–
4024. (TTY/TDD users may call the
Federal relay service toll free at 1–800–
877–8339 and ask to be connected to
202–326–4024.)
SUPPLEMENTARY INFORMATION: PBGC’s
regulations on Allocation of Assets in
Single-Employer Plans (29 CFR part
4044) and Benefits Payable in
Terminated Single-Employer Plans (29
CFR part 4022) prescribe actuarial
SUMMARY:
E:\FR\FM\15DER1.SGM
15DER1
]]>Agencies
[Federal Register Volume 79, Number 240 (Monday, December 15, 2014)]
[Unknown Section]
[Page 74021]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-29248]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 520
[Docket No. FDA-2014-N-0002]
Oral Dosage Form New Animal Drugs; Withdrawal of Approval of New
Animal Drug Application; Oxytetracycline
AGENCY: Food and Drug Administration, HHS.
ACTION: Notification of withdrawal of approval.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is withdrawing approval
of an abbreviated new animal drug application (ANADA) for an
oxytetracycline soluble powder used to make medicated drinking water
for livestock and poultry. 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 December 26, 2014.
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: V[eacute]toquinol N.-A., Inc., 2000 chemin
Georges, Lavaltrie (PQ), Canada, J5T 3S5 has requested that FDA
withdraw approval of ANADA 200-305 for Oxytetracycline Hydrochloride
Soluble Powder because the product is no longer manufactured or
marketed. Note this ANADA was identified as being affected by guidance
for industry (GFI) #213, ``New Animal Drugs and New Animal Drug
Combination Products Administered in or on Medicated Feed or Drinking
Water of Food-Producing Animals: Recommendations for Drug Sponsors for
Voluntarily Aligning Product Use Conditions with GFI #209'', December
2013.
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 ANADA
200-305, and all supplements and amendments thereto, is hereby
withdrawn, effective December 26, 2014.
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: December 9, 2014.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2014-29248 Filed 12-12-14; 8:45 am]
BILLING CODE 4164-01-P
