New Animal Drugs; Withdrawal of Approval of a New Animal Drug Application, 12170-12171 [2017-03931]
Download as PDF
<![CDATA[
12170
Federal Register / Vol. 82, No. 39 / Wednesday, March 1, 2017 / Rules and Regulations
‘‘000409, 054771, and 068330’’ and in
its place add ‘‘054771 and 068330’’.
14. In § 522.2075, revise paragraph (c)
to read as follows:
■
§ 522.2075
Robenacoxib.
*
*
*
*
*
(c) Conditions of use—(1) Dogs—(i)
Amount. Administer 0.91 mg per pound
(2 mg/kilogram (kg)) by subcutaneous
injection, once daily, for a maximum of
3 days. After the initial subcutaneous
dose, subsequent doses can be given by
subcutaneous injection or as the oral
tablet in dogs weighing at least 5.5
pounds (2.5 kg) and at least 4 months of
age, for a maximum of 3 total doses over
3 days, not to exceed 1 dose per day.
See § 520.2075(c)(1) of this chapter.
(ii) Indications for use. For the control
of postoperative pain and inflammation
associated with soft tissue surgery in
Lincomycin
grams/ton
*
*
PART 529—CERTAIN OTHER DOSAGE
FORM NEW ANIMAL DRUGS
15. The authority citation for part 529
continues to read as follows:
■
Combination
in grams/ton
*
(ii) 2 .........................
*
dogs at least 4 months of age for a
maximum of 3 days.
(iii) Limitations. Federal law restricts
this drug to use by or on the order of
a licensed veterinarian.
(2) Cats—(i) Amount. Administer 0.91
mg per pound (2 mg/kg) by
subcutaneous injection, once daily, for a
maximum of 3 days.
(ii) Indications for use. For the control
of postoperative pain and inflammation
associated with orthopedic surgery,
ovariohysterectomy, and castration in
cats at least 4 months of age for a
maximum of 3 days.
(iii) Limitations. Federal law restricts
this drug to use by or on the order of
a licensed veterinarian.
*
*
Halofuginone 2.72
*
§ 529.1186
[Amended]
16. Effective March 13, 2017, in
§ 529.1186, in paragraph (b), remove
‘‘010019,’’.
■
PART 558—NEW ANIMAL DRUGS FOR
USE IN ANIMAL FEEDS
17. The authority citation for part 558
continues to read as follows:
■
Authority: 21 U.S.C. 354, 360b, 360ccc,
360ccc–1, 371.
18. In § 558.325, revise paragraph
(e)(1)(ii) to read as follows:
■
§ 558.325
*
Lincomycin.
*
*
(e) * * *
(1) * * *
*
*
Indications for use
Limitations
*
*
Broiler chickens: For the control of necrotic enteritis caused or complicated
by Clostridium spp. or other organisms susceptible to lincomycin; and
the prevention of coccidiosis caused
by Eimeria tenella, E. necatrix, E.
acervulina, E. brunetti, E. mivati, and
E. maxima.
*
*
Feed continuously as sole ration. Withdraw 4 days before slaughter. Do not
feed to laying chickens or waterfowl.
Halofuginone hydrobromide as provided by No. 016592 in § 510.600 of
this chapter.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Dated: February 23, 2017.
Leslie Kux,
Associate Commissioner for Policy.
Authority: 21 U.S.C. 360b.
Food and Drug Administration
[FR Doc. 2017–03930 Filed 2–28–17; 8:45 am]
21 CFR Parts 510, 522, and 529
BILLING CODE 4164–01–P
[Docket No. FDA–2017–N–0002]
New Animal Drugs; Withdrawal of
Approval of a New Animal Drug
Application
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notification of withdrawal.
The Food and Drug
Administration (FDA) is withdrawing
approval of a new animal drug
application (NADA) and an abbreviated
SUMMARY:
Sponsor
*
016592
new animal drug application (ANADA)
at the sponsors’ requests because the
products are no longer manufactured or
marketed.
DATES: Withdrawal of approval is
effective March 13, 2017.
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,sujaya.dessai@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: The
sponsors of the following applications
have requested that FDA withdraw
approval of the NADA and ANADA
listed in the following table because the
products are no longer manufactured or
marketed:
21 CFR
section
jstallworth on DSK7TPTVN1PROD with RULES
File No.
Sponsor
Product name
135–773 .........................................
Baxter Healthcare Corp., One Baxter Pkwy., Deerfield, IL 60015.
Hospira, Inc., 275 North Field Dr., Lake Forest, IL
60045.
AERRANE (isoflurane USP) ..........
529.1186
Ceftiofur (ceftiofur Na) for Injection
522.313c
200–421 .........................................
VerDate Sep<11>2014
14:27 Feb 28, 2017
Jkt 241001
PO 00000
Frm 00004
Fmt 4700
Sfmt 4700
E:\FR\FM\01MRR1.SGM
01MRR1
Federal Register / Vol. 82, No. 39 / Wednesday, March 1, 2017 / Rules and Regulations
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 135–773 and ANADA 200–
421, and all supplements and
amendments thereto, is hereby
withdrawn, effective March 13, 2017.
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: February 23, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017–03931 Filed 2–28–17; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 876
[Docket No. FDA–2016–N–4661]
Gastroenterology-Urology Devices;
Manual Gastroenterology-Urology
Surgical Instruments and Accessories
AGENCY:
Food and Drug Administration,
HHS.
Final rule; technical
amendment.
ACTION:
The Food and Drug
Administration (FDA) is amending the
identification of manual
gastroenterology-urology surgical
instruments and accessories to reflect
that the device does not include
specialized surgical instrumentation for
use with urogyencologic surgical mesh
specifically intended for use as an aid
in the insertion, placement, fixation, or
anchoring of surgical mesh during
urogynecologic procedures
(‘‘specialized surgical instrumentation
for use with urogynecologic surgical
mesh’’). These amendments are being
made to reflect changes made in the
recently issued final reclassification
order for specialized surgical
instrumentation for use with
urogynecologic surgical mesh.
DATES: This rule is effective March 1,
2017.
FOR FURTHER INFORMATION CONTACT:
Sharon Andrews, Center for Devices and
Radiological Health, 10903 New
Hampshire Ave., Bldg. 66, Rm. G110,
Silver Spring, MD 20993, 301–796–
6529, Sharon.Andrews@fda.hhs.gov.
jstallworth on DSK7TPTVN1PROD with RULES
SUMMARY:
VerDate Sep<11>2014
14:27 Feb 28, 2017
Jkt 241001
FDA is
amending § 876.4730 (21 CFR 876.4730,
Manual gastroenterology-urology
surgical instrument and accessories), by
adding language to the identification of
the device to reflect that specialized
surgical instrumentation for use with
urogynecologic surgical mesh is no
longer regulated under § 876.4730.
In the Federal Register of November
23, 1983 (48 FR 53012), FDA issued a
final rule classifying manual
gastroenterology-urology surgical
instrument and accessories into class I
under § 876.4730 (48 FR 53012 at
53025). Certain specialized surgical
instrumentation for use with
urogynecologic surgical mesh was
regulated as class I devices under that
regulation. In the Federal Register of
January 6, 2017 (82 FR 1598), FDA
issued a final order reclassifying
specialized surgical instrumentation for
use with urogynecologic surgical mesh
from class I (general controls) exempt
from premarket notification to class II
(special controls) and subject to
premarket notification. As a result of
that final reclassification order, FDA is
amending the identification at
§ 876.4730(a) to reflect that specialized
surgical instrumentation for use with
urogynecologic surgical mesh is now
regulated under 21 CFR 884.4910.
FDA finds good cause for issuing this
amendment as a final rule without
notice and comment because this rule
only updates the identification of the
device under § 876.4730 to reflect
changes made in the recently issued
final reclassification order for
specialized surgical instrumentation for
use with urogynecologic surgical mesh
(5 U.S.C. 553(b)(B)). In addition, FDA
finds good cause for this amendment to
become effective on the date of
publication of this action. The
Administrative Procedure Act allows an
effective date less than 30 days after
publication as ‘‘provided by the agency
for good cause found and published
with the rule’’ (5 U.S.C. 553(d)(3)). A
delayed effective date is unnecessary in
this case because the amendment to
§ 876.4730 does not impose any new
regulatory requirements on affected
parties. As a result, affected parties do
not need time to prepare before the rule
takes effect. Therefore, FDA finds good
cause for this amendment to become
effective on the date of publication of
this action.
SUPPLEMENTARY INFORMATION:
List of Subjects in 21 CFR Part 876
Gastroenterology-urology devices,
Medical devices.
Therefore, under the Federal Food,
Drug, and Cosmetic Act and under
authority delegated to the Commissioner
PO 00000
Frm 00005
Fmt 4700
Sfmt 4700
12171
of Food and Drugs, 21 CFR part 876 is
amended as follows:
PART 876—GASTROENTEROLOGYUROLOGY DEVICES
1. The authority citation for part 876
continues to read as follows:
■
Authority: 21 U.S.C. 351, 360, 360c, 360e,
360j, 360l, 371.
2. Amend § 876.4730 by revising
paragraph (a) to read as follows:
■
§ 876.4730 Manual gastroenterologyurology surgical instrument and
accessories.
(a) Identification. A manual
gastroenterology-urology surgical
instrument and accessories is a device
designed to be used for
gastroenterological and urological
surgical procedures. The device may be
nonpowered, hand-held, or handmanipulated. Manual gastroenterologyurology surgical instruments include the
biopsy forceps cover, biopsy tray
without biopsy instruments, line clamp,
nonpowered rectal probe, nonelectrical
clamp, colostomy spur-crushers, locking
device for intestinal clamp, needle
holder, gastro-urology hook, gastrourology probe and director, nonselfretaining retractor, laparotomy rings,
nonelectrical snare, rectal specula,
bladder neck spreader, self-retaining
retractor, and scoop. A manual surgical
instrument that is intended specifically
for use as an aid in the insertion,
placement, fixation, or anchoring of
surgical mesh during urogynecologic
procedures are classified under
§ 884.4910 of this chapter.
*
*
*
*
*
Dated: February 23, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017–03997 Filed 2–28–17; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
21 CFR Part 1308
[Docket No. DEA–436]
Schedules of Controlled Substances:
Placement of 10 Synthetic Cathinones
Into Schedule I
Drug Enforcement
Administration, Department of Justice.
ACTION: Final rule.
AGENCY:
With the issuance of this final
rule, the Drug Enforcement
Administration places 10 synthetic
SUMMARY:
E:\FR\FM\01MRR1.SGM
01MRR1
]]>Agencies
[Federal Register Volume 82, Number 39 (Wednesday, March 1, 2017)]
[Rules and Regulations]
[Pages 12170-12171]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-03931]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 510, 522, and 529
[Docket No. FDA-2017-N-0002]
New Animal Drugs; Withdrawal of Approval of a New Animal Drug
Application
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) and an abbreviated new animal
drug application (ANADA) at the sponsors' requests because the products
are no longer manufactured or marketed.
DATES: Withdrawal of approval is effective March 13, 2017.
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,sujaya.dessai@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: The sponsors of the following applications
have requested that FDA withdraw approval of the NADA and ANADA listed
in the following table because the products are no longer manufactured
or marketed:
----------------------------------------------------------------------------------------------------------------
21 CFR
File No. Sponsor Product name section
----------------------------------------------------------------------------------------------------------------
135-773................................. Baxter Healthcare Corp., AERRANE (isoflurane USP).. 529.1186
One Baxter Pkwy.,
Deerfield, IL 60015.
200-421................................. Hospira, Inc., 275 North Ceftiofur (ceftiofur Na) 522.313c
Field Dr., Lake Forest, for Injection.
IL 60045.
----------------------------------------------------------------------------------------------------------------
[[Page 12171]]
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
135-773 and ANADA 200-421, and all supplements and amendments thereto,
is hereby withdrawn, effective March 13, 2017.
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: February 23, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-03931 Filed 2-28-17; 8:45 am]
BILLING CODE 4164-01-P
