Withdrawal of Approval of New Animal Drug Applications; Chorionic Gonadotropin; Naloxone; Oxymorphone; Oxytocin, 55481-55482 [2012-22195]
Download as PDF
<![CDATA[
55481
Federal Register / Vol. 77, No. 175 / Monday, September 10, 2012 / Notices
requirements of the applicable statutes
and regulations.
III. Paperwork Reduction Act of 1995
Under the Paperwork Reduction Act
of 1995 (the PRA) (44 U.S.C. 3501–
3520), Federal Agencies must obtain
approval from the Office of Management
and Budget (OMB) for each collection of
information they conduct or sponsor.
‘‘Collection of information’’ is defined
in 44 U.S.C. 3502(3) and 5 CFR 1320.3
and includes Agency requests or
requirements that members of the public
submit reports, keep records, or provide
information to a third party. Section
3506(c)(2)(A) of the PRA (44 U.S.C. 3506
(c)(2)(A)) requires Federal Agencies to
provide a 60-day notice in the Federal
Register concerning each proposed
collection of information before
submitting the collection to OMB for
approval. To comply with this
requirement, we are publishing a notice
of the proposed collection of
information set forth below.
With respect to the following
collection of information, we invite
comments on: (1) Whether the proposed
collection of information is necessary
for the proper performance of our
functions, including whether the
information will have practical utility;
(2) the accuracy of our estimate of the
burden of the proposed collection of
information, including the validity of
the methodology and assumptions used;
(3) ways to enhance the quality, utility,
and clarity of the information to be
collected; and (4) ways to minimize the
burden of the collection of information
on respondents, including through the
use of automated collection techniques,
when appropriate, and other forms of
information technology.
Title: Draft Compliance Policy Guide
on Labeling and Marketing of
Nutritional Products Intended for Use to
Diagnose, Cure, Mitigate, Treat, or
Prevent Disease in Dogs and Cats.
Description: The purpose of this CPG
is to communicate FDA’s strategy with
respect to dog and cat food products
that are labeled and/or marketed as
intending to diagnose, cure, mitigate,
treat, or prevent diseases and to provide
nutrients in support of meeting the
animal’s total daily nutrient
requirements.
Description of Respondents:
Manufacturers of dog and cat foods that
are labeled and/or marketed as
intending to diagnose, cure, mitigate,
treat, or prevent diseases and to provide
nutrients in support of meeting the
animal’s total daily nutrient
requirements.
We estimate the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Sections 402 and 403 of the FD&C Act ..............................
mstockstill on DSK4VPTVN1PROD with NOTICES
1 There
Number of
responses per
respondent
Number of
respondents
Activity
5
Total annual
responses
75
Average
burden per
response
375
Total hours
.25
94
are no operating costs or maintenance costs associated with this collection of information.
CVM estimates from its experience
that approximately 5 manufacturers will
be affected by the draft CPG, times 75
products produced annually equals 375
total annual responses. The hours per
response are based on approximately .25
hour per response for respondents to
look up the ingredient names in the
AFFCO Official Publication.
This draft CPG also refers to
previously approved collections of
information found in FDA regulations.
These collections of information are
subject to review by the Office of
Management and Budget (OMB) under
the Paperwork Reduction Act of 1995
(44 U.S.C. 3501–3520). The collections
of information in 21 CFR part 571 (Food
Additive Petitions and FAP Labeling)
have been approved under OMB control
number 0910–0546. The collection of
information in 21 CFR 570.35 (GRAS)
has been approved under OMB control
number 0910–0342. The requirement for
food facility registration has been
approved under OMB control number
0910–0502.
comments. Received comments may be
seen in the Division of Dockets
Management between 9 a.m. and 4 p.m.,
Monday through Friday.
V. Electronic Access
Dated: August 24, 2012.
Dara A. Corrigan,
Associate Commissioner for Regulatory
Affairs.
[FR Doc. 2012–22231 Filed 9–7–12; 8:45 am]
BILLING CODE 4160–01–P
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES) electronic or written
comments regarding this document. It is
only necessary to send one set of
16:57 Sep 07, 2012
Jkt 226001
PO 00000
Frm 00031
Fmt 4703
Food and Drug Administration
[Docket No. FDA–2012–N–0902]
Copies of the CPG may be
downloaded to a personal computer
with access to the Internet. The Office
of Regulatory Affairs home pages
include this draft CPG and may be
accessed at https://www.fda.gov/ICECI/
ComplianceManuals/ under
‘‘Compliance Policy Guides.’’
IV. Comments
VerDate Mar<15>2010
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Sfmt 4703
Withdrawal of Approval of New Animal
Drug Applications; Chorionic
Gonadotropin; Naloxone;
Oxymorphone; Oxytocin
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is withdrawing
approval of four new animal drug
applications (NADAs) at the sponsor’s
request because the products are no
longer manufactured or marketed.
DATES: Withdrawal of approval is
effective September 20, 2012.
FOR FURTHER INFORMATION CONTACT:
David Alterman, Center for Veterinary
Medicine (HFV–212), Food and Drug
Administration, 7519 Standish Pl.,
Rockville, MD 20855, 240–453–6843,
email: david.alterman@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: The
sponsors in table 1 of this document
have requested that FDA withdraw
approval of the four NADAs listed
SUMMARY:
E:\FR\FM\10SEN1.SGM
10SEN1
55482
Federal Register / Vol. 77, No. 175 / Monday, September 10, 2012 / Notices
because the products are no longer
manufactured or marketed.
TABLE 1—WITHDRAWAL OF APPROVAL REQUESTS
NADA No.
Trade name (drug)
Applicant
030–525 ...............................
NUMORPHAN (oxymorphone hydrochloride) Injection ..
035–825 ...............................
NARCAN (naloxone hydrochloride) Injection ..................
046–822 ...............................
VETOCIN (oxytocin) Injection .........................................
103–090 ...............................
CHORTROPIN (chorionic gonadotropin) Injection .........
Endo Pharmaceuticals Inc., 100 Painters Dr., Chadds
Ford, PA 19317.
Endo Pharmaceuticals Inc., 100 Painters Dr., Chadds
Ford, PA 19317.
United Vaccines, A Harlan Sprague Dawley, Inc., Co.,
P.O. Box 4220, Madison, WI 53711.
United Vaccines, A Harlan Sprague Dawley, Inc., Co.,
P.O. Box 4220, Madison, WI 53711.
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 NADAs 030–525, 035–825, 046–822,
and 103–090, and all supplements and
amendments thereto, is hereby
withdrawn, effective September 20,
2012.
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: September 5, 2012.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2012–22195 Filed 9–7–12; 8:45 am]
BILLING CODE 4160–01–P
[FR Doc. 2012–22167 Filed 9–7–12; 8:45 am]
Substance Abuse and Mental Health
Services Administration
BILLING CODE 4162–20–P
mstockstill on DSK4VPTVN1PROD with NOTICES
Center for Substance Abuse
Prevention; Notice of Meeting
Pursuant to Public Law 92–463,
notice is hereby given that the
Substance Abuse and Mental Health
Services Administration’s (SAMHSA)
Center for Substance Abuse Prevention
(CSAP) Drug Testing Advisory Board
(DTAB) will meet on September 24,
2012 from 9 a.m. to 5 p.m. and
September 25, 2012 from 9 a.m. to 2
p.m. E.D.T.
The Board will discuss proposed
revisions to the Mandatory Guidelines
for Federal Workplace Drug Testing
Programs. Therefore, this meeting is
closed to the public as determined by
the Administrator, SAMHSA, in
accordance with 5 U.S.C. 552b(c)(9)(B)
and 5 U.S.C. App. 2, Section 10(d).
Meeting information and a roster of
DTAB members may be obtained by
16:57 Sep 07, 2012
Jkt 226001
Committee Name: Substance Abuse and
Mental Health Services Administration’s
Center for Substance Abuse Prevention, Drug
Testing Advisory Board.
Dates/Time/Type: September 24, 2012
from 9 a.m. to 5 p.m. E.D.T.: CLOSED,
September 25, 2012 from 9 a.m. to 2 p.m.
E.D.T.: CLOSED.
Place: Sugarloaf Conference Room,
SAMHSA Office Building, 1 Choke Cherry
Road, Rockville, Maryland 20857.
Contact: Janine Denis Cook, Ph.D.,
Designated Federal Official, CSAP Drug
Testing Advisory Board, 1 Choke Cherry
Road, Room 7–1043, Rockville, Maryland
20857, Telephone: 240–276–2600, Fax: 240–
276–2610, Email:
janine.cook@samhsa.hhs.gov.
Janine Denis Cook,
Designated Federal Official, DTAB, Division
of Workplace Programs, Center for Substance
Abuse Prevention, Substance Abuse and
Mental Health Services Administration.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
VerDate Mar<15>2010
accessing the SAMHSA Advisory
Committees’ Web site, https://
www.nac.samhsa.gov/DTAB/
meetings.aspx, or by contacting Dr.
Cook.
DEPARTMENT OF HOMELAND
SECURITY
Coast Guard
[Docket No. USCG–2012–0782]
Public Workshop on Marine
Technology and Standards
Coast Guard, DHS.
Notice.
AGENCY:
ACTION:
The American Society of
Mechanical Engineers (ASME), in
coordination with the United States
Coast Guard (USCG), is sponsoring a
two-day public workshop on marine
technology and standards in Arlington,
VA. This public workshop will provide
a unique opportunity for classification
societies, industry groups, standards
development organizations, government
SUMMARY:
PO 00000
Frm 00032
Fmt 4703
Sfmt 4703
organizations, and other interested
members of the public to come together
for a professional exchange of
information on topics ranging from
technological impacts on the marine
industry, corresponding coverage in
related codes and standards, and
government regulations.
The two-day workshop will be
held on Wednesday, July 24, 2013, and
Thursday, July 25, 2013. The deadline
for advance registration is Monday, July,
1, 2013. If you are interested in
presenting a paper at the workshop, you
must submit a 100 word abstract by
email to workshop@uscg.mil. Abstracts
are due on or before November 2, 2012.
See SUPPLEMENTARY INFORMATION
below for other dates related to
submission of abstracts, draft papers,
and presentations, as well as more
information on how to register for the
workshop.
DATES:
The workshop will be held
at The Double Tree by Hilton Hotel, in
the Crystal City neighborhood of
Arlington VA. The hotel is located at
300 Army Navy Drive, Arlington, VA;
the hotel phone number is (703) 416–
4100. The hotel is located
approximately three miles from Ronald
Reagan Washington National Airport
(DCA) and approximately four blocks
from the Pentagon City Metro station.
For registration information or to obtain
further information about this
workshop, visit the USCG Web site at
https://www.uscg.mil/marine_event. The
docket for this notice is available for
inspection or copying at the Docket
Management Facility (M–30), U.S.
Department of Transportation, West
Building Ground Floor, Room W12–140,
1200 New Jersey Avenue SE,
Washington, DC 20590, between 9 a.m.
and 5 p.m., Monday through Friday,
except Federal holidays. You may also
find this docket on the Internet by going
to https://www.regulations.gov, inserting
USCG–2012–0782 in the ‘‘Search’’ box,
and then clicking ‘‘Search.’’
ADDRESSES:
E:\FR\FM\10SEN1.SGM
10SEN1
]]>Agencies
[Federal Register Volume 77, Number 175 (Monday, September 10, 2012)]
[Notices]
[Pages 55481-55482]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-22195]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2012-N-0902]
Withdrawal of Approval of New Animal Drug Applications; Chorionic
Gonadotropin; Naloxone; Oxymorphone; Oxytocin
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is withdrawing approval
of four new animal drug applications (NADAs) at the sponsor's request
because the products are no longer manufactured or marketed.
DATES: Withdrawal of approval is effective September 20, 2012.
FOR FURTHER INFORMATION CONTACT: David Alterman, Center for Veterinary
Medicine (HFV-212), Food and Drug Administration, 7519 Standish Pl.,
Rockville, MD 20855, 240-453-6843, email: david.alterman@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: The sponsors in table 1 of this document
have requested that FDA withdraw approval of the four NADAs listed
[[Page 55482]]
because the products are no longer manufactured or marketed.
Table 1--Withdrawal of Approval Requests
------------------------------------------------------------------------
NADA No. Trade name (drug) Applicant
------------------------------------------------------------------------
030-525..................... NUMORPHAN Endo Pharmaceuticals
(oxymorphone Inc., 100 Painters
hydrochloride) Dr., Chadds Ford,
Injection. PA 19317.
035-825..................... NARCAN (naloxone Endo Pharmaceuticals
hydrochloride) Inc., 100 Painters
Injection. Dr., Chadds Ford,
PA 19317.
046-822..................... VETOCIN (oxytocin) United Vaccines, A
Injection. Harlan Sprague
Dawley, Inc., Co.,
P.O. Box 4220,
Madison, WI 53711.
103-090..................... CHORTROPIN United Vaccines, A
(chorionic Harlan Sprague
gonadotropin) Dawley, Inc., Co.,
Injection. P.O. Box 4220,
Madison, WI 53711.
------------------------------------------------------------------------
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 NADAs
030-525, 035-825, 046-822, and 103-090, and all supplements and
amendments thereto, is hereby withdrawn, effective September 20, 2012.
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: September 5, 2012.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2012-22195 Filed 9-7-12; 8:45 am]
BILLING CODE 4160-01-P
