Draft Guidance for Industry on Anesthetics for Companion Animals; Availability, 76657-76658 [E8-29953]
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76657
Federal Register / Vol. 73, No. 243 / Wednesday, December 17, 2008 / Notices
TABLE 2.—TOTAL ESTIMATED ANNUAL REPORTING BURDEN1—Continued
No. of
Respondents
FDA Center
Center for Devices and Radiological
Health
1
6,091
2
12,182
1
664
1
664
5
8,876
2
17,752
14,853
21,935
36,902
are no capital costs or operating and maintenance costs associated with this collection of information.
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES) written or electronic
comments regarding this document.
Submit a single copy of electronic
comments or two paper copies of any
mailed comments, except that
individuals may submit one paper copy.
Comments are to be identified with the
docket number found in brackets in the
heading of this document. Received
comments may be seen in the Division
of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday.
Please note that on January 15, 2008,
the FDA Division of Dockets
Management Web site transitioned to
the Federal Dockets Management
System (FDMS). FDMS is a
Government-wide, electronic docket
management system. Electronic
comments or submissions will be
accepted by FDA only through FDMS at
https://www.regulations.gov.
Dated: December 10, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E8–29897 Filed 12–16–08; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2008–D–0623]
Draft Guidance for Industry on
Anesthetics for Companion Animals;
Availability
AGENCY:
Total Hours
1,794
Total
1 There
Hours per
Response
664
Center for Food Safety and Applied
Nutrition
Food and Drug Administration,
HHS.
pwalker on PROD1PC71 with NOTICES
Total Annual
Responses
6,091
Center for Veterinary Medicine
ACTION:
Annual Frequency
per Response
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing the
availability of a draft guidance for
industry #192 entitled ‘‘Anesthetics for
Companion Animals.’’ This guidance
makes recommendations for the
development of anesthetic new animal
VerDate Aug<31>2005
18:58 Dec 16, 2008
Jkt 217001
drug products for companion animals.
The guidance discusses the contents of
the target animal safety, effectiveness,
and labeling technical sections of a new
animal drug application (NADA) for
general anesthetics.
DATES: Although you can comment on
any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the agency
considers your comment on this draft
guidance before it begins work on the
final version of the guidance, submit
written or electronic comments on the
draft guidance by March 2, 2009.
ADDRESSES: Submit written requests for
single copies of the guidance to the
Communications Staff (HFV–12), Center
for Veterinary Medicine, Food and Drug
Administration, 7519 Standish Pl.,
Rockville, MD 20855. Send one selfaddressed adhesive label to assist that
office in processing your requests.
Submit written comments on the draft
guidance to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. Submit
electronic comments to https://
www.regulations.gov. See the
SUPPLEMENTARY INFORMATION section for
electronic access to the draft guidance
document.
FOR FURTHER INFORMATION CONTACT:
Germaine Connolly, Center for
Veterinary Medicine (HFV–116), Food
and Drug Administration, 7500 Standish
Pl., Rockville, MD 20855, 240–276–
8331, e-mail:
germaine.connolly@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
a draft guidance for industry #192
entitled ‘‘Anesthetics for Companion
Animals.’’ This guidance document
makes recommendations to assist
developers of general anesthetic drugs
(injectable or inhalational) for use in
companion animals (dogs, cats, and
horses). The guidance specifically
describes what should be considered
PO 00000
Frm 00051
Fmt 4703
Sfmt 4703
while planning and executing safety and
field studies for the proposed
anesthetic. In addition, the guidance
includes recommendations on how to
analyze and package the collected data
for submission to the Center for
Veterinary Medicine.
II. Significance of Guidance
This level 1 draft guidance is being
issued consistent with FDA’s good
guidance practices regulation (21 CFR
10.115). The draft guidance, when
finalized, will represent the agency’s
current thinking on this topic. It does
not create or confer any rights for or on
any person and does not operate to bind
FDA or the public. An alternative
approach may be used if such approach
satisfies the requirements of the
applicable statutes and regulations.
III. Paperwork Reduction Act of 1995
This draft guidance 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 have been approved
under OMB control number 0910–0032.
IV. Comments
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES) written or electronic
comments regarding this document.
Submit a single copy of electronic
comments or two paper copies of any
mailed comments, except that
individuals may submit one paper copy.
Comments are to be identified with the
docket number found in brackets in the
heading of this document. Received
comments may be seen in the Division
of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday.
Please note that on January 15, 2008,
the FDA Division of Dockets
Management Web site transitioned to
the Federal Dockets Management
E:\FR\FM\17DEN1.SGM
17DEN1
76658
Federal Register / Vol. 73, No. 243 / Wednesday, December 17, 2008 / Notices
System (FDMS). FDMS is a
Government-wide, electronic docket
management system. Electronic
comments or submissions will be
accepted by FDA only through FDMS at
https://www.regulations.gov.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
V. Electronic Access
Memorandum of Understanding
Between the Office of the Assistant
Secretary of Defense (Health Affairs),
the Veterans Health Administration,
and the U.S. Food and Drug
Administration
Persons with access to the Internet
may obtain the draft guidance at either
https://www.fda.gov/cvm or https://
www.regulations.gov.
Dated: December 11, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E8–29953 Filed 12–16–08; 8:45 am]
pwalker on PROD1PC71 with NOTICES
BILLING CODE 4160–01–S
VerDate Aug<31>2005
18:58 Dec 16, 2008
Jkt 217001
Food and Drug Administration
[Docket No. FDA–2008–N–0043]
[FDA No. 225–08–8003]
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is providing
notice of a memorandum of
understanding (MOU) between the
Office of the Assistant Secretary of
Defense (Health Affairs), the Veterans
Health Administration, and the U.S.
Food and Drug Administration. The
purpose of the MOU is to enhance
knowledge and efficiency by providing
for the sharing of information and
expertise between the Federal partners.
The goals of the collaboration are to
explore ways to: Further enhance
information sharing efforts through
PO 00000
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Fmt 4703
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more efficient and robust interagency
activities; promote efficient utilization
of tools and expertise for product risk
identification, validation and analysis;
and build infrastructure and processes
that meet the common needs for
evaluating the safety, efficacy, and
utilization of drugs, biologics, and
medical devices, as well as the safety
and utilization of foods. The MOU is
available on FDA’s Web site at
www.fda.gov/oc/mous/domestic/
domesticmous.htm.
DATES: The agreement became effective
November 25, 2008.
FOR FURTHER INFORMATION CONTACT: Erik
Mettler, Office of Policy, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 1, rm. 4324, Silver Spring,
MD 20993, 301–796–4830.
SUPPLEMENTARY INFORMATION: In
accordance with 21 CFR 20.108(c),
which states that all written agreements
and MOUs between FDA and others
shall be published in the Federal
Register, the agency is publishing notice
of this MOU.
Dated: December 11, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
E:\FR\FM\17DEN1.SGM
17DEN1
]]>Agencies
[Federal Register Volume 73, Number 243 (Wednesday, December 17, 2008)]
[Notices]
[Pages 76657-76658]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-29953]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2008-D-0623]
Draft Guidance for Industry on Anesthetics for Companion Animals;
Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a draft guidance for industry 192 entitled
``Anesthetics for Companion Animals.'' This guidance makes
recommendations for the development of anesthetic new animal drug
products for companion animals. The guidance discusses the contents of
the target animal safety, effectiveness, and labeling technical
sections of a new animal drug application (NADA) for general
anesthetics.
DATES: Although you can comment on any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the agency considers your comment on this
draft guidance before it begins work on the final version of the
guidance, submit written or electronic comments on the draft guidance
by March 2, 2009.
ADDRESSES: Submit written requests for single copies of the guidance to
the Communications Staff (HFV-12), Center for Veterinary Medicine, Food
and Drug Administration, 7519 Standish Pl., Rockville, MD 20855. Send
one self-addressed adhesive label to assist that office in processing
your requests.
Submit written comments on the draft guidance to the Division of
Dockets Management (HFA-305), Food and Drug Administration, 5630
Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments
to https://www.regulations.gov. See the SUPPLEMENTARY INFORMATION
section for electronic access to the draft guidance document.
FOR FURTHER INFORMATION CONTACT: Germaine Connolly, Center for
Veterinary Medicine (HFV-116), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 240-276-8331, e-mail:
germaine.connolly@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a draft guidance for industry
192 entitled ``Anesthetics for Companion Animals.'' This
guidance document makes recommendations to assist developers of general
anesthetic drugs (injectable or inhalational) for use in companion
animals (dogs, cats, and horses). The guidance specifically describes
what should be considered while planning and executing safety and field
studies for the proposed anesthetic. In addition, the guidance includes
recommendations on how to analyze and package the collected data for
submission to the Center for Veterinary Medicine.
II. Significance of Guidance
This level 1 draft guidance is being issued consistent with FDA's
good guidance practices regulation (21 CFR 10.115). The draft guidance,
when finalized, will represent the agency's current thinking on this
topic. It does not create or confer any rights for or on any person and
does not operate to bind FDA or the public. An alternative approach may
be used if such approach satisfies the requirements of the applicable
statutes and regulations.
III. Paperwork Reduction Act of 1995
This draft guidance 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 have been approved under OMB control number
0910-0032.
IV. Comments
Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) written or electronic comments regarding this document.
Submit a single copy of electronic comments or two paper copies of any
mailed comments, except that individuals may submit one paper copy.
Comments are to be identified with the docket number found in brackets
in the heading of this document. Received comments may be seen in the
Division of Dockets Management between 9 a.m. and 4 p.m., Monday
through Friday.
Please note that on January 15, 2008, the FDA Division of Dockets
Management Web site transitioned to the Federal Dockets Management
[[Page 76658]]
System (FDMS). FDMS is a Government-wide, electronic docket management
system. Electronic comments or submissions will be accepted by FDA only
through FDMS at https://www.regulations.gov.
V. Electronic Access
Persons with access to the Internet may obtain the draft guidance
at either https://www.fda.gov/cvm or https://www.regulations.gov.
Dated: December 11, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-29953 Filed 12-16-08; 8:45 am]
BILLING CODE 4160-01-S
