Center for Scientific Review; Notice of Closed Meeting, 14604 [2010-6663]
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Federal Register / Vol. 75, No. 58 / Friday, March 26, 2010 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2008–D–0623]
Guidance for Industry on Anesthetics
for Companion Animals; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
emcdonald on DSK2BSOYB1PROD with NOTICES
SUMMARY: The Food and Drug
Administration (FDA) is announcing the
availability of 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: Submit written or electronic
comments on agency guidances at any
time.
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
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 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 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
VerDate Nov<24>2008
15:23 Mar 25, 2010
Jkt 220001
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 (CVM).
In the Federal Register of December
17, 2008, (73 FR 76657), FDA published
the notice of availability for a draft
guidance entitled ‘‘Anesthetics for
Companion Animals’’ which gave
interested persons until March 2, 2009,
to comment on the draft guidance. FDA
received a few comments on the draft
guidance and those comments were
considered as the guidance was
finalized. In addition to some of the
changes based on the comments
received, CVM made a few minor
changes to the guidance to add clarity
and accuracy. The guidance announced
in this notice finalizes the draft
guidance dated December 17, 2008.
II. Significance of Guidance
This level 1 guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The guidance represents 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 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
No. 0910–0032 (expiration date 04/30/
2010).
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.
V. Electronic Access
Persons with access to the Internet
may obtain the guidance at either https://
www.fda.gov/AnimalVeterinary/
PO 00000
Frm 00050
Fmt 4703
Sfmt 9990
default.htm or https://
www.regulations.gov.
Dated: March 22, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010–6700 Filed 3–25–10; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Center for Scientific Review; Notice of
Closed Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of the following meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: Center for Scientific
Review Special Emphasis Panel, GWAS of
Arthritis, Osteoporosis and Lupus.
Date: March 31, 2010.
Time: 2 p.m. to 4 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892
(Telephone Conference Call).
Contact Person: David J. Remondini, PhD,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 2210,
MSC 7890, Bethesda, MD 20892, 301–435–
1038, remondid@csr.nih.gov.
This notice is being published less than 15
days prior to the meeting due to the timing
limitations imposed by the review and
funding cycle.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.306, Comparative Medicine;
93.333, Clinical Research, 93.306, 93.333,
93.337, 93.393–93.396, 93.837–93.844,
93.846–93.878, 93.892, 93.893, National
Institutes of Health, HHS)
Dated: March 19, 2010.
Jennifer Spaeth,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. 2010–6663 Filed 3–25–10; 8:45 am]
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[Federal Register Volume 75, Number 58 (Friday, March 26, 2010)]
[Notices]
[Page 14604]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-6663]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Center for Scientific Review; Notice of Closed Meeting
Pursuant to section 10(d) of the Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is hereby given of the following
meeting.
The meeting will be closed to the public in accordance with the
provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5
U.S.C., as amended. The grant applications and the discussions could
disclose confidential trade secrets or commercial property such as
patentable material, and personal information concerning individuals
associated with the grant applications, the disclosure of which would
constitute a clearly unwarranted invasion of personal privacy.
Name of Committee: Center for Scientific Review Special Emphasis
Panel, GWAS of Arthritis, Osteoporosis and Lupus.
Date: March 31, 2010.
Time: 2 p.m. to 4 p.m.
Agenda: To review and evaluate grant applications.
Place: National Institutes of Health, 6701 Rockledge Drive,
Bethesda, MD 20892 (Telephone Conference Call).
Contact Person: David J. Remondini, PhD, Scientific Review
Officer, Center for Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 2210, MSC 7890, Bethesda, MD
20892, 301-435-1038, remondid@csr.nih.gov.
This notice is being published less than 15 days prior to the
meeting due to the timing limitations imposed by the review and
funding cycle.
(Catalogue of Federal Domestic Assistance Program Nos. 93.306,
Comparative Medicine; 93.333, Clinical Research, 93.306, 93.333,
93.337, 93.393-93.396, 93.837-93.844, 93.846-93.878, 93.892, 93.893,
National Institutes of Health, HHS)
Dated: March 19, 2010.
Jennifer Spaeth,
Director, Office of Federal Advisory Committee Policy.
[FR Doc. 2010-6663 Filed 3-25-10; 8:45 am]
BILLING CODE 4140-01-P
