Unapproved Animal Drugs; Extension of Comment Period, 9584 [2011-3712]
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Federal Register / Vol. 76, No. 34 / Friday, February 18, 2011 / Notices
early phase clinical studies. 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 requirement of the
applicable statutes and regulations.
II. Paperwork Reduction Act of 1995
This draft guidance refers to
previously approved collections of
information that 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
201.57 have been approved under OMB
control number 0910–0572.
III. Comments
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES) either electronic or written
comments regarding this document. It is
only necessary to send one set of
comments. It is no longer necessary to
send two copies of mailed comments.
Identify comments 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.
IV. Electronic Access
Persons with access to the Internet
may obtain the document at either
https://www.fda.gov/Drugs/
GuidanceCompliance
RegulatoryInformation/Guidances, or
https://www.fda.gov/
BiologicsBloodVaccines/
GuidanceComplianceRegulatory
Information/Guidances, or https://
www.regulations.gov.
Dated: February 14, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011–3679 Filed 2–17–11; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
WReier-Aviles on DSKGBLS3C1PROD with NOTICES
[Docket No. FDA–2010–N–0528]
Unapproved Animal Drugs; Extension
of Comment Period
AGENCY:
Food and Drug Administration,
HHS.
the notice that appeared in the Federal
Register of December 20, 2010 (75 FR
79383). In the notice FDA requested
comments on strategies to address the
prevalence of animal drug products
marketed in the United States without
approval or other legal marketing status.
The Agency is taking this action in
response to requests for an extension to
allow interested persons additional time
to submit comments.
DATES: Submit electronic or written
comments by April 19, 2011.
ADDRESSES: You may submit comments,
identified by Docket No. FDA–2010–N–
0528 by any of the following methods:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the
instructions for submitting comments.
Written Submissions
Submit written submissions in the
following ways:
• FAX: 301–827–6870.
• Mail/Hand delivery/Courier (for
paper, disk, or CD–ROM submissions):
Division of Dockets Management (HFA–
305), Food and Drug Administration,
5630 Fishers Lane, rm. 1061, Rockville,
MD 20852.
Instructions: All submissions received
must include the Agency name and
Docket No. FDA–2010–N–0528. All
comments received may be posted
without change to https://
www.regulations.gov, including any
personal information provided. For
additional information on submitting
comments, see the ‘‘Request for
Comments’’ heading of the
SUPPLEMENTARY INFORMATION section of
this document.
Docket: For access to the docket to
read background documents or
comments received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Division of Dockets
Management, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
Tracey H. Forfa, Center for Veterinary
Medicine (HFV–1), Food and Drug
Administration, 7500 Standish Pl.,
Rockville, MD 20855, 240–276–9000,
e-mail: Tracey.Forfa@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
Request for comments;
extension of comment period.
I. Background
The Food and Drug
Administration (FDA) is extending to
April 19, 2011, the comment period for
In the Federal Register of December
20, 2010 (75 FR 79383), FDA published
a notice with a 60-day comment period
ACTION:
SUMMARY:
VerDate Mar<15>2010
13:57 Feb 17, 2011
Jkt 223001
PO 00000
Frm 00051
Fmt 4703
to request comments from stakeholders
on strategies to address the prevalence
of animal drug products marketed in the
United States without approval or other
legal marketing status. The notice
expressed FDA’s interest in receiving
comments on strategies that utilize
FDA’s existing regulatory framework for
addressing this issue as well as on novel
strategies not currently employed by the
Agency.
The Agency has received requests for
a 60-day extension of the comment
period. The requests conveyed concern
that the current 60-day comment period
does not allow respondents sufficient
time to address fully the many
important issues FDA raised in the
notice.
FDA has considered the requests and
is extending the comment period for the
notice for 60 days, until April 19, 2011.
The Agency believes that a 60-day
extension allows adequate time for
interested persons to submit comments
without significantly delaying the
Agency’s consideration of these
important issues.
II. Request for Comments
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES) either electronic or written
comments regarding this document. It is
only necessary to send one set of
comments. It is no longer necessary to
send two copies of mailed comments.
Identify comments 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.
Dated: February 15, 2011.
David Dorsey,
Acting Deputy Commissioner for Policy,
Planning and Budget.
[FR Doc. 2011–3712 Filed 2–17–11; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Agency Information Collection
Activities: Submission for OMB
Review; Comment Request
Health Resources and Services
Administration, HHS.
ACTION: Correction of Burden Table.
AGENCY:
The Health Resources and
Services Administration published an
Agency Information Collection
document in the Federal Register of
SUMMARY:
Sfmt 4703
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18FEN1
]]>Agencies
[Federal Register Volume 76, Number 34 (Friday, February 18, 2011)]
[Notices]
[Page 9584]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-3712]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-N-0528]
Unapproved Animal Drugs; Extension of Comment Period
AGENCY: Food and Drug Administration, HHS.
ACTION: Request for comments; extension of comment period.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is extending to April
19, 2011, the comment period for the notice that appeared in the
Federal Register of December 20, 2010 (75 FR 79383). In the notice FDA
requested comments on strategies to address the prevalence of animal
drug products marketed in the United States without approval or other
legal marketing status. The Agency is taking this action in response to
requests for an extension to allow interested persons additional time
to submit comments.
DATES: Submit electronic or written comments by April 19, 2011.
ADDRESSES: You may submit comments, identified by Docket No. FDA-2010-
N-0528 by any of the following methods:
Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments.
Written Submissions
Submit written submissions in the following ways:
FAX: 301-827-6870.
Mail/Hand delivery/Courier (for paper, disk, or CD-ROM
submissions): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
Instructions: All submissions received must include the Agency name
and Docket No. FDA-2010-N-0528. All comments received may be posted
without change to https://www.regulations.gov, including any personal
information provided. For additional information on submitting
comments, see the ``Request for Comments'' heading of the SUPPLEMENTARY
INFORMATION section of this document.
Docket: For access to the docket to read background documents or
comments received, go to https://www.regulations.gov and insert the
docket number, found in brackets in the heading of this document, into
the ``Search'' box and follow the prompts and/or go to the Division of
Dockets Management, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Tracey H. Forfa, Center for Veterinary
Medicine (HFV-1), Food and Drug Administration, 7500 Standish Pl.,
Rockville, MD 20855, 240-276-9000, e-mail: Tracey.Forfa@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of December 20, 2010 (75 FR 79383), FDA
published a notice with a 60-day comment period to request comments
from stakeholders on strategies to address the prevalence of animal
drug products marketed in the United States without approval or other
legal marketing status. The notice expressed FDA's interest in
receiving comments on strategies that utilize FDA's existing regulatory
framework for addressing this issue as well as on novel strategies not
currently employed by the Agency.
The Agency has received requests for a 60-day extension of the
comment period. The requests conveyed concern that the current 60-day
comment period does not allow respondents sufficient time to address
fully the many important issues FDA raised in the notice.
FDA has considered the requests and is extending the comment period
for the notice for 60 days, until April 19, 2011. The Agency believes
that a 60-day extension allows adequate time for interested persons to
submit comments without significantly delaying the Agency's
consideration of these important issues.
II. Request for Comments
Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) either electronic or written comments regarding this
document. It is only necessary to send one set of comments. It is no
longer necessary to send two copies of mailed comments. Identify
comments 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.
Dated: February 15, 2011.
David Dorsey,
Acting Deputy Commissioner for Policy, Planning and Budget.
[FR Doc. 2011-3712 Filed 2-17-11; 8:45 am]
BILLING CODE 4160-01-P
