From:
"Joan"
Date: 2011-03-16 00:43:24 UTC
Subject: [ferrethealth] A note to our Vets - FDA Unapproved Animal Drugs; Extension of Comment Period
To: ferrethealth@yahoogroups.com
http://www.gpo.gov/fdsys/pkg/FR-2011-02-18/pdf/2011-3712.pdf
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA=E2=80"2010=E2=80"N=E2=80"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=E2=80"2010=E2=80"N=E2=80"
0528 by any of the following methods:
Electronic Submissions
Submit electronic comments in the
following way:
=E2=80=A2 Federal eRulemaking Portal: http://
www.regulations.gov. Follow the
instructions for submitting comments.
Written Submissions
Submit written submissions in the
following ways:
=E2=80=A2 FAX: 301=E2=80"827=E2=80"6870.
=E2=80=A2 Mail/Hand delivery/Courier (for
paper, disk, or CD=E2=80"ROM submissions):
Division of Dockets Management (HFA=E2=80"
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=E2=80"2010=E2=80"N=E2=80"0528. All
comments received may be posted
without change to http://
www.regulations.gov, including any
personal information provided. For
additional information on submitting
comments, see the =E2=80=98=E2=80=98Request for
Comments=E2=80=99=E2=80=99 heading of the
SUPPLEMENTARY INFORMATION section of
this document.
Docket: For access to the docket to
read background documents or
comments received, go to http://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
=E2=80=98=E2=80=98Search=E2=80=99=E2=80=99 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=E2=80"1), Food and Drug
Administration, 7500 Standish Pl.,
Rockville, MD 20855, 240=E2=80"276=E2=80"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=E2=80=99s interest in receiving
comments on strategies that utilize
FDA=E2=80=99s 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=E2=80=99s 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=E2=80"3712 Filed 2=E2=80"17=E2=80"11;
------------------------------------
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