[Federal Register Volume 76, Number 99 (Monday, May 23, 2011)]
[Notices]
[Pages 29765-29766]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-12617]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-N-0633]
Determination of System Attributes for the Tracking and Tracing
of Prescription Drugs; Reopening of the Comment Period
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice; reopening of the comment period.
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[[Page 29766]]
SUMMARY: The Food and Drug Administration (FDA) is reopening the
comment period for the notice of public workshop published in the
Federal Register of January 7, 2011 (76 FR 1182). In that notice, FDA
announced a public workshop that took place on February 15 and 16,
2011, and requested public comment regarding the topics discussed at
the workshop on determining system attributes for tracking and tracing
prescription drugs. The workshop provided a forum for discussing
possible approaches to developing a track-and-trace system and for
obtaining input from supply chain partners on potential attributes and
standards for the identification, authentication, and tracking and
tracing of prescription drug packages. FDA is reopening the comment
period to allow additional time for interested persons both to consider
all the information provided by the Agency related to the workshop and
to submit additional comments.
DATES: Submit either electronic or written comments by June 22, 2011.
ADDRESSES: Submit electronic comments to http://www.regulations.gov.
Submit written comments to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Connie Jung, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Silver Spring, MD 20993-0002, 301-796-3100,
[email protected].
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of January 7, 2011 (76 FR 1182), FDA
published a notice announcing a public workshop entitled
``Determination of System Attributes for the Tracking and Tracing of
Prescription Drugs; Public Workshop.'' In that notice, FDA requested
the following: (1) Input and comments from interested stakeholders
regarding possible approaches to developing a track-and-trace system
and (2) input from supply chain partners on potential attributes and
standards for the identification, authentication, and tracking and
tracing of prescription drug packages.
Interested persons were originally given until April 16, 2011, to
submit comments.
II. Request for Comments
On April 4, 2011, FDA posted on the FDA Web site a summary of the
main comments shared by the public workshop participants. To allow
adequate time for interested persons both to consider all the
information provided by the Agency related to the workshop and to
submit additional comments, FDA is reopening the comment period.
III. How to Submit 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: May 13, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-12617 Filed 5-20-11; 8:45 am]
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