Document ID: FDA-2010-N-0633-0033
Agency: fda
Document Type: Notice
Title: Determination of System Attributes for the Tracking and Tracing of Prescription Drugs
Posted Date: 2011-05-23T04:00Z

[Federal Register Volume 76, Number 99 (Monday, May 23, 2011)]
[Notices]
[Pages 29765-29766]
From the Federal Register Online via the Government Printing 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, 
connie.jung@fda.hhs.gov.

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]
BILLING CODE 4160-01-P