2011-12617. 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.

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, [e-mail].

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.