Daily Rules, Proposed Rules, and Notices of the Federal Government


Food and Drug Administration

21 CFR Parts 16, 801, 803, 806, 810, 814, 820, 821, 822, and 830

[Docket No. FDA-2011-N-0090]

RIN 0910-AG31

Agency Information Collection Activities; Proposed Collection; Unique Device Identification System; Extension of Comment Period

AGENCY: Food and Drug Administration, HHS.
ACTION: Notification; extension of comment period.
SUMMARY: The Food and Drug Administration (FDA) is extending the comment period pertaining to information collection issues under the Paperwork Reduction Act of 1995 (the PRA) associated with the proposed rule, Unique Device Identification System, that appeared in theFederal Registerof July 10, 2012 (77 FR 40736). The Agency is taking this action in response to requests for an extension to allow interested persons additional time to submit comments.
DATES: Submit either electronic or written comments on the proposed collection of information by October 25, 2012.
ADDRESSES: Submit electronic comments on the collection of information to the Office of Regulatory Affairs, Office of Management and Budget (OMB) at FAX: 202-395-7285, or email comments mark your comment to the FDA desk officer and reference this rule.
FOR FURTHER INFORMATION CONTACT: Jay Crowley, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993, 301-796-5995,

I. Background

In theFederal Registerof July 10, 2012 (77 FR 40736), FDA published a notice of proposed rulemaking with a 60-day comment period concerning the proposed information collection. Comments on the proposed rulemaking will inform FDA's rulemaking to establish regulations for Unique Device Identification System.

The Agency has received requests for a 45-day extension of the comment period for the information collection. Each request conveyed concern that the current 60-day comment period does not allow sufficient time to develop a meaningful or thoughtful response to the information collection.

FDA has considered the requests and is extending the comment period for the information collection for 45 days, until October 25, 2012. The Agency believes that a 45-day extension allows adequate time for interested persons to submit comments without significantly delaying rulemaking on these important issues.

Dated: September 12, 2012. Leslie Kux, Assistant Commissioner for Policy.