[Federal Register Volume 77, Number 180 (Monday, September 17, 2012)]
[Proposed Rules]
[Page 57055]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-22821]


=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

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 the Federal 
Register of 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 to [email protected]. Please 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, email: 
[email protected].

SUPPLEMENTARY INFORMATION: 

I. Background

    In the Federal Register of 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.
[FR Doc. 2012-22821 Filed 9-14-12; 8:45 am]
BILLING CODE 4160-01-P