Document ID: FDA-2012-N-1205-0003
Agency: fda
Document Type: Notice
Title: Accessible Medical Device Labeling in a Standard Content and Format - Notice of Extension of Comment
Posted Date: 2013-03-25T04:00Z

[Federal Register Volume 78, Number 57 (Monday, March 25, 2013)]
[Notices]
[Pages 17934-17935]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-06725]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-1205]

Accessible Medical Device Labeling in a Standard Content and 
Format Public Workshop; Extension of Comment Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshop; request for comments; extension of 
comment period.

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SUMMARY: The Food and Drug Administration (FDA) is extending the 
comment period for the notice that appeared in the Federal Register of 
January 7, 2013 (78 FR 951). In the notice, FDA requested comments on 
the public workshop entitled ``Accessible Standardized Medical Device 
Labeling.'' The agency is taking this action in response to a request 
for an extension to allow interested persons additional time to submit 
comments.

DATES: Submit either electronic or written comments by May 17, 2013.

ADDRESSES: You may submit comments, identified by Docket No. FDA-2012-
N-1205, by any of the following methods:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments.

Written Submissions

    Submit written submissions in the following ways:
     Mail/Hand delivery/Courier (for paper or CD-ROM 
submissions): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
    Instructions: All submissions received must include the agency name 
and Docket No. FDA-2012-N-1205. All comments received may be posted

[[Page 17935]]

without change to http://www.regulations.gov, including any personal 
information provided. For additional information on submitting 
comments, see the ``Request for Comments'' heading of the SUPPLEMENTARY 
INFORMATION section.
    Docket: For access to the docket to read background documents or 
comments received, go to http://www.regulations.gov and insert the 
docket number, found in brackets in the heading of this document, into 
the ``Search'' box and follow the prompts and/or go to the Division of 
Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Mary Weick-Brady, Center for Devices 
and Radiological Health, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 66, Rm. 5426, 301-796-6089, FAX: 301-847-8510, 
email: Mary.Brady@fda.hhs.gov.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of January 7, 2013 (78 FR 951), FDA 
published a notice of public workshop with a 90-day comment period to 
request comments on all aspects of the public workshop, including 
topics outlined in section II of that document (78 FR 951 at 952).
    The agency has received a request for an extension of the comment 
period until May 30, 2013. The request conveyed concern that the 
current comment period does not allow sufficient time to develop a 
meaningful or thoughtful response that allows for consideration of 
presentations by FDA and other stakeholders at the public workshop on 
April 29 and 30, 2013.
    FDA has considered the request and is extending the comment period 
for the notice of public workshop until May 17, 2013. The agency 
believes that the extension allows adequate time for interested persons 
to submit comments without significantly delaying consideration of 
these important issues.

II. Request for Comments

    Regardless of attendance at the public workshop, interested persons 
may submit either electronic comments regarding this document to http://www.regulations.gov or written comments to the Division of Dockets 
Management (see ADDRESSES). It is only necessary to send one set of 
comments. Identify comments with the docket number found in brackets in 
the heading of this document. In addition, when responding to specific 
questions as outlined in section II of the notice of public workshop 
(78 FR 951 at 952), please identify the question you are addressing. 
Received comments may be seen in the Division of Dockets Management 
between 9 a.m. and 4 p.m., Monday through Friday, and will be posted to 
the docket at http://www.regulations.gov.

    Dated: March 20, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-06725 Filed 3-22-13; 8:45 am]
BILLING CODE 4160-01-P