Document ID: FDA-2013-D-1446-0003
Agency: fda
Document Type: Notice
Title: Self-Monitoring Blood Glucose Test Systems for Over-the-Counter Use;
Draft Guidance for Industry and Food and Drug Administration Staff;
Extension of Comment Period
Posted Date: 2014-04-09T04:00Z

[Federal Register Volume 79, Number 68 (Wednesday, April 9, 2014)]
[Notices]
[Pages 19622-19623]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-07899]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-D-1446]

Self-Monitoring Blood Glucose Test Systems for Over-the-Counter 
Use; Draft Guidance for Industry and Food and Drug Administration 
Staff; Extension of Comment Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; extension of comment period.

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SUMMARY: The Food and Drug Administration (FDA) is extending to May 7, 
2014, the comment period for the notice that appeared in the Federal 
Register of January 7, 2014 (79 FR 829). In the notice, FDA requested 
comments on the draft guidance document entitled ``Self-Monitoring 
Blood Glucose Test Systems for Over-the-Counter Use.'' The Agency is 
taking this action in response to requests for an extension to allow 
interested persons additional time to submit comments.

DATES: FDA is extending the comment period on the draft guidance 
entitled ``Self-Monitoring Blood Glucose Test

[[Page 19623]]

Systems for Over-the-Counter Use.'' Submit either electronic or written 
comments by May 7, 2014.

ADDRESSES: Submit electronic comments on the draft guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
rm. 1601, Rockville, MD 20852. Identify comments with the docket number 
found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Patricia Bernhardt, Center for Devices 
and Radiological Health, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 66, rm. 5654, Silver Spring, MD 20993-0002, 301-
796-6136.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of January 7, 2014 (79 FR 829), FDA 
published a notice announcing the availability of the draft guidance 
entitled ``Self-Monitoring Blood Glucose Test Systems for Over-the-
Counter Use.'' Interested persons were invited to submit comments by 
April 7, 2014. At this time the Agency is extending the comment period 
until May 7, 2014, to continue to receive public comments. Comments 
submitted to the docket will assist in identifying issues to be 
addressed in the finalized guidance document.

II. Request for Comments

    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. 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: April 2, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-07899 Filed 4-8-14; 8:45 am]
BILLING CODE 4160-01-P