Document ID: FDA-2013-D-1445-0013
Agency: fda
Document Type: Notice
Title: Blood Glucose Monitoring Test Systems for Prescription Point-of-Care
Use; Draft Guidance for Industry and Food and Drug Administration Staff;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]
[Page 19622]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-07898]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-D-1445]

Blood Glucose Monitoring Test Systems for Prescription Point-of-
Care Use; Draft Guidance for Industry and Food and Drug Administration 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 830). In the notice, FDA requested 
comments on a draft guidance document entitled ``Blood Glucose 
Monitoring Test Systems for Prescription Point-of-Care 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DATES: FDA is extending the comment period on the draft guidance 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 ``Blood Glucose Monitoring Test Systems for Prescription 
Point-of-Care 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ADDRESSES: Submit electronic comments on the draft guidance to http://www.regulations.gov.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.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of January 7, 2014 (79 FR 830), FDA 
published a notice announcing the availability of the draft guidance 
entitled ``Blood Glucose Monitoring Test Systems for Prescription 
Point-of-Care 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. 2014-07898 Filed 4-8-14; 8:45 am]
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