[Federal Register Volume 76, Number 224 (Monday, November 21, 2011)]
[Notices]
[Pages 71982-71983]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-29937]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0557]


Advancing Regulatory Science for Highly Multiplexed Microbiology/
Medical Countermeasure Devices; Public Meeting; Reopening of Comment 
Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; reopening of comment period.

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SUMMARY: The Food and Drug Administration (FDA) is reopening the 
comment period for the notice announcing a public meeting for the 
``Advancing Regulatory Science for Highly Multiplexed Microbiology/
Medical Countermeasure Devices'' that published in the Federal Register 
of August 8, 2011 (76 FR 48169). In the notice, FDA requested public 
comments regarding matters to be discussed at the October 13, 2011, 
meeting, including the performance evaluation of highly multiplexed 
microbiology/medical countermeasure (MCM) devices, their clinical 
application and public health/clinical needs, and quality criteria for 
establishing the accuracy of reference databases. FDA is reopening the 
comment period to receive comment updates or any new information on the 
concept paper entitled ''Advancing Regulatory Science for Highly 
Multiplexed Microbiology/Medical Countermeasure Devices,'' for FDA's 
proposed evaluation approach for assessing the performance of highly 
multiplexed microbiology/MCM devices.

DATES: Submit either electronic or written comments and information by 
December 21, 2011.

ADDRESSES: Submit electronic comments to http://www.regulations.gov. 
Submit written comments to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Raquel Peat, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, rm. 5561, Silver Spring,

[[Page 71983]]

MD 20993-0002, (301) 796-6218, email: [email protected].

SUPPLEMENTARY INFORMATION: 

I. Background

    In the Federal Register of August 8, 2011, FDA published a notice 
announcing a public meeting for the ``Advancing Regulatory Science for 
Highly Multiplexed Microbiology/Medical Countermeasure Devices,'' and 
opening of a public docket to seek input and comments from interested 
stakeholders to discuss the concept paper \1\ for FDA's proposed 
evaluation approach for assessing the performance of highly multiplexed 
microbiology/MCM devices, including the following topics:
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    \1\ This concept paper may be found at http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/ucm267410.htm.
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    1. Clinical Application of Highly Multiplexed Microbiology Devices: 
Their clinical application and public health/clinical needs; inclusion 
of MCM-related pathogens that are expected to be rarely present in the 
tested specimens; the composition of clinically relevant panels of 
pathogens; the interpretation of the test results taking into 
consideration the possible detection of microorganisms that are not 
clinically relevant, and what is known and unknown about co-infections.
    2. Device Evaluation: How to evaluate the analytical and clinical 
performance of highly multiplexed microbiology devices; approaches to 
device validation when positive specimens are not easily available, 
which is the case for many MCM pathogens; the sufficiency, feasibility, 
and practicality of the proposed FDA evaluation approach to establish 
device performance.
    3. Reference Databases: Quality criteria for establishing the 
accuracy of reference databases; methods for curating, maintaining, and 
updating these databases; what is the current practice for creating and 
maintaining reference databases.
    In the Federal Register notice of August 8, 2011, interested 
persons were originally given until September 13, 2011, to submit 
comments.

II. Request for Comments

    Following publication of the August 8, 2011, Federal Register 
notice and posting of the concept paper, FDA received requests to allow 
interested persons additional time to comment. The Agency has 
considered the requests and is reopening the comment period until 
December 21, 2011.

III. How To Submit Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) either electronic or written comments regarding this 
document. It is only necessary to send one set of comments. It is no 
longer necessary to send two copies of mailed 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 I of this document, 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.

    Dated: November 15, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-29937 Filed 11-18-11; 8:45 am]
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