[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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