Advancing Regulatory Science for Highly Multiplexed Microbiology/Medical Countermeasure Devices; Public Meeting, 48169-48171 [2011-19996]
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Federal Register / Vol. 76, No. 152 / Monday, August 8, 2011 / Notices
I. Background
Section 306(b)(2)(B)(i)(I) of the FD&C
Act (21 U.S.C. 335a(b)(2)(B)(i)(I))
permits FDA to debar an individual if it
finds that the individual has been
convicted of a misdemeanor under
Federal law for conduct relating to the
regulation of drug products under the
FD&C Act, and if FDA finds that the
type of conduct that served as the basis
for the conviction undermines the
process for the regulation of drugs.
On April 2, 2007, Dr. Choi pleaded
guilty to one count of receipt in
interstate commerce of a misbranded
drug and delivery thereof in violation of
sections 301(c), 303(c), and 502(f) of the
FD&C Act (21 U.S.C. 331(c), 333(a)(1),
and 352(f)). On August 11, 2008, the
U.S. District Court for the Central
District of California entered judgment
against Dr. Choi for the misdemeanor
offense of receipt in interstate commerce
of a misbranded drug and delivery
thereof.
FDA’s finding that debarment is
appropriate is based on the
misdemeanor conviction referenced
herein. The factual basis for the
conviction is as follows: Dr. Choi was a
licensed physician in the State of
California. Prior to November 13, 2003,
Dr. Choi injected patients with Botox®,
an FDA-approved Botulinum Toxin
Type A drug product manufactured by
Allergan, Inc. In 2003, Dr. Choi began
ordering an unapproved drug purported
to be Botulinum Toxin Type A (TRI–
Toxin) manufactured by Toxin Research
International, Inc. (TRI), located in
Tucson, Arizona, instead of the
approved Botox®. From on or about
November 13, 2003, and continuing
until about August 3, 2004, Dr. Choi
placed 14 orders for a total of 28 vials
of TRI–Toxin, which he had shipped to
his office in the Central District of
California. The TRI–Toxin did not come
with labeling or directions on how to
dilute the product for injection. The
TRI–Toxin label stated ‘‘for research
purposes only’’ and ‘‘not for human
use,’’ as did the TRI–Toxin invoices. Dr.
Choi admitted to injecting the TRI–
Toxin into his employees and patients.
Between on or about November 13,
2003, and continuing until on or about
August 3, 2004, Dr. Choi received and
delivered the TRI–Toxin when he
administered it to other persons, all in
violation of sections 301(c), 303(c), and
502(f) of the FD&C Act.
As a result of his conviction, on April
22, 2011, FDA sent Dr. Choi a notice by
certified mail proposing to debar him
for 4 years from providing services in
any capacity to a person that has an
approved or pending drug product
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application. FDA subsequently
confirmed on May 9, 2011, that Dr. Choi
personally received the notice. The
proposal was based on a finding, under
section 306(b)(2)(B)(i)(I) of the FD&C
Act that Dr. Choi was convicted of a
misdemeanor under Federal law for
conduct relating to the regulation of
drug products under the FD&C Act, and
that the conduct that served as a basis
for the conviction undermines the
process for the regulation of drugs. The
proposal also offered Dr. Choi an
opportunity to request a hearing,
providing him 30 days from the date of
receipt of the letter in which to file the
request, and advised him that failure to
request a hearing constituted a waiver of
the opportunity for a hearing and of any
contentions concerning this action. Dr.
Choi failed to respond within the
timeframe prescribed by regulation and
has therefore, waived his opportunity
for a hearing and waived any
contentions concerning his debarment
(21 CFR part 12).
II. Findings and Order
Therefore, the Director, Office of
Enforcement, Office of Regulatory
Affairs, under section 306(b)(2)(B)(i)(I)
of the FD&C Act under authority
delegated to him (Staff Manual Guide
1410.35), finds that Andrew K. Choi has
been convicted of a misdemeanor under
Federal law for conduct relating to the
regulation of a drug product under the
FD&C Act, and that the type of conduct
that served as a basis for the conviction
undermines the process for the
regulation of drugs.
As a result of the foregoing finding,
Dr. Choi is debarred for 4 years from
providing services in any capacity to a
person with an approved or pending
drug product application under sections
505, 512, or 802 of the FD&C Act (21
U.S.C. 355, 360b, or 382), or under
section 351 of the Public Health Service
Act (42 U.S.C. 262), effective (see
DATES), (see sections 306(c)(1)(B),
(c)(2)(A)(iii), and 201(dd) of the FD&C
Act (21 U.S.C. 335a(c)(1)(B),
(c)(2)(A)(iii), and 321(dd))). Any person
with an approved or pending drug
product application who knowingly
employs or retains as a consultant or
contractor, or otherwise uses the
services of Dr. Choi, in any capacity
during Dr. Choi’s debarment, will be
subject to civil money penalties (section
307(a)(6) of the FD&C Act (21 U.S.C.
335b(a)(6))). If Dr. Choi provides
services in any capacity to a person with
an approved or pending drug product
application during his period of
debarment he will be subject to civil
money penalties (section 307(a)(7) of the
FD&C Act). In addition, FDA will not
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48169
accept or review any abbreviated new
drug applications submitted by or with
the assistance of Dr. Choi during his
period of debarment (section
306(c)(1)(B) of the FD&C Act).
Any application by Dr. Choi for
termination of debarment under section
306(d)(1) of the FD&C Act (21 U.S.C.
335a(d)(1)) should be identified with
Docket No. FDA–2011–N–0126 and sent
to the Division of Dockets Management
(see ADDRESSES). All such submissions
are to be filed in four copies. The public
availability of information in these
submissions is governed by 21 CFR
10.20(j).
Publicly available submissions may
be seen in the Division of Dockets
Management between 9 a.m. and 4 p.m.,
Monday through Friday.
Dated: July 27, 2011.
Armando Zamora,
Acting Director, Office of Enforcement, Office
of Regulatory Affairs.
[FR Doc. 2011–19976 Filed 8–5–11; 8:45 am]
BILLING CODE 4160–01–P
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
AGENCY:
Food and Drug Administration,
HHS.
Notice of public meeting;
request for comments.
ACTION:
The Food and Drug Administration
(FDA) is announcing the following
public meeting: ‘‘Advancing Regulatory
Science for Highly Multiplexed
Microbiology/Medical Countermeasure
Devices.’’ The purpose of the public
meeting is to discuss 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. These considerations are
essential to establish the safety and
effectiveness of highly multiplexed
devices when used for the clinical
diagnosis of infectious diseases from a
human specimen.
Date and Time: The public meeting
will be held on October 13, 2011, from
8 a.m. to 6 p.m.
Location: The public meeting will be
held at the FDA White Oak Campus,
10903 New Hampshire Ave., Bldg. 31,
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rm. 1503 (the Great Room), Silver
Spring, MD 20993–0002. For parking
and security information, please visit
the following Web site: https://
www.fda.gov/AboutFDA/
WorkingatFDA/BuildingsandFacilities/
WhiteOakCampusInformation/
ucm241740.htm. The public meeting
will also be available to be viewed
online via webcast.
Contact Person: Raquel Peat, Center
for Devices and Radiological Health,
Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 66, rm.
5561, Silver Spring, MD 20993–0002,
301–796–6218, e-mail:
raquel.peat@fda.hhs.gov.
Registration and Requests for Oral
Presentations: If you wish to attend or
view the webcast of the public meeting,
you must register online at https://
www.fda.gov/MedicalDevices/
NewsEvents/WorkshopsConferences/
default.htm (select the appropriate
meeting from the list).
Provide complete contact information
for each attendee, including name, title,
affiliation, email, and telephone
number. Registration requests should be
received by September 13, 2011.
If you wish to make an oral
presentation during the open comment
session at the meeting, you must
indicate this at the time of registration.
FDA has included general discussion
topics for comment in section III of this
document, Topics for Input. You should
also identify which discussion topic you
wish to address in your presentation.
FDA will do its best to accommodate
requests to speak. Individuals and
organizations with common interests are
urged to consolidate or coordinate their
presentations and to request time for a
joint presentation. FDA will determine
the amount of time allotted to each
presenter and the approximate time that
each oral presentation is scheduled to
begin. If the number of registrants
requesting to speak is greater than what
can be reasonably accommodated
during the scheduled open public
hearing session, FDA may conduct a
lottery to determine the speakers for the
scheduled open comment session.
Registration is free and will be on a
first-come, first-served basis. Early
registration is recommended because
seating is limited. FDA may limit the
number of participants from each
organization based on space limitations.
Registrants will receive confirmation
once their registration has been
accepted. Onsite registration on the day
of the public meeting will be provided
on a space-available basis beginning at
7 a.m. Non-U.S. citizens are subject to
additional security screening, and they
should register as soon as possible.
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If you need special accommodations
due to a disability, please contact Susan
Monahan, Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 4321, Silver Spring,
MD 20993–0002, 301–796–5661, e-mail:
susan.monahan@fda.hhs.gov at least 7
days in advance of the meeting.
Streaming Webcast of the Public
Meeting: There will be a registration
process for the webcast, and it will be
on a first-come, first-served basis
(maximum capacity: 900). If you have
never attended a Connect Pro meeting
before, test your connection at: https://
collaboration.fda.gov/common/help/en/
support/meeting_test.htm. To get a
quick overview of the Connect Pro
program, visit: https://www.adobe.com/
go/connectpro_overview. (FDA has
verified the Web site addresses in this
document, but FDA is not responsible
for any subsequent changes to the Web
sites after this document publishes in
the Federal Register.)
Comments: In advance of the meeting,
FDA will place its proposed evaluation
approach to assess the performance of
highly multiplexed microbiology/MCM
devices on file in the public docket
(docket number found in brackets in the
heading of this document) and will post
it at https://www.fda.gov/
MedicalDevices/NewsEvents/
WorkshopsConferences/default.htm.
The deadline for submitting comments
to be presented at this public meeting is
September 13, 2011 (see section III of
this document.)
Regardless of attendance at the public
meeting, interested persons may submit
either electronic or written comments
on any discussion topic(s) to the open
docket. The deadline for submitting
comments to the docket is September
13, 2011. Submit electronic comments
to https://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. 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,
if responding to specific topics as
outlined in section III of this document,
please identify the topic 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.
SUPPLEMENTARY INFORMATION:
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I. Background
Highly multiplexed devices for the
diagnosis of infectious diseases,
including those caused by MCM-related
pathogens, are a new generation of
diagnostic products designed to
simultaneously identify and
differentiate a large number of
pathogens from a single clinical
specimen. This involves the testing of
multiple targets through a common
process of sample preparation,
amplification and/or detection, and
result interpretation. The identification
of the organism is often based on
sequence information compared to
reference databases created either by the
device manufacturer or otherwise
publicly available.
These diagnostic devices present
several advantages, such as identifying
potential disease etiology in situations
where many different pathogens share a
common clinical manifestation and the
simultaneous detection of co-infections.
However, establishing and validating
the performance of these devices to
make informed clinical and public
health decisions poses significant
scientific challenges. This public
meeting is to discuss the performance
evaluation of highly multiplexed
microbiology/MCM device, their
clinical application and public health/
clinical needs and quality criteria for
establishing the accuracy of reference
databases. These considerations are
essential to establish the safety and
effectiveness of highly multiplexed
devices when used for the clinical
diagnosis of infectious diseases from a
human specimen.
FDA is holding this public meeting to
obtain input from academia,
government, industry, clinical
laboratories, and other stakeholders on
the performance evaluation approach to
be proposed by FDA, which includes
validation methods, reference panels,
and bioinformatic concepts needed to
address the clinical and analytical
performance requirements for highly
multiplexed microbiology/MCM
devices. The ultimate goal is to advance
regulatory science for highly
multiplexed devices used in pathogen
detection in order to ensure their safety
and effectiveness and thereby provide
potential clinical and public health
benefits.
II. Meeting Overview
The public meeting will consist of
presentations providing background on
current and anticipated uses for highly
multiplexed microbiology devices that
may contain MCM analytes, the
performance evaluation approach
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Federal Register / Vol. 76, No. 152 / Monday, August 8, 2011 / Notices
proposed by FDA, and information on
reference databases; an open public
comment session; and an open
discussion on selected topics raised by
the presentations (see section III of this
document.) During the discussions, the
participants will not be asked to
develop consensus opinions but rather
to provide their individual perspectives.
Additional information, including a
meeting agenda, will be available on the
Internet, immediately after publication
of this document in the Federal
Register. The evaluation approach
proposed by FDA is expected to be
available at a later date. This
information will be placed on file in the
public docket (docket number found in
brackets in the heading of this
document), which is available at
https://www.regulations.gov. This
information will also be available at
https://www.fda.gov/MedicalDevices/
NewsEvents/WorkshopsConferences/
default.htm (select the appropriate
meeting from the list).
III. Topics for Input
FDA will seek input on its proposed
performance evaluation approach,
which will include the following topics:
1. Clinical Application of Highly
Multiplexed Microbiology Devices: Their
clinical application and public health/
clinical needs; inclusion of MCMrelated 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; 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.
IV. Transcripts
Please be advised that as soon as a
transcript is available, it will be
accessible at https://
www.regulations.gov. It may be viewed
at the Division of Dockets Management
(HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. A transcript
will also be available in either hardcopy
or on CD–ROM, after submission of a
Freedom of Information request. Written
requests are to be sent to Division of
Freedom of Information (ELEM–1029),
Food and Drug Administration, 12420
Parklawn Dr., Element Bldg., rm. 1050,
Rockville, MD 20857.
Dated: August 2, 2011.
Nancy K. Stade,
Deputy Director for Policy, Center for Devices
and Radiological Health.
[FR Doc. 2011–19996 Filed 8–5–11; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Agency Information Collection
Activities: Proposed Collection:
Comment Request
In compliance with the requirement
for opportunity for public comment on
proposed data collection projects
(section 3506(c)(2)(A) of Title 44, United
States Code, as amended by the
Paperwork Reduction Act of 1995, Pub.
L. 104–13), the Health Resources and
Services Administration (HRSA)
publishes periodic summaries of
proposed projects being developed for
submission to the Office of Management
and Budget (OMB) under the Paperwork
Reduction Act of 1995. To request more
information on the proposed project or
to obtain a copy of the data collection
plans and draft instruments, e-mail
paperwork@hrsa.gov or call the HRSA
Reports Clearance Officer at (301) 443–
1129.
Comments are invited on: (a) Whether
the proposed collection of information
is necessary for the proper performance
of the functions of the agency; (b) the
accuracy of the agency’s estimate of the
burden of the proposed collection of
information; (c) ways to enhance the
quality, utility, and clarity of the
information to be collected; and (d)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques or
other forms of information technology.
Proposed Project: National Health
Service Corps Site Application (OMB
No. 0915–0230)—Revision
The National Health Service Corps
(NHSC) of the Bureau of Clinician
Recruitment and Service (BCRS), Health
Resources and Services Administration,
is committed to improving the health of
the Nation’s underserved by uniting
communities in need with caring health
professionals, and by supporting their
efforts to build better systems of care.
The NHSC Site Application, which
renames and revises the previous
Recruitment and Retention Assistance
Application, requests information on
the clinical service site, sponsoring
agency, recruitment contact, staffing
levels, service users, charges for
services, employment policies, and
fiscal management capabilities.
Assistance in completing the
application may be obtained through the
appropriate State Primary Care Offices,
State Primary Care Associations and the
NHSC. The information on the
application is used for determining the
eligibility of sites for assignment of
NHSC-obligated health professionals
and to verify the need for NHSC
clinicians. Approval as an NHSC service
site is good for 3 years; sites wishing to
remain eligible for assignment of NHSC
providers must submit a new Site
Application every 3 years.
The annual estimate of burden is as
follows:
mstockstill on DSK4VPTVN1PROD with NOTICES
Instrument
Number of
respondents
Responses
per
respondent
Total
responses
Hours per
response
Total burden
hours
NHSC Site Application .........................................................
3000
1
3000
0.5
1500
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E:\FR\FM\08AUN1.SGM
08AUN1
Agencies
[Federal Register Volume 76, Number 152 (Monday, August 8, 2011)]
[Notices]
[Pages 48169-48171]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-19996]
-----------------------------------------------------------------------
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
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public meeting; request for comments.
-----------------------------------------------------------------------
The Food and Drug Administration (FDA) is announcing the following
public meeting: ``Advancing Regulatory Science for Highly Multiplexed
Microbiology/Medical Countermeasure Devices.'' The purpose of the
public meeting is to discuss 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. These
considerations are essential to establish the safety and effectiveness
of highly multiplexed devices when used for the clinical diagnosis of
infectious diseases from a human specimen.
Date and Time: The public meeting will be held on October 13, 2011,
from 8 a.m. to 6 p.m.
Location: The public meeting will be held at the FDA White Oak
Campus, 10903 New Hampshire Ave., Bldg. 31,
[[Page 48170]]
rm. 1503 (the Great Room), Silver Spring, MD 20993-0002. For parking
and security information, please visit the following Web site: https://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm. The public meeting will also
be available to be viewed online via webcast.
Contact Person: Raquel Peat, Center for Devices and Radiological
Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
66, rm. 5561, Silver Spring, MD 20993-0002, 301-796-6218, e-mail:
raquel.peat@fda.hhs.gov.
Registration and Requests for Oral Presentations: If you wish to
attend or view the webcast of the public meeting, you must register
online at https://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/default.htm (select the appropriate meeting from
the list).
Provide complete contact information for each attendee, including
name, title, affiliation, email, and telephone number. Registration
requests should be received by September 13, 2011.
If you wish to make an oral presentation during the open comment
session at the meeting, you must indicate this at the time of
registration. FDA has included general discussion topics for comment in
section III of this document, Topics for Input. You should also
identify which discussion topic you wish to address in your
presentation. FDA will do its best to accommodate requests to speak.
Individuals and organizations with common interests are urged to
consolidate or coordinate their presentations and to request time for a
joint presentation. FDA will determine the amount of time allotted to
each presenter and the approximate time that each oral presentation is
scheduled to begin. If the number of registrants requesting to speak is
greater than what can be reasonably accommodated during the scheduled
open public hearing session, FDA may conduct a lottery to determine the
speakers for the scheduled open comment session.
Registration is free and will be on a first-come, first-served
basis. Early registration is recommended because seating is limited.
FDA may limit the number of participants from each organization based
on space limitations. Registrants will receive confirmation once their
registration has been accepted. Onsite registration on the day of the
public meeting will be provided on a space-available basis beginning at
7 a.m. Non-U.S. citizens are subject to additional security screening,
and they should register as soon as possible.
If you need special accommodations due to a disability, please
contact Susan Monahan, Center for Devices and Radiological Health, Food
and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 4321,
Silver Spring, MD 20993-0002, 301-796-5661, e-mail:
susan.monahan@fda.hhs.gov at least 7 days in advance of the meeting.
Streaming Webcast of the Public Meeting: There will be a
registration process for the webcast, and it will be on a first-come,
first-served basis (maximum capacity: 900). If you have never attended
a Connect Pro meeting before, test your connection at: https://collaboration.fda.gov/common/help/en/support/meeting_test.htm. To get
a quick overview of the Connect Pro program, visit: https://www.adobe.com/go/connectpro_overview. (FDA has verified the Web site
addresses in this document, but FDA is not responsible for any
subsequent changes to the Web sites after this document publishes in
the Federal Register.)
Comments: In advance of the meeting, FDA will place its proposed
evaluation approach to assess the performance of highly multiplexed
microbiology/MCM devices on file in the public docket (docket number
found in brackets in the heading of this document) and will post it at
https://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/default.htm. The deadline for submitting comments to be presented at
this public meeting is September 13, 2011 (see section III of this
document.)
Regardless of attendance at the public meeting, interested persons
may submit either electronic or written comments on any discussion
topic(s) to the open docket. The deadline for submitting comments to
the docket is September 13, 2011. Submit electronic comments to https://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. 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, if responding to specific
topics as outlined in section III of this document, please identify the
topic 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.
SUPPLEMENTARY INFORMATION:
I. Background
Highly multiplexed devices for the diagnosis of infectious
diseases, including those caused by MCM-related pathogens, are a new
generation of diagnostic products designed to simultaneously identify
and differentiate a large number of pathogens from a single clinical
specimen. This involves the testing of multiple targets through a
common process of sample preparation, amplification and/or detection,
and result interpretation. The identification of the organism is often
based on sequence information compared to reference databases created
either by the device manufacturer or otherwise publicly available.
These diagnostic devices present several advantages, such as
identifying potential disease etiology in situations where many
different pathogens share a common clinical manifestation and the
simultaneous detection of co-infections. However, establishing and
validating the performance of these devices to make informed clinical
and public health decisions poses significant scientific challenges.
This public meeting is to discuss the performance evaluation of highly
multiplexed microbiology/MCM device, their clinical application and
public health/clinical needs and quality criteria for establishing the
accuracy of reference databases. These considerations are essential to
establish the safety and effectiveness of highly multiplexed devices
when used for the clinical diagnosis of infectious diseases from a
human specimen.
FDA is holding this public meeting to obtain input from academia,
government, industry, clinical laboratories, and other stakeholders on
the performance evaluation approach to be proposed by FDA, which
includes validation methods, reference panels, and bioinformatic
concepts needed to address the clinical and analytical performance
requirements for highly multiplexed microbiology/MCM devices. The
ultimate goal is to advance regulatory science for highly multiplexed
devices used in pathogen detection in order to ensure their safety and
effectiveness and thereby provide potential clinical and public health
benefits.
II. Meeting Overview
The public meeting will consist of presentations providing
background on current and anticipated uses for highly multiplexed
microbiology devices that may contain MCM analytes, the performance
evaluation approach
[[Page 48171]]
proposed by FDA, and information on reference databases; an open public
comment session; and an open discussion on selected topics raised by
the presentations (see section III of this document.) During the
discussions, the participants will not be asked to develop consensus
opinions but rather to provide their individual perspectives.
Additional information, including a meeting agenda, will be
available on the Internet, immediately after publication of this
document in the Federal Register. The evaluation approach proposed by
FDA is expected to be available at a later date. This information will
be placed on file in the public docket (docket number found in brackets
in the heading of this document), which is available at https://www.regulations.gov. This information will also be available at https://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/default.htm
(select the appropriate meeting from the list).
III. Topics for Input
FDA will seek input on its proposed performance evaluation
approach, which will include the following topics:
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; 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.
IV. Transcripts
Please be advised that as soon as a transcript is available, it
will be accessible at https://www.regulations.gov. It may be viewed at
the Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. A
transcript will also be available in either hardcopy or on CD-ROM,
after submission of a Freedom of Information request. Written requests
are to be sent to Division of Freedom of Information (ELEM-1029), Food
and Drug Administration, 12420 Parklawn Dr., Element Bldg., rm. 1050,
Rockville, MD 20857.
Dated: August 2, 2011.
Nancy K. Stade,
Deputy Director for Policy, Center for Devices and Radiological Health.
[FR Doc. 2011-19996 Filed 8-5-11; 8:45 am]
BILLING CODE 4160-01-P