[Federal Register Volume 78, Number 16 (Thursday, January 24, 2013)]
[Notices]
[Pages 5186-5188]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-01419]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-N-0046]
Clinical Flow Cytometry in Hematologic Malignancies; Public
Workshop; Request for Comments
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public workshop; request for comments.
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The Food and Drug Administration (FDA) is announcing the following
public workshop entitled ``Clinical Flow Cytometry in Hematologic
Malignancies.'' The purpose of this public workshop is to seek public
input from academia, Government, laboratorians, industry, clinicians,
patients and other stakeholders on the role of clinical flow cytometry
in hematologic malignancies, in order to develop a specific regulatory
policy for this class of in vitro diagnostic devices.
Date and Time: The workshop will be held on February 25 and 26,
2013 from 8 a.m. to 5 p.m.
Location: The public workshop will be held at FDA's White Oak
Campus, 10903 New Hampshire Ave., Rm. 1503 (Section A of the Great
Room) in Bldg. 31, Silver Spring, MD 20993-0002. All visiting public
workshop participants (non- FDA employees) must enter through Building
1 for routine security check procedures. For parking and security
information, please visit the following Web site: http://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm.
Contact Person: Carol Krueger, Center for Devices and Radiological
Health (CDRH), Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 66, Rm. 5437, Silver Spring, MD 20993-0002, 301-796-3241,
Carol.Krueger@fda.hhs.gov.
Registration: Registration is free and on a first-come, first-
served basis. Persons interested in attending this public workshop must
register online by 5 p.m. on February 11, 2013. Early registration is
recommended because facilities are limited and, therefore, FDA may
limit the number of participants from each organization. If time and
space permit, onsite registration on the day of the public workshop
will be provided beginning at 7 a.m.
To register for the public workshop, please visit FDA's Medical
Devices News & Events--Workshops & Conferences calendar at http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/default.htm.
(Select this public workshop from the posted events list.) Please
provide complete contact information for each attendee, including name,
title, affiliation, mailing address, email address, and telephone
number. Those without Internet access should contact Carol Krueger to
register (see Contact Person). Registrants will receive confirmation
after they have been accepted. You will be notified if you are on a
waiting list.
If you need special accommodations due to a disability, please
contact Susan Monahan (email: Susan.Monahan@fda.hhs.gov or phone:
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301-796-5661) no later than February 11, 2013.
Streaming Webcast of the Public Workshop: This workshop will also
be available via Webcast. Persons interested in viewing the Webcast
must register online by 5:00 p.m. on February 11, 2013. Early
registration is recommended because Webcast connections are limited.
Organizations are requested to register all participants, but to view
using one connection per location. Webcast participants will be sent
technical system requirements after registration and will be sent
connection access information after February 20, 2013. If you have
never attended a Connect Pro event 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 http://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.)
Requests for Oral Presentations: This workshop includes public
comment sessions. If you wish to present during a public comment
session, you must indicate this at the time of registration. At the
time of registration identify which discussion topic you wish to
address. The topics under consideration for this workshop are
identified in section II of this document. FDA will do its best to
accommodate requests to present. Individuals and organizations with
common interests are urged to consolidate or coordinate their comments,
and request time to present a joint comment. Following the close of
registration, the Agency will determine the amount of time allotted to
each presenter, the approximate time each comment is to begin, and will
select and notify speakers by February 20, 2013. All requests to make
oral presentations must be received by the close of registration on
February 11, 2013. No commercial or promotional material will be
permitted to be presented or distributed at the workshop.
Comments: FDA is holding this public workshop to obtain information
on the topics identified in section II of this document.
In order to permit the widest possible opportunity to obtain public
comment, FDA is soliciting either electronic or written comments on all
aspects of the public workshop topics. The deadline for submitting
comments related to this public workshop is March 29, 2013.
Regardless of attendance at the public workshop, interested persons
may submit either electronic or written comments. 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. It is only necessary
to send one set of comments. Please 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 II of this
document, please identify the question you are addressing. Received
comments may be seen in the Division of Dockets Management between 9:00
a.m. and 4:00 p.m., Monday through Friday and will be posted to the
docket at http://www.regulations.gov.
Transcripts: Please be advised that as soon as a transcript is
available, it will be accessible at http://www.regulations.gov. It may
be viewed at the Division of Dockets Management (see Comments). 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 the Division of Freedom of Information (ELEM-1029),
Food and Drug Administration, 12420 Parklawn Dr., Element Bldg.,
Rockville, MD 20857. A link to the transcripts will also be available
approximately 45 days after the public workshop on the Internet at
http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/default.htm. (Select this public workshop from the posted events list).
SUPPLEMENTARY INFORMATION:
I. Background
The earliest determination of B and T cell subsets was based on
microscopic counting of cells expressing surface immunoglobulins for B
cell enumeration, and sheep red blood cells rosette formation was used
to enumerate T cells. The subsequent development of leukocyte-specific
monoclonal antibodies and flow cytometry contributed to the automation
of lymphocyte subset analysis. Flow cytometric lymphocyte subset
analysis was initially used to immunophenotype hematological
malignancies; however, the HIV epidemic led to a large number of 510(k)
submissions addressing use for HIV immune monitoring in AIDS.
In response to these submissions, Draft Guidance for 510(k)
Submission of Lymphocyte Immunophenotyping Monoclonal Antibodies was
issued September 26, 1991. Prior to this draft document, reagents for
CD2 and CD20 were 510(k) cleared based on methodological correlation
with accepted reference methods. Following the issuance of the 1991
draft guidance, several test systems identifying CD3 T cells, CD4 and
CD8 T cell subsets, NK cells and B cells were cleared under 510(k),
with either single reagents or combination of reagents based on the
previous clearance of CD2 and CD20 reagents. These clearances for flow
cytometry system devices included flow cytometers, reagents, controls,
and associated software for data acquisition and data analysis.
In 1997, the FDA issued the Analyte Specific Reagent (ASR) Rule (21
CFR 864.4020) to provide some assurance that 1) critical reagents
manufacturers provided to laboratories for use in tests developed by
the laboratories were made under current Good Manufacturing Practices
(cGMP), 2) manufacturers registered with the FDA and listed such
reagents, and 3) manufacturers reported malfunctions, injuries and
deaths related to the use of such reagents to the FDA (62 FR 62260,
November 21, 1997). Subsequent to publication of the ASR rule in 1997,
some manufacturers began to bundle individual ASRs together in the form
of reagent panels (``cocktails'') creating devices that went beyond the
single reagent ASRs that the rule had anticipated. In 2007, the Agency
reiterated and clarified the intentions of the ASR rule in the Guidance
for Industry and FDA Staff on Commercially Distributed Analyte Specific
Reagents (ASRs): Frequently Asked Questions http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm078423.htm. The 2007 guidance clarifies that the bundling of ASRs
into a panel of multi-analytes is inconsistent with the definition of
an ASR per 21 CFR 864.4020. Subsequent to issuance of the guidance,
many uncleared, multi-analyte panels were withdrawn from distribution
in order to comply with the interpretation of the ``ASR rule.''
Clinical flow cytometry plays a major role world-wide in the
diagnosis of leukemia and lymphoma and more recently in the detection
of minimal residual disease (MRD). Because there are currently no FDA
cleared or approved in vitro diagnostics (IVD) panels for the
diagnostic evaluation of hematological malignancies, FDA recognizes
that there is an unmet need for such products to assist clinical
laboratories in performing this testing. FDA has been working to define
the regulatory guidelines for the review of this family of devices and
has been actively working with industry and
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academia to help bring additional products for clinical flow cytometry
to market that are safe and effective.
In partnership with the National Institutes of Health (NIH) and
National Institute of Standards and Technology (NIST), CDRH intends to
utilize the findings of this workshop in the development of an
appropriate, risk-based regulatory framework for Clinical Flow
Cytometry, which promotes innovation and protects patient safety.
II. Topics
Topics for discussion during this workshop include: (1) Overview of
Quality control and standardization issues associated with Clinical
Flow Cytometry (FCM), including discussion of a NIST traceable
standard; (2) Biological controls in Clinical FCM: The use of
stabilized whole blood samples and cryopreserved cells for normals and
chronic lymphocytic leukemia (CLL); (3) Third-party flow cytometry data
analysis software; and (4) Overview of FDA regulation of Clinical FCM
using the 510(k) clearance process.
The FDA is seeking representation from both North American and
European clinical investigators at this workshop. This Clinical FCM
Workshop is being planned to occur just prior to a CDER Workshop on the
role of MRD in CLL which will be held February 27, 2013 (77 FR 76051,
December 26, 2012). An FDA workshop for acute lymphocytic leukemia
(ALL) MRD was held April 18, 2012, and a separate workshop on acute
myelogenous leukemia (AML) MRD will be held March 4, 2013 (77 FR 76050,
December 26, 2012).
Dated: January 17, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-01419 Filed 1-23-13; 8:45 am]
BILLING CODE 4160-01-P