Food and Drug Administration Critical Path Workshop on Clinical Trials for Local Treatment of Breast Cancer by Thermal Ablation, 42356-42357 [E8-16638]
Download as PDF
<![CDATA[
42356
Federal Register / Vol. 73, No. 140 / Monday, July 21, 2008 / Notices
L’Enfant Promenade, SW., Washington,
DC 20447, Attn: ACF Reports Clearance
Officer. E-mail address:
infocollection@acf.hhs.gov. All requests
should be identified by the title of the
information collection.
The Department specifically requests
comments on: (a) Whether the proposed
collection of information is necessary
for the proper performance of the
functions of the agency, including
whether the information shall have
practical utility; (b) the accuracy of the
agency’s estimate of the burden of the
proposed collection of information; (c)
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.
Consideration will be given to
comments and suggestions submitted
within 60 days of this publication.
Dated: July 16, 2008.
Janean Chambers,
Reports Clearance Officer.
[FR Doc. E8–16616 Filed 7–18–08; 8:45 am]
BILLING CODE 4184–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2008–N–0038]
Food and Drug Administration Critical
Path Workshop on Clinical Trials for
Local Treatment of Breast Cancer by
Thermal Ablation
AGENCY:
Food and Drug Administration,
HHS.
PWALKER on PROD1PC71 with NOTICES
ACTION:
Notice of public workshop.
SUMMARY: The Food and Drug
Administration (FDA) is announcing a
public workshop to discuss the issues
associated with the development and
implementation of feasibility trials for
local treatment of breast cancer by
thermal ablation (i.e., cryoablation,
focused ultrasound, interstitial laser,
microwave, radiofrequency ablation).
We are inviting individuals, companies,
organizations, and other stakeholders to
attend this public workshop to discuss
how standardized protocols for
evaluation of tissue biopsy pathology,
selection of tumors amenable to
ablation, image guidance for ablation,
post-ablation imaging and assessment,
and tissue pathology of ablated
specimens can be developed and used
in breast cancer thermal ablation
clinical trials. The public workshop will
VerDate Aug<31>2005
19:22 Jul 18, 2008
Jkt 214001
also serve as a forum for discussing
where within the multispecialty care
path involving operative therapy,
chemotherapy, and radiation therapy,
thermal ablation may play a role.
Date and Time: The public workshop
will be held on September 15, 2008,
from 9 a.m. to 6 p.m. Online registration
is available at https://
www.blsmeetings.net/
2008ThermalAblationWorkshop until 5
p.m. on August 30, 2008 (see section III
of this document for details).
Location: The public workshop will
be held at the FDA White Oak Campus,
conference rooms 2047 F and G (https://
grouper.ieee.org/groups/scc34/sc2/
meeting_info/Meeting_WhiteOak_1518OCT2007/
White_Oak_Campus_Info_2007.pdf)
located at 10903 New Hampshire Ave.,
Silver Spring, MD 20993.
Contact: Binita Ashar, Center for
Devices and Radiological Health (HFZ–
410), Food and Drug Administration,
9200 Corporate Blvd., Rockville, MD
20850, 240–276–3600, e-mail:
Binita.Ashar@FDA.HHS.gov.
If you need special accommodations
due to a disability, please contact Paula
Gumbs at 301–594–4453 at least 7 days
in advance.
SUPPLEMENTARY INFORMATION:
I. Background
On July 24, 2003, the FDA’s General
and Plastic Surgery Devices Advisory
Panel discussed issues pertaining to the
use of thermal ablation devices to
percutaneously or non-invasively treat
breast cancer by causing coagulation
necrosis of the tumor. The panel
discussed clinical trial issues pertaining
to the local treatment of breast cancer
using thermal ablation versus operative
resection.
The panel addressed the following
issues: (1) The level of evidence that
would be required, in initial studies of
treatment of primary breast cancer by
minimally invasive ablation followed by
immediate lumpectomy for pathologic
examination of margins (i.e., feasibility
ablate and resect studies), to permit
initiation of studies that use minimally
invasive ablation to definitively treat the
cancer without followup resection (i.e.,
ablate and follow studies); (2) the type
of pivotal study that could demonstrate
the efficacy of a thermal ablation device
to provide local breast cancer treatment
in lieu of lumpectomy; (3) how to
mitigate concerns regarding the effect of
thermal ablation on surrounding breast
tissue and radio/chemosensitivity; and
(4) the limitations of breast imaging and
its effect on patient selection and
treatment followup. This panel’s
discussion of these issues has
PO 00000
Frm 00044
Fmt 4703
Sfmt 4703
significantly contributed to FDA’s
evaluation of these technologies.
Investigators studying the feasibility
of thermal ablation devices for the
treatment of breast cancers have refined
their techniques. In fact, there have been
small studies demonstrating nearly 100
percent ablation accuracy.
Unfortunately, the lack of uniformity
among different feasibility study
protocols has resulted in various study
results that cannot be easily compared.
Uniformity with respect to standardized
evaluation of tissue biopsy pathology,
selection of tumors amenable to
ablation, image guidance for ablation,
timing of ablation (with respect to
lymph node biopsy, radiation therapy
and chemotherapy), post-ablation
imaging and assessment, and tissue
pathology of ablated specimens would
facilitate the assembly of results across
both studies and ablation modalities
and better allow the formulation of
science-based hypotheses regarding best
practices for breast cancer ablation
therapy. The purpose of this critical
path effort is to motivate the breast
cancer ablation industry to standardize
its feasibility study protocols so that
data emerging are comparable in all
respects except for the specific ablation
modality. Such data could be used to
create a validated imaging tool that
correlates pathological results with
imaging findings of an ablated breast
cancer and hypothesize best practices
that could potentially serve as the basis
for longitudinal prospective clinical
trials.
We believe that there may be a variety
of opinions and experiences regarding
the information required to obtain
uniformity with respect to standardized
evaluation of tissue biopsy pathology,
selection of tumors amenable to
ablation, image guidance for ablation,
timing of ablation (with respect to
lymph node biopsy, radiation therapy
and chemotherapy), post-ablation
imaging and assessment, and tissue
pathology of ablated specimens to
facilitate the assembly of results across
both studies and ablation modalities
and better allow the formulation of
science-based hypotheses regarding best
practices for breast cancer ablation
therapy. We therefore published a
notice in the Federal Register of May
28, 2008 (73 FR 30619) (https://
www.access.gpo.gov) requesting
comments by November 24, 2008, to
help the agency understand how a
potential registry of breast cancer
treatment using thermal ablation
devices may motivate this effort.
E:\FR\FM\21JYN1.SGM
21JYN1
Federal Register / Vol. 73, No. 140 / Monday, July 21, 2008 / Notices
II. Agenda
The purpose of the public workshop
is to discuss the development and
implementation of a rational,
standardized approach for conducting
feasibility trials (i.e., ablate and resect
trials) examining thermal ablation of
breast cancer as part of the treatment
care path for patients with breast cancer.
Representatives from various areas
involved with the development, testing,
and use of thermal ablation devices for
breast cancer have been invited. There
will be focused sessions, addressing the
key issues of breast cancer thermal
ablation treatment related to imaging,
pathology, operative resection and
axillary staging, chemotherapy and
radiation therapy.
Participation in the workshop is open
to both invited participants and
audience members. The invited
participants include medical experts
from various specialties involved in the
care of patients with breast cancer and
use of thermal ablation devices. Invited
participants will have completed a work
assignment in advance of the public
workshop in order to optimize the time
spent during the public workshop.
Audience participation is open to all
who are interested in clinical trials for
local treatment of breast cancer by
thermal ablation and will be scheduled
throughout the sessions.
The agenda for this public workshop
is available on the Internet at https://
www.blsmeetings.net/
2008ThermalAblationWorkshop.
III. Registration
Those interested in attending may
register online at https://
www.blsmeetings.net/
2008ThermalAblationWorkshop. There
is no registration fee to attend the public
workshop, however all participants
must submit a registration form. Space
is limited, so please submit your
registration early to reserve a space.
Registrations will be accepted through
August 30, 2008; however, onsite
registration will be permitted on a
space-available basis.
Persons without Internet access may
call Paula Gumb at 301–577–0244, ext.
25 by September 12, 2008, to register for
onsite workshop attendance.
PWALKER on PROD1PC71 with NOTICES
IV. Transcripts
Please be advised that as soon as a
transcript is available, it will be
accessible at either https://www.fda.gov/
ohrms/dockets/ac/acmenu.htm or
https://www.blsmeetings.net/
2008ThermalAblationWorkshop. It may
be viewed at the Division of Dockets
Management (HFA–305), Food and Drug
VerDate Aug<31>2005
19:22 Jul 18, 2008
Jkt 214001
42357
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD. 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 (HFI–35),
Office of Management Programs, Food
and Drug Administration, 5600 Fishers
Lane, rm. 6–30, Rockville, MD 20857.
DERA, National Heart, Lung, and Blood
Institute, 6701 Rockledge Drive, Room 7186,
Bethesda, MD 20892–7924, 301–435–0280,
mintzerk@nhlbi.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.233, National Center for
Sleep Disorders Research; 93.837, Heart and
Vascular Diseases Research; 93.838, Lung
Diseases Research; 93.839, Blood Diseases
and Resources Research, National Institutes
of Health, HHS)
Dated: July 11, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E8–16638 Filed 7–18–08; 8:45 am]
Dated: July 11, 2008.
Jennifer Spaeth,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. E8–16407 Filed 7–18–08; 8:45 am]
BILLING CODE 4160–01–S
BILLING CODE 4140–01–M
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institutes of Health
National Heart, Lung, and Blood
Institute; Notice of Closed Meetings
National Institute of Child Health and
Human Development; Notice of Closed
Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. Appendix 2), notice
is hereby given of the following
meetings.
The meetings will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Heart, Lung,
and Blood Institute Special Emphasis Panel;
Ancillary Studies in Clinical Trials.
Date: August 14, 2008.
Time: 8 a.m. to 4 p.m.
Agenda: To review and evaluate grant
applications.
Place: Bethesda Marriott, 5151 Pooks Hill
Rd., Bethesda, MD 20814.
Contact Person: Chang Sook Kim, PhD,
Scientific Review Officer, Review Branch,
DERA, National Heart, Lung, and Blood
Institute, 6701 Rockledge Drive, Room 7190
Bethesda, MD 20892, 301–435–0287,
carolko@mail.nih.gov.
Name of Committee: National Heart, Lung,
and Blood Institute Special Emphasis Panel;
Research Projects in Lung Diseases.
Date: August 14, 2008.
Time: 9 a.m. to 5 p.m.
Agenda: To review and evaluate grant
applications.
Place: Hyatt Regency Bethesda, One
Bethesda Metro Center, 7400 Wisconsin
Avenue, Bethesda, MD 20814.
Contact Person: Keith A. Mintzer, PhD,
Scientific Review Officer, Review Branch/
PO 00000
Frm 00045
Fmt 4703
Sfmt 4703
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. Appendix 2), notice
is hereby given of the following
meetings.
The meetings will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Institute of
Child Health and Human Development
Special Emphasis Panel; ‘‘Aging In Adults
With Down Syndrome’’.
Date: August 14, 2008
Time: 3:30 p.m. to 4:30 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6100
Executive Boulevard, Room 5B01, Rockville,
MD 20852, (Telephone Conference Call).
Contact Person: Norman Chang, PhD.,
Scientific Review Administrator, Division of
Scientific Review, National Institute of Child
Health and Human Development. NIH, 6100
Executive Blvd., Room 5b01, Bethesda, MD
20892, (301) 496–1485,
changn@mail.nih.gov.
Name of Committee: National Institute of
Child Health and Human Development
Special Emphasis Panel; ‘‘Changes In
Functioning Among Mentally Retarded
Adults’’.
Date: August 14, 2008.
Time: 12 p.m. to 3 p.m.
E:\FR\FM\21JYN1.SGM
21JYN1
]]>Agencies
[Federal Register Volume 73, Number 140 (Monday, July 21, 2008)]
[Notices]
[Pages 42356-42357]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-16638]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2008-N-0038]
Food and Drug Administration Critical Path Workshop on Clinical
Trials for Local Treatment of Breast Cancer by Thermal Ablation
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public workshop.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing a public
workshop to discuss the issues associated with the development and
implementation of feasibility trials for local treatment of breast
cancer by thermal ablation (i.e., cryoablation, focused ultrasound,
interstitial laser, microwave, radiofrequency ablation). We are
inviting individuals, companies, organizations, and other stakeholders
to attend this public workshop to discuss how standardized protocols
for evaluation of tissue biopsy pathology, selection of tumors amenable
to ablation, image guidance for ablation, post-ablation imaging and
assessment, and tissue pathology of ablated specimens can be developed
and used in breast cancer thermal ablation clinical trials. The public
workshop will also serve as a forum for discussing where within the
multispecialty care path involving operative therapy, chemotherapy, and
radiation therapy, thermal ablation may play a role.
Date and Time: The public workshop will be held on September 15,
2008, from 9 a.m. to 6 p.m. Online registration is available at https://
www.blsmeetings.net/2008ThermalAblationWorkshop until 5 p.m. on August
30, 2008 (see section III of this document for details).
Location: The public workshop will be held at the FDA White Oak
Campus, conference rooms 2047 F and G (https://grouper.ieee.org/groups/
scc34/sc2/meeting_info/Meeting_WhiteOak_15-18OCT2007/White_Oak_
Campus_Info_2007.pdf) located at 10903 New Hampshire Ave., Silver
Spring, MD 20993.
Contact: Binita Ashar, Center for Devices and Radiological Health
(HFZ-410), Food and Drug Administration, 9200 Corporate Blvd.,
Rockville, MD 20850, 240-276-3600, e-mail: Binita.Ashar@FDA.HHS.gov.
If you need special accommodations due to a disability, please
contact Paula Gumbs at 301-594-4453 at least 7 days in advance.
SUPPLEMENTARY INFORMATION:
I. Background
On July 24, 2003, the FDA's General and Plastic Surgery Devices
Advisory Panel discussed issues pertaining to the use of thermal
ablation devices to percutaneously or non-invasively treat breast
cancer by causing coagulation necrosis of the tumor. The panel
discussed clinical trial issues pertaining to the local treatment of
breast cancer using thermal ablation versus operative resection.
The panel addressed the following issues: (1) The level of evidence
that would be required, in initial studies of treatment of primary
breast cancer by minimally invasive ablation followed by immediate
lumpectomy for pathologic examination of margins (i.e., feasibility
ablate and resect studies), to permit initiation of studies that use
minimally invasive ablation to definitively treat the cancer without
followup resection (i.e., ablate and follow studies); (2) the type of
pivotal study that could demonstrate the efficacy of a thermal ablation
device to provide local breast cancer treatment in lieu of lumpectomy;
(3) how to mitigate concerns regarding the effect of thermal ablation
on surrounding breast tissue and radio/chemosensitivity; and (4) the
limitations of breast imaging and its effect on patient selection and
treatment followup. This panel's discussion of these issues has
significantly contributed to FDA's evaluation of these technologies.
Investigators studying the feasibility of thermal ablation devices
for the treatment of breast cancers have refined their techniques. In
fact, there have been small studies demonstrating nearly 100 percent
ablation accuracy. Unfortunately, the lack of uniformity among
different feasibility study protocols has resulted in various study
results that cannot be easily compared. Uniformity with respect to
standardized evaluation of tissue biopsy pathology, selection of tumors
amenable to ablation, image guidance for ablation, timing of ablation
(with respect to lymph node biopsy, radiation therapy and
chemotherapy), post-ablation imaging and assessment, and tissue
pathology of ablated specimens would facilitate the assembly of results
across both studies and ablation modalities and better allow the
formulation of science-based hypotheses regarding best practices for
breast cancer ablation therapy. The purpose of this critical path
effort is to motivate the breast cancer ablation industry to
standardize its feasibility study protocols so that data emerging are
comparable in all respects except for the specific ablation modality.
Such data could be used to create a validated imaging tool that
correlates pathological results with imaging findings of an ablated
breast cancer and hypothesize best practices that could potentially
serve as the basis for longitudinal prospective clinical trials.
We believe that there may be a variety of opinions and experiences
regarding the information required to obtain uniformity with respect to
standardized evaluation of tissue biopsy pathology, selection of tumors
amenable to ablation, image guidance for ablation, timing of ablation
(with respect to lymph node biopsy, radiation therapy and
chemotherapy), post-ablation imaging and assessment, and tissue
pathology of ablated specimens to facilitate the assembly of results
across both studies and ablation modalities and better allow the
formulation of science-based hypotheses regarding best practices for
breast cancer ablation therapy. We therefore published a notice in the
Federal Register of May 28, 2008 (73 FR 30619) (https://
www.access.gpo.gov) requesting comments by November 24, 2008, to help
the agency understand how a potential registry of breast cancer
treatment using thermal ablation devices may motivate this effort.
[[Page 42357]]
II. Agenda
The purpose of the public workshop is to discuss the development
and implementation of a rational, standardized approach for conducting
feasibility trials (i.e., ablate and resect trials) examining thermal
ablation of breast cancer as part of the treatment care path for
patients with breast cancer. Representatives from various areas
involved with the development, testing, and use of thermal ablation
devices for breast cancer have been invited. There will be focused
sessions, addressing the key issues of breast cancer thermal ablation
treatment related to imaging, pathology, operative resection and
axillary staging, chemotherapy and radiation therapy.
Participation in the workshop is open to both invited participants
and audience members. The invited participants include medical experts
from various specialties involved in the care of patients with breast
cancer and use of thermal ablation devices. Invited participants will
have completed a work assignment in advance of the public workshop in
order to optimize the time spent during the public workshop. Audience
participation is open to all who are interested in clinical trials for
local treatment of breast cancer by thermal ablation and will be
scheduled throughout the sessions.
The agenda for this public workshop is available on the Internet at
https://www.blsmeetings.net/2008ThermalAblationWorkshop.
III. Registration
Those interested in attending may register online at https://
www.blsmeetings.net/2008ThermalAblationWorkshop. There is no
registration fee to attend the public workshop, however all
participants must submit a registration form. Space is limited, so
please submit your registration early to reserve a space. Registrations
will be accepted through August 30, 2008; however, onsite registration
will be permitted on a space-available basis.
Persons without Internet access may call Paula Gumb at 301-577-
0244, ext. 25 by September 12, 2008, to register for onsite workshop
attendance.
IV. Transcripts
Please be advised that as soon as a transcript is available, it
will be accessible at either https://www.fda.gov/ohrms/dockets/ac/
acmenu.htm or https://www.blsmeetings.net/2008ThermalAblationWorkshop.
It may be viewed at the Division of Dockets Management (HFA-305), Food
and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD. 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 (HFI-35),
Office of Management Programs, Food and Drug Administration, 5600
Fishers Lane, rm. 6-30, Rockville, MD 20857.
Dated: July 11, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-16638 Filed 7-18-08; 8:45 am]
BILLING CODE 4160-01-S
