Public Workshop on Minimal Residual Disease; Public Workshop, 76050-76051 [2012-31043]
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76050
Federal Register / Vol. 77, No. 247 / Wednesday, December 26, 2012 / Notices
The Food and Drug
Administration (FDA) is correcting a
notice that appeared in the Federal
Register of Tuesday, November 20, 2012
(77 FR 69632). The document
announced the availability of a draft
guidance entitled ‘‘Electronic Source
Data in Clinical Investigations.’’ The
document was published with an
incorrect date in the DATES section. This
document corrects that error.
FOR FURTHER INFORMATION CONTACT: Ron
Fitzmartin, Office of Planning &
Informatics, Center for Drug Evaluation
and Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 51, Rm. 1160, Silver Spring,
MD 20993–0002, 301–796–5333, FAX:
301–847–8443.
SUPPLEMENTARY INFORMATION: In FR Doc.
2012–28198, appearing on page 69632
in the Federal Register of Tuesday,
November 20, 2012, the following
correction is made:
1. On page 69632, in the third
column, in the DATES section, the date
‘‘January 22, 2013’’ is corrected to read
‘‘March 26, 2013.’’
SUMMARY:
Dated: December 20, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012–31027 Filed 12–21–12; 4:15 pm]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0899]
Draft Environmental Assessment and
Preliminary Finding of No Significant
Impact Concerning a Genetically
Engineered Atlantic Salmon;
Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA, the Agency) is
announcing the availability for public
comment of the Agency’s draft
environmental assessment (EA) of the
proposed conditions of use specified in
materials submitted by AquaBounty
Technologies, Inc., in support of a new
animal drug application (NADA)
concerning a genetically engineered
(GE) Atlantic salmon. Also available for
comment is the Agency’s preliminary
finding of no significant impact (FONSI)
for those specific conditions of use.
DATES: Submit either electronic or
written comments on the Agency’s draft
tkelley on DSK3SPTVN1PROD with
SUMMARY:
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06:31 Dec 22, 2012
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EA and preliminary FONSI by February
25, 2013.
ADDRESSES: 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. Identify
comments with the docket number
found in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT: Eric
Silberhorn, Center for Veterinary
Medicine (HFV–162), Food and Drug
Administration, 7500 Standish Pl.,
Rockville, MD 20855, 240–276–8247,
email:abig@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Notice is
given that a draft EA prepared by FDA
in support of an NADA associated with
AQUADVANTAGE Salmon, a GE
Atlantic salmon containing the opAFP–
GHc2 recombinant DNA construct is
being made available for public
comment. FDA is also making available
for comment the Agency’s preliminary
FONSI for those specific conditions of
use. In the event of an approval of the
application, the approval would only
allow AQUADVANTAGE Salmon to be
produced and grown-out in the
physically contained freshwater culture
facilities specified in the sponsor’s
NADA.
To encourage public participation
consistent with regulations
implementing the National
Environmental Policy Act (40 CFR
1501.4(b)), the Agency is placing the
draft EA and the preliminary FONSI
that are the subject of this notice on
public display at the Division of Dockets
Management (see DATES and ADDRESSES)
for public review and comment for 60
days. Given that the substance of this
draft EA was made available to the
public in advance of the Agency’s 2010
Veterinary Medicine Advisory
Committee meeting and consistent with
the Agency’s regulations implementing
the National Environmental Policy Act
(21 CFR 25.51(b)(3)), FDA believes that
a 60-day comment period is appropriate
and does not intend to grant requests for
extension of the comment period.
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. Identify comments with the
docket number found in brackets in the
heading of this document. Received
comments may be seen in the Division
of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday.
FDA will also place on public display
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any amendments to, or comments on,
the Agency’s draft EA and preliminary
FONSI without further announcement
in the Federal Register.
If, based on its review, the Agency
finds that an environmental impact
statement is not required and the NADA
results in an approval by the Agency,
the notice of availability of the Agency’s
EA and FONSI, as well as any
supporting evidence, will be published
with the regulation describing the
approval in the Federal Register in
accordance with 21 CFR 25.51(b).
Dated: December 20, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012–31118 Filed 12–21–12; 11:15 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–N–0001]
Public Workshop on Minimal Residual
Disease; Public Workshop
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of public workshop.
The Food and Drug
Administration (FDA), in cosponsorship
with the American Society of Clinical
Oncology, is announcing a public
workshop that will provide a forum for
discussion of extending the
qualification of minimal residual
disease (MRD) detection as a prognostic
biomarker to an efficacy/response
biomarker in evaluating new drugs for
the treatment of acute myeloid leukemia
(AML). Our objective is for the
workshop to provide a venue for an indepth discussion of potential endpoints
for trials intended to support the
approval of new drugs or biologics for
treatment of AML. Participants in the
workshop will examine if any currently
used biomarker can be used as a
surrogate endpoint, identify the
preferred technology platform and
performance characteristics for the assay
of the biomarker, discuss any issues
regarding ongoing deficiencies in
methodological standardization for the
biomarker, and determine the need for
additional FDA-approved in-vitro
diagnostics for AML drug development.
The primary focus will be on the
biomarkers that are or will soon be
ready for incorporation into clinical
trials, and the technical and regulatory
challenges for use of these markers.
SUMMARY:
E:\FR\FM\26DEN1.SGM
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Federal Register / Vol. 77, No. 247 / Wednesday, December 26, 2012 / Notices
The public workshop will be
held on March 4, 2013, from 8 a.m. to
4 p.m.
ADDRESSES: The public workshop will
be held at the FDA White Oak Campus,
10903 New Hampshire Ave., Building
31 Conference Center, the Great Room
(rm. 1503), Silver Spring, MD 20993–
0002. Entrance for the public workshop
participants (non-FDA employees) is
through Building 1 where routine
security check procedures will be
performed. For parking and security
information please refer to https://www.
fda.gov/AboutFDA/WorkingatFDA/
BuildingsandFacilities/WhiteOak
CampusInformation/ucm241740.htm.
FOR FURTHER INFORMATION CONTACT:
Christine Lincoln, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, rm. 6413,
Silver Spring, MD 20993–0002, 301–
796–2340, email:
Christine.Lincoln@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
tkelley on DSK3SPTVN1PROD with
DATES:
I. Background
Complete remission, relapse-free
survival, and overall survival are
frequently used as endpoints in clinical
trials of new therapeutics for AML.
These endpoints have some limitations,
especially in the context of minimal
residual disease. Use of morphological
complete remission may miss
individuals with clinically significant
residual disease who are not truly in
remission. For those being followed
after remission induction, new evidence
of submorphological disease may
prompt therapy before morphological
relapse. Additionally, for patients with
good prognosis, the length of the
clinical trial followup may be very long
when survival is the outcome measured,
raising logistical and financial
challenges for study conduct. More
information is needed on whether MRD
in AML can be qualified as a response
biomarker and then used as a clinical
trial endpoint and what the challenges
would be to implement use of such an
endpoint.
This Public Workshop on Minimal
Residual Disease in AML will be one of
a series of FDA workshops to establish
processes and procedures necessary to
qualify a prognostic biomarker, MRD, as
a possible response or efficacy
biomarker in a group of hematological
malignancies. Evaluation of clinical data
suggests that MRD can be established as
a potential surrogate endpoint for
pivotal clinical trials and drug approval
given its prominent role as a prognostic
indicator in certain subtypes of acute
and chronic leukemia. The Office of
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06:31 Dec 22, 2012
Jkt 229001
Hematology and Oncology Products has
explored, or plans to explore, the
potential utility of MRD as a surrogate
endpoint in acute lymphoblastic
leukemia (ALL) (including the relapsed
setting), chronic lymphocytic leukemia
(CLL), and AML. Given the diverse
pathophysiology and natural history of
these diseases and current practice
standards, individualized consideration
of MRD as a surrogate endpoint is
warranted. The ALL workshop was held
on April 18, 2012, and the CLL
workshop will be held on February 27,
2013.
II. Structure and Scope of the
Workshop
The workshop’s scope will include
discussions of the use of flow cytometry
and molecular methods used to detect
and measure minimal residual disease
in patients being treated for AML. The
workshop will consist of formal
presentations examining the regulatory,
scientific, and clinical basis for use of
biomarkers as potential clinical trial
endpoints in AML interspersed with
discussions on issues associated with
these endpoints.
III. Attendance and Registration
FDA encourages patient advocates,
representatives from industry, consumer
groups, health care professionals,
researchers, and other interested
persons to attend this public workshop.
There is no registration fee for the
public workshop. To register
electronically, please use the following
Web site: https://www.zoomerang.com/
Survey/WEB22GPAXN9NQB (FDA has
verified the Web site address, but we are
not responsible for any subsequent
changes to the Web site after this
document publishes in the Federal
Register.) Seats are limited and
conference space will be filled in the
order in which registrations are
received. Onsite registration will be
available to the extent that space is
available on the day of the conference.
Information regarding special
accommodations due to a disability,
visitor parking, and transportation may
be accessed at: https://www.fda.gov/
AdvisoryCommittees/default.htm.
Under the heading ‘‘Resources for You,’’
click on ‘‘Public Meetings at the FDA
White Oak Campus.’’
Dated: December 20, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012–31043 Filed 12–21–12; 4:15 pm]
BILLING CODE 4160–01–P
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76051
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–N–0001]
Public Workshop on Minimal Residual
Disease; Public Workshop
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of public workshop.
The Food and Drug
Administration (FDA), in cosponsorship
with the American Society of Clinical
Oncology, is announcing a public
workshop that will provide a forum for
discussion of extending the
qualification of minimal residual
disease (MRD) detection as a prognostic
biomarker to that of an efficacy/
response biomarker in evaluating new
drugs for the treatment of chronic
lymphocytic leukemia (CLL). Our
objective for the workshop is to provide
a venue for an in-depth discussion of
potential surrogate endpoints for trials
intended to support the approval of new
drugs or biologics for the treatment of
CLL. Participants in the workshop will
examine the advantages and
disadvantages of MRD as a surrogate
endpoint for approval, identify the
preferred technology platform and
performance characteristics for the assay
of this biomarker, and discuss any
issues regarding methodological
standardization for the biomarker. The
primary focus will be on the biomarkers
that are ready for incorporation into
clinical trials and the technical and
regulatory challenges for use of these
markers.
SUMMARY:
The public workshop will be
held on February 27, 2013, from 8 a.m.
to 4 p.m.
ADDRESSES: The public workshop will
be held at the FDA White Oak Campus,
10903 New Hampshire Ave., Building
31 Conference Center, the Great Room
(rm. 1503), Silver Spring, MD 20993–
0002. Entrance for the public workshop
participants (non-FDA employees) is
through Building 1 where routine
security check procedures will be
performed. For parking and security
information please refer to https://www.
fda.gov/AboutFDA/WorkingatFDA/
BuildingsandFacilities/WhiteOak
CampusInformation/ucm241740.htm.
FOR FURTHER INFORMATION CONTACT:
Christine Lincoln, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, rm. 6413,
Silver Spring, MD 20993–0002, 301–
DATES:
E:\FR\FM\26DEN1.SGM
26DEN1
]]>Agencies
[Federal Register Volume 77, Number 247 (Wednesday, December 26, 2012)]
[Notices]
[Pages 76050-76051]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-31043]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2012-N-0001]
Public Workshop on Minimal Residual Disease; Public Workshop
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public workshop.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA), in cosponsorship with
the American Society of Clinical Oncology, is announcing a public
workshop that will provide a forum for discussion of extending the
qualification of minimal residual disease (MRD) detection as a
prognostic biomarker to an efficacy/response biomarker in evaluating
new drugs for the treatment of acute myeloid leukemia (AML). Our
objective is for the workshop to provide a venue for an in-depth
discussion of potential endpoints for trials intended to support the
approval of new drugs or biologics for treatment of AML. Participants
in the workshop will examine if any currently used biomarker can be
used as a surrogate endpoint, identify the preferred technology
platform and performance characteristics for the assay of the
biomarker, discuss any issues regarding ongoing deficiencies in
methodological standardization for the biomarker, and determine the
need for additional FDA-approved in-vitro diagnostics for AML drug
development. The primary focus will be on the biomarkers that are or
will soon be ready for incorporation into clinical trials, and the
technical and regulatory challenges for use of these markers.
[[Page 76051]]
DATES: The public workshop will be held on March 4, 2013, from 8 a.m.
to 4 p.m.
ADDRESSES: The public workshop will be held at the FDA White Oak
Campus, 10903 New Hampshire Ave., Building 31 Conference Center, the
Great Room (rm. 1503), Silver Spring, MD 20993-0002. Entrance for the
public workshop participants (non-FDA employees) is through Building 1
where routine security check procedures will be performed. For parking
and security information please refer to https://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm.
FOR FURTHER INFORMATION CONTACT: Christine Lincoln, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, rm. 6413, Silver Spring, MD 20993-0002, 301-
796-2340, email: Christine.Lincoln@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
Complete remission, relapse-free survival, and overall survival are
frequently used as endpoints in clinical trials of new therapeutics for
AML. These endpoints have some limitations, especially in the context
of minimal residual disease. Use of morphological complete remission
may miss individuals with clinically significant residual disease who
are not truly in remission. For those being followed after remission
induction, new evidence of submorphological disease may prompt therapy
before morphological relapse. Additionally, for patients with good
prognosis, the length of the clinical trial followup may be very long
when survival is the outcome measured, raising logistical and financial
challenges for study conduct. More information is needed on whether MRD
in AML can be qualified as a response biomarker and then used as a
clinical trial endpoint and what the challenges would be to implement
use of such an endpoint.
This Public Workshop on Minimal Residual Disease in AML will be one
of a series of FDA workshops to establish processes and procedures
necessary to qualify a prognostic biomarker, MRD, as a possible
response or efficacy biomarker in a group of hematological
malignancies. Evaluation of clinical data suggests that MRD can be
established as a potential surrogate endpoint for pivotal clinical
trials and drug approval given its prominent role as a prognostic
indicator in certain subtypes of acute and chronic leukemia. The Office
of Hematology and Oncology Products has explored, or plans to explore,
the potential utility of MRD as a surrogate endpoint in acute
lymphoblastic leukemia (ALL) (including the relapsed setting), chronic
lymphocytic leukemia (CLL), and AML. Given the diverse pathophysiology
and natural history of these diseases and current practice standards,
individualized consideration of MRD as a surrogate endpoint is
warranted. The ALL workshop was held on April 18, 2012, and the CLL
workshop will be held on February 27, 2013.
II. Structure and Scope of the Workshop
The workshop's scope will include discussions of the use of flow
cytometry and molecular methods used to detect and measure minimal
residual disease in patients being treated for AML. The workshop will
consist of formal presentations examining the regulatory, scientific,
and clinical basis for use of biomarkers as potential clinical trial
endpoints in AML interspersed with discussions on issues associated
with these endpoints.
III. Attendance and Registration
FDA encourages patient advocates, representatives from industry,
consumer groups, health care professionals, researchers, and other
interested persons to attend this public workshop. There is no
registration fee for the public workshop. To register electronically,
please use the following Web site: https://www.zoomerang.com/Survey/WEB22GPAXN9NQB (FDA has verified the Web site address, but we are not
responsible for any subsequent changes to the Web site after this
document publishes in the Federal Register.) Seats are limited and
conference space will be filled in the order in which registrations are
received. Onsite registration will be available to the extent that
space is available on the day of the conference.
Information regarding special accommodations due to a disability,
visitor parking, and transportation may be accessed at: https://www.fda.gov/AdvisoryCommittees/default.htm. Under the heading
``Resources for You,'' click on ``Public Meetings at the FDA White Oak
Campus.''
Dated: December 20, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-31043 Filed 12-21-12; 4:15 pm]
BILLING CODE 4160-01-P
