Public Workshop on Minimal Residual Disease; Public Workshop, 14813-14814 [2012-6038]
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14813
Federal Register / Vol. 77, No. 49 / Tuesday, March 13, 2012 / Notices
accompany the TV ad submission
package. This collection of information
for Form FDA 2253 has been approved
under OMB control number 0910–0001.
Therefore, we estimate the annual
reporting burden as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
Type of submission
Number of
responses per
respondent
Average
burden per
response
(in hours)
Total annual
responses
Total hours
Advertisements prepared in accordance with section 503B
of the FD&C Act ...............................................................
Resubmissions of incomplete submission packages ..........
45-Day review clock decision letter .....................................
32
6
1
2.56
1
1
82
6
1
25
5
1
2,050
30
1
Total ..............................................................................
........................
........................
........................
........................
2,581
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
III. 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. 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.
IV. Electronic Access
Persons with access to the Internet
may obtain the document at either http:
//www.fda.gov/Drugs/Guidance
ComplianceRegulatoryInformation/
Guidances/default.htm, https://
www.fda.gov/BiologicsBloodVaccines/
GuidanceComplianceRegulatory
Information/default.htm, or https://
www.regulations.gov.
Dated: March 8, 2012.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2012–6040 Filed 3–12–12; 8:45 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.
mstockstill on DSK4VPTVN1PROD with NOTICES
ACTION:
Notice of public workshop.
The Food and Drug Administration
(FDA) is announcing a public workshop
to provide a forum for discussion of the
use of minimal residual disease (MRD)
as a biomarker for evaluating new drugs
for the treatment of acute lymphoblastic
leukemia (ALL). The meeting is
cosponsored with the American Society
VerDate Mar<15>2010
18:29 Mar 12, 2012
Jkt 226001
of Clinical Oncology and will be the
first in a series of workshops intended
to bring together scientific and advocacy
communities and the pharmaceutical
and in vitro diagnostic device industries
to help develop processes and
procedures to qualify MRD as a
biomarker of efficacy and/or response to
treatment in a group of hematological
malignancies.
DATES: Date and Time: The public
workshop will be held on April 18,
2012, from 8 a.m. to 4 p.m.
Location: The public workshop will
be held at the FDA White Oak Campus,
10903 New Hampshire Ave. Bldg. 31
Conference Center, the Great Room (rm.
1503), Silver Spring, MD 20993–0002.
Contact Person: 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.
SUPPLEMENTARY INFORMATION:
I. Background
Clinical data from patients with
certain subtypes of acute and chronic
leukemia suggest that MRD can be
established as a surrogate endpoint for
clinical trials and drug approval. This
public workshop will provide a forum
for discussion among scientific and
advocacy communities and the
pharmaceutical and in vitro diagnostic
device industries of issues related to the
qualification (validation) of MRD as a
biomarker (i.e., a measurable
characteristic that is predictive of
disease outcome) that can be used to
determine efficacy and/or response in
evaluation of new drugs for the
treatment of ALL. Although the data
related to the prognostic significance of
MRD are most extensive in the pediatric
population, and are currently used to
stratify patients for risk-adjusted
therapy, MRD may also be pertinent to
subtypes of adult ALL; hematologists
who treat adult patients have been
PO 00000
Frm 00090
Fmt 4703
Sfmt 4703
invited to participate, as well as
hematologists who treat pediatric
patients. Topics to be discussed at the
workshop include: (1) Evaluation of the
prognostic biomarker data that is
currently available to support the
qualification of MRD as a marker of
response and/or efficacy in both
pediatric and adult ALL; (2) the
specificity, sensitivity, and
comparability of techniques that might
be used in a standardized fashion to
measure MRD; (3) the performance
characteristics and proficiency
assessment of current technology
platforms; and (4) the design and
analysis of the clinical trials needed to
establish the use of postinduction MRD
as an alternative endpoint for approval
of new drugs to treat ALL.
This workshop is part of a series in
which FDA’s Office of Hematology and
Oncology Products will explore the
utility of MRD as a surrogate endpoint
in ALL (including ALL that has
recurred), chronic lymphocytic
leukemia (CLL), and acute myeloid
leukemia (AML). Given the diverse
etiologies, pathophysiologies, and
natural histories of these diseases and
current practice standards, separate
consideration of MRD as a surrogate
endpoint in each disease is warranted.
FDA is seeking representation from both
North American and European
academic investigators as well as
cooperative groups at the workshops.
The workshops for CLL and AML are
tentatively scheduled for October 10
and 11, 2012, respectively.
II. 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.
Registration: There is no registration
fee for the public workshop. To register
electronically, please use the following
Web site: https://www.zoomerang.com/
E:\FR\FM\13MRN1.SGM
13MRN1
14814
Federal Register / Vol. 77, No. 49 / Tuesday, March 13, 2012 / Notices
Survey/WEB22EJ4HRZLW9. (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.’’ Please note that visitors
to the White Oak Campus must enter
through Bldg. 1.
Dated: March 8, 2012.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2012–6038 Filed 3–12–12; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–N–0212]
Tobacco Product Analysis; Scientific
Workshop; Request for Comments
AGENCY:
Food and Drug Administration,
HHS.
Notice of public workshop;
request for comments.
mstockstill on DSK4VPTVN1PROD with NOTICES
ACTION:
The Food and Drug Administration
(FDA), Center for Tobacco Products is
announcing a scientific workshop to
solicit feedback on analysis of tobacco
products. The analyses of tobacco
products often involve tobacco reference
products, which are used primarily as
controls to ensure that the results of the
analyses are reliable and accurate. This
scientific workshop will focus on
understanding how tobacco reference
products are used and the testing
methods used to analyze tobacco
products. FDA will invite speakers to
address scientific and technical matters
relating to the testing of tobacco
reference products and the analytical
methods used to measure constituent
levels in tobacco products and smoke.
FDA is also opening a public docket to
receive comments on these topics.
DATES: Dates and Time: The public
workshop will be held on April 11,
2012, from 8:30 a.m. to 5:30 p.m., and
on April 12, 2012, from 8:30 a.m. to 4
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18:29 Mar 12, 2012
Jkt 226001
p.m. Individuals who wish to attend the
public workshop must register by close
of business on March 30, 2012. Submit
either electronic or written comments to
the docket by May 11, 2012.
Location: The public workshop will
be held at 9200 Corporate Blvd.,
Rockville, MD 20850, 1–877–287–1373.
Contact Person: Anuja Patel, Center
for Tobacco Products, Food and Drug
Administration, 9200 Corporate Blvd.,
Rockville, MD, 20850, 1–877–287–1373,
FAX: 240–276–3761, email:
workshop.CTPOS@fda.hhs.gov.
Registration to Attend the Workshop
and Requests for Oral Presentations: If
you wish to attend the workshop or
make an oral presentation at the
workshop, please email your
registration to
workshop.CTPOS@fda.hhs.gov by close
of business on March 30, 2012. Those
without email access may register by
contacting Anuja Patel (see Contact
Person). Please provide contact
information for each attendee, including
name, title, affiliation, address, email
address, and telephone number.
Registration is free and will be on a firstcome, first-served basis. Early
registration is recommended because
seating is limited. FDA may limit the
number of participants from each
organization as well as the total number
of participants based on space
limitations. Registrants will receive
confirmation once they have been
accepted for the workshop. Onsite
registration on the day of the workshop
will be based on space availability. If
registration reaches maximum capacity,
FDA will post a notice closing
registration for the workshop at https://
www.fda.gov/TobaccoProducts/
NewsEvents/ucm238308.htm.
There will be opportunities for
audience participation at this workshop.
FDA has included topics for comment
in section II of this document. FDA will
do its best to accommodate requests to
speak during the workshop sessions,
although questions from the audience
may be limited. In addition, we strongly
encourage submitting comments to the
docket (see Comments).
If you need special accommodations
because of disability, please contact
Anuja Patel (see Contact Person) at least
7 days before the workshop.
Comments: Regardless of attendance
at the public workshop, interested
persons may submit either electronic or
written comments on any of the topics
for discussion in section II of this
document by May 11, 2012. Submit
electronic comments to https://
www.regulations.gov. Submit written
comments to the Division of Dockets
Management (HFA–305), Food and Drug
PO 00000
Frm 00091
Fmt 4703
Sfmt 4703
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. 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.
SUPPLEMENTARY INFORMATION:
I. Background and Workshop Topics
The purpose of this scientific
workshop is to obtain information and
comments from appropriate scientific
experts on analysis of tobacco products.
Such experts could include, but are not
limited to, scientists from academia,
tobacco product manufacturers, and
contract testing laboratories. The
workshop will include scientific experts
who will present scientific and
technical information on testing of
tobacco reference products for different
types of tobacco products. The types of
tobacco reference products to be
discussed include, but are not limited
to, smoked tobacco products, smokeless
tobacco products, and other tobacco
products not classified as either smoked
or smokeless products. FDA would like
to discuss how the tobacco reference
products are used for testing purposes to
ensure accuracy of analysis of tobacco
products. Tobacco reference products
are analyzed alongside test tobacco
products (i.e., during every step of the
analysis). Tobacco reference products
are intended for use during analysis of
tobacco products and are not intended
for human consumption. Tobacco
reference products are finished tobacco
products and are distinct from internal
reference standards, which are
chemicals or mixtures of chemicals.
Internal reference standards are used
during only certain steps of the analysis
of test tobacco products (e.g., when
running samples).
The scientific workshop will include
discussion of analytical methods for
measuring certain constituents in
tobacco products and smoke. The
aspects of analytical methods that will
be discussed include extraction,
separation, and detection methods. For
example, FDA would like to get input
from scientific experts on how tobaccospecific nitrosamines (TSNAs) are
extracted from smokeless tobacco
products and cigarette smoke particulate
matter and what instrumentation (e.g.,
gas chromatography-mass spectrometry)
is used to measure the levels of TSNAs.
FDA is interested in receiving
substantive scientific input at the
workshop and in the docket. The input
from the scientific workshop may assist
us in developing future scientific
E:\FR\FM\13MRN1.SGM
13MRN1
]]>Agencies
[Federal Register Volume 77, Number 49 (Tuesday, March 13, 2012)]
[Notices]
[Pages 14813-14814]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-6038]
-----------------------------------------------------------------------
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) is announcing a public
workshop to provide a forum for discussion of the use of minimal
residual disease (MRD) as a biomarker for evaluating new drugs for the
treatment of acute lymphoblastic leukemia (ALL). The meeting is
cosponsored with the American Society of Clinical Oncology and will be
the first in a series of workshops intended to bring together
scientific and advocacy communities and the pharmaceutical and in vitro
diagnostic device industries to help develop processes and procedures
to qualify MRD as a biomarker of efficacy and/or response to treatment
in a group of hematological malignancies.
DATES: Date and Time: The public workshop will be held on April 18,
2012, from 8 a.m. to 4 p.m.
Location: The public workshop will be held at the FDA White Oak
Campus, 10903 New Hampshire Ave. Bldg. 31 Conference Center, the Great
Room (rm. 1503), Silver Spring, MD 20993-0002.
Contact Person: 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.
SUPPLEMENTARY INFORMATION:
I. Background
Clinical data from patients with certain subtypes of acute and
chronic leukemia suggest that MRD can be established as a surrogate
endpoint for clinical trials and drug approval. This public workshop
will provide a forum for discussion among scientific and advocacy
communities and the pharmaceutical and in vitro diagnostic device
industries of issues related to the qualification (validation) of MRD
as a biomarker (i.e., a measurable characteristic that is predictive of
disease outcome) that can be used to determine efficacy and/or response
in evaluation of new drugs for the treatment of ALL. Although the data
related to the prognostic significance of MRD are most extensive in the
pediatric population, and are currently used to stratify patients for
risk-adjusted therapy, MRD may also be pertinent to subtypes of adult
ALL; hematologists who treat adult patients have been invited to
participate, as well as hematologists who treat pediatric patients.
Topics to be discussed at the workshop include: (1) Evaluation of the
prognostic biomarker data that is currently available to support the
qualification of MRD as a marker of response and/or efficacy in both
pediatric and adult ALL; (2) the specificity, sensitivity, and
comparability of techniques that might be used in a standardized
fashion to measure MRD; (3) the performance characteristics and
proficiency assessment of current technology platforms; and (4) the
design and analysis of the clinical trials needed to establish the use
of postinduction MRD as an alternative endpoint for approval of new
drugs to treat ALL.
This workshop is part of a series in which FDA's Office of
Hematology and Oncology Products will explore the utility of MRD as a
surrogate endpoint in ALL (including ALL that has recurred), chronic
lymphocytic leukemia (CLL), and acute myeloid leukemia (AML). Given the
diverse etiologies, pathophysiologies, and natural histories of these
diseases and current practice standards, separate consideration of MRD
as a surrogate endpoint in each disease is warranted. FDA is seeking
representation from both North American and European academic
investigators as well as cooperative groups at the workshops. The
workshops for CLL and AML are tentatively scheduled for October 10 and
11, 2012, respectively.
II. 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.
Registration: There is no registration fee for the public workshop.
To register electronically, please use the following Web site: https://
www.zoomerang.com/
[[Page 14814]]
Survey/WEB22EJ4HRZLW9. (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.'' Please note that visitors to the White Oak Campus must enter
through Bldg. 1.
Dated: March 8, 2012.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2012-6038 Filed 3-12-12; 8:45 am]
BILLING CODE 4160-01-P
