Public Workshop: International Conference on Harmonisation S2 Genetic Toxicology Issues; Request for Comments, 56856-56857 [E9-26397]
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Federal Register / Vol. 74, No. 211 / Tuesday, November 3, 2009 / Notices
Dated: October 27, 2009
Jennifer Spaeth,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. E9–26421 Filed 11–2–09; 8:45 am]
BILLING CODE 4140–01–P
In accordance with Section 10(a)(2) of
the Federal Advisory Committee Act
(Pub. L. 92–463), the Centers for Disease
Control and Prevention (CDC)
announces the aforementioned SEP:
mstockstill on DSKH9S0YB1PROD with NOTICES
Time and Date: 12:30 p.m.–4:30 p.m.,
December 1, 2009 (Closed).
Place: Teleconference.
Status: The meeting will be closed to the
public in accordance with provisions set
forth in Section 552b(c) (4) and (6), Title 5
U.S.C., and the Determination of the Director,
Management Analysis and Services Office,
CDC, pursuant to Public Law 92–463.
Matters To Be Discussed: The meeting will
include the initial review, discussion, and
evaluation of applications received in
response to ‘‘CDC Grants for Public Health
Research Dissertation, FOA PAR07–231,
Panel D.’’
Contact Person for More Information:
Maurine Goodman, MA, MPH, Scientific
Review Administrator, CDC, 1600 Clifton
Road, NE., Mailstop D72, Atlanta, GA 30333,
Telephone (404)639–4747.
The Director, Management Analysis and
Services Office, has been delegated the
authority to sign Federal Register notices
pertaining to announcements of meetings and
other committee management activities, for
both CDC and the Agency for Toxic
Substances and Disease Registry.
Dated: October 23, 2009.
Elaine L. Baker,
Director, Management Analysis and Services
Office, Centers for Disease Control and
Prevention.
[FR Doc. E9–26389 Filed 11–2–09; 8:45 am]
Jkt 220001
Food and Drug Administration,
HHS.
Disease, Disability, and Injury
Prevention and Control Special
Emphasis Panel (SEP): CDC Grants for
Public Health Research Dissertation
(Panel D), Funding Opportunity
Announcement (FOA) PAR07–231,
Initial Review
18:15 Nov 02, 2009
[Docket No. FDA–2009–N–0519]
AGENCY:
Centers for Disease Control and
Prevention
VerDate Nov<24>2008
Food and Drug Administration
Public Workshop: International
Conference on Harmonisation S2
Genetic Toxicology Issues; Request
for Comments
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
ACTION: Notice of public workshop;
request for comments.
SUMMARY: The Food and Drug
Administration (FDA) is announcing a
public workshop entitled ‘‘ICH S2
Genetic Toxicology Issues.’’ The 1-day
public workshop is intended to seek
constructive input from experts in the
field of genetic toxicology on proposed
changes to the International Conference
on Harmonisation (ICH) guidance
‘‘S2(R1) Genotoxicity Testing and Data
Interpretation for Pharmaceuticals
Intended for Human Use’’ that was
published in March 2008.
DATES: The public workshop will be
held on January 25, 2010, from 8:30 a.m.
to 5 p.m. Register by January 15, 2010,
to make a presentation at the workshop.
See section II in the SUPPLEMENTARY
INFORMATION section for information on
how to attend the workshop. We are
opening a docket to receive your written
or electronic comments. Written or
electronic comments must be submitted
to the docket by February 24, 2010, to
receive consideration.
ADDRESSES: The public workshop will
be held at the Food and Drug
Administration, Center for Drug
Evaluation and Research Advisory
Committee Conference Room, 5630
Fishers Lane, rm. 1066, Rockville, MD
20857. Submit written or electronic
requests to make a presentation to Adele
Seifried (see FOR FURTHER INFORMATION
CONTACT). Submit written comments to
the Division of Dockets Management
(HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. Submit
electronic comments to https://
www.regulations.gov. All comments
should be identified with the docket
number found in brackets in the
heading of this document.
FOR FURTHER INFORMATION CONTACT:
Adele Seifried, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, rm. 6482,
Silver Spring, MD 20993–0002, 301–
796–0535, FAX: 301–796–9855, e-mail:
Adele.Seifried@fda.hhs.gov.
PO 00000
Frm 00065
Fmt 4703
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SUPPLEMENTARY INFORMATION:
I. Objectives
The objectives of this workshop are to
provide a scientific forum where experts
in the field of genetic toxicology can
provide their views on proposed
changes to ICH S2(R1). These proposed
changes are described in the following
paragraphs.
A. The Genetox Battery and Followup
Testing: Options 1 and 2
The ICH steering committee agreed
that revision of ICH S2 was appropriate
because the 2 guidances that comprise
it, ICH S2A and ICH S2B, were finalized
nearly 15 years ago and much has been
learned in the interim. ICH S2(R1) is a
draft version that discusses the
components of a basic genetic
toxicology battery as well as in vivo
followup testing that should be
conducted when in vitro tests are
positive. ICH S2(R1) offers two test
options: Option 1 is similar to the
current ICH and CDER test battery with
some modifications. Option 2 removes
the in vitro mammalian cell test from
the test battery and instead includes two
in vivo endpoints that can be assessed
in a single assay. The workshop will
examine these options in addressing
what constitutes an adequate genetic
toxicology battery, including which
tests are reasonable followups to a
positive in vitro cytogenetic assay or
mouse lymphoma assay. The workshop
will also examine the following: (1)
Whether an in vivo comet assay is a
reasonable followup test to a positive in
vitro cytogenetic or mouse lymphoma
assay, and if not, what alternatives exist,
and (2) whether the two-option system
being proposed would provide
comparable or superior patient
protection to the current single-option
test battery.
B. Top Concentration for Mammalian In
Vitro Genotoxicity Assays
The current ICH safety guidances
specify that drug substances should be
tested up to a concentration of 10
millimolars (mM) in vitro if no toxicity
is seen at lower concentrations. The
draft ICH S2(R1) proposes to lower this
top concentration for required testing to
1 mM. This workshop will examine the
scientific basis for this proposal and its
potential effect on patient safety.
II. Attendance and Registration to
Speak
There is no fee to attend the
workshop, and attendees who do not
wish to make a formal presentation to
the scientific panel do not need to
register. Seating will be on a first-come,
E:\FR\FM\03NON1.SGM
03NON1
Federal Register / Vol. 74, No. 211 / Tuesday, November 3, 2009 / Notices
first-served basis. Opportunities to
address the panel during the meeting
will occur during discussion of each
topic, and speakers will be required to
register ahead of time. If you would like
to make a formal presentation during
the open public sessions, you must
register and provide an abstract of your
presentation by 5 p.m. e.s.t. on January
15, 2010. To speak, submit your name,
title, business affiliation (if applicable),
address, telephone and fax numbers,
and e-mail address to Adele Seifried
(see FOR FURTHER INFORMATION CONTACT).
FDA has included issues for comment
in section I of the SUPPLEMENTARY
INFORMATION section. You should also
identify by letter each issue you wish to
address in your presentation and the
approximate time requested for your
presentation.
FDA will do its best to accommodate
those who wish to speak. Individuals
and organizations with common
interests are urged to consolidate or
coordinate their comments and to
request time for a joint presentation.
FDA will determine the amount of time
allotted to each presenter. Persons
registered to make a formal presentation
should check in before the workshop. In
addition, we strongly encourage written
comments to the docket. Written or
electronic comments will be accepted
until February 24, 2010.
If you need special accommodations
because of disability, contact Adele
Seifried (see FOR FURTHER INFORMATION
CONTACT) at least 7 days before the
workshop.
mstockstill on DSKH9S0YB1PROD with NOTICES
III. Comments
Regardless of attendance at the public
workshop, interested persons may
submit written or electronic comments
to the Division of Dockets Management
(see ADDRESSES). Submit a single copy
of electronic comments or two paper
copies of any mailed comments, except
that individuals may submit one paper
copy. Comments should be identified
with the docket number found in
brackets in the heading of this
document. To ensure consideration,
submit comments by (see DATES).
Received comments may be seen in the
Division of Dockets Management
between 9 a.m. and 4 p.m., Monday
through Friday.
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 (see
ADDRESSES). A transcript will also be
available in either hardcopy or on CD–
ROM, after submission of a Freedom of
VerDate Nov<24>2008
18:15 Nov 02, 2009
Jkt 220001
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: October 27, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9–26397 Filed 11–2–09; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
Disease, Disability, and Injury
Prevention and Control Special
Emphasis Panel (SEP): CDC Grants for
Public Health Research Dissertation
(Panel G), Funding Opportunity
Announcement (FOA) PAR07–231,
Initial Review
In accordance with Section 10(a)(2) of
the Federal Advisory Committee Act
(Pub. L. 92–463), the Centers for Disease
Control and Prevention (CDC)
announces the aforementioned SEP:
Time and Date: 12:30 p.m.–4:30 p.m.,
December 2, 2009 (Closed).
Place: Teleconference.
Status: The meeting will be closed to the
public in accordance with provisions set
forth in Section 552b(c) (4) and (6), Title 5
U.S.C., and the Determination of the Director,
Management Analysis and Services Office,
CDC, pursuant to Public Law 92–463.
Matters To Be Discussed: The meeting will
include the initial review, discussion, and
evaluation of applications received in
response to ‘‘CDC Grants for Public Health
Research Dissertation, FOA PAR07–231,
Panel G.’’
Contact Person for More Information:
Maurine Goodman, MA, MPH, Scientific
Review Administrator, CDC, 1600 Clifton
Road, NE., Mailstop D72, Atlanta, GA 30333,
Telephone (404) 639–4747.
The Director, Management Analysis and
Services Office, has been delegated the
authority to sign Federal Register notices
pertaining to announcements of meetings and
other committee management activities, for
both CDC and the Agency for Toxic
Substances and Disease Registry.
Dated: October 23, 2009.
Elaine L. Baker,
Director, Management Analysis and Services
Office, Centers for Disease Control and
Prevention.
[FR Doc. E9–26283 Filed 11–2–09; 8:45 am]
BILLING CODE 4163–18–P
PO 00000
Frm 00066
Fmt 4703
Sfmt 4703
56857
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Prospective Grant of Exclusive
License: Development of a Companion
Diagnostic Kit To Detect Asparagine
Synthetase Expression Levels as a
Method To Screen for the Drug
Efficacy in Treatments for Pancreatic
Cancer, Ovarian Cancer, and Multiple
Myeloma
AGENCY: National Institutes of Health,
Public Health Service, HHS.
ACTION: Notice.
SUMMARY: This is notice, in accordance
with 35 U.S.C. 209(c)(1) and 37 CFR
404.7(a)(1)(i), that the National
Institutes of Health, Department of
Health and Human Services, is
contemplating the grant of an exclusive
patent license to practice the inventions
embodied in U.S. Patent Application
No. 12/281,589 and PCT Application
No. PCT/US07/05555 entitled
‘‘Materials and Methods Directed to
Asparagine Synthetase and
Asparaginase Therapies’’ (HHS Ref. No.
E–132–2006/2), to the French-based
ERYtech Pharma LLC which is located
in Lyon, France (with an additional
office in Philadelphia, Pennsylvania).
The patent rights in this invention have
been assigned to the United States of
America.
The prospective exclusive license
territory may be worldwide and the
field of use may be for to the use of the
Licensed Patent Rights limited to a
FDA-approved companion diagnostic
test predictive of L-asparaginase
therapeutic effect in the treatment of
pancreatic cancer, ovarian cancer, and
multiple myeloma as claimed in the
Licensed Patent Rights.
DATES: Only written comments and/or
applications for a license which are
received by the NIH Office of
Technology Transfer on or before
January 4, 2010 will be considered.
ADDRESSES: Requests for copies of the
patent application, inquiries, comments,
and other materials relating to the
contemplated exclusive license should
be directed to: Samuel E. Bish, Ph.D.,
Licensing and Patenting Manager, Office
of Technology Transfer, National
Institutes of Health, 6011 Executive
Boulevard, Suite 325, Rockville, MD
20852–3804; Telephone: (301) 435–
5282; Facsimile: (301) 402–0220; E-mail:
bishse@mail.nih.gov.
SUPPLEMENTARY INFORMATION: The
technology describes methods and
therapies involving asparagine
synthetase (ASNS) and L-asparaginase
E:\FR\FM\03NON1.SGM
03NON1
]]>Agencies
[Federal Register Volume 74, Number 211 (Tuesday, November 3, 2009)]
[Notices]
[Pages 56856-56857]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-26397]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2009-N-0519]
Public Workshop: International Conference on Harmonisation S2
Genetic Toxicology Issues; Request for Comments
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public workshop; request for comments.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing a public
workshop entitled ``ICH S2 Genetic Toxicology Issues.'' The 1-day
public workshop is intended to seek constructive input from experts in
the field of genetic toxicology on proposed changes to the
International Conference on Harmonisation (ICH) guidance ``S2(R1)
Genotoxicity Testing and Data Interpretation for Pharmaceuticals
Intended for Human Use'' that was published in March 2008.
DATES: The public workshop will be held on January 25, 2010, from 8:30
a.m. to 5 p.m. Register by January 15, 2010, to make a presentation at
the workshop. See section II in the SUPPLEMENTARY INFORMATION section
for information on how to attend the workshop. We are opening a docket
to receive your written or electronic comments. Written or electronic
comments must be submitted to the docket by February 24, 2010, to
receive consideration.
ADDRESSES: The public workshop will be held at the Food and Drug
Administration, Center for Drug Evaluation and Research Advisory
Committee Conference Room, 5630 Fishers Lane, rm. 1066, Rockville, MD
20857. Submit written or electronic requests to make a presentation to
Adele Seifried (see FOR FURTHER INFORMATION CONTACT). Submit written
comments to the Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
Submit electronic comments to https://www.regulations.gov. All comments
should be identified with the docket number found in brackets in the
heading of this document.
FOR FURTHER INFORMATION CONTACT: Adele Seifried, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, rm. 6482, Silver Spring, MD 20993-0002, 301-
796-0535, FAX: 301-796-9855, e-mail: Adele.Seifried@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Objectives
The objectives of this workshop are to provide a scientific forum
where experts in the field of genetic toxicology can provide their
views on proposed changes to ICH S2(R1). These proposed changes are
described in the following paragraphs.
A. The Genetox Battery and Followup Testing: Options 1 and 2
The ICH steering committee agreed that revision of ICH S2 was
appropriate because the 2 guidances that comprise it, ICH S2A and ICH
S2B, were finalized nearly 15 years ago and much has been learned in
the interim. ICH S2(R1) is a draft version that discusses the
components of a basic genetic toxicology battery as well as in vivo
followup testing that should be conducted when in vitro tests are
positive. ICH S2(R1) offers two test options: Option 1 is similar to
the current ICH and CDER test battery with some modifications. Option 2
removes the in vitro mammalian cell test from the test battery and
instead includes two in vivo endpoints that can be assessed in a single
assay. The workshop will examine these options in addressing what
constitutes an adequate genetic toxicology battery, including which
tests are reasonable followups to a positive in vitro cytogenetic assay
or mouse lymphoma assay. The workshop will also examine the following:
(1) Whether an in vivo comet assay is a reasonable followup test to a
positive in vitro cytogenetic or mouse lymphoma assay, and if not, what
alternatives exist, and (2) whether the two-option system being
proposed would provide comparable or superior patient protection to the
current single-option test battery.
B. Top Concentration for Mammalian In Vitro Genotoxicity Assays
The current ICH safety guidances specify that drug substances
should be tested up to a concentration of 10 millimolars (mM) in vitro
if no toxicity is seen at lower concentrations. The draft ICH S2(R1)
proposes to lower this top concentration for required testing to 1 mM.
This workshop will examine the scientific basis for this proposal and
its potential effect on patient safety.
II. Attendance and Registration to Speak
There is no fee to attend the workshop, and attendees who do not
wish to make a formal presentation to the scientific panel do not need
to register. Seating will be on a first-come,
[[Page 56857]]
first-served basis. Opportunities to address the panel during the
meeting will occur during discussion of each topic, and speakers will
be required to register ahead of time. If you would like to make a
formal presentation during the open public sessions, you must register
and provide an abstract of your presentation by 5 p.m. e.s.t. on
January 15, 2010. To speak, submit your name, title, business
affiliation (if applicable), address, telephone and fax numbers, and e-
mail address to Adele Seifried (see FOR FURTHER INFORMATION CONTACT).
FDA has included issues for comment in section I of the SUPPLEMENTARY
INFORMATION section. You should also identify by letter each issue you
wish to address in your presentation and the approximate time requested
for your presentation.
FDA will do its best to accommodate those who wish to speak.
Individuals and organizations with common interests are urged to
consolidate or coordinate their comments and to request time for a
joint presentation. FDA will determine the amount of time allotted to
each presenter. Persons registered to make a formal presentation should
check in before the workshop. In addition, we strongly encourage
written comments to the docket. Written or electronic comments will be
accepted until February 24, 2010.
If you need special accommodations because of disability, contact
Adele Seifried (see FOR FURTHER INFORMATION CONTACT) at least 7 days
before the workshop.
III. Comments
Regardless of attendance at the public workshop, interested persons
may submit written or electronic comments to the Division of Dockets
Management (see ADDRESSES). Submit a single copy of electronic comments
or two paper copies of any mailed comments, except that individuals may
submit one paper copy. Comments should be identified with the docket
number found in brackets in the heading of this document. To ensure
consideration, submit comments by (see DATES). Received comments may be
seen in the Division of Dockets Management between 9 a.m. and 4 p.m.,
Monday through Friday.
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 (see ADDRESSES). 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: October 27, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9-26397 Filed 11-2-09; 8:45 am]
BILLING CODE 4160-01-S
