[Federal Register Volume 74, Number 211 (Tuesday, November 3, 2009)]
[Notices]
[Pages 56856-56857]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-26397]
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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.
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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 http://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: [email protected].
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 http://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