[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