[Federal Register Volume 77, Number 190 (Monday, October 1, 2012)]
[Notices]
[Pages 59930-59931]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-24037]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2012-N-0972]
Clinical Development Programs for Disease-Modifying Agents for
Peripheral Neuropathy; Public Workshop; 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), Center for Drug
Evaluation and Research (CDER), is announcing a scientific public
workshop to solicit information on a variety of issues related to the
clinical development of disease-modifying agents for the treatment of
peripheral neuropathy. Discussion will focus on possible therapeutic
targets for these agents, the types of painful peripheral neuropathies
amenable to treatment with disease-modifying agents, and clinical trial
design. FDA intends to take this information into account in developing
FDA guidance on clinical development programs for disease-modifying
products for the management of peripheral neuropathy.
Date and Time: The public workshop will be held on February 11,
2013, from 8:30 a.m. to 5 p.m. and February 12, 2013, from 8:30 a.m. to
2 p.m.
Location: The public workshop will be held at FDA White Oak Campus,
Building 31, The Great Room (Rm. 1503),White Oak Conference Center,
10903 New Hampshire Ave., Silver Spring, MD 20993-0002. Entrance for
the consultation meeting's participants (non-FDA employees) is through
Building 1 where routine security check procedures will be performed.
For parking and security information, please refer to http://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm
Contacts:
Randi Clark, Center for Drug Evaluation and Research, Food and Drug
Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002,
301-796-4287, [email protected],
or
Allison Meyer, Center for Drug Evaluation and Research, Food and Drug
Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002,
301-796-1258, [email protected].
Registration to Attend the Workshop and Requests to Participate in
Open Public Hearing: As part of the public workshop, an open public
hearing will be held between 11 a.m. and 12 p.m. on February 11, 2013.
If you wish to attend the public workshop or provide oral comments
during the open public hearing, please email your registration to
[email protected] by February 1, 2013. Those
without email access may register by contacting one of the persons
listed in the Contacts section of this document. Please provide
complete contact information for each attendee, including name, title,
affiliation, address, email address, and telephone number.
For those interested in providing oral comments for the open public
hearing, please also provide a short abstract of your remarks by
February 1, 2013. We will try to accommodate all persons who wish to
speak; however, the duration of each speaker's comments during this
open public hearing may be limited by time constraints.
Registration is free and will be on a first-come, 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 meeting will be
based on space availability. If registration reaches maximum capacity,
FDA will post a notice closing meeting registration for the workshop at
http://www.fda.gov/Drugs/NewsEvents/ucm310416.htm.
If you need special accommodations because of a disability, please
contact Randi Clark or Allison Meyer (see Contacts) at least 7 days in
advance of the public workshop.
Comments: Submit either electronic or written comments by March 11,
2013. Submit electronic comments to http://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. 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, and will
be posted to the docket at http://www.regulations.gov.
SUPPLEMENTARY INFORMATION:
I. Introduction
FDA is announcing this public workshop to further the understanding
of the development of disease-modifying agents for the treatment of
painful peripheral neuropathies. Discussion will focus on possible
therapeutic targets for these agents, the types of painful peripheral
neuropathies amenable to treatment with disease-modifying agents, and
clinical trial design.
FDA will explore the following topics during this public workshop:
1. Pharmacodynamic mechanisms and pharmacogenetic/pharmacogenomic
targets of therapeutic agents intended to prevent, slow, modify,
arrest, or reverse the course of disease for peripheral neuropathies.
2. Periperal neuropathy patient populations and study entry
criteria for clinical trials designed to evaluate disease-modifying
effects of therapeutic agents.
3. Clinically relevant endpoints for trials evaluating therapeutic
agents intended to prevent, slow, modify, arrest, or reverse the course
of these diseases.
[[Page 59931]]
4. Study duration, overall study design, and analysis of clinical
trials needed to demonstrate a treatment effect on disease modification
for peripheral neuropathy.
FDA will post the agenda and additional workshop background
material approximately 5 days before the workshop at http://www.fda.gov/Drugs/NewsEvents/ucm310416.htm.
II. 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 Comments). 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 (ELEM-1029), Food and Drug
Administration, 12420 Parklawn Dr., Element Bldg., Rockville, MD 20857.
Dated: September 25, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-24037 Filed 9-28-12; 8:45 am]
BILLING CODE 4160-01-P