[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