[Federal Register Volume 76, Number 213 (Thursday, November 3, 2011)]
[Notices]
[Pages 68197-68198]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-28475]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0547]


Clinical Development Programs for Sedation Products; Public 
Workshop; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshop; request for comments.

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    The Food and Drug Administration's (FDA), Center for Drug 
Evaluation and Research (CDER) is announcing a scientific workshop to 
solicit information on a variety of issues related to the clinical 
development and use of sedation products in adult and pediatric age 
groups. FDA intends to take into account the information provided from 
this workshop as we develop FDA guidance on clinical development 
programs for sedation products. FDA issued a notice in the Federal 
Register of November 29, 2010, inviting an interested party, or 
parties, to facilitate an evaluation of the critical fundamentals of 
the science related to sedation products and to plan and conduct one or 
more public meetings to bring together experts in the field, including 
from academia, patient organizations, and industry, to discuss these 
issues. FDA has since determined that it will facilitate the evaluation 
itself, and as a first step, is announcing this workshop.
    Date and Time: The public workshop will be held on May 3, 2012, 
from 8:30 a.m. to 5 p.m.
    Location: The workshop will be held at FDA White Oak Campus, 10903 
New Hampshire Ave., Building 31 Conference Center, the Great Room (rm. 
1503), Silver Spring, MD 20993-0002.
    Contact Person: Mary C. Gross, Center for Drug Evaluation and 
Research, Food and Drug Administration, 10903 New Hampshire Ave., 
Silver Spring, MD 20993-0002, (301) 796-3519, email: 
[email protected]; or Diana Walker, Center for Drug Evaluation and 
Research, Food and Drug Administration, 10903 New Hampshire Ave., 
Silver Spring, MD 20993-0002, (301) 796-4029, email: 
[email protected].
    Registration to Participate in Scientific Panels: If you wish to 
participate as part of a scientific panel, please email your request to 
[email protected] by December 2, 2011. As part of 
your request, please describe your area of expertise and interest based 
on the questions identified below. If selected, a subset of panel 
representatives may be asked to provide formal presentations and/or 
participate in panel discussions.
    Registration to Attend the Workshop and Requests to Participate in 
Open Public Hearing: If you wish to attend or testify at the open 
public hearing, please email your registration to [email protected] by April 2, 2012. Those without email access may 
register by contacting one of the persons listed in the Contact Person 
section of the document. Please provide complete contact information 
for each attendee, including name, title, affiliation, address, email 
address, and telephone number. 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/ucm221185.htm.
    An open public hearing will be held between 1:30 p.m. to 2:30 p.m. 
on May 3, 2012, during which speaker testimony will be accepted. We 
will try to accommodate all persons who wish to testify, however, the 
duration of each speaker's testimony during this open public hearing 
may be limited by time constraints.
    Comments: Submit either electronic or written comments by July 3, 
2012. 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. It is no 
longer necessary to send two copies of mailed 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.
    If you need special accommodations due to a disability, contact 
Mary Gross or Diana Walker (see Contact Person) at least 7 days in 
advance.

SUPPLEMENTARY INFORMATION:

I. Introduction

    In the Federal Register of November 29, 2010 (75 FR 73104), FDA 
indicated that it was seeking information on a variety of issues 
related to the clinical development and use of sedation products in 
adult and pediatric age groups. In the notice, FDA invited any 
interested party to take on the role of facilitating an evaluation of 
these issues and as a first step, plan or hold one or more public 
meetings to discuss these issues. FDA was going to take into account 
the information provided by these activities in the development of 
guidance on clinical development programs for sedation products. FDA 
has now determined that it will conduct the evaluation itself, and is 
announcing this workshop to further understand the physiology of 
sedation and clinical trial design issues related to the development of 
sedation products.
    FDA will explore the following topics during this public workshop:
    1. For clinical trials of sedation drug products, which surgical 
and diagnostic procedures would provide the most relevant efficacy and 
safety data, while still allowing for a reasonable level of feasibility 
and efficiency?
    2. What patient subgroups, other than pediatric, geriatric, and 
patients with hepatic or renal impairment, would require specific 
evaluation in clinical trials involving sedation drug products?
    3. What is the most appropriate primary efficacy endpoint to assess 
in a clinical trial of a sedation drug product?
    a. Which measurement scales have been adequately studied and 
validated for use in assessing the endpoint measure recommended 
previously.
    b. Is there a clinically meaningful effect size that should be 
considered as a minimal requirement for a determination of efficacy?
    c. How do the responses to the previous questions differ, if at 
all, for the pediatric population, in particular, the youngest of these 
patients who have no or limited communication skills.

[[Page 68198]]

    4. What secondary efficacy endpoints might be considered clinically 
meaningful (e.g., subjective and objective assessments of memory, 
recall, anxiety, agitation, or delirium) if appropriately studied?
    5. How should responses to rapid changes in procedural stimulation 
be considered in the evaluation of efficacy, e.g., the time of initial 
incision or negotiating a colonoscope around the splenic or hepatic 
flexure.
    6. How do the responses for each of the previous questions differ 
for evaluation of sedation products used in the operating room (OR), 
the intensive care unit (ICU), the emergency department (ED), and the 
gastro-intestinal (GI) suite?
    FDA will post the agenda and additional workshop background 
material approximately 5 days before the workshop at: http://www.fda.gov/Drugs/NewsEvents/ucm221185.htm.

II. Transcripts

    Please be advised that approximately 30 days after the public 
workshop, a transcript will be available. It will be accessible at 
http://www.regulations.gov and 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 Division of 
Freedom of Information (ELEM-1029), Food and Drug Administration, 12420 
Parklawn Dr., Element Bldg., Rockville, MD 20857.

    Dated: October 28, 2011.
Leslie Kux,
 Acting Assistant Commissioner for Policy.
[FR Doc. 2011-28475 Filed 11-2-11; 8:45 am]
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