Clinical Development Programs for Sedation Products; Request for Assistance, 73104-73106 [2010-29927]
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73104
Federal Register / Vol. 75, No. 228 / Monday, November 29, 2010 / Notices
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Office of Management and Budget
(OMB) for each collection of
information they conduct or sponsor.
‘‘Collection of information’’ is defined in
44 U.S.C. 3502(3) and 5 CFR 1320.3(c)
and includes Agency requests or
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Animal Drug User Fee Cover Sheet;
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0910–0539)—Extension
Under section 740 of the Federal
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FD&C Act) (21 U.S.C. 379j–12), as
amended by ADUFA, FDA has the
authority to assess and collect for
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with applications and supplements is
required, review of an application
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The types of fees that require a cover
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the payment. FDA will use the
information collected to initiate
administrative screening of new animal
drug applications and supplements to
determine if payment has been received.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of respondents
Annual
frequency per
response
740(a)(1), FDA Form 3546 (Cover Sheet) ..........................
76
1
76
1
76
Total ..............................................................................
........................
........................
........................
........................
76
Section of the FD&C Act as amended by ADUFA
1 There
Hours per
response
Total hours
are no capital costs or operating and maintenance costs associated with this collection of information.
Respondents to this collection of
information are new animal drug
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mstockstill on DSKH9S0YB1PROD with NOTICES
Total annual
responses
Dated: November 22, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010–29820 Filed 11–26–10; 8:45 am]
BILLING CODE 4160–01–P
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17:57 Nov 26, 2010
Jkt 223001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–N–0547]
Clinical Development Programs for
Sedation Products; Request for
Assistance
AGENCY:
Food and Drug Administration,
Notice.
The Food and Drug
Administration (FDA) is seeking
information on a variety of issues
related to the clinical development and
use of sedation products in adult and
pediatric age groups. FDA is inviting
any interested party, or parties, to
facilitate an evaluation of critical
fundamentals of the science related to
sedation products by conducting and
managing a coordination of activities
that will bring together experts in the
field, including from academia, patient
organizations, and industry. The first
step in this process would be for the
party or parties to plan and hold one or
SUMMARY:
PO 00000
Submit electronic or written
comments on this notice by January 28,
2011.
ADDRESSES: Submit electronic
comments on this notice to https://
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.
FOR FURTHER INFORMATION CONTACT: Sara
E. Stradley, Center for Drug Evaluation
and Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 22, rm. 3162, Silver Spring,
MD 20993–0002, 301–796–1298,
FAX:301–796–9713, e-mail:
sara.stradley@fda.hhs.gov.
DATES:
HHS.
ACTION:
more public meetings to discuss these
issues. FDA intends to take into account
the information provided from these
activities as we develop FDA guidance
on clinical development programs for
sedation products. We intend to submit
to the docket all the information
received in response to this notice so
that interested parties may be fully
informed.
Frm 00078
Fmt 4703
Sfmt 4703
E:\FR\FM\29NON1.SGM
29NON1
Federal Register / Vol. 75, No. 228 / Monday, November 29, 2010 / Notices
SUPPLEMENTARY INFORMATION:
I. Background
Because of the need for more
information on the development of
products intended to be used in humans
for sedation in hospital and outpatient
settings, FDA is requesting assistance
from the public in conducting scientific
analyses for the purpose of further
understanding the physiology of
sedation and clinical trial design issues
related to the development of sedation
products.
II. Request for Assistance
FDA is inviting any interested group
or consortium of interested groups from
academia, industry, practitioners, as
well as patients and their
representatives to conduct and manage
the coordination of a critical evaluation
of certain fundamentals of the science
related to sedation products. Initially,
the party or parties would organize and
hold one or more public meetings or
workshops to discuss relevant questions
associated with the spectrum of
sedation, particularly as it relates to
procedural and intensive care unit (ICU)
sedation, as well as associated clinical
trial design issues. FDA believes that a
public meeting would help solicit
feedback from all parties leading to
conceptual advances and a discussion of
such advances in a concept paper. This
discussion would take into account
challenges involved in assessment of
sedation and emphasize the rationale for
various approaches to key clinical trial
design issues involving sedation
products. The effort would ultimately
lead to developing a draft guidance that
would be issued by FDA for broad
public comment before finalization,
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
mstockstill on DSKH9S0YB1PROD with NOTICES
III. Suggestions
FDA welcomes other suggestions of
activities that could be undertaken as
part of this guidance development
effort.
IV. Possible Questions/Issues o Be
Considered
To provide a starting point for
discussion, FDA has developed a list of
some key concepts that the interested
parties may want to consider for
discussion at the meeting as follows:
1. Currently, sedation is studied
primarily in the procedural and ICU
settings. Procedural sedation may
involve an outpatient setting, and may
require the institution of Monitored
Anesthesia Care (MAC). There is great
interest among health care providers
with varied medical backgrounds in
VerDate Mar<15>2010
17:57 Nov 26, 2010
Jkt 223001
sedation for surgical and diagnostic
procedures in the outpatient setting.
What generally constitutes MAC, and
what qualifies a product for MAC? How
should the need for MAC be assessed in
clinical trials involving sedation
products?
2. Assessment of procedural sedation
involves conducting clinical trials in a
wide range of diagnostic and surgical
procedures. What surgical and
diagnostic procedures are of particular
value in assessing the procedural
sedation indication? Are there certain
procedures that should be evaluated for
every product that seeks the procedural
sedation indication, or can the range of
trials be governed by the pharmacologic
profile of the product? Should the scope
of the sedation guidance apply to
settings other than procedural or ICU
sedation?
3. There are patient subgroups in
which the use of sedation products
should be particularly evaluated. For
example, pediatric and geriatric age
groups often require dose adjustment
because of varying metabolic needs and
other clinical parameters. In addition,
dose adjustment may be required in
patients with renal and hepatic
impairment. Are there other patient
subgroups that require specific
evaluation in clinical trials involving
sedation products?
4. Sedation products usually are used
as infusions that are titrated to achieve
the desired sedation effect. What are
optimal trial designs for sedation
products? Should clinical trials
involving sedation products be placebocontrolled or active-controlled?
Currently, Midazolam, Propofol,
Ketamine, and Dexmedetomidine are
commonly used sedation products. Of
these, Midazolam is the most commonly
used active comparator in sedation
product trial designs. Is it possible to
accurately predict the actual size of the
treatment effect based on use of
Midazolam or other commonly used
sedation products? Although trial
designs involving these products are
believed to be predictive, it may not be
possible to generalize from them. If
active- and placebo-controlled product
trial designs are not optimal, what
alternative designs can be used to
support sedation claims? Would doseescalation comparative trial designs be
useful in studying sedation products?
5. How is sedation defined and what
are appropriate outcome measures to
assess sedation? At present, there is
diverse opinion among health care
providers regarding the definition of
sedation. For example, is the assessment
of anxiolysis and agitation a separate
entity or is it contained within the
PO 00000
Frm 00079
Fmt 4703
Sfmt 4703
73105
spectrum of sedation itself? Should this
depend upon the known pharmacologic
profile of the product? Currently, the
primary efficacy endpoint in sedation
clinical trials is usually assessed using
sedation scales. Commonly used
sedation scales include the Ramsey
Sedation Scale, Richmond Agitation and
Sedation Scale, and Mean Observer’s
Assessment of Agitation/Sedation Scale.
How appropriate is the use of such
sedation scales in clinical trials
involving sedation products? Should all
sedation scales be standardized and
validated?
6. Sedation scales are used for
assessing the primary efficacy endpoint
for sedation products. What are
meaningful secondary efficacy
endpoints in such trials? Are subjective
and objective assessments of memory,
recall, anxiety, agitation, delirium,
among others, appropriate as efficacy
endpoints? Which of these efficacy
endpoints should be considered
clinically significant? If so, what
outcome measures and trial designs
should be used? Specifically, how
should anxiolysis and agitation be
assessed within the realm of products
primarily indicated for sedation
purposes and not to treat an anxiety
disorder or agitation? Should there be
different scales for assessing each
component, or can the assessment be
contained within the spectrum of
sedation using an appropriate scale?
Further, is an accurate assessment of
anxiolysis feasible given the multiple
variables that can affect anxiety in a
procedural sedation setting that would
have to be standardized (e.g., physician
and practice setting profile, preprocedure anticipatory patient
prepping, individual thresholds for
anxiety)?
7. ICU sedation products are often
used for periods longer than 24 hours.
Should an ICU sedation indication
include a short-term (less than 24 hours)
and long-term (more than 24 hours) use
assessment for purposes of efficacy and
safety? Long-term use may be associated
with tolerance/tachyphylaxis and a
dose-related increase in adverse effects.
What should the size and duration of
exposure of the safety database be for
sedation products?
V. Comments
Interested persons should submit
comments and expressions of interest in
conducting and managing a critical
evaluation to the Division of Dockets
Management (see ADDRESSES). 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
E:\FR\FM\29NON1.SGM
29NON1
73106
Federal Register / Vol. 75, No. 228 / Monday, November 29, 2010 / Notices
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.
Dated: November 17, 2010.
Leslie Kux,
Acting Assisitant Commissioner for Policy.
[FR Doc. 2010–29927 Filed 11–26–10; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–D–0565]
Draft Guidance for Industry and Food
and Drug Administration Staff;
Establishing the Performance
Characteristics of In Vitro Diagnostic
Devices for the Detection of
Clostridium difficile; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
availability of the draft guidance
document entitled ‘‘Establishing the
Performance Characteristics of In Vitro
Diagnostic Devices for the Detection of
Clostridium difficile.’’ This draft
guidance document describes FDA’s
recommendations concerning 510(k)
submissions for various types of in vitro
diagnostic devices (IVDs) intended to be
used for detecting Clostridium difficile
(C. difficile). This draft guidance is not
final nor is it in effect at this time.
DATES: Although you can comment on
any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency
considers your comment on this draft
guidance before it begins work on the
final version of the guidance, submit
written or electronic comments on the
draft guidance by February 28, 2011.
ADDRESSES: Submit written requests for
single copies of the draft guidance
document entitled ‘‘Establishing the
Performance Characteristics of In Vitro
Diagnostic Devices for the Detection of
Clostridium difficile’’ to the Division of
Small Manufacturers, International, and
Consumer Assistance, Center for
Devices and Radiological Health, Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, Rm. 4613,
Silver Spring, MD 20993–0002. Send
one self-addressed adhesive label to
assist that office in processing your
request, or fax your request to 301–847–
8149. See the SUPPLEMENTARY
mstockstill on DSKH9S0YB1PROD with NOTICES
SUMMARY:
VerDate Mar<15>2010
17:57 Nov 26, 2010
Jkt 223001
section for information on
electronic access to the guidance.
Submit electronic comments on the
draft guidance to https://
www.regulations.gov. Submit written
comments to the Division of Dockets
Management, Food and Drug
Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852. Identify
comments with the docket number
found in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT:
Stephen Lovell, Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 4435, Silver Spring,
MD 20993–0002, 301–796–6968.
SUPPLEMENTARY INFORMATION:
INFORMATION
I. Background
This draft guidance includes
recommendations concerning 510(k)
submissions for various types of (IVDs)
intended to be used for detecting C.
difficile. The document is a revision of
‘‘Review Criteria for Assessment of
Laboratory Tests Directed at Assisting in
the Diagnosis of C. difficile Associated
Disease’’ issued on May 31, 1990. It is
updated to include new issues and
technologies identified since the 1990
guidance. Such methods include
detection of C. difficile nucleic acids
(e.g., C. difficile toxin B gene by nucleic
acid amplification methods such as the
Real-Time Polymerase Chain Reaction
technique).
difficile,’’ you may either send an e-mail
request to dsmica@fda.hhs.gov to
receive an electronic copy of the
document or send a fax request to 301–
847–8149 to receive a hard copy. Please
use the document number 1715 to
identify the guidance you are
requesting.
IV. Paperwork Reduction Act of 1995
This draft guidance refers to
previously approved collections of
information found in FDA regulations
and guidance documents. These
collections of information are subject to
review by the Office of Management and
Budget (OMB) under the Paperwork
Reduction Act of 1995 (44 U.S.C. 3501–
3520). The collections of information in
21 CFR part 807 subpart E have been
approved under OMB control number
0910–0120; the collections of
information in 21 CFR part 812 have
been approved under OMB control
number 0910–0078; the collections of
information in 42 CFR section 493.15
have been approved under OMB control
number 0910–0598; the collections of
information in 21 CFR section 50.23
have been approved under OMB control
number 0910–0586; and the collections
of information in 21 CFR section 56.115
have been approved under OMB control
number 0910–0130.
V. Comments
II. Significance of Guidance
This draft guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The draft guidance, when finalized will
represent the Agency’s current thinking
on establishing the performance
characteristics of in vitro diagnostic
devices for the detection of C. difficile.
It does not create or confer any rights for
or on any person and does not operate
to bind FDA or the public. An
alternative approach may be used if
such approach satisfies the
requirements of the applicable statute
and regulations.
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES) either electronic or written
comments regarding this document. 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.
III. Electronic Access
Persons interested in obtaining a copy
of the draft guidance may do so by using
the Internet. A search capability for all
CDRH guidance documents is available
at https://www.fda.gov/MedicalDevices/
DeviceRegulationandGuidance/
GuidanceDocuments/default.htm.
Guidance documents are also available
at https://www.regulations.gov. To
receive ‘‘Establishing the Performance
Characteristics of In Vitro Diagnostic
Devices for the Detection of Clostridium
[FR Doc. 2010–29794 Filed 11–26–10; 8:45 am]
PO 00000
Frm 00080
Fmt 4703
Sfmt 9990
Dated: November 22, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
BILLING CODE 4160–01–P
E:\FR\FM\29NON1.SGM
29NON1
]]>Agencies
[Federal Register Volume 75, Number 228 (Monday, November 29, 2010)]
[Notices]
[Pages 73104-73106]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-29927]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-N-0547]
Clinical Development Programs for Sedation Products; Request for
Assistance
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is seeking information
on a variety of issues related to the clinical development and use of
sedation products in adult and pediatric age groups. FDA is inviting
any interested party, or parties, to facilitate an evaluation of
critical fundamentals of the science related to sedation products by
conducting and managing a coordination of activities that will bring
together experts in the field, including from academia, patient
organizations, and industry. The first step in this process would be
for the party or parties to plan and hold one or more public meetings
to discuss these issues. FDA intends to take into account the
information provided from these activities as we develop FDA guidance
on clinical development programs for sedation products. We intend to
submit to the docket all the information received in response to this
notice so that interested parties may be fully informed.
DATES: Submit electronic or written comments on this notice by January
28, 2011.
ADDRESSES: Submit electronic comments on this notice to https://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.
FOR FURTHER INFORMATION CONTACT: Sara E. Stradley, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, rm. 3162, Silver Spring, MD 20993-0002, 301-
796-1298, FAX:301-796-9713, e-mail: sara.stradley@fda.hhs.gov.
[[Page 73105]]
SUPPLEMENTARY INFORMATION:
I. Background
Because of the need for more information on the development of
products intended to be used in humans for sedation in hospital and
outpatient settings, FDA is requesting assistance from the public in
conducting scientific analyses for the purpose of further understanding
the physiology of sedation and clinical trial design issues related to
the development of sedation products.
II. Request for Assistance
FDA is inviting any interested group or consortium of interested
groups from academia, industry, practitioners, as well as patients and
their representatives to conduct and manage the coordination of a
critical evaluation of certain fundamentals of the science related to
sedation products. Initially, the party or parties would organize and
hold one or more public meetings or workshops to discuss relevant
questions associated with the spectrum of sedation, particularly as it
relates to procedural and intensive care unit (ICU) sedation, as well
as associated clinical trial design issues. FDA believes that a public
meeting would help solicit feedback from all parties leading to
conceptual advances and a discussion of such advances in a concept
paper. This discussion would take into account challenges involved in
assessment of sedation and emphasize the rationale for various
approaches to key clinical trial design issues involving sedation
products. The effort would ultimately lead to developing a draft
guidance that would be issued by FDA for broad public comment before
finalization, consistent with FDA's good guidance practices regulation
(21 CFR 10.115).
III. Suggestions
FDA welcomes other suggestions of activities that could be
undertaken as part of this guidance development effort.
IV. Possible Questions/Issues o Be Considered
To provide a starting point for discussion, FDA has developed a
list of some key concepts that the interested parties may want to
consider for discussion at the meeting as follows:
1. Currently, sedation is studied primarily in the procedural and
ICU settings. Procedural sedation may involve an outpatient setting,
and may require the institution of Monitored Anesthesia Care (MAC).
There is great interest among health care providers with varied medical
backgrounds in sedation for surgical and diagnostic procedures in the
outpatient setting. What generally constitutes MAC, and what qualifies
a product for MAC? How should the need for MAC be assessed in clinical
trials involving sedation products?
2. Assessment of procedural sedation involves conducting clinical
trials in a wide range of diagnostic and surgical procedures. What
surgical and diagnostic procedures are of particular value in assessing
the procedural sedation indication? Are there certain procedures that
should be evaluated for every product that seeks the procedural
sedation indication, or can the range of trials be governed by the
pharmacologic profile of the product? Should the scope of the sedation
guidance apply to settings other than procedural or ICU sedation?
3. There are patient subgroups in which the use of sedation
products should be particularly evaluated. For example, pediatric and
geriatric age groups often require dose adjustment because of varying
metabolic needs and other clinical parameters. In addition, dose
adjustment may be required in patients with renal and hepatic
impairment. Are there other patient subgroups that require specific
evaluation in clinical trials involving sedation products?
4. Sedation products usually are used as infusions that are
titrated to achieve the desired sedation effect. What are optimal trial
designs for sedation products? Should clinical trials involving
sedation products be placebo-controlled or active-controlled?
Currently, Midazolam, Propofol, Ketamine, and Dexmedetomidine are
commonly used sedation products. Of these, Midazolam is the most
commonly used active comparator in sedation product trial designs. Is
it possible to accurately predict the actual size of the treatment
effect based on use of Midazolam or other commonly used sedation
products? Although trial designs involving these products are believed
to be predictive, it may not be possible to generalize from them. If
active- and placebo-controlled product trial designs are not optimal,
what alternative designs can be used to support sedation claims? Would
dose-escalation comparative trial designs be useful in studying
sedation products?
5. How is sedation defined and what are appropriate outcome
measures to assess sedation? At present, there is diverse opinion among
health care providers regarding the definition of sedation. For
example, is the assessment of anxiolysis and agitation a separate
entity or is it contained within the spectrum of sedation itself?
Should this depend upon the known pharmacologic profile of the product?
Currently, the primary efficacy endpoint in sedation clinical trials is
usually assessed using sedation scales. Commonly used sedation scales
include the Ramsey Sedation Scale, Richmond Agitation and Sedation
Scale, and Mean Observer's Assessment of Agitation/Sedation Scale. How
appropriate is the use of such sedation scales in clinical trials
involving sedation products? Should all sedation scales be standardized
and validated?
6. Sedation scales are used for assessing the primary efficacy
endpoint for sedation products. What are meaningful secondary efficacy
endpoints in such trials? Are subjective and objective assessments of
memory, recall, anxiety, agitation, delirium, among others, appropriate
as efficacy endpoints? Which of these efficacy endpoints should be
considered clinically significant? If so, what outcome measures and
trial designs should be used? Specifically, how should anxiolysis and
agitation be assessed within the realm of products primarily indicated
for sedation purposes and not to treat an anxiety disorder or
agitation? Should there be different scales for assessing each
component, or can the assessment be contained within the spectrum of
sedation using an appropriate scale? Further, is an accurate assessment
of anxiolysis feasible given the multiple variables that can affect
anxiety in a procedural sedation setting that would have to be
standardized (e.g., physician and practice setting profile, pre-
procedure anticipatory patient prepping, individual thresholds for
anxiety)?
7. ICU sedation products are often used for periods longer than 24
hours. Should an ICU sedation indication include a short-term (less
than 24 hours) and long-term (more than 24 hours) use assessment for
purposes of efficacy and safety? Long-term use may be associated with
tolerance/tachyphylaxis and a dose-related increase in adverse effects.
What should the size and duration of exposure of the safety database be
for sedation products?
V. Comments
Interested persons should submit comments and expressions of
interest in conducting and managing a critical evaluation to the
Division of Dockets Management (see ADDRESSES). 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
[[Page 73106]]
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.
Dated: November 17, 2010.
Leslie Kux,
Acting Assisitant Commissioner for Policy.
[FR Doc. 2010-29927 Filed 11-26-10; 8:45 am]
BILLING CODE 4160-01-P
