Clinical Development Programs for Sedation Products; Public Workshop; Request for Comments, 68197-68198 [2011-28475]
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Federal Register / Vol. 76, No. 213 / Thursday, November 3, 2011 / Notices
FDA. However, it is assumed that some
effort will need to be expended for
keeping such lists current.
The burden estimate for the
recordkeeping requirements under
section 223 of FDAAA in table 2 of this
document reflect other recordkeeping
requirements for devices listed with
FDA and the requirement to provide
these records upon request from FDA.
These estimates are based on FDA
experience.
Dated: October 28, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011–28476 Filed 11–2–11; 8:45 am]
BILLING CODE 4160–01–P
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.
Notice of public workshop;
request for comments.
srobinson on DSK4SPTVN1PROD with NOTICES
ACTION:
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.
VerDate Mar<15>2010
16:50 Nov 02, 2011
Jkt 226001
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:
mary.gross@fda.hhs.gov; 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: Diana.Walker@
fda.hhs.gov.
Registration to Participate in
Scientific Panels: If you wish to
participate as part of a scientific panel,
please email your request to CDER_
Sedation_Workshop@FDA.HHS.gov 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 CDER_
Sedation_Workshop@FDA.HHS.gov 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: https://
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 https://
www.regulations.gov. Submit written
comments to the Division of Dockets
Management (HFA–305), Food and Drug
PO 00000
Frm 00072
Fmt 4703
Sfmt 4703
68197
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.
E:\FR\FM\03NON1.SGM
03NON1
68198
Federal Register / Vol. 76, No. 213 / Thursday, November 3, 2011 / Notices
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 gastrointestinal (GI) suite?
FDA will post the agenda and
additional workshop background
material approximately 5 days before
the workshop at: https://www.fda.gov/
Drugs/NewsEvents/ucm221185.htm.
Administration (HRSA) Web site at
https://bhpr.hrsa.gov/shortage/
index.html. HPSAs are designated or
withdrawn by the Secretary of Health
and Human Services (HHS) under the
authority of section 332 of the Public
Health Service (PHS) Act and 42 CFR
part 5.
FOR FURTHER INFORMATION CONTACT:
Requests for further information on the
HPSA designations listed below and
requests for additional designations,
withdrawals, or reapplication for
designation should be submitted to
Andy Jordan, Office of Shortage
Designation, Bureau of Health
Professions, Health Resources and
Services Administration, Room 9A–18,
Parklawn Building, 5600 Fishers Lane,
Rockville, Maryland 20857, (301) 594–
0816), https://bhpr.hrsa.gov/shortage/
index.html.
II. Transcripts
Background
Please be advised that approximately
30 days after the public workshop, a
transcript will be available. It will be
accessible at https://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.
Section 332 of the PHS Act, 42 U.S.C.
254e, provides that the Secretary of HHS
shall designate HPSAs based on criteria
established by regulation. HPSAs are
defined in section 332 to include (1)
urban and rural geographic areas with
shortages of health professionals, (2)
population groups with such shortages,
and (3) facilities with such shortages.
Section 332 further requires that the
Secretary annually publish a list of the
designated geographic areas, population
groups, and facilities. The lists of
HPSAs are to be reviewed at least
annually and revised as necessary.
HRSA’s Bureau of Health Professions
(BHPr) has the responsibility for
designating and updating HPSAs.
Public or private nonprofit entities are
eligible to apply for assignment of
National Health Service Corps (NHSC)
personnel to provide primary health
services in or to these HPSAs. NHSC
health professionals with a service
obligation may serve only in federally
designated HPSAs. Entities with clinical
training sites located in HPSAs are
eligible to receive priority for certain
training program grants administered by
BHPr. Many other Federal programs also
utilize HPSA designations. For example,
under authorities administered by the
Centers for Medicare and Medicaid
Services, certain qualified providers in
HPSAs are eligible for increased levels
of Medicare reimbursement.
Dated: October 28, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011–28475 Filed 11–2–11; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Lists of Designated Primary Medical
Care, Mental Health, and Dental Health
Professional Shortage Areas
Health Resources and Services
Administration, HHS.
ACTION: Notice.
srobinson on DSK4SPTVN1PROD with NOTICES
AGENCY:
This notice advises the public
of the published lists of all geographic
areas, population groups, and facilities
designated as primary medical care,
mental health, and dental health
professional shortage areas (HPSAs) as
of September 1, 2011, available on the
Health Resources and Services
SUMMARY:
VerDate Mar<15>2010
16:50 Nov 02, 2011
Jkt 226001
SUPPLEMENTARY INFORMATION:
Development of the Designation and
Withdrawal Lists
Criteria for designating HPSAs were
published as final regulations (42 CFR
part 5) in 1980. Criteria then were
defined for each of seven health
PO 00000
Frm 00073
Fmt 4703
Sfmt 4703
professional types (primary medical
care, dental, psychiatric, vision care,
podiatric, pharmacy, and veterinary
care). The criteria for correctional
facility HPSAs were revised and
published on March 2, 1989, in the
Federal Register (54 FR 8735). The
criteria for psychiatric HPSAs were
expanded to mental health HPSAs on
January 22, 1992 (57 FR 2473).
Currently funded PHS Act programs use
only the primary medical care, mental
health, or dental HPSA designations.
Individual requests for designation or
withdrawal of a particular geographic
area, population group, or a facility as
a HPSA are received and reviewed
continuously by BHPr. The majority of
the requests come from the Primary Care
Offices (PCOs) in the State Health
Departments, who have access to the online application and review system.
Requests that come from other sources
are referred to the PCOs for their review
and concurrence. In addition, applicants
are expected to share copies of the
requests with other interested parties,
including the Governor, the State
Primary Care Association and state
professional associations for their
comments and recommendations.
Annually, lists of designated HPSAs
are provided to all PCOs, state medical
and dental societies and others, with a
request to review and update the data
on which the designations are based.
Emphasis is placed on updating those
designations that are more than 3 years
old or where significant changes
relevant to the designation criteria have
occurred.
Recommendations for possible
additions, continuations, revisions or
withdrawals from a HPSA list are
reviewed by BHPr, and the review
findings are provided by letter to the
agency or individual requesting action
or providing data, with copies to other
interested organizations and
individuals. These letters constitute the
official notice of designation as a HPSA,
rejection of recommendations for HPSA
designation, revision of a HPSA
designation, and/or advance notice of
pending withdrawals from the HPSA
list. Designations (or revisions of
designations) are effective as of the date
of the notification letter from BHPr.
Proposed withdrawals become effective
only after interested parties in the area
affected have been afforded the
opportunity to submit additional
information to BHPr in support of its
continued or revised designation. If no
new data are submitted, or if BHPr
review confirms the proposed
withdrawal, it becomes effective upon
publication in the Federal Register of
the lists of HPSAs that do not include
E:\FR\FM\03NON1.SGM
03NON1
]]>Agencies
[Federal Register Volume 76, Number 213 (Thursday, November 3, 2011)]
[Notices]
[Pages 68197-68198]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-28475]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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:
mary.gross@fda.hhs.gov; 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:
Diana.Walker@fda.hhs.gov.
Registration to Participate in Scientific Panels: If you wish to
participate as part of a scientific panel, please email your request to
CDER_Sedation_Workshop@FDA.HHS.gov 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 CDER_Sedation_Workshop@FDA.HHS.gov 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: https://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 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. 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: https://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
https://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]
BILLING CODE 4160-01-P
