Proposed Data Collections Submitted for Public Comment and Recommendations, 48079-48080 [E9-22646]
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48079
Federal Register / Vol. 74, No. 181 / Monday, September 21, 2009 / Notices
Dated: September 14, 2009.
Maryam I. Daneshvar,
Acting Reports Clearance Officer, Centers for
Disease Control and Prevention.
[FR Doc. E9–22648 Filed 9–18–09; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
In an effort to encourage use of
improved triage procedures, CDC’s
National Center for Injury Prevention
and Control (NCIPC) worked with
experts and partner organizations to
develop the 2006 Field Triage Decision
Scheme. In support of the 2006 Field
Triage Decision Scheme, NCIPC
developed a multi-media toolkit aimed
at EMS professionals. The toolkit
includes A Guide to the Field Triage
Decision Scheme: The National Trauma
Triage Protocol, a poster, CD–ROM, and
pocket card to help EMS providers,
planners, and administrators effectively
train others and use the Decision
Scheme criteria within their own
systems.
After the national distribution, NCIPC
will conduct an online survey of EMS
professionals who have received a
toolkit to assess the short-term impact of
the communication initiative directed at
EMS professionals about field triage
procedures. Specifically, the survey will
assess how many EMS professionals
who received a copy of the Decision
Scheme are using it, how EMS
professionals have used the Decision
Scheme and accompanying toolkit
materials, how the materials have been
used to educate others, what EMS
professionals learned from the
materials, and how the Decision Scheme
changed EMS professional’s triage
practices. Survey results will be used to
identify the impact and applicability of
the Decision Scheme and toolkit
materials for EMS professionals.
NCIPC will also conduct focus groups
with a segment of the survey
respondents in order to have them
elaborate on data submitted through the
survey. These group interviews will
focus on the extent the Decision Scheme
is being used, how it is being
implemented, self-reported changes in
knowledge, and perceived impact on
treatment of trauma patients. There are
no costs to respondents other than their
time.
be received within 60 days of this
notice.
Proposed Project
Evaluation of the Field Triage
Decision Scheme: The National Trauma
Triage Protocol—New—Division of
Injury Response (DIR), National Center
for Injury Prevention and Control
(NCIPC), Centers for Disease Control
and Prevention (CDC).
Background and Brief Description
[60Day–09–09AD]
Proposed Data Collections Submitted
for Public Comment and
Recommendations
In compliance with the requirement
of Section 3506(c)(2)(A) of the
Paperwork Reduction Act of 1995 for
opportunity for public comment on
proposed data collection projects, the
Centers for Disease Control and
Prevention (CDC) will publish periodic
summaries of proposed projects. To
request more information on the
proposed projects or to obtain a copy of
the data collection plans and
instruments, call 404–639–5960 or send
comments to CDC Acting Reports
Clearance Officer, 1600 Clifton Road,
MS–D74, Atlanta, GA 30333 or send an
e-mail to omb@cdc.gov.
Comments are invited on: (a) Whether
the proposed collection of information
is necessary for the proper performance
of the functions of the agency, including
whether the information shall have
practical utility; (b) the accuracy of the
agency’s estimate of the burden of the
proposed collection of information; (c)
ways to enhance the quality, utility, and
clarity of the information to be
collected; and (d) ways to minimize the
burden of the collection of information
on respondents, including through the
use of automated collection techniques
or other forms of information
technology. Written comments should
The Field Triage Decision Scheme:
The National Trauma Triage Protocol
educational initiative was developed to
help emergency medical services (EMS)
professionals (administrators, medical
directors, trauma system leadership, and
providers) learn about and implement
the revised Field Triage Decision
Scheme. The Decision Scheme is
intended to be the foundation for the
development of local and regional field
triage protocols.
In the United States, injury is the
leading cause of death for persons aged
1–44 years. EMS professionals have a
substantial impact on care of the injured
and on public health. At an injury
scene, EMS professionals determine the
severity of injury, initiate medical
management, and identify the most
appropriate facility to which the patient
should be transported. This destination
decision is made through a process
called field triage. Certain hospitals
have additional expertise, resources,
and equipment to treat severely injured
patients. These facilities are known as
trauma centers and are classified from
Level I to Level IV. The risk for death
of a severely injured person is 25%
lower if the patient receives care at a
Level I trauma center. However, not all
patients require the services of a Level
I trauma center; proper triage will
ensure that patients who are injured less
severely will be transported to a closer
emergency department that is capable of
managing their injuries.
ESTIMATE OF ANNUALIZED BURDEN HOURS
Average
burden per
response
(in hours)
EMS professionals ............................
mstockstill on DSKH9S0YB1PROD with NOTICES
Form name
Online survey ...................................
Screening and Recruitment for
Focus Groups.
Focus Groups ...................................
3,000
48
1
1
15/60
5/60
750
4
64
1
1
64
...........................................................
........................
........................
........................
818
Total ...........................................
VerDate Nov<24>2008
17:24 Sep 18, 2009
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Frm 00029
No. of
respondents
No. of
responses per
respondent
Type of
respondents
Fmt 4703
Sfmt 4703
E:\FR\FM\21SEN1.SGM
21SEN1
Total burden
(in hours)
48080
Federal Register / Vol. 74, No. 181 / Monday, September 21, 2009 / Notices
Dated: September 14, 2009.
Maryam I. Daneshvar,
Acting Reports Clearance Officer, Centers for
Disease Control and Prevention.
[FR Doc. E9–22646 Filed 9–18–09; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2008–D–0514]
Guidance for Industry on End-of-Phase
2A Meetings; Availability
AGENCY:
Food and Drug Administration,
HHS.
mstockstill on DSKH9S0YB1PROD with NOTICES
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing the
availability of a guidance for industry
entitled ‘‘End-of-Phase 2A Meetings.’’
This guidance provides information on
end-of-phase 2A (EOP2A) meetings for
sponsors of investigational new drug
applications (INDs). The purpose of an
EOP2A meeting is to facilitate
interaction between FDA and sponsors
who seek guidance related to clinical
trial design employing clinical trial
simulation and quantitative modeling of
prior knowledge (e.g., drug, disease,
placebo), designing trials for better dose
response estimation and dose selection,
and other related issues. This guidance
is intended to further FDA initiatives
directed at identifying opportunities to
facilitate the development of innovative
medical products and improve the
quality of drug applications through
early meetings with sponsors.
DATES: Submit written or electronic
comments on agency guidances at any
time.
ADDRESSES: Submit written requests for
single copies of this guidance to the
Division of Drug Information, Center for
Drug Evaluation and Research, Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 2201,
Silver Spring, MD 20993–0002. Send
one self-addressed adhesive label to
assist that office in processing your
requests. Submit written comments on
the guidance to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. Submit
electronic comments to https://
www.regulations.gov. See the
SUPPLEMENTARY INFORMATION section for
electronic access to the guidance
document.
FOR FURTHER INFORMATION CONTACT:
Jogarao Gobburu, Center for Drug
VerDate Nov<24>2008
17:24 Sep 18, 2009
Jkt 217001
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 3186,
Silver Spring, MD 20993–0002, 301–
796–2460.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
a guidance for industry entitled ‘‘Endof-Phase 2A Meetings.’’ This guidance
will meet one of the performance goals
agreed to under the September 27, 2007,
reauthorization of the Prescription Drug
User Fee Act (PDUFA IV). Under section
XI of the PDUFA IV Performance Goals,
Expediting Drug Development, FDA
agreed to publish by the end of fiscal
year 2008 a draft guidance on EOP2A
meetings and to complete the final
guidance within 1 year of the close of
the public comment period (see https://
www.fda.gov/ForIndustry/UserFees/
PrescriptionDrugUserFee/
ucm119243.htm at section XI.A).
FDA has a long-standing interest in
defining dose or exposure-response
relationships for the effectiveness and
safety of new drugs. Accurate doseresponse information is important for
understanding how patients should take
drugs to maximize desirable effects and
minimize undesirable effects. Dose
selection for phase 2 and phase 3
studies is a challenge in many drug
development programs and poor choice
may lead to trial failure. Improving early
dose selection may increase the
likelihood of future trial success. FDA
recognizes trial planning may be
improved by clinical trial simulations
that employ quantitative models of drug
exposure-response, placebo effect, and
disease progression. This guidance on
EOP2A meetings is intended to
encourage the best use of this science to
facilitate the exploration of trial design
alternatives to increase the likelihood
for successful trials.
In the Federal Register of September
26, 2008 (73 FR 55851), FDA announced
the availability of a draft guidance of the
same title. In response to public
comments on the draft version, the
guidance has been revised to clarify the
following topics: (1) The type of
information that should be submitted
with the meeting request and the
background package and (2) the role of
the Office of New Drugs in preparing for
and conducting EOP2A meetings.
This guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The guidance represents the agency’s
current thinking on the roles of modelbased drug development together with
early interaction between FDA and
industry to improve late phase clinical
PO 00000
Frm 00030
Fmt 4703
Sfmt 4703
trial success. 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 statutes
and regulations.
II. Comments
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES) written or electronic
comments regarding this document.
Submit a single copy of electronic
comments or two paper copies of any
mailed comments, except that
individuals may submit one paper copy.
Comments are to be identified 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. Paperwork Reduction Act of 1995
This guidance refers to previously
approved collections of information
found in FDA regulations. 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 312 and the guidance on
‘‘Formal Meetings with Sponsors and
Applicants for PDUFA Products’’ have
been approved under OMB control
numbers 0910–0014 and 0910–0429,
respectively.
IV. Electronic Access
Persons with access to the Internet
may obtain the document at either
https://www.fda.gov/Drugs/Guidance
ComplianceRegulatoryInformation/
Guidances/default.htm or https://
www.regulations.gov.
Dated: September 16, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9–22623 Filed 9–18–09; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Center for Scientific Review; Notice of
Closed Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of the following meetings.
The meetings will be closed to the
public in accordance with the
provisions set forth in sections
E:\FR\FM\21SEN1.SGM
21SEN1
Agencies
[Federal Register Volume 74, Number 181 (Monday, September 21, 2009)]
[Notices]
[Pages 48079-48080]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-22646]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[60Day-09-09AD]
Proposed Data Collections Submitted for Public Comment and
Recommendations
In compliance with the requirement of Section 3506(c)(2)(A) of the
Paperwork Reduction Act of 1995 for opportunity for public comment on
proposed data collection projects, the Centers for Disease Control and
Prevention (CDC) will publish periodic summaries of proposed projects.
To request more information on the proposed projects or to obtain a
copy of the data collection plans and instruments, call 404-639-5960 or
send comments to CDC Acting Reports Clearance Officer, 1600 Clifton
Road, MS-D74, Atlanta, GA 30333 or send an e-mail to omb@cdc.gov.
Comments are invited on: (a) Whether the proposed collection of
information is necessary for the proper performance of the functions of
the agency, including whether the information shall have practical
utility; (b) the accuracy of the agency's estimate of the burden of the
proposed collection of information; (c) ways to enhance the quality,
utility, and clarity of the information to be collected; and (d) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques or other
forms of information technology. Written comments should be received
within 60 days of this notice.
Proposed Project
Evaluation of the Field Triage Decision Scheme: The National Trauma
Triage Protocol--New--Division of Injury Response (DIR), National
Center for Injury Prevention and Control (NCIPC), Centers for Disease
Control and Prevention (CDC).
Background and Brief Description
The Field Triage Decision Scheme: The National Trauma Triage
Protocol educational initiative was developed to help emergency medical
services (EMS) professionals (administrators, medical directors, trauma
system leadership, and providers) learn about and implement the revised
Field Triage Decision Scheme. The Decision Scheme is intended to be the
foundation for the development of local and regional field triage
protocols.
In the United States, injury is the leading cause of death for
persons aged 1-44 years. EMS professionals have a substantial impact on
care of the injured and on public health. At an injury scene, EMS
professionals determine the severity of injury, initiate medical
management, and identify the most appropriate facility to which the
patient should be transported. This destination decision is made
through a process called field triage. Certain hospitals have
additional expertise, resources, and equipment to treat severely
injured patients. These facilities are known as trauma centers and are
classified from Level I to Level IV. The risk for death of a severely
injured person is 25% lower if the patient receives care at a Level I
trauma center. However, not all patients require the services of a
Level I trauma center; proper triage will ensure that patients who are
injured less severely will be transported to a closer emergency
department that is capable of managing their injuries.
In an effort to encourage use of improved triage procedures, CDC's
National Center for Injury Prevention and Control (NCIPC) worked with
experts and partner organizations to develop the 2006 Field Triage
Decision Scheme. In support of the 2006 Field Triage Decision Scheme,
NCIPC developed a multi-media toolkit aimed at EMS professionals. The
toolkit includes A Guide to the Field Triage Decision Scheme: The
National Trauma Triage Protocol, a poster, CD-ROM, and pocket card to
help EMS providers, planners, and administrators effectively train
others and use the Decision Scheme criteria within their own systems.
After the national distribution, NCIPC will conduct an online
survey of EMS professionals who have received a toolkit to assess the
short-term impact of the communication initiative directed at EMS
professionals about field triage procedures. Specifically, the survey
will assess how many EMS professionals who received a copy of the
Decision Scheme are using it, how EMS professionals have used the
Decision Scheme and accompanying toolkit materials, how the materials
have been used to educate others, what EMS professionals learned from
the materials, and how the Decision Scheme changed EMS professional's
triage practices. Survey results will be used to identify the impact
and applicability of the Decision Scheme and toolkit materials for EMS
professionals.
NCIPC will also conduct focus groups with a segment of the survey
respondents in order to have them elaborate on data submitted through
the survey. These group interviews will focus on the extent the
Decision Scheme is being used, how it is being implemented, self-
reported changes in knowledge, and perceived impact on treatment of
trauma patients. There are no costs to respondents other than their
time.
Estimate of Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
No. of Average burden
Type of respondents Form name No. of responses per per response Total burden
respondents respondent (in hours) (in hours)
----------------------------------------------------------------------------------------------------------------
EMS professionals............. Online survey... 3,000 1 15/60 750
Screening and 48 1 5/60 4
Recruitment for
Focus Groups.
Focus Groups.... 64 1 1 64
---------------------------------------------------------------
Total..................... ................ .............. .............. .............. 818
----------------------------------------------------------------------------------------------------------------
[[Page 48080]]
Dated: September 14, 2009.
Maryam I. Daneshvar,
Acting Reports Clearance Officer, Centers for Disease Control and
Prevention.
[FR Doc. E9-22646 Filed 9-18-09; 8:45 am]
BILLING CODE 4163-18-P