Federal Register Notice - Published 60 Day

ATTACHMENT B:
60-Day Published Federal Register Notice

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 [email protected].
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.

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ESTIMATE OF ANNUALIZED BURDEN HOURS
Average
burden per
response
(in hours)

Form name

EMS professionals ............................

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 ...........................................

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No. of
respondents

No. of
responses per
respondent

Type of
respondents

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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 http://
www.regulations.gov. See the
SUPPLEMENTARY INFORMATION section for
electronic access to the guidance
document.
FOR FURTHER INFORMATION CONTACT:

Jogarao Gobburu, Center for Drug

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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 http://
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

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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
http://www.fda.gov/Drugs/Guidance
ComplianceRegulatoryInformation/
Guidances/default.htm or http://
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

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