Proposed collection; comment request; Web-Based Skills Training for SBIRT (Screening Brief Intervention and Referral to Treatment), 30177-30178 [2011-12726]
Download as PDF
30177
Federal Register / Vol. 76, No. 100 / Tuesday, May 24, 2011 / Notices
possible modifications before coming to
the meeting.
Agenda: On June 17, 2011, the
committee will discuss biologics license
application (BLA) 125387, aflibercept
ophthalmic solution, proposed trade
name EYLEA, sponsored by Regeneron
Pharmaceuticals, Inc., indicated for the
treatment of neovascular age-related
macular degeneration (wet AMD).
FDA intends to make background
material available to the public no later
than 2 business days before the meeting.
If FDA is unable to post the background
material on its Web site prior to the
meeting, the background material will
be made publicly available at the
location of the advisory committee
meeting, and the background material
will be posted on FDA’s Web site after
the meeting. Background material is
available at: https://www.fda.gov/
AdvisoryCommittees/Calendar/
default.htm. Scroll down to the
appropriate advisory committee link.
Procedure: Interested persons may
present data, information, or views,
orally or in writing, on issues pending
before the committee. Written
submissions may be made to the contact
person on or before June 3, 2011. Oral
presentations from the public will be
scheduled between approximately 1
p.m. and 2 p.m. Those individuals
interested in making formal oral
presentations should notify the contact
person and submit a brief statement of
the general nature of the evidence or
arguments they wish to present, the
names and addresses of proposed
participants, and an indication of the
approximate time requested to make
their presentation on or before May 25,
2011. Time allotted for each
presentation may be limited. If the
number of registrants requesting to
speak is greater than can be reasonably
accommodated during the scheduled
open public hearing session, FDA may
conduct a lottery to determine the
speakers for the scheduled open public
hearing session. The contact person will
notify interested persons regarding their
request to speak by May 26, 2011.
Persons attending FDA’s advisory
committee meetings are advised that the
Agency is not responsible for providing
access to electrical outlets.
FDA welcomes the attendance of the
public at its advisory committee
meetings and will make every effort to
accommodate persons with physical
disabilities or special needs. If you
require special accommodations due to
a disability, please contact Yvette
Waples at least 7 days in advance of the
meeting.
FDA is committed to the orderly
conduct of its advisory committee
meetings. Please visit our Web site at:
https://www.fda.gov/
AdvisoryCommittees/
AboutAdvisoryCommittees/
ucm111462.htm for procedures on
public conduct during advisory
committee meetings.
Notice of this meeting is given under
the Federal Advisory Committee Act
(5 U.S.C. app. 2).
Dated: May 18, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011–12741 Filed 5–23–11; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Proposed collection; comment
request; Web-Based Skills Training for
SBIRT (Screening Brief Intervention
and Referral to Treatment)
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
SUMMARY:
National Institute on Drug Abuse, the
National Institutes of Health (NIH) will
publish periodic summaries of proposed
projects to be submitted to the Office of
Management and Budget (OMB) for
review and approval.
Proposed Collection
Title: Web-based Skills Training for
SBIRT (Screening Brief Intervention and
Referral to Treatment).
Type of Information Collection
Request: New.
Need and Use of Information
Collection: The project aims to increase
the provision of screening, brief
intervention, and referral to treatment
(SBIRT) for substance use in primary
care by developing an engaging,
interactive case-based training program
that will be delivered over the Internet,
providing convenient access to
screening and brief intervention skills
training and resources for busy PCPs.
The goal of this study is to evaluate the
effectiveness of this training on provider
behavior and/or patient outcome and
the program’s utility as a training tool in
a real-world medical setting. The
training is named SBIRT–PC. Study
participants will be randomly assigned
to complete SBIRT–PC or a control
training, consisting of online reading
materials. Effectiveness will be
evaluated in terms of differential SBIRTrelated knowledge, attitudes, selfefficacy, self-reported clinical practices,
skills as measured by virtual
standardized patient evaluations (VSPE)
and a telephone-based standardized
patient (SP) interaction. Participants in
each condition will also complete a
training satisfaction questionnaire.
Frequency of Response: On occasion.
Affected Public: Private Sector;
Businesses or other for-profit.
Type of Respondents: Primary Care
Providers.
The annual reporting burden is as
follows:
Estimated
number of
respondents
Estimated
number of responses per
respondent
Average burden hours per
set of
responses
Estimated total
annual burden
hours
requested
Primary Care Providers ...................................................................................
jlentini on DSK4TPTVN1PROD with NOTICES
Type of respondents
94
1
2.0
188
There are no Capital Costs to report.
There are no Operating or Maintenance
Costs to report.
Request for Comments: Written
comments and/or suggestions from the
public and affected agencies are invited
on one or more of the following points:
(1) Whether the proposed collection of
information is necessary for the proper
VerDate Mar<15>2010
16:47 May 23, 2011
Jkt 223001
performance of the function of the
agency, including whether the
information will have practical utility;
(2) The accuracy of the agency’s
estimate of the burden of the proposed
collection of information, including the
validity of the methodology and
assumptions used; (3) Ways to enhance
the quality, utility, and clarity of the
PO 00000
Frm 00090
Fmt 4703
Sfmt 4703
information to be collected; and (4)
Ways to minimize the burden of the
collection of information on those who
are to respond, including the use of
appropriate automated, electronic,
mechanical, or other technological
collection techniques or other forms of
information technology.
E:\FR\FM\24MYN1.SGM
24MYN1
30178
Federal Register / Vol. 76, No. 100 / Tuesday, May 24, 2011 / Notices
To
request more information on the
proposed project or to obtain a copy of
the data collection plans and
instruments, contact Quandra Scudder,
Project Officer, National Institute on
Drug Abuse NIDA, NIH, 6001 Executive
Boulevard, Bethesda, MD 20892–9557,
or call non-toll-free number (301) 594–
0394 or E-mail your request, including
your address to scudderq@nida.nih.gov.
Comments Due Date: Comments
regarding this information collection are
best assured of having their full effect if
received within 60 days of the date of
this publication.
FOR FURTHER INFORMATION CONTACT:
Dated: May 18, 2011.
Mary Affeldt,
Executive Officer, (OM Director) NIDA.
[FR Doc. 2011–12726 Filed 5–23–11; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Submission for OMB review; Comment
Request; Process Evaluation of the
NIH Roadmap Epigenomics Program
Under the provisions of
Section 3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, the National
Institute on Drug Abuse (NIDA), the
National Institutes of Health (NIH), has
submitted to the Office of Management
and Budget (OMB) a request to review
and approve the information collection
listed below. This proposed information
collection was previously published in
the Federal Register in Vol. 76, No. 49,
pages 13648–13649 on March 14, 2011,
and allowed 60 days for public
SUMMARY:
comment. No public comments were
received on the planned study or any of
the specific topics outlined in the 60day notice. The purpose of this notice
is to allow an additional 30 days for
public comment. 5 CFR 1320.5 (General
requirements) Reporting and
Recordkeeping Requirements: Final
Rule requires that the agency inform the
potential persons who are to respond to
the collection of information that such
persons are not required to respond to
the collection of information unless it
displays a currently valid OMB control
number.
Proposed Collection
Title: Process Evaluation of the NIH
Roadmap Epigenomics Program.
Type of Information Collection
Request: New.
Need and Use of Information
Collection: The proposed information
collection is essential to the process
evaluation of the NIH Roadmap
Epigenomics Program. The process
evaluation is a requirement of each of
the relevant RFAs funded under the NIH
Roadmap Epigenomics Program which
require participating in evaluation
research activities.
This evaluation study, a mixedmethods study which uses secondary
source documentation and information
from tracking and monitoring systems
along with primary data to assess
program process and progress, is nonexperimental. The assessment is based
on secondary source information, with
primary source information collection
added to augment the reliability and
internal validity. The primary data
collection uses information categories
that genuinely tap added distinctions
and opinions that relate to it to build the
weight of evidence from first-hand
sources that substantiate the initial
hypotheses about the program
phenomenon and its differences from a
typical research portfolio of individual
and insular projects.
The synthesized results across
primary and secondary data sources will
provide critical insights on
transformativeness of high-impact,
trans-NIH programs and contribute
important information about the
synergies and collaborations in multicomponent scientific research. It will
also identify areas for program
improvement and lessons learned that
might be useful to other research
programs of the Agency.
To reduce response bias and to make
the survey as accessible as possible to
busy principal investigators, the survey
will be web-based.
Frequency of Response: Once.
Affected Public: Principal
Investigators of the program at not-forprofit institutions.
Type of Respondents: Principle
Investigators.
The annual reporting burden is as
follows:
Estimated Number of Respondents:
53.
Estimated Number of Responses per
Respondent: 1.
Average Burden Hours per Response:
.33.
Estimated Total Annual Burden
Hours Requested: 17.49.
The annualized cost to respondents is
estimated at: $891.99.
There are no Capital Costs, Operating
Costs and/or Maintenance Costs to
report.
ESTIMATED ANNUALIZED BURDEN HOURS AND COSTS
Type of respondent
Number of respondents
Number of responses per
respondent
53
1
Principal Investigators ..
jlentini on DSK4TPTVN1PROD with NOTICES
1 20
Total number
of responses
Avg. burden
hours per response
1
Annual burden
hours requested
133
17.49
Avg. hourly
wage rate
51
Total annual
respondent
cost
891.99
minutes.
Request for Comments: Written
comments and/or suggestions from the
public and affected agencies are invited
on one or more of the following points:
(1) Whether the proposed collection of
information is necessary for the proper
performance of the function of the
agency, including whether the
information will have practical utility;
(2) The accuracy of the agency’s
estimate of the burden of the proposed
collection of information, including the
validity of the methodology and
VerDate Mar<15>2010
16:47 May 23, 2011
Jkt 223001
assumptions used; (3) Ways to enhance
the quality, utility, and clarity of the
information to be collected; and (4)
Ways to minimize the burden of the
collection of information on those who
are to respond, including the use of
appropriate automated, electronic,
mechanical, or other technological
collection techniques or other forms of
information technology.
Direct Comments to OMB: Written
comments and/or suggestions regarding
the item(s) contained in this notice,
PO 00000
Frm 00091
Fmt 4703
Sfmt 4703
especially regarding the estimated
public burden and associated response
time, should be directed to the: Office of
Management and Budget, Office of
Regulatory Affairs, OIRA_submission@
omb.eop.gov or by fax to 202–395–6974,
Attention: Desk Officer for NIH. To
request more information on the
proposed project or to obtain a copy of
the data collection plans and
instruments, contact Genevieve
deAlmeida-Morris, PhD, M.P.H., Project
Officer, Office of Science Policy and
E:\FR\FM\24MYN1.SGM
24MYN1
Agencies
[Federal Register Volume 76, Number 100 (Tuesday, May 24, 2011)]
[Notices]
[Pages 30177-30178]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-12726]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Proposed collection; comment request; Web-Based Skills Training
for SBIRT (Screening Brief Intervention and Referral to Treatment)
SUMMARY: 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 National Institute on
Drug Abuse, the National Institutes of Health (NIH) will publish
periodic summaries of proposed projects to be submitted to the Office
of Management and Budget (OMB) for review and approval.
Proposed Collection
Title: Web-based Skills Training for SBIRT (Screening Brief
Intervention and Referral to Treatment).
Type of Information Collection Request: New.
Need and Use of Information Collection: The project aims to
increase the provision of screening, brief intervention, and referral
to treatment (SBIRT) for substance use in primary care by developing an
engaging, interactive case-based training program that will be
delivered over the Internet, providing convenient access to screening
and brief intervention skills training and resources for busy PCPs. The
goal of this study is to evaluate the effectiveness of this training on
provider behavior and/or patient outcome and the program's utility as a
training tool in a real-world medical setting. The training is named
SBIRT-PC. Study participants will be randomly assigned to complete
SBIRT-PC or a control training, consisting of online reading materials.
Effectiveness will be evaluated in terms of differential SBIRT-related
knowledge, attitudes, self-efficacy, self-reported clinical practices,
skills as measured by virtual standardized patient evaluations (VSPE)
and a telephone-based standardized patient (SP) interaction.
Participants in each condition will also complete a training
satisfaction questionnaire.
Frequency of Response: On occasion.
Affected Public: Private Sector; Businesses or other for-profit.
Type of Respondents: Primary Care Providers.
The annual reporting burden is as follows:
----------------------------------------------------------------------------------------------------------------
Estimated Estimated total
Estimated number of Average burden annual burden
Type of respondents number of responses per hours per set hours
respondents respondent of responses requested
----------------------------------------------------------------------------------------------------------------
Primary Care Providers...................... 94 1 2.0 188
----------------------------------------------------------------------------------------------------------------
There are no Capital Costs to report. There are no Operating or
Maintenance Costs to report.
Request for Comments: Written comments and/or suggestions from the
public and affected agencies are invited on one or more of the
following points: (1) Whether the proposed collection of information is
necessary for the proper performance of the function of the agency,
including whether the information will have practical utility; (2) The
accuracy of the agency's estimate of the burden of the proposed
collection of information, including the validity of the methodology
and assumptions used; (3) Ways to enhance the quality, utility, and
clarity of the information to be collected; and (4) Ways to minimize
the burden of the collection of information on those who are to
respond, including the use of appropriate automated, electronic,
mechanical, or other technological collection techniques or other forms
of information technology.
[[Page 30178]]
FOR FURTHER INFORMATION CONTACT: To request more information on the
proposed project or to obtain a copy of the data collection plans and
instruments, contact Quandra Scudder, Project Officer, National
Institute on Drug Abuse NIDA, NIH, 6001 Executive Boulevard, Bethesda,
MD 20892-9557, or call non-toll-free number (301) 594-0394 or E-mail
your request, including your address to scudderq@nida.nih.gov.
Comments Due Date: Comments regarding this information collection
are best assured of having their full effect if received within 60 days
of the date of this publication.
Dated: May 18, 2011.
Mary Affeldt,
Executive Officer, (OM Director) NIDA.
[FR Doc. 2011-12726 Filed 5-23-11; 8:45 am]
BILLING CODE 4140-01-P