Submission for OMB Review; Comment Request; Web-Based Skills Training for SBIRT (Screening Brief Intervention and Referral to Treatment), 50233-50234 [2011-20542]
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Federal Register / Vol. 76, No. 156 / Friday, August 12, 2011 / Notices
electronically or through manual entry
of the device data) for purposes of
automatically assessing patient specific
data or for providing support in making
clinical decisions. FDA plans to address
such stand-alone software in a separate
guidance. In order to provide a
reasonable assurance of the safety and
effectiveness of such software, and to
ensure consistency between the draft
guidance, ‘‘Mobile Medical
Applications,’’ and the planned
guidance on stand-alone software that
provides clinical decision support
(CDS), FDA is seeking comment on the
following issues:
• What factors should FDA consider
in determining the risk classification of
different types of software that provide
CDS functionality? Please provide
examples of how those factors would be
applied for such software that you
believe should be in class I, class II, and
class III;
• How should the FDA assess standalone software that provides CDS
functionality, to assure reasonable safety
and effectiveness? For example, to what
extent can FDA rely on a manufacturer’s
demonstration that it has a robust
quality system with appropriate quality
assurance and design controls? Under
what circumstances should the
submission of clinical data be required?;
and
• Are there specific controls that
manufacturers should implement that
could change the risk classification or
reduce the premarket data requirements
for particular types of stand-alone
software that provide CDS
functionality?
III. Where can I find out more about
this public workshop?
Background information on the public
workshop, registration information, the
agenda, information about lodging,
transcripts, and other relevant
information will be posted, as it
becomes available, on the Internet at
https://www.fda.gov/MedicalDevices/
NewsEvents/WorkshopsConferences/
default.htm.
IV. Will there be transcripts of the
meeting?
Please be advised that as soon as a
transcript is available, it will be
accessible at https://
www.regulations.gov. It may be viewed
at the Division of Dockets Management
(HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. A transcript
will also be available in either hard
copy or on CD–ROM, after submission
of a Freedom of Information request.
Written requests are to be sent to
Division of Freedom of Information
(HFI–35), Office of Management
Programs, Food and Drug
Administration, 5600 Fishers Lane, rm.
6–30, Rockville, MD 20857.
Dated: August 9, 2011.
Nancy K. Stade,
Deputy Director for Policy, Center for Devices
and Radiological Health.
[FR Doc. 2011–20574 Filed 8–11–11; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Submission for OMB Review;
Comment Request; Web-Based Skills
Training for SBIRT (Screening Brief
Intervention and Referral to Treatment)
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 for review
and approval of the information
collection listed below. This proposed
information collection was previously
published in the Federal Register on
May 24, 2011, Vol 76, #100, page
30177–30178, and allowed 60 days for
public comment. One request for the
draft instruments was received from the
public. These were provided to the
requestor. The purpose of this notice is
SUMMARY:
to allow an additional 30 days for public
comment. The National Institutes of
Health may not conduct or sponsor, and
the respondent is not required to
respond to, an information collection
that has been extended, revised, or
implemented on or after October 1,
1995, unless it displays a currently valid
OMB control number.
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:
mstockstill on DSK4VPTVN1PROD with NOTICES
Type of respondents
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 ...................................................................................
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
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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
PO 00000
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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
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50234
Federal Register / Vol. 76, No. 156 / Friday, August 12, 2011 / Notices
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.
Direct Comments to OMB: Written
comments and/or suggestions regarding
the item(s) contained in this notice,
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, 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 30 days of the date of
this publication.
Name of Committee: National Cancer
Institute Initial Review Group; Subcommittee
G—Education.
Date: September 20–21, 2011.
Time: 8 a.m. to 5 p.m.
Agenda: To review and evaluate grant
applications.
Place: Hilton Washington/Rockville, 1750
Rockville Pike, Rockville, MD 20852.
Contact Person: Jeannette F. Korczak, PhD,
Scientific Review Administrator, Resources
and Training Review Branch, Division of
Extramural Activities, National Cancer
Institute, NIH, 6116 Executive Blvd., Room
8115, Bethesda, MD 20892, 301–496–9767,
korczakj@mail.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.392, Cancer Construction;
93.393, Cancer Cause and Prevention
Research; 93.394, Cancer Detection and
Diagnosis Research; 93.395, Cancer
Treatment Research; 93.396, Cancer Biology
Research; 93.397, Cancer Centers Support;
93.398, Cancer Research Manpower; 93.399,
Cancer Control, National Institutes of Health,
HHS)
Dated: August 4, 2011.
Mary Affeldt,
Executive Officer, (OM Director) NIDA.
National Institute of Environmental
Health Sciences Notice of Meetings
[FR Doc. 2011–20542 Filed 8–11–11; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
mstockstill on DSK4VPTVN1PROD with NOTICES
National Cancer Institute; Notice of
Closed Meeting
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 meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
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Dated: August 8, 2011.
Anna P. Snouffer,
Deputy Director, Office of Federal Advisory
Committee Policy.
[FR Doc. 2011–20536 Filed 8–11–11; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Pursuant to section 10(a) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of meetings of the
Interagency Breast Cancer and
Environmental Research Coordinating
Committee.
The meetings will be open to the
public, with attendance limited to space
available. Individuals who plan to
attend and need special assistance, such
as sign language interpretation or other
reasonable accommodations, should
notify the Contact Person listed below
in advance of the meeting.
Name of Committee: Interagency Breast
Cancer and Environmental Research
Coordinating Committee.
Date: October 12, 2011.
Time: 1 p.m. to 3 p.m.
Agenda: The purpose of the meeting is to
continue the work of the Research Process
Subcommittee as it addresses a broad set of
objectives related to the overall mandate of
the IBCERC. The meeting agenda will be
available on the Web at https://
www.niehs.nih.gov/about/orgstructure/
boards/ibcercc/.
Place: NIEHS/National Institutes of Health,
Building 4401, East Campus, 79 T.W.
PO 00000
Frm 00069
Fmt 4703
Sfmt 4703
Alexander Drive, Research Triangle Park, NC
27709 (Telephone Conference Call).
To attend the meeting, please RSVP via email to ibcercc@niehs.nih.gov at least 10 days
in advance and instructions for joining the
meeting will be provided.
Contact Person: Gwen W. Collman, PhD,
Director, Division of Extramural Research
and Training (DERT), Nat. Inst. of
Environmental Health Sciences, National
Institutes of Health, 615 Davis Dr., KEY615/
3112, Research Triangle Park, NC 27709,
(919) 541–4980, collman@niehs.nih.gov.
Name of Committee: Interagency Breast
Cancer and Environmental Research
Coordinating Committee.
Date: October 26, 2011.
Time: 1 p.m. to 3 p.m.
Agenda: The purpose of the meeting is to
continue the work of the Research Process
Subcommittee as it addresses a broad set of
objectives related to the overall mandate of
the IBCERC. The meeting agenda will be
available on the Web at https://
www.niehs.nih.gov/about/orgstructure/
boards/ibcercc/.
To attend the meeting, please RSVP via email to ibcercc@niehs.nih.gov at least 10 days
in advance and instructions for joining the
meeting will be provided.
Place: NIEHS/National Institutes of Health,
Building 4401, East Campus, 79 T.W.
Alexander Drive, Research Triangle Park, NC
27709 (Telephone Conference Call).
Contact Person: Gwen W. Collman, PhD,
Director, Division of Extramural Research
and Training (DERT), Nat. Inst. of
Environmental Health Sciences, National
Institutes of Health, 615 Davis Dr., KEY615/
3112, Research Triangle Park, NC 27709,
(919) 541–4980, collman@niehs.nih.gov.
Name of Committee: Interagency Breast
Cancer and Environmental Research
Coordinating Committee.
Date: November 10, 2011.
Time: 1 p.m. to 3 p.m.
Agenda: The purpose of the meeting is to
continue the work of the Research Process
Subcommittee as it addresses a broad set of
objectives related to the overall mandate of
the IBCERC. The meeting agenda will be
available on the Web at https://
www.niehs.nih.gov/about/orgstructure/
boards/ibcercc/.
Place: NIEHS/National Institutes of Health,
Building 4401, East Campus, 79 T.W.
Alexander Drive, Research Triangle Park, NC
27709 (Telephone Conference Call).
To attend the meeting, please RSVP via email to ibcercc@niehs.nih.gov at least 10 days
in advance and instructions for joining the
meeting will be provided.
Contact Person: Gwen W. Collman, PhD,
Director, Division of Extramural Research
and Training (DERT), Nat. Inst. of
Environmental Health Sciences, National
Institutes of Health, 615 Davis Dr., KEY615/
3112, Research Triangle Park, NC 27709,
(919) 541–4980, collman@niehs.nih.gov.
Any member of the public interested in
presenting oral comments to the committee
should submit their remarks in writing at
least 10 days in advance of the meeting.
Comments in document format (i.e. WORD,
Rich Text, PDF) may be submitted via e-mail
to ibcercc@niehs.nih.gov or mailed to the
E:\FR\FM\12AUN1.SGM
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]]>Agencies
[Federal Register Volume 76, Number 156 (Friday, August 12, 2011)]
[Notices]
[Pages 50233-50234]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-20542]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Submission for OMB Review; Comment Request; Web-Based Skills
Training for SBIRT (Screening Brief Intervention and Referral to
Treatment)
SUMMARY: 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 for review and approval of the
information collection listed below. This proposed information
collection was previously published in the Federal Register on May 24,
2011, Vol 76, 100, page 30177-30178, and allowed 60 days for
public comment. One request for the draft instruments was received from
the public. These were provided to the requestor. The purpose of this
notice is to allow an additional 30 days for public comment. The
National Institutes of Health may not conduct or sponsor, and the
respondent is not required to respond to, an information collection
that has been extended, revised, or implemented on or after October 1,
1995, unless it displays a currently valid OMB control number.
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
Estimated number of Average burden total annual
Type of respondents number of responses per hours per set burden 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
[[Page 50234]]
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.
Direct Comments to OMB: Written comments and/or suggestions
regarding the item(s) contained in this notice, 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,
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 30 days
of the date of this publication.
Dated: August 4, 2011.
Mary Affeldt,
Executive Officer, (OM Director) NIDA.
[FR Doc. 2011-20542 Filed 8-11-11; 8:45 am]
BILLING CODE 4140-01-P
