Agency Information Collection Activities: Submission for OMB Review; Comment Request, 61147-61148 [2010-24849]
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Federal Register / Vol. 75, No. 191 / Monday, October 4, 2010 / Notices
outcome assessment will examine the
effectiveness of the State Videos project
in meeting the core project objectives
and will capture the State’s
dissemination efforts. The process and
outcome assessments will encompass
State videos that will be produced in
2010–2013 and those that were
produced in 2007 and 2009. State
contacts will be asked to update their
Dated: September 28, 2010.
dissemination information online if
Elaine Parry,
there have been changes in these figures
Director, Office of Management, Technology
during the previous 6 months, up
and Operations.
through 2013. Additionally, data will be
[FR Doc. 2010–24847 Filed 10–1–10; 8:45 am]
collected from viewers of the State
BILLING CODE 4162–20–P
videos using an online survey.
The information will be collected
from the primary contact employee
DEPARTMENT OF HEALTH AND
designated by the States that have
HUMAN SERVICES
agreed to participate in the production
of a video for the State Videos project.
Substance Abuse and Mental Health
The viewers’ information will be
Services Administration
collected from those who voluntarily
decide to complete a short survey after
Agency Information Collection
seeing the video.
Activities: Submission for OMB
SAMHSA/CSAP intends to support
Review; Comment Request
annual videos on State underage
Periodically, the Substance Abuse and drinking prevention videos. The
Mental Health Services Administration
information collected will be used by
(SAMHSA) will publish a summary of
CSAP to help plan for these annual
information collection requests under
video productions and provide
OMB review, in compliance with the
technical assistance to the participating
Paperwork Reduction Act (44 U.S.C.
States. The collected information will
Chapter 35). To request a copy of these
also provide a descriptive picture of the
documents, call the SAMHSA Reports
initiative, indicate how the videos have
Clearance Officer on (240) 276–1243.
been received, and highlight some
factors that may be associated with
Project: Assessment of the Underage
successful dissemination outcomes.
Drinking Prevention Education
The information needs to be obtained
Initiatives State Videos Project—New
using a combination of initial telephone
The Substance Abuse and Mental
interviews to collect process data,
Health Services Administration’s Center followed by online forms to collect
for Substance Abuse Prevention (CSAP) outcome and dissemination data. A
is requesting Office of Management and survey of viewers, collected online, will
Budget (OMB) approval of three new
also be used to assess the effectiveness
data collection instruments—
of the State videos in increasing
• State Video Contacts Form.
awareness of the underage drinking
• Video Viewers Form.
prevention activities in these States.
• Dissemination Update Online Form. This information collection is being
This new information collection is for implemented under authority of Section
the assessment of the 2010–2013
501(d)(4) of the Public Health Service
Underage Drinking Prevention
Act (42 U.S.C. 290aa).
Education Initiatives State Videos
State staff members will be contacted
project. In 2007, four States participated once the video has been finalized. These
in a pilot study to produce videos on the State staff members will be asked to
topic of underage drinking prevention.
complete a short telephone interview
Based upon the success of those videos, that asks questions about the process of
10 additional States and 1 Territory
producing the State video. The State
were provided funds to produce videos
Video Contacts Form includes nine
in 2009. Contingent on available funds,
items about the State video, including:
CSAP hopes to invite approximately 10
• State’s objectives for the video on
States/Territories per year to produce
underage drinking prevention.
their own videos.
• Targeted audiences.
Over the next 4 years, CSAP will
• Satisfaction with technical
conduct a process and outcome
assistance (TA) received.
assessment of this project. The process
• Usefulness of preplanning
assessment will focus on the
materials.
• Helpfulness of TA during different
experiences associated with planning
phases of production.
and producing the State videos. The
jlentini on DSKJ8SOYB1PROD with NOTICES
Resources and Housing Branch, Office
of Management and Budget, New
Executive Office Building, Room 10235,
Washington, DC 20503; due to potential
delays in OMB’s receipt and processing
of mail sent through the U.S. Postal
Service, respondents are encouraged to
submit comments by fax to: 202–395–
7285.
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17:23 Oct 01, 2010
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PO 00000
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61147
• Recommendations for improving
the process.
• Recommendations for improving
the content of the video.
• Advice to other States interested in
producing a video.
If the State has disseminated the
video at the time of the initial telephone
interview, then they will also be asked
to complete the second part of the State
Video Contacts Form, which collects
information on dissemination outcomes.
The State Video Contacts Form includes
19 items about the dissemination
activities of the State’s video, including:
• Time when they disseminated the
video.
• Methods of dissemination.
• Number of people who viewed the
video.
• Number of DVDs and videotapes
requested.
• Effectiveness of the dissemination
methods.
• Factors that contributed to the
effectiveness of dissemination.
• Effect of TA received.
• Effect of the video in raising
awareness about underage drinking
prevention successes in the State.
• Effect of the video in raising
awareness about underage drinking
prevention challenges in the State.
• Effectiveness of the video in
presenting State’s/Territory’s prevention
activities.
• Feedback received.
• Unintended positive outcomes.
• Effect of TA in improving the
capacity to provide effective prevention
services.
After the State points of contact have
completed the State Video Contacts
Form online, they will be requested to
update dissemination activities online if
there have been any changes during the
past 6 months. This form includes seven
items, including:
• If there have been changes in
dissemination during the past 6 months.
• Most recent dissemination numbers
by method.
• Facilitation factors.
• Additional feedback.
• Additional unintended positive
outcomes.
Data will also be collected from
viewers of the State videos. Each State
video will include instructions to
viewers on how to access the Video
Viewers Form. The instructions may be
a unique URL, or they may consist of
instructions on each State’s Web site on
underage drinking prevention. This
information will allow the CSAP to
provide feedback to the States on their
video and to measure the effectiveness
of their video. The Video Viewers Form
includes 24 items about the video,
including:
E:\FR\FM\04OCN1.SGM
04OCN1
61148
Federal Register / Vol. 75, No. 191 / Monday, October 4, 2010 / Notices
• When and where they viewed the
video.
• Whom they recommended to view
the video.
• What they learned from watching
the video.
• What actions they may take because
of the video.
• Whether they plan to change
behaviors and knowledge about their
State’s activities.
The process assessment of the State
videos will be conducted using
telephone interviews with the State
points of contact. This interview should
take 10 minutes (0.167 hours). The
short form, and submit it electronically.
The burden estimate is based on
comments from several potential
respondents who completed the online
form, submitted it, and provided
feedback on how long it would take
them to complete it. The respondents
will be employees of the State.
A short survey will also be used to
collect data from viewers of the State
videos. An estimated 1,000 viewers will
voluntarily choose to complete this
online survey, which will take 10
minutes (0.167 hours) to review,
complete, and submit. The viewers are
expected to represent the general public.
outcome assessment of the State videos
will be collected using an online form
that will be completed by no more than
26 respondents and will require only 1
response per respondent. It will take an
average of 10 minutes (0.167 hours) to
review the instructions, complete the
form, and submit it electronically.
Dissemination updates will be
requested from each State point of
contact every 6 months if there have
been changes during that time period.
These updates will be submitted
electronically, and it should take
approximately 5 minutes (0.083 hours)
to review the instructions, complete the
Responses
per
respondent
Number of
respondents
Form name
Burden per
response
(hrs.)
Total burden
Process Interview ............................................................................................
Dissemination Outcome ...................................................................................
Dissemination Updates ....................................................................................
Viewers Survey ................................................................................................
26
26
26
1,000
1
1
1
1
0.167
0.167
0.083
0.167
4.34
4.34
2.16
167
Total ..........................................................................................................
1,078
........................
........................
177.84
Written comments and
recommendations concerning the
proposed information collection should
be sent by November 3, 2010 to:
SAMHSA Desk Officer, Human
Resources and Housing Branch, Office
of Management and Budget, New
Executive Office Building, Room 10235,
Washington, DC 20503; due to potential
delays in OMB’s receipt and processing
of mail sent through the U.S. Postal
Service, respondents are encouraged to
submit comments by fax to: 202–395–
5806.
Dated: September 28, 2010.
Elaine Parry
Director, Office of Management Technology
and Operations.
[FR Doc. 2010–24849 Filed 10–1–10; 8:45 am]
BILLING CODE 4162–20–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
jlentini on DSKJ8SOYB1PROD with NOTICES
[Docket No. FDA–2004–N–0451] (formerly
Docket No. 2004N–0226)
Food and Drug Administration
Modernization Act of 1997:
Modifications to the List of Recognized
Standards, Recognition List Number:
025
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
VerDate Mar<15>2010
17:23 Oct 01, 2010
Jkt 223001
The Food and Drug
Administration (FDA) is announcing a
publication containing modifications
the Agency is making to the list of
standards FDA recognizes for use in
premarket reviews (FDA recognized
consensus standards). This publication,
entitled ‘‘Modifications to the List of
Recognized Standards, Recognition List
Number: 025’’ (Recognition List
Number: 025), will assist manufacturers
who elect to declare conformity with
consensus standards to meet certain
requirements for medical devices.
DATES: Submit either electronic or
written comments concerning this
document at any time. See section VII
of this document for the effective date
of the recognition of standards
announced in this document.
ADDRESSES: Submit written requests for
single copies of ‘‘Modifications to the
List of Recognized Standards,
Recognition List Number: 025’’ to the
Division of Small Manufacturers,
International, and Consumer Assistance,
Center for Devices and Radiological
Health, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 66,
Silver Spring, MD 20993–0002. Send
two self-addressed adhesive labels to
assist that office in processing your
requests, or fax your request to 301–
847–8149. Submit written comments
concerning this document, or
recommendations for additional
standards for recognition, to the contact
person (see FOR FURTHER INFORMATION
CONTACT). Submit electronic comments
by email: standards@cdrh.fda.gov. This
SUMMARY:
PO 00000
Frm 00030
Fmt 4703
Sfmt 4703
document may also be accessed on
FDA’s Internet site at https://
www.fda.gov/MedicalDevices/
DeviceRegulationandGuidance/
Standards/ucm123792.htm. See section
VI of this document for electronic access
to the searchable database for the
current list of FDA recognized
consensus standards, including
Recognition List Number: 025
modifications and other standards
related information.
FOR FURTHER INFORMATION CONTACT:
Carol L. Herman, Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, rm. 3632, Silver Spring,
MD 20993–0002, 301–796–6574.
SUPPLEMENTARY INFORMATION:
I. Background
Section 204 of the Food and Drug
Administration Modernization Act of
1997 (FDAMA) (Public Law 105–115)
amended section 514 of the Federal
Food, Drug, and Cosmetic Act (the act)
(21 U.S.C. 360d). Amended section 514
allows FDA to recognize consensus
standards developed by international
and national organizations for use in
satisfying portions of device premarket
review submissions or other
requirements.
In a notice published in the Federal
Register of February 25, 1998 (63 FR
9561), FDA announced the availability
of a guidance entitled ‘‘Recognition and
Use of Consensus Standards.’’ The
notice described how FDA would
implement its standard recognition
E:\FR\FM\04OCN1.SGM
04OCN1
]]>Agencies
[Federal Register Volume 75, Number 191 (Monday, October 4, 2010)]
[Notices]
[Pages 61147-61148]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-24849]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Substance Abuse and Mental Health Services Administration
Agency Information Collection Activities: Submission for OMB
Review; Comment Request
Periodically, the Substance Abuse and Mental Health Services
Administration (SAMHSA) will publish a summary of information
collection requests under OMB review, in compliance with the Paperwork
Reduction Act (44 U.S.C. Chapter 35). To request a copy of these
documents, call the SAMHSA Reports Clearance Officer on (240) 276-1243.
Project: Assessment of the Underage Drinking Prevention Education
Initiatives State Videos Project--New
The Substance Abuse and Mental Health Services Administration's
Center for Substance Abuse Prevention (CSAP) is requesting Office of
Management and Budget (OMB) approval of three new data collection
instruments--
State Video Contacts Form.
Video Viewers Form.
Dissemination Update Online Form.
This new information collection is for the assessment of the 2010-
2013 Underage Drinking Prevention Education Initiatives State Videos
project. In 2007, four States participated in a pilot study to produce
videos on the topic of underage drinking prevention. Based upon the
success of those videos, 10 additional States and 1 Territory were
provided funds to produce videos in 2009. Contingent on available
funds, CSAP hopes to invite approximately 10 States/Territories per
year to produce their own videos.
Over the next 4 years, CSAP will conduct a process and outcome
assessment of this project. The process assessment will focus on the
experiences associated with planning and producing the State videos.
The outcome assessment will examine the effectiveness of the State
Videos project in meeting the core project objectives and will capture
the State's dissemination efforts. The process and outcome assessments
will encompass State videos that will be produced in 2010-2013 and
those that were produced in 2007 and 2009. State contacts will be asked
to update their dissemination information online if there have been
changes in these figures during the previous 6 months, up through 2013.
Additionally, data will be collected from viewers of the State videos
using an online survey.
The information will be collected from the primary contact employee
designated by the States that have agreed to participate in the
production of a video for the State Videos project. The viewers'
information will be collected from those who voluntarily decide to
complete a short survey after seeing the video.
SAMHSA/CSAP intends to support annual videos on State underage
drinking prevention videos. The information collected will be used by
CSAP to help plan for these annual video productions and provide
technical assistance to the participating States. The collected
information will also provide a descriptive picture of the initiative,
indicate how the videos have been received, and highlight some factors
that may be associated with successful dissemination outcomes.
The information needs to be obtained using a combination of initial
telephone interviews to collect process data, followed by online forms
to collect outcome and dissemination data. A survey of viewers,
collected online, will also be used to assess the effectiveness of the
State videos in increasing awareness of the underage drinking
prevention activities in these States. This information collection is
being implemented under authority of Section 501(d)(4) of the Public
Health Service Act (42 U.S.C. 290aa).
State staff members will be contacted once the video has been
finalized. These State staff members will be asked to complete a short
telephone interview that asks questions about the process of producing
the State video. The State Video Contacts Form includes nine items
about the State video, including:
State's objectives for the video on underage drinking
prevention.
Targeted audiences.
Satisfaction with technical assistance (TA) received.
Usefulness of preplanning materials.
Helpfulness of TA during different phases of production.
Recommendations for improving the process.
Recommendations for improving the content of the video.
Advice to other States interested in producing a video.
If the State has disseminated the video at the time of the initial
telephone interview, then they will also be asked to complete the
second part of the State Video Contacts Form, which collects
information on dissemination outcomes. The State Video Contacts Form
includes 19 items about the dissemination activities of the State's
video, including:
Time when they disseminated the video.
Methods of dissemination.
Number of people who viewed the video.
Number of DVDs and videotapes requested.
Effectiveness of the dissemination methods.
Factors that contributed to the effectiveness of
dissemination.
Effect of TA received.
Effect of the video in raising awareness about underage
drinking prevention successes in the State.
Effect of the video in raising awareness about underage
drinking prevention challenges in the State.
Effectiveness of the video in presenting State's/
Territory's prevention activities.
Feedback received.
Unintended positive outcomes.
Effect of TA in improving the capacity to provide
effective prevention services.
After the State points of contact have completed the State Video
Contacts Form online, they will be requested to update dissemination
activities online if there have been any changes during the past 6
months. This form includes seven items, including:
If there have been changes in dissemination during the
past 6 months.
Most recent dissemination numbers by method.
Facilitation factors.
Additional feedback.
Additional unintended positive outcomes.
Data will also be collected from viewers of the State videos. Each
State video will include instructions to viewers on how to access the
Video Viewers Form. The instructions may be a unique URL, or they may
consist of instructions on each State's Web site on underage drinking
prevention. This information will allow the CSAP to provide feedback to
the States on their video and to measure the effectiveness of their
video. The Video Viewers Form includes 24 items about the video,
including:
[[Page 61148]]
When and where they viewed the video.
Whom they recommended to view the video.
What they learned from watching the video.
What actions they may take because of the video.
Whether they plan to change behaviors and knowledge about
their State's activities.
The process assessment of the State videos will be conducted using
telephone interviews with the State points of contact. This interview
should take 10 minutes (0.167 hours). The outcome assessment of the
State videos will be collected using an online form that will be
completed by no more than 26 respondents and will require only 1
response per respondent. It will take an average of 10 minutes (0.167
hours) to review the instructions, complete the form, and submit it
electronically.
Dissemination updates will be requested from each State point of
contact every 6 months if there have been changes during that time
period. These updates will be submitted electronically, and it should
take approximately 5 minutes (0.083 hours) to review the instructions,
complete the short form, and submit it electronically. The burden
estimate is based on comments from several potential respondents who
completed the online form, submitted it, and provided feedback on how
long it would take them to complete it. The respondents will be
employees of the State.
A short survey will also be used to collect data from viewers of
the State videos. An estimated 1,000 viewers will voluntarily choose to
complete this online survey, which will take 10 minutes (0.167 hours)
to review, complete, and submit. The viewers are expected to represent
the general public.
----------------------------------------------------------------------------------------------------------------
Burden per
Form name Number of Responses per response Total burden
respondents respondent (hrs.)
----------------------------------------------------------------------------------------------------------------
Process Interview............................... 26 1 0.167 4.34
Dissemination Outcome........................... 26 1 0.167 4.34
Dissemination Updates........................... 26 1 0.083 2.16
Viewers Survey.................................. 1,000 1 0.167 167
�������������������������������������������������
Total....................................... 1,078 .............. .............. 177.84
----------------------------------------------------------------------------------------------------------------
Written comments and recommendations concerning the proposed
information collection should be sent by November 3, 2010 to: SAMHSA
Desk Officer, Human Resources and Housing Branch, Office of Management
and Budget, New Executive Office Building, Room 10235, Washington, DC
20503; due to potential delays in OMB's receipt and processing of mail
sent through the U.S. Postal Service, respondents are encouraged to
submit comments by fax to: 202-395-5806.
Dated: September 28, 2010.
Elaine Parry
Director, Office of Management Technology and Operations.
[FR Doc. 2010-24849 Filed 10-1-10; 8:45 am]
BILLING CODE 4162-20-P
