Agency Forms Undergoing Paperwork Reduction Act Review, 8962-8963 [2016-03687]
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8962
Federal Register / Vol. 81, No. 35 / Tuesday, February 23, 2016 / Notices
Privacy Act, see https://www.ftc.gov/ftc/
privacy.htm.
David C. Shonka,
Principal Deputy General Counsel.
[FR Doc. 2016–03718 Filed 2–22–16; 8:45 am]
BILLING CODE 6750–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[30Day–16–16OJ]
mstockstill on DSK4VPTVN1PROD with NOTICES
Agency Forms Undergoing Paperwork
Reduction Act Review
The Centers for Disease Control and
Prevention (CDC) has submitted the
following information collection request
to the Office of Management and Budget
(OMB) for review and approval in
accordance with the Paperwork
Reduction Act of 1995. The notice for
the proposed information collection is
published to obtain comments from the
public and affected agencies.
Written comments and suggestions
from the public and affected agencies
concerning the proposed collection of
information are encouraged. Your
comments should address any of the
following: (a) Evaluate whether the
proposed collection of information is
necessary for the proper performance of
the functions of the agency, including
whether the information will have
practical utility; (b) Evaluate the
accuracy of the agencies estimate of the
burden of the proposed collection of
information, including the validity of
the methodology and assumptions used;
(c) Enhance the quality, utility, and
clarity of the information to be
collected; (d) Minimize the burden of
the collection of information on those
who are to respond, including through
the use of appropriate automated,
electronic, mechanical, or other
technological collection techniques or
other forms of information technology,
e.g., permitting electronic submission of
responses; and (e) Assess information
collection costs.
To request additional information on
the proposed project or to obtain a copy
of the information collection plan and
instruments, call (404) 639–7570 or
send an email to omb@cdc.gov. Written
comments and/or suggestions regarding
the items contained in this notice
should be directed to the Attention:
CDC Desk Officer, Office of Management
and Budget, Washington, DC 20503 or
by fax to (202) 395–5806. Written
comments should be received within 30
days of this notice.
VerDate Sep<11>2014
17:06 Feb 22, 2016
Jkt 238001
Proposed Project
The Girl Power Project Efficacy
Trial—New—National Center for
Chronic Disease Prevention and Health
Promotion (NCCDPHP), Centers for
Disease Control and Prevention (CDC).
The 60-day Federal Register Notice,
published on August 12, 2015, was
titled ‘‘Efficacy Study of a Mobile
Application to Provide Comprehensive
and Medically Accurate Sexual Health
Information for Adolescent Girls.’’ On
January 19, 2016, a 30-day Federal
Register Notice was published under
the revised title ‘‘The Girl Power Project
Efficacy Trial.’’ The burden table in the
30-day Notice was incorrect due to
omission of information collection
conducted to screen potential study
participants for eligibility. This Notice
corrects the error and provides an
updated estimate of total burden to
respondents.
Background and Brief Description
Despite drastic reductions in teen
births across all racial and ethnic
groups, Black and Latino girls continue
to have disproportionately high rates of
teen births. Increasing girls’ access to
medically accurate and comprehensive
sexual health information is the first
step in sustaining momentum in teen
pregnancy reduction among all racial
and ethnic groups, and in promoting
healthy sexual behaviors, especially
among minority girls.
CDC plans to collect the information
needed to test the efficacy of a
comprehensive and medically accurate
mobile application, titled Crush, in
increasing adolescent girls’
contraception use and clinic visitation
for sexual and reproductive health
services. The information disseminated
via Crush is similar to the sexual health
information youth can access via other
Web sites, sexual health promotion
educational materials or in clinics.
The study will randomize a sample of
1,200 girls, ages 14–18 years, into two
groups: the intervention group and the
control group. The intervention group
will have access to Crush and will
receive weekly sexual health
information via text to their phones for
six months. The control group will have
access to a fitness mobile application
(‘‘app’’) and will receive general health
information via text to their phones for
six months. Participants are expected to
access either app frequently throughout
a six month period. As part of the
analysis, sexual behavior and key
psychosocial factors will be assessed at
three points in time: at baseline, and at
three- and six-month follow-ups.
Efficacy testing will respond to the
following research questions:
PO 00000
Frm 00068
Fmt 4703
Sfmt 4703
1. Does exposure to Crush increase
consistent contraception use among
participants?
2. Does exposure to Crush increase
clinic utilization rate among
participants?
3. Is media content more attractive to
participants than text-based content?
For research questions 1 and 2, we
hypothesize that participants in the
intervention group will report increased
intent to use effective contraception and
utilize clinic services at three and six
months post-intervention.
The study will also include a usability
testing component to identify the
content and features of Crush that are
most attractive to participants, the
frequency in which Crush was used,
and the navigation patterns within
Crush. Participants will create an
account in the Enrollment Database.
This database will host participants’
enrollment information, basic
demographic information, and will also
track their navigation pattern to monitor
Crush visitation frequency and visit
duration. Navigation data will be used
to assess intervention exposure and
dosage to specific content areas of
Crush. To test real-world utilization of
Crush, control group participants will
gain access to Crush six months after
enrolling into the study, but will not
receive weekly text messages. The study
will track visitation frequency and
duration of each visit. Usability testing
will respond to Research Question #3.
We hypothesize that participants in the
intervention group will spend more
time using media features than textbased content.
All information will be collected
electronically. This study will collect
data through two mechanisms: (1) Selfadministered online surveys, and (2) the
Crush enrollment database. Interested
participants will initially complete
screening questions to confirm their
eligibility. CDC estimates that 3,000
respondents will be screened in order to
reach the target number of 1,200
enrolled study participants. Information
collection for enrolled participants
consists of three self-administered
online surveys at conduct at baseline,
three months after baseline, and six
months after baseline. Survey questions
will assess behavior, attitudes, social
norms about sexual behavior,
contraception use and clinic utilization,
and satisfaction with Crush.
The mobile response surveys will be
sent to participants via text message
which they can complete on a
smartphone. The estimated burden per
response is 5–15 minutes. Survey
responses will be matched by each
participant’s unique identifying
E:\FR\FM\23FEN1.SGM
23FEN1
8963
Federal Register / Vol. 81, No. 35 / Tuesday, February 23, 2016 / Notices
number. Each participant will receive
up to two survey reminders starting one
week after the initial survey link is sent,
for two consecutive weeks. There are
minor differences in survey content for
the control and intervention groups.
Each participant will create a profile
in the database upon enrollment. This
database will collect initial
demographic and contact information,
informed consent signatures, and
information about the participant’s
navigation pattern through Crush. Any
information entered directly into Crush
interactive features will not be stored in
the system. The database only collects
web analytics data about page visits and
duration of each visit by User
Identification (ID) and Internet Protocol
(IP) address. Web analytics will only be
collected from participants navigating
Crush and only when they are logged in
as users. Web analytics are generated for
any Web site and are a standard
evaluation mechanism for assessing the
traffic patterns on Web pages. This
technology permits development of an
objective and quantifiable measure that
tracks and records participants’
exposure to Crush. This study
component does not entail any response
burden to participants.
Findings will be used to inform the
development and delivery of effective
health communications.
OMB approval is requested for one
year. Participation is voluntary and
there are no costs to respondents other
than their time. The total estimated
annualized burden hours are 802.
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
Type of respondents
Form name
Girls 14–18 years old ......................................
Screener Questions .......................................
Enrollment Questions .....................................
Baseline Survey .............................................
3-Month Survey ..............................................
6-Month Survey ..............................................
Baseline Survey .............................................
3-Month Survey ..............................................
6-Month Survey ..............................................
Intervention Group ..........................................
Control Group .................................................
Leroy A. Richardson,
Chief, Information Collection Review Office,
Office of Scientific Integrity, Office of the
Associate Director for Science, Office of the
Director, Centers for Disease Control and
Prevention.
[FR Doc. 2016–03687 Filed 2–22–16; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[CMS–1637–N]
Medicare Program; Public Meetings in
Calendar Year 2016 for All New Public
Requests for Revisions to the
Healthcare Common Procedure Coding
System (HCPCS) Coding and Payment
Determinations
Centers for Medicare &
Medicaid Services (CMS), HHS.
ACTION: Notice.
AGENCY:
This notice announces the
dates, time, and location of the
Healthcare Common Procedure Coding
System (HCPCS) public meetings to be
held in calendar year 2016 to discuss
our preliminary coding and payment
determinations for all new public
requests for revisions to the HCPCS.
These meetings provide a forum for
interested parties to make oral
presentations or to submit written
comments in response to preliminary
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SUMMARY:
VerDate Sep<11>2014
17:06 Feb 22, 2016
Jkt 238001
coding and payment determinations.
The discussion will be focused on
responses to our specific preliminary
recommendations and will include all
items on the public meeting agenda. As
indicated in this notice, we are
reorganizing public meeting content
under two main headings: (1) Drugs/
Biologics, Radiopharmaceuticals/
Radiologic Imaging Agents, and (2)
Durable Medical Equipment (DME) and
Accessories; Orthotics and Prosthetics
(O & P); Supplies and Other.
DATES: Meeting Dates: The following are
the 2016 HCPCS public meeting dates:
1. Tuesday, May 17, 2016, 9:00 a.m.
to 5:00 p.m., eastern daylight time
(e.d.t.) (Drugs/Biologicals,
Radiopharmaceuticals/Radiologic
Imaging Agents).
2. Wednesday, May 18, 2016, 9:00
a.m. to 5:00 p.m., e.d.t. (Drugs/
Biologicals, Radiopharmaceuticals/
Radiologic Imaging Agents).
3. Thursday, May 19, 2016, 9:00 a.m.
to 5:00 p.m., e.d.t. (Drugs/Biologicals,
Radiopharmaceuticals/Radiologic
Imaging Agents).
4. Wednesday, June 1, 2016, 9:00 a.m.
to 5:00 p.m., e.d.t. (Durable Medical
Equipment (DME) and Accessories;
Orthotics and Prosthetics (O & P);
Supplies and Other).
5. Thursday, June 2, 2016, 9:00 a.m.
to 5:00 p.m., e.d.t. (Durable Medical
Equipment (DME) and Accessories;
Orthotics and Prosthetics (O & P);
Supplies and Other).
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Fmt 4703
Sfmt 4703
3,000
1,200
600
480
384
600
480
384
Number of
responses per
respondent
1
1
1
1
1
1
1
1
Avg. burden
per response
(in hrs.)
1/60
5/60
15/60
10/60
15/60
15/60
10/60
15/60
Deadlines for Primary Speaker
Registration and Presentation Materials:
The deadline for registering to be a
primary speaker and submitting
materials and writings that will be used
in support of an oral presentation are as
follows:
• May 3, 2016 for the May 17, 2016,
May 18, 2016 and May 19, 2016 public
meetings.
• May 18, 2016 for the June 1, 2016
and June 2, 2016 public meetings.
Registration Deadline for Attendees
that are Foreign Nationals: All Foreign
National visitors must present a valid
passport as proof of identification.
Attendees that are foreign nationals (as
described in section IV. of this notice)
are required to identify themselves as
such, and provide the necessary
information for security clearance (as
described in section IV. of this notice)
to the public meeting coordinator at
least 21 business days in advance of the
date of the public meeting the
individual plans to attend. Therefore,
the registration deadlines for attendees
that are foreign nationals are as follows:
• April 28, 2016 for the May 17, 2016,
May 18, 2016 and May 19, 2016 public
meetings.
• May 12, 2016 for the June 1, 2016
and June 2, 2016 public meetings.
Registration Deadlines for all Other
Attendees: All individuals who are not
foreign nationals who plan to enter the
building to attend the public meeting
must register for each date that they
plan on attending. The registration
E:\FR\FM\23FEN1.SGM
23FEN1
]]>Agencies
[Federal Register Volume 81, Number 35 (Tuesday, February 23, 2016)]
[Notices]
[Pages 8962-8963]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-03687]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[30Day-16-16OJ]
Agency Forms Undergoing Paperwork Reduction Act Review
The Centers for Disease Control and Prevention (CDC) has submitted
the following information collection request to the Office of
Management and Budget (OMB) for review and approval in accordance with
the Paperwork Reduction Act of 1995. The notice for the proposed
information collection is published to obtain comments from the public
and affected agencies.
Written comments and suggestions from the public and affected
agencies concerning the proposed collection of information are
encouraged. Your comments should address any of the following: (a)
Evaluate whether the proposed collection of information is necessary
for the proper performance of the functions of the agency, including
whether the information will have practical utility; (b) Evaluate the
accuracy of the agencies estimate of the burden of the proposed
collection of information, including the validity of the methodology
and assumptions used; (c) Enhance the quality, utility, and clarity of
the information to be collected; (d) Minimize the burden of the
collection of information on those who are to respond, including
through the use of appropriate automated, electronic, mechanical, or
other technological collection techniques or other forms of information
technology, e.g., permitting electronic submission of responses; and
(e) Assess information collection costs.
To request additional information on the proposed project or to
obtain a copy of the information collection plan and instruments, call
(404) 639-7570 or send an email to omb@cdc.gov. Written comments and/or
suggestions regarding the items contained in this notice should be
directed to the Attention: CDC Desk Officer, Office of Management and
Budget, Washington, DC 20503 or by fax to (202) 395-5806. Written
comments should be received within 30 days of this notice.
Proposed Project
The Girl Power Project Efficacy Trial--New--National Center for
Chronic Disease Prevention and Health Promotion (NCCDPHP), Centers for
Disease Control and Prevention (CDC).
The 60-day Federal Register Notice, published on August 12, 2015,
was titled ``Efficacy Study of a Mobile Application to Provide
Comprehensive and Medically Accurate Sexual Health Information for
Adolescent Girls.'' On January 19, 2016, a 30-day Federal Register
Notice was published under the revised title ``The Girl Power Project
Efficacy Trial.'' The burden table in the 30-day Notice was incorrect
due to omission of information collection conducted to screen potential
study participants for eligibility. This Notice corrects the error and
provides an updated estimate of total burden to respondents.
Background and Brief Description
Despite drastic reductions in teen births across all racial and
ethnic groups, Black and Latino girls continue to have
disproportionately high rates of teen births. Increasing girls' access
to medically accurate and comprehensive sexual health information is
the first step in sustaining momentum in teen pregnancy reduction among
all racial and ethnic groups, and in promoting healthy sexual
behaviors, especially among minority girls.
CDC plans to collect the information needed to test the efficacy of
a comprehensive and medically accurate mobile application, titled
Crush, in increasing adolescent girls' contraception use and clinic
visitation for sexual and reproductive health services. The information
disseminated via Crush is similar to the sexual health information
youth can access via other Web sites, sexual health promotion
educational materials or in clinics.
The study will randomize a sample of 1,200 girls, ages 14-18 years,
into two groups: the intervention group and the control group. The
intervention group will have access to Crush and will receive weekly
sexual health information via text to their phones for six months. The
control group will have access to a fitness mobile application
(``app'') and will receive general health information via text to their
phones for six months. Participants are expected to access either app
frequently throughout a six month period. As part of the analysis,
sexual behavior and key psychosocial factors will be assessed at three
points in time: at baseline, and at three- and six-month follow-ups.
Efficacy testing will respond to the following research questions:
1. Does exposure to Crush increase consistent contraception use
among participants?
2. Does exposure to Crush increase clinic utilization rate among
participants?
3. Is media content more attractive to participants than text-based
content?
For research questions 1 and 2, we hypothesize that participants in
the intervention group will report increased intent to use effective
contraception and utilize clinic services at three and six months post-
intervention.
The study will also include a usability testing component to
identify the content and features of Crush that are most attractive to
participants, the frequency in which Crush was used, and the navigation
patterns within Crush. Participants will create an account in the
Enrollment Database. This database will host participants' enrollment
information, basic demographic information, and will also track their
navigation pattern to monitor Crush visitation frequency and visit
duration. Navigation data will be used to assess intervention exposure
and dosage to specific content areas of Crush. To test real-world
utilization of Crush, control group participants will gain access to
Crush six months after enrolling into the study, but will not receive
weekly text messages. The study will track visitation frequency and
duration of each visit. Usability testing will respond to Research
Question #3. We hypothesize that participants in the intervention group
will spend more time using media features than text-based content.
All information will be collected electronically. This study will
collect data through two mechanisms: (1) Self-administered online
surveys, and (2) the Crush enrollment database. Interested participants
will initially complete screening questions to confirm their
eligibility. CDC estimates that 3,000 respondents will be screened in
order to reach the target number of 1,200 enrolled study participants.
Information collection for enrolled participants consists of three
self-administered online surveys at conduct at baseline, three months
after baseline, and six months after baseline. Survey questions will
assess behavior, attitudes, social norms about sexual behavior,
contraception use and clinic utilization, and satisfaction with Crush.
The mobile response surveys will be sent to participants via text
message which they can complete on a smartphone. The estimated burden
per response is 5-15 minutes. Survey responses will be matched by each
participant's unique identifying
[[Page 8963]]
number. Each participant will receive up to two survey reminders
starting one week after the initial survey link is sent, for two
consecutive weeks. There are minor differences in survey content for
the control and intervention groups.
Each participant will create a profile in the database upon
enrollment. This database will collect initial demographic and contact
information, informed consent signatures, and information about the
participant's navigation pattern through Crush. Any information entered
directly into Crush interactive features will not be stored in the
system. The database only collects web analytics data about page visits
and duration of each visit by User Identification (ID) and Internet
Protocol (IP) address. Web analytics will only be collected from
participants navigating Crush and only when they are logged in as
users. Web analytics are generated for any Web site and are a standard
evaluation mechanism for assessing the traffic patterns on Web pages.
This technology permits development of an objective and quantifiable
measure that tracks and records participants' exposure to Crush. This
study component does not entail any response burden to participants.
Findings will be used to inform the development and delivery of
effective health communications.
OMB approval is requested for one year. Participation is voluntary
and there are no costs to respondents other than their time. The total
estimated annualized burden hours are 802.
Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Number of Avg. burden
Type of respondents Form name Number of responses per per response
respondents respondent (in hrs.)
----------------------------------------------------------------------------------------------------------------
Girls 14-18 years old................. Screener Questions...... 3,000 1 1/60
Enrollment Questions.... 1,200 1 5/60
Intervention Group.................... Baseline Survey......... 600 1 15/60
3-Month Survey.......... 480 1 10/60
6-Month Survey.......... 384 1 15/60
Control Group......................... Baseline Survey......... 600 1 15/60
3-Month Survey.......... 480 1 10/60
6-Month Survey.......... 384 1 15/60
----------------------------------------------------------------------------------------------------------------
Leroy A. Richardson,
Chief, Information Collection Review Office, Office of Scientific
Integrity, Office of the Associate Director for Science, Office of the
Director, Centers for Disease Control and Prevention.
[FR Doc. 2016-03687 Filed 2-22-16; 8:45 am]
BILLING CODE 4163-18-P
