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The Girl Power Project Efficacy Trial

30d FRN

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8962

Federal Register / Vol. 81, No. 35 / Tuesday, February 23, 2016 / Notices

Privacy Act, see http://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]

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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 [email protected]. 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.

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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:

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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

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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
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

SUMMARY:

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Number of
respondents

Type of respondents

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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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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

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