[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]


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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 [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.

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
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                                                                                     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
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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