[Federal Register Volume 80, Number 156 (Thursday, August 13, 2015)]
[Notices]
[Pages 48534-48536]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-19860]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60Day-15-15BBU]; [Docket No. CDC-2015-0069]


Proposed Data Collection Submitted for Public Comment and 
Recommendations

AGENCY: Centers for Disease Control and Prevention (CDC), Department of 
Health and Human Services (HHS).

ACTION: Notice with comment period.

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SUMMARY: The Centers for Disease Control and Prevention (CDC), as part 
of its continuing efforts to reduce public burden and maximize the 
utility of government information, invites the general public and other 
Federal agencies to take this opportunity to

[[Page 48535]]

comment on proposed and/or continuing information collections, as 
required by the Paperwork Reduction Act of 1995. This notice invites 
comment on a proposed information collection request entitled 
``Efficacy Study of a Mobile Application to Provide Comprehensive and 
Medically Accurate Sexual Health Information for Adolescent Girls''. 
The study will examine the efficacy of the mobile application in 
achieving two behavioral outcomes: Use of effective contraception and 
clinic utilization.

DATES: Written comments must be received on or before October 13, 2015.

ADDRESSES: You may submit comments, identified by Docket No. CDC-2015-
0069 by any of the following methods:
    Federal eRulemaking Portal: Regulation.gov. Follow the instructions 
for submitting comments.
    Mail: Leroy A. Richardson, Information Collection Review Office, 
Centers for Disease Control and Prevention, 1600 Clifton Road, NE., MS-
D74, Atlanta, Georgia 30329.
    Instructions: All submissions received must include the agency name 
and Docket Number. All relevant comments received will be posted 
without change to Regulations.gov, including any personal information 
provided. For access to the docket to read background documents or 
comments received, go to Regulations.gov.

    Please note:  All public comment should be submitted through the 
Federal eRulemaking portal (Regulations.gov) or by U.S. mail to the 
address listed above.


FOR FURTHER INFORMATION CONTACT: To request more information on the 
proposed project or to obtain a copy of the information collection plan 
and instruments, contact the Information Collection Review Office, 
Centers for Disease Control and Prevention, 1600 Clifton Road, NE., MS-
D74, Atlanta, Georgia 30329; phone: 404-639-7570; Email: [email protected].

SUPPLEMENTARY INFORMATION: Under the Paperwork Reduction Act of 1995 
(PRA) (44 U.S.C. 3501-3520), Federal agencies must obtain approval from 
the Office of Management and Budget (OMB) for each collection of 
information they conduct or sponsor. In addition, the PRA also requires 
Federal agencies to provide a 60-day notice in the Federal Register 
concerning each proposed collection of information, including each new 
proposed collection, each proposed extension of existing collection of 
information, and each reinstatement of previously approved information 
collection before submitting the collection to OMB for approval. To 
comply with this requirement, we are publishing this notice of a 
proposed data collection as described below.
    Comments are invited on: (a) Whether the proposed collection of 
information is necessary for the proper performance of the functions of 
the agency, including whether the information shall have practical 
utility; (b) the accuracy of the agency's estimate of the burden of the 
proposed collection of information; (c) ways to enhance the quality, 
utility, and clarity of the information to be collected; (d) ways to 
minimize the burden of the collection of information on respondents, 
including through the use of automated collection techniques or other 
forms of information technology; and (e) estimates of capital or start-
up costs and costs of operation, maintenance, and purchase of services 
to provide information. Burden means the total time, effort, or 
financial resources expended by persons to generate, maintain, retain, 
disclose or provide information to or for a Federal agency. This 
includes the time needed to review instructions; to develop, acquire, 
install and utilize technology and systems for the purpose of 
collecting, validating and verifying information, processing and 
maintaining information, and disclosing and providing information; to 
train personnel and to be able to respond to a collection of 
information, to search data sources, to complete and review the 
collection of information; and to transmit or otherwise disclose the 
information.

Proposed Project

    Efficacy Study of a Mobile Application to Provide Comprehensive and 
Medically Accurate Sexual Health Information for Adolescent Girls--
New--National Center for Chronic Disease Prevention and Health 
Promotion (NCCDPHP), Centers for Disease Control and Prevention (CDC).

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, 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 the 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 three 
points in time: At baseline, and at three- and six-month follow-ups.
    Efficacy testing will respond to the following research questions: 
Research Question #1 is: Does exposure to Crush increase consistent 
contraception use among participants? We hypothesize that participants 
in the intervention group will report increased intent to use effective 
contraception at three and six months post-intervention. Research 
Question #2 is: Does exposure to Crush increase clinic utilization rate 
among participants? We hypothesize that participants in the 
intervention group will report higher rates of intent to 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: Is media content more attractive to participants? We 
hypothesize that participants in the intervention group

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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. Participants will 
complete a total of three self-administered online surveys at baseline, 
three and six month follow-up. Survey questions will assess behavior, 
attitudes, social norms about sexual behavior, contraception 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 13-20 minutes. Survey responses will be matched by each 
participant's unique identifying 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 
visited and duration of each visit by User ID and IP address. 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.

                                        Estimated Annualized Burden Hours
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                                                                                      Average
                                                     Number of       Number of      burden per     Total burden
      Type of respondent            Form name       respondents    responses per   response (in      (in hrs.)
                                                                    respondent         hrs.)
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Girls Ages 14-18 Years........  Enrollment......           1,200               1            5/60             100
                                Consent.........           1,200               1            5/60             100
Control Group.................  Baseline Survey.             600               1           13/60             130
                                3-Month Follow-              600               1           20/60             200
                                 up Survey.
                                6-Month Follow-              600               1           20/60             200
                                 up Survey.
Intervention Group............  Baseline Survey.             600               1              13             130
                                3-Month Follow-              600               1              20             200
                                 up Survey.
                                6-Month Follow-              600               1              20             200
                                 up Survey.
                                                 ---------------------------------------------------------------
    Total.....................  ................  ..............  ..............  ..............           1,260
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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. 2015-19860 Filed 8-12-15; 8:45 am]
BILLING CODE 4163-18-P