81 FR 8962 - Agency Forms Undergoing Paperwork Reduction Act Review
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention Federal Register Volume 81, Issue 35 (February 23, 2016)
Centers for Disease Control and Prevention
Federal Register Volume 81, Issue 35 (February 23, 2016)
| Page Range | 8962-8963 | |
| FR Document | 2016-03687 |
[Federal Register Volume 81, Number 35 (Tuesday, February 23, 2016)] [Notices] [Pages 8962-8963] From the Federal Register Online [www.thefederalregister.org] [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 [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 ---------------------------------------------------------------------------------------------------------------- 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
![8962 Federal Register / Vol. 81, No. 35 / Tuesday, February 23, 2016 / Notices
Privacy Act, see http://www.ftc.gov/ftc/ Proposed Project 1. Does exposure to Crush increase
privacy.htm. The Girl Power Project Efficacy consistent contraception use among
Trial—New—National Center for participants?
David C. Shonka,
Chronic Disease Prevention and Health 2. Does exposure to Crush increase
Principal Deputy General Counsel. clinic utilization rate among
[FR Doc. 2016–03718 Filed 2–22–16; 8:45 am]
Promotion (NCCDPHP), Centers for
Disease Control and Prevention (CDC). participants?
BILLING CODE 6750–01–P
The 60-day Federal Register Notice, 3. Is media content more attractive to
published on August 12, 2015, was participants than text-based content?
For research questions 1 and 2, we
titled ‘‘Efficacy Study of a Mobile
DEPARTMENT OF HEALTH AND hypothesize that participants in the
Application to Provide Comprehensive
HUMAN SERVICES intervention group will report increased
and Medically Accurate Sexual Health
intent to use effective contraception and
Information for Adolescent Girls.’’ On
Centers for Disease Control and utilize clinic services at three and six
January 19, 2016, a 30-day Federal
Prevention months post-intervention.
Register Notice was published under The study will also include a usability
[30Day–16–16OJ] the revised title ‘‘The Girl Power Project testing component to identify the
Efficacy Trial.’’ The burden table in the content and features of Crush that are
Agency Forms Undergoing Paperwork 30-day Notice was incorrect due to
Reduction Act Review most attractive to participants, the
omission of information collection frequency in which Crush was used,
The Centers for Disease Control and conducted to screen potential study and the navigation patterns within
Prevention (CDC) has submitted the participants for eligibility. This Notice Crush. Participants will create an
following information collection request corrects the error and provides an account in the Enrollment Database.
to the Office of Management and Budget updated estimate of total burden to This database will host participants’
(OMB) for review and approval in respondents. enrollment information, basic
accordance with the Paperwork Background and Brief Description demographic information, and will also
Reduction Act of 1995. The notice for track their navigation pattern to monitor
Despite drastic reductions in teen
the proposed information collection is Crush visitation frequency and visit
births across all racial and ethnic
published to obtain comments from the duration. Navigation data will be used
groups, Black and Latino girls continue
public and affected agencies. to have disproportionately high rates of to assess intervention exposure and
Written comments and suggestions dosage to specific content areas of
teen births. Increasing girls’ access to
from the public and affected agencies Crush. To test real-world utilization of
medically accurate and comprehensive
concerning the proposed collection of Crush, control group participants will
sexual health information is the first
information are encouraged. Your gain access to Crush six months after
step in sustaining momentum in teen
comments should address any of the enrolling into the study, but will not
pregnancy reduction among all racial
following: (a) Evaluate whether the receive weekly text messages. The study
and ethnic groups, and in promoting
proposed collection of information is will track visitation frequency and
healthy sexual behaviors, especially
necessary for the proper performance of among minority girls. duration of each visit. Usability testing
the functions of the agency, including CDC plans to collect the information will respond to Research Question #3.
whether the information will have needed to test the efficacy of a We hypothesize that participants in the
practical utility; (b) Evaluate the comprehensive and medically accurate intervention group will spend more
accuracy of the agencies estimate of the mobile application, titled Crush, in time using media features than text-
burden of the proposed collection of increasing adolescent girls’ based content.
information, including the validity of contraception use and clinic visitation All information will be collected
the methodology and assumptions used; for sexual and reproductive health electronically. This study will collect
(c) Enhance the quality, utility, and services. The information disseminated data through two mechanisms: (1) Self-
clarity of the information to be via Crush is similar to the sexual health administered online surveys, and (2) the
collected; (d) Minimize the burden of information youth can access via other Crush enrollment database. Interested
the collection of information on those Web sites, sexual health promotion participants will initially complete
who are to respond, including through educational materials or in clinics. screening questions to confirm their
the use of appropriate automated, The study will randomize a sample of eligibility. CDC estimates that 3,000
electronic, mechanical, or other 1,200 girls, ages 14–18 years, into two respondents will be screened in order to
technological collection techniques or groups: the intervention group and the reach the target number of 1,200
other forms of information technology, control group. The intervention group enrolled study participants. Information
e.g., permitting electronic submission of will have access to Crush and will collection for enrolled participants
responses; and (e) Assess information receive weekly sexual health consists of three self-administered
collection costs. information via text to their phones for online surveys at conduct at baseline,
To request additional information on six months. The control group will have three months after baseline, and six
the proposed project or to obtain a copy access to a fitness mobile application months after baseline. Survey questions
of the information collection plan and (‘‘app’’) and will receive general health will assess behavior, attitudes, social
instruments, call (404) 639–7570 or information via text to their phones for norms about sexual behavior,
send an email to omb@cdc.gov. Written six months. Participants are expected to contraception use and clinic utilization,
mstockstill on DSK4VPTVN1PROD with NOTICES
comments and/or suggestions regarding access either app frequently throughout and satisfaction with Crush.
the items contained in this notice a six month period. As part of the The mobile response surveys will be
should be directed to the Attention: analysis, sexual behavior and key sent to participants via text message
CDC Desk Officer, Office of Management psychosocial factors will be assessed at which they can complete on a
and Budget, Washington, DC 20503 or three points in time: at baseline, and at smartphone. The estimated burden per
by fax to (202) 395–5806. Written three- and six-month follow-ups. response is 5–15 minutes. Survey
comments should be received within 30 Efficacy testing will respond to the responses will be matched by each
days of this notice. following research questions: participant’s unique identifying
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![Federal Register / Vol. 81, No. 35 / Tuesday, February 23, 2016 / Notices 8963
number. Each participant will receive interactive features will not be stored in objective and quantifiable measure that
up to two survey reminders starting one the system. The database only collects tracks and records participants’
week after the initial survey link is sent, web analytics data about page visits and exposure to Crush. This study
for two consecutive weeks. There are duration of each visit by User component does not entail any response
minor differences in survey content for Identification (ID) and Internet Protocol burden to participants.
the control and intervention groups. (IP) address. Web analytics will only be Findings will be used to inform the
Each participant will create a profile collected from participants navigating
in the database upon enrollment. This development and delivery of effective
Crush and only when they are logged in health communications.
database will collect initial
as users. Web analytics are generated for OMB approval is requested for one
demographic and contact information,
any Web site and are a standard year. Participation is voluntary and
informed consent signatures, and
information about the participant’s evaluation mechanism for assessing the there are no costs to respondents other
navigation pattern through Crush. Any traffic patterns on Web pages. This than their time. The total estimated
information entered directly into Crush technology permits development of an annualized burden hours are 802.
ESTIMATED ANNUALIZED BURDEN HOURS
Number of Avg. burden
Number of
Type of respondents Form name 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, coding and payment determinations. Deadlines for Primary Speaker
Chief, Information Collection Review Office, The discussion will be focused on Registration and Presentation Materials:
Office of Scientific Integrity, Office of the responses to our specific preliminary The deadline for registering to be a
Associate Director for Science, Office of the recommendations and will include all primary speaker and submitting
Director, Centers for Disease Control and items on the public meeting agenda. As materials and writings that will be used
Prevention.
indicated in this notice, we are in support of an oral presentation are as
[FR Doc. 2016–03687 Filed 2–22–16; 8:45 am]
reorganizing public meeting content follows:
BILLING CODE 4163–18–P under two main headings: (1) Drugs/ • May 3, 2016 for the May 17, 2016,
Biologics, Radiopharmaceuticals/ May 18, 2016 and May 19, 2016 public
Radiologic Imaging Agents, and (2) meetings.
DEPARTMENT OF HEALTH AND • May 18, 2016 for the June 1, 2016
Durable Medical Equipment (DME) and
HUMAN SERVICES and June 2, 2016 public meetings.
Accessories; Orthotics and Prosthetics
Centers for Medicare & Medicaid (O & P); Supplies and Other. Registration Deadline for Attendees
Services DATES: Meeting Dates: The following are
that are Foreign Nationals: All Foreign
the 2016 HCPCS public meeting dates: National visitors must present a valid
[CMS–1637–N] passport as proof of identification.
1. Tuesday, May 17, 2016, 9:00 a.m.
Attendees that are foreign nationals (as
Medicare Program; Public Meetings in to 5:00 p.m., eastern daylight time
described in section IV. of this notice)
Calendar Year 2016 for All New Public (e.d.t.) (Drugs/Biologicals,
are required to identify themselves as
Requests for Revisions to the Radiopharmaceuticals/Radiologic
such, and provide the necessary
Healthcare Common Procedure Coding Imaging Agents).
information for security clearance (as
System (HCPCS) Coding and Payment 2. Wednesday, May 18, 2016, 9:00 described in section IV. of this notice)
Determinations a.m. to 5:00 p.m., e.d.t. (Drugs/ to the public meeting coordinator at
Biologicals, Radiopharmaceuticals/ least 21 business days in advance of the
AGENCY: Centers for Medicare &
Radiologic Imaging Agents). date of the public meeting the
Medicaid Services (CMS), HHS.
3. Thursday, May 19, 2016, 9:00 a.m. individual plans to attend. Therefore,
ACTION: Notice.
to 5:00 p.m., e.d.t. (Drugs/Biologicals, the registration deadlines for attendees
SUMMARY: This notice announces the Radiopharmaceuticals/Radiologic that are foreign nationals are as follows:
dates, time, and location of the Imaging Agents). • April 28, 2016 for the May 17, 2016,
Healthcare Common Procedure Coding 4. Wednesday, June 1, 2016, 9:00 a.m. May 18, 2016 and May 19, 2016 public
System (HCPCS) public meetings to be to 5:00 p.m., e.d.t. (Durable Medical meetings.
Equipment (DME) and Accessories; • May 12, 2016 for the June 1, 2016
mstockstill on DSK4VPTVN1PROD with NOTICES
held in calendar year 2016 to discuss
our preliminary coding and payment Orthotics and Prosthetics (O & P); and June 2, 2016 public meetings.
determinations for all new public Supplies and Other). Registration Deadlines for all Other
requests for revisions to the HCPCS. 5. Thursday, June 2, 2016, 9:00 a.m. Attendees: All individuals who are not
These meetings provide a forum for to 5:00 p.m., e.d.t. (Durable Medical foreign nationals who plan to enter the
interested parties to make oral Equipment (DME) and Accessories; building to attend the public meeting
presentations or to submit written Orthotics and Prosthetics (O & P); must register for each date that they
comments in response to preliminary Supplies and Other). plan on attending. The registration
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Document Created: 2018-02-02 14:33:49
Document Modified: 2018-02-02 14:33:49
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| FR Citation | 81 FR 8962 |
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