[Federal Register Volume 89, Number 139 (Friday, July 19, 2024)]
[Notices]
[Pages 58740-58741]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-15965]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[30Day-24-24CB]


Agency Forms Undergoing Paperwork Reduction Act Review

    In accordance with the Paperwork Reduction Act of 1995, the Centers 
for Disease Control and Prevention (CDC) has submitted the information 
collection request titled ``Evaluation of an Online Prostate Cancer 
Decision Aid'' to the Office of Management and Budget (OMB) for review 
and approval. CDC previously published a ``Proposed Data Collection 
Submitted for Public Comment and Recommendations'' notice on January 
26, 2024 to obtain comments from the public and affected agencies. CDC 
received two comments related to the previous notice. This notice 
serves to allow an additional 30 days for public and affected agency 
comments.
    CDC will accept all comments for this proposed information 
collection project. The Office of Management and Budget is particularly 
interested in comments that:
    (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. Comments and recommendations for the proposed 
information collection should be sent within 30 days of publication of 
this notice to www.reginfo.gov/public/do/PRAMain. Find this particular 
information collection by selecting ``Currently under 30-day Review--
Open for Public Comments'' or by using the search function. Direct 
written comments and/or suggestions regarding the items contained in 
this notice to the Attention: CDC Desk Officer, Office of Management 
and Budget, 725 17th Street NW, Washington, DC 20503 or by fax to (202) 
395-5806. Provide written comments within 30 days of notice 
publication.

[[Page 58741]]

Proposed Project

    Evaluation of an Online Prostate Cancer Decision Aid--New--National 
Center for Chronic Disease Prevention and Health Promotion (NCCDPHP), 
Centers for Disease Control and Prevention (CDC).

Background and Brief Description

    The Centers for Disease Control and Prevention (CDC), Division of 
Cancer Prevention and Control (DCPC) is requesting a new, three-year 
OMB approval to conduct a three-arm, randomized controlled trial (RCT) 
to evaluate the impact of a virtual human decision aid to help improve 
the quality of prostate cancer screening and treatment decisions. Talk 
to Nathan About Prostate Cancer Screening (hereafter referred to as 
Nathan) is DCPC's online, interactive, human simulation decision aid 
designed to help men learn and make informed decisions about prostate 
cancer screening. A small, preliminary evaluation of Nathan showed 
promise in increasing men's knowledge about prostate cancer and 
likelihood of engaging in shared decision-making about prostate cancer 
screening with their health care providers. At this time, a larger, 
more systematic evaluation can help to understand whether Nathan is 
effective in areas such as improving knowledge, overcoming health 
literacy barriers, and resolving decisional conflict, especially among 
priority populations who are most likely to be affected by prostate 
cancer and least likely to be screened. Further, as some experts 
consider the digital divide to be the newest social determinant of 
health, it is important to explore how, where, and for which 
populations there may be disparities in accessing and using Nathan.
    Broadly, the purpose of this information collection is to: (1) 
assess whether Nathan is more effective at helping men make decisions 
about prostate cancer screening than an established decision aid or 
standard educational materials; (2) determine if changes or 
improvements to Nathan are warranted; and (3) identify ways to 
incorporate Nathan into primary care. We will select four primary care 
clinics to participate in this study. The RCT includes a three-group 
parallel design with one treatment arm and two control arms to test the 
effectiveness of Nathan for men aged 55-69. We will recruit 900 men 
aged 55-69 who have an upcoming general health exam at one of the four 
primary care clinics and randomize them to one of three arms: (1) 
Nathan (intervention = 300 men); (2) the Massachusetts Department of 
Public Health's (MDPH's) Patient Decision Aid, Get the Latest Facts 
about Screening for Prostate Cancer (control 1 = 300 men); and (3) 
standard educational materials from the National Cancer Institute 
(NCI), Prostate Cancer Screening (PDQ[supreg])--Patient Version 
(control 2 = 300 men).
    Eight forms of information collection will be implemented to answer 
our evaluation questions. These include a provider survey; a patient 
eligibility screener; patient pre-exposure, post-exposure, and post-
clinic visit surveys; a patient usability survey; patient user 
experience interviews; and clinic coordinator interviews. Each 
instrument will be administered once per respondent throughout the 
course of the study. The provider survey and clinic coordinator 
interviews will be conducted in English only. All other information 
collections will be conducted in English or Spanish. The total response 
burden is estimated to be 1,129 hours. There are no costs to 
respondents other than their time to participate in data collection 
activities.

                                        Estimated Annualized Burden Hours
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                                                                                                      Average
                                                                     Number of       Number of      burden per
          Type of respondents                   Form name           respondents    responses per   response  (in
                                                                                    respondent        hours)
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Primary care providers................  Provider survey.........              40               1           10/60
Men ages 55-69........................  Patient eligibility                  900               1            8/60
                                         screener.
Men ages 55-69........................  Pre-exposure survey.....             900               1           20/60
Men ages 55-69........................  Post-exposure survey....             900               1           20/60
Men ages 55-69........................  Usability survey........             300               1           18/60
Men ages 55-69........................  User experience                       30               1           20/60
                                         interview.
Men ages 55-69........................  Post-clinic survey......             900               1           20/60
Clinic coordinators...................  Clinic coordinator                     4               1           30/60
                                         interview.
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Jeffrey M. Zirger,
Lead, Information Collection Review Office, Office of Public Health 
Ethics and Regulations, Office of Science, Centers for Disease Control 
and Prevention.
[FR Doc. 2024-15965 Filed 7-18-24; 8:45 am]
BILLING CODE 4163-18-P