[Federal Register Volume 89, Number 18 (Friday, January 26, 2024)]
[Notices]
[Pages 5237-5239]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-01550]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60Day-24-24CB; Docket No. CDC-2024-0004]


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 effort to reduce public burden and maximize the 
utility of government information, invites the general public and other 
Federal agencies the opportunity to comment on a proposed information 
collection, as required by the Paperwork Reduction Act of 1995. This 
notice invites comment on a proposed information collection project 
titled Evaluation of an Online Prostate Cancer Decision Aid. This 
three-arm, randomized controlled

[[Page 5238]]

trial (RCT) includes eight forms of data collection including surveys 
and interviews and will evaluate the impact of a virtual human decision 
aid to help improve the quality of prostate cancer screening and 
treatment decisions.

DATES: CDC must receive written comments on or before March 26, 2024.

ADDRESSES: You may submit comments, identified by Docket No. CDC-2024-
0004 by either of the following methods:
     Federal eRulemaking Portal: www.regulations.gov. Follow 
the instructions for submitting comments.
     Mail: Jeffrey M. Zirger, Information Collection Review 
Office, Centers for Disease Control and Prevention, 1600 Clifton Road 
NE, MS H21-8, Atlanta, Georgia 30329.
    Instructions: All submissions received must include the agency name 
and Docket Number. CDC will post, without change, all relevant comments 
to www.regulations.gov.
    Please note: Submit all comments through the Federal eRulemaking 
portal (www.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 Jeffrey M. Zirger, Information Collection 
Review Office, Centers for Disease Control and Prevention, 1600 Clifton 
Road NE, MS H21-8, Atlanta, Georgia 30329; Telephone: 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 the OMB for approval. To 
comply with this requirement, we are publishing this notice of a 
proposed data collection as described below.
    The OMB is particularly interested in comments that will help:
    1. 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;
    2. Evaluate the accuracy of the agency's estimate of the burden of 
the proposed collection of information, including the validity of the 
methodology and assumptions used;
    3. Enhance the quality, utility, and clarity of the information to 
be collected;
    4. 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 
submissions of responses; and
    5. Assess information collection costs.

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 information collection forms 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.

[[Page 5239]]



                                        Estimated Annualized Burden Hours
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                                                                     Number of    Average burden
      Type of respondents           Form name        Number of     responses per   per response    Total burden
                                                    respondents     respondent      (in hours)      (in hours)
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Primary care providers........  Provider survey.              40               1           10/60               7
Men ages 55-69................  Patient                      900               1            8/60             120
                                 eligibility
                                 screener.
Men ages 55-69................  Pre-exposure                 900               1           20/60             300
                                 survey.
Men ages 55-69................  Post-exposure                900               1           20/60             300
                                 survey.
Men ages 55-69................  Post-clinic                  300               1           18/60              90
                                 survey.
Men ages 55-69................  Usability survey              30               1           20/60              10
Men ages 55-69................  User experience              900               1           20/60             300
                                 interview.
Clinic coordinators...........  Clinic                         4               1           30/60               2
                                 coordinator
                                 interview.
                                                 ---------------------------------------------------------------
    Total.....................  ................  ..............  ..............  ..............           1,129
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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. 2024-01550 Filed 1-25-24; 8:45 am]
BILLING CODE 4163-18-P