Notice2024-15965
Agency Forms Undergoing Paperwork Reduction Act Review
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
July 19, 2024
Issuing agencies
Health and Human Services DepartmentCenters for Disease Control and Prevention
Full Text
<html>
<head>
<title>Federal Register, Volume 89 Issue 139 (Friday, July 19, 2024)</title>
</head>
<body><pre>
[Federal Register Volume 89, Number 139 (Friday, July 19, 2024)]
[Notices]
[Pages 58740-58741]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-15965]
-----------------------------------------------------------------------
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 <a href="http://www.reginfo.gov/public/do/PRAMain">www.reginfo.gov/public/do/PRAMain</a>. 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
----------------------------------------------------------------------------------------------------------------
Average
Number of Number of burden per
Type of respondents Form name respondents responses per response (in
respondent hours)
----------------------------------------------------------------------------------------------------------------
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.
----------------------------------------------------------------------------------------------------------------
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
</pre></body>
</html>Indexed from Federal Register on July 19, 2024.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.