Notice2024-01550
Proposed Data Collection Submitted for Public Comment and Recommendations
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
January 26, 2024
Issuing agencies
Health and Human Services DepartmentCenters for Disease Control and Prevention
Abstract
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 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.
Full Text
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<title>Federal Register, Volume 89 Issue 18 (Friday, January 26, 2024)</title>
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[Federal Register Volume 89, Number 18 (Friday, January 26, 2024)]
[Notices]
[Pages 5237-5239]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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:
<bullet> Federal eRulemaking Portal: <a href="http://www.regulations.gov">www.regulations.gov</a>. Follow
the instructions for submitting comments.
<bullet> 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 <a href="http://www.regulations.gov">www.regulations.gov</a>.
Please note: Submit all comments through the Federal eRulemaking
portal (<a href="http://www.regulations.gov">www.regulations.gov</a>) 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: <a href="/cdn-cgi/l/email-protection#127d7f70527176713c757d64"><span class="__cf_email__" data-cfemail="56393b341635323578313920">[email protected]</span></a>.
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.
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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
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