[Federal Register Volume 88, Number 53 (Monday, March 20, 2023)]
[Notices]
[Pages 16593-16594]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-05643]


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DEPARTMENT OF DEFENSE

Office of the Secretary

[Docket ID: DoD-2023-HA-0020]


Proposed Collection; Comment Request

AGENCY: Defense Health Agency (DHA), Department of Defense (DoD).

ACTION: 60-Day information collection notice.

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SUMMARY: In compliance with the Paperwork Reduction Act of 1995, the 
DHA announces a proposed public information collection and seeks public 
comment on the provisions thereof. Comments are invited on: whether the 
proposed collection of information is necessary for the proper 
performance of the functions of the agency, including whether the 
information shall have practical utility; the accuracy of the agency's 
estimate of the burden of the proposed information collection; ways to 
enhance the quality, utility, and clarity of the information to be 
collected; and ways to minimize the burden of the information 
collection on respondents, including through the use of automated 
collection techniques or other forms of information technology.

DATES: Consideration will be given to all comments received by May 19, 
2023.

ADDRESSES: You may submit comments, identified by docket number and 
title, by any of the following methods:
    Federal eRulemaking Portal: http://www.regulations.gov. Follow the 
instructions for submitting comments.
    Mail: Department of Defense, Office of the Assistant to the 
Secretary of Defense for Privacy, Civil Liberties, and Transparency, 
4800 Mark Center Drive, Mailbox #24, Suite 08D09, Alexandria, VA 22350-
1700.
    Instructions: All submissions received must include the agency 
name, docket number and title for this Federal Register document. The 
general policy for comments and other submissions from members of the 
public is to make these submissions available for public viewing on the 
internet at http://www.regulations.gov as they are received without 
change, including any personal identifiers or contact information.

FOR FURTHER INFORMATION CONTACT: To request more information on this 
proposed information collection or to obtain a copy of the proposal and 
associated collection instruments, please write to Department of 
Defense, Washington Headquarters Services, ATTN: Executive Services 
Directorate, Directives Division, 4800 Mark Center

[[Page 16594]]

Drive, Suite 03F09-09, Alexandria, VA 22350-3100, Angela Duncan, 571-
372-7574.

SUPPLEMENTARY INFORMATION: 
    Title; Associated Form; and OMB Number: Utilization of the Novel 
ECC Eagle External Condom Catheter System; OMB Control Number 0720-
EECC.
    Needs and Uses: There are numerous methods to manage urinary 
incontinence, from pads/diapers to condom catheters to invasive 
urethral foley catheters. Pads or diapers can lead to skin irritation 
due to their occlusive barriers which can leave skin moist and lead to 
breakdown. Current condom catheters can be difficult to size and cause 
skin breakdown and infections. They can also fall off in patients with 
a large suprapubic fat pad and a shorter penis. Foley catheters can be 
uncomfortable and can lead to urinary tract infections. Thus, there is 
a need for a better way to manage urinary incontinence in men. The ECC 
Eagle is a novel design for a condom catheter that is intended to be 
more comfortable and secure than current models. We need to ask 
patients questions on their experience with the ECC Eagle, the degree 
of urinary symptoms they experience and the impact this has on their 
lives. This information is vital to the development of this product.
    Affected Public: Individuals and households.

ECC Eagle Patient Satisfaction Questionnaire

    Annual Burden Hours: 0.8.
    Number of Respondents: 10.
    Responses per Respondent: 1.
    Annual Responses: 10.
    Average Burden per Response: 5 minutes.

Male Urinary Symptom Impact Questionnaire (MUSIQ)

    Annual Burden Hours: 3.3.
    Number of Respondents: 10.
    Responses per Respondent: 2.
    Annual Responses: 20.
    Average Burden per Response: 10 minutes.

PROMIS General Life Satisfaction Questionnaire

    Annual Burden Hours: 1.7.
    Number of Respondents: 10.
    Responses per Respondent: 2.
    Annual Responses: 20.
    Average Burden per Response: 5 minutes.
    The respondents will be adult men with stress urinary incontinence. 
They will be responding to this information collection because this is 
required if they want to trial the novel ECC Eagle external condom 
catheter. Each collection instrument will be done electronically via 
Qualtrics, a secure web-based survey platform. Patients will access 
this via their smartphone. The results will automatically be received 
via Qualtrics when they submit the responses.
    Participants in the ECC Eagle trial will get to keep the external 
condom catheter they used for the study. There is no other gift, 
payment, or incentive to participate.

    Dated: March 15, 2023.
Aaron T. Siegel,
Alternate OSD Federal Register Liaison Officer, Department of Defense.
[FR Doc. 2023-05643 Filed 3-17-23; 8:45 am]
BILLING CODE 5001-06-P