2023-18400. Submission for OMB Review; Comment Request

AGENCY:

Office of the Assistant Secretary of Defense for Health Affairs (OASD(HA)), Department of Defense (DoD).

ACTION:

30-Day information collection notice.

SUMMARY:

The DoD has submitted to the Office of Management and Budget (OMB) for clearance the following proposal for collection of information under the provisions of the Paperwork Reduction Act.

DATES:

Consideration will be given to all comments received by September 27, 2023.

ADDRESSES:

Written 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.

FOR FURTHER INFORMATION CONTACT:

Angela Duncan, 571–372–7574, [e-mail].

SUPPLEMENTARY INFORMATION:

Title; Associated Form; and OMB Number: Utilization of the Novel ECC Eagle External Condom Catheter System; OMB Control Number 0720–EECC.

Type of Request: New.

ECC Eagle Patient Satisfaction Questionnaire

Number of Respondents: 10.

Responses per Respondent: 1.

Annual Responses: 10.

Average Burden per Response: 5 minutes.

Annual Burden Hours: 0.8.

Male Urinary Symptom Impact Questionnaire (MUSIQ)

Number of Respondents: 10.

Responses per Respondent: 2.

Annual Responses: 20.

Average Burden per Response: 5 Minutes.

Annual Burden Hours: 1.67.

PROMIS General Life Satisfaction Questionnaire

Number of Respondents: 10.

Responses per Respondent: 2.

Annual Responses: 20.

Average Burden per Response: 5 Minutes.

Annual Burden Hours: 1.7.

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 or households.

Frequency: On occasion.

Respondent's Obligation: Voluntary.

OMB Desk Officer: Mr. Matthew Eliseo.

You may also submit comments and recommendations, identified by Docket ID number and title, by the following method:

• Federal eRulemaking Portal: http://www.regulations.gov. Follow the instructions for submitting comments.

Instructions: All submissions received must include the agency name, Docket ID 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.

DOD Clearance Officer: Ms. Angela Duncan.

Requests for copies of the information collection proposal should be sent to Ms. Duncan at [e-mail].

Dated: August 21, 2023.

Aaron T. Siegel,

Alternate OSD Federal Register Liaison Officer, Department of Defense.