2023-17878. Proposed Collection; Comment Request

AGENCY:

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

ACTION:

60-Day information collection notice.

SUMMARY:

In compliance with the Paperwork Reduction Act of 1995, the Defense Health Agency (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 October 20, 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 Drive, Suite 03F09–09, Alexandria, VA 22350–3100, Angela Duncan, 571–372–7574.

SUPPLEMENTARY INFORMATION:

Title; Associated Form; and OMB Number: Penile Implant Satisfaction in a Military Population; OMB control number 0720–PISM.

Needs and Uses: Inflatable Penile Prostheses (IPPs) are common procedures worldwide with over 53,000 American men aged ≥65 years-old undergoing penile implant surgery over a 9-year period. Despite the prevalence of these surgeries, the data on patient satisfaction has been limited. For example, Akakpo et al. (2017) evaluated almost 50 articles on patient satisfaction with penile implants from 2006–2016. 44% of the articles used questionnaires that were not intended for nor validated in IPP patients, while the remaining articles used proprietary, non-validated questionnaires.

These earlier IPP outcome assessments are problematic. The use of different instruments makes it difficult to compare results between studies. Thus, it is unsurprising that the satisfaction results vary widely. For example, one study found that 91% of IPP patients were `very satisfied' whereas another study showed only 69% of men were satisfied with their IPP. This demonstrates the importance of a standardized IPP satisfaction questionnaire.

Recently, the first English-validated IPP satisfaction questionnaire- the Satisfaction Survey for Inflatable Penile Implant (SSIPI) was developed. This 16-item questionnaire assesses overall satisfaction, pain, function and appearance in men with IPPs. With the advent of SSIPI, it is vital that we use this novel instrument to accurately access IPP satisfaction in a military population.

The authority that authorizes this collection is: § 876.3350, 5 CFR 1320.5(d)(2), Title 10, Title 20, Title 42, American Urological Association, America Board of Urology, and the Sexual Medicine Society of North America.

The respondents are adult men with inflatable penile implants who are patients at Madigan Army Medical Center. They are responding to this information collection as it will be part of their postoperative medical follow-ups. The survey will be given via Qualtrics, a web-based secure survey platform. Patients will access this via a QR code and answer the questions on their smartphones. They will complete the questions at the time of their medical follow-ups. This is returned electronically when they submit the survey.

Affected Public: Individuals and households.

Annual Burden Hours: 3.4.

Number of Respondents: 20.

Responses per Respondent: 1.

Annual Responses: 20.

Average Burden per Response: 10 minutes.

Frequency: On occasion.

Dated: August 16, 2023.

Natalie M. Ragland,

Alternate OSD Federal Register Liaison Officer, Department of Defense.