2023-19849. Proposed Collection; Comment Request

AGENCY:

The 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 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 November 13, 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 the Defense Health Agency, 7700 Arlington Blvd., Falls Church, VA 22042, Terry McDavid, 703–681–3645.

SUPPLEMENTARY INFORMATION:

Title; Associated Form; and OMB Number: The Effect of Alcohol Intake on Resilience and Recovery Outcomes Using Alcohol Flush as an Instrumental Variable (Alcohol Flush); OMB Control Number 0720–FLSH.

Needs and Uses: The study's objective is to investigate causal models of alcohol use on resilience measures ( e.g., posttraumatic stress disorder [PTSD]). This research objective will be accomplished by (a) collecting a self-report survey and (b) conducting genotyping and sequencing of DNA (potentially up to whole genomic sequencing) from samples of Active Duty Service Members (ADSM; ≥21 years old, n=999.). The compelling need for administration of the survey component of the Alcohol Flush Study rests on these four methodological requirements:

• Concurrent collection of demographics, research health information (RHI), and self-reported alcohol consumption
• Avoid potential statistical confounding by implementing systematic data collection across all participants to address research questions and perform statistical modeling,
• Ability to link survey data to genotyping and sequencing data,
• Ability to re-contact participants for future research.

This research will deliver a knowledge product that will inform policy and practice in the Military Health System (MHS). We further expect to identify alcohol as a potential modifiable risk factor related to PTSD and other mental health conditions, which could go beyond the MHS into embedded mental health services for prevention and intervention for at-risk individuals. In the context of Precision Medicine, this survey establishes a cohort who may be contacted for participation in additional research, tailors medical care to optimize efficiency, effectiveness, safety, and patient-centeredness of therapeutic approaches using genetic profiling. The long-term impact of this study has the potential to lower inappropriate utilization, thus reducing costs while improving health-related quality of life and optimizing Readiness.

Information collected in this survey will be used for research purposes to fulfill the objectives of this grant-funded study which aligns to a requirement to “better understand the impact of alcohol use on resiliency and recovery.” The findings will be interpreted by a multidisciplinary team of physicians, scientists, behavioral psychologists, and healthcare services researchers to (a) inform policy and (b) make recommendations for practice in the contest of Precision Medicine.

Affected Public: Individuals and households.

Annual Burden Hours: 999.

Number of Respondents: 999.

Responses per Respondent: 1.

Annual Responses: 999.

Average Burden per Response: 1 Hour.

Frequency: On occasion.

Dated: September 5, 2023.

Aaron T. Siegel,

Alternate OSD Federal Register Liaison Officer, Department of Defense.