Department of Health and Human Services October 24, 2023 – Federal Register Recent Federal Regulation Documents

Findings of research misconduct have been made against Lara S. Hwa, Ph.D. (Respondent), who is an Assistant Professor, Department of Psychology and Neuroscience, Baylor University (BU), and formerly was a Postdoctoral Fellow, School of Medicine, University of North Carolina at Chapel Hill (UNC-CH). Respondent engaged in research misconduct in research supported by U.S. Public Health Service (PHS) funds, specifically National Institute on Alcohol Abuse and Alcoholism (NIAAA), National Institutes of Health (NIH), grants K99/R00 AA027576, T32 AA007573, F31 AA027129, F32 AA026485, R01 AA019454, U01 AA020911, R01 AA025582, and P60 AA011605 and included in two grant applications submitted for PHS funds, specifically K99 AA027576 submitted to NIAAA, NIH, and R01 DK136486 submitted to the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), NIH. The administrative actions, including supervision for a period of four (4) years, were implemented beginning on August 24, 2023, and are detailed below.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a revised draft guidance for industry entitled ``Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products: Questions and Answers.'' This revised draft guidance, when finalized, will provide FDA's current thinking on common questions regarding certain communications by firms to health care providers (HCPs) of scientific information on unapproved use(s) of approved/ cleared medical products (the scope of the italicized terms is further explained in the revised draft guidance). This revised guidance supersedes the revised draft guidance entitled ``Distributing Scientific and Medical Publications on Unapproved New UsesRecommended Practices'' issued in 2014 (2014 revised draft guidance).

The Administration for Children and Families (ACF), within the U.S. Department of Health and Human Services (HHS), oversees the Title IV-E Prevention Services Clearinghouse. ACF seeks comments on proposed changes and clarifications to existing standards and procedures in the Handbook of Standards and Procedures, Version 2.0.

The Administration for Community Living (ACL) is announcing an opportunity for the public to comment on the proposed collection of information listed above. Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish a notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the proposed Revision for the information collection requirements related to Alzheimer's and Dementia Program Data Reporting Tool (ADP-DRT).

In accordance with regulatory provisions, the Centers for Disease Control and Prevention (CDC) announces the following meeting of the Mine Safety and Health Research Advisory Committee (MSHRAC). This is a hybrid meeting, accessible both in person and virtually. It is open to the public and limited only by the space available and the number of web conference lines available. Time will be available for public comment.