Department of Health and Human Services October 11, 2022 – Federal Register Recent Federal Regulation Documents

In compliance with the requirement of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, is publishing the following summary of a proposed collection for public comment.

Notice is hereby given for the meeting on November 15-17, 2022 of the Substance Abuse and Mental Health Services Administration's Tribal Technical Advisory Committee (TTAC). The meeting is open to the public and will be held in person. Agenda with call-in information will be posted on the SAMHSA website prior to the meeting at: https://www.samhsa.gov/about-us/advisory-councils/ meetings. The meeting will include, but not be limited to, remarks from the Assistant Secretary for Mental Health and Substance Use; updates on SAMHSA priorities; follow up on topics related to the previous TTAC meetings; and council discussions.

This notice announces a virtual public meeting of the Medicare Evidence Development & Coverage Advisory Committee (MEDCAC) (``Committee'') will be held on Wednesday, December 7, 2022. National Coverage Determinations resulting in coverage with evidence development (CED) can expedite earlier Medicare beneficiary access to innovative technology while ensuring that systematic patient safeguards are in place to reduce the risks inherent to new technologies, or to new applications of older technologies. This meeting will examine the general requirements for clinical studies submitted for CMS coverage requiring CED. The MEDCAC will evaluate the CED criteria to assure that CED studies are evaluated with consistent, feasible, transparent and methodologically rigorous criteria and advise CMS on whether the criteria are appropriate to ensure that CED-approved studies will produce reliable evidence that CMS can rely on to help determine whether a particular item or service is reasonable and necessary. This meeting is open to the public in accordance with the Federal Advisory Committee Act.

In compliance with the requirement of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, is publishing the following summary of a proposed collection for public comment.

The Centers for Disease Control and Prevention (CDC), as part of its continuing effort to reduce public burden and maximize the utility of government information, invites the general public and other federal agencies the opportunity to comment on a continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled Public Health Laboratory Testing for Emerging Antibiotic Resistance and Fungal Threats. This collection will allow CDC to partner with public health laboratories and will help equip them to detect and characterize isolates.

The Director of the Center for Drug Evaluation and Research (Center Director) at the Food and Drug Administration (FDA or Agency) is proposing to refuse to approve a supplemental new drug application (sNDA) submitted by Vanda Pharmaceuticals, Inc. (Vanda), for HETLIOZ (tasimelteon) capsules, 20 milligrams (mg), in its present form. This notice summarizes the grounds for the Center Director's proposal and offers Vanda an opportunity to request a hearing on the matter.