Department of Health and Human Services September 8, 2023 – Federal Register Recent Federal Regulation Documents

The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. Under the Paperwork Reduction Act of 1995 (the PRA), federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information (including each proposed extension or reinstatement of an existing collection of information) and to allow 60 days for public comment on the proposed action. Interested persons are invited to send comments regarding our burden estimates or any other aspect of this collection of information, including the necessity and utility of the proposed information collection for the proper performance of the agency's functions, the accuracy of the estimated burden, ways to enhance the quality, utility, and clarity of the information to be collected, and the use of automated collection techniques or other forms of information technology to minimize the information collection burden.

The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. Under the Paperwork Reduction Act of 1995 (PRA), federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension or reinstatement of an existing collection of information, and to allow a second opportunity for public comment on the notice. Interested persons are invited to send comments regarding the burden estimate or any other aspect of this collection of information, including the necessity and utility of the proposed information collection for the proper performance of the agency's functions, the accuracy of the estimated burden, ways to enhance the quality, utility, and clarity of the information to be collected, and the use of automated collection techniques or other forms of information technology to minimize the information collection burden.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry and FDA staff entitled ``Application of Human Factors Engineering Principles for Combination Products: Questions and Answers.'' This document provides questions and answers for industry and FDA staff on the application of human factors engineering (HFE) principles to the development of combination products as defined under the regulations. The guidance clarifies how the unique aspects of a combination product influence the considerations within the HFE process. This guidance is intended to facilitate the development of combination products. This guidance finalizes the draft guidance entitled ``Human Factors Studies and Related Clinical Study Considerations in Combination Product Design and Development'' issued on February 3, 2016.

In accordance with the Federal Advisory Committee Act, this notice announces that the Secretary's Advisory Council on Blood Stem Cell Transplantation (ACBSCT or Advisory Council) has scheduled public meetings. Information about the Advisory Council and the agenda for these meetings can be found on the ACBSCT website at: https:// bloodstemcell.hrsa.gov/about/advisory-council.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Endogenous Cushing's Syndrome: Developing Drugs for Treatment.'' The purpose of this guidance is to provide recommendations to sponsors regarding clinical trial designs for drugs intended for the treatment of adults with endogenous Cushing's syndrome for whom surgery is not an option or has not been curative. This draft guidance is intended to focus continued discussions among FDA's Division of General Endocrinology, pharmaceutical sponsors, the academic community, and the public.