Department of Health and Human Services December 21, 2021 – 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 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 proposed and/or continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comments on a proposed information collection project titled Characteristics of Patients with Environmentally-derived Triazole-resistant Aspergillus fumigatus. This case report form collects information on demographics, underlying conditions, treatments, and outcomes of patients with triazole- resistant A. fumigatus to inform clinical and public health practice.

The Food and Drug Administration (FDA or the Agency) is extending the comment period for the notice of availability entitled ``Data Standards for Drug and Biological Product Submissions Containing Real-World Data; Draft Guidance for Industry'' that appeared in the Federal Register on October 22, 2021. The Agency is taking this action in response to requests for an extension to allow interested persons additional time to submit comments.

In compliance with the requirement for opportunity for public comment on proposed data collection projects of the Paperwork Reduction Act of 1995, HRSA announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). Prior to submitting the ICR to OMB, HRSA seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR.