Department of Health and Human Services June 13, 2019 – Federal Register Recent Federal Regulation Documents
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Agency Information Collection Activities: Proposed Collection; Comment Request
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.
Meeting of the Pain Management Best Practices Inter-Agency Task Force; Correction
The Office of the Assistant Secretary for Health published a document in the Federal Register of June 3, 2019, announcing the Pain Management Best Practices Inter-Agency Task Force's virtual public meeting. This document is announcing a change in the meeting date.
Content and Format of Substantial Equivalence Reports; Food and Drug Administration Actions on Substantial Equivalence Reports; Extension of Comment Period
The Food and Drug Administration (FDA or the Agency) is extending the comment period for the proposed rule that appeared in the Federal Register of April 2, 2019. The Agency is taking this action in response to requests for an extension to allow interested parties additional time to submit comments.
Agency Information Collection Activities; Proposed Collection; Comment Request; Requirements Under the Comprehensive Smokeless Tobacco Health Education Act of 1986, as Amended by the Family Smoking Prevention and Tobacco Control Act
The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. 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 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 information collection ``Requirements Under the Comprehensive Smokeless Tobacco Health Education Act of 1986, as Amended by the Family Smoking Prevention and Tobacco Control Act.''
Mouse Embryo Assay for Assisted Reproduction Technology Devices; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled ``Mouse Embryo Assay for Assisted Reproduction Technology Devices.'' This draft guidance document provides recommendations on conducting the Mouse Embryo Assay (MEA) to support premarket submissions and lot release of assisted reproduction technology devices. This draft guidance is not final nor is it in effect at this time.
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