Department of Health and Human Services February 14, 2020 – 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 Food and Drug Administration (FDA or the Agency) is extending the comment period for the notice of availability that appeared in the Federal Register of December 19, 2019. In the notice of availability, FDA requested comments on the draft guidance for industry entitled ``Bridging for Drug-Device and Biologic-Device Combination Products.'' The Agency is taking this action in response to requests for an extension to allow interested persons additional time to submit comments.

The Food and Drug Administration (FDA, we, or Agency) is announcing the availability of a supplemental draft guidance for industry entitled ``Mitigation Strategies to Protect Food Against Intentional Adulteration: Guidance for Industry.'' This supplemental draft guidance document, when finalized, will help food facilities that manufacture, process, pack, or hold food, and that are required to register under the Federal Food, Drug, and Cosmetic Act (FD&C Act) comply with the requirements of our regulation entitled ``Mitigation Strategies to Protect Food Against Intentional Adulteration.''

HHS proposes to revise the National Institute for Occupational Safety and Health (NIOSH), Coal Workers' Health Surveillance Program (Program) regulations by adding a provision to allow NIOSH to suspend or revoke B Reader certification. Certification may be revoked for any B Reader found by NIOSH to have engaged in a pattern of providing unreasonably inaccurate chest radiograph classifications in practice those that are found by the Program to diverge substantially from a competent interpretation of the radiographs, as determined by a panel of practicing, certified B Readers selected by NIOSH. In addition to the B Reader provisions, HHS would also amend existing regulatory text to allow compensation for pathologists who perform autopsies on coal miners at a market rate, on a discretionary basis as needed for public health purposes.