Department of Health and Human Services February 2020 – Federal Register Recent Federal Regulation Documents

This proposed rule would modernize the requirements for Preadmission Screening and Resident Review (PASRR), currently referred to in regulation as Preadmission Screening and Annual Resident Review, by incorporating statutory changes, reflecting updates to diagnostic criteria for mental illness and intellectual disability, reducing duplicative requirements and other administrative burdens on State PASRR programs, and making the process more streamlined and person- centered.

As required by the Federal Advisory Committee Act, the Department of Health and Human Services (HHS) is hereby giving notice that the Tick-Borne Disease Working Group (TBDWG) will hold a meeting. The meeting will be open to the public. For this meeting, the TBDWG will be discussing and voting on recommendations for the 2020 TBDWG Report to the HHS Secretary and Congress. Most of the recommendations the TBDWG will consider are from the reports of eight TBDWG subcommittees, which were created to examine critical topic areas related to tick-borne diseases. Additionally, the TBDWG created the Federal Inventory Subcommittee and Public Comment Subcommittee. The Federal Inventory Subcommittee will present an analysis of tick-borne disease research and funding within federal agencies. The Public Comment subcommittee will provide an update on key themes of the written comments to the TBDWG. The 2020 report will address ongoing tick-borne disease research, including research related to causes, prevention, treatment, surveillance, diagnosis, diagnostics, duration of illness, and intervention for individuals with tick-borne diseases; advances made pursuant to such research; federal activities related to tick-borne diseases; and gaps in tick-borne disease research.

The Food and Drug Administration (FDA) is opening a docket to obtain data and information related to the use of vaping products that are associated with recent lung injuries. This request for information (RFI) responds to direction from Congress to gather information from the public that could help identify and evaluate additional steps the Agency could take to ``address the recent pulmonary illnesses reported to be associated with the use of e-cigarettes and vaping products.'' FDA is seeking information on product design and potential ways to prevent consumers from modifying or adding substances to these products that are not intended by the manufacturers. In particular, FDA is seeking data and information in the form of reports and manuscripts that are unpublished or not available through indexed bibliographic databases. FDA has searched the publicly available scientific literature and is now seeking to supplement that with information not included in the published scientific literature.

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.

This proposed notice acknowledges the receipt of an application from the Joint Commission for continued recognition as a national accrediting organization for hospitals that wish to participate in the Medicare or Medicaid programs.

In accordance with subsection (e)(12) of the Privacy Act of 1974, as amended, the Department of Health and Human Services (HHS), Centers for Medicare & Medicaid Services (CMS) is providing notice of a new matching program between CMS and the Department of the Treasury (Treasury), Internal Revenue Services (IRS), ``Verification of Household Income and Family Size for Insurance Affordability Programs and Exemptions.''

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.

This Request for Information (RFI) is intended to gather broad public input to assist the National Institutes of Health (NIH) in developing the NIH-Wide Strategic Plan for Fiscal Years (FYs) 2021- 2025. NIH invites input from stakeholders throughout the scientific research, advocacy, and clinical practice communities, as well as the general public, regarding the proposed framework for the FY 2021-2025 NIH-Wide Strategic Plan. Organizations are strongly encouraged to submit a single response that reflects the views of their organization and their membership as a whole.

The invention listed below is owned by an agency of the U.S. Government and is available for licensing to achieve expeditious commercialization of results of federally funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.

In compliance with the Paperwork Reduction Act of 1995, the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below.

The Food and Drug Administration (FDA) is requesting that industry organizations interested in participating in the selection of a pool of nonvoting industry representatives to serve as temporary nonvoting members on the Patient Engagement Advisory Committee (the Committee) in the Center for Devices and Radiological Health notify FDA in writing. FDA is also requesting nominations for temporary nonvoting industry representatives to be included in a pool of individuals to serve on the Committee. Nominees recommended to serve as a temporary nonvoting industry representative may either be self-nominated or nominated by an industry organization. This position may be filled by representatives from different medical device areas based on expertise relevant to the topics being considered by the Committee. Nominations will be accepted for upcoming vacancies effective with this notice. FDA seeks to include the views of women and men, members of all racial and ethnic groups, and individuals with and without disabilities on its advisory committees and, therefore, encourages nominations of appropriately qualified candidates from these groups.

In compliance with 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 or any other aspect of the ICR.