Department of Health and Human Services July 13, 2021 – Federal Register Recent Federal Regulation Documents

Emergency Clearance: Public Information Collection Requirements Submitted to the Office of Management and Budget (OMB)
Document Number: 2021-14866
Type: Notice
Date: 2021-07-13
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
The Centers for Medicare & Medicaid Services (CMS) is requesting that this information collection request (ICR), for revisions to the form CMS-2567 be processed under the emergency Paperwork Reduction Act of 1995 (PRA) clearance process.
Announcement of the Advisory Panel on Outreach and Education (APOE) July 28, 2021 Virtual Meeting
Document Number: 2021-14830
Type: Notice
Date: 2021-07-13
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This notice announces the next meeting of the APOE (the Panel) in accordance with the Federal Advisory Committee Act. The Panel advises and makes recommendations to the Secretary of the U.S. Department of Health and Human Services (HHS) (the Secretary) and the Administrator of the Centers for Medicare & Medicaid Services (CMS) on opportunities to enhance the effectiveness of consumer education strategies concerning the Health Insurance Marketplace[supreg], Medicare, Medicaid, and the Children's Health Insurance Program (CHIP). This meeting is open to the public.
Government-Owned Inventions; Availability for Licensing
Document Number: 2021-14820
Type: Notice
Date: 2021-07-13
Agency: Department of Health and Human Services, National Institutes of Health
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.
Agency Information Collection Activities: Proposed Collection: Public Comment Request; Information Collection Request Title: Advanced Nursing Education Program Specific Form OMB No. 0915-0375-Revision
Document Number: 2021-14804
Type: Notice
Date: 2021-07-13
Agency: Department of Health and Human Services, Health Resources and Services Administration
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.
Draft-Approaches to Developing Occupational Exposure Limits or Bands for Engineered Nanomaterials: User Guide and Technical Report
Document Number: 2021-14801
Type: Notice
Date: 2021-07-13
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
NIOSH announces the availability of a draft technical report entitled Approaches to Developing Occupational Exposure Limits or Bands for Engineered Nanomaterials: User Guide and Technical Report now available for public comment. To view the notice and related materials, visit https://www.regulations.gov and enter CDC-2021-0067 in the search field and click ``Search.''
Issuance of Priority Review Voucher; Material Threat Medical Countermeasure Product
Document Number: 2021-14779
Type: Notice
Date: 2021-07-13
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the issuance of a priority review voucher to the sponsor of a material threat medical countermeasure (MCM) product application. The Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the 21st Century Cures Act (Cures Act), authorizes FDA to award priority review vouchers to sponsors of approved material threat MCM product applications that meet certain criteria. FDA is required to publish notice of the award of the priority review voucher. FDA has determined that STRATAGRAFT (allogeneic cultured keratinocytes and dermal fibroblasts in murine collagendsat), manufactured by Stratatech, a Mallinckrodt Company, meets the criteria for a priority review voucher.
Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Device Labeling Regulations
Document Number: 2021-14768
Type: Notice
Date: 2021-07-13
Agency: Food and Drug Administration, Department of Health and Human Services
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 information collection associated with medical device labeling regulations.
Requirements Related to Surprise Billing; Part I
Document Number: 2021-14379
Type: Rule
Date: 2021-07-13
Agency: Employee Benefits Security Administration, Department of Labor, Department of Health and Human Services, Internal Revenue Service, Department of Treasury, Department of the Treasury, Office of Personnel Management
This document sets forth interim final rules implementing certain provisions of the No Surprises Act, which was enacted as part of the Consolidated Appropriations Act, 2021. These interim final rules amend and add provisions to existing rules under the Internal Revenue Code, the Employee Retirement Income Security Act, the Public Health Service Act, and the Federal Employees Health Benefits Act. These interim final rules implement provisions of the No Surprises Act that protect participants, beneficiaries, and enrollees in group health plans and group and individual health insurance coverage from surprise medical bills when they receive emergency services, non-emergency services from nonparticipating providers at participating facilities, and air ambulance services from nonparticipating providers of air ambulance services, under certain circumstances. In this rulemaking, the Department of Health and Human Services (HHS), the Department of Labor (DOL), and the Department of the Treasury (collectively, the Departments) are issuing interim final rules with largely parallel provisions that apply to group health plans and health insurance issuers offering group or individual health insurance coverage. HHS is also issuing in this rulemaking additional interim final rules that apply to emergency departments of hospitals and independent freestanding emergency departments, health care providers and facilities, and providers of air ambulance services related to the protections against surprise billing. The Office of Personnel Management (OPM) is issuing in this rulemaking interim final rules that specify how certain provisions of the No Surprises Act apply to health benefits plans offered by carriers under the Federal Employees Health Benefits Act (FEHBA).