Department of Health and Human Services May 13, 2021 – Federal Register Recent Federal Regulation Documents
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Medicare and Medicaid Programs; COVID-19 Vaccine Requirements for Long-Term Care (LTC) Facilities and Intermediate Care Facilities for Individuals With Intellectual Disabilities (ICFs-IID) Residents, Clients, and Staff
This interim final rule with comment period (IFC) revises the infection control requirements that long-term care (LTC) facilities (Medicaid nursing facilities and Medicare skilled nursing facilities, also collectively known as ``nursing homes'') and intermediate care facilities for individuals with intellectual disabilities (ICFs-IID) must meet to participate in the Medicare and Medicaid programs. This IFC aims to reduce the spread of SARS-CoV-2 infections, the virus that causes COVID-19, by requiring education about COVID-19 vaccines for LTC facility residents, ICF-IID clients, and staff serving both populations, and by requiring that such vaccines, when available, be offered to all residents, clients, and staff. It also requires LTC facilities to report COVID-19 vaccination status of residents and staff to the Centers for Disease Control and Prevention (CDC). These requirements are necessary to help protect the health and safety of ICF-IID clients and LTC facility residents. In addition, the rule solicits public comments on the potential application of these or other requirements to other congregate living settings over which CMS has regulatory or other oversight authority.
CDC Draft 2021 Update to the HIV Preexposure Prophylaxis Clinical Practice Guideline and Supplement; Webinars
The Centers for Disease Control and Prevention (CDC), located within the Department of Health and Human Services (HHS), announces webinars that will be held on two dates to receive comments on the draft 2021 update to the HIV Preexposure Prophylaxis (PrEP) Clinical Practice Guideline and Providers Supplement. The webinars are an opportunity for all interested parties to ask questions and provide feedback, but are specifically directed toward clinicians, such as medical doctors, nurse practitioners, physician's assistants, and pharmacists. CDC will consider comments made during the webinars prior to finalizing the draft HIV Preexposure Prophylaxis Clinical Practice Guideline and Providers Supplement: 2021 Update for publication.
Intent To Prepare an Environmental Impact Statement for Certain Sunscreen Drug Products for Over-the-Counter Use
Under the National Environmental Policy Act of 1969 (NEPA), as implemented by the Council on Environmental Quality (CEQ) regulations, the Food and Drug Administration (FDA or Agency) announces its intent to prepare an environmental impact statement (EIS) to evaluate the potential environmental effects of revised conditions for marketing certain sunscreen products for over-the-counter (OTC) use without prior approval of a new drug application (NDA). By this notice, FDA is announcing the beginning of the scoping process to solicit public comments and identify issues to be analyzed in this EIS.
Agency Information Collection Activities: Proposed Collection: Public Comment Request; Information Collection Request Title: Black Lung Clinics Program, OMB No. 0915-0292-Revision
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.
National Advisory Committee on Seniors and Disasters: Establishment
The Office of the Assistant Secretary for Preparedness and Response (ASPR), in the Department of Health and Human Services (HHS) Office of the Secretary announces establishment of the National Advisory Committee on Seniors and Disasters (NACSD or Advisory Committee). The Advisory Committee will provide advice and recommendations to the Secretary of HHS, in accordance with the Federal Advisory Committee Act (FACA), to support and enhance all-hazards public health and medical preparedness, response activities, and recovery aimed at meeting the unique needs of seniors (older adults). The ASPR shall provide management and administrative oversight to support the activities of the Advisory Committee. The Office of the Secretary is accepting application submissions from qualified individuals who wish to be considered for membership on the NACSD. Up to seven new voting members with expertise in senior medical disaster planning, preparedness, response, or recovery will be selected for the Committee. Please visit the NACSD website at www.phe.gov/nacsd for all application submission information and instructions. Application submissions will be accepted for 30 calendar days from the date this posting is published in the Federal Register.
National Advisory Committee on Individuals With Disabilities and Disasters
The Office of the Assistant Secretary for Preparedness and Response (ASPR), in the Department of Health and Human Services (HHS) Office of the Secretary announces establishment of the National Advisory Committee on Individuals with Disabilities and Disasters (NACIDD). The Advisory Committee will provide advice and consultation to the HHS Secretary with respect to the medical, public health, and accessibility needs of individuals with disabilities related to preparation for, response to, and recovery from all-hazards emergencies. The Office of the Assistant Secretary for Preparedness and Response (ASPR) shall provide management and administrative oversight to support the activities of the Advisory Committee. The Office of the Secretary is accepting application submissions from qualified individuals who wish to be considered for membership on the NACIDD. Up to seven voting members with expertise disability accessibility, disaster planning, preparedness, response, or recovery will be selected for the Committee. Please visit the NACIDD website at www.phe.gov/ nacidd for all application submission information and instructions. Application submissions will be accepted for 30 calendar days from the date this posting is published in the Federal Register.
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