Department of Health and Human Services July 7, 2021 – Federal Register Recent Federal Regulation Documents

Determination of Regulatory Review Period for Purposes of Patent Extension; Zephyr Endobronchial Valve Implant
Document Number: 2021-14482
Type: Notice
Date: 2021-07-07
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for Zephyr Endobronchial Valve Implant and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that medical device.
Determination of Regulatory Review Period for Purposes of Patent Extension; BEOVU
Document Number: 2021-14473
Type: Notice
Date: 2021-07-07
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for BEOVU and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human biological product.
Biomin Holding GmbH; Filing of Food Additive Petition (Animal Use)
Document Number: 2021-14465
Type: Notice
Date: 2021-07-07
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) is announcing that we have filed a petition, submitted by Biomin Holding GmbH, proposing that the food additive regulations be amended to provide for the safe use of fumonisin esterase to degrade fumonisins in poultry feed.
Unique Device Identification System: Form and Content of the Unique Device Identifier; Guidance for Industry and Food and Drug Administration Staff; Availability
Document Number: 2021-14462
Type: Notice
Date: 2021-07-07
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a final guidance entitled ``Unique Device Identification System: Form and Content of the Unique Device Identifier (UDI).'' This document describes the requirements for, and FDA's recommendations regarding, the form and content of the UDI to help ensure that the UDIs developed under systems for the issuance of UDIs meet the objectives of the Unique Device Identification System Final Rule.
Determination of Regulatory Review Period for Purposes of Patent Extension; BARHEMSYS
Document Number: 2021-14461
Type: Notice
Date: 2021-07-07
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for BARHEMSYS and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human drug product.
Proposed Collection; 60-Day Comment Request; NIH NeuroBioBank Tissue Access Request Form, National Institutes of Health (NIH)
Document Number: 2021-14449
Type: Notice
Date: 2021-07-07
Agency: Department of Health and Human Services, National Institutes of Health
In compliance with the requirement of the Paperwork Reduction Act of 1995 to provide opportunity for public comment on proposed data collection projects, the National Institutes of Health (NIH) will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval.
Submission for OMB Review; Request for Assistance for Child Victims of Human Trafficking
Document Number: 2021-14448
Type: Notice
Date: 2021-07-07
Agency: Department of Health and Human Services, Administration for Children and Families
The Administration for Children and Families (ACF), Office on Trafficking in Persons (OTIP) is requesting a three-year extension of the form: Request for Assistance (RFA) for Child Victims of Human Trafficking (OMB #0970-0362, expiration 07/31/2021). Minor revisions have been made to the form, including the addition of a few fields that will enable the OTIP Child Protection Specialist team to better understand the child's specific needs, connect the child to appropriate services, and help ensure the safety of the child.
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2021-14441
Type: Notice
Date: 2021-07-07
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
The Centers for Disease Control and Prevention (CDC), as part of its continuing effort to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies the opportunity to comment on a proposed and/or continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on an information collection project titled National Quitline Data Warehouse. The National Quitline Data Warehouse (NQDW) collects a core set of information from all U.S. states, the District of Columbia, Guam, Puerto Rico, and the Asian Smoker's Quitline, regarding what services telephone quitlines offer to tobacco users as well as the number and type of tobacco users who receive services from telephone quitlines.
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2021-14439
Type: Notice
Date: 2021-07-07
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2021-14437
Type: Notice
Date: 2021-07-07
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
The Centers for Disease Control and Prevention (CDC), as part of its continuing effort to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies the opportunity to comment on a proposed and/or continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled The Muscular Dystrophy Surveillance, Tracking, and Research Network (MD STARnet) Muscular Dystrophy Questionnaire: Understanding the impact of COVID-19, flu, pain, fatigue, pregnancy and infertility, on adults with muscular dystrophy. The purpose of the proposed study is to describe the epidemiology of COVID-19 and flu and the experience with pain, fatigue, pregnancy, and infertility for adults living with muscular dystrophy who are identified through the Muscular Dystrophy Surveillance Tracking and Research Network (MD STARnet). Information will be used to develop interventions that improve the lives of people with muscular dystrophy and their families.
Agency Information Collection Request: 60-Day Public Comment Request
Document Number: 2021-14436
Type: Notice
Date: 2021-07-07
Agency: Department of Health and Human Services
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.
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2021-14434
Type: Notice
Date: 2021-07-07
Agency: Department of Health and Human Services, National Institutes of Health
National Heart, Lung, and Blood Institute; Notice of Closed Meeting
Document Number: 2021-14421
Type: Notice
Date: 2021-07-07
Agency: Department of Health and Human Services, National Institutes of Health
National Heart, Lung, and Blood Institute; Notice of Charter Renewal
Document Number: 2021-14420
Type: Notice
Date: 2021-07-07
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meeting
Document Number: 2021-14419
Type: Notice
Date: 2021-07-07
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2021-14418
Type: Notice
Date: 2021-07-07
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2021-14417
Type: Notice
Date: 2021-07-07
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Closed Meeting
Document Number: 2021-14416
Type: Notice
Date: 2021-07-07
Agency: Department of Health and Human Services, National Institutes of Health
Agency Information Collection Activities: Proposed Collection: Public Comment Request; Information Collection Request Title: The Maternal, Infant, and Early Childhood Home Visiting Program Quarterly Performance Report, OMB No. 0906-0016, Revision
Document Number: 2021-14412
Type: Notice
Date: 2021-07-07
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.
Lists of Designated Primary Medical Care, Mental Health, and Dental Health Professional Shortage Areas
Document Number: 2021-14408
Type: Notice
Date: 2021-07-07
Agency: Department of Health and Human Services, Health Resources and Services Administration
This notice informs the public of the availability of the complete lists of all geographic areas, population groups, and facilities designated as primary medical care, dental health, and mental health professional shortage areas (HPSAs) as of April 30, 2021. The lists are available on the shortage area topic page on HRSA's data.hrsa.gov website.
Basic Health Program; Federal Funding Methodology for Program Year 2022
Document Number: 2021-14393
Type: Rule
Date: 2021-07-07
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This document finalizes the methodology and data sources necessary to determine federal payment amounts to be made for program year 2022 to states that elect to establish a Basic Health Program under the Patient Protection and Affordable Care Act to offer health benefits coverage to low-income individuals otherwise eligible to purchase coverage through Health Insurance Exchanges, and incorporates the effects on such payment amounts the American Rescue Plan Act of 2021 (ARP).
Extension of Designation of Scarce Materials or Threatened Materials Subject to COVID-19 Hoarding Prevention Measures; Extension of Effective Date With Modifications
Document Number: 2021-14383
Type: Notice
Date: 2021-07-07
Agency: Department of Health and Human Services, Office of the Secretary
The Department of Health and Humans Services (HHS) provides notice of the extension of the designation issued on February 1, 2021, under Executive Order 13910 (Executive Order) and section 102 of the Defense Production Act of 1950 (the Act), as amended, designating health and medical resources necessary to respond to the spread of the virus associated with Coronavirus Disease 2019 (COVID-19) that are scarce or the supply of which would be threatened by excessive accumulation by people or entities not needing the excess supplies. These designated materials are subject to the hoarding prevention measures authorized under the Executive Order and the Act.
Office of the Director Notice of Charter Renewal
Document Number: 2021-14368
Type: Notice
Date: 2021-07-07
Agency: Department of Health and Human Services, National Institutes of Health
Medicare and Medicaid Programs; CY 2022 Home Health Prospective Payment System Rate Update; Home Health Value-Based Purchasing Model Requirements and Proposed Model Expansion; Home Health Quality Reporting Requirements; Home Infusion Therapy Services Requirements; Survey and Enforcement Requirements for Hospice Programs; Medicare Provider Enrollment Requirements; Inpatient Rehabilitation Facility Quality Reporting Program Requirements; and Long-Term Care Hospital Quality Reporting Program Requirements
Document Number: 2021-13763
Type: Proposed Rule
Date: 2021-07-07
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This proposed rule would set forth routine updates to the home health and home infusion therapy services payment rates for calendar year (CY) 2022 in accordance with existing statutory and regulatory requirements. This rule also provides monitoring and analysis of the Patient-Driven Groupings Model (PDGM); solicits comments on a methodology for determining the difference between assumed versus actual behavior change on estimated aggregate expenditures for home health payments as result of the change in the unit of payment to 30 days and the implementation of the PDGM case-mix adjustment methodology; and proposes to recalibrate the PDGM case-mix weights, functional levels, and comorbidity adjustment subgroups while maintaining the low utilization payment adjustment (LUPA) thresholds for CY 2022. Additionally, this rulemaking proposes to utilize the physical therapy LUPA add-on factor to establish the occupational therapy add-on factor for the LUPA add-on payment amounts; and make conforming regulations text changes to reflect that allowed practitioners are able to establish and review the plan of care. This rulemaking also proposes changes to the Home Health Quality Reporting Program (QRP) to remove one measure, remove two claims-based measures and replace them with one claims-based measure, publicly report two measures, propose a modification to the effective date for the reporting of the Transfer of Health to Provider-Post Acute Care and Transfer of Health to Patient-Post Acute Care (TOH) measures and Standardized Patient Assessment Data Elements and requests information on two topics: Advancing to digital quality measurement through the use of Fast Healthcare Interoperability Resources and our efforts surrounding closing the health equity gap. It also proposes modifications to the effective date for the reporting of TOH measures and certain Standardized Patient Assessment Data Elements. Additionally, this proposed rule requests information on two topics: Advancing to digital quality measurement through the use of Fast Healthcare Interoperability Resources and our efforts surrounding closing the health equity gap. It also proposes modifications to the effective date for the reporting of TOH measures and certain Standardized Patient Assessment Data Elements in the Inpatient Rehabilitation Facility (IRF) QRP and Long-Term Care Hospital (LTCH) QRP. In addition, this proposed rule would incorporate into regulation certain Medicare provider and supplier enrollment policies. In addition, this rulemaking proposes to make permanent selected regulatory blanket waivers related to home health aide supervision that were issued to Medicare participating home health agencies during the COVID-19 public health emergency (PHE), and would update the home health conditions of participation to implement Division CC, section 115 of the Consolidated Appropriations Act, 2021 (CAA 2021) regarding occupational therapists completing the initial and comprehensive assessments reflect these changes. This proposed rule also would expand the Home Health Value-Based Purchasing (HHVBP) Model, beginning January 1, 2022, to the 50 States, territories, and District of Columbia. This rulemaking also proposes to end the original HHVBP Model one year early for the home health agencies (HHAs) in the nine original Model States, such that CY 2020 performance data would not be used to calculate a payment adjustment for CY 2022 under the original Model. Additionally, this proposed rule establishes survey and enforcement requirements for hospice programs as set forth in Division CC, section 407, of the CAA 2021.