Department of Health and Human Services September 27, 2021 – Federal Register Recent Federal Regulation Documents

Approval of Respiratory Protective Devices
Document Number: 2021-21061
Type: Rule
Date: 2021-09-27
Agency: Department of Health and Human Services, Public Health Service
Medicare Program; Application by the American Diabetes Association (ADA) for Continued CMS Approval of Its Diabetes Outpatient Self-Management Training Program
Document Number: 2021-20943
Type: Notice
Date: 2021-09-27
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This final notice announces our decision to approve the American Diabetes Association (ADA) application for continued recognition as a national accrediting organization (AO) for accrediting entities that wish to furnish diabetes outpatient self-management training services to Medicare beneficiaries.
Interventions To Prevent Work-Related Stress and Support Health Worker Mental Health; Request for Information
Document Number: 2021-20931
Type: Notice
Date: 2021-09-27
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
The National Institute for Occupational Safety and Health (NIOSH), within the Centers for Disease Control and Prevention (CDC), announces an opportunity for the public to provide information and comments on current evidence-based, workplace and occupational safety and health interventions to prevent work-associated stress, support stress reduction, and foster positive mental health and well-being among the nation's health workers. Information and comments are also requested on interventions under development and research in progress to support and promote the mental health and well-being of health workers. NIOSH is seeking information on related best practices, promising practices, or successful programs related to providing stress prevention and mental health services to health workers. Examples of such services include, but are not limited to, employee assistance programs, screenings, supervisor trainings, workplace policies, talk therapy, mindfulness, peer support, and mobile apps.
Board of Scientific Counselors, Center for Preparedness and Response, (BSC, CPR)
Document Number: 2021-20928
Type: Notice
Date: 2021-09-27
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
In accordance with the Federal Advisory Committee Act, the CDC announces the following meeting for the Board of Scientific Counselors, Center for Preparedness and Response, (BSC, CPR). This is a virtual meeting that is open to the public, limited only by the number of internet conference accesses available, which is 500. Pre-registration is required by accessing the link in the ADDRESSES section.
Solicitation of Nominations for Appointment to the Clinical Laboratory Improvement Advisory Committee (CLIAC)
Document Number: 2021-20925
Type: Notice
Date: 2021-09-27
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
The Centers for Disease Control and Prevention (CDC) is seeking nominations for membership on the CLIAC. The CLIAC consists of 20 experts including the Chair, represents a diverse membership across laboratory specialties, professional roles (laboratory management, technical specialists, physicians, nurses) and practice settings (academic, clinical, public health), and includes a consumer representative.
Solicitation of Nominations for Appointment to the Interagency Committee on Smoking and Health (ICSH)
Document Number: 2021-20920
Type: Notice
Date: 2021-09-27
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
The Centers for Disease Control and Prevention (CDC) is seeking nominations for membership on the ICSH. The ICSH consists of five public members, as deemed by statute, that represent private entities involved in informing the public about the health effects of smoking.
Submission for OMB Review; Administration and Oversight of the Unaccompanied Children Program (OMB #0970-0547)
Document Number: 2021-20918
Type: Notice
Date: 2021-09-27
Agency: Department of Health and Human Services, Administration for Children and Families
The Office of Refugee Resettlement (ORR), Administration for Children and Families (ACF), U.S. Department of Health and Human Services (HHS), is inviting public comments on revisions to an approved information collection. The request consists of several forms that allow the Unaccompanied Children (UC) Program to monitor care provider facility compliance with federal laws and regulations, legal agreements, and ORR policies and procedures; and perform other administrative tasks.
Prospective Grant of an Exclusive Patent License: Development of a Bispecific T Cell Engager for the Treatment and Cure of HIV-1
Document Number: 2021-20908
Type: Notice
Date: 2021-09-27
Agency: Department of Health and Human Services, National Institutes of Health
The National Cancer Institute, an institute of the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an Exclusive Patent License to practice the inventions embodied in the Patents and Patent Applications listed in the Supplementary Information section of this notice to Gilead Sciences, Inc. (``Gilead'') located in Foster City, CA.
Performance Review Board Membership
Document Number: 2021-20886
Type: Notice
Date: 2021-09-27
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
National Institute on Alcohol Abuse and Alcoholism; Notice of Closed Meeting
Document Number: 2021-20885
Type: Notice
Date: 2021-09-27
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Nursing Research; Notice of Closed Meeting
Document Number: 2021-20884
Type: Notice
Date: 2021-09-27
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2021-20881
Type: Notice
Date: 2021-09-27
Agency: Department of Health and Human Services, National Institutes of Health
National Center for Complementary & Integrative Health; Notice of Closed Meeting
Document Number: 2021-20879
Type: Notice
Date: 2021-09-27
Agency: Department of Health and Human Services, National Institutes of Health
Criteria for Determining Maternity Care Health Professional Target Areas
Document Number: 2021-20855
Type: Notice
Date: 2021-09-27
Agency: Department of Health and Human Services, Health Resources and Services Administration
In accordance with the requirements of the Public Health Service Act, HRSA, authorized by the Secretary of HHS, shall establish the criteria which will be used to determine maternity care health professional target areas (MCTAs) in existing primary care Health Professional Shortage Areas (HPSAs). This notice sets forth the proposed criteria which will be used to identify and score MCTAs.
Statutory Requirements and Process Standardization: Maternal, Infant, and Early Childhood Home Visiting (MIECHV) Program Model Eligibility Review
Document Number: 2021-20853
Type: Notice
Date: 2021-09-27
Agency: Department of Health and Human Services, Health Resources and Services Administration
HRSA, in partnership with the Administration for Children and Families (ACF) within HHS, oversees the MIECHV Program, which supports voluntary, evidence-based home visiting services during pregnancy and to families with young children up to kindergarten entry. HRSA proposes to standardize a process for also assessing Home Visiting Evidence of Effectiveness (HomVEE)-approved home visiting models against the MIECHV statutory requirements for a model to determine which of the HomVEE- approved models can be used to implement the MIECHV Program.
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2021-20847
Type: Notice
Date: 2021-09-27
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 existing information collection project titled the CDC Worksite Health Scorecard. The collection is an organizational assessment and planning tool designed to help employers identify gaps in their health promotion programs and prioritize high-impact strategies for health promotion at their worksites.
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2021-20846
Type: Notice
Date: 2021-09-27
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 National Healthcare Safety Network (NHSN). NHSN is the nation's most widely used healthcare- associated infection tracking system, providing facilities, states, regions, and the nation with data needed to identify problem areas, measure progress of prevention efforts, and ultimately eliminate healthcare-associated infections.
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2021-20845
Type: Notice
Date: 2021-09-27
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 Annual Submission of the Ingredients Added to, and the Quantity of Nicotine Contained in, Smokeless Tobacco Manufactured, Imported, or Packaged in the U.S. This Extension permits CDC to collect a list of ingredients added to tobacco in the manufacture of smokeless tobacco products, and a specification of the quantity of nicotine contained in each product. CDC's Office of Smoking and Health (OSH) has been delegated with the responsibility for implementing the required information collection by HHS.
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2021-20844
Type: Notice
Date: 2021-09-27
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 continuing information collection project titled List of Ingredients Added to Tobacco in the Manufacture of Cigarette Products. The proposed collection allows CDC's Office of Smoking and Health (OSH) to collect information about the ingredients used in cigarette products, a responsibility that has been delegated to CDC by HHS.
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2021-20843
Type: Notice
Date: 2021-09-27
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 Understanding Health System Approaches to Chronic Pain Management. The proposed study is designed to evaluate the effects of evidence-based guidelines related to chronic pain management and opioid prescribing.
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2021-20842
Type: Notice
Date: 2021-09-27
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Agency Information Collection Request; 60-Day Public Comment Request
Document Number: 2021-20838
Type: Notice
Date: 2021-09-27
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.
Agency Information Collection Request; 60-Day Public Comment Request
Document Number: 2021-20837
Type: Notice
Date: 2021-09-27
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.
Agency Information Collection Request; 60-Day Public Comment Request
Document Number: 2021-20835
Type: Notice
Date: 2021-09-27
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.
Agency Information Collection Request; 60-Day Public Comment Request
Document Number: 2021-20831
Type: Notice
Date: 2021-09-27
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.
Amending Over-the-Counter Monograph M020: Sunscreen Drug Products for Over-the-Counter Human Use; Over the Counter Monograph Proposed Order; Availability
Document Number: 2021-20780
Type: Notice
Date: 2021-09-27
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 an over-the-counter (OTC) monograph proposed order (order ID OTC000008) entitled ``Amending Over-the- Counter (OTC) Monograph M020: Sunscreen Drug Products for OTC Human Use.'' FDA is issuing this proposed order to amend and revise the deemed final administrative order concerning nonprescription sunscreen drug products (Deemed Final Order) established by the enactment of the Coronavirus Aid, Relief, and Economic Security Act (CARES Act). This proposed order, if finalized, would replace the Deemed Final Order in its entirety with new conditions under which nonprescription sunscreen drug products would be determined to be generally recognized as safe and effective (GRASE) under the Federal Food, Drug, and Cosmetic Act (FD&C Act). It also sets forth certain characteristics that would establish that a sunscreen drug product is not GRASE.
Patient Protection and Affordable Care Act; Updating Payment Parameters, Section 1332 Waiver Implementing Regulations, and Improving Health Insurance Markets for 2022 and Beyond
Document Number: 2021-20509
Type: Rule
Date: 2021-09-27
Agency: Department of Health and Human Services, Department of the Treasury
This final rule sets forth revised 2022 user fee rates for issuers offering qualified health plans (QHPs) through federally- facilitated Exchanges and State-based Exchanges on the Federal platform; repeals separate billing requirements related to the collection of separate payments for the portion of QHP premiums attributable to coverage for certain abortion services; expands the annual open enrollment period and Navigator duties; implements a new monthly special enrollment period for qualified individuals or enrollees, or the dependents of a qualified individual or enrollee, who are eligible for advance payments of the premium tax credit (APTC) and whose household income does not exceed 150 percent of the Federal poverty level, available during periods of time during which APTC benefits are available such that certain applicable taxpayers' applicable percentage is set at zero, such as during tax years 2021 and 2022 under the section 9661 of the American Rescue Plan Act of 2021; repeals the recent establishment of a Direct Enrollment option for Exchanges; and modifies regulations and policies related to section 1332 waivers.
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