Department of Health and Human Services May 2021 – Federal Register Recent Federal Regulation Documents

Results 251 - 291 of 291
National Institute of Environmental Health Sciences; Notice of Closed Meeting
Document Number: 2021-09575
Type: Notice
Date: 2021-05-06
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Deafness and Other Communication Disorders; Notice of Closed Meetings
Document Number: 2021-09563
Type: Notice
Date: 2021-05-06
Agency: Department of Health and Human Services, National Institutes of Health
Office of the Secretary, Muscular Dystrophy Coordinating Committee Call for Committee Membership Nominations
Document Number: 2021-09562
Type: Notice
Date: 2021-05-06
Agency: Department of Health and Human Services, National Institutes of Health
The Office of the Secretary of the Department of Health and Human Services (HHS) is seeking nominations for two individuals to serve as non-federal public members on the Muscular Dystrophy Coordinating Committee.
National Institute on Aging; Notice of Closed Meetings
Document Number: 2021-09522
Type: Notice
Date: 2021-05-06
Agency: Department of Health and Human Services, National Institutes of Health
Coal Workers' Health Surveillance Program: Autopsy Payment
Document Number: 2021-09499
Type: Rule
Date: 2021-05-06
Agency: Department of Health and Human Services
With this final rule, HHS amends 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. HHS has determined that the agency needs additional time to consider the public comments received on the addition of procedures for suspending or revoking B Reader certification, as proposed in the notice of proposed rulemaking preceding this final rule; those procedures will be finalized at a later date.
National Institute of Biomedical Imaging and Bioengineering; Notice of Closed Meeting
Document Number: 2021-09492
Type: Notice
Date: 2021-05-05
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Biomedical Imaging and Bioengineering; Notice of Closed Meeting
Document Number: 2021-09491
Type: Notice
Date: 2021-05-05
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: 2021-09490
Type: Notice
Date: 2021-05-05
Agency: Department of Health and Human Services, National Institutes of Health
Proposed Collection; 60-Day Comment Request; Generic Clearance To Collect Stakeholder Feedback on the Research Domain Criteria (RDoC) Initiative, (NIMH)
Document Number: 2021-09486
Type: Notice
Date: 2021-05-05
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; Grants to States for Access and Visitation, OMB #0970-0204
Document Number: 2021-09452
Type: Notice
Date: 2021-05-05
Agency: Department of Health and Human Services, Administration for Children and Families
The Division of Program Innovation (DPI), Office of Child Support Enforcement (OCSE), Administration for Children and Families (ACF) is requesting a 3-year extension of the Access and Visitation Survey: Annual Report (OMB #0970-0204, expiration 10/31/2021). There are no changes requested to the form.
Patient Protection and Affordable Care Act; HHS Notice of Benefit and Payment Parameters for 2022 and Pharmacy Benefit Manager Standards
Document Number: 2021-09102
Type: Rule
Date: 2021-05-05
Agency: Department of Health and Human Services
This final rule sets forth payment parameters and provisions related to the risk adjustment program and cost-sharing parameters. It includes changes related to special enrollment periods; direct enrollment entities; the administrative appeals processes with respect to health insurance issuers and non-federal governmental group health plans; the medical loss ratio program; income verification by Exchanges; and other related topics. It also revises the regulation requiring the reporting of certain prescription drug information by qualified health plans or their pharmacy benefit managers.
Rescission of the Requirement for Airlines To Collect Designated Information for Passengers Destined for the United States Who Are Departing From, or Were Otherwise Present in the Democratic Republic of the Congo
Document Number: 2021-09470
Type: Notice
Date: 2021-05-04
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
The Centers for Disease Control and Prevention (CDC), a component of the Department of Health and Human Services (HHS), announces the rescission of the requirement for airlines and aircraft operators to collect designated information for passengers who are departing from, or were otherwise present in, the Democratic Republic of the Congo (DRC) within 21 days prior to their entry or attempted entry into the United States. This rescission is based on the CDC Director's determination that such passengers are no longer at risk of exposure to Ebola virus disease (EVD) and that their accurate and complete contact information is no longer needed to protect the health of fellow travelers and United States communities. All requirements pertaining to Guinea remain in effect.
National Institute of Mental Health; Notice of Closed Meetings
Document Number: 2021-09375
Type: Notice
Date: 2021-05-04
Agency: Department of Health and Human Services, National Institutes of Health
Request for Nominations to the Advisory Council on Alzheimer's Research, Care, and Services
Document Number: 2021-09363
Type: Notice
Date: 2021-05-04
Agency: Department of Health and Human Services
The Secretary of HHS established the Advisory Council on Alzheimer's Research, Care, and Services to provide advice and consultation to the Secretary on how to prevent or reduce the burden of Alzheimer's disease and related dementias on people with the disease and their caregivers. The Secretary signed the charter establishing the Advisory Council on May 23, 2011. HHS is soliciting nominations for seven (7) new non-federal members of the Advisory Council to replace the seven (7) members whose terms will end September 30, 2021. Nominations should include, at a minimum, the nominee's contact information (current mailing address, email address, and telephone number) and current curriculum vitae or resume.
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2021-09360
Type: Notice
Date: 2021-05-04
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
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.
Prospective Grant of an Exclusive Patent License: Development and Commercialization of Cell Therapies for Cancer
Document Number: 2021-09333
Type: Notice
Date: 2021-05-04
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 Ziopharm Oncology, Inc. (``Ziopharm''), headquartered in Boston, MA.
Prospective Grant of an Exclusive Patent License: Natural Product Based Nanoparticles as Dietary Management and/or Treatment of Inflammatory Related Diseases
Document Number: 2021-09332
Type: Notice
Date: 2021-05-04
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 MaDu, LLC located at 2025 Broadway, Suite 23E, New York, NY 10023.
National Toxicology Program Board of Scientific Counselors; Announcement of Meeting; Request for Comments
Document Number: 2021-09331
Type: Notice
Date: 2021-05-04
Agency: Department of Health and Human Services, National Institutes of Health
This notice announces the next meeting of the National Toxicology Program (NTP) Board of Scientific Counselors (BSC). The BSC, a federally chartered, external advisory group composed of scientists from the public and private sectors, will review and provide advice on programmatic activities. This meeting is a virtual meeting and is open to the public. Written comments will be accepted and registration is required to present oral comments. Information about the meeting and registration are available at https://ntp.niehs.nih.gov/go/165.
Prospective Grant of an Exclusive Patent License: Development and Commercialization of Cell Therapies for Cancer
Document Number: 2021-09330
Type: Notice
Date: 2021-05-04
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 Athenex, Inc. (``Athenex'') headquartered in Buffalo, NY.
National Institute on Aging; Notice of Closed Meeting
Document Number: 2021-09328
Type: Notice
Date: 2021-05-04
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2021-09327
Type: Notice
Date: 2021-05-04
Agency: Department of Health and Human Services, National Institutes of Health
Privacy Act of 1974; Matching Program
Document Number: 2021-09292
Type: Notice
Date: 2021-05-04
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
In accordance with 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 the re-establishment of a computer matching program between CMS and the Office of Personnel Management (OPM), ``Verification of Eligibility of Minimum Essential Coverage Under the Patient Protection and Affordable Care Act through an Office of Personnel Management Health Benefit Plan.''
Eleventh Meeting of the National Clinical Care Commission
Document Number: 2021-09277
Type: Notice
Date: 2021-05-04
Agency: Department of Health and Human Services
The National Clinical Care Commission (the Commission) will conduct its eleventh meeting virtually on May 19 and June 1, 2021. The Commission is charged to evaluate and make recommendations to the U.S. Department of Health and Human Services (HHS) Secretary and Congress regarding improvements to the coordination and leveraging of federal programs related to diabetes and its complications.
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2021-09270
Type: Notice
Date: 2021-05-04
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2021-09268
Type: Notice
Date: 2021-05-04
Agency: Department of Health and Human Services, National Institutes of Health
Medicare Program; Meeting Announcement for the Medicare Advisory Panel on Clinical Diagnostic Laboratory Tests
Document Number: 2021-09261
Type: Notice
Date: 2021-05-03
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This notice announces the public meeting dates for the Medicare Advisory Panel on Clinical Diagnostic Laboratory Tests (the Panel) on Wednesday, July 28, 2021 and Thursday, July 29, 2021. The purpose of the Panel is to advise the Secretary of the Department of Health and Human Services and the Administrator of the Centers for Medicare & Medicaid Services on issues related to clinical diagnostic laboratory tests.
Medicare Program; Public Meeting on June 24, 2021 Regarding New and Reconsidered Clinical Diagnostic Laboratory Test Codes for the Clinical Laboratory Fee Schedule for Calendar Year 2022
Document Number: 2021-09260
Type: Notice
Date: 2021-05-03
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This notice announces a public meeting to receive comments and recommendations (including data on which recommendations are based) on the appropriate basis for establishing payment amounts for new or substantially revised Healthcare Common Procedure Coding System codes being considered for Medicare payment under the Clinical Laboratory Fee Schedule (CLFS) for calendar year (CY) 2022. This meeting also provides a forum for those who submitted certain reconsideration requests regarding final determinations made last year on new test codes and for the public to provide comment on the requests.
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2021-09256
Type: Notice
Date: 2021-05-03
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
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.
Request for Information (RFI) Developing the National Public Health Strategy for the Prevention and Control of Vector-Borne Diseases in Humans; Correction
Document Number: 2021-09241
Type: Notice
Date: 2021-05-03
Agency: Department of Health and Human Services
The Office of the Assistant Secretary for Health published a document in the Federal Register of April 27, 2021, requesting comments be sent via www.regulations.gov with a docket number of HHS-OASH-2021- 0001. The referenced docket number was incorrect and also inadvertently omitted two additional questions on page 22215.
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2021-09237
Type: Notice
Date: 2021-05-03
Agency: Department of Health and Human Services, National Institutes of Health
National Heart, Lung, and Blood Institute; Notice of Closed Meeting
Document Number: 2021-09236
Type: Notice
Date: 2021-05-03
Agency: Department of Health and Human Services, National Institutes of Health
Current List of HHS-Certified Laboratories and Instrumented Initial Testing Facilities which Meet Minimum Standards to Engage in Urine and Oral Fluid Drug Testing for Federal Agencies
Document Number: 2021-09214
Type: Notice
Date: 2021-05-03
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
The Department of Health and Human Services (HHS) notifies federal agencies of the laboratories and Instrumented Initial Testing Facilities (IITFs) currently certified to meet the standards of the Mandatory Guidelines for Federal Workplace Drug Testing Programs using Urine or Oral Fluid (Mandatory Guidelines).
Patient Safety Organizations: Voluntary Relinquishment for the Sigma PSO, LLC
Document Number: 2021-09180
Type: Notice
Date: 2021-05-03
Agency: Agency for Healthcare Research and Quality, Department of Health and Human Services
The Patient Safety and Quality Improvement Final Rule (Patient Safety Rule) authorizes AHRQ, on behalf of the Secretary of HHS, to list as a patient safety organization (PSO) an entity that attests that it meets the statutory and regulatory requirements for listing. A PSO can be ``delisted'' by the Secretary if it is found to no longer meet the requirements of the Patient Safety and Quality Improvement Act of 2005 (Patient Safety Act) and Patient Safety Rule, when a PSO chooses to voluntarily relinquish its status as a PSO for any reason, or when a PSO's listing expires. AHRQ accepted a notification of proposed voluntary relinquishment from the Sigma PSO, LLC, PSO number P0190, of its status as a PSO, and has delisted the PSO accordingly.
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2021-09139
Type: Notice
Date: 2021-05-03
Agency: Agency for Healthcare Research and Quality, Department of Health and Human Services
This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) approve the renewal of the information collection project ``Medical Office Survey on Patient Safety Culture Database.''
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2021-09138
Type: Notice
Date: 2021-05-03
Agency: Agency for Healthcare Research and Quality, Department of Health and Human Services
This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) approve the proposed information collection project ``The AHRQ Safety Program for Methicillin-Resistant Staphylococcus aureus (MRSA) Prevention.''
Withdrawal of Notice Regarding the Food and Drug Administration Drug Review Timeline Transparency; Revocation of Statement of Policy
Document Number: 2021-09134
Type: Notice
Date: 2021-05-03
Agency: Food and Drug Administration, Department of Health and Human Services
The Department of Health and Human Services (Department or HHS) and the Food and Drug Administration (FDA or Agency) are issuing this notice to withdraw the notice published in the Federal Register of January 15, 2021, announcing a Statement of Policy indicating that FDA will publish certain information regarding the timeline for its review of drug product applications. The Department and FDA are withdrawing the notice and revoking the Statement of Policy because, among other things, the notice did not account for all relevant considerations related to information that is already publicly available about FDA's review of drug applications.
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2021-09110
Type: Notice
Date: 2021-05-03
Agency: Department of Health and Human Services, National Institutes of Health
Medicare Program: Comprehensive Care for Joint Replacement Model Three-Year Extension and Changes to Episode Definition and Pricing; Medicare and Medicaid Programs; Policies and Regulatory Revisions in Response to the COVID-19 Public Health Emergency
Document Number: 2021-09097
Type: Rule
Date: 2021-05-03
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This final rule extends the length of the Comprehensive Care for Joint Replacement (CJR) model through December 31, 2024 by adding an additional 3 performance years (PYs). PY 6 will begin on October 1, 2021 and end on December 31, 2022; PY 7 will begin on January 1, 2023 and end on December 31, 2023; and PY 8 will begin on January 1, 2024 and end on December 31, 2024. In addition, this final rule revises certain aspects of the CJR model including the episode of care definition, the target price calculation, the reconciliation process, the beneficiary notice requirements, and the appeals process. In addition, for PY 6 through 8, this final rule eliminates the 50 percent cap on gainsharing payments, distribution payments, and downstream distribution payments for certain recipients. This final rule extends the additional flexibilities provided to participant hospitals related to certain Medicare program rules consistent with the revised episode of care definition.
Medicare and Medicaid Programs; Quarterly Listing of Program Issuances-January Through March 2021
Document Number: 2021-09081
Type: Notice
Date: 2021-05-03
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This quarterly notice lists CMS manual instructions, substantive and interpretive regulations, and other Federal Register notices that were published from January through March 2021, relating to the Medicare and Medicaid programs and other programs administered by CMS.
Advisory Board on Radiation and Worker Health (ABRWH), National Institute for Occupational Safety and Health (NIOSH)
Document Number: 2021-09007
Type: Notice
Date: 2021-05-03
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 of the Advisory Board on Radiation and Worker Health (ABRWH or Advisory Board). This meeting is open to the public, but without a public comment period. The public is welcome to submit written comments in advance of the meeting, to the contact person below. Written comments received in advance of the meeting will be included in the official record of the meeting. The public is also welcome to listen to the meeting by joining the teleconference (information below). The audio conference line has 150 ports for callers.
Advisory Council for the Elimination of Tuberculosis (ACET)
Document Number: 2021-09006
Type: Notice
Date: 2021-05-03
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 of the Advisory Council for the Elimination of Tuberculosis Meeting (ACET). This meeting is open to the public and limited to 1,000 audio and web conference lines. Time will be available for public comment.