Department of Health and Human Services December 2, 2020 – Federal Register Recent Federal Regulation Documents

Advisory Committee on Immunization Practices (ACIP)
Document Number: 2020-26587
Type: Notice
Date: 2020-12-02
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
In accordance with the Federal Advisory Committee Act, the Centers for Disease Control and Prevention (CDC), announces the following meeting of the Advisory Committee on Immunization Practices (ACIP). This meeting is open to the public. The meeting will be webcast live via the World Wide Web.
Request for Information: HIV National Strategic Plan 2021-2025 Available for Public Comment
Document Number: 2020-26586
Type: Notice
Date: 2020-12-02
Agency: Department of Health and Human Services
The Department of Health and Human Services' (HHS) Office of Infectious Disease and HIV/AIDS Policy (OIDP) in the Office of the Assistant Secretary for Health (OASH) announces the draft HIV National Strategic Plan: A Roadmap to End the HIV Epidemic (2021-2025) (HIV Plan) available for public comment. The draft HIV Plan may be reviewed at www.hiv.gov.
Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals
Document Number: 2020-26571
Type: Notice
Date: 2020-12-02
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is publishing a list of information collections that have been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Supplemental Evidence and Data Request on Living Systematic Review on Plant-Based Treatment for Chronic Pain
Document Number: 2020-26570
Type: Notice
Date: 2020-12-02
Agency: Agency for Healthcare Research and Quality, Department of Health and Human Services
The Agency for Healthcare Research and Quality (AHRQ) is seeking scientific information submissions from the public. Scientific information is being solicited to inform our Living Systematic Review on Plant-Based Treatment for Chronic Pain, which is currently being conducted by the AHRQ's Evidence-based Practice Centers (EPC) Program. Access to published and unpublished pertinent scientific information will improve the quality of this review.
Supplemental Evidence and Data Request on Transitions of Care From Pediatric to Adult Services for Children With Special Healthcare Needs
Document Number: 2020-26569
Type: Notice
Date: 2020-12-02
Agency: Agency for Healthcare Research and Quality, Department of Health and Human Services
The Agency for Healthcare Research and Quality (AHRQ) is seeking scientific information submissions from the public. Scientific information is being solicited to inform our review on Transitions of Care from Pediatric to Adult Services for Children with Special Healthcare Needs, which is currently being conducted by the AHRQ's Evidence-based Practice Centers (EPC) Program. Access to published and unpublished pertinent scientific information will improve the quality of this review.
National Institute on Alcohol Abuse and Alcoholism; Notice of Closed Meeting
Document Number: 2020-26561
Type: Notice
Date: 2020-12-02
Agency: Department of Health and Human Services, National Institutes of Health
Notice of Closed Meeting
Document Number: 2020-26558
Type: Notice
Date: 2020-12-02
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Agency Information Collection Activities; Proposed Collection; Comment Request; Infant Formula Requirements
Document Number: 2020-26537
Type: Notice
Date: 2020-12-02
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 the information collection provisions of our infant formula regulations, including infant formula labeling, quality control procedures, notification requirements, and recordkeeping. The notice also invites comment on electronic Form FDA 3978 that allows manufacturers of infant formula to submit reports and notifications in a standardized format.
Canned Pacific Salmon Deviating From Identity Standard; Amendment of Temporary Marketing Permit
Document Number: 2020-26533
Type: Notice
Date: 2020-12-02
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is amending Bumble Bee Seafoods Inc.'s temporary permit to market test canned skinless and boneless chunk salmon packed in water that contains sodium tripolyphosphate to inhibit protein curd formation during retorting. The temporary permit is amended to add an additional manufacturing location. This amendment will allow the applicant to continue to test market the test product and collect data on consumer acceptance of the test product.
Medicare Program; Specialty Care Models To Improve Quality of Care and Reduce Expenditures; Correction
Document Number: 2020-26512
Type: Rule
Date: 2020-12-02
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This document corrects technical and typographical errors that appeared in the final rule published in the September 29, 2020 Federal Register entitled ``Medicare Program; Specialty Care Models To Improve Quality of Care and Reduce Expenditures,'' which established the Radiation Oncology Model and the End-Stage Renal Disease Treatment Choices Model.
Medicare and Medicaid Programs; Organ Procurement Organizations Conditions for Coverage: Revisions to the Outcome Measure Requirements for Organ Procurement Organizations
Document Number: 2020-26329
Type: Rule
Date: 2020-12-02
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This final rule revises the Organ Procurement Organizations (OPOs) Conditions for Coverage (CfCs) to increase donation rates and organ transplantation rates by replacing the current outcome measures with new transparent, reliable, and objective outcome measures and increasing competition for open donation service areas (DSAs).
Medicare Program; Modernizing and Clarifying the Physician Self-Referral Regulations
Document Number: 2020-26140
Type: Rule
Date: 2020-12-02
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This final rule addresses any undue regulatory impact and burden of the physician self-referral law. This final rule is being issued in conjunction with the Centers for Medicare & Medicaid Services' (CMS) Patients over Paperwork initiative and the Department of Health and Human Services' (the Department or HHS) Regulatory Sprint to Coordinated Care. This final rule establishes exceptions to the physician self-referral law for certain value-based compensation arrangements between or among physicians, providers, and suppliers. It also establishes a new exception for certain arrangements under which a physician receives limited remuneration for items or services actually provided by the physician; establishes a new exception for donations of cybersecurity technology and related services; and amends the existing exception for electronic health records (EHR) items and services. This final rule also provides critically necessary guidance for physicians and health care providers and suppliers whose financial relationships are governed by the physician self-referral statute and regulations.
Medicare and State Health Care Programs: Fraud and Abuse; Revisions to Safe Harbors Under the Anti-Kickback Statute, and Civil Monetary Penalty Rules Regarding Beneficiary Inducements
Document Number: 2020-26072
Type: Rule
Date: 2020-12-02
Agency: Department of Health and Human Services, Office of Inspector General
This final rule amends the safe harbors to the Federal anti- kickback statute by adding new safe harbors and modifying existing safe harbors that protect certain payment practices and business arrangements from sanctions under the anti-kickback statute. This rule is issued in conjunction with the Department of Health and Human Services' (HHS's) Regulatory Sprint to Coordinated Care and focuses on care coordination and value-based care. This rule also amends the civil monetary penalty (CMP) rules by codifying a revision to the definition of ``remuneration'' added by the Bipartisan Budget Act of 2018 (Budget Act of 2018).
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