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

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry and FDA staff entitled ``Requesting FDA Feedback on Combination Products.'' The purpose of this guidance is to discuss ways in which combination product sponsors can obtain feedback from FDA on scientific and regulatory questions and to describe best practices for FDA and sponsors when interacting on these topics. These interactions can occur through application-based mechanisms, such as the pre-submission process used in the Center for Devices and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER) and the formal meetings used in the Center for Drug Evaluation and Research (CDER) and CBER, or through Combination Product Agreement Meetings (CPAMs), as appropriate.

The Food and Drug Administration (FDA) is announcing the renewal of the Pharmacy Compounding Advisory Committee by the Commissioner of Food and Drugs (the Commissioner). The Commissioner has determined that it is in the public interest to renew the Pharmacy Compounding Advisory Committee for an additional 2 years beyond the charter expiration date. The new charter will be in effect until April 25, 2022.

The Food and Drug Administration (FDA or Agency) is correcting a notice entitled ``Formal Meetings Between the Food and Drug Administration and Abbreviated New Drug Application Applicants of Complex Products Under Generic Drug User Fee Amendments; Guidance for Industry; Availability'' that appeared in the Federal Register of November 25, 2020. The document announced the availability for a guidance for industry. The document was published with incorrect information in the Paperwork Reduction Act of 1995 section. This document corrects that error.

The Department of Health and Human Services (HHS), Office of Minority Health (OMH) is seeking nominations of qualified candidates to be considered for appointment as a member of the Advisory Committee on Minority Health (hereafter referred to as the ``Committee or ACMH''). The Committee provides advice to the Deputy Assistant Secretary for Minority Health on the development of goals and specific program activities for improving the health and the quality of health care minorities receive and eliminating racial and ethnic health disparities consistent with the Public Health Service (PHS) Act.

The Food and Drug Administration (FDA or Agency) announces a forthcoming public advisory committee meeting of the Vaccines and Related Biological Products Advisory Committee. The general function of the committee is to provide advice and recommendations to the Agency on FDA's regulatory issues. The meeting will be open to the public. FDA is establishing a docket for public comment on this document. Consistent with FDA's regulations, this notice is being published with less than 15 days prior to the date of the meeting based on a determination that convening a meeting of the Vaccines and Related Biological Products Advisory Committee as soon as possible is warranted. This Federal Register notice could not be published 15 days prior to the date of the meeting due to a recent submission by Moderna, Inc., of a request for Emergency Use Authorization (EUA) for an investigational vaccine to prevent Coronavirus Disease 2019 (COVID-19) and the need for prompt discussion of such submission, given the COVID-19 pandemic.

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 the existing information collection project titled Paul Coverdell National Acute Stroke Program (PCNASP) reporting system, which was established to improve quality of care for acute stroke patients from onset of signs and symptoms through hospital care and rehabilitation and recovery.

The Administration for Community Living is announcing that the proposed collection of information listed above has been submitted to the Office of Management and Budget (OMB) for review and clearance as required under the Paperwork Reduction Act of 1995. This 30-Day notice collects comments on the information collection requirements related to the proposed information collection, Certification of Maintenance of Effort for Title III and Certification of Long Term Care Ombudsman Program Expenditures OMB #0985-0009.

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.

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.

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.

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.

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.

The Administration for Community Living (ACL) is announcing an opportunity for the public to comment on the proposed collection of information listed above. Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish a 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 survey previously ran a 60-day FRN in 83 FR 66276 on 12/ 26/2018. As required under the PRA we are providing the public an opportunity to comment on any changes or updates applied to this IC since the 2018 publication. We are requesting an abbreviated public comment period for additional 30-days prior to publication of a 30-day FRN and submittal to OMB. Any changes to the survey from the initial 60-day FRN publication are incorporated into the revised version of the survey. This notice solicits comments on any revisions since the initial publication in 2018. This is a new information collection 0985-New Inventory of Adult Protective Services Practices and Service Innovations.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Evaluation of Gastric pH-Dependent Drug Interactions With Acid-Reducing Agents: Study Design, Data Analysis, and Clinical Implications.'' This draft guidance focuses on specific recommendations pertinent to gastric pH- dependent drug-drug interaction (DDI) assessment and describes the FDA's recommendations regarding when clinical DDI studies with acid- reducing agents (ARAs) are needed; design of the clinical studies; interpretation of study results; and communicating findings and options for managing pH-dependent DDIs in product labeling.

The Food and Drug Administration (FDA or Agency) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

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).

This final rule adopts certain changes to the risk adjustment data validation error estimation methodology beginning with the 2019 benefit year for states where the Department of Health and Human Services (HHS) operates the risk adjustment program. This rule is finalizing changes to the HHS-RADV error estimation methodology, which is used to calculate adjusted risk scores and risk adjustment transfers, beginning with the 2019 benefit year of HHS-RADV. This rule also finalizes a change to the benefit year to which HHS-RADV adjustments to risk scores and risk adjustment transfers would be applied beginning with the 2020 benefit year of HHS-RADV. These policies seek to further the integrity of HHS-RADV, address stakeholder feedback, promote fairness, and improve the predictability of HHS-RADV adjustments.