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

The Office of Planning, Research, and Evaluation (OPRE) within the Administration for Children and Families (ACF) is proposing to conduct data collection activities for the Engaging Fathers and Paternal Relatives: A Continuous Quality Improvement Approach in the Child Welfare System (Fathers and Continuous Learning in Child Welfare [FCL]) Project. This evaluation is a descriptive study of child welfare agencies' use of a continuous quality improvement process called the Breakthrough Series Collaborative (BSC) to implement strategies to improve father and paternal relative engagement in the child welfare system. The project is designed to examine the use of the BSC methodology to strengthen fathers' and paternal relatives' engagement with children involved in child welfare and to add to the evidence base on engagement strategies for fathers and paternal relatives in child welfare.

The Ryan White HIV/AIDS Program (RWHAP) statute of the Public Health Services Act requires that RWHAP Part A, B, and C recipients expend 75 percent of Parts A, B, and C grant funds on core medical services for individuals with HIV/AIDS identified and eligible under the statute, after reserving statutory permissible amounts for administrative and clinical quality management costs. The statute also grants the Secretary authority to waive this requirement if certain requirements are met. HRSA is proposing to simplify the process for RWHAP Part A, B, and C recipients to request a waiver of the core medical services expenditure amount requirement by replacing HRSA Policy Number 13-07, ``Uniform Standard for Waiver of Core Medical Services Requirement for Grantees Under Parts, A, B, and C'' (accessible at the following link) https://hab.hrsa.gov/sites/default/ files/hab/Global/13-07waiver.pdf. This notice seeks to make public the proposed policy and provide an opportunity for public comment before its implementation. In a separate notice entitled, Updates to Uniform Standard for Waiver of the Ryan White HIV/AIDS Program Core Medical Services Expenditure Requirement, OMB No. 0906-XXXX-NEW, HRSA is inviting comments on the data collection changes associated with this proposed policy change.

In compliance with 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.

HRSA is publishing this notice of petitions received under the National Vaccine Injury Compensation Program (the Program), as required by the Public Health Service (PHS) Act, as amended. While the Secretary of HHS is named as the respondent in all proceedings brought by the filing of petitions for compensation under the Program, the United States Court of Federal Claims is charged by statute with responsibility for considering and acting upon the petitions.

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.

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 SimpleReport Mobile Application. SimpleReport is a free web-based application that provides an easy way to manage the testing workflow, to record results for rapid point of care COVID tests, to report the results to the appropriate public health department on behalf of the testing site, and to comply with existing requirements.

The Food and Drug Administration (FDA or Agency) is announcing the following public workshop entitled ``Morphine Milligram Equivalents: Current Applications and Knowledge Gaps, Research Opportunities, and Future Directions.'' The purpose of the workshop is to bring stakeholders together to discuss the scientific basis of morphine milligram equivalents (MMEs) with the goals of providing an understanding of the science and data underlying existing MME calculations for opioid analgesics, discussing the gaps in these data, and discussing future directions to refine and improve the scientific basis of MME applications.

The Department of Health and Human Services (HHS or ``The Department'') issued a Notice in the Federal Register of January 15, 2021, that, among other things, proposed to exempt 83 class II devices and 1 unclassified device from premarket notification. This Notice announces HHS's and the Food and Drug Administration's (FDA or ``the Agency'') withdrawal of the proposed exemptions for the 83 class II devices and 1 unclassified device. The comment period for the proposed class II and unclassified device exemptions closed on March 15, 2021. HHS and FDA are withdrawing the proposed exemptions after reviewing the Notice, its comments, inquiries to FDA, and other relevant information, and determining that the proposed exemptions and bases for them are flawed.

The Department of Health and Human Services, National Institutes of Health published a Notice in the Federal Register on April 9, 2021. That Notice requires a correction in the SUPPLEMENTARY INFORMATION section.

The Office of Population Affairs (OPA), in the Office of the Assistant Secretary for Health, proposes to revise the rules issued on March 4, 2019, establishing standards for compliance by family planning services projects authorized by Title X of the Public Health Service Act. Those rules have undermined the public health of the population the program is meant to serve. The Department proposes to revise the 2019 rules by readopting the 2000 regulations, with several modifications needed to strengthen the program and ensure access to equitable, affordable, client-centered, quality family planning services for all clients, especially for low-income clients.

This proposed rule would update the payment rates used under the prospective payment system (PPS) for skilled nursing facilities (SNFs) for fiscal year (FY) 2022. In addition, the proposed rule includes a proposed forecast error adjustment for FY 2022, proposes updates to the diagnosis code mappings used under the Patient Driven Payment Model (PDPM), proposes to rebase and revise the SNF market basket, proposes to implement a recently-enacted SNF consolidated billing exclusion along with the required proportional reduction in the SNF PPS base rates, and includes a discussion of a methodology to recalibrate the PDPM parity adjustment. In addition, the proposed rule includes proposals for the SNF Quality Reporting Program (QRP) and the SNF Value-Based Purchasing (VBP) Program, including a proposal to suppress the use of the SNF readmission measure for scoring and payment adjustment purposes in the FY 2022 SNF VBP program because we have determined that circumstances caused by the public health emergency for COVID-19 have significantly affected the validity and reliability of the measure and resulting performance scores.

The Food and Drug Administration (FDA) 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.

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.