Department of Health and Human Services April 24, 2019 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA or we) is announcing the availability of an update to the immediately in effect guidance for industry entitled ``Compliance Policy for Combination Product Postmarketing Safety Reporting.'' This guidance describes FDA's compliance policy for combination product applicants and constituent part applicants and activities under FDA regulations that addresses combination product postmarketing safety reporting. FDA is updating this guidance by extending the period of time during which FDA does not intend to enforce certain combination product postmarketing safety reporting requirements.

The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the General and Plastic Surgery Devices Panel of the Medical Devices 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.

The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled ``Surgical Staplers and Staples for Internal UseLabeling Recommendations.'' FDA is issuing this draft guidance to provide labeling recommendations for surgical staplers and staples for internal use. These labeling recommendations are being issued because malfunctions and misuse associated with these devices have resulted in serious adverse events, including deaths. This draft guidance is not final nor is it currently in effect.

The Food and Drug Administration (FDA or the Agency) is reopening the comment period provided in the notice entitled ``Food Handler Antiseptic Drug Products for Over-the-Counter Human Use; Request for Data and Information'' that appeared in the Federal Register of December 7, 2018. That notice announced the establishment of a docket to obtain data, information, and comments that will assist the Agency in assessing the safety and effectiveness of food handler antiseptic drug products (i.e., antiseptic hand washes or rubs intended for use in food handling settings) for over-the-counter human use. The Agency is taking this action to allow interested persons additional time to submit comments, data, or information.

The Administration for Children and Families (ACF) at the U.S. Department of Health and Human Services (HHS) seeks approval to collect descriptive information for the Early Head Start Family and Child Experiences Survey 2020 (Baby FACES 2020).

The Food and Drug Administration (FDA, the Agency, or we) is announcing the following public meeting entitled ``Characterizing FDA's Approach to Benefit-Risk Assessment Throughout the Medical Product Life Cycle'' and an opportunity for public comment. The meeting will be convened by Duke University's Robert J. Margolis, MD, Center for Health Policy (Duke-Margolis) and supported by a cooperative agreement with FDA. The meeting is intended to gather industry, patient, researcher, and other stakeholder input on applying FDA's Benefit-Risk Framework throughout the human drug lifecycle and best approaches to communicating FDA's benefit-risk assessment. Input from this meeting will support development of a draft guidance on benefit-risk assessment for new drugs and biologics and result in a publicly available summary report from Duke-Margolis. This meeting is intended to meet an FDA commitment included in the sixth authorization of the Prescription Drug User Fee Amendments of 2017 (PDUFA VI).

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 (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 a second opportunity for public comment on the notice. Interested persons are invited to send comments regarding the burden estimate 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.

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.

The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Antimicrobial Drugs Advisory Committee. The general function of the committee is to provide advice and recommendations to FDA on regulatory issues. The meeting will be open to the public. FDA is establishing a docket for public comment on this document.

This proposed rule would update the prospective payment rates for inpatient rehabilitation facilities (IRFs) for federal fiscal year (FY) 2020. As required by the Social Security Act (the Act), this proposed rule includes the classification and weighting factors for the IRF prospective payment system's (PPS) case-mix groups (CMGs) and a description of the methodologies and data used in computing the prospective payment rates for FY 2020. We are proposing to rebase and revise the IRF market basket to reflect a 2016 base year rather than the current 2012 base year. Additionally, we are proposing to replace the previously finalized unweighted motor score with a weighted motor score to assign patients to CMGs and remove one item from the score beginning with FY 2020 and to revise the CMGs and update the CMG relative weights and average length of stay values beginning with FY 2020, based on analysis of 2 years of data (FY 2017 and FY 2018). We are proposing to update the IRF wage index to use the concurrent FY inpatient prospective payment system (IPPS) wage index beginning with FY 2020. We are soliciting comments on stakeholder concerns regarding the appropriateness of the wage index used to adjust IRF payments. We are proposing to amend the regulations to clarify that the determination as to whether a physician qualifies as a rehabilitation physician (that is, a licensed physician with specialized training and experience in inpatient rehabilitation) is made by the IRF. For the IRF Quality Reporting Program (QRP), we are proposing to adopt two new measures, modify an existing measure, and adopt new standardized patient assessment data elements. We also propose to expand data collection to all patients, regardless of payer, as well as proposing updates related to the system used for the submission of data and related regulation text.