Department of Health and Human Services August 8, 2019 – Federal Register Recent Federal Regulation Documents

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.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Fabry Disease: Developing Drugs for Treatment.'' This draft guidance describes the Agency's current recommendations regarding eligibility criteria, trial design considerations, and efficacy endpoints to be used in clinical development programs of investigational drugs to treat Fabry disease. Through this draft guidance, the Agency provides clear and specific guidance to foster greater efficiency in drug development in this rare disease with the goal of enhancing clinical trial data quality and supporting the development of treatments for Fabry disease.

The Office of Child Support Enforcement (OCSE), Administration for Children and Families (ACF) is requesting a three-year extension of the Hague Child Support Forms (OMB #0970-0488, expiration 4/30/2020). There are no changes requested to the form.

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 National Electronic Health Records Survey (NEHRS) which will collect data on office-based physicians' adoption and use of electronic health record (EHR) systems, practice information, patient engagement, controlled substances prescribing practices, use of health information exchange, and documentation and burden associated with medical record systems.

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 `Templates for Extramural Data Management Plans.' The aim of this collection is to provide Cooperative Agreement applicants and awardees with templates for the creation of Data Management Plans (DMP).

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.

This final rule updates the prospective payment rates for inpatient rehabilitation facilities (IRFs) for federal fiscal year (FY) 2020. As required by the statute, this final 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. This final rule rebases and revises the IRF market basket to reflect a 2016 base year rather than the current 2012 base year. Additionally, this final rule revises the CMGs and updates the CMG relative weights and average length of stay (LOS) values beginning with FY 2020, based on analysis of 2 years of data (FYs 2017 and 2018). Although we proposed to use a weighted motor score to assign patients to CMGs, we are finalizing based on public comments the use of an unweighted motor score to assign patients to CMGs beginning with FY 2020. Additionally, we are finalizing the removal of one item from the motor score. We are updating the IRF wage index to use the concurrent fiscal year inpatient prospective payment system (IPPS) wage index beginning with FY 2020. We are amending 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 adopting two new measures, modifying an existing measure, and adopting new standardized patient assessment data elements. We are also making updates to reflect our migration to a new data submission system.