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

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.

The Food and Drug Administration (FDA) is announcing the revocation of the Emergency Use Authorization (EUA) (the Authorization) issued to InBios International, Inc. (InBios), for the ZIKV Detect 2.0 IgM Capture ELISA. FDA revoked this Authorization on May 23, 2019, under the Federal Food, Drug, and Cosmetic Act (the FD&C Act), in consideration of the De Novo classification request granted to the InBios ZIKV Detect 2.0 IgM Capture ELISA as a Class II device under the generic name Zika virus serological reagents on May 23, 2019. The revocation, which includes an explanation of the reasons for revocation, is reprinted in this document.

The Food and Drug Administration (FDA or Agency) is announcing the availability of the Agency's annual report entitled ``Report on the Performance of Drug and Biologics Firms in Conducting Postmarketing Requirements and Commitments.'' Under the Federal Food, Drug, and Cosmetic Act (FD&C Act), FDA is required to report annually on the status of postmarketing requirements (PMRs) and postmarketing commitments (PMCs) required of, or agreed upon by, application holders of approved drug and biological products.

In compliance with the Paperwork Reduction Act of 1995, HRSA submitted an Information Collection Request (ICR) to the Office of Management and Budget (OMB) for review and approval. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public during the review and approval period.

In accordance with the Federal Advisory Committee Act, this notice announces that the Secretary's National Advisory Committee on Rural Health and Human Services (NACRHHS) has scheduled a public meeting. Information about NACRHHS and the agenda for this meeting can be found on the NACRHHS website at https://www.hrsa.gov/advisory- committees/rural-health/.

NIOSH announces the availability of the final National Occupational Research Agenda for Hearing Loss Prevention.

On March 11, 2019, the Administrator of the World Trade Center (WTC) Health Program received a petition (Petition 022) to add ``monoclonal gammopathy of undetermined significance (MGUS)'' to the List of WTC-Related Health Conditions (List). Upon reviewing the scientific and medical literature, including information provided by the petitioner, the Administrator has determined that the available evidence does not have the potential to provide a basis for a decision on whether to add MGUS to the List. The Administrator also finds that insufficient evidence exists to request a recommendation of the WTC Health Program Scientific/Technical Advisory Committee (STAC), to publish a proposed rule, or to publish a determination not to publish a proposed rule.

This final rule updates the prospective payment rates, the outlier threshold, and the wage index for Medicare inpatient hospital services provided by Inpatient Psychiatric Facilities (IPFs), which include psychiatric hospitals and excluded psychiatric units of an inpatient prospective payment system hospital or critical access hospital. Additionally, this final rule revises and rebases the IPF market basket to reflect a 2016 base year and removes the IPF Prospective Payment System (PPS) 1-year lag of the wage index data. Finally, this final rule implements updates to the Inpatient Psychiatric Facilities Quality Reporting Program. These changes will be effective for IPF discharges beginning during the fiscal year (FY) from October 1, 2019 through September 30, 2020 (FY 2020).

HHS gives notice concerning the final effect of the HHS decision to designate a class of employees from the Idaho National Laboratory in Scoville, Idaho, as an addition to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000.

In accordance with the Federal Advisory Committee Act, the CDC announces the following meeting of the Board of Scientific Counselors, National Institute for Occupational Safety and Health (BSC, NIOSH). This meeting is open to the public, limited only by the space available. The meeting room accommodates approximately 33 people. The meeting is also open to the public via webcast. If you wish to attend in person or by webcast, please see the NIOSH website to register (https://www.cdc.gov/niosh/bsc/) or call (404-498-2539) at least five business days in advance of the meeting. Teleconference is available toll-free; please dial (888) 397-9578, Participant Pass Code 63257516. Adobe Connect webcast will be available at https:// odniosh.adobeconnect.com/nioshbsc/ for participants wanting to connect remotely. This meeting is open to the public, limited only by the space available. The public is welcome to participate during the public comment period, 12:30 p.m. to 1 p.m. EDT September 24, 2019. Please note that the public comment period ends at the time indicated above. Each commenter will be provided up to five minutes for comment. A limited number of time slots are available and will be assigned on a first come-first served basis. Written comments will also be accepted from those unable to attend the public session via an on-line form at the following website: https://www.cdc.gov/niosh/bsc/contact.html.

In accordance with the Federal Advisory Committee Act, the Centers for Disease Control and Prevention (CDC), announces the following meeting for the Interagency Committee on Smoking and Health (ICSH). This meeting is open to the public; however, visitors must be processed in accordance with established federal policies and procedures. For foreign nationals or non-U.S. citizens, pre-approval is required (please contact Monica Swann, 202-245-0552, zqe0@cdc.gov at least 10 days in advance for requirements). All visitors are required to present a valid form of picture identification issued by a state, federal or international government. As required by the Federal Property Management Regulations, Title 41, Code of Federal Regulation, Subpart 101-20.301, all persons entering in or on Federal controlled property and their packages, briefcases, and other containers in their immediate possession are subject to being x-rayed and inspected. Federal law prohibits the knowing possession or the causing to be present of firearms, explosives and other dangerous weapons and illegal substances. The meeting room accommodates approximately 135 people and there are 50 lines/ports available. The public is also welcome to listen to the meeting by dialing: Toll Free Phone: (888) 790-1712 Participant Passcode: 9556145. Participants will be able participate for the visual portion of the meeting by the following link: https://www.hhs.gov/live/.

In accordance with the Federal Advisory Committee Act, the CDC announces the following meeting for the Board of Scientific Counselors, National Center for Injury Prevention and Control, (BSC, NCIPC).

The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled ``Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment.'' FDA developed this draft guidance to provide FDA's recommendations on the testing needed for assessing the safety and compatibility of medical devices in the Magnetic Resonance (MR) Environment and the recommended format for Magnetic Resonance Imaging (MRI) Safety Information in medical device labeling. This draft guidance document is anticipated to aid in consistency of reviews, testing, and MRI safety labeling across a variety of medical devices. This draft guidance is not final nor is it in effect at this time.