Department of Health and Human Services February 7, 2013 – Federal Register Recent Federal Regulation Documents

The National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC) announces the following public meeting: ``Stakeholder Meeting on Respiratory Protection for Healthcare Workers''. Stakeholder Meeting Time and Date: 8 a.m.-5:15 p.m. EDT, June 18, 2013. Place: CDC Tom Harkin Global Communications Center located at 1600 Clifton Road, Building 19, Atlanta, Georgia 30333. This meeting will also be available by videoconference at select CDC locations. Purpose of the Meeting: This meeting is being held to exchange ideas and solutions to improve healthcare worker compliance with personal protective technologies (PPT), with a focus on respiratory protection. Stakeholder feedback is sought to (1) provide input to future updates of the NIOSH PPT program research agenda and (2) assess progress toward better respirators for healthcare workers. This meeting will include presentations and moderated roundtable discussions on ``Improving the Evidence Base to Support Guidance on the Appropriate Level of Respiratory Protection'', ``Healthcare Worker Observational Studies of Respirator Use & New Educational Resources'', ``Considerations for Extending Respirator Supplies During an Outbreak or Pandemic'', ``Standards & Test Methods for Improved Respirators for Healthcare Workers'', and ``Advances toward Improved Respirators for Healthcare Workers''. Status: The meeting is open to the public, limited only by the capacity (100) of the conference room. Registration will be accepted on a first come first served basis. Participants are encouraged to consider attending by video conference, which will be provided at select CDC locations (to be announced). Registration for both in person and video conference attendance is available on the NIOSH NPPTL Web site, www.cdc.gov/niosh/npptl. Preregistration is required on or before May 31, 2013, even for remote attendees and US citizens. Non-US citizens need to register on or before May 18, 2013, to allow sufficient time for mandatory CDC facility security clearance procedures to be completed. An email confirming registration will be sent from NIOSH and will include details needed to participate. A government issued photo ID will be required to obtain entrance to any of the CDC locations. Background: The NIOSH PPT program publishes and periodically updates its research agenda on personal protective equipment (PPE) for healthcare workers (https://www.cdc.gov/niosh/docket/archive/ docket129.html). The research agenda, last updated in 2010, describes the near term and long term strategy for the PPT program's influenza pandemic research, development, and investigative testing activities. Recently, the Institute of Medicine (IOM) published a report (https:// www.iom.edu/Reports/2011/Preventing-Transmission-of-Pandemic- Influenza- and-Other-Viral-Respiratory-Diseases.aspx) that assessed the nation's progress on improving PPE for healthcare personnel exposed to infectious respiratory diseases and made recommendations to address research gaps. Furthermore, a chapter in the recent HHS 2009 H1N1 Influenza Improvement Plan (https://www.phe.gov/Preparedness/mcm/h1n1- retrospective/Documents/2009-h1n1-improvementplan.pdf) discusses research needs for respiratory protective devices as part of a broader non-vaccine medical countermeasures strategy. A key area of discussion at this stakeholder meeting will be progress on research gaps identified in the 2011 IOM and 2012 HHS reports and how NIOSH can use this information to update the 2010 PPT research agenda. The current version of PPT program research agenda for healthcare worker PPE focuses on conducting research to design and promote the appropriate use of PPE. Compliance with appropriate respirator use practices is important because healthcare workers often wear them incorrectly or fail to use them at all. Poor compliance has been linked to safety culture, workload issues, time constraints, risk perception, effectiveness concerns, availability, discomfort, interference with patient care, and communication difficulties. One strategy taken to improve healthcare worker compliance is to develop better respirators. In this stakeholder meeting, progress toward better respirators for healthcare workers will be discussed.

This request for information solicits ways in which an eligible professional (EP) might use the clinical quality measures (CQM) data reported to specialty boards, specialty societies, regional health care quality organizations or other non-federal reporting programs to also report under the Physician Quality Reporting System (PQRS), as well as the Electronic Health Record (EHR) Incentive Program. It also solicits ways by which the entities already collecting CQM data for other reporting programs to submit this data on behalf of EPs and group practices for reporting under the PQRS and the EHR Incentive Program. It also requests information regarding section 601(b) of the American Taxpayer Relief Act of 2012 which provides for treating an EP as satisfactorily reporting data on quality measures if the EP is satisfactorily participating in a qualified clinical data registry. We are requesting information from medical specialty societies, boards, and registries, other third party registry vendors, eligible professionals using registries to report quality measures, and any other party interested in providing information on this request for information.

The Food and Drug Administration (FDA) is issuing a proposed order to reclassify temporary mandibular condyle prosthesis, a preamendments class III device, into class II (special controls), and rename the device ``temporary mandibular condyle reconstruction plate.'' FDA is also issuing the draft special controls guideline, ``Class II Special Controls Guideline: Temporary Mandibular Condyle Reconstruction Plate,'' which sets forth the special controls that the Agency believes are necessary to provide a reasonable assurance of the safety and effectiveness of the device.

This proposed rule would reform Medicare regulations that CMS has identified as unnecessary, obsolete, or excessively burdensome on health care providers and suppliers, as well as certain regulations under the Clinical Laboratory Improvement Amendments of 1988 (CLIA). This proposed rule would increase the ability of health care professionals to devote resources to improving patient care, by eliminating or reducing requirements that impede quality patient care or that divert resources away from providing high quality patient care. This is one of several rules that we are proposing to achieve regulatory reforms under Executive Order 13563 on improving regulation and regulatory review and the Department's plan for retrospective review of existing rules.