Department of Health and Human Services December 27, 2013 – Federal Register Recent Federal Regulation Documents

The National Practitioner Data Bank (NPDB) announces the release of a draft of the revised user Guidebook. The public is able to request a copy of the draft of the revised Guidebook and submit comments to the NPDB by the deadline below. The revised Guidebook includes expanded and improved reporting and querying examples; useful tables explaining Data Bank policies; and live links to statutes, regulations, and the Web site. The NPDB is a confidential information clearinghouse created by Congress intended to facilitate a comprehensive review of the professional credentials of health care practitioners, health care entities, providers, and suppliers. The Guidebook is a policy manual that serves as an essential reference for Data Bank users to clarify legislative and regulatory requirements through the use of reporting and querying examples, explanations, definitions, and frequently asked questions (FAQs). The new Guidebook incorporates legislative and regulatory changes adopted since its last edition, including the merger of the NPDB with the Healthcare Integrity and Protection Data Bank. Once the comments have been reviewed, a final version of the revised Guidebook will be made available and will replace previous Guidebooks. For information on how to request a PDF copy of the draft Guidebook and instructions on how to submit comments, visit the NPDB Web site at: https://www.npdb.hrsa.gov/news/news.jsp.

The National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC), announces the availability of the following publication: ``Protecting the Nanotechnology Workforce: NIOSH Nanotechnology Research and Guidance Strategic Plan 2013-2016'' [NIOSH 2014-106].

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 (the 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 60 days for public comment on the proposed action. Interested persons are invited to send comments regarding our burden estimates or any other aspect of this collection of information, including any of the following subjects: (1) The necessity and utility of the proposed information collection for the proper performance of the agency's functions; (2) the accuracy of the estimated burden; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) the use of automated collection techniques or other forms of information technology to minimize the information collection burden.

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 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 (the 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 60 days for public comment on the proposed action. Interested persons are invited to send comments regarding our burden estimates or any other aspect of this collection of information, including any of the following subjects: (1) the necessity and utility of the proposed information collection for the proper performance of the agency's functions; (2) the accuracy of the estimated burden; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) the use of automated collection techniques or other forms of information technology to minimize the information collection burden.

This document corrects a date in the December 23, 2013, Federal Register notice (document identifier: CMS-10510) entitled ``Basic Health Program Report for Health Insurance Exchange Premium.''

This final rule revises the exception to the physician self- referral law that permits certain arrangements involving the donation of electronic health records items and services. Specifically, this final rule extends the expiration date of the exception to December 31, 2021, excludes laboratory companies from the types of entities that may donate electronic health records items and services, updates the provision under which electronic health records software is deemed interoperable, removes the electronic prescribing capability requirement, and clarifies the requirement prohibiting any action that limits or restricts the use, compatibility, or interoperability of donated items or services.

The Food and Drug Administration (FDA) is correcting, and extending the comment period for, the proposed rule that appeared in the Federal Register of November 13, 2013. In the proposed rule, FDA requested comments on the proposal to revise and clarify procedures for application holders of an approved drug or biological product to change the product labeling to reflect certain types of newly acquired information in advance of FDA's review of the change. The proposed rule published without a reference or a link to the accompanying Regulatory Impact Analysis. The Agency is taking this action to correct this omission and to extend the comment period in response to requests for an extension to allow interested persons additional time to submit comments on the proposed rule.

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect the withdrawal approval of five new animal drug applications (NADAs) for roxarsone oral dosage form products at the sponsor's request because the products are no longer manufactured or marketed.

This proposed rule would establish national emergency preparedness requirements for Medicare- and Medicaid-participating providers and suppliers to ensure that they adequately plan for both natural and man-made disasters, and coordinate with federal, state, tribal, regional, and local emergency preparedness systems. It would also ensure that these providers and suppliers are adequately prepared to meet the needs of patients, residents, clients, and participants during disasters and emergency situations. We are proposing emergency preparedness requirements that 17 provider and supplier types must meet to participate in the Medicare and Medicaid programs. Since existing Medicare and Medicaid requirements vary across the types of providers and suppliers, we are also proposing variations in these requirements. These variations are based on existing statutory and regulatory policies and differing needs of each provider or supplier type and the individuals to whom they provide health care services. Despite these variations, our proposed regulations would provide generally consistent emergency preparedness requirements, enhance patient safety during emergencies for persons served by Medicare- and Medicaid-participating facilities, and establish a more coordinated and defined response to natural and man- made disasters.

In accordance with section 205 of the Health Insurance Portability and Accountability Act of 1996 (HIPAA), this annual notice solicits proposals and recommendations for developing new and modifying existing safe harbor provisions under the Federal anti-kickback statute (section 1128B(b) of the Social Security Act), as well as developing new OIG Special Fraud Alerts.