Department of Health and Human Services August 5, 2014 – Federal Register Recent Federal Regulation Documents

Design Considerations for Devices Intended for Home Use; Guidance for Industry and Food and Drug Administration Staff; Availability
Document Number: 2014-18470
Type: Notice
Date: 2014-08-05
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled ``Design Considerations for Devices Intended for Home Use.'' This document is intended to assist manufacturers in designing and developing home use medical devices that comply with applicable standards of safety and effectiveness and other regulatory requirements. Devices used in the home or other non-clinical environments are associated with unique risks created by the interactions among the user (often a layperson), the use environment, and the device. This document identifies several factors that manufacturers should consider, especially during device design and development, and provides recommendations for minimizing these unique risks.
Proposed Information Collection Activity; Comment Request
Document Number: 2014-18468
Type: Notice
Date: 2014-08-05
Agency: Department of Health and Human Services, Administration for Children and Families
Agency Information Collection Activities; Proposed Collection; Comment Request; Senior Legal Helplines Operating Within Model Approaches to Statewide Legal Assistance Systems Demonstrations
Document Number: 2014-18463
Type: Notice
Date: 2014-08-05
Agency: Department of Health and Human Services
The Administration for Community Living (ACL) is announcing an opportunity for public comment on the proposed collection of certain information by the agency. 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 of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on proposed information collection requirements relating to Senior Legal Helplines (SLHs) operating within Model Approaches to Statewide Legal Assistance Systems Demonstrations.
National Institute on Aging; Notice of Closed Meeting
Document Number: 2014-18420
Type: Notice
Date: 2014-08-05
Agency: Department of Health and Human Services, National Institutes of Health
Center For Scientific Review; Notice of Closed Meeting
Document Number: 2014-18419
Type: Notice
Date: 2014-08-05
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Aging; Notice of Closed Meeting
Document Number: 2014-18418
Type: Notice
Date: 2014-08-05
Agency: Department of Health and Human Services, National Institutes of Health
Medicare Program; Prospective Payment System and Consolidated Billing for Skilled Nursing Facilities for FY 2015
Document Number: 2014-18335
Type: Rule
Date: 2014-08-05
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This final rule updates the payment rates used under the prospective payment system (PPS) for skilled nursing facilities (SNFs) for fiscal year (FY) 2015. In addition, it adopts the most recent Office of Management and Budget (OMB) statistical area delineations to identify a facility's urban or rural status for the purpose of determining which set of rate tables will apply to the facility, and to determine the SNF PPS wage index including a 1-year transition with a blended wage index for all providers for FY 2015. This final rule also contains a revision to policies related to the Change of Therapy (COT) Other Medicare Required Assessment (OMRA). This final rule includes a discussion of a provision related to the Affordable Care Act involving Civil Money Penalties. Finally, this final rule discusses the SNF therapy payment research currently underway within CMS, observed trends related to therapy utilization among SNF providers, and the agency's commitment to accelerating health information exchange in SNFs.
Draft Guidance for Industry on Reference Product Exclusivity for Biological Products Filed Under Section 351(a) of the Public Health Service Act; Availability
Document Number: 2014-18169
Type: Notice
Date: 2014-08-05
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Reference Product Exclusivity for Biological Products Filed Under Section 351(a) of the PHS Act.'' This draft guidance is intended to assist sponsors developing biological products, sponsors holding biologics license applications (BLAs), and other interested parties in providing information and data that will help the Agency determine the date of first licensure for a reference product under 351(k)(7)(C) of the Public Health Service Act (PHS Act), as added by the Biologics Price Competition and Innovation Act of 2009 (BPCI Act). The BPCI Act amends the PHS Act and other statutes to create an abbreviated licensure pathway for biological products shown to be biosimilar to, or interchangeable with, an FDA-licensed biological reference product.