Department of Health and Human Services August 2016 – Federal Register Recent Federal Regulation Documents

The invention listed below is owned by an agency of the U.S. Government and is available for licensing and/or co-development in the U.S. in accordance with 35 U.S.C. 209 and 37 CFR part 404 to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing and/or co-development.

The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee. The general function of the committee is to provide advice and recommendations to the Agency on FDA's regulatory issues. The meeting will be open to the public. FDA is establishing a docket for public comment on this document.

The Administration on Community Living, Administration on Aging (ACL/AoA) 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 the information collection requirements relating to the National Ombudsman Reporting System per 45 CFR part 1324.21 and Older Americans Act Title VII.

The Food and Drug Administration (FDA) is reopening the comment period for the document that announced a public meeting in the Federal Register of May 11, 2016. In the document, FDA invited public comment as the Agency considers a user-fee program for nonprescription (over-the-counter or OTC) monograph drugs. FDA will hold a Webinar for stakeholders on September 6, 2016. This Webinar is intended to be a followup to the June 10, 2016, public meeting on this topic and to provide stakeholders with a status update on the process of FDA and industry discussions that began in July 2016.

The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled ``Deciding When to Submit a 510(k) for a Software Change to an Existing Device.'' FDA is issuing this draft guidance document to clarify when a software change in a legally marketed medical device would require that a manufacturer submit a premarket notification (510(k)) to FDA. This draft guidance is not final nor is it in effect at this time.

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) has determined that the drug products listed in this document were not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to these drug products, and it will allow FDA to continue to approve ANDAs that refer to the products as long as they meet relevant legal and regulatory requirements.

The Food and Drug Administration (FDA) is confirming the effective date of September 16, 2016, for the final rule that appeared in the Federal Register of May 4, 2016. The direct final rule amends the general biological products standards relating to dating periods and removes certain standards relating to standard preparations and limits of potency. FDA is taking this action to update outdated requirements, and accommodate new and evolving technology and testing capabilities without diminishing public health concerns. This action is part of FDA's retrospective review of its regulations in response to an Executive order. This document confirms the effective date of the direct final rule.

The Food and Drug Administration (FDA) is issuing a proposed rule describing when FDA would refuse to accept a tobacco product submission (or application) because the application has not met a minimum threshold for acceptability for FDA review. Under the proposed rule, FDA would refuse to accept a tobacco product submission, for example, that is not in English, does not pertain to a tobacco product, or does not identify the type of submission. By refusing to accept submissions that have the deficiencies identified in the proposed rule, FDA would be able to focus our review resources on submissions that meet a threshold of acceptability and encourage quality submissions. If we receive any significant adverse comments that warrant terminating the direct final rule, we will consider such comments on the proposed rule in developing the final rule.

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: The necessity and utility of the proposed information collection for the proper performance of the agency's functions; the accuracy of the estimated burden; ways to enhance the quality, utility, and clarity of the information to be collected; and the use of automated collection techniques or other forms of information technology to minimize the information collection burden.

The National Institutes of Health (NIH) is requesting public comment on a proposal to amend Section IV and Section V of the NIH Guidelines for Human Stem Cell Research and on the proposed scope of certain human-animal chimera research that will be considered internally by an NIH steering committee to provide programmatic input to the director of the relevant NIH Institute(s) or Center(s) or equivalent NIH officials responsible for funding decisions.

The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Cellular, Tissue, and Gene Therapies Advisory Committee. The general function of the committee is to provide advice and recommendations to the Agency on FDA's regulatory issues. At least one portion of the meeting will be closed to the public.

This quarterly notice lists CMS manual instructions, substantive and interpretive regulations, and other Federal Register notices that were published from April through June 2016, relating to the Medicare and Medicaid programs and other programs administered by CMS.

This final rule will update the hospice wage index, payment rates, and cap amount for fiscal year (FY) 2017. In addition, this rule changes the hospice quality reporting program, including adopting new quality measures. Finally, this final rule includes information regarding the Medicare Care Choices Model (MCCM).

This final rule updates the payment rates used under the prospective payment system (PPS) for skilled nursing facilities (SNFs) for fiscal year (FY) 2017. In addition, it specifies a potentially preventable readmission measure for the Skilled Nursing Facility Value- Based Purchasing Program (SNF VBP), and implements requirements for that program, including performance standards, a scoring methodology, and a review and correction process for performance information to be made public, aimed at implementing value-based purchasing for SNFs. Additionally, this final rule includes additional polices and measures in the Skilled Nursing Facility Quality Reporting Program (SNF QRP). This final rule also responds to comments on the SNF Payment Models Research (PMR) project.

The Food and Drug Administration (FDA) is publishing a list of premarket approval applications (PMAs) that have been approved. This list is intended to inform the public of the availability of safety and effectiveness summaries of approved PMAs through the Internet and the Agency's Division of Dockets Management.

The Food and Drug Administration (FDA) 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 and to allow 60 days for public comment in response to the notice. This notice solicits comments on ``Certification of Identity for Freedom of Information Act and Privacy Act Requests.''

The Medical Reserve Corps (MRC) Program housed under the Office of the Assistant Secretary for Preparedness and Response (ASPR) within the U.S. Department of Health and Human Services (HHS), announces the launch of the ``MRC Serves'' Video Challenge. The MRC is a national network of volunteers, organized locally to improve the health and safety of their communities. MRC volunteers have medical, public health, other backgrounds and have responded to natural disasters, public health and other emergencies, while also supporting community health activities. The MRC Program is looking for innovative and cost effective ways to promote these activities and demonstrate how MRC units and their volunteers make their communities healthier, prepared, and more resilient. Today there are nearly 200,000 volunteers, in almost 1,000 MRC units nationwide, who give their skills and time year around to support their communities and serve as ambassadors for the MRC to their friends, families, neighbors, and co- workers. The MRC Program would like to engage MRC volunteers to also be national ambassadors by creating short promotional videos that will be used by the MRC Program to highlight how serving as MRC volunteers makes communities healthier, more prepared, and more resilient.