Department of Health and Human Services January 2015 – Federal Register Recent Federal Regulation Documents

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The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Evaluating Drug Effects on the Ability to Operate a Motor Vehicle.'' The purpose of this guidance is to assist sponsors in the evaluation of the effects of psychoactive drugs on the ability to operate a motor vehicle. Driving is a complex activity involving a wide range of cognitive, perceptual, and motor activities. Reducing the incidence of motor vehicle accidents (MVAs) that occur because of drug-impaired driving is a public health priority. This draft guidance recommends using a systematic effort to identify drugs that increase the risk of MVAs as a critical component of assessing drug risk and designing strategies to reduce this risk.

This notice announces the public meeting of the Advisory Council on Alzheimer's Research, Care, and Services (Advisory Council). The Advisory Council on Alzheimer's Research, Care, and Services provides advice on how to prevent or reduce the burden of Alzheimer's disease and related dementias on people with the disease and their caregivers. During the January meeting, the Advisory Council will hear a presentation on IOM's final expert panel on Advanced Dementia, which will provide additional recommendations for the Council to consider. The Advisory Council will spend the majority of the meeting considering recommendations made by each of the three subcommittees for updates to the 2015 National Plan.

The inventions listed below are owned by an agency of the U.S. Government and are available for licensing 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.

As stipulated by the Federal Advisory Committee Act, the Department of Health and Human Services (DHHS) is hereby giving notice that the Advisory Committee on Minority Health (ACMH) will hold a meeting. This meeting will be open to the public. Preregistration is required for both public attendance and comment. Any individual who wishes to attend the meetings and/or participate in the public comment session should email OMH-ACMH@hhs.gov.

The Food and Drug Administration (FDA or we) has made available for public review and comment the Draft Environmental Impact Statement (EIS) for the proposed rule establishing standards for the growing, harvesting, packing, and holding of produce for human consumption. The document is available in Docket No. FDA-2014-N-2244. FDA is also announcing a public meeting to discuss the Draft EIS. The purpose of the public meeting is to inform the public of the findings in the Draft EIS, to provide information about the EIS process (including how to submit comments, data, and other information to the docket), to solicit oral stakeholder and public comments on the Draft EIS, and to provide clarification, as needed, about the contents of the Draft EIS.

This document extends the comment period for the Payment for Physician and Other Health Care Professional Services Purchased by Indian Health Programs and Medical Charges Associated with Non- Hospital-Based Care proposed rule, which was published in the Federal Register on December 5, 2014. The comment period for the proposed rule, which would have ended on January 20, 2015, is extended to February 4, 2015.

Through the ``Innovations in Measuring and Managing Addiction Treatment Quality'' Challenge (the ``Challenge''), the National Institute on Drug Abuse (NIDA), a component of the National Institutes of Health (NIH), challenges the general public to make concrete advances toward improving the quality of addiction treatment. Specifically, through this Challenge, NIDA hopes to incentivize the development of innovative concepts for quality measurement and quality management systems based on the latest science of addiction and its treatment and of quality measurement and management. These new concepts would be game-changing because they would go beyond current performance measurement concepts in that they would not be limited by the data commonly available in current provider and payer data systems. Instead, they would (a) more directly reflect the clinical effects that can and should be expected from high-quality addiction treatment; (b) capture what clinicians and provider organizations need to measure to help them provide high-quality addiction treatment; and (c) provide a solid basis for measuring clinician and provider performance that may be used by patients and other purchasers to select and incent high-quality treatment. NIDA believes that the development of such quality measures and management systems has the potential to meaningfully improve the quality of addiction treatment both by giving clinicians and providers the information they need to assess and improve the quality of the care they provide and by providing tools patients and purchasers can use to shop for the highest quality providers, allowing market forces to provide another incentive for improvement.