Department of Health and Human Services August 3, 2016 – Federal Register Recent Federal Regulation Documents

Delegation of Authorities
Document Number: 2016-18417
Type: Notice
Date: 2016-08-03
Agency: Department of Health and Human Services, Office of the Secretary
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2016-18392
Type: Notice
Date: 2016-08-03
Agency: Agency for Healthcare Research and Quality, Department of Health and Human Services
This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) approve the proposed information collection project: ``The Patient-Centered Medical Home (PCMH) Items Demonstration Study.'' In accordance with the Paperwork Reduction Act, 44 U.S.C. 3501-3521, AHRQ invites the public to comment on this proposed information collection.
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2016-18391
Type: Notice
Date: 2016-08-03
Agency: Department of Health and Human Services, National Institutes of Health
Medicare, Medicaid, and Children's Health Insurance Programs: Announcement of the Implementation and Extension of Temporary Moratoria on Enrollment of Part B Non-Emergency Ground Ambulance Suppliers and Home Health Agencies in Designated Geographic Locations and Lifting of the Temporary Moratoria on Enrollment of Part B Emergency Ground Ambulance Suppliers in All Geographic Locations
Document Number: 2016-18383
Type: Rule
Date: 2016-08-03
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This document announces the extension of temporary moratoria on the enrollment of new Medicare Part B non-emergency ground ambulance suppliers and Medicare home health agencies (HHAs), subunits, and branch locations in specific locations within designated metropolitan areas in Florida, Illinois, Michigan, Texas, Pennsylvania, and New Jersey to prevent and combat fraud, waste, and abuse. It also announces the implementation of temporary moratoria on the enrollment of new Medicare Part B non-emergency ground ambulance suppliers and Medicare HHAs, subunits, and branch locations in Florida, Illinois, Michigan, Texas, Pennsylvania, and New Jersey on a statewide basis. In addition, it announces the lifting of the moratoria on all Part B emergency ground ambulance suppliers. These moratoria, and the changes described in this document, also apply to the enrollment of HHAs and non- emergency ground ambulance suppliers in Medicaid and the Children's Health Insurance Program.
Medicare, Medicaid, and Children's Health Insurance Programs: Announcement of the Provider Enrollment Moratoria Access Waiver Demonstration of Part B Non-Emergency Ground Ambulance Suppliers and Home Health Agencies in Moratoria-Designated Geographic Locations
Document Number: 2016-18381
Type: Rule
Date: 2016-08-03
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This notice announces the Provider Enrollment Moratoria Access Waiver Demonstration of Part B Non-Emergency Ground Ambulance Suppliers and Home Health Agencies in 6 states. The demonstration is being implemented in accordance with section 402 of the Social Security Amendments of 1967 and gives CMS the authority to grant waivers to the statewide enrollment moratoria on a case-by-case basis in response to access to care issues, and to subject providers and suppliers enrolling via such waivers to heightened screening, oversight, and investigations.
Request for Comment on Report Entitled: Advancing the Care of Pregnant and Parenting Women With Opioid Use Disorder and Their Infants: A Foundation for Clinical Guidance
Document Number: 2016-18324
Type: Notice
Date: 2016-08-03
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
SAMHSA, Center for Substance Abuse Treatment (CSAT), in HHS announces the opening of a docket to obtain public comment on a report entitled: Advancing the Care of Pregnant and Parenting Women with Opioid Use Disorder and their Infants: A Foundation for Clinical Guidance. This report describes the formal process agreed on and followed under the guidance of the federal steering committee (FSC). It explains the RAND Corporation (RAND)/University of California Los Angeles (UCLA) Appropriateness Method (RAM), justifies its adoption, and reports the outcomes of its application that will form the basis for the development of clinical guidance. This report will serve as the foundation for the development of clinical guidance to be used by providers caring for women with opioid use disorder and their infants.
Medical X-Ray Imaging Devices Conformance With International Electrotechnical Commission Standards; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
Document Number: 2016-18300
Type: Notice
Date: 2016-08-03
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled ``Medical X-Ray Imaging Devices Conformance With IEC Standards.'' This draft guidance describes FDA's policy regarding the regulation of medical x-ray imaging equipment that are subject to requirements in the Federal Food, Drug, and Cosmetic Act (the FD&C Act) and FDA's regulations that apply to medical devices and electronic products. The draft guidance also provides recommendations to industry on how to comply with the applicable requirements. This draft guidance is not final nor is it in effect at this time.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Agreement for Shipment of Devices for Sterilization
Document Number: 2016-18299
Type: Notice
Date: 2016-08-03
Agency: Food and Drug Administration, Department of Health and Human Services
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.
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