Department of Health and Human Services February 2, 2016 – Federal Register Recent Federal Regulation Documents

Request for Information: Certification Frequency and Requirements for the Reporting of Quality Measures Under CMS Programs; Extension of Comment Period
Document Number: 2016-01937
Type: Notice
Date: 2016-02-02
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This document extends the comment period for the December 31, 2015 request for information entitled ``Request for Information: Certification Frequency and Requirements for the Reporting of Quality Measures Under CMS Programs'' (80 FR 81824) (referred to in this document as December 31 RFI). The comment period for the December 31 RFI, which would have ended on February 1, 2016, is extended for 15 days.
Medicaid Program; Final FY 2013 and Preliminary FY 2015 Disproportionate Share Hospital Allotments, and Final FY 2013 and Preliminary FY 2015 Institutions for Mental Diseases Disproportionate Share Hospital Limits
Document Number: 2016-01836
Type: Notice
Date: 2016-02-02
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This notice announces the final federal share disproportionate share hospital (DSH) allotments for federal fiscal year (FY) 2013 and the preliminary federal share DSH allotments for FY 2015. This notice also announces the final FY 2013 and the preliminary FY 2015 limitations on aggregate DSH payments that states may make to institutions for mental disease and other mental health facilities. In addition, this notice includes background information describing the methodology for determining the amounts of states' FY DSH allotments.
Medicare, Medicaid, and Children's Health Insurance Programs: Announcement of the Extended Temporary Moratoria on Enrollment of Ground Ambulance Suppliers and Home Health Agencies in Designated Geographic Locations
Document Number: 2016-01835
Type: Notice
Date: 2016-02-02
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 ground ambulance suppliers and Medicare home health agencies, 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. These moratoria also apply to the enrollment of home health agencies and ground ambulance suppliers in Medicaid and the Children's Health Insurance Program.
Statement of Organization, Functions, and Delegations of Authority
Document Number: 2016-01833
Type: Notice
Date: 2016-02-02
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Medicare Program; Request for an Exception to the Prohibition on Expansion of Facility Capacity Under the Hospital Ownership and Rural Provider Exceptions to the Physician Self-Referral Prohibition
Document Number: 2016-01830
Type: Notice
Date: 2016-02-02
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
The Social Security Act (the Act) prohibits a physician-owned hospital from expanding its facility capacity, unless the Secretary of the Department of Health and Human Services (the Secretary) grants the hospital's request for an exception to that prohibition after considering input on the hospital's request from individuals and entities in the community where the hospital is located. The Centers for Medicare & Medicaid Services (CMS) has received a request from a physician-owned hospital for an exception to the prohibition against expansion of facility capacity. This notice solicits comments on the request from individuals and entities in the community in which the physician-owned hospital is located. Community input may inform our determination regarding whether the requesting hospital qualifies for an exception to the prohibition against expansion of facility capacity.
Current List of HHS-Certified Laboratories and Instrumented Initial Testing Facilities Which Meet Minimum Standards To Engage in Urine Drug Testing for Federal Agencies
Document Number: 2016-01819
Type: Notice
Date: 2016-02-02
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
The Department of Health and Human Services (HHS) notifies federal agencies of the laboratories and Instrumented Initial Testing Facilities (IITF) currently certified to meet the standards of the Mandatory Guidelines for Federal Workplace Drug Testing Programs (Mandatory Guidelines). The Mandatory Guidelines were first published in the Federal Register on April 11, 1988 (53 FR 11970), and subsequently revised in the Federal Register on June 9, 1994 (59 FR 29908); September 30, 1997 (62 FR 51118); April 13, 2004 (69 FR 19644); November 25, 2008 (73 FR 71858); December 10, 2008 (73 FR 75122); and on April 30, 2010 (75 FR 22809). A notice listing all currently HHS-certified laboratories and IITFs is published in the Federal Register during the first week of each month. If any laboratory or IITF certification is suspended or revoked, the laboratory or IITF will be omitted from subsequent lists until such time as it is restored to full certification under the Mandatory Guidelines. If any laboratory or IITF has withdrawn from the HHS National Laboratory Certification Program (NLCP) during the past month, it will be listed at the end and will be omitted from the monthly listing thereafter. This notice is also available on the Internet at http:// www.samhsa.gov/workplace.
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2016-01818
Type: Notice
Date: 2016-02-02
Agency: Department of Health and Human Services, National Institutes of Health
National Heart, Lung, and Blood Institute; Notice of Closed Meetings
Document Number: 2016-01817
Type: Notice
Date: 2016-02-02
Agency: Department of Health and Human Services, National Institutes of Health
National Heart, Lung, and Blood Institute; Notice of Closed Meeting
Document Number: 2016-01816
Type: Notice
Date: 2016-02-02
Agency: Department of Health and Human Services, National Institutes of Health
Medicare Program: Expanding Uses of Medicare Data by Qualified Entities
Document Number: 2016-01790
Type: Proposed Rule
Date: 2016-02-02
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This proposed rule would implement new statutory requirements that would expand how qualified entities may use and disclose data under the qualified entity program to the extent consistent with applicable program requirements and other applicable laws, including information, privacy, security and disclosure laws. In doing so, this proposed rule would explain how qualified entities may create non- public analyses and provide or sell such analyses to authorized users, as well as how qualified entities may provide or sell combined data, or provide Medicare claims data alone at no cost, to certain authorized users. This proposed rule would also implement certain privacy and security requirements, and impose assessments on qualified entities if the qualified entity or the authorized user violates the terms of a data use agreement (DUA) required by the qualified entity program.
The Arthritis Foundation-Food and Drug Administration Accelerating Osteoarthritis Clinical Trials Workshop
Document Number: 2016-01789
Type: Notice
Date: 2016-02-02
Agency: Food and Drug Administration, Department of Health and Human Services
Osteoarthritis is the most common form of arthritis, and occurs when the cartilage that cushions the bones of the joint break down and the bones begin to rub together. This can cause pain, swelling, and loss of motion of the joint. The Food and Drug Administration's (FDA) Center for Drug Evaluation and Research, in co- sponsorship with the Arthritis Foundation is announcing a workshop entitled, ``Accelerating OA Clinical Trials Workshop''. The purpose of the workshop is to discuss recommendations from the international Arthritis Foundation Accelerating Osteoarthritis Clinical Trial workgroup and identify next steps in forging new approaches to osteoarthritis clinical trials that may improve the likelihood of successful conduct and outcomes of these trials and lead to the development of safe and effective treatments for osteoarthritis.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Experimental Studies on Consumer Perceptions of Modified Risk Tobacco Products
Document Number: 2016-01788
Type: Notice
Date: 2016-02-02
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.
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Voluntary Labeling Indicating Whether Foods Have or Have Not Been Derived From Genetically Engineered Plants
Document Number: 2016-01786
Type: Notice
Date: 2016-02-02
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Voluntary Labeling Indicating Whether Foods Have or Have Not Been Derived From Genetically Engineered Plants'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Improving Food Safety and Defense Capacity of the State and Local Level: Review of State and Local Capacities
Document Number: 2016-01785
Type: Notice
Date: 2016-02-02
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Improving Food Safety and Defense Capacity of the State and Local Level: Review of State and Local Capacities'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Guidance for Industry on Drug Supply Chain Security Act Implementation: Identification of Suspect Product and Notification
Document Number: 2016-01784
Type: Notice
Date: 2016-02-02
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Guidance for Industry on Drug Supply Chain Security Act Implementation: Identification of Suspect Product and Notification'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; General Licensing Provisions; Section 351(k) Biosimilar Applications
Document Number: 2016-01783
Type: Notice
Date: 2016-02-02
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``General Licensing Provisions; Section 351(k) Biosimilar Applications'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Agency Information Collection Activities: Proposed Collection; Comment Request; Applications for Food and Drug Administration Approval to Market a New Drug: Patent Submission and Listing Requirements and Application of 30-Month Stays on Approval of Abbreviated New Drug Applications Certifying That a Patent Claiming a Drug Is Valid or Will Not Be Infringed
Document Number: 2016-01782
Type: Notice
Date: 2016-02-02
Agency: Food and Drug Administration, Department of Health and Human Services
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, 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 reporting requirements for submission and listing of patent information associated with a new drug application (NDA), an amendment, or a supplement.
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Guidance for Clinical Trial Sponsors: Establishment and Operation of Clinical Trial Data Monitoring Committees
Document Number: 2016-01781
Type: Notice
Date: 2016-02-02
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Guidance for Clinical Trial Sponsors: Establishment and Operation of Clinical Trial Data Monitoring Committees'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Regulatory Site Visit Training Program
Document Number: 2016-01780
Type: Notice
Date: 2016-02-02
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration's (FDA's) Center for Biologics Evaluation and Research (CBER) is announcing an invitation for participation in its Regulatory Site Visit Training Program (RSVP). This training program is intended to give CBER regulatory review, compliance, and other relevant staff an opportunity to visit biologics facilities. These visits are intended to allow CBER staff to directly observe routine manufacturing practices and to give CBER staff a better understanding of the biologics industry, including its challenges and operations. The purpose of this document is to invite biologics facilities to contact CBER for more information if they are interested in participating in this program.
Medicaid Program; Face-to-Face Requirements for Home Health Services; Policy Changes and Clarifications Related to Home Health
Document Number: 2016-01585
Type: Rule
Date: 2016-02-02
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This final rule revises the Medicaid home health service definition consistent with section 6407 of the Patient Protection and Affordable Care Act of 2010 (the Affordable Care Act) and section 504 of the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) to add requirements that, for home health services, physicians document, and, for certain medical equipment, physicians or certain authorized non-physician practitioners (NPP) document the occurrence of a face-to- face encounter (including through the use of telehealth) with the Medicaid eligible beneficiary within reasonable timeframes. This rule also aligns the timeframes for the face-to-face encounter with similar regulatory requirements for Medicare home health services. In addition, this rule amends the definitions of medical supplies, equipment, and appliances. We expect minimal impact with the implementation of section 6407 of the Affordable Care Act and section 504 of MACRA. We recognize that states may have budgetary implications as a result of the amended definitions of medical supplies, equipment and appliances. Specifically, this rule may expand coverage of medical supplies, equipment and appliances under the home health benefit. There will be items that had previously only been offered under certain sections of the Act that will now be covered under the home health benefit.