Department of Health and Human Services October 5, 2016 – Federal Register Recent Federal Regulation Documents

Request for Nominations for Voting Members for the Patient Engagement Advisory Committee
Document Number: 2016-24100
Type: Notice
Date: 2016-10-05
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration's (FDA) is requesting additional nominations for members to serve on the Center for Devices and Radiological Health's (CDRH) Patient Engagement Advisory Committee (the PEAC or Committee). The Committee provides relevant skills and perspectives in order to improve communication of benefits, risks and clinical outcomes, and increase integration of patient perspectives into the regulatory process for medical devices. It performs its duties by identifying new approaches, promoting innovation, recognizing unforeseen risks or barriers, and identifying unintended consequences that could result from FDA policy. FDA seeks to include the views of women and men, members of all racial and ethnic groups, and individuals with and without disabilities on its advisory committees and, therefore, particularly encourages nominations of appropriately qualified candidates from these groups.
Pharmacy Compounding Advisory Committee; Notice of Meeting
Document Number: 2016-24085
Type: Notice
Date: 2016-10-05
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Pharmacy Compounding Advisory Committee (PCAC). The general function of the committee is to provide advice on scientific, technical, and medical issues concerning drug compounding, as well as any other product for which FDA has regulatory responsibility, and to make appropriate recommendations to the Agency. The meeting will be open to the public.
Product-Specific Bioequivalence Recommendations; Draft and Revised Draft Guidances for Industry; Availability
Document Number: 2016-24050
Type: Notice
Date: 2016-10-05
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing the availability of additional draft and revised draft product-specific bioequivalence (BE) recommendations. The recommendations provide product-specific guidance on the design of BE studies to support abbreviated new drug applications (ANDAs). In the Federal Register of June 11, 2010, FDA announced the availability of a guidance for industry entitled ``Bioequivalence Recommendations for Specific Products'' that explained the process that would be used to make product-specific BE recommendations available to the public on FDA's Web site. The BE recommendations identified in this notice were developed using the process described in that guidance.
Medicare Program; Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System and Policy Changes and Fiscal Year 2017 Rates; Quality Reporting Requirements for Specific Providers; Graduate Medical Education; Hospital Notification Procedures Applicable to Beneficiaries Receiving Observation Services; Technical Changes Relating to Costs to Organizations and Medicare Cost Reports; Finalization of Interim Final Rules With Comment Period on LTCH PPS Payments for Severe Wounds, Modifications of Limitations on Redesignation by the Medicare Geographic Classification Review Board, and Extensions of Payments to MDHs and Low-Volume Hospitals; Correction
Document Number: 2016-24042
Type: Rule
Date: 2016-10-05
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This document corrects technical and typographical errors in the final rule that appeared in the August 22, 2016 Federal Register titled ``Medicare Program; Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System and Policy Changes and Fiscal Year 2017 Rates; Quality Reporting Requirements for Specific Providers; Graduate Medical Education; Hospital Notification Procedures Applicable to Beneficiaries Receiving Observation Services; Technical Changes Relating to Costs to Organizations and Medicare Cost Reports; Finalization of Interim Final Rules With Comment Period on LTCH PPS Payments for Severe Wounds, Modifications of Limitations on Redesignation by the Medicare Geographic Classification Review Board, and Extensions of Payments to MDHs and Low-Volume Hospitals.''
Prospective Grant of Exclusive Patent License: Development of Anti-CD70 Chimeric Antigen Receptors for the Treatment of CD70 Expressing Cancers
Document Number: 2016-24030
Type: Notice
Date: 2016-10-05
Agency: Department of Health and Human Services, National Institutes of Health
The National Cancer Institute, National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an Exclusive Patent License to Kite Pharma, Inc. (``Kite'') located in Santa Monica, CA to practice the inventions embodied in the patent applications listed in the Supplementary Information section of this notice.
National Institute on Minority Health and Health Disparities; Notice of Closed Meeting
Document Number: 2016-24028
Type: Notice
Date: 2016-10-05
Agency: Department of Health and Human Services, National Institutes of Health
Eunice Kennedy Shriver National Institute of Child Health & Human Development; Notice of Closed Meeting
Document Number: 2016-24027
Type: Notice
Date: 2016-10-05
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2016-24026
Type: Notice
Date: 2016-10-05
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2016-24025
Type: Notice
Date: 2016-10-05
Agency: Department of Health and Human Services, National Institutes of Health
National Heart, Lung, And Blood Institute; Notice of Closed Meeting
Document Number: 2016-24024
Type: Notice
Date: 2016-10-05
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meeting
Document Number: 2016-24023
Type: Notice
Date: 2016-10-05
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2016-24022
Type: Notice
Date: 2016-10-05
Agency: Department of Health and Human Services, National Institutes of Health
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 2016-24012
Type: Notice
Date: 2016-10-05
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration