Department of Health and Human Services January 2018 – Federal Register Recent Federal Regulation Documents

Medicare Program: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems and Quality Reporting Programs
Document Number: C1-2017-27949
Type: Rule
Date: 2018-01-31
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
National Heart, Lung, and Blood Institute; Notice of Closed Meeting
Document Number: 2018-01930
Type: Notice
Date: 2018-01-31
Agency: Department of Health and Human Services, National Institutes of Health
National Heart, Lung, and Blood Institute; Notice of Closed Meeting
Document Number: 2018-01929
Type: Notice
Date: 2018-01-31
Agency: Department of Health and Human Services, National Institutes of Health
Government-Owned Inventions; Availability for Licensing
Document Number: 2018-01928
Type: Notice
Date: 2018-01-31
Agency: Department of Health and Human Services, National Institutes of Health
The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S.
Center for Scientific Review; Amended Notice of Meeting
Document Number: 2018-01927
Type: Notice
Date: 2018-01-31
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Amended Notice of Meeting
Document Number: 2018-01926
Type: Notice
Date: 2018-01-31
Agency: Department of Health and Human Services, National Institutes of Health
Determination of Regulatory Review Period for Purposes of Patent Extension; LENVIMA
Document Number: 2018-01920
Type: Notice
Date: 2018-01-31
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for LENVIMA and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human drug product.
Listing of Color Additives Exempt From Certification; Calcium Carbonate; Confirmation of Effective Date
Document Number: 2018-01912
Type: Rule
Date: 2018-01-31
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) is confirming the effective date of December 8, 2017, for the final rule that appeared in the Federal Register of November 7, 2017, and that amended the color additive regulations to provide for the safe use of calcium carbonate to color hard and soft candy, mints, and in inks used on the surface of chewing gum.
Final National Occupational Research Agenda for Manufacturing
Document Number: 2018-01906
Type: Notice
Date: 2018-01-31
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
NIOSH announces the availability of the final National Occupational Research Agenda for Manufacturing
Determination of Regulatory Review Period for Purposes of Patent Extension; DUAVEE
Document Number: 2018-01894
Type: Notice
Date: 2018-01-31
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for DUAVEE and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human drug product.
Determination of Regulatory Review Period for Purposes of Patent Extension; CRESEMBA-New Drug Application 207501
Document Number: 2018-01892
Type: Notice
Date: 2018-01-31
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for CRESEMBA as approved under new drug application (NDA) 207501 and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human drug product as approved under NDA 207501.
Determination of Regulatory Review Period for Purposes of Patent Extension; SAPIEN XT TRANSCATHETER HEART VALVE
Document Number: 2018-01891
Type: Notice
Date: 2018-01-31
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for SAPIEN XT TRANSCATHETER HEART VALVE and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that medical device.
Determination of Regulatory Review Period for Purposes of Patent Extension; KEYTRUDA
Document Number: 2018-01890
Type: Notice
Date: 2018-01-31
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for KEYTRUDA and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human biological product.
Determination of Regulatory Review Period for Purposes of Patent Extension; MOBI-C CERVICAL DISC PROSTHESIS
Document Number: 2018-01889
Type: Notice
Date: 2018-01-31
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for MOBI-C CERVICAL DISC PROSTHESIS and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that medical device.
Notice of Interest Rate on Overdue Debts
Document Number: 2018-01878
Type: Notice
Date: 2018-01-31
Agency: Department of Health and Human Services, Office of the Secretary
National Institute of Nursing Research; Notice of Closed Meeting
Document Number: 2018-01857
Type: Notice
Date: 2018-01-31
Agency: Department of Health and Human Services, National Institutes of Health
Agency Information Collection Request. 60-Day Public Comment Request
Document Number: 2018-01849
Type: Notice
Date: 2018-01-31
Agency: Department of Health and Human Services
In compliance with the requirement of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, is publishing the following summary of a proposed collection for public comment.
National Institute of Nursing Research; Notice to Close Meeting
Document Number: 2018-01829
Type: Notice
Date: 2018-01-31
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Nursing Research; Notice to Close Meeting
Document Number: 2018-01828
Type: Notice
Date: 2018-01-31
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Nursing Research; Notice of Closed Meeting
Document Number: 2018-01827
Type: Notice
Date: 2018-01-31
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Neurological Disorders and Stroke; Notice of Closed Meetings
Document Number: 2018-01826
Type: Notice
Date: 2018-01-31
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of General Medical Sciences; Notice of Closed Meetings
Document Number: 2018-01825
Type: Notice
Date: 2018-01-31
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Deafness and Other Communication Disorders; Amended Notice of Meeting
Document Number: 2018-01824
Type: Notice
Date: 2018-01-31
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Aging; Amended Notice of Meeting
Document Number: 2018-01823
Type: Notice
Date: 2018-01-31
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Amended Notice of Meeting
Document Number: 2018-01821
Type: Notice
Date: 2018-01-31
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2018-01820
Type: Notice
Date: 2018-01-31
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Amended Notice of Meeting
Document Number: 2018-01819
Type: Notice
Date: 2018-01-31
Agency: Department of Health and Human Services, National Institutes of Health
Notice of Meetings
Document Number: 2018-01814
Type: Notice
Date: 2018-01-31
Agency: Agency for Healthcare Research and Quality, Department of Health and Human Services
The subcommittees listed below are part of AHRQ's Health Services Research Initial Review Group Committee. Grant applications are to be reviewed and discussed at these meetings. Each subcommittee meeting will commence in open session before closing to the public for the duration of the meeting.
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2018-01805
Type: Notice
Date: 2018-01-31
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
The Centers for Disease Control and Prevention (CDC), as part of its continuing effort to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies the opportunity to comment on a proposed and/or continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled Information Collection for U.S. Tuberculosis Follow-up Worksheet for Newly-Arrived Persons with Overseas Tuberculosis ClassificationsCDC is proposing a TB follow-up worksheet to capture domestic TB examination data for persons arriving to the U.S. with overseas TB classifications.
National Center for Advancing Translational Sciences; Notice of Closed Meetings
Document Number: 2018-01822
Type: Notice
Date: 2018-01-30
Agency: Department of Health and Human Services, National Institutes of Health
Medicare, Medicaid, and Children's Health Insurance Programs: Announcement of the Extension of Temporary Moratoria on Enrollment of Part B Non-Emergency Ground Ambulance Suppliers and Home Health Agencies in Designated Geographic Locations
Document Number: 2018-01783
Type: Rule
Date: 2018-01-30
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This document announces the extension of statewide temporary moratoria on the enrollment of new Medicare Part B non-emergency ground ambulance providers and suppliers and Medicare home health agencies, subunits, and branch locations in Florida, Illinois, Michigan, Texas, Pennsylvania, and New Jersey, as applicable, to prevent and combat fraud, waste, and abuse. This extension also applies to the enrollment of new non-emergency ground ambulance suppliers and home health agencies, subunits, and branch locations in Medicaid and the Children's Health Insurance Program in those states. For purposes of these moratoria, providers that were participating as network providers in one or more Medicaid managed care organizations prior to January 1, 2018 will not be considered ``newly enrolling'' when they are required to enroll with the State Medicaid agency pursuant to a new statutory requirement, and thus will not be subject to the moratoria.
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2018-01743
Type: Notice
Date: 2018-01-30
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
The Centers for Disease Control and Prevention (CDC), as part of its continuing effort to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995. This notice invites comment on the proposed information collection project entitled ``Evaluation of TransLife Center (TLC): A Locally-Developed Combination Prevention Intervention for Transgender Women at High Risk of HIV Infection.'' The collection is part of a research study designed to evaluate the efficacy of a locally developed and potentially effective intervention, TransLife Center (TLC), which provides combination HIV prevention services to adult transgender women at high risk for HIV infection.
Proposed Information Collection Activity; Comment Request Title:
Document Number: 2018-01705
Type: Notice
Date: 2018-01-30
Agency: Department of Health and Human Services, Administration for Children and Families
Proposed Information Collection Activity; Comment Request
Document Number: 2018-01683
Type: Notice
Date: 2018-01-30
Agency: Department of Health and Human Services, Administration for Children and Families
National Institute of General Medical Sciences; Notice of Closed Meetings
Document Number: 2018-01671
Type: Notice
Date: 2018-01-30
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Aging; Notice of Closed Meeting
Document Number: 2018-01670
Type: Notice
Date: 2018-01-30
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Aging; Notice of Closed Meetings
Document Number: 2018-01669
Type: Notice
Date: 2018-01-30
Agency: Department of Health and Human Services, National Institutes of Health
Qualified Infectious Disease Product Designation Questions and Answers; Draft Guidance for Industry; Availability
Document Number: 2018-01662
Type: Notice
Date: 2018-01-30
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Qualified Infectious Disease Product Designation Questions and Answers.'' The Food and Drug Administration Safety and Innovation Act (FDASIA) creates incentives for the development of antibacterial and antifungal drug products that treat serious or life-threatening infections. The purpose of this draft guidance is to provide a resource for information on FDA's policies and procedures related to the designation of a qualified infectious disease product (QIDP).
Determination of Regulatory Review Period for Purposes of Patent Extension; SAPIEN 3 TRANSCATHETER HEART VALVE
Document Number: 2018-01655
Type: Notice
Date: 2018-01-30
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for SAPIEN 3 TRANSCATHETER HEART VALVE and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that medical device.
Determination of Regulatory Review Period for Purposes of Patent Extension; VIEKIRA PAK
Document Number: 2018-01651
Type: Notice
Date: 2018-01-30
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for VIEKIRA PAK and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human drug product.
Determination of Regulatory Review Period for Purposes of Patent Extension; CRESEMBA-New Drug Aapplication 207500
Document Number: 2018-01645
Type: Notice
Date: 2018-01-30
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for CRESEMBA as approved under new drug application (NDA) 207500 and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human drug product as approved under NDA 207500.
Determination of Regulatory Review Period for Purposes of Patent Extension; Cardiomems HF Monitoring System
Document Number: 2018-01644
Type: Notice
Date: 2018-01-30
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for CARDIOMEMS HF MONITORING SYSTEM and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that medical device.
Evaluating Inclusion and Exclusion Criteria in Clinical Trials; Public Meeting
Document Number: 2018-01643
Type: Notice
Date: 2018-01-30
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA, the Agency, or we) is announcing a public meeting entitled ``Evaluating Inclusion and Exclusion Criteria in Clinical Trials.'' Convened by the Duke-Robert J. Margolis, MD, Center for Health Policy at Duke University and supported by a cooperative agreement with FDA, the purpose of the public meeting is to bring the stakeholder community together to discuss a variety of topics related to eligibility criteria in clinical trials and their potential impact on patient access to investigational drugs, and how to facilitate the enrollment of a diverse patient population.
Determination of Regulatory Review Period for Purposes of Patent Extension; ZEPATIER
Document Number: 2018-01642
Type: Notice
Date: 2018-01-30
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for ZEPATIER and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human drug product.
Determination of Regulatory Review Period for Purposes of Patent Extension; LONSURF
Document Number: 2018-01641
Type: Notice
Date: 2018-01-30
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for LONSURF and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human drug product.
Determination of Regulatory Review Period for Purposes of Patent Extension; GALLIPRANT
Document Number: 2018-01640
Type: Notice
Date: 2018-01-30
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for GALLIPRANT and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that animal drug product.
Medical Devices; General and Plastic Surgery Devices; Classification of the Surgical Smoke Precipitator
Document Number: 2018-01639
Type: Rule
Date: 2018-01-30
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) is classifying the surgical smoke precipitator into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the surgical smoke precipitator's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.
Medical Devices; Cardiovascular Devices; Classification of the Temporary Catheter for Embolic Protection During Transcatheter Intracardiac Procedures
Document Number: 2018-01638
Type: Rule
Date: 2018-01-30
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) is classifying the temporary catheter for embolic protection during transcatheter intracardiac procedures into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the temporary catheter for embolic protection during transcatheter intracardiac procedures' classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.
Determination of Regulatory Review Period for Purposes of Patent Extension; UPTRAVI
Document Number: 2018-01637
Type: Notice
Date: 2018-01-30
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for UPTRAVI and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human drug product.
Privacy Act of 1974; Matching Program
Document Number: 2018-01627
Type: Notice
Date: 2018-01-29
Agency: Department of Health and Human Services
In accordance with subsection (e)(12) of the Privacy Act of 1974, as amended, the Department of Health and Human Services, Administration for Children and Families, Office of Planning, Research and Evaluation (HHS/ACF/OPRE), is providing notice of a re-established matching program between the Department of Veterans Affairs (VA) and State Public Assistance Agencies (SPAAs), ``Information Comparisons and Disclosure to Assist in Administering the Public Assistance Reporting Information System (PARIS) Program.'' The matching program provides VA pay and pension data to SPAAs, which SPAAs use to identify individual public assistance clients (applicants and recipients) who are receiving compensation and pension payments from VA, in order to determine their eligibility for benefits under HHS' Medicaid and Temporary Assistance to Needy Families (TANF) programs and the Department of Agriculture's Supplemental Nutrition Assistance Program (SNAP). HHS/ACF/OPRE facilitates the matching program, with computer assistance from the Department of Defense, Defense Manpower Data Center (DOD/DMDC).