Department of Health and Human Services December 28, 2017 – Federal Register Recent Federal Regulation Documents

Healthcare Infection Control Practices Advisory Committee (HICPAC)
Document Number: 2017-28072
Type: Notice
Date: 2017-12-28
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
In accordance with the Federal Advisory Committee Act, the CDC announces the following meeting for the Healthcare Infection Control Practices Advisory Committee (HICPAC). This meeting is open to the public, limited only by audio phone lines available. The public is also welcome to listen to the meeting by dialing 888-946-7207, passcode: 5023213. A total of 200 lines will be available. To register for this call, please go to www.cdc.gov/hicpac.
Office for State, Tribal, Local and Territorial Support (OSTLTS), Tribal Advisory Committee (TAC) Meeting and 18th Biannual Tribal Consultation Session
Document Number: 2017-28071
Type: Notice
Date: 2017-12-28
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
The Centers for Disease Control and Prevention (CDC)/Agency for Toxic Substances and Disease Registry (ATSDR), announces the following meeting and Tribal Consultation Session. The meetings are being hosted by CDC/ATSDR in-person only and are open to the public. Attendees must pre-register for the event by March 2, 2018, at the following link: www.cdc.gov/tribal/meetings.html.
Board of Scientific Counselors, National Center for Injury Prevention and Control, (BSC, NCIPC)
Document Number: 2017-28070
Type: Notice
Date: 2017-12-28
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
In accordance with the Federal Advisory Committee Act, the CDC announces the following meeting for the Board of Scientific Counselors, National Center for Injury Prevention and Control, (BSC, NCIPC). This meeting is open to the public limited only by the 75 telephone ports available. There will be a public comment period at the end of the meeting day from 3:30 p.m.-3:45 p.m., February 26, 2018.
Advisory Committee on Immunization Practices (ACIP); Notice of Charter Amendment
Document Number: 2017-28069
Type: Notice
Date: 2017-12-28
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
This gives notice under (the Federal Advisory Committee Act of October 6, 1972, that the Advisory Committee on Immunization Practices (ACIP), Centers for Disease Control and Prevention, Department of Health and Human Services, has amended their charter to include a non- voting liaison representative; American Immunization Registry Association. The amended filing date is October 17, 2017.
Fostering Medical Innovation: Case for Quality Voluntary Medical Device Manufacturing and Product Quality Pilot Program
Document Number: 2017-28044
Type: Notice
Date: 2017-12-28
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration's (FDA or Agency or we) Center for Devices and Radiological Health (CDRH or Center) is announcing its Case for Quality Voluntary Medical Device Manufacturing and Product Quality Pilot Program (CfQ Pilot Program). The CfQ Pilot Program is voluntary and intends to evaluate product and manufacturing quality within the medical device ecosystem. The CfQ Pilot Program also intends to explore the effectiveness of a quality maturity appraisal, the use of objective metrics, optimization of resources, and impact on quality culture. The pilot program seeks to demonstrate better patient safety and outcomes, a lower regulatory burden on demonstrating quality assurance, and assure safety and effectiveness during product development and manufacturing.
Medical Devices; Obstetrical and Gynecological Devices; Classification of the Pressure Wedge for the Reduction of Cesarean Delivery
Document Number: 2017-28042
Type: Rule
Date: 2017-12-28
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) is classifying the pressure wedge for the reduction of cesarean delivery 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 pressure wedge for the reduction of cesarean delivery'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.
Council on Graduate Medical Education
Document Number: 2017-28015
Type: Notice
Date: 2017-12-28
Agency: Department of Health and Human Services, Health Resources and Services Administration
In accordance with the Federal Advisory Committee Act, this notice announces that the Council on Graduate Medical Education (COGME) will hold a public meeting.
Neurological Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting
Document Number: 2017-27974
Type: Notice
Date: 2017-12-28
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 Neurological Devices Panel of the Medical Devices Advisory Committee. The general function of the committee is to provide advice and recommendations to the Agency on FDA's regulatory issues. The meeting will be open to the public.
New Animal Drugs for Investigational Use; Disqualification of a Clinical Investigator
Document Number: 2017-27973
Type: Rule
Date: 2017-12-28
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA, the Agency, or we) is issuing a final rule amending the regulations for new animal drugs for investigational use to expand the scope of clinical investigator disqualification to include ineligibility to conduct nonclinical laboratory studies. Under this final rule, when the Commissioner of Food and Drugs (the Commissioner) determines that an investigator is ineligible to receive a new animal drug for investigational use, the investigator also will be ineligible to conduct any nonclinical study intended to support an application for a research or marketing permit for a new animal drug. This final rule will help ensure adequate protection of animal research subjects and the quality and integrity of data submitted to FDA.
Medicare Program Contract Year 2019 Policy and Technical Changes to the Medicare Advantage, Medicare Cost Plan, Medicare Fee-For-Service, the Medicare Prescription Drug Benefit Programs, and the PACE Program; Correction
Document Number: 2017-27943
Type: Proposed Rule
Date: 2017-12-28
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This document corrects technical and typographical errors in the proposed rule that appeared in the November 28, 2017 issue of the Federal Register titled ``Medicare Program Contract Year 2019 Policy and Technical Changes to the Medicare Advantage, Medicare Cost Plan, Medicare Fee-For-Service, the Medicare Prescription Drug Benefit Programs, and the PACE Program''.
National Eye Institute; Notice of Closed Meeting
Document Number: 2017-27936
Type: Notice
Date: 2017-12-28
Agency: Department of Health and Human Services, National Institutes of Health