Department of Health and Human Services November 22, 2017 – Federal Register Recent Federal Regulation Documents

Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 2017-25313
Type: Notice
Date: 2017-11-22
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. Under the Paperwork Reduction Act of 1995 (PRA), federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension or reinstatement of an existing collection of information, and to allow a second opportunity for public comment on the notice. Interested persons are invited to send comments regarding the burden estimate or any other aspect of this collection of information, including the necessity and utility of the proposed information collection for the proper performance of the agency's functions, the accuracy of the estimated burden, ways to enhance the quality, utility, and clarity of the information to be collected; and the use of automated collection techniques or other forms of information technology to minimize the information collection burden.
Bone, Reproductive and Urologic Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments
Document Number: 2017-25295
Type: Notice
Date: 2017-11-22
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) announces a forthcoming public advisory committee meeting of the Bone, Reproductive and Urologic Drugs 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. FDA is establishing a docket for public comment on this document.
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2017-25261
Type: Notice
Date: 2017-11-22
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 Workplace Violence Prevention Programs in NJ Healthcare Facilities. Through nursing home administrator interviews, CDC seeks to continue measuring compliance to the state regulations for workplace violence prevention program: Violence prevention policies, reporting systems for violent events, violence prevention committee, written violence prevention plan, violence risk assessments, post incident response and violence prevention training.
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2017-25260
Type: Notice
Date: 2017-11-22
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 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 Monitoring Breastfeeding-Related Maternity CareUS hospitals. The Maternity Practices in Infant Nutrition and Care (mPINC) survey is a census of maternity care hospitals in the United States and Territories, that CDC has administered every other year since 2007 in order to monitor and examine changes in breastfeeding-related maternity care practices over time.
Tenth Annual Sentinel Initiative; Public Workshop
Document Number: 2017-25251
Type: Notice
Date: 2017-11-22
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing a public workshop entitled ``Tenth Annual Sentinel Initiative Public Workshop.'' The purpose of this 2-day public workshop is to bring the stakeholder community together to discuss a variety of topics on active medical product surveillance. Attendees will leave with a deeper understanding of how to use the Sentinel System tools to address safety questions.
General Principles for Evaluating the Abuse Deterrence of Generic Solid Oral Opioid Drug Products; Guidance for Industry; Availability
Document Number: 2017-25248
Type: Notice
Date: 2017-11-22
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 guidance for industry entitled ``General Principles for Evaluating the Abuse Deterrence of Generic Solid Oral Opioid Drug Products.'' This guidance is intended to assist a person who plans to develop and submit an abbreviated new drug application (ANDA) to seek approval of a generic version of a solid oral opioid drug product that references an opioid drug product with abuse- deterrent properties described in its labeling. The guidance recommends studies, including comparative in vitro and pharmacokinetic (PK) studies, that a potential ANDA applicant should conduct and submit to FDA to demonstrate that a generic solid oral opioid drug product is no less abuse deterrent than its reference listed drug (RLD) with respect to all potential routes of abuse.
Tobacco Product Manufacturing Practice; Request for Comments
Document Number: 2017-25245
Type: Notice
Date: 2017-11-22
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is requesting public input on updated recommendations for regulations on good manufacturing practice for electronic nicotine delivery systems (ENDS) that were submitted to FDA by a group of 13 tobacco companies (tobacco companies' ENDS recommendations). FDA is providing an opportunity for interested parties to comment on the tobacco companies' ENDS recommendations.
Modified Risk Tobacco Product Applications: Applications for IQOS System With Marlboro Heatsticks, IQOS System With Marlboro Smooth Menthol Heatsticks, and IQOS System With Marlboro Fresh Menthol Heatsticks Submitted by Philip Morris Products S.A.; Extension of Comment Period
Document Number: 2017-25224
Type: Notice
Date: 2017-11-22
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is extending the period for public comment on modified risk tobacco product applications (MRTPAs) submitted by Philip Morris Products S.A. for its IQOS system with Marlboro Heatsticks, IQOS system with Marlboro Smooth Menthol Heatsticks, and IQOS system with Marlboro Fresh Menthol Heatsticks.
National Eye Institute; Notice of Closed Meeting
Document Number: 2017-25218
Type: Notice
Date: 2017-11-22
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review Cancellation of Meeting
Document Number: 2017-25217
Type: Notice
Date: 2017-11-22
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review Notice of Closed Meetings
Document Number: 2017-25216
Type: Notice
Date: 2017-11-22
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review Notice of Closed Meetings
Document Number: 2017-25215
Type: Notice
Date: 2017-11-22
Agency: Department of Health and Human Services, National Institutes of Health
Sanitary Transportation of Human and Animal Food: What You Need to Know About the Food and Drug Administration Regulation; Small Entity Compliance Guide; Availability
Document Number: 2017-25204
Type: Rule
Date: 2017-11-22
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA, the Agency, or we) is announcing the availability of a guidance for industry entitled ``Sanitary Transportation of Human and Animal Food: What You Need to Know About the FDA RegulationSmall Entity Compliance Guide.'' The small entity compliance guide (SECG) is intended to help small entities comply with the final rule entitled ``Sanitary Transportation of Human and Animal Food.''