Department of Health and Human Services May 31, 2019 – Federal Register Recent Federal Regulation Documents

Submission for OMB Review; 30-Day Comment Request; Proposed Collection; Generic Clearance for Conferences, Meetings, Workshops, Poster Sessions and Registration (OD)
Document Number: 2019-11422
Type: Notice
Date: 2019-05-31
Agency: Department of Health and Human Services, National Institutes of Health
In compliance with the Paperwork Reduction Act of 1995, the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Food Labeling; Notification Procedures for Statements on Dietary Supplements
Document Number: 2019-11419
Type: Notice
Date: 2019-05-31
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) 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.
Improving the Implementation of Risk-Based Monitoring Approaches of Clinical Investigations; Public Workshop
Document Number: 2019-11411
Type: Notice
Date: 2019-05-31
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA, we) is announcing the following pubic workshop entitled ``Improving the Implementation of Risk-Based Monitoring Approaches of Clinical Investigations.'' This public workshop is convened by Duke University's Robert J. Margolis, MD, Center for Health Policy and supported by a cooperative agreement with FDA. The purpose of the public workshop is to capture stakeholder experiences with risk-based approaches to monitoring of clinical investigations and gather stakeholder input on opportunities to further the implementation of risk-based approaches to monitoring.
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 2019-11389
Type: Notice
Date: 2019-05-31
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.
Proposed Information Collection Activity; American Indian and Alaska Native (AIAN) Facility Survey (New Collection)
Document Number: 2019-11371
Type: Notice
Date: 2019-05-31
Agency: Department of Health and Human Services, Administration for Children and Families
The Office Head Start (OHS), Administration for Children and Families (ACF), U.S. Department of Health and Human Services (HHS), is proposing to collect data on the condition and ownership of American Indian and Alaska Native (AIAN) facilities to meet congressional reporting requirements under the Head Start Act.
Proposed Information Collection Activity; Head Start Program Performance Standards (OMB #0970-0148)
Document Number: 2019-11370
Type: Notice
Date: 2019-05-31
Agency: Department of Health and Human Services, Administration for Children and Families
The Office Head Start (OHS), Administration for Children and Families (ACF), U.S. Department of Health and Human Services (HHS), is requesting a three-year extension of the Head Start Program Performance Standards (HSPPS) information collection (OMB #0970-0148, expiration 1/ 31/2020). There are no changes requested to these record keeping requirements.
National Institute of Nursing Research; Amended Notice of Meeting
Document Number: 2019-11341
Type: Notice
Date: 2019-05-31
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Neurological Disorders and Stroke; Notice of Closed Meetings
Document Number: 2019-11339
Type: Notice
Date: 2019-05-31
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Mental Health; Notice of Closed Meeting
Document Number: 2019-11338
Type: Notice
Date: 2019-05-31
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of General Medical Sciences; Notice of Closed Meetings
Document Number: 2019-11337
Type: Notice
Date: 2019-05-31
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Aging; Notice of Closed Meeting
Document Number: 2019-11336
Type: Notice
Date: 2019-05-31
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Aging; Notice of Closed Meeting
Document Number: 2019-11335
Type: Notice
Date: 2019-05-31
Agency: Department of Health and Human Services, National Institutes of Health
National Heart, Lung, and Blood Institute; Amended Notice of Meeting
Document Number: 2019-11334
Type: Notice
Date: 2019-05-31
Agency: Department of Health and Human Services, National Institutes of Health
National Heart, Lung, and Blood Institute; Notice of Closed Meetings
Document Number: 2019-11333
Type: Notice
Date: 2019-05-31
Agency: Department of Health and Human Services, National Institutes of Health
National Center for Complementary & Integrative Health; Notice of Closed Meeting
Document Number: 2019-11332
Type: Notice
Date: 2019-05-31
Agency: Department of Health and Human Services, National Institutes of Health
National Center for Complementary and Integrative Health; Notice of Closed Meeting
Document Number: 2019-11331
Type: Notice
Date: 2019-05-31
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Amended Notice of Meeting
Document Number: 2019-11328
Type: Notice
Date: 2019-05-31
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2019-11327
Type: Notice
Date: 2019-05-31
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2019-11326
Type: Notice
Date: 2019-05-31
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meeting
Document Number: 2019-11325
Type: Notice
Date: 2019-05-31
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2019-11324
Type: Notice
Date: 2019-05-31
Agency: Department of Health and Human Services, National Institutes of Health
Fixed-Quantity Unit-of-Use Blister Packaging for Certain Immediate-Release Opioid Analgesics for Treatment of Acute Pain; Establishment of a Public Docket; Request for Comments
Document Number: 2019-11283
Type: Notice
Date: 2019-05-31
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or the Agency) is announcing the establishment of a docket to solicit public comment on a potential modification to the Opioid Analgesic Risk Evaluation and Mitigation Strategy (OA REMS) to require that certain solid, oral dosage forms of immediate-release (IR) opioid analgesics commonly prescribed for treatment of acute pain be made available in fixed- quantity unit-of-use blister packaging for outpatient dispensing. This could reduce the amount of unused opioid analgesics, thereby reducing opportunities for misuse, abuse, inappropriate access, and overdose, and possibly reducing the development of new opioid addiction.
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