Department of Health and Human Services July 26, 2017 – Federal Register Recent Federal Regulation Documents

Sunshine Act Meeting: Board of Scientific Counselors, National Center for Health Statistics (NCHS)
Document Number: 2017-15783
Type: Notice
Date: 2017-07-26
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
A Performance Test Protocol for Closed System Transfer Devices Used During Pharmacy Compounding and Administration of Hazardous Drugs; Extension of Comment Period
Document Number: 2017-15727
Type: Notice
Date: 2017-07-26
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
On September 15, 2016 the National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC), published a notice in the Federal Register [81 FR 63482] announcing a public meeting and request for public comment on a draft testing protocol. Written comments were to be received by December 7, 2016. NIOSH initially extended the public comment period to June 7, 2017 [81 FR 88687]. NIOSH extended the comment period again to August 30, 2017 [82 FR 25290]. NIOSH is extending the public comment period to close on February 28, 2018. The longer timeframe will allow companies to test the protocol with the proposed challenge agents and permit full participation in the protocol design process.
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 2017-15726
Type: Notice
Date: 2017-07-26
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.
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2017-15671
Type: Notice
Date: 2017-07-26
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Advisory Committee on Training in Primary Care Medicine and Dentistry
Document Number: 2017-15665
Type: Notice
Date: 2017-07-26
Agency: Department of Health and Human Services, Health Resources and Services Administration
The Advisory Committee on Training in Primary Care Medicine and Dentistry (ACTPCMD) has scheduled a meeting. This meeting will be open to the public. Information about ACTPCMD and the agenda for this meeting can be found on the ACTPCMD Web site at https://www.hrsa.gov/ advisorycommittees/bhpradvisory/ACTPCMD.
Notice of Intent To Award a Single-Source Non-Competing Continuation Application To Fund Grant Number 90DN0295 University of Massachusetts for an Additional 12 Months
Document Number: 2017-15663
Type: Notice
Date: 2017-07-26
Agency: Department of Health and Human Services
The Administration for Community Living (ACL) recently announced the awarding of the University of Massachusetts-Boston to the Institute of Community Inclusion (ICI). The University of Massachusetts-Boston will maintain and advance the longitudinal study describing day and employment services nationwide for individuals with developmental disabilities.
Notice of Intent To Award a Single-Source Non-Competing Continuation Application To Fund Grant Number 90DN0296 the University of Colorado for an Additional 12 Months
Document Number: 2017-15662
Type: Notice
Date: 2017-07-26
Agency: Department of Health and Human Services
The Administration for Community Living (ACL) recently announced the awarding of the University of Colorado for the State of the States in Intellectual and Developmental Disabilities (State of the States) project. The University of Colorado will maintain and advance a comparative nationwide longitudinal study of public financial commitments and programmatic trends in developmental disabilities services and supports.
Notice of Intent To Award a Single-Source Non-Competing Continuation Application to the University of Minnesota for an Additional 12 Months
Document Number: 2017-15661
Type: Notice
Date: 2017-07-26
Agency: Department of Health and Human Services
The Administration for Community Living (ACL) recently announced the awarding of the University of Minnesota to the Residential Information System Project (RISP). The University of Minnesota will maintain and continue the longitudinal study of annual state-by-state and national statistics on residential services and supports for people with intellectual and developmental disabilities.
Patient Engagement Advisory Committee; Notice of Meeting
Document Number: 2017-15657
Type: Notice
Date: 2017-07-26
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 Patient Engagement Advisory Committee (PEAC). The general function of the committee is to provide advice and recommendations to the Agency on complex issues relating to medical devices, the regulation of devices, and their use by patients. The meeting will be open to the public. This meeting will be the inaugural meeting of a new advisory committee.
Generic Drug User Fee Amendments of 2012: Questions and Answers Related to Self-Identification of Facilities, Review of Generic Drug Submissions, and Inspections and Compliance; Guidance for Industry; Availability
Document Number: 2017-15654
Type: Notice
Date: 2017-07-26
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing the availability of the guidance entitled ``Generic Drug User Fee Amendments of 2012: Questions and Answers Related to Self- Identification of Facilities, Review of Generic Drug Submissions, and Inspections and Compliance.'' The Generic Drug User Fee Amendments of 2012 (GDUFA) are designed to speed the delivery of safe and effective generic drugs to the public and to improve the review process for abbreviated new drug applications (ANDAs). This guidance is intended to provide answers to common questions from the generic drug industry and other interested parties involved in the development and/or testing of generic drug products regarding the requirements and commitments of GDUFA. This guidance finalizes the draft guidance originally issued in August 2012 and issued in revised draft form in September 2013.
Consumer Antiseptic Wash Final Rule Questions and Answers; Guidance for Industry; Small Entity Compliance Guide; Availability
Document Number: 2017-15653
Type: Notice
Date: 2017-07-26
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 ``Consumer Antiseptic Wash Final Rule Questions and Answers.'' We are issuing this guidance in accordance with the Small Business Regulatory Enforcement Fairness Act to assist small businesses in better understanding and complying with the consumer antiseptic wash final rule, which established that certain active ingredients, including triclosan, used in over-the-counter (OTC) consumer antiseptic wash products are not generally recognized as safe and effective (GRASE). This guidance explains the scope of the final rule, how and when manufacturers must comply with the final rule, and which consumer antiseptic wash active ingredients were deferred from the final rule.
National Eye Institute; Notice of Closed Meeting
Document Number: 2017-15616
Type: Notice
Date: 2017-07-26
Agency: Department of Health and Human Services, National Institutes of Health
National Cancer Institute; Notice of Closed Meetings
Document Number: 2017-15615
Type: Notice
Date: 2017-07-26
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Amended Notice of Meeting
Document Number: 2017-15614
Type: Notice
Date: 2017-07-26
Agency: Department of Health and Human Services, National Institutes of Health
Juice Products Association; Filing of Food Additive Petition
Document Number: 2017-15535
Type: Proposed Rule
Date: 2017-07-26
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) is announcing that we have filed a petition, submitted by the Juice Products Association, proposing that the food additive regulations be amended to replace the current Recommended Daily Intake (RDI) percentage values of calcium in fruit juices and fruit juice drinks in the regulation for vitamin D3 with absolute values and to update the specifications for vitamin D3.
Zinpro Corp.; Filing of Food Additive Petition (Animal Use)
Document Number: 2017-15533
Type: Proposed Rule
Date: 2017-07-26
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) is announcing that Zinpro Corp. has filed a petition proposing that the food additive regulations be amended to provide for the safe use of zinc-L- selenomethionine as a nutritional source of selenium in complete feed for laying hens and for the safe use of the approved food additive silicon dioxide as an anticaking agent for use with zinc-L- selenomethionine as a feed component.
Agency Information Collection Activities: Proposed Collection; Comment Request; Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery
Document Number: 2017-15318
Type: Notice
Date: 2017-07-26
Agency: Department of Health and Human Services
As part of a Federal Government-wide effort to streamline the process to seek feedback from the public on service delivery, U.S. Department of Health and Human Services has submitted a Generic Information Collection Request (Generic ICR): ``Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery'' to OMB for approval under the Paperwork Reduction Act (PRA).
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