Department of Health and Human Services October 4, 2016 – Federal Register Recent Federal Regulation Documents

Proposed Information Collection Activity; Comment Request
Document Number: 2016-23951
Type: Notice
Date: 2016-10-04
Agency: Department of Health and Human Services, Administration for Children and Families
Submission for OMB Review; Comment Request
Document Number: 2016-23950
Type: Notice
Date: 2016-10-04
Agency: Department of Health and Human Services, Administration for Children and Families
Dietary Supplements: New Dietary Ingredient Notifications and Related Issues; Revised Draft Guidance for Industry; Extension of Comment Period
Document Number: 2016-23931
Type: Notice
Date: 2016-10-04
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) is extending the comment period for the revised draft guidance for industry entitled ``Dietary Supplements: New Dietary Ingredient Notifications and Related Issues,'' that appeared in the Federal Register of August 12, 2016. We are taking this action in response to requests to extend the comment period to allow interested persons additional time to submit comments.
Agency Information Collection Activities; Proposed Collection; Comment Request; Information From United States Firms and Processors That Export to the European Union
Document Number: 2016-23930
Type: Notice
Date: 2016-10-04
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on reporting requirements in implementing the lists of United States (U.S.) firms/processors exporting shell eggs, game meat and game meat products, gelatin, and collagen to the European Union (the EU).
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2016-23925
Type: Notice
Date: 2016-10-04
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 efforts 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 a proposed study project entitled ``Survey of Sexually Transmitted Disease (STD) Provider Practices in the United States''. The primary goal of this study is to better understand policies and practices for STD care delivery among medical providers who typically see patients for STDs. Another goal is to assess awareness and use of CDC's STD treatment guidelines.
Center for Devices and Radiological Health Veteran Amputee Devices; Public Workshop; Request for Comments
Document Number: 2016-23924
Type: Notice
Date: 2016-10-04
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the following public workshop entitled ``Center for Devices and Radiological Health Veteran Amputee Devices.'' The purpose of this workshop is to engage all stakeholders involved in the research, development, and marketing of prosthetic limb medical devices used by veteran amputees. A specific goal is to engage veteran amputees who use prosthetic limb medical devices and hear their views on these devices so that these perspectives may be considered in the total product life cycle of prosthetic limb devices.
Announcement of a Single-Source Supplement Grant to the National Child Welfare Capacity Building Center for Tribes
Document Number: 2016-23909
Type: Notice
Date: 2016-10-04
Agency: Department of Health and Human Services, Administration for Children and Families
The Administration for Children and Families (ACF), Administration for Children Youth and Families (ACYF), Children's Bureau announces the award of a single-source supplement grant in the amount of $547,000 to the National Child Welfare Capacity Building Center for Tribes (CBCT), operated by the University of Denver (Colorado Seminary). The primary goal of this grant is to provide capacity-building services to title IV-E and IV-B American Indian and Alaska Native Nations (AI/AN), and to promote intergovernmental collaboration between tribes and state child welfare agencies in system improvement work.
Medical Devices; Exemption From Premarket Notification; Method, Metallic Reduction, Glucose (Urinary, Nonquantitative) Test System in a Reagent Tablet Format
Document Number: 2016-23901
Type: Rule
Date: 2016-10-04
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is publishing an order denying a petition requesting exemption from the premarket notification requirements for method, metallic reduction, glucose (urinary, nonquantitative) devices that are in a reagent tablet format and are classified as class II devices as urinary glucose (nonquantitative) test system (hereinafter referred to as ''copper reduction tablet test''). Urinary glucose (nonquantitative) measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, hypoglycemia, and hyperglycemia. FDA is publishing this order in accordance with procedures established by the Food and Drug Administration Modernization Act of 1997 (FDAMA).
Medical Devices; Exemption From Premarket Notification: Method, Metallic Reduction, Glucose (Urinary, Nonquantitative) Test System in a Reagent Tablet Format
Document Number: 2016-23899
Type: Rule
Date: 2016-10-04
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is publishing an order denying a petition requesting exemption from the premarket notification requirements for ``method, metallic reduction, glucose (urinary, nonquantitative)'' devices that are in a reagent tablet format and are classified as class II devices as urinary glucose (nonquantitative) test system (hereinafter referred to as ``copper reduction tablet test''). Urinary glucose (nonquantitative) measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, hypoglycemia, and hyperglycemia. FDA is publishing this order in accordance with procedures established by the Food and Drug Administration Modernization Act of 1997 (FDAMA).
Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals
Document Number: 2016-23898
Type: Notice
Date: 2016-10-04
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is publishing a list of information collections that have been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance for Industry on How To Submit Information in Electronic Format to the Center for Veterinary Medicine Using the Food and Drug Administration Electronic Submission Gateway
Document Number: 2016-23897
Type: Notice
Date: 2016-10-04
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) 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.
Microbiology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments
Document Number: 2016-23895
Type: Notice
Date: 2016-10-04
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 Microbiology 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. FDA is establishing a docket for public comment on this document.
Workshop on Promoting Semantic Interoperability of Laboratory Data; Public Workshop; Request for Comments
Document Number: 2016-23894
Type: Notice
Date: 2016-10-04
Agency: Food and Drug Administration, Department of Health and Human Services
The Centers for Disease Control and Prevention (CDC), the Food and Drug Administration (FDA), the National Library of Medicine (NLM) of the National Institutes of Health (NIH), the Office of the National Coordinator for Health Information Technology (ONC), and the Centers for Medicare and Medicaid Services (CMS) are announcing the following public workshop entitled ``CDC/FDA/NLM/ONC/CMS Workshop on Promoting Semantic Interoperability of Laboratory Data.'' The purpose of this public workshop is to receive and discuss input from stakeholders regarding proposed approaches to facilitate the adoption and implementation of interoperability standards in a manner that enables consistent, accurate, and harmonized descriptions of in vitro diagnostic tests and results.
Hospira, Inc. et al.; Withdrawal of Approval of 44 New Drug Applications and 158 Abbreviated New Drug Applications
Document Number: 2016-23893
Type: Notice
Date: 2016-10-04
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is withdrawing approval of 44 new drug applications (NDAs) and 158 abbreviated new drug applications (ANDAs) from multiple applicants. The holders of the applications notified the Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.
National Institute of Mental Health; Amended Notice of Meeting
Document Number: 2016-23885
Type: Notice
Date: 2016-10-04
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases Notice of Closed Meeting
Document Number: 2016-23883
Type: Notice
Date: 2016-10-04
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2016-23882
Type: Notice
Date: 2016-10-04
Agency: Department of Health and Human Services, National Institutes of Health
National Heart, Lung, and Blood Institute; Notice of Closed Meeting
Document Number: 2016-23881
Type: Notice
Date: 2016-10-04
Agency: Department of Health and Human Services, National Institutes of Health
National Heart, Lung, and Blood Institute; Notice of Closed Meeting
Document Number: 2016-23880
Type: Notice
Date: 2016-10-04
Agency: Department of Health and Human Services, National Institutes of Health
National Heart, Lung, and Blood Institute; Notice of Closed Meeting
Document Number: 2016-23879
Type: Notice
Date: 2016-10-04
Agency: Department of Health and Human Services, National Institutes of Health
National Center for Complementary & Integrative Health; Notice of Closed Meeting
Document Number: 2016-23878
Type: Notice
Date: 2016-10-04
Agency: Department of Health and Human Services, National Institutes of Health
National Center for Complementary & Integrative Health; Notice of Closed Meeting
Document Number: 2016-23877
Type: Notice
Date: 2016-10-04
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2016-23876
Type: Notice
Date: 2016-10-04
Agency: Department of Health and Human Services, National Institutes of Health
Eunice Kennedy Shriver National Institute of Child Health & Human Development; Notice of Closed Meetings
Document Number: 2016-23875
Type: Notice
Date: 2016-10-04
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2016-23874
Type: Notice
Date: 2016-10-04
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2016-23873
Type: Notice
Date: 2016-10-04
Agency: Department of Health and Human Services, National Institutes of Health
Privacy Act of 1974; CMS Computer Match No. 2016-15; HHS Computer Match No. 1609
Document Number: 2016-23866
Type: Notice
Date: 2016-10-04
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
In accordance with the requirements of the Privacy Act of 1974, as amended, this notice announces the establishment of a Computer Matching Program that CMS plans to conduct with the Peace Corps (PC).
Proposed Information Collection Activity; Comment Request
Document Number: 2016-23865
Type: Notice
Date: 2016-10-04
Agency: Department of Health and Human Services, Administration for Children and Families
Medicare and Medicaid Programs; Reform of Requirements for Long-Term Care Facilities
Document Number: 2016-23503
Type: Rule
Date: 2016-10-04
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This final rule will revise the requirements that Long-Term Care facilities must meet to participate in the Medicare and Medicaid programs. These changes are necessary to reflect the substantial advances that have been made over the past several years in the theory and practice of service delivery and safety. These revisions are also an integral part of our efforts to achieve broad-based improvements both in the quality of health care furnished through federal programs, and in patient safety, while at the same time reducing procedural burdens on providers.