Department of Health and Human Services April 25, 2016 – Federal Register Recent Federal Regulation Documents

Announcement of the Intent To Award Single-Source Cooperative Agreement to the University of Southern California, Department of Family Medicine and Geriatrics, National Center on Elder Abuse
Document Number: 2016-09560
Type: Notice
Date: 2016-04-25
Agency: Department of Health and Human Services
The Administration for Community Living (ACL) announces the intent to award a supplemental single-source cooperative agreement in the amount of $275,000 to the University of Southern (U.S.C.) California, Department of Family Medicine and Geriatrics, National Center on Elder Abuse (NCEA) to support and stimulate the expansion of work already underway by U.S.C./NCEA proving public awareness and improving the national response to elder abuse, neglect and exploitation to all.
Disease, Disability, and Injury Prevention and Control Special Emphasis Panel (SEP): Initial Review
Document Number: 2016-09536
Type: Notice
Date: 2016-04-25
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Disease, Disability, and Injury Prevention and Control Special Emphasis Panel (SEP): Initial Review
Document Number: 2016-09535
Type: Notice
Date: 2016-04-25
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
World Trade Center Health Program; Petition 011-Autoimmune Diseases; Finding of Insufficient Evidence
Document Number: 2016-09527
Type: Proposed Rule
Date: 2016-04-25
Agency: Department of Health and Human Services
On January 25, 2016, the Administrator of the World Trade Center (WTC) Health Program received a petition (Petition 011) to add ``autoimmune disease, lupus, and rheumatoid arthritis'' to the List of WTC-Related Health Conditions (List). Upon reviewing the information provided by the petitioner, the Administrator has determined that Petition 011 is not substantially different from Petitions 007, 008, and 009, which also requested the addition of autoimmune diseases. The Administrator recently published responses to Petitions 007, 008, and 009 in the Federal Register and has determined that Petition 011 does not provide additional evidence of a causal relationship between 9/11 exposures and autoimmune diseases. Accordingly, the Administrator finds that insufficient evidence exists to request a recommendation of the WTC Health Program Scientific/Technical Advisory Committee (STAC), to publish a proposed rule, or to publish a determination not to publish a proposed rule.
Request for Public Comment: 60-Day Information Collection: Indian Self-Determination and Education Assistance Act Contracts
Document Number: 2016-09501
Type: Notice
Date: 2016-04-25
Agency: Department of Health and Human Services, Indian Health Service
In compliance the Paperwork Reduction Act of 1995, the Indian Health Service (IHS) invites the general public to comment on the information collection titled, ``Indian Self-Determination and Education Assistance Act Contracts,'' Office of Management and Budget (OMB) Control Number 0917-0037. IHS is requesting OMB to approve an extension for this collection, which expires on July 31, 2016.
National Institute of Neurological Disorders and Stroke; Notice of Closed Meeting
Document Number: 2016-09467
Type: Notice
Date: 2016-04-25
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Dental & Craniofacial Research; Notice of Closed Meeting
Document Number: 2016-09466
Type: Notice
Date: 2016-04-25
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meetings
Document Number: 2016-09465
Type: Notice
Date: 2016-04-25
Agency: Department of Health and Human Services, National Institutes of Health
National Heart, Lung, and Blood Institute; Notice of Closed Meetings
Document Number: 2016-09464
Type: Notice
Date: 2016-04-25
Agency: Department of Health and Human Services, National Institutes of Health
Eunice Kennedy Shriver National Institute of Child Health & Human Development (NICHD) Notice of Meeting
Document Number: 2016-09463
Type: Notice
Date: 2016-04-25
Agency: Department of Health and Human Services, National Institutes of Health
National Center for Complementary & Integrative Health; Notice of Meeting
Document Number: 2016-09462
Type: Notice
Date: 2016-04-25
Agency: Department of Health and Human Services, National Institutes of Health
National Toxicology Program Board of Scientific Counselors; Announcement of Meeting; Request for Comments
Document Number: 2016-09461
Type: Notice
Date: 2016-04-25
Agency: Department of Health and Human Services, National Institutes of Health
This notice announces the next meeting of the National Toxicology Program (NTP) Board of Scientific Counselors (BSC). The BSC, a federally chartered, external advisory group composed of scientists from the public and private sectors, will review and provide advice on programmatic activities. The meeting is open to the public and registration is requested for both attendance and oral comment and required to access the webcast. Information about the meeting and registration are available at http://ntp.niehs.nih.gov/go/165.
Office of the Director, National Institutes of Health Notice of Meeting
Document Number: 2016-09460
Type: Notice
Date: 2016-04-25
Agency: Department of Health and Human Services, National Institutes of Health
Determination That THALITONE (Chlorthalidone USP) Tablets, 15 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness
Document Number: 2016-09450
Type: Notice
Date: 2016-04-25
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) has determined that THALITONE (chlorthalidone USP) tablets, 15 milligrams (mg), were not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for chlorthalidone USP tablets, 15 mg, if all other legal and regulatory requirements are met.
Assay Development and Validation for Immunogenicity Testing of Therapeutic Protein Products; Revised Draft Guidance for Industry; Availability
Document Number: 2016-09449
Type: Notice
Date: 2016-04-25
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 revised draft guidance for industry entitled ``Assay Development and Validation for Immunogenicity Testing of Therapeutic Protein Products.'' This guidance provides recommendations to facilitate industry's development and validation of immune assays for assessment of the immunogenicity of therapeutic protein products during clinical trials. The guidance for assay development and validation provided in this document applies to assays for detection of anti-drug antibodies (ADA). This document includes guidance regarding the development and validation of screening assays, confirmatory assays, titering assays, and neutralization assays. This guidance revises the draft guidance for industry entitled ``Assay Development for Immunogenicity Testing of Therapeutic Proteins'' issued in December 2009. This revised draft guidance includes new information on titering and confirmatory assays.
Refurbishing, Reconditioning, Rebuilding, Remarketing, Remanufacturing, and Servicing of Medical Devices Performed by Third-Party Entities and Original Equipment Manufacturers; Extension of Comment Period
Document Number: 2016-09443
Type: Proposed Rule
Date: 2016-04-25
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 document entitled ``Refurbishing, Reconditioning, Rebuilding, Remarketing, Remanufacturing, and Servicing of Medical Devices Performed by Third-Party Entities and Original Equipment Manufacturers'' that appeared in the Federal Register of March 4, 2016. In the document, FDA requested comments about the quality, safety, and continued effectiveness of medical devices that have been subject to one or more of these activities that are performed by both original equipment manufacturers (OEM) and third parties, including health care establishments. The Agency is taking this action due to the unanticipated high-level of interest from interested persons.
Banned Devices; Proposal To Ban Electrical Stimulation Devices Used To Treat Self-Injurious or Aggressive Behavior
Document Number: 2016-09433
Type: Proposed Rule
Date: 2016-04-25
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) is proposing to ban electrical stimulation devices used to treat aggressive or self- injurious behavior. FDA has determined that these devices present an unreasonable and substantial risk of illness or injury that cannot be corrected or eliminated by labeling. FDA is proposing to include in this ban both new devices and devices already in distribution and use.
Medicare Program; Prospective Payment System and Consolidated Billing for Skilled Nursing Facilities Proposed Rule for FY 2017, SNF Value-Based Purchasing Program, SNF Quality Reporting Program, and SNF Payment Models Research
Document Number: 2016-09399
Type: Proposed Rule
Date: 2016-04-25
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This proposed rule would update the payment rates used under the prospective payment system (PPS) for skilled nursing facilities (SNFs) for fiscal year (FY) 2017. In addition, it includes a proposal to specify a potentially preventable readmission measure for the Skilled Nursing Facility Value-Based Purchasing Program (SNF VBP), and other proposals for that program aimed at implementing value-based purchasing for SNFs. Additionally, this proposed rule proposes additional polices and measures in the Skilled Nursing Facility Quality Reporting Program (SNF QRP). This proposed rule also includes an update on the SNF Payment Models Research (PMR) project.
Medicare Program; Inpatient Rehabilitation Facility Prospective Payment System for Federal Fiscal Year 2017
Document Number: 2016-09397
Type: Proposed Rule
Date: 2016-04-25
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This proposed rule would update the prospective payment rates for inpatient rehabilitation facilities (IRFs) for federal fiscal year (FY) 2017 as required by the statute. As required by section 1886(j)(5) of the Act, this rule includes the classification and weighting factors for the IRF prospective payment system's (IRF PPS's) case-mix groups and a description of the methodologies and data used in computing the prospective payment rates for FY 2017. We are also proposing to revise and update quality measures and reporting requirements under the IRF quality reporting program (QRP).