Department of Health and Human Services November 2016 – Federal Register Recent Federal Regulation Documents

Results 201 - 250 of 300
Medical Device Reporting for Manufacturers; Guidance for Industry and Food and Drug Administration Staff; Availability
Document Number: 2016-26933
Type: Notice
Date: 2016-11-08
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled ``Medical Device Reporting for Manufacturers; Guidance for Industry and Food and Drug Administration Staff.'' This guidance document is intended to assist medical device manufacturers meet applicable reporting and recordkeeping requirements for certain device-related adverse events and malfunctions.
Determination That CALAN SR (Verapamil Hydrochloride) Extended-Release Oral Tablet, 180 Milligrams, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
Document Number: 2016-26932
Type: Notice
Date: 2016-11-08
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) has determined that CALAN SR (verapamil hydrochloride) extended-release oral tablet, 180 milligrams (mg), was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for verapamil hydrochloride extended-release oral tablet, 180 mg, if all other legal and regulatory requirements are met.
Non-Inferiority Clinical Trials To Establish Effectiveness; Guidance for Industry; Availability
Document Number: 2016-26931
Type: Notice
Date: 2016-11-08
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 ``Non-Inferiority Clinical Trials to Establish Effectiveness.'' This document provides guidance to sponsors and applicants submitting investigational new drug applications (INDs), new drug applications (NDAs), biologics licensing applications (BLAs), or supplemental applications on the appropriate use of non-inferiority (NI) study designs to provide evidence of the effectiveness of a drug or biologic. The guidance gives advice on when NI studies demonstrating effectiveness of an investigational drug can provide interpretable results, how to choose the NI margin, and how to test the NI hypothesis.
Questions and Answers Regarding Food Facility Registration (Seventh Edition); Draft Guidance for Industry; Availability
Document Number: 2016-26930
Type: Proposed Rule
Date: 2016-11-08
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) is announcing the availability of a draft guidance for industry entitled ``Questions and Answers Regarding Food Facility Registration (Seventh Edition): Guidance for Industry.'' This draft guidance contains 15 sections of a multisection guidance intended to provide updated information relating to the food facility registration requirements in the Federal Food, Drug, and Cosmetic Act (the FD&C Act).
Multi-Agency Informational Meeting Concerning Compliance With the Federal Select Agent Program; Public Webcast
Document Number: 2016-26927
Type: Notice
Date: 2016-11-08
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
The HHS/CDC's Division of Select Agents and Toxins (DSAT) and the U.S. Department of Agriculture's Animal and Plant Health Inspection Service, Agriculture Select Agent Services (AgSAS) are jointly charged with the regulation of the possession, use and transfer of biological agents and toxins that have the potential to pose a severe threat to public, animal or plant health or to animal or plant products (select agents and toxins). This joint effort constitutes the Federal Select Agent Program. The purpose of the webcast is to provide guidance and information related to the Federal Select Agent Program for interested individuals.
Agency Information Collection Activities; Proposed Collection; Public Comment Request; Evaluation of the State Health Insurance Assistance Program (SHIP)
Document Number: 2016-26924
Type: Notice
Date: 2016-11-08
Agency: Department of Health and Human Services
The Administration for Community Living (ACL) is announcing that the proposed collection of information listed above has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Agency Information Collection Activities; Proposed Collection; Public Comment Request; Senior Medicare Patrol (SMP) Program National Beneficiary Survey
Document Number: 2016-26923
Type: Notice
Date: 2016-11-08
Agency: Department of Health and Human Services
The Administration for Community Living (ACL) is announcing that the proposed collection of information listed above has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Novus International, Inc.; Filing of Food Additive Petition (Animal Use)
Document Number: 2016-26922
Type: Proposed Rule
Date: 2016-11-08
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing that Novus International, Inc., has filed a petition proposing that the food additive regulations be amended to provide for the safe use of poly (2- vinylpyridine-co-styrene) as a nutrient protectant for methionine hydroxy analog in animal food for beef cattle, dairy cattle, and replacement dairy heifers. Additionally, the petition proposes that the food additive regulations be amended to provide for the safe use of ethyl cellulose as a binder for methionine hydroxy analog to be incorporated into animal food.
Proposed Information Collection Activity; Comment Request
Document Number: 2016-26917
Type: Notice
Date: 2016-11-08
Agency: Department of Health and Human Services, Administration for Children and Families
Intent To Review a Study Data Standardization Plan Template; Notice of Availability; Establishment of a Public Docket; Request for Comments
Document Number: 2016-26913
Type: Notice
Date: 2016-11-08
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA), Center for Drug Evaluation and Research, is establishing a public docket to collect comments related to a proposed Study Data Standardization Plan (SDSP) template. As part of FDA's ongoing collaboration with the Pharmaceutical Users Software Exchange (PhUSE), an independent, non- profit consortium addressing computational science issues, a PhUSE working group developed the PhUSE SDSP template. The purpose of this review is to evaluate the template and determine whether FDA will recommend its use either as is, or in a modified form, for regulatory submissions of study data. FDA is seeking public comment on the use of the PhUSE SDSP template for regulatory submissions.
Amendments to Regulations on Citizen Petitions, Petitions for Stay of Action, and Submission of Documents to Dockets
Document Number: 2016-26912
Type: Rule
Date: 2016-11-08
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA, the Agency, or we) is amending certain regulations relating to citizen petitions, petitions for stay of action (PSAs), and the submission of documents to the Agency. In particular, the final rule establishes new regulations to implement certain provisions of the Federal Food, Drug, and Cosmetic Act (the FD&C Act), which concern certain citizen petitions and PSAs that involve a request for FDA to take any form of action relating to a pending abbreviated new drug application (ANDA), 505(b)(2) application, or certain applications submitted under the Public Health Service Act (PHS Act). We are making these changes to implement provisions of the Food and Drug Administration Amendments Act of 2007 (FDAAA) and the Food and Drug Administration Safety and Innovation Act (FDASIA).
Agency Information Collection Activities: Proposed Collection: Public Comment Request; The Advanced Education Nursing Traineeship (AENT) Program Specific Data Collection Forms
Document Number: 2016-26893
Type: Notice
Date: 2016-11-08
Agency: Department of Health and Human Services, Health Resources and Services Administration
In compliance with the requirement for opportunity for public comment on proposed data collection projects of the Paperwork Reduction Act of 1995), HRSA announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). Prior to submitting the ICR to OMB, HRSA seeks comments from the public regarding the burden estimate below, or any other aspect of the ICR.
National Human Genome Research Institute; Notice of Meetings
Document Number: 2016-26892
Type: Notice
Date: 2016-11-08
Agency: Department of Health and Human Services, National Institutes of Health
Proposed Collection; 60-Day Comment Request; NCI Genomic Data Commons (GDC) Data Submission Request Form (National Cancer Institute)
Document Number: 2016-26891
Type: Notice
Date: 2016-11-08
Agency: Department of Health and Human Services, National Institutes of Health
In compliance with the requirement of the Paperwork Reduction Act of 1995 to provide opportunity for public comment on proposed data collection projects, the National Cancer Institute (NCI) will publish periodic summaries of propose projects to be submitted to the Office of Management and Budget (OMB) for review and approval.
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2016-26875
Type: Notice
Date: 2016-11-08
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 (the 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 60 days for public comment on the proposed action. Interested persons are invited to send comments regarding our burden estimates or any other aspect of this collection of information, including any of the following subjects: 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: 2016-26831
Type: Notice
Date: 2016-11-07
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2016-26830
Type: Notice
Date: 2016-11-07
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2016-26829
Type: Notice
Date: 2016-11-07
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Medicare, Medicaid, and Children's Health Insurance Programs; Provider Enrollment Application Fee Amount for Calendar Year 2017
Document Number: 2016-26828
Type: Notice
Date: 2016-11-07
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This notice announces a $560.00 calendar year (CY) 2017 application fee for institutional providers that are initially enrolling in the Medicare or Medicaid program or the Children's Health Insurance Program (CHIP); revalidating their Medicare, Medicaid, or CHIP enrollment; or adding a new Medicare practice location. This fee is required with any enrollment application submitted on or after January 1, 2017 and on or before December 31, 2017.
Proposed Information Collection Activity; Comment Request
Document Number: 2016-26806
Type: Notice
Date: 2016-11-07
Agency: Department of Health and Human Services, Administration for Children and Families
Revision of Organization and Conforming Changes to Regulation
Document Number: 2016-26799
Type: Rule
Date: 2016-11-07
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is issuing this final rule to amend the regulations to reflect organization change in the Agency and to make other conforming changes. This action is editorial in nature and is intended to improve the accuracy of the Agency's regulations.
Agency Information Collection Activities; Proposed Collection; Comment Request; Focus Groups About Drug Products as Used by the Food and Drug Administration
Document Number: 2016-26794
Type: Notice
Date: 2016-11-07
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) 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 the information collection resulting from focus groups about drug products as used by FDA.
Agency Information Collection Activities; Proposed Collection; Comment Request; Character-Space-Limited Online Prescription Drug Communications
Document Number: 2016-26793
Type: Notice
Date: 2016-11-07
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) 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 and to allow 60 days for public comment in response to the notice. This notice solicits comments on research entitled, ``Character-Space- Limited Online Prescription Drug Communications.'' The objective of this research is to test whether a link to prescription drug risk information can effectively convey the risks associated with a drug when benefit claims about that drug are made within character-space- limited communications used in prescription drug promotion.
Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for Industry: Use of Serological Tests To Reduce the Risk of Transmission of Trypanosoma cruzi Infection in Whole Blood and Blood Components Intended for Transfusion
Document Number: 2016-26792
Type: Notice
Date: 2016-11-07
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 establishing notification of a consignee and consignee notification of a recipient's physician of record regarding a possible increased risk of Trypanosoma cruzi (T. cruzi) infection.
Establishment of the Patient and Care-Partner Connection; Establishment of a Public Docket; Request for Comments
Document Number: 2016-26784
Type: Notice
Date: 2016-11-07
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is establishing a public docket to receive input on the Center for Devices and Radiological Health's (CDRH) new program, entitled the Patient and Care-partner Connection (P&CC). P&CC will partner with patient organizations to provide a means for CDRH staff to formally engage with patients and care-partners. The purpose of this partnership is to gain perspective and feedback from patients, care-partners, and patient organizations on particular topics of interest, such as, the scope and nature of P&CC and how to partner with patient organizations. The Agency is interested in facilitating staff engagement with patients and care-partners regarding specific disease states and/or medical devices used for treatment, diagnosis, or assessment.
Clinical Considerations for Investigational Device Exemptions for Neurological Devices Targeting Disease Progression and Clinical Outcomes; Guidance for Industry and Food and Drug Administration Staff; Availability
Document Number: 2016-26783
Type: Notice
Date: 2016-11-07
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 ``Clinical Considerations for Investigational Device Exemptions (IDEs) for Neurological Devices Targeting Disease Progression and Clinical Outcomes.'' The Center for Devices and Radiological Health (CDRH) developed this guidance to assist sponsors who intend to submit an IDE to FDA to conduct clinical trials on medical devices targeting neurological disease progression and clinically meaningful patient centered outcomes. FDA considered comments received on the draft guidance and revised the guidance as appropriate.
Eunice Kennedy Shriver National Institute of Child Health and Human Development; Notice of Meeting
Document Number: 2016-26774
Type: Notice
Date: 2016-11-07
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2016-26773
Type: Notice
Date: 2016-11-07
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meetings
Document Number: 2016-26772
Type: Notice
Date: 2016-11-07
Agency: Department of Health and Human Services, National Institutes of Health
National Cancer Institute; Notice of Closed Meetings
Document Number: 2016-26771
Type: Notice
Date: 2016-11-07
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meeting
Document Number: 2016-26769
Type: Notice
Date: 2016-11-07
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2016-26768
Type: Notice
Date: 2016-11-07
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Environmental Health Sciences; Notice of Closed Meeting
Document Number: 2016-26767
Type: Notice
Date: 2016-11-07
Agency: Department of Health and Human Services, National Institutes of Health
Agency Information Collection Activities; Proposed Collection; Comment Request; Potential Tobacco Product Violations Reporting Form
Document Number: 2016-26758
Type: Notice
Date: 2016-11-07
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) 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 the collection of information contained in FDA's Tobacco Product Violations Reporting Form.
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2016-26770
Type: Notice
Date: 2016-11-04
Agency: Department of Health and Human Services, National Institutes of Health
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2016-26745
Type: Notice
Date: 2016-11-04
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 (the 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 60 days for public comment on the proposed action. Interested persons are invited to send comments regarding our burden estimates or any other aspect of this collection of information, including any of the following subjects: (1) The necessity and utility of the proposed information collection for the proper performance of the agency's functions; (2) the accuracy of the estimated burden; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) the use of automated collection techniques or other forms of information technology to minimize the information collection burden.
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 2016-26743
Type: Notice
Date: 2016-11-04
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 any of the following subjects: 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.
Withdrawal of 60-Day Notice of Proposed Information Collection: Unaccompanied Children Case Summary Form
Document Number: 2016-26686
Type: Notice
Date: 2016-11-04
Agency: Department of Health and Human Services, Administration for Children and Families
On October 4, 2016 at 81 FR 68420, ACF published a 60 Day Notice of Proposed Information Collection entitled ``Unaccompanied Children Case Summary Form.'' ACF is withdrawing this notice from the Federal Register.
Announcement of the Award of Nine Single-Source Program Expansion Supplement Grants Under the Unaccompanied Children's (UC) Program
Document Number: 2016-26673
Type: Notice
Date: 2016-11-04
Agency: Department of Health and Human Services, Administration for Children and Families
ACF, ORR announces the award of nine single-source program expansion supplement grants for a total of $21,164,141 under the UC's Program.
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2016-26667
Type: Notice
Date: 2016-11-04
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
National Institute of Aging (NIA), National Institute of Mental Health (NIMH), and National Center for Advancing Translational Sciences (NCATS): Cooperative Research and Development Agreement (CRADA) and Licensing Opportunity for Ketamine for the Treatment of Depression and Other Anxiety-Related Disorders
Document Number: 2016-26628
Type: Notice
Date: 2016-11-04
Agency: Department of Health and Human Services, National Institutes of Health
The National Institute of Aging (NIA), National Institute of Mental Health (NIMH), and National Center for Advancing Translational Sciences (NCATS) of the National Institutes of Health (NIH), University of Maryland at Baltimore (UMB) and their collaborators are seeking Cooperative Research and Development Agreement (CRADA) partners to collaborate in the preclinical and clinical development of ketamine metabolite (2R, 6R-HNK) for the treatment of depression and other anxiety-related disorders.
Proposed Collection; 60-Day Comment Request; The Atherosclerosis Risk in Communities Study (National Heart Lung and Blood Institute)
Document Number: 2016-26627
Type: Notice
Date: 2016-11-04
Agency: Department of Health and Human Services, National Institutes of Health
In compliance with the requirement of the Paperwork Reduction Act of 1995 to provide opportunity for public comment on proposed data collection projects, the National Institutes of Health, National Heart, Lung, and Blood Institute (NHLBI) will publish periodic summaries of propose projects to be submitted to the Office of Management and Budget (OMB) for review and approval.
National Institute of Mental Health Amended Notice of Meeting
Document Number: 2016-26625
Type: Notice
Date: 2016-11-04
Agency: Department of Health and Human Services, National Institutes of Health
Eunice Kennedy Shriver National Institute of Child Health and Human Development; Notice of Meeting
Document Number: 2016-26624
Type: Notice
Date: 2016-11-04
Agency: Department of Health and Human Services, National Institutes of Health
Submission for OMB Review; Comment Request
Document Number: 2016-26615
Type: Notice
Date: 2016-11-04
Agency: Department of Health and Human Services, Administration for Children and Families
Medicare and Medicaid Programs; Fire Safety Requirements for Certain Dialysis Facilities
Document Number: 2016-26583
Type: Proposed Rule
Date: 2016-11-04
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This proposed rule would update fire safety standards for Medicare and Medicaid participating ESRD facilities, adopt the 2012 edition of the Life Safety Code and eliminate references in our regulations to all earlier editions of the Life Safety Code and adopt the 2012 edition of the Health Care Facilities Code, with some exceptions.
Medicare Program; End-Stage Renal Disease Prospective Payment System, Coverage and Payment for Renal Dialysis Services Furnished to Individuals With Acute Kidney Injury, End-Stage Renal Disease Quality Incentive Program, Durable Medical Equipment, Prosthetics, Orthotics and Supplies Competitive Bidding Program Bid Surety Bonds, State Licensure and Appeals Process for Breach of Contract Actions, Durable Medical Equipment, Prosthetics, Orthotics and Supplies Competitive Bidding Program and Fee Schedule Adjustments, Access to Care Issues for Durable Medical Equipment; and the Comprehensive End-Stage Renal Disease Care Model
Document Number: 2016-26152
Type: Rule
Date: 2016-11-04
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This rule updates and makes revisions to the End-Stage Renal Disease (ESRD) Prospective Payment System (PPS) for calendar year 2017. It also finalizes policies for coverage and payment for renal dialysis services furnished by an ESRD facility to individuals with acute kidney injury. This rule also sets forth requirements for the ESRD Quality Incentive Program, including the inclusion of new quality measures beginning with payment year (PY) 2020 and provides updates to programmatic policies for the PY 2018 and PY 2019 ESRD QIP. This rule also implements statutory requirements for bid surety bonds and state licensure for the Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) Competitive Bidding Program (CBP). This rule also expands suppliers' appeal rights in the event of a breach of contract action taken by CMS, by revising the appeals regulation to extend the appeals process to all types of actions taken by CMS for a supplier's breach of contract, rather than limit an appeal for the termination of a competitive bidding contract. The rule also finalizes changes to the methodologies for adjusting fee schedule amounts for DMEPOS using information from CBPs and for submitting bids and establishing single payment amounts under the CBPs for certain groupings of similar items with different features to address price inversions. Final changes also are made to the method for establishing bid limits for items under the DMEPOS CBPs. In addition, this rule summarizes comments on the impacts of coordinating Medicare and Medicaid Durable Medical Equipment for dually eligible beneficiaries. Finally, this rule also summarizes comments received in response to a request for information related to the Comprehensive ESRD Care Model and future payment models affecting renal care.
Medicare Program; Merit-Based Incentive Payment System (MIPS) and Alternative Payment Model (APM) Incentive Under the Physician Fee Schedule, and Criteria for Physician-Focused Payment Models
Document Number: 2016-25240
Type: Rule
Date: 2016-11-04
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
The Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) repeals the Medicare sustainable growth rate (SGR) methodology for updates to the physician fee schedule (PFS) and replaces it with a new approach to payment called the Quality Payment Program that rewards the delivery of high-quality patient care through two avenues: Advanced Alternative Payment Models (Advanced APMs) and the Merit-based Incentive Payment System (MIPS) for eligible clinicians or groups under the PFS. This final rule with comment period establishes incentives for participation in certain alternative payment models (APMs) and includes the criteria for use by the Physician-Focused Payment Model Technical Advisory Committee (PTAC) in making comments and recommendations on physician-focused payment models (PFPMs). Alternative Payment Models are payment approaches, developed in partnership with the clinician community, that provide added incentives to deliver high-quality and cost-efficient care. APMs can apply to a specific clinical condition, a care episode, or a population. This final rule with comment period also establishes the MIPS, a new program for certain Medicare-enrolled practitioners. MIPS will consolidate components of three existing programs, the Physician Quality Reporting System (PQRS), the Physician Value-based Payment Modifier (VM), and the Medicare Electronic Health Record (EHR) Incentive Program for Eligible Professionals (EPs), and will continue the focus on quality, cost, and use of certified EHR technology (CEHRT) in a cohesive program that avoids redundancies. In this final rule with comment period we have rebranded key terminology based on feedback from stakeholders, with the goal of selecting terms that will be more easily identified and understood by our stakeholders.
National Toxicology Program Board of Scientific Counselors; Announcement of Meeting; Request for Comments
Document Number: 2016-26609
Type: Notice
Date: 2016-11-03
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 except for parts that are closed, as indicated on the agenda. 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.