Department of Health and Human Services March 4, 2016 – Federal Register Recent Federal Regulation Documents
Results 1 - 15 of 15
Agency Information Collection Activities: Proposed Collection; Comment Request
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 require; 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
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: (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.
Announcement of Requirements and Registration for the Opioid Overdose Prevention Challenge
In summarizing the challenge that will be issued by your agency, please answer the following four questions: (1) What action is being taken? The Substance Abuse and Mental Health Services Administration (SAMHSA) has issued a challenge to developers to help support patients in recovery who are receiving medication assisted treatment for opioid use disorder with an innovative app that provides features and information that support their recovery. (2) Why is this action necessary? Addressing the opioid epidemic is a top priority for the U.S. Department of Health and Human Services and the Secretary is committed to evidence-informed interventions to turn the tide against opioid drug-related overdose and misuse. To that end, Substance Abuse and Mental Health Services Administration (SAMHSA) is issuing a three-month challenge to spur developers to create an app that provides additional recovery support to patients receiving outpatient medication-assisted treatment for opioid use disorder. (3) What is the objective of the challenge? To provide support to people in recovery from opioid use disorder receiving medication assisted-treatment so that they can maintain treatment and achieve long-term recovery. (4) What is the intended effect of this action? An increase in the number of individuals with opioid use disorders maintaining recovery; and a reduction in the number of deaths from opioid overdose.
Intent to Review a Nonclinical Study Data Reviewer's Guide Template
The Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER), is establishing a public docket to collect comments related to a proposed Nonclinical Study Data Reviewer's Guide (SDRG) 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 Nonclinical SRDG 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 nonclinical study data. FDA is seeking public comment on the use of the PhUSE Nonclinical SDRG template for regulatory submissions.
Labeling for Permanent Hysteroscopically-Placed Tubal Implants Intended for Sterilization, Draft Guidance for Industry and Food and Drug Administration Staff; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled ``Labeling for Permanent Hysteroscopically-Placed Tubal Implants Intended for Sterilization.'' This draft guidance addresses the inclusion of a boxed warning and a patient decision checklist in the product labeling for permanent hysteroscopically-placed tubal implants intended for female sterilization and as well as the content and format of those materials. This draft guidance is being issued in response to information provided to FDA, including in comments made at a 2015 Panel meeting and in comments submitted to the associated public docket, that women are not receiving or understanding information relating to the risks and benefits of this type of device. This draft guidance is not final nor is it in effect at this time.
Medicare Program; Comprehensive Care for Joint Replacement Payment Model for Acute Care Hospitals Furnishing Lower Extremity Joint Replacement Services; Corrections and Correcting Amendments
In the November 24, 2015 Federal Register (80 FR 73274), we published a final rule to implement a new Medicare Part A and B payment model under section 1115A of the Social Security Act, called the Comprehensive Care for Joint Replacement (CJR) model, in which acute care hospitals in certain selected geographic areas will receive retrospective bundled payments for episodes of care for lower extremity joint replacement (LEJR) or reattachment of a lower extremity. The effective date was January 15, 2016. This correcting amendment corrects a limited number of technical and typographical errors identified in the November 24, 2015 final rule.
Medicare and Medicaid Programs; Electronic Health Record Initiative Program-Stage 3 and Modifications to Meaningful Use in 2015 Through 2017; Corrections and Correcting Amendment
This document corrects certain technical and typographical errors that appeared in the October 16, 2015 final rule with comment period titled ``Medicare and Medicaid Programs; Electronic Health Record Incentive ProgramStage 3 and Modifications to Meaningful Use in 2015 through 2017.''
Risk Assessment of Foodborne Illness Associated With Pathogens From Produce Grown in Fields Amended With Untreated Biological Soil Amendments of Animal Origin; Request for Scientific Data, Information, and Comments
The Food and Drug Administration (FDA or we) is requesting scientific data, information, and comments that would assist the Agency in its plan to develop a risk assessment for produce grown in fields or other growing areas amended with untreated biological soil amendments of animal origin (including raw manure). The risk assessment will evaluate and, if feasible, quantify the risk of human illness associated with consumption of produce grown in fields or other growing areas amended with untreated biological soil amendments of animal origin that are potentially contaminated with enteric pathogens, such as Escherichia coli O157:H7 or Salmonella. The risk assessment also will evaluate the impact of certain interventions, such as use of a time interval between application of the soil amendment and crop harvest, on the predicted risk. The risk assessment is intended to inform policy decisions with regard to produce safety.
Unique Device Identification System; Editorial Provisions; Technical Amendment
The Food and Drug Administration (FDA or Agency) is amending the Unique Device Identification (UDI) System regulation to make editorial changes. This technical amendment updates the email address associated with FDA's UDI system, which allows FDA to obtain information and offer support and assistance on medical devices through their distribution and use, ensuring consistency with the requirements in the Federal Food, Drug, and Cosmetic Act (the FD&C Act). This change is necessary to ensure that the UDI team continues to maintain regular email communications with device labelers.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medical Device User Fee Small Business Qualification and Certification
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.
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Registration and Product Listing for Owners and Operators of Domestic Tobacco Product Establishments and Listing of Ingredients in Tobacco Products
The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Registration and Product Listing for Owners and Operators of Domestic Tobacco Product Establishments and Listing of Ingredients in Tobacco Products'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Refurbishing, Reconditioning, Rebuilding, Remarketing, Remanufacturing, and Servicing of Medical Devices Performed by Third-Party Entities and Original Equipment Manufacturers; Request for Comments
The Food and Drug Administration (FDA or we) is announcing the establishment of a docket to receive information and comments on the medical device industry and healthcare community that refurbish, recondition, rebuild, remarket, remanufacture, service, and repair medical devices (hereafter termed ``third-party entity or entities''), including radiation-emitting devices subject to the electronic product radiation control (EPRC) provisions of the Federal Food, Drug, and Cosmetic Act (the FD&C Act). FDA is taking this action, in part, because various stakeholders have expressed concerns 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. We are seeking comments from the widest range of interested persons, including those who are engaged in one or more of the activities noted previously or who utilize refurbished, reconditioned, rebuilt, remarketed, remanufactured, or third-party serviced and repaired medical devices.
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