Department of Health and Human Services May 11, 2018 – Federal Register Recent Federal Regulation Documents
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Meeting of the Advisory Committee on Minority Health
As stipulated by the Federal Advisory Committee Act, the Department of Health and Human Services (HHS) is hereby giving notice that the Advisory Committee on Minority Health (ACMH) will hold a meeting conducted as a telephone conference call. This call will be open to the public. Preregistration is required for both public participation and comment. Any individual who wishes to participate in the call should email OMH-ACMH@hhs.gov by June 18, 2018. Instructions regarding participating in the call and how to provide verbal public comments will be given at the time of preregistration. Information about the meeting is available from the designated contact and will be posted on the website for the Office of Minority Health (OMH), www.minorityhealth.hhs.gov. Information about ACMH activities can be found on the OMH website under the heading About OMH.
Medicare Program; Meeting of the Medicare Evidence Development and Coverage Advisory Committee-July 25, 2018
This notice announces that a public meeting of the Medicare Evidence Development & Coverage Advisory Committee (MEDCAC) (``Committee'') will be held on Wednesday, July 25, 2018. This meeting will specifically focus on obtaining the MEDCAC's appraisal and recommendations regarding the state of evidence for procedural volume requirements, especially pertaining to surgical aortic valve replacements (SAVRs), transcatheter aortic valve replacements (TAVRs) and percutaneous coronary interventions (PCIs), for hospitals to begin and maintain TAVR programs. This meeting is open to the public in accordance with the Federal Advisory Committee Act.
Advisory Board on Radiation and Worker Health (ABRWH or the Advisory Board), National Institute for Occupational Safety and Health (NIOSH)
In accordance with the Federal Advisory Committee Act, the CDC announces the following meeting of the Advisory Board on Radiation and Worker Health (ABRWH). This meeting is open to the public, but without a public comment period. The public is welcome to submit written comments in advance of the meeting, to the contact person below. Written comments received in advance of the meeting will be included in the official record of the meeting. The public is also welcome to listen to the meeting by joining the teleconference at the USA toll- free, dial-in number at 1-866-659-0537; the pass code is 9933701. The conference line has 150 ports for callers.
Determination That SODIUM IODIDE I 123 (Sodium Iodide I-123), Oral Solution, 2 Millicuries/Milliliter, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
The Food and Drug Administration (FDA or Agency) has determined that SODIUM IODIDE I 123 (sodium iodide I-123), oral solution, 2 millicuries (mCi)/milliliter (mL), was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for sodium iodide I 123, oral solution, 2 mCi/mL, if all other legal and regulatory requirements are met.
Proposed Data Collection Submitted for Public Comment and Recommendations
The Centers for Disease Control and Prevention (CDC), as part of its continuing effort to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies the opportunity to comment on a proposed and/or continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled National Healthcare Safety Network (NHSN). NHSN is a public health surveillance system that collects, analyzes, reports, and makes available data for monitoring, measuring, and responding to healthcare associated infections (HAIs), antimicrobial use and resistance, blood transfusion safety events, and the extent to which healthcare facilities adhere to infection prevention practices and antimicrobial stewardship.
Agency Information Collection Activities: Proposed Collection; Comment Request
The Agency for Healthcare Research and Quality (AHRQ) has a comprehensive web-based Library of Patient-Centered Outcomes Research (PCOR) Resources to help make available the PCOR research, findings, tools, and other resources that have been developed as a result of investments by public, private, nonprofit, and academic organizations. This Library of PCOR Resources includes PCOR findings and evidence- based tools that have appeared in the published literature, as well as studies and projects that are in progress. The information in this web-based library is intended to assist researchers who may be conducting new studies, as well as clinicians, policymakers, consumers, and others who are seeking access to evidence- based health information. Each resource provided in the library provides a summary and access to information on PCOR studies and related syntheses and translations. Through this Request for Information (RFI), AHRQ is seeking feedback about the Library of PCOR Resources and the materials that can be accessed there to gauge how well the Library and those materials meet the needs of potential users in the general public.
Patient Protection and Affordable Care Act; HHS Notice of Benefit and Payment Parameters for 2019; Correction
This document corrects technical errors that appeared in the final rule published in the Federal Register on April 17, 2018 entitled ``Patient Protection and Affordable Care Act; HHS Notice of Benefit and Payment Parameters for 2019.''
Medicare Program; Durable Medical Equipment Fee Schedule Adjustments To Resume the Transitional 50/50 Blended Rates To Provide Relief in Rural Areas and Non-Contiguous Areas
This interim final rule with comment period makes technical amendments to the regulation to reflect the extension of the transition period from June 30, 2016 to December 31, 2016 that was mandated by the 21st Century Cures Act for phasing in fee schedule adjustments for certain durable medical equipment (DME) and enteral nutrition paid in areas not subject to the Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) Competitive Bidding Program (CBP). In addition, this interim final rule with comment period amends the regulation to resume the transition period's blended fee schedule rates for items furnished in rural areas and non-contiguous areas (Alaska, Hawaii, and United States territories) not subject to the CBP from June 1, 2018 through December 31, 2018. This interim final rule with comment period also makes technical amendments to existing regulations for DMEPOS items and services to reflect the exclusion of infusion drugs used with DME from the DMEPOS CBP.
Draft Report on Carcinogens Monograph on Helicobacter pylori: Chronic Infection; Availability of Document; Request for Comments
The National Toxicology Program (NTP) announces the availability of the Draft Report on Carcinogens (RoC) Monograph on Helicobacter pylori: Chronic Infection for public comment. The Office of the Report on Carcinogens (ORoC), Division of the National Toxicology Program (DNTP), National Institute of Environmental Health Sciences (NIEHS) prepared the monograph.
Proposed Data Collection Submitted for Public Comment and Recommendations
The Centers for Disease Control and Prevention (CDC), as part of its continuing effort to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies the opportunity to comment on a proposed and/or continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled World Trade Center Health Program Enrollment, Treatment, Appeals & Reimbursement.
Proposed Data Collection Submitted for Public Comment and Recommendations
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 the opportunity to comment on proposed and/or continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled National Health and Nutrition Examination Survey (NHANES). NHANES programs produce descriptive statistics, which measure the health and nutrition status of the general population.
Agency Information Collection Activities; Proposed Collection; Comment Request; Request for Samples and Protocols
The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. 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 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 requirements relating to the regulations which state that protocols for samples of biological products must be submitted to the Agency.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Pilot Project Program Under the Drug Supply Chain Security Act
The Food and Drug Administration (FDA, Agency, or we) 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 (PRA).
Circulatory System Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting
The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Circulatory System 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.
Facility Definition Under Section 503B of the Federal Food, Drug, and Cosmetic Act; Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled ``Facility Definition Under Section 503B of the Federal Food, Drug, and Cosmetic Act.'' Section 503B defines an outsourcing facility, in part, as ``a facility at one geographic location or address.'' FDA has received questions from outsourcing facilities and other stakeholders about the meaning of this term, such as whether multiple suites used for compounding human drugs at a single street address constitute one or multiple facilities, or whether a single location where human drugs are compounded can be subdivided into separate operations compounding under different standards. FDA is issuing this guidance to provide the Agency's current thinking on these questions and related issues regarding how to ensure that the compounding of drugs in an outsourcing facility occurs only in accordance with section 503B.
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