Department of Health and Human Services April 16, 2018 – Federal Register Recent Federal Regulation Documents
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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 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 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.
Special Protocol Assessment; Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a guidance for industry entitled ``Special Protocol Assessment.'' This guidance provides information about the procedures and general policies adopted by the Center for Drug Evaluation and Research and the Center for Biologics Evaluation and Research for special protocol assessment (SPA). This guidance is intended to improve the quality of requests for SPAs and accompanying submission materials, and the quality of the resulting interactions between sponsors and FDA. This guidance finalizes the draft guidance of the same name issued May 4, 2016, and replaces the guidance of the same name issued May 17, 2002.
Submission for OMB Review; 30-Day Comment Request; Generic Clearance for the Research Domain Criteria (RDoC) Initiative (National Institute of Mental Health)
In compliance with the Paperwork Reduction Act of 1995, the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below.
Highly Concentrated Caffeine in Dietary Supplements; Guidance for Industry; Availability
The Food and Drug Administration (FDA or we) is announcing the availability of a guidance for industry, ``Highly Concentrated Caffeine in Dietary Supplements.'' FDA considers some dietary supplements that consist of only or primarily pure or highly concentrated caffeine to be adulterated. FDA is issuing this document to provide guidance to firms that manufacture, market, or distribute dietary supplement products that contain pure or highly concentrated caffeine, or are considering doing so. This guidance should help such parties determine whether their products are or would be adulterated under the Federal Food, Drug, and Cosmetic Act (FD&C Act) and to help them understand how to reduce the likelihood that their products will be considered adulterated.
Policy Clarification and Premarket Notification Submissions for Ultrasonic Diathermy Devices; Guidance for Industry and Food and Drug Administration Staff; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of the guidance entitled ``Policy Clarification and Premarket Notification [510(k)] Submissions for Ultrasonic Diathermy Devices; Guidance for Industry and Food and Drug Administration Staff.'' This guidance clarifies FDA's policy related to compliance with applicable performance standards and conformance to International Electrotechnical Commission (IEC) consensus standards for ultrasonic diathermy devices. This guidance provides recommendations for information to provide in 510(k) submissions for ultrasonic diathermy devices.
Government-Owned Inventions; Availability for Licensing
The invention listed below is owned by an agency of the U.S. Government and is available for licensing to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.
Government-Owned Inventions; Availability for Licensing
The invention listed below is owned by an agency of the U.S. Government and is available for licensing to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.
Investigational In Vitro Diagnostics in Oncology Trials: Streamlined Submission Process for Study Risk Determination; Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Investigational In Vitro Diagnostics in Oncology Trials: Streamlined Submission Process for Study Risk Determination.'' This guidance, developed by the Oncology Center of Excellence, Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER), and Center for Devices and Radiological Health (CDRH) at FDA, describes an optional streamlined submission process to determine whether an investigational in vitro diagnostic in an oncology clinical trial under an investigational new drug application (IND) (an oncology co-development program) is significant risk. In the streamlined process, all information about the oncology trial (including information about the investigational in vitro diagnostic) is submitted to the IND. As part of IND review, CBER or CDER works with CDRH to determine if the investigational in vitro diagnostic is significant risk.
Findings of Research Misconduct
Notice is hereby given that on April 2, 2018, the Department of Health and Human Services (HHS) Debarring Official, on behalf of the Secretary of HHS, issued a final notice of debarment based on the findings of research misconduct made by the Office of Research Integrity (ORI) against H.M. Krishna Murthy, Ph.D., former Research Associate Professor, Department of Vision Sciences, University of Alabama at Birmingham (UAB). Dr. Murthy engaged in research misconduct in research supported by U.S. Public Health Service (PHS) grants, specifically National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), grants R01 AI051615, R01 AI032078, and R01 AI045623; National Heart, Lung, and Blood Institute (NHLBI), NIH, grants P01 HL034343 and R01 HL064272; and National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), NIH, grant R01 DK046900. The administrative actions, including ten (10) years of debarment, were implemented beginning on April 2, 2018, and are detailed below.
Advisory Committee to the Director (ACD), Centers for Disease Control and Prevention (CDC)-State, Tribal, Local and Territorial Subcommittee (STLT)
In accordance with the Federal Advisory Committee Act, the CDC announces the following meeting for the Advisory Committee to the Director, Centers for Disease Control and PreventionState, Tribal, Local and Territorial Subcommittee (ACD, CDC-STLT). This meeting is open to the public, limited only by the room seating, audio phone lines and net conference access available. The public is also welcome to listen to the meeting by dialing (877) 692-1879, entering participant code 57852858, with 100 ports available. The public comment period is from 2:00 p.m.-2:15 p.m. No advance registration is required.
Advisory Committee to the Director (ACD), Centers for Disease Control and Prevention (CDC)-Health Disparities Subcommittee (HDS)
In accordance with the Federal Advisory Committee Act, the CDC announces the following meeting for the Advisory Committee to the Director, Centers for Disease Control and PreventionHealth Disparities Subcommittee (ACD, CDC-HDS). This meeting is open to the public, limited only by the by the space and phone lines available. The public is also welcome to listen to the meeting by teleconference call in number is (866) 918-8397 and enter code 9346283. The public comment period is from 12:45 p.m.-12:50 p.m.
Advisory Board on Radiation and Worker Health (ABRWH); Notice of Charter Renewal
This gives notice under the Federal Advisory Committee Act of October 6, 1972, that the Advisory Board on Radiation and Worker Health (ABRWH), Centers for Disease Control and Prevention, Department of Health and Human Services, has been renewed for a 2-year period through March 22, 2020.
Mine Safety and Health Research Advisory Committee (MSHRAC)
In accordance with the Federal Advisory Committee Act, the CDC announces the following meeting for the Mine Safety and Health Research Advisory Committee (MSHRAC). This meeting is open to the public, limited only by the space available. The meeting room accommodates approximately 33 people. If you wish to attend in person or by phone, please contact Marie Chovanec by email at MChovanec@cdc.gov or by phone at 412-386-5302 at least 5 business days in advance of the meeting.
Medicare Program; Contract Year 2019 Policy and Technical Changes to the Medicare Advantage, Medicare Cost Plan, Medicare Fee-for-Service, the Medicare Prescription Drug Benefit Programs, and the PACE Program
This final rule will revise the Medicare Advantage (MA) program (Part C) regulations and Prescription Drug Benefit program (Part D) regulations to implement certain provisions of the Comprehensive Addiction and Recovery Act (CARA) to further reduce the number of beneficiaries who may potentially misuse or overdose on opioids while still having access to important treatment options; implement certain provisions of the 21st Century Cures Act; support innovative approaches to improve program quality, accessibility, and affordability; offer beneficiaries more choices and better care; improve the CMS customer experience and maintain high beneficiary satisfaction; address program integrity policies related to payments based on prescriber, provider and supplier status in MA, Medicare cost plan, Medicare Part D and the PACE programs; provide an update to the official Medicare Part D electronic prescribing standards; and clarify program requirements and certain technical changes regarding treatment of Medicare Part A and Part B appeal rights related to premiums adjustments.
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