Department of Health and Human Services 2018 – Federal Register Recent Federal Regulation Documents
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Food Additives Permitted in Feed and Drinking Water of Animals; Formic Acid
The Food and Drug Administration (FDA) is amending the food additive regulations for a required labeling statement for use of formic acid in complete feed for swine and poultry. This action is being taken to improve the accuracy and clarity of the regulations.
Ranjan Bhandari: Debarment Order
The Food and Drug Administration (FDA or Agency) is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) debarring Ranjan Bhandari, MD (Dr. Bhandari), for a period of 3 years from providing services in any capacity to a person that has an approved or pending drug product application. FDA bases this order on a finding that Dr. Bhandari was convicted of a misdemeanor under the FD&C Act for causing the introduction or delivery for introduction into interstate commerce of prescription drugs that were misbranded. In addition, FDA has determined that the type of conduct that served as the basis for the conviction undermines the process for the regulation of drugs. Dr. Bhandari was given notice of the proposed debarment and an opportunity to request a hearing within the timeframe prescribed by regulation. Dr. Bhandari failed to request a hearing. Dr. Bhandari's failure to request a hearing constitutes a waiver of his right to a hearing concerning this action.
Agency Information Collection Activities; Proposed Collection; Public Comment Request; Inventory of Adult Protective Services Practices and Service Innovations
The Administration for Community Living (ACL) is announcing an opportunity for the public to comment on the proposed collection of certain information listed above. Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish a 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 a new data collection (ICR New) effort titled ``Inventory of Adult Protective Services Practices and Service Innovations.''
Agency Information Collection Activities; Submission for OMB Review; Public Comment Request; Independent Living Services (ILS) Program Performance Report (PPR) (0985-0043)
The Administration for Community Living 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 as required under the Paperwork Reduction Act of 1995. This 30-Day notice collects comments on the information collection requirements related to Independent Living Services Program Performance Report (Proposed Extension with Changes of a Currently Approved Collection (ICR Rev)).
Agency Information Collection Activities; Submission for OMB Review; Public Comment Request; Centers for Independent Living Program Performance Report (0985-NEW)
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 as required under section 506(c)(2)(A) of the Paperwork Reduction Act of 1995. This 30-Day notice collects comments on the information collection requirements related to Centers for Independent Living Program Performance Report (New Data Collection (ICR New)).
Findings of Research Misconduct
Findings of research misconduct have been made against Uthra Rajamani, Ph.D. (Respondent), former project scientist in the Induced Pluripotent Stem Cell Core Facility, Cedars-Sinai Medical Center (CSMC). Dr. Rajamani engaged in research misconduct in research supported by National Center for Advancing Translational Science (NCATS), National Institutes of Health (NIH), grant UL1 TR000124. The administrative actions, including supervision for a period of one (1) year, were implemented beginning on November 27, 2018, and are detailed below.
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 on the Well-Integrated Screening and Evaluation for Women Across the Nation (WISEWOMAN) program. The WISEWOMAN program is designed to prevent, detect, and control, hypertension and other cardiovascular disease risk factors through healthy behavior support services, which are tailored for individual and group behavior change.
Proposed Data Collection Submitted for Public Comment and Recommendations
The Agency for Toxic Substances and Disease Registry (ATSDR), 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 ``Exposure Characterization and Measurements during Activities Conducted on Synthetic Turf Fields with Tire Crumb Rubber Infill.'' The purpose of the proposed study is to evaluate and characterize human exposure potential to select chemicals during play on synthetic turf fields with tire crumb rubber infill.
Agency Information Collection Activities; Proposed Collection; Comment Request; Medicated Feed Mill License Application
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 medicated feed mill licensing system.
Neurological Devices; Reclassification of Electroconvulsive Therapy Devices; Effective Date of Requirement for Premarket Approval for Electroconvulsive Therapy Devices for Certain Specified Intended Uses
The Food and Drug Administration (FDA) is issuing a final order to reclassify the electroconvulsive therapy (ECT) device for use in treating catatonia or a severe major depressive episode (MDE) associated with major depressive disorder (MDD) or bipolar disorder (BPD) in patients age 13 years and older who are treatment-resistant or who require a rapid response due to the severity of their psychiatric or medical condition, which is a preamendments class III device, into class II (special controls). FDA is also issuing this final order to require the filing of a premarket approval application (PMA) or a notice of completion of a product development protocol (PDP) for the preamendments class III ECT devices for all other uses that are not being reclassified to class II (product code GXC).
Modified Risk Tobacco Product Applications for IQOS System With Marlboro Heatsticks, IQOS System With Marlboro Smooth Menthol Heatsticks, and IQOS System With Marlboro Fresh Menthol Heatsticks Submitted by Philip Morris Products S.A.; Closing of Comment Period
The Food and Drug Administration (FDA) is announcing a closing date for the period for public comment on modified risk tobacco product applications (MRTPAs) submitted by Philip Morris Products S.A. for its IQOS system products. FDA recently received amendments to these MRTPAs and has made them available for public comment.
Determination of Regulatory Review Period for Purposes of Patent Extension; ADLYXIN
The Food and Drug Administration (FDA or Agency) has determined the regulatory review period for ADLYXIN and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human drug product.
Medicare & Medicaid Programs, and Other Program Initiatives, and Priorities; Meeting of the Advisory Panel on Outreach and Education (APOE), January 16, 2019
This notice announces the next meeting of the Advisory Panel on Outreach and Education (APOE) (the Panel) in accordance with the Federal Advisory Committee Act. The Panel advises and makes recommendations to the Secretary of the U.S. Department of Health and Human Services (HHS) and the Administrator of the Centers for Medicare & Medicaid Services (CMS) on opportunities to enhance the effectiveness of consumer education strategies concerning CMS programs, initiatives, and priorities. This meeting is open to the public.
Medicare Program; Request for Renewal of Deeming Authority of the Utilization Review Accreditation Commission (URAC) for Health Maintenance Organizations and Preferred Provider Organizations
This proposed notice announces that CMS is considering granting approval of the Utilization Review Accreditation Commission's (URAC) renewal application for Medicare Advantage ``deeming authority'' of Health Maintenance Organizations and Preferred Provider Organizations. This new 6-year term of approval would begin on the date of publication of the final notice. This notice also announces a 30-day period for the public to submit comments on CMS' renewal of the application.
National Institute of Neurological Disorders and Stroke, Interagency Pain Research Coordinating Committee Call for Committee Membership Nominations
The Department of Health and Human Services (HHS) (Department) has created the Interagency Pain Research Coordinating Committee (IPRCC) and is seeking nominations for this committee.
CDC/Mine Safety and Health Research Advisory Committee (MSHRAC); Notice of Charter Renewal
This gives notice that under the Federal Advisory Committee Act of October 6, 1972, that the Mine Safety and Health Research Advisory Committee (MSHRAC), Centers for Disease Control and Prevention, Department of Health and Human Services, has been renewed for a 2-year period through November 30, 2020.
Board of Scientific Counselors, National Center for Health Statistics (BSC, NCHS)
In accordance with the Federal Advisory Committee Act, the Centers for Disease Control and Prevention (CDC), announces the following meeting for the Board of Scientific Counselors, National Center for Health Statistics (BSC, NCHS). This meeting is open to the public.
CDC/HRSA Advisory Committee on HIV, Viral Hepatitis and STD Prevention and Treatment (CHACHSPT); Notice of Charter Renewal
This gives notice under the Federal Advisory Committee Act of October 6, 1972, that the CDC/HRSA Advisory Committee on HIV, Viral Hepatitis and STD Prevention and Treatment (CHACHSPT), Centers for Disease Control and Prevention, Department of Health and Human Services, has been renewed for a 2-year period through November 25, 2020.
Determination of Regulatory Review Period for Purposes of Patent Extension; ABSORB GT1 BIORESORBABLE SCAFFOLD
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for ABSORB GT1 Bioresorbable Scaffold and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that medical device.
Prospective Grant of Exclusive Patent License: Production of Live Respiratory Syncytial Virus and Parainfluenza Virus Vaccines
The National Institute of Allergy and Infectious Diseases, an institute of the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an Exclusive Commercialization Patent License to practice the inventions embodied in the Patents and Patent Applications listed in the Summary Information section of this notice to Medigen Vaccines Biologics Corp. (Medigen), having a place of business in Zhubei, Taiwan.
Prospective Grant of Exclusive Patent License: Production of Monovalent Live Attenuated Zika Vaccines and Multivalent Live Attenuated Zika and Dengue Vaccines
The National Institute of Allergy and Infectious Diseases, an institute of the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an Exclusive Commercialization Patent License to practice the inventions embodied in the Patents and Patent Applications listed in the Summary Information section of this notice to Fundacao Butantan (Butantan), having a place of business in Sao Paulo, Brazil.
Prospective Grant of Co-Exclusive Patent License: Production of Monovalent Live Attenuated Zika Vaccines and Multivalent Live Attenuated Zika and Dengue Vaccines
The National Institute of Allergy and Infectious Diseases, an institute of the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of a Co-Exclusive Commercialization Patent License to practice the inventions embodied in the Patents and Patent Applications listed in the Summary Information section of this notice to Medigen Vaccines Biologics Corp. (Medigen), having a place of business in Zhubei, Taiwan, and Panacea Biotec Ltd., having a place of business in New Delhi, India.
Prospective Grant of an Exclusive Patent License: “Multifunctional RNA Nanoparticles and Methods of Uses” and “RNA/DNA Hybrid Nanoparticles Modified With Single Stranded RNA Toeholds and Uses Thereof”
The National Cancer Institute, an institute of the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an Exclusive Patent License to practice the inventions embodied in the Patent Applications listed in the Supplementary Information section of this notice to Sixfold Biosciences Inc., (``Sixfold'') of Walnut, California.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Experimental Study of Cigarette Warnings
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.
Developing and Submitting Proposed Draft Guidance Relating to Patient Experience Data; Draft Guidance for Industry and Other Stakeholders; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Developing and Submitting Proposed Draft Guidance Relating to Patient Experience Data.'' This draft guidance is being developed under the 21st Century Cures Act (Cures Act), which directs FDA to issue guidance on how a person seeking to develop and submit a proposed draft guidance relating to patient experience data for consideration by FDA may submit such proposed draft guidance to the Agency.
Agency Information Collection Activities; Proposed Collection; Comment Request; Substances Prohibited From Use in Animal Food or Feed; Animal Proteins Prohibited in Ruminant Feed
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 recordkeeping requirements regarding animal proteins prohibited in ruminant feed.
Agency Information Collection Activities; Proposed Collection; Comment Request; Administrative Detention and Banned Medical Devices
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 information collection for administrative detention and banned medical devices.
Labeling of Red Blood Cell Units With Historical Antigen Typing Results; Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled ``Labeling of Red Blood Cell Units with Historical Antigen Typing Results; Guidance for Industry.'' The guidance document provides establishments that collect blood and blood components for transfusion with recommendations for labeling Red Blood Cell (RBC) units with non-ABO/Rh(D) antigen typing results obtained from previous donations (historical antigen typing results). The guidance provides recommendations to transfusion services for managing RBC units labeled with historical antigen typing results. The guidance also provides licensed blood establishments that choose to implement labeling of RBC units with historical antigen typing results instructions regarding how to report the manufacturing and labeling changes under the biologics regulations. The guidance does not apply to test results for ABO and Rh(D) antigens. The guidance announced in this notice finalizes the draft guidance of the same title dated January 2017.
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