Department of Health and Human Services April 2019 – Federal Register Recent Federal Regulation Documents
Results 251 - 293 of 293
Advisory Committee; Technical Electronic Product Radiation Safety Standards Committee; Renewal
The Food and Drug Administration (FDA) is announcing the renewal of the Technical Electronic Product Radiation Safety Standards Committee (Committee) by the Commissioner of Food and Drugs (the Commissioner). The Commissioner has determined that it is in the public interest to renew the Committee for an additional 2 years beyond the charter expiration date. The new charter will be in effect until December 24, 2020.
Biodefense Summit: Implementing the National Biodefense Strategy: Notification of Public Meeting and Solicitation of Advice
The HHS Assistant Secretary for Preparedness and Response (ASPR) in the Department of Health and Human Services (HHS) is announcing a public meeting, Biodefense Summit: Implementing the National Biodefense Strategy (Strategy). Implementing the Strategy involves partners among multiple sectors, including medical; public, animal, and plant health; emergency response; scientific and technical; law enforcement; industrial; academic; diplomatic; defense and security; intelligence; and nonproliferation and counterproliferation stakeholders. This meeting is being held to introduce the Strategy to these groups and to solicit feedback from them. The meeting will be open to representatives from invited organizations and the public.
National Biodefense Science Board: Call for Nominees
The Office of the Assistant Secretary for Preparedness and Response (ASPR), in the Department of Health and Human Services (HHS) seeks applications from qualified individuals for membership on the National Biodefense Science Board (NBSB) or (Board). Terms of five members expire December 31, 2019; therefore, the HHS Secretary (Secretary) will appoint five new voting members. Applicants to those positions may be nominated by a relevant organization or may nominate themselves based on their expertise within the following stakeholder groups: Industry, academia, health care consumer organizations, and organizations representing other appropriate stakeholders. Please visit the NBSB website at https://www.phe.gov/nbsb for all application submission information, additional information regarding the qualifications expected for applicants, and application instructions.
Meeting of the Pain Management Best Practices Inter-Agency Task Force
As stipulated by the Federal Advisory Committee Act, the Department of Health and Human Services (HHS) is hereby giving notice that a meeting is scheduled to be held for the Pain Management Best Practices Inter-Agency Task Force (Task Force). The meeting will be open to the public; public comment sessions will be held during the meeting.
Training Program for Regulatory Project Managers; Information Available to Industry
The Food and Drug Administration's (FDA or the Agency) Center for Drug Evaluation and Research (CDER) is announcing the continuation of the Regulatory Project Management Site Tours and Regulatory Interaction Program (the Site Tours Program). The purpose of this document is to invite pharmaceutical companies interested in participating in this program to contact CDER.
Current List of HHS-Certified Laboratories and Instrumented Initial Testing Facilities Which Meet Minimum Standards To Engage in Urine Drug Testing for Federal Agencies
The Department of Health and Human Services (HHS) notifies federal agencies of the laboratories and Instrumented Initial Testing Facilities (IITF) currently certified to meet the standards of the Mandatory Guidelines for Federal Workplace Drug Testing Programs (Mandatory Guidelines). A notice listing all currently HHS-certified laboratories and IITFs is published in the Federal Register during the first week of each month. If any laboratory or IITF certification is suspended or revoked, the laboratory or IITF will be omitted from subsequent lists until such time as it is restored to full certification under the Mandatory Guidelines. If any laboratory or IITF has withdrawn from the HHS National Laboratory Certification Program (NLCP) during the past month, it will be listed at the end and will be omitted from the monthly listing thereafter. This notice is also available on the internet at https:// www.samhsa.gov/workplace.
Youth Tobacco Cessation: Science and Treatment Strategies; Public Scientific Workshop; Request for Comments
The Food and Drug Administration (FDA, the Agency, or we) is announcing the following public scientific workshop entitled ``Youth Tobacco Cessation: Science and Treatment Strategies.'' The purpose of the workshop is to discuss the unique challenges associated with youth tobacco addiction and cessation, and the current science regarding youth tobacco use and addiction as well as treatment strategies to support youth tobacco cessation.
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 The Childcare Survey of Activity and Wellness (C-SAW) Pilot Study. The pilot study will determine the current practices and policies of early care and education (ECE) providers in four states around nutrition, physical activity, and wellness and will inform the development of a potential national surveillance system.
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 information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on the Million Hearts[supreg] Hospital/Health System Recognition Program that recognizes institutions working systematically to improve the cardiovascular health of the population and communities they serve.
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 to take this 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 Information Collection on Soil- transmitted Helminth Infections in Alabama and Mississippi. CDC requests OMB approval to collect information on prevalence and distribution of soil-transmitted helminth infections and potential risk factors.
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 ``Drug Overdose Surveillance and Epidemiology (DOSE).'' This new data collection effort is an essential component toward reducing the opioid crisis, one of HHS Department's top priorities. DOSE data is critical to our ability to rapidly identify outbreaks and provide situational awareness of changes in emergency department (ED) visits involving suspected drug, opioid, heroin and stimulant overdoses at the local, state, and regional level.
Basic Health Program; Federal Funding Methodology for Program Years 2019 and 2020
This document proposes the methodology and data sources necessary to determine federal payment amounts to be made in program years 2019 and 2020 to states that elect to establish a Basic Health Program under the Patient Protection and Affordable Care Act to offer health benefits coverage to low-income individuals otherwise eligible to purchase coverage through Affordable Insurance Exchanges. Prior to the final notice being published, Basic Health Program (BHP) payments will be made using the methodology described in the Final Administrative Order published on August 24, 2018. Payments for 2019 will be conformed to the finalized 2019 payment methodology through reconciliation.
Revocation of the Test for Mycoplasma
The Food and Drug Administration (FDA, Agency, or we) is proposing to amend the biologics regulations by removing the specified test for the presence of Mycoplasma for live virus vaccines and inactivated virus vaccines produced from in vitro living cell cultures. FDA is proposing this action because the existing test for Mycoplasma is restrictive in that it identifies only one test method in detail to be used even though other methods also may be appropriate. More sensitive and specific methods exist and are currently being practiced, and removal of the specific method to test for Mycoplasma provides flexibility for accommodating new and evolving technology and capabilities without diminishing public health protections. This action is part of FDA's implementation of Executive Orders 13771 and 13777. Under these Executive orders, FDA is comprehensively reviewing existing regulations to identify opportunities for repeal, replacement, or modification that will result in meaningful burden reduction, while allowing the Agency to achieve our public health mission and fulfill statutory obligations.
Removal of Certain Time of Inspection and Duties of Inspector Regulations for Biological Products
The Food and Drug Administration (FDA, the Agency, or we) is issuing a final rule amending the general biologics regulations relating to time of inspection requirements and also removing duties of inspector requirements. FDA is taking this action to remove outdated requirements and accommodate new approaches, such as a risk-based inspection frequency for drug and device establishments, thereby providing flexibility without diminishing public health protections. This action is part of FDA's implementation of Executive Orders (E.O.s) 13771 and 13777. Under these E.O.s, FDA is comprehensively reviewing existing regulations to identify opportunities for repeal, replacement, or modification that will result in meaningful burden reduction, while allowing the Agency to achieve our public health mission and fulfill statutory obligations.
Implementing the Food and Drug Administration Food Safety Modernization Act; Technical Amendment
The Food and Drug Administration (FDA, the Agency, or we) is correcting with technical amendments two final rules that published in the Federal Register of September 17, 2015, and one final rule that published in the Federal Register of November 27, 2015. The final rules published with editorial and inadvertent errors. This document corrects those errors.
New Animal Drugs; Approval of New Animal Drug Applications; Changes of Sponsorship
The Food and Drug Administration (FDA or we) is amending the animal drug regulations to reflect application-related actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during October, November, and December 2018. FDA is informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable. The animal drug regulations are also being amended to make technical amendments to improve the readability of the regulations.
Content and Format of Substantial Equivalence Reports; Food and Drug Administration Actions on Substantial Equivalence Reports
The Food and Drug Administration (FDA) is issuing a proposed rule to establish requirements for the content and format of reports intended to establish the substantial equivalence of a tobacco product (SE Reports). The proposed rule would establish the information an SE Report must include so that FDA may make a substantial equivalence determination. In addition, the proposed rule would establish the general procedures FDA intends to follow when evaluating SE Reports, including procedures that would address communications with the applicant and the confidentiality of data in an SE Report. The proposed rule is intended to provide more clarity to applicants and support efficient and predictable reviews of SE Reports.
Medicaid Program; Covered Outpatient Drug; Line Extension Definition; and Change to the Rebate Calculation for Line Extension Drugs
This interim final rule with comment period revises the regulatory text to accurately reflect the applicable statutory language describing the rebate calculation for line extension drugs, which was revised by the Bipartisan Budget Act (BBA) of 2018. In addition, we also are issuing a final rule which responds to comments on the definition and identification of line extension drugs for which we requested additional comments in the Covered Outpatient Drugs final rule with comment period published in the February 1, 2016 Federal Register.
Reinstatement of Color Additive Listing for Lead Acetate
The Food and Drug Administration (FDA or we) is reinstating the provision removed by our October 2018 final rule to amend the color additive regulations to no longer provide for the use of lead acetate in cosmetics intended for coloring hair on the scalp. This action does not reflect any change in our determination that new data demonstrate that there is no longer a reasonable certainty of no harm from the use of this color additive. We are reinstating this provision only because it was removed from the Code of Federal Regulations before we had the opportunity to take final action on the objections we received to the October 2018 final rule. This provision is being reinstated pending final FDA action on objections to the final rule.
Teva Women's Health, Inc., et al.; Withdrawal of Approval of 16 New Drug Applications
The Food and Drug Administration (FDA or Agency) is withdrawing approval of 16 new drug applications (NDAs) from multiple applicants. The applicants notified the Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.
Findings of Research Misconduct
Findings of research misconduct have been made against Edward J. Fox, Ph.D. (Respondent), Acting Assistant Professor in the Department of Pathology, University of Washington (UW). Dr. Fox engaged in research misconduct in research supported by National Cancer Institute (NCI), National Institutes of Health (NIH), grants R01 CA193649, R01 CA160674, P01 CA77852, and R01 CA102029. The administrative actions, including supervision for a period of one (1) year, were implemented beginning on March 18, 2019, and are detailed below.
Agency Information Collection Activities: Proposed Collection; Comment Request
This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) approve a revision and to extend the time period of the proposed information collection project ``The AHRQ Safety Program for Improving Antibiotic Use.''
Agency Information Collection Activities: Proposed Collection; Comment Request
This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) approve the proposed information collection project ``Online Submission Form for Supplemental Evidence and Data for Systematic Reviews for the Evidence-based Practice Center Program.''
Charter Renewal for the Advisory Committee on Interdiciplinary, Community-Based Linkages
The Advisory Committee on Interdiciplinary, Community-Based Linkages (ACICBL or the Committee) has been rechartered. The effective date of the renewed charter is March 24, 2019.
Charter Renewal for the Advisory Committee on Training in Primary Care Medicine and Dentistry
The Advisory Committee on Training in Primary Care Medicine and Dentistry (ACTPCMD or the Committee) has been rechartered. The effective date of the renewed charter is March 24, 2019.
Medicare and Medicaid Programs: Application From the American Association for Accreditation of Ambulatory Surgery Facilities, Inc. (AAAASF) for Its Outpatient Physical Therapy and Speech Language Pathology Services Accreditation Program
This final notice announces our decision to approve the American Association for Accreditation of Ambulatory Surgery Facilities, Inc. (AAAASF) for continued recognition as a national accrediting organization for clinics, rehabilitation agencies, or public health agencies that furnish outpatient physical therapy and speech language pathology services that wish to participate in the Medicare or Medicaid programs.
Medicare Program; Public Meeting on June 24, 2019 Regarding New and Reconsidered Clinical Diagnostic Laboratory Test Codes for the Clinical Laboratory Fee Schedule for Calendar Year 2020
This notice announces a public meeting to receive comments and recommendations (including data on which recommendations are based) from the public on the appropriate basis for establishing payment amounts for new or substantially revised Healthcare Common Procedure Coding System (HCPCS) codes being considered for Medicare payment under the Clinical Laboratory Fee Schedule (CLFS) for calendar year (CY) 2020. This meeting also provides a forum for those who submitted certain reconsideration requests regarding final determinations made last year on new test codes and for the public to provide comment on the requests. The Medicare Advisory Panel on Clinical Diagnostic Laboratory Tests (Advisory Panel on CDLTs) will participate in this CLFS Annual Public Meeting by gathering information and asking questions to presenters, and will hold its next public meeting on July 22 and 23, 2019. The public meeting for the Advisory Panel on CDLTs will focus on the discussion of and recommendations for test codes presented during the June 24, 2019 CLFS Annual Public Meeting. The Panel meeting also will address any other CY 2020 CLFS issues that are designated in the Panel's charter and specified on the meeting agenda.
Medicare Program; Meeting Announcement for the Medicare Advisory Panel on Clinical Diagnostic Laboratory Tests
This notice announces the next public meeting dates for the Medicare Advisory Panel on Clinical Diagnostic Laboratory Tests (the Panel) on Monday, July 22, 2019 and Tuesday, July 23, 2019. The purpose of the Panel is to advise the Secretary of the Department of Health and Human Services and the Administrator of the Centers for Medicare & Medicaid Services on issues related to clinical diagnostic laboratory tests.
Issuance of Priority Review Voucher; Material Threat Medical Countermeasure Product
The Food and Drug Administration (FDA) is announcing the issuance of a priority review voucher to the sponsor of a material threat medical countermeasure (MCM) product application. The Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the 21st Century Cures Act (Cures Act), authorizes FDA to award priority review vouchers to sponsors of approved material threat MCM product applications that meet certain criteria. FDA is required to publish notice of the award of the priority review voucher. On July 13, 2018, FDA determined that TPOXX (tecovirimat), manufactured by SIGA Technologies, Inc., meets the criteria for a priority review voucher.
Medical Devices; Technical Amendment
The Food and Drug Administration (FDA or Agency) is amending the medical device reports of corrections and removals regulation to correct three inaccurate cross-references. This action is editorial in nature and is intended to improve the accuracy of the Agency's regulations.
Microbiology Devices; Classification of In Vitro Diagnostic Devices for Bacillus Species Detection
The Food and Drug Administration (FDA, the Agency, or we) is issuing a final rule to classify in vitro diagnostic devices for Bacillus species (spp.) detection into class II (special controls) and to continue to require a premarket notification (510(k)) to provide a reasonable assurance of safety and effectiveness of the device. FDA is also establishing special controls in a special controls guideline in addition to restricting use and distribution of the devices. An in vitro diagnostic device for Bacillus spp. detection is a prescription device used to detect and differentiate among Bacillus spp. and presumptively identify B. anthracis and other Bacillus spp. from cultured isolates or clinical specimens as an aid in the diagnosis of anthrax and other diseases caused by Bacillus spp.
Medical Devices; Orthopedic Devices; Classification of Posterior Cervical Screw Systems
The Food and Drug Administration (FDA, the Agency, or we) is issuing a final rule to classify posterior cervical screw systems into class II (special controls) and to continue to require a premarket notification (510(k)) to provide a reasonable assurance of safety and effectiveness of the device. A posterior cervical screw system is a device used to provide immobilization and stabilization in the cervical spine as an adjunct to spinal fusion surgery. The term ``posterior cervical screw systems'' is used to distinguish these devices from currently classified thoracolumbosacral pedicle screw systems for use in other spinal regions.
Radiological Health Regulations; Amendments to Records and Reports for Radiation Emitting Electronic Products; Amendments to Performance Standards for Diagnostic X-Ray, Laser and Ultrasonic Products
The Food and Drug Administration (FDA, Agency, or we) is proposing to amend and repeal parts of the radiological health regulations covering recommendations for radiation protection during medical procedures, certain records and reporting for electronic products, and performance standards for diagnostic x-ray systems and their major components, laser products, and ultrasonic therapy products. The Agency is proposing this action to clarify and update the regulations to reduce regulatory requirements that are outdated and duplicate other means to better protect the public health against harmful exposure to radiation emitting electronic products and medical devices. This action is part of FDA's implementation of Executive Orders (EOs) 13771 and 13777. Under these EOs, FDA is comprehensively reviewing existing regulations to identify opportunities for repealing and amending regulations that will result in meaningful burden reduction while allowing the Agency to achieve our public health mission and fulfill statutory obligations.
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