<![CDATA[Federal Register Recent Federal Regulation Documents - Justia Regulation Tracker - Justia Regulations Tracker]]> https://regulations.justia.com/regulations/fedreg/agencies/department-of-health-and-human-services/2018/11?registers=between&min-day=1&max-day=30 Thu, 23 May 2024 22:21:26 -0700 Thu, 23 May 2024 22:21:26 -0700 Justia Regulations Tracker Copyright 2011 Justia Inc. https://regulations.justia.com/images/justiafedregulations.gif <![CDATA[Federal Register Recent Federal Regulation Documents - Justia Regulation Tracker - Justia Regulations Tracker]]> https://regulations.justia.com/regulations/fedreg/agencies/department-of-health-and-human-services/2018/11?registers=between&min-day=1&max-day=30 Rule - 340B Drug Pricing Program Ceiling Price and Manufacturer Civil Monetary Penalties Regulation https://regulations.justia.com/regulations/fedreg/2018/11/30/2018-26223.html https://regulations.justia.com/regulations/fedreg/2018/11/30/2018-26223.html Fri, 30 Nov 2018 00:00:00 -0800 2018-26223 Rule https://www.gpo.gov/fdsys/pkg/FR-2018-11-30/pdf/2018-26223.pdf Notice - Medicare Program; Request for Nominations for Members for the Medicare Evidence Development & Coverage Advisory Committee https://regulations.justia.com/regulations/fedreg/2018/11/30/2018-26090.html https://regulations.justia.com/regulations/fedreg/2018/11/30/2018-26090.html Fri, 30 Nov 2018 00:00:00 -0800 2018-26090 Notice https://www.gpo.gov/fdsys/pkg/FR-2018-11-30/pdf/2018-26090.pdf Notice - Meeting of the Advisory Commission on Childhood Vaccines https://regulations.justia.com/regulations/fedreg/2018/11/30/2018-26080.html https://regulations.justia.com/regulations/fedreg/2018/11/30/2018-26080.html Fri, 30 Nov 2018 00:00:00 -0800 2018-26080 Notice https://www.gpo.gov/fdsys/pkg/FR-2018-11-30/pdf/2018-26080.pdf Rule - Medicare Program: Changes to Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems and Quality Reporting Programs; Correction https://regulations.justia.com/regulations/fedreg/2018/11/30/2018-26079.html https://regulations.justia.com/regulations/fedreg/2018/11/30/2018-26079.html Fri, 30 Nov 2018 00:00:00 -0800 2018-26079 Rule https://www.gpo.gov/fdsys/pkg/FR-2018-11-30/pdf/2018-26079.pdf Notice - Agency Information Collection Activities: Proposed Collection; Comment Request https://regulations.justia.com/regulations/fedreg/2018/11/30/2018-26052.html https://regulations.justia.com/regulations/fedreg/2018/11/30/2018-26052.html Fri, 30 Nov 2018 00:00:00 -0800 2018-26052 Notice https://www.gpo.gov/fdsys/pkg/FR-2018-11-30/pdf/2018-26052.pdf Notice - Determination of Regulatory Review Period for Purposes of Patent Extension; PROVAYBLUE https://regulations.justia.com/regulations/fedreg/2018/11/30/2018-26035.html https://regulations.justia.com/regulations/fedreg/2018/11/30/2018-26035.html Fri, 30 Nov 2018 00:00:00 -0800 2018-26035 Notice https://www.gpo.gov/fdsys/pkg/FR-2018-11-30/pdf/2018-26035.pdf Notice - Blood Glucose Monitoring Test Systems for Prescription Point-of-Care Use; Draft Guidance for Industry and Food and Drug Administration Staff; Availability https://regulations.justia.com/regulations/fedreg/2018/11/30/2018-26034.html https://regulations.justia.com/regulations/fedreg/2018/11/30/2018-26034.html Fri, 30 Nov 2018 00:00:00 -0800 2018-26034 Notice https://www.gpo.gov/fdsys/pkg/FR-2018-11-30/pdf/2018-26034.pdf Notice - Determination of Regulatory Review Period for Purposes of Patent Extension; KEVZARA https://regulations.justia.com/regulations/fedreg/2018/11/30/2018-26033.html https://regulations.justia.com/regulations/fedreg/2018/11/30/2018-26033.html Fri, 30 Nov 2018 00:00:00 -0800 2018-26033 Notice https://www.gpo.gov/fdsys/pkg/FR-2018-11-30/pdf/2018-26033.pdf Notice - Agency Information Collection Activities; Proposed Collection; Comment Request; Oversight of Clinical Investigations: A Risk-Based Approach to Monitoring https://regulations.justia.com/regulations/fedreg/2018/11/30/2018-26032.html https://regulations.justia.com/regulations/fedreg/2018/11/30/2018-26032.html Fri, 30 Nov 2018 00:00:00 -0800 2018-26032 Notice https://www.gpo.gov/fdsys/pkg/FR-2018-11-30/pdf/2018-26032.pdf Notice - Agency Information Collection Activities; Proposed Collection; Comment Request; Food and Drug Administration Adverse Event Reports; Electronic Submissions https://regulations.justia.com/regulations/fedreg/2018/11/30/2018-26031.html https://regulations.justia.com/regulations/fedreg/2018/11/30/2018-26031.html Fri, 30 Nov 2018 00:00:00 -0800 2018-26031 Notice https://www.gpo.gov/fdsys/pkg/FR-2018-11-30/pdf/2018-26031.pdf Notice - Bone, Reproductive and Urologic Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments https://regulations.justia.com/regulations/fedreg/2018/11/30/2018-26029.html https://regulations.justia.com/regulations/fedreg/2018/11/30/2018-26029.html Fri, 30 Nov 2018 00:00:00 -0800 2018-26029 Notice https://www.gpo.gov/fdsys/pkg/FR-2018-11-30/pdf/2018-26029.pdf Notice - Self-Monitoring Blood Glucose Test Systems for Over-the-Counter Use; Draft Guidance for Industry and Food and Drug Administration Staff; Availability https://regulations.justia.com/regulations/fedreg/2018/11/30/2018-26028.html https://regulations.justia.com/regulations/fedreg/2018/11/30/2018-26028.html Fri, 30 Nov 2018 00:00:00 -0800 2018-26028 Notice https://www.gpo.gov/fdsys/pkg/FR-2018-11-30/pdf/2018-26028.pdf Notice - National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Closed Meeting https://regulations.justia.com/regulations/fedreg/2018/11/30/2018-26017.html https://regulations.justia.com/regulations/fedreg/2018/11/30/2018-26017.html Fri, 30 Nov 2018 00:00:00 -0800 2018-26017 Notice https://www.gpo.gov/fdsys/pkg/FR-2018-11-30/pdf/2018-26017.pdf Notice - Prospective Grant of an Exclusive Patent License: Agonist/Antagonist Compositions and Methods of Use https://regulations.justia.com/regulations/fedreg/2018/11/30/2018-26016.html https://regulations.justia.com/regulations/fedreg/2018/11/30/2018-26016.html Fri, 30 Nov 2018 00:00:00 -0800 2018-26016 Notice https://www.gpo.gov/fdsys/pkg/FR-2018-11-30/pdf/2018-26016.pdf Notice - National Cancer Institute; Notice of Closed Meeting https://regulations.justia.com/regulations/fedreg/2018/11/30/2018-26015.html https://regulations.justia.com/regulations/fedreg/2018/11/30/2018-26015.html Fri, 30 Nov 2018 00:00:00 -0800 2018-26015 Notice https://www.gpo.gov/fdsys/pkg/FR-2018-11-30/pdf/2018-26015.pdf Notice - National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting https://regulations.justia.com/regulations/fedreg/2018/11/30/2018-26014.html https://regulations.justia.com/regulations/fedreg/2018/11/30/2018-26014.html Fri, 30 Nov 2018 00:00:00 -0800 2018-26014 Notice https://www.gpo.gov/fdsys/pkg/FR-2018-11-30/pdf/2018-26014.pdf Notice - Meetings Announcement for the Physician-Focused Payment Model Technical Advisory Committee Required by the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA); Correction https://regulations.justia.com/regulations/fedreg/2018/11/30/2018-25992.html https://regulations.justia.com/regulations/fedreg/2018/11/30/2018-25992.html Fri, 30 Nov 2018 00:00:00 -0800 2018-25992 Notice https://www.gpo.gov/fdsys/pkg/FR-2018-11-30/pdf/2018-25992.pdf Notice - Joint Meeting of the Arthritis Advisory Committee and the Drug Safety and Risk Management Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments https://regulations.justia.com/regulations/fedreg/2018/11/30/2018-25991.html https://regulations.justia.com/regulations/fedreg/2018/11/30/2018-25991.html Fri, 30 Nov 2018 00:00:00 -0800 2018-25991 Notice https://www.gpo.gov/fdsys/pkg/FR-2018-11-30/pdf/2018-25991.pdf Notice - Endocrinologic and Metabolic Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments https://regulations.justia.com/regulations/fedreg/2018/11/30/2018-25990.html https://regulations.justia.com/regulations/fedreg/2018/11/30/2018-25990.html Fri, 30 Nov 2018 00:00:00 -0800 2018-25990 Notice https://www.gpo.gov/fdsys/pkg/FR-2018-11-30/pdf/2018-25990.pdf Proposed Rule - Modernizing Part D and Medicare Advantage To Lower Drug Prices and Reduce Out-of-Pocket Expenses https://regulations.justia.com/regulations/fedreg/2018/11/30/2018-25945.html https://regulations.justia.com/regulations/fedreg/2018/11/30/2018-25945.html Fri, 30 Nov 2018 00:00:00 -0800 2018-25945 Proposed Rule https://www.gpo.gov/fdsys/pkg/FR-2018-11-30/pdf/2018-25945.pdf Notice - Agency Information Collection Activities: Submission for OMB Review; Comment Request https://regulations.justia.com/regulations/fedreg/2018/11/29/2018-25978.html https://regulations.justia.com/regulations/fedreg/2018/11/29/2018-25978.html Thu, 29 Nov 2018 00:00:00 -0800 2018-25978 Notice https://www.gpo.gov/fdsys/pkg/FR-2018-11-29/pdf/2018-25978.pdf Notice - Common Formats for Patient Safety Data Collection https://regulations.justia.com/regulations/fedreg/2018/11/29/2018-25971.html https://regulations.justia.com/regulations/fedreg/2018/11/29/2018-25971.html Thu, 29 Nov 2018 00:00:00 -0800 2018-25971 Notice https://www.gpo.gov/fdsys/pkg/FR-2018-11-29/pdf/2018-25971.pdf Notice - Recommendations for Dual 510(k) and Clinical Laboratory Improvement Amendments Waiver by Application Studies; Draft Guidance for Industry and Food and Drug Administration Staff; Availability https://regulations.justia.com/regulations/fedreg/2018/11/29/2018-25960.html https://regulations.justia.com/regulations/fedreg/2018/11/29/2018-25960.html Thu, 29 Nov 2018 00:00:00 -0800 2018-25960 Notice https://www.gpo.gov/fdsys/pkg/FR-2018-11-29/pdf/2018-25960.pdf Notice - Select Updates for Recommendations for Clinical Laboratory Improvement Amendments of 1988 Waiver Applications for Manufacturers of In Vitro Diagnostic Devices; Draft Guidance for Industry and Food and Drug Administration Staff; Availability https://regulations.justia.com/regulations/fedreg/2018/11/29/2018-25959.html https://regulations.justia.com/regulations/fedreg/2018/11/29/2018-25959.html Thu, 29 Nov 2018 00:00:00 -0800 2018-25959 Notice https://www.gpo.gov/fdsys/pkg/FR-2018-11-29/pdf/2018-25959.pdf Notice - Prescription Drug User Fee Act of 2017; Electronic Submissions and Data Standards; Announcement of Public Meeting; Request for Comments https://regulations.justia.com/regulations/fedreg/2018/11/29/2018-25958.html https://regulations.justia.com/regulations/fedreg/2018/11/29/2018-25958.html Thu, 29 Nov 2018 00:00:00 -0800 2018-25958 Notice https://www.gpo.gov/fdsys/pkg/FR-2018-11-29/pdf/2018-25958.pdf Notice - Product-Specific Guidances; Draft and Revised Draft Guidances for Industry; Availability https://regulations.justia.com/regulations/fedreg/2018/11/29/2018-25950.html https://regulations.justia.com/regulations/fedreg/2018/11/29/2018-25950.html Thu, 29 Nov 2018 00:00:00 -0800 2018-25950 Notice https://www.gpo.gov/fdsys/pkg/FR-2018-11-29/pdf/2018-25950.pdf Notice - Notice of Allotment Percentages to States for Child Welfare Services State Grants; CFDA Number: 93.645 https://regulations.justia.com/regulations/fedreg/2018/11/29/2018-25932.html https://regulations.justia.com/regulations/fedreg/2018/11/29/2018-25932.html Thu, 29 Nov 2018 00:00:00 -0800 2018-25932 Notice https://www.gpo.gov/fdsys/pkg/FR-2018-11-29/pdf/2018-25932.pdf Notice - Federal Financial Participation in State Assistance Expenditures; Federal Matching Shares for Medicaid, the Children's Health Insurance Program, and Aid to Needy Aged, Blind, or Disabled Persons for October 1, 2019 Through September 30, 2020 https://regulations.justia.com/regulations/fedreg/2018/11/28/2018-25944.html https://regulations.justia.com/regulations/fedreg/2018/11/28/2018-25944.html Wed, 28 Nov 2018 00:00:00 -0800 2018-25944 Notice https://www.gpo.gov/fdsys/pkg/FR-2018-11-28/pdf/2018-25944.pdf Notice - Submission for OMB Review https://regulations.justia.com/regulations/fedreg/2018/11/28/2018-25512.html https://regulations.justia.com/regulations/fedreg/2018/11/28/2018-25512.html Wed, 28 Nov 2018 00:00:00 -0800 2018-25512 Notice https://www.gpo.gov/fdsys/pkg/FR-2018-11-28/pdf/2018-25512.pdf Notice - Agency Information Collection Activities: Proposed Collection; Comment Request https://regulations.justia.com/regulations/fedreg/2018/11/27/2018-25858.html https://regulations.justia.com/regulations/fedreg/2018/11/27/2018-25858.html Tue, 27 Nov 2018 00:00:00 -0800 2018-25858 Notice https://www.gpo.gov/fdsys/pkg/FR-2018-11-27/pdf/2018-25858.pdf Notice - Agency Information Collection Activities: Proposed Collection; Comment Request https://regulations.justia.com/regulations/fedreg/2018/11/27/2018-25840.html https://regulations.justia.com/regulations/fedreg/2018/11/27/2018-25840.html Tue, 27 Nov 2018 00:00:00 -0800 2018-25840 Notice https://www.gpo.gov/fdsys/pkg/FR-2018-11-27/pdf/2018-25840.pdf Notice - Solicitation for Written Comments on Proposed Objectives for Healthy People 2030 https://regulations.justia.com/regulations/fedreg/2018/11/27/2018-25836.html https://regulations.justia.com/regulations/fedreg/2018/11/27/2018-25836.html Tue, 27 Nov 2018 00:00:00 -0800 2018-25836 Notice https://www.gpo.gov/fdsys/pkg/FR-2018-11-27/pdf/2018-25836.pdf Notice - Statewide Data Indicators for Child and Family Services Reviews: Request for Public Comment https://regulations.justia.com/regulations/fedreg/2018/11/27/2018-25835.html https://regulations.justia.com/regulations/fedreg/2018/11/27/2018-25835.html Tue, 27 Nov 2018 00:00:00 -0800 2018-25835 Notice https://www.gpo.gov/fdsys/pkg/FR-2018-11-27/pdf/2018-25835.pdf Proposed Rule - Change to the Definition of “Human Organ” Under Section 301 of the National Organ Transplant Act of 1984; Withdrawal https://regulations.justia.com/regulations/fedreg/2018/11/27/2018-25833.html https://regulations.justia.com/regulations/fedreg/2018/11/27/2018-25833.html Tue, 27 Nov 2018 00:00:00 -0800 2018-25833 Proposed Rule https://www.gpo.gov/fdsys/pkg/FR-2018-11-27/pdf/2018-25833.pdf Notice - Request for Public Comment: 30-Day Proposed Information Collection: Addendum to Declaration for Federal Employment, Child Care and Indian Child Care Worker Positions https://regulations.justia.com/regulations/fedreg/2018/11/27/2018-25819.html https://regulations.justia.com/regulations/fedreg/2018/11/27/2018-25819.html Tue, 27 Nov 2018 00:00:00 -0800 2018-25819 Notice https://www.gpo.gov/fdsys/pkg/FR-2018-11-27/pdf/2018-25819.pdf Notice - National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Closed Meetings https://regulations.justia.com/regulations/fedreg/2018/11/27/2018-25792.html https://regulations.justia.com/regulations/fedreg/2018/11/27/2018-25792.html Tue, 27 Nov 2018 00:00:00 -0800 2018-25792 Notice https://www.gpo.gov/fdsys/pkg/FR-2018-11-27/pdf/2018-25792.pdf Notice - National Cancer Institute; Notice of Closed Meetings https://regulations.justia.com/regulations/fedreg/2018/11/27/2018-25791.html https://regulations.justia.com/regulations/fedreg/2018/11/27/2018-25791.html Tue, 27 Nov 2018 00:00:00 -0800 2018-25791 Notice https://www.gpo.gov/fdsys/pkg/FR-2018-11-27/pdf/2018-25791.pdf Notice - National Institute of Allergy and Infectious Diseases; Notice of Closed Meetings https://regulations.justia.com/regulations/fedreg/2018/11/27/2018-25789.html https://regulations.justia.com/regulations/fedreg/2018/11/27/2018-25789.html Tue, 27 Nov 2018 00:00:00 -0800 2018-25789 Notice https://www.gpo.gov/fdsys/pkg/FR-2018-11-27/pdf/2018-25789.pdf Notice - National Institute of Allergy and Infectious Diseases; Notice of Closed Meetings https://regulations.justia.com/regulations/fedreg/2018/11/27/2018-25788.html https://regulations.justia.com/regulations/fedreg/2018/11/27/2018-25788.html Tue, 27 Nov 2018 00:00:00 -0800 2018-25788 Notice https://www.gpo.gov/fdsys/pkg/FR-2018-11-27/pdf/2018-25788.pdf Notice - Government-Owned Inventions; Availability for Licensing https://regulations.justia.com/regulations/fedreg/2018/11/27/2018-25787.html https://regulations.justia.com/regulations/fedreg/2018/11/27/2018-25787.html Tue, 27 Nov 2018 00:00:00 -0800 2018-25787 Notice https://www.gpo.gov/fdsys/pkg/FR-2018-11-27/pdf/2018-25787.pdf Notice - National Institute on Alcohol Abuse and Alcoholism; Notice of Meeting https://regulations.justia.com/regulations/fedreg/2018/11/27/2018-25785.html https://regulations.justia.com/regulations/fedreg/2018/11/27/2018-25785.html Tue, 27 Nov 2018 00:00:00 -0800 2018-25785 Notice https://www.gpo.gov/fdsys/pkg/FR-2018-11-27/pdf/2018-25785.pdf Notice - Submission for OMB Review; 30-Day Comment Request Data and Specimen Hub (DASH) (Eunice Kennedy Shriver National Institute of Child Health and Human Development); Correction https://regulations.justia.com/regulations/fedreg/2018/11/27/2018-25784.html https://regulations.justia.com/regulations/fedreg/2018/11/27/2018-25784.html Tue, 27 Nov 2018 00:00:00 -0800 2018-25784 Notice https://www.gpo.gov/fdsys/pkg/FR-2018-11-27/pdf/2018-25784.pdf Notice - Proposed Data Collection Submitted for Public Comment and Recommendations https://regulations.justia.com/regulations/fedreg/2018/11/27/2018-25752.html https://regulations.justia.com/regulations/fedreg/2018/11/27/2018-25752.html Tue, 27 Nov 2018 00:00:00 -0800 2018-25752 Notice https://www.gpo.gov/fdsys/pkg/FR-2018-11-27/pdf/2018-25752.pdf Notice - Agency Forms Undergoing Paperwork Reduction Act Review https://regulations.justia.com/regulations/fedreg/2018/11/27/2018-25751.html https://regulations.justia.com/regulations/fedreg/2018/11/27/2018-25751.html Tue, 27 Nov 2018 00:00:00 -0800 2018-25751 Notice https://www.gpo.gov/fdsys/pkg/FR-2018-11-27/pdf/2018-25751.pdf Notice - Agency Forms Undergoing Paperwork Reduction Act Review https://regulations.justia.com/regulations/fedreg/2018/11/27/2018-25750.html https://regulations.justia.com/regulations/fedreg/2018/11/27/2018-25750.html Tue, 27 Nov 2018 00:00:00 -0800 2018-25750 Notice https://www.gpo.gov/fdsys/pkg/FR-2018-11-27/pdf/2018-25750.pdf Notice - Agency Forms Undergoing Paperwork Reduction Act Review https://regulations.justia.com/regulations/fedreg/2018/11/27/2018-25626.html https://regulations.justia.com/regulations/fedreg/2018/11/27/2018-25626.html Tue, 27 Nov 2018 00:00:00 -0800 2018-25626 Notice https://www.gpo.gov/fdsys/pkg/FR-2018-11-27/pdf/2018-25626.pdf Notice - Agency Information Collection Activities: Proposed Collection; Comment Request https://regulations.justia.com/regulations/fedreg/2018/11/26/2018-25700.html https://regulations.justia.com/regulations/fedreg/2018/11/26/2018-25700.html Mon, 26 Nov 2018 00:00:00 -0800 2018-25700 Notice https://www.gpo.gov/fdsys/pkg/FR-2018-11-26/pdf/2018-25700.pdf Notice - Privacy Act of 1974; Matching Program https://regulations.justia.com/regulations/fedreg/2018/11/26/2018-25639.html https://regulations.justia.com/regulations/fedreg/2018/11/26/2018-25639.html Mon, 26 Nov 2018 00:00:00 -0800 2018-25639 Notice https://www.gpo.gov/fdsys/pkg/FR-2018-11-26/pdf/2018-25639.pdf Notice - National Institute of Allergy and Infectious Diseases; Notice of Meetings https://regulations.justia.com/regulations/fedreg/2018/11/26/2018-25630.html https://regulations.justia.com/regulations/fedreg/2018/11/26/2018-25630.html Mon, 26 Nov 2018 00:00:00 -0800 2018-25630 Notice https://www.gpo.gov/fdsys/pkg/FR-2018-11-26/pdf/2018-25630.pdf Notice - National Institute of Allergy and Infectious Diseases; Notice of Meetings https://regulations.justia.com/regulations/fedreg/2018/11/26/2018-25629.html https://regulations.justia.com/regulations/fedreg/2018/11/26/2018-25629.html Mon, 26 Nov 2018 00:00:00 -0800 2018-25629 Notice https://www.gpo.gov/fdsys/pkg/FR-2018-11-26/pdf/2018-25629.pdf