<![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/2015/10?registers=between&min-day=1&max-day=31 Thu, 23 May 2024 21:17:32 -0700 Thu, 23 May 2024 21:17:32 -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/2015/10?registers=between&min-day=1&max-day=31 Notice - Performance Review Board Members https://regulations.justia.com/regulations/fedreg/2015/10/30/2015-27749.html https://regulations.justia.com/regulations/fedreg/2015/10/30/2015-27749.html Fri, 30 Oct 2015 00:00:00 -0700 2015-27749 Notice http://www.gpo.gov/fdsys/pkg/FR-2015-10-30/pdf/2015-27749.pdf Notice - Liposome Drug Products: Chemistry, Manufacturing, and Controls; Human Pharmacokinetics and Bioavailability; and Labeling Documentation; Draft Guidance for Industry; Availability https://regulations.justia.com/regulations/fedreg/2015/10/30/2015-27744.html https://regulations.justia.com/regulations/fedreg/2015/10/30/2015-27744.html Fri, 30 Oct 2015 00:00:00 -0700 2015-27744 Notice http://www.gpo.gov/fdsys/pkg/FR-2015-10-30/pdf/2015-27744.pdf Notice - Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Impact of Ad Exposure Frequency on Perception and Mental Processing of Risks and Benefit Information in Direct-to-Consumer Prescription Drug Ads https://regulations.justia.com/regulations/fedreg/2015/10/30/2015-27743.html https://regulations.justia.com/regulations/fedreg/2015/10/30/2015-27743.html Fri, 30 Oct 2015 00:00:00 -0700 2015-27743 Notice http://www.gpo.gov/fdsys/pkg/FR-2015-10-30/pdf/2015-27743.pdf Notice - Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Survey of Pharmacists and Patients; Variations in the Physical Characteristics of Generic Drug Pills and Patient Perceptions https://regulations.justia.com/regulations/fedreg/2015/10/30/2015-27742.html https://regulations.justia.com/regulations/fedreg/2015/10/30/2015-27742.html Fri, 30 Oct 2015 00:00:00 -0700 2015-27742 Notice http://www.gpo.gov/fdsys/pkg/FR-2015-10-30/pdf/2015-27742.pdf Notice - Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Guidance for Industry on Controlled Correspondence Related to Generic Drug Development https://regulations.justia.com/regulations/fedreg/2015/10/30/2015-27741.html https://regulations.justia.com/regulations/fedreg/2015/10/30/2015-27741.html Fri, 30 Oct 2015 00:00:00 -0700 2015-27741 Notice http://www.gpo.gov/fdsys/pkg/FR-2015-10-30/pdf/2015-27741.pdf Notice - Determination That TENSILON and TENSILON Preservative Free (Edrophonium Chloride) Injectable and Other Drug Products Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness https://regulations.justia.com/regulations/fedreg/2015/10/30/2015-27740.html https://regulations.justia.com/regulations/fedreg/2015/10/30/2015-27740.html Fri, 30 Oct 2015 00:00:00 -0700 2015-27740 Notice http://www.gpo.gov/fdsys/pkg/FR-2015-10-30/pdf/2015-27740.pdf Notice - Investigational New Drug Applications-Determining Whether Human Research Studies Can Be Conducted Without an Investigational New Drug Application; Guidance for Clinical Investigators, Sponsors, and Institutional Review Boards; Partial Stay and Republication of Guidance https://regulations.justia.com/regulations/fedreg/2015/10/30/2015-27729.html https://regulations.justia.com/regulations/fedreg/2015/10/30/2015-27729.html Fri, 30 Oct 2015 00:00:00 -0700 2015-27729 Notice http://www.gpo.gov/fdsys/pkg/FR-2015-10-30/pdf/2015-27729.pdf Notice - Clinical Trials-Assessing Safety and Efficacy for Diverse Populations; Public Meeting; Request for Comments https://regulations.justia.com/regulations/fedreg/2015/10/30/2015-27728.html https://regulations.justia.com/regulations/fedreg/2015/10/30/2015-27728.html Fri, 30 Oct 2015 00:00:00 -0700 2015-27728 Notice http://www.gpo.gov/fdsys/pkg/FR-2015-10-30/pdf/2015-27728.pdf Notice - Proposed Collection; 60-Day Comment Request; A Generic Clearance for the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Data and Specimen Hub (DASH) https://regulations.justia.com/regulations/fedreg/2015/10/30/2015-27717.html https://regulations.justia.com/regulations/fedreg/2015/10/30/2015-27717.html Fri, 30 Oct 2015 00:00:00 -0700 2015-27717 Notice http://www.gpo.gov/fdsys/pkg/FR-2015-10-30/pdf/2015-27717.pdf Proposed Rule - Same Surgical Procedure Exception: Questions and Answers Regarding the Scope of the Exception; Draft Guidance for Industry; Reopening of the Comment Period https://regulations.justia.com/regulations/fedreg/2015/10/30/2015-27707.html https://regulations.justia.com/regulations/fedreg/2015/10/30/2015-27707.html Fri, 30 Oct 2015 00:00:00 -0700 2015-27707 Proposed Rule http://www.gpo.gov/fdsys/pkg/FR-2015-10-30/pdf/2015-27707.pdf Proposed Rule - Human Cells, Tissues, and Cellular and Tissue-Based Products From Adipose Tissue: Regulatory Considerations; Draft Guidance for Industry; Reopening of the Comment Period https://regulations.justia.com/regulations/fedreg/2015/10/30/2015-27706.html https://regulations.justia.com/regulations/fedreg/2015/10/30/2015-27706.html Fri, 30 Oct 2015 00:00:00 -0700 2015-27706 Proposed Rule http://www.gpo.gov/fdsys/pkg/FR-2015-10-30/pdf/2015-27706.pdf Proposed Rule - Minimal Manipulation of Human Cells, Tissues, and Cellular and Tissue-Based Products; Draft Guidance for Industry and Food and Drug Administration Staff; Reopening of the Comment Period https://regulations.justia.com/regulations/fedreg/2015/10/30/2015-27705.html https://regulations.justia.com/regulations/fedreg/2015/10/30/2015-27705.html Fri, 30 Oct 2015 00:00:00 -0700 2015-27705 Proposed Rule http://www.gpo.gov/fdsys/pkg/FR-2015-10-30/pdf/2015-27705.pdf Proposed Rule - Homologous Use of Human Cells, Tissues, and Cellular and Tissue-Based Products; Draft Guidance for Industry and Food and Drug Administration Staff; Availability https://regulations.justia.com/regulations/fedreg/2015/10/30/2015-27704.html https://regulations.justia.com/regulations/fedreg/2015/10/30/2015-27704.html Fri, 30 Oct 2015 00:00:00 -0700 2015-27704 Proposed Rule http://www.gpo.gov/fdsys/pkg/FR-2015-10-30/pdf/2015-27704.pdf Proposed Rule - Draft Guidances Relating to the Regulation of Human Cells, Tissues, or Cellular or Tissue-Based Products; Public Hearing; Request for Comments https://regulations.justia.com/regulations/fedreg/2015/10/30/2015-27703.html https://regulations.justia.com/regulations/fedreg/2015/10/30/2015-27703.html Fri, 30 Oct 2015 00:00:00 -0700 2015-27703 Proposed Rule http://www.gpo.gov/fdsys/pkg/FR-2015-10-30/pdf/2015-27703.pdf Notice - Final Effect of Designation of a Class of Employees for Addition to the Special Exposure Cohort https://regulations.justia.com/regulations/fedreg/2015/10/30/2015-27701.html https://regulations.justia.com/regulations/fedreg/2015/10/30/2015-27701.html Fri, 30 Oct 2015 00:00:00 -0700 2015-27701 Notice http://www.gpo.gov/fdsys/pkg/FR-2015-10-30/pdf/2015-27701.pdf Notice - Proposed Collection; 60-Day Comment Request Consumer Health Information in Public Libraries User Needs Survey (NLM) https://regulations.justia.com/regulations/fedreg/2015/10/30/2015-27678.html https://regulations.justia.com/regulations/fedreg/2015/10/30/2015-27678.html Fri, 30 Oct 2015 00:00:00 -0700 2015-27678 Notice http://www.gpo.gov/fdsys/pkg/FR-2015-10-30/pdf/2015-27678.pdf Notice - Submission for OMB Review; Comment Request https://regulations.justia.com/regulations/fedreg/2015/10/30/2015-27666.html https://regulations.justia.com/regulations/fedreg/2015/10/30/2015-27666.html Fri, 30 Oct 2015 00:00:00 -0700 2015-27666 Notice http://www.gpo.gov/fdsys/pkg/FR-2015-10-30/pdf/2015-27666.pdf Notice - Agency Information Collection Activities: Proposed Collection; Comment Request https://regulations.justia.com/regulations/fedreg/2015/10/30/2015-27619.html https://regulations.justia.com/regulations/fedreg/2015/10/30/2015-27619.html Fri, 30 Oct 2015 00:00:00 -0700 2015-27619 Notice http://www.gpo.gov/fdsys/pkg/FR-2015-10-30/pdf/2015-27619.pdf Notice - NIH Pathways to Prevention Workshop: Total Worker Health®-What's Work Got To Do With It? https://regulations.justia.com/regulations/fedreg/2015/10/29/2015-27627.html https://regulations.justia.com/regulations/fedreg/2015/10/29/2015-27627.html Thu, 29 Oct 2015 00:00:00 -0700 2015-27627 Notice http://www.gpo.gov/fdsys/pkg/FR-2015-10-29/pdf/2015-27627.pdf Notice - Notice of Opportunity for Public Comment on the Dietary Supplement Label Database https://regulations.justia.com/regulations/fedreg/2015/10/29/2015-27625.html https://regulations.justia.com/regulations/fedreg/2015/10/29/2015-27625.html Thu, 29 Oct 2015 00:00:00 -0700 2015-27625 Notice http://www.gpo.gov/fdsys/pkg/FR-2015-10-29/pdf/2015-27625.pdf Rule - Medicare Program; Final Waivers in Connection With the Shared Savings Program https://regulations.justia.com/regulations/fedreg/2015/10/29/2015-27599.html https://regulations.justia.com/regulations/fedreg/2015/10/29/2015-27599.html Thu, 29 Oct 2015 00:00:00 -0700 2015-27599 Rule http://www.gpo.gov/fdsys/pkg/FR-2015-10-29/pdf/2015-27599.pdf Notice - Statement of Organization, Functions and Delegations of Authority https://regulations.justia.com/regulations/fedreg/2015/10/29/2015-27592.html https://regulations.justia.com/regulations/fedreg/2015/10/29/2015-27592.html Thu, 29 Oct 2015 00:00:00 -0700 2015-27592 Notice http://www.gpo.gov/fdsys/pkg/FR-2015-10-29/pdf/2015-27592.pdf Notice - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Labeling of Certain Beers Subject to the Labeling Jurisdiction of the Food and Drug Administration https://regulations.justia.com/regulations/fedreg/2015/10/29/2015-27588.html https://regulations.justia.com/regulations/fedreg/2015/10/29/2015-27588.html Thu, 29 Oct 2015 00:00:00 -0700 2015-27588 Notice http://www.gpo.gov/fdsys/pkg/FR-2015-10-29/pdf/2015-27588.pdf Notice - Findings of Research Misconduct https://regulations.justia.com/regulations/fedreg/2015/10/29/2015-27587.html https://regulations.justia.com/regulations/fedreg/2015/10/29/2015-27587.html Thu, 29 Oct 2015 00:00:00 -0700 2015-27587 Notice http://www.gpo.gov/fdsys/pkg/FR-2015-10-29/pdf/2015-27587.pdf Notice - Submission for OMB Review; 30-Day Comment Request; A Multi-Center International Hospital-Based Case-Control Study of Lymphoma in Asia (AsiaLymph) (NCI) https://regulations.justia.com/regulations/fedreg/2015/10/29/2015-27586.html https://regulations.justia.com/regulations/fedreg/2015/10/29/2015-27586.html Thu, 29 Oct 2015 00:00:00 -0700 2015-27586 Notice http://www.gpo.gov/fdsys/pkg/FR-2015-10-29/pdf/2015-27586.pdf Notice - Center For Scientific Review; Amended Notice of Meeting https://regulations.justia.com/regulations/fedreg/2015/10/29/2015-27584.html https://regulations.justia.com/regulations/fedreg/2015/10/29/2015-27584.html Thu, 29 Oct 2015 00:00:00 -0700 2015-27584 Notice http://www.gpo.gov/fdsys/pkg/FR-2015-10-29/pdf/2015-27584.pdf Notice - Center for Scientific Review; Notice of Closed Meetings https://regulations.justia.com/regulations/fedreg/2015/10/29/2015-27583.html https://regulations.justia.com/regulations/fedreg/2015/10/29/2015-27583.html Thu, 29 Oct 2015 00:00:00 -0700 2015-27583 Notice http://www.gpo.gov/fdsys/pkg/FR-2015-10-29/pdf/2015-27583.pdf Notice - National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting https://regulations.justia.com/regulations/fedreg/2015/10/29/2015-27582.html https://regulations.justia.com/regulations/fedreg/2015/10/29/2015-27582.html Thu, 29 Oct 2015 00:00:00 -0700 2015-27582 Notice http://www.gpo.gov/fdsys/pkg/FR-2015-10-29/pdf/2015-27582.pdf Notice - Using Technologies and Innovative Methods To Conduct Food and Drug Administration-Regulated Clinical Investigations of Investigational Drugs; Establishment of a Public Docket https://regulations.justia.com/regulations/fedreg/2015/10/29/2015-27581.html https://regulations.justia.com/regulations/fedreg/2015/10/29/2015-27581.html Thu, 29 Oct 2015 00:00:00 -0700 2015-27581 Notice http://www.gpo.gov/fdsys/pkg/FR-2015-10-29/pdf/2015-27581.pdf Notice - Disease, Disability, and Injury Prevention and Control Special Emphasis Panel (SEP): Initial Review https://regulations.justia.com/regulations/fedreg/2015/10/29/2015-27563.html https://regulations.justia.com/regulations/fedreg/2015/10/29/2015-27563.html Thu, 29 Oct 2015 00:00:00 -0700 2015-27563 Notice http://www.gpo.gov/fdsys/pkg/FR-2015-10-29/pdf/2015-27563.pdf Notice - Board of Scientific Counselors, National Center for Environmental Health/Agency for Toxic Substances and Disease Registry (BSC, NCEH/ATSDR) https://regulations.justia.com/regulations/fedreg/2015/10/29/2015-27562.html https://regulations.justia.com/regulations/fedreg/2015/10/29/2015-27562.html Thu, 29 Oct 2015 00:00:00 -0700 2015-27562 Notice http://www.gpo.gov/fdsys/pkg/FR-2015-10-29/pdf/2015-27562.pdf Notice - Subcommittee for Dose Reconstruction Reviews (SDRR), Advisory Board on Radiation and Worker Health (ABRWH or the Advisory Board), National Institute for Occupational Safety and Health (NIOSH) https://regulations.justia.com/regulations/fedreg/2015/10/29/2015-27561.html https://regulations.justia.com/regulations/fedreg/2015/10/29/2015-27561.html Thu, 29 Oct 2015 00:00:00 -0700 2015-27561 Notice http://www.gpo.gov/fdsys/pkg/FR-2015-10-29/pdf/2015-27561.pdf Notice - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Financial Disclosure by Clinical Investigators https://regulations.justia.com/regulations/fedreg/2015/10/29/2015-27559.html https://regulations.justia.com/regulations/fedreg/2015/10/29/2015-27559.html Thu, 29 Oct 2015 00:00:00 -0700 2015-27559 Notice http://www.gpo.gov/fdsys/pkg/FR-2015-10-29/pdf/2015-27559.pdf Notice - Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Guidance for Industry on Formal Meetings Between the Food and Drug Administration and Biosimilar Biological Product Sponsors or Applicants https://regulations.justia.com/regulations/fedreg/2015/10/29/2015-27558.html https://regulations.justia.com/regulations/fedreg/2015/10/29/2015-27558.html Thu, 29 Oct 2015 00:00:00 -0700 2015-27558 Notice http://www.gpo.gov/fdsys/pkg/FR-2015-10-29/pdf/2015-27558.pdf Notice - Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Guidance for Industry on Adverse Event Reporting for Outsourcing Facilities https://regulations.justia.com/regulations/fedreg/2015/10/29/2015-27557.html https://regulations.justia.com/regulations/fedreg/2015/10/29/2015-27557.html Thu, 29 Oct 2015 00:00:00 -0700 2015-27557 Notice http://www.gpo.gov/fdsys/pkg/FR-2015-10-29/pdf/2015-27557.pdf Notice - Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Survey on Occurrence of Foodborne Illness Risk Factors in Selected Institutional Foodservice and Retail Food Stores Facility Types https://regulations.justia.com/regulations/fedreg/2015/10/29/2015-27556.html https://regulations.justia.com/regulations/fedreg/2015/10/29/2015-27556.html Thu, 29 Oct 2015 00:00:00 -0700 2015-27556 Notice http://www.gpo.gov/fdsys/pkg/FR-2015-10-29/pdf/2015-27556.pdf Notice - Agency Information Collection Activities; Proposed Collection; Comment Request; Small Business Innovation Research Program-Phase II https://regulations.justia.com/regulations/fedreg/2015/10/29/2015-27512.html https://regulations.justia.com/regulations/fedreg/2015/10/29/2015-27512.html Thu, 29 Oct 2015 00:00:00 -0700 2015-27512 Notice http://www.gpo.gov/fdsys/pkg/FR-2015-10-29/pdf/2015-27512.pdf Notice - Proposed Information Collection Activity; Comment Request; State Developmental Disabilities Council-Annual Program Performance Report (PPR) https://regulations.justia.com/regulations/fedreg/2015/10/29/2015-27511.html https://regulations.justia.com/regulations/fedreg/2015/10/29/2015-27511.html Thu, 29 Oct 2015 00:00:00 -0700 2015-27511 Notice http://www.gpo.gov/fdsys/pkg/FR-2015-10-29/pdf/2015-27511.pdf Notice - Agency Information Collection Activities: Proposed Collection; Comment Request https://regulations.justia.com/regulations/fedreg/2015/10/29/2015-27499.html https://regulations.justia.com/regulations/fedreg/2015/10/29/2015-27499.html Thu, 29 Oct 2015 00:00:00 -0700 2015-27499 Notice http://www.gpo.gov/fdsys/pkg/FR-2015-10-29/pdf/2015-27499.pdf Rule - Listing of Color Additives Exempt From Certification; Spirulina Extract; Confirmation of Effective Date https://regulations.justia.com/regulations/fedreg/2015/10/29/2015-27369.html https://regulations.justia.com/regulations/fedreg/2015/10/29/2015-27369.html Thu, 29 Oct 2015 00:00:00 -0700 2015-27369 Rule http://www.gpo.gov/fdsys/pkg/FR-2015-10-29/pdf/2015-27369.pdf Notice - Prospective Grant of Exclusive License: Development of Therapeutics To Treat Obesity, Type 2 Diabetes, Fatty Liver Disease, and Liver Fibrosis in Humans https://regulations.justia.com/regulations/fedreg/2015/10/28/2015-27454.html https://regulations.justia.com/regulations/fedreg/2015/10/28/2015-27454.html Wed, 28 Oct 2015 00:00:00 -0700 2015-27454 Notice http://www.gpo.gov/fdsys/pkg/FR-2015-10-28/pdf/2015-27454.pdf Proposed Rule - World Trade Center Health Program; Petition 009-Autoimmune Diseases; Finding of Insufficient Evidence https://regulations.justia.com/regulations/fedreg/2015/10/28/2015-27435.html https://regulations.justia.com/regulations/fedreg/2015/10/28/2015-27435.html Wed, 28 Oct 2015 00:00:00 -0700 2015-27435 Proposed Rule http://www.gpo.gov/fdsys/pkg/FR-2015-10-28/pdf/2015-27435.pdf Notice - Agency Forms Undergoing Paperwork Reduction Act Review https://regulations.justia.com/regulations/fedreg/2015/10/28/2015-27431.html https://regulations.justia.com/regulations/fedreg/2015/10/28/2015-27431.html Wed, 28 Oct 2015 00:00:00 -0700 2015-27431 Notice http://www.gpo.gov/fdsys/pkg/FR-2015-10-28/pdf/2015-27431.pdf Notice - Center for Scientific Review; Notice of Closed Meetings https://regulations.justia.com/regulations/fedreg/2015/10/28/2015-27427.html https://regulations.justia.com/regulations/fedreg/2015/10/28/2015-27427.html Wed, 28 Oct 2015 00:00:00 -0700 2015-27427 Notice http://www.gpo.gov/fdsys/pkg/FR-2015-10-28/pdf/2015-27427.pdf Notice - Agency Information Collection Activities; Proposed Collection; Comment Request; Investigational Device Exemptions Reports and Records https://regulations.justia.com/regulations/fedreg/2015/10/28/2015-27420.html https://regulations.justia.com/regulations/fedreg/2015/10/28/2015-27420.html Wed, 28 Oct 2015 00:00:00 -0700 2015-27420 Notice http://www.gpo.gov/fdsys/pkg/FR-2015-10-28/pdf/2015-27420.pdf Notice - Nonclinical Safety Evaluation of Reformulated Drug Products and Products Intended for Administration by an Alternate Route; Guidance for Industry and Review Staff; Availability https://regulations.justia.com/regulations/fedreg/2015/10/28/2015-27418.html https://regulations.justia.com/regulations/fedreg/2015/10/28/2015-27418.html Wed, 28 Oct 2015 00:00:00 -0700 2015-27418 Notice http://www.gpo.gov/fdsys/pkg/FR-2015-10-28/pdf/2015-27418.pdf Notice - Proposed Information Collection Activity; Comment Request https://regulations.justia.com/regulations/fedreg/2015/10/28/2015-27416.html https://regulations.justia.com/regulations/fedreg/2015/10/28/2015-27416.html Wed, 28 Oct 2015 00:00:00 -0700 2015-27416 Notice http://www.gpo.gov/fdsys/pkg/FR-2015-10-28/pdf/2015-27416.pdf Notice - Product Development Under the Animal Rule; Guidance for Industry; Availability https://regulations.justia.com/regulations/fedreg/2015/10/28/2015-27361.html https://regulations.justia.com/regulations/fedreg/2015/10/28/2015-27361.html Wed, 28 Oct 2015 00:00:00 -0700 2015-27361 Notice http://www.gpo.gov/fdsys/pkg/FR-2015-10-28/pdf/2015-27361.pdf Proposed Rule - Grocery Manufacturers Association; Filing of Food Additive Petition https://regulations.justia.com/regulations/fedreg/2015/10/28/2015-27277.html https://regulations.justia.com/regulations/fedreg/2015/10/28/2015-27277.html Wed, 28 Oct 2015 00:00:00 -0700 2015-27277 Proposed Rule http://www.gpo.gov/fdsys/pkg/FR-2015-10-28/pdf/2015-27277.pdf Notice - National Institute on Aging; Notice of Closed Meeting https://regulations.justia.com/regulations/fedreg/2015/10/27/2015-27327.html https://regulations.justia.com/regulations/fedreg/2015/10/27/2015-27327.html Tue, 27 Oct 2015 00:00:00 -0700 2015-27327 Notice http://www.gpo.gov/fdsys/pkg/FR-2015-10-27/pdf/2015-27327.pdf