Federal Register Recent Federal Regulation Documents - Justia Regulation Tracker - Justia Regulations Trackerhttps://regulations.justia.com/regulations/fedreg/agencies/department-of-health-and-human-services/2025/01/07?limit=200®isters=between&mode=atom2025-01-10T06:46:29-08:00Justia Inchttps://www.justia.com/Justia Regulations Trackerhttps://regulations.justia.com/images/justiafedregulations.gifCopyright 2011 Justia Inchttps://regulations.justia.com/regulations/fedreg/2025/01/07/2024-31527.htmlNotice - Accelerated Approval and Considerations for Determining Whether a Confirmatory Trial is Underway; Draft Guidance for Industry; Availability2025-01-07T00:00:00-08:002025-01-07T00:00:00-08:002024-31527Noticehttps://www.govinfo.gov/content/pkg/FR-2025-01-07/pdf/2024-31527.pdfhttps://regulations.justia.com/regulations/fedreg/2025/01/07/2024-31526.htmlNotice - Evaluation of Sex-Specific and Gender-Specific Data in Medical Device Clinical Studies; Draft Guidance for Industry and Food and Drug Administration Staff; Availability2025-01-07T00:00:00-08:002025-01-07T00:00:00-08:002024-31526Noticehttps://www.govinfo.gov/content/pkg/FR-2025-01-07/pdf/2024-31526.pdfhttps://regulations.justia.com/regulations/fedreg/2025/01/07/2024-31525.htmlNotice - Food and Drug Administration Animal Food Ingredient Consultation; Guidance for Industry; Availability2025-01-07T00:00:00-08:002025-01-07T00:00:00-08:002024-31525Noticehttps://www.govinfo.gov/content/pkg/FR-2025-01-07/pdf/2024-31525.pdfhttps://regulations.justia.com/regulations/fedreg/2025/01/07/2024-31524.htmlNotice - Recommendations for Determining Eligibility of Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products; Draft Guidance for Industry; Availability2025-01-07T00:00:00-08:002025-01-07T00:00:00-08:002024-31524Noticehttps://www.govinfo.gov/content/pkg/FR-2025-01-07/pdf/2024-31524.pdfhttps://regulations.justia.com/regulations/fedreg/2025/01/07/2024-31523.htmlNotice - Draft Guidances Relating to Recommendations To Reduce the Risk of Transmission of Relevant Communicable Disease Agents and Diseases by Human Cells, Tissues, and Cellular and Tissue-Based Products; Draft Guidances for Industry; Availability2025-01-07T00:00:00-08:002025-01-07T00:00:00-08:002024-31523Noticehttps://www.govinfo.gov/content/pkg/FR-2025-01-07/pdf/2024-31523.pdfhttps://regulations.justia.com/regulations/fedreg/2025/01/07/2024-31522.htmlNotice - Validation of Certain In Vitro Diagnostic Devices for Emerging Pathogens During a Section 564 Declared Emergency; Draft Guidance for Industry and Food and Drug Administration Staff; Availability2025-01-07T00:00:00-08:002025-01-07T00:00:00-08:002024-31522Noticehttps://www.govinfo.gov/content/pkg/FR-2025-01-07/pdf/2024-31522.pdfhttps://regulations.justia.com/regulations/fedreg/2025/01/07/2024-31547.htmlNotice - Notifying the Food and Drug Administration of a Permanent Discontinuance or Interruption in Manufacturing of a Device Under Section 506J of the Federal Food, Drug, and Cosmetic Act; Guidance for Industry and Food and Drug Administration Staff; Availability2025-01-07T00:00:00-08:002025-01-07T00:00:00-08:002024-31547Noticehttps://www.govinfo.gov/content/pkg/FR-2025-01-07/pdf/2024-31547.pdfhttps://regulations.justia.com/regulations/fedreg/2025/01/07/2024-31546.htmlNotice - Interim Policy on Compounding Using Bulk Drug Substances Under Section 503A of the Federal Food, Drug, and Cosmetic Act; Guidance for Industry; Availability2025-01-07T00:00:00-08:002025-01-07T00:00:00-08:002024-31546Noticehttps://www.govinfo.gov/content/pkg/FR-2025-01-07/pdf/2024-31546.pdfhttps://regulations.justia.com/regulations/fedreg/2025/01/07/2024-31545.htmlNotice - Interim Policy on Compounding Using Bulk Drug Substances Under Section 503B of the Federal Food, Drug, and Cosmetic Act; Guidance for Industry; Availability2025-01-07T00:00:00-08:002025-01-07T00:00:00-08:002024-31545Noticehttps://www.govinfo.gov/content/pkg/FR-2025-01-07/pdf/2024-31545.pdfhttps://regulations.justia.com/regulations/fedreg/2025/01/07/2024-31544.htmlNotice - Recommendations To Reduce the Risk of Transmission of Mycobacterium Tuberculosis by Human Cells, Tissues, and Cellular and Tissue-Based Products; Guidance for Industry; Availability2025-01-07T00:00:00-08:002025-01-07T00:00:00-08:002024-31544Noticehttps://www.govinfo.gov/content/pkg/FR-2025-01-07/pdf/2024-31544.pdfhttps://regulations.justia.com/regulations/fedreg/2025/01/07/2024-31543.htmlNotice - Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations; Draft Guidance for Industry and Food and Drug Administration Staff; Availability2025-01-07T00:00:00-08:002025-01-07T00:00:00-08:002024-31543Noticehttps://www.govinfo.gov/content/pkg/FR-2025-01-07/pdf/2024-31543.pdfhttps://regulations.justia.com/regulations/fedreg/2025/01/07/2024-31542.htmlNotice - Considerations for the Use of Artificial Intelligence To Support Regulatory Decision-Making for Drug and Biological Products; Draft Guidance for Industry; Availability; Comment Request2025-01-07T00:00:00-08:002025-01-07T00:00:00-08:002024-31542Noticehttps://www.govinfo.gov/content/pkg/FR-2025-01-07/pdf/2024-31542.pdfhttps://regulations.justia.com/regulations/fedreg/2025/01/07/2024-31541.htmlNotice - Validation and Verification of Analytical Testing Methods Used for Tobacco Products; Guidance for Industry; Availability2025-01-07T00:00:00-08:002025-01-07T00:00:00-08:002024-31541Noticehttps://www.govinfo.gov/content/pkg/FR-2025-01-07/pdf/2024-31541.pdfhttps://regulations.justia.com/regulations/fedreg/2025/01/07/2024-31540.htmlNotice - Pulse Oximeters for Medical Purposes-Non-Clinical and Clinical Performance Testing, Labeling, and Premarket Submission Recommendations; Draft Guidance for Industry and Food and Drug Administration Staff; Availability2025-01-07T00:00:00-08:002025-01-07T00:00:00-08:002024-31540Noticehttps://www.govinfo.gov/content/pkg/FR-2025-01-07/pdf/2024-31540.pdfhttps://regulations.justia.com/regulations/fedreg/2025/01/07/2024-31539.htmlNotice - Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products: Questions and Answers; Guidance for Industry; Availability; Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request2025-01-07T00:00:00-08:002025-01-07T00:00:00-08:002024-31539Noticehttps://www.govinfo.gov/content/pkg/FR-2025-01-07/pdf/2024-31539.pdfhttps://regulations.justia.com/regulations/fedreg/2025/01/07/2024-31538.htmlNotice - Recommendations To Reduce the Risk of Transmission of Disease Agents Associated With Sepsis by Human Cells, Tissues, and Cellular and Tissue-Based Products; Guidance for Industry; Availability2025-01-07T00:00:00-08:002025-01-07T00:00:00-08:002024-31538Noticehttps://www.govinfo.gov/content/pkg/FR-2025-01-07/pdf/2024-31538.pdfhttps://regulations.justia.com/regulations/fedreg/2025/01/07/2024-31537.htmlNotice - Study of Sex Differences in the Clinical Evaluation of Medical Products; Draft Guidance for Industry; Availability2025-01-07T00:00:00-08:002025-01-07T00:00:00-08:002024-31537Noticehttps://www.govinfo.gov/content/pkg/FR-2025-01-07/pdf/2024-31537.pdfhttps://regulations.justia.com/regulations/fedreg/2025/01/07/2024-31536.htmlNotice - Considerations for Including Tissue Biopsies in Clinical Trials; Draft Guidance for Industry, Investigators, Institutions, and Institutional Review Boards; Availability2025-01-07T00:00:00-08:002025-01-07T00:00:00-08:002024-31536Noticehttps://www.govinfo.gov/content/pkg/FR-2025-01-07/pdf/2024-31536.pdfhttps://regulations.justia.com/regulations/fedreg/2025/01/07/2024-31535.htmlNotice - Labeling of Plant-Based Alternatives to Animal-Derived Foods: Draft Guidance for Industry; Availability; Agency Information Collection Activities; Proposed Collection; Comment Request2025-01-07T00:00:00-08:002025-01-07T00:00:00-08:002024-31535Noticehttps://www.govinfo.gov/content/pkg/FR-2025-01-07/pdf/2024-31535.pdfhttps://regulations.justia.com/regulations/fedreg/2025/01/07/2024-31534.htmlNotice - Action Levels for Lead in Processed Food Intended for Babies and Young Children; Guidance for Industry; Availability2025-01-07T00:00:00-08:002025-01-07T00:00:00-08:002024-31534Noticehttps://www.govinfo.gov/content/pkg/FR-2025-01-07/pdf/2024-31534.pdfhttps://regulations.justia.com/regulations/fedreg/2025/01/07/2024-31533.htmlNotice - Questions and Answers Regarding Food Allergens, Including the Food Allergen Labeling Requirements of the Federal Food, Drug, and Cosmetic Act (Edition 5): Guidance for Industry; Availability2025-01-07T00:00:00-08:002025-01-07T00:00:00-08:002024-31533Noticehttps://www.govinfo.gov/content/pkg/FR-2025-01-07/pdf/2024-31533.pdfhttps://regulations.justia.com/regulations/fedreg/2025/01/07/2024-31532.htmlNotice - Heritable Intentional Genomic Alterations in Animals: The Approval Process; Guidance for Industry; Availability2025-01-07T00:00:00-08:002025-01-07T00:00:00-08:002024-31532Noticehttps://www.govinfo.gov/content/pkg/FR-2025-01-07/pdf/2024-31532.pdfhttps://regulations.justia.com/regulations/fedreg/2025/01/07/2024-31531.htmlNotice - Type VII Veterinary Master File for Research and Development and Risk Reviews; Draft Guidance for Industry; Availability2025-01-07T00:00:00-08:002025-01-07T00:00:00-08:002024-31531Noticehttps://www.govinfo.gov/content/pkg/FR-2025-01-07/pdf/2024-31531.pdfhttps://regulations.justia.com/regulations/fedreg/2025/01/07/2024-31530.htmlNotice - Heritable Intentional Genomic Alterations in Animals of Food-Producing Species for Use as Models of Disease; Draft Guidance for Industry; Availability2025-01-07T00:00:00-08:002025-01-07T00:00:00-08:002024-31530Noticehttps://www.govinfo.gov/content/pkg/FR-2025-01-07/pdf/2024-31530.pdfhttps://regulations.justia.com/regulations/fedreg/2025/01/07/2024-31529.htmlNotice - Evaluating the Public Health Importance of Food Allergens Other Than the Major Food Allergens Listed in the Federal Food, Drug, and Cosmetic Act; Guidance for FDA Staff and Interested Parties; Availability2025-01-07T00:00:00-08:002025-01-07T00:00:00-08:002024-31529Noticehttps://www.govinfo.gov/content/pkg/FR-2025-01-07/pdf/2024-31529.pdfhttps://regulations.justia.com/regulations/fedreg/2025/01/07/2024-31528.htmlProposed Rule - Establishing Sanitation Programs for Low-Moisture Ready-To-Eat Human Foods and Taking Corrective Actions Following a Pathogen Contamination Event; Draft Guidance for Industry; Availability2025-01-07T00:00:00-08:002025-01-07T00:00:00-08:002024-31528Proposed Rulehttps://www.govinfo.gov/content/pkg/FR-2025-01-07/pdf/2024-31528.pdfhttps://regulations.justia.com/regulations/fedreg/2025/01/07/2025-00105.htmlNotice - National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting2025-01-07T00:00:00-08:002025-01-07T00:00:00-08:002025-00105Noticehttps://www.govinfo.gov/content/pkg/FR-2025-01-07/pdf/2025-00105.pdfhttps://regulations.justia.com/regulations/fedreg/2025/01/07/2025-00104.htmlNotice - National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting2025-01-07T00:00:00-08:002025-01-07T00:00:00-08:002025-00104Noticehttps://www.govinfo.gov/content/pkg/FR-2025-01-07/pdf/2025-00104.pdfhttps://regulations.justia.com/regulations/fedreg/2025/01/07/2025-00103.htmlNotice - National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting2025-01-07T00:00:00-08:002025-01-07T00:00:00-08:002025-00103Noticehttps://www.govinfo.gov/content/pkg/FR-2025-01-07/pdf/2025-00103.pdfhttps://regulations.justia.com/regulations/fedreg/2025/01/07/2025-00102.htmlNotice - National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting2025-01-07T00:00:00-08:002025-01-07T00:00:00-08:002025-00102Noticehttps://www.govinfo.gov/content/pkg/FR-2025-01-07/pdf/2025-00102.pdfhttps://regulations.justia.com/regulations/fedreg/2025/01/07/2025-00101.htmlNotice - National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting2025-01-07T00:00:00-08:002025-01-07T00:00:00-08:002025-00101Noticehttps://www.govinfo.gov/content/pkg/FR-2025-01-07/pdf/2025-00101.pdfhttps://regulations.justia.com/regulations/fedreg/2025/01/07/2025-00100.htmlNotice - National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting2025-01-07T00:00:00-08:002025-01-07T00:00:00-08:002025-00100Noticehttps://www.govinfo.gov/content/pkg/FR-2025-01-07/pdf/2025-00100.pdfhttps://regulations.justia.com/regulations/fedreg/2025/01/07/2025-00099.htmlNotice - National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting2025-01-07T00:00:00-08:002025-01-07T00:00:00-08:002025-00099Noticehttps://www.govinfo.gov/content/pkg/FR-2025-01-07/pdf/2025-00099.pdfhttps://regulations.justia.com/regulations/fedreg/2025/01/07/2025-00111.htmlNotice - National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting2025-01-07T00:00:00-08:002025-01-07T00:00:00-08:002025-00111Noticehttps://www.govinfo.gov/content/pkg/FR-2025-01-07/pdf/2025-00111.pdfhttps://regulations.justia.com/regulations/fedreg/2025/01/07/2025-00110.htmlNotice - National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting2025-01-07T00:00:00-08:002025-01-07T00:00:00-08:002025-00110Noticehttps://www.govinfo.gov/content/pkg/FR-2025-01-07/pdf/2025-00110.pdfhttps://regulations.justia.com/regulations/fedreg/2025/01/07/2025-00109.htmlNotice - National Institute on Deafness and Other Communication Disorders; Notice of Closed Meeting2025-01-07T00:00:00-08:002025-01-07T00:00:00-08:002025-00109Noticehttps://www.govinfo.gov/content/pkg/FR-2025-01-07/pdf/2025-00109.pdfhttps://regulations.justia.com/regulations/fedreg/2025/01/07/2025-00108.htmlNotice - National Institute on Drug Abuse; Notice of Closed Meeting2025-01-07T00:00:00-08:002025-01-07T00:00:00-08:002025-00108Noticehttps://www.govinfo.gov/content/pkg/FR-2025-01-07/pdf/2025-00108.pdfhttps://regulations.justia.com/regulations/fedreg/2025/01/07/2025-00107.htmlNotice - Center for Scientific Review; Notice of Closed Meetings2025-01-07T00:00:00-08:002025-01-07T00:00:00-08:002025-00107Noticehttps://www.govinfo.gov/content/pkg/FR-2025-01-07/pdf/2025-00107.pdfhttps://regulations.justia.com/regulations/fedreg/2025/01/07/2025-00106.htmlNotice - National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting2025-01-07T00:00:00-08:002025-01-07T00:00:00-08:002025-00106Noticehttps://www.govinfo.gov/content/pkg/FR-2025-01-07/pdf/2025-00106.pdfhttps://regulations.justia.com/regulations/fedreg/2025/01/07/C1-2024-30444.htmlNotice - Agency Information Collection Activities: Submission for OMB Review; Comment Request2025-01-07T00:00:00-08:002025-01-07T00:00:00-08:00C1-2024-30444Noticehttps://www.govinfo.gov/content/pkg/FR-2025-01-07/pdf/C1-2024-30444.pdfhttps://regulations.justia.com/regulations/fedreg/2025/01/07/2025-00004.htmlNotice - Statement of Organization, Functions, and Delegations of Authority; Delegation From Office of Refugee Resettlement Director to Unaccompanied Children Bureau Chief2025-01-07T00:00:00-08:002025-01-07T00:00:00-08:002025-00004Noticehttps://www.govinfo.gov/content/pkg/FR-2025-01-07/pdf/2025-00004.pdfhttps://regulations.justia.com/regulations/fedreg/2025/01/07/2025-00080.htmlNotice - Statement of Organization, Functions, and Delegations of Authority2025-01-07T00:00:00-08:002025-01-07T00:00:00-08:002025-00080Noticehttps://www.govinfo.gov/content/pkg/FR-2025-01-07/pdf/2025-00080.pdf