Federal Register Recent Federal Regulation Documents - Justia Regulation Tracker - Justia Regulations Trackerhttps://regulations.justia.com/regulations/fedreg/agencies/department-of-health-and-human-services/2021/09/30?limit=200®isters=between&mode=atom2024-11-23T17:57:15-08:00Justia Inchttps://www.justia.com/Justia Regulations Trackerhttps://regulations.justia.com/images/justiafedregulations.gifCopyright 2011 Justia Inchttps://regulations.justia.com/regulations/fedreg/2021/09/30/2021-21329.htmlNotice - Fee Rate for Using a Rare Pediatric Disease Priority Review Voucher in Fiscal Year 20222021-09-30T00:00:00-07:002021-09-30T00:00:00-07:002021-21329Noticehttps://www.govinfo.gov/content/pkg/FR-2021-09-30/pdf/2021-21329.pdfhttps://regulations.justia.com/regulations/fedreg/2021/09/30/2021-21328.htmlNotice - Fee Rate for Using a Tropical Disease Priority Review Voucher in Fiscal Year 20222021-09-30T00:00:00-07:002021-09-30T00:00:00-07:002021-21328Noticehttps://www.govinfo.gov/content/pkg/FR-2021-09-30/pdf/2021-21328.pdfhttps://regulations.justia.com/regulations/fedreg/2021/09/30/2021-21324.htmlNotice - Interpreting Sameness of Gene Therapy Products Under the Orphan Drug Regulations; Guidance for Industry; Availability2021-09-30T00:00:00-07:002021-09-30T00:00:00-07:002021-21324Noticehttps://www.govinfo.gov/content/pkg/FR-2021-09-30/pdf/2021-21324.pdfhttps://regulations.justia.com/regulations/fedreg/2021/09/30/2021-21322.htmlNotice - Studying Multiple Versions of a Cellular or Gene Therapy Product in an Early Phase Clinical Trial; Draft Guidance for Industry; Availability2021-09-30T00:00:00-07:002021-09-30T00:00:00-07:002021-21322Noticehttps://www.govinfo.gov/content/pkg/FR-2021-09-30/pdf/2021-21322.pdfhttps://regulations.justia.com/regulations/fedreg/2021/09/30/2021-21319.htmlNotice - Request for Information on Research Opportunities and Operational Activities Related to the NIH Strategic Plan To Advance Research on the Health and Well-Being of Sexual & Gender Minorities Fiscal Years 2021-20252021-09-30T00:00:00-07:002021-09-30T00:00:00-07:002021-21319Noticehttps://www.govinfo.gov/content/pkg/FR-2021-09-30/pdf/2021-21319.pdfhttps://regulations.justia.com/regulations/fedreg/2021/09/30/2021-21317.htmlNotice - Fee Rate for Using a Material Threat Medical Countermeasure Priority Review Voucher in Fiscal Year 20222021-09-30T00:00:00-07:002021-09-30T00:00:00-07:002021-21317Noticehttps://www.govinfo.gov/content/pkg/FR-2021-09-30/pdf/2021-21317.pdfhttps://regulations.justia.com/regulations/fedreg/2021/09/30/2021-21316.htmlNotice - Investigator Responsibilities-Safety Reporting for Investigational Drugs and Devices; Draft Guidance for Industry; Availability2021-09-30T00:00:00-07:002021-09-30T00:00:00-07:002021-21316Noticehttps://www.govinfo.gov/content/pkg/FR-2021-09-30/pdf/2021-21316.pdfhttps://regulations.justia.com/regulations/fedreg/2021/09/30/2021-21315.htmlNotice - Real-World Data: Assessing Electronic Health Records and Medical Claims Data To Support Regulatory Decision-Making for Drug and Biological Products; Draft Guidance for Industry; Availability2021-09-30T00:00:00-07:002021-09-30T00:00:00-07:002021-21315Noticehttps://www.govinfo.gov/content/pkg/FR-2021-09-30/pdf/2021-21315.pdfhttps://regulations.justia.com/regulations/fedreg/2021/09/30/2021-21311.htmlNotice - Issuance of Priority Review Voucher; Rare Pediatric Disease Product2021-09-30T00:00:00-07:002021-09-30T00:00:00-07:002021-21311Noticehttps://www.govinfo.gov/content/pkg/FR-2021-09-30/pdf/2021-21311.pdfhttps://regulations.justia.com/regulations/fedreg/2021/09/30/2021-21288.htmlNotice - Medicare Program; Medicare Appeals; Adjustment to the Amount in Controversy Threshold Amounts for Calendar Year 20222021-09-30T00:00:00-07:002021-09-30T00:00:00-07:002021-21288Noticehttps://www.govinfo.gov/content/pkg/FR-2021-09-30/pdf/2021-21288.pdfhttps://regulations.justia.com/regulations/fedreg/2021/09/30/2021-21282.htmlNotice - Submission for OMB Review; Services Provided to Unaccompanied Children (0970-0553)2021-09-30T00:00:00-07:002021-09-30T00:00:00-07:002021-21282Noticehttps://www.govinfo.gov/content/pkg/FR-2021-09-30/pdf/2021-21282.pdfhttps://regulations.justia.com/regulations/fedreg/2021/09/30/2021-21281.htmlNotice - Submission for OMB Review; Release of Unaccompanied Children From ORR Custody (OMB #0970-0552)2021-09-30T00:00:00-07:002021-09-30T00:00:00-07:002021-21281Noticehttps://www.govinfo.gov/content/pkg/FR-2021-09-30/pdf/2021-21281.pdfhttps://regulations.justia.com/regulations/fedreg/2021/09/30/2021-21280.htmlNotice - Submission for OMB Review; Mental Health Care Services for Unaccompanied Children (New Collection)2021-09-30T00:00:00-07:002021-09-30T00:00:00-07:002021-21280Noticehttps://www.govinfo.gov/content/pkg/FR-2021-09-30/pdf/2021-21280.pdfhttps://regulations.justia.com/regulations/fedreg/2021/09/30/2021-21277.htmlNotice - Charter Renewal for the Advisory Committee on Infant and Maternal Mortality (Formerly the Advisory Committee on Infant Mortality)2021-09-30T00:00:00-07:002021-09-30T00:00:00-07:002021-21277Noticehttps://www.govinfo.gov/content/pkg/FR-2021-09-30/pdf/2021-21277.pdfhttps://regulations.justia.com/regulations/fedreg/2021/09/30/2021-21275.htmlNotice - Meeting of the Presidential Advisory Council on HIV/AIDS2021-09-30T00:00:00-07:002021-09-30T00:00:00-07:002021-21275Noticehttps://www.govinfo.gov/content/pkg/FR-2021-09-30/pdf/2021-21275.pdfhttps://regulations.justia.com/regulations/fedreg/2021/09/30/2021-21222.htmlNotice - Microbiological Quality Considerations in Non-Sterile Drug Manufacturing; Draft Guidance for Industry; Availability2021-09-30T00:00:00-07:002021-09-30T00:00:00-07:002021-21222Noticehttps://www.govinfo.gov/content/pkg/FR-2021-09-30/pdf/2021-21222.pdfhttps://regulations.justia.com/regulations/fedreg/2021/09/30/2021-21207.htmlNotice - Agency Information Collection Activities: Proposed Collection: Public Comment Request Information Collection Request Title: The HRSA Community-Based Outreach Reporting Module, OMB #0906-0064, Revision2021-09-30T00:00:00-07:002021-09-30T00:00:00-07:002021-21207Noticehttps://www.govinfo.gov/content/pkg/FR-2021-09-30/pdf/2021-21207.pdfhttps://regulations.justia.com/regulations/fedreg/2021/09/30/2021-21204.htmlNotice - Clinical Center; Notice of Closed Meeting2021-09-30T00:00:00-07:002021-09-30T00:00:00-07:002021-21204Noticehttps://www.govinfo.gov/content/pkg/FR-2021-09-30/pdf/2021-21204.pdfhttps://regulations.justia.com/regulations/fedreg/2021/09/30/2021-21194.htmlNotice - Benefit-Risk Assessment for New Drug and Biological Products; Draft Guidance for Industry; Availability2021-09-30T00:00:00-07:002021-09-30T00:00:00-07:002021-21194Noticehttps://www.govinfo.gov/content/pkg/FR-2021-09-30/pdf/2021-21194.pdf