<![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/2021/09/30?registers=between Thu, 02 May 2024 11:50:58 -0700 Thu, 02 May 2024 11:50:58 -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/2021/09/30?registers=between Notice - Fee Rate for Using a Rare Pediatric Disease Priority Review Voucher in Fiscal Year 2022 https://regulations.justia.com/regulations/fedreg/2021/09/30/2021-21329.html https://regulations.justia.com/regulations/fedreg/2021/09/30/2021-21329.html Thu, 30 Sep 2021 00:00:00 -0700 2021-21329 Notice https://www.govinfo.gov/content/pkg/FR-2021-09-30/pdf/2021-21329.pdf Notice - Fee Rate for Using a Tropical Disease Priority Review Voucher in Fiscal Year 2022 https://regulations.justia.com/regulations/fedreg/2021/09/30/2021-21328.html https://regulations.justia.com/regulations/fedreg/2021/09/30/2021-21328.html Thu, 30 Sep 2021 00:00:00 -0700 2021-21328 Notice https://www.govinfo.gov/content/pkg/FR-2021-09-30/pdf/2021-21328.pdf Notice - Interpreting Sameness of Gene Therapy Products Under the Orphan Drug Regulations; Guidance for Industry; Availability https://regulations.justia.com/regulations/fedreg/2021/09/30/2021-21324.html https://regulations.justia.com/regulations/fedreg/2021/09/30/2021-21324.html Thu, 30 Sep 2021 00:00:00 -0700 2021-21324 Notice https://www.govinfo.gov/content/pkg/FR-2021-09-30/pdf/2021-21324.pdf Notice - Studying Multiple Versions of a Cellular or Gene Therapy Product in an Early Phase Clinical Trial; Draft Guidance for Industry; Availability https://regulations.justia.com/regulations/fedreg/2021/09/30/2021-21322.html https://regulations.justia.com/regulations/fedreg/2021/09/30/2021-21322.html Thu, 30 Sep 2021 00:00:00 -0700 2021-21322 Notice https://www.govinfo.gov/content/pkg/FR-2021-09-30/pdf/2021-21322.pdf Notice - 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 2021-2025 https://regulations.justia.com/regulations/fedreg/2021/09/30/2021-21319.html https://regulations.justia.com/regulations/fedreg/2021/09/30/2021-21319.html Thu, 30 Sep 2021 00:00:00 -0700 2021-21319 Notice https://www.govinfo.gov/content/pkg/FR-2021-09-30/pdf/2021-21319.pdf Notice - Fee Rate for Using a Material Threat Medical Countermeasure Priority Review Voucher in Fiscal Year 2022 https://regulations.justia.com/regulations/fedreg/2021/09/30/2021-21317.html https://regulations.justia.com/regulations/fedreg/2021/09/30/2021-21317.html Thu, 30 Sep 2021 00:00:00 -0700 2021-21317 Notice https://www.govinfo.gov/content/pkg/FR-2021-09-30/pdf/2021-21317.pdf Notice - Investigator Responsibilities-Safety Reporting for Investigational Drugs and Devices; Draft Guidance for Industry; Availability https://regulations.justia.com/regulations/fedreg/2021/09/30/2021-21316.html https://regulations.justia.com/regulations/fedreg/2021/09/30/2021-21316.html Thu, 30 Sep 2021 00:00:00 -0700 2021-21316 Notice https://www.govinfo.gov/content/pkg/FR-2021-09-30/pdf/2021-21316.pdf Notice - 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; Availability https://regulations.justia.com/regulations/fedreg/2021/09/30/2021-21315.html https://regulations.justia.com/regulations/fedreg/2021/09/30/2021-21315.html Thu, 30 Sep 2021 00:00:00 -0700 2021-21315 Notice https://www.govinfo.gov/content/pkg/FR-2021-09-30/pdf/2021-21315.pdf Notice - Issuance of Priority Review Voucher; Rare Pediatric Disease Product https://regulations.justia.com/regulations/fedreg/2021/09/30/2021-21311.html https://regulations.justia.com/regulations/fedreg/2021/09/30/2021-21311.html Thu, 30 Sep 2021 00:00:00 -0700 2021-21311 Notice https://www.govinfo.gov/content/pkg/FR-2021-09-30/pdf/2021-21311.pdf Notice - Medicare Program; Medicare Appeals; Adjustment to the Amount in Controversy Threshold Amounts for Calendar Year 2022 https://regulations.justia.com/regulations/fedreg/2021/09/30/2021-21288.html https://regulations.justia.com/regulations/fedreg/2021/09/30/2021-21288.html Thu, 30 Sep 2021 00:00:00 -0700 2021-21288 Notice https://www.govinfo.gov/content/pkg/FR-2021-09-30/pdf/2021-21288.pdf Notice - Submission for OMB Review; Services Provided to Unaccompanied Children (0970-0553) https://regulations.justia.com/regulations/fedreg/2021/09/30/2021-21282.html https://regulations.justia.com/regulations/fedreg/2021/09/30/2021-21282.html Thu, 30 Sep 2021 00:00:00 -0700 2021-21282 Notice https://www.govinfo.gov/content/pkg/FR-2021-09-30/pdf/2021-21282.pdf Notice - Submission for OMB Review; Release of Unaccompanied Children From ORR Custody (OMB #0970-0552) https://regulations.justia.com/regulations/fedreg/2021/09/30/2021-21281.html https://regulations.justia.com/regulations/fedreg/2021/09/30/2021-21281.html Thu, 30 Sep 2021 00:00:00 -0700 2021-21281 Notice https://www.govinfo.gov/content/pkg/FR-2021-09-30/pdf/2021-21281.pdf Notice - Submission for OMB Review; Mental Health Care Services for Unaccompanied Children (New Collection) https://regulations.justia.com/regulations/fedreg/2021/09/30/2021-21280.html https://regulations.justia.com/regulations/fedreg/2021/09/30/2021-21280.html Thu, 30 Sep 2021 00:00:00 -0700 2021-21280 Notice https://www.govinfo.gov/content/pkg/FR-2021-09-30/pdf/2021-21280.pdf Notice - Charter Renewal for the Advisory Committee on Infant and Maternal Mortality (Formerly the Advisory Committee on Infant Mortality) https://regulations.justia.com/regulations/fedreg/2021/09/30/2021-21277.html https://regulations.justia.com/regulations/fedreg/2021/09/30/2021-21277.html Thu, 30 Sep 2021 00:00:00 -0700 2021-21277 Notice https://www.govinfo.gov/content/pkg/FR-2021-09-30/pdf/2021-21277.pdf Notice - Meeting of the Presidential Advisory Council on HIV/AIDS https://regulations.justia.com/regulations/fedreg/2021/09/30/2021-21275.html https://regulations.justia.com/regulations/fedreg/2021/09/30/2021-21275.html Thu, 30 Sep 2021 00:00:00 -0700 2021-21275 Notice https://www.govinfo.gov/content/pkg/FR-2021-09-30/pdf/2021-21275.pdf Notice - Microbiological Quality Considerations in Non-Sterile Drug Manufacturing; Draft Guidance for Industry; Availability https://regulations.justia.com/regulations/fedreg/2021/09/30/2021-21222.html https://regulations.justia.com/regulations/fedreg/2021/09/30/2021-21222.html Thu, 30 Sep 2021 00:00:00 -0700 2021-21222 Notice https://www.govinfo.gov/content/pkg/FR-2021-09-30/pdf/2021-21222.pdf Notice - Agency Information Collection Activities: Proposed Collection: Public Comment Request Information Collection Request Title: The HRSA Community-Based Outreach Reporting Module, OMB #0906-0064, Revision https://regulations.justia.com/regulations/fedreg/2021/09/30/2021-21207.html https://regulations.justia.com/regulations/fedreg/2021/09/30/2021-21207.html Thu, 30 Sep 2021 00:00:00 -0700 2021-21207 Notice https://www.govinfo.gov/content/pkg/FR-2021-09-30/pdf/2021-21207.pdf Notice - Clinical Center; Notice of Closed Meeting https://regulations.justia.com/regulations/fedreg/2021/09/30/2021-21204.html https://regulations.justia.com/regulations/fedreg/2021/09/30/2021-21204.html Thu, 30 Sep 2021 00:00:00 -0700 2021-21204 Notice https://www.govinfo.gov/content/pkg/FR-2021-09-30/pdf/2021-21204.pdf Notice - Benefit-Risk Assessment for New Drug and Biological Products; Draft Guidance for Industry; Availability https://regulations.justia.com/regulations/fedreg/2021/09/30/2021-21194.html https://regulations.justia.com/regulations/fedreg/2021/09/30/2021-21194.html Thu, 30 Sep 2021 00:00:00 -0700 2021-21194 Notice https://www.govinfo.gov/content/pkg/FR-2021-09-30/pdf/2021-21194.pdf