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/2018/09?limit=200&registers=between&min-day=1&max-day=30&mode=atom 2024-04-25T22:57:18-07:00 Justia Inc https://www.justia.com/ Justia Regulations Tracker https://regulations.justia.com/images/justiafedregulations.gif Copyright 2011 Justia Inc https://regulations.justia.com/regulations/fedreg/2018/09/28/2018-21211.html Notice - John D. McCoy; Denial of Hearing; Final Debarment Order 2018-09-28T00:00:00-07:00 2018-09-28T00:00:00-07:00 2018-21211 Notice https://www.gpo.gov/fdsys/pkg/FR-2018-09-28/pdf/2018-21211.pdf https://regulations.justia.com/regulations/fedreg/2018/09/28/2018-21210.html Notice - Richard M. Fleming; Denial of Hearing; Final Debarment Order 2018-09-28T00:00:00-07:00 2018-09-28T00:00:00-07:00 2018-21210 Notice https://www.gpo.gov/fdsys/pkg/FR-2018-09-28/pdf/2018-21210.pdf https://regulations.justia.com/regulations/fedreg/2018/09/28/2018-21209.html Notice - Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals 2018-09-28T00:00:00-07:00 2018-09-28T00:00:00-07:00 2018-21209 Notice https://www.gpo.gov/fdsys/pkg/FR-2018-09-28/pdf/2018-21209.pdf https://regulations.justia.com/regulations/fedreg/2018/09/28/2018-21200.html Notice - Use of the Names of Dairy Foods in the Labeling of Plant-Based Products 2018-09-28T00:00:00-07:00 2018-09-28T00:00:00-07:00 2018-21200 Notice https://www.gpo.gov/fdsys/pkg/FR-2018-09-28/pdf/2018-21200.pdf https://regulations.justia.com/regulations/fedreg/2018/09/28/2018-21199.html Notice - GlaxoSmithKline, LLC, et al.; Withdrawal of Approval of 24 Abbreviated New Drug Applications 2018-09-28T00:00:00-07:00 2018-09-28T00:00:00-07:00 2018-21199 Notice https://www.gpo.gov/fdsys/pkg/FR-2018-09-28/pdf/2018-21199.pdf https://regulations.justia.com/regulations/fedreg/2018/09/28/2018-21177.html Notice - Center for Scientific Review; Notice of Closed Meetings 2018-09-28T00:00:00-07:00 2018-09-28T00:00:00-07:00 2018-21177 Notice https://www.gpo.gov/fdsys/pkg/FR-2018-09-28/pdf/2018-21177.pdf https://regulations.justia.com/regulations/fedreg/2018/09/28/2018-21176.html Notice - Center for Scientific Review; Notice of Closed Meetings 2018-09-28T00:00:00-07:00 2018-09-28T00:00:00-07:00 2018-21176 Notice https://www.gpo.gov/fdsys/pkg/FR-2018-09-28/pdf/2018-21176.pdf https://regulations.justia.com/regulations/fedreg/2018/09/28/2018-21175.html Notice - National Human Genome Research Institute; Notice of Closed Meetings 2018-09-28T00:00:00-07:00 2018-09-28T00:00:00-07:00 2018-21175 Notice https://www.gpo.gov/fdsys/pkg/FR-2018-09-28/pdf/2018-21175.pdf https://regulations.justia.com/regulations/fedreg/2018/09/28/2018-21174.html Notice - National Institute on Deafness and Other Communication Disorders; Notice of Closed Meetings 2018-09-28T00:00:00-07:00 2018-09-28T00:00:00-07:00 2018-21174 Notice https://www.gpo.gov/fdsys/pkg/FR-2018-09-28/pdf/2018-21174.pdf https://regulations.justia.com/regulations/fedreg/2018/09/28/2018-21173.html Notice - National Institute of Neurological Disorders and Stroke; Notice of Closed Meetings 2018-09-28T00:00:00-07:00 2018-09-28T00:00:00-07:00 2018-21173 Notice https://www.gpo.gov/fdsys/pkg/FR-2018-09-28/pdf/2018-21173.pdf https://regulations.justia.com/regulations/fedreg/2018/09/28/2018-21171.html Notice - Agency Information Collection Activities: Proposed Collection; Comment Request 2018-09-28T00:00:00-07:00 2018-09-28T00:00:00-07:00 2018-21171 Notice https://www.gpo.gov/fdsys/pkg/FR-2018-09-28/pdf/2018-21171.pdf https://regulations.justia.com/regulations/fedreg/2018/09/28/2018-21169.html Notice - Notice of Listing of Members of the National Institutes of Health's Senior Executive Service 2018 Performance Review Board (PRB) 2018-09-28T00:00:00-07:00 2018-09-28T00:00:00-07:00 2018-21169 Notice https://www.gpo.gov/fdsys/pkg/FR-2018-09-28/pdf/2018-21169.pdf https://regulations.justia.com/regulations/fedreg/2018/09/28/2018-21148.html Notice - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Early Food Safety Evaluation of New Non-Pesticidal Proteins Produced by New Plant Varieties Intended for Food Use 2018-09-28T00:00:00-07:00 2018-09-28T00:00:00-07:00 2018-21148 Notice https://www.gpo.gov/fdsys/pkg/FR-2018-09-28/pdf/2018-21148.pdf https://regulations.justia.com/regulations/fedreg/2018/09/28/2018-21147.html Rule - New Animal Drugs; Withdrawal of Approval of New Animal Drug Applications 2018-09-28T00:00:00-07:00 2018-09-28T00:00:00-07:00 2018-21147 Rule https://www.gpo.gov/fdsys/pkg/FR-2018-09-28/pdf/2018-21147.pdf https://regulations.justia.com/regulations/fedreg/2018/09/28/2018-21146.html Rule - New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Applications; Changes of Sponsorship; Change of a Sponsor's Name 2018-09-28T00:00:00-07:00 2018-09-28T00:00:00-07:00 2018-21146 Rule https://www.gpo.gov/fdsys/pkg/FR-2018-09-28/pdf/2018-21146.pdf https://regulations.justia.com/regulations/fedreg/2018/09/28/2018-21145.html Proposed Rule - Label Requirement for Food That Has Been Refused Admission Into the United States 2018-09-28T00:00:00-07:00 2018-09-28T00:00:00-07:00 2018-21145 Proposed Rule https://www.gpo.gov/fdsys/pkg/FR-2018-09-28/pdf/2018-21145.pdf https://regulations.justia.com/regulations/fedreg/2018/09/28/2018-21141.html Notice - The Special 510(k) Program; Draft Guidance for Industry and Food and Drug Administration Staff; Availability 2018-09-28T00:00:00-07:00 2018-09-28T00:00:00-07:00 2018-21141 Notice https://www.gpo.gov/fdsys/pkg/FR-2018-09-28/pdf/2018-21141.pdf https://regulations.justia.com/regulations/fedreg/2018/09/28/2018-21137.html Notice - Vaccines and Related Biological Products Advisory Committee; Notice of Meeting 2018-09-28T00:00:00-07:00 2018-09-28T00:00:00-07:00 2018-21137 Notice https://www.gpo.gov/fdsys/pkg/FR-2018-09-28/pdf/2018-21137.pdf https://regulations.justia.com/regulations/fedreg/2018/09/28/2018-21133.html Proposed Rule - Use of Materials Derived From Cattle in Medical Products Intended for Use in Humans and Drugs Intended for Use in Ruminants; Reporting Information Regarding Falsification of Data 2018-09-28T00:00:00-07:00 2018-09-28T00:00:00-07:00 2018-21133 Proposed Rule https://www.gpo.gov/fdsys/pkg/FR-2018-09-28/pdf/2018-21133.pdf https://regulations.justia.com/regulations/fedreg/2018/09/28/2018-21096.html Notice - Prospective Grant of an Exclusive Patent License: Development and Commercialization of Cell Therapies for Cancer 2018-09-28T00:00:00-07:00 2018-09-28T00:00:00-07:00 2018-21096 Notice https://www.gpo.gov/fdsys/pkg/FR-2018-09-28/pdf/2018-21096.pdf https://regulations.justia.com/regulations/fedreg/2018/09/28/2018-21093.html Notice - National Cancer Institute; Notice of Closed Meetings 2018-09-28T00:00:00-07:00 2018-09-28T00:00:00-07:00 2018-21093 Notice https://www.gpo.gov/fdsys/pkg/FR-2018-09-28/pdf/2018-21093.pdf https://regulations.justia.com/regulations/fedreg/2018/09/28/2018-21092.html Notice - National Heart, Lung, and Blood Institute; Notice of Closed Meetings 2018-09-28T00:00:00-07:00 2018-09-28T00:00:00-07:00 2018-21092 Notice https://www.gpo.gov/fdsys/pkg/FR-2018-09-28/pdf/2018-21092.pdf https://regulations.justia.com/regulations/fedreg/2018/09/28/2018-21090.html Notice - National Institute on Aging; Notice of Closed Meeting 2018-09-28T00:00:00-07:00 2018-09-28T00:00:00-07:00 2018-21090 Notice https://www.gpo.gov/fdsys/pkg/FR-2018-09-28/pdf/2018-21090.pdf https://regulations.justia.com/regulations/fedreg/2018/09/27/2018-21083.html Notice - Clinical Laboratory Improvement Advisory Committee (CLIAC); Meeting 2018-09-27T00:00:00-07:00 2018-09-27T00:00:00-07:00 2018-21083 Notice https://www.gpo.gov/fdsys/pkg/FR-2018-09-27/pdf/2018-21083.pdf https://regulations.justia.com/regulations/fedreg/2018/09/27/2018-21044.html Rule - Obstetrical and Gynecological Devices; Reclassification of Single-Use Female Condom, To Be Renamed Single-Use Internal Condom 2018-09-27T00:00:00-07:00 2018-09-27T00:00:00-07:00 2018-21044 Rule https://www.gpo.gov/fdsys/pkg/FR-2018-09-27/pdf/2018-21044.pdf https://regulations.justia.com/regulations/fedreg/2018/09/27/2018-21042.html Notice - Public Availability of Lists of Retail Consignees To Effectuate Certain Human and Animal Food Recalls; Draft Guidance for Industry and Food and Drug Administration Staff; Availability 2018-09-27T00:00:00-07:00 2018-09-27T00:00:00-07:00 2018-21042 Notice https://www.gpo.gov/fdsys/pkg/FR-2018-09-27/pdf/2018-21042.pdf https://regulations.justia.com/regulations/fedreg/2018/09/27/2018-21041.html Notice - Coronary Drug-Eluting Stents-Nonclinical and Clinical Studies and Companion Guidance Document; Draft Guidance for Industry and Food and Drug Administration Staff; Availability; Reopening of the Comment Period 2018-09-27T00:00:00-07:00 2018-09-27T00:00:00-07:00 2018-21041 Notice https://www.gpo.gov/fdsys/pkg/FR-2018-09-27/pdf/2018-21041.pdf https://regulations.justia.com/regulations/fedreg/2018/09/27/2018-21039.html Notice - Agency Information Collection Activities; Proposed Collection; Comment Request; Financial Disclosure by Clinical Investigators 2018-09-27T00:00:00-07:00 2018-09-27T00:00:00-07:00 2018-21039 Notice https://www.gpo.gov/fdsys/pkg/FR-2018-09-27/pdf/2018-21039.pdf https://regulations.justia.com/regulations/fedreg/2018/09/27/2018-21038.html Notice - Agency Information Collection Activities; Proposed Collection; Comment Request; Assessment of Combination Product Review Practices 2018-09-27T00:00:00-07:00 2018-09-27T00:00:00-07:00 2018-21038 Notice https://www.gpo.gov/fdsys/pkg/FR-2018-09-27/pdf/2018-21038.pdf https://regulations.justia.com/regulations/fedreg/2018/09/27/2018-21033.html Notice - Fee for Using a Rare Pediatric Disease Priority Review Voucher in Fiscal Year 2019 2018-09-27T00:00:00-07:00 2018-09-27T00:00:00-07:00 2018-21033 Notice https://www.gpo.gov/fdsys/pkg/FR-2018-09-27/pdf/2018-21033.pdf https://regulations.justia.com/regulations/fedreg/2018/09/27/2018-20994.html Notice - Agency Information Collection Activities: Submission for OMB Review; Comment Request 2018-09-27T00:00:00-07:00 2018-09-27T00:00:00-07:00 2018-20994 Notice https://www.gpo.gov/fdsys/pkg/FR-2018-09-27/pdf/2018-20994.pdf https://regulations.justia.com/regulations/fedreg/2018/09/27/2018-20989.html Notice - Request for Public Comment: 60-Day Proposed Information Collection: Addendum to Declaration for Federal Employment, Child Care and Indian Child Care Worker Positions 2018-09-27T00:00:00-07:00 2018-09-27T00:00:00-07:00 2018-20989 Notice https://www.gpo.gov/fdsys/pkg/FR-2018-09-27/pdf/2018-20989.pdf https://regulations.justia.com/regulations/fedreg/2018/09/27/2018-20984.html Notice - National Institute on Minority Health and Health Disparities; Notice of Closed Meeting 2018-09-27T00:00:00-07:00 2018-09-27T00:00:00-07:00 2018-20984 Notice https://www.gpo.gov/fdsys/pkg/FR-2018-09-27/pdf/2018-20984.pdf https://regulations.justia.com/regulations/fedreg/2018/09/27/2018-20983.html Notice - Center for Scientific Review; Notice of Closed Meetings 2018-09-27T00:00:00-07:00 2018-09-27T00:00:00-07:00 2018-20983 Notice https://www.gpo.gov/fdsys/pkg/FR-2018-09-27/pdf/2018-20983.pdf https://regulations.justia.com/regulations/fedreg/2018/09/27/2018-20982.html Notice - Center for Scientific Review; Notice of Closed Meetings 2018-09-27T00:00:00-07:00 2018-09-27T00:00:00-07:00 2018-20982 Notice https://www.gpo.gov/fdsys/pkg/FR-2018-09-27/pdf/2018-20982.pdf https://regulations.justia.com/regulations/fedreg/2018/09/27/2018-20981.html Notice - National Center for Advancing Translational Sciences; Notice of Closed Meeting 2018-09-27T00:00:00-07:00 2018-09-27T00:00:00-07:00 2018-20981 Notice https://www.gpo.gov/fdsys/pkg/FR-2018-09-27/pdf/2018-20981.pdf https://regulations.justia.com/regulations/fedreg/2018/09/27/2018-20980.html Notice - Center for Scientific Review; Notice of Closed Meetings 2018-09-27T00:00:00-07:00 2018-09-27T00:00:00-07:00 2018-20980 Notice https://www.gpo.gov/fdsys/pkg/FR-2018-09-27/pdf/2018-20980.pdf https://regulations.justia.com/regulations/fedreg/2018/09/27/2018-20979.html Notice - National Eye Institute; Notice of Closed Meeting 2018-09-27T00:00:00-07:00 2018-09-27T00:00:00-07:00 2018-20979 Notice https://www.gpo.gov/fdsys/pkg/FR-2018-09-27/pdf/2018-20979.pdf https://regulations.justia.com/regulations/fedreg/2018/09/27/2018-20978.html Notice - Center for Scientific Review; Notice of Closed Meetings 2018-09-27T00:00:00-07:00 2018-09-27T00:00:00-07:00 2018-20978 Notice https://www.gpo.gov/fdsys/pkg/FR-2018-09-27/pdf/2018-20978.pdf https://regulations.justia.com/regulations/fedreg/2018/09/27/2018-20977.html Notice - Dilip Patel; Denial of Hearing; Final Debarment Order 2018-09-27T00:00:00-07:00 2018-09-27T00:00:00-07:00 2018-20977 Notice https://www.gpo.gov/fdsys/pkg/FR-2018-09-27/pdf/2018-20977.pdf https://regulations.justia.com/regulations/fedreg/2018/09/26/2018-20947.html Notice - Aurolife Pharma, LLC, et al.; Withdrawal of Approval of Seven Abbreviated New Drug Applications 2018-09-26T00:00:00-07:00 2018-09-26T00:00:00-07:00 2018-20947 Notice https://www.gpo.gov/fdsys/pkg/FR-2018-09-26/pdf/2018-20947.pdf https://regulations.justia.com/regulations/fedreg/2018/09/26/2018-20913.html Notice - Agency Information Collection Activities; Proposed Collection; Comment Request; Experimental Study of Cigarette Warnings 2018-09-26T00:00:00-07:00 2018-09-26T00:00:00-07:00 2018-20913 Notice https://www.gpo.gov/fdsys/pkg/FR-2018-09-26/pdf/2018-20913.pdf https://regulations.justia.com/regulations/fedreg/2018/09/26/2018-20912.html Notice - Animal Generic Drug User Fee Rates and Payment Procedures for Fiscal Year 2019 2018-09-26T00:00:00-07:00 2018-09-26T00:00:00-07:00 2018-20912 Notice https://www.gpo.gov/fdsys/pkg/FR-2018-09-26/pdf/2018-20912.pdf https://regulations.justia.com/regulations/fedreg/2018/09/26/2018-20911.html Notice - Animal Drug User Fee Rates and Payment Procedures for Fiscal Year 2019 2018-09-26T00:00:00-07:00 2018-09-26T00:00:00-07:00 2018-20911 Notice https://www.gpo.gov/fdsys/pkg/FR-2018-09-26/pdf/2018-20911.pdf https://regulations.justia.com/regulations/fedreg/2018/09/26/2018-20910.html Notice - Fee for Using a Material Threat Medical Countermeasure Priority Review Voucher in Fiscal Year 2019 2018-09-26T00:00:00-07:00 2018-09-26T00:00:00-07:00 2018-20910 Notice https://www.gpo.gov/fdsys/pkg/FR-2018-09-26/pdf/2018-20910.pdf https://regulations.justia.com/regulations/fedreg/2018/09/26/2018-20909.html Notice - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance for Industry: Adverse Event Reporting for Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act 2018-09-26T00:00:00-07:00 2018-09-26T00:00:00-07:00 2018-20909 Notice https://www.gpo.gov/fdsys/pkg/FR-2018-09-26/pdf/2018-20909.pdf https://regulations.justia.com/regulations/fedreg/2018/09/26/2018-20908.html Notice - Joint Meeting of the Psychopharmacologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments 2018-09-26T00:00:00-07:00 2018-09-26T00:00:00-07:00 2018-20908 Notice https://www.gpo.gov/fdsys/pkg/FR-2018-09-26/pdf/2018-20908.pdf https://regulations.justia.com/regulations/fedreg/2018/09/26/2018-20905.html Notice - Allergenic Products Advisory Committee; Notice of Meeting 2018-09-26T00:00:00-07:00 2018-09-26T00:00:00-07:00 2018-20905 Notice https://www.gpo.gov/fdsys/pkg/FR-2018-09-26/pdf/2018-20905.pdf https://regulations.justia.com/regulations/fedreg/2018/09/26/2018-20904.html Notice - Tobacco Product Application Review; Public Meeting; Request for Comments 2018-09-26T00:00:00-07:00 2018-09-26T00:00:00-07:00 2018-20904 Notice https://www.gpo.gov/fdsys/pkg/FR-2018-09-26/pdf/2018-20904.pdf https://regulations.justia.com/regulations/fedreg/2018/09/26/2018-20903.html Notice - Insanitary Conditions at Compounding Facilities; Revised Draft Guidance for Industry; Availability 2018-09-26T00:00:00-07:00 2018-09-26T00:00:00-07:00 2018-20903 Notice https://www.gpo.gov/fdsys/pkg/FR-2018-09-26/pdf/2018-20903.pdf https://regulations.justia.com/regulations/fedreg/2018/09/26/2018-20902.html Notice - Compounding and Repackaging of Radiopharmaceuticals by State-Licensed Nuclear Pharmacies, Federal Facilities, and Certain Other Entities; Guidance for Industry; Availability 2018-09-26T00:00:00-07:00 2018-09-26T00:00:00-07:00 2018-20902 Notice https://www.gpo.gov/fdsys/pkg/FR-2018-09-26/pdf/2018-20902.pdf https://regulations.justia.com/regulations/fedreg/2018/09/26/2018-20901.html Notice - Compounding and Repackaging of Radiopharmaceuticals by Outsourcing Facilities; Guidance for Industry; Availability 2018-09-26T00:00:00-07:00 2018-09-26T00:00:00-07:00 2018-20901 Notice https://www.gpo.gov/fdsys/pkg/FR-2018-09-26/pdf/2018-20901.pdf https://regulations.justia.com/regulations/fedreg/2018/09/26/2018-20887.html Notice - Agency Information Collection Activities: Submission for OMB Review; Comment Request 2018-09-26T00:00:00-07:00 2018-09-26T00:00:00-07:00 2018-20887 Notice https://www.gpo.gov/fdsys/pkg/FR-2018-09-26/pdf/2018-20887.pdf https://regulations.justia.com/regulations/fedreg/2018/09/26/2018-20868.html Notice - Agency Information Collection Activities: Proposed Collection; Comment Request 2018-09-26T00:00:00-07:00 2018-09-26T00:00:00-07:00 2018-20868 Notice https://www.gpo.gov/fdsys/pkg/FR-2018-09-26/pdf/2018-20868.pdf https://regulations.justia.com/regulations/fedreg/2018/09/26/2018-20863.html Notice - National Vaccine Injury Compensation Program: List of Petitions Received 2018-09-26T00:00:00-07:00 2018-09-26T00:00:00-07:00 2018-20863 Notice https://www.gpo.gov/fdsys/pkg/FR-2018-09-26/pdf/2018-20863.pdf https://regulations.justia.com/regulations/fedreg/2018/09/26/2018-20848.html Rule - Head Start Program 2018-09-26T00:00:00-07:00 2018-09-26T00:00:00-07:00 2018-20848 Rule https://www.gpo.gov/fdsys/pkg/FR-2018-09-26/pdf/2018-20848.pdf https://regulations.justia.com/regulations/fedreg/2018/09/26/2018-20842.html Notice - National Institute on Aging; Notice of Closed Meeting 2018-09-26T00:00:00-07:00 2018-09-26T00:00:00-07:00 2018-20842 Notice https://www.gpo.gov/fdsys/pkg/FR-2018-09-26/pdf/2018-20842.pdf https://regulations.justia.com/regulations/fedreg/2018/09/26/2018-20841.html Notice - National Institute of General Medical Sciences; Notice of Closed Meeting 2018-09-26T00:00:00-07:00 2018-09-26T00:00:00-07:00 2018-20841 Notice https://www.gpo.gov/fdsys/pkg/FR-2018-09-26/pdf/2018-20841.pdf https://regulations.justia.com/regulations/fedreg/2018/09/26/2018-20840.html Notice - National Institute of General Medical Sciences; Notice of Closed Meeting 2018-09-26T00:00:00-07:00 2018-09-26T00:00:00-07:00 2018-20840 Notice https://www.gpo.gov/fdsys/pkg/FR-2018-09-26/pdf/2018-20840.pdf https://regulations.justia.com/regulations/fedreg/2018/09/25/2018-20835.html Notice - Statement of Organization, Functions, and Delegations of Authority 2018-09-25T00:00:00-07:00 2018-09-25T00:00:00-07:00 2018-20835 Notice https://www.gpo.gov/fdsys/pkg/FR-2018-09-25/pdf/2018-20835.pdf https://regulations.justia.com/regulations/fedreg/2018/09/25/2018-20818.html Notice - Request for Public Comment: 30-Day Proposed Information Collection: Indian Health Service Purchased/Referred Care Proof of Residency 2018-09-25T00:00:00-07:00 2018-09-25T00:00:00-07:00 2018-20818 Notice https://www.gpo.gov/fdsys/pkg/FR-2018-09-25/pdf/2018-20818.pdf https://regulations.justia.com/regulations/fedreg/2018/09/25/2018-20815.html Notice - Agency Information Collection Request. 30-Day Public Comment Request 2018-09-25T00:00:00-07:00 2018-09-25T00:00:00-07:00 2018-20815 Notice https://www.gpo.gov/fdsys/pkg/FR-2018-09-25/pdf/2018-20815.pdf https://regulations.justia.com/regulations/fedreg/2018/09/25/2018-20809.html Notice - Agency Forms Undergoing Paperwork Reduction Act Review; Withdraw 2018-09-25T00:00:00-07:00 2018-09-25T00:00:00-07:00 2018-20809 Notice https://www.gpo.gov/fdsys/pkg/FR-2018-09-25/pdf/2018-20809.pdf https://regulations.justia.com/regulations/fedreg/2018/09/25/2018-20808.html Notice - Proposed Data Collection Submitted for Public Comment and Recommendations 2018-09-25T00:00:00-07:00 2018-09-25T00:00:00-07:00 2018-20808 Notice https://www.gpo.gov/fdsys/pkg/FR-2018-09-25/pdf/2018-20808.pdf https://regulations.justia.com/regulations/fedreg/2018/09/25/2018-20807.html Notice - Agency Forms Undergoing Paperwork Reduction Act Review 2018-09-25T00:00:00-07:00 2018-09-25T00:00:00-07:00 2018-20807 Notice https://www.gpo.gov/fdsys/pkg/FR-2018-09-25/pdf/2018-20807.pdf https://regulations.justia.com/regulations/fedreg/2018/09/25/2018-20795.html Notice - Pediatric Medical Device Development; Public Meeting; Request for Comments; Reopening of Comment Period 2018-09-25T00:00:00-07:00 2018-09-25T00:00:00-07:00 2018-20795 Notice https://www.gpo.gov/fdsys/pkg/FR-2018-09-25/pdf/2018-20795.pdf https://regulations.justia.com/regulations/fedreg/2018/09/25/2018-20790.html Notice - Abbreviated New Drug Application Submissions-Content and Format; Guidance for Industry; Availability 2018-09-25T00:00:00-07:00 2018-09-25T00:00:00-07:00 2018-20790 Notice https://www.gpo.gov/fdsys/pkg/FR-2018-09-25/pdf/2018-20790.pdf https://regulations.justia.com/regulations/fedreg/2018/09/25/2018-20789.html Notice - Good Review Management Principles and Practices for New Drug Applications and Biologics License Applications; Draft Guidance for Industry and Review Staff; Availability 2018-09-25T00:00:00-07:00 2018-09-25T00:00:00-07:00 2018-20789 Notice https://www.gpo.gov/fdsys/pkg/FR-2018-09-25/pdf/2018-20789.pdf https://regulations.justia.com/regulations/fedreg/2018/09/25/2018-20776.html Notice - Further Testing of Donations That Are Reactive on a Licensed Donor Screening Test for Antibodies to Hepatitis C Virus; Draft Guidance for Industry; Availability 2018-09-25T00:00:00-07:00 2018-09-25T00:00:00-07:00 2018-20776 Notice https://www.gpo.gov/fdsys/pkg/FR-2018-09-25/pdf/2018-20776.pdf https://regulations.justia.com/regulations/fedreg/2018/09/25/2018-20775.html Notice - Recommendations for Requalification of Blood Donors Deferred Because of Reactive Test Results for Antibodies to Human T-Lymphotropic Virus Types I and II; Draft Guidance for Industry; Availability 2018-09-25T00:00:00-07:00 2018-09-25T00:00:00-07:00 2018-20775 Notice https://www.gpo.gov/fdsys/pkg/FR-2018-09-25/pdf/2018-20775.pdf https://regulations.justia.com/regulations/fedreg/2018/09/25/2018-20772.html Notice - Fee for Using a Tropical Disease Priority Review Voucher in Fiscal Year 2019 2018-09-25T00:00:00-07:00 2018-09-25T00:00:00-07:00 2018-20772 Notice https://www.gpo.gov/fdsys/pkg/FR-2018-09-25/pdf/2018-20772.pdf https://regulations.justia.com/regulations/fedreg/2018/09/25/2018-20771.html Notice - Benefit-Risk Factors To Consider When Determining Substantial Equivalence in Premarket Notifications (510(k)) With Different Technological Characteristics; Guidance for Industry and Food and Drug Administration Staff; Availability 2018-09-25T00:00:00-07:00 2018-09-25T00:00:00-07:00 2018-20771 Notice https://www.gpo.gov/fdsys/pkg/FR-2018-09-25/pdf/2018-20771.pdf https://regulations.justia.com/regulations/fedreg/2018/09/25/2018-20767.html Rule - Listing of Color Additives Subject to Certification; D&C Yellow No. 8 2018-09-25T00:00:00-07:00 2018-09-25T00:00:00-07:00 2018-20767 Rule https://www.gpo.gov/fdsys/pkg/FR-2018-09-25/pdf/2018-20767.pdf https://regulations.justia.com/regulations/fedreg/2018/09/25/2018-20766.html Notice - Agency Information Collection Activities; Proposed Collection; Comment Request; Adverse Event Reporting and Recordkeeping for Dietary Supplements as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act 2018-09-25T00:00:00-07:00 2018-09-25T00:00:00-07:00 2018-20766 Notice https://www.gpo.gov/fdsys/pkg/FR-2018-09-25/pdf/2018-20766.pdf https://regulations.justia.com/regulations/fedreg/2018/09/25/2018-20765.html Notice - Agency Information Collection Activities; Proposed Collection; Comment Request; Generic Drug User Fee Cover Sheet 2018-09-25T00:00:00-07:00 2018-09-25T00:00:00-07:00 2018-20765 Notice https://www.gpo.gov/fdsys/pkg/FR-2018-09-25/pdf/2018-20765.pdf https://regulations.justia.com/regulations/fedreg/2018/09/25/2018-20764.html Notice - Agency Information Collection Activities; Proposed Collection; Comment Request; Public Health Service Guideline on Infectious Disease Issues in Xenotransplantation 2018-09-25T00:00:00-07:00 2018-09-25T00:00:00-07:00 2018-20764 Notice https://www.gpo.gov/fdsys/pkg/FR-2018-09-25/pdf/2018-20764.pdf https://regulations.justia.com/regulations/fedreg/2018/09/25/2018-20763.html Proposed Rule - Ophthalmic Devices; Reclassification of Ultrasound Cyclodestructive Device 2018-09-25T00:00:00-07:00 2018-09-25T00:00:00-07:00 2018-20763 Proposed Rule https://www.gpo.gov/fdsys/pkg/FR-2018-09-25/pdf/2018-20763.pdf https://regulations.justia.com/regulations/fedreg/2018/09/25/2018-20755.html Notice - National Institute of Nursing Research; Notice of Closed Meetings 2018-09-25T00:00:00-07:00 2018-09-25T00:00:00-07:00 2018-20755 Notice https://www.gpo.gov/fdsys/pkg/FR-2018-09-25/pdf/2018-20755.pdf https://regulations.justia.com/regulations/fedreg/2018/09/25/2018-20754.html Notice - National Institute of General Medical Sciences; Notice of Closed Meeting 2018-09-25T00:00:00-07:00 2018-09-25T00:00:00-07:00 2018-20754 Notice https://www.gpo.gov/fdsys/pkg/FR-2018-09-25/pdf/2018-20754.pdf https://regulations.justia.com/regulations/fedreg/2018/09/24/2018-20708.html Notice - Agency Information Collection Activities: Proposed Collection: Public Comment Request; Information Collection Request Title: National Health Service Corps Scholar/Students to Service Travel Worksheet, OMB No. 0915-0278-Extension 2018-09-24T00:00:00-07:00 2018-09-24T00:00:00-07:00 2018-20708 Notice https://www.gpo.gov/fdsys/pkg/FR-2018-09-24/pdf/2018-20708.pdf https://regulations.justia.com/regulations/fedreg/2018/09/24/2018-20676.html Notice - Meeting of the Secretary's Advisory Committee on Human Research Protections 2018-09-24T00:00:00-07:00 2018-09-24T00:00:00-07:00 2018-20676 Notice https://www.gpo.gov/fdsys/pkg/FR-2018-09-24/pdf/2018-20676.pdf https://regulations.justia.com/regulations/fedreg/2018/09/24/2018-20666.html Notice - National Institute of Arthritis and Musculoskeletal and Skin Diseases; Notice of Closed Meetings 2018-09-24T00:00:00-07:00 2018-09-24T00:00:00-07:00 2018-20666 Notice https://www.gpo.gov/fdsys/pkg/FR-2018-09-24/pdf/2018-20666.pdf https://regulations.justia.com/regulations/fedreg/2018/09/24/2018-20665.html Notice - Office of the Director, National Institutes of Health; Notice of Meeting 2018-09-24T00:00:00-07:00 2018-09-24T00:00:00-07:00 2018-20665 Notice https://www.gpo.gov/fdsys/pkg/FR-2018-09-24/pdf/2018-20665.pdf https://regulations.justia.com/regulations/fedreg/2018/09/24/2018-20664.html Notice - Government-Owned Inventions; Availability for Licensing 2018-09-24T00:00:00-07:00 2018-09-24T00:00:00-07:00 2018-20664 Notice https://www.gpo.gov/fdsys/pkg/FR-2018-09-24/pdf/2018-20664.pdf https://regulations.justia.com/regulations/fedreg/2018/09/24/2018-20663.html Notice - Office of the Director, National Institutes of Health; Notice of Meeting 2018-09-24T00:00:00-07:00 2018-09-24T00:00:00-07:00 2018-20663 Notice https://www.gpo.gov/fdsys/pkg/FR-2018-09-24/pdf/2018-20663.pdf https://regulations.justia.com/regulations/fedreg/2018/09/24/2018-20640.html Notice - Patient Engagement Advisory Committee; Notice of Meeting 2018-09-24T00:00:00-07:00 2018-09-24T00:00:00-07:00 2018-20640 Notice https://www.gpo.gov/fdsys/pkg/FR-2018-09-24/pdf/2018-20640.pdf https://regulations.justia.com/regulations/fedreg/2018/09/21/2018-20594.html Notice - Proposed Information Collection Activity; Comment Request 2018-09-21T00:00:00-07:00 2018-09-21T00:00:00-07:00 2018-20594 Notice https://www.gpo.gov/fdsys/pkg/FR-2018-09-21/pdf/2018-20594.pdf https://regulations.justia.com/regulations/fedreg/2018/09/21/2018-20571.html Notice - Joint Meeting of the Psychopharmacologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments 2018-09-21T00:00:00-07:00 2018-09-21T00:00:00-07:00 2018-20571 Notice https://www.gpo.gov/fdsys/pkg/FR-2018-09-21/pdf/2018-20571.pdf https://regulations.justia.com/regulations/fedreg/2018/09/21/2018-20562.html Notice - Modified Risk Tobacco Product Application: Application for Copenhagen® Snuff Fine Cut, a Loose Moist Snuff Tobacco Product Submitted by U.S. Smokeless Tobacco Company LLC 2018-09-21T00:00:00-07:00 2018-09-21T00:00:00-07:00 2018-20562 Notice https://www.gpo.gov/fdsys/pkg/FR-2018-09-21/pdf/2018-20562.pdf https://regulations.justia.com/regulations/fedreg/2018/09/21/2018-20560.html Notice - Civil Money Penalties Relating to the ClinicalTrials.gov Data Bank; Draft Guidance for Food and Drug Administration Staff, Responsible Parties, and Submitters of Certain Applications and Submissions to the Food and Drug Administration; Availability 2018-09-21T00:00:00-07:00 2018-09-21T00:00:00-07:00 2018-20560 Notice https://www.gpo.gov/fdsys/pkg/FR-2018-09-21/pdf/2018-20560.pdf https://regulations.justia.com/regulations/fedreg/2018/09/21/2018-20525.html Notice - National Eye Institute; Notice of Closed Meeting 2018-09-21T00:00:00-07:00 2018-09-21T00:00:00-07:00 2018-20525 Notice https://www.gpo.gov/fdsys/pkg/FR-2018-09-21/pdf/2018-20525.pdf https://regulations.justia.com/regulations/fedreg/2018/09/21/2018-20524.html Notice - National Institute of Mental Health; Notice of Closed Meetings 2018-09-21T00:00:00-07:00 2018-09-21T00:00:00-07:00 2018-20524 Notice https://www.gpo.gov/fdsys/pkg/FR-2018-09-21/pdf/2018-20524.pdf https://regulations.justia.com/regulations/fedreg/2018/09/21/2018-20522.html Notice - Center for Scientific Review; Notice of Closed Meetings 2018-09-21T00:00:00-07:00 2018-09-21T00:00:00-07:00 2018-20522 Notice https://www.gpo.gov/fdsys/pkg/FR-2018-09-21/pdf/2018-20522.pdf https://regulations.justia.com/regulations/fedreg/2018/09/21/2018-20520.html Notice - Center for Scientific Review; Notice of Closed Meetings 2018-09-21T00:00:00-07:00 2018-09-21T00:00:00-07:00 2018-20520 Notice https://www.gpo.gov/fdsys/pkg/FR-2018-09-21/pdf/2018-20520.pdf https://regulations.justia.com/regulations/fedreg/2018/09/20/2018-20510.html Notice - Privacy Act of 1974; Matching Program 2018-09-20T00:00:00-07:00 2018-09-20T00:00:00-07:00 2018-20510 Notice https://www.gpo.gov/fdsys/pkg/FR-2018-09-20/pdf/2018-20510.pdf https://regulations.justia.com/regulations/fedreg/2018/09/20/2018-20506.html Notice - Medicare Program; Medicare Appeals; Adjustment to the Amount in Controversy Threshold Amounts for Calendar Year 2019 2018-09-20T00:00:00-07:00 2018-09-20T00:00:00-07:00 2018-20506 Notice https://www.gpo.gov/fdsys/pkg/FR-2018-09-20/pdf/2018-20506.pdf https://regulations.justia.com/regulations/fedreg/2018/09/20/2018-20505.html Notice - Notice of New NIH Policy Manual 1311-Preventing and Addressing Harassment and Inappropriate Conduct and New Policy Statement on Inappropriate Relationships in the Workplace 2018-09-20T00:00:00-07:00 2018-09-20T00:00:00-07:00 2018-20505 Notice https://www.gpo.gov/fdsys/pkg/FR-2018-09-20/pdf/2018-20505.pdf https://regulations.justia.com/regulations/fedreg/2018/09/20/2018-20503.html Notice - Grandfathering Policy for Packages and Homogenous Cases of Product Without a Product Identifier; Guidance for Industry; Availability 2018-09-20T00:00:00-07:00 2018-09-20T00:00:00-07:00 2018-20503 Notice https://www.gpo.gov/fdsys/pkg/FR-2018-09-20/pdf/2018-20503.pdf https://regulations.justia.com/regulations/fedreg/2018/09/20/2018-20502.html Notice - Product Identifiers Under the Drug Supply Chain Security Act Questions and Answers; Draft Guidance for Industry; Availability 2018-09-20T00:00:00-07:00 2018-09-20T00:00:00-07:00 2018-20502 Notice https://www.gpo.gov/fdsys/pkg/FR-2018-09-20/pdf/2018-20502.pdf https://regulations.justia.com/regulations/fedreg/2018/09/20/2018-20484.html Notice - Government-Owned Inventions; Availability for Licensing 2018-09-20T00:00:00-07:00 2018-09-20T00:00:00-07:00 2018-20484 Notice https://www.gpo.gov/fdsys/pkg/FR-2018-09-20/pdf/2018-20484.pdf https://regulations.justia.com/regulations/fedreg/2018/09/20/2018-20483.html Notice - National Center for Complementary & Integrative Health; Amended Notice of Meeting 2018-09-20T00:00:00-07:00 2018-09-20T00:00:00-07:00 2018-20483 Notice https://www.gpo.gov/fdsys/pkg/FR-2018-09-20/pdf/2018-20483.pdf https://regulations.justia.com/regulations/fedreg/2018/09/20/2018-20481.html Notice - Supplemental Evidence and Data Request on Depression in Children: Systematic Review 2018-09-20T00:00:00-07:00 2018-09-20T00:00:00-07:00 2018-20481 Notice https://www.gpo.gov/fdsys/pkg/FR-2018-09-20/pdf/2018-20481.pdf https://regulations.justia.com/regulations/fedreg/2018/09/20/2018-20472.html Notice - Heparin-Containing Medical Devices and Combination Products: Recommendations for Labeling and Safety Testing; Guidance for Industry and Food and Drug Administration Staff; Availability 2018-09-20T00:00:00-07:00 2018-09-20T00:00:00-07:00 2018-20472 Notice https://www.gpo.gov/fdsys/pkg/FR-2018-09-20/pdf/2018-20472.pdf https://regulations.justia.com/regulations/fedreg/2018/09/20/2018-20445.html Notice - Performance Review Board Members 2018-09-20T00:00:00-07:00 2018-09-20T00:00:00-07:00 2018-20445 Notice https://www.gpo.gov/fdsys/pkg/FR-2018-09-20/pdf/2018-20445.pdf https://regulations.justia.com/regulations/fedreg/2018/09/20/2018-20444.html Notice - Product Identifier Requirements Under the Drug Supply Chain Security Act-Compliance Policy; Guidance for Industry; Availability 2018-09-20T00:00:00-07:00 2018-09-20T00:00:00-07:00 2018-20444 Notice https://www.gpo.gov/fdsys/pkg/FR-2018-09-20/pdf/2018-20444.pdf https://regulations.justia.com/regulations/fedreg/2018/09/20/2018-20428.html Notice - Health Resources and Services Administration Meeting of the Advisory Committee on Heritable Disorders in Newborns and Children 2018-09-20T00:00:00-07:00 2018-09-20T00:00:00-07:00 2018-20428 Notice https://www.gpo.gov/fdsys/pkg/FR-2018-09-20/pdf/2018-20428.pdf https://regulations.justia.com/regulations/fedreg/2018/09/20/2018-20425.html Notice - National Institute of General Medical Sciences; Notice of Closed Meeting 2018-09-20T00:00:00-07:00 2018-09-20T00:00:00-07:00 2018-20425 Notice https://www.gpo.gov/fdsys/pkg/FR-2018-09-20/pdf/2018-20425.pdf https://regulations.justia.com/regulations/fedreg/2018/09/20/2018-20424.html Notice - National Institute of Dental & Craniofacial Research; Notice of Closed Meetings 2018-09-20T00:00:00-07:00 2018-09-20T00:00:00-07:00 2018-20424 Notice https://www.gpo.gov/fdsys/pkg/FR-2018-09-20/pdf/2018-20424.pdf https://regulations.justia.com/regulations/fedreg/2018/09/20/2018-20423.html Notice - National Institute on Drug Abuse; Notice of Closed Meetings 2018-09-20T00:00:00-07:00 2018-09-20T00:00:00-07:00 2018-20423 Notice https://www.gpo.gov/fdsys/pkg/FR-2018-09-20/pdf/2018-20423.pdf https://regulations.justia.com/regulations/fedreg/2018/09/20/2018-20422.html Notice - National Institute of Allergy and Infectious Diseases Notice of Closed Meeting 2018-09-20T00:00:00-07:00 2018-09-20T00:00:00-07:00 2018-20422 Notice https://www.gpo.gov/fdsys/pkg/FR-2018-09-20/pdf/2018-20422.pdf https://regulations.justia.com/regulations/fedreg/2018/09/20/2018-20421.html Notice - National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting 2018-09-20T00:00:00-07:00 2018-09-20T00:00:00-07:00 2018-20421 Notice https://www.gpo.gov/fdsys/pkg/FR-2018-09-20/pdf/2018-20421.pdf https://regulations.justia.com/regulations/fedreg/2018/09/20/2018-20420.html Notice - National Institute on Aging; Notice of Closed Meeting 2018-09-20T00:00:00-07:00 2018-09-20T00:00:00-07:00 2018-20420 Notice https://www.gpo.gov/fdsys/pkg/FR-2018-09-20/pdf/2018-20420.pdf https://regulations.justia.com/regulations/fedreg/2018/09/20/2018-20419.html Notice - National Cancer Institute Notice of Closed Meetings 2018-09-20T00:00:00-07:00 2018-09-20T00:00:00-07:00 2018-20419 Notice https://www.gpo.gov/fdsys/pkg/FR-2018-09-20/pdf/2018-20419.pdf https://regulations.justia.com/regulations/fedreg/2018/09/20/2018-20418.html Notice - National Cancer Institute; Notice of Meeting 2018-09-20T00:00:00-07:00 2018-09-20T00:00:00-07:00 2018-20418 Notice https://www.gpo.gov/fdsys/pkg/FR-2018-09-20/pdf/2018-20418.pdf https://regulations.justia.com/regulations/fedreg/2018/09/20/2018-20417.html Notice - National Institute on Drug Abuse; Notice of Closed Meetings 2018-09-20T00:00:00-07:00 2018-09-20T00:00:00-07:00 2018-20417 Notice https://www.gpo.gov/fdsys/pkg/FR-2018-09-20/pdf/2018-20417.pdf https://regulations.justia.com/regulations/fedreg/2018/09/20/2018-20416.html Notice - Center for Scientific Review; Notice of Closed Meetings 2018-09-20T00:00:00-07:00 2018-09-20T00:00:00-07:00 2018-20416 Notice https://www.gpo.gov/fdsys/pkg/FR-2018-09-20/pdf/2018-20416.pdf https://regulations.justia.com/regulations/fedreg/2018/09/20/2018-20415.html Notice - Center for Scientific Review; Amended Notice of Meeting 2018-09-20T00:00:00-07:00 2018-09-20T00:00:00-07:00 2018-20415 Notice https://www.gpo.gov/fdsys/pkg/FR-2018-09-20/pdf/2018-20415.pdf https://regulations.justia.com/regulations/fedreg/2018/09/20/2018-20414.html Notice - Center for Scientific Review; Notice of Closed Meetings 2018-09-20T00:00:00-07:00 2018-09-20T00:00:00-07:00 2018-20414 Notice https://www.gpo.gov/fdsys/pkg/FR-2018-09-20/pdf/2018-20414.pdf https://regulations.justia.com/regulations/fedreg/2018/09/20/2018-20413.html Notice - Center for Scientific Review; Notice of Closed Meetings 2018-09-20T00:00:00-07:00 2018-09-20T00:00:00-07:00 2018-20413 Notice https://www.gpo.gov/fdsys/pkg/FR-2018-09-20/pdf/2018-20413.pdf https://regulations.justia.com/regulations/fedreg/2018/09/20/2018-20375.html Rule - Food Additives Permitted for Direct Addition to Food for Human Consumption; Vitamin D3 2018-09-20T00:00:00-07:00 2018-09-20T00:00:00-07:00 2018-20375 Rule https://www.gpo.gov/fdsys/pkg/FR-2018-09-20/pdf/2018-20375.pdf https://regulations.justia.com/regulations/fedreg/2018/09/20/2018-19599.html Proposed Rule - Medicare and Medicaid Programs; Regulatory Provisions To Promote Program Efficiency, Transparency, and Burden Reduction 2018-09-20T00:00:00-07:00 2018-09-20T00:00:00-07:00 2018-19599 Proposed Rule https://www.gpo.gov/fdsys/pkg/FR-2018-09-20/pdf/2018-19599.pdf https://regulations.justia.com/regulations/fedreg/2018/09/19/2018-20372.html Notice - Agency Information Collection Activities: Submission for OMB Review; Comment Request 2018-09-19T00:00:00-07:00 2018-09-19T00:00:00-07:00 2018-20372 Notice https://www.gpo.gov/fdsys/pkg/FR-2018-09-19/pdf/2018-20372.pdf https://regulations.justia.com/regulations/fedreg/2018/09/19/2018-20317.html Notice - Postapproval Changes to Drug Substances; Draft Guidance for Industry; Availability; Correction 2018-09-19T00:00:00-07:00 2018-09-19T00:00:00-07:00 2018-20317 Notice https://www.gpo.gov/fdsys/pkg/FR-2018-09-19/pdf/2018-20317.pdf https://regulations.justia.com/regulations/fedreg/2018/09/18/2018-20295.html Notice - Announcement of Intent To Issue an OPDIV-Initiated Supplement Under the Standing Announcement for Residential (Shelter) Services for Unaccompanied Children, HHS-2017-ACF-ORR-ZU-1132 2018-09-18T00:00:00-07:00 2018-09-18T00:00:00-07:00 2018-20295 Notice https://www.gpo.gov/fdsys/pkg/FR-2018-09-18/pdf/2018-20295.pdf https://regulations.justia.com/regulations/fedreg/2018/09/18/2018-20289.html Notice - Notice of Closed Meeting 2018-09-18T00:00:00-07:00 2018-09-18T00:00:00-07:00 2018-20289 Notice https://www.gpo.gov/fdsys/pkg/FR-2018-09-18/pdf/2018-20289.pdf https://regulations.justia.com/regulations/fedreg/2018/09/18/2018-20288.html Rule - Listing of Color Additives Subject to Certification; D&C Black No. 4; Confirmation of Effective Date 2018-09-18T00:00:00-07:00 2018-09-18T00:00:00-07:00 2018-20288 Rule https://www.gpo.gov/fdsys/pkg/FR-2018-09-18/pdf/2018-20288.pdf https://regulations.justia.com/regulations/fedreg/2018/09/18/2018-20269.html Notice - Meeting of the CDC/HRSA Advisory Committee on HIV, Viral Hepatitis and STD Prevention and Treatment 2018-09-18T00:00:00-07:00 2018-09-18T00:00:00-07:00 2018-20269 Notice https://www.gpo.gov/fdsys/pkg/FR-2018-09-18/pdf/2018-20269.pdf https://regulations.justia.com/regulations/fedreg/2018/09/18/2018-20268.html Notice - National Advisory Council on Migrant Health 2018-09-18T00:00:00-07:00 2018-09-18T00:00:00-07:00 2018-20268 Notice https://www.gpo.gov/fdsys/pkg/FR-2018-09-18/pdf/2018-20268.pdf https://regulations.justia.com/regulations/fedreg/2018/09/18/2018-20267.html Notice - National Institute of Neurological Disorders and Stroke; Notice of Closed Meetings 2018-09-18T00:00:00-07:00 2018-09-18T00:00:00-07:00 2018-20267 Notice https://www.gpo.gov/fdsys/pkg/FR-2018-09-18/pdf/2018-20267.pdf https://regulations.justia.com/regulations/fedreg/2018/09/18/2018-20266.html Notice - National Institute on Deafness and Other Communication Disorders; Notice of Meeting 2018-09-18T00:00:00-07:00 2018-09-18T00:00:00-07:00 2018-20266 Notice https://www.gpo.gov/fdsys/pkg/FR-2018-09-18/pdf/2018-20266.pdf https://regulations.justia.com/regulations/fedreg/2018/09/18/2018-20265.html Notice - National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Closed Meetings 2018-09-18T00:00:00-07:00 2018-09-18T00:00:00-07:00 2018-20265 Notice https://www.gpo.gov/fdsys/pkg/FR-2018-09-18/pdf/2018-20265.pdf https://regulations.justia.com/regulations/fedreg/2018/09/18/2018-20264.html Notice - National Center for Advancing Translational Sciences; Notice of Closed Meeting 2018-09-18T00:00:00-07:00 2018-09-18T00:00:00-07:00 2018-20264 Notice https://www.gpo.gov/fdsys/pkg/FR-2018-09-18/pdf/2018-20264.pdf https://regulations.justia.com/regulations/fedreg/2018/09/18/2018-20263.html Notice - National Institute of Neurological Disorders and Stroke; Notice of Closed Meetings 2018-09-18T00:00:00-07:00 2018-09-18T00:00:00-07:00 2018-20263 Notice https://www.gpo.gov/fdsys/pkg/FR-2018-09-18/pdf/2018-20263.pdf https://regulations.justia.com/regulations/fedreg/2018/09/18/2018-20262.html Notice - Center for Scientific Review; Notice of Closed Meetings 2018-09-18T00:00:00-07:00 2018-09-18T00:00:00-07:00 2018-20262 Notice https://www.gpo.gov/fdsys/pkg/FR-2018-09-18/pdf/2018-20262.pdf https://regulations.justia.com/regulations/fedreg/2018/09/18/2018-20261.html Notice - National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Closed Meeting 2018-09-18T00:00:00-07:00 2018-09-18T00:00:00-07:00 2018-20261 Notice https://www.gpo.gov/fdsys/pkg/FR-2018-09-18/pdf/2018-20261.pdf https://regulations.justia.com/regulations/fedreg/2018/09/18/2018-20260.html Notice - National Institute on Deafness and Other Communication Disorders; Notice of Closed Meetings 2018-09-18T00:00:00-07:00 2018-09-18T00:00:00-07:00 2018-20260 Notice https://www.gpo.gov/fdsys/pkg/FR-2018-09-18/pdf/2018-20260.pdf https://regulations.justia.com/regulations/fedreg/2018/09/18/2018-20248.html Notice - Proposed Data Collection Submitted for Public Comment and Recommendations 2018-09-18T00:00:00-07:00 2018-09-18T00:00:00-07:00 2018-20248 Notice https://www.gpo.gov/fdsys/pkg/FR-2018-09-18/pdf/2018-20248.pdf https://regulations.justia.com/regulations/fedreg/2018/09/18/2018-20247.html Notice - Proposed Data Collection Submitted for Public Comment and Recommendations 2018-09-18T00:00:00-07:00 2018-09-18T00:00:00-07:00 2018-20247 Notice https://www.gpo.gov/fdsys/pkg/FR-2018-09-18/pdf/2018-20247.pdf https://regulations.justia.com/regulations/fedreg/2018/09/18/2018-20245.html Notice - Agency Forms Undergoing Paperwork Reduction Act Review 2018-09-18T00:00:00-07:00 2018-09-18T00:00:00-07:00 2018-20245 Notice https://www.gpo.gov/fdsys/pkg/FR-2018-09-18/pdf/2018-20245.pdf https://regulations.justia.com/regulations/fedreg/2018/09/18/2018-20244.html Notice - Agency Forms Undergoing Paperwork Reduction Act Review 2018-09-18T00:00:00-07:00 2018-09-18T00:00:00-07:00 2018-20244 Notice https://www.gpo.gov/fdsys/pkg/FR-2018-09-18/pdf/2018-20244.pdf https://regulations.justia.com/regulations/fedreg/2018/09/18/2018-20233.html Notice - Endocrinologic and Metabolic Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments 2018-09-18T00:00:00-07:00 2018-09-18T00:00:00-07:00 2018-20233 Notice https://www.gpo.gov/fdsys/pkg/FR-2018-09-18/pdf/2018-20233.pdf https://regulations.justia.com/regulations/fedreg/2018/09/18/2018-20223.html Notice - Proposed Information Collection Activity 2018-09-18T00:00:00-07:00 2018-09-18T00:00:00-07:00 2018-20223 Notice https://www.gpo.gov/fdsys/pkg/FR-2018-09-18/pdf/2018-20223.pdf https://regulations.justia.com/regulations/fedreg/2018/09/18/2018-20217.html Proposed Rule - Oakshire Naturals LP; Filing of Food Additive Petition 2018-09-18T00:00:00-07:00 2018-09-18T00:00:00-07:00 2018-20217 Proposed Rule https://www.gpo.gov/fdsys/pkg/FR-2018-09-18/pdf/2018-20217.pdf https://regulations.justia.com/regulations/fedreg/2018/09/18/2018-20214.html Notice - Post-Marketing Pediatric-Focused Product Safety Reviews; Establishment of a Public Docket; Request for Comments 2018-09-18T00:00:00-07:00 2018-09-18T00:00:00-07:00 2018-20214 Notice https://www.gpo.gov/fdsys/pkg/FR-2018-09-18/pdf/2018-20214.pdf https://regulations.justia.com/regulations/fedreg/2018/09/18/2018-20169.html Notice - Revised Draft NIOSH Current Intelligence Bulletin: Health Effects of Occupational Exposure to Silver Nanomaterials 2018-09-18T00:00:00-07:00 2018-09-18T00:00:00-07:00 2018-20169 Notice https://www.gpo.gov/fdsys/pkg/FR-2018-09-18/pdf/2018-20169.pdf https://regulations.justia.com/regulations/fedreg/2018/09/17/2018-20153.html Notice - Medicare & Medicaid Programs, and Other Program Initiatives, and Priorities; Meeting of the Advisory Panel on Outreach and Education (APOE), September 26, 2018; Correction 2018-09-17T00:00:00-07:00 2018-09-17T00:00:00-07:00 2018-20153 Notice https://www.gpo.gov/fdsys/pkg/FR-2018-09-17/pdf/2018-20153.pdf https://regulations.justia.com/regulations/fedreg/2018/09/17/2018-20126.html Notice - Agency for Healthcare Research and Quality; Notice of Meetings 2018-09-17T00:00:00-07:00 2018-09-17T00:00:00-07:00 2018-20126 Notice https://www.gpo.gov/fdsys/pkg/FR-2018-09-17/pdf/2018-20126.pdf https://regulations.justia.com/regulations/fedreg/2018/09/17/2018-20118.html Notice - Draft Update to the Centers for Disease Control and Prevention Infection Prevention and Control Recommendation Categorization Scheme 2018-09-17T00:00:00-07:00 2018-09-17T00:00:00-07:00 2018-20118 Notice https://www.gpo.gov/fdsys/pkg/FR-2018-09-17/pdf/2018-20118.pdf https://regulations.justia.com/regulations/fedreg/2018/09/17/2018-20113.html Notice - Center for Scientific Review; Notice of Closed Meetings 2018-09-17T00:00:00-07:00 2018-09-17T00:00:00-07:00 2018-20113 Notice https://www.gpo.gov/fdsys/pkg/FR-2018-09-17/pdf/2018-20113.pdf https://regulations.justia.com/regulations/fedreg/2018/09/17/2018-20112.html Notice - Center for Scientific Review; Notice of Closed Meetings 2018-09-17T00:00:00-07:00 2018-09-17T00:00:00-07:00 2018-20112 Notice https://www.gpo.gov/fdsys/pkg/FR-2018-09-17/pdf/2018-20112.pdf https://regulations.justia.com/regulations/fedreg/2018/09/17/2018-20111.html Notice - National Institute on Aging; Notice of Closed Meeting 2018-09-17T00:00:00-07:00 2018-09-17T00:00:00-07:00 2018-20111 Notice https://www.gpo.gov/fdsys/pkg/FR-2018-09-17/pdf/2018-20111.pdf https://regulations.justia.com/regulations/fedreg/2018/09/17/2018-20110.html Notice - Advisory Council on Alzheimer's Research, Care, and Services; Meeting 2018-09-17T00:00:00-07:00 2018-09-17T00:00:00-07:00 2018-20110 Notice https://www.gpo.gov/fdsys/pkg/FR-2018-09-17/pdf/2018-20110.pdf https://regulations.justia.com/regulations/fedreg/2018/09/17/2018-20109.html Rule - Determination of Status as a Qualified Facility Under the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human and Animal Food Rules; Guidance for Industry; Availability 2018-09-17T00:00:00-07:00 2018-09-17T00:00:00-07:00 2018-20109 Rule https://www.gpo.gov/fdsys/pkg/FR-2018-09-17/pdf/2018-20109.pdf https://regulations.justia.com/regulations/fedreg/2018/09/17/2018-20108.html Notice - Advisory Committee; Oncologic Drugs Advisory Committee; Renewal 2018-09-17T00:00:00-07:00 2018-09-17T00:00:00-07:00 2018-20108 Notice https://www.gpo.gov/fdsys/pkg/FR-2018-09-17/pdf/2018-20108.pdf https://regulations.justia.com/regulations/fedreg/2018/09/17/2018-20092.html Notice - Agency Information Collection Activities; Proposed Collection; Comment Request; Obtaining Information for Evaluating Nominated Bulk Drug Substances for Use in Compounding Drug Products Under Section 503B of the Federal Food, Drug, and Cosmetic Act 2018-09-17T00:00:00-07:00 2018-09-17T00:00:00-07:00 2018-20092 Notice https://www.gpo.gov/fdsys/pkg/FR-2018-09-17/pdf/2018-20092.pdf https://regulations.justia.com/regulations/fedreg/2018/09/17/2018-20091.html Notice - Anesthetic and Analgesic Drug Products Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments; Correction 2018-09-17T00:00:00-07:00 2018-09-17T00:00:00-07:00 2018-20091 Notice https://www.gpo.gov/fdsys/pkg/FR-2018-09-17/pdf/2018-20091.pdf https://regulations.justia.com/regulations/fedreg/2018/09/17/2018-20090.html Notice - Pathogen Reduction Technologies for Blood Safety; Public Workshop 2018-09-17T00:00:00-07:00 2018-09-17T00:00:00-07:00 2018-20090 Notice https://www.gpo.gov/fdsys/pkg/FR-2018-09-17/pdf/2018-20090.pdf https://regulations.justia.com/regulations/fedreg/2018/09/17/2018-20087.html Notice - Submission for OMB Review; Comment Request 2018-09-17T00:00:00-07:00 2018-09-17T00:00:00-07:00 2018-20087 Notice https://www.gpo.gov/fdsys/pkg/FR-2018-09-17/pdf/2018-20087.pdf https://regulations.justia.com/regulations/fedreg/2018/09/17/2018-20085.html Notice - Temporary Assistance for Needy Families (TANF) Data Innovations (TDI) Project (New Collection) 2018-09-17T00:00:00-07:00 2018-09-17T00:00:00-07:00 2018-20085 Notice https://www.gpo.gov/fdsys/pkg/FR-2018-09-17/pdf/2018-20085.pdf https://regulations.justia.com/regulations/fedreg/2018/09/17/2018-20068.html Notice - Proposed Information Collection Activity; Descriptive Study of the Unaccompanied Refugee Minors Program (New Collection) 2018-09-17T00:00:00-07:00 2018-09-17T00:00:00-07:00 2018-20068 Notice https://www.gpo.gov/fdsys/pkg/FR-2018-09-17/pdf/2018-20068.pdf https://regulations.justia.com/regulations/fedreg/2018/09/17/2018-20063.html Notice - Privacy Act of 1974; System of Records 2018-09-17T00:00:00-07:00 2018-09-17T00:00:00-07:00 2018-20063 Notice https://www.gpo.gov/fdsys/pkg/FR-2018-09-17/pdf/2018-20063.pdf https://regulations.justia.com/regulations/fedreg/2018/09/14/2018-20040.html Notice - Meeting of the Advisory Committee on Minority Health 2018-09-14T00:00:00-07:00 2018-09-14T00:00:00-07:00 2018-20040 Notice https://www.gpo.gov/fdsys/pkg/FR-2018-09-14/pdf/2018-20040.pdf https://regulations.justia.com/regulations/fedreg/2018/09/14/2018-20024.html Notice - Disease, Disability, and Injury Prevention and Control Special Emphasis Panel (SEP)-CE19-001, Injury Control Research Centers; Amended Notice of Meeting 2018-09-14T00:00:00-07:00 2018-09-14T00:00:00-07:00 2018-20024 Notice https://www.gpo.gov/fdsys/pkg/FR-2018-09-14/pdf/2018-20024.pdf https://regulations.justia.com/regulations/fedreg/2018/09/14/2018-20018.html Notice - Product-Specific Guidances; Draft and Revised Draft Guidances for Industry; Availability 2018-09-14T00:00:00-07:00 2018-09-14T00:00:00-07:00 2018-20018 Notice https://www.gpo.gov/fdsys/pkg/FR-2018-09-14/pdf/2018-20018.pdf https://regulations.justia.com/regulations/fedreg/2018/09/14/2018-20017.html Notice - Solicitation of Nominations for Appointment to the Board of Scientific Counselors Office of Public Health Preparedness and Response 2018-09-14T00:00:00-07:00 2018-09-14T00:00:00-07:00 2018-20017 Notice https://www.gpo.gov/fdsys/pkg/FR-2018-09-14/pdf/2018-20017.pdf https://regulations.justia.com/regulations/fedreg/2018/09/14/2018-20016.html Notice - Advisory Board on Radiation and Worker Health (ABRWH or the Advisory Board), Subcommittee on Procedures Review (SPR), National Institute for Occupational Safety and Health (NIOSH) 2018-09-14T00:00:00-07:00 2018-09-14T00:00:00-07:00 2018-20016 Notice https://www.gpo.gov/fdsys/pkg/FR-2018-09-14/pdf/2018-20016.pdf https://regulations.justia.com/regulations/fedreg/2018/09/14/2018-20015.html Notice - Advisory Board on Radiation and Worker Health (ABRWH or the Advisory Board), National Institute for Occupational Safety and Health (NIOSH) 2018-09-14T00:00:00-07:00 2018-09-14T00:00:00-07:00 2018-20015 Notice https://www.gpo.gov/fdsys/pkg/FR-2018-09-14/pdf/2018-20015.pdf https://regulations.justia.com/regulations/fedreg/2018/09/14/2018-20013.html Notice - Announcement of Intent To Establish the 2020 Dietary Guidelines Advisory Committee and Solicitation of Nominations for Membership 2018-09-14T00:00:00-07:00 2018-09-14T00:00:00-07:00 2018-20013 Notice https://www.gpo.gov/fdsys/pkg/FR-2018-09-14/pdf/2018-20013.pdf https://regulations.justia.com/regulations/fedreg/2018/09/14/2018-19993.html Notice - Recognition and Withdrawal of Voluntary Consensus Standards; Draft Guidance for Industry and Food and Drug Administration Staff; Availability 2018-09-14T00:00:00-07:00 2018-09-14T00:00:00-07:00 2018-19993 Notice https://www.gpo.gov/fdsys/pkg/FR-2018-09-14/pdf/2018-19993.pdf https://regulations.justia.com/regulations/fedreg/2018/09/14/2018-19992.html Notice - 510(k) Third-Party Review Program; Draft Guidance for Industry, Food and Drug Administration Staff, and Third-Party Review Organizations; Availability 2018-09-14T00:00:00-07:00 2018-09-14T00:00:00-07:00 2018-19992 Notice https://www.gpo.gov/fdsys/pkg/FR-2018-09-14/pdf/2018-19992.pdf https://regulations.justia.com/regulations/fedreg/2018/09/14/2018-19989.html Notice - Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices; Guidance for Industry and Food and Drug Administration Staff; Availability 2018-09-14T00:00:00-07:00 2018-09-14T00:00:00-07:00 2018-19989 Notice https://www.gpo.gov/fdsys/pkg/FR-2018-09-14/pdf/2018-19989.pdf https://regulations.justia.com/regulations/fedreg/2018/09/14/2018-19925.html Notice - Intent To Award a Single-Source Supplement; Notice 2018-09-14T00:00:00-07:00 2018-09-14T00:00:00-07:00 2018-19925 Notice https://www.gpo.gov/fdsys/pkg/FR-2018-09-14/pdf/2018-19925.pdf https://regulations.justia.com/regulations/fedreg/2018/09/13/2018-19922.html Notice - Request for Nominations on the Tobacco Products Scientific Advisory Committee 2018-09-13T00:00:00-07:00 2018-09-13T00:00:00-07:00 2018-19922 Notice https://www.gpo.gov/fdsys/pkg/FR-2018-09-13/pdf/2018-19922.pdf https://regulations.justia.com/regulations/fedreg/2018/09/13/2018-19921.html Notice - Request for Nominations for Voting Members on the Tobacco Products Scientific Advisory Committee 2018-09-13T00:00:00-07:00 2018-09-13T00:00:00-07:00 2018-19921 Notice https://www.gpo.gov/fdsys/pkg/FR-2018-09-13/pdf/2018-19921.pdf https://regulations.justia.com/regulations/fedreg/2018/09/13/2018-19920.html Notice - National Institute of General Medical Sciences; Notice of Closed Meeting 2018-09-13T00:00:00-07:00 2018-09-13T00:00:00-07:00 2018-19920 Notice https://www.gpo.gov/fdsys/pkg/FR-2018-09-13/pdf/2018-19920.pdf https://regulations.justia.com/regulations/fedreg/2018/09/13/2018-19919.html Notice - Center for Scientific Review; Notice of Closed Meetings 2018-09-13T00:00:00-07:00 2018-09-13T00:00:00-07:00 2018-19919 Notice https://www.gpo.gov/fdsys/pkg/FR-2018-09-13/pdf/2018-19919.pdf https://regulations.justia.com/regulations/fedreg/2018/09/13/2018-19916.html Notice - National Institute of General Medical Sciences; Notice of Closed Meeting 2018-09-13T00:00:00-07:00 2018-09-13T00:00:00-07:00 2018-19916 Notice https://www.gpo.gov/fdsys/pkg/FR-2018-09-13/pdf/2018-19916.pdf https://regulations.justia.com/regulations/fedreg/2018/09/13/2018-19915.html Notice - National Institute of General Medical Sciences; Notice of Closed Meeting 2018-09-13T00:00:00-07:00 2018-09-13T00:00:00-07:00 2018-19915 Notice https://www.gpo.gov/fdsys/pkg/FR-2018-09-13/pdf/2018-19915.pdf https://regulations.justia.com/regulations/fedreg/2018/09/13/2018-19914.html Notice - National Cancer Institute; Notice of Closed Meetings 2018-09-13T00:00:00-07:00 2018-09-13T00:00:00-07:00 2018-19914 Notice https://www.gpo.gov/fdsys/pkg/FR-2018-09-13/pdf/2018-19914.pdf https://regulations.justia.com/regulations/fedreg/2018/09/13/2018-19913.html Notice - Agency Information Collection Activities; Proposed Collection; Comment Request; Exemptions From Substantial Equivalence Requirements for Tobacco Products 2018-09-13T00:00:00-07:00 2018-09-13T00:00:00-07:00 2018-19913 Notice https://www.gpo.gov/fdsys/pkg/FR-2018-09-13/pdf/2018-19913.pdf https://regulations.justia.com/regulations/fedreg/2018/09/13/2018-19912.html Notice - National Institute of General Medical Sciences; Notice of Closed Meeting 2018-09-13T00:00:00-07:00 2018-09-13T00:00:00-07:00 2018-19912 Notice https://www.gpo.gov/fdsys/pkg/FR-2018-09-13/pdf/2018-19912.pdf https://regulations.justia.com/regulations/fedreg/2018/09/13/2018-19911.html Notice - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food 2018-09-13T00:00:00-07:00 2018-09-13T00:00:00-07:00 2018-19911 Notice https://www.gpo.gov/fdsys/pkg/FR-2018-09-13/pdf/2018-19911.pdf https://regulations.justia.com/regulations/fedreg/2018/09/13/2018-19909.html Notice - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals 2018-09-13T00:00:00-07:00 2018-09-13T00:00:00-07:00 2018-19909 Notice https://www.gpo.gov/fdsys/pkg/FR-2018-09-13/pdf/2018-19909.pdf https://regulations.justia.com/regulations/fedreg/2018/09/13/2018-19907.html Notice - Joint Public Meeting on the Use of Cell Culture Technology To Develop Products Derived From Livestock and Poultry 2018-09-13T00:00:00-07:00 2018-09-13T00:00:00-07:00 2018-19907 Notice https://www.gpo.gov/fdsys/pkg/FR-2018-09-13/pdf/2018-19907.pdf https://regulations.justia.com/regulations/fedreg/2018/09/13/2018-19906.html Notice - Science Board to the Food and Drug Administration Advisory Committee; Notice of Meeting 2018-09-13T00:00:00-07:00 2018-09-13T00:00:00-07:00 2018-19906 Notice https://www.gpo.gov/fdsys/pkg/FR-2018-09-13/pdf/2018-19906.pdf https://regulations.justia.com/regulations/fedreg/2018/09/13/2018-19903.html Notice - Agency Information Collection Activities: Proposed Collection: Public Comment Request; Forms for Use With Applications to the Maternal and Child Health Bureau Research and Training Grants, OMB No. 0906-New 2018-09-13T00:00:00-07:00 2018-09-13T00:00:00-07:00 2018-19903 Notice https://www.gpo.gov/fdsys/pkg/FR-2018-09-13/pdf/2018-19903.pdf https://regulations.justia.com/regulations/fedreg/2018/09/13/2018-19902.html Notice - Agency Forms Undergoing Paperwork Reduction Act Review 2018-09-13T00:00:00-07:00 2018-09-13T00:00:00-07:00 2018-19902 Notice https://www.gpo.gov/fdsys/pkg/FR-2018-09-13/pdf/2018-19902.pdf https://regulations.justia.com/regulations/fedreg/2018/09/13/2018-19901.html Notice - Proposed Data Collection Submitted for Public Comment and Recommendations 2018-09-13T00:00:00-07:00 2018-09-13T00:00:00-07:00 2018-19901 Notice https://www.gpo.gov/fdsys/pkg/FR-2018-09-13/pdf/2018-19901.pdf https://regulations.justia.com/regulations/fedreg/2018/09/13/2018-19898.html Notice - Agency Information Collection Activities; Proposed Collection; Comment Request; Food Contact Substance Notification Program 2018-09-13T00:00:00-07:00 2018-09-13T00:00:00-07:00 2018-19898 Notice https://www.gpo.gov/fdsys/pkg/FR-2018-09-13/pdf/2018-19898.pdf https://regulations.justia.com/regulations/fedreg/2018/09/13/2018-19865.html Proposed Rule - Medical Device Submissions: Amending Premarket Regulations That Require Multiple Copies and Specify Paper Copies To Be Allowed in Electronic Format 2018-09-13T00:00:00-07:00 2018-09-13T00:00:00-07:00 2018-19865 Proposed Rule https://www.gpo.gov/fdsys/pkg/FR-2018-09-13/pdf/2018-19865.pdf https://regulations.justia.com/regulations/fedreg/2018/09/13/2018-19864.html Proposed Rule - Public Information 2018-09-13T00:00:00-07:00 2018-09-13T00:00:00-07:00 2018-19864 Proposed Rule https://www.gpo.gov/fdsys/pkg/FR-2018-09-13/pdf/2018-19864.pdf https://regulations.justia.com/regulations/fedreg/2018/09/12/2018-19855.html Rule - Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food 2018-09-12T00:00:00-07:00 2018-09-12T00:00:00-07:00 2018-19855 Rule https://www.gpo.gov/fdsys/pkg/FR-2018-09-12/pdf/2018-19855.pdf https://regulations.justia.com/regulations/fedreg/2018/09/12/2018-19845.html Proposed Rule - Repeal of Regulation Requiring an Approved New Drug Application for Drugs Sterilized by Irradiation 2018-09-12T00:00:00-07:00 2018-09-12T00:00:00-07:00 2018-19845 Proposed Rule https://www.gpo.gov/fdsys/pkg/FR-2018-09-12/pdf/2018-19845.pdf https://regulations.justia.com/regulations/fedreg/2018/09/12/2018-19816.html Notice - Evidence-Based Treatment Decision in Transplantation: Patient Individualized Treatment; Choosing the Right Regimen for the Right Patient; Public Workshop; Request for Comments 2018-09-12T00:00:00-07:00 2018-09-12T00:00:00-07:00 2018-19816 Notice https://www.gpo.gov/fdsys/pkg/FR-2018-09-12/pdf/2018-19816.pdf https://regulations.justia.com/regulations/fedreg/2018/09/12/2018-19811.html Notice - Receipt of Notice That a Patent Infringement Complaint Was Filed Against a Biosimilar Applicant 2018-09-12T00:00:00-07:00 2018-09-12T00:00:00-07:00 2018-19811 Notice https://www.gpo.gov/fdsys/pkg/FR-2018-09-12/pdf/2018-19811.pdf https://regulations.justia.com/regulations/fedreg/2018/09/12/2018-19799.html Notice - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance for Clinical Trial Sponsors: Establishment and Operation of Clinical Trial Data Monitoring Committees 2018-09-12T00:00:00-07:00 2018-09-12T00:00:00-07:00 2018-19799 Notice https://www.gpo.gov/fdsys/pkg/FR-2018-09-12/pdf/2018-19799.pdf https://regulations.justia.com/regulations/fedreg/2018/09/12/2018-19796.html Notice - Center for Scientific Review; Notice of Closed Meetings 2018-09-12T00:00:00-07:00 2018-09-12T00:00:00-07:00 2018-19796 Notice https://www.gpo.gov/fdsys/pkg/FR-2018-09-12/pdf/2018-19796.pdf https://regulations.justia.com/regulations/fedreg/2018/09/12/2018-19795.html Notice - Eunice Kennedy Shriver National Institute of Child Health and Human Development; Notice of Closed Meetings 2018-09-12T00:00:00-07:00 2018-09-12T00:00:00-07:00 2018-19795 Notice https://www.gpo.gov/fdsys/pkg/FR-2018-09-12/pdf/2018-19795.pdf https://regulations.justia.com/regulations/fedreg/2018/09/12/2018-19794.html Notice - National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Closed Meetings 2018-09-12T00:00:00-07:00 2018-09-12T00:00:00-07:00 2018-19794 Notice https://www.gpo.gov/fdsys/pkg/FR-2018-09-12/pdf/2018-19794.pdf https://regulations.justia.com/regulations/fedreg/2018/09/12/2018-19793.html Notice - Center for Scientific Review; Notice of Closed Meetings 2018-09-12T00:00:00-07:00 2018-09-12T00:00:00-07:00 2018-19793 Notice https://www.gpo.gov/fdsys/pkg/FR-2018-09-12/pdf/2018-19793.pdf