Agency Archive

Health and Human Services Department

Recent Federal Register documents and issues associated with this agency.

Recent Documents

Agency Forms Undergoing Paperwork Reduction Act Review Monday, September 14, 2026 91 FR 58123
Agency Forms Undergoing Paperwork Reduction Act Review Monday, September 14, 2026 91 FR 58124
Announcing the Intent To Award a Single-Source Supplement for Expanding Outreach and Professional Training To Engage Older Adults With Behavioral Health Conditions in Evidence-Based Health Promotion Programs Monday, September 14, 2026 91 FR 58129
Solicitation for Nominations To Serve on the Advisory Council To Support Grandparents Raising Grandchildren Monday, September 14, 2026 91 FR 58128
Solicitation for Nominations To Serve on the Family Caregiving Advisory Council Monday, September 14, 2026 91 FR 58127
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Customer/Partner Customer Service Satisfaction Surveys Monday, September 14, 2026 91 FR 58130
Office of the National Coordinator for Health Information Technology; Health Information Technology Advisory Committee; Amended Notice of Meeting Monday, September 14, 2026 91 FR 58131
Agency Information Collection Activities: Proposed Collection; Comment Request Monday, September 14, 2026 91 FR 58125
Proposed Collection; 60-Day Comment Request; NIH Electronic Application System for NIH Certificates of Confidentiality (CoC) Monday, September 14, 2026 91 FR 58131
Draft NIH Biosafety Policy for Research Involving Biohazards Monday, September 14, 2026 91 FR 58132
National Heart, Lung, and Blood Institute; Notice of Meeting Friday, September 11, 2026 91 FR 57900
Medical Devices; Cardiovascular Devices; Classification of the Cardiovascular Machine Learning-Based Notification Software Friday, September 11, 2026 91 FR 57785
Agency Information Collection Activities: Submission for OMB Review; Comment Request Friday, September 11, 2026 91 FR 57892
Notice of Supplemental Funding, Appalachian Region Healthcare Support Program Friday, September 11, 2026 91 FR 57897
Notice of Supplemental Funding, Infant-Toddler Court Program-State Awards Friday, September 11, 2026 91 FR 57898
Agency Information Collection Activities: Proposed Collection: Public Comment Request; Information Collection Request Title: Rural Health Network Development Program Performance Improvement and Measurement System, OMB No. 0906-0010-Revision Friday, September 11, 2026 91 FR 57897
Amending Over-the-Counter Monograph M020: Sunscreen Drug Products for Over-the-Counter Human Use, and Related Information; Aminobenzoic Acid (PABA) and Trolamine Salicylate Friday, September 11, 2026 91 FR 57892
Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Device Tracking Friday, September 11, 2026 91 FR 57893
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Generic Clearance for Qualitative Data To Support Social and Behavioral Research for Food, Dietary Supplements, Cosmetics, and Animal Food and Feed Friday, September 11, 2026 91 FR 57895
Notice of Supplemental Funding, Rural Hospital Stabilization Pilot Program Friday, September 11, 2026 91 FR 57899
National Institute on Aging; Amended Notice of Meeting Friday, September 11, 2026 91 FR 57901
National Institute of Diabetes and Digestive and Kidney Diseases; Amended Notice of Meeting Friday, September 11, 2026 91 FR 57900
Center for Scientific Review; Notice of Closed Meetings Friday, September 11, 2026 91 FR 57900
Green Innovation GmbH; Withdrawal of Food Additive Petition (Animal Use) Thursday, September 10, 2026 91 FR 57531
Fee Rate for Using a Priority Review Voucher in Fiscal Year 2027 Thursday, September 10, 2026 91 FR 57617
Center for Scientific Review; Notice of Closed Meetings Thursday, September 10, 2026 91 FR 57620
National Center for Advancing Translational Sciences; Notice of Public Online Roundtable Thursday, September 10, 2026 91 FR 57621
Medical Devices; Cardiovascular Devices; Classification of the Mechanical Deviation Device for Esophageal Protection During Cardiac Ablation Procedures Thursday, September 10, 2026 91 FR 57495
Medical Devices; Cardiovascular Devices; Classification of the Temperature Regulation Device for Esophageal Protection During Cardiac Ablation Procedures Thursday, September 10, 2026 91 FR 57500
Medical Devices; Cardiovascular Devices; Classification of the Extravascular Support for an Arteriovenous Fistula for Vascular Access Thursday, September 10, 2026 91 FR 57498
Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Anti-Tumor Necrosis Factor Alpha Monoclonal Antibody Test System for Inflammatory Bowel Disease Thursday, September 10, 2026 91 FR 57493
Medical Devices; Ear, Nose, and Throat Devices; Classification of the Cooperative Powered Surgical Assist Device for ENT Surgery Thursday, September 10, 2026 91 FR 57502
Medical Devices; Gastroenterology-Urology Devices; Classification of the Implanted Tibial Electrical Urinary Continence Device Thursday, September 10, 2026 91 FR 57504
Medical Devices; Radiology Devices; Classification of the Vaginal Hydrogel Packing System Thursday, September 10, 2026 91 FR 57509
Medical Devices; General Hospital and Personal Use Devices; Classification of the Whole Room Microbial Reduction Device Thursday, September 10, 2026 91 FR 57507
Notice of Supplemental Funding, Medicare Rural Hospital Flexibility Program Thursday, September 10, 2026 91 FR 57619
Announcing the Intent To Award a Single-Source Supplement to the Senior Medicare Patrol (SMP) Resource Center Thursday, September 10, 2026 91 FR 57616
Temporary Policies for Compounding Certain Starter Parenteral Nutrition Drug Products for Neonates; Guidance for Industry; Availability Wednesday, September 9, 2026 91 FR 57358
Vaccines and Related Biological Products Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments-2027 Southern Hemisphere Influenza Virus Vaccines Wednesday, September 9, 2026 91 FR 57359
Agency Information Collection Activities; Proposed Collection; Comment Request; Human Cells, Tissues, and Cellular and Tissue-Based Products Wednesday, September 9, 2026 91 FR 57347
Privacy Act of 1974; System of Records Wednesday, September 9, 2026 91 FR 57344
Determination of Regulatory Review Period for Purposes of Patent Extension; ANDEMBRY Wednesday, September 9, 2026 91 FR 57356
Agency Information Collection Activities; Proposed Collection; Comment Request; Pregnancy Exposure Registry Enrollment Project: A Survey of Health Care Providers To Advance Pregnancy Safety Data Collection and Improve Health Communications Wednesday, September 9, 2026 91 FR 57352
Determination of Regulatory Review Period for Purposes of Patent Extension; ANZUPGO Wednesday, September 9, 2026 91 FR 57355
Determination of Regulatory Review Period for Purposes of Patent Extension; ANKTIVA Wednesday, September 9, 2026 91 FR 57350
National Vaccine Injury Compensation Program; List of Petitions Received Wednesday, September 9, 2026 91 FR 57361
Reorganization of the National Center for Immunization and Respiratory Diseases Wednesday, September 9, 2026 91 FR 57343
Agency Information Collection Activities: Proposed Collection: Public Comment Request; Information Collection Request Title: Bureau of Health Workforce Performance Data Collection, OMB No. 0906-0086-Revision Tuesday, September 8, 2026 91 FR 57155
Medicare Program; Town Hall Meeting on the Fiscal Year 2028 Applications for New Technology Add-On Payments Tuesday, September 8, 2026 91 FR 57153
Proposed Data Collection Submitted for Public Comment and Recommendations Tuesday, September 8, 2026 91 FR 57150
Center for Scientific Review; Amended Notice of Meeting Tuesday, September 8, 2026 91 FR 57159
Center for Scientific Review; Notice of Closed Meetings Tuesday, September 8, 2026 91 FR 57156
Submission for OMB Review; 30-Day Comment Request Data and Specimen Hub (DASH) (Eunice Kennedy Shriver National Institute of Child Health and Human Development) Tuesday, September 8, 2026 91 FR 57157
Reducing Bureaucracy and Burden for the Repatriation of Mentally Ill Nationals Friday, September 4, 2026 91 FR 56826
Advancing Development of Botanical Drug Products; Request for Information Friday, September 4, 2026 91 FR 56887
Performance Review Board Members Friday, September 4, 2026 91 FR 56890
Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request; Information Collection Request Title: Rural Communities Opioid Response Program Performance Measures, OMB No. 0906-XXXX-New Friday, September 4, 2026 91 FR 56889
Agency Information Collection Request. 30-Day Public Comment Request Thursday, September 3, 2026 91 FR 56656
Determination That PHENAPHEN WITH CODEINE NO. 3 (Acetaminophen; Codeine Phosphate) Oral Capsules, 325 Milligrams and 30 Milligrams, and PHENAPHEN WITH CODEINE NO. 4 (Acetaminophen; Codeine Phosphate) Oral Capsules, 325 Milligrams and 60 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness Thursday, September 3, 2026 91 FR 56654
Emergency Use Authorization Declaration Thursday, September 3, 2026 91 FR 56655
National Institute of Mental Health; Notice of Meeting Thursday, September 3, 2026 91 FR 56657
Prospective Grant of an Exclusive Patent License: Development and Commercialization of Mifepristone and Analogues To Treat Hypercortisolism-Related Insulin Resistance Disorders Wednesday, September 2, 2026 91 FR 56458
Submission for Office of Management and Budget Review; TANF Contingency Fund Application Wednesday, September 2, 2026 91 FR 56449
Agency Information Collection Activities: Submission for OMB Review; Comment Request Wednesday, September 2, 2026 91 FR 56447
Determination That CARAFATE (Sucralfate) Oral Suspension, 1 Gram/10 Milliliters, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness Wednesday, September 2, 2026 91 FR 56455
Pharmacokinetics in Patients With Impaired Hepatic Function: Study Design, Data Analysis, and Impact on Dosage; Draft Guidance for Industry; Availability Wednesday, September 2, 2026 91 FR 56449
Announcement of the Intent To Award a Single-Source Cooperative Agreement to Spaulding for Children for the National Training and Development Curriculum for Foster/Adoptive Parents (NTDC) in Southfield, Michigan Wednesday, September 2, 2026 91 FR 56448
Dental Composite Resin Devices and Dental Curing Lights-Premarket Notification (510(k)) Submissions Guidances; Guidances for Industry and Food and Drug Administration Staff; Availability Wednesday, September 2, 2026 91 FR 56452
Issuance of Priority Review Voucher; Rare Pediatric Disease Product; GENGLYCOS (parisglasgene brecaparvovec-opnr) Wednesday, September 2, 2026 91 FR 56456
International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products; Studies To Evaluate the Safety of Residues of Veterinary Drugs in Human Food: Genotoxicity Testing (Revision 2); Guidance for Industry; Availability Wednesday, September 2, 2026 91 FR 56454
International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products; Studies To Evaluate the Safety of Residues of Veterinary Drugs in Human Food: Reproduction Testing (Revision 1); Guidance for Industry; Availability Wednesday, September 2, 2026 91 FR 56451
Privacy Act of 1974; Matching Program Wednesday, September 2, 2026 91 FR 56457
Proposed Collection; 60-Day Comment Request; Assurance (Interinstitutional, Foreign, and Domestic) and Annual Report (Office of the Director) Wednesday, September 2, 2026 91 FR 56458
National Institute on Alcohol Abuse and Alcoholism; Notice of Closed Meeting Tuesday, September 1, 2026 91 FR 56151
Center for Scientific Review; Notice of Closed Meetings Tuesday, September 1, 2026 91 FR 56151
National Institute on Drug Abuse; Notice of Meeting Tuesday, September 1, 2026 91 FR 56150
Agency Information Collection Activities: Proposed Collection; Comment Request Tuesday, September 1, 2026 91 FR 56147
Emergency Office of Management and Budget Review and Public Comment: Questionnaire for the Refugee Outreach and Well-Being Initiative Tuesday, September 1, 2026 91 FR 56148
Current List of HHS-Certified Laboratories and Instrumented Initial Testing Facilities Which Meet Minimum Standards To Engage in Urine and Oral Fluid Drug Testing for Federal Agencies Tuesday, September 1, 2026 91 FR 56152
Center for Scientific Review; Amended Notice of Meeting Tuesday, September 1, 2026 91 FR 56150
National Institute of Allergy and Infectious Diseases; Amended Notice of Meeting Tuesday, September 1, 2026 91 FR 56152
Determination That NAMENDA (Memantine Hydrochloride) Tablets, 5 Milligrams and 10 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness Tuesday, September 1, 2026 91 FR 56149
Meeting of the Microbiome Subcommittee of the Presidential Advisory Council on Combating Antibiotic-Resistant Bacteria; Correction Tuesday, September 1, 2026 91 FR 56150
Notice of Interest Rate on Overdue Debts Monday, August 31, 2026 91 FR 55890
Submission for Office of Management and Budget Review; Head Start State Collaboration Office Grant Application Monday, August 31, 2026 91 FR 55855
Authorization of Emergency Use for Three Animal Drugs for the Prevention and Treatment of New World Screwworm; Availability Monday, August 31, 2026 91 FR 55861
Center for Scientific Review; Notice of Closed Meetings Monday, August 31, 2026 91 FR 55890
National Center for Advancing Translational Sciences; Amended Notice of Meeting Monday, August 31, 2026 91 FR 55890
Notice of Public Hearing: NIAID Proposed Reorganization Monday, August 31, 2026 91 FR 55891
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Potential Tobacco Product Violations Reporting Form Monday, August 31, 2026 91 FR 55856
Agency Information Collection Activities; Proposed Collection; Comment Request; Registration of Human Drug Compounding Outsourcing Facilities Under the Federal Food, Drug, and Cosmetic Act and Associated Fees Monday, August 31, 2026 91 FR 55857
Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Devices; Reports of Removals and Corrections Monday, August 31, 2026 91 FR 55859
Rahim Shafa; Denial of Hearing; Final Debarment Order Monday, August 31, 2026 91 FR 55886
Agency Information Collection Activities: Proposed Collection: Public Comment Request; Information Collection Request Title: The National Health Service Corps Loan Repayment Programs OMB No. 0915-0127-Revision Friday, August 28, 2026 91 FR 55609
Proposed Data Collection Submitted for Public Comment and Recommendations Friday, August 28, 2026 91 FR 55594
Agency Forms Undergoing Paperwork Reduction Act Review Friday, August 28, 2026 91 FR 55593
Federal Independent Dispute Resolution Operations; Correction Friday, August 28, 2026 91 FR 55462
Agency Information Collection Activities; Proposed Collection; Comment Request; Qualitative Feedback on Agency Service Delivery Friday, August 28, 2026 91 FR 55600
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Importation of Prescription Drugs Friday, August 28, 2026 91 FR 55608
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Reporting Associated With Animal Drug and Animal Generic Drug User Fees Friday, August 28, 2026 91 FR 55606
Agency Information Collection Activities; Proposed Collection; Comment Request; Food Canning Establishment Registration, Process Filing, and Recordkeeping for Acidified Foods and Thermally Processed Low-Acid Foods in Hermetically Sealed Containers Friday, August 28, 2026 91 FR 55598
Agency Information Collection Activities; Proposed Collection; Comment Request; Focus Groups and Interviews as Used by the Food and Drug Administration Friday, August 28, 2026 91 FR 55596
Compounding Animal Drugs From Bulk Drug Substances: Compounding Under CGMP in Federally-Registered Facilities; Draft Guidance for Industry; Availability; Agency Information Collection Activities; Proposed Collection; Comment Request Friday, August 28, 2026 91 FR 55602
Submission for Office of Management and Budget Review; National and State Survey of Child and Adolescent Well-Being (NSSCAW): Site Recruitment and Baseline Data Collection Friday, August 28, 2026 91 FR 55596
Center for Scientific Review; Notice of Closed Meetings Thursday, August 27, 2026 91 FR 55351
Drugs for Human Use; Drug Efficacy Study Implementation: Estrogen-Androgen Fixed-Combination Drug Products; Second Extension of Effective Date of Final Resolution of Drug Efficacy Study Implementation 7661 Thursday, August 27, 2026 91 FR 55348
Agency Information Collection Activities: Proposed Collection; Comment Request Thursday, August 27, 2026 91 FR 55348
Center for Scientific Review; Notice of Closed Meetings Thursday, August 27, 2026 91 FR 55350
Center for Scientific Review; Amended Notice of Meeting Thursday, August 27, 2026 91 FR 55349
Notice of Award of a Sole Source Cooperative Agreement To Fund Vietnam Administration of Medical Services, National Institute of Medical Research, and ASEAN-Plus Field Epidemiology Training Network Foundation Thursday, August 27, 2026 91 FR 55347
Notice of Award of a Single Source Cooperative Agreement To Fund Elizabeth Glaser Pediatric AIDS Foundation Thursday, August 27, 2026 91 FR 55346
Center For Scientific Review; Notice of Closed Meetings Thursday, August 27, 2026 91 FR 55349
Hydroxymitragynine Above a Specified Threshold in Schedule I; Extension of Comment Period Wednesday, August 26, 2026 91 FR 55104
Meeting of the Microbiome Subcommittee of the Presidential Advisory Council on Combating Antibiotic-Resistant Bacteria Wednesday, August 26, 2026 91 FR 55103
Determination That CABAZITAXEL (Cabazitaxel) Solution (Injection), 60 Milligrams/6 Milliliters (10 Milligrams/Milliliter), Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness Wednesday, August 26, 2026 91 FR 55102
International Drug Scheduling; Single Convention on Narcotic Drugs; Convention on Psychotropic Substances; Clobromazolam (Phenazolam); Cychlorphine (N-Propionitrile Chlorphine); Desalkylgidazepam (Bromonordiazepam); Ethylbromazolam; Etomethazene (5-Methyl Etodesnitazene); Spirochlorphine (R6980); Etomidate; Medetomidine; Request for Comments Wednesday, August 26, 2026 91 FR 55098
Agency Information Collection Activities; Proposed Collection; Comment Request; Allegations of Regulatory Misconduct Voluntarily Submitted to the Center for Devices and Radiological Health Wednesday, August 26, 2026 91 FR 55101
Request for Information (RFI): Request for Information on New and Emerging Areas of Science Relevant to the NIDCD Mission, To Inform an Update of the NIDCD Strategic Plan for 2028-2032 Tuesday, August 25, 2026 91 FR 54874
National Institute of Diabetes and Digestive and Kidney Diseases; Amended Notice of Meeting Tuesday, August 25, 2026 91 FR 54875
Office of the Director, National Institutes of Health; Notice of Meeting Tuesday, August 25, 2026 91 FR 54874
National Heart, Lung, and Blood Institute; Notice of Closed Meeting Tuesday, August 25, 2026 91 FR 54875
National Heart, Lung, and Blood Institute; Notice of Meeting Tuesday, August 25, 2026 91 FR 54874
Request for Information: Categories Used in Federal Vaccine Recommendations and the Role of Shared Clinical Decision-Making Monday, August 24, 2026 91 FR 54724
Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 066 Monday, August 24, 2026 91 FR 54715
Product-Specific Guidances; Draft and Revised Draft Guidances for Industry; Availability Monday, August 24, 2026 91 FR 54722
Evaluation of Therapeutic Equivalence; Guidance for Industry; Availability Monday, August 24, 2026 91 FR 54721
Government Owned Invention Available for License: T Cell Receptors Targeting HPV 6 or HPV 11 Monday, August 24, 2026 91 FR 54728
Agency Information Collection Activities: Proposed Collection: Public Comment Request; Information Collection Request Title: Faculty Loan Repayment Program, OMB No. 0906-0082-Revision Friday, August 21, 2026 91 FR 54335
Agency Information Collection Activities: Proposed Collection; Comment Request Friday, August 21, 2026 91 FR 54328
Government Owned Invention Available for License: Matched Patient-Derived 3D Isocitrate Dehydrogenase (IDH)-Mutant Glioma Cell Lines for Modeling Malignant Transformation Friday, August 21, 2026 91 FR 54338
Center for Scientific Review; Notice of Closed Meetings Friday, August 21, 2026 91 FR 54337
Agency Information Collection Activities: Proposed Collection; Comment Request Friday, August 21, 2026 91 FR 54330
Agency Information Collection Activities: Proposed Collection; Comment Request Friday, August 21, 2026 91 FR 54331
Advisory Committee; Oncologic Drugs Advisory Committee; Renewal Friday, August 21, 2026 91 FR 54332
Agency Forms Undergoing Paperwork Reduction Act Review Thursday, August 20, 2026 91 FR 53871
Proposed Data Collection Submitted for Public Comment and Recommendations Thursday, August 20, 2026 91 FR 53869
Proposed Data Collection Submitted for Public Comment and Recommendations Thursday, August 20, 2026 91 FR 53867
Center for Scientific Review; Notice of Closed Meetings Thursday, August 20, 2026 91 FR 53887
Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request; Black Lung Clinics Program Performance Measures Thursday, August 20, 2026 91 FR 53884
Privacy Act of 1974; System of Records Thursday, August 20, 2026 91 FR 53873
Advisory Committee; Cardiovascular and Renal Drugs Advisory Committee; Renewal Thursday, August 20, 2026 91 FR 53882
Advisory Committee; Endocrinologic and Metabolic Drugs Advisory Committee; Renewal Thursday, August 20, 2026 91 FR 53876
Potency Assessment of Active Immunotherapy Products; Draft Guidance for Industry; Availability Thursday, August 20, 2026 91 FR 53880
Frequently Asked Questions-Developing Potential Cellular and Gene Therapy Products; Final Guidance for Industry; Availability Thursday, August 20, 2026 91 FR 53879
Center or Scientific Review; Notice of Closed Meetings Thursday, August 20, 2026 91 FR 53886
Center for Scientific Review; Notice of Closed Meetings Thursday, August 20, 2026 91 FR 53885
Privacy Act of 1974; System of Records Thursday, August 20, 2026 91 FR 53876
Agency Information Collection Activities: Proposed Collection; Comment Request Wednesday, August 19, 2026 91 FR 53620
Gardenia Blue Interest Group; Filing of Color Additive Petition Wednesday, August 19, 2026 91 FR 53545
International Association of Color Manufacturers; Filing of Color Additive Petition Wednesday, August 19, 2026 91 FR 53546
Food Additives Permitted in Feed and Drinking Water of Animals; Chromium DL-methionine Chelate Wednesday, August 19, 2026 91 FR 53524
GNT USA, LLC.; Filing of Color Additive Petition Wednesday, August 19, 2026 91 FR 53545
Agency Information Collection Activities: Proposed Collection: Public Comment Request; Information Collection Request Title: Voluntary Partner Survey on HRSA Customer Service, OMB No. 0906-0084-Revision Wednesday, August 19, 2026 91 FR 53623
Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request; Health Professions Student Loan Program, Loans for Disadvantaged Students Program, Primary Care Loan Program, and Nursing Student Loan Program Administrative Requirements, OMB No. 0906-0088-Extension Wednesday, August 19, 2026 91 FR 53624
Agency Information Collection Activities: Proposed Collection: Public Comment Request; Information Collection Request Title: Rural Maternity and Obstetrics Management Strategies Program Data Collection, OMB No. 0915-0394-Revision Wednesday, August 19, 2026 91 FR 53622
Notice of Award of a Sole Source Cooperative Agreement To Fund Ministry of Health Zambia Wednesday, August 19, 2026 91 FR 53621
Solicitation of Nominations for Appointment to the World Trade Center Health Program Scientific/Technical Advisory Committee Wednesday, August 19, 2026 91 FR 53620
Determining Whether To Submit an ANDA or a 505(b)(2) Application; Draft Guidance for Industry; Availability Tuesday, August 18, 2026 91 FR 53418
Testosterone Use in Menopausal Women; Public Workshop; Request for Comments Tuesday, August 18, 2026 91 FR 53417
Tribal Consultation Meeting Tuesday, August 18, 2026 91 FR 53416
Submission for Office of Management and Budget Review; ACF-700 Tribal Annual Report Tuesday, August 18, 2026 91 FR 53416
National Institute of Allergy and Infectious Diseases; Amended Notice of Meeting Tuesday, August 18, 2026 91 FR 53420
National Institute of Neurological Disorders and Stroke; Notice of Partially Closed Meeting Tuesday, August 18, 2026 91 FR 53420
Agency Information Collection Request; 30-Day Public Comment Request; Submission for Office of Management and Budget Review; Generic Clearance for the Trusted Exchange Framework and Common Agreement (TEFCA) Monitoring Activities Monday, August 17, 2026 91 FR 53272
Proposed Collection: 30-Day Comment Request; Specimen Resource Locator (National Cancer Institute) Monday, August 17, 2026 91 FR 53274
Withdrawal of the Announcement of the Intent To Award a Single-Source Cooperative Agreement to Burke Law Group, PLLC in Houston, Texas Monday, August 17, 2026 91 FR 53257
Notice of Award of a Sole Source Cooperative Agreement To Fund Public Health Center of the Ministry of Health of Ukraine Monday, August 17, 2026 91 FR 53251
Notice of Award of a Sole Source Cooperative Agreement To Fund University Teaching Hospital in Zambia Monday, August 17, 2026 91 FR 53257
Notice of Award of a Sole Source Cooperative Agreement To Fund the Ministry of Health of Ethiopia Monday, August 17, 2026 91 FR 53256
Medical Devices; Classification of Accessories Distinct From Other Devices; Proposed List of Accessories Suitable for Class I; Request for Comments Monday, August 17, 2026 91 FR 53205
Gastroenterology-Urology Devices; Reclassification of Diagnostic Endoscopic Light Source Systems To Be Renamed Cystoscopic Systems Intended as an Aid for Detection of Bladder Cancer Monday, August 17, 2026 91 FR 53209
Hematology and Pathology Devices; Reclassification of In Situ Hybridization Test Systems for Use With a Corresponding Approved Oncology Therapeutic Product Monday, August 17, 2026 91 FR 53184
Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals Monday, August 17, 2026 91 FR 53268
Agency Information Collection Activities; Proposed Collection; Comment Request; Investigational New Drug Application Requirements Monday, August 17, 2026 91 FR 53262
Agency Information Collection Activities; Proposed Collection; Comment Request; Third Party Disclosure and Recordkeeping Requirements for Reportable Food Monday, August 17, 2026 91 FR 53269
Determination of Regulatory Review Period for Purposes of Patent Extension; BIZENGRI Monday, August 17, 2026 91 FR 53261
Agency Information Collection Activities; Proposed Collection; Comment Request; Imports and Electronic Import Entries Monday, August 17, 2026 91 FR 53259
Type VII Veterinary Master File for Research and Development and Risk Reviews; Guidance for Industry; Availability Monday, August 17, 2026 91 FR 53257
Order Under Sections 362 and 365 of the Public Health Service Act Continuing the Suspension of the Right To Introduce Certain Persons From Countries Where a Quarantinable Communicable Disease Exists Monday, August 17, 2026 91 FR 53252
Proposed Collection; 60-Day Comment Request; Data Use Certification for the NIH National Institute on Drug Abuse Data Share Site Monday, August 17, 2026 91 FR 53273
National Institute on Alcohol Abuse and Alcoholism; Notice of Partially Closed Meeting Friday, August 14, 2026 91 FR 52709
Determination That ANSAID (Flurbiprofen) Tablets, 50 Milligrams and 100 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness Friday, August 14, 2026 91 FR 52708
Notice of Award of a Single Source Cooperative Agreement To Fund International Rescue Committee Friday, August 14, 2026 91 FR 52696
Reauthorization of the Prescription Drug User Fee Act; Public Meeting; Request for Comments Friday, August 14, 2026 91 FR 52702
Determination That LASIX (Furosemide) Tablets, 20 Milligrams, 40 Milligrams, and 80 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness Friday, August 14, 2026 91 FR 52702
Container Closure Systems for Human Drugs and Biological Products; Draft Guidance for Industry; Availability Friday, August 14, 2026 91 FR 52700
Regulatory Agenda Friday, August 14, 2026 91 FR 52992
Proposed Data Collections Submitted for Public Comment and Recommendations Friday, August 14, 2026 91 FR 52697
Submission for Office of Management and Budget Review; Administration for Children and Families Generic for Information Collections Related to Gatherings Friday, August 14, 2026 91 FR 52698
Government-Owned Inventions; Availability for Licensing Thursday, August 13, 2026 91 FR 52310
National Eye Institute; Notice of Meeting Thursday, August 13, 2026 91 FR 52310
Kremers Urban Pharmaceuticals, Inc.; Grant of Hearing Request Regarding a Proposal To Withdraw Approval of an Abbreviated New Drug Application for Extended-Release Methylphenidate Tablets Thursday, August 13, 2026 91 FR 52307
Agency Information Collection Activities: Proposed Collection; Public Comment Request: Information Collection Request Title: SAMHSA Data Security Requirements for Accessing Confidential Data (OMB No. 0930-0396) Thursday, August 13, 2026 91 FR 52312
Medicaid Program; Prohibition on Federal Medicaid and Children's Health Insurance Program Funding for Sex-Rejecting Procedures Furnished to Children Thursday, August 13, 2026 91 FR 52406
Medicare Program; Alternative Payment Model (APM) Incentive Payment Advisory for Clinicians-Request for Current Billing Information for Qualifying APM Participants Thursday, August 13, 2026 91 FR 52305
Center For Scientific Review; Notice of Closed Meetings Thursday, August 13, 2026 91 FR 52311
Agency Information Collection Activities: Proposed Collection; Comment Request Thursday, August 13, 2026 91 FR 52303
Formal Meetings Between the Food and Drug Administration and Sponsors or Applicants of Prescription Drug User Fee Act Products; Guidance for Industry; Availability Thursday, August 13, 2026 91 FR 52305
Government Owned Invention Available for License: MC38 B2m KO Cell Line Wednesday, August 12, 2026 91 FR 52062
Prospective Grant of an Exclusive Patent License: Development and Commercialization of BL-760 Dye for Intraoperative Fluorescence Imaging Wednesday, August 12, 2026 91 FR 52061
Government Owned Invention Available for License: Monoclonal Antibody (RO4) That Reacts With the Juxta-Membrane Region of Mesothelin Wednesday, August 12, 2026 91 FR 52064
Government Owned Invention Available for License: Human Antibodies Targeting Beneficial Viral Peptide in Liver Cancer Wednesday, August 12, 2026 91 FR 52060
Government Owned Invention Available for License: DNA Methylation-Based Cancer Diagnostics for Accurate Tumor Classification Wednesday, August 12, 2026 91 FR 52063
NIH Owned Invention Available for License: Soluble Tissue Factor, a Novel Target, and Antibodies, for Diagnosis, Prevention and Treatment of Thrombosis and Related Conditions Wednesday, August 12, 2026 91 FR 52066
Government Owned Invention Available for License: Quantitative Particle Identification (QPID) Digital Autoradiography System Wednesday, August 12, 2026 91 FR 52065
NIH Owned Invention Available for License: Drug-Regulatable, Inducible Expression of Membrane-Bound Interleukin 12 (DRIM-IL-12) for Use in Adoptive Cell Therapy Wednesday, August 12, 2026 91 FR 52063
Guide To Minimize Biological Hazards in Ready-to-Eat Fresh-Cut Produce; Guidance for Industry; Availability Wednesday, August 12, 2026 91 FR 52011
Adoption and Foster Care Analysis and Reporting System Wednesday, August 12, 2026 91 FR 52038
Solicitation of Nominations for Membership on the National Vaccine Advisory Committee Wednesday, August 12, 2026 91 FR 52060
National Newborn Screening Stakeholder Workgroup Wednesday, August 12, 2026 91 FR 52059
Announcement of the Intent To Award Sole-Source Awards to the Federated States of Micronesia and the Republic of the Marshall Islands Wednesday, August 12, 2026 91 FR 52058
Agency Information Collection Activities: Proposed Collection; Comment Request Wednesday, August 12, 2026 91 FR 52057
Center for Scientific Review; Notice of Closed Meetings Wednesday, August 12, 2026 91 FR 52066
Medicare Program; Regulatory Alignment for Predictable and Immediate Device (RAPID) Coverage Pathway Tuesday, August 11, 2026 91 FR 51710
Reauthorization of the Generic Drug User Fee Amendments; Public Meeting; Request for Comments Tuesday, August 11, 2026 91 FR 51718
Notice of Availability of Final Health Center Program Scope of Project Policy Manual Guidance Tuesday, August 11, 2026 91 FR 51722
Proposed Collection; 60-Day Comment Request Generic Clearance for the Collection of Customer Participation and Performance Management With NIH Programs, Products, and Services (Office of the Director) Tuesday, August 11, 2026 91 FR 51723
Substances Generally Recognized as Safe Tuesday, August 11, 2026 91 FR 51834
Office of the Director, Notice of Charter Renewal Monday, August 10, 2026 91 FR 51499
Determination That OZOBAX (Baclofen) Oral Solution, 5 Milligrams/5 Milliliters Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness Monday, August 10, 2026 91 FR 51492
Determination of Regulatory Review Period for Purposes of Patent Extension; BRINSUPRI Monday, August 10, 2026 91 FR 51493
Determination of Regulatory Review Period for Purposes of Patent Extension; DAYVIGO Monday, August 10, 2026 91 FR 51494
Molecular and Clinical Genetics Panel of the Medical Devices Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments-GRAIL, Inc. Galleri Monday, August 10, 2026 91 FR 51496
Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request; Transforming Pediatrics for Early Childhood Program Performance Measures Monday, August 10, 2026 91 FR 51498
Radiology Devices; Reclassification of Digital Breast Tomosynthesis System Monday, August 10, 2026 91 FR 51406
National Institute on Deafness and Other Communication Disorders; Notice of Meeting Monday, August 10, 2026 91 FR 51501
National Institute on Deafness and Other Communication Disorders; Notice of Closed Meeting Monday, August 10, 2026 91 FR 51501
Agency Information Collection Activities: Proposed Collection; Comment Request Monday, August 10, 2026 91 FR 51502
Submission for Office of Management and Budget Review; National Communication System for Runaway and Homeless Youth, Currently Operated by the National Runaway Safeline Data Collection Friday, August 7, 2026 91 FR 51174
Privacy Act of 1974; System of Records Friday, August 7, 2026 91 FR 51174
National Eye Institute; Notice of Closed Meeting Friday, August 7, 2026 91 FR 51176
Center for Scientific Review; Notice of Closed Meetings Friday, August 7, 2026 91 FR 51177
Submission for 0MB Review; 30-Day Comment Request Friday, August 7, 2026 91 FR 51175
Reducing Federal Burden for Head Start Programs Friday, August 7, 2026 91 FR 51248
Notice of Award of a Single Source Cooperative Agreement To Fund Institute of Epidemiology, Disease Control and Research, Bangladesh; National Institute of Public Health, Cambodia; Institut Pasteur de Madagascar; National Health Laboratory Service, South Africa; L.Sakvarelidze National Center for Disease Control and Public Health, Georgia. Friday, August 7, 2026 91 FR 51173
Announcement of the Intent To Award a Single-Source Cooperative Agreement to Burke Law Group, PLLC in Houston, Texas Thursday, August 6, 2026 91 FR 50848
Proposed Collection; 60-Day Comment Request: The Impact of Clinical Research Training and Medical Education at the Clinical Center on Physician Careers in Academia and Clinical Research (Clinical Center) Thursday, August 6, 2026 91 FR 50864
National Institute of Dental & Craniofacial Research; Notice of Meeting Thursday, August 6, 2026 91 FR 50863
Agency Information Collection Activities: Proposed Collection: Public Comment Request; Information Collection Request Title: Organ Procurement and Transplantation Network Board of Directors and Committee Member Applications and Forms Thursday, August 6, 2026 91 FR 50861
Proposed Data Collection Submitted for Public Comment and Recommendations Thursday, August 6, 2026 91 FR 50845
Agency Forms Undergoing Paperwork Reduction Act Review Thursday, August 6, 2026 91 FR 50846
Agency Forms Undergoing Paperwork Reduction Act Review Thursday, August 6, 2026 91 FR 50843
Agency Forms Undergoing Paperwork Reduction Act Review Thursday, August 6, 2026 91 FR 50842
Authorization of Emergency Use of an In Vitro Diagnostic Device in Response to an Outbreak of Mpox; Availability Thursday, August 6, 2026 91 FR 50848
Medical Devices; Radiology Devices; Classification of the Fludeoxyglucose F18-Guided Radiation Therapy System Thursday, August 6, 2026 91 FR 50708
Evaluating the Safety of Antimicrobial New Animal Drugs With Regard to their Microbiological Effects on Bacteria of Human Health Concern; Guidance for Industry; Availability Thursday, August 6, 2026 91 FR 50860
Center for Scientific Review; Notice of Closed Meeting Thursday, August 6, 2026 91 FR 50863
Micro-Tracers, Inc.; Response to Objections and Requests for a Public Hearing Wednesday, August 5, 2026 91 FR 50475
Center for Scientific Review; Notice of Closed Meetings Wednesday, August 5, 2026 91 FR 50556
Notice of Award of a Single Source Grant To Fund Fundacion Mexico-Estados Unidos Para La Ciencia, A.C. Wednesday, August 5, 2026 91 FR 50543

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