The Federal and Congressional Scoop on Research (May 2026)

Access S.P.I.R.I.T.: The Federal and Congressional Scoop on Research (May 2026)

References

1. Rule: Medical Devices: General and Plastic Surgery Devices; Classification of the Phototherapy Device for Reducing the Appearance of Acute Post-Surgical Incisions (FDA Federal Register)
2. Notice: List of Bulk Drug Substances for Which There Is a Clinical Need under the Federal Food, Drug, and Cosmetic Act (FDA Federal Register)
3. Notice: Medical Devices: Exemptions from Premarket Notification: Certain Class II Devices (FDA Federal Register)
4. Notice: Obesity and Drug Dosing: Clinical Pharmacology Considerations (FDA Federal Register)
5. Notice: Request for Information: Impacts of Patient-Focused Drug Development Meetings; Establishment of a Public Docket (FDA Federal Register)
6. FDA Approves First Non-Antipsychotic Drug to Treat Agitation Associated with Dementia (FDA Press Release)
7. FDA Permits Expanded Access for Investigational Pancreatic Cancer Drug (FDA Press Release)
8. Rule: Medical Devices: Immunology and Microbiology Devices; Classification of the Circulating Tumor Cell Enrichment Device (FDA Federal Register)
9. Rule: Medical Devices: Immunology and Microbiology Devices; Classification of the Device to Preserve and Stabilize Relative Abundances of Microbial Nucleic Acids in Clinical Samples (FDA Federal Register)
10. Rule: Medical Devices: Ophthalmic Devices; Classification of the Corneal Storage Medium With Preservatives Including Antifungals (FDA Federal Register)
11. FDA Launches One-Day Inspectional Assessments to Strengthen and Expand Oversight (FDA Press Release)
12. Chemistry, Manufacturing, and Controls Flexibilities for Developing Human Cellular and Gene Therapy Products for a Biologics License Application: Guidance for Industry (FDA Final Guidance Document)
13. Notice: Guidance: Patient-Matched Guides for Orthopedic Implants (FDA Federal Register)
14. Patient-Matched Guides for Orthopedic Implants: Guidance for Industry and Food and Drug Administration Staff (FDA Final Guidance Document)
15. FDA Expands AI Capabilities and Completes Data Platform Consolidation (FDA Press Release)
16. Rule: Medical Device: Obstetrical and Gynecological Devices; Classification of the External Condom for Anal Intercourse or Vaginal Intercourse (FDA Federal Register)
17. Adding weekly GLP-1 to cognitive behavioral therapy further reduces heavy drinking (NIH Intramural News)
18. New Video Overview for NIH’s Collaborative International Research Projects (PF5) (NIH Extramural News)
19. Selecting the Right Models for Your Research: A Focus on New Approach Methodologies (NAMs) (NIH Extramural News)
20. NIH-funded study suggests that testosterone suppresses brain tumor growth in males (NIH Intramural News)
21. Oral small-molecule GLP-1 drugs penetrate deep into the brain to suppress cravings (NIH Intramural News)
22. WTAS: FDA Announces Major Steps to Implement Real-Time Clinical Trials (HHS Press Release)
23. Notice: Findings of Research Misconduct (HHS Federal Register)
24. Research Misconduct Finding: Ariel Fernandez (HHS ORI Update)
25. HHS Launches MAHA Action Plan to Curb Psychiatric Overprescribing (HHS Press Release)
26. Proposed Rule: Modification of Certain Terminology (HHS Federal Register)
27. ARPA-H Launches New Program to Deliver Rigorous, Gold-Standard Research Faster (HHS Press Release)
28. Artificial Intelligence: Uses and Risks for Small Business Contracting and Innovation Research (GAO Report)
29. M-26-13 Reopening the Department of Homeland Security (OMB Memoranda)
30. Chairman Babin, Subcommittee Chairman Weber Applaud Committee Passage of National Quantum Initiative Reauthorization Act (House Committee on Space, Science, and Technology Press Release)
31. Savings from Most-Favored-Nation Drug Pricing Policy (White House News)
32. Notice: Guidance: Clostridioides difficile Infection: Developing Drugs for Treatment, Reduction of Recurrence, or Prevention (FDA Federal Register)
33. Clostridioides difficile Infection: Developing Drugs for Treatment, Reduction of Recurrence, and Prevention (FDA Final Guidance Document)
34. Notice: Guidance: Postapproval Pregnancy Safety Studies (FDA Federal Register)
35. Postapproval Pregnancy Safety Studies (FDA Final Guidance Document)
36. Notice: Guidance: Pulmonary Tuberculosis: Developing Drugs for Treatment (FDA Federal Register)
37. Pulmonary Tuberculosis: Developing Drugs for Treatment (FDA Final Guidance Document)
38. Rule: Nondiscrimination on the Basis of Disability; Accessibility of Web Content and Mobile Applications of Recipients of Departmental Financial Assistance; Extension of Compliance Dates (HHS Federal Register)
39. Rule: Medical Devices: Immunology and Microbiology Devices; Classification of the Device to Detect and Identify Microorganism Nucleic Acids and Resistance Markers from Patients with Suspected Orthopedic Infection (FDA Federal Register)
40. Notice: 21st Century Cures Act: Annual Compilation of Notices of Updates from the Susceptibility Test Interpretive Criteria Web Page (FDA Federal Register)
41. Notice: Request for Information: Drug Repurposing for Unmet Medical Needs (FDA Federal Register)
42. FDA Advances Drug Repurposing to Address Unmet Medical Needs (FDA Press Release)
43. Rule: Restoring Flexibility in the Child Care and Development Fund (HHS Federal Register)
44. Trump Administration Launches Moms.Gov for New and Expecting Mothers (HHS Press Release)
45. President Trump Honors America’s Moms with New Support for Families (White House News)
46. HHS Supports Repatriation of U.S. Citizens to Specialized Care Facilities (HHS Press Release)
47. FDA Grants Seventh Approval under the National Priority Voucher Pilot Program (FDA Press Release)
48. Consolidate Your eRA Commons Accounts with New Feature (NIH Extramural News)
49. An Update on How NIH Protects NIH-Funded Research from Undue Foreign Interference (NIH Extramural News)
50. Researchers develop innovative model for risk assessment for hypertrophic cardiomyopathy (NIH Intramural News)
51. NIH-funded study maps human pancreatic islet cells, offering new clues to diabetes risk (NIH Intramural News)
52. Notice: Request for Information: Azodicarbonamide (ADA) (FDA Federal Register)
53. Notice: Request for Information: Butylated hydroxytoluene (BHT) (FDA Federal Register)
54. FDA Finalizes Food Chemical Safety Post-Market Assessment Program, Launches Reassessment of BHT, ADA (FDA Press Release)
55. Notice: Request for Information: Biomarker Incubator: Urinary Kidney Safety Biomarkers (FDA Federal Register)
56. Proposed Rule: Excepted Fertility Benefits (HHS Federal Register)
57. HHS Announces Heartland Forward MOU to Advance Maternal Health (HHS Press Release)
58. (GENERAL-26-27) Technology Security Alert – Ongoing Cybersecurity Incident Involving the Canvas Learning Management System (Federal Student Aid Announcement)
59. What to know after the Canvas cyberattack (FTC Consumer Alert)
60. Chairman Cassidy, Tuberville Seek Answers on Canvas Cybersecurity Incident, Calls for More Safeguards to Protect Students (SENATE Help Committee Press Release)
61. Notice: Delegation of Authority: Agency for Healthcare Research and Quality (HHS Federal Register)
62. SAMHSA Awards $255 Million to Administer 988 Lifeline (HHS Press Release)
63. ORI is Currently Reviewing 2026 Co-sponsorship Expressions of Interest (ORI Update)
64. NIH-supported project expands access to care for children with amblyopia (NIH Intramural News)
65. Helpful Reminders to Ensure Integrity of NIH-Supported Research When Using Artificial Intelligence (NIH Extramural News)
66. Chairmen Cassidy, Walberg, Moolenaar, Banks Sound Alarm on Chinese Communist Party Infiltrating American Universities, Threatening National Security (Senate HELP Committee Press Release)
67. HHS Announces Restructuring of its Office for Civil Rights (HHS Press Release)
68. Secretary Kennedy Brings ‘Take Back Your Health’ Tour to California, Highlights Microbiome Research and Addiction Recovery (HHS Press Release)
69. Fact Sheet: President Donald J. Trump Announces Expansion of TrumpRx.gov to Bring Americans Transparency and Choice on Everyday Medicines (White House News)
70. Rule: Patient Protection and Affordable Care Act: HHS Notice of Benefit and Payment Parameters for 2027; and Basic Health Program (HHS Federal Register)
71. Notice: Requirements and Registration for `EHIgnite Challenge’ (HHS Federal Register)
72. HHS, USDA Announce Investments to Expand Protein Access, Strengthen Cold Chain Infrastructure (HHS Press Release)
73. Telecommunications: Selected Agencies Have Taken Steps to Address Risks of Equipment Linked to China (GAO Report)
74. Science & Tech Spotlight: Privacy Enhancing Technologies (GAO Report)
75. HHS Launches Phase 1 of the Cultivating Connected Communities Challenge (HHS Press Release)
76. Secretary Kennedy Announces HHS Action to Reduce Harmful Screen Use and Protect Children Online (HHS Press Release)
77. Reinforcing NIH’s Continued Commitment to Fundamental Research (NIH Extramural News)
78. Artificial Intelligence: A Framework to Assess U.S. Competitiveness and Inform Policy Options (GAO Report)
79. Privacy and Cybersecurity: VA Has Made Progress Enhancing Security Controls for Protected Health Information (GAO Report)
80. Federal Research: Agencies Should Better Manage Anticipated Publishing Cost Increases Amid Shift to Public Access (GAO Report)
81. Notice: Guidance: M11 Clinical Electronic Structured Harmonised Protocol; International Council for Harmonisation (FDA Federal Register)
82. M11 Clinical Electronic Structured Harmonised Protocol (FDA Final Guidance Document)
83. HHS Cracks Down on Years of Unchecked Audit Findings (HHS Press Release)
84. FDA Approves First Treatment for Chronic Hepatitis Delta Virus (HDV) Infection (FDA Press Release)
85. Assessing the Effects of Food on Drugs in INDs and NDAs – Clinical Pharmacology Considerations (FDA Final Guidance Document)
86. NIH researchers identify avenue for enhanced GLP-1-induced weight loss (NIH Intramural News)
87. Implementing SimplerNOFO at NIH: A Clearer, Simpler Path for Applicants (NIH Extramural News)
88. Looking for Animal Welfare Content? OLAW has moved to NIH Grants and Funding! (NIH Extramural News)
89. M-26-14 Ensuring Effective and Efficient Agency Logging and Network Visibility to Defend Against Evolving Cyber Threats  (OMB Memoranda)
90. Rule: Medical Device: Gastroenterology-Urology Devices; Classification of the Endoscopic Suturing Device for Altering Gastric Anatomy for Weight Loss (FDA Federal Register)
91. Notice: Request for Information: AI-Enabled Optimization of Early-Phase Clinical Trials Pilot Program (FDA Federal Register)
92. NOT-OD-26-084: Reminder – Definition of Foreign Components (NIH Policy Notice)
93. FY25 Enrollment Data from NIH-Supported Clinical Research Now Available (NIH Extramural News)
94. Rule: Medical Devices: Neurological Devices; Classification of the Transcutaneous Electrical Nerve Stimulator to Treat Fibromyalgia Symptoms (FDA Federal Register)
95. Notice: Guidance: Bioequivalence Studies with Pharmacokinetic Endpoints for Drugs Submitted under an Abbreviated New Drug Application (FDA Federal Register)
96. Bioequivalence Studies With Pharmacokinetic Endpoints for Drugs Submitted Under an Abbreviated New Drug Application (FDA Final Guidance)
97. Notice: Guidance: Content of Human Factors Information in Medical Device Marketing Submissions (FDA Federal Register)
98. Content of Human Factors Information in Medical Device Marketing Submissions: Guidance for Industry and Food and Drug Administration Staff (FDA Final Guidance)
99. Notice: Guidance: Statistical Approaches to Establishing Bioequivalence (FDA Federal Register)
100. Statistical Approaches to Establishing Bioequivalence (FDA Final Guidance)
101. Proposed Rule: Regulation for Federal Financial Assistance (HHS Federal Register)
102. New Guidance Documents Available (ORI Update)