On July 3, 2026, the U.S. Office of Information and Regulatory Affairs (OIRA), within the Office of Management and Budget (OMB), released the government’s 2026 Regulatory Plan and Unified Agenda of Federal Regulatory and Deregulatory Actions (Unified Agenda). The Unified Agenda includes proposed rules, guidance, and other actions federal agencies currently plan to advance within the next 12 months. It’s published online at reginfo.gov.
Several Department of Health and Human Services (DHHS) entries could materially change how clinical research is designed, authorized, overseen, documented, and supported after approval. Overall, DHHS appears to be moving toward faster, more risk-based, centralized, and technology-enabled research, potentially with greater reliance on documented organizational judgment.
It’s important to note, however, that inclusion in the Unified Agenda doesn’t mean that a described policy action is already effective or will definitely be published or finalized. Clinical research leaders should view the Unified Agenda as a planning and transparency tool.
The challenge is knowing which planned actions justify preparation now, which require only monitoring, and which may never emerge in their current form. Organizations may want to assess preparedness for key actions, but they should wait to actively adapt to proposed changes until the final text is published.
This article focuses on the actions most likely to matter to the clinical research community. Here is what research organizations should watch and what they can prepare for now.
What does an entry in the Unified Agenda actually mean?
The Unified Agenda is compiled by the Regulatory Information Service Center within OIRA and reports regulatory and deregulatory activities under development.
Inclusion in the Unified Agenda signals that an action is among the government’s more significant stated priorities, though it doesn’t guarantee the action will be completed or finalized.
For actions that include a proposed rulemaking, the process involves two pathways: informal and formal. Informal rulemaking is the most common process and involves an agency publishing a proposed rule with a request for the public to comment. The agency reviews these comments before issuing a final rule. Research professionals might think of it as a public feedback process used to develop most regulations.
Formal rulemaking is much less common and resembles a court proceeding. It requires trial-like hearings, witness testimony, and a formal record before a rule can be issued. Congress must specifically require this more rigorous process in the statute authorizing the rulemaking. For example, an informal rulemaking by the Food and Drug Administration (FDA) might include revising its food labeling regulations (e.g., updates to the required Nutrition Facts label). By contrast, a formal rulemaking on food and color additives would require a formal evidentiary public hearing (e.g., 21 Code of Federal Regulations [CFR] 12).
The Unified Agenda assigns each action a regulation identifier number (RIN) as a permanent tracking identifier as the action progresses through the review process. Each listed action is also assigned a stage:
- An action labeled “proposed rule stage” means the agency expects a notice of proposed rulemaking (NPRM) or a related comment-period action.
- An action labeled “final rule stage” means the agency anticipates final or other concluding action.
An action’s agenda date estimates when the action will likely be published. These dates can change, and they should not be interpreted as effective or compliance dates. Because of this, the Agenda is best used as a regulatory early-warning tool.
Five regulatory shifts, not two dozen disconnected rules
To help clinical research leaders understand the 2026 Unified Agenda’s potential key impacts, this article categorizes key DHHS actions into five regulatory shifts.
(Note: These regulatory shifts are an organizing structure created for this blog. DHHS does not explicitly use or recommend these categories.)
For each shift, this article suggests potential risks and benefits of the planned actions. These possible risks and benefits are drawn from our assessment of the Agenda and other publicly available information. They’re offered as reasoned possibilities to support assessment and preparation.
Shift 1: Human subject oversight could become more explicitly risk-based
OHRP 0937-AA16: Human Research Protections: Exemptions and Clarifying Provisions Related to Institutional Review Board Oversight
Agenda date for NPRM: July 2026*
The Office for Human Research Protections (OHRP) is considering revising 45 CFR 46 to include additional exemptions for low-risk research and flexibility for review of de minimis protocol changes. This change may also clarify concepts (e.g., undue influence) and might make changes to reduce burdens for learning health systems and clinically integrated research. The agency appears to be planning to concentrate oversight resources on higher-risk activities.
FDA 0910-AI08: Institutional Review Boards; Cooperative Research
Agenda date for final rule: December 2026
FDA’s final-stage cooperative research action would require U.S. institutions participating in FDA-regulated multisite research to rely on a single institutional review board (sIRB) for the U.S. portion of the research (unless certain exemption criteria are met) and would add a recordkeeping requirement for institutions relying on an outside institutional review board (IRB). FDA released the NPRM for this action in September 2022. (Learn more about this proposed rule in our blog.)
Relatedly, FDA released a second NPRM in September 2022 proposing to harmonize certain aspects of FDA regulations (21 CFR 50 and 56) and the Common Rule (45 CFR 46). The associated final rule (RIN 0910-AI07) is included in a separate list of long-term actions and is targeted for July 2027.
Shift 2: Early development could move faster, and accountability may become more important
FDA 0910-AJ30: Amendments to 21 CFR Parts 56 and 312; Expedited Investigational New Drug Application for Phase 1 Clinical Trial Reform
Agenda date for NPRM: July 2026*
FDA’s planned expedited Phase 1 action could potentially revise the investigational new drug (IND) process and application, sponsor responsibilities, risk-based exemptions and/or flexibilities, and elements of the IRB regulations. The agency’s objective is to accelerate access and reduce disproportionate burden while maintaining human subject protections. FDA also acknowledges potential risks from inconsistent sponsor interpretation, safety concerns, and data quality problems.
FDA 0910-AJ13: Responsibilities of Sponsors and Investigators for Clinical Investigations of Human Drugs and Biological Products
Agenda date for NPRM: December 2026
These planned changes to sponsor and investigator responsibilities would update 21 CFR 312 subpart D to reflect the modern trial ecosystem, with the goal of improving clinical trial quality, protecting participants, preserving reliable results and U.S.-based trial conduct, and aligning more closely with global regulatory expectations.
FDA 0910-AH07: Investigational New Drug Applications; Exemptions for Clinical Investigations to Evaluate a Drug Use of a Product Lawfully Marketed as a Conventional Food, Dietary Supplement, or Cosmetic
Agenda date for final rule: July 2026*
This final-stage action around marketed products would broaden and clarify the criteria for studies that are exempt from IND requirements and when studies evaluating drug uses of products already lawfully marketed as conventional foods, dietary supplements, or cosmetics are subject to IND review.
FDA 0910-AI57: Conduct of Analytical and Clinical Pharmacology, Bioavailability, and Bioequivalence Studies
Agenda date for NPRM: September 2026
The proposed action concerning clinical pharmacology and clinical and analytical bioavailability/bioequivalence (BA/BE) studies could change study conduct requirements. FDA is proposing to amend 21 CFR 320, in certain parts, and establish a new 21 CFR 321 to clarify FDA’s study conduct expectations for analytical and clinical pharmacology, bioavailability (BA), and bioequivalence (BE) studies that support marketing applications for human drug and biological products. FDA notes such a change could help provide the agency with the information needed to ensure appropriate study conduct and reliable study data.
Shift 3: FDA may rethink the foundation of electronic research records
FDA 0910-AJ25: Amendment of Regulations on Electronic Records and Electronic Signatures
Agenda date for NPRM: September 2026
FDA intends to streamline and modernize 21 CFR 11 while retaining requirements supporting the reliability, authenticity, and integrity of electronic records and signatures.
OCR 0945-AA00: HIPAA Privacy Rule: Changes to Support Coordinated Care and Individual Engagement and Reduce Regulatory Burdens
Agenda date for final rule: August 2026*
This Health Insurance Portability and Accountability Act (HIPAA) action proposed by the Office for Civil Rights (OCR) involves strengthening individuals’ rights to access their own protected health information (PHI), improving information sharing, and other concerns related to patient access.
OCR 0945-AA28: HIPAA Privacy Rule to Promote Individuals’ Timely Access to their Protected Health Information
Agenda date for NPRM: November 2026
OCR’s related proposal would address the amount of time that covered entities have to respond to requests for PHI.
ONC 0955-AA10: Health Data, Technology, and Interoperability: Application Programming Interfaces and Information Blocking
Agenda date for NPRM: November 2026
This Office of the National Coordinator for Health IT (ONC) action seeks to advance system interoperability, expand uses of application programming interfaces (APIs), and enhance conditions of certification. It would also seek to update information blocking regulations to support information sharing and improved patient health outcomes.
Shift 4: The regulatory story continues after product approval
FDA 0910-AI61: Postmarketing Safety Reporting Requirements, Pharmacovigilance Plans, and Pharmacovigilance Quality Systems for Human Drug and Biological Products
Agenda date for NPRM: July 2026*
FDA’s proposed pharmacovigilance action seeks to modernize postmarketing safety reporting, improve the quality and utility of reports, align with international standards, and require covered application holders to maintain a pharmacovigilance quality system. Note that this proposed rule previously appeared in the 2022 and 2025 Unified Agendas.
FDA 0910-AH55: Supplemental Applications and Certain Postapproval Reporting Requirements for Drug and Biological Products
Agenda date for NPRM: November 2026
FDA’s postapproval reporting action would update rules governing changes to approved new drug applications (NDAs), abbreviated new drug applications (ANDAs), and biologic license applications (BLAs), as well as certain postapproval reports.
FDA 0910-AH68: Medication Guide; Patient Medication Information
Agenda date for final rule: December 2026
FDA’s patient medication information (PMI) action intends to establish standardized patient labeling for outpatient prescription drugs and certain blood products.
Shift 5: Narrower actions may have major consequences for specialized programs
Examples:
- CDC 0920-AA85: Import Regulations for Infectious Biological Agents, Infectious Substances, Vectors, and Nucleic Acids Capable of Producing Infectious Viruses. Agenda date for NPRM: November 2026.
- CMS 0938-AV89: Clinical Laboratory Improvement Amendments of 1988 (CLIA) Virtual Access, Gynecologic Cytology Proficiency Testing (PT), Personnel Qualification Requirements, and Other Changes (CMS-3478). Agenda date for NPRM: September 2026.
- CMS 0938-AV90: Medicare Drug Price Negotiation Program (CMS-4215) (Section 610 Review). Agenda date for NPRM: July 2026*.
- FDA 0910-AI89: Pediatric Study Plan Requirements for New Drug and Biologics License Applications. Agenda date for NPRM: November 2026.
- FDA 0910-AJ01: Good Laboratory Practice for Nonclinical Laboratory Studies. Agenda date for NPRM: August 2026*.
- FDA 0910-AI14: Biologics Regulation Modernization. Agenda date for NPRM: October 2026.
- FDA 0910-AJ27: Nonclinical Testing Terminology. Agenda date for NPRM and direct final rule: December 2026.
While these actions may affect a more targeted segment of the clinical research community, they could be highly consequential for:
- Gene therapy and infectious disease programs.
- Organizations importing biological materials.
- Pediatric and rare disease development.
- Products intended to be marketed to Medicare recipients.
- Laboratories compliant with Good Laboratory Practice (GLP) and organizations conducting nonclinical research.
- Research laboratories returning individual results.
- Biologics and biosimilar developers.
Note: The National Institutes of Health (NIH)-specific rulemaking is not a principal theme in this Agenda. NIH-funded organizations may be affected more substantially through OHRP/Common Rule changes, FDA rules, grant conditions, and NIH policies that do not necessarily appear as legislative rules in the Unified Agenda.
What signals matter more than the agenda date?
For contract research organizations (CROs) seeking to prepare for the Unified Agenda’s proposed actions, monitor the following:
- OIRA review activity
- Federal Register publication
- Proposed regulatory text
- Docket questions and comment deadlines
- Final-rule effective and compliance dates
- Agency guidance, FAQs, templates, or enforcement statements
- Litigation or statutory developments
- Changes to an action’s stage or date in later Agenda editions
Preparation now can pay off later
The 2026 DHHS Unified Agenda suggests a potentially significant shift toward more risk-based, centralized, and technology-enabled research oversight. These proposed changes could reduce unnecessary burden and support faster research, as long as organizations preserve clear accountability, defensible judgment, reliable records, and strong participant protections.
To prepare for these myriad changes, establish a coordinated watchlist for the individual RINs most relevant to an organization’s unique priorities, needs, and regulatory compliance requirements. Consider identifying internal owners for each relevant Agenda item. Assess (or reassess) internal readiness when proposed or final text is published.
Have questions about the Unified Agenda or another regulation? Contact us for support.
*As of September 8, 2026, no additional information has been published regarding this Agenda item.
