HHS, NRC, and FWS Issue Guidance, Policy Proposals, and Regulatory Corrections Across Five Federal Actions

FDA Draft Guidance: Robotically-Assisted Surgical Devices

The Food and Drug Administration is announcing the availability of a draft guidance titled "Robotically-Assisted Surgical Devices--Premarket Submissions," which provides draft recommendations for premarket submissions for robotically-assisted surgical devices (RASDs). According to the document, RASDs are teleoperated, software-controlled systems that integrate robotic technologies and subassemblies designed to assist qualified practitioners in precisely positioning and controlling multiple surgical instruments to safely and effectively perform open, minimally invasive, or endoluminal procedures. The draft recommendations cover non-clinical and clinical testing as well as premarket submission content for these devices.

The agency states that the draft recommendations reflect FDA's current thinking and are intended to promote consistency and facilitate efficient review of premarket submissions. The guidance is being issued consistent with FDA's good guidance practices regulation at 21 CFR 10.115. The document notes that, as FDA develops final guidance, it will consider comments on costs or cost savings the guidance may generate, which the agency identifies as relevant to Executive Order 14192. The draft guidance, when finalized, will represent FDA's current thinking but does not establish any rights for any person and is not binding on FDA or the public; the document states that an alternative approach may be used if it satisfies applicable statutes and regulations. Comments must be submitted by November 24, 2026.

NIH Proposes Policy to Share Study Results Directly With Clinical Trial Participants

The National Institutes of Health is seeking public input on a proposed NIH Policy on Sharing Summary Level Study Results with Clinical Research Participants. The policy, as described in the notice, would set clear requirements for sharing summary level study results in plain language with participants, unless justifiably not appropriate. NIH states that the goal is to ensure that clinical research participants are responsibly informed about outcomes and overall results in ways that are understandable and meaningful to them.

The notice explains that existing NIH efforts—including the NIH Policy for Data Management and Sharing, the NIH Policy on the Dissemination of NIH-Funded Clinical Trial Information (requiring results reporting in ClinicalTrials.gov), and the NIH Public Access Policy—have largely focused on sharing data with the scientific community rather than directly with participants. NIH states that inconsistency in practice across the research enterprise leaves a significant gap. The agency further states that sharing results can help build trust and communication between researchers and participants, improve participant recruitment and retention rates, enhance clinical research study design and feasibility, and ensure health discoveries are meaningful, accessible, and understandable. The notice also states that establishing this policy as standard practice directly supports the goals of HHS's Operation TrialBlazer, which seeks to strengthen America's leadership in clinical research. The notice references the Novel and Exceptional Technology and Research Advisory Committee as having identified returning research results as one important strategy for returning value to research participants. Comments must be submitted on or before October 26, 2026.

CMS Seeks Comment on Medicaid and CHIP Generic Information Collections

The Centers for Medicare & Medicaid Services is soliciting public comment on several information collection requests under the Medicaid and CHIP generic clearance process, operating under OMB control number 0938-1148. CMS notes that OMB initially approved use of the generic clearance process on October 23, 2011, and that it was last approved on April 26, 2021 via the standard Paperwork Reduction Act process. The current umbrella covers Medicaid and CHIP state plan amendments, waivers, demonstrations, and reporting.

Five specific collections are described. First, the Model Application Template for State Child Health Plan Under Title XXI is being revised to add an assurance that the state Medicaid agency does not make payment for sex-rejecting procedures for children under the age of 19, with 41 respondents, 112 total annual responses, and 448 total annual hours. Second, the Medicaid Managed Care Rate Development Guide is being revised; CMS is required to annually publish this guide, which outlines rate development standards and documentation expectations for rate certifications, with 47 respondents, 137 total annual responses, and 1,233 total annual hours. Third, a new Sex-Rejecting Procedures Medicaid State Plan Amendment Template is being introduced, associated with CMS's August 13, 2026, final rule (CMS-2451-F), to allow states to add an assurance that the Medicaid agency does not claim federal financial participation for sex-rejecting procedures for children under the age of 18, with 56 respondents, 56 total annual responses, and 168 total annual hours. Fourth, new Medicaid Emergency Response Templates are being introduced; CMS explains that earlier templates included COVID-19 Public Health Emergency flexibilities that are no longer in effect, and the 2026 templates are designed to be usable for all future public health emergencies, with 33 respondents, 33 total annual responses, and 62 total annual hours. Comments must be received by October 9, 2026.

NRC Sunshine Act Meetings: Reorganization Review Scheduled

The Nuclear Regulatory Commission has published its Sunshine Act meeting schedule covering the weeks of September 28 through November 2, 2026. Two specific public meetings are listed. An All Employees Meeting is scheduled for Tuesday, September 29, 2026, at 9:30 a.m., to be held in the TWFN Auditorium at 11545 Rockville Pike, Rockville, Maryland, open to the public in person or via webcast. A second public meeting is tentatively scheduled for Thursday, October 15, 2026, at 9:00 a.m. CDT, focused on "Nuclear Regulatory Commission Reorganization First 100 Days: Enhancing Reactor and Materials Oversight Integration and Performance," to be held at NRC Region IV offices at 1600 East Lamar Boulevard, Arlington, Texas. No meetings are currently scheduled for the weeks of October 5, October 19, October 26, or November 2, 2026. The NRC notes that the schedule is subject to change on short notice.

FWS Corrects Hunting Regulations for National Fish Hatcheries

The U.S. Fish and Wildlife Service is issuing correcting amendments, effective September 25, 2026, to a final rule originally published September 1, 2026, that opened or expanded hunting opportunities on 111 field stations—including 107 units of the National Wildlife Refuge System and 4 units of the National Fish Hatchery System. The service states that the September 1 final rule included erroneous paragraph designations for National Fish Hatchery System units as part of amendatory instruction 33, which resulted in incorrect paragraph designations for several new entries. To address this, FWS is revising and republishing 50 CFR § 71.11, which governs national fish hatcheries open for hunting, in full. The correction covers four hatcheries: Craig Brook, Green Lake, Iron River, and Jordan River National Fish Hatcheries, each with station-specific conditions governing migratory game bird, upland game, and big game hunting.

What to Watch

• October 9, 2026 — Deadline for comments on CMS Medicaid and CHIP generic information collection activities.
• October 26, 2026 — Deadline for comments on the NIH draft policy on sharing summary-level study results with clinical research participants.
• October 15, 2026 — Tentative NRC public meeting on agency reorganization and reactor/materials oversight integration, Arlington, Texas.
• November 24, 2026 — Deadline for comments on FDA's draft guidance on robotically-assisted surgical device premarket submissions.

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