This document is scheduled to be published in the Federal Register on 2026-08-24 and available online at https://www.federalregister.gov/d/2026-17250, and on https://govinfo.gov

DEPARTMENT OF HEALTH AND HUMAN SERVICES Office of the Secretary [Docket No. HHS–OS–2026–0332] RIN: 0991-ZA62 Request for Information: Categories Used in Federal Vaccine Recommendations and the Role of Shared Clinical Decision-Making AGENCY: Office of the Secretary, Department of Health and Human Services (HHS). ACTION: Notice; request for information. SUMMARY: The Department of Health and Human Services (HHS or the Department), in support of the Task Force on Safer Childhood Vaccines and in furtherance of the Executive Order of August 10, 2026, “Delivering Gold Standard Childhood Vaccine Recommendations for Americans,” seeks public comment on whether the categories currently used in Federal vaccine recommendations are adequate.

Those categories are routine (universal) recommendations, riskbased recommendations, and recommendations based on shared clinical decision-making, also referred to as individual-based decision-making. The Department seeks comment on these categories and whether additional or different categories should be adopted. The Department further seeks comment on the considerations that should be relied upon in setting vaccine recommendations, including the availability and strength of available scientific evidence, the appropriate approach when randomized controlled trial evidence is limited or absent, a presumption in favor of individual autonomy and religious freedom, the downstream legal and programmatic consequences of category assignment, and the communication practices necessary to earn and maintain public trust.

DATES: To be assured consideration, comments must be received at the address provided below no later than September 20, 2026.

ADDRESSES: Interested persons are invited to submit written comments identified by Docket No. HHS–OS–2026–0332 by either of the following methods: (1) Federal eRulemaking Portal: https://www.regulations.gov.

Follow the instructions for submitting comments; or (2) Mail: Cyntha Goss, 200 Independence Ave SW, Washington, DC 20201. All submissions received must include the agency name and docket number.

Comments received will be posted without change to https://www.regulations.gov, including any personal information provided.

FOR FURTHER INFORMATION CONTACT: Cynthia Goss, Deputy Assistant Secretary for Planning and Evaluation (Health Policy), Performing the Delegable Duties of the Assistant Secretary for Planning and Evaluation, Office of the Secretary, Department of Health and Human Services, (202) 690-7858 or by email at: osaspeinfo@hhs.gov

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