Federal Register #HHS-OS-2026-0332

Request for Public Comment on Vaccine Recommendation Categories and License Opportunity for HPV T Cell Receptors

The Department of Health and Human Services (HHS), Office of the Secretary, is seeking public input on Federal vaccine recommendation categories and licensing opportunities for novel immunotherapies. - Government Buyer: - U.S. Department of Health and Human Services (HHS), Office of the Secretary - Request for Information: - Solicits public comment on the adequacy and clarity of current vaccine recommendation categories: routine, risk-based, and shared clinical decision-making (SCDM) - Seeks input on potential new categories, communication strategies, and trust-building measures - Focuses on criteria for setting recommendations, including scientific evidence, individual autonomy, legal consequences, and communication practices - License Opportunity: - National Cancer Institute offers a license for T cell receptors targeting HPV 6 or HPV 11 - Intended for treatment of recurrent respiratory papillomatosis and anogenital condyloma - OEMs and Vendors: - No specific OEMs or commercial vendors are named; the T cell receptor technology originates from the National Cancer Institute - Products/Services Requested: - Public comment and policy input (no physical products or services procured) - Licensing of T cell receptor technology for HPV 6/11 - Unique Requirements: - Input sought on vaccine policy categories and communication strategies - License opportunity addresses unmet clinical needs in HPV-related diseases

Description

The Department of Health and Human Services (HHS) is seeking public comment on the adequacy of current categories used in Federal vaccine recommendations, which include routine (universal) recommendations, risk-based recommendations, and recommendations based on shared clinical decision-making. The Department is interested in whether additional or different categories should be adopted and seeks input on considerations for setting vaccine recommendations, such as scientific evidence strength, individual autonomy, legal consequences, and communication practices to maintain public trust. Comments are requested to help inform the Task Force on Safer Childhood Vaccines and support the Executive Order on delivering gold standard childhood vaccine recommendations.

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