H.R. 1082, Shandra Eisenga Human Cell and Tissue Product Safety Act

H.R. 1082 would direct the Department of Health and Human Services (HHS) to conduct a public awareness campaign about human cell and tissue products that are intended for human use and expand oversight of these products by the Food and Drug Administration (FDA). The act would require HHS to develop educational materials for health professionals concerning tissue donation and screening, and direct the FDA to publish annual data on registrations and inspections of human cell and tissue manufacturers. The act also would require the FDA to hold public workshops, solicit public input on modernizing the regulation of human cell and tissue products, and report to the Congress with recommendations for those regulations.

Using information about the costs of similar activities, CBO estimates that implementing H.R. 1082 would increase administrative costs for HHS by $2 million over the 2026-2030 period; any related spending would be subject to the availability of appropriated funds.

In addition, the act would establish civil penalties for violations of requirements that govern the donation and handling of human cell and tissue products. Civil monetary penalties are recorded as revenues in the federal budget. CBO expects that individuals subject to these requirements generally would comply with them, and thus any additional penalties collected over the 2026-2035 period would not be significant.

The costs of the legislation, detailed in Table 1, fall within budget function 550 (health).

The CBO staff contact for this estimate is Ryan Greenfield. The estimate was reviewed by Chad Chirico, Director of Budget Analysis.