# 119-hr-340: The HCT/P Modernization Act of 2025

119-hr-340, The HCT/P Modernization Act of 2025, is a 119th Congress bill sponsored by Rep. Crenshaw, Dan [R-TX-2] (R-TX); status introduced; PRIA reads it as touching household money (as of 2026-07-17).

- Canonical: https://policyrisk.com/legislation/119-hr-340
- As of: 2026-07-17
- Plain-text twin of the page above; the HTML and this file carry the same facts.

## Facts
- Bill: 119-hr-340
- Congress: 119
- Title: The HCT/P Modernization Act of 2025
- Status: introduced
- Introduced: 2025-01-13
- Sponsor: Rep. Crenshaw, Dan [R-TX-2] (R-TX)
- Cosponsors: 1
- Policy area: Health
- Touches household money: yes
- Last recorded action: 2026-07-17

## Summary

**Modernize FDA oversight of human cell and tissue products** to increase transparency and make regulation more predictable. This bill would require the Food and Drug Administration to publish guidance, collect public input, run workshops, and deliver recommendations on updating HCT/P rules. - Industry and manufacturers would get clearer guidance. The FDA would publish educational materials about the Tissue Reference Group and updated best practices aimed at supporting development of stem cell and other cellular therapies. - Regulators and the public would see more data. The FDA would post annual information for 4 years on HCT/P establishments registered since Jan. 1, 2019, inspections since that date, the number and type of Tissue Reference Group inquiries, and average response times. - Researchers, patients, and health systems would gain more input and predictability. The bill would create a public docket within 60 days, require stakeholder workshops, and direct the FDA to report recommendations by Sept. 30, 2026, considering burden, science, access, and public health.

## Cosponsors (1)

- Rep. Barragán, Nanette Diaz [D-CA-44] (D-CA), 2025-01-13T00:00:00.000Z

## Provisions PRIA read

- Clearer FDA guidance on cell and tissue products: benefit, low. If enacted, FDA would post plain-language materials about the Tissue Reference Group and how to get timely, accurate advice. FDA would share information with industry, tissue centers, hospitals, research groups, and patients, and hold workshops as needed. The bill would update a 2022 law so best pr…
- FDA recommendations to Congress by 2026: benefit, low. If enacted, the Secretary would send Congress a report by September 30, 2026 with recommendations on how to regulate human cell and tissue products. The report would summarize input from the public workshop and docket. It would consider 21 C.F.R. §§1271.10(a) and 1271.3, regulatory burden, new scie…
- More public input and FDA reporting: benefit, low. If enacted, the Secretary would open a public docket within 60 days to take written comments on a planned workshop and on modernizing rules for human cell and tissue products. Comments could address how to assess “minimal manipulation” and “homologous use.” FDA would also post a public report no la…

## Related bills

- 119-hr-3151: SHIPS for America Act of 2025
- 119-hr-137: TCJA Permanency Act
- 119-hr-9599: SECURE 340B Act
- 119-hr-5106: Restore Trust in Congress Act
- 119-hres-23: Proxy Voting for New Parents Resolution
- 119-hr-842: Nancy Gardner Sewell Medicare Multi-Cancer Early Detection Screening Coverage Act

## Sources
- [119-hr-340 on Congress.gov](https://www.congress.gov/bill/119th-congress/house-bill/340)

## Related
- [119-hr-3151: SHIPS for America Act of 2025](https://policyrisk.com/legislation/119-hr-3151)
- [119-hr-137: TCJA Permanency Act](https://policyrisk.com/legislation/119-hr-137)
- [119-hr-9599: SECURE 340B Act](https://policyrisk.com/legislation/119-hr-9599)
- [119-hr-5106: Restore Trust in Congress Act](https://policyrisk.com/legislation/119-hr-5106)
- [119-hres-23: Proxy Voting for New Parents Resolution](https://policyrisk.com/legislation/119-hres-23)
- [119-hr-842: Nancy Gardner Sewell Medicare Multi-Cancer Early Detection Screening Coverage A…](https://policyrisk.com/legislation/119-hr-842)
- [All bills in Congress](https://policyrisk.com/legislation)

Source: PRIA, https://policyrisk.com/legislation/119-hr-340 (as of 2026-07-17).