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H.R. 4762: REGROW Act

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H.R. 4762: REGROW Act

114th Congress · introduced 2016-03-16 · Health · Latest: Referred to the Subcommittee on Health.

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Follow this bill, step by step

  1. Where it came from: introduced 2016-03-16 · official record
  2. Who proposed it: Rep. Coffman, Mike [R-CO-6] · what a sponsor is
  3. What happened next: no floor votes in our records yet. Why?
  4. Where it stands now: Referred to the Subcommittee on Health. Not final yet: this can still change. We check for updates every day.
  5. If it becomes law and spends money: follow the money to money laws, then agencies and contracts and grants.

What does this mean?

Official title

REGROW Act

Plain summary

Reliable and Effective Growth for Regenerative Health Options that Improve Wellness or the REGROW Act This bill amends the Public Health Service Act to require the Food and Drug Administration (FDA) to conditionally approve certain cellular therapeutic products without initiation of large-scale clinical trials. A conditionally approved cellular therapy may be marketed if certain conditions are met, including conditions on the source, processing, and function of the cells in the product. The sponsor of a conditionally approved cellular therapy must apply for approval of the product as a biological product within five years. Unless the FDA has decided not to approve the product, the product may be marketed during this five-year period and the FDA may permit continued marketing while the application is being reviewed. An individual administering a conditionally approved cellular therapy must inform the recipient regarding conditional approval. The premarket report for a medical device used for cellular therapy must include specified information regarding the preparation or delivery of the cellular therapy. The approval of a medical device that is a cellular therapy must be based on laboratory performance testing and not clinical trials. A medical device used for cellular therapy is subject to medical device classification. The FDA must not limit the use of these devices to only specific cell types unless unique to the use of the device. The Center for Biologics Evaluation and Research has primary jurisdiction for premarket review of combination products that act primarily through cellular components. The Department of Health and Human Services must work with stakeholders to promote the development of standards for regenerative medicine products.

Congressional Research Service summary (Introduced in House), quoted unchanged (nonpartisan). Read the source.

What a vote does

A “Yea” vote

If it passes both chambers and is signed, it becomes law.

A “Nay” vote

If it is not passed, current law stays as it is.

PSI Sci description of the legislative step (not an opinion).

What does this mean? (plain words)

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The strongest published arguments

Arguments for (supporters)

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Arguments against (opponents)

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Alternatives

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How did my representative vote? · This bill's floor votes

Officials and money

Sponsor: Rep. Coffman, Mike [R-CO-6] · 4 cosponsors

Cost estimate: No cost estimate published yet.

Cosponsors on this site

H. Morgan Griffith (R-VA)

No linked floor roll calls in our collected records yet. This does not mean the bill has never had a vote. Check the official bill history.

Words on this page, explained (2)
Bill
A proposed law. It becomes law only if it passes the legislature and is signed by the president or governor (or a veto is overridden).
Jurisdiction
The area or the matters a government or court has authority over.

Plain meanings written from linked sources. All words.

Sources

Record fed-us-cong114-hr4762 · catalog fed-us-congress-bills-cong114 · updated 2026-11-15 by psicol fed-bills-cong114