H.R. 2415: To amend the Federal Food, Drug, and Cosmetic Act to provide for establishment of a streamlined data review program.

114th Congress · introduced 2015-05-19 · Health · Latest: Referred to the Subcommittee on Health.

federal

Follow this bill, step by step

Where it came from: introduced 2015-05-19 · official record
Who proposed it: Rep. Burgess, Michael C. [R-TX-26] · what a sponsor is
What happened next: no floor votes in our records yet. Why?
Where it stands now: Referred to the Subcommittee on Health. Not final yet: this can still change. We check for updates every day.
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

To amend the Federal Food, Drug, and Cosmetic Act to provide for establishment of a streamlined data review program.

Plain summary

This bill amends the Federal Food, Drug, and Cosmetic Act to require the Food and Drug Administration (FDA) to establish a streamlined data review program under which the holder of an approved application for a drug or biological product may submit a summary of clinical data to support approval of the drug for the treatment of cancer or another indication subject to the program. For a drug to be eligible for the streamlined data review program there must be a database regarding the safety of the drug and the full data sets used to develop the data summaries must be submitted, unless the FDA determines that the full data sets are not required. The FDA must annually publish: (1) the number of applications reviewed under the streamlined data review program, (2) the average time for completion of review under the streamlined data review program compared to review of other applications for new indications, and (3) the number of applications reviewed under the streamlined data review program for which the FDA made use of full data sets.

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)

Official text

To amend the Federal Food, Drug, and Cosmetic Act to provide for establishment of a streamlined data review program.

Source: Congressional Research Service summary (Introduced in House)

AI explanation – may be wrong, check the official text

No AI explanation yet. It takes up to a minute to write and is then saved for everyone.

Limited to a few requests an hour per person.

The strongest published arguments

Arguments for (supporters)

Needs sources: no published arguments on this side yet. We only show items backed by a published source. Suggest one.

Arguments against (opponents)

Needs sources: no published arguments on this side yet. We only show items backed by a published source. Suggest one.

Alternatives

Needs sources: no published alternatives yet (for example a different bill, a law instead of an amendment, or keeping current law). We only show items backed by a published source. Suggest one.

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

Officials and money

Sponsor: Rep. Burgess, Michael C. [R-TX-26] · 1 cosponsors

Cost estimate: No cost estimate published yet.

Cosponsors on this site

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 (1)

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).

Plain meanings written from linked sources. All words.

Sources

Congressional Research Service summary (Introduced in House)
Congress.gov
Data: GovInfo BILLSTATUS bulk data (Library of Congress), BILLSTATUS-114hr2415.xml <https://www.govinfo.gov/bulkdata/BILLSTATUS/114/hr>

Record fed-us-cong114-hr2415 · catalog fed-us-congress-bills-cong114 · updated 2026-11-15 by psicol fed-bills-cong114