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Ideology gap
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92Swing
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Sponsored by Rep. Robert E. Latta (R-OH) · 3 active : 1 Republican, 2 Democrats
Latest action: Placed on the Union Calendar, Calendar No. 254.
Over-the-Counter Monograph Drug User Fee Amendments
This bill reauthorizes the Over-the-Counter (OTC) Monograph Drug User Fee Program (OMUFA) through FY2030 and revises certain aspects of the program, including total fees to be collected and fee due dates.
Under current law, many OTC drugs are marketed through compliance with an OTC monograph issued by the Food and Drug Administration (FDA), rather than through an approved new drug application. Monographs establish the conditions under which OTC drugs are generally recognized as safe and effective, and include ingredients, dosages, and other requirements. OMUFA permits the FDA to collect fees from OTC drug facilities and entities requesting changes to a monograph.
The bill makes certain changes to OMUFA, including by
revising the total facility fee revenue amount to be collected for FY2026-FY2030,
revising due dates for facility fees,
permitting the FDA to implement a one-time adjustment to facility fees if certain conditions exist, and
requiring the FDA to publish facility and order request fee amounts at least 60 days before the start of each fiscal year.
Finally, the bill adds as a
Tier 2 OTC monograph order request
a request for the addition or modification of a testing procedure applicable to a monograph drug, provided the testing procedure reflects a voluntary consensus standard with respect to pharmaceutical quality. (Requestors seeking certain kinds of changes to a monograph are awarded a period of market exclusivity if the FDA makes the requested changes; tier 2 requests are not eligible for market exclusivity.)
Members fall into . 2 representatives don’t have enough data yet and are marked “insufficient data”. Non-voting delegates are not counted.
: only movement toward the other party counts, so members who sit further from the center than their party no longer score as swing votes.
Bars show each input from 0 to 100: ideology gap, scorecard gap, . is the seat’s partisan lean, and shows how much of the input data a score has.
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These members have less than half of the model’s inputs, so their scores are not banded or ranked.
Ideology is each member’s score. The cluster low on the chart includes the bill’s 4 sponsor and cosponsors in the House: they have already committed, so they score as entrenched. 2 representatives without a DW-NOMINATE score or with insufficient data are not plotted.
Similar votes count toward swing-v3 in the House: total similarity weight 8.5 (needs 5.0).
