S. 830 · 105th Congress · enacted
Food and Drug Administration Modernization Act of 1997
Became Public Law No: 105-115.
Latest official action 1997-11-21 · Enacted
The bill, briefly
TABLE OF CONTENTS: Title I: Improving Regulation of Drugs Title II: Improving Regulation of Devices Title III: Improving Regulation of Food Food and Drug Administration Regulatory Modernization Act of 1997 - Title I: Improving Regulation of Drugs - Amends Federal Food, Drug, and Cosmetic Act (FDCA) provisions regarding fees relating to drugs to revise and add various definitions. Makes the fee (currently, 50 percent of the fee) for human drug applications or supplements due on submission. Mandates a refund of 75 (currently, 50) percent if the application or supplement is refused for filing. Exempts from the fee: (1) an application for a drug for a rare condition (orphan drug) or a supplement proposing a new indication for a rare condition; and (2) supplements for indications for use in pediatric populations. Allows fee refund if an application or supplement is withdrawn. Modifies requirements regarding: (1) the annual prescription drug establishment fee; (2) the prescription drug product fee; (3) fee amounts; (4) fee adjustments; (5) fee waiver or reduction; (6) assessment of fees; and (7) crediting and availability of fees (including authorizing appropriations). Terminates, on specified dates, the effectiveness of the amendments made by this paragraph. (Sec. 102) Allows for additional deferred effective dates for the approval of certain new drug applications to allow for addit…
Congressional Research Service · 1997-10-07
Who reported lobbying on this bill?
Amount spent specifically on this bill: not disclosed
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No matching lobbying report is imported yet. This is not evidence that no lobbying occurred.
2,409 latest lobbying reports imported. Some source imports are still in progress.
Politicians behind the bill
Sponsors and cosponsors from the official source, limited to members currently in office. Campaign amounts are cycle-wide and are not payments for this bill.
No current-officeholder sponsorship match is available. Historical sponsors may have left office.
7 of 7 source cosponsor records retrieved; only current officials and unwithdrawn sponsorships appear.
PAC donors to the listed sponsors
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The largest 40 donor totals appear here. Open each politician for their complete, paginated PAC donor list.
What happened after enactment?
Dated agency-reported implementation and uptake measures are shown with their scope. They do not by themselves establish causal success. If no evidence is listed, the outcome is not established.
Measured outcome: not established
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