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S.1082 - Federal Government - An act to amend the Federal Food, Drug, and cosmetic Act and the Public Health Service Act to reauthorize drug and device user fees and ensure the safety of medical products, and for other purposes.

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An act to amend the Federal Food, Drug, and cosmetic Act and the Public Health Service Act to reauthorize drug and device user fees and ensure the safety of medical products, and for other purposes. 5/9/2007--Passed Senate amended. (There are 2 other summaries) Food and Drug Administration Revitalization Act - Title I: Prescription Drug User Fees - (Sec. 101) - Prescription Drug User Fee Amendments of 2007 - (Sec. 102) Amends the Federal Food, Drug, and Cosmetic Act (FFDCA) to set forth as a purpose that authorized prescription drug fees be dedicated toward expediting the drug development process, the process for the review of human drug applications, and postmarket drug safety. Sets forth reporting requirements, including requiring the Secretary of Human Services (the Secretary) to present to Congress recommendations developed for achieving certain goals for the review process of human drug applications and for reauthorization of user [...]

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05/10/2007 - Received in the House.
05/10/2007 - Message on Senate action sent to the House.
05/10/2007 - Held at the desk.
05/09/2007 - Considered by Senate. (consideration: CR S5759-5824)
05/09/2007 - S.AMDT.998 Considered by Senate. (consideration: CR S5759, S5769-5770, S5772)

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05/10/2007 - Received in the House.
05/10/2007 - Message on Senate action sent to the House.
05/10/2007 - Held at the desk.
05/09/2007 - Considered by Senate. (consideration: CR S5759-5824)
05/09/2007 - S.AMDT.998 Considered by Senate. (consideration: CR S5759, S5769-5770, S5772)
05/09/2007 - S.AMDT.1034 Considered by Senate. (consideration: CR S5759, S5765-5768, S5770-5771, S5772-5773)
05/09/2007 - S.AMDT.1039 Considered by Senate. (consideration: CR S5759, S5768-5769, S5771-5772)
05/09/2007 - S.AMDT.1039 Amendment SA 1039 not agreed to in Senate by Yea-Nay Vote. 46 - 47. Record Vote Number: 154.
05/09/2007 - S.AMDT.998 Amendment SA 998 agreed to in Senate by Yea-Nay Vote. 64 - 30. Record Vote Number: 155.
05/09/2007 - S.AMDT.1034 Amendment SA 1034 not agreed to in Senate by Yea-Nay Vote. 47 - 47. Record Vote Number: 156.
05/09/2007 - The committee substitute as amended agreed to by Unanimous Consent.
05/09/2007 - Cloture motion on the bill withdrawn by unanimous consent in Senate.
05/09/2007 - Passed Senate with an amendment and an amendment to the Title by Yea-Nay Vote. 93 - 1. Record Vote Number: 157. (text: CR S5773-5822)
05/08/2007 - S.AMDT.1019 Amendment SA 1019 proposed by Senator Brown for Senator Casey. (consideration: CR S5699-5705; text: CR S5702) To express the sense of the Senate concerning orphan disease treatment in children.
05/08/2007 - S.AMDT.1053 Amendment SA 1053 proposed by Senator Brown for Senator Enzi. (consideration: CR S5699-5705; text: CR S5702-5703) to modify provisions related to pediatric testing and medical products.
05/08/2007 - S.AMDT.1050 Amendment SA 1050 proposed by Senator Brown for Senator Enzi. (consideration: CR S5699-5705; text: CR S5703) To provide for color certification reports.
05/08/2007 - S.AMDT.1047 Amendment SA 1047 proposed by Senator Brown for Senator Roberts. (consideration: CR S5699-5705; text: CR S5704-5705) To modify provisions relating to direct-to-consumer advertisements.
05/08/2007 - S.AMDT.1056 Amendment SA 1056 proposed by Senator Brown for Senator Reed. (consideration: CR S5699-5705; text: CR S5705) To require the FDA to conduct consumer testing to determine the appropriateness of the labeling requirements for indoor tanning devices.
05/08/2007 - S.AMDT.1039 Amendment SA 1039 proposed by Senator Brown for Senator Grassley. (consideration: CR S5705-5706; text: CR S5705) To clarify the authority of the Office of Surveillance and Epidemiology with respect to postmarket drug safety pursuant to recommendations by the Institute of Medicine.
05/08/2007 - S.AMDT.998 Amendment SA 998 proposed by Senator Brown for Senator Grassley. (consideration: CR S5705-5706; text: CR S5705) To provide for the application of stronger civil penalties for violations of approved risk evaluation and mitigation strategies.
05/08/2007 - S.AMDT.1034 Amendment SA 1034 proposed by Senator Brown for Senator Durbin. (consideration: CR S5705-5706; text: CR S5705-5706) To reduce financial conflict of interest in FDA Advisory Panels.
05/08/2007 - Considered by Senate. (consideration: CR S5682-5686, S5689-5707)
05/08/2007 - S.AMDT.983 Considered by Senate. (consideration: CR S5682)
05/08/2007 - S.AMDT.985 Considered by Senate. (consideration: CR S5682, S5699-5705)
05/08/2007 - S.AMDT.988 Considered by Senate. (consideration: CR S5682)
05/08/2007 - S.AMDT.993 Considered by Senate. (consideration: CR S5682, S5707)
05/08/2007 - S.AMDT.1004 Considered by Senate. (consideration: CR S5682, S5699-5705)
05/08/2007 - S.AMDT.1011 Considered by Senate. (consideration: CR S5682, S5699-5705)
05/08/2007 - S.AMDT.1009 Amendment SA 1009 proposed by Senator Brown for Senator Hatch. (consideration: CR S5699-5705) To insert provisions relating to antibiotic access and innovation and certain enantiomer drugs.
05/08/2007 - S.AMDT.1026 Amendment SA 1026 proposed by Senator Brown for Senator Feingold. (consideration: CR S5699-5705) To require the Food and Drug Administration to publish certain annual reports.
05/08/2007 - S.AMDT.987 Amendment SA 987 proposed by Senator Brown for Senator Inhofe. (consideration: CR S5699-5705) To amend the Head Start Act to require parental consent for nonemergency intrusive physical examinations.
05/08/2007 - S.AMDT.1006 Amendment SA 1006 proposed by Senator Brown for Senator Murkowski. (consideration: CR S5699-5705) To modify provisions relating to required experience or certification for prescribing or dispensing certain drugs, and for other purposes.
05/08/2007 - S.AMDT.1005 Amendment SA 1005 proposed by Senator Brown for Senator Levin. (consideration: CR S5699-5705) To require the Food and Drug Administration to determine whether certain substances create any health risks and mislead consumers.
05/08/2007 - S.AMDT.1041 Amendment SA 1041 proposed by Senator Brown for Senator Obama. (consideration: CR S5699-5705) To improve the safety and efficacy of genetic tests.
05/08/2007 - S.AMDT.1019 Amendment SA 1019 proposed by Senator Brown for Senator Casey. (consideration: CR S5699-5705 text: CR S5702) To express the sense of the Senate concerning orphan disease treatment in children.
05/08/2007 - S.AMDT.1053 Amendment SA 1053 proposed by Senator Brown for Senator Enzi. (consideration: CR S5699-5705 text: CR S5702-5703) to modify provisions related to pediatric testing and medical products.
05/08/2007 - S.AMDT.1050 Amendment SA 1050 proposed by Senator Brown for Senator Enzi. (consideration: CR S5699-5705 text: CR S5703) To provide for color certification reports.
05/08/2007 - S.AMDT.1049 Amendment SA 1049 proposed by Senator Brown for Senator Enzi. (consideration: CR S5699-5705) To modify provisions relating to user fees, and for other purposes.
05/08/2007 - S.AMDT.1047 Amendment SA 1047 proposed by Senator Brown for Senator Roberts. (consideration: CR S5699-5705 text: CR S5704-5705) To modify provisions relating to direct-to-consumer advertisements.
05/08/2007 - S.AMDT.1056 Amendment SA 1056 proposed by Senator Brown for Senator Reed. (consideration: CR S5699-5705 text: CR S5705) To require the FDA to conduct consumer testing to determine the appropriateness of the labeling requirements for indoor tanning devices.
05/08/2007 - S.AMDT.985 Amendment SA 985 as modified agreed to in Senate by Unanimous Consent. (text as modified: CR S5699)
05/08/2007 - S.AMDT.1011 Amendment SA 1011 as modified agreed to in Senate by Unanimous Consent. (text as modified: CR S5699-5700)
05/08/2007 - S.AMDT.1009 Amendment SA 1009 as modified agreed to in Senate by Unanimous Consent. (text as modified: CR S5700-5701)
05/08/2007 - S.AMDT.1026 Amendment SA 1026 as modified agreed to in Senate by Unanimous Consent. (text as modified: CR S5701)
05/08/2007 - S.AMDT.987 Amendment SA 987 as modified agreed to in Senate by Unanimous Consent. (text as modified: CR S5701-5702)
05/08/2007 - S.AMDT.1006 Amendment SA 1006 as modified agreed to in Senate by Unanimous Consent. (text as modified: CR S5702)
05/08/2007 - S.AMDT.1005 Amendment SA 1005 as modified agreed to in Senate by Unanimous Consent. (text as modified: CR S5702)
05/08/2007 - S.AMDT.1004 Amendment SA 1004 as modified agreed to in Senate by Unanimous Consent. (text as modified: CR S5702)
05/08/2007 - S.AMDT.1041 Amendment SA 1041 as modified agreed to in Senate by Unanimous Consent. (text as modified: CR S5702)
05/08/2007 - S.AMDT.1019 Amendment SA 1019 agreed to in Senate by Unanimous Consent.
05/08/2007 - S.AMDT.1053 Amendment SA 1053 agreed to in Senate by Unanimous Consent.
05/08/2007 - S.AMDT.1050 Amendment SA 1050 agreed to in Senate by Unanimous Consent.
05/08/2007 - S.AMDT.1049 Amendment SA 1049 as modified agreed to in Senate by Unanimous Consent. (text as modified: CR S5703-5704)
05/08/2007 - S.AMDT.1047 Amendment SA 1047 agreed to in Senate by Unanimous Consent.
05/08/2007 - S.AMDT.1056 Amendment SA 1056 agreed to in Senate by Unanimous Consent.
05/08/2007 - S.AMDT.983 Proposed amendment SA 983 withdrawn in Senate.
05/08/2007 - S.AMDT.988 Proposed amendment SA 988 withdrawn in Senate.
05/08/2007 - S.AMDT.993 Proposed amendment SA 993 withdrawn in Senate.
05/08/2007 - S.AMDT.1039 Amendment SA 1039 proposed by Senator Brown for Senator Grassley. (consideration: CR S5705-5706 text: CR S5705) To clarify the authority of the Office of Surveillance and Epidemiology with respect to postmarket drug safety pursuant to recommendations by the Institute of Medicine.
05/08/2007 - S.AMDT.998 Amendment SA 998 proposed by Senator Brown for Senator Grassley. (consideration: CR S5705-5706 text: CR S5705) To provide for the application of stronger civil penalties for violations of approved risk evaluation and mitigation strategies.
05/08/2007 - S.AMDT.1034 Amendment SA 1034 proposed by Senator Brown for Senator Durbin. (consideration: CR S5705-5706 text: CR S5705-5706) To reduce financial conflict of interest in FDA Advisory Panels.
05/07/2007 - Cloture on the committee substitute amendment as modified invoked in Senate by Yea-Nay Vote. 82 - 8. Record Vote Number: 152. (consideration: CR S5641-5642; text: CR S5641)
05/07/2007 - Considered by Senate. (consideration: CR S5634-5651)
05/07/2007 - S.AMDT.983 Considered by Senate. (consideration: CR S5634)
05/07/2007 - S.AMDT.985 Considered by Senate. (consideration: CR S5634)
05/07/2007 - S.AMDT.988 Considered by Senate. (consideration: CR S5634)
05/07/2007 - S.AMDT.990 Considered by Senate. (consideration: CR S5634, S5641)
05/07/2007 - S.AMDT.993 Considered by Senate. (consideration: CR S5634, S5647-5650)
05/07/2007 - S.AMDT.1004 Considered by Senate. (consideration: CR S5634)
05/07/2007 - S.AMDT.1010 Considered by Senate. (consideration: CR S5634, S5637-5641)
05/07/2007 - S.AMDT.1011 Considered by Senate. (consideration: CR S5634)
05/07/2007 - S.AMDT.1010 Amendment SA 1010 agreed to in Senate by Yea-Nay Vote. 49 - 40. Record Vote Number: 151.
05/07/2007 - S.AMDT.990 Amendment SA 990 agreed to in Senate by Voice Vote.
05/07/2007 - Cloture on the committee substitute amendment as modified invoked in Senate by Yea-Nay Vote. 82 - 8. Record Vote Number: 152. (consideration: CR S5641-5642 text: CR S5641)
05/03/2007 - Considered by Senate. (consideration: CR S5526-5558)
05/03/2007 - S.AMDT.983 Considered by Senate. (consideration: CR S5526)
05/03/2007 - S.AMDT.985 Considered by Senate. (consideration: CR S5526)
05/03/2007 - S.AMDT.988 Considered by Senate. (consideration: CR S5526)
05/03/2007 - S.AMDT.990 Considered by Senate. (consideration: CR S5526)
05/03/2007 - S.AMDT.993 Considered by Senate. (consideration: CR S5526)
05/03/2007 - S.AMDT.1004 Considered by Senate. (consideration: CR S5526)
05/03/2007 - S.AMDT.1010 Considered by Senate. (consideration: CR S5526, S5532)
05/03/2007 - S.AMDT.1011 Considered by Senate. (consideration: CR S5526)
05/03/2007 - S.AMDT.990 Cloture on amendment SA 990 invoked in Senate by Yea-Nay Vote. 63 - 28. Record Vote Number: 150. (consideration: CR S5531-5532)
05/03/2007 - Cloture motion on the committee substitute amendment as modified presented in Senate. (consideration: CR S5556-5557)
05/03/2007 - Cloture motion on the measure presented in Senate. (consideration: CR S5557)
05/02/2007 - S.AMDT.1010 Amendment SA 1010 proposed by Senator Cochran to Amendment SA 990. (consideration: CR S5444-5445, S5490; text: CR S5444) To protect the health and safety of the public.
05/02/2007 - S.AMDT.982 Amendment SA 982 proposed by Senator Allard. (consideration: CR S5445-5452, S5455-5461; text: CR S5445) To strike provisions related to market exclusivity.
05/02/2007 - S.AMDT.1011 Amendment SA 1011 proposed by Senator Stabenow. (consideration: CR S5453-5455, S5474, S5490-5491; text: CR S5453-5454) To insert provisions related to citizens petitions.
05/02/2007 - S.AMDT.1018 Amendment SA 1018 proposed by Senator DeMint. (consideration: CR S5469-5470, S5471-5472; text: CR S5469) To amend the notification provision with respect to drugs deemed to have risk evaluation and mitigation strategies.
05/02/2007 - Considered by Senate. (consideration: CR S5444-5485, S5486-5492)
05/02/2007 - S.AMDT.985 Amendment SA 985 proposed by Senator Brown for Senator Brownback. (consideration: CR S5473-5474; text: CR S5473-5474) To establish a priority drug review process to encourage treatments of tropical diseases.
05/02/2007 - S.AMDT.990 Considered by Senate. (consideration: CR S5444, S5452-5453, S5461-5469, S5470-5471, S5472-5473, S5474-5478)
05/02/2007 - S.AMDT.983 Amendment SA 983 proposed by Senator Vitter. (consideration: CR S5482-5485; text: CR S5482-5483) To require counterfeit-resistant technologies for prescription drugs.
05/02/2007 - S.AMDT.1004 Considered by Senate. (consideration: CR S5444)
05/02/2007 - S.AMDT.1025 Amendment SA 1025 proposed by Senator Schumer. (consideration: CR S5485; text: CR S5485) To express the sense of the Senate with respect to follow-on biologics.
05/02/2007 - S.AMDT.1010 Amendment SA 1010 proposed by Senator Cochran to Amendment SA 990. (consideration: CR S5444-5445, S5490 text: CR S5444) To protect the health and safety of the public.
05/02/2007 - S.AMDT.988 Amendment SA 988 proposed by Senator Inhofe. (consideration: CR S5487-5488; text: CR S5487-5488) To protect children and their parents from being coerced into administering a controlled substance in order to attend school, and for other purposes.
05/02/2007 - S.AMDT.982 Amendment SA 982 proposed by Senator Allard. (consideration: CR S5445-5452, S5455-5461 text: CR S5445) To strike provisions related to market exclusivity.
05/02/2007 - S.AMDT.1011 Amendment SA 1011 proposed by Senator Stabenow. (consideration: CR S5453-5455, S5474, S5490-5491 text: CR S5453-5454) To insert provisions related to citizens petitions.
05/02/2007 - S.AMDT.982 Amendment SA 982 not agreed to in Senate by Yea-Nay Vote. 41 - 53. Record Vote Number: 148.
05/02/2007 - S.AMDT.1018 Amendment SA 1018 proposed by Senator DeMint. (consideration: CR S5469-5470, S5471-5472 text: CR S5469) To amend the notification provision with respect to drugs deemed to have risk evaluation and mitigation strategies.
05/02/2007 - S.AMDT.1018 Amendment SA 1018 agreed to in Senate by Unanimous Consent.
05/02/2007 - S.AMDT.985 Amendment SA 985 proposed by Senator Brown for Senator Brownback. (consideration: CR S5473-5474 text: CR S5473-5474) To establish a priority drug review process to encourage treatments of tropical diseases.
05/02/2007 - S.AMDT.1022 Amendment SA 1022 proposed by Senator Durbin. (consideration: CR S5478-5482) To ensure the safety of human and pet food.
05/02/2007 - S.AMDT.1022 Amendment SA 1022 as modified agreed to in Senate by Yea-Nay Vote. 94 - 0. Record Vote Number: 149. (text as modified: CR S5481)
05/02/2007 - S.AMDT.983 Amendment SA 983 proposed by Senator Vitter. (consideration: CR S5482-5485 text: CR S5482-5483) To require counterfeit-resistant technologies for prescription drugs.
05/02/2007 - S.AMDT.1025 Amendment SA 1025 proposed by Senator Schumer. (consideration: CR S5485 text: CR S5485) To express the sense of the Senate with respect to follow-on biologics.
05/02/2007 - S.AMDT.1025 Amendment SA 1025 agreed to in Senate by Voice Vote.
05/02/2007 - S.AMDT.988 Amendment SA 988 proposed by Senator Inhofe. (consideration: CR S5487-5488 text: CR S5487-5488) To protect children and their parents from being coerced into administering a controlled substance in order to attend school, and for other purposes.
05/02/2007 - S.AMDT.993 Amendment SA 993 proposed by Senator Gregg. (consideration: CR S5488-5490) To provide for the regulation of Internet pharmacies.
05/01/2007 - Considered by Senate. (consideration: CR S5325-5329, S5332-5362, S5367, S5368-5371, S5372-5379, S5380-5385, S5387-5388)
05/01/2007 - S.AMDT.1004 Amendment SA 1004 proposed by Senator Landrieu. (consideration: CR S5375-5376, S5380; text: CR S5375) To require the Food and Drug Administration to permit the sale of baby turtles as pets so long as the seller uses proven methods to effectively treat salmonella.
05/01/2007 - The committee reported substitute amendment was modified by Unanimous Consent. (text as modified: CR S5333-5361)
05/01/2007 - S.AMDT.1004 Amendment SA 1004 proposed by Senator Landrieu. (consideration: CR S5375-5376, S5380 text: CR S5375) To require the Food and Drug Administration to permit the sale of baby turtles as pets so long as the seller uses proven methods to effectively treat salmonella.
05/01/2007 - S.AMDT.990 Amendment SA 990 proposed by Senator Dorgan. (consideration: CR S5380-5385, S5387-5388) To provide for the importation of prescription drugs.
05/01/2007 - S.AMDT.990 Cloture motion on amendment SA 990 presented in Senate. (consideration: CR S5387-5388)
04/30/2007 - Measure laid before Senate by unanimous consent. (consideration: CR S5270-5303 text of measure as reported in Senate: CR S5270-5294)
04/30/2007 - Measure laid before Senate by unanimous consent. (consideration: CR S5270-5303; text of measure as reported in Senate: CR S5270-5294)
04/24/2007 - Committee on Health, Education, Labor, and Pensions. Reported by Senator Kennedy with an amendment in the nature of a substitute and an amendment to the title. Without written report.
04/24/2007 - Placed on Senate Legislative Calendar under General Orders. Calendar No. 120.
04/18/2007 - Committee on Health, Education, Labor, and Pensions. Ordered to be reported with an amendment in the nature of a substitute favorably.
04/18/2007 - Committee on Health, Education, Labor, and Pensions. Date of scheduled consideration. SH-216. 10:00 a.m.
04/10/2007 - Read twice and referred to the Committee on Health, Education, Labor, and Pensions.

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Bill Text

File name		Last Updated
	S.1082 Engrossed as Agreed to or Passed by Senate	08/31/2007
	S.1082 Reported in Senate	08/31/2007
	S.1082 Introduced in Senate	08/31/2007