S. Amdt. 1053 - To Modify Provisions Related to Pediatric Testing and Medical Products.

Sponsor:
This is an amendment to S. 1082 - Food and Drug Administration Revitalization Act
Senate Vote: Amendment SA 1053 agreed to in Senate by Unanimous Consent.

PASSED by voice vote on May 8, 2007.

Other Votes:

Prescription Drug User Fee Amendments of 2007

S. 1082 — 110th Congress (2007–2008)

Summary
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. (by CRS)
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At OpenCongress
Title
A bill to amend the Federal Food, Drug, and Cosmetic Act to reauthorize and amend the prescription drug user fee provisions, and for other purposes.
Other Titles
  • Prescription Drug User Fee Amendments of 2007
  • Food and Drug Administration Revitalization Act
  • Best Pharmaceuticals for Children Amendments of 2007
  • Enhancing Drug Safety and Innovation Act of 2007
  • Medical Device User Fee Amendments of 2007
  • Pediatric Medical Device Safety and Improvement Act of 2007
  • Pediatric Research Improvement Act
  • Food and Drug Administration Revitalization Act
  • Best Pharmaceuticals for Children Amendments of 2007
  • Domestic Pet Turtle Market Access Act of 2007
  • Enhancing Drug Safety and Innovation Act of 2007
  • Medical Device User Fee Amendments of 2007
  • Pediatric Medical Device Safety and Improvement Act of 2007
  • Pediatric Research Improvement Act
  • Pharmaceutical Market Access and Drug Safety Act of 2007
  • 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.
Sponsor
Edward Kennedy
Co-Sponsors
    Subjects
    • Medicine
    • Abortion
    • Actions and defenses
    • Administrative fees
    • Administrative procedure
    • Agriculture
    • Agriculture in foreign trade
    • Animals
    • Antibiotics
    • Biomedical engineering
    • Budgets
    • Business
    • Canada
    • Cancer
    • Chemotherapy
    • Child health
    • Children
    • Clinical trials
    • Communicable diseases
    • Communication in medicine
    • Communications
    • Conflict of interests
    • Congress
    • Congressional investigations
    • Congressional oversight
    • Congressional reporting requirements
    • Consumer education
    • Consumers
    • Cosmetics
    • Counterfeiting
    • Criminal justice
    • Data banks
    • Defective products
    • Department of Health and Human Services
    • Drug abuse
    • Drug adulteration
    • Drug approvals
    • Drug industry
    • Drug interactions
    • Drug law enforcement
    • Drug therapy
    • Drug utilization
    • Drugs
    • Education
    • Electronic data interchange
    • Elementary and secondary education
    • Environmental protection
    • Executive departments
    • Eye diseases
    • Families
    • Federal advisory bodies
    • Federal aid to education
    • Federal aid to research
    • Federal reserve system
    • Fines (Penalties)
    • Food
    • Food additives
    • Food and Drug Administration (FDA)
    • Food industry
    • Food preservation
    • Food safety
    • Food supply
    • Foodborne diseases
    • Foundations
    • Fraud
    • Generic drugs
    • Genetic counseling
    • Genetic engineering
    • Genetics
    • Government information
    • Government paperwork
    • Government publicity
    • Hazardous substances
    • Health information systems
    • Health surveys
    • Health warnings
    • Higher education
    • Imaging systems in medicine
    • Import restrictions
    • Intellectual property
    • Internet
    • Labeling
    • Law
    • Marijuana
    • Meat
    • Medical care
    • Medical education
    • Medical laboratories
    • Medical records
    • Medical statistics
    • Medical supplies
    • Medicinal plants
    • Orphan drugs
    • Packaging
    • Parent and child
    • Patent infringement
    • Pesticides
    • Pets
    • Pharmaceutical research
    • Pharmacists
    • Physical examinations
    • Politics and government
    • Preschool education
    • Prescription pricing
    • Prices
    • Produce trade
    • Product development
    • Product safety
    • Protection of animals
    • Public meetings
    • Research and development
    • Research grants
    • Restrictive trade practices
    • Risk
    • Salmonella
    • Scholarships
    • Science policy
    • Seafood
    • Shellfish
    • Skin cancer
    • Skin diseases
    • Small business
    • Social services
    • Strategic planning
    • Student loan funds
    • Technology
    • Telecommunication
    • Trade
    • Turtles
    • User charges
    • Web sites
    Related Bills
    Major Actions
    Introduced4/10/2007
    Referred to Committee
    Amendments (82 proposed)
    Passed Senate5/09/2007
    Bill History
    Chamber/CommitteeMotionDateResult
    select this voteSenateAmendment SA 1018 agreed to in Senate by Unanimous Consent.5/02/2007PASSED by voice vote
    select this voteSenateAmendment SA 1025 agreed to in Senate by Voice Vote.5/02/2007PASSED by voice vote
    select this voteSenateAllard Amdt. No. 9825/02/2007This amendment DID NOT PASS the Senate
    41 voted YES 53 voted NO 6 voted present/not voting
    select this voteSenateDurbin Amdt. No. 1022, as Modified5/02/2007This amendment PASSED the Senate
    94 voted YES 0 voted NO 6 voted present/not voting
    select this voteSenateMotion to Invoke Cloture on the Dorgan Amdt. No. 9905/03/2007This amendment PASSED the Senate
    63 voted YES 28 voted NO 9 voted present/not voting
    select this voteSenateAmendment SA 990 agreed to in Senate by Voice Vote.5/07/2007PASSED by voice vote
    select this voteSenateCochran Amdt. No. 10105/07/2007This amendment PASSED the Senate
    49 voted YES 40 voted NO 11 voted present/not voting
    select this voteSenateMotion to Invoke Cloture on the Committee Substitute as Modified and Amended to S.10825/07/2007This motion PASSED the Senate
    82 voted YES 8 voted NO 10 voted present/not voting
    select this voteSenateAmendment SA 985 as modified agreed to in Senate by Unanimous Consent.5/08/2007PASSED by voice vote
    select this voteSenateAmendment SA 987 as modified agreed to in Senate by Unanimous Consent.5/08/2007PASSED by voice vote
    select this voteSenateAmendment SA 1004 as modified agreed to in Senate by Unanimous Consent.5/08/2007PASSED by voice vote
    select this voteSenateAmendment SA 1005 as modified agreed to in Senate by Unanimous Consent.5/08/2007PASSED by voice vote
    select this voteSenateAmendment SA 1006 as modified agreed to in Senate by Unanimous Consent.5/08/2007PASSED by voice vote
    select this voteSenateAmendment SA 1009 as modified agreed to in Senate by Unanimous Consent.5/08/2007PASSED by voice vote
    select this voteSenateAmendment SA 1011 as modified agreed to in Senate by Unanimous Consent.5/08/2007PASSED by voice vote
    select this voteSenateAmendment SA 1019 agreed to in Senate by Unanimous Consent.5/08/2007PASSED by voice vote
    select this voteSenateAmendment SA 1026 as modified agreed to in Senate by Unanimous Consent.5/08/2007PASSED by voice vote
    select this voteSenateAmendment SA 1041 as modified agreed to in Senate by Unanimous Consent.5/08/2007PASSED by voice vote
    select this voteSenateAmendment SA 1047 agreed to in Senate by Unanimous Consent.5/08/2007PASSED by voice vote
    select this voteSenateAmendment SA 1049 as modified agreed to in Senate by Unanimous Consent.5/08/2007PASSED by voice vote
    select this voteSenateAmendment SA 1050 agreed to in Senate by Unanimous Consent.5/08/2007PASSED by voice vote
    currently selectedSenateAmendment SA 1053 agreed to in Senate by Unanimous Consent.5/08/2007PASSED by voice vote
    select this voteSenateAmendment SA 1056 agreed to in Senate by Unanimous Consent.5/08/2007PASSED by voice vote
    select this voteSenateGrassley Amdt. No. 10395/09/2007This amendment DID NOT PASS the Senate
    46 voted YES 47 voted NO 7 voted present/not voting
    select this voteSenateGrassley Amdt. No. 9985/09/2007This amendment PASSED the Senate
    64 voted YES 30 voted NO 6 voted present/not voting
    select this voteSenateDurbin Amdt. No. 10345/09/2007This amendment DID NOT PASS the Senate
    47 voted YES 47 voted NO 6 voted present/not voting
    select this voteSenateOn Passage - Senate - S.1082 as Amended5/09/2007This bill PASSED the Senate
    93 voted YES 1 voted NO 6 voted present/not voting
    ActionDateDescription
    Introduced4/10/2007
    4/10/2007Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
    Put on a legislative calendar4/18/2007Committee on Health, Education, Labor, and Pensions. Ordered to be reported with an amendment in the nature of a substitute favorably.
    4/24/2007Committee 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.
    Put on a legislative calendar4/24/2007Placed on Senate Legislative Calendar under General Orders. Calendar No. 120.
    4/30/2007Measure laid before Senate by unanimous consent.
    5/01/2007Amendment SA 990 proposed by Senator Dorgan.
    5/01/2007Considered by Senate.
    5/01/2007The committee reported substitute amendment was modified by Unanimous Consent.
    5/01/2007Cloture motion on amendment SA 990 presented in Senate.
    5/01/2007Amendment SA 1004 proposed by Senator Landrieu.
    5/02/2007Considered by Senate.
    5/02/2007Amendment SA 982 proposed by Senator Allard.
    5/02/2007Amendment SA 983 proposed by Senator Vitter.
    5/02/2007Amendment SA 985 proposed by Senator Brown for Senator Brownback.
    5/02/2007Amendment SA 988 proposed by Senator Inhofe.
    5/02/2007Considered by Senate.
    5/02/2007Amendment SA 993 proposed by Senator Gregg.
    5/02/2007Considered by Senate.
    5/02/2007Amendment SA 1010 proposed by Senator Cochran to Amendment SA 990.
    5/02/2007Amendment SA 1011 proposed by Senator Stabenow.
    5/02/2007Amendment SA 1018 proposed by Senator DeMint.
    select this voteVote5/02/2007Amendment SA 1018 agreed to in Senate by Unanimous Consent.
    5/02/2007Amendment SA 1022 proposed by Senator Durbin.
    5/02/2007Amendment SA 1025 proposed by Senator Schumer.
    select this voteVote5/02/2007Amendment SA 1025 agreed to in Senate by Voice Vote.
    select this voteVote5/02/2007Allard Amdt. No. 982
    select this voteVote5/02/2007Durbin Amdt. No. 1022, as Modified
    5/03/2007Considered by Senate.
    5/03/2007Considered by Senate.
    5/03/2007Cloture motion on the committee substitute amendment as modified presented in Senate.
    5/03/2007Cloture motion on the measure presented in Senate.
    5/03/2007Considered by Senate.
    5/03/2007Considered by Senate.
    5/03/2007Considered by Senate.
    5/03/2007Considered by Senate.
    5/03/2007Considered by Senate.
    5/03/2007Considered by Senate.
    5/03/2007Considered by Senate.
    select this voteVote5/03/2007Motion to Invoke Cloture on the Dorgan Amdt. No. 990
    5/07/2007Considered by Senate.
    5/07/2007Considered by Senate.
    5/07/2007Considered by Senate.
    5/07/2007Considered by Senate.
    5/07/2007Considered by Senate.
    select this voteVote5/07/2007Amendment SA 990 agreed to in Senate by Voice Vote.
    5/07/2007Considered by Senate.
    5/07/2007Considered by Senate.
    5/07/2007Considered by Senate.
    5/07/2007Considered by Senate.
    select this voteVote5/07/2007Cochran Amdt. No. 1010
    select this voteVote5/07/2007Motion to Invoke Cloture on the Committee Substitute as Modified and Amended to S.1082
    5/08/2007Considered by Senate.
    5/08/2007Considered by Senate.
    5/08/2007Proposed amendment SA 983 withdrawn in Senate.
    5/08/2007Considered by Senate.
    select this voteVote5/08/2007Amendment SA 985 as modified agreed to in Senate by Unanimous Consent.
    5/08/2007Amendment SA 987 proposed by Senator Brown for Senator Inhofe.
    select this voteVote5/08/2007Amendment SA 987 as modified agreed to in Senate by Unanimous Consent.
    5/08/2007Considered by Senate.
    5/08/2007Proposed amendment SA 988 withdrawn in Senate.
    5/08/2007Considered by Senate.
    5/08/2007Proposed amendment SA 993 withdrawn in Senate.
    5/08/2007Amendment SA 998 proposed by Senator Brown for Senator Grassley.
    5/08/2007Considered by Senate.
    select this voteVote5/08/2007Amendment SA 1004 as modified agreed to in Senate by Unanimous Consent.
    5/08/2007Amendment SA 1005 proposed by Senator Brown for Senator Levin.
    select this voteVote5/08/2007Amendment SA 1005 as modified agreed to in Senate by Unanimous Consent.
    5/08/2007Amendment SA 1006 proposed by Senator Brown for Senator Murkowski.
    select this voteVote5/08/2007Amendment SA 1006 as modified agreed to in Senate by Unanimous Consent.
    5/08/2007Amendment SA 1009 proposed by Senator Brown for Senator Hatch.
    select this voteVote5/08/2007Amendment SA 1009 as modified agreed to in Senate by Unanimous Consent.
    5/08/2007Considered by Senate.
    select this voteVote5/08/2007Amendment SA 1011 as modified agreed to in Senate by Unanimous Consent.
    5/08/2007Amendment SA 1019 proposed by Senator Brown for Senator Casey.
    select this voteVote5/08/2007Amendment SA 1019 agreed to in Senate by Unanimous Consent.
    5/08/2007Amendment SA 1026 proposed by Senator Brown for Senator Feingold.
    select this voteVote5/08/2007Amendment SA 1026 as modified agreed to in Senate by Unanimous Consent.
    5/08/2007Amendment SA 1034 proposed by Senator Brown for Senator Durbin.
    5/08/2007Amendment SA 1039 proposed by Senator Brown for Senator Grassley.
    5/08/2007Amendment SA 1041 proposed by Senator Brown for Senator Obama.
    select this voteVote5/08/2007Amendment SA 1041 as modified agreed to in Senate by Unanimous Consent.
    5/08/2007Amendment SA 1047 proposed by Senator Brown for Senator Roberts.
    select this voteVote5/08/2007Amendment SA 1047 agreed to in Senate by Unanimous Consent.
    5/08/2007Amendment SA 1049 proposed by Senator Brown for Senator Enzi.
    select this voteVote5/08/2007Amendment SA 1049 as modified agreed to in Senate by Unanimous Consent.
    5/08/2007Amendment SA 1050 proposed by Senator Brown for Senator Enzi.
    select this voteVote5/08/2007Amendment SA 1050 agreed to in Senate by Unanimous Consent.
    5/08/2007Amendment SA 1053 proposed by Senator Brown for Senator Enzi.
    currently selectedVote5/08/2007Amendment SA 1053 agreed to in Senate by Unanimous Consent.
    5/08/2007Amendment SA 1056 proposed by Senator Brown for Senator Reed.
    select this voteVote5/08/2007Amendment SA 1056 agreed to in Senate by Unanimous Consent.
    5/09/2007Considered by Senate.
    5/09/2007The committee substitute as amended agreed to by Unanimous Consent.
    5/09/2007Cloture motion on the bill withdrawn by unanimous consent in Senate.
    5/09/2007Considered by Senate.
    5/09/2007Considered by Senate.
    5/09/2007Considered by Senate.
    select this voteVote5/09/2007Grassley Amdt. No. 1039
    select this voteVote5/09/2007Grassley Amdt. No. 998
    select this voteVote5/09/2007Durbin Amdt. No. 1034
    select this voteSenate Vote on Passage5/09/2007On Passage - Senate - S.1082 as Amended
    5/10/2007Message on Senate action sent to the House.
    5/10/2007Received in the House.
    5/11/2007Held at the desk.
    NumberSponsorDate OfferedStatus
    select this voteS. Amdt. 982Allard, Wayne [R-CO]April 30, 2007Failed by roll call vote on May 1, 2007.

    To strike provisions related to market exclusivity.

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    S. Amdt. 983Vitter, David [R-LA]May 1, 2007Withdrawn on May 7, 2007.

    To require counterfeit-resistant technologies for prescription drugs.

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    S. Amdt. 984Vitter, David [R-LA]May 1, 2007Offered on April 30, 2007.

    Amendment information not available.

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    select this voteS. Amdt. 985Brownback, Samuel [R-KS]May 1, 2007Passed by voice vote on May 7, 2007.

    To establish a priority drug review process to encourage treatments of tropical diseases.

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    S. Amdt. 986Landrieu, Mary [D-LA]May 1, 2007Offered on April 30, 2007.

    Amendment information not available.

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    select this voteS. Amdt. 987Inhofe, James [R-OK]May 1, 2007Passed by voice vote on May 7, 2007.

    To amend the Head Start Act to require parental consent for nonemergency intrusive physical examinations.

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    S. Amdt. 988Inhofe, James [R-OK]May 1, 2007Withdrawn on May 7, 2007.

    To protect children and their parents from being coerced into administering a controlled substance in order to attend school, and for other purposes.

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    S. Amdt. 989Harkin, Thomas [D-IA]May 1, 2007Offered on April 30, 2007.

    Amendment information not available.

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    select this voteS. Amdt. 990Dorgan, Byron [D-ND]May 1, 2007Passed by voice vote on May 6, 2007.

    To provide for the importation of prescription drugs.

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    S. Amdt. 991Kohl, Herbert [D-WI]May 1, 2007Offered on April 30, 2007.

    Amendment information not available.

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    S. Amdt. 992Kohl, Herbert [D-WI]May 1, 2007Offered on April 30, 2007.

    Amendment information not available.

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    S. Amdt. 993Gregg, Judd [R-NH]May 1, 2007Withdrawn on May 7, 2007.

    To provide for the regulation of Internet pharmacies.

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    S. Amdt. 994Grassley, Charles [R-IA]May 1, 2007Offered on April 30, 2007.

    Amendment information not available.

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    S. Amdt. 995Grassley, Charles [R-IA]May 1, 2007Offered on April 30, 2007.

    Amendment information not available.

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    S. Amdt. 996Grassley, Charles [R-IA]May 1, 2007Offered on April 30, 2007.

    Amendment information not available.

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    S. Amdt. 997Grassley, Charles [R-IA]May 1, 2007Offered on April 30, 2007.

    Amendment information not available.

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    select this voteS. Amdt. 998Grassley, Charles [R-IA]May 1, 2007Passed by roll call vote on May 8, 2007.

    To provide for the application of stronger civil penalties for violations of approved risk evaluation and mitigation strategies.

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    S. Amdt. 999Grassley, Charles [R-IA]May 1, 2007Offered on April 30, 2007.

    Amendment information not available.

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    S. Amdt. 1000Grassley, Charles [R-IA]May 1, 2007Offered on April 30, 2007.

    Amendment information not available.

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    S. Amdt. 1001Grassley, Charles [R-IA]May 1, 2007Offered on April 30, 2007.

    Amendment information not available.

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    S. Amdt. 1002Grassley, Charles [R-IA]May 1, 2007Offered on April 30, 2007.

    Amendment information not available.

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    S. Amdt. 1003Grassley, Charles [R-IA]May 1, 2007Offered on April 30, 2007.

    Amendment information not available.

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    select this voteS. Amdt. 1004Landrieu, Mary [D-LA]May 1, 2007Passed by voice vote on May 7, 2007.

    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.

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    select this voteS. Amdt. 1005Levin, Carl [D-MI]May 1, 2007Passed by voice vote on May 7, 2007.

    To require the Food and Drug Administration to determine whether certain substances create any health risks and mislead consumers.

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    select this voteS. Amdt. 1006Murkowski, Lisa [R-AK]May 1, 2007Passed by voice vote on May 7, 2007.

    To modify provisions relating to required experience or certification for prescribing or dispensing certain drugs, and for other purposes.

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    S. Amdt. 1008Grassley, Charles [R-IA]May 2, 2007Offered on May 1, 2007.

    Amendment information not available.

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    select this voteS. Amdt. 1009Hatch, Orrin [R-UT]May 2, 2007Passed by voice vote on May 7, 2007.

    To insert provisions relating to antibiotic access and innovation and certain enantiomer drugs.

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    select this voteS. Amdt. 1010Cochran, Thad [R-MS]May 2, 2007Passed by roll call vote on May 6, 2007.

    To protect the health and safety of the public.

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    select this voteS. Amdt. 1011Stabenow, Debbie [D-MI]May 2, 2007Passed by voice vote on May 7, 2007.

    To insert provisions related to citizens petitions.

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    S. Amdt. 1012Vitter, David [R-LA]May 2, 2007Offered on May 1, 2007.

    Amendment information not available.

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    S. Amdt. 1013Vitter, David [R-LA]May 2, 2007Offered on May 1, 2007.

    Amendment information not available.

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    S. Amdt. 1014Vitter, David [R-LA]May 2, 2007Offered on May 1, 2007.

    Amendment information not available.

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    S. Amdt. 1015Hagel, Charles [R-NE]May 2, 2007Offered on May 1, 2007.

    Amendment information not available.

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    S. Amdt. 1016Specter, Arlen [D-PA]May 2, 2007Offered on May 1, 2007.

    Amendment information not available.

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    S. Amdt. 1017Gregg, Judd [R-NH]May 2, 2007Offered on May 1, 2007.

    Amendment information not available.

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    select this voteS. Amdt. 1018DeMint, Jim [R-SC]May 2, 2007Passed by voice vote on May 1, 2007.

    To amend the notification provision with respect to drugs deemed to have risk evaluation and mitigation strategies.

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    select this voteS. Amdt. 1019Casey, Robert [D-PA]May 2, 2007Passed by voice vote on May 7, 2007.

    To express the sense of the Senate concerning orphan disease treatment in children.

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    S. Amdt. 1020Grassley, Charles [R-IA]May 2, 2007Offered on May 1, 2007.

    Amendment information not available.

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    S. Amdt. 1021Clinton, Hillary [D-NY]May 2, 2007Offered on May 1, 2007.

    Amendment information not available.

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    select this voteS. Amdt. 1022Durbin, Richard [D-IL]May 2, 2007Passed by roll call vote on May 1, 2007.

    To ensure the safety of human and pet food.

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    S. Amdt. 1023Durbin, Richard [D-IL]May 2, 2007Offered on May 1, 2007.

    Amendment information not available.

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    S. Amdt. 1024Salazar, Ken [D-CO]May 2, 2007Offered on May 1, 2007.

    Amendment information not available.

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    select this voteS. Amdt. 1025Schumer, Charles [D-NY]May 2, 2007Passed by voice vote on May 1, 2007.

    To express the sense of the Senate with respect to follow-on biologics.

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    select this voteS. Amdt. 1026Feingold, Russell [D-WI]May 2, 2007Passed by voice vote on May 7, 2007.

    To require the Food and Drug Administration to publish certain annual reports.

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    S. Amdt. 1027Durbin, Richard [D-IL]May 2, 2007Offered on May 1, 2007.

    Amendment information not available.

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    S. Amdt. 1028Rockefeller, John [D-WV]May 2, 2007Offered on May 1, 2007.

    Amendment information not available.

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    S. Amdt. 1029Sanders, Bernard [I-VT]May 2, 2007Offered on May 1, 2007.

    Amendment information not available.

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    S. Amdt. 1030Sanders, Bernard [I-VT]May 2, 2007Offered on May 1, 2007.

    Amendment information not available.

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    S. Amdt. 1031Sanders, Bernard [I-VT]May 2, 2007Offered on May 1, 2007.

    Amendment information not available.

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    S. Amdt. 1032Sanders, Bernard [I-VT]May 2, 2007Offered on May 1, 2007.

    Amendment information not available.

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    S. Amdt. 1033Sanders, Bernard [I-VT]May 2, 2007Offered on May 1, 2007.

    Amendment information not available.

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    select this voteS. Amdt. 1034Durbin, Richard [D-IL]May 3, 2007Failed by roll call vote on May 8, 2007.

    To reduce financial conflict of interest in FDA Advisory Panels.

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    S. Amdt. 1035Burr, Richard [R-NC]May 3, 2007Offered on May 2, 2007.

    Amendment information not available.

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    S. Amdt. 1036Corker, Bob [R-TN]May 3, 2007Offered on May 2, 2007.

    Amendment information not available.

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    S. Amdt. 1037Vitter, David [R-LA]May 3, 2007Offered on May 2, 2007.

    Amendment information not available.

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    S. Amdt. 1038Vitter, David [R-LA]May 3, 2007Offered on May 2, 2007.

    Amendment information not available.

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    select this voteS. Amdt. 1039Grassley, Charles [R-IA]May 3, 2007Failed by roll call vote on May 8, 2007.

    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.

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    S. Amdt. 1040Clinton, Hillary [D-NY]May 3, 2007Offered on May 2, 2007.

    Amendment information not available.

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    select this voteS. Amdt. 1041Obama, Barack [D-IL]May 3, 2007Passed by voice vote on May 7, 2007.

    To improve the safety and efficacy of genetic tests.

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    S. Amdt. 1042Ensign, John [R-NV]May 3, 2007Offered on May 2, 2007.

    Amendment information not available.

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    S. Amdt. 1043Reed, John [D-RI]May 3, 2007Offered on May 2, 2007.

    Amendment information not available.

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    S. Amdt. 1044Kohl, Herbert [D-WI]May 3, 2007Offered on May 2, 2007.

    Amendment information not available.

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    S. Amdt. 1045Obama, Barack [D-IL]May 7, 2007Offered on May 6, 2007.

    Amendment information not available.

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    S. Amdt. 1046Stabenow, Debbie [D-MI]May 7, 2007Offered on May 6, 2007.

    Amendment information not available.

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    select this voteS. Amdt. 1047Roberts, Pat [R-KS]May 7, 2007Passed by voice vote on May 7, 2007.

    To modify provisions relating to direct-to-consumer advertisements.

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    S. Amdt. 1048Snowe, Olympia [R-ME]May 7, 2007Offered on May 6, 2007.

    Amendment information not available.

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    select this voteS. Amdt. 1049Enzi, Michael [R-WY]May 7, 2007Passed by voice vote on May 7, 2007.

    To modify provisions relating to user fees, and for other purposes.

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    select this voteS. Amdt. 1050Enzi, Michael [R-WY]May 7, 2007Passed by voice vote on May 7, 2007.

    To provide for color certification reports.

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    S. Amdt. 1051Stevens, Ted [R-AK]May 7, 2007Offered on May 6, 2007.

    Amendment information not available.

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    S. Amdt. 1052Corker, Bob [R-TN]May 7, 2007Offered on May 6, 2007.

    Amendment information not available.

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    currently selectedS. Amdt. 1053Enzi, Michael [R-WY]May 7, 2007Passed by voice vote on May 8, 2007.

    to modify provisions related to pediatric testing and medical products.

    Actions

    May 8, 2007, 12:00 am ET - Amendment SA 1053 proposed by Senator Brown for Senator Enzi.
    May 8, 2007, 12:00 am ET - Amendment SA 1053 agreed to in Senate by Unanimous Consent.

    Full Text of this Amendment

    SA 1053. Mr. ENZI (for himself, Mr. Kennedy, Mr. Dodd, and Mrs. Clinton) submitted an amendment intended to be proposed by him to the bill S. 1082, to amend the Federal Food, Drug, and Cosmetic Act to reauthorize and amend the prescription drug user fee provisions, and for other purposes; which was ordered to lie on the table; as follows:

    On page 226, line 4, strike ``later'' and insert ``if the determination made under subsection (d)(3) is made less''.
    On page 228, line 3, strike ``later'' and insert ``if the determination made under subsection (d)(3) is made less''.
    On page 233, line 12, insert ``, such as expertise in child and adolescent psychiatry,'' after ``expertise''.
    On page 233, line 15, strike ``including'' and insert ``which may include''.
    On page 233, between lines 18 and 19, insert the following:
    ``(C) ACTION BY COMMITTEE.--The committee established under this paragraph may perform a function under this section using appropriate members of the committee under subparagraph (B) and need not convene all members of the committee under subparagraph (B) in order to perform a function under this section.
    ``(D) DOCUMENTATION OF COMMITTEE ACTION.--The committee established under this paragraph shall document for each function under paragraphs (2) and (3), which members of the committee participated in such function.
    On page 234, line 1, strike ``determine'' and insert ``make a recommendation to the Secretary''.
    On page 235, line 2, strike ``and''.
    On page 235, line 6, strike ``.'';'' and insert ``; and''
    On page 235, between lines 6 and 7, insert the following:
    ``(H) the number of times the committee established under paragraph (1) made a recommendation to the Secretary under paragraph (3), the number of times the Secretary did not follow such a recommendation to accept reports under subsection (d)(3), and the number of times the Secretary did not follow such a recommendation to reject such reports under section (d)(3).
    ``(5) COMMITTEE.--The committee established under paragraph (1) is the committee established under section 505B(f)(1).'';
    On page 260, lines 17 through 19, strike ``of a letter, or a written request under section 505A that was declined by the sponsor or holder'' and insert ``of a written request under section 505A that was declined by the sponsor or holder, or a letter referencing such declined written request,''.
    On page 261, line 3, strike ``appropriate'' and insert ``appropriate, for the labeled indication or indications,''.
    On page 263, line 14, insert ``, such as expertise in child and adolescent psychiatry,'' after ``expertise''
    On page 263, between lines 19 and 20, insert the following and redesignate the remaining paragraphs accordingly:
    ``(2) ACTION BY THE COMMITTEE.--The committee established under paragraph (1) may perform a function under this section using appropriate members of the committee under paragraph (1) and need not convene all members of the committee under paragraph (1) in order to perform a function under this section.
    ``(3) DOCUMENTATION OF COMMITTEE ACTION.--For each drug or biological product, the committee established under this paragraph shall document for each function under paragraph (4) or (5), which members of the committee participated in such function.
    On page 265, between lines 18 and 19, insert the following:
    ``(7) COMMITTEE.--The committee established under paragraph (1) is the committee established under section 505A(f)(1).
    On page 289, line 16, strike ``
    SURVEILLANCES'' and insert ``POSTMARKET SURVEILLANCE''.
    On page 289, line 17, strike ``Surveillances'' and insert ``Surveillance''.
    On page 290, strike lines 9 through 12 and insert the following:
    ``(iii) that is intended to be--
    ``(I) implanted in the human body for more than 1 year; or
    ``(II) a life-sustaining or life-supporting device used outside a device user facility.
    On page 290, line 15, strike ``of an'' and all that follows through ``section 510(k) only for'' on line 19, and insert ``or clearance of''.


    (As printed in the Congressional Record for the Senate on May 7, 2007.)
    S. Amdt. 1054Feingold, Russell [D-WI]May 7, 2007Offered on May 7, 2007.

    Amendment information not available.

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    S. Amdt. 1055Levin, Carl [D-MI]May 7, 2007Offered on May 7, 2007.

    Amendment information not available.

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    select this voteS. Amdt. 1056Reed, John [D-RI]May 7, 2007Passed by voice vote on May 8, 2007.

    To require the FDA to conduct consumer testing to determine the appropriateness of the labeling requirements for indoor tanning devices.

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    S. Amdt. 1057Gregg, Judd [R-NH]May 7, 2007Offered on May 7, 2007.

    Amendment information not available.

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    S. Amdt. 1058DeMint, Jim [R-SC]May 7, 2007Offered on May 7, 2007.

    Amendment information not available.

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    S. Amdt. 1059Sessions, Jefferson [R-AL]May 7, 2007Offered on May 7, 2007.

    Amendment information not available.

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    S. Amdt. 1060Hatch, Orrin [R-UT]May 7, 2007Offered on May 7, 2007.

    Amendment information not available.

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    S. Amdt. 1061Dorgan, Byron [D-ND]May 8, 2007Offered on May 8, 2007.

    Amendment information not available.

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    S. Amdt. 1062Dorgan, Byron [D-ND]May 8, 2007Offered on May 8, 2007.

    Amendment information not available.

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    S. Amdt. 1063Dorgan, Byron [D-ND]May 8, 2007Offered on May 8, 2007.

    Amendment information not available.

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    S. Amdt. 1064Sessions, Jefferson [R-AL]May 8, 2007Offered on May 8, 2007.

    Amendment information not available.

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    0 Organizations Supported and 0 Opposed

    Organizations that took a position on
    Food and Drug Administration Revitalization Act: Amendment SA 1053 agreed to in Senate by Unanimous Consent.

    0 organizations supported this amendment

    0 organizations opposed this amendment

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    Includes reported contributions to congressional campaigns of Senators in office on day of vote, from interest groups invested in the vote according to MapLight, January 1, 2003 – December 31, 2008.
    Contributions data source: OpenSecrets.org

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    NamePartyState$ From Interest Groups
    That Supported
    $ From Interest Groups
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    Vote
    Daniel K. AkakaDHI$0$0Yes
    Andrew Lamar AlexanderRTN$0$0Yes
    Alan Wayne AllardRCO$0$0Yes
    Max BaucusDMT$0$0Yes
    Birch "Evan" BayhDIN$0$0Yes
    Bob BennettRUT$0$0Yes
    Joe BidenDDE$0$0Yes
    Jesse "Jeff" BingamanDNM$0$0Yes
    Christopher "Kit" BondRMO$0$0Yes
    Barbara BoxerDCA$0$0Yes
    Sherrod BrownDOH$0$0Yes
    Sam BrownbackRKS$0$0Yes
    Jim BunningRKY$0$0Yes
    Richard BurrRNC$0$0Yes
    Robert ByrdDWV$0$0Yes
    Maria CantwellDWA$0$0Yes
    Ben CardinDMD$0$0Yes
    Tom CarperDDE$0$0Yes
    Bob CaseyDPA$0$0Yes
    Clarence Saxby ChamblissRGA$0$0Yes
    Hillary ClintonDNY$0$0Yes
    Tom CoburnROK$0$0Yes
    William Thad CochranRMS$0$0Yes
    Norm ColemanRMN$0$0Yes
    Susan CollinsRME$0$0Yes
    Gaylord Kent ConradDND$0$0Yes
    Bob CorkerRTN$0$0Yes
    John CornynRTX$0$0Yes
    Larry CraigRID$0$0Yes
    Mike CrapoRID$0$0Yes
    Jim DeMintRSC$0$0Yes
    Chris DoddDCT$0$0Yes
    Mary Elizabeth DoleRNC$0$0Yes
    Pete DomeniciRNM$0$0Yes
    Byron DorganDND$0$0Yes
    Dick DurbinDIL$0$0Yes
    John EnsignRNV$0$0Yes
    Mike EnziRWY$0$0Yes
    Russ FeingoldDWI$0$0Yes
    Dianne FeinsteinDCA$0$0Yes
    Lindsey GrahamRSC$0$0Yes
    Chuck GrassleyRIA$0$0Yes
    Judd GreggRNH$0$0Yes
    Chuck HagelRNE$0$0Yes
    Tom HarkinDIA$0$0Yes
    Orrin HatchRUT$0$0Yes
    Kay Bailey HutchisonRTX$0$0Yes
    Jim InhofeROK$0$0Yes
    Dan InouyeDHI$0$0Yes
    Johnny IsaksonRGA$0$0Yes
    Tim JohnsonDSD$0$0Yes
    Ted KennedyDMA$0$0Yes
    John KerryDMA$0$0Yes
    Amy KlobucharDMN$0$0Yes
    Herb KohlDWI$0$0Yes
    Jon KylRAZ$0$0Yes
    Mary LandrieuDLA$0$0Yes
    Frank LautenbergDNJ$0$0Yes
    Patrick LeahyDVT$0$0Yes
    Carl LevinDMI$0$0Yes
    Joe LiebermanICT$0$0Yes
    Blanche LincolnDAR$0$0Yes
    Chester Trent LottRMS$0$0Yes
    Dick LugarRIN$0$0Yes
    Mel MartinezRFL$0$0Yes
    John McCainRAZ$0$0Yes
    Claire McCaskillDMO$0$0Yes
    Addison "Mitch" McConnellRKY$0$0Yes
    Bob MenéndezDNJ$0$0Yes
    Barbara MikulskiDMD$0$0Yes
    Lisa MurkowskiRAK$0$0Yes
    Patty MurrayDWA$0$0Yes
    Earl "Ben" NelsonDNE$0$0Yes
    Clarence "Bill" NelsonDFL$0$0Yes
    Barack ObamaDIL$0$0Yes
    Mark PryorDAR$0$0Yes
    John "Jack" ReedDRI$0$0Yes
    Harry ReidDNV$0$0Yes
    Charles "Pat" RobertsRKS$0$0Yes
    John "Jay" RockefellerDWV$0$0Yes
    Ken SalazarDCO$0$0Yes
    Bernie SandersIVT$0$0Yes
    Chuck SchumerDNY$0$0Yes
    Jeff SessionsRAL$0$0Yes
    Richard ShelbyRAL$0$0Yes
    Gordon SmithROR$0$0Yes
    Olympia SnoweRME$0$0Yes
    Arlen SpecterDPA$0$0Yes
    Debbie StabenowDMI$0$0Yes
    Ted StevensRAK$0$0Yes
    John SununuRNH$0$0Yes
    Jon TesterDMT$0$0Yes
    Craig ThomasRWY$0$0Yes
    John ThuneRSD$0$0Yes
    David VitterRLA$0$0Yes
    George VoinovichROH$0$0Yes
    John WarnerRVA$0$0Yes
    Jim WebbDVA$0$0Yes
    Sheldon WhitehouseDRI$0$0Yes
    Ron WydenDOR$0$0Yes

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