S. Amdt. 1034 - To Reduce Financial Conflict of Interest in FDA Advisory Panels.

110th Congress (2007-2008) View amendment details
Sponsor:
This is an amendment to S. 1082 - Food and Drug Administration Revitalization Act
Senate Vote: Durbin Amdt. No. 1034

DID NOT PASS on May 9, 2007.

1/2 required to pass

voted YES: 47 voted NO: 47
6 voted present/not voting

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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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
    select this voteSenateAmendment 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
    currently selectedSenateDurbin 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.
    select this voteVote5/08/2007Amendment 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
    currently selectedVote5/09/2007Durbin 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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    currently selectedS. Amdt. 1034Durbin, Richard [D-IL]May 3, 2007Failed by roll call vote on May 9, 2007.

    To reduce financial conflict of interest in FDA Advisory Panels.

    Actions

    May 8, 2007, 12:00 am ET - Amendment SA 1034 proposed by Senator Brown for Senator Durbin.
    May 9, 2007, 12:00 am ET - Considered by Senate.
    May 9, 2007, 12:37 pm ET - Durbin Amdt. No. 1034

    Full Text of this Amendment

    SA 1034. Mr. DURBIN (for himself and Mr. Bingaman) 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:

    In title II, strike subtitle D and insert the following:
    Subtitle D--Conflicts of Interest


    SEC. 241. CONFLICTS OF INTEREST.
    (a) In General.--Subchapter A of chapter VII of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 371 et seq.) is amended by inserting at the end the following:
    ``SEC. 712. CONFLICTS OF INTEREST.
    ``(a) Definitions.--For purposes of this section:
    ``(1) ADVISORY COMMITTEE.--The term `advisory committee' means an advisory committee under the Federal Advisory Committee Act that provides advice or recommendations to the Secretary regarding activities of the Food and Drug Administration.
    ``(2) FINANCIAL INTEREST.--The term `financial interest' means a financial interest under section 208(a) of title 18, United States Code.
    ``(b) Appointments to Advisory Committees.--
    ``(1) RECRUITMENT.--
    ``(A) IN GENERAL.--Given the importance of advisory committees to the review process at the Food and Drug Administration, the Secretary, through the Office of Women's Health, the Office of Orphan Product Development, the Office of Pediatric Therapeutics, and other offices within the Food and Drug Administration with relevant expertise, shall develop and implement strategies on effective outreach to potential members of advisory committees at universities, colleges, other academic research
    centers, professional and medical societies, and patient and consumer groups. The Secretary shall seek input from professional medical and scientific societies to determine the most effective informational and recruitment activities. The Secretary shall also take into account the advisory committees with the greatest number of vacancies.
    ``(B) RECRUITMENT ACTIVITIES.--The recruitment activities under subparagraph (A) may include--
    ``(i) advertising the process for becoming an advisory committee member at medical and scientific society conferences;
    ``(ii) making widely available, including by using existing electronic communications channels, the contact information for the Food and Drug Administration point of contact regarding advisory committee nominations; and
    ``(iii) developing a method through which an entity receiving funding from the National Institutes of Health, the Agency for Healthcare Research and Quality, the Centers for Disease Control and Prevention, or the Veterans Health Administration can identify a person who the Food and Drug Administration can contact regarding the nomination of individuals to serve on advisory committees.
    ``(2) EVALUATION AND CRITERIA.--When considering a term appointment to an advisory committee, the Secretary shall review the expertise of the individual and the financial disclosure report filed by the individual pursuant to the Ethics in Government Act of 1978 for each individual under consideration for the appointment, so as to reduce the likelihood that an appointed individual will later require a written determination as referred to in section 208(b)(1) of title 18, United States
    Code, a written certification as referred to in section 208(b)(3) of title 18, United States Code, or a waiver as referred to in subsection (c)(3) of this section for service on the committee at a meeting of the committee.
    ``(3) PARTICIPATION OF GUEST EXPERT WITH FINANCIAL INTEREST.--Notwithstanding any other provision of this section, an individual with a financial interest with respect to any matter considered by an advisory committee may be allowed to participate in a meeting of an advisory committee as a guest expert if the Secretary determines that the individual has particular expertise required for the meeting. An individual participating as a guest expert may provide information and expert opinion,
    but shall not participate in the discussion or voting by the members of the advisory committee.
    ``(c) Granting and Disclosure of Waivers.--
    ``(1) IN GENERAL.--Prior to a meeting of an advisory committee regarding a `particular matter' (as that term is used in section 208 of title 18, United States Code), each member of the committee who is a full-time Government employee or special Government employee shall disclose to the Secretary financial interests in accordance with subsection (b) of such section 208.
    ``(2) FINANCIAL INTEREST OF ADVISORY COMMITTEE MEMBER OR FAMILY MEMBER.--No member of an advisory committee may vote with respect to any matter considered by the advisory committee if such member (or an immediate family member of such member) has a financial interest that could be affected by the advice given to the Secretary with respect to such matter, excluding interests exempted in regulations issued by the Director of the Office of Government Ethics as too remote or inconsequential
    to affect the integrity of the services of the Government officers or employees to which such regulations apply.
    ``(3) WAIVER.--The Secretary may grant a waiver of the prohibition in paragraph (2) if such waiver is necessary to afford the advisory committee essential expertise.
    ``(4) LIMITATIONS.--
    ``(A) ONE WAIVER PER COMMITTEE MEETING.--Notwithstanding any other provision of this section, with respect to each advisory committee, the Secretary shall not grant more than 1 waiver under paragraph (3) per committee meeting.
    ``(B) SCIENTIFIC WORK.--The Secretary may not grant a waiver under paragraph (3) for a member of an advisory committee when the member's own scientific work is involved.
    ``(5) DISCLOSURE OF WAIVER.--Notwithstanding section 107(a)(2) of the Ethics in Government Act (5 U.S.C. App.), the following shall apply:
    ``(A) 15 OR MORE DAYS IN ADVANCE.--As soon as practicable, but in no case later than 15 days prior to a meeting of an advisory committee to which a written determination as referred to in section 208(b)(1) of title 18, United States Code, a written certification as referred to in section 208(b)(3) of title 18, United States Code, or a waiver as referred to in paragraph (3) applies, the Secretary shall disclose (other than information exempted from disclosure under section 552
    of title 5, United States Code, and section 552a of title 5, United States Code (popularly known as the Freedom of Information Act and the Privacy Act of 1974, respectively)) on the Internet website of the Food and Drug Administration--
    ``(i) the type, nature, and magnitude of the financial interests of the advisory committee member to which such determination, certification, or waiver applies; and
    ``(ii) the reasons of the Secretary for such determination, certification, or waiver.
    ``(B) LESS THAN 30 DAYS IN ADVANCE.--In the case of a financial interest that becomes known to the Secretary less than 30 days prior to a meeting of an advisory committee to which a written determination as referred to in section 208(b)(1) of title 18, United States Code, a written certification as referred to in section 208(b)(3) of title 18, United States Code, or a waiver as referred to in paragraph (3) applies, the Secretary shall disclose (other than information exempted from disclosure
    under section 552 of title 5, United States Code, and section 552a of title 5, United States Code) on the Internet website of the Food and Drug Administration, the information described in clauses (i) and (ii) of subparagraph (A) as soon as practicable after the Secretary makes such determination, certification, or waiver, but in no case later than the date of such meeting.
    ``(d) Public Record.--The Secretary shall ensure that the public record and transcript of each meeting of an advisory committee includes the disclosure required under subsection (c)(5) (other than information exempted from disclosure under section 552 of title 5, United States Code, and section 552a of title 5, United States Code).
    ``(e) Annual Report.--Not later than February 1 of each year, the Secretary shall submit to the Committee on Appropriations and the Committee on Health, Education, Labor, and Pensions of the Senate, and the Committee on Appropriations and the Committee on Energy and Commerce of the House of Representatives a report that describes--
    ``(1) with respect to the fiscal year that ended on September 30 of the previous year, the number of vacancies on each advisory committee, the number of nominees received for each committee, and the number of such nominees willing to serve;
    ``(2) with respect to such year, the aggregate number of disclosures required under subsection (c)(5) for each meeting of each advisory committee and the percentage of individuals to whom such disclosures did not apply who served on such committee for each such meeting;
    ``(3) with respect to such year, the number of times the disclosures required under subsection (c)(5) occurred under subparagraph (B) of such subsection; and
    ``(4) how the Secretary plans to reduce the number of vacancies reported under paragraph (1) during the fiscal year following such year, and mechanisms to encourage the nomination of individuals for service on an advisory committee, including those who are classified by the Food and Drug Administration as academicians or practitioners.
    ``(f) Periodic Review of Guidance.--Not less than once every 5 years, the Secretary shall review guidance of the Food and Drug Administration regarding conflict of interest waiver determinations with respect to advisory committees and update such guidance as necessary.''.
    (b) Conforming Amendment.--Section 505(n) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(n)) is amended by--
    (1) striking paragraph (4); and
    (2) redesignating paragraphs (5), (6), (7), and (8) as paragraphs (4), (5), (6), and (7), respectively.
    (c) Effective Date.--The amendments made by this section shall take effect on October 1, 2007.


    (As printed in the Congressional Record for the Senate on May 3, 2007.)
    S. Amdt. 1035Burr, Richard [R-NC]May 3, 2007Offered on May 3, 2007.

    Amendment information not available.

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

    Amendment information not available.

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

    Amendment information not available.

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    S. Amdt. 1038Vitter, David [R-LA]May 3, 2007Offered on May 3, 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 9, 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 3, 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 8, 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 3, 2007.

    Amendment information not available.

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

    Amendment information not available.

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

    Amendment information not available.

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

    Amendment information not available.

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    S. Amdt. 1046Stabenow, Debbie [D-MI]May 7, 2007Offered on May 7, 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 8, 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 7, 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 8, 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 8, 2007.

    To provide for color certification reports.

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

    Amendment information not available.

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

    Amendment information not available.

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    select this voteS. 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.

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    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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    MapLight did not identify any interest groups that took a position on this vote.
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    0 Organizations Supported and 0 Opposed

    Organizations that took a position on
    Food and Drug Administration Revitalization Act: Durbin Amdt. No. 1034

    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, April 9, 2007 – June 8, 2007.
    Contributions data source: OpenSecrets.org

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    NamePartyState$ From Interest Groups
    That Supported
    $ From Interest Groups
    That Opposed
    Vote
    Daniel K. AkakaDHI$0$0Yes
    Andrew Lamar AlexanderRTN$0$0No
    Alan Wayne AllardRCO$0$0No
    Max BaucusDMT$0$0Yes
    Birch "Evan" BayhDIN$0$0Yes
    Bob BennettRUT$0$0No
    Joe BidenDDE$0$0Yes
    Jesse "Jeff" BingamanDNM$0$0Yes
    Christopher "Kit" BondRMO$0$0No
    Barbara BoxerDCA$0$0Yes
    Sherrod BrownDOH$0$0Yes
    Sam BrownbackRKS$0$0Not Voting
    Jim BunningRKY$0$0No
    Richard BurrRNC$0$0No
    Robert ByrdDWV$0$0No
    Maria CantwellDWA$0$0Yes
    Ben CardinDMD$0$0Yes
    Tom CarperDDE$0$0Yes
    Bob CaseyDPA$0$0Yes
    Clarence Saxby ChamblissRGA$0$0No
    Hillary ClintonDNY$0$0Yes
    Tom CoburnROK$0$0No
    William Thad CochranRMS$0$0No
    Norm ColemanRMN$0$0No
    Susan CollinsRME$0$0Yes
    Gaylord Kent ConradDND$0$0Yes
    Bob CorkerRTN$0$0No
    John CornynRTX$0$0No
    Larry CraigRID$0$0No
    Mike CrapoRID$0$0Not Voting
    Jim DeMintRSC$0$0No
    Chris DoddDCT$0$0No
    Mary Elizabeth DoleRNC$0$0No
    Pete DomeniciRNM$0$0No
    Byron DorganDND$0$0Yes
    Dick DurbinDIL$0$0Yes
    John EnsignRNV$0$0No
    Mike EnziRWY$0$0No
    Russ FeingoldDWI$0$0Yes
    Dianne FeinsteinDCA$0$0Yes
    Lindsey GrahamRSC$0$0No
    Chuck GrassleyRIA$0$0Yes
    Judd GreggRNH$0$0No
    Chuck HagelRNE$0$0No
    Tom HarkinDIA$0$0Yes
    Orrin HatchRUT$0$0No
    Kay Bailey HutchisonRTX$0$0No
    Jim InhofeROK$0$0No
    Dan InouyeDHI$0$0Yes
    Johnny IsaksonRGA$0$0No
    Tim JohnsonDSD$0$0Not Voting
    Ted KennedyDMA$0$0No
    John KerryDMA$0$0No
    Amy KlobucharDMN$0$0Yes
    Herb KohlDWI$0$0Yes
    Jon KylRAZ$0$0No
    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$0No
    Dick LugarRIN$0$0No
    Mel MartinezRFL$0$0No
    John McCainRAZ$0$0Not Voting
    Claire McCaskillDMO$0$0Yes
    Addison "Mitch" McConnellRKY$0$0No
    Bob MenéndezDNJ$0$0Yes
    Barbara MikulskiDMD$0$0Yes
    Lisa MurkowskiRAK$0$0No
    Patty MurrayDWA$0$0Yes
    Earl "Ben" NelsonDNE$0$0No
    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$0Not Voting
    John "Jay" RockefellerDWV$0$0No
    Ken SalazarDCO$0$0Yes
    Bernie SandersIVT$0$0Yes
    Chuck SchumerDNY$0$0Yes
    Jeff SessionsRAL$0$0No
    Richard ShelbyRAL$0$0No
    Gordon SmithROR$0$0No
    Olympia SnoweRME$0$0Yes
    Arlen SpecterDPA$0$0No
    Debbie StabenowDMI$0$0Yes
    Ted StevensRAK$0$0No
    John SununuRNH$0$0No
    Jon TesterDMT$0$0Yes
    Craig ThomasRWY$0$0No
    John ThuneRSD$0$0No
    David VitterRLA$0$0Not Voting
    George VoinovichROH$0$0No
    John WarnerRVA$0$0No
    Jim WebbDVA$0$0Yes
    Sheldon WhitehouseDRI$0$0Yes
    Ron WydenDOR$0$0Yes

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