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United States · Law · HR

H.R. 3580 (110th)

Food and Drug Administration Amendments Act of 2007

enactedUnited States· United States Congress· EN

Introduced

19 September 2007

Last action

27 September 2007 · President

Status

Became Public Law No: 110-85.

Sponsors

Rep. Dingell, John D. [D-MI-12], Rep. Barton, Joe [R-TX-6], Rep. Pallone, Frank [D-NJ-6]

Subjects

Healthcare

Source updated

7 April 2025

Healthcare

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Summary

Food and Drug Administration Amendments Act of 2007 - Prescription Drug User Fee Amendments of 2007 - Amends the Federal Food, Drug, and Cosmetic Act to reauthorize the collection of prescription drug user fees for FY2008-FY2012. Requires the Secretary of Health and Human Services to assess and collect fees for advisory review of direct-to-consumer television advertisements of prescription drugs. Medical Device User Fee Amendments of 2007 - Reauthorizes the collection of medical device user fees for FY2008-FY2012. Sets forth provisions governing the inspection of medical device establishments by accredited persons. Pediatric Medical Device Safety and Improvement Act of 2007 - Requires a person that submits an application for approval of a medical device to provide information on pediatric subpopulations that suffer from the disease or condition that the device is intended to treat, diagnose, or cure. Pediatric Research Equity Act of 2007 - Sets forth conditions under which the Secretary may grant waivers or deferrals of requirements that applicants submit a pediatric assessment for new drugs and biological products. Best Pharmaceuticals for Children Act of 2007 - Makes changes to provisions regarding market exclusivity for conducting pediatric drug studies on new or already approved drugs. Establishes the Reagan-Udall Foundation for the Food and Drug Administration as a nonprofit corporation to advance the mission of the Food and Drug Administration (FDA) to modernize medical, veterinary, food, food ingredient, and cosmetic product development, accelerate innovation, and enhance product safety. Provides for recruitment of potential members of FDA advisory committees. Requires the Secretary, acting through the Director of the National Institutes of Health (NIH), to expand the clinical trials registry data bank. Authorizes the Secretary to require a responsible person for a drug to conduct a postapproval study on the basis of appropriate scientific data. Requires the Secretary to: (1) develop ingredient, processing, and labeling standards for pet foods; and (2) establish a Reportable Food Registry. Requires the Secretary, acting through the Commissioner of Food and Drugs, to identify and make public clinically susceptible concentrations of antimicrobials.

This text is taken from the official record. PoliticalRepo does not editorialize.

Timeline

  1. 19 September 2007

    Introduced

    Received in the Senate, read twice.

    Source: IntroReferral

  2. 19 September 2007

    Passed

    Motion to reconsider laid on the table Agreed to without objection.

    Source: Floor

  3. 19 September 2007

    Vote

    On motion to suspend the rules and pass the bill Agreed to by the Yeas and Nays: (2/3 required): 405 - 7 (Roll no. 885). (text: CR H10551-10594)

    Source: Floor

  4. 19 September 2007

    Vote

    Passed/agreed to in House: On motion to suspend the rules and pass the bill Agreed to by the Yeas and Nays: (2/3 required): 405 - 7 (Roll no. 885).(text: CR H10551-10594)

    Source: Floor

  5. 19 September 2007

    Floor

    DEBATE - The House proceeded with forty minutes of debate on H.R. 3580.

    Source: Floor

  6. 19 September 2007

    Floor

    Considered under suspension of the rules. (consideration: CR H10551-10599)

    Source: Floor

  7. 19 September 2007

    Floor

    Mr. Dingell moved to suspend the rules and pass the bill.

    Source: Floor

  8. 19 September 2007

    Introduced

    Referred to the House Committee on Energy and Commerce.

    Source: IntroReferral

  9. 19 September 2007

    Introduced

    Introduced in House

    Source: IntroReferral

  10. 19 September 2007

    Introduced

    Introduced in House

    Source: IntroReferral

  11. 20 September 2007

    Action

    Cleared for White House.

  12. 20 September 2007

    Passed

    Passed Senate without amendment by Unanimous Consent. (consideration: CR S11831-11841)

    Source: Floor

  13. 20 September 2007

    Passed

    Passed/agreed to in Senate: Passed Senate without amendment by Unanimous Consent.(consideration: CR S11831-11841)

    Source: Floor

  14. 21 September 2007

    Floor

    Message on Senate action sent to the House.

    Source: Floor

  15. 26 September 2007

    Floor

    Presented to President.

    Source: Floor

  16. 26 September 2007

    President

    Presented to President.

    Source: President

  17. 27 September 2007

    Became law

    Became Public Law No: 110-85.

    Source: President

  18. 27 September 2007

    Became law

    Signed by President.

    Source: BecameLaw

  19. 27 September 2007

    President

    Signed by President.

    Source: President

Votes

No vote records are attached yet.

Versions

Documents

12 official files

Enrolled Bill (text)

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  • Enrolled Bill (text)

    Enrolled Bill · EN

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  • Enrolled Bill (PDF)

    Enrolled Bill · EN

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  • Public Law (text)

    Public Law · EN · 27 September 2007

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  • Public Law (PDF)

    Public Law · EN · 27 September 2007

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  • Public Law

    summary · EN · 27 September 2007

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  • Received in Senate (text)

    Received in Senate · EN · 19 September 2007

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  • Received in Senate (PDF)

    Received in Senate · EN · 19 September 2007

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  • Engrossed in House (text)

    Engrossed in House · EN · 19 September 2007

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  • Engrossed in House (PDF)

    Engrossed in House · EN · 19 September 2007

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  • Considered and Passed House (text)

    Considered and Passed House · EN · 19 September 2007

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  • Considered and Passed House (PDF)

    Considered and Passed House · EN · 19 September 2007

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  • Introduced in House

    summary · EN · 19 September 2007

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