Medical Device User Fee Stabilization Act of 2005

Summary

Medical Device User Fee Stabilization Act of 2005 - Amends the Federal Food, Drug, and Cosmetic Act to adjust medical device user fees (e.g., premarket application, premarket report, supplement, and submission fees). Repeals the fee revenue target amounts for FY2006 and FY2007. Eliminates the inflation, workload, compensating, and final year adjustments of revenues used for setting fees. Sets the premarket application fee for devices for FY2006 and FY2007. Allows the Secretary of Health and Human Services to use unobligated carryover balances from fees collected in previous fiscal years with notice to the appropriate congressional committees. Increases the annual gross receipts or sales threshold below which businesses are eligible for reduced fees or a waiver of fees by the Secretary. Removes the prohibition against the Secretary assessing fees unless certain cumulative fee revenues were met for FY2003 through 2006. Requires the Secretary to include in annual reports to Congress: (1) information on the number and total amount of fees paid for each different type of application or notification from small businesses; and (2) a certification that the amounts obligated for the performance of functions other than the review of device applications is not less than such amount for FY2002 multiplied by the adjustment factor. Deems as misbranded any reprocessed single use device unless the device or an attachment identifies the manufacturer of the reprocessed device, or the identity of the manufacturer of the original device is provided by a detachable label intended to be affixed to the medical record of a patient.

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Timeline

1. 25 July 2005

   Introduced

   Referred to the House Committee on Energy and Commerce.

   Source: IntroReferral

2. 25 July 2005

   Introduced

   Introduced in House

   Source: IntroReferral

3. 25 July 2005

   Introduced

   Introduced in House

   Source: IntroReferral

4. 26 July 2005

   Passed

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

   Source: Floor

5. 26 July 2005

   Passed

   On passage Passed without objection. (text: CR H6510-6511)

   Source: Floor

6. 26 July 2005

   Passed

   Passed/agreed to in House: On passage Passed without objection.(text: CR H6510-6511)

   Source: Floor

7. 26 July 2005

   Floor

   Mr. Deal (GA) asked unanimous consent to discharge from committee and consider.

   Source: Floor

8. 26 July 2005

   Floor

   Considered by unanimous consent. (consideration: CR H6510-6511)

   Source: Floor

9. 26 July 2005

   Discharge

   Committee on Energy and Commerce discharged.

   Source: Discharge

10. 26 July 2005

    Committee

    Committee on Energy and Commerce discharged.

    Source: Committee

11. 27 July 2005

    Action

    Cleared for White House.

12. 27 July 2005

    Introduced

    Received in the Senate, read twice, considered, read the third time, and passed without amendment by Unanimous Consent. (consideration: CR S9196-9197)

    Source: Floor

13. 27 July 2005

    Introduced

    Passed/agreed to in Senate: Received in the Senate, read twice, considered, read the third time, and passed without amendment by Unanimous Consent.(consideration: CR S9196-9197)

    Source: Floor

14. 28 July 2005

    Floor

    Message on Senate action sent to the House.

    Source: Floor

15. 29 July 2005

    Floor

    Presented to President.

    Source: Floor

16. 29 July 2005

    President

    Presented to President.

    Source: President

17. 29 July 2005

    Referred

    Referred to the Subcommittee on Health.

    Source: Committee

18. 1 August 2005

    Became law

    Became Public Law No: 109-43.

    Source: President

19. 1 August 2005

    Became law

    Signed by President.

    Source: BecameLaw

20. 1 August 2005

    President

    Signed by President.

    Source: President

Votes

No vote records are attached yet.

Versions

• Public Law · 1 August 2005 · Official file
• Enrolled Bill · 28 July 2005 · Official file
• Received in Senate · 27 July 2005 · Official file
• Engrossed in House · 26 July 2005 · Official file
• Introduced in House · 25 July 2005 · Official file

Documents

14 official files

• Public Law (text)

  Public Law · EN · 1 August 2005

  ViewDownloadOpen at official source

• Public Law (PDF)

  Public Law · EN · 1 August 2005

  ViewDownloadOpen at official source

• Public Law

  summary · EN · 1 August 2005

  Open at official source

• Enrolled Bill (text)

  Enrolled Bill · EN · 28 July 2005

  ViewDownloadOpen at official source

• Enrolled Bill (PDF)

  Enrolled Bill · EN · 28 July 2005

  ViewDownloadOpen at official source

• Received in Senate (text)

  Received in Senate · EN · 27 July 2005

  ViewDownloadOpen at official source

• Received in Senate (PDF)

  Received in Senate · EN · 27 July 2005

  ViewDownloadOpen at official source

• Passed Senate without amendment

  summary · EN · 27 July 2005

  Open at official source

• Engrossed in House (text)

  Engrossed in House · EN · 26 July 2005

  ViewDownloadOpen at official source

• Engrossed in House (PDF)

  Engrossed in House · EN · 26 July 2005

  ViewDownloadOpen at official source

• Passed House without amendment

  summary · EN · 26 July 2005

  Open at official source

• Introduced in House (text)

  Introduced in House · EN · 25 July 2005

  ViewDownloadOpen at official source

• Introduced in House (PDF)

  Introduced in House · EN · 25 July 2005

  ViewDownloadOpen at official source

• Introduced in House

  summary · EN · 25 July 2005

  Open at official source

Sponsors

• Rep. Pitts, Joseph R. [R-PA-16] · R · Sponsor
• Anna Eshoo · D · Sponsor
• Rep. Bono Mack, Mary [R-CA-45] · R · Sponsor
• Rep. Whitfield, Ed [R-KY-1] · R · Sponsor
• FRED UPTON · R · Sponsor
• Rep. Pickering, Charles W. "Chip" [R-MS-3] · R · Sponsor
• Rep. Ferguson, Mike [R-NJ-7] · R · Sponsor
• Rep. Norwood, Charles W. [R-GA-10] · R · Sponsor
• Rep. Strickland, Ted [D-OH-6] · D · Sponsor
• Rep. Davis, Jim [D-FL-11] · D · Sponsor
• Rep. Inslee, Jay [D-WA-1] · D · Cosponsor
• · hsif00 · Standing

Related records

• related to ← Medical Device User Fee Stabilization Act of 2005