3.0.0 3423 2023-03-24T16:27:30Z 2023-03-24T16:27:30Z House H HR 2005-07-25 109 hsif00 Energy and Commerce Committee House Standing hsif14 Health Subcommittee Referred to 2005-07-29T19:59:38Z Discharged from 2005-07-26T22:41:41Z Referred to 2005-07-25T16:31:50Z Medical Device User Fee Stabilization Act of 2005 109 1420 S 2005-07-25 Placed on Senate Legislative Calendar under General Orders. Calendar No. 173. Related bill CRS Related bill House 2005-08-01 Became Public Law No: 109-43. President E40000 2 House floor actions 2005-08-01 Became Public Law No: 109-43. BecameLaw 36000 9 Library of Congress 2005-08-01 Signed by President. President E30000 2 House floor actions 2005-08-01 Signed by President. BecameLaw 36000 9 Library of Congress 2005-07-29 Presented to President. Floor E20000 2 House floor actions 2005-07-29 Presented to President. President 28000 9 Library of Congress 2005-07-29 hsif14 Health Subcommittee 1 House committee actions Referred to the Subcommittee on Health. Committee 2005-07-28 Senate Message on Senate action sent to the House. Floor 2005-07-27 Cleared for White House. 2005-07-27 Senate Received in the Senate, read twice, considered, read the third time, and passed without amendment by Unanimous Consent. (consideration: CR S9196-9197) Floor 2005-07-27 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) Floor 17000 9 Library of Congress 2005-07-26 18:46:37 Motion to reconsider laid on the table Agreed to without objection. Floor H38310 2 House floor actions 2005-07-26 18:46:34 On passage Passed without objection. (text: CR H6510-6511) Floor H37100 2 House floor actions 2005-07-26 18:46:34 Passed/agreed to in House: On passage Passed without objection.(text: CR H6510-6511) Floor 8000 9 Library of Congress 2005-07-26 18:42:47 Mr. Deal (GA) asked unanimous consent to discharge from committee and consider. Floor H30200 2 House floor actions 2005-07-26 18:42:47 Considered by unanimous consent. (consideration: CR H6510-6511) Floor H30000 2 House floor actions 2005-07-26 Committee on Energy and Commerce discharged. Discharge H12300 2 House floor actions hsif00 Energy and Commerce Committee 2005-07-26 Committee on Energy and Commerce discharged. Committee 5500 9 Library of Congress hsif00 Energy and Commerce Committee 2005-07-25 Referred to the House Committee on Energy and Commerce. IntroReferral H11100 2 House floor actions hsif00 Energy and Commerce Committee 2005-07-25 Introduced in House IntroReferral Intro-H 9 Library of Congress 2005-07-25 Introduced in House IntroReferral 1000 9 Library of Congress P000373 Rep. Pitts, Joseph R. [R-PA-16] JOSEPH PITTS R PA R. 16 N E000215 Rep. Eshoo, Anna G. [D-CA-14] ANNA ESHOO D CA G. 14 2005-07-25 True B001228 Rep. Bono, Mary [R-CA-45] Mary Bono R CA 45 2005-07-25 True W000413 Rep. Whitfield, Ed [R-KY-1] EDWARD WHITFIELD R KY 1 2005-07-25 True U000031 Rep. Upton, Fred [R-MI-6] FRED UPTON R MI 6 2005-07-25 True P000323 Rep. Pickering, Charles W. "Chip" [R-MS-3] CHARLES PICKERING R MS W. 3 2005-07-25 True F000443 Rep. Ferguson, Mike [R-NJ-7] MIKE FERGUSON R NJ 7 2005-07-25 True N000159 Rep. Norwood, Charles W. [R-GA-9] CHARLES NORWOOD R GA W. 9 2005-07-25 True S001004 Rep. Strickland, Ted [D-OH-6] TED STRICKLAND D OH 6 2005-07-25 True D000114 Rep. Davis, Jim [D-FL-11] JIM DAVIS D FL 11 2005-07-25 True I000026 Rep. Inslee, Jay [D-WA-1] JAY INSLEE D WA 1 2005-07-26 False Public Law 109-43 Health Administrative procedure Appropriations Biomedical engineering Collection of accounts Commerce Congress Congressional reporting requirements Department of Health and Human Services Economics and Public Finance Food and Drug Administration (FDA) Government Operations and Politics Government publicity Identification devices Labeling Law Medical supplies Medical technology Science, Technology, Communications Small business User charges Health 00 2005-07-25 Introduced in House 2005-11-14T15:11:33Z 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.

]]> 81 2005-07-26 Passed House without amendment 2005-11-02T19:09:43Z (This measure has not been amended since it was introduced. The summary of that version is repeated here.)

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 branded any reprocessed single use device unless it identifies the manufacturer, but allows such information to be provided by a detachable label intended to be affixed to the medical record of a patient.

]]> 82 2005-07-27 Passed Senate without amendment 2005-11-02T19:10:48Z (This measure has not been amended since it was introduced. The summary of that version is repeated here.)

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 branded any reprocessed single use device unless it identifies the manufacturer, but allows such information to be provided by a detachable label intended to be affixed to the medical record of a patient.

]]> 49 2005-08-01 Public Law 2005-11-02T19:11:03Z (This measure has not been amended since it was introduced. The summary of that version is repeated here.)

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 branded any reprocessed single use device unless it identifies the manufacturer, but allows such information to be provided by a detachable label intended to be affixed to the medical record of a patient.

]]> Medical Device User Fee Stabilization Act of 2005 Short Titles as Introduced Medical Device User Fee Stabilization Act of 2005 Short Titles as Passed House Medical Device User Fee Stabilization Act of 2005 H House Short Titles as Passed Senate Medical Device User Fee Stabilization Act of 2005 S Senate Short Titles as Enacted Medical Device User Fee Stabilization Act of 2005 Display Title Medical Device User Fee Stabilization Act of 2005 Official Title as Introduced To amend the Federal Food, Drug, and Cosmetic Act with respect to medical device user fees. Enrolled Bill 2005-07-28T04:00:00Z Received in Senate 2005-07-27T04:00:00Z Engrossed in House 2005-07-26T04:00:00Z Introduced in House 2005-07-25T04:00:00Z https://www.govinfo.gov/content/pkg/BILLS-109hr3423ih/xml/BILLS-109hr3423ih.xml 2005-08-02T03:59:59Z Public Law 2005-08-01 Became Public Law No: 109-43. text/xml EN Pursuant to Title 17 Section 105 of the United States Code, this file is not subject to copyright protection and is in the public domain. Congressional Research Service, Library of Congress This file contains bill summaries and statuses for federal legislation. A bill summary describes the most significant provisions of a piece of legislation and details the effects the legislative text may have on current law and federal programs. Bill summaries are authored by the Congressional Research Service (CRS) of the Library of Congress. As stated in Public Law 91-510 (2 USC 166 (d)(6)), one of the duties of CRS is "to prepare summaries and digests of bills and resolutions of a public general nature introduced in the Senate or House of Representatives". For more information, refer to the User Guide that accompanies this file.