Medical Device User Fee Stabilization Act of 2005

Bill: 109-hr-3423
Sponsor: Rep. Pitts, Joseph R. [R-PA-16]
Introduced: 2005-07-25 in the House
Policy area: Health
Subjects: 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

Summary:
action_date: 2005-07-25
text: 
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.

action_date: 2005-07-26
text: 

(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.
 

action_date: 2005-07-27
text: 

(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.

action_date: 2005-08-01
text: 

(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.


Legislative actions:
action_date: 2005-08-01
text: Became Public Law No: 109-43.
action_date: 2005-08-01
text: Became Public Law No: 109-43.
action_date: 2005-08-01
text: Signed by President.
action_date: 2005-08-01
text: Signed by President.
action_date: 2005-07-29
text: Presented to President.
action_date: 2005-07-29
text: Presented to President.
action_date: 2005-07-29
text: Referred to the Subcommittee on Health.
action_date: 2005-07-28
text: Message on Senate action sent to the House.
action_date: 2005-07-27
text: Cleared for White House.
action_date: 2005-07-27
text: Received in the Senate, read twice, considered, read the third time, and passed without amendment by Unanimous Consent. (consideration: CR S9196-9197)
action_date: 2005-07-27
text: 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)
action_date: 2005-07-26
text: Motion to reconsider laid on the table Agreed to without objection.
action_date: 2005-07-26
text: On passage Passed without objection. (text: CR H6510-6511)
action_date: 2005-07-26
text: Passed/agreed to in House: On passage Passed without objection.(text: CR H6510-6511)
action_date: 2005-07-26
text: Mr. Deal (GA) asked unanimous consent to discharge from committee and consider.
action_date: 2005-07-26
text: Considered by unanimous consent. (consideration: CR H6510-6511)
action_date: 2005-07-26
text: Committee on Energy and Commerce discharged.
action_date: 2005-07-26
text: Committee on Energy and Commerce discharged.
action_date: 2005-07-25
text: Referred to the House Committee on Energy and Commerce.
action_date: 2005-07-25
text: Introduced in House
action_date: 2005-07-25
text: Introduced in House

Enacted as: number: 109-43