FDA User Fee Corrections Act of 2012

Bill: 112-hr-6433
Sponsor: Rep. Upton, Fred [R-MI-6]
Introduced: 2012-09-19 in the House
Policy area: Health
Subjects: Appropriations
Department of Health and Human Services
Drug safety, medical device, and laboratory regulation
Executive agency funding and structure
Food and Drug Administration (FDA)
Prescription drugs
User charges and fees

Summary:
action_date: 2012-09-19
text: 
FDA User Fee Corrections Act of 2012 - Amends the Federal Food, Drug, and Cosmetic Act (FFDCA), as amended by the Food and Drug Administration Safety and Innovation Act (P.L. 112-144), to: (1) make clerical corrections to provisions of such Act; and (2) eliminate the restriction that appropriated funds shall be available only for payment of increases in the cost of reviewing medical device applications, including related personnel costs.
 
Specifies due dates in FY2013 under FFDCA for the drug master file fee, the abbreviated new drug application and prior approval supplement filing fees, and the generic drug facility and active pharmaceutical ingredient facility fees.

action_date: 2012-10-05
text: 

(This measure has not been amended since it was introduced. The summary of that version is repeated here.)

 
FDA User Fee Corrections Act of 2012 - Amends the Federal Food, Drug, and Cosmetic Act (FFDCA), as amended by the Food and Drug Administration Safety and Innovation Act (P.L. 112-144), to: (1) make clerical corrections to provisions of such Act; and (2) eliminate the restriction that appropriated funds shall be available only for payment of increases in the cost of reviewing medical device applications, including related personnel costs.
 
Specifies due dates in FY2013 under FFDCA for the drug master file fee, the abbreviated new drug application and prior approval supplement filing fees, and the generic drug facility and active pharmaceutical ingredient facility fees. 


Legislative actions:
action_date: 2012-10-05
text: Became Public Law No: 112-193.
action_date: 2012-10-05
text: Became Public Law No: 112-193.
action_date: 2012-10-05
text: Signed by President.
action_date: 2012-10-05
text: Signed by President.
action_date: 2012-09-25
text: Presented to President.
action_date: 2012-09-25
text: Presented to President.
action_date: 2012-09-24
text: Message on Senate action sent to the House.
action_date: 2012-09-22
text: Passed Senate without amendment by Unanimous Consent. (consideration: CR 9/21/2012 S6671)
action_date: 2012-09-22
text: Passed/agreed to in Senate: Passed Senate without amendment by Unanimous Consent.(consideration: CR 9/21/2012 S6671)
action_date: 2012-09-20
text: Received in the Senate, read twice.
action_date: 2012-09-19
text: Motion to reconsider laid on the table Agreed to without objection.
action_date: 2012-09-19
text: On passage Passed without objection. (text: CR H6137-6138)
action_date: 2012-09-19
text: Passed/agreed to in House: On passage Passed without objection.(text: CR H6137-6138)
action_date: 2012-09-19
text: Considered by unanimous consent. (consideration: CR H6137-6138)
action_date: 2012-09-19
text: Mr. Upton asked unanimous consent to discharge from committee and consider.
action_date: 2012-09-19
text: Committee on Energy and Commerce discharged.
action_date: 2012-09-19
text: Committee on Energy and Commerce discharged.
action_date: 2012-09-19
text: Referred to the House Committee on Energy and Commerce.
action_date: 2012-09-19
text: Introduced in House
action_date: 2012-09-19
text: Introduced in House

Enacted as: number: 112-193