Animal Drug and Animal Generic Drug User Fee Amendments of 2023

Bill: 118-hr-1418
Sponsor: Rep. Pence, Greg [R-IN-6]
Introduced: 2023-03-07 in the House
Policy area: Health
Subjects: Research and development
User charges and fees
Veterinary medicine and animal diseases

Summary:
action_date: 2023-03-07
text: 

Animal Drug User Fee Amendments of 2023

 
This bill reauthorizes the Food and Drug Administration (FDA) to collect fees for brand-name and generic animal drug applications through FY2028. It also makes related updates to fee calculations and FDA reporting requirements. 
 
The bill also provides for a specific fee for requests to establish generic investigational new animal drug files and requires other application fees to be adjusted accordingly.
 
Animal drugs are drugs that are intended for animals other than humans (e.g., pets and livestock). Animal drugs must be approved by the FDA before they may be offered on the commercial market. The FDA is authorized to collect fees for animal drug applications in order to support its regulatory activities; this authority currently expires at the end of FY2023.

action_date: 2023-06-09
text: 

Animal Drug and Animal Generic Drug User Fee Amendments of 2023

 
This bill reauthorizes the Food and Drug Administration (FDA) to collect fees for brand-name and generic animal drug applications through FY2028. It also makes related updates to fee calculations and FDA reporting requirements. 
 
The bill also (1) provides for a specific fee for requests to establish generic investigational new animal drug files and requires other application fees to be adjusted accordingly; (2) authorizes the FDA to remove species from the definition of 
major species
 (currently horses, dogs, cats, cattle, pigs, chickens, and turkeys); and (3) provides statutory authority for FDA to report on its progress supporting antimicrobial stewardship in veterinary settings (i.e., supporting responsible use of antimicrobial drugs for animals to slow the development of drug-resistant bacteria).
 
Animal drugs are drugs that are intended for animals other than humans (e.g., pets and livestock). Animal drugs must be approved by the FDA before they may be offered on the commercial market. The FDA is authorized to collect fees for animal drug applications in order to support its regulatory activities; this authority currently expires at the end of FY2023.

action_date: 2023-07-17
text: 

Animal Drug and Animal Generic Drug User Fee Amendments of 2023

 
This bill reauthorizes the Food and Drug Administration (FDA) to collect fees for brand-name and generic animal drug applications through FY2028. It also makes related updates to fee calculations and FDA reporting requirements. 
 
The bill also (1) provides for a specific fee for requests to establish generic investigational new animal drug files and requires other application fees to be adjusted accordingly; (2) authorizes the FDA to remove species from the definition of 
major species
 (currently horses, dogs, cats, cattle, pigs, chickens, and turkeys); and (3) provides statutory authority for the FDA to report on its progress supporting antimicrobial stewardship in veterinary settings (i.e., supporting responsible use of antimicrobial drugs for animals to slow the development of drug-resistant bacteria).
 
Animal drugs are drugs that are intended for animals other than humans (e.g., pets and livestock). Animal drugs must be approved by the FDA before they may be offered on the commercial market. The FDA is authorized to collect fees for animal drug applications in order to support its regulatory activities; this authority currently expires at the end of FY2023.


Legislative actions:
action_date: 2023-09-20
text: Read twice. Placed on Senate Legislative Calendar under General Orders. Calendar No. 210.
action_date: 2023-07-18
text: Received in the Senate.
action_date: 2023-07-17
text: Motion to reconsider laid on the table Agreed to without objection.
action_date: 2023-07-17
text: On motion to suspend the rules and pass the bill, as amended Agreed to by voice vote. (text: CR H3620-3623)
action_date: 2023-07-17
text: Passed/agreed to in House: On motion to suspend the rules and pass the bill, as amended Agreed to by voice vote. (text: CR H3620-3623)
action_date: 2023-07-17
text: DEBATE - The House proceeded with forty minutes of debate on H.R. 1418.
action_date: 2023-07-17
text: Considered under suspension of the rules. (consideration: CR H3620-3624)
action_date: 2023-07-17
text: Mr. Bilirakis moved to suspend the rules and pass the bill, as amended.
action_date: 2023-06-09
text: Placed on the Union Calendar, Calendar No. 80.
action_date: 2023-06-09
text: Reported (Amended) by the Committee on Energy and Commerce. H. Rept. 118-104.
action_date: 2023-06-09
text: Reported (Amended) by the Committee on Energy and Commerce. H. Rept. 118-104.
action_date: 2023-05-24
text: Ordered to be Reported (Amended) by the Yeas and Nays: 49 - 0.
action_date: 2023-05-24
text: Committee Consideration and Mark-up Session Held.
action_date: 2023-05-17
text: Forwarded by Subcommittee to Full Committee in the Nature of a Substitute (Amended) by the Yeas and Nays: 29 - 0 .
action_date: 2023-05-17
text: Subcommittee Consideration and Mark-up Session Held.
action_date: 2023-03-17
text: Referred to the Subcommittee on Health.
action_date: 2023-03-07
text: Referred to the House Committee on Energy and Commerce.
action_date: 2023-03-07
text: Introduced in House
action_date: 2023-03-07
text: Introduced in House