Animal Generic Drug User Fee Amendments of 2013
Latest action. Referred to the subcommitteeA smaller panel inside a standing committee with jurisdiction over a slice of its subject matter. Most hearings and the first markup usually happen here.Read the full definition (opens a new tab) on Health.
Animal Generic Drug User Fee Amendments of 2013 - Amends the Federal Food, Drug, and Cosmetic Act to extend for FY2014-FY2018 the authority of the Food and Drug Administration (FDA) to collect generic animal drug user fees, specifically abbreviated application fees for generic new animal drugs, generic new animal drug product fees, and generic new animal drug sponsor fees.
Subjects generic animal drug applications to a fee 50% of the amount of the normal fee if the application is for an animal drug which contains more than one active ingredient, or the labeling of the drug prescribes, recommends, or suggests use of the drug in combination with one or more other animal drugs, and the active ingredients or drugs intended for use in the combination have previously been separately approved.
Revises the due date for annual generic animal drug user fees to the later of January 31 of each year or the first business day after enactment of an appropriations act providing for the collection and obligation of fees for the fiscal year.
Establishes the total amount of revenue each type of generic user fee shall generate.
Authorizes the Secretary of Health and Human Services (HHS) to accept payment of user fees prior to their due date.
Extends requirements for the FDA to report to Congress on achieving goals related to the generic animal drug development and review process and the implementation of the authority to collect generic animal drug fees.
Terminates the authority to collect generic animal drug user fees October 1, 2018.
Written by analysts at the Congressional Research Service and published on Congress.gov, not by Civibrief. Summarized at the "Introduced in House" stage on April 9, 2013. It describes the bill, it is not the legal text.
Where is it in the process, and what happens next?
4 steps remain before this bill could become law.
The record's latest action, on April 12, 2013: Referred to the Subcommittee on Health.
- Clearing the committees it was referred to, and being scheduled for a floor vote
- Passage by the House
- Passage by the Senate
- The President's signature. If the President vetoes it, two-thirds of both chambers must vote to override.
How likely is it to become law?
Civibrief does not forecast outcomes and this page has no opinion about this one. What the record supports is a base rate, which is a fact about the whole pile, not a prediction about this measure.
In the 113th Congress (2013-14), 296 of the 9,091 bills and joint resolutions introduced became law, about 3.3 percent. That count covers every measure at every stage, including the many that never left committee.
This one is not there yet: 4 steps are still outstanding, listed above.
Has anyone actually voted on it?
No. No roll call in this Congress cites this measure. That is the ordinary outcome: most measures never reach a recorded floor vote, and a committee ends most of them simply by not acting.
A vote is not the only thing that happens to a measure. Hearings, markups, and referrals are all recorded actions, and none of them is a vote of the full chamber.
Who is behind it?
Cory Gardner (R-CO) introduced it on April 9, 2013, and 8 members have since signed on as cosponsors.
They come from both major parties: 2 Democrats, 6 Republicans.
Cosponsoring is a formal signature on the text. It is not a commitment to vote for the measure, it does not bind anyone's party, and a long list of cosponsors is a measure of attention rather than of prospects.
How long has it been in play?
It was introduced on April 9, 2013, 4949 days ago. The most recent recorded action was 4946 days ago, on April 12, 2013.
Measures do not carry over. Anything the 113th Congress has not finished by January 3, 2015 dies when the term ends, and has to be introduced again from the start in the next Congress.
Every answer above is assembled from this measure's own record on Congress.gov and from published counts of what Congress has passed before. Civibrief does not predict outcomes and takes no position on any measure.
Vote history
- HouseIn committee, no floor vote yet
- SenateAwaits House passage
- PresidentAwaits both chambers