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Animal Drug and Animal Generic Drug User Fee Reauthorization Act of 2013

Public Law 113-14 · S. 622 · 113th Congress · began in the Senate

Signed by Barack Obama (D) on Jun 13, 2013 · Health

Sponsor: Sen. Tom Harkin (D-IA)

Cosponsors: None

Passage votesYeaNay

  • HouseRecorded vote: 390 yea, 12 nay390–12
  • SenateUnanimous consent
Data notes

The final version of the law, as each chamber passed it. A chamber that passed it by voice vote or unanimous consent has no count. “Method not stated” means the record does not say how the chamber voted. Where the record has a member-by-member vote, the “Who voted for it” section shows who voted yea.

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Summary

The Congressional Research Service’s plain-language summary of what the law does.

Animal Drug and Animal Generic Drug User Fee Reauthorization Act of 2013 - Title I: Fees Relating to Animal Drugs - Animal Drug User Fee Amendments of 2013 - (Sec. 103) Amends the Federal Food, Drug, and Cosmetic Act to extend for FY2014-FY2018 the authority of the Food and Drug Administration (FDA) to collect animal drug user fees, specifically new animal drug application or supplemental animal drug application fees, animal drug product fees, animal drug establishment fees, and animal drug sponsor fees.

Revises the due date for annual 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 amount of revenue such fees can generate. Specifies percentages of the total revenue that shall be derived from each type of user fee.

Requires the Secretary of Health and Human Services (HHS) to adjust the total revenue amounts for FY2015 and subsequent fiscal years for inflation.

Authorizes the Secretary to accept payment of user fees prior to their due date.

Requires the total fees collected for FY2016-FY2018 to be increased by the cumulative amount, if any, by which the amount of user fees collected and appropriated for prior fiscal year falls below the cumulative amount of fees authorized.

(Sec. 104) Extends requirements for the FDA to report to Congress on achieving goals related to animal drug development and review processes and implementation of authority to collect animal drug user fees.

(Sec. 107) Terminates the authority to collect user fees October 1, 2018.

Title II: Fees Relating to Generic Animal Drugs - Animal Generic Drug User Fee Amendments of 2013 - (Sec. 202) Extends for FY2014-FY2018 the authority of the 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 to accept payment of user fees prior to their due date.

(Sec. 203) 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.

(Sec. 206) Terminates the authority to collect generic animal drug user fees October 1, 2018.

Who voted for it

Every House member of the 113th Congress on the ideology compass. Highlighted: the 390 who voted yea on final passage. Faded: everyone else, including those who voted nay, did not vote, or had not yet taken office.

390 yea12 nay31 present or did not vote

ProEstablishmentAnti
Economic left–right
More liberalMore conservative

Democrats who voted yea(168)

Republicans who voted yea(222)

  • Rep. Christopher GibsonR-NY-19
  • Rep. Michael FitzpatrickR-PA-8
  • Rep. Michael GrimmR-NY-11
  • Rep. Pete KingR-NY-2
  • Rep. Jon RunyanR-NJ-3
  • Rep. Frank LoBiondoR-NJ-2
  • Rep. David ReichertR-WA-8
  • Rep. Mario Diaz-BalartR-FL-25
  • Rep. Jim GerlachR-PA-6
  • Rep. Richard HannaR-NY-22
  • Rep. Charles DentR-PA-15
  • Rep. Patrick MeehanR-PA-7
  • Rep. Ileana Ros-LehtinenR-FL-27
  • Rep. David JoyceR-OH-14
  • Rep. David ValadaoR-CA-21
  • Rep. Chris SmithR-NJ-4
  • Rep. Michael TurnerR-OH-10
  • Rep. Rodney FrelinghuysenR-NJ-11
  • Rep. Tom LathamR-IA-3
  • Rep. Tom ReedR-NY-23
  • Rep. Jeff FortenberryR-NE-1
  • Rep. Frank WolfR-VA-10
  • Rep. Don YoungR-AK
  • Rep. Lou BarlettaR-PA-11
  • Rep. Jeff DenhamR-CA-10
  • Rep. Glenn ThompsonR-PA-5
  • Rep. Adam KinzingerR-IL-16
  • Rep. Ander CrenshawR-FL-4
  • Rep. Hal RogersR-KY-5
  • Rep. Tom ColeR-OK-4
  • Rep. Mike SimpsonR-ID-2
  • Rep. Shelley CapitoR-WV-2
  • Rep. Ken CalvertR-CA-42
  • Rep. Aaron SchockR-IL-18
  • Rep. Buck McKeonR-CA-25
  • Rep. Walter JonesR-NC-3
  • Rep. David McKinleyR-WV-1
  • Rep. Martha RobyR-AL-2
  • Rep. Doc HastingsR-WA-4
  • Rep. Frank LucasR-OK-3
  • Rep. Joseph HeckR-NV-3
  • Rep. Gregg HarperR-MS-3
  • Rep. Steve StiversR-OH-15
  • Rep. Rick CrawfordR-AR-1
  • Rep. Spencer BachusR-AL-6
  • Rep. Steve WomackR-AR-3
  • Rep. Tom MarinoR-PA-10
  • Rep. Gary MillerR-CA-31
  • Rep. Mike KellyR-PA-3
  • Rep. Greg WaldenR-OR-2
  • Rep. James RenacciR-OH-16
  • Rep. Kevin CramerR-ND
  • Rep. W. Bill YoungR-FL-13
  • Rep. Randy ForbesR-VA-4
  • Rep. Robert AderholtR-AL-4
  • Rep. Devin NunesR-CA-22
  • Rep. Jaime Herrera BeutlerR-WA-3
  • Rep. Tim MurphyR-PA-18
  • Rep. Leonard LanceR-NJ-7
  • Rep. Kristi NoemR-SD
  • Rep. Renee EllmersR-NC-2
  • Rep. Chris CollinsR-NY-27
  • Rep. Mike RogersR-MI-8
  • Rep. Tim GriffinR-AR-2
  • Rep. Bill ShusterR-PA-9
  • Rep. Peter RoskamR-IL-6
  • Rep. John CulbersonR-TX-7
  • Rep. Charles BoustanyR-LA-3
  • Rep. Fred UptonR-MI-6
  • Rep. Mark AmodeiR-NV-2
  • Rep. Kevin McCarthyR-CA-23
  • Rep. Lee TerryR-NE-2
  • Rep. Susan BrooksR-IN-5
  • Rep. Dave CampR-MI-4
  • Rep. Jackie WalorskiR-IN-2
  • Rep. Pat TiberiR-OH-12
  • Rep. Daniel WebsterR-FL-10
  • Rep. Blaine LuetkemeyerR-MO-3
  • Rep. Vern BuchananR-FL-16
  • Rep. Brett GuthrieR-KY-2
  • Rep. Cory GardnerR-CO-4
  • Rep. Bob GibbsR-OH-7
  • Rep. Eric CantorR-VA-7
  • Rep. Robert WittmanR-VA-1
  • Rep. Cathy McMorris RodgersR-WA-5
  • Rep. Paul CookR-CA-8
  • Rep. John CarterR-TX-31
  • Rep. Thomas RooneyR-FL-17
  • Rep. Steve PearceR-NM-2
  • Rep. Larry BucshonR-IN-8
  • Rep. John KlineR-MN-2
  • Rep. Todd YoungR-IN-9
  • Rep. Andy BarrR-KY-6
  • Rep. Mike RogersR-AL-3
  • Rep. Dan BenishekR-MI-1
  • Rep. Mike CoffmanR-CO-6
  • Rep. Vicky HartzlerR-MO-4
  • Rep. Sam GravesR-MO-6
  • Rep. Ann WagnerR-MO-2
  • Rep. Darrell IssaR-CA-49
  • Rep. Bill JohnsonR-OH-6
  • Rep. Keith RothfusR-PA-12
  • Rep. Richard NugentR-FL-11
  • Rep. Scott RigellR-VA-2
  • Rep. Alan NunneleeR-MS-1
  • Rep. Scott TiptonR-CO-3
  • Rep. Ralph HallR-TX-4
  • Rep. Chris StewartR-UT-2
  • Rep. Howard CobleR-NC-6
  • Rep. Steve DainesR-MT
  • Rep. Candice MillerR-MI-10
  • Rep. Adrian SmithR-NE-3
  • Rep. Dennis RossR-FL-15
  • Rep. Phil RoeR-TN-1
  • Rep. Steve SoutherlandR-FL-2
  • Rep. Erik PaulsenR-MN-3
  • Rep. Lamar SmithR-TX-21
  • Rep. Michael McCaulR-TX-10
  • Rep. Bob GoodlatteR-VA-6
  • Rep. Blake FarentholdR-TX-27
  • Rep. John MicaR-FL-7
  • Rep. Paul RyanR-WI-1
  • Rep. Robert LattaR-OH-5
  • Rep. Markwayne MullinR-OK-2
  • Rep. Steve KingR-IA-4
  • Rep. Morgan GriffithR-VA-9
  • Rep. Duncan HunterR-CA-50
  • Rep. Pete SessionsR-TX-32
  • Rep. Lynn JenkinsR-KS-2
  • Rep. Mac ThornberryR-TX-13
  • Rep. Sean DuffyR-WI-7
  • Rep. Joe BartonR-TX-6
  • Rep. Joseph PittsR-PA-16
  • Rep. Austin ScottR-GA-8
  • Rep. Bill PoseyR-FL-8
  • Rep. Randy HultgrenR-IL-14
  • Rep. Kevin YoderR-KS-3
  • Rep. Tom PetriR-WI-6
  • Rep. Patrick McHenryR-NC-10
  • Rep. Stephen FincherR-TN-8
  • Rep. Kevin BradyR-TX-8
  • Rep. Brad WenstrupR-OH-2
  • Rep. Diane BlackR-TN-6
  • Rep. Billy LongR-MO-7
  • Rep. Luke MesserR-IN-6
  • Rep. Robert HurtR-VA-5
  • Rep. Ed RoyceR-CA-39
  • Rep. Tim WalbergR-MI-7
  • Rep. Pete OlsonR-TX-22
  • Rep. Sam JohnsonR-TX-3
  • Rep. Doug LaMalfaR-CA-1
  • Rep. Phil GingreyR-GA-11
  • Rep. Joe WilsonR-SC-2
  • Rep. Jeff MillerR-FL-1
  • Rep. Mo BrooksR-AL-5
  • Rep. Michele BachmannR-MN-6
  • Rep. Robert PittengerR-NC-9
  • Rep. Marsha BlackburnR-TN-7
  • Rep. James LankfordR-OK-5
  • Rep. Roger WilliamsR-TX-25
  • Rep. Todd RokitaR-IN-4
  • Rep. Jason ChaffetzR-UT-3
  • Rep. Scott PerryR-PA-4
  • Rep. Steven PalazzoR-MS-4
  • Rep. Steve ScaliseR-LA-1
  • Rep. Bill FloresR-TX-17
  • Rep. Rob BishopR-UT-1
  • Rep. Andy HarrisR-MD-1
  • Rep. Tom RiceR-SC-7
  • Rep. Michael ConawayR-TX-11
  • Rep. Doug LambornR-CO-5
  • Rep. Mark MeadowsR-NC-11
  • Rep. Paul GosarR-AZ-4
  • Rep. Scott DesJarlaisR-TN-4
  • Rep. Tom CottonR-AR-4
  • Rep. Mike PompeoR-KS-4
  • Rep. Jimmy DuncanR-TN-2
  • Rep. Steve ChabotR-OH-1
  • Rep. Doug CollinsR-GA-9
  • Rep. Bill HuizengaR-MI-2
  • Rep. Jeb HensarlingR-TX-5
  • Rep. Ted PoeR-TX-2
  • Rep. David SchweikertR-AZ-6
  • Rep. Lynn WestmorelandR-GA-3
  • Rep. Tom PriceR-GA-6
  • Rep. Cynthia LummisR-WY
  • Rep. James SensenbrennerR-WI-5
  • Rep. Virginia FoxxR-NC-5
  • Rep. John FlemingR-LA-4
  • Rep. George HoldingR-NC-13
  • Rep. Dana RohrabacherR-CA-48
  • Rep. Trey GowdyR-SC-4
  • Rep. Scott GarrettR-NJ-5
  • Rep. Randy NeugebauerR-TX-19
  • Rep. Michael BurgessR-TX-26
  • Rep. Mark SanfordR-SC-1
  • Rep. Jack KingstonR-GA-1
  • Rep. Ron DeSantisR-FL-6
  • Rep. Trey RadelR-FL-19
  • Rep. Reid RibbleR-WI-8
  • Rep. Richard HudsonR-NC-8
  • Rep. Rob WoodallR-GA-7
  • Rep. Trent FranksR-AZ-8
  • Rep. Matt SalmonR-AZ-5
  • Rep. Mick MulvaneyR-SC-5
  • Rep. Kerry BentivolioR-MI-11
  • Rep. Kenny MarchantR-TX-24
  • Rep. Ted YohoR-FL-3
  • Rep. Tom McClintockR-CA-4
  • Rep. Marlin StutzmanR-IN-3
  • Rep. Jim BridenstineR-OK-1
  • Rep. Jim JordanR-OH-4
  • Rep. Tom GravesR-GA-14
  • Rep. Thomas MassieR-KY-4
  • Rep. Raúl LabradorR-ID-1
  • Rep. Louie GohmertR-TX-1
  • Rep. Randy WeberR-TX-14
  • Rep. Jeff DuncanR-SC-3
  • Rep. Tim HuelskampR-KS-1
  • Rep. Justin AmashR-MI-3
  • Rep. Steve StockmanR-TX-36
  • Rep. Paul BrounR-GA-10
Data notes

The House’s recorded vote on the final version of the law (roll call 184 in Voteview), matched to the vote the record cites and checked against its totals. Positions are each member’s DW-NOMINATE score for that Congress, as on the Ideology page; left to right is more liberal to more conservative. Paired and announced yea votes count as yea. Lists follow the compass, most liberal first. A name links to a profile only for members of the current Congress. A law passed by voice vote or unanimous consent has no member list, and neither does a vote Voteview has not yet recorded.

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Committees

The committees the bill was sent to, and what each did with it.

Data notes

A committee links to its page only where it exists in the current Congress; older and renamed committees are named without a link.

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Related bills

2 bills the Library of Congress relates to this one.

  • H.R. 1407Related bill

    Animal Drug User Fee Amendments of 2013

  • H.R. 1408Related bill

    Animal Generic Drug User Fee Amendments of 2013

Data notes

Related bills are identified by the Congressional Research Service, the House and the Senate: companion and identical bills, bills with similar text, bills that were folded into this law, and rules that brought it to the floor. A bill that is itself a public law in this site’s data links here; the others link to Congress.gov.

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Timeline

From introduction to signing, newest first: the committees, the floor and the president. 17 actions.

  1. Jun 13, 2013Became lawBecame law · Became Public Law No: 113-14.
  2. Became lawBecame law · Signed by President.
  3. Jun 6, 2013FloorFloor · Presented to President.
  4. Jun 3, 2013FloorFloor · Motion to reconsider laid on the table Agreed to without objection.
  5. FloorFloor · On motion to suspend the rules and pass the bill Agreed to by the Yeas and Nays: (2/3 required): 390 - 12 (Roll no. 185).House roll call 185
  6. FloorFloor · Considered as unfinished business.
  7. FloorFloor · At the conclusion of debate, the Yeas and Nays were demanded and ordered. Pursuant to the provisions of clause 8, rule XX, the Chair announced that further proceedings on the motion would be postponed.
  8. FloorFloor · DEBATE - The House proceeded with forty minutes of debate on S. 622.
  9. FloorFloor · Considered under suspension of the rules.
  10. FloorFloor · Mr. Latta moved to suspend the rules and pass the bill.
  11. May 9, 2013FloorFloor · Held at the desk.
  12. FloorFloor · Message on Senate action sent to the House.
  13. FloorFloor · Received in the House.
  14. May 8, 2013FloorFloor · Passed Senate without amendment by Unanimous Consent.
  15. Mar 20, 2013CalendarCalendar · Placed on Senate Legislative Calendar under General Orders. Calendar No. 31.
  16. CommitteeCommittee · Committee on Health, Education, Labor, and Pensions. Original measure reported to Senate by Senator Harkin. Without written report.
  17. IntroducedIntroduced · Introduced in Senate
Data notes

Every action the Library of Congress lists for the bill, from introduction to signing, plus the dated committee hearings. The source lists many steps twice (the chamber’s own entry and the Library of Congress copy, or a presidential and a became-law entry with the same words); those are shown once. Amendments are listed in their own section.

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Amendments

No amendments to this bill are on record.

Data notes

Amendments offered to this bill in either chamber, as the Library of Congress records them: each with a status read from its last recorded step: agreed to, rejected, withdrawn, ruled out of order, fell with another amendment, or offered with no vote recorded (most Senate amendments are only ever offered). The wording of each amendment is the source’s. Amendments to amendments and amendments to other bills are not listed.

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Official record

The bill’s full text is on Congress.gov. Data through Oct 7, 2026.