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Animal Drug and Animal Generic Drug User Fee Amendments of 2018
Legislative Progress
Momentum (last 30 days)
0
score
0 actions · 0 new cosponsors · 0 votes
Speed vs cohort
87pct
118d open
vs 7,393 other HR bills in the 115th — cohort avg 50d
Animal Drug and Animal Generic Drug User Fee Amendments of 2018 TITLE I--FEES RELATING TO ANIMAL DRUGS This bill addresses the authority of the Food and Drug Administration (FDA)to collect new animal drug (brand name animal drug)and generic animal drug user fees. Animal Drug User Fee Amendments of 2018 (Sec.103)The bill amends the Federal Food, Drug, and Cosmetic Act to reauthorize through FY2023 the authority of the FDA to collect and use brand name animal drug user fees. The FDA must not collect fees for (1) supplemental applications that are submitted solely to add the animal drug application number to the label of the drug, and (2) applications for genetically engineered animals that are intended to produce human medical products. The bill revises the total amount of revenue brand name animal drug user fees can generate. The bill also revises the requirements for calculating adjustments to revenue amounts based on changes in the workload for reviewing brand name animal drug applications. (Sec.104)The bill extends requirements for the FDA to report to Congress on achieving goals related to the animal drug development and review processes and implementation of the authority to collect brand name animal drug user fees. (Sec.107)The bill terminates the authority of the FDA to collect brand name animal drug user fees on October 1, 2023. TITLE II--FEES RELATING TO GENERIC ANIMAL DRUGS Animal Generic Drug User Fee Amendments of 2018 (Sec.202)The bill reauthorizes through FY2023 the authority of the FDA to collect and use generic animal drug user fees.The FDA must not collect fees for supplemental abbreviated applications that are submitted solely to add the generic animal drug application number to the label of the drug. The bill revises the total amount of revenue each type of generic animal drug user fee must generate. The bill also revises the requirements for calculating adjustments to revenue amounts based on changes in the workload for reviewing generic animal drug applications. (Sec.203)The bill 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)The bill terminates the authority of the FDA to collect generic animal drug user fees on October 1, 2023. TITLE III--MISCELLANEOUS PROVISIONS (Sec.301)Brand name and generic animal drug applications must be submitted electronically beginning in FY2019. Additionally, applications for conditional approval of brand name animal drugs for minor use and minor species must be submitted electronically beginning in FY2019. (Minor use drugs are for intended uses in major species [horses, dogs, cats, cattle, pigs, turkeys, and chickens] for diseases that occur infrequently or in limited geographic areas and in only a small number of animals annually.) (Sec.302)Product labeling for certain unapproved brand name animal drugs for minor species must include the index number in order to be marketed. (Sec.303)The bill prohibits the sale of brand name animal drugs that do not include the FDA application number. (Sec.304)The bill authorizes the FDA to grant conditional approval of a brand name animal drug not intended for a minor use or minor species if (1) the drug is intended to treat a serious or life-threatening disease or condition or addresses an unmet animal or human health need, and (2) the FDA determines that a demonstration of effectiveness of the drug would require a complex or particularly difficult study or studies. The FDA must issue guidance or regulations that provide further details regarding the criteria for conditional approval. The bill terminates this conditional approval authority on October 1, 2028. The Government Accountability Office must study the effects of the conditional approval pathway for brand name animal drugs. (Sec.305)The FDA must issue guidance on how to evaluate certain elements of investigations as part of the animal drug application process, and how drug sponsors may obtain feedback from the agency on technical issues before submitting an application. (Sec.306)The FDA must review investigations conducted in foreign countries when acting on a petition for a food additive intended for use in animal food. The FDA must also issue guidance on the voluntary pre-petition consultation process for such food additives.
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Filing registrants (11)
Became Public Law No: 115-234.
Became Public Law No: 115-234.
Signed by President.
Signed by President.
Presented to President.
Presented to President.
Message on Senate action sent to the House.
Passed Senate without amendment by Voice Vote. (consideration: CR S5474)
Passed/agreed to in Senate: Passed Senate without amendment by Voice Vote.(consideration: CR S5474)
Received in the Senate, read twice.
Motion to reconsider laid on the table Agreed to without objection.
Bills with similar content found using semantic analysis.
Sources: Congress.gov
2018 · fourth_quarter · Animals
Issues related to animal health, and food safety; antimicrobial resistance; HR 1587 Preservation of Antibiotics for Medical Treatment Act of 2017; S. 2434 and H.R. 5554, Animal Drug and Generic Animal Drug User Fee Act Amendments of 2018 and conditional approval
Client expense: $30,000 · Firm income: Not reported
Government targets: Agriculture, Dept of (USDA), HOUSE OF REPRESENTATIVES, Office of Management & Budget (OMB), SENATE, U.S. Trade Representative (USTR)
2018 · fourth_quarter · Health Issues
Issues related to health care, the Food and Drug Administration (FDA), the 340B Program, animal health, drug pricing, oncology coverage, and direct-to-consumer (DTC) advertising; Vaccine provisions and TRICARE Pilot Program in H.R.5515/S.2987, National Defense Authorization Act for Fiscal Year 2019 (P.L.115-232); Implementation of P.L.114-255, 21st Century Cures Act; S.2434/H.R.5554, Animal Drug and Animal Generic Drug User Fee Amendments of 2018 (P.L.115-234); S.2852/H.R.6378, Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2018; H.R.6, SUPPORT for Patients and Communities Act (P.L.115-271); H.R.2/S.3042, Agriculture Improvement Act of 2018 (P.L.115-334); H.R.6642, To amend title XIX of the Social Security Act to sunset the limit on the maximum rebate amount for single source drugs and innovator multiple source drugs.
Client expense: Not reported · Firm income: $40,000
Government targets: Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
2018 · fourth_quarter · Animals
Issues related to animal health, veterinary medicine, antimicrobials, and food safety - no specific legislation; Issues related to the Animal Drug User Fee Act (ADUFA) S.2434/H.R.5554; Codex Alimentarius Commission (food safety, animal health), no specific legislation; Issues related to veterinary biologics, no specific legislation;
Client expense: $260,000 · Firm income: Not reported
Government targets: Agriculture, Dept of (USDA), Commerce, Dept of (DOC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, State, Dept of (DOS), U.S. Trade Representative (USTR)
2018 · fourth_quarter · Health Issues
Issues related to Over the Counter (OTC) Monograph reform, influenza, and drug pricing; S.2852/H.R.6378, Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2018; S.2434/H.R.5554, Animal Drug and Animal Generic Drug User Fee Amendments of 2018 (P.L.115-234); S.2315, Over-the-Counter Drug Safety, Innovation, and Reform Act; H.R.5333, Over-the-Counter Monograph Safety, Innovation, and Reform Act of 2018.
Client expense: Not reported · Firm income: $40,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2018 · fourth_quarter · Health Issues
340B drug discount program; truthful non-misleading industry communications; compassionate use/right to try; importation of biopharmaceuticals; drug pricing; transparency; direct-to-consumer (DTC) advertising; H.R.2051, FAST Generics Act of 2017; TRICARE issues in H.R.5515/S.2987, National Defense Authorization Act for Fiscal Year 2019 (P.L.115-232); S.2434/H.R.5554, Animal Drug and Animal Generic Drug User Fee Amendments of 2018 (P.L.115-234); S.2852/H.R.6378, Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2018; H.R.6, SUPPORT for Patients and Communities Act (P.L.115-271); H.R.6642, To amend title XIX of the Social Security Act to sunset the limit on the maximum rebate amount for single source drugs and innovator multiple source drugs.
Client expense: Not reported · Firm income: $50,000
On motion to suspend the rules and pass the bill, as amended Agreed to by voice vote. (text: CR H6237-6241)
Passed/agreed to in House: On motion to suspend the rules and pass the bill, as amended Agreed to by voice vote.(text: CR H6237-6241)
DEBATE - The House proceeded with forty minutes of debate on H.R. 5554.
Considered under suspension of the rules. (consideration: CR H6237-6242)
Mr. Mullin moved to suspend the rules and pass the bill, as amended.
Ordered to be Reported (Amended) by Voice Vote.
Committee Consideration and Mark-up Session Held.
Forwarded by Subcommittee to Full Committee (Amended) by Voice Vote .
Subcommittee Consideration and Mark-up Session Held.
Referred to the Subcommittee on Health.
Referred to the House Committee on Energy and Commerce.
Introduced in House
Congress.gov source codes: 1000, Intro-H
| April 18, 2018 |
| Enrolled Bill | -- |
| Democratic |
| OR |
| Michael C. Burgess | Republican | TX |
Government targets: Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), SENATE
2018 · fourth_quarter · Budget/Appropriations
S.2976/H.R.5961 - Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, FY'19 (APHIS and FDA) S.1839/H.R.2321 - CREAATE Act S.2434/H.R.5554 - Animal Drug and Animal Generic Drug User Fee Amendments of 2018
Client expense: Not reported · Firm income: $50,000
Government targets: Agriculture, Dept of (USDA), HOUSE OF REPRESENTATIVES, SENATE, U.S. Trade Representative (USTR)
2018 · fourth_quarter · Budget/Appropriations
S.2976/H.R.5961 - Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, FY'19 (APHIS and FDA) H.R.1625 - Consolidated Appropriations Act of 2018 (Antibiotics and Animal Health) - no specific legislation S.2434/H.R.5554 - Animal Drug and Animal Generic Drug User Fee Amendments of 2018
Client expense: Not reported · Firm income: $20,000
Government targets: Agriculture, Dept of (USDA), HOUSE OF REPRESENTATIVES, SENATE
2018 · fourth_quarter · Animals
Agricultural Improvement Act of 2018, S.3042/H.R. 2; Implementation of the Tax Cuts and Jobs Act; Issues related to animal health, veterinary medicine, antimicrobials, and food safety - no specific legislation; Issues related to the Animal Drug User Fee Act (ADUFA) S.2434/H.R. 5554; Codex Alimentarius Commission (food safety, animal health); Issues related to veterinary biologics - no specific legislation. Sanitary and phyto-sanitary (SPS) issues, no specific legislation; Food safety and public health, no specific legislation; Bilateral and multilateral trade negotiations, no specific legislation;
Client expense: Not reported · Firm income: Not reported
2018 · fourth_quarter · Trade (domestic/foreign)
Agricultural Improvement Act of 2018, S.3042/H.R. 2; Implementation of the Tax Cuts and Jobs Act; Issues related to animal health, veterinary medicine, antimicrobials, and food safety - no specific legislation; Issues related to the Animal Drug User Fee Act (ADUFA) S.2434/H.R. 5554; Codex Alimentarius Commission (food safety, animal health); Issues related to veterinary biologics - no specific legislation. Sanitary and phyto-sanitary (SPS) issues, no specific legislation; Food safety and public health, no specific legislation; Bilateral and multilateral trade negotiations, no specific legislation;
Client expense: Not reported · Firm income: Not reported
2018 · fourth_quarter · Food Industry (safety, labeling, etc.)
Agricultural Improvement Act of 2018, S.3042/H.R. 2; Implementation of the Tax Cuts and Jobs Act; Issues related to animal health, veterinary medicine, antimicrobials, and food safety - no specific legislation; Issues related to the Animal Drug User Fee Act (ADUFA) S.2434/H.R. 5554; Codex Alimentarius Commission (food safety, animal health); Issues related to veterinary biologics - no specific legislation. Sanitary and phyto-sanitary (SPS) issues, no specific legislation; Food safety and public health, no specific legislation; Bilateral and multilateral trade negotiations, no specific legislation;
Client expense: Not reported · Firm income: Not reported
2018 · fourth_quarter · Agriculture
Agricultural Improvement Act of 2018, S.3042/H.R. 2; Implementation of the Tax Cuts and Jobs Act; Issues related to animal health, veterinary medicine, antimicrobials, and food safety - no specific legislation; Issues related to the Animal Drug User Fee Act (ADUFA) S.2434/H.R. 5554; Codex Alimentarius Commission (food safety, animal health); Issues related to veterinary biologics - no specific legislation. Sanitary and phyto-sanitary (SPS) issues, no specific legislation; Food safety and public health, no specific legislation; Bilateral and multilateral trade negotiations, no specific legislation;
Client expense: Not reported · Firm income: Not reported
2018 · fourth_quarter · Health Issues
Agricultural Improvement Act of 2018, S.3042/H.R. 2; Implementation of the Tax Cuts and Jobs Act; Issues related to animal health, veterinary medicine, antimicrobials, and food safety - no specific legislation; Issues related to the Animal Drug User Fee Act (ADUFA) S.2434/H.R. 5554; Codex Alimentarius Commission (food safety, animal health); Issues related to veterinary biologics - no specific legislation. Sanitary and phyto-sanitary (SPS) issues, no specific legislation; Food safety and public health, no specific legislation; Bilateral and multilateral trade negotiations, no specific legislation;
Client expense: Not reported · Firm income: Not reported
2018 · fourth_quarter · Taxation/Internal Revenue Code
Agricultural Improvement Act of 2018, S.3042/H.R. 2; Implementation of the Tax Cuts and Jobs Act; Issues related to animal health, veterinary medicine, antimicrobials, and food safety - no specific legislation; Issues related to the Animal Drug User Fee Act (ADUFA) S.2434/H.R. 5554; Codex Alimentarius Commission (food safety, animal health); Issues related to veterinary biologics - no specific legislation. Sanitary and phyto-sanitary (SPS) issues, no specific legislation; Food safety and public health, no specific legislation; Bilateral and multilateral trade negotiations, no specific legislation;
Client expense: Not reported · Firm income: Not reported
2018 · fourth_quarter · Copyright/Patent/Trademark
Agricultural Improvement Act of 2018, S.3042/H.R. 2; Implementation of the Tax Cuts and Jobs Act; Issues related to animal health, veterinary medicine, antimicrobials, and food safety - no specific legislation; Issues related to the Animal Drug User Fee Act (ADUFA) S.2434/H.R. 5554; Codex Alimentarius Commission (food safety, animal health); Issues related to veterinary biologics - no specific legislation. Sanitary and phyto-sanitary (SPS) issues, no specific legislation; Food safety and public health, no specific legislation; Bilateral and multilateral trade negotiations, no specific legislation;
Client expense: Not reported · Firm income: Not reported
2018 · third_quarter · Animals
Issues related to animal health, and food safety; antimicrobial resistance; HR 1587 Preservation of Antibiotics for Medical Treatment Act of 2017; S. 2434 and H.R. 5554, Animal Drug and Generic Animal Drug User Fee Act Amendments of 2018 and conditional approval
Client expense: $30,000 · Firm income: Not reported
Government targets: Agriculture, Dept of (USDA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Office of Management & Budget (OMB), SENATE, U.S. Trade Representative (USTR)
2018 · third_quarter · Pharmacy
H.R. 547/S. 2651 Fairness to Pet Owners Act H.R. 5554/S. 2434 Animal Drug and Animal Generic Drug User Fee Amendments of 2018; all provisions related to animal health and drug development H.R. 6, Support for Patients and Communities Act, provisions related to veterinary access to controlled substances for veterinary use, as prescribers and DEA registrants
Client expense: $220,000 · Firm income: Not reported
Government targets: Agriculture, Dept of (USDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Internal Revenue Service (IRS), Labor, Dept of (DOL), SENATE, Transportation, Dept of (DOT)
2018 · third_quarter · Health Issues
Issues related to antimicrobials; issues related to the reauthorization of PAHPA, including S. 2852 / H.R. 6378, Pandemic All Hazards Preparedness Act of 2018; monitored issues related to H.R. 5554, The Animal Drug and Animal Generic Drug User Fee Amendments of 2018 (ADUFA) and (AGDUFA). Issues regarding drug pricing.
Client expense: Not reported · Firm income: $45,000
Government targets: Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, SENATE
2018 · third_quarter · Health Issues
Issues related to Over the Counter (OTC) Monograph reform, influenza, and drug pricing; S.2852, Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2018; H.R.6378, To reauthorize certain programs under the Pandemic and All-Hazards Preparedness Reauthorization Act; S.2434/H.R.5554, Animal Drug and Animal Generic Drug User Fee Amendments of 2018 (P.L.115-234); S.2315, Over-the-Counter Drug Safety, Innovation, and Reform Act; H.R.5333, Over-the-Counter Monograph Safety, Innovation, and Reform Act of 2018.
Client expense: Not reported · Firm income: $40,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2018 · third_quarter · Health Issues
340B drug discount program; truthful non-misleading industry communications; compassionate use/right to try; importation of biopharmaceuticals; drug pricing; transparency; direct-to-consumer (DTC) advertising; H.R.2051, FAST Generics Act of 2017; Implementation of P.L.115-176, Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2017; TRICARE issues in H.R.5515/S.2987, National Defense Authorization Act for Fiscal Year 2019 (P.L.115-232); S.2434/H.R.5554, Animal Drug and Animal Generic Drug User Fee Amendments of 2018 (P.L.115-234); S.2852, Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2018; H.R.6378, To reauthorize certain programs under the Pandemic and All-Hazards Preparedness Reauthorization Act; H.R.6, SUPPORT for Patients and Communities Act.
Client expense: Not reported · Firm income: $50,000
Government targets: Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), SENATE
2018 · third_quarter · Budget/Appropriations
S.2976/H.R.5961 - Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, FY'19 (APHIS and FDA) S.1839/H.R.2321 - CREAATE Act S.2434/H.R.5554 - Animal Drug and Animal Generic Drug User Fee Amendments of 2018
Client expense: Not reported · Firm income: $50,000
Government targets: Agriculture, Dept of (USDA), HOUSE OF REPRESENTATIVES, SENATE, U.S. Trade Representative (USTR)
2018 · third_quarter · Budget/Appropriations
S.2976/H.R.5961 - Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, FY'19 (APHIS, FDA, and Foreign Market Development Program) H.R.1625 - Consolidated Appropriations Act of 2018 (Antibiotics and Animal Health) - no specific legislation S.2434/H.R.5554 - Animal Drug and Animal Generic Drug User Fee Amendments of 2018
Client expense: Not reported · Firm income: $20,000
Government targets: Agriculture, Dept of (USDA), HOUSE OF REPRESENTATIVES, SENATE
2018 · third_quarter · Agriculture
Issues related to animal health and animal disease prevention, specifically the introduction of USDA and FDA regulated products to the market; H.R. 5554, the Animal Drug and Animal Generic Drug User Fee Amendments of 2018 (ADUFA and AGDUFA); H.R. 2/S. 3042, Agriculture Improvement Act of 2018; H.R.5961/S.2976, Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2019.
Client expense: Not reported · Firm income: $50,000
Government targets: Agriculture, Dept of (USDA), HOUSE OF REPRESENTATIVES, SENATE
2018 · third_quarter · Pharmacy
H.R. 547/S. 2651 Fairness to Pet Owners Act H.R. 5554/S. 2434 Animal Drug and Animal Generic Drug User Fee Amendments of 2018; all provisions related to animal health and drug development H.R. 6, Support for Patients and Communities Act, provisions related to veterinary access to controlled substances for veterinary use, as prescribers and DEA registrants
Client expense: $220,000 · Firm income: Not reported
Government targets: Agriculture, Dept of (USDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Internal Revenue Service (IRS), Labor, Dept of (DOL), SENATE, Transportation, Dept of (DOT)
2018 · third_quarter · Health Issues
Issues related to health care, the Food and Drug Administration (FDA), the 340B Program, animal health, drug pricing, oncology coverage, and direct-to-consumer (DTC) advertising; Vaccine provisions and TRICARE Pilot Program in H.R.5515/S.2987, National Defense Authorization Act for Fiscal Year 2019 (P.L.115-232); Implementation of P.L.114-255, 21st Century Cures Act; Implementation of P.L.115-176, Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2017; S.2434/H.R.5554, Animal Drug and Animal Generic Drug User Fee Amendments of 2018 (P.L.115-234); S.2852, Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2018; H.R.6378, To reauthorize certain programs under the Pandemic and All-Hazards Preparedness Reauthorization Act; H.R.6, SUPPORT for Patients and Communities Act.
Client expense: Not reported · Firm income: $40,000
Government targets: Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), SENATE
2018 · third_quarter · Health Issues
H.R. 5554, Animal Drug User Fee Act, we lobbied to cut conditional approval expansion and include duration limits on all medically important antibiotics. S 3099 Strengthening Antibiotic Oversight Act, we lobbied for legislators to co-sponsor the bill.
Client expense: $20,000 · Firm income: Not reported
Government targets: Agriculture, Dept of (USDA), Consumer Product Safety Commission (CPSC), Executive Office of the President (EOP), Federal Deposit Insurance Corporation (FDIC), Federal Reserve System, Federal Trade Commission (FTC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Natl Credit Union Administration (NCUA), Natl Economic Council (NEC), Office of Management & Budget (OMB), Office of the Comptroller of the Currency (OCC), SENATE, Securities & Exchange Commission (SEC), Treasury, Dept of
2018 · second_quarter · Animals
Issues related to animal health, and food safety; antimicrobial resistance; HR 1587 Preservation of Antibiotics for Medical Treatment Act of 2017; S. 2434 and H.R. 5554, Animal Drug and Generic Animal Drug User Fee Act Amendments of 2018 and conditional approval
Client expense: $45,000 · Firm income: Not reported
Government targets: Agriculture, Dept of (USDA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Office of Management & Budget (OMB), SENATE, U.S. Trade Representative (USTR)
2018 · second_quarter · Health Issues
Issues related to antimicrobials; issues related to the reauthorization of PAHPA; monitored issues related to the Right to Try Act of 2018; H.R. 5599, Animal Health and Innovation Act; H.R. 5554, The Animal Drug and Animal Generic Drug User Fee Amendments of 2018 (ADUFA) and (AGDUFA). Issues regarding drug pricing.
Client expense: Not reported · Firm income: $45,000
Government targets: Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, SENATE
2018 · second_quarter · Budget/Appropriations
S.2976/H.R.5961 - Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, FY'19 (APHIS, FDA, and Foreign Market Development Program) H.R.1625 - Consolidated Appropriations Act of 2018 (Antibiotics and Animal Health) - no specific legislation S.2434/H.R.5554 - Animal Drug and Animal Generic Drug User Fee Amendments of 2018
Client expense: Not reported · Firm income: $20,000
Government targets: Agriculture, Dept of (USDA), HOUSE OF REPRESENTATIVES, SENATE
2018 · second_quarter · Budget/Appropriations
S.2976/H.R.5961 - Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, FY'19 (APHIS and FDA) S.1839/H.R.2321 - CREAATE Act S.2434/H.R.5554 - Animal Drug and Animal Generic Drug User Fee Amendments of 2018
Client expense: Not reported · Firm income: $50,000
Government targets: Agriculture, Dept of (USDA), HOUSE OF REPRESENTATIVES, SENATE, U.S. Trade Representative (USTR)
2018 · second_quarter · Pharmacy
H.R. 5472/S. 2651 Fairness to Pet Owners Act HR 5554/S.2434 Animal Drug and Animal Generic Drug User Fee Amendments Act of 2018 S. 2680, Opioid crisis response act of 2018; provisions related to veterinary access to controlled substances for veterinary use, as prescribers and DEA registrants H.R. 6, Support for Patients and Communities Act, provisions related to veterinary access to controlled substances for veterinary use, as prescribers and DEA registrants
Client expense: $200,000 · Firm income: Not reported
Government targets: Agriculture, Dept of (USDA), Education, Dept of, HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Internal Revenue Service (IRS), Labor, Dept of (DOL), Office of Management & Budget (OMB), SENATE, Transportation, Dept of (DOT), Treasury, Dept of
2018 · second_quarter · Agriculture
Issues related to animal health and animal disease prevention, specifically the introduction of USDA and FDA regulated products to the market; H.R. 5554, the Animal Drug and Animal Generic Drug User Fee Amendments of 2018 (ADUFA and AGDUFA); H.R.2 - Agriculture Improvement Act of 2018; FY 2019 Agriculture Appropriations.
Client expense: Not reported · Firm income: $50,000
Government targets: Agriculture, Dept of (USDA), HOUSE OF REPRESENTATIVES, SENATE
2018 · second_quarter · Health Issues
H.R. 5554, Animal Drug User Fee Act, we lobbied to cut conditional approval expansion and include duration limits on all medically important antibiotics. S 3099 Strengthening Antibiotic Oversight Act, we lobbied for legislators to co-sponsor the bill.
Client expense: $20,000 · Firm income: Not reported
Government targets: Agriculture, Dept of (USDA), Consumer Product Safety Commission (CPSC), Environmental Protection Agency (EPA), Federal Deposit Insurance Corporation (FDIC), Federal Housing Finance Agency (FHFA), Federal Reserve System, Federal Trade Commission (FTC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Office of Management & Budget (OMB), Office of Thrift Supervision (OTS), Office of the Comptroller of the Currency (OCC), SENATE, Securities & Exchange Commission (SEC), State, Dept of (DOS), Transportation, Dept of (DOT), Treasury, Dept of, U.S. Trade Representative (USTR)
2018 · second_quarter · Health Issues
HR 5554-antibiotics amendments to animal drug user fees; HR 5599-antibiotics
Client expense: $317,146 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2018 · second_quarter · Food Industry (safety, labeling, etc.)
S.221 Common Sense Nutrition Disclosure Act of 2017 (menu labeling); H.R.1687 Sweet Act (sugary beverages); S.3042 & H.R.2 Farm bill 2018; H.R.5425 Food Labeling Modernization Act and Food Allergen Labeling and Consumer Protection Act; S.2434 & H.R.5554 Animal Drug User Fees Act; S.3099 Strengthening Antibiotic Oversight Act; S.1113 Modernization of Cosmetics Regulation Act
Client expense: $10,000 · Firm income: Not reported
Government targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, SENATE
2018 · second_quarter · Animals
HR 5554 and S 2434, Animal Drug User Fee Act HR 4577, The Domestic Explosives Detection Canine Capacity Building Act of 2017
Client expense: $50,000 · Firm income: Not reported
Government targets: Agriculture, Dept of (USDA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Homeland Security, Dept of (DHS), Labor, Dept of (DOL), SENATE
2018 · first_quarter · Animals
Issues related to animal health, and food safety; antimicrobial resistance; HR 1587 Preservation of Antibiotics for Medical Treatment Act of 2017; S. 2434 and H.R. 5554, Animal Drug and Generic Animal Drug User Fee Act Amendments of 2018 and conditional approval
Client expense: $55,000 · Firm income: Not reported
Government targets: Agriculture, Dept of (USDA), HOUSE OF REPRESENTATIVES, Office of Management & Budget (OMB), SENATE, U.S. Trade Representative (USTR)
2018 · first_quarter · Animals
Issues related to animal health, and food safety; antimicrobial resistance; HR 1587 Preservation of Antibiotics for Medical Treatment Act of 2017; S. 2434 and H.R. 5554, Animal Drug and Generic Animal Drug User Fee Act Amendments of 2018 and conditional approval
Client expense: $35,000 · Firm income: Not reported
Government targets: Agriculture, Dept of (USDA), HOUSE OF REPRESENTATIVES, Office of Management & Budget (OMB), SENATE, U.S. Trade Representative (USTR)