What changed between these versions
A substantive set of changes. v2 modifies several appropriation amounts across various USDA agencies, resulting in both increases and decreases in funding for specific offices and programs. Additionally, v2 introduces three new general provisions, including prohibitions on certain animal testing guidance and research, and a directive for expedited FDA review of critical cancer drugs.
Overview
A significant number of changes, primarily affecting appropriations and introducing new general provisions. · v2 adjusts funding levels for various programs, with some increases and some decreases, and introduces new policy directives related to animal welfare and drug shortages.
v2 includes numerous adjustments to appropriations across the Department of Agriculture and related agencies, with several offices experiencing net reductions while others see increases. Notably, the Office of the Chief Information Officer and Office of the General Counsel face significant cuts, while the Agricultural Research Service and various rural development programs receive additional funds. Furthermore, three new general provisions are added, establishing prohibitions on certain animal testing practices by the FDA and NIFA, and mandating expedited review for sterile injectable cancer drugs in shortage.
Major additions
This new provision prohibits the Center for Drug Evaluation and Research, Center for Biologics Evaluation and Research, or Center for Devices and Radiological Health within the Food and Drug Administration from issuing or finalizing guidance that recommends or requires testing in dogs.
This addition places a direct restriction on FDA's regulatory and guidance development processes concerning animal testing, specifically for dogs, impacting pharmaceutical and medical device industries that might rely on such testing.
This new provision prohibits the National Institute of Food and Agriculture (NIFA) within the Department of Agriculture from conducting or funding research involving dogs or cats classified in pain category D or E, as defined by the Department of Agriculture.
This addition imposes a new ethical and operational constraint on NIFA-funded research, specifically targeting studies that involve high levels of pain for dogs and cats. It will affect research institutions and projects receiving NIFA funding.
This new provision prohibits the use of funds to contravene section 506C(g) of the Federal Food, Drug, and Cosmetic Act, which relates to the expedited review of applications, supplements, or inspections for sterile injectable drugs used in cancer treatment that are listed as being in shortage by the FDA.
This addition reinforces and prioritizes FDA's role in mitigating shortages of critical cancer drugs, potentially accelerating the availability of these essential medicines by ensuring that funding is not used to impede their review or facility inspections.
Modifications
The Office of the Chief Information Officer will have $10,500,000 less in appropriated funds for its necessary expenses, potentially impacting cybersecurity and other IT requirements.
Before
Appropriated $134,913,000 for necessary expenses.
After
Appropriated $134,913,000, but with explicit reductions totaling $10,500,000 from this amount.
The Office of the Chief Financial Officer will have $500,000 less in appropriated funds for its necessary expenses.
Before
Appropriated $5,813,000 for necessary expenses.
After
Appropriated $5,813,000, but with an explicit reduction of $500,000 from this amount.
The Office of Inspector General will have an additional $2,000,000 in appropriated funds, which could enhance its oversight and investigative capabilities.
Before
Appropriated $99,975,000 for necessary expenses.
After
Appropriated $99,975,000, but with explicit increases totaling $2,000,000 from this amount.
The Office of the General Counsel will have $4,000,000 less in appropriated funds for its necessary expenses, potentially affecting legal services provided to the Department.
Before
Appropriated $46,500,000 for necessary expenses.
After
Appropriated $46,500,000, but with explicit reductions totaling $4,000,000 from this amount.
The Agricultural Research Service will receive an additional $3,000,000 for salaries and expenses, supporting its research programs and operations.
Before
Appropriated $1,795,813,000 for necessary expenses.
After
Appropriated $1,795,813,000, but with explicit increases totaling $3,000,000 from this amount.
There is no operative impact on the final appropriated amount for research and education activities. The textual change reflects internal adjustments that cancelled each other out.
Before
Appropriated $1,046,500,000 for research and education activities.
After
Appropriated $1,046,500,000, with textual annotations indicating both increases and reductions that net to zero.
Extension activities will receive an additional $2,000,000, supporting cooperative extension services in states and territories.
Before
Appropriated $557,100,000 for extension activities.
After
Appropriated $557,100,000, but with an explicit increase of $2,000,000 from this amount.
The Animal and Plant Health Inspection Service will receive an additional $2,000,000 for its salaries and expenses, supporting animal and plant health programs.
Before
Appropriated $1,157,850,000 for necessary expenses.
After
Appropriated $1,157,850,000, but with explicit increases totaling $2,000,000 from this amount.
The Farm Production and Conservation Business Center will have $2,000,000 less in appropriated funds for its necessary expenses.
Before
Appropriated $150,598,000 for necessary expenses.
After
Appropriated $150,598,000, but with an explicit reduction of $2,000,000 from this amount.
The Farm Service Agency will receive an additional $2,000,000 for salaries and expenses, supporting its programs and county offices.
Before
Appropriated $1,105,526,000 for necessary expenses.
After
Appropriated $1,105,526,000, but with explicit increases totaling $2,000,000 from this amount.
The Natural Resources Conservation Service will receive an additional $2,000,000 for conservation operations, supporting soil and water conservation efforts.
Before
Appropriated $800,000,000 for conservation operations.
After
Appropriated $800,000,000, but with an explicit increase of $2,000,000 from this amount.
Rural Development will receive an additional $2,000,000 for salaries and expenses, supporting the administration and implementation of its programs.
Before
Appropriated $270,000,000 for necessary expenses.
After
Appropriated $270,000,000, but with an explicit increase of $2,000,000 from this amount.
There is no operative impact on the final specified amount for value-added agricultural product market development grants. The textual change reflects internal adjustments that cancelled each other out.
Before
Specified $6,500,000 for value-added agricultural product market development grants.
After
Specified $6,500,000 for value-added agricultural product market development grants, with textual annotations indicating both reductions and increases that net to zero.
Rural water and waste disposal programs will receive an additional $2,000,000, supporting essential infrastructure in rural areas.
Before
Appropriated $385,343,050 for rural water and waste disposal programs.
After
Appropriated $385,343,050, but with an explicit increase of $2,000,000 from this amount.
There is no operative impact on the final appropriated amount for distance learning, telemedicine, and broadband programs. The textual change reflects internal adjustments that cancelled each other out.
Before
Appropriated $33,160,198 for grants for telemedicine and distance learning services.
After
Appropriated $33,160,198 for grants for telemedicine and distance learning services, with textual annotations indicating both reductions and increases that net to zero.
There is no operative impact on the final appropriated amount for FDA salaries and expenses. The textual change reflects internal adjustments that cancelled each other out.
Before
Appropriated $7,109,336,000 for necessary expenses.
After
Appropriated $7,109,336,000 for necessary expenses, with textual annotations indicating both increases and reductions that net to zero.
There is no operative impact on the final specified amount for the Commodity Futures Trading Commission. The textual change reflects internal adjustments that cancelled each other out.
Before
Appropriated $355,000,000 for necessary expenses, with $80,000,000 remaining available until September 30, 2029.
After
Appropriated $355,000,000 for necessary expenses, with $80,000,000 (with textual annotations indicating both reductions and increases that net to zero) remaining available until September 30, 2029.
Scope
Meaningful expansion or narrowing — The changes are scattered throughout the bill, affecting multiple titles and agencies, particularly in the appropriations sections and the general provisions. — v2 introduces new policy directives regarding animal welfare in research and regulatory processes, and reinforces a focus on mitigating drug shortages, representing a meaningful refinement and expansion of policy in these specific areas. The appropriation changes represent adjustments within existing program scopes. — The new general provisions directly interact with and impose constraints on the operational activities of the FDA and NIFA, affecting how they conduct or fund certain types of research and regulatory actions. The appropriation changes directly alter the funding available for existing programs.
Impact analysis
Office of the Chief Information Officer (USDA)
Negative, reduced funding for operations.
Faces a significant reduction in appropriated funds.
Office of the Chief Financial Officer (USDA)
Negative, reduced funding for operations.
Faces a reduction in appropriated funds.
Office of Inspector General (USDA)
Positive, increased funding for oversight activities.
Receives an increase in appropriated funds.
Office of the General Counsel (USDA)
Negative, reduced funding for legal services.
Faces a reduction in appropriated funds.
Agricultural Research Service (USDA)
Positive, increased funding for research programs.
Receives an increase in appropriated funds for salaries and expenses.
National Institute of Food and Agriculture (NIFA) Extension Activities (USDA)
Positive, increased funding for extension services.
Receives an increase in appropriated funds.
Animal and Plant Health Inspection Service (APHIS) (USDA)
Positive, increased funding for animal and plant health programs.
Receives an increase in appropriated funds for salaries and expenses.
Farm Production and Conservation Business Center (USDA)
Negative, reduced funding for business center operations.
Faces a reduction in appropriated funds.
Farm Service Agency (USDA)
Positive, increased funding for agency operations and county offices.
Receives an increase in appropriated funds for salaries and expenses.
Natural Resources Conservation Service (NRCS) Conservation Operations (USDA)
Positive, increased funding for conservation efforts.
Receives an increase in appropriated funds.
Rural Development (USDA)
Positive, increased funding for program administration.
Receives an increase in appropriated funds for salaries and expenses.
Rural Utilities Service (RUS) Water and Waste Disposal Programs (USDA)
Positive, increased funding for rural water and waste infrastructure.
Receives an increase in appropriated funds.
Food and Drug Administration (FDA) Centers (CDER, CBER, CDRH)
Procedural change, restricting certain types of guidance development.
Prohibited from issuing or finalizing guidance recommending or requiring testing in dogs.
National Institute of Food and Agriculture (NIFA) researchers
Procedural change, restricting certain types of animal research.
Prohibited from conducting or funding research involving dogs or cats in high pain categories (D or E).
Manufacturers of sterile injectable cancer drugs in shortage
Positive, reinforcing expedited review for critical drugs.
FDA is directed to not contravene expedited review processes for applications, supplements, or inspections related to these drugs.