On June 26, 1956, the U.S. Congress approves the Federal Highway Act, which allocates more than $30 billion for the construction of some 41,000 miles of interstate highways; it will be the largest public construction project in U.S. history to that date.
Among the pressing questions involved in passing highway legislation were where exactly the highways should be built, and how much of the cost should be carried by the federal government versus the individual states. Several competing bills went through Congress before 1956, including plans spearheaded by the retired general and engineer Lucius D. Clay; Senator Albert Gore Sr.; and Rep. George H. Fallon, who called his program the “National System of Interstate and Defense Highways,” thus linking the construction of highways with the preservation of a strong national defense.
President Dwight D. Eisenhower had first realized the value of a national system of roads after participating in the U.S. Army’s first transcontinental motor convoy in 1919; during World War II, he had admired Germany’s autobahn network. In January 1956, Eisenhower called in his State of the Union address (as he had in 1954) for a “modern, interstate highway system.” Later that month, Fallon introduced a revised version of his bill as the Federal Highway Act of 1956. It provided for a 65,000-km national system of interstate and defense highways to be built over 13 years, with the federal government paying for 90 percent, or $24.8 billion. To raise funds for the project, Congress would increase the gas tax from two to three cents per gallon and impose a series of other highway user tax changes. On June 26, 1956, the Senate approved the final version of the bill by a vote of 89 to 1; Senator Russell Long, who opposed the gas tax increase, cast the single “no” vote. That same day, the House approved the bill by a voice vote, and three days later, Eisenhower signed it into law.
Highway construction began almost immediately, employing tens of thousands of workers and billions of tons of gravel and asphalt. The system fueled a surge in the interstate trucking industry, which soon pushed aside the railroads to gain the lion’s share of the domestic shipping market. Interstate highway construction also fostered the growth of roadside businesses such as restaurants (often fast-food chains), hotels and amusement parks. By the 1960s, an estimated one in seven Americans was employed directly or indirectly by the automobile industry, and America had become a nation of drivers.
Legislation has extended the Interstate Highway Revenue Act three times, and it is remembered by many historians as Eisenhower’s greatest domestic achievement. On the other side of the coin, critics of the system have pointed to its less positive effects, including the loss of productive farmland and the demise of small businesses and towns in more isolated parts of the country.
READ MORE: The Interstate Highway System
Federal Aid Road Act of 1916
The Federal Aid Road Act of 1916 (also known as the Bankhead–Shackleford Act), 39 Stat. 355, was enacted on July 11, 1916, and was the first federal highway funding legislation in the United States.  With the Model T craze roaring along, the demand for better roads was irresistible. The Act provided federal subsidies to road-building efforts. 
The act was introduced by Rep. Dorsey W. Shackleford (D) of Missouri, then amended by Sen. John H. Bankhead (D) of Alabama to conform with model legislation written by the American Association of State Highway Officials (AASHO). It provided $75 million of federal money in 50–50 matching funds to the states to build up to 6% of their roads statewide over a five-year period.
President Woodrow Wilson signed the Federal Aid Road Act on July 11, 1916 at a ceremony attended by members of AASHO, American Automobile Association, and various farm organizations. 
Wilson was an ardent advocate of good roads and made them a party platform in 1916: "The happiness, comfort and prosperity of rural life, and the development of the city, are alike conserved by the construction of public highways. We, therefore, favor national aid in the construction of post roads and roads for military purposes". 
Under the act, federal funding was provided for rural post roads on the condition that they be open to the public at no charge. Funding was to be distributed to the states based on a formula incorporating each state's geographic area, population, and existing road network. To obtain the funding, states were required to submit project plans, surveys, specifications and estimates to the United States Secretary of Agriculture. 
The Federal Aid Road Act, as the first federal highway funding law, was instrumental in extending and improving the country's road system. Prior to its passage (and for several decades afterward), the condition of many roads was deplorable "They were often little more than trails that were muddy in the rain and dusty the rest of the time. Any long trip by automobile required not only time, patience, and ingenuity, but tire-patching equipment, tools, spare parts, and emergency food and fuel".  A growing interest in road improvements was spurred by farmers who needed roads to take their goods to market, the introduction of Rural Free Delivery by the Postal Service, and the burgeoning popularity of the personal automobile. The 1907 Supreme Court case Wilson v. Shaw also paved the way for passage of the roads act by holding that the Commerce Clause authorized Congress to construct interstate highways. 
By 1917, every state had a highway agency to administer the federal funds. World War I and its concomitant demands on personnel and materials impeded the implementation of the 1916 act, as did the act's small appropriation and its limit on federal funding to $10,000 per mile. These and other problems were addressed in the next national road bill, the Federal Aid Highway Act of 1921 (Phipps Act).  Most felt that the 1921 legislation was far superior.
National Interstate and Defense Highways Act (1956)
This act authorized the building of highways throughout the nation, which would be the biggest public works project in the nation's history.
Popularly known as the National Interstate and Defense Highways Act of 1956, the Federal-Aid Highway Act of 1956 established an interstate highway system in the United States. The movement behind the construction of a transcontinental superhighway started in the 1930s when President Franklin D. Roosevelt expressed interest in the construction of a network of toll superhighways that would provide more jobs for people in need of work during the Great Depression. The resulting legislation was the Federal-Aid Highway Act of 1938, which directed the chief of the Bureau of Public Roads (BPR) to study the feasibility of a six-route toll network. But with America on the verge of joining the war in Europe, the time for a massive highway program had not arrived. At the end of the war, the Federal-Aid Highway Act of 1944 funded highway improvements and established major new ground by authorizing and designating, in Section 7, the construction of 40,000 miles of a "National System of Interstate Highways."
When President Dwight D. Eisenhower took office in January 1953, however, the states had only completed 6,500 miles of the system improvements. Eisenhower had first realized the value of good highways in 1919, when he participated in the U.S. Army's first transcontinental motor convoy from Washington, DC, to San Francisco. Again, during World War II, Eisenhower saw the German advantage that resulted from their autobahn highway network, and he also noted the enhanced mobility of the Allies, on those same highways, when they fought their way into Germany. These experiences significantly shaped Eisenhower's views on highways and their role in national defense. During his State of the Union Address on January 7, 1954, Eisenhower made it clear that he was ready to turn his attention to the nation's highway problems. He considered it important to "protect the vital interest of every citizen in a safe and adequate highway system."
Between 1954 and 1956, there were several failed attempts to pass a national highway bill through the Congress. The main controversy over the highway construction was the apportionment of the funding between the Federal Government and the states. Undaunted, the President renewed his call for a "modern, interstate highway system” in his 1956 State of the Union Address. Within a few months, after considerable debate and amendment in the Congress, The Federal-Aid Highway Act of 1956 emerged from the House-Senate conference committee. In the act, the interstate system was expanded to 41,000 miles, and to construct the network, $25 billion was authorized for fiscal years 1957 through 1969. During his recovery from a minor illness, Eisenhower signed the bill into law at Walter Reed Army Medical Center on the 29th of June. Because of the 1956 law, and the subsequent Highway Act of 1958, the pattern of community development in America was fundamentally altered and was henceforth based on the automobile.
Prior to the Federal Aid Highway Act of 1956 and the establishment of the Highway Trust Fund, roads were financed directly from the General Fund of the United States Department of the Treasury. The 1956 Act directed federal fuel tax to the Treasury’s General Fund to be used exclusively for highway construction and maintenance. The Highway Revenue Act, pre-dating the Fund, mandated a tax of three cents per gallon. This original Act, also known as Highway Revenue Act, was set to expire at the end of fiscal year 1972. In the late 1950s, the gas tax was increased to four cents. The 1982 Surface Transportation Assistance Act, approved by President Ronald Reagan in January 1983, increased the tax to nine cents with one cent going into a new Mass Transit Account to support public transport. In 1990, the gas tax was increased by President George H. W. Bush with the Omnibus Budget Reconciliation Act of 1990 to 14 cents, with 2.5 cents of the increase going to the Highway Fund. The other 2.5 cents of the Omnibus Act was directed towards deficit reduction. In 1993, President Clinton increased the gas tax to 18.4 cents with the Omnibus Budget Reconciliation Act of 1993 with all of the increase going towards deficit reduction. The Taxpayer Relief Act of 1997 redirected the 1993 increase to the newer Fund. 
During 2008, the Fund required an additional $8 billion, which was provided by the Treasury’s general revenue funds to cover a shortage in the Fund. This shortage was due to lower gas consumption as a result of the recession and higher gas prices, together meaning an overall decrease in revenues that would otherwise have been directed to the Fund.  Further transfers of $7 billion and an additional $19.5 billion were made in 2009 and 2010, respectively. 
During the 2008 presidential campaign, Senator John McCain proposed a 'gas holiday', suspending the tax during the peak summer driving season. Senator Hillary Clinton endorsed this idea soon afterwards, while Senator Barack Obama opposed the holiday. As an alternative, Senator Clinton proposed a 'windfall tax' on oil companies, which would make up for the lost revenue from the federal tax on gasoline and diesel fuel without affecting any existing or planned projects. 
Since 2000, there have been at least half a dozen attempts by individual members of Congress to suspend the federal gas tax, without which (and without a replacement) would have halted repair and expand the Federal highway system. All such attempts have failed. 
Account balance for fiscal year 2016 (October 1, 2015 – September 30, 2016). 
|Opening Balance||$12 B|
|Highway Outlays||$39 B|
|Mass Transit Outlays||$8 B|
|Receipts from Dedicated Fund||$35 B|
|Receipts from General Fund||$70 B|
|Closing Balance||$70 B|
From 2008 to 2010, Congress authorized the transfer of $35 billion from the General Fund of the U.S. Treasury to keep the Trust Fund solvent. 
The Congressional Budget Office (CBO) projected in 2012 that the Fund's Highway Account and Mass Transit Account would become insolvent by 2014. CBO said that although vehicles would travel more miles in the future (therefore consuming more taxable fuel), congressional refusal to increase the fuel tax would have caused the Fund to receive less money. Further, CBO assumed that Congress would not increase transportation spending beyond inflation (adjusted from 2012). 
As of June 2015, the CBO projected that payments from the Highway Trust Fund to the many states would need to be delayed at some point before the end of federal fiscal year 2015 (i.e., before the end of September 2015) to keep the balance above zero, without either some increase in the federal motor fuel excise tax (or allocation of other revenues to the Trust Fund). Alternatively, Congress would have had to reduce Trust Fund spending commitments. 
In 2013, the U.S. Chamber of Commerce supported raising the federal gasoline tax to keep the Fund solvent. 
The United States Congress passed a stopgap plan on July 31, 2014 to prevent a funding lapse. 
As of 2015, despite a considerable drop in gas prices, there was still little support among the US public and Congress for any increase(s) of the gasoline excise tax. 
U.S. Department of Transportation Established
The Interstate Highway System employed highway engineers for decades was a massive public works project and achievement. However, it was not without new concerns about how these highways affected the environment, city development, and the ability to provide public mass transit. These concerns were part of the mission created by the establishment of the U.S. Department of Transportation (DOT) in 1966. BPR was renamed the Federal Highway Administration (FHWA) under this new department in April 1967.
The Interstate System became a reality through the next two decades, opening 99 percent of the designated 42,800 miles of the Dwight D. Eisenhower National System of Interstate and Defense Highways.
Congress passes legislation to make Juneteenth a federal holiday
For the first time in nearly 40 years, Congress has moved to establish a new national holiday, this time for Juneteenth, and just in time for Saturday's 156th anniversary of the day that marks the last African American slaves being freed in Texas in the wake of the Civil War.
The House voted Wednesday night to pass the legislation. It heads next to President Joe Biden's desk for a signature. When Biden signs it, as he's expected to at 3:30 p.m. ET Thursday, according to the White House, Juneteenth will officially become a federal holiday -- the first since Martin Luther King Jr. Day was signed into law in 1983.
Democratic Rep. Sheila Jackson Lee of Texas, a fierce advocate for the Black community who sponsored the legislation in the House, proudly announced from the podium the "bill is passed" before bringing the gavel down.
One Republican, Rep. Matt Rosendale of Montana, said in a charged statement ahead of the evening vote that he opposed the legislation that was "an effort by the Left to create a day out of whole cloth to celebrate identity politics." Sen. John Cornyn, R-Texas, a lead sponsor of the Senate bill, called the statement "kooky" in a tweet.
The final vote in the House was 415-14.
Other House Republicans who voted no on the legislation include Reps. Thomas Massie, Scott DesJarlais, Mo Brooks, Andy Biggs, Tom Tiffany, Doug LaMalfa, Tom McClintock, Mike Rogers, Andrew Clyde, Ralph Norman, Chip Roy, Paul Gosar and Ronny Jackson of Texas.
The House vote came after the Senate -- in a surprise move Tuesday -- passed the measure by unanimous consent following a single Republican senator dropping his opposition.
Republican Sen. Ron Johnson of Wisconsin, who opposed the legislation last year, said in a statement that he would no longer raise his objections on the floor, though, as of last week, the bill already had the support of 60 cosponsors to overcome a filibuster.
"Although I strongly support celebrating Emancipation, I objected to the cost and lack of debate," Johnson said, referring to his previous stance. "While it still seems strange that having taxpayers provide federal employees paid time off is now required to celebrate the end of slavery, it is clear that there is no appetite in Congress to further discuss the matter."
Biden will be accompanied for the signing by Vice President Kamala Harris, who was one of the Democrats to introduce the legislation in the Senate last year alongside Cornyn.
Steve Williams, the president of the National Juneteenth Observance Foundation, thanked lawmakers in a press conference on Capitol Hill earlier for, he said, "put(ting) that exclamation mark on the fabulous work."
"The Juneteenth nation is ecstatic," he said.
What is Juneteenth?
Juneteenth -- also known as Freedom Day, Liberation Day and Emancipation Day -- marks the day when federal troops arrived in Galveston, Texas, on June 19, 1865, to ensure that African Americans still enslaved were freed following both the signing of the Emancipation Proclamation and end of the Civil War.
The advance by Union Army Gen. Gordon Granger came 30 months and 19 days after President Abraham Lincoln signed the Emancipation Proclamation on Jan. 1, 1863, which had declared, "all persons held as slaves within any States, or designated part of the State, the people whereof shall be in rebellion against the United States, shall be then, thenceforward, and forever free."
A $305 Billion Highway Deal in Congress
We’re Not Ready for Another Pandemic
Manchin and Sinema Now Face the Weight of History
The Senate approved the highway bill on an 83-16 vote. All but two Democrats—Senators Elizabeth Warren and Tom Carper—voted for it. Among the 14 Republican opponents were three of the four presidential candidates serving in the Senate: Ted Cruz, Marco Rubio, and Rand Paul. (Senator Bernie Sanders missed the vote.) The House cleared it, 359-65, earlier on Thursday. It won unanimous support from Democrats and opposition mainly from conservatives. Negotiators had struck a deal on the legislation only on Tuesday, but the House and Senate needed to act quickly before the Highway Trust Fund again ran dry.
Perhaps the most important single provision in the 1,300-page bill had little to do with transportation. It was the renewal of the Export-Import Bank, the federal lending agency that Congress allowed to expire with its inaction over the summer. While relatively obscure to much of the public, the battle over the bank’s future had become a fierce fight within the Republican Party. Conservatives assailed it as a form of corporate welfare and crony capitalism that benefits giants like Boeing and G.E. that shouldn’t need government help. But along with most Democrats and under heavy pressure from business groups, moderate Republicans warned that its demise would cost jobs in their districts. Test votes in the House and Senate demonstrated that the Export-Import Bank maintained majority support, and in the end, Republican leaders did not object to its inclusion in the highway bill.
Congress will now turn its attention to passing a rewrite of the No Child Left Behind education law and to striking a deal on an omnibus spending package to fund the government through September and avoid a shutdown next week. The debate over infrastructure funding won’t end, but it moves to the presidential campaign trail. Hillary Clinton has proposed spending $275 billion on top of what Congress just authorized, while Sanders has called for a more robust program costing $1 trillion in taxpayer money. Several plans from Republicans would cut federal infrastructure spending, although it is the current GOP frontrunner, Donald Trump, who has spoken the most about the need to upgrade the nation’s outdated infrastructure.
H.R.2 - Moving Forward Act 116th Congress (2019-2020)
Shown Here: Passed House (07/01/2020)
DIVISION A--FEDERAL SURFACE TRANSPORTATION PROGRAMS FOR FISCAL YEAR 2021
This division extends FY2020 enacted levels through FY2021 for federal-aid highway, transit, and safety programs. It also provides additional contract authority in FY2021 for (1) the Federal Highway Administration, (2) the Federal Transit Administration, (3) National Highway Traffic Safety Administration highway safety programs, and (4) Federal Motor Carrier Safety Administration motor carrier safety programs.
Among other provisions, the division
- includes additional routes within the Central Texas Corridor, a high priority corridor on the National Highway System
- includes the Central Louisiana Corridor and the Central Mississippi Corridor as high priority corridors in such system and
- directs the Department of Transportation (DOT) to report on the unique challenges that residents in areas of concentrated poverty face when riding public transportation.
DIVISION B--SURFACE TRANSPORTATION
This division reauthorizes for FY2022-FY2025 several surface transportation programs, including the federal-aid highway program, transit programs, highway safety, motor carrier safety, and rail programs.
Among other provisions, this division
- addresses climate change, including strategies to reduce the climate change impacts of the surface transportation system and conduct a vulnerability assessment to identify opportunities to enhance the resilience of the surface transportation system and ensure the efficient use of federal resources
- revises Buy America procurement requirements for highways, mass transit, and rail
- establishes a rebuild rural grant program to improve the safety, state-of-good repair, and connectivity of transportation infrastructure in rural communities
- expands the DOT highway safety high visibility enforcement program
- require DOT to carry out a safe routes to school program
- sets forth motor vehicle safety standards that require new commercial motor vehicles to be equipped with an automatic emergency braking system, establishes performance requirements for such braking systems, and requires the systems to be used while the commercial vehicles are in operation
- directs DOT to establish a pilot program to demonstrate a national motor vehicle per-mile user fee to restore and maintain the long-term solvency of the Highway Trust Fund and achieve and maintain a state of good repair in the surface transportation system
- modifies requirements for the national multimodal freight policy and state freight plans to include further consideration of environmental and equity impacts and
- revises the transportation infrastructure finance and innovation (TIFIA) program of DOT to include an expedited decision time line for public agency borrowers seeking secured loans.
The effective date of this division applies beginning on October 1, 2021.
DIVISION C--HAZARDOUS MATERIALS TRANSPORTATION
This division addresses provisions related to hazardous materials transportation, including provisions to reauthorize through FY2025 the hazardous materials programs of the Pipeline and Hazardous Materials Safety Administration (PHMSA).
Among other provisions, this division
- repeals certain requirements related to lithium cells and batteries
- directs the Federal Railroad Administration to initiate an evaluation of the safety, security, and environmental risks of transporting liquefied natural gas by rail
- provides grants to nonprofit organizations to develop hazardous materials response training for emergency responders and make such training available electronically or in person and
- requires DOT to ensure that the PHMSA shares with all relevant stakeholders, including state and local governments, all materials and information received, reviewed, or produced related to pipeline leaks, damage, or disruption.
This division addresses various rail related provisions, including the National Rail Passenger Corporation (Amtrak), intercity passenger rail policy, commuter rail policy, and rail safety.
Among other provisions, this division
- authorizes appropriations through FY2025 to provide grants to support Amtrak's intercity passenger rail service on the Northeast Corridor and the National Network
- prohibits Amtrak from imposing mandatory arbitration clauses when passengers purchase tickets
- modifies provisions related to the Northeast Corridor Commission, including to require the commission to submit a strategic development plan that identifies key state-of-good repair, capacity expansion, and capital improvement projects planned for the corridor.
- directs Metra (Chicago commuter rail system) and Amtrak to develop one-year and five-year improvement plans for Chicago Union Station
- requires DOT to enter into an agreement with the National Academies to conduct a study and issue a report on the safety impacts of freight trains longer than 7,500 feet and
- directs DOT to issue and publish a national strategy on how it plans to address blocked railroad crossings.
This division reauthorizes through FY2025 airport planning and development and noise compatibility planning and programs. It also addresses environmental concerns related to aviation, including development of low-emission aviation technologies.
Among other provisions, this division
- authorizes certain funding to be used exclusively to bring air traffic control facilities of the Federal Aviation Administration (FAA) into acceptable condition, including sustaining, rehabilitating, replacing, or modernizing such facilities and associated costs
- sets forth requirements for a change in airport sponsorship or operations with respect to airport operating certificates
- establishes a competitive grant and cost-sharing agreement program to develop, demonstrate, or apply low emission aviation technologies, and produce, transport, blend, or store sustainable aviation fuels that would reduce greenhouse gas emissions
- requires DOT to enter into an agreement with the National Academies of Sciences, Engineering, and Medicine to conduct a study on climate change mitigation efforts with respect to the civil aviation and aerospace industries and
- directs DOT to establish a Joint Task Force on Air Travel to develop recommended requirements, plans, and guidelines to address the health, safety, security, and logistical issues relating to the continuation of air travel during and after the COVID-19 (i.e., coronavirus disease 2019) public health emergency
DIVISION F--INVESTMENT IN WATER RESOURCES AND WATER-RELATED INFRASTRUCTURE
This division addresses provisions related to water resources and water-related infrastructure, including wastewater infrastructure to help communities with storm water needs.
Among other provisions, this division
- allows the Environmental Protection Agency (EPA) to enter into agreements to provide grants for the establishment of hazard mitigation revolving loan funds to provide funding assistance to local governments to carry out projects to reduce disaster risks for homeowners, businesses, nonprofit organizations, and communities
- reauthorizes through FY2025 the Sport Fish Restoration and Boating Trust Fund which provides funding for several programs, including fisheries conservation and management, water and boating infrastructure, and recreational boating safety
- requires the EPA to establishes a grant program for purchasing or installing equipment and technology that is used at a port and produces zero exhaust emissions of certain pollutants and greenhouse gases, or captures 100% of the exhaust emissions produced by an ocean-going vessel at berth
- establishes a pilot program to provide funding to states to incorporate wastewater testing for drugs at municipal wastewater treatment plants in order to monitor drug consumption and detect new drug use more quickly and in a more specific geographic region than methods currently in use
- establishes a California New River restoration program
- directs the EPA to establish a program to award research grants to wastewater utilities, institutions of higher education, and other entities to investigate the use of wastewater surveillance as an indicator of the distribution of COVID-19 in communities and
- provides direct grants to owners and operators of publicly-owned treatment works for planning, design, construction, and operations training of intelligent wastewater collection systems and storm water management operations, and of innovative and alternative combined sewer and storm water control projects.
DIVISION G--ENERGY AND COMMERCE
This division creates the Office of Internet Connectivity and Growth, and it provides funding for programs that (1) promote digital equity and broadband capacity building, (2) provide discounts on phone service for low-income consumers, and (3) subsidize internet services for schools and libraries. The bill also establishes specified transparency requirements, such as making federal broadband data available to local governments and changing the way broadband data is collected, disputed, and reported. Further, the bill requires the Federal Communications Commission to redefine unserved and underserved communities and to update its rules permitting Wi-Fi access on school buses. The bill also prohibits states from erecting barriers to locally owned broadband networks.
The division establishes requirements related to motor vehicle safety, including rulemakings for crash avoidance, updating the 5-Star Safety Rating System, and establishing standards to reduce injuries and fatalities suffered by pedestrians and cyclists struck by motor vehicles.
The division provides funding for certain energy and infrastructure measures, including grant programs to (1) assist water utilities with treatment for per- and polyfluoroalkyl substances, (2) assist rural electric cooperatives or nonprofit entities with designing and demonstrating energy storage and microgrid projects using renewable energy sources, and (3) construct or install community solar facilities that serve multi-family affordable housing. Further, the bill establishes a rebate program, requirements, and funding for specified energy efficiency retrofits.
The division also allows a tax credit for purchasing zero-emission vehicles and supports deployment of electric vehicle charging infrastructure.
The division provides funds to increase hospital capacity and support community health centers in their response to COVID-19.
DIVISION H--ADDITIONAL PROGRAMS
This division addresses various provisions, including those related to the national scenic byways program, the COVID-19 pandemic with respect to passenger or freight transportation facilities, and certain transportation policies.
Among other provisions, this division
- reauthorizes appropriations through FY2025 for the national scenic byways program
- requires, during the COVID-19 pandemic, the owners and operators of equipment or facilities used by passenger or freight transportation employers to implement personal protective equipment and disinfection and sanitization procedures, and air carriers to submit to the FAA a proposal to permit pilots to wear masks or protective face coverings in the flight deck
- authorizes the U.S. Geological Survey to fund, through a cooperative agreement with an academic partner, the design, construction, and tenant build-out of a facility to support energy and minerals research and appurtenant associated structures
- requires the Government Accountability Office to conduct a study to identify the impact of certain transportation policies on people based on their race, ethnicity, nationality, age, disability status, and gender identity and
- directs the Department of Labor to award implementation or renewal grants, on a competitive basis, to eligible industry or sector partnerships to achieve certain strategic objectives with respect to targeted infrastructure industries (e.g., transportation, construction, energy, information technology, or utilities industries).
DIVISION I--ZERO-EMISSION POSTAL FLEET AND OTHER MATTERS
This division authorizes appropriations to the U.S. Postal Service (USPS) for the modernization of postal infrastructure and operations, including through capital expenditures to purchase delivery vehicles, processing equipment, trailers, and other goods. The USPS must ensure that at least 75% of the total number of vehicles purchased using such funds are electric or zero-emission vehicles.
Additionally, not later than January 1, 2026, the USPS must provide at least one electric vehicle charging station at each publicly available postal facility for use by the public or its employees.
DIVISION J--COMMITTEE ON FINANCIAL SERVICES
This division expands and otherwise modifies various housing and community development programs. Specifically, the division authorizes additional assistance under the following programs
- the Multifamily Preservation and Revitalization demonstration program,
- the Flood Mitigation Assistance Grant program,
- the Native American Housing Block Grant program, the HOME Investment Partnership program,
- the Community Development Block Grant program,
- supportive housing for individuals with disabilities and for the elderly, and
- single-family repair loans and grants for very low-income homeowners in rural areas.
The division also authorizes the Department of Housing and Urban Development (HUD) to provide additional assistance from the Public Housing Capital Fund, the Housing Trust Fund, and the Capital Magnet Fund.
- establish a grant program for the preservation of manufactured housing,
- develop a plan for retrofitting federally assisted housing to support broadband service, and
- identify public housing and federally assisted housing with lead-based water service pipes.
HUD may also award grants for the removal and replacement of such pipes.
The division makes permanent, and otherwise revises, the Interagency Council on Homelessness.
In general, the division requires that projects, other than housing development projects, that use Community Development Block Grant funds must use construction materials produced domestically.
HUD may use capital or operating funds to construct new public housing units even if doing so results in a net increase of public housing units.
The Government Accountability Office must study
- inequities in flood disaster assistance,
- broadband service in federally assisted housing, and
- the housing infrastructure needs of populations that are at higher risk of homelesness.
DIVISION K--REOPEN AND REBUILD AMERICA'S SCHOOLS ACT OF 2020
The purpose of this division is to support long-term improvements to public school facilities.
The division sets forth allocations to states and establishes a need-based grant program for local educational agencies (LEAs).
The division requires LEAs that receive funds for new construction to comply with hazard-resistance building codes and performance criteria under the Water Sense Program of the Energy Policy and Conservation Act.
The division sets forth requirements for green practices (environmental standards) and requires the use of iron, steel, and manufactured products made in the United States (Buy America).
Funds may not be used for charter schools operated by a nonprofit entity.
The division sets forth reporting requirements, including annual reports on grant program projects and a report by the Government Accountability Office that requires a study of the geographic distribution of projects, the impact of projects on student and staff health and safety, and the accessibility of projects to high-poverty schools.
The division increases funding for the Impact Aid Construction program under the Elementary and Secondary Education Act in each of FY2020-2024. It also awards grant to LEAs for the repair or replacement of crumbling school foundations affected by pyrrhotite.
DIVSION L--PUBLIC LANDS, TRIBAL COMMUNITIES, AND RESILIENT INFRASTRUCTURE
This division addresses provisions related to public and tribal lands, water infrastructure, wildlife conservation, and energy.
Among other provisions, the division
- makes permanent the Reclamation Water Settlements Fund
- authorizes appropriations to provide funding to repair certain water conveyance facilities and restore and maintain fish populations in the San Joaquin River in California
- establishes a grant program to help disadvantaged communities address a significant decline in the quantity or quality of drinking water
- addresses water management infrastructure and improvement, groundwater management, and water conservation and environmental restoration in certain western states
- directs the Department of Health and Human Services to award through FY2024 additional funds to the Indian Health Service Sanitation Facilities Construction Program
- ratifies and modifies the Navajo Utah Water Rights Settlement Agreement negotiated between the Navajo Nation, the United States, and Utah
- allows certain agencies to retain and use rental fees for rights-of-way and other telecommunications infrastructure use authorizations
- establishes a grant program for projects that acquire land and water for parks and outdoor recreation purposes
- establishes the Western Riverside County National Wildlife Refuge in California
- takes certain land into trust for the benefit of the Agua Caliente Band of Cahuilla Indians
- establishes the National Wildlife Corridors System and authorizes tribal wildlife corridors
- establishes a program to remediate, reclaim, and close orphaned oil and gas wells
- expands payments from the Abandoned Mine Reclamation Fund for abandoned coal mine cleanups
- creates priority areas for geothermal, solar, and wind energy projects on public lands and
- establishes an offshore wind career training grant program.
DIVISION M--REVENUE PROVISIONS
This division provides for infrastructure financing through the issuance of infrastructure bonds, including school infrastructure bonds, and revisions to advance funding bond and private activity bond provisions. It also revises and makes permanent the new markets tax credit and increases the rehabilitation tax credit.
The division allows a credit for operations and maintenance costs of government-owned broadband.
DHS must make an immediate needs assessment of the condition of child care facilities throughout the United States and award grants to states for such facilities.
The division extends through 2020 the tax credit for the production of energy from certain renewable resources (e.g., biomass, landfill and trash facilities). It also extends other energy-related tax credits, including credits for solar energy, onshore and offshore wind projects, carbon sequestration, alternative fuel refueling property, nonbusiness energy property, two-wheeled plug-in electric vehicles, and energy-efficient homes.
The division also revises provisions relating to the low-income housing tax credit and provides a new neighborhood homes tax credit.
The division extends the Highway Trust Fund expenditure authority and certain highway-related excise taxes.
DIVISION N--RIGHTS FOR TRANSPORTATION SECURITY OFFICERS
This division converts employees of the Transportation Security Administrations (TSA) to the civil service system applicable to all other federal employees. DHS must consult with labor representatives of TSA employees with respect to the plans and deadlines for the conversion of TSA employees to the standard civil service regime.
This division does not repeal or otherwise affect prohibitions against strikes by TSA employees or certain crimes relating to terrorism.
The GAO must report on efforts of the TSA regarding recruitment, including recruitment of veterans and members of the Armed Forces.
The TSA must address concerns of the Federal Air Marshall relating to mental health, suicide rate, and morale and recruitment and must provide guidance to TSA employees regarding prevention and protections against COVID-19 (i.e., coronavirus disease 2019) .
DIVISION O--AGRICULTURE INFRASTRUCTURE IMPROVEMENTS
This division increases to $60 million the amount that may be transferred from Treasury to the Reforestation Trust Fund.
DIVISION P--BUDGETARY EFFECTS
This division excludes the budgetary effects of each division of this bill from PAYGO scorecards under the Statutory Pay-As-You-Go Act of 2010 and from Senate PAYGO scorecards.
DIVISION Q--STATE-OWNED ENTERPRISES
This division prohibits funding an entity that is owned by a corporation based in a country that is identified as a nonmarket economy or that infringes on intellectual property or human rights.
Congress approves Federal Highway Act - HISTORY
The powers of Congress are enumerated in several places in the Constitution. The most important listing of congressional powers appears in Article I, Section 8 (see left) which identifies in seventeen paragraphs many important powers of Congress. In this section, we consider how the federal government's power to spend tax dollars has been interpreted by the Supreme Court..
The Congress shall have Power To lay and collect Taxes, Duties, Imposts and Excises,
to pay the Debts and provide for the common Defence and general Welfare of the United States.
Opponents of the Affordable Care Act ("Obamacare") won a small victory when the Court held that states which refuse to expand Medicaid coverage
cannot be denied federal funds for their more limited, existing, programs.
The Congress shall have Power To lay and collect Taxes, Duties, Imposts and Excises, to pay the Debts and provide for the common Defence and general Welfare of the United States but all Duties, Imposts and Excises shall be uniform throughout the United States
To borrow Money on the credit of the United States
To regulate Commerce with foreign Nations, and among the several States, and with the Indian Tribes
To establish an uniform Rule of Naturalization, and uniform Laws on the subject of Bankruptcies throughout the United States
To coin Money, regulate the Value thereof, and of foreign Coin, and fix the Standard of Weights and Measures
To provide for the Punishment of counterfeiting the Securities and current Coin of the United States
To establish Post Offices and post Roads
To promote the Progress of Science and useful Arts, by securing for limited Times to Authors and Inventors the exclusive Right to their respective Writings and Discoveries
To constitute Tribunals inferior to the supreme Court
To define and punish Piracies and Felonies committed on the high Seas, and Offences against the Law of Nations
To declare War, grant Letters of Marque and Reprisal, and make Rules concerning Captures on Land and Water
To raise and support Armies, but no Appropriation of Money to that Use shall be for a longer Term than two Years
To provide and maintain a Navy
To make Rules for the Government and Regulation of the land and naval Forces
To provide for calling forth the Militia to execute the Laws of the Union, suppress Insurrections and repel Invasions
To provide for organizing, arming, and disciplining, the Militia, and for governing such Part of them as may be employed in the Service of the United States, reserving to the States respectively, the Appointment of the Officers, and the Authority of training the Militia according to the discipline prescribed by Congress
To exercise exclusive Legislation in all Cases whatsoever, over such District (not exceeding ten Miles square) as may, by Cession of particular States, and the Acceptance of Congress, become the Seat of the Government of the United States, and to exercise like Authority over all Places purchased by the Consent of the Legislature of the State in which the Same shall be, for the Erection of Forts, Magazines, Arsenals, dock-Yards, and other needful Buildings--And
To make all Laws which shall be necessary and proper for carrying into Execution the foregoing Powers, and all other Powers vested by this Constitution in the Government of the United States, or in any Department or Officer thereof.
SPENDING POWER-- QUESTIONS
1. In South Dakota vs Dole, is it clear that South Dakota's lower drinking age jeopardized federal interests in the national highway program? If so, how substantially?
2. Could Congress condition the receiving of federal dollars to fight crime on a state's having enacted the death penalty? How--if at all--would such a condition differ from the condition upheld in South Dakota vs Dole?
3. What result in South Dakota vs Dole if South Dakota stood to lose all federal highway money if it didn't raise its drinking age? What if it stood to lose 30%?
4. Does the Court's ruling in the Affordable Care Act case suggest the Court will be closely scrutinizing large federal grant programs in the future? Note that SEVEN justices agreed that withholding federal funds from states that failed to expand their Medicaid coverage was outside of Congress's Spending Clause power.
Milestones in U.S. Food and Drug Law
From the beginnings of civilization people have been concerned about the quality and safety of foods and medicines. In 1202, King John of England proclaimed the first English food law, the Assize of Bread, which prohibited adulteration of bread with such ingredients as ground peas or beans. Regulation of food in the United States dates from early colonial times. Federal controls over the drug supply began with inspection of imported drugs in 1848, although the first federal biologics law, which addressed the provision of reliable smallpox vaccine to citizens, was passed in 1813. The following chronology describes some of the milestones in the history of food and drug regulation in the United States.
Eleven physicians meet in Washington, D.C., to establish the U.S. Pharmacopeia, the first compendium of standard drugs for the United States.
Drug Importation Act passed by Congress requires U.S. Customs Service inspection to stop entry of adulterated drugs from overseas.
President Lincoln appoints a chemist, Charles M. Wetherill, to serve in the new Department of Agriculture. This was the beginning of the Bureau of Chemistry, the predecessor of the Food and Drug Administration.
Peter Collier, chief chemist, U.S. Department of Agriculture, recommends passage of a national food and drug law, following his own food adulteration investigations. The bill was defeated, but during the next 25 years more than 100 food and drug bills were introduced in Congress.
Dr. Harvey W. Wiley becomes chief chemist, expanding the Bureau of Chemistry's food adulteration studies. Campaigning for a federal law, Dr. Wiley is called the "Crusading Chemist" and "Father of the Pure Food and Drugs Act." He retired from government service in 1912 and died in 1930.
Tea Importation Act passed, providing for Customs inspection of all tea entering U.S. ports, at the expense of the importers.
Association of Official Agricultural Chemists (now AOAC International) establishes a Committee on Food Standards headed by Dr. Wiley. States begin incorporating these standards into their food statutes.
The Biologics Control Act is passed to ensure purity and safety of serums, vaccines, and similar products used to prevent or treat diseases in humans.
Congress appropriates $5,000 to the Bureau of Chemistry to study chemical preservatives and colors and their effects on digestion and health. Dr. Wiley's studies draw widespread attention to the problem of food adulteration. Public support for passage of a federal food and drug law grows.
The original Food and Drugs Act is passed by Congress on June 30 and signed by President Theodore Roosevelt. It prohibits interstate commerce in misbranded and adulterated foods, drinks and drugs.
The Meat Inspection Act is passed the same day.
Shocking disclosures of insanitary conditions in meat-packing plants, the use of poisonous preservatives and dyes in foods, and cure-all claims for worthless and dangerous patent medicines were the major problems leading to the enactment of these laws.
First Certified Color Regulations, requested by manufacturers and users, list seven colors found suitable for use in foods.
In U.S. v. Johnson, the Supreme Court rules that the 1906 Food and Drugs Act does not prohibit false therapeutic claims but only false and misleading statements about the ingredients or identity of a drug.
Congress enacts the Sherley Amendment to over come the ruling in U.S. v. Johnson. It prohibits labeling medicines with false therapeutic claims intended to defraud the purchaser, a standard difficult to prove.
Mrs. Winslow's Soothing Syrup for teething and colicky babies, unlabeled yet laced with morphine, killed many infants.
Gould Amendment requires that food package contents be "plainly and conspicuously marked on the outside of the package in terms of weight, measure, or numerical count."
In U.S. v. Lexington Mill and Elevator Company, the Supreme Court issues its first ruling on food additives. It ruled that in order for bleached flour with nitrite residues to be banned from foods, the government must show a relationship between the chemical additive and the harm it allegedly caused in humans. The court also noted that the mere presence of such an ingredient was not sufficient to render the food illegal.
The Harrison Narcotic Act requires prescriptions for products exceeding the allowable limit of narcotics and mandates increased record-keeping for physicians and pharmacists who dispense narcotics.
In U.S. v. 95 Barrels Alleged Apple Cider Vinegar, the Supreme Court rules that the Food and Drugs Act condemns every statement, design, or device on a product's label that may mislead or deceive, even if technically true.
The Bureau of Chemistry is reorganized into two separate entities. Regulatory functions are located in the Food, Drug, and Insecticide Administration, and nonregulatory research is located in the Bureau of Chemistry and Soils.
McNary-Mapes Amendment authorizes FDA standards of quality and fill-of-container for canned food, excluding meat and milk products.
The name of the Food, Drug, and Insecticide Administration is shortened to Food and Drug Administration (FDA) under an agricultural appropriations act.
FDA recommends a complete revision of the obsolete 1906 Food and Drugs Act. The first bill is introduced into the Senate, launching a five-year legislative battle.
U.S. Government begins publication of the Federal Register.
Elixir of Sulfanilamide, containing the poisonous solvent diethylene glycol, kills 107 persons, many of whom are children, dramatizing the need to establish drug safety before marketing and to enact the pending food and drug law.
The Federal Food, Drug, and Cosmetic (FDC) Act of 1938 is passed by Congress, containing new provisions:
- Extending control to cosmetics and therapeutic devices.
- Requiring new drugs to be shown safe before marketing-starting a new system of drug regulation.
- Eliminating the Sherley Amendment requirement to prove intent to defraud in drug misbranding cases.
- Providing that safe tolerances be set for unavoidable poisonous substances.
- Authorizing standards of identity, quality, and fill-of-container for foods.
- Authorizing factory inspections.
- Adding the remedy of court injunctions to the previous penalties of seizures and prosecutions.
Under the Wheeler-Lea Act, the Federal Trade Commission is charged with overseeing advertising associated with products otherwise regulated by FDA.
First Food Standards issued (canned tomatoes, tomato purée, and tomato paste).
FDA transferred from the Department of Agriculture to the Federal Security Agency, with Walter G. Campbell appointed as the first Commissioner of Food and Drugs.
Insulin Amendment requires FDA to test and certify purity and potency of this lifesaving drug for diabetes
In U.S. v. Dotterweich, the Supreme Court rules that the responsible officials of a corporation, as well as the corporation itself, may be prosecuted for violations. It need not be proven that the officials intended, or even knew of, the violations.
Public Health Service Act is passed, covering a broad spectrum of health concerns, including regulation of biological products and control of communicable diseases.
Penicillin Amendment requires FDA testing and certification of safety and effectiveness of all penicillin products. Later amendments extended this requirement to all antibiotics. In 1983 such control was found no longer needed and was abolished.
Miller Amendment affirms that the Federal Food, Drug, and Cosmetic Act applies to goods regulated by the Agency that have been transported from one state to another and have reached the consumer.
FDA publishes guidance to industry for the first time. This guidance, "Procedures for the Appraisal of the Toxicity of Chemicals in Food," came to be known as the "black book."
In Alberty Food Products Co. v. U.S. , a court of appeals rules that the directions for use on a drug label must include the purpose for which the drug is offered. Therefore, a worthless remedy cannot escape the law by not stating the condition it is supposed to treat.
Oleomargarine Act requires prominent labeling of colored oleomargarine, to distinguish it from butter.
Delaney Committee starts congressional investigation of the safety of chemicals in foods and cosmetics, laying the foundation for the 1954 Miller Pesticide Amendment, the 1958 Food Additives Amendment, and the 1960 Color Additive Amendment.
Durham-Humphrey Amendment defines the kinds of drugs that cannot be safely used without medical supervision and restricts their sale to prescription by a licensed practitioner.
In U.S. v. Cardiff, the Supreme Court rules that the factory inspection provision of the 1938 FDC Act is too vague to be enforced as criminal law.
FDA consumer consultants are appointed in each field district to maintain communications with consumers and ensure that FDA considers their needs and problems.
Federal Security Agency becomes the Department of Health, Education, and Welfare (HEW).
Factory Inspection Amendment clarifies previous law and requires FDA to give manufacturers written reports of conditions observed during inspections and analyses of factory samples.
Miller Pesticide Amendment spells out procedures for setting safety limits for pesticide residues on raw agricultural commodities.
First large-scale radiological examination of food carried out by FDA when it received reports that tuna suspected of being radioactive was being imported from Japan following atomic blasts in the Pacific. FDA begins monitoring around the clock to meet the emergency.
HEW Secretary Oveta Culp Hobby appoints a committee of 14 citizens to study the adequacy of FDA's facilities and programs. The committee recommends a substantial expansion of FDA staff and facilities, a new headquarters building, and more use of educational and informational programs.
The Division of Biologics Control became an independent entity within the National Institutes of Health, after polio vaccine thought to have been inactivated is associated with about 260 cases of polio.
Food Additives Amendment enacted, requiring manufacturers of new food additives to establish safety. The Delaney proviso prohibits the approval of any food additive shown to induce cancer in humans or animals.
FDA publishes in the Federal Register the first list of substances generally recognized as safe (GRAS). The list contains nearly 200 substances.
U.S. cranberry crop recalled three weeks before Thanksgiving for FDA tests to check for aminotriazole, a weedkiller found to cause cancer in laboratory animals. Cleared berries were allowed a label stating that they had been tested and had passed FDA inspection, the only such endorsement ever allowed by FDA on a food product.
Color Additive Amendment enacted, requiring manufacturers to establish the safety of color additives in foods, drugs and cosmetics. The Delaney proviso prohibits the approval of any color additive shown to induce cancer in humans or animals.
Federal Hazardous Substances Labeling Act, enforced by FDA, requires prominent label warnings on hazardous household chemical products.
Thalidomide, a new sleeping pill, is found to have caused birth defects in thousands of babies born in western Europe. News reports on the role of Dr. Frances Kelsey, FDA medical officer, in keeping the drug off the U.S. market, arouse public support for stronger drug regulation.
Kefauver-Harris Drug Amendments passed to ensure drug efficacy and greater drug safety. For the first time, drug manufacturers are required to prove to FDA the effectiveness of their products before marketing them. The new law also exempts from the Delaney proviso animal drugs and animal feed additives shown to induce cancer but which leave no detectable levels of residue in the human food supply.
Consumer Bill of Rights is proclaimed by President John F. Kennedy in a message to Congress. Included are the right to safety, the right to be informed, the right to choose, and the right to be heard.
Drug Abuse Control Amendments are enacted to deal with problems caused by abuse of depressants, stimulants and hallucinogens.
FDA contracts with the National Academy of Sciences/National Research Council to evaluate the effectiveness of 4,000 drugs approved on the basis of safety alone between 1938 and 1962.
Child Protection Act enlarges the scope of the Federal Hazardous Substances Labeling Act to ban hazardous toys and other articles so hazardous that adequate label warnings could not be written.
Fair Packaging and Labeling Act requires all consumer products in interstate commerce to be honestly and informatively labeled, with FDA enforcing provisions on foods, drugs, cosmetics, and medical devices.
FDA Bureau of Drug Abuse Control and Treasury Department Bureau of Narcotics are transferred to the Department of Justice to form the Bureau of Narcotics and Dangerous Drugs (BNDD), consolidating efforts to police traffic in abused drugs.
Reorganization of federal health programs places FDA in the Public Health Service.
FDA forms the Drug Efficacy Study Implementation (DESI) to implement recommendations of the National Academy of Sciences investigation of effectiveness of drugs first marketed between 1938 and 1962.
Animal Drug Amendments place all regulation of new animal drugs under one section of the Food, Drug, and Cosmetic Act-Section 512-making approval of animal drugs and medicated feeds more efficient.
FDA begins administering Sanitation Programs for milk, shellfish, food service, and interstate travel facilities, and for preventing poisoning and accidents. These responsibilities were transferred from other units of the Public Health Service.
The White House Conference on Food, Nutrition, and Health recommends systematic review of GRAS substances in light of FDA's ban of the artificial sweetener cyclamate. President Nixon orders FDA to review its GRAS list.
In Upjohn v. Finch the Court of Appeals upholds enforcement of the 1962 drug effectiveness amendments by ruling that commercial success alone does not constitute substantial evidence of drug safety and efficacy.
FDA requires the first patient package insert: oral contraceptives must contain information for the patient about specific risks and benefits.
Drug Abuse Prevention and Control Act replaces previous laws and categorizes drugs based on abuse and addiction potential compared to their therapeutic value.
Environmental Protection Agency established takes over FDA program for setting pesticide tolerances.
PHS Bureau of Radiological Health transferred to FDA. Its mission: protection against unnecessary human exposure to radiation from electronic products in the home, industry, and the healing arts.
National Center for Toxicological Research is established in the biological facilities of the Pine Bluff Arsenal in Arkansas. Its mission is to examine biological effects of chemicals in the environment, extrapolating data from experimental animals to human health.
Artificial sweetener saccharin, included in FDA's original GRAS list, is removed from the list pending new scientific study.
Over-the-Counter Drug Review begun to enhance the safety, effectiveness and appropriate labeling of drugs sold without prescription.
Regulation of Biologics--including serums, vaccines, and blood products--is transferred from NIH to FDA.
The U.S. Supreme Court upholds the 1962 drug effectiveness law and endorses FDA action to control entire classes of products by regulations rather than to rely only on time-consuming litigation.
Low-acid food processing regulations issued, after botulism outbreaks from canned foods, to ensure that low-acid packaged foods have adequate heat treatment and are not hazardous.
Consumer Product Safety Commission created by Congress takes over programs pioneered by FDA under 1927 Caustic Poison Act, 1960 Federal Hazardous Substances Labeling Act, 1966 Child Protection Act, and PHS accident prevention activities for safety of toys, home appliances, etc.
Medical Device Amendments passed to ensure safety and effectiveness of medical devices, including diagnostic products. The amendments require manufacturers to register with FDA and follow quality control procedures. Some products must have pre-market approval by FDA others must meet performance standards before marketing.
Vitamins and Minerals Amendments ("Proxmire Amendments") stop FDA from establishing standards limiting potency of vitamins and minerals in food supplements or regulating them as drugs based solely on potency.
Saccharin Study and Labeling Act passed by Congress to stop FDA from banning the chemical sweetener but requiring a label warning that it has been found to cause cancer in laboratory animals.
Introduction of the Bioresearch Monitoring Program as an agency-wide initiative ensures the quality and integrity of data submitted to FDA and provides for the protection of human subjects in clinical trials by focusing on preclinical studies on animals, clinical investigations, and the work of institutional review boards.
In the hours following the Three Mile Island nuclear emergency of March 28, 1979, FDA contracted with firms in Missouri, Michigan, and New Jersey to prepare and package enough doses of potassium iodide to protect those threatened with thyroid cancer if exposed to radiation. Nearly one quarter of a million bottles-enough for every household in the area-were delivered to Harrisburg, Pennsylvania within 72 hours.
Infant Formula Act establishes special FDA controls to ensure necessary nutritional content and safety
FDA and the Department of Health and Human Services revise regulations for human subject protections, based on the 1979 Belmont Report, which had been issued by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The revised rules provide for wider representation on institutional review boards and they detail elements of what constitutes informed consent, among other provisions.
Tamper-resistant Packing Regulations issued by FDA to prevent poisonings such as deaths from cyanide placed in Tylenol capsules. The Federal Anti-Tampering Act passed in 1983 makes it a crime to tamper with packaged consumer products.
FDA publishes first Red Book (successor to 1949 "black book"), officially known as Toxicological Principles for the Safety Assessment of Direct Food Additives and Color Additives Used in Food.
Orphan Drug Act passed, enabling FDA to promote research and marketing of drugs needed for treating rare diseases.
Fines Enhancement Laws of 1984 and 1987 amend the U.S. Code to greatly increase penalties for all federal offenses. The maximum fine for individuals is now $100,000 for each offense and $250,000 if the violation is a felony or causes death. For corporations, the amounts are doubled.
Drug Price Competition and Patent Term Restoration Act expedites the availability of less costly generic drugs by permitting FDA to approve applications to market generic versions of brand-name drugs without repeating the research done to prove them safe and effective. At the same time, the brand-name companies can apply for up to five years additional patent protection for the new medicines they developed to make up for time lost while their products were going through FDA's approval process.
AIDS test for blood approved by FDA in its first major action to protect patients from infected donors.
Childhood Vaccine Act requires patient information on vaccines, gives FDA authority to recall biologics, and authorizes civil penalties.
Investigational drug regulations revised to expand access to experimental drugs for patients with serious diseases with no alternative therapies.
Food and Drug Administration Act of 1988 officially establishes FDA as an agency of the Department of Health and Human Services with a Commissioner of Food and Drugs appointed by the President with the advice and consent of the Senate, and broadly spells out the responsibilities of the Secretary and the Commissioner for research, enforcement, education, and information.
The Prescription Drug Marketing Act bans the diversion of prescription drugs from legitimate commercial channels. Congress finds that the resale of such drugs leads to the distribution of mislabeled, adulterated, subpotent, and counterfeit drugs to the public. The new law requires drug wholesalers to be licensed by the states restricts reimportation from other countries and bans sale, trade or purchase of drug samples, and traffic or counterfeiting of redeemable drug coupons.
Generic Animal Drug and Patent Term Restoration Act extends to veterinary products benefits given to human drugs under the 1984 Drug Price Competition and Patent Term Restoration Act. Companies can produce and sell generic versions of animal drugs approved after October 1962 without duplicating research done to prove them safe and effective. The act also authorizes extension of animal drug patents.
FDA issues a nationwide recall of all over-the-counter dietary supplements containing 100 milligrams or more of L-Tryptophan, due to a clear link between the consumption of L-tryptophan tablets and its association with a U.S. outbreak of Eosinophilia Myalgia Syndrome (EMS), characterized by fatigue, shortness of breath, and other symptoms. By 1990 the Centers for Disease Control and Prevention confirm over 1,500 cases of EMS, including 38 deaths, and FDA prohibits the importation of l-tryptophan.
Responding to increasing illicit traffic, Congress passes the Anabolic Steroid Act of 1990, which identifies anabolic steroids as a class of drugs and specifies over two dozen items as controlled substances. In addition, a four-part definition of this class is established to permit new, black market compounds to be assigned to this category, and thus subject to regulation as controlled substances.
Nutrition Labeling and Education Act requires all packaged foods to bear nutrition labeling and all health claims for foods to be consistent with terms defined by the Secretary of Health and Human Services. The law preempts state requirements about food standards, nutrition labeling, and health claims and, for the first time, authorizes some health claims for foods. The food ingredient panel, serving sizes, and terms such as "low fat" and "light" are standardized.
Safe Medical Devices Act is passed, requiring nursing homes, hospitals, and other facilities that use medical devices to report to FDA incidents that suggest that a medical device probably caused or contributed to the death, serious illness, or serious injury of a patient. Manufacturers are required to conduct post-market surveillance on permanently implanted devices whose failure might cause serious harm or death, and to establish methods for tracing and locating patients depending on such devices. The act authorizes FDA to order device product recalls and other actions.
Regulations published to Accelerate the Review of Drugs for life-threatening diseases.
The policy for protection of human subjects in research, promulgated in 1981 by FDA and the Department of Health and Human Services, is adopted by more than a dozen federal entities involved in human subject research and becomes known as the Common Rule. This rule issues requirements for researchers who obtain and document informed consent, secures special protection for children, women, and prisoners, elaborates on required procedures for institutional review boards, and ensures that research institutions comply with the regulations.
Generic Drug Enforcement Act imposes debarment and other penalties for illegal acts involving abbreviated drug applications.
Prescription Drug User Fee Act requires drug and biologics manufacturers to pay fees for product applications and supplements, and other services. The act also requires FDA to use these funds to hire more reviewers to assess applications.
Mammography Quality Standards Act requires all mammography facilities in the United States to be accredited and federally certified as meeting quality standards effective Oct. 1, 1994. After initial certification, facilities must pass annual inspections by federal or state inspectors.
Nutrition facts, basic per-serving nutritional information, are required on foods under the Nutrition Labeling and Education Act of 1990. Based on the latest public health recommendations, FDA and the Food Safety and Inspection Service of the Department of Agriculture recreate the food label to list the most important nutrients in an easy-to-follow format.
A consolidation of several adverse reaction reporting systems is launched as MedWatch, designed for voluntary reporting of problems associated with medical products to be filed with FDA by health professionals.
Revising a policy from 1977 that excluded women of childbearing potential from early drug studies, FDA issues guidelines calling for improved assessments of medication responses as a function of gender. Companies are encouraged to include patients of both sexes in their investigations of drugs and to analyze any gender-specific phenomena.
Dietary Supplement Health and Education Act establishes specific labeling requirements, provides a regulatory framework, and authorizes FDA to promulgate good manufacturing practice regulations for dietary supplements. This act defines "dietary supplements" and "dietary ingredients" and classifies them as food. The act also establishes a commission to recommend how to regulate claims.
FDA announces it could consider regulating nicotine in cigarettes as a drug, in response to a Citizen's Petition by the Coalition on Smoking OR Health.
Uruguay Round Agreements Act extends the patent terms of U.S. drugs from 17 to 20 years.
Animal Medicinal Drug Use Clarification Act allows veterinarians to prescribe extra-label use of veterinary drugs for animals under specific circumstances. In addition, the legislation allows licensed veterinarians to prescribe human drugs for use in animals under certain conditions.
FDA declares cigarettes to be "drug delivery devices." Restrictions are proposed on marketing and sales to reduce smoking by young people.
A series of proposed reforms to reduce regulatory burden on pharmaceutical manufacturers is announced, including an expansion of allowable promotional material on approved uses of drugs that firms can distribute to health professionals, streamlining certain elements in the documentation of investigational drug studies, and a reduction in both environmental impact filings and pre-approval requirements in tablet manufacture.
Federal Tea Tasters Repeal Act repeals the Tea Importation Act of 1897 to eliminate the Board of Tea Experts and user fees for FDA's testing of all imported tea. Tea itself is still regulated by FDA.
Saccharin Notice Repeal Act repeals the saccharin notice requirements.
Animal Drug Availability Act adds flexibility to animal drug approval process, providing for flexible labeling and more direct communication between drug sponsors and FDA.
Food Quality Protection Act amends the Food, Drug, and Cosmetic Act, eliminating application of the Delaney proviso to pesticides.
Food and Drug Administration Modernization Act reauthorizes the Prescription Drug User Fee Act of 1992 and mandates the most wide-ranging reforms in agency practices since 1938. Provisions include measures to accelerate review of devices, regulate advertising of unapproved uses of approved drugs and devices, and regulate health claims for foods.
FDA promulgates the Pediatric Rule, a regulation that requires manufacturers of selected new and extant drug and biological products to conduct studies to assess their safety and efficacy in children.
Mammography Quality Standards Reauthorization Act continues 1992 Act until 2002.
First phase to consolidate FDA laboratories nationwide from 19 facilities to 9 by 2014 includes dedication of the first of five new regional laboratories.
ClinicalTrials.gov is founded to provide the public with updated information on enrollment in federally and privately supported clinical research, thereby expanding patient access to studies of promising therapies.
A final rule mandates that all over-the-counter drug labels must contain data in a standardized format. These drug facts are designed to provide the patient with easy-to-find information, analogous to the nutrition facts label for foods.
The U. S. Supreme Court, upholding an earlier decision in Food and Drug Administration v. Brown & Williamson Tobacco Corp. et al., ruled 5-4 that FDA does not have authority to regulate tobacco as a drug. Within weeks of this ruling, FDA revokes its final rule, issued in 1996, that restricted the sale and distribution of cigarettes and smokeless tobacco products to children and adolescents, and that determined that cigarettes and smokeless tobacco products are combination products consisting of a drug (nicotine) and device components intended to deliver nicotine to the body.
Federal agencies are required to issue guidelines to maximize the quality, objectivity, utility, and integrity of the information they generate, and to provide a mechanism whereby those affected can secure correction of information that does not meet these guidelines, under the Data Quality Act.
Publication of a rule on dietary supplements defines the type of statement that can be labeled regarding the effect of supplements on the structure or function of the body.
The Best Pharmaceuticals for Children Act improves safety and efficacy of patented and off-patent medicines for children. It continues the exclusivity provisions for pediatric drugs as mandated under the Food and Drug Administration Modernization Act of 1997, in which market exclusivity of a drug is extended by six months, and in exchange the manufacturer carries out studies of the effects of drugs when taken by children. The provisions both clarify aspects of the exclusivity period and amend procedures for generic drug approval in cases when pediatric guidelines are added to the labeling.
In the wake of the events of September 11, 2001, the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 is designed to improve the country's ability to prevent and respond to public health emergencies, and provisions include a requirement that FDA issue regulations to enhance controls over imported and domestically produced commodities it regulates.
Under the Medical Device User Fee and Modernization Act, fees are assessed sponsors of medical device applications for evaluation, provisions are established for device establishment inspections by accredited third-parties, and new requirements emerge for reprocessed single-use devices.
The Office of Combination Products is formed within the Office of the Commissioner, as mandated under the Medical Device User Fee and Modernization Act, to oversee review of products that fall into multiple jurisdictions within FDA.
An effort to enhance and update the regulation of manufacturing processes and end-product quality of animal and human drugs and biological medicines is announced, the current good manufacturing practice (cGMP) initiative. The goals of the initiative are to focus on the greatest risks to public health in manufacturing procedures, to ensure that process and product quality standards do not impede innovation, and to apply a consistent approach to these issues across FDA.
The Medicare Prescription Drug Improvement and Modernization Act requires, among other elements, that a study be made of how current and emerging technologies can be utilized to make essential information about prescription drugs available to the blind and visually impaired.
To help consumers choose heart-healthy foods, the Department of Health and Human Services announces that FDA will require food labels to include trans fat content, the first substantive change to the nutrition facts panel on foods since the label was changed in 1993.
An obesity working group is established by the Commissioner of Food and Drugs, charged to develop an action plan to deal with the nation's obesity epidemic from the perspective of FDA. In March 2004 the group releases "Calories Count: Report of the Obesity Working Group," which addresses issues connected to the food label, obesity therapeutics, research needs, the role of education, and other topics.
The National Academy of Sciences releases "Scientific Criteria to Ensure Safe Food," a report commissioned by FDA and the Department of Agriculture, which buttresses the value of the Hazard Analysis and Critical Control Point (HACCP) approach to food safety already in place at FDA and invokes the need for continued efforts to make food safety a vital part of our overall public health mission.
The Animal Drug User Fee Act permits FDA to collect subsidies for the review of certain animal drug applications from sponsors, analogous to laws passed for the evaluation of other products FDA regulates, ensuring the safety and effectiveness of drugs for animals and the safety of animals used as foodstuffs.
FDA is given clear authority under the Pediatric Research Equity Act to require that sponsors conduct clinical research into pediatric applications for new drugs and biological products.
Project BioShield Act of 2004 authorizes FDA to expedite its review procedures to enable rapid distribution of treatments as countermeasures to chemical, biological, and nuclear agents that may be used in a terrorist attack against the U. S., among other provisions.
Passage of the Food Allergy Labeling and Consumer Protection Act requires the labeling of any food that contains a protein derived from any one of the following foods that, as a group, account for the vast majority of food allergies: peanuts, soybeans, cow's milk, eggs, fish, crustacean shellfish, tree nuts, and wheat.
A ban on over-the-counter steroid precursors, increased penalties for making, selling, or possessing illegal steroids precursors, and funds for preventive education to children are features of the Anabolic Steroid Control Act of 2004.
FDA publishes "Innovation or Stagnation? -- Challenge and Opportunity on the Critical Path to New Medical Products," which examines the critical path needed to bring therapeutic products to fruition, and how FDA can collaborate in the process, from laboratory to production to end use, to make medical breakthroughs available to those in need as quickly as possible.
Based on recent results from controlled clinical studies indicating that Cox-2 selective agents may be connected to an elevated risk of serious cardiovascular events, including heart attack and stroke, FDA issues a public health advisory urging health professionals to limit the use of these drugs.
To provide for the treatment of animal species other than cattle, horses, swine, chickens, turkeys, dogs, and cats, as well as other species that may be added at a later time, the Minor Use and Minor Species Animal Health Act is passed to encourage the development of treatments for species that would otherwise attract little interest in the development of veterinary therapies.
Deeming such products to present an unreasonable risk of harm, FDA bans dietary supplements containing ephedrine alkaloids based on an increasing number of adverse events linked to these products and the known pharmacology of these alkaloids.
Formation of the Drug Safety Board is announced, consisting of FDA staff and representatives from the National Institutes of Health and the Veterans Administration. The Board will advise the Director, Center for Drug Evaluation and Research, FDA, on drug safety issues and work with the agency in communicating safety information to health professionals and patients.
President Obama signs the Family Smoking Prevention and Tobacco Control Act into law. The Tobacco Control Act gives FDA authority to regulate the manufacture, distribution, and marketing of tobacco products to protect public health.
FDA Center for Tobacco Products established.
FDA announced a ban on cigarettes with flavors characterizing fruit, candy, or clove.
FDA Food Safety and Modernization Act (FSMA). FSMA provides FDA with new enforcement authorities related to food safety standards, gives FDA tools to hold imported foods to the same standards as domestic foods, and directs FDA to build an integrated national food safety system in partnership with state and local authorities.
Food and Drug Administration Safety and Innovation Act (FDASIA). Expands FDA authorities to collect user fees from industry to fund reviews of innovator drugs, medical devices, generic drugs and biosimilar biological products promotes innovation to speed patient access to safe and effective products increases stakeholder involvement in FDA processes, and enhances the safety of the drug supply chain.
Medical Device User Fee and Modernization Act (MDUFMA III). As part of FDASIA, reauthorizes user fees from industry to fund reviews of medical devices in exchange for FDA to meet certain performance goals.
In 2012, an outbreak of fungal meningitis linked to a contaminated compounded drug product resulted in the loss of 64 lives and caused more than 751 illnesses. In response, Congress enacted the 2013 Drug Quality and Security Act (DQSA) that insures greater regulatory oversight of facilities creating compounded drugs.
Pandemic and All-Hazards Preparedness Reauthorization Act (PAHPRA). Establishes and reauthorizes certain programs under the Public Health Service Act and the Food, Drug, and Cosmetic Act with respect to public health security and all-hazards preparedness and response.