United States · United States Congress · 26 October 2015
Nullifies the Environmental Protection Agency's rule published on October 23, 2015, that establishes new source performance standards under the Clean Air Act for carbon dioxide emissions from fossil fuel-fired electric utility generating units (EGUs) if the EGUs are newly constructed, modified, or reconstructed. (Those EGUs convert fossil fuel energy to electric energy.)
United States · United States Congress · 22 October 2015
Broadband Conduit Deployment Act of 2015 This bill directs the Department of Transportation (DOT) to require states to evaluate the need for broadband conduit (fiber optic cables that support broadband or wireless facilities for broadband service) as part of any covered highway construction project (a project to construct a new highway or an additional lane or paved shoulder for an existing highway that receives funding under federal-aid highway provisions), in consultation with telecommunications providers. If the evaluation reveals a need in the next 15 years for broadband conduit beneath hard surfaces to be constructed by the project, the conduit shall be installed. DOT shall establish standards to carry out installation requirements that consider: the ability to accommodate broadband installation without impacting the safety, operations, and maintenance of the highway facility, its users, or others; population density in the area; the type of highway involved; and existing broadband access in the area. DOT shall ensure that: an appropriate number of broadband conduits are installed along such highway to accommodate multiple broadband providers, the size of conduit is consistent with industry best practices and sufficient to accommodate potential demand, hand holes and manholes for fiber access and pulling such conduit are placed at intervals consistent with industry best practices, installed conduit includes a pull tape and is capable of supporting fiber optic cable placement techniques consistent with industry best practices, installed conduit is placed at a depth consistent with industry best practices and cable separation requirements of electrical codes, and any requesting broadband provider has access to each broadband conduit installed on a competitively neutral and nondiscriminatory basis for a charge not to exceed a cost-based rate. DOT may waive the requirements of this Act upon determining that the waiver is appropriate based upon: a showing of undue burden, a determination that the installation of conduit beneath hard surfaces is not necessary based on the availability of existing broadband infrastructure, or a cost-benefit analysis.
United States · United States Congress · 30 September 2015
Positive Train Control Enforcement and Implementation Act of 2015 This bill extends deadlines and modifies requirements for railroad carriers and providers of intercity or commuter rail passenger transportation to implement positive train control (PTC) systems. (A PTC system is a communications and signaling system designed to prevent train-to-train collisions, over-speed derailments, incursions into established work zone limits, and the movement of a train through a switch left in the wrong position. Railroads which carry passengers or have high-volume freight traffic with certain hazardous materials are required to implement a PTC system.) Within 60 days of enactment of this bill, each Class I railroad carrier (the largest operators by revenue) and provider of intercity or commuter rail passenger transportation must submit to the Department of Transportation (DOT) a plan for implementing PTC by December 31, 2018, instead of the December 31, 2015, deadline required under current law. DOT may extend the deadline if specified requirements are met. The revised plan must include a detailed schedule and sequence for fully implementing PTC in a manner that complies with specified regulations, and railroads must implement PTC in accordance with the plan. DOT may authorize a railroad carrier or other entity to begin the provisional operation of a PTC system without the required certification if it is necessary to enable the safe implementation of PTC in phases.
United States · United States Congress · 18 September 2015
Refugee Resettlement Oversight and Security Act of 2015 This bill amends the Immigration and Nationality Act to require the President, after appropriate consultation with certain congressional committees, to recommend to Congress the number of refugees who may be admitted into the United States in a fiscal year. Except in the case of an unforeseen emergency refugee situation, no refugees may be admitted in a fiscal year until Congress enacts a joint resolution setting the number of refugees who may be admitted in that fiscal year. In determining an alien's admissibility on security and related grounds the Department of Homeland Security shall consult with the Director of National Intelligence and the Federal Bureau of Investigation. Beginning in FY2016 and ending in FY2020, the President, when considering the admission of refugees who are nationals or citizens of Iraq or Syria, shall give priority to members of a persecuted religious minority. The Government Accountability Office shall report to Congress on the effectiveness of the refugee screening process in protecting U.S. security.
United States · United States Congress · 17 September 2015
No Exemptions for EPA Act of 2015 This bill removes the government's discretionary function exemption from tort claims in connection with a response under the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA), thereby allowing claims against the Environmental Protection Agency for damages caused by its response at a hazardous waste cleanup site under CERCLA.
United States · United States Congress · 17 September 2015
Reinvigorating Antibiotic and Diagnostic Innovation Act of 2015 This bill amends the Internal Revenue Code to allow tax credits for 50% of the clinical testing expenses for: (1) infectious disease products that are intended to treat a serious or life-threatening infection, including one caused by an antibacterial or antifungal resistant pathogen or a qualifying pathogen listed by the Department of Health and Human Services as having the potential to pose a serious threat to public health; and (2) in-vitro diagnostic devices that identify in less than four hours the presence, concentration, or characteristics of a serious or life-threatening infection.
United States · United States Congress · 15 September 2015
Born-Alive Abortion Survivors Protection Act This bill amends the federal criminal code to require any health care practitioner who is present when a child is born alive following an abortion or attempted abortion to: (1) exercise the same degree of care as reasonably provided to any other child born alive at the same gestational age, and (2) ensure that such child is immediately admitted to a hospital. The term "born alive" means the complete expulsion or extraction from his or her mother, at any stage of development, who after such expulsion or extraction breathes or has a beating heart, pulsation of the umbilical cord, or definite movement of voluntary muscles, regardless of whether the umbilical cord has been cut. Also, a health care practitioner or other employee who has knowledge of a failure to comply with these requirements must immediately report such failure to an appropriate law enforcement agency. An individual who violates the provisions of this Act is subject to a criminal fine, up to five years in prison, or both. An individual who commits an overt act that kills a child born alive is subject to criminal prosecution for murder. The legislation bars the criminal prosecution of a mother of a child born alive for conspiracy to violate the provisions of this Act, for being an accessory after the fact, or for concealment of felony. A woman who undergoes an abortion or attempted abortion may file a civil action for damages against an individual who violates this Act.
United States · United States Congress · 9 September 2015
Protecting Local Business Opportunity Act T his bill amends the National Labor Relations Act to allow two or more employers to be considered joint employers for purposes of the Act only if each shares and exercises control over essential terms and conditions of employment and such control over these matters is actual, direct, and immediate.
United States · United States Congress · 9 September 2015
Justice for Victims of Iranian Terrorism Act This bill prohibits the President from waiving, suspending, reducing, providing relief from, or otherwise limiting the application of sanctions against Iran under any provision of law, or refraining from applying sanctions pursuant to requirements under the Atomic Energy Act of 1954 (as amended by the Iran Nuclear Agreement Review Act of 2015) for any nuclear agreement with Iran, until the President has certified to Congress that Iran has paid each judgment: that was brought against it, or against it and any other country; for which Iran was not immune from the jurisdiction of U.S. courts under specified terrorism exceptions to immunity under the judicial code; and that was entered during the period March 4, 2000-May 22, 2015.
United States · United States Congress · 29 July 2015
Prohibiting the Life-Ending Industry of Fetal Organ Exchange Act or the Pro-LIFE Act This bill amends the Public Health Service Act to prohibit the transfer of fetal tissue in exchange for valuable consideration, including payments associated with the transportation, implantation, processing, preservation, quality control, or storage of human fetal tissue.
United States · United States Congress · 29 July 2015
Strengthening Public Health Emergency Response Act of 2015 This bill amends the Public Health Service Act to require the program to enhance community and hospital preparedness for public health emergencies to use at least 97% of its funding for awards. The Government Accountability Office must report on programs for public health emergency preparedness. The Department of Health and Human Services (HHS) must ensure procedures are in place to coordinate the ongoing stockpiling of countermeasures (certain medical supplies) by the Biomedical Advanced Research and Development Authority (BARDA) and Centers for Disease Control and Prevention. Procurement of countermeasures using the Biodefense Countermeasures appropriations account no longer requires Presidential approval or an agreement between HHS and the Department of Homeland Security (DHS). BARDA is given direct contracting authority. The annual countermeasures plan developed by the Office of the Assistant Secretary for Preparedness and Response must report on the amount of time between a BARDA request and the award of a contract. This bill amends the Federal Food, Drug, and Cosmetic Act to add diseases and other agents that are determined to be a material threat by DHS to the list of tropical diseases under the priority review voucher program, which awards a voucher to the sponsor of a new drug or biological product that is approved to prevent or treat a listed disease. (A voucher entitles the holder to have a future new drug or biological product application acted upon by the Food and Drug Administration within six months.)
United States · United States Congress · 28 July 2015
This bill authorizes the Department of Veterans Affairs (VA) to convey to the Danville Area Community College of Danville, Illinois, all right, title, and interest of the United States in and to certain real property, including improvements, known as Building Number 48, which is part of the VA Illiana Health Care System. As consideration for such conveyance the College shall convey to the United States all right, title, and interest in and to certain real property, including improvements, near the College Library Building.
United States · United States Congress · 27 July 2015
Expresses the sense of the House of Representatives that: (1) the July 16, 2015, attack upon members of the Armed Forces at the Navy Operational Support Center and Marine Corps Reserve Center and the Armed Forces Career Center in Chattanooga, Tennessee, meets the criteria for the award of the Purple Heart, and (2) the Secretary of the Navy should award the Purple Heart to the members of the Marine Corps and Navy who were killed or wounded in the attack.
United States · United States Congress · 27 July 2015
Timothy Nugent Congressional Gold Medal Act This bill directs the Speaker of the House of Representatives and the President pro tempore of the Senate to make arrangements for the presentation, on behalf of the Congress, of a gold medal of appropriate design to Timothy Nugent, in recognition of his pioneering work on behalf of people with disabilities, including disabled veterans.
United States · United States Congress · 23 July 2015
Honors the working-class families of Illinois who lost their lives as a result of the Eastland shipwreck disaster. Recognizes the brave first responders, both volunteers and professionals, for their rapid response in their community's time of need. Reaffirms the importance of intelligent maritime safety policy.
United States · United States Congress · 21 July 2015
This bill exempts broadcast television stations from the Federal Communications Commission's (FCC's) amended joint sales agreement (JSA) rules if the stations were parties to a JSA that was in effect on the effective date of the amendment adopted by the FCC on March 31, 2014. Under the FCC's amended rule, a television station that sells more than 15% of the weekly advertising time of another station in the same market is attributed an ownership interest subject to ownership limitations. The bill exempts stations from being considered in violation of such ownership limitations by reason of the amended rule if they were a party to an existing JSA that was in effect on the effective date of the amendment.
United States · United States Congress · 21 July 2015
Securing Military Personnel Response Firearm Initiative Act or SEMPER FI Act This bill directs the Secretary concerned to authorize an eligible member of the Armed Forces assigned to an Armed Forces recruitment center to carry a service-issue sidearm as a personal- or force-protection measure while on duty at the recruiting center, notwithstanding any federal, state, or local law or Department of Defense policy to the contrary. In lieu of authorizing eligible members of the Armed Forces to carry a service-issue sidearm, or in addition, the Secretary concerned may implement additional security measures for Armed Forces recruitment centers, including improved structural security measures. This Act shall not be interpreted to grant any member of the Armed Forces the authority to conduct civilian law enforcement functions within U.S. territory.
United States · United States Congress · 16 July 2015
National Disaster Tax Relief Act of 2015 Amends the Internal Revenue Code to provide tax relief for disasters declared in 2012, 2013, 2014, and 2015 by: allowing an election to expense qualified disaster expenses (i.e., for the abatement of hazardous substances, removal of debris, demolition, and repair of business-related property); increasing the tax deduction for charitable contributions for disaster relief for individual and corporate taxpayers; allowing through 2015 the deduction of losses and net operating losses attributable to disasters; allowing waivers of requirements relating to mortgage revenue bonds; extending through 2015 the additional allowance for depreciation of business property (bonus depreciation); allowing an increase through 2015 of the new markets tax credit limitation amount within a federally-declared disaster area; permitting the use of tax-exempt retirement plan funds in federally-declared disasters without penalty; allowing an additional tax exemption for individuals who are displaced as a result of a federally-declared disaster; allowing an exclusion from gross income of imputed income from the cancellation of indebtedness resulting from federally-declared disasters; providing a special rule to allow individuals affected by a disaster in 2012, 2013, 2014, or 2015 to claim a full earned income tax credit; increasing the rehabilitation tax credit for buildings affected by a federally-declared disaster; permitting one additional advance refunding of a tax-exempt bond that is outstanding on the date on which a federally-declared disaster occurs; allowing the issuance of qualified disaster area recovery bonds; allowing an additional allocation of the low-income housing tax credit in 2016 to states affected by a federally-declared disaster occurring in 2012, 2013, 2014, or 2015; allowing payments of disaster assistance to tax-exempt mutual ditch or irrigation companies without affecting their tax-exempt status; allowing an exclusion from gross income for disaster mitigation payments received from state and local governments; allowing a tax deduction for payments to a tax-exempt natural disaster fund; allowing a five-year replacement period for property located in a disaster area for purposes of the exclusion of gain from an involuntary conversion; allowing employers a business-related tax credit for up to 40% of wages paid to employees in a disaster area; and allowing an enhanced tax deduction for medical expenses related to an injury occurring in a disaster area.
United States · United States Congress · 16 July 2015
Expresses disapproval of the Joint Comprehensive Plan of Action agreed to by the P5+1 and Iran on July 14, 2015. Reaffirms the commitment of the House of Representatives to: (1) prevent Iran from ever acquiring a nuclear weapons capability, and (2) encourage global stability and security by strongly supporting strategic regional allies.
United States · United States Congress · 9 July 2015
Merchant Marine of World War II Congressional Gold Medal Act This bill requires the Speaker of the House of Representatives and the President pro tempore of the Senate to arrange for the award, on behalf of Congress, of a single gold medal to the U.S. Merchant Marine of World War II, in recognition of their dedicated and vital service during World War II.
United States · United States Congress · 8 July 2015
Thirteenth Amendment Commemorative Coin Act Directs the Department of the Treasury to mint and issue the following coins in commemoration of the sesquicentennial anniversary of the passage of the Thirteenth Amendment to the Constitution: up to 250,000 $50 bi-metallic platinum and gold coins, up to 250,000 $20 gold coins, and up to 500,000 $1 silver coins. Requires such coins to be considered legal tender and numismatic items. Permits Treasury to issue such coins only during the one-year period beginning January 1 of the issuance year, except that sales may be initiated, without issuance, before such date. Requires specified surcharges that Treasury receives from the sale of such coins to be paid to the Smithsonian National Museum of African American History and Culture. Directs Treasury to ensure that: (1) the minting and issuing of such coins will not result in any net cost to the U.S. government; and (2) no funds, including applicable surcharges, are disbursed to the Museum until the total cost of designing and issuing all such coins is recovered by the Treasury.
United States · United States Congress · 25 June 2015
Small Business Healthcare Relief Act This bill amends the Internal Revenue Code and the Employee Retirement Income Security Act of 1974 (ERISA) to allow an employer with fewer than 50 employees that does not offer group health insurance coverage to establish a health reimbursement arrangement. Under the arrangement, funds contributed by an employer are excluded from the employer's taxable income and are used to pay or reimburse employees for medical care expenses, including premiums for individual health insurance coverage or Medicare supplemental insurance. Such a reimbursement arrangement: (1) must not pay premiums for an employee covered by a family member's coverage, (2) must be offered to all eligible employees on the same terms and may only vary based on the number of individuals covered, and (3) is not required to provide continuation coverage. Employer contributions to a reimbursement arrangement are not included in an employee's gross income if the employee was covered by the reimbursement arrangement for more than nine months of the year. Employees covered for less than nine months have a percentage of employer contributions included in their gross income, with exceptions. An employee offered affordable individual health insurance coverage under a reimbursement arrangement is not eligible for a premium assistance tax credit. Employers must report contributions to a reimbursement arrangement on their employees' W-2. This bill amends the Public Health Service Act to exempt reimbursement arrangements from requirements for health insurance coverage. Insurance offered under a reimbursement arrangement remains subject to the requirements.
United States · United States Congress · 25 June 2015
Craft Beverage Modernization and Tax Reform Act of 2015 Amends the Internal Revenue Code to: allow taxpayers who are liable for not more than $50,000 per year in excise taxes on distilled spirits, wine, or beer to file and pay such taxes quarterly without the requirement of posting a bond covering the operations and withdrawals of such distilled spirits, wines, or beer; allow such taxpayers who reasonably expect to have a tax liability of not more than $1,000 per year and who were liable for not more than $1,000 in taxes in the preceding calendar year to file and pay such taxes annually rather than quarterly; exclude the aging period from the production period for beer, wine, or distilled spirits for purposes of determining whether a taxpayer can expense, rather than capitalize, interest costs paid or incurred during the production period; reduce excise tax rates on beer, wine, and distilled spirits produced in the United States; permit the transfer of beer between bonded facilities without payment of tax; modify the definition of "hard cider" for excise tax purposes; and exempt home distillery establishments that produce distilled spirits solely for personal or family use from excise tax and bonding requirements. Directs the Department of the Treasury to amend applicable Treasury regulations with respect to the use of wholesome products suitable for human consumption in the production of fermented beverages. Amends the Balanced Budget and Emergency Deficit Control Act of 1985 to establish funding levels in FY2016-FY2021 for the enforcement and compliance activities of the Alcohol and Tobacco Tax and Trade Bureau.
United States · United States Congress · 24 June 2015
Abraham Lincoln National Heritage Area Amendment Act This bill amends the Consolidated Natural Resources Act of 2008 to add Livingston County, the city of Jonesboro in Union County, and the city of Freeport in Stephenson County in Illinois to the Abraham Lincoln National Heritage Area.
United States · United States Congress · 17 June 2015
Furthering Access to Stroke Telemedicine Act or the FAST Act This bill amends title XVIII (Medicare) of the Social Security Act to: (1) expand access to certain stroke telehealth services to any originating site at which the eligible telehealth individual is located at the time the service is furnished, regardless of where the site is located; and (2) waive the facility fee for certain such originating sites.
United States · United States Congress · 12 June 2015
Mental Health Access Improvement Act of 2015 Amends title XVIII (Medicare) of the Social Security Act to cover marriage and family therapist services and mental health counselor services under Medicare part B (Supplementary Medical Insurance), particularly those provided in rural health clinics, federally qualified health centers, and in hospice programs. Amends Medicare part E (Miscellaneous) to exclude such services from the skilled nursing facility prospective payment system. Authorizes marriage and family therapists and mental health counselors to develop discharge plans for post-hospital services.
United States · United States Congress · 10 June 2015
Apollo 11 50th Anniversary Commemorative Coin Act This bill directs the Department of the Treasury to mint and issue gold, silver, half-dollar clad, and proof silver coins in recognition and celebration of the 50th anniversary of the first manned landing on the moon. Treasury may issue coins minted under this Act for only a one-year period, beginning January 1, 2019. All sales of coins minted under this Act shall include a surcharge of $35 per gold coin, $10 per silver coin, $5 per half-dollar clad coin, and $50 per proof silver coin. All of the surcharges received from the sale of such coins shall be paid as follows: one-half to the Smithsonian Institution's National Air and Space Museum's "Destination Moon" exhibit; one-quarter to the Astronauts Memorial Foundation; and one-quarter to the Astronaut Scholarship Foundation, to aid its missions by providing college scholarships for the very best and brightest students pursuing degrees in science, technology, engineering, or mathematics (STEM).
United States · United States Congress · 10 June 2015
Breast Cancer Awareness Commemorative Coin Act This bill directs the Department of the Treasury to mint and issue up to 50,000 $5 gold coins, 400,000 $1 silver coins, and 750,000 half-dollar clad coins emblematic of the fight against breast cancer. The Treasury shall: select the design for the coins based upon the winning design from a juried, compensated design competition following certain specifications; and issue the coins only during the one-year period beginning on January 1, 2018. All such coin sales must include the following surcharges: $35 per $5 gold coin, $10 per $1 dollar silver coin, and $5 per half-dollar coin. The Treasury shall pay received surcharges promptly to the Susan G. Komen for the Cure and the Breast Cancer Research Foundation according to a specified distribution formula.
United States · United States Congress · 4 June 2015
Helping Families in Mental Health Crisis Act of 2015 This bill creates the position of Assistant Secretary for Mental Health and Substance Use Disorders to take over the responsibilities of the Administrator of the Substance Abuse and Mental Health Services Administration (SAMHSA). Mental health programs are extended and training regarding mental health is expanded. SAMHSA must establish the National Mental Health Policy Laboratory and the Interagency Serious Mental Illness Coordinating Committee. This bill amends the Public Health Service Act to require the National Institute of Mental Health to translate evidence-based interventions and the best available science into systems of care. Certain mental health care professional volunteers are provided liability protection. Pediatric mental health subspecialists are eligible for National Health Service Corps programs. An underserved population of children or a site for training in child psychiatry can be designated as a health professional shortage area. The protected health information of an individual with a serious mental illness may be disclosed to a caregiver under certain conditions. This bill amends title XIX (Medicaid) of the Social Security Act (SSAct) to conditionally expand coverage of mental health services. Part D (Voluntary Prescription Drug Benefit Program) of title XVIII (Medicare) of the SSAct is amended to require coverage of antidepressants and antipsychotics. If it will not increase Medicare spending, Medicare's 190-day lifetime limit on inpatient psychiatric hospital services is eliminated. Health information technology activities and incentives are expanded to include certain mental health and substance abuse professionals and facilities. This bill restricts the lobbying and counseling activities of protection and advocacy systems for individuals with mental illness. These systems must focus on safeguarding the rights of individuals with mental illness to be free from abuse and neglect.
United States · United States Congress · 4 June 2015
No Rate Regulation of Broadband Internet Access Ac t Prohibits the Federal Communications Commission from regulating the rates charged for broadband Internet access service.
United States · United States Congress · 3 June 2015
Antibiotic Development to Advance Patient Treatment Act This bill amends the Federal Food, Drug, and Cosmetic Act to allow the Food and Drug Administration (FDA) to agree with the sponsor of an applicable medication on a process for approving the medication for use in a limited population of patients. Applicable medications are antibacterial or antifungal drugs or biological products for the treatment of a serious infection. The FDA may rely on alternate study endpoints, limited data sets, and additional data, including preclinical evidence, in approving such a medication. A medication approved for use in a limited population must be labeled accordingly. The Public Health Service Act is amended to require the Department of Health and Human Services to monitor the use of antibacterial and antifungal medications and monitor antibacterial and antifungal resistance. (An individual infected by a strain of bacteria or fungi that is resistant to a medication cannot be treated with that medication. Resistance can develop naturally with the use of a medication.) The FDA must identify and publish susceptibility test interpretive criteria for antimicrobial medications. (These criteria are used to characterize the resistance of microbes to antimicrobial medications. "Microbes" or "microorganisms" include bacteria, some fungi, and other organisms.) Every six months, the FDA must evaluate any new or updated susceptibility test interpretive criteria established by a standard development organization and recognize new criteria or withdraw recognition of criteria, as appropriate. The FDA may allow marketing of medical devices that use these criteria without premarket approval.
United States · United States Congress · 1 June 2015
Accelerating Innovation in Medicine Act of 2015 or the AIM Act of 2015 Amends title XVIII (Medicare) of the Social Security Act to direct the Department of Health and Human Services (HHS) to develop an accelerating innovation in medicine (AIM) list of medical devices for which, because of their inclusion on the list, insurance benefits and payments are prohibited under Medicare (either directly or on a capitated basis), with the result that no Medicare claim may be submitted and an individual who consents to receive such a device is responsible for paying for it and for any related services. Directs the Secretary to post on a public HHS website or other publicly accessible media an updated list of the medical devices on the AIM list.
United States · United States Congress · 26 May 2015
TSCA Modernization Act of 2015 This bill amends the Toxic Substances Control Act (TSCA) to revise regulations on chemicals. TSCA's scope is revised by requiring the Environmental Protection Agency (EPA) to regulate chemicals so that they no longer present unreasonable risks of injury to health or environment instead of requiring the EPA to provide adequate protection against those risks using the least burdensome requirements. The EPA must conduct and publish a risk evaluation for a chemical if: (1) the EPA determines it may present an unreasonable risk of injury to health or the environment, or (2) a manufacturer of a chemical requests an evaluation. The EPA must initiate 10 or more risk evaluations in each fiscal year. The EPA is authorized to require testing on a chemical when it is necessary to conduct an evaluation. If an evaluation determines a chemical will pose an unreasonable risk, the EPA must issue a risk management rule for the chemical. The bill establishes deadlines for conducting and publishing evaluations as well deadlines for publishing risk management rules. The EPA may grant exemptions from risk management requirements for a specific use of a chemical if: (1) the requirement is not cost-effective with respect to that use; and (2) the specific use is a critical or essential use, or the requirement would significantly disrupt the national economy, national security, or critical infrastructure. The EPA must: (1) publish a list of certain persistent, bioaccumulative, and toxic (PBT) chemicals; (2) designate certain chemicals as PBT chemicals of concern; and (3) promulgate rules with respect to those designated PBTs to reduce likely exposure to the extent practicable. This bill revises requirements concerning the disclosure of confidential business information, preemption of state law, fees to defray the cost of administering TSCA, and scientific standards and evidence.
United States · United States Congress · 21 May 2015
Voluntary Protection Program Act This bill provides statutory authority for the Occupational Safety and Health Administration's (OSHA's) voluntary protection program, under which management, labor, and OSHA establish cooperative relationships at workplaces that have implemented a comprehensive safety and health management system.
United States · United States Congress · 21 May 2015
American Trade Enforcement Effectiveness Act This bill amends the Tariff Act of 1930 with respect to the administration and enforcement of antidumping (AD) and countervailing duty (CVD) orders. Neither the administering authority (the Secretary of Commerce, or another U.S. officer given the responsibility by law) nor the U.S. International Trade Commission (USITC), as the case may be, is required to determine, or make any adjustments to, a countervailable subsidy rate or weighted average dumping margin based on any assumptions about information the interested party would have provided if it had complied with a request for information. The USITC shall not determine that there is no material injury or threat of material injury to a domestic industry from imports merely because that industry is profitable or its performance has recently improved. This bill includes gross profits, operating profits, net profits, and ability to service debt among the relevant economic factors the USITC must evaluate in examining the impact of imports of merchandise on a domestic industry in material injury determinations. The administering authority may use another calculation methodology than the ordinary one in determining the constructed value of subject merchandise being imported at less than fair value if a particular market situation exists where the cost of materials and fabrication or other processing of any kind does not accurately reflect the cost production in the ordinary course of trade. This bill revises requirements regarding administering authority determinations as to whether there are reasonable grounds to believe or suspect that a foreign like product is being sold at less than cost of production in AD investigations or reviews. The administering authority in making its determinations, however, shall request information necessary to calculate the constructed value and cost of production of subject merchandise in such investigations or reviews. The administering authority, in valuing the factors of production to determine the normal value of merchandise exported from a nonmarket economy country, may disregard price or cost values without further investigation if it determines that broadly available export subsidies existed or instances of subsidization occurred with respect to those price or cost values or if they were subject to an AD order. Certain factors are specified for the administering authority to consider when deciding whether it would be unduly burdensome in CVD or AD investigations and reviews to examine voluntary responses from exporters or producers which are not the subjects of the investigation or review.
United States · United States Congress · 21 May 2015
Hero Street USA Commemorative Coin Act This bill directs the Department of the Treasury to mint and issue coins emblematic of Hero Street (in Silvis, Illinois) in the following amounts in commemoration of the semi-centennial of the naming of Hero Street: (1) 50,000 $5 gold coins, (2) 400,000 $1 silver coins, and (3) 750,000 half-dollar clad coins. Coins may be issued only between January 1 and December 31, 2018. There must be surcharges of: (1) $35 per coin for the $5 coin, (2) $10 per coin for the $1 coin, and (3) $5 per coin for the half-dollar coin, all to be paid to implement the Wounded Warrior Project. The Treasury must act to ensure that coin minting and issuance do not result in any net cost to the federal government.
United States · United States Congress · 19 May 2015
This bill amends the Federal Food, Drug, and Cosmetic Act to expand the humanitarian device exemption to authorize the Food and Drug Administration (FDA) to exempt from effectiveness requirements certain medical devices intended to benefit fewer than 8,000 individuals. Currently, the FDA may exempt devices intended to benefit fewer than 4,000 individuals. Within 18 months of enactment of this Act, the FDA must define “probable benefit” for these devices.
United States · United States Congress · 19 May 2015
This bill amends the Federal Food, Drug, and Cosmetic Act to require the Food and Drug Administration (FDA) to provide an opportunity for a person whose premarket submission for a medical device is subject to review by a classification panel to provide recommendations on the expertise needed among the members of the panel. The FDA must consider these recommendations and ensure that panels include at least two members with expertise clinically relevant to the device and at least one member who is knowledgeable about the technology of the device. The person whose device is under review may designate a representative (who may be accompanied by experts) to participate in panel meetings.
United States · United States Congress · 19 May 2015
This bill amends the Federal Food, Drug, and Cosmetic Act to require the Food and Drug Administration (FDA), not later than 120 days after enactment of the 21st Century Cures Act (H.R. 6, a bill introduced on May 19, 2015), to identify types of class I medical devices (devices that do not need special controls to assure their safety and effectiveness) for which a report is no longer needed prior to marketing to provide reasonable assurance of safety and effectiveness. (Currently, a report is needed for a class I device only if the device is of substantial importance in preventing impairment of human health or if it presents a potential unreasonable risk of illness or injury.) Not later than 180 days after enactment of the 21st Century Cures Act, the FDA must publish a list of types of class II medical devices (devices that need special controls to assure their safety and effectiveness) for which a report is no longer needed prior to marketing to provide reasonable assurance of safety and effectiveness. (Currently, such a list must be published each time the FDA exempts a type of class II device from the reporting requirement.) The public comment period for such an exemption is extended to 60 days.
United States · United States Congress · 19 May 2015
This bill amends the Federal Food, Drug, and Cosmetic Act to allow a person to request that the Food and Drug Administration (FDA) recognize all or part of a performance standard established by a nationally or internationally recognized standard organization as a standard to which a medical device may conform in order to meet an FDA requirement. When a request to recognize a standard is received, the FDA must determine whether to recognize all, part, or none of the standard and publish the rationale for that determination. (Currently, the FDA recognizes certain performance standards, but it is not required to respond to requests or publish rationales for recognizing standards.) The FDA must: (1) publish the rationale for recognizing only part of a standard, (2) periodically train employees who review premarket submissions for medical devices on the concept and use of recognized standards for purposes of meeting requirements, and (3) publish its principles for recognizing standards.
United States · United States Congress · 19 May 2015
This bill amends the Federal Food, Drug, and Cosmetic Act to require Food and Drug Administration (FDA) employees involved in reviewing premarket submissions of medical devices to receive training regarding the "least burdensome appropriate means" concept. (Currently, the FDA must consider evaluating medical devices by the least burdensome appropriate means that would have a reasonable likelihood of resulting in approval.) The ombudsman for the FDA unit responsible for the premarket review of devices must audit this training and include in the audit interviews with persons from industry regarding their experience in the device premarket review process. When the FDA requests additional information about a medical device that is required to have premarket approval, it must consider the least burdensome appropriate means necessary for an applicant to demonstrate the safety and effectiveness of the device.
United States · United States Congress · 19 May 2015
This bill amends the Federal Food, Drug, and Cosmetic Act to define “valid scientific evidence” to include well-documented case histories or studies published in peer-reviewed journals for purposes of the Food and Drug Administration (FDA) determining the effectiveness of a medical device without clinical investigation. Under specified conditions, the FDA may request the data underlying a study that is offered as valid scientific evidence.
United States · United States Congress · 19 May 2015
This bill amends the Federal Food, Drug, and Cosmetic Act to require the Food and Drug Administration (FDA) to establish a third-party quality system assessment program to accredit persons to assess whether a medical device manufacturer's quality system can ensure the safety and effectiveness of an approved medical device after certain changes, including changes in manufacturing or changes to enhance device safety. Device manufacturers are allowed to make changes to a device without submitting to the FDA the 30-day notice required for manufacturing changes or a premarket approval supplement if their quality system has been certified by an accredited person. An accredited person who assesses a device manufacturer's quality system must submit a summary of their assessment and, as appropriate, a certification to the FDA within 30 days of the assessment. An assessment summary and certification is deemed accepted by the FDA 30 days after submission unless the FDA determines that additional information is needed to support certification, the assessment or certification is unwarranted, or an action other than acceptance of the certification is otherwise justified. Periodic reports by device manufacturers must describe any changes made to a device without submission of the 30-day notice or the premarket approval supplement. Certifications accepted by the FDA remain in effect for two years. The FDA must report on this quality system assessment program no later than January 31, 2022. The program is terminated at the end of FY2022.
United States · United States Congress · 19 May 2015
21st Century Cures Act This bill amends the Public Health Service Act to reauthorize the National Institutes of Health (NIH) through FY2018. The NIH Innovation Fund is established to fund a strategic plan, early stage investigators, and high-risk, high-reward research. The NIH may require scientific data to be shared if the research is fully funded by the NIH. The NIH and the Food and Drug Administration (FDA) must implement a system that allows further research on clinical trial data. The Centers for Disease Control and Prevention must expand surveillance of neurological diseases. The Council for 21st Century Cures is established to accelerate the discovery, development, and delivery of innovative cures, treatments, and preventive measures. The Department of Health and Human Services must monitor the use of antibacterial and antifungal drugs and resistance to these drugs. Requirements are established for interoperability and certification of health information technology. Practices that discourage the exchange of electronic health information are prohibited. This bill amends the Federal Food, Drug, and Cosmetic Act to revise the drug approval process, including by: (1) allowing patient experience data to be considered in the risk-benefit assessment of a new drug, (2) requiring the FDA to qualify drug development tools, (3) allowing the FDA to rely upon data previously submitted for a different purpose to expedite the development of certain drugs, and (4) establishing a streamlined data review program for approval of a drug for an additional indication. Manufacturers and distributors of investigational drugs for serious conditions must publish their policies on compassionate use requests. The marketing exclusivity period is extended by six months for a drug approved for a new indication that is a rare disease or condition. The priority review voucher program for rare pediatric diseases is revised and extended. The FDA must: (1) establish a program for priority review of breakthrough medical devices, (2) identify types of devices that do not require a report preceding introduction, and (3) rely on a third-party to determine the safety and effectiveness of changes to medical devices. Regarding medical devices, this bill defines “valid scientific evidence” and makes changes to classification panels and the humanitarian device exemption. “Health software” is defined and, with certain exceptions, exempted from FDA regulations. This bill amends title XVIII (Medicare) of the Social Security Act to require the Centers for Medicare & Medicaid Services (CMS) to: (1) increase certain payments for new antimicrobial drugs, (2) establish a payment methodology for certain medical devices, and (3) publish online estimated payments for certain outpatient items and services. A pharmaceutical and technology ombudsman within the CMS must respond to complaints from manufacturers of medical products. Medicare prescription drug plan sponsors may limit the access of certain beneficiaries to frequently abused drugs. This bill amends the Controlled Substances Import and Export Act to allow exported controlled substances to be re-exported within the European Economic Area.
United States · United States Congress · 18 May 2015
Treat and Reduce Obesity Act of 2015 Amends title XVIII (Medicare) of the Social Security Act to authorize the Department of Health and Human Services (HHS), in addition to qualified primary care physicians and other primary care practitioners, to cover intensive behavioral therapy for obesity furnished by: (1) a physician who is not a qualified primary care physician; (2) an evidence-based, community-based HHS-approved lifestyle counseling program; or (3) any other appropriate health care provider (including a physician assistant, nurse practitioner, clinical nurse specialist, a clinical psychologist, and a registered dietitian or nutrition professional). Allows coverage of intensive behavioral therapy for obesity furnished by another appropriate health care provider or program only if it is furnished: (1) upon referral from, and in coordination with, a physician or primary care practitioner in a primary care or other HHS-specified setting; and (2) in an office setting, a hospital outpatient department, a community-based site that complies with the federal regulations concerning the privacy of individually identifiable health information, or another HHS-specified setting. Authorizes HHS to cover under Medicare part D (Voluntary Prescription Drug Benefit Program) medication for treatment of obesity or for weight loss management for an overweight individual with one or more related comorbidities.
United States · United States Congress · 14 May 2015
Physical Therapist Workforce and Patient Access Act of 2015 Amends the Public Health Service Act to include physical therapy within the definition of "primary health services" for purposes of the National Health Service Corps. Makes physical therapists eligible for repayment of their educational loans in order to ensure an adequate supply of physical therapists.
United States · United States Congress · 13 May 2015
Preventing Animal Cruelty and Torture (PACT) Act Amends the federal criminal code to prohibit intentionally engaging in animal crushing in or affecting interstate or foreign commerce or within the special maritime and territorial jurisdiction of the United States. (Current law prohibits knowingly creating or distributing an animal crush video.) Adds exceptions for conduct that is for predator or pest control, medical or scientific research, or necessary to protect the life or property of a person from a serious threat caused by an animal.
United States · United States Congress · 30 April 2015
Ghost Army Congressional Gold Medal Act This bill directs the Speaker of the House of Representatives and the President pro tempore of the Senate to award a Congressional Gold Medal to the 23rd Headquarters Special Troops, known collectively as the "Ghost Army," in recognition of its service during World War II. The bill expresses the sense of Congress that the Smithsonian Institution should make the medal available for display elsewhere, particularly at appropriate locations associated with the Ghost Army, and that preference should be given to locations affiliated with the Smithsonian.
![Official portrait of Rep. Shimkus, John [R-IL-15]](https://www.congress.gov/img/member/s000364_200.jpg)