Energy and Commerce

Committee on Energy and Commerce

Greg Walden

Legislation Addressing Pipeline and Hydropower Infrastructure Modernization

2017/05/03

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Combating Waste, Fraud, and Abuse in Medicaid’s Personal Care Services Program

2017/05/02

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Examining Improvements to the Regulation of Medical Technologies

2017/05/02

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HHS Secretary Price: Administration is Committed to Fighting the Opioid Crisis

2017/04/29

WASHINGTON, DC – As HHS Secretary Tom Price, M.D. settles into his new role, he’s making it clear that fighting the opioid epidemic is a top priority for the Trump administration. As Secretary Price explained in the Cincinnati Enquirer earlier this week, “[o]pioid addiction is so deadly, so virulent, that we need the very best, most advanced treatments possible to confront it.” While the administration’s opioid commission conducts its review, Secretary Price is already hitting the ground running. Following HHS’ release of the first round of state grants as part of the 21st Century Cures Act to combat the opioid epidemic, he visited a drug manufacturer in Ohio and held a listening session about the crisis. “The Trump administration is committed to bringing everything we have to this fight,” wrote Secretary Price. In addition to the state grants within Cures, Energy and Commerce Committee investigations also led to legislative solutions that ultimately were included in the Comprehensive Addiction and Recovery Act (CARA). The committee continues to look at all aspects of the opioid epidemic, most recently holding a hearing examining the federal government's response to fentanyl, a synthetic opioid that is 50 times more potent than heroin and 100 times more potent than morphine. [[{"fid":"2596","view_mode":"full","fields":{"format":"full","field_file_image_alt_text[und][0][value]":false,"field_file_image_title_text[und][0][value]":false},"type":"media","field_deltas":{"1":{"format":"full","field_file_image_alt_text[und][0][value]":false,"field_file_image_title_text[und][0][value]":false}},"link_text":null,"attributes":{"class":"media-element file-full","data-delta":"1"}}]] April 27, 2017 How the Trump administration is fighting the opioid epidemic By HHS Secretary Tom Price, M.D. One of the most exciting lines of work we get to support at the U.S. Department of Health and Human Services is the development of new drugs to combat deadly diseases. America’s scientists are constantly pushing the boundaries of what is possible, solving or ameliorating conditions we once thought incurable. So it is both heartening and heartbreaking that one of our top priorities in that work is now fighting a disease that is largely of our own making: opioid addiction. Opioid addiction is so deadly, so virulent, that we need the very best, most advanced treatments possible to confront it. Sometimes that means new drugs that can help people on their path to recovery, often derived from research performed at the National Institutes of Health or supported by federal grants across the country. Sometimes that means easier access to existing drugs that treat addiction. On Wednesday, to begin a national listening tour about the opioid crisis, I visited the Alkermes manufacturing plant in Wilmington, where they produce one such drug. Most Ohioans need no reminder of how devastating this epidemic is, and how important it is to have an aggressive response. Consider that Clinton County, home to the Alkermes plant, lost 48 men over the course of four years in World War II. It has lost 71 residents to overdoses since 2010. Nationally, we’re losing as many Americans to overdoses every year as we did in the entire Vietnam War. States have done an admirable job responding to this crisis. Ohio has taken the lead on monitoring opioid prescriptions and overdoses and improving access to overdose-reversing drugs, through a program called Project DAWN (Deaths Avoided With Naloxone). Kentucky has been hit hard by the opioid epidemic, too, and they have also responded with groundbreaking public health programs. Local governments and civil-society groups – everything from sheriffs’ departments to faith-based recovery houses – are fighting hard against this crisis as well. It is crucial for the federal government to support this local work. The Trump administration is committed to bringing everything we have to this fight. In just the first 100 days of this administration, we have taken several major steps to combat the epidemic. First, in March, President Trump announced his Commission on Combating Drug Addiction and the Opioid Crisis, which will assess what the federal government is doing to fight the crisis, what is working, and what we can be doing better. Then, last week, the administration announced $485 million worth of grants to states and territories for the express purpose of supporting access to addiction treatment, with $26 million of that headed to Ohio. Next year, the administration will distribute a second round of funding. Traveling the country to places like Ohio will help inform both next year’s grant decisions and the findings of the president’s commission. Last week, HHS also announced a comprehensive five-point strategy for combating the opioid epidemic. One of our priorities is cutting-edge research, supported by the National Institutes of Health and especially the National Institute on Drug Abuse, to unlock new knowledge about addiction and develop new treatments. Second, we have to expand access to treatment and recovery services. Sometimes that means grants like the ones announced last week from the Substance Abuse and Mental Health Services Administration, but it also means empowering doctors to get patients the treatments they need without undue government burdens. Third, we need better public health surveillance and data-gathering, because we cannot beat an epidemic we do not understand. Grants and technical assistance from the Centers for Disease Control and Prevention have already helped Kentucky and Ohio improve their understanding of the scourge within their borders. Fourth, we need to support the lifesaving work states have done to provide access to overdose-reversing drugs. Fifth, and closest to my heart as a physician, is figuring out the right way to treat pain for the millions of Americans who suffer from it. Our country consumes a vastly disproportionate share of the world’s opioid painkillers. Far too many opioids have been prescribed without an adequate understanding of whether they are effective and how addictive they can be. HHS is committed to reviewing all of the important work the department does – in payments for programs like Medicare and Medicaid, prescribing guidelines we issue, and more – to ensure that we are treating pain in ways that work. Scientists and pharmaceutical researchers are also contributing to this effort, by coming up with new ways to treat pain without risking addiction. The scourge of addiction across our land is a health crisis and the Trump administration is committed to treating it. Every Ohioan – from the researcher in Columbus to the pastor in Cleveland – and every American has a part to play. This administration stands ready to support them. To read the column online, click here. ### Read More

DIGITAL RECAP: #Path2Portrait Edition

2017/04/28

WASHINGTON, DC – Thursday was a big day at the Energy & Commerce Committee, as former Chairman, Rep. Fred Upton (R-MI), had his official portrait unveiled during a special ceremony in the hearing room. The room was packed with family, friends, and colleagues from across the aisle, and country – each of whom played a special role in helping Rep. Upton achieve major legislative accomplishments.   During his six years ­­as Chairman, Rep. Upton’s bipartisan #RecordOfSuccess included 562 hearings, 354 E&C bills and provisions that passed through the House, and 202 E&C bills and provisions that became law. SGR repeal, TSCA, 21st Century Cures, comprehensive opioid legislation, mental health reform, and pipeline safety are just a few of the multi-year, multi-Congress efforts that define Rep. Upton’s legacy as chairman.   The official portrait showed Rep. Upton, gavel in hand, with his signature “jacket-over-the-shoulder.” Take a look below for a quick recap of the special event!   For more updates on the committee’s activities, be sure to follow us on our Facebook, Twitter and Instagram pages.  [[{"fid":"2587","view_mode":"teaser","fields":{"format":"teaser","field_file_image_alt_text[und][0][value]":false,"field_file_image_title_text[und][0][value]":false},"type":"media","field_deltas":{"2":{"format":"teaser","field_file_image_alt_text[und][0][value]":false,"field_file_image_title_text[und][0][value]":false}},"link_text":null,"attributes":{"class":"media-element file-teaser","data-delta":"2"}}]] Rep. Diana DeGette (D-CO) and Rep. Fred Upton share a moment before the portrait unveiling. This dynamic duo led the game-changing 21st Century Cures Act, which included landmark mental health reform and critical resources to fight the opioid epidemic.  [[{"fid":"2595","view_mode":"teaser","fields":{"format":"teaser","field_file_image_alt_text[und][0][value]":false,"field_file_image_title_text[und][0][value]":false},"type":"media","field_deltas":{"10":{"format":"teaser","field_file_image_alt_text[und][0][value]":false,"field_file_image_title_text[und][0][value]":false}},"link_text":null,"attributes":{"class":"media-element file-teaser","data-delta":"10"}}]] Speaker of the House, Paul D. Ryan (R-WI), shares his thanks and appreciation for Rep. Upton’s work during his time as chairman as his wife, Amey, and son, Stephen, beam with pride. [[{"fid":"2589","view_mode":"teaser","fields":{"format":"teaser","field_file_image_alt_text[und][0][value]":false,"field_file_image_title_text[und][0][value]":false},"type":"media","field_deltas":{"4":{"format":"teaser","field_file_image_alt_text[und][0][value]":false,"field_file_image_title_text[und][0][value]":false}},"link_text":null,"attributes":{"class":"media-element file-teaser","data-delta":"4"}}]] Rep. Steny Hoyer (D-MD) shakes hands with Rep. Upton after relaying, “You’re not just my ‘Republican friend.’ You’re my friend.” [[{"fid":"2590","view_mode":"teaser","fields":{"format":"teaser","field_file_image_alt_text[und][0][value]":false,"field_file_image_title_text[und][0][value]":false},"type":"media","field_deltas":{"5":{"format":"teaser","field_file_image_alt_text[und][0][value]":false,"field_file_image_title_text[und][0][value]":false}},"link_text":null,"attributes":{"class":"media-element file-teaser","data-delta":"5"}}]] Sen. Lamar Alexander (R-TN) was one of Rep. Upton’s biggest advocates and one of 21st Century Cures’ champions. Both leaders were relentless in their efforts to ensure that 21st Century Cures made it across the finish line. Current Chairman Greg Walden (R-OR), and longtime friend of Rep. Upton, emceed the event. [[{"fid":"2591","view_mode":"teaser","fields":{"format":"teaser","field_file_image_alt_text[und][0][value]":false,"field_file_image_title_text[und][0][value]":false},"type":"media","field_deltas":{"6":{"format":"teaser","field_file_image_alt_text[und][0][value]":false,"field_file_image_title_text[und][0][value]":false}},"link_text":null,"attributes":{"class":"media-element file-teaser","data-delta":"6"}}]] Majority Leader Kevin McCarthy (R-CA) jokes with Rep. Upton about his old-school, and ever-popular, Maui Jim sunglasses.   [[{"fid":"2592","view_mode":"teaser","fields":{"format":"teaser","field_file_image_alt_text[und][0][value]":false,"field_file_image_title_text[und][0][value]":false},"type":"media","field_deltas":{"7":{"format":"teaser","field_file_image_alt_text[und][0][value]":false,"field_file_image_title_text[und][0][value]":false}},"link_text":null,"attributes":{"class":"media-element file-teaser","data-delta":"7"}}]] After special guests finish speaking, Rep. Upton takes the mic with his family to express gratitude for the support and encouragement during his time as chairman.  [[{"fid":"2593","view_mode":"teaser","fields":{"format":"teaser","field_file_image_alt_text[und][0][value]":false,"field_file_image_title_text[und][0][value]":false},"type":"media","field_deltas":{"8":{"format":"teaser","field_file_image_alt_text[und][0][value]":false,"field_file_image_title_text[und][0][value]":false}},"link_text":null,"attributes":{"class":"media-element file-teaser","data-delta":"8"}}]] Stephen pulls the cord to unveil the new portrait that will hang in the green and gold committee hearing room as Rep. Upton and Amey eagerly wait.  [[{"fid":"2594","view_mode":"teaser","fields":{"format":"teaser","field_file_image_alt_text[und][0][value]":false,"field_file_image_title_text[und][0][value]":false},"type":"media","field_deltas":{"9":{"format":"teaser","field_file_image_alt_text[und][0][value]":false,"field_file_image_title_text[und][0][value]":false}},"link_text":null,"attributes":{"class":"media-element file-teaser","data-delta":"9"}}]] Congratulations, Chairman Upton. You sure do have a lot to be proud of.  Read More

#SubDCCP Discusses Great Potential of the Outdoor Recreation Industry

2017/04/27

[[{"fid":"2580","view_mode":"default","fields":{"format":"default","field_file_image_alt_text[und][0][value]":false,"field_file_image_title_text[und][0][value]":false},"type":"media","field_deltas":{"1":{"format":"default","field_file_image_alt_text[und][0][value]":false,"field_file_image_title_text[und][0][value]":false}},"link_text":null,"attributes":{"class":"media-element file-default","data-delta":"1"}}]] WASHINGTON, DC – The Subcommittee on Digital Commerce and Consumer Protection, chaired by Rep. Bob Latta (R-OH), today held a hearing to discuss the benefits of the outdoor recreation industry and explore how it is driving economic growth, creating millions of jobs, and generating investment opportunities in communities across the country. Opening up the hearing, Chairman Latta discussed the contributions to our economy from the increasing popularity and growth of the outdoor recreation sector, citing that “Americans spend $887 billion in outdoor recreation annually helping create 7.6 million jobs and generate almost $125 billion in federal, state and local revenue.”    A common theme throughout the hearing was the far reaching effects that the outdoor recreation industry has on jobs, and its specific trickle-down effect in rural communities. Amy Roberts, Executive Director of the Outdoor Industry Association, relayed, “More American workers are employed by outdoor recreation than by computer technology, construction, finance or insurance.” She added, “From park rangers to land planners, outdoor recreation provides jobs across the skill spectrum. These jobs are predominantly based in rural communities, strengthening local economies.” Touching on another facet of the outdoor recreation industry was Ginger Mihalik, the Executive Director for Baltimore Chesapeake Bay Outward Bound School. While many know of Outward Bound for its work with underserved youth, it also does extensive work with veterans. Outward Bound’s wilderness program model for veterans “helps to increase mental health, interpersonal relations, resilience, [and] sense of purpose” for many veterans after returning home from serving overseas. Mihalik explained how outdoor activities like kayaking, sailing, and hiking help veterans to “overcome shared obstacles and achieve shared goals in a non-combative wilderness setting.” [[{"fid":"2581","view_mode":"default","fields":{"format":"default","field_file_image_alt_text[und][0][value]":false,"field_file_image_title_text[und][0][value]":false},"type":"media","field_deltas":{"2":{"format":"default","field_file_image_alt_text[und][0][value]":false,"field_file_image_title_text[und][0][value]":false}},"link_text":null,"attributes":{"class":"media-element file-default","data-delta":"2"}}]] Rep. Latta welcomes witnesses to today's hearing. The Recreation Vehicle (RV) industry is another sector of the outdoor recreation industry that is, according to James Landers, Vice President of Government Affairs at the Recreation Vehicle Industry Association, “creating jobs faster than we can fill them.” While it contributes “$50 billion annually to the U.S. economy,” Landers also presented some of the challenges that the RV industry is experiencing. “RV-associated stays within National Park Service campgrounds have declined from nearly 4.5 million overnights …to less than 2 million overnight stays.” Landers believes much of this has to do with the fact that “many campgrounds operated by federal agencies were constructed half a century ago and no longer meet the needs of the current and next generations of RVers.” Jeffrey Tooze, Vice President of Global Customs & Trade at Columbia Sportswear Company also presented testimony about some of the barriers their company faces in the marketplace and challenges specific to the outdoor apparel industry. “…[T]he U.S. assess among the highest import tariffs on our categories of apparel, footware, and accessories, making them more expensive for U.S. consumers than they would otherwise need to be.” He goes on to iterate that these high tariffs “[hamper] our ability to keep our prices within the reach of the broadest consumer base possible.” Touting the committee’s work in the outdoor recreation space was Marc Berejka, Director of Government & Community Affairs and REI Corporation, stating that the bill will assist in “mov[ing] economic development along even faster.” Berejka also spoke to the “spillover benefits” the outdoor recreation industry has on other sectors of our economy like materials science, advanced manufacturing and other high-tech fields. For more information on today’s hearing, including a background memo, witness testimony, and archived webcast, click HERE.     Read More

Outdoor Recreation: Vast Impact of the Great Outdoors

2017/04/27

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#SubEnergy to Examine 10 Energy Infrastructure Bills NEXT WEEK

2017/04/26

WASHINGTON, DC – The Subcommittee on Energy, chaired by Rep. Fred Upton (R-MI), today announced a hearing for Wednesday, May 3, 2017, at 10 a.m. in room 2123 of the Rayburn House Office Building. The hearing is entitled, “Legislation Addressing Pipeline and Hydropower Infrastructure Modernization.” Members of #SubEnergy will examine 10 bills to promote and modernize the nation’s hydropower and pipeline infrastructure. The bills under review were informed through testimony received at previous hearings before the Energy and Commerce Committee. In May, the subcommittee reviewed the federal licensing process and recommendations to improve coordination between government agencies, promote new infrastructure, and ensure consumers have access to reliable and affordable electricity generated from hydropower. In February, the subcommittee examined the state of America’s evolving energy infrastructure and barriers to innovation, modernization, and further job creation and economic growth. Discussion Draft, “Hydropower Policy Modernization Act of 2017” Discussion Draft, “Promoting Hydropower Development at Existing Non-Powered Dams Act” Discussion Draft, “Promoting Closed Loop Pumped Storage Hydropower Act”  Discussion Draft, “Promoting Small Conduit Hydropower Facilities Act of 2017” H.R. 1538, “Supporting Home Owners Rights Enforcement Act” H.R. 446, “To extend the deadline for commencement of construction of a hydroelectric project” H.R. 447, “To extend the deadline for commencement of construction of a hydroelectric project” H.R. 2122, “To reinstate and extend the deadline for commencement of construction of a hydroelectric project” Discussion Draft, “Promoting Interagency Coordination for Review of Natural Gas Pipelines Act”    Discussion Draft, “Promoting Cross-Border Energy Infrastructure Act”   “As our nation’s energy portfolio and production continues to change and expand, so too should our nation’s energy infrastructure,” said Chairman Upton. “Next week’s hearing provides us an opportunity to continue our work to modernize our energy infrastructure and improve siting, permitting, and coordination between government agencies in an effort to further innovation, job creation, and economic growth.” The Majority Memorandum, witness list, and witness testimony will be available here as they are posted. ###  Read More

#SubEnvironment Examines Legislation Related to the Nation’s Nuclear Waste Management

2017/04/26

WASHINGTON, DC – The Subcommittee on Environment, chaired by Rep. John Shimkus (R-IL), today held a hearing examining a discussion draft of legislation related to the nation’s nuclear waste management. H.R.___, the Nuclear Waste Policy Amendments Act of 2017, provides practical reforms to the nation’s nuclear waste management policy to ensure the federal government’s obligations to dispose used nuclear fuel and high-level waste can be fulfilled. The discussion draft builds on the committee’s previous work as it relates to ensuring a comprehensive solution for the nation’s nuclear waste management policy. In the 114th Congress, the Subcommittee on Environment and the economy held seven hearings to inform its efforts to draft legislation. Representative Joe Wilson (R-SC), discussed the ongoing storage problems states face due to the delay in getting Yucca Mountain across the finish line, “Today, there are currently 121 communities across 39 states that are grappling with the limitations of storing nuclear waste while our country lacks a permanent geological repository. Communities of my home state of South Carolina, in the Chairman’s state of Illinois, the Ranking Member’s state of New York – in the home states of the majority of members of the committee all store nuclear material. Each of the 121 communities has been forced to store nuclear waste while they wait for the federal government to honor its promise by providing interim storage at Yucca Mountain.”  Edward Sproat, former Director of the Office of Civilian Radioactive Waste Management at the Department of Energy, outlined the three things that need to happen to ensure the proper disposal of nuclear waste, stating, “In order for the Country to move forward with the permanent disposal of its high-level radioactive waste and spent nuclear fuel, it needs three things: 1) a licensed place to put it, 2) the ability to move it from around the Country to that site, and 3) an organization that is adequately funded and has the requisite authorities so that it can be held accountable for the cost and schedule of executing the program in accordance with the law.” Anthony O’Donnell, Chairman of the Nuclear Issues Subcommittee at the Nation Association of Regulatory Utility Commissioners, discussed his support for the discussion draft, testifying, “The federal government missed the statutory deadline to start accepting nuclear waste in 1998. In 2002, the project site – Yucca Mountain, was approved by Congress, but since then efforts to block funding to complete the Yucca Mountain license review, in tandem with the U.S. Department of Energy’s illegal refusal to pursue the license application at the NRC, stymied progress. … We welcome the “Discussion Draft” released last week as a very positive step forward to correct unanticipated, but serious, structure flaws in the nation’s nuclear waste disposal policy framework.” Mark McManus, General President of the United Association Union of Plumbers, Pipefitters, Welders and Service Techs of the United States and Canada, noted findings concerning the safety of Yucca Mountain, stating, “Yucca Mountain is in a remote section of the Mojave Desert and the secure storage facility is located 1,000 feet underground. A study released by the Nuclear Regulatory Commission in 2014 concluded that the design met all the agency’s requirements. They stated,  the ‘proposed repository as designed will be capable of safely isolating used nuclear fuel and high-level radioactive waste for the 1-million-year period specified in the regulations.’” Steven Nesbit, Chairman of the Backend Working Group at the Nuclear Infrastructure Council, echoed O’Donnell’s support, commenting, “The discussion draft of the Nuclear Waste Policy Amendments Act of 2017 would make important and desirable changes to the country’s framework for waste management. … Congress should appropriate funding to the DOE and the NRC to restart the Yucca Mountain licensing process.” [[{"fid":"2577","view_mode":"default","fields":{"format":"default","field_file_image_alt_text[und][0][value]":false,"field_file_image_title_text[und][0][value]":false},"type":"media","field_deltas":{"1":{"format":"default","field_file_image_alt_text[und][0][value]":false,"field_file_image_title_text[und][0][value]":false}},"link_text":null,"attributes":{"class":"media-element file-default","data-delta":"1"}}]] Chairman Walden delivers his opening statement “Along with 33 other states, Oregon ratepayers fulfilled their financial obligations under the law and paid the Department of Energy over $160 million to dispose of commercial spent nuclear fuel,” said full committee Chairman Greg Walden (R-OR). “The costs to the American taxpayer to pay for the federal government’s delay in opening the Yucca Mountain repository have nearly doubled to $30 billion since 2009 and that figure continues to escalate. The time to fix this problem is now and today’s hearing began the process of providing a path forward.”  [[{"fid":"2578","view_mode":"default","fields":{"format":"default","field_file_image_alt_text[und][0][value]":false,"field_file_image_title_text[und][0][value]":false},"type":"media","field_deltas":{"2":{"format":"default","field_file_image_alt_text[und][0][value]":false,"field_file_image_title_text[und][0][value]":false}},"link_text":null,"attributes":{"class":"media-element file-default","data-delta":"2"}}]] #SubEnvironment Chairman Shimkus listens to witness opening statements “The committee has heard from scores of expert witnesses over the past six years about challenges and opportunities to advance our nation’s nuclear waste management policy. This discussion draft reflects what we learned through those hearings, oversight activities and related work. However, it is just that: a discussion draft. And today we began the process of taking input from all stakeholders involved on this draft. Our goal here is to identify the right reforms to ensure we can fulfill the government’s obligation to dispose of our nation’s nuclear material,” concluded #SubEnvironment Chairman Shimkus. For a list of the Energy and Commerce Committee’s work on nuclear waste management policy, click HERE. To read the letter sent by the committee to Energy Secretary Perry regarding nuclear waste management policy, and Secretary Perry's response, click HERE.  A background memo, witness testimony, and an archived webcast of the hearing can be found online HERE. ###  Read More

Bicameral Leaders Comment on Pai’s Internet Regulations Announcement

2017/04/26

WASHINGTON, DC – House Energy and Commerce Committee Chairman Greg Walden (R-OR), Senate Commerce, Science, and Transportation Committee Chairman John Thune (R-SD), House Communications and Technology Subcommittee Chairman Marsha Blackburn (R-TN), and Senate Communications, Technology, and the Internet Subcommittee Chairman Roger Wicker (R-MS), today issued the following statement after Federal Communications Commission (FCC) Chairman Ajit Pai issued a Notice of Proposed Rulemaking rolling back the FCC’s reclassification of broadband as a “common carrier” under Title II of the Communications Act of 1934. “We have long said that imposing a Depression-era, utility-style regulatory structure onto the internet was the wrong approach, and we applaud Chairman Pai’s efforts to roll back these misguided regulations. Consumers want an open internet that doesn’t discriminate on content and protects free speech and consumer privacy,” said Walden, Thune, Blackburn, and Wicker. “It’s now time for Republicans and Democrats, internet service providers, edge providers, and the internet community as a whole to come together and work toward a legislative solution that benefits consumers and the future of the internet.” ### Read More

H.R.___, the Nuclear Waste Policy Amendments Act of 2017

2017/04/26

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HEARING: #SubOversight to Examine Waste, Fraud, and Abuse of Medicaid’s Personal Care Services Program

2017/04/25

WASHINGTON, DC – The Subcommittee on Oversight and Investigations, chaired by Rep. Tim Murphy (R-PA), announced a hearing for Tuesday, May 2, 2017, at 10:15 a.m. in room 2322 of the Rayburn House Office Building. The hearing is entitled, “Combating Waste, Fraud, and Abuse in Medicaid’s Personal Care Services Program.” #SubOversight will examine waste, fraud, and abuse in Medicaid’s Personal Care Services (PCS) program. In recent months, both the Department of Health and Human Services (HHS) Office of Inspector General (OIG) and the Government Accountability Office (GAO) have issued reports highlighting fraud schemes, poor program integrity, and mismanagement that have harmed beneficiaries. Confirmed to testify are: Katherine Iritani, Director, Health Care, GAO Christi Grimm, Chief of Staff, HHS OIG Timothy Hill, Deputy Director of Medicaid and CHIP at CMS “These reports chronicle systemic fraud and mismanagement within an important Medicaid program that the elderly and disabled populations rely on,” said Chairman Murphy. “These concerning findings, in addition to others about the treatment of patients, must be addressed.” Click HERE to read the GAO’s November 2016 report on ways CMS could harmonize requirements across programs, and their January 2017 report on the need for better data to monitor PCS. Click HERE to read the HHS OIG’s October 2016 investigative advisory on fraud and patient harm within Medicaid’s PCS program, which builds upon OIG’s 2012 PCS Portfolio. The Majority Memorandum and witness testimony for the hearing will be available here as they are posted. ### Read More

HEARING: #SubHealth to Examine Additional Medical Device Policies

2017/04/25

WASHINGTON, DC – The Subcommittee on Health, chaired by Rep. Michael C. Burgess, M.D. (R-TX), announced a legislative hearing for Tuesday, May 2, 2017, at 10 a.m. in room 2123 of the Rayburn House Office Building. The hearing is entitled, “Examining Improvements to the Regulation of Medical Technologies.” Earlier this month, bipartisan leaders of the Energy and Commerce Committee, along with bipartisan leaders of the Senate Health, Education, Labor and Pensions (HELP) Committee, released a discussion draft of the Food and Drug Administration (FDA) Reauthorization Act of 2017, reauthorizing FDA’s user fee agreements. The draft followed hearings examining the Generic Drug User Fee Amendments (GDUFA) and the Biosimilar User Fee Act (BsUFA), the Prescription Drug User Fee Act (PDUFA), and the Medical Device User Fee Amendments (MDUFA). As part of the effort to reauthorize these agreements, #SubHealth will consider additional bills consistent with efforts to support the review and regulation of medical devices. “Medical devices play an important part in caring for and bettering the lives of patients with a variety of prognoses,” said Chairman Burgess. “As we work toward advancing the FDA Reauthorization Act of 2017, it is important we consider some additional policies that will help patients and bolster this vital reauthorization.” The Majority Memorandum, witness list, and witness testimony for the hearing will be available here as they are posted. ### Read More

ICYMI: Sec. Chao Emphasizes Administration’s Interest in Development of Self-Driving Vehicles

2017/04/25

WASHINGTON, DC – Since the start of the new Congress, the Digital Commerce and Consumer Protection Subcommittee has been leading the charge to modernize our transportation system, improve the safety of roadways, and, in turn, save thousands of American lives through its focus on self-driving cars. As discussed in a recent hearing, this technology has shown great potential to reduce crashes, protect drivers, and increase mobility for underserved populations. To witness the benefits of this technology in action, Subcommittee Chairman Bob Latta (R-OH) spent time just last week visiting Ohio’s acclaimed Transportation Resource Center – one of the country’s leading automotive research and testing grounds for autonomous vehicles. This facility specializes in testing much of the automotive technology at work in self-driving vehicles in order to determine how they perform in various environmental conditions. [[{"fid":"2569","view_mode":"default","fields":{"format":"default","field_file_image_alt_text[und][0][value]":false,"field_file_image_title_text[und][0][value]":false},"type":"media","field_deltas":{"1":{"format":"default","field_file_image_alt_text[und][0][value]":false,"field_file_image_title_text[und][0][value]":false}},"link_text":null,"attributes":{"class":"media-element file-default","data-delta":"1"}}]] Chairman Latta learns how testing is performed to maximize safety potential of autonomous vehicles. Just yesterday, Transportation Secretary Elaine Chao visited the same facility and echoed similar support for the development of self-driving cars. “It has been so impressive to view this whole facility. To see the wonderful professionals that are so dedicated to reducing highway fatalities," Sec. Chao said. Adding, “The president is very interested in autonomous vehicles, in technology of the future.” Read more about Sec. Chao’s visit and her thoughts on the benefits of self-driving technology below. [[{"fid":"2570","view_mode":"default","fields":{"format":"default","field_file_image_alt_text[und][0][value]":false,"field_file_image_title_text[und][0][value]":false},"type":"media","field_deltas":{"2":{"format":"default","field_file_image_alt_text[und][0][value]":false,"field_file_image_title_text[und][0][value]":false}},"link_text":null,"attributes":{"class":"media-element file-default","data-delta":"2"}}]] April 24, 2017 Trump administration gets look at Central Ohio car technology President Donald Trump's secretary of transportation said she was impressed with what she saw at a Logan County facility where technology is being developed that will eventually become self-driving cars. Elaine Chao toured the Transportation Research Center in East Liberty Monday. The TRC is home to a branch of the National Highway Safety Transportation Agency, which is working on safety improvements to vehicles. Chao saw two demonstrations of cars that brake automatically to avoid hitting pedestrians. The center is also a proving ground for other companies working on automotive design. The TRC recently got a $45 million investment from the state of Ohio to continue development of technology that will lead to self-driving cars. "The first autonomous vehicle will be on the highway before the last driver vehicle comes off. So really part of the challenge is how do you mix the two," said Mark-Tami Hotta, director of the TRC. Chao advanced Trump's message of job creation and infrastructure improvement in the US. She said he is keeping tabs on the development of the self-driving car. "The president is very interested in autonomous vehicles," Chao said. To read the article online, click here. Read More

Committee Members Highlight New Resources in Battle Against Opioid Addiction

2017/04/24

With the Department of Health and Human Services’ (HHS) recent release of $485 million in grants to battle the opioid epidemic, several committee members greeted the news determined to stem the tide of overdoses and deaths in their districts. “The heroin and opioid abuse crisis has hit Hoosiers and our communities hard,” said Rep. Susan Brooks (R-IN). “Thanks to the 21st Century Cures Act, Indiana is getting the resources it desperately needs to reduce overdose deaths; help Hoosiers get treatment for substance abuse and stay in recovery; and reduce the over-prescription of opioids.” In Marion County, part of Rep. Brooks’ district, EMS teams have responded to more than 500 heroin overdose calls since February 1.  In West Virginia, Rep. David McKinley (R-WV) advocated his constituents and district leaders speak out about the crisis as their state has been among the hardest hit by the addiction epidemic. "Use Facebook, use Twitter accounts, get out and become more vocal about the problems associated with drug use in America, because it's killing our kids," said Rep. McKinley. Rep. Gus Bilirakis (R-FL) echoed Rep. McKinley’s sentiments, and called on everyone in his district and across the state to band together in the fight against opioid addiction. “The opioid crisis is not only a national epidemic, it’s happening here in our local communities,” said Rep. Bilirakis. “We must take action as opioid-related deaths continue to rise across the board in Florida, regardless of race, age, income, or zip code. This critical grant will support an all-hands-on-deck approach in our state to curb opioid abuse and save lives.” The grants from HHS mark the first phase of state grants being released to combat the epidemic, as part of the landmark 21st Century Cures Act.   Read More

Committee Leaders Request Information from EPA Regarding Grant Management Process

2017/04/21

WASHINGTON, DC – House Energy and Commerce Committee Chairman Greg Walden (R-OR), Oversight and Investigations Subcommittee Chairman Tim Murphy (R-PA), and Environment Subcommittee Chairman John Shimkus (R-IL), today sent a letter to Environmental Protection Agency (EPA) Administrator Scott Pruitt seeking information regarding the process by which EPA closes out its grants. “For the past decade, investigations and reports by the Committee, Office of Inspector General, and Government Accountability Office (GAO) have uncovered waste and mismanagement in EPA’s grant programs,” write Walden, Murphy, and Shimkus. “This comes in light of a 2016 GAO report that found $994 million in expired grant accounts at the federal entities it reviewed. Because EPA was not among the agencies GAO examined, questions remain about whether EPA properly manages its grant closeouts. This is crucial given that EPA awards almost half of its budget, approximately $4 billion annually, in grants.” The members continue, “While EPA has made some improvements, recent reports continue to show the need for improved grant practices, including EPA grant money apparently spent by a subgrantee for political advocacy, a state grant recipient accumulating millions of dollars in unspent grant funds while continuing to receive additional money, and concerns that EPA could improve grant monitoring practices.” The committee requested EPA provide documents to assist in its oversight of whether or not the agency is properly closing out grants in a manner that is timely and efficient. The committee requested: Reports from EPA’s cash management systems and grant management systems of all expired grant accounts from FY 2012, FY 2013, FY 2014, and FY 2015.   All documents relating to expired grant accounts, including how long the accounts have been expired, whether an extension on the period of performance has been given, total monthly banking fees for each expired grant, and any information regarding the reason the grant was not closed out in a timely manner.   All final reports, performance reports, and progress reports submitted for each of the expired grant accounts.   A list of all grant applicants and grantees designated as high risk, including information relating to any additional monitoring conducted on high risk grantees. To read the letter online, click here. ### Read More

Letter to EPA Regarding Grant Management Process

2017/04/21

Excerpt: "For the past decade, investigations and reports by the Committee, Office of Inspector General, and Government Accountability Office (GAO) have uncovered waste and mismanagement in EPA’s grant programs. This comes in light of a 2016 GAO report that found $994 million in expired grant accounts at the federal entities it reviewed. Because EPA was not among the agencies GAO examined, questions remain about whether EPA properly manages its grant closeouts. This is crucial given that EPA awards almost half of its budget, approximately $4 billion annually, in grants." To read a copy of the letter, click here. Read More

Committee Leaders Press HHS for Status of Pandemic Influenza Plan, Amidst Global Concerns

2017/04/21

WASHINGTON, DC – Energy and Commerce Committee Chairman Greg Walden (R-OR) and Oversight and Investigations Subcommittee Chairman Tim Murphy (R-PA) sent a letter to the U.S. Department of Health and Human Services (HHS) on Thursday requesting information about the status of the department’s Pandemic Influenza Plan. During an Oversight and Investigations Subcommittee hearing in November 2015, the committee reviewed the federal public health preparedness for the seasonal flu. Subcommittee member Rep. Gene Green (D-TX) issued a question for the record following the hearing, inquiring with the Biomedical Advanced Research and Development Authority (BARDA) and HHS if our national public health response was prepared to respond to a possible pandemic. An August 2016 response to the committee reads, “HHS is reviewing the HHS Pandemic Influenza Plan (2005) and preparing a revised plan that acknowledges our progress in MCM [medical countermeasures] development and will incorporate lessons learned from the 2009 H1N1 pandemic and other influenza outbreaks. …The new HHS Pandemic Influenza Plan is slated for release in late 2016.” In the letter sent to HHS on Thursday, chairmen Walden and Murphy write, “As of the date of this letter, HHS has not yet released the Pandemic Influenza Plan. The need for the updated Pandemic Influenza Plan is vital as there is a current potential pandemic threat.” The leaders continued, “The H7N9 avian influenza virus that emerged in 2013 is suddenly spreading in China, causing 918 laboratory-confirmed human infections and 359 deaths, as of January 16, 2017, according to the World Health Organization (WHO). …The WHO Director-General warned that H7N9 is particularly worrying as it could be a flu pandemic strain.” Click HERE to read a copy of the letter. ### Read More

Letter to HHS Regarding Status of Pandemic Influenza Plan

2017/04/21

Excerpt: "As of the date of this letter, HHS has not yet released the Pandemic Influenza Plan. The need for the updated Pandemic Influenza Plan is vital as there is a current potential pandemic threat." To read a copy of the letter, click here. Read More

#SubDCCP to Explore Economic Benefits of Outdoor Recreation Industry

2017/04/20

WASHINGTON, DC – The Subcommittee on Digital Commerce and Consumer Protection, chaired by Rep. Bob Latta (R-OH), today announced a hearing for Thursday, April 27, 2017, at 10:00 a.m. in room 2123 of the Rayburn House Office Building. The hearing is entitled, “Outdoor Recreation: Vast Impact of the Great Outdoors.” Outdoor recreation is a growing and diverse industry that contributes significantly to major traditional American economic sectors.  Whether it be through purchasing products or participating in outdoor activities, American consumers drive this industry by spending billions of dollars on outdoor recreation.  Last year, Congress recognized the importance of this industry by passing the Outdoor REC Act, which ensures the outdoor recreation economy is counted as part of the U.S. GDP. Next week, members will continue exploring the many benefits of outdoor recreation and any barriers that may stifle any continued growth in this important and far reaching industry. “Outdoor recreation has become a significant catalyst for economic growth in so many communities across our country,” said Chairman Latta. “Whether Americans are hiking, fishing, or picnicking, they are spending billions each year on outdoor activities. Next week’s hearing allows our members to learn more about this industry’s economic opportunities and how the federal government is helping, or hindering, its ability to flourish. I look forward to hearing first-hand from witnesses on the ways we can support this sector’s growth and viability. The Majority Memorandum, witness list, and witness testimony for the hearing will be available here as they are posted. Read More

Upton on Release of Opioid Grants: “Help is on its way”

2017/04/20

HHS announced yesterday the first round of grants to help states and territories combat the opioid epidemic. The $485 million in grants will be administered by the Substance Abuse and Mental Health Services Administration (SAMHSA). The resources, made available through Rep. Fred Upton’s (R-MI) landmark 21st Century Cures Act, will be used toward the prevention of opioid abuse and treatment to those affected. “As part of our bipartisan 21st Century Cures Act, we fought hard to include this funding to aid in this public health crisis,” said Rep. Upton. “Now, we’re delivering. To those in the midst of this fight: Help is on its way.” [[{"fid":"2565","view_mode":"full","fields":{"format":"full","field_file_image_alt_text[und][0][value]":false,"field_file_image_title_text[und][0][value]":false},"type":"media","field_deltas":{"1":{"format":"full","field_file_image_alt_text[und][0][value]":false,"field_file_image_title_text[und][0][value]":false}},"link_text":null,"attributes":{"class":"media-element file-full","data-delta":"1"}}]] April 20, 2017 Mich. Lawmaker: Help in opioid fight on way The U.S. Department of Health and Human Services’ announced Wednesday the first round of grants to help the state and others fight opioid addition. “It seems like everyone I meet is in some way impacted by this tragic opioid epidemic,” said U.S. Rep. Fred Upton, R-St. Joseph, applauding the announcement in a statement. “These grants will directly help those in need here in southwest Michigan and across the country. I applaud the administration for getting these grants out in an expedited manner.” The federal government is providing states nearly half a billion dollars for prevention and treatment programs aimed at confronting the opioid epidemic, which Health and Human Services Secretary Tom Price described Wednesday as a “crisis.” According to HHS, Michigan was awarded $16,372,680 in the first round of grants administered by the Substance Abuse and Mental Health Services Administration. During a drug prevention summit in Atlanta on Wednesday, Price announced that HHS will soon provide $485 million in grants to all 50 states, the District of Columbia and six U.S. territories. The funding is the first of two rounds provided for in the 21st Century Cures Act, bipartisan legislation Upton was involved in that Congress approved last year and former President Barack Obama signed. The funding, which supports prevention, treatment and recovery services depending on the needs of recipients, was awarded based on rates of overdose deaths and unmet need for opioid addiction treatment, HHS officials said Wednesday. The growing dependence on opioids has mushroomed into a national health crisis, ripping apart communities and straining police and health departments. In 2015, more than 33,000 people fatally overdosed on opioids, including prescription drugs and heroin. According to the Centers for Disease Control and Prevention, no other year on record has seen a higher number. Nearly half of the deaths involved a prescription opioid. The situation has prompted some Metro Detroit officials to offer training and take other action. “As part of our bipartisan 21st Century Cures Act, we fought hard to include this funding to aid in this public health crisis,” Upton said Wednesday. “Now, we’re delivering. To those in the midst of this fight: Help is on its way.” Price said the Trump administration has a five-part strategy on opioids: improved access to treatment and recovery services; making overdose-reversing drugs more widely available; stepped-up public health surveillance of the epidemic; support for research on pain and addiction; and promoting better ways to help patients manage pain. To read the article online, click HERE. ### Read More

HHS to Issue First Round of Opioid Grants from 21st Century Cures Act

2017/04/19

WASHINGTON, DC – As part of the 21st Century Cures Act, HHS announced today the first round of grants to help states and territories combat the opioid epidemic. The $485 million in grants will be administered by the Substance Abuse and Mental Health Services Administration (SAMHSA), and be used toward the prevention of opioid abuse and treatment to those affected. “The opioid crisis has hit every community and knows no bounds. Combating the epidemic requires an all-hands-on-deck approach, and these critical dollars will play an important role in that effort,” said Energy and Commerce Committee Chairman Greg Walden (R-OR), Health Subcommittee Chairman Michael C. Burgess, M.D. (R-TX), and Oversight and Investigations Subcommittee Chairman Tim Murphy (R-PA). “American families have been devastated by this epidemic, and we're encouraged by the Trump administration’s renewed focus to tackle this crisis head-on.” The Energy and Commerce Committee has led the charge in responding to the epidemic. In addition to the state grants within the 21st Century Cures Act, committee investigations also led to legislative solutions that ultimately were included in the Comprehensive Addiction and Recovery Act (CARA). The committee continues to look at all aspects of the opioid epidemic, most recently holding a hearing examining the federal government's response to fentanyl, a synthetic opioid that is 50 times more potent than heroin and 100 times more potent than morphine. ### Read More

#SubEnvironment to Examine Legislative Discussion Draft Related to Nation’s Nuclear Waste Management

2017/04/19

WASHINGTON, DC – The Subcommittee on Environment, chaired by Rep. John Shimkus (R-IL), today announced a hearing for Wednesday, April 26, 2017, at 10 a.m. in room 2123 of the Rayburn House Office Building. The hearing is entitled, “H.R.___, the Nuclear Waste Policy Amendments Act of 2017.”   In the 114th Congress, the Subcommittee on Environment and the Economy held seven hearings and the committee sent five letters to inform the committee’s efforts as it relates to a comprehensive solution for the nation’s nuclear waste management policy. Next week, #SubEnvironment will examine H.R.___, the Nuclear Waste Policy Amendments Act of 2017, which provides practical reforms to the nation’s nuclear waste management policy to ensure the federal government’s obligations to dispose of used nuclear fuel and high-level waste can be fulfilled. The discussion draft serves to facilitate feedback from stakeholders as to how best to update our nuclear waste management policy. “We look forward to receiving feedback on this discussion draft,” said full committee Chairman Greg Walden (R-OR) and subcommittee Chairman Shimkus. “This proposal was thoughtfully developed through an extensive record of hearings and other oversight over the past six years to identify what may be needed to strengthen the Nuclear Waste Policy Act. Now it is time to get our nation’s nuclear waste management policy back on track through consideration of this legislative proposal.” For a list of the Energy and Commerce Committee’s work on nuclear waste management policy, click HERE. The Majority Memorandum, witness list, and witness testimony for the hearing will be available here as they are posted.  ###  Read More

Latta Pleased to See Process Reforms Well Underway at FTC

2017/04/17

WASHINGTON, DC – Today, the Acting Chairwoman of the Federal Trade Commission (FTC) Maureen Ohlhausen, announced six internal reform initiatives aimed at improving efficiency and promoting transparency within the agency. Digital Commerce and Consumer Protection Subcommittee Chairman Bob Latta (R-OH) issued the below statement following that announcement: "Today's process reform initiatives are great news for both consumers and businesses alike," said Chairman Latta. "Already underway, these initiatives will eliminate unnecessary regulations and improve transparency, ultimately ensuring this agency can better focus on its core mission of protecting consumers and promoting competition." "Today's announcement is just the first step to strengthening FTC’s consumer protection and providing greater certainty for businesses, fostering an environment that gives way to more innovation, and improving transparency for consumers. I commend Acting Chairwoman Ohlhausen, as she has wasted no time in implementing important reforms that that the committee has long championed." Last year, the committee was proud to put forth an FTC Process Reform package introduced by then-Subcommittee Chairman, Dr. Michael C. Burgess, M.D., HR 5510, that included a number of important reforms to the FTC. Many of these proposals are mirrored in the reforms put forth today by Acting Chairwoman Ohlhausen, including: H.R. 5097, the Start Taking Action on Lingering Liabilities (STALL) Act, authored by Rep. Susan Brooks (R-IN) - The bill would ensure that FTC investigations are conducted in an efficient manner with improved commission oversight.   H.R. 5098, the FTC Robust Elderly Protections and Organizational Requirements to Track Scams (REPORTS) Act, authored by Rep. Gus Bilirakis (R-FL) - The bill would require the FTC to give more transparency by publishing an annual plan for the upcoming year including policy priorities, plans to establish new working groups within the FTC, and other initiatives.   H.R. 5109, the Clarifying Legality and Enforcement Action Reasoning (CLEAR) Act, authored by Rep. Brett Guthrie (R-KY) - The bill would require the FTC to submit more information about its investigations to provide transparency into the legal analysis supporting the FTC’s decisions.     H.R. 5136, the Revealing Economic Conclusions for Suggestions (RECS) Act, authored by then-Rep. Mike Pompeo (R-KS) - The bill would ensure FTC receives more resources to ensure that real world economic analysis is used to support FTC recommendations and initiatives. Read More

House, Senate Health Committee Leaders Release Discussion Draft of FDA User Fees Reauthorization

2017/04/14

WASHINGTON, DC – The leaders of the Senate and House health committees today released a discussion draft of bipartisan legislation reauthorizing the Food and Drug Administration user fee agreements. The Food and Drug Administration (FDA) Reauthorization Act of 2017 renews FDA's authority to collect user fees from the makers of prescription brand drugs, medical devices, generic drugs and biosimilars, and several vital programs at the FDA. The 2012 prescription drug user fee amendments (PDUFA), medical device user fee amendments (MDUFA), generic drug user fee amendments (GDUFA), and biosimilar user fee amendments (BsUFA) all must be updated and reauthorized by Congress before the current user fee agreements expire on September 30. If the agreements are not reauthorized before the August work period, the agency will be forced to send layoff notices to more than 5,000 FDA employees. A delay in reauthorizing these agreements would delay the reviews of critical drugs and devices. “We are fully committed to a timely reauthorization of the agreements and are well on our way,” said Energy and Commerce Committee Chairman Greg Walden (R-OR). “This represents another opportunity to help expedite the review and approval of new cures and treatments for patients, and we must prioritize it. As this process proceeds, I look forward to continued discussions with my colleagues in the House on other member priorities that could strengthen this important legislation.” "The swift reauthorization of these user fee agreements is critical to making sure FDA has the resources and personnel it needs to ensure timely review and approval of safe and effective medical treatments,” said Energy and Commerce Committee Ranking Member Frank Pallone, Jr. (D-NJ). “These carefully negotiated agreements encourage innovation, improve our regulatory review process, and provide certainty to both patients and industry. I look forward to working with my colleagues to move this legislation through Congress and to the President's desk.” “If we do not move quickly to reauthorize these agreements, in late July, the FDA will be forced to begin sending layoff notices to more than 5,000 employees to notify them that they may lose their job in 60 days,” said Senate Health, Education, Labor and Pensions Committee Chairman Lamar Alexander (R-TN). “The sooner we reauthorize the agreements, the better – to give patients, reviewers, and companies certainty. In addition to harming patients and families that rely on medical innovation, a delay in reauthorizing the user fees would threaten biomedical industry jobs and America’s global leadership in biomedical innovation.” “I’m encouraged by our bipartisan work to reauthorize these agreements to advance safe, effective, and innovative medical products,” said Senate Health, Education, Labor and Pensions Committee Ranking Member Patty Murray (D-WA). “Patients and families nationwide are relying on us to ensure FDA can continue its vital work without interruption. I hope that we can continue to put partisanship aside and advance this important legislation.” The FDA Reauthorization Act of 2017: Updates and reauthorizes the user fee programs, which, in Fiscal Year 2016, accounted for 70 percent of the brand drug review budget, 36 percent of the medical device review budget, 75 percent of the generic drug review budget, and 29 percent of the biosimilar review budget. Reflects the recommendations sent by FDA to Congress in January, which were based on over a year of negotiations and discussions with industry, Congress, patients, and other stakeholders. Implements the four user fee agreements authorized by FDARA, which support the goals of the 21st Century Cures act and advance key bipartisan priorities: Prescription Drug User Fee Amendments (PDUFA VI): Enhances patient-focused drug development, supports biomarker development and qualification, dedicates staff to assist in the development and review of rare disease drugs, sets clear timelines and improves guidance for drug and device combination products, and evaluates ways to modernize the clinical trial process.   Medical Device User Fee Amendments (MDUFA IV): Enhances the patient voice in the device development process, supports the collection of real world evidence on the safety and effectiveness of devices, and improves the review process for  “de novo” devices—low- to moderate-risk devices that are the first of their kind.   Generic Drug User Fee Amendments (GDUFA II): Improves the fee structure to support small businesses, provides goal dates for all outstanding generic applications, and establishes priority review timelines.   Biosimilar User Fee Amendments (BsUFA II): Continues to build the biosimilars program, and supports guidance for product developers.  Click HERE for the text of the discussion draft, HERE for a section-by-section summary of the discussion draft, and HERE for a one-pager. Health committee leaders ask that stakeholders who wish to comment on the contents of this draft please submit to FDAuserfees2017@help.senate.gov by April 28th. ###  Read More

Walden, Upton, and Shimkus Ask POTUS to Fill Nuclear Regulatory Commission Vacancies

2017/04/12

WASHINGTON, DC – House Energy and Commerce Committee Chairman Greg Walden (R-OR), Subcommittee on Energy Chairman Fred Upton (R-MI), and Subcommittee on Environment Chairman John Shimkus (R-IL), today sent a letter to President Donald Trump requesting he fill the current and future vacancies at the Nuclear Regulatory Commission (NRC). The committee leaders write, “Absent a nomination and confirmation of additional commissioners, the Commission will lack a quorum on July 1 when Chairman Svinicki’s current term expires. This situation could severely inhibit the NRC’s ability to execute its vital responsibility and hamper the nuclear industry.” “We urge you to nominate commissioners to the NRC so the confirmation process may be completed as soon as possible and provide the NRC a full contingent of commissioners to fulfill its critical mission in overseeing and regulating the civilian use of radioactive material,” concluded Walden, Upton, and Shimkus. To read the letter online, click here. ###  Read More

Letter to President Trump Regarding Nuclear Regulatory Commission Vacancies

2017/04/12

Excerpt: “We urge you to nominate commissioners to the NRC so the confirmation process may be completed as soon as possible and provide the NRC a full contingent of commissioners to fulfill its critical mission in overseeing and regulating the civilian use of radioactive material." To read the letter online, click here.  Read More

#NPHW: Highlighting Critical Efforts to Advance Public Health

2017/04/07

[[{"fid":"2545","view_mode":"full","fields":{"format":"full","field_file_image_alt_text[und][0][value]":false,"field_file_image_title_text[und][0][value]":false},"type":"media","field_deltas":{"1":{"format":"full","field_file_image_alt_text[und][0][value]":false,"field_file_image_title_text[und][0][value]":false}},"link_text":null,"attributes":{"height":"168","width":"468","class":"media-element file-full","data-delta":"1"}}]] WASHINGTON, DC – This week paid homage to the important work of advancing the public health. From the opioid epidemic and drug overdoses to accelerating the cycle of discovering, developing, and delivering new cures and treatments, there’s been a lot to focus on for this year’s National Public Health Week (#NPHW). Here’s how some Energy & Commerce Committee members chose to spotlight the important week. 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[[{"fid":"2550","view_mode":"full","fields":{"format":"full","field_file_image_alt_text[und][0][value]":false,"field_file_image_title_text[und][0][value]":false},"type":"media","field_deltas":{"6":{"format":"full","field_file_image_alt_text[und][0][value]":false,"field_file_image_title_text[und][0][value]":false}},"link_text":null,"attributes":{"height":"647","width":"459","class":"media-element file-full","data-delta":"6"}}]] [[{"fid":"2551","view_mode":"full","fields":{"format":"full","field_file_image_alt_text[und][0][value]":false,"field_file_image_title_text[und][0][value]":false},"type":"media","field_deltas":{"7":{"format":"full","field_file_image_alt_text[und][0][value]":false,"field_file_image_title_text[und][0][value]":false}},"link_text":null,"attributes":{"height":"403","width":"468","class":"media-element file-full","data-delta":"7"}}]] [[{"fid":"2552","view_mode":"full","fields":{"format":"full","field_file_image_alt_text[und][0][value]":false,"field_file_image_title_text[und][0][value]":false},"type":"media","field_deltas":{"8":{"format":"full","field_file_image_alt_text[und][0][value]":false,"field_file_image_title_text[und][0][value]":false}},"link_text":null,"attributes":{"height":"417","width":"468","class":"media-element file-full","data-delta":"8"}}]] [[{"fid":"2553","view_mode":"full","fields":{"format":"full","field_file_image_alt_text[und][0][value]":false,"field_file_image_title_text[und][0][value]":false},"type":"media","field_deltas":{"9":{"format":"full","field_file_image_alt_text[und][0][value]":false,"field_file_image_title_text[und][0][value]":false}},"link_text":null,"attributes":{"height":"391","width":"468","class":"media-element file-full","data-delta":"9"}}]] [[{"fid":"2554","view_mode":"full","fields":{"format":"full","field_file_image_alt_text[und][0][value]":false,"field_file_image_title_text[und][0][value]":false},"type":"media","field_deltas":{"10":{"format":"full","field_file_image_alt_text[und][0][value]":false,"field_file_image_title_text[und][0][value]":false}},"link_text":null,"attributes":{"height":"541","width":"468","class":"media-element file-full","data-delta":"10"}}]] [[{"fid":"2555","view_mode":"full","fields":{"format":"full","field_file_image_alt_text[und][0][value]":false,"field_file_image_title_text[und][0][value]":false},"type":"media","field_deltas":{"11":{"format":"full","field_file_image_alt_text[und][0][value]":false,"field_file_image_title_text[und][0][value]":false}},"link_text":null,"attributes":{"height":"253","width":"468","class":"media-element file-full","data-delta":"11"}}]] [[{"fid":"2556","view_mode":"full","fields":{"format":"full","field_file_image_alt_text[und][0][value]":false,"field_file_image_title_text[und][0][value]":false},"type":"media","field_deltas":{"12":{"format":"full","field_file_image_alt_text[und][0][value]":false,"field_file_image_title_text[und][0][value]":false}},"link_text":null,"attributes":{"height":"255","width":"467","class":"media-element file-full","data-delta":"12"}}]] [[{"fid":"2557","view_mode":"full","fields":{"format":"full","field_file_image_alt_text[und][0][value]":false,"field_file_image_title_text[und][0][value]":false},"type":"media","field_deltas":{"13":{"format":"full","field_file_image_alt_text[und][0][value]":false,"field_file_image_title_text[und][0][value]":false}},"link_text":null,"attributes":{"height":"559","width":"467","class":"media-element file-full","data-delta":"13"}}]] ### Read More

Letter to FCC Chairman Ajit Pai Regarding Privacy

2017/04/07

Excerpt: “Protecting consumer privacy while allowing for innovation has been critical to American innovation. Maintaining an environment that permits innovation without sacrificing consumer privacy is critical to our nation's future prosperity and the creation of new consumer services.” To read the letter online, click here.  Read More

House GOP Urges FCC to Fulfill Data Privacy Promises to Consumers

2017/04/07

WASHINGTON, DC – Energy and Commerce Committee Chairman Greg Walden (R-OR), Communications and Technology Subcommittee Chairman Marsha Blackburn (R-TN) and Digital Commerce and Consumer Protection Subcommittee Chairman Bob Latta (R-OH) today sent a letter to Federal Communications Commission Chairman (FCC) Ajit Pai regarding consumer privacy. In the letter, signed by 50 Republican colleagues, Walden, Blackburn, and Latta direct the FCC to continue ensuring that ISPs fulfill their promises to consumers regarding their use of data until the FCC remedies the Title II reclassification, which incorrectly removed ISP’s from the jurisdiction of the Federal Trade Commission (FTC). Walden, Latta and Blackburn write, “Protecting consumer privacy while allowing for innovation has been critical to American innovation. Maintaining an environment that permits innovation without sacrificing consumer privacy is critical to our nation's future prosperity and the creation of new consumer services.” In the letter, members point to Section 201 and 202 of the Communications Act of 1934 as providing the authority to follow the FTC’s approach and protect consumer privacy. They continue, “The FTC’s time-tested approach to privacy has protected Americans’ since the dawn of the Internet.  An FCC approach that mirrors the FTC will continue to protect consumers in this tumultuous time.” To read the full letter, click here. Read More

DIGITAL RECAP: The Week in Review

2017/04/07

WASHINGTON, DC – The Energy and Commerce Committee held three hearings this week ranging from cybersecurity in the health care sector to spectrum. During Tuesday’s hearings, #SubEnvironment members examined  legislation that would improve the existing Brownfields Program and, in #SubOversight, members explored how to better utilize public-private partnerships in order to bolster cybersecurity in the health care industry. Rounding out the week, #SubCommTech discussed the impact of spectrum on economic growth and the federal government’s role in meeting spectrum needs. For more updates on the committee’s activities, be sure to follow us on our Facebook, Twitter and Instagram pages. [[{"fid":"2537","view_mode":"default","fields":{"format":"default","field_file_image_alt_text[und][0][value]":false,"field_file_image_title_text[und][0][value]":false},"type":"media","field_deltas":{"1":{"format":"default","field_file_image_alt_text[und][0][value]":false,"field_file_image_title_text[und][0][value]":false}},"link_text":null,"attributes":{"height":"204","width":"382","class":"media-element file-default","data-delta":"1"}}]] #SubEnvironment Chairman John Shimkus (R-IL) and vice chairman Rep. David McKinley (R-WV) discuss opening statements ahead of Tuesday’s hearing. [[{"fid":"2538","view_mode":"default","fields":{"format":"default","field_file_image_alt_text[und][0][value]":false,"field_file_image_title_text[und][0][value]":false},"type":"media","field_deltas":{"2":{"format":"default","field_file_image_alt_text[und][0][value]":false,"field_file_image_title_text[und][0][value]":false}},"link_text":null,"attributes":{"height":"130","width":"480","class":"media-element file-default","data-delta":"2"}}]] #SubEnvironment witnesses prepare to testify ahead of the Brownfields Reauthorization hearing. Witnesses identified issues with existing Brownfields Program and how the discussion draft will benefit communities across the country. [[{"fid":"2539","view_mode":"default","fields":{"format":"default","field_file_image_alt_text[und][0][value]":false,"field_file_image_title_text[und][0][value]":false},"type":"media","field_deltas":{"3":{"format":"default","field_file_image_alt_text[und][0][value]":false,"field_file_image_title_text[und][0][value]":false}},"link_text":null,"attributes":{"height":"217","width":"291","class":"media-element file-default","data-delta":"3"}}]] Full Committee Chairman Greg Walden (R-OR) and Rep. Bill Flores (R-TX) laugh ahead of the gavel dropping in the #SubEnvironment hearing. [[{"fid":"2540","view_mode":"default","fields":{"format":"default","field_file_image_alt_text[und][0][value]":false,"field_file_image_title_text[und][0][value]":false},"type":"media","field_deltas":{"4":{"format":"default","field_file_image_alt_text[und][0][value]":false,"field_file_image_title_text[und][0][value]":false}},"link_text":null,"attributes":{"height":"193","width":"295","class":"media-element file-default","data-delta":"4"}}]] During Tuesday’s #SubOversight hearing, Chairman Tim Murphy (R-PA) asks witnesses to rise from their chairs so he can officially swear them in. [[{"fid":"2541","view_mode":"default","fields":{"format":"default","field_file_image_alt_text[und][0][value]":false,"field_file_image_title_text[und][0][value]":false},"type":"media","field_deltas":{"5":{"format":"default","field_file_image_alt_text[und][0][value]":false,"field_file_image_title_text[und][0][value]":false}},"link_text":null,"attributes":{"height":"186","width":"280","class":"media-element file-default","data-delta":"5"}}]] Representative Susan Brooks (R-IN) leans over during the #SubOversight hearing on #cybersecurity to talk with seatmate, and #SubHealth chairman, Michael C. Burgess, M.D. (R-TX). [[{"fid":"2542","view_mode":"default","fields":{"format":"default","field_file_image_alt_text[und][0][value]":false,"field_file_image_title_text[und][0][value]":false},"type":"media","field_deltas":{"6":{"format":"default","field_file_image_alt_text[und][0][value]":false,"field_file_image_title_text[und][0][value]":false}},"link_text":null,"attributes":{"height":"161","width":"270","class":"media-element file-default","data-delta":"6"}}]] #SubCommTech Chairman Marsha Blackburn (R-TN) listens to Rep. Bob Latta (R-OH) present his opening statement during Wednesday’s hearing on spectrum. [[{"fid":"2543","view_mode":"default","fields":{"format":"default","field_file_image_alt_text[und][0][value]":false,"field_file_image_title_text[und][0][value]":false},"type":"media","field_deltas":{"7":{"format":"default","field_file_image_alt_text[und][0][value]":false,"field_file_image_title_text[und][0][value]":false}},"link_text":null,"attributes":{"height":"159","width":"271","class":"media-element file-default","data-delta":"7"}}]] Rep. Leonard Lance (R-NJ), the #SubCommTech vice chairman, laughs at a joke cracked during Wednesday’s hearing to examine solutions on America’s growing spectrum needs. Read More

Iowa’s Insurer Exodus: Wellmark BCBS and Aetna Announce Departures from Obamacare Marketplace

2017/04/06

WASHINGTON, DC – It’s been another bad week for the so-called “Affordable Care Act.” On Tuesday, Wellmark Blue Cross and Blue Shield announced they will not sell or renew plans in Iowa next year. Wellmark cited double-digit premium increases and a net loss of approximately $90 million for their decision. “No one really benefits from rising costs,” said Wellmark’s Chairman and CEO, John Forsyth. Today, Aenta announced they also will not participate in Iowa’s individual market next year, citing significant financial risk. The insurer exodus continues it’s drip-drip-drip effect on patients, leaving them guessing on the future of the marketplace. This year, Iowans had four insurers offering plans on the individual market. Next year they will have just one state-wide insurer. Patients deserve better – a health care system that puts them first and delivers on being more affordable and accessible. ### Read More

#SubCommTech Examines Solutions to Meet America’s Growing Spectrum Needs

2017/04/05

WASHINGTON, DC – The Communications and Technology Subcommittee, chaired by Rep. Marsha Blackburn (R-TN), today held a hearing examining the impact of spectrum on economic growth and how the federal government can help meet America’s ever-growing spectrum needs. Members also discussed several pieces of legislation including Rep. Brett Guthrie (R-KY) and Rep. Doris Matsui’s (D-CA) Federal Spectrum Incentive Act, Rep. Adam Kinzinger’s (R-IL) H.R. 1814, which encourages spectrum licensees to make unused or underused spectrum available for rural and smaller carrier use, and S. 19, the MOBILE NOW Act, which seeks to ensure an adequate amount of spectrum is available to ensure the deployment of next generation 5G wireless broadband technology, as well as other spectrum. “It is often said that spectrum is the lifeblood of wireless connectivity, and wireless demand continues to surge at an incredible rate. As a result, it is imperative that the subcommittee continues working to unleash spectrum for commercial purposes. The FCC and NTIA must work quickly to identify bands of spectrum which can be reallocated and cleared for commercial use as we push to develop 5G networks,” stated #SubCommTech Chairman Blackburn. [[{"fid":"2524","view_mode":"default","fields":{"format":"default","field_file_image_alt_text[und][0][value]":false,"field_file_image_title_text[und][0][value]":false},"type":"media","field_deltas":{"1":{"format":"default","field_file_image_alt_text[und][0][value]":false,"field_file_image_title_text[und][0][value]":false}},"link_text":null,"attributes":{"height":"212","width":"368","class":"media-element file-default","data-delta":"1"}}]] Witnesses listen to member opening statements at today’s #SubCommTech hearing Scott Bergmann, Vice President of Regulatory Affairs at CTIA, discussed the importance of modernizing federal siting processes, commenting, “We must move forward with modernizing our nation’s infrastructure siting policies so that spectrum can be fully utilized and wireless networks can be rapidly and efficiently deployed. … In particular, streamlined processes for siting on federal lands in rural and remote areas would greatly improve the ability of the wireless industry to serve these hard-to-reach customers.” Jennifer Manner, Senior Vice President of Regulatory Affairs at EchoStar Corporation and Hughes Network Systems, outlined the importance of Congress remaining technology neutral as they move towards meeting America’s growing spectrum needs, stating, “It is critical that Congress and the FCC ensure that all technologies are given the resources they need to meet the needs of consumers, no matter where they are located. Broadband means economic opportunity. By allocating spectrum in a technology-neutral manner to enable competition among platforms, we can ensure that consumers, not the government, are able to pick the best technology for their use and the digital economy will continue to blossom. … Meeting broadband infrastructure challenges, especially in rural America, is critical to job creation and economic development.” In his line of questioning, Rep. Kinzinger asked Mr. Bergmann, “What other actions should congress take that the FCC can’t in order to promote the deployment of 5G services and infrastructure?” Mr. Bergmman replied, “The two most important things that this committee can do is to focus on spectrum and infrastructure siting.”  [[{"fid":"2525","view_mode":"default","fields":{"format":"default","field_file_image_alt_text[und][0][value]":false,"field_file_image_title_text[und][0][value]":false},"type":"media","field_deltas":{"1":{"format":"default","field_file_image_alt_text[und][0][value]":false,"field_file_image_title_text[und][0][value]":false}},"link_text":null,"attributes":{"height":"198","width":"187","class":"media-element file-default","data-delta":"1"}}]] Chairman Blackburn listens intently to witness testimony “The 5G revolution is upon us and America must not fall behind. Deploying and promoting efficient use of spectrum is the two-sided solution we must adopt as wireless communications networks expand and the Internet of Things seemingly grows into the Internet of Everything,” concluded Chairman Blackburn. Republicans and Democrats are eager to tackle the spectrum crunch. The societal and financial value of spectrum is simply too great for it to not be maximized.” A background memo, witness testimony, and an archived webcast of the hearing can be found online HERE. ###  Read More

Fueling the 21st Century Wireless Economy

2017/04/05

[[{"fid":"2506","view_mode":"full","fields":{"format":"full"},"type":"media","field_deltas":{"1":{"format":"full"}},"link_text":null,"attributes":{"alt":"Facilitating the 21st Century Wireless Economy.","height":"380","width":"640","class":"media-element file-full","data-delta":"1"}}]] Read More

ICYMI: FCC & FTC Chairs Set the Record Straight on Online Privacy

2017/04/05

On the heels of last week’s House vote to roll back the Federal Communications Commission’s (FCC) flawed Internet Service Provider (ISP) rules and President Trump signing the bill into law earlier this week; FCC Chairman Ajit Pai and acting chairman of the Federal Trade Commission (FTC) Maureen Ohlhausen penned an op-ed in The Washington Post setting the record straight on exactly what the privacy CRA was all about. “First, despite hyperventilating headlines, Internet service providers have never planned to sell your individual browsing history to third parties. That’s simply not how online advertising works. And doing so would violate ISP’s privacy promises. Second, Congress’s decision last week didn’t remove existing privacy protections; it simply cleared the way for us to work together to reinstate a rational and effective system for protecting consumer privacy,” write Pai and Ohlhausen.   They conclude, “The American people deserve a comprehensive framework that will protect their privacy throughout the Internet. And that’s why we’ll be working together to restore the FTC’s authority to police ISPs’ privacy practices. We need to put the nation’s most experienced and expert privacy cop back on the beat, and we need to end the uncertainty and confusion that was created in 2015 when the FCC intruded in this space. In short, the Obama administration fractured our nation’s online privacy law, and it is our job to fix it. We pledge to the American people that we will do just that.” [[{"fid":"2521","view_mode":"full","fields":{"format":"full","field_file_image_alt_text[und][0][value]":false,"field_file_image_title_text[und][0][value]":false},"type":"media","field_deltas":{"1":{"format":"full","field_file_image_alt_text[und][0][value]":false,"field_file_image_title_text[und][0][value]":false}},"link_text":null,"attributes":{"height":"113","width":"597","class":"media-element file-full","data-delta":"1"}}]]   No, Republicans didn’t just strip away your Internet privacy rights By: Ajit Pai and Maureen Ohlhausen April Fools’ Day came early last week, as professional lobbyists lit a wildfire of misinformation about Congress’s action — signed into law Monday by President Trump — to nullify the Federal Communications Commission’s broadband privacy rules. So as the nation’s chief communications regulator and the nation’s chief privacy enforcer, we want to let the American people know what’s really going on and how we will ensure that consumers’ online privacy is protected. Let’s set the record straight: First, despite hyperventilating headlines, Internet service providers have never planned to sell your individual browsing history to third parties. That’s simply not how online advertising works. And doing so would violate ISPs’ privacy promises. Second, Congress’s decision last week didn’t remove existing privacy protections; it simply cleared the way for us to work together to reinstate a rational and effective system for protecting consumer privacy. Both of us warned two years ago that the FCC’s party-line vote to strip the Federal Trade Commission of its jurisdiction over Internet broadband providers was a mistake that would weaken Americans’ online privacy. Up until that decision, the FTC was an effective cop on the privacy beat, using a consistent framework for protecting privacy and data security throughout the entire Internet ecosystem. Indeed, under that framework, the FTC carried out more than 150 enforcement actions, including actions against some of the nation’s largest Internet companies. But in 2015, the FCC decided to treat the Internet like a public utility, taking away the FTC’s ability to police the privacy practices of broadband providers. This shifted responsibility from the agency with the most expertise handling online privacy (the FTC) to an agency with no real experience in the field (the FCC). As we feared, this 2015 decision has not turned out well for the American people. During the Obama administration, the FTC concluded that “any privacy framework should be technology neutral” because “ISPs are just one type of large platform provider” and “operating systems and browsers may be in a position to track all, or virtually all, of a consumer’s online activity to create highly detailed profiles.” But the FCC didn’t follow this guidance. Instead, it adopted rules that would have created a fractured privacy framework under which ISPs would have been subject to one standard and content providers would have been subject to another. The Obama FTC, in a unanimous bipartisan comment, criticized this approach as “not optimal.” In Washington-speak, that’s a major rebuke. The FCC’s regulations weren’t about protecting consumers’ privacy. They were about government picking winners and losers in the marketplace. If two online companies have access to the same data about your Internet usage, why should the federal government give one company greater leeway to use it than the other? Some argue that Internet service providers should be treated differently because they have access to more of your personal information than companies such as Google and Facebook. But that’s not true. As Peter Swire, President Bill Clinton’s chief counselor for privacy and President Barack Obama’s special assistant for economic policy, explained in a paper he co-wrote for Georgia Tech’s Institute for Information Security and Privacy, “ISPs have neither comprehensive nor unique access to information about users’ online activity. Rather, the most commercially valuable information about online users . . . is coming from other contexts,” such as social-media interactions and search terms. Others argue that ISPs should be treated differently because consumers face a unique lack of choice and competition in the broadband marketplace. But that claim doesn’t hold up to scrutiny either. For example, according to one industry analysis, Google dominates desktop search with an estimated 81 percent market share (and 96 percent of the mobile search market), whereas Verizon, the largest mobile broadband provider, holds only an estimated 35 percent of its market. As a result, it shouldn’t come as a surprise that Congress decided to disapprove the FCC’s unbalanced rules. Indeed, the FTC’s criticism of the FCC’s rules last year noted specifically that they “would not generally apply to other services that collect and use significant amounts of consumer data.” Put simply, the Chicken Little-like reaction doesn’t make any sense, particularly when compared with the virtual silence when the FCC stripped away existing privacy protections in 2015. But we understand that more needs to be done to protect online privacy. The American people deserve a comprehensive framework that will protect their privacy throughout the Internet. And that’s why we’ll be working together to restore the FTC’s authority to police ISPs’ privacy practices. We need to put the nation’s most experienced and expert privacy cop back on the beat, and we need to end the uncertainty and confusion that was created in 2015 when the FCC intruded in this space. In short, the Obama administration fractured our nation’s online privacy law, and it is our job to fix it. We pledge to the American people that we will do just that. Read the op-ed online HERE. ### Read More

#SubOversight Examines Ways to Bolster Cybersecurity Efforts in Health Care Sector

2017/04/04

WASHINGTON, DC – The Subcommittee on Oversight and Investigations, chaired by Rep. Tim Murphy (R-PA), today held a hearing examining the need for greater coordination and leadership on cybersecurity issues across the health care industry, particularly challenges in public-private partnerships. Full committee Chairman Greg Walden (R-OR) stated, “As technology becomes increasingly integrated with all levels of our health care, cyber threats pose a challenge to the entire sector. Everyone – from the smallest rural hospitals, to large providers and device manufacturers – faces some level of exposure and risk.” [[{"fid":"2518","view_mode":"full","fields":{"format":"full","field_file_image_alt_text[und][0][value]":false,"field_file_image_title_text[und][0][value]":false},"type":"media","field_deltas":{"1":{"format":"full","field_file_image_alt_text[und][0][value]":false,"field_file_image_title_text[und][0][value]":false}},"link_text":null,"attributes":{"height":"243","width":"265","class":"media-element file-full","data-delta":"1"}}]] Chairman Murphy gives his opening statement at today’s #SubOversight hearing. Chairman Murphy highlighted the importance of the health care sector strengthening engagement in public-private partnerships for cybersecurity. Chairman Murphy stated, “Cybersecurity is a collective responsibility and that is why it is imperative that this sector find a way to come together to find a sustainable path forward.” Mr. Terence M. Rice, Vice President, IT Risk Management & Chief Information Security Officer (CISO) at Merck & Company, Inc., made a series of recommendations in his opening remarks that he suggested could help expand upon existing partnerships and boost collaboration. Among those recommendations were: appoint a health care cybersecurity liaison to the private sector, create an appendix on cybersecurity to agency plans, and facilitate exercises and simulations. [[{"fid":"2519","view_mode":"full","fields":{"format":"full","field_file_image_alt_text[und][0][value]":false,"field_file_image_title_text[und][0][value]":false},"type":"media","field_deltas":{"1":{"format":"full","field_file_image_alt_text[und][0][value]":false,"field_file_image_title_text[und][0][value]":false}},"link_text":null,"attributes":{"height":"194","width":"468","class":"media-element file-full","data-delta":"1"}}]] Mr. McNeil testifies before #SubOversight. Ms. Denise Anderson, President, National Health Information Sharing and Analysis Center, also offered up some key areas where Congress can help in this challenge – education and facilitation of information sharing, better protections for information sharing, clarify the terms “ISAC” and “ISAO” [Information Sharing and Analysis Organizations], and establish cybersecurity professionals as key liaisons. Mr. Michael McNeil, Global Product Security & Services Officer, Royal Phillips, highlighted the FDA’s role in cybersecurity efforts pertaining to medical devices, saying, “Moreover, the FDA entered into a Memorandum of Understanding with the National Health Information Sharing and Analysis Organization and the Medical Device Innovation, Safety and Security Consortium to promote cybersecurity information sharing for medical devices. These efforts have led to the creation of a medical device-specific information sharing and analysis organization… for medical device manufacturers to submit and share information concerning cybersecurity-related issues, as well as other members of the broader health care ecosystem.” “This isn’t just about protecting patient data or information – this is about patient safety,” stressed Chairman Murphy. For more information on today’s hearing, including a background memo, witness testimony, and archived webcast, click HERE. ### Read More

#SubEnvironment Examines Legislation Related to Brownfields Reauthorization

2017/04/04

WASHINGTON, DC – The Subcommittee on Environment, chaired by Rep. John Shimkus (R-IL), today held a hearing examining a discussion draft of a Brownfields reauthorization bill that seeks to make several improvements to the Brownfields Program. Brownfields are often abandoned, closed, or under-utilized industrial or commercial facilities, such as an abandoned factory in a town, a closed commercial building or warehouse, or a former dry cleaning establishment or gas station. EPA estimates that there are more than 450,000 brownfields in the U.S., and each of these sites has the potential to encourage economic development through the Brownfields Program. The committee and #SubEnvironment has a long history when it comes to examining EPA’s Brownfields Program. Last year, the committee held a hearing identifying issues with the Brownfields Program, many of which were addressed in the discussion draft the committee considered today.  [[{"fid":"2514","view_mode":"default","fields":{"format":"default","field_file_image_alt_text[und][0][value]":false,"field_file_image_title_text[und][0][value]":false},"type":"media","field_deltas":{"1":{"format":"default","field_file_image_alt_text[und][0][value]":false,"field_file_image_title_text[und][0][value]":false}},"link_text":null,"attributes":{"height":"288","width":"480","class":"media-element file-default","data-delta":"1"}}]] Witnesses prepare to testify ahead of today’s #SubEnvironment hearing Meade Anderson, Brownfields Program Manager at the Virginia Department of Environmental Quality, testifying on behalf of the Association of State and Territorial Solid Waste Management Officials, stated, “Brownfield redevelopment plays an important role in addressing our country’s ailing infrastructure, spurring economic development while cleaning up environmentally challenged properties. Redevelopment of brownfields reuses existing roads, bridges, water treatment plants and other infrastructure elements resulting in savings in development costs and the need to build new infrastructure that also requires maintenance.” Robert Martineau Jr., Commissioner at the Tennessee Department of Environment and Conservation, testifying on behalf of the Environmental Council of States, echoed Mr. Anderson’s thoughts and threw his weight behind the discussion draft, commenting, “Across our nation, Brownfields programs play an integral role in the redevelopment of infrastructure that has fallen out of use. Brownfields grants facilitate economic growth and encourage meaningful investment in communities. Brownfield redevelopment is, at its heart, economic and community development with improved environmental outcomes. Legislative approaches like those embedded in the Discussion Draft will make this already successful program even more so. I commend you for taking up this topic and for your thoughtful Discussion Draft.” The Honorable Parris N. Glendening, President of Smart Growth America’s Leadership Institute, discussed his support for the draft bill, stating, “Historically, the EPA Brownfields program has been a lifeline for communities that are struggling to overcome blight and contamination at abandoned industrial sites. … This discussion draft, if enacted into law, stands to benefit hundreds of communities – big and small, urban and rural – across the nation looking to transform their vacant properties to create new engines of economic growth.” [[{"fid":"2515","view_mode":"default","fields":{"format":"default","field_file_image_alt_text[und][0][value]":false,"field_file_image_title_text[und][0][value]":false},"type":"media","field_deltas":{"1":{"format":"default","field_file_image_alt_text[und][0][value]":false,"field_file_image_title_text[und][0][value]":false}},"link_text":null,"attributes":{"height":"307","width":"480","class":"media-element file-default","data-delta":"1"}}]] Chairman Walden delivers his opening statement “My home state of Oregon has a very active Brownfields Program and we’ve seen some great recent success in my district in particular,” said full committee Chairman Greg Walden (R-OR). “We remain committed to working with our colleagues across the aisle and on the Transportation and Infrastructure Committee to ensure that the Brownfields Program will encourage EPA, states, and local governments to work together to redevelop brownfields properties and create new jobs, leverage private investment, and provide for economic development.”  [[{"fid":"2517","view_mode":"default","fields":{"format":"default","field_file_image_alt_text[und][0][value]":false,"field_file_image_title_text[und][0][value]":false},"type":"media","field_deltas":{"1":{"format":"default","field_file_image_alt_text[und][0][value]":false,"field_file_image_title_text[und][0][value]":false}},"link_text":null,"attributes":{"height":"221","width":"480","class":"media-element file-default","data-delta":"1"}}]] Chairman Shimkus listens to witnesses deliver their tesitmony #SubEnvironment Chairman Shimkus concluded, “The Discussion Draft contains improvements to the Brownfields Program such as the creation of multipurpose grants that can be used for brownfields assessment and cleanup, and which will provide flexibility to communities trying to cleanup multiple brownfields sites within an area in the community. The EPA Brownfields Program is vital to states and local communities as they try to address contaminated industrial and commercial properties and return them to productive use. I stand ready to roll up my sleeves and continue to work to reauthorize and improve EPA’s Brownfields Program.” A background memo, witness testimony, and an archived webcast of the hearing can be found online HERE. ### Read More

Cybersecurity in the Health Care Sector: Strengthening Public-Private Partnerships

2017/04/04

[[{"fid":"2505","view_mode":"full","fields":{"format":"full"},"type":"media","field_deltas":{"1":{"format":"full"}},"link_text":null,"attributes":{"alt":"Cybersecurity in the Heath Care Sector: Strengthening Public-Private Partnerships.","height":"380","width":"640","class":"media-element file-full","data-delta":"1"}}]] Read More

Discussion Draft: Brownfields Reauthorization

2017/04/04

[[{"fid":"2504","view_mode":"full","fields":{"format":"full"},"type":"media","field_deltas":{"1":{"format":"full"}},"link_text":null,"attributes":{"alt":"Discussion Draft: Brownfields Reauthorization.","height":"380","width":"640","class":"media-element file-full","data-delta":"1"}}]] Read More

#SubCommTech Chair Blackburn on FCC’s Charter Decision

2017/04/03

WASHINGTON, DC – Communications and Technology Subcommittee Chairman Marsha Blackburn (R-TN) today issued the following statement on FCC Chairman Pai’s decision to reverse the conditions imposed on Charter Communications. “Today’s announcement by Chairman Pai reversing the mandatory overbuilding imposed on Charter Communications as part of the FCC’s merger approval is a big step toward restoring faith in the merger review process. We have long said that merger conditions should not be used to make an end run around the rule-making process to achieve unrelated policy goals,” said Chairman Blackburn. “As we work to ensure that all Americans have access to broadband, we should focus on targeting service to areas that are truly unserved, not attempting to manufacture competition through government mandated buildout. Today’s action will result in consumers in unserved areas benefitting from new broadband connectivity, and that’s something we should all celebrate."  ###  Read More

Acting Drug Czar: We Share Your Concerns Regarding Fentanyl Threat

2017/04/03

Shortly after the establishment of the President’s Commission on Combating Drug Addiction and the Opioid Crisis, the Office of National Drug Control Policy (ONDCP) responded to a bipartisan letter from Energy and Commerce Committee leaders. The initial letter posed questions for all federal agencies within ONDCP’s jurisdiction about their plans to address the urgent public health threat of fentanyl, a synthetic opioid. The detailed response highlights the severity of the fentanyl crisis, which has drawn the attention of national security groups and organizations. Click HERE to read a copy of ONDCP’s response. [[{"fid":"2503","view_mode":"full","fields":{"format":"full","field_file_image_alt_text[und][0][value]":false,"field_file_image_title_text[und][0][value]":false},"type":"media","field_deltas":{"1":{"format":"full","field_file_image_alt_text[und][0][value]":false,"field_file_image_title_text[und][0][value]":false}},"link_text":null,"attributes":{"height":"42","width":"447","class":"media-element file-full","data-delta":"1"}}]] March 31, 2017 Drug Czar’s Letter to Congress Highlights Fentanyl Crisis The potent opioid fentanyl, which is worsening a deadly U.S. drug epidemic, is pouring into the country from an array of sources and presenting law enforcement with complex challenges, according to new information from the nation’s drug czar. A detailed letter to U.S. House lawmakers, responding to a request from the Energy and Commerce Committee, laid out many details about how authorities believe traffickers are moving and selling fentanyl. The drug czar’s office acknowledged available data don’t capture the full scope of the fentanyl crisis, yet still underscore an overwhelming problem. “Please know that we share the Committee’s view that illicit fentanyl is an urgent public health threat,” said Richard Baum, acting director of the White House Office of National Drug Control Policy, in the letter dated Wednesday. Recently extracted data from a federal database showed authorities seized at least 668 kilograms of illicit powdered fentanyl last year, according to the letter, which was reviewed by The Wall Street Journal. Because fentanyl is lethal in such tiny amounts—just 2 milligrams—that is enough of the synthetic opioid to kill every American. “And that’s just what they can count,” an aide with the Energy and Commerce Committee said. “That’s exactly why it’s a clear and present danger to the United States.” Authorities also have seen large increases in the liquid and pill form of the drug, and seizures of all types of illicit fentanyl have been climbing rapidly. The data for 2016 are still incomplete. … To read the full article online, click HERE. ### Read More

Committee Leaders Ask Nonpartisan GAO to Review DOE’s Environmental Cleanup Decision-Making

2017/03/31

WASHINGTON, DC – House Energy and Commerce Committee Chairman Greg Walden (R-OR), Energy and Commerce Committee Vice Chairman Joe Barton (R-TX), Subcommittee on Energy Chairman Fred Upton (R-MI), and Subcommittee on Environment Chairman John Shimkus (R-IL), today asked the nonpartisan U.S. Government Accountability Office (GAO) to assist the committee’s review of the Department of Energy’s (DOE) environmental cleanup operations and its use of modeling and assessments to ensure the most cost-effective reduction of public health risks.  The letter comes as part of the committee’s review of DOE’s management practices. An important element of that review will be to examine DOE’s management and execution of its cleanup responsibilities. “We are particularly interested in departmental decision-making concerning DOE’s efforts to cost effectively address environmental liabilities while minimizing health and safety risks to the public and the environment – the importance of which were underscored by the GAO high-risk designation last month for federal environmental liabilities,” write Walden, Barton, Upton, and Shimkus. The members continued, “DOE’s Office of Environmental Management (EM) is responsible for remediating the environmental contamination attributable to the nation’s nuclear weapons program. Since its inception in 1989, EM has spent more than$164 billion on this effort, and estimates that it will need approximately $257 billion to complete its mission. …  Given the enormous amount of cleanup work in the years ahead, we seek to understand whether EM is adequately assessing the performance of its cleanup projects and managing the majority of its annual budget as effectively and as efficiently as possible.” “In light of $370 billion environmental liability for DOE’s future environmental remediation requirements, DOE may be missing opportunities to work with states to make risk-informed decisions using current information that reflect scientific and technical advancements. To assist us with these management-oversight inquiries, we request GAO undertake an evaluation of the performance of EM’s operational activities and the role of performance assessments in informing those activities,” concluded Walden, Barton, Upton, and Shimkus. To read the letter online, click here. ###  Read More

Letter to GAO Comptroller General Gene Dodaro Regarding DOE's Environmental Cleanup Decision-Making

2017/03/31

Excerpt: “In light of $370 billion environmental liability for DOE’s future environmental remediation requirements, DOE may be missing opportunities to work with states to make risk-informed decisions using current information that reflect scientific and technical advancements. To assist us with these management-oversight inquiries, we request GAO undertake an evaluation of the performance of EM’s operational activities and the role of performance assessments in informing those activities." To read the letter to GAO, click here.  Read More

Committee Leaders Seek to Evaluate Management and Performance of Critical Cyber Database

2017/03/30

WASHINGTON, DC – Today, Energy and Commerce Committee Chairman Greg Walden (R-OR), Oversight and Investigations Subcommittee Chairman Tim Murphy (R-PA), Digital Commerce and Consumer Protection Subcommittee Chairman Bob Latta (R-OH) and Communications and Technology Subcommittee Chairman Marsha Blackburn (R-TN), sent two letters to the Department of Homeland Security (DHS) and MITRE Corporation. In both letters, committee leaders ask for an evaluation of the Common Vulnerabilities and Exposures (CVE) program—a program that tracks and monitors cyber vulnerabilities and risks relevant to modern security. In light of recent reports indicating that the CVE program may not be keeping up with present day vulnerabilities and risks, members are requesting documents from both MITRE and DHS in order to better understand the program’s shortcomings and what steps need to be taken to rectify these deficiencies.   “In spring 2016, press reports revealed complaints that requests for CVE numbers for vulnerabilities reported to MITRE either were taking several weeks or months to process, or were going unanswered. In addition, some individuals and organizations seeking CVE numbers were told that their vulnerabilities were ‘out of scope’ for CVE, and had their vulnerabilities rejected from the program.  Over the past year, MITRE has made several updates to the CVE program. While these changes have improved the functioning of the system, and MITRE’s engagement with its stakeholder community has greatly increased, both the larger community and MITRE agree that significant work is necessary to ensure timely coverage of affected products and services,” write Walden, Murphy, Latta and Blackburn. The leaders continue, “The explosion of connected devices and services that has been associated with the CVE program’s shortcomings, while rapid, did not occur overnight. In light of this, we seek to understand how MITRE and the CVE program failed to anticipate and prepare for this growth in demand for its services and what more may be done to ensure this program can more effectively serve its essential mission.” To read a copy of the letter to DHS, click here. To read a copy of the letter to MITRE, click here. Read More

Letters to DHS and MITRE Regarding Performance of Critical Cyber Database

2017/03/30

Excerpt: "We seek your assistance in evaluating the management and performance of the Common Vulnerabilities and Exposures (CVE) program, which has become an essential service for modern cybersecurity practices." To read a copy of the letter to MITRE, click here. Excerpt: "The program provides a reliable, standardized mechanism for describing information technology and cybersecurity vulnerabilities. Recent reports indicate it may not be keeping up with the increasing vulnerabilities and related risks inherent in modern cybersecurity." To read a copy of the letter to DHS, click here. Read More

Members Examine FTC’s Role in Protecting Consumers from Fraudulent Charitable Crowdfunding Websites

2017/03/30

WASHINGTON, DC – Today, Energy and Commerce Committee Chairman Greg Walden (R-OR), full committee Ranking Member Frank Pallone, Jr. (D-NJ), Oversight and Investigations Subcommittee Chairman Tim Murphy (R-PA), Oversight and Investigations Subcommittee Ranking Member Diana DeGette (D-CO), Digital Commerce and Consumer Protection Subcommittee Chairman Bob Latta (R-OH) and Digital Commerce and Consumer Protection Subcommittee Ranking Member Jan Schakowsky (D-IL), sent a letter to Maureen Ohlhausen, Acting Chairwoman of the Federal Trade Commission (FTC). In the letter, committee leaders express concern with the increase in crowdfunding scams – where consumers unknowingly donate to fraudulent charitable campaigns. In today’s letter, members request a briefing from the FTC about its actions and policies to ensure that crowdfunding platforms are not used fraudulently or deceptively to solicit charitable donations. “In 2015, crowdfunding websites raised an estimated total of $2 billion. While the majority of donations on crowdfunding platforms likely reach intended beneficiaries, it appears this is not always the case. For example, the Associated Press reviewed 30 out of 430 crowdfunding campaigns on GoFundMe.com intended for victims of the June 12, 2016, Orlando nightclub shooting. The review found that ‘most campaigns lacked key details, such as exactly what the donations would cover or even who was asking for them.’ Similarly, in 2012, before Hurricane Sandy even reached the United States, over 1,000 websites were created to support victims of the storm, including many questionable campaigns attempting to solicit donations while providing virtually no information about who was organizing the campaign or how the money would be spent. Additional news reports have highlighted numerous instances of fraudulent charitable crowdfunding campaigns, including a campaign organizer pocketing a portion of money raised to pay for a funeral, and another who raised thousands,” write Walden, Pallone, Murphy, DeGette, Latta. and Schakowsky. The leaders continue, “The Committee seeks information about the FTC’s actions and policies for ensuring that crowdfunding platforms are not being used to fraudulently or deceptively solicit charitable contributions, and requests that the FTC provide Committee staff with a briefing on the matter.  Please make arrangements to schedule this briefing no later than April 12, 2017.” To read a copy of the letter online, click here. Read More

Walden & Blackburn Applaud Announcement of Public-Private Partnership to Deploy Nationwide Public Safety Network

2017/03/30

WASHINGTON, DC – House Energy and Commerce Committee Chairman Greg Walden (R-OR) and Communications and Technology Subcommittee Chairman Marsha Blackburn (R-TN) today delivered remarks at the U.S. Department of Commerce’s event announcing a public-private partnership between FirstNet and AT&T to create a nationwide broadband public safety network.  [[{"fid":"2497","view_mode":"full","fields":{"format":"full","field_file_image_alt_text[und][0][value]":false,"field_file_image_title_text[und][0][value]":false},"type":"media","field_deltas":{"1":{"format":"full","field_file_image_alt_text[und][0][value]":false,"field_file_image_title_text[und][0][value]":false}},"link_text":null,"attributes":{"height":"181","width":"351","class":"media-element file-full","data-delta":"1"}}]] Watch Chairman Walden Deliver his Remarks HERE (Excerpt of remarks) In 2012, when I was serving as chairman of the Subcommittee on Communications and Technology in the House, I had the opportunity to work with my colleagues to carefully craft legislation that would make FirstNet a reality. Today, with FirstNet’s award of the contract to AT&T, the product of all that hard work will be realized. Through this public-private partnership, FirstNet can begin to deliver on its mission: to provide our first responders with a nationwide, high-speed, interoperable broadband network; to equip our first responders with the same robust communications capabilities enjoyed by the public; and to provide tools that transcend the limits of the land mobile radios on which they had for so long relied. Perhaps most importantly, FirstNet will help deliver on the final recommendation of the 9/11 Commission, and bring the most up-to-date communications capabilities to our nation’s first responders, the brave men and women who protect us daily, throughout the states, territories, and tribal lands – in all areas -- rural, urban, and in-between.  [[{"fid":"2498","view_mode":"full","fields":{"format":"full","field_file_image_alt_text[und][0][value]":false,"field_file_image_title_text[und][0][value]":false},"type":"media","field_deltas":{"1":{"format":"full","field_file_image_alt_text[und][0][value]":false,"field_file_image_title_text[und][0][value]":false}},"link_text":null,"attributes":{"height":"202","width":"297","class":"media-element file-full","data-delta":"1"}}]] Watch #SubCommTech Chair Blackburn deliver remarks HERE. (Excerpt of remarks) We are so thrilled to be able to join you all today and to say thank you to those of you who risk your lives and to be able to say you know what, we celebrate solving a problem that was recognized, was defined, and Chairman Walden came forward with a solution. And on behalf of the American people it is a solution that is going to work, that is going to bring safety to our communities, to our streets, and allow our first responders who now can be knitted together, to provide the type of safety that is expected. To provide the type of response that is expected. ###  Read More

Letter to FTC Regarding Charitable Crowdfunding Websites

2017/03/30

Excerpt: “The Committee seeks information about the FTC’s actions and policies for ensuring that crowdfunding platforms are not being used to fraudulently or deceptively solicit charitable contributions, and requests that the FTC provide Committee staff with a briefing on the matter.  Please make arrangements to schedule this briefing no later than April 12, 2017.” To read a copy of the letter, click here. Read More

E&C Leaders Comment on President Trump’s Executive Action to Address Opioid Epidemic

2017/03/29

WASHINGTON, DC – House Energy and Commerce Committee Chairman Greg Walden (R-OR), Health Subcommittee Chairman Michael C. Burgess, M.D. (R-TX), and Oversight and Investigations Subcommittee Chairman Tim Murphy (R-PA) today issued the following statement after President Trump took executive action to commence a commission that will conduct a review of our federal policies regarding ways to combat the opioid epidemic and provide assistance to those suffering. “Combating the opioid epidemic has been a top priority for this committee and we applaud President Trump’s decisive action today,” said Walden, Burgess, and Murphy. “Last Congress, our committee’s investigation into the rise of heroin and opioid overdoses hit close to home as we spoke with constituents, addiction treatment specialists, and local law enforcement officials who have been on the front lines of this battle. We know all too well that this crisis is still playing out in our very own communities and the people affected are our friends, family, and neighbors. In light of the committee’s recent oversight efforts, we are encouraged that the commission's review includes a focus on fentanyl, a synthetic opioid that is increasingly responsible for overdose deaths across the country. This is truly an all-hands-on-deck effort and we look forward to working with the Trump administration in the shared goal of ending this catastrophic crisis.” Last Congress, Energy and Commerce investigations led to legislative solutions that ultimately were included in the Comprehensive Addiction and Recovery Act (CARA) and the 21st Century Cures Act. ### Read More

HEARING: #SubCommTech to Hold Hearing on Spectrum NEXT WEEK

2017/03/29

WASHINGTON, DC – The Subcommittee on Communications and Technology, chaired by Rep. Marsha Blackburn (R-TN), today announced a hearing for Wednesday, April 5, 2017, at 10 a.m. in room 2123 of the Rayburn House Office Building. The hearing is entitled, “Facilitating the 21st Century Wireless Economy.”   Spectrum allocation policy will play an ever-increasing role in the economic growth of the United States. Members will examine the impact of spectrum on economic growth and how the federal government can help meet America’s ever-growing spectrum needs. #SubCommTech will take a look at S. 19, the MOBILE NOW ACT, which seeks to ensure an adequate amount of spectrum is available to ensure the deployment and development of next generation 5G wireless broadband technology, as well as other spectrum issues. “Ensuring the efficient use of federally held spectrum will be a key function of the committee due to the important role of this resource in broadband deployment and promoting safe, secure communications networks,” said Chairman Blackburn. “Mobile technology plays a vital role in the future of our economy and we must ensure that spectrum demand is met with adequate supply. I’m looking forward to examining the federal government’s continued role in spectrum policy next week.” The Majority Memorandum, witness list, and witness testimony for the hearing will be available here as they are posted. ###  Read More

#SubEnergy Examines Energy Tax Policy and its Impact on Markets, Prices, and Consumers

2017/03/29

WASHINGTON, DC – The Subcommittee on Energy, chaired by Rep. Fred Upton (R-MI), today held a hearing examining federal energy tax policy and its effect on markets, prices, and consumers. The federal government has several tools it can use to influence energy policy, one of which is to provide support for energy development, production, and use of fuels and energy technologies through the tax code or spending programs administered by the Department of Energy (DOE). In fact, the tax code has played a significant role in driving energy policy by providing targeted incentives for fossil fuels, nuclear power, renewable energy, and energy efficiency technologies. #SubEnergy today examined the history of energy-related tax policies and their effect on energy and electricity markets, prices, and most importantly on consumers.   “What ultimately matters most are these policy impacts on consumers. We need to do what is best for households struggling to pay the electric or gas bill. Open, competitive markets are the surest way to keep prices down for families while taking full advantage of the technological improvements that give consumers more control over the way they use energy,” full committee Chairmen Greg Walden (R-OR) stated. “We will continue to examine how energy and electricity markets, and the policies affecting those markets, are impacting consumers. But before we reach that point, we need to have a broader understanding of where our energy policies stand right now.” [[{"fid":"2494","view_mode":"full","fields":{"format":"full","field_file_image_alt_text[und][0][value]":false,"field_file_image_title_text[und][0][value]":false},"type":"media","field_deltas":{"1":{"format":"full","field_file_image_alt_text[und][0][value]":false,"field_file_image_title_text[und][0][value]":false}},"link_text":null,"attributes":{"height":"211","width":"306","class":"media-element file-full","data-delta":"1"}}]] Robert Murphy, Senior Economist at the Institute for Energy Research, discussed his thoughts on the impact of tax incentives on energy markets, commenting, “Economists generally agree that decentralized markets, operating through private property and the profit-and-loss test, allocate resources better than top-down central planning. … Adding artificial privileges to particular groups is a self-defeating and inefficient process, because it distorts consumer and producer behavior and invites “rent seeking” from groups trying to shield themselves from unfavorable tax treatment. When policymakers try to steer markets through the tax code, it makes Americans poorer because resources are no longer being channeled into their most important uses.” Devin Hartman, Electricity Policy Manager at the R Street Institute, commented on the importance of steering energy policy toward market-based principles, stating, “Well-functioning competitive energy markets are the best choice for innovation, consumers and the environment. The United States cannot affordably mandate and subsidize its way to a clean energy future. Industrial policies increasingly subvert competitive energy markets and contribute to a mounting public debt burden. It’s time to reawaken the markets. Industries and technologies should excel based on their merits, not political popularity. Congress can steer U.S. energy policy back toward market principles, where competitive forces pick winners, not government.” [[{"fid":"2495","view_mode":"full","fields":{"format":"full","field_file_image_alt_text[und][0][value]":false,"field_file_image_title_text[und][0][value]":false},"type":"media","field_deltas":{"1":{"format":"full","field_file_image_alt_text[und][0][value]":false,"field_file_image_title_text[und][0][value]":false}},"link_text":null,"attributes":{"height":"224","width":"293","class":"media-element file-full","data-delta":"1"}}]] “Clearly a strong argument can be made that specialized energy tax treatments have played a major role in helping the United States achieve its energy goals. However, given the lasting market and price distorting impacts that these policies place on effective price formation and bidding in competitive markets, some are questioning whether yesterday’s justifications for energy tax policies remain appropriate for today,” concluded Chairman Upton. “As we look to modernize our energy policies, we’re going to put consumers first. Consumers should be driving energy markets from the bottom up, rather than having the federal government driving it from the top down.” A background memo, witness testimony, and an archived webcast of the hearing can be found on the Energy and Commerce Committee’s website HERE. ###  Read More

#SubCommTech Examines Nation’s 911 Networks

2017/03/29

WASHINGTON, DC – The Communications and Technology Subcommittee, chaired by Rep. Marsha Blackburn (R-TN), today held a hearing entitled, “Realizing Nationwide Next-Generation 911.” The voice, text, video and data capabilities of today’s smartphones have redefined the way we communicate and live our lives and our first responders will soon have the robust broadband communications capabilities of FirstNet. But the nation’s 911 network – which ties the public to our first responders – may not be keeping pace with these technologies. #SubCommTech examined where the nation currently stands in modernizing our 911 services with these next generation technologies and avenues to move this critical component to public safety forward. “Today we all carry devices that allow us to communicate by voice, by text, by email, and by video. And now that we are at the threshold of deployment of FirstNet, our nation’s first responders will have a dedicated network to do the same. But our 911 networks, which are based on the technologies of the past, do not provide a seamless connection between the two,” said full committee Chairman Greg Walden (R-OR). “Only by bringing IP-based technology to the Nation’s Public Safety Answering Points – the professionals that are the first voice you hear when you call for help – can we bring the full promise of modern technology to serve us in times of emergency.”  [[{"fid":"2493","view_mode":"default","fields":{"format":"default","field_file_image_alt_text[und][0][value]":false,"field_file_image_title_text[und][0][value]":false},"type":"media","field_deltas":{"1":{"format":"default","field_file_image_alt_text[und][0][value]":false,"field_file_image_title_text[und][0][value]":false}},"link_text":null,"attributes":{"height":"232","width":"480","class":"media-element file-default","data-delta":"1"}}]] Barry Ritter, Executive Director of the State 911 Board for the State of Indiana, discussed the importance of public-private collaboration, commenting, “It is important to understand that funding alone is not enough to achieve NG911 in the US. Leadership, collaboration and cooperation between local, state and federal government – and between industry partners and industry associations is also a must.” Mary Boyd, Vice President of Regulatory, Policy and External Affairs at West Safety Services on behalf of Industry Council for Emergency Response Technologies, discussed the urgency to implementing NG911 in a more timely manner, stating, “As a nation, we cannot continue to let 9-1-1 fall behind – we must act. The good news is that much of the work has been done to enable the transition to NG911. The roadmap is there. … Now is the time to accelerate our progress down the transition path. Funding for accelerated implementation of NG911 services across the U.S. will provide significant benefits and improved security and emergency services for; the public, vulnerable and underserved populations, 9-1-1 professionals, and our first responders.” “Realizing NG911 services throughout the nation is critical, but as with any large-scale transition there are challenges that must be overcome. Issues regarding such matters as funding, governance, and ensuring the security of the network are but a few. … Yet while funding is a challenge, studies reveal a troubling pattern whereby some states divert money collected from consumers intended for 911 services that could assist with the NG911 transition,” said Chairman Blackburn. “Every member of this committee should agree to work together to tackle this issue aggressively. We should recognize that this transition is underway and these challenges are not insurmountable. According to an FCC report, twelve states report that NG911 is operational in 100 percent of the state – my home state of Tennessee among them. A solid start for our nation but well short of where I think we need to be.” A background memo, witness testimony, and an archived webcast of the hearing can be found on the Energy and Commerce Committee’s website HERE. ###  Read More

Walden & Upton Comment on Westinghouse Bankruptcy Announcement

2017/03/29

WASHINGTON, DC – Energy and Commerce Committee Chairman Greg Walden (R-OR) and Subcommittee on Energy Chairman Fred Upton (R-MI), today issued the following statement after Westinghouse announced this morning that they were filing for Chapter 11 bankruptcy protection. “Nuclear is and must remain a vital component of a reliable, affordable, and diverse electricity portfolio. Despite today's news, we remain confident that progress on the new reactors under construction at the Vogtle site in Georgia and V.C. Summer site in South Carolina will continue,” said Walden and Upton. "We believe a robust domestic nuclear industry is critical for the United States to remain a leader in the global market. The committee will continue to monitor the situation as it progresses.” ###  Read More

Federal Energy Related Tax Policy and its Effects on Markets, Prices, and Consumers

2017/03/29

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Realizing Nationwide Next-Generation 911

2017/03/29

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HEARING: #SubEnvironment to Examine Legislation Related to EPA’s Brownfields Program

2017/03/28

WASHINGTON, DC – The Subcommittee on Environment, chaired by Rep. John Shimkus (R-IL), today announced a hearing for Tuesday, April 4, 2017, at 10 a.m. in room 2123 of the Rayburn House Office Building. The hearing is entitled, “Discussion Draft: Brownfields Reauthorization.” The committee and #SubEnvironment have a long track record when it comes to examining EPA’s Brownfields Program under the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA). Just last year, the committee held a hearing to identify issues with the Brownfields Program that can be addressed through legislation as well as to examine environmental liability concerns and potential financial and legal barriers to getting sites cleaned up. The subcommittee has also looked at how successful the Brownfields Program is at leveraging grant money and at how cleaning up brownfields sites will encourage economic development. Members of the subcommittee will look at a discussion draft of a Brownfields reauthorization bill that makes several improvements to the Brownfields Program. “The EPA’s Brownfields Program is an important tool used by states, local government, and private stakeholders to clean up under-used or abandoned industrial and commercial properties in order to economically redevelop these sites to return them to beneficial use,” said Chairman Shimkus. “Next week’s legislative hearing will provide us the opportunity to look at ways to promote investment in new infrastructure projects and also better utilize existing infrastructure while seeking to improve the Brownfields Program.” The Majority Memorandum, witness list, and witness testimony for the hearing will be available here as they are posted. ###  Read More

House Advances Resolution Rolling Back FCC’s Flawed ISP Privacy Rules

2017/03/28

WASHINGTON, DC – The House of Representatives today advanced S.J. Res 34, a Congressional Review Act resolution rolling back the Federal Communications Commission’s (FCC) flawed privacy rules. The Senate last week passed the resolution and #SubCommTech Chairman Marsha Blackburn (R-TN) introduced an identical resolution in the House earlier this month.  The CRA allows Congress to nullify overreaching agency regulations by passing a joint resolution of disapproval. For decades, the Federal Trade Commission (FTC) had been America’s sole online privacy regulator and under the FTC, our internet economy and data economy thrived. In a bid to expand its own power, the Federal Communications Commission stripped the FTC of its jurisdictional authority and reclassified Internet Service Providers (ISPs) as common carriers. The FCC’s power grab created a dual track system in which the FCC applies its own set of rules for ISPs while the FTC monitors the rest of the internet ecosystem. “The FCC’s broadband privacy rules will harm consumers by creating confusion within the internet-ecosystem and we are dedicated to ensuring the most effective and efficient privacy protections possible,” said Chairman Blackburn. “These rules are nothing more than a big government power grab that will hurt hardworking taxpayers, and I’m thankful the House took an important step today in protecting consumers and the future of internet innovations.”  Energy and Commerce Committee Chairman Greg Walden (R-OR) concluded, “This resolution reverses overreaching, shortsighted, and misguided rules adopted by unelected bureaucrats at the Federal Communications Commission that do little to enhance privacy, but clearly add a new layer of federal red tape on innovators and job creators. Once these rules are reversed, the FCC can again work effectively with the FTC to ensure that our privacy framework allows the internet to flourish while truly protecting consumers.” ###  Read More

HEARING: #SubOversight to Examine Improvements to Health Care Cybersecurity Efforts

2017/03/28

WASHINGTON, DC – The Subcommittee on Oversight and Investigations, chaired by Rep. Tim Murphy (R-PA), announced a hearing for Tuesday, April 4, 2017, at 10:15 a.m. in room 2322 of the Rayburn House Office Building. The hearing is entitled, “Cybersecurity in the Health Care Sector: Strengthening Public-Private Partnerships.” #SubOversight will examine the need for greater coordination and leadership on cybersecurity issues across the health care industry. Specifically, members will have the opportunity to review persistent challenges in public-private partnerships for health care cybersecurity and key areas in need of improvement. “Efforts to boost our cybersecurity in the health care sector have been sporadic and largely ineffective,” said Chairman Murphy. “We need to strengthen our cybersecurity infrastructure across the board. I look forward to hearing ideas from private sector experts on how to improve engagement and leadership to accomplish that goal.” The Majority Memorandum, witness list, and witness testimony for the hearing will be available here as they are posted. ### Read More

#SubDCCP Discusses Benefits of Driver Assistance Systems

2017/03/28

[[{"fid":"2483","view_mode":"default","fields":{"format":"default","field_file_image_alt_text[und][0][value]":false,"field_file_image_title_text[und][0][value]":false},"type":"media","field_deltas":{"1":{"format":"default","field_file_image_alt_text[und][0][value]":false,"field_file_image_title_text[und][0][value]":false}},"link_text":null,"attributes":{"height":"245","width":"480","class":"media-element file-default","data-delta":"1"}}]] WASHINGTON, DC – The Subcommittee on Digital Commerce and Consumer Protection, chaired by Rep. Bob Latta (R-OH), today held a hearing to discuss the benefits of automated technology available in self-driving cars. During the hearing, members learned about the advantages of crash avoidance technologies and how this innovation is improving safety on the roadways. During his opening statement, Chairman Latta spoke to the ways that advanced driver assistance systems are changing the marketplace and providing significant safety benefits. “Advanced driver assistance systems are crash avoidance technologies that can protect drivers, reduce crashes, and enhance the convenience of driving. ‘Forward Collision Warning,’ ‘Blind Spot Detection,’ and ‘Lane Departure Warning’ are examples of advanced driver assistance systems.  These systems help drivers make safer decisions on the road by providing real-time information about surrounding roadway activity.” Speaking to the innovative features available in this market, as well as the testing and deployment process in place for the technologies, was Jeff Klei, President of the North America Automotive Divisions at Continental. “Our Vision Zero philosophy is embedded in each technology we develop as we continue to enable automated driving. At Continental, we describe our systems approach through three primary actions—sense, plan, and act.” He continues, “Sophisticated sensor systems can help eliminate human error and distractions by providing 360-degree awareness of the road at all times...” The Director of Federal Programs at SAE International, Bill Gouse, testified on the work of its association to provide voluntary recommendations and guidance for automated vehicles. After briefly describing the classification system they developed to define six different levels of driving automation, he continued, “[W]hile work continues to improve passive safety and crashworthiness of vehicles, the potential of implementing technological solutions to avoid or reduce the severity of crashes is a major focus of our members’ committee activities.” [[{"fid":"2482","view_mode":"default","fields":{"format":"default","field_file_image_alt_text[und][0][value]":false,"field_file_image_title_text[und][0][value]":false},"type":"media","field_deltas":{"1":{"format":"default","field_file_image_alt_text[und][0][value]":false,"field_file_image_title_text[und][0][value]":false}},"link_text":null,"attributes":{"height":"310","width":"480","class":"media-element file-default","data-delta":"1"}}]] Speaking to the safety benefits of automated technology was Dr. Kay Stepper, the Vice President for Automated Driving and Driver Assistance Systems at Bosch. He relayed, “The truth is that many drivers and passengers are already experiencing the benefits of vehicle automation every day. The active safety system Electronic Stability Control (ESC) is integrated in to every new passenger car sold in the United States. This revolutionary technology, invented by Bosch engineer Dr. Anton van Zanten, has saved thousands of lives.”  He added that Tuesday’s hearing touches on “two topics that lie at the heart” of the transition to vehicular autonomy: “the levels of automation and the importance of the deployment of driver assistance systems.” Full committee chairman Walden concluded, “We often say that the development of self-driving cars is a life-saving endeavor. Following a devastating year on our nation’s roads, this could not be truer now.” For more information on today’s hearing, including a background memo, witness testimony, and archived webcast, click HERE. Read More

#SubHealth Looks at Reauthorization of Medical Device User Fee Program

2017/03/28

WASHINGTON, DC – The Subcommittee on Health, chaired by Rep. Michael C. Burgess, M.D. (R-TX), today held a hearing examining the medical device user fee program. As reauthorized by the Food and Drug Administration Safety and Innovation Act (FDASIA) of 2012, the Medical Device User Fee Amendments (MDUFA) support the review and regulation of medical devices. “In 2009, it took an average of 427 days before FDA even reached a decision on a premarket approval application (PMA). As of 2015, the average review time was down to 276 days – a 35 percent decrease. More work lies ahead, but great strides have been made,” stated full committee Chairman Walden (R-OR). “FDASIA included meaningful regulatory reforms, improved communication between industry and FDA, and increased accountability at the Center for Devices and Radiological Health (CDRH). It is important that the next medical device user fee agreement continue to build upon the progress made in FDASIA, as well as the good policies members of this subcommittee championed in the 21st Century Cures Act,” said Chairman Burgess. “I am encouraged that the proposed agreement transmitted to Congress in January contains many promising elements that will be good for FDA, industry, and most importantly, patients.” Rep. Fred Upton (R-MI) highlighted the artificial pancreas as an innovative advancement made possible through this process. In this exchange with Dr. Jeffrey Shuren, Director of FDA’s CDRH, Rep. Upton asked what other once-thought impossible advancements are on the horizon. Dr. Shuren said we can expect to see more user robotics and less invasive surgeries – like using an ultrasound for a surgical procedure instead of a scalpel. “I think the U.S. can truly be the world’s leader if we continue on the trajectory we’ve been on,” stated Dr. Shuren. Ms. Diane Wurzburger, Executive of Regulatory Affairs for GE Healthcare, spoke as member of the Medical Imaging and Technology Alliance (MITA), saying, “Advancements in medical imaging are transforming health care through earlier disease detection, less invasive procedures and more effective treatments. …This agreement, negotiated between FDA and the medical device industry, advances our shared goals of ensuring that patients have timely access to the most innovative devices and diagnostics necessary for the public health.” For more information on today’s hearing, including a background memo, witness testimony, and archived webcast, click HERE. ### Read More

Committee Leaders Comment on Administration’s Energy Executive Order

2017/03/28

WASHINGTON, DC – Energy and Commerce Committee Chairman Greg Walden (R-OR), Energy Subcommittee Chairman Fred Upton (R-MI), and Environment Subcommittee Chairman John Shimkus (R-IL), today issued the following statement after President Trump signed an executive order rolling back several Obama-era energy regulations. “As the committee’s oversight record shows, the previous administration’s expansive and legally controversial interpretations of EPA’s authorities under the Clean Air Act created federal influence over state electricity systems never considered by Congress. The Clean Power Plan and related rules inappropriately elevated EPA’s influence in state energy decisions and threatened serious economic harms to the workers and consumers who benefited from a robust coal sector and reliable, affordable electric power,” said Walden, Shimkus, and Upton. “Following through on his promises, President Trump’s executive order today marks a return to the appropriate interpretation of the law and respect for state interests. This will provide the regulatory certainty needed to grow our economy and lead to environmental rules that promote the productive and innovative capacity of American enterprise. Looking forward, we will continue to monitor EPA’s rulemakings with respect to the power sector and ways to keep electricity reliable, efficient, and affordable.” For a summary and links to the committee’s Clean Air Act hearings, legislation, and oversight during the 112th-114th Congresses, click HERE. ###  Read More

Examining FDA’s Medical Device User Fee Program

2017/03/28

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Self-Driving Cars: Levels of Automation

2017/03/28

[[{"fid":"2470","view_mode":"full","fields":{"format":"full"},"type":"media","field_deltas":{"1":{"format":"full"}},"link_text":null,"attributes":{"alt":"Self-Driving Cars: Levels of Automation.","height":"380","width":"640","class":"media-element file-full","data-delta":"1"}}]] Read More

ICYMI: Latta on Promise and Safety Benefits of Self-Driving Cars

2017/03/27

WASHINGTON, DC – The Subcommittee Chairman on Digital Commerce and Consumer Protection Bob Latta (R-OH) penned a piece to Axios ahead of Tuesday’s hearing on the benefits of vehicle automation. In the op-ed, Chairman Latta discusses the potential stemming from this technology including increased mobility and safety. Encouraging a measured approach by Congress, and responsible oversight of this emerging industry, Chairman Latta relays that innovation and technology can go hand in hand to provide new opportunities for millions of Americans. Read the full op-ed below. [[{"fid":"2474","view_mode":"full","fields":{"format":"full","field_file_image_alt_text[und][0][value]":false,"field_file_image_title_text[und][0][value]":false},"type":"media","field_deltas":{"1":{"format":"full","field_file_image_alt_text[und][0][value]":false,"field_file_image_title_text[und][0][value]":false}},"link_text":null,"attributes":{"height":"116","width":"349","class":"media-element file-full","data-delta":"1"}}]] March 28, 2017 The Potential of Self-Driving Cars By Chairman Bob Latta (R-OH) Every year on our nation's roadways, more than 35,000 people tragically lose their lives due to traffic accidents—a large number of them caused by distracted driving. With so many traffic fatalities resulting from human error, we have to ask ourselves if there is a better way. American innovation may have the answer to this problem — in the form of self-driving cars. While it may seem like science fiction, the reality is that technological breakthroughs have allowed for deployment of these cars to be right around the corner. Recently, I chaired a hearing of the Digital Commerce and Consumer Protection Subcommittee where my colleagues and I listened to industry leaders testify about the possibilities of their self-driving vehicles. The takeaway was clear: the heavy hand of government can't obstruct the development of such vital, life-saving technology. While there is no doubt that safety parameters will be needed, we should be leaving the innovating to the innovators. Of course, self-driving cars are not just about improving safety; they would positively impact the quality of life for countless Americans. For instance, the increased mobility that self-driving cars would provide for individuals with disabilities or underserved communities would make it easier for them to get to and from their job, take a trip to the grocery store, and go to the doctor.  At the same time, seniors would be aided by the use of self-driving cars as well. Many of us can think of family members that will benefit from the freedom that this new form of transportation would provide. So, what role does Congress play with such brand-new technology? The first role is to be both a listener and observer. While concerns of government overreach were mentioned in our recent hearing, these stakeholders also brought up the difficulty of planning, testing, and deploying technology with the prospect of facing an inconsistent patchwork of rules across 50 different states. We have to ensure that innovators have the certainty they need to thrive. Like game-changing innovation of the past 50 years — the personal computer, the mobile phone, and the internet — self-driving cars have the potential to improve the lives of millions. Congress needs to take the right, measured approach to allow innovative minds do what they do best and change the world. Read the op-ed in its entirety here.   Read More

Committee Leaders Comment on Approval of Keystone XL Pipeline

2017/03/24

WASHINGTON, DC – Energy and Commerce Committee Chairman Greg Walden (R-OR), Subcommittee on Energy Chairman Fred Upton (R-MI), and Subcommittee on Environment Chairman John Shimkus (R-IL), today issued the following statement after the State Department approved the Keystone XL pipeline. “We’ve turned a new page under this administration and the days of government holding back energy development are a thing of the past,” said Walden, Upton, and Shimkus. “Now we can begin to roll-back red tape and enact policies that create jobs and promote economic growth. A key component to modernizing the nation’s energy infrastructure and keeping up with the nation’s growing production of oil and gas will be ensuring projects aren’t bogged down in permitting delays – like Keystone XL pipeline was for so long. We’re looking forward to continuing to work on enacting policies that promote American businesses and benefit American consumers.” ###  Read More

#SubCommTech Chairman Blackburn Applauds Senate Passage of Privacy CRA

2017/03/23

WASHINGTON, DC – Communications and Technology Subcommittee Chairman Marsha Blackburn (R-TN) today issued the following statement after the Senate passed a broadband privacy CRA. Chairman Blackburn has introduced an identical privacy CRA in the House. “I applaud the Senate’s vote today to roll back the FCC’s overreach. When the FCC adopted unnecessary and discriminatory rules for ISPs it didn’t improve Americans online privacy, it harmed it by taking the FTC off the job,” said Chairman Blackburn. “Today’s action takes us one step closer to restoring the FTC’s role as America’s expert agency on privacy.” ###  Read More

#SubEnergy to Examine Federal Energy Tax Policy and its Effect on Markets, Prices, and Consumers

2017/03/22

WASHINGTON, DC – The Subcommittee on Energy, chaired by Rep. Fred Upton (R-MI), today announced a hearing for Wednesday, March 29, 2017, at 10:15 a.m. in room 2322 of the Rayburn House Office Building. The hearing is entitled, “Federal Energy Related Tax Policy and its Effects on Markets, Prices, and Consumers.”  The federal government has several tools it can use to influence energy policy, one of which is to provide support for energy development, production, and use of fuels and energy technologies through the tax code or spending programs administered by the Department of Energy (DOE). In fact, the tax code has played a significant role in driving energy policy by providing targeted incentives for fossil fuels, nuclear power, renewable energy, and energy efficiency technologies. #SubEnergy will examine the history of energy-related tax policies and their effect on energy and electricity markets, prices, and most importantly on consumers.   “Our nation’s energy landscape has changed for the better, with technological innovation driving changes in how we produce, deliver, and consume energy. Tax code provisions have played a role in this transformation. With tax reform on the horizon, it is important for us to understand how these policies can leave lasting impacts on energy and electricity markets, prices, and consumers,” said Chairman Upton. The Majority Memorandum, witness list, and witness testimony for the hearing will be available here as they are posted. ###  Read More

NEXT WEEK: #SubCommTech to Examine Nation’s 911 Networks

2017/03/22

WASHINGTON, DC – The Communications and Technology Subcommittee, chaired by Rep. Marsha Blackburn (R-TN), today announced a hearing for Wednesday, March 29, 2017, at 10 a.m. in room 2123 of the Rayburn House Office Building. The hearing is entitled, “Realizing Nationwide Next-Generation 911.” The voice, text, video and data capabilities of today’s smartphones have redefined the way we communicate and live our lives. Our nation’s first responders will soon have the robust broadband communications capabilities of FirstNet. But the nation’s 911 network – which ties the public to our first responders – may not be keeping pace with these technologies. Next week, #SubCommTech will examine where the nation currently stands in modernizing 911 services with these next generation technologies and avenues to move this critical component to public safety forward. “It’s imperative our 911 systems take advantage of 21st century smartphones and networks,” said Chairman Blackburn. “Next week’s hearing will provide our members an opportunity to look at things that are working, things that may not be working, and what we can do to ensure that Americans have the benefits of 21st century technology when they need it most.” The Majority Memorandum, witness list, and witness testimony for the hearing will be available here as they are posted. ###  Read More

#SubHealth Looks at Reauthorization of Prescription Drug User Fee Act

2017/03/22

WASHINGTON, DC – The Subcommittee on Health, chaired by Rep. Michael C. Burgess, M.D. (R-TX), today held a hearing examining the Prescription Drug User Fee Act (PDUFA), which needs to be reauthorized before its expiration in September 2017. PDUFA supports the review and regulation of innovative drug products and helps ensure patients receive timely access to safe and effective new therapies. Discussed throughout the hearing was the 21st Century Cures Act, game-changing legislation to accelerate the discovery, development, and delivery of new cures and treatments. Dr. Janet Woodcock, Director of the Food and Drug Administration, Center for Drug Evaluation and Research, stressed the shared goals within Cures and PDUFA VI. Dr. Woodcock stated, “Center to PDUFA VI, and its largest single investment component, are plans to elevate patient voices in developing new drugs to treat their diseases. The agreement shares the committee’s goals reflected in the 21st Century Cures Act – and the highest priority of our stakeholders – to leverage essential patient input and insights to fight disease.” Chairman Burgess reiterated the shared goals of the 21st Century Cures, saying, “Over the course of the 113th and 114th Congresses, members of this subcommittee worked to uncover opportunities to strengthen and streamline the process by which cures are discovered and made available to patients. The resulting law touches each step of the process through which new treatments and cures come to market. I am encouraged to see in our witnesses’ testimonies that PDUFA VI will dedicate resources to complement the implementation of many of the priorities in 21st Century Cures.” [[{"fid":"2469","view_mode":"full","fields":{"format":"full","field_file_image_alt_text[und][0][value]":false,"field_file_image_title_text[und][0][value]":false},"type":"media","field_deltas":{"1":{"format":"full","field_file_image_alt_text[und][0][value]":false,"field_file_image_title_text[und][0][value]":false}},"link_text":null,"attributes":{"height":"211","width":"315","class":"media-element file-full","data-delta":"1"}}]] Vice Chairman Guthrie listens to Dr. Woodcock. Vice Chairman Brett Guthrie (R-KY) asked Dr. Woodcock for an update on FDA’s Oncology Center of Excellence, a key component of 21st Century Cures and a committee-supported initiative. Dr. Woodcock elaborated on the center’s structure and the important work they’ll be doing. Mr. Jeff Allen, President and CEO of Friends of Cancer Research, spoke to the evolution of the user fee agreements, stating, “Over time, the FDA’s more active role in product development has led to expansions to the agreements between the FDA and the drug manufacturers that supply the user fees. Recent user fee agreements have allowed funds to be applied to activities that are beyond the primary application review functions, such as programs to advance the science that serves as the basis for new product development. In addition to funding core product review and personnel, the sixth authorization of the user fee agreement will support key projects that ensure the FDA can conduct scientific programming, participate in public workshops, and develop guidance for its employees and external stakeholders regarding cutting-edge science and new strategies for drug development and regulation.” #SubHealth recently held a hearing examining the Generic Drug User Fee Amendments (GDUFA) and the Biosimilar User Fee Act (BsUFA), both of which also expire in September 2017. The subcommittee will also hold a hearing next week examining FDA’s Medical Device User Fee Program. All of these user fee programs must be reauthorized by the end of Fiscal Year 2017. For more information on today’s hearing, including a background memo, witness testimony, and archived webcast, click HERE. ### Read More

#SubEnvironment Reviews Legislation to Provide States Flexibility when Implementing Ozone Standards

2017/03/22

WASHINGTON, DC – The Subcommittee on Environment, chaired by Rep. John Shimkus (R-IL), today held a hearing examining legislation that gives states the flexibility need to implement the National Ambient Air Quality Standards (NAAQS) for ground-level ozone on an efficient and realistic timeline. In October of 2015, while states and communities were just beginning to implement the 2008 standards following long-overdue EPA guidance, EPA revised those standards and imposed additional new planning and compliance obligations on states. H.R. 806, Ozone Standards Implementation Act of 2017, introduced by Subcommittee on Energy Vice Chairman Pete Olson (R-TX), builds on the committee’s work last year to enact targeted, commonsense reforms to provide states relief from simultaneously implementing plans for two ozone standards. H.R. 806 updates the Clean Air Act to provide state and local authorities the time and guidance necessary so they can more effectively implement ozone and other air quality standards going forward.   [[{"fid":"2467","view_mode":"full","fields":{"format":"full","field_file_image_alt_text[und][0][value]":false,"field_file_image_title_text[und][0][value]":false},"type":"media","field_deltas":{"1":{"format":"full","field_file_image_alt_text[und][0][value]":false,"field_file_image_title_text[und][0][value]":false}},"link_text":null,"attributes":{"height":"221","width":"342","class":"media-element file-full","data-delta":"1"}}]] Witnesses deliver testimony during today’s #SubEnvironment hearing Sean Alteri, Director of Air Quality at the Kentucky Department of Environmental Protection, declared his support for H.R. 806, stating, “The reasonable amendments proposed in H.R. 806 will further enable all of our states to continue to grow our economy, enhance our quality of life, and improve air quality.” Marc A. R. Cone, P.E., Director at the Bureau of Air Quality at the Maine Department of Environmental Protection, discussed the importance of additional time for air-quality standard setting and implementation, commenting, “The changes included in this bill would allow the EPA more time for strategies to be more thoughtfully developed, would help provide greater certainty within a more realistic timeframe for implementation of a new standard, and would allow for assessment of the effectiveness of control measures that have been put in place.” In his questioning with Seyed Sadredin, Executive Director and Air Pollution Control Officer at the San Joaquin Air Pollution Control District, Chairman Shimkus asked whether or not there was anything in H.R. 806 that would make his job more difficult in implementing air quality standards. Mr. Sadredin said, “There is nothing in this bill that would roll back even a single measure that we have already put in place or will hold back anything we have to do or are planning to do moving forward to meet the current standards. Nancy Vehr, Air Quality Administrator at the Wyoming Department of Environmental Quality, discussed why EPA’s one-size-fits-all approach to regulating simply doesn’t work, commenting, “Wyoming’s characteristics as an expansive, high-elevation, sparsely populated rural state differs from EPA’s traditional focus. As a result, we face unique challenges in implementing the EPA’s Ozone Standards in Wyoming. … Wyoming’s experience highlights why a one-size-fits-all approach to Ozone is not defensible. One-size-fits-all does not fit Wyoming.” Chairman Shimkus delivers his opening statement “The Ozone Standards Implementation Act makes practical reforms to the Clean Air Act to streamline implementation of national air quality standards by state and local authorities,” concluded Chairman Shimkus. “These reforms seek to improve the states’ ability to meet the new ozone and other air-quality standards without undermining efforts to ensure and promote the productive capacity of their citizens.” A background memo, witness testimony, and an archived webcast of the hearing can be found online HERE. ###  Read More

Examining FDA’s Prescription Drug User Fee Program

2017/03/22

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H.R. 806, Ozone Standards Implementation Act of 2017

2017/03/22

[[{"fid":"2443","view_mode":"full","fields":{"format":"full"},"type":"media","field_deltas":{"1":{"format":"full"}},"link_text":null,"attributes":{"alt":"HR 806, Ozone Standards Implementation Act of 2017.","height":"380","width":"640","class":"media-element file-full","data-delta":"1"}}]] Read More

HEARING: #SubHealth to Continue User Fee Hearings, Examining MDUFA

2017/03/21

WASHINGTON, DC – The Subcommittee on Health, chaired by Rep. Michael C. Burgess, M.D. (R-TX), announced a hearing for Tuesday, March 28, 2017, at 10:15 a.m. in room 2123 of the Rayburn House Office Building. The hearing is entitled, “Examining FDA’s Medical Device User Fee Program.” The Medical Device User Fee Amendments (MDUFA), as reauthorized by the Food and Drug Administration Safety and Innovation Act (FDASIA) of 2012, supports the review and regulation of medical devices. The Health Subcommittee recently held a hearing examining the Generic Drug User Fee Amendments (GDUFA) and the Biosimilar User Fee Act (BsUFA), both of which also expire in September 2017, and will hold a hearing examining the Prescription Drug User Fee Act (PDUFA) on Wednesday. All of these user fee programs must be reauthorized by the end of Fiscal Year 2017. “Medical devices play an increasingly important role in improving and often prolonging the lives of patients with a wide range of conditions and diseases,” said Chairman Burgess. “Both FDASIA and the 21st Century Cures Act included numerous provisions improving the device development and review process and I look forward to learning more about how the proposed MDUFA agreement would build upon these efforts to benefit patients and foster innovation.” The Majority Memorandum, witness list, and witness testimony for the hearing will be available here as they are posted. ### Read More

#SubDCCP to Examine Automated Technology in Self-Driving Cars

2017/03/21

WASHINGTON, DC – The Subcommittee on Digital Commerce and Consumer Protection, chaired by Rep. Bob Latta (R-OH), today announced a hearing for Tuesday, March 28, 2017, at 10:00 a.m. in room 2322 of the Rayburn House Office Building. The hearing is entitled, “Self-Driving Cars: Levels of Automation.” Advanced driver assistance systems and crash avoidance technologies have been on the market for over a decade. These safety technologies are reducing crashes, improving driver awareness, and laying the groundwork for fully-autonomous driving.  Next week, members will take another look at self-driving cars, exploring the different levels of vehicle automation and how today’s driver assistance systems are making roads safer.  Members will also examine how crash avoidance systems are being deployed and how they are building consumer confidence in automated driving systems. “Next week’s hearing allows members to explore the benefits of automated technology in self-driving cars and learn how this innovation is keeping drivers safe, decongesting roadways, and reducing crashes,” said Chairman Latta. “I look forward to learning how crash avoidance systems are implemented and the direct impact this has on improving safety and traffic flow. Understanding the various levels of vehicle automation is important to recognizing the full potential of self-driving cars, and next week’s witnesses will provide a detailed account of how these technologies are changing lives for the better.                    The Majority Memorandum, witness list, and witness testimony for the hearing will be available here as they are posted. Read More

#SubOversight Examines Deadly Fentanyl Crisis

2017/03/21

[[{"fid":"2457","view_mode":"full","fields":{"format":"full","field_file_image_alt_text[und][0][value]":false,"field_file_image_title_text[und][0][value]":false},"type":"media","field_deltas":{"1":{"format":"full","field_file_image_alt_text[und][0][value]":false,"field_file_image_title_text[und][0][value]":false}},"link_text":null,"attributes":{"height":"258","width":"467","class":"media-element file-full","data-delta":"1"}}]] WASHINGTON, DC – The Subcommittee on Oversight and Investigations, chaired by Rep. Tim Murphy (R-PA), today held a hearing examining fentanyl, a synthetic opioid that is 50 times more potent than heroin and 100 times more potent than morphine. While fentanyl is a tightly controlled prescription medicine used to treat extreme pain, it is also easy and cheap to illicitly manufacture, making it easy to find on the streets and the Internet. Rep. Michael C. Burgess, M.D. (R-TX) reiterated how easy it is to obtain illicit fentanyl, saying, “I went online and looked at how to order fentanyl online just while we’re sitting here and there are a lot of opportunities.” Mr. William Brownfield, Assistant Secretary of State, International Narcotics and Law Enforcement Affairs at the U.S. Department of State, said we are moving “in a positive direction” when it comes to working with other nations involved in the production and trafficking of fentanyl. “We have a dialogue, we are talking to one another,” Mr. Brownfield added. [[{"fid":"2458","view_mode":"full","fields":{"format":"full","field_file_image_alt_text[und][0][value]":false,"field_file_image_title_text[und][0][value]":false},"type":"media","field_deltas":{"1":{"format":"full","field_file_image_alt_text[und][0][value]":false,"field_file_image_title_text[und][0][value]":false}},"link_text":null,"attributes":{"height":"247","width":"467","class":"media-element file-full","data-delta":"1"}}]] “The threat posed by heroin has continued to grow dramatically over the past several years – between 2007 and 2015, deaths involving heroin have risen 441 percent, from 2,402 to 12,990, and since 2013, available public health data indicate fentanyl-laced heroin has been increasingly involved in these deaths,” said Kemp Chester, Acting Director of the Office of National Drug Control Policy. “In 2015, 9,580 drug overdose deaths involved synthetic opioids other than methadone (a statistical category that is dominated by fentanyl), up from 3,105 deaths in 2013, a 209 percent increase.” “Those suffering from an overdose involving fentanyl may require both higher doses and multiple administrations of naloxone to reverse the overdose and to become stabilized,” explained Chairman Murphy. “Even the police and first responders are at risk from inadvertently touching or inhaling fentanyl powder at a crime scene or helping an overdose victim.” Rep. Susan Brooks (R-IN) reiterated the concern about first responders arriving to a scene with fentanyl, highlighting her experience as U.S. Attorney in Southern District of Indiana from 2001-2007, saying, that there has not been much discussion about how dangerous contact with fentanyl can be. Mr. Matthew Allen, Assistant Director, Homeland Security Investigative Programs, Homeland Security Investigations, US. Immigration and Customs Enforcement at the Department of Homeland Security, spoke to current training exercises their agents have taken part in to physically prepare for fentanyl being on scene. Full committee Chairman Greg Walden (R-OR) highlighted recent action at the United Nations, supported by China, which would dramatically limit the supply of two precursors to fentanyl from being shipped. This process would provide national authorities of the country receiving the shipment with basic information about the shipment – when it will arrive, how much is being shipped, the purpose of the shipment, etc. “This is a way to shutdown the diversion of legal and illicitly produced fentanyl,” explained Mr. Brownfield. Chairman Walden praised this effort, saying similar efforts helped dramatically reduce problems with the supply of methamphetamine precursor ingredients in Oregon and other states. For more information on today’s hearing, including a background memo, witness testimony, and archived webcast, click HERE. ### Read More

#SubCommTech Examines Opportunities to Boost Broadband Deployment and Infrastructure

2017/03/21

WASHINGTON, DC – The Communications and Technology Subcommittee, chaired by Rep. Marsha Blackburn (R-TN), today held a hearing examining barriers to broadband deployment throughout the country. In addition to receiving testimony from two panels of witnesses, #SubCommTech looked at two discussion drafts aimed at alleviating the burden and eliminating the red tape when it comes to deploying broadband throughout the country. Discussion Draft to facilitate the deployment of communications infrastructure, would; Create an inventory of federal assets that can be used to attach or install broadband infrastructure, Require all landholding agencies to use common templates when leasing space for wireless broadband attachments, and; Streamline processes for communications facilities locations applications at the Department Interior and Forest Service. Discussion Draft Broadband Conduit Deployment Act of 2017, would; Mandate the inclusion of broadband conduit during the construction of certain highway projects that receive federal funding. There is general agreement among the federal government, private industry, and public stakeholders that the framework of federal permitting, siting, and permissions to access rights-of-way present a barrier to investment and are slowing broadband deployment. Broadband infrastructure is particularly lacking in rural areas throughout the country and consumers in these areas are falling behind their urban counterparts in what has been described as the “digital divide.”  “Lack of broadband access, particularly in rural areas, is an issue which affects the constituents of numerous members of the subcommittee, Republican and Democrat,” said Chairman Blackburn. “We must cut through the red tape by streamlining permitting processes and implement accurate availability data in order to solve the broadband dilemma.”   Joanne S. Hovis, President of CTC Technology and Energy, spoke to the importance of public-private partnerships when deploying broadband, stating, “By working cooperatively with state and local governments, the private sector stands to benefit in multiple ways – as partners, as users of the networks to market their goods and services in the rapidly emerging information-based global economy, and as contributors to the next generation of innovations.” Thomas Murray, Founder and Managing Member of Community Wireless Structures and Chairman of the Board of Directors at the Wireless Infrastructure Association, echoed Ms. Hovis’ testimony, commenting, “To reap the tremendous benefits of next generation broadband, we must all work together to encourage and incentivize responsible and efficient wireless infrastructure deployment. Your draft bill is a significant and positive step in that direction, and there is much work to be done.”  [[{"fid":"2456","view_mode":"full","fields":{"format":"full","field_file_image_alt_text[und][0][value]":false,"field_file_image_title_text[und][0][value]":false},"type":"media","field_deltas":{"1":{"format":"full","field_file_image_alt_text[und][0][value]":false,"field_file_image_title_text[und][0][value]":false}},"link_text":null,"attributes":{"height":"217","width":"261","class":"media-element file-full","data-delta":"1"}}]] Chairman Blackburn listens to witness testimony “We are all tired of hearing stories about parents driving their children to the local McDonald’s for Internet access in order to finish their homework assignments. We owe them better, period. The 5G revolution is upon us and we should modernize our laws to address issues such as tower siting and federal rights of ways, which are tying the hands of the private sector,” concluded Chairman Blackburn. “Unleashing broadband will create economic, educational and healthcare opportunities for millions of hardworking taxpayers.” A background memo, witness testimony, and an archived webcast of the hearing can be found on the Energy and Commerce Committee’s website HERE. ###  Read More

ICYMI: WSJ Touts Stability Fund Within House GOP Health Care Bill

2017/03/21

WASHINGTON, DC – As the House gears up to vote on landmark legislation that would repeal Obamacare and replace it with a patient-centered, 21st century health care system, The Wall Street Journal highlights a critical provision within the GOP plan: The Patient and State Stability Fund. It’s no secret that Obamacare has experienced a death spiral, and its individual insurance market is largely to blame. The good news, however, is that the American Health Care Act (AHCA) presents us with a #BetterWay. The creation of the Patient and State Stability Fund will help repair state markets damaged by Obamacare. It will lower patient costs, stabilize markets, and provide states with greater flexibility– allowing each to use the funds to cut out-of-pocket costs for patients and families. The House plan will help lower the cost of care for some of our nation’s most vulnerable, and the Patient and State Stability Fund helps ensure that. Read more below. [[{"fid":"2454","view_mode":"full","fields":{"format":"full","field_file_image_alt_text[und][0][value]":false,"field_file_image_title_text[und][0][value]":false},"type":"media","field_deltas":{"1":{"format":"full","field_file_image_alt_text[und][0][value]":false,"field_file_image_title_text[und][0][value]":false}},"link_text":null,"attributes":{"height":"44","width":"387","class":"media-element file-full","data-delta":"1"}}]] March 21, 2017 Saving Private Health Insurance By WSJ Editorial Board The biggest gamble in the House health-care bill is whether it includes enough reform to arrest the current death spiral in the individual insurance market. No one knows for sure, but critics are overlooking important provisions that will help people who are now exposed to ObamaCare’s rapidly rising premiums. Notably, the bill includes a new 10-year $100 billion “stability fund” that allows states to start to repair their individual insurance markets. Before ObamaCare, it wasn’t inevitable that costs would increase by 25% on average this year, or that nearly a third of U.S. counties would become single-insurer monopolies. With better policy choices, states can make coverage cheaper and more attractive for consumers and coax insurers back into the market, and the stability fund is a powerful tool. Governors could draw on the stability fund, for instance, to reestablish the high-risk pools that prevailed in 35 states before ObamaCare. The Affordable Care Act uses regulatory mispricing to force the young to make a transfer to the old, and the healthy to the sick. The result has been insurance that the young and healthy don’t want to buy or can’t afford. Risk pools can mitigate this cycle by removing the people with the highest costs. Over time, they can generate a compounding effect with stable or even falling premiums, which begets growing enrollment, which begets more insurer participation. … States could also decide to use the stability fund to supplement premiums and out-of-pocket costs to help people with lower incomes or chronic conditions. Or they could target the heroin and fentanyl crisis. Death rates from opiod overdoses now exceed those from HIV/AIDS at the height of the epidemic in the 1990s. The larger goal is to start to restore the traditional state regulatory authority over heath insurance that ObamaCare supplanted for federal control. Local governments understand local needs best. With more flexibility, autonomy and accountability, the GOP hope is that reform Governors can pry open markets and help promote a larger and more dynamic business. … Republicans have an obligation to try to revitalize insurance markets, and not only because Americans depend on coverage. Repealing and replacing ObamaCare is also an opportunity to show that conservative ideas can work in health care. The reason the opposition is so furious is that liberals fear they might succeed. To read the full column online, click here. ### Read More

Fentanyl: The Next Wave of the Opioid Crisis

2017/03/21

[[{"fid":"2442","view_mode":"full","fields":{"format":"full"},"type":"media","field_deltas":{"1":{"format":"full"}},"link_text":null,"attributes":{"alt":"Fentanyl: The Next Wave of the Opioid Crisis.","height":"380","width":"640","class":"media-element file-full","data-delta":"1"}}]] Read More

Broadband: Deploying America's 21st Century Infrastructure

2017/03/21

[[{"fid":"2441","view_mode":"full","fields":{"format":"full"},"type":"media","field_deltas":{"1":{"format":"full"}},"link_text":null,"attributes":{"alt":"Broadband: Deploying America’s 21st Century Infrastructure.","height":"380","width":"640","class":"media-element file-full","data-delta":"1"}}]] Read More

Murphy on Fentanyl Crisis: “We must act, and act now.”

2017/03/21

WASHINGTON, DC – Ahead of today’s #SubOversight hearing, Chairman Tim Murphy (R-PA) previews the growing public health threat of fentanyl, a synthetic opioid that is 50 times more potent than heroin and 100 times more potent than morphine. Watch the video below and be sure to tune into today’s hearing, “Fentanyl: The Next Wave of the Opioid Crisis” at 10:15 a.m. [[{"fid":"2450","view_mode":"full","fields":{"format":"full","field_file_image_alt_text[und][0][value]":false,"field_file_image_title_text[und][0][value]":false},"type":"media","field_deltas":{"1":{"format":"full","field_file_image_alt_text[und][0][value]":false,"field_file_image_title_text[und][0][value]":false}},"link_text":null,"attributes":{"height":"263","width":"468","class":"media-element file-full","data-delta":"1"}}]] Click here to watch the video. ### Read More

Murphy in Morning Consult: “The fentanyl crisis needs our immediate attention…”

2017/03/21

WASHINGTON, DC – #SubOversight will continue its investigation today of the opioid epidemic that’s waged tremendous loss in every American community. The focus will be the third wave of the epidemic, fentanyl. Learn more from #SubOversight Chairman Tim Murphy (R-PA) about the synthetic opioid that’s 50 times more potent than heroin and 100 times more potent than morphine. [[{"fid":"2449","view_mode":"full","fields":{"format":"full","field_file_image_alt_text[und][0][value]":false,"field_file_image_title_text[und][0][value]":false},"type":"media","field_deltas":{"1":{"format":"full","field_file_image_alt_text[und][0][value]":false,"field_file_image_title_text[und][0][value]":false}},"link_text":null,"attributes":{"height":"52","width":"311","class":"media-element file-full","data-delta":"1"}}]] March 21, 2017 Fentanyl: The Next Wave of the Opioid Crisis By Rep. Tim Murphy (R-PA) Communities across the country have felt the devastating effects of the opioid epidemic. It knows no bounds and takes a crippling hold on families in our very own neighborhoods. We’re in the midst of a rampant opioid epidemic that has surged in three successive waves. The first involved prescription opioids. The second saw increased usage of heroin as many of those addicted to prescription opioids sought a different source of pain relief, for various reasons. The third wave has been fentanyl. The drug that killed Prince has been linked to a soaring amount of overdoses and deaths across the country.  Fentanyl is a staggering 50 times more potent than heroin and 100 times more potent than morphine. It has a high potential for abuse and can be fatal in incredibly small amounts.  Drug traffickers frequently mix fentanyl with more expensive drugs such as heroin, cocaine, and counterfeit pills advertised to be a more common opioid. Often times, individuals do not specifically seek out fentanyl and do not know that they are taking something containing fentanyl. Fentanyl is uniquely dangerous because of its high potency and the speed with which it reaches the brain. Emergency medical personnel have reported finding patients dead with needles still in their arms. Rescues more frequently involve not one, but multiple administrations of the overdose reversal drug Naloxone. In March 2015, the Drug Enforcement Administration (DEA) issued a nationwide alert on fentanyl as a threat to health and public safety. A year later, the DEA sent another alert calling the spike in fentanyl seizures “an unprecedented threat.” Sadly, in the past year, fentanyl overdoses and deaths have only grown – signaling urgency in how we address the epidemic. The fentanyl killing Americans is not one chemical entity, but includes up to 19 chemical variations or analogues currently scheduled by the DEA. Yet, the number of potential fentanyl analogues is far higher. There is no exhaustive list of fentanyl analogues due to the existence of numerous chemical variations of fentanyl according to recent scientific literature. One of the known variations is carfentanil, a drug 100 times more deadly than fentanyl. Carfentanil is so dangerous that it is classified by international treaty as a chemical weapon. While carfentanil has been legitimately used to tranquilize large animals, such as elephants, the drug must be administered and handled in a hazmat suit because just a few granules the size of salt can be lethal.  Since late 2013, fentanyl and its analogues have contributed to at least 5,000 overdose deaths in the United States. Due to gaps in data collection and the fact that fentanyl is difficult for labs to detect, it is likely that the number of overdose deaths in the United States is actually much higher.  The business model of fentanyl illustrates why this drug is quickly becoming the driver of our nation’s drug overdose epidemic and why overdose deaths will continue to surge. The DEA estimates that a kilogram of heroin purchased from Colombia for roughly $6,000 can be sold wholesale for $80,000. However, a kilogram of pure fentanyl, purchased from China for less than $5,000, is so potent that it can be stretched into 16 to 24 kilograms when using cutting agents like talcum powder or caffeine. Each kilogram of fentanyl can be sold wholesale for $80,000—for a total profit in the neighborhood of $1.6 million.  The low-cost, high-profit, hard-to-detect profile of fentanyl is increasingly more attractive to traffickers. It is relatively easy for traffickers to manufacture or obtain on the street or Internet, especially from the dark web. An emerging threat is the illicit manufacturing of fentanyl in China, which is primarily shipped directly into the U.S. or to Mexico where it is processed at clandestine labs and then smuggled into the U.S by drug cartels such as El Chapo’s Sinaloa group. Although national data does not track fentanyl specifically, the sharpest increases in fatal opioid overdoses are in regions experiencing distribution of illicit fentanyl. This trend is consistent with statistics from the handful of states tracking fentanyl-related overdoses in 2015.  Without a distinctive and systematic response to the unique threat of fentanyl, law enforcement and our health care system may soon be overwhelmed. Other countries have realized to their horror that they were slow to react to the emergence of the fentanyl crisis.  America must not make that mistake – we need to act now. Today, we will hold a hearing kicking off the next phase of our efforts – examining this growing public health threat. The fentanyl crisis needs our immediate attention, and together we will work to strengthen our federal response. To read the column online, click here. ### Read More

House Republicans Announce Updates to Strengthen American Health Care Act

2017/03/20

This week the House is expected to vote on the American Health Care Act (AHCA)—legislation to repeal Obamacare and lay the foundation for a 21st century health care system based on what Americans want and need, not what Washington thinks is best. This bill is the product of months of work, dozens of hours of debate, and action in three House Committees— Energy & Commerce, Ways & Means, and Budget. After working on policies to further improve AHCA and ensure more Americans have access to quality, affordable health care, Energy & Commerce Committee Chairman Greg Walden (R-OR) and Ways & Means Committee Chairman Kevin Brady (R-X) introduced technical and policy amendments to the legislation. Upon introducing the amendments, the Chairmen said: “We’re taking additional action tonight to strengthen the American Health Care Act to better serve the millions of Americans who have been hurt by Obamacare. Our legislation includes ideas from Republican members who are committed to improving health care for patients and families across the country. We're confident these changes will set AHCA up for success in the House. We look forward to working with our Senate colleagues to get this bill over the finish line and send it to the President as quickly as possible. "President Trump deserves tremendous credit for rolling up his sleeves and working tirelessly to deliver on his healthcare promise to the American people.” Under the Energy and Commerce Committee's jurisdiction, the amendment would: Give states additional flexibility for their Medicaid programs. In order to better care for their unique populations, states and governors have asked for additional flexibility in the way they administer their Medicaid program. This amendment would allow states to opt out of the per capita allotment baseline and instead receive federal funds through a block grant. The grant would only apply to traditional adult and children Medicaid populations, with funding for elderly and disabled populations calculated through a per capita allotment.  After ten years, states that selected the block grant option could revisit whether or not to continue receiving block granted funds or return to a per capita allotment for their full Medicaid population. Give states the ability to implement optional work requirements for their Medicaid programs. To ensure Medicaid funds are focused on our most vulnerable populations and encourage healthy adults to transition into full-time employment, the amendment would allow states the flexibility to implement reasonable work requirements for able-bodied adults without dependents.  Modeled after work requirements in the Temporary Assistance for Needy Families (TANF) program, the requirement could be satisfied through employment, vocational or skills training, education in pursuit of employment, and community service among others. Freeze and Unwind Obamacare’s Medicaid expansion. As a first step, the amendment would prevent new states from opting in to Obamacare’s Medicaid expansion. Next, the underlying bill allows that beneficiaries who enroll in the expansion prior to December 31, 2019 to be “grandfathered” into the program, ensuring that states will continue to receive the enhanced funding levels, as long as those individuals remain in the program. As enrollees see their life circumstances and incomes change, they will naturally cycle off the program, allowing for a responsible unwinding of the expansion. Provide a more generous reimbursement for elderly and disabled Medicaid enrollees. Recognizing the unique needs of the elderly and the disabled, the amendment increases the annual inflation rate for the elderly and disabled Medicaid populations. This ensures that Medicaid spending on our most vulnerable more accurately reflects shifting demographics due to the aging of the Baby Boomers and the practical challenges of high-fixed costs for this vulnerable population. Under the Ways and Means Committee's jurisdiction, the amendment would: Deliver more immediate relief from Obamacare’s taxes. AHCA dismantles Obamacare’s crushing taxes and mandate penalties that have hurt patients, families, job creators, and health care providers. The legislation eliminates the individual and employer mandate penalties and delivers nearly $900 billion in tax relief. To provide more immediate help, the amendment accelerates repealing the Obamacare taxes to 2017, rather than 2018. This change will help ensure millions of individuals, families, and businesses who paid Obamacare’s penalties or taxes this year can reclaim their hard-earned dollars from the IRS. Additionally, the bill provides the maximum relief possible from the Cadillac tax, given the rules of the Senate. Ensure Americans have the help they need to access care that’s right for them. AHCA helps low- and middle-income individuals and families who do not receive health insurance through work or a government program access insurance by providing an advanceable, refundable tax credit. It also establishes a Patient and State Stability Fund, providing states $100 billion to design programs that meet the needs of their unique patient populations. To further ensure older Americans have the help they need to access the care that’s right for them, the amendment to AHCA would provide the financing for additional support for those with high health care costs before the bill goes to the Senate. Under current law, Americans can deduct from their taxes the cost of medical expenses that exceed 10 percent of their income. Our proposed amendment reduces this threshold to 5.8 percent of income. This change provides the Senate flexibility to potentially enhance the tax credit for those ages 50 to 64 who may need additional assistance. Combined with the current age-based tax credit and the Patient and State Stability Fund, which provides $100 billion to states to help targeted populations, our amendment to AHCA will provide meaningful support for the individuals and families who need it most. Protect life by prohibiting taxpayer dollars from being used for abortion services. AHCA prohibits taxpayer dollars, both through new tax credits and State Stability Funds, from being used for abortions and abortion coverage. The amendment specifically will help ensure individuals and families can only use the federally funded tax credit to help purchase insurance plans that do not cover abortions or abortion services.  CLICK HERE to read the technical amendments to AHCA. CLICK HERE to read the section-by-section of the technical amendments. CLICK HERE to read the policy amendments to AHCA. CLICK HERE to read a section-by-section of the policy amendments. CLICK HERE to read more about AHCA. ### Read More

Letter to Department of Energy Secretary Rick Perry Regarding Nuclear Waste Management Policy

2017/03/20

Excerpt: "You have a challenging task ahead as you constitute DOE's senior leadership team and develop your priorities and policies. We request that you work with us and committee staff to identify constructively a path forward to manage our nation's spent nuclear fuel as you fill out your leadership team and senior staff at the Department." To read the letter, click here.  To read DOE's response, click here.  Read More

CBO in Their Own Words: AHCA’s Patient and State Stability Fund

2017/03/17

WASHINGTON, DC – Earlier today we shared an explainer on a provision within the American Health Care Act (AHCA) that would provide solutions to help lower costs and repair insurance markets damaged by Obamacare: The Patient and State Stability Fund. This program provides states $100 billion over 10 years to promote innovative solutions to lower costs and increase access to health care for their unique patient populations. And while the Congressional Budget Office (CBO) has repeatedly missed the mark on the individual mandate, they appear to understand the value of giving states flexibility to innovate. Here’s what they have to say: “In 2020, CBO estimates, grants to states from the Patient and State Stability Fund, once fully implemented, would significantly reduce premiums in the nongroup market and encourage participation by insurers.”   “…several factors that would decrease those premiums: grants to states from the Patient and State Stability Fund…”   “…the Patient and State Stability Fund would help stabilize premiums…”   “Grants from the Patient and State Stability Fund would begin to take effect in 2018 to help mitigate losses and encourage participation by insurers.”   “…programs supported by the Patient and State Stability Fund are estimated to reduce premiums.”   “Under the legislation, in the agencies’ view, key factors bringing about market stability include subsidies to purchase insurance, which would maintain sufficient demand for insurance by people with low health care expenditures, and grants to states from the Patient and State Stability Fund, which would reduce the costs to insurers of people with high health care expenditures.” It’s not just CBO. Respected policy analysts and actuaries like Avalere and Oliver Wyman agree too. ### Read More

The AHCA Patient and State Stability Fund

2017/03/17

WASHINGTON, DC – The American Health Care Act (AHCA) provides a solution to help repair the insurance market damaged by Obamacare and provide more affordable coverage options to consumers: The Patient and State Stability Fund. This fund provides states $100 billion over 10 years to promote innovative solutions to lower costs and increase access to health care for their unique patient populations. The goal is simple – to provide states with maximum flexibility in how they address the cost of care for their citizens. “Many of the stability funds may be used to improve affordability and access to coverage in the individual market specifically,” explains Avalere. “The AHCA provides states with options for how to use the funds, including providing financial assistance for high cost individuals, incentivizing insurer participation in their markets, reducing the cost of insurance, promoting access to preventive services, and reducing out-of-pocket costs for patients” Avalare also noted, “In its recent score of the AHCA, the Congressional Budget Office (CBO) estimated that a combination of the Stability Fund and other changes in the market would reduce premiums by 10 percent below current law projections by 2026.” [[{"fid":"2437","view_mode":"full","fields":{"format":"full","field_file_image_alt_text[und][0][value]":false,"field_file_image_title_text[und][0][value]":false},"type":"media","field_deltas":{"1":{"format":"full","field_file_image_alt_text[und][0][value]":false,"field_file_image_title_text[und][0][value]":false}},"link_text":null,"attributes":{"height":"358","width":"467","class":"media-element file-full","data-delta":"1"}}]] Avalere details the country’s funding levels under the Patient and Stability Fund, which are on a per capita basis and not the size of a state’s individual market. We all want patients to have access to high-quality, affordably-priced health coverage. The Patient and State Stability Fund can help states lower costs and increase access to high-quality health care for their citizens. Sounds like a win. ### Read More

#SubEnvironment Examines Nation’s Drinking Water Infrastructure

2017/03/16

WASHINGTON, DC – The Subcommittee on Environment, chaired by Rep. John Shimkus (R-IL), today held a hearing entitled, “Reinvestment and Rehabilitation of Our Nation’s Drinking Water Delivery Systems.” Last Congress, the Water Infrastructure Improvements for the Nation (WIIN) Act was signed into law and included new funding provisions under the Safe Drinking Water Act, which fall under the committee’s jurisdiction. That legislation provided new funding for disadvantaged communities, lead pipe replacement, and deployment of innovative technologies across the country to improve drinking water infrastructure. Members of the subcommittee examined drinking water infrastructure needs across the country and ways to bring greater investment in and updates to these systems so they can operate well in the future. [[{"fid":"2434","view_mode":"full","fields":{"format":"full","field_file_image_alt_text[und][0][value]":false,"field_file_image_title_text[und][0][value]":false},"type":"media","field_deltas":{"1":{"format":"full","field_file_image_alt_text[und][0][value]":false,"field_file_image_title_text[und][0][value]":false}},"link_text":null,"attributes":{"height":"188","width":"279","class":"media-element file-full","data-delta":"1"}}]] Chairman Shimkus and Ranking Member Paul Tonko (D-NY) talk ahead of today’s hearing “Currently, more than 51,000 community water systems treat 42 billion gallons of water for use by 299 million Americans daily,” said Chairman Shimkus. “Last year, the Water Infrastructure Improvements for the Nation Act authorized $600 million between two new programs dedicated to tackling lead pipe replacement and aiding economically disadvantaged and underserved communities. While I think these are solid steps, we must also reauthorize the Drinking Water State Revolving Loan Fund (DWSRF).” [[{"fid":"2436","view_mode":"full","fields":{"format":"full","field_file_image_alt_text[und][0][value]":false,"field_file_image_title_text[und][0][value]":false},"type":"media","field_deltas":{"1":{"format":"full","field_file_image_alt_text[und][0][value]":false,"field_file_image_title_text[und][0][value]":false}},"link_text":null,"attributes":{"height":"173","width":"388","class":"media-element file-full","data-delta":"1"}}]] Witnesses begin to deliver their testimony to #SubEnvironment committee members Rudolph Chow, P.E., Director of the Baltimore, MD, Department of Public Works, on behalf of the American Municipal Water Association, testified, “Fortunately, Congress has begun to give this issue the attention it deserves. Last year’s passage of the Water Infrastructure for the Nation Act authorized funding for a new program aimed at removing and replacing outdated lead service lines and helping low-income customers absorb their share of these replacement costs. …All of this represents good progress, but we know that much more remains to be done.” Martin A. Kropelnicki, President and CEO of the California Water Service Group, on behalf of the National Association of Water Companies, spoke to the importance of private water utilities, commenting, “The private water utility sector stands able, ready, and willing to partner with local and state governments, as well as the federal government, to help meet the challenges our nation’s water infrastructure will face in the coming years and decades.” John J. Donahue, CEO of North Park Public Water District and former President of the American Water Works Association, commented on the importance of working closely with Congress, stating, “Working closely with Congress, we hope to stimulate reinvestment in water infrastructure, top-shelf cybersecurity, protection of source water, smart approaches to affordability, an efficient energy-water nexus and a focus on scientific integrity in our regulatory processes.” “Moving forward, this is not going to be an easy discussion, but to be successful; it is one we must have. I believe we must not be afraid to spend more federal money on this issue, but we must maintain local fees as the primary generator of funds for daily operation and maintenance of public water systems, as well as their long-term capital investment needs,” concluded Chairman Shimkus. “Today’s hearing provided us the opportunity to look broadly at our nation’s drinking water infrastructure and examine questions about what is necessary for the federal government to do in the way of reinvestment and rehabilitation of these systems to meet future needs.” A background memo, witness testimony, and an archived webcast of today’s hearing can be found on the Energy and Commerce Committee’s website HERE. ###  Read More

#SubDCCP Explores How Communities Can Benefit from Adoption of Technology

2017/03/16

[[{"fid":"2430","view_mode":"default","fields":{"format":"default","field_file_image_alt_text[und][0][value]":false,"field_file_image_title_text[und][0][value]":false},"type":"media","field_deltas":{"1":{"format":"default","field_file_image_alt_text[und][0][value]":false,"field_file_image_title_text[und][0][value]":false}},"link_text":null,"attributes":{"height":"219","width":"480","class":"media-element file-default","data-delta":"1"}}]] WASHINGTON, DC – The Subcommittee on Digital Commerce and Consumer Protection, chaired by Rep. Bob Latta (R-OH), today held a hearing to examine the ways that communities across the country are tapping into new technology and collaborating with private sector companies to deliver new initiatives that will improve safety, increase efficiency and create opportunity.      The opportunities provided to citizens living within smart communities are endless. As Chairman Latta pointed out, “There are opportunities to improve education, traffic and health.  We can drastically increase mobility and access to jobs. From safety to sanitation to the environment, communities that wisely invest in technologies can make a real difference in American’s lives.” Sharing the ways that Columbus, Ohio, is utilizing disruptive technologies to improve communication among local government agencies and boost the in-state transportation network, is Jennifer Gallagher, the Director of the Department of Public Service for the City of Columbus, Ohio. Columbus has several “smart projects” in the works, one of which is an event parking system that “will allow travelers to plan, reserve and book a parking space for large events.” She states this “parking system will be a partnership with our local tourism office to ensure critical transportation and parking information can be shared with our visitors and residents...” Other projects in the works will provide “transportation to employment centers, well-checks for mothers and their infants, and so much more.” Full committee Chairman Walden expressed some of the challenges that local governments face when adopting and promoting new technologies. “These ideas may face difficulties with both funding and adoption. There are also important data sharing, cybersecurity, and privacy issues that need to be addressed when government entities are engaging with private companies to provide transportation, energy, or other community services.” Chairman Walden’s home state, Oregon, is another area of our country helping to pave the way with regard to innovation and collaboration. Speaking about their unique public-private partnerships across sectors like transportation, and how adoption of new technology is increasing mobility and improving traffic safety for the public, was Kyle Chisek, the Director of Bureau Relations at the Office of Mayor Ted Wheeler. He stated, “These agreements with private companies give Portland access to cutting edge technologies needed for smart cities programs. As we have seen with Portland Streetcar and other public-private partnerships, when cities work in tandem with the private sector, it builds community trust and contributes to increased private development near public infrastructure.” [[{"fid":"2431","view_mode":"default","fields":{"format":"default","field_file_image_alt_text[und][0][value]":false,"field_file_image_title_text[und][0][value]":false},"type":"media","field_deltas":{"1":{"format":"default","field_file_image_alt_text[und][0][value]":false,"field_file_image_title_text[und][0][value]":false}},"link_text":null,"attributes":{"height":"383","width":"480","class":"media-element file-default","data-delta":"1"}}]] Outlining several reasons why research universities are key to the continuation of smart communities, is Dr. Jennifer Clark, Director of the Center for Urban Innovation at the Georgia Institute of Technology. “In the smart communities context, research universities are again serving an essential role in the research and development phase of smart communities innovation.” She continues, “Research universities are built to test new technologies, evaluate alternatives,  assess investments, evaluate economic impacts, measure distributional consequences, and certify  processes, materials, products, and standards… and [they] also have vested interest in the upgrading and maintenance of intelligent infrastructure in the cities and communities in which they are located.” Another benefit of communities embracing new technology is the additional protection that it provides to consumers and added elements of customer service for residents. Expanding on this idea is Alexander Pazuchanics, Policy Advisor at Office of the Mayor in the City of Pittsburgh, Pennsylvania. He stated, “A number of city departments are using custom, interactive maps to view and make decisions based on city data. These maps, cleverly named Burgh’s Eye View, allow our fire department to see up-to-date building code violations - to better understand a building before entering it. They allow our police department to monitor 311 requests for city service and see when residents request graffiti removal, note excessive noise, or submit a host of other requests connected to their quality of life.” For more information on today’s hearing, including a background memo, witness testimony, and archived webcast, click HERE. Read More

Disrupter Series: Smart Communities

2017/03/16

[[{"fid":"2398","view_mode":"full","fields":{"format":"full"},"type":"media","field_deltas":{"2":{"format":"full"}},"link_text":null,"attributes":{"alt":"Disrupter Series: Smart Communities","height":"380","width":"640","class":"media-element file-full","data-delta":"2"}}]] Read More

Reinvestment and Rehabilitation of Our Nation’s Safe Drinking Water Delivery Systems

2017/03/16

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#SubEnvironment to Examine Legislation to Provide States Flexibility in Implementing Ozone Standards

2017/03/15

WASHINGTON, DC – The Subcommittee on Environment, chaired by Rep. John Shimkus (R-IL), today announced a hearing for Wednesday, March 22, 2017, at 10 a.m. in room 2123 of the Rayburn House Office Building. The hearing is entitled, “HR 806, Ozone Standards Implementation Act of 2017.” Next week, the subcommittee will hold a legislative hearing on H.R. 806, Ozone Standards Implementation Act, introduced by Subcommittee on Energy Vice Chairman Pete Olson (R-TX). The legislation builds on the committee’s work last year to provide a commonsense solution that gives states the flexibility needed to implement the National Ambient Air Quality Standards (NAAQS) for ground-level ozone on an efficient and realistic timeline. In October 2015, while states and communities were just beginning to implement the 2008 standards following long-overdue EPA guidance, EPA revised those standards and imposed additional new planning and compliance obligations on states. Now states face the prospect of simultaneously implementing plans for two ozone standards. “Ozone levels are down one-third since 1980 and continue to trend downward, yet states are now expected to divert resources from these ongoing efforts in order to simultaneously implement duplicative, stringent standards,” said Chairman Shimkus. “This commonsense bill will provide states the time and flexibility needed to implement these standards while working to protect public health, jobs, and economic growth. Next week’s hearing will be the first-step in bringing much needed regulatory relief to the states.” For a fact sheet on the bill, click HERE. The Majority Memorandum, witness list, and witness testimony for the hearing will all be available here as they are posted.   ###  Read More

#SubDCCP Explores Potential of Advanced Materials Across Various Industries

2017/03/15

[[{"fid":"2418","view_mode":"default","fields":{"format":"default","field_file_image_alt_text[und][0][value]":false,"field_file_image_title_text[und][0][value]":false},"type":"media","field_deltas":{"1":{"format":"default","field_file_image_alt_text[und][0][value]":false,"field_file_image_title_text[und][0][value]":false}},"link_text":null,"attributes":{"height":"311","width":"480","class":"media-element file-default","data-delta":"1"}}]] WASHINGTON, DC – The Subcommittee on Digital Commerce and Consumer Protection, chaired by Rep. Bob Latta (R-OH), today held a hearing to examine some of the materials and fabrication methods that bolster many of the groundbreaking advancements made in various industries. Today’s discussion centered around the ways in which these materials are being used in industries like energy, telecommunications, and health care and the steps that need to be taken to ensure the U.S. remains at the forefront of research and development. Chairman Latta emphasized some of the hurdles to the development and commercialization of advanced materials, saying, “The path to future applications, and investment in early stage development, can be uncertain given immediate capital investment requirements. However, on the other end of the equation is the potential for improved safety and long - term cost savings.” Discussing the benefits of a particular material, graphene, and its enormous potential, was Dr. James M. Tour, T.T. and W.F. Chao Professor of Chemistry, Professor of Computer Science, and Professor of Materials Science and NanoEngineering at Rice University.  He testified, “At its size scale, graphene has many superlatives to its name including highest strength which is good for composites, highest mobility which means the high information transfer rate in electronic devices, the highest heat transfer rate which means that it is good at pulling excess heat of computers or machines, and the most efficient gas barriers, which means no molecules can pass through it.” The health care industry is just one market where advanced materials is helping to change the landscape and produce new possibilities for patients. Because of technology like 3D printing, companies like Organovo are designing human tissue models that can be used to repair organ function or replace damaged tissues. Keith Murphy, President and CEO of Organovo Holdings Inc., relayed just how these new advancements are disrupting the drug innovation process to create revolutionary therapies for patients. “…[G]iv[ing] researchers and regulators new tools and capabilities to make drug discovery safer, speedier, more likely to find breakthrough drugs in new areas, and less costly. Bioprinting also enables future implantable therapies to restore or cure failing organ function and address the long waiting lists for organ transplant.” [[{"fid":"2419","view_mode":"default","fields":{"format":"default","field_file_image_alt_text[und][0][value]":false,"field_file_image_title_text[und][0][value]":false},"type":"media","field_deltas":{"1":{"format":"default","field_file_image_alt_text[und][0][value]":false,"field_file_image_title_text[und][0][value]":false}},"link_text":null,"attributes":{"height":"321","width":"480","class":"media-element file-default","data-delta":"1"}}]] The energy industry is yet another example where advanced materials are positively disrupting traditional infrastructure and construction markets. Offering a prime example of how this is happening within the nation’s electric grid, was witness Shane Weyant, President and CEO of Creative Pultrusions, Inc.  He stated, “Electric grid systems that rely on FRP composite utility poles and cross arms find superior performance on every front—durability, strength, flexibility, service life and resistance to natural weather threats. Maintenance-free composites can revitalize and harden the electric grid, making it more reliable and resilient in the face of storms, reducing outages, and enabling faster service restoration after storms and other natural events.” Finally, a critical aspect of today’s hearing included the barriers for broader use of advanced composites. Adding to this discussion was Dr. Hota GangaRao, PhD, the Director of Constructed Facilities Center and Director of Center for Integration of Composites into Infrastructure at West Virginia University. Adding, “The most common barriers identified included training and education, codes and standards, composites durability and service life prediction, and testing. The US government can play a key role in breaking down these barriers by supporting efforts to evaluate in-service FRP composites, which would provide the data needed to evaluate durability and develop specifications.” For more information on today’s hearing, including a background memo, witness testimony, and archived webcast, click HERE.   Read More

HEARING: #SubHealth to Continue User Fee Hearings, Examining PDUFA

2017/03/15

WASHINGTON, DC – The Subcommittee on Health, chaired by Rep. Michael C. Burgess, M.D. (R-TX), announced a hearing for Wednesday, March 22, 2017, at 10:15 a.m. in room 2322 of the Rayburn House Office Building. The hearing is entitled, “Examining FDA’s Prescription Drug User Fee Program.” The Prescription Drug User Fee Act (PDUFA), which is up for reauthorization, supports the review and regulation of innovative drug products and helps ensure patients receive timely access to safe and effective new therapies. The Health Subcommittee recently held a hearing examining the Generic Drug User Fee Amendments (GDUFA) and the Biosimilar User Fee Act (BsUFA), both of which also expire in September 2017. “Next week’s hearing on PDUFA will examine how this important user fee program has been implemented since it was reauthorized in 2012 as part of the Food and Drug Administration Safety and Innovation Act (FDASIA),” said Chairman Burgess. “I am encouraged to see that the proposed agreement between FDA and industry builds upon several key provisions in the 21st Century Cures Act, and will further streamline the development and review of innovative new drugs for patients.”   The Majority Memorandum, witness list, and witness testimony for the hearing will be available here as they are posted. ### Read More

#SubEnergy Examines Hydropower and Ways to Modernize Energy Infrastructure

2017/03/15

WASHINGTON, DC – The Energy Subcommittee, chaired by Rep. Fred Upton (R-MI), today held a hearing examining the state of the nation’s dams and hydropower resources. The subcommittee reviewed the federal licensing process and recommendations to improve coordination between government agencies, promote new infrastructure, and ensure consumers have access to reliable and affordable electricity generated from hydropower.  [[{"fid":"2416","view_mode":"full","fields":{"format":"full","field_file_image_alt_text[und][0][value]":false,"field_file_image_title_text[und][0][value]":false},"type":"media","field_deltas":{"1":{"format":"full","field_file_image_alt_text[und][0][value]":false,"field_file_image_title_text[und][0][value]":false}},"link_text":null,"attributes":{"height":"224","width":"225","class":"media-element file-full","data-delta":"1"}}]] Mr. Chuck Hookham, P.E. testifying on behalf of the American Society of Civil Engineers, discussed ways in which improvements can be made, commenting, “Legislation that purely focuses on improving hydropower licensing/regulation and adds certainty to permit/approval timelines is needed; current permit/licensing challenges inhibit inclusion of hydroelectric projects in integrated resource planning.”  [[{"fid":"2417","view_mode":"full","fields":{"format":"full","field_file_image_alt_text[und][0][value]":false,"field_file_image_title_text[und][0][value]":false},"type":"media","field_deltas":{"1":{"format":"full","field_file_image_alt_text[und][0][value]":false,"field_file_image_title_text[und][0][value]":false}},"link_text":null,"attributes":{"height":"215","width":"279","class":"media-element file-full","data-delta":"1"}}]] Ms. Ramya Swaminathan, CEO of Rye Development, echoed Mr. Hookham’s testimony, stating, “The length, redundancy, and opacity of the federal permitting processes that govern the timeline for new hydropower on existing dams is a significant barrier to additional capital being invested into this sector. … Duplication and opacity in the overall federal process, both at FERC and USACE, must be minimized with regulatory risks throughout the overall federal permitting process being sequentially taken ‘off the table.’” “The potential increase in hydropower production would boost job growth, increase economic investment, facilitate the use of wind and other intermittent renewables, and avoid harmful emissions from the electric power sector,” stated full committee Chairman Greg Walden (R-OR). “As the subcommittee continues its efforts to modernize our nation’s infrastructure through technology-neutral improvement and expansion, we must bring greater transparency, efficiency and accountability to the regulatory processes affecting hydropower.” “The regulatory environment for hydropower has become increasingly challenging. Licensing new hydropower facilities and relicensing existing facilities requires extensive consultation with multiple federal, state, and local government entities,” concluded Chairman Upton. “With sound policy and smarter regulations, hydropower could have a very bright future. Updating and modernizing hydropower infrastructure will incentivize economic development, create jobs, and strengthen energy security.” A background memo, witness testimony, and an archived webcast of the hearing can be found on the Energy and Commerce Committee’s website HERE. ###  Read More

Shimkus & Latta Comment on Administration’s Decision to Review Fuel Economy Standards

2017/03/15

WASHINGTON, DC – Environment Subcommittee Chairman John Shimkus (R-IL) and Digital Commerce and Consumer Protection Subcommittee Chairman Bob Latta (R-OH) today issued the following statement after President Trump announced that the administration will be reviewing the fuel economy standards under the Corporate Average Fuel Economy  (CAFE) Program and Greenhouse Gas Emissions Standards for motor vehicles. These rules were previously put forth by the Obama administration. “We applaud President Trump on his decision to resume a collaborative examination of the stringent fuel economy standards rather than the midnight political decision of the previous administration,” said Shimkus and Latta. “Our nation’s motor vehicles are getting more efficient and will continue to do so, but we must ensure that the standards set are not rigid and that they do not raise sticker prices or threaten the auto industry. We’re looking forward to NHTSA and EPA’s review and remain hopeful they can propose standards that strike the right balance between efficiency and sound economic policy.” ###  Read More

Committee Leaders Request Documents Related to Heparin Contamination Crisis

2017/03/15

WASHINGTON, DC – Energy and Commerce Committee Chairman Greg Walden (R-OR), Oversight and Investigations Subcommittee Chairman Tim Murphy (R-PA), Health Subcommittee Chairman Michael C. Burgess, M.D. (R-TX), and full committee Vice Chairman Joe Barton (R-TX), today sent a letter to Dr. Stephen Ostroff, Acting Commissioner at the Food and Drug Administration regarding the ongoing heparin contamination crisis. “The Committee on Energy and Commerce continues to examine the heparin contamination crisis from 2007-2008 to help improve the Food and Drug Administration’s (FDA) strategy in combating economically-motivated adulteration of medical and food products imported to the U.S.,” write Walden, Murphy, Burgess, and Barton. In March of 2016, the committee sent a letter to then FDA Commissioner Dr. Robert Califf raising questions about the then-ongoing criminal investigation. For years, the committee has tried to obtain documents from the FDA and has been consistently turned away because of an open Office of Criminal Investigations (OCI) investigation. In the letter, the committee leaders write requesting further information, including case files from the two recently closed FDA OCI matters involving heparin contamination. To read a copy of the letter online, click here. ### Read More

Letter to FDA Regarding Heparin Contamination Crisis

2017/03/15

Excerpt: “The Committee on Energy and Commerce continues to examine the heparin contamination crisis from 2007-2008 to help improve the Food and Drug Administration’s (FDA) strategy in combating economically-motivated adulteration of medical and food products imported to the U.S.” To read a copy of the letter, click here. Read More

Disrupter Series: Advanced Materials and Production

2017/03/15

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Modernizing Energy Infrastructure: Challenges and Opportunities to Expanding Hydropower Generation

2017/03/15

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NEXT WEEK: #SubOversight to Examine Fentanyl Crisis

2017/03/14

WASHINGTON, DC – The Subcommittee on Oversight and Investigations, chaired by Rep. Tim Murphy (R-PA), today announced a hearing for Tuesday, March 21, 2017, at 10:15 a.m. in room 2123 of the Rayburn House Office Building. The hearing is entitled, “Fentanyl: The Next Wave of the Opioid Crisis.”  Subcommittee members will examine the rapidly-growing threat of fentanyl, a synthetic opioid that is 50 times more potent than heroin and 100 times more potent than morphine. While fentanyl is a tightly controlled prescription medicine used to treat extreme pain, it is also easy to illicitly manufacture and has been increasingly seen on the streets and the Internet. This powerful opioid and its chemical variations have contributed to more than 5,000 overdose deaths in the United States since 2013. The Energy and Commerce Committee has led the charge in combating the opioid epidemic, beginning with the Subcommittee on Oversight and Investigations’ examination of heroin and opioids. This work resulted in legislative solutions, many of which were included in the Comprehensive Addiction and Recovery Act (CARA), which is now law. The 21st Century Cures Act, also law, authorized additional funding for state grants to address the epidemic.  “With the surge of fentanyl, we’ve seen an uptick in fatal overdoses that are hitting families in our very own neighborhoods,” said Chairman Murphy. “The passage of CARA and 21st Century Cures were critical first steps, but more work remains. Next week’s hearing will be important to further examine this crisis and how we can bolster our federal response.” The Majority Memorandum, witness list, and witness testimony for the hearing will be available here as they are posted. ### Read More

HEARING: #SubCommTech to Examine Ways to Eliminate Barriers to Broadband Infrastructure NEXT WEEK

2017/03/14

WASHINGTON, DC – The Communications and Technology Subcommittee, chaired by Rep. Marsha Blackburn (R-TN), today announced a hearing for Tuesday, March 21, 2017, at 10 a.m. in room 2322 of the Rayburn House Office Building. The hearing is entitled, “Broadband: Deploying America’s 21st Century Infrastructure.” Last Congress, #SubCommTech reviewed several proposals to improve broadband deployment. Next week’s hearing will build off of that work and will examine ways to eliminate barriers to broadband infrastructure development. Members will look at draft legislation to streamline the permitting and siting process at the federal level to spur private sector investment and bring increased and more efficient broadband across the country. “Broadband is a necessity for business in the 21st century and its time our policies reflect that. In fact, many communities across the country would rather have better access to broadband than an additional lane on a highway.  For too long problems with permitting and siting have held back further investment in expanding broadband infrastructure across the country,” said Chairman Blackburn. “Constituents and businesses back in Tennessee consistently have issues gaining access to broadband. And without a high-speed internet connection, it remains difficult to attract businesses and jobs to these rural areas. I’m looking forward to exploring ways in which we can eliminate the barriers to broadband deployment and get these communities access to vital broadband they desperately need.” The Majority Memorandum, witness list, and witness testimony for the hearing will be available here as they are posted. ###  Read More

Contact Information

2125 Rayburn HOB
Washington, DC 20515
Phone 202-225-2927
Fax 202-225-1919
energycommerce.house.gov


Membership

Greg Walden

OREGON's 2nd DISTRICT

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