September 1, 2017
Capitol Update

In this issue:


FOOD AND DRUG ADMINISTRATION APPROVAL REQUIREMENTS REMOVED FOR 1,000 LOW-RISK MEDICAL DEVICES

More than 1,000 medical devices considered “low risk” will no longer need to be approved by Federal regulators before they are made available to doctors and patients.

The U.S. Food and Drug Administration (FDA) published a notice to the Federal Register earlier this summer announcing a list of class II medical devices that are now exempt from both premarket approval and the FDA’s fast-track 510(k) of the Food Drug & Cosmetic Act’s (generally referred to as a premarket notification) accelerated approval process pursuant to the 21st Century Cures Act (Pub. L. 114-255) to provide reasonable assurance of safety and effectiveness. The 21st Century Cures Act was signed into law on December 13, 2016, and designed to make it easier for new medical devices and new drugs to make it to market. The FDA was required to issue a list of devices to be newly exempt from pre-market approval requirements with 90 days of the law’s passage. Every five years the FDA will be required to issue an updated list of exemptions.

Consumer and patient safety advocates have raised concerns that it will now be too easy for untested medical devices to reach the mass market in the U.S. and be adopted. The door is now open for new features, new manufacturing processes, materials, and surgical techniques being allowed onto the market due to bypassing the “gold standard,” used for medical device manufacturers, which involves conducting extensive randomized, double-blind clinical trials.

President Donald Trump has also recently signed a bill to renew the Medical Device User Fee Amendments (MDUFA) within the FDA Reauthorization Act of 2017, where medical device companies would pay user fees to help cover the cost of the FDA’s reviews of their products. The medical device fee and others types of fees were signed into law support the FDA’s operations.

The full Federal Register notice is available at: https://tinyurl.com/ycp8jdmc


DEPARTMENT OF ENERGY STAFF REPORT TO THE SECRETARY ON ELECTRICITY MARKETS AND RELIABILITY

The Department of Energy recently released a staff report to the Secretary of Energy that provides an assessment of the reliability and resilience of the electric grid and an overview of the evolution of electricity markets. The study contains seven policy recommendations to guide and inform policy makers, regulators, and the general public about the challenges facing the grid, some of which require actions by other federal agencies or the private sector.

Key recommendations included:

  • Promote Research and Development (R&D) of next-generation/21st century grid reliability and resilience tools: DOE should focus R&D efforts to enhance utility, grid operator, and consumer efforts to enhance system reliability and resilience.
  • Infrastructure development: DOE and related Federal agencies should accelerate and reduce costs for the licensing, relicensing, and permitting of grid infrastructure, such as nuclear, hydro, coal, advanced generation technologies, and transmission.
  • Wholesale markets: Federal Electric Reliability Commission (FERC) should expedite to improve energy price formation in centrally-organized wholesale electricity markets.
  • Valuation of Essential Reliability Services (ERS): FERC should study and make recommendations regarding efforts to require valuation of new and existing ERS by creating fuel-neutral markets and/or regulatory mechanisms that compensate grid participants for services that are necessary to support reliable grid operations.

To download and read the report, please visit: https://tinyurl.com/ydcfzr8z

You can also submit your input about this report: https://epsa.energy.gov/grid-report-input/


NIST CRAFTS NEXT-GENERATION SAFEGUARDS FOR INFORMATION SYSTEMS AND THE INTERNET OF THINGS

The National Institute of Standards and Technology (NIST) has issued a new draft of its widely used Special Publication (SP) 800-53, “Security and Privacy Controls for Information Systems and Organizations.” Revision 5 of this publication is meant to assist in designing the next-generation catalog of controls, which are applicable to the Internet of Things (IoT) applications and would fully integrate privacy controls throughout the catalog. This draft represents an ongoing effort to produce a unified information security framework for the Federal government.

The report details a number of challenges facing IoT designers, such as balancing security and privacy protocols. For examples, one privacy control recommendation addresses sensor data captures and advises configuring sensors in a way to help minimize capturing data about individuals that are not necessary for monitoring systems to carry out operational requirements.

The draft is now available at: https://tinyurl.com/yc2hxalh

Comments on the draft are also being requested by September 12, 2017. Comments may be emailed to sec-cert@nist.gov (please use the following subject line: "Comments on Draft SP 800-53 Rev. 5").


NEW REPORT PROMOTES WAYS TO BETTER INTEGRATE EDUCATION IN EMERGING TECHNOLOGIES

A recent report titled Aligning Technology and Talent Development was released this summer by the Aligning Technology and Talent Development Initiative, an effort led by the Association of Public and Land-grant Universities (APLU) and the National Center for Manufacturing Sciences (NCMS) in partnership with the Lightweight Innovations for Tomorrow (LIFT) manufacturing institute. LIFT is one of several regional institutes with specific technology focus that make up Manufacturing USA, formed to secure the future of manufacturing in the U.S. through innovation, collaboration, and education.

A team of education experts assisted in identifying the knowledge, skills, and abilities that workers at all levels will need in order to deploy the technologies, materials, and processes created at LIFT. Efforts are ongoing to aligning LIFT technology development plans with training competencies and strategies, and to strengthen the connection between emerging technologies and educational programs. By identifying the competencies needed for emerging technologies in the design or production environment, this information can be used to prepare students to enter the workforce with those competencies.

An example of one of the recommendations from the report is to make the LIFT high-bay and learning lab a premier space to “educate-the-educators.” It will provide educators access to a lightweight materials manufacturing technologies facility, and the processes LIFT is developing. It will also serve as a work-and-learn experience for students.

To review the report, go to: https://lift.technology/wp-content/uploads/2017/07/EET-Report-1-Summer-2017.pdf


CONGRESS HOLDS HEARING ON EXAMINING ADVANCEMENTS IN BIOFUELS: BALANCING FEDERAL RESEARCH AND MARKET INNOVATION

The House Committee on Science, Space, and Technology held a hearing this summer entitled “Examining Advancements in Biofuels: Balancing Federal Research and Market Innovation.” There were four witnesses from Oak Ridge National Laboratory, University of Michigan Energy Institute (UMEI), Growth Energy, and The Heritage Foundation.

In Chairman Andy Biggs’ (R-AZ) opening statement, he stated that the hearing would examine federal biofuel funding and the effects of federal mandates on the market, as well as what is happening in basic research in biology and biochemistry and the ways that it can be best utilized to spur private innovation. He stated it was time to focus on and pursue more market-friendly policies for biofuels in order to make sure that tax dollars were being used effectively. 

The first witness was Paul Gilna, Director, BioEnergy Science Center Oak Ridge National Laboratory (BESC), one of three established to work on the scientific challenges associated with achieving the cost-effective, sustainable, commercial production of fuels from cellulosic biomass. He said that crucial progress has been made toward manipulating plant cell wall conversion to yield perennial bioenergy feedstocks. Furthermore, BESC has successfully demonstrated the ability to combine the processes of cellulose digestion and fermentation of released sugars into biofuel in a single microbial organism. Discoveries such as this represent a significant step forward toward the development of improved feedstocks and advanced biofuel production.

One path to achieving cost-effective, sustainable, commercial production of fuels from cellulosic biomass has been partnering with industry stakeholders to pursue fundamental science and engineering that supports new technologies to increase the sustainability and economic viability of advanced biofuels. In his testimony, John M. DeCicco, Research Professor at the University of Michigan Energy Institute, said that federal biofuels policy has resulted in the inefficient use of taxpayer funds since none of the promised cellulosic fuels have become commercially viable, and harmed the environment because biofuels are making CO2 emissions worse and the Renewable Fuel Standard (RFS) has caused damage. Protecting the climate from a worsening disruption due to excess CO2 in the atmosphere is now a top challenge for energy research and policy. The choice of technologies to invest and deploy should be left to the marketplace and private funds rather than public. 

The Department of Energy (DOE) - Biological and Environmental Research programs within the DOE’s Office of Science support fundamental research to predict, manage, and control biological systems to support bioenergy production, environmental remediation and stewardship.

To read all the testimony and watch the video of the hearing, please visit:  https://science.house.gov/legislation/hearings/joint-subcommittee-environment-and-subcommittee-energy-hearing-examining


DEPARTMENT OF ENERGY RELEASES WIND TECHNOLOGIES MARKET REPORT

The Department of Energy has published its key findings from the 2016 wind technologies market report.  The National Renewable Energy Laboratory (NREL) and the Department of Energy’s Office of Energy Efficiency and Renewable Energy, Wind Energy Technologies Office took part in supplying the information.

The report covers the status of over 100 operating offshore wind projects and provides an analysis of the pipeline of nearly 600 wind projects in various stages of development. There is also an assessment of domestic developments through the second quarter of 2017.

One of the findings from the report is that confidence in the U.S. offshore wind market has grown due to the decreasing global costs as evidenced in places like Europe. In addition, states such as Massachusetts, New York, and Maryland have enacted new policies or bolstered their existing policies to provide incentives for the offshore wind development.

The impact on the American workforce is also being felt. Wind power development is supporting 101,738 jobs, which is an increase of 32 percent from 2015.

According to the U.S. Energy Information Administration, American wind energy almost doubled from about 120 million megawatt hours generated in 2011 to more than 226 million megawatt hours in 2016, which represents about 6 percent of U.S. electricity generation.

Additional information about this report can be found at:
https://energy.gov/articles/energy-department-reports-wind-energy-continues-rapid-growth-2016

Visit the ASME Public Policy Education Center at http://ppec.asme.org/ for daily news and policy developments, including the following:

Accepting Congressional Fellowships Applications for Energy and Bioengineering Beginning September 15, 2017
https://www.asme.org/about-asme/advocacy-government-relations/federal-fellows-program/new-20182019-congressional-fellowship-energy
Advanced Manufacturing Industry Reacts to America Makes’ Five-Year Milestone
https://tinyurl.com/y8c8smmb
While Keeping CPP Litigation on Ice, Judges Warn EPA About Delaying GHG Regulation
http://ppec.asme.org/latest-news/while-keeping-cpp-litigation-on-ice-judges-warn-epa-about-delaying-ghg-regulation/
Printed, Flexible, Rechargeable Battery Powers Wearable Sensors
http://ppec.asme.org/latest-news/printed-flexible-rechargeable-battery-powers-wearable-sensors/