October 11, 2019

FDA Publishes Technical Specifications Guidance For Bioanalytical Methods Templates

By Lynn L. Bergeson On October 3, 2019, the U.S. Food and Drug Administration (FDA) announced that a technical guidance for industry titled “Bioanalytical Methods Templates” is now available.  The technical specifications guidance provides ready-to-use templates for sponsors to submit summaries of bioanalytical methods used in clinical pharmacology studies that require pharmacokinetic concentration evaluation.  The templates provided are applicable to bioanalytical...
October 11, 2019

Negotiated Agreement On RFS

By Lynn L. Bergeson On October 4, 2019, U.S. Environmental Protection Agency (EPA) Administrator, Andrew Wheeler, and U.S. Department of Agriculture (USDA) Secretary, Sonny Perdue, announced President Trump’s negotiated agreement on the Renewable Fuel Standard (RFS).  Under the agreement, EPA and USDA will undertake the following actions: In a forthcoming supplemental notice building off the recently proposed 2020 Renewable Volume Standards and the Biomass-Based Diesel Volume for...
October 4, 2019

FDA Announces Availability Of Draft Guidance On Bioequivalency For Soluble Powder Oral Dosage Form P

By Lynn L. Bergeson The U.S. Food and Drug Administration (FDA), on September 30, 2019, announced the availability of a draft guidance for industry (GFI) #171 titled “Demonstrating Bioequivalence for Soluble Powder Oral Dosage Form Products and Type A Medicated Articles Manufactured from Active Pharmaceutical Ingredients Considered to be Soluble in Aqueous Media.” The draft GFI describes how EPA intends to evaluate requests for waiving the requirement for performing in vivo...
October 4, 2019

DOE SBIR/STTR Programs Office Opens Applications For The Cohort of Innovators

By Lynn L. Bergeson On September 30, 2019, DOE’s Smart Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) Programs Office announced the opening of applications for Cohort of Innovators through October 31, 2019. Three DOE National Laboratories are accepting such applications: (1) Argonne National Laboratory (ANL) Chain Reaction Innovation; (2) Oak Ridge National Laboratory (ORNL) Innovation Crossroads; and (3) Lawrence Berkeley National Laboratory (LBL)...
October 4, 2019

LLNL To Host Webinar On HPC4EI Program

By Lynn L. Bergeson On September 30, 2019, DOE announced that the Lawrence Livermore National Laboratory (LLNL) will host an informational webinar about the High Performance Computing for Energy Innovation (HPC4EI) Program. In honor of National Manufacturing Day, the webinar is scheduled for October 4, 2019, at 12:00 p.m. (EDT). The HPC4EI Program pairs national laboratory scientists with partners in industry to apply high-performance computing technology and improve energy utilization in the...
October 4, 2019

DOE Announces Funding For Bioenergy R&D Projects

By Lynn L. Bergeson On October 1, 2019, the U.S. Department of Energy (DOE) announced that 35 projects have been selected to receive funding for bioenergy research and development (R&D). Totaling $73 million in funding provided by DOE’s Office of Energy Efficiency and Renewable Energy (EERE), the selected projects aim to: Reduce the price of drop-in biofuels; Lower the cost of biopower; and Enable high-value products from biomass or waste resources. According to DOE, the...
September 27, 2019

USGBC Publishes Report On ZE Buildings In Massachusetts

By Lynn L. Bergeson The U.S. Green Building Council Massachusetts (USGBC) recently published its 2019 Report titled Zero Energy Buildings in Massachusetts: Saving Money from the Start. The report assesses zero energy (ZE) upfront building costs, model performance, and life-cycle costs in Massachusetts (MA). Local MA leaders have been working to curb greenhouse gas (GHG) emissions and reduce energy use in the built environment. This work has been done by retrofitting existing buildings and...
September 27, 2019

DOE Announces American-Made Solar Prize Winners

By Lynn L. Bergeson On September 24, 2019, DOE EERE’s Assistant Secretary, Daniel R. Simmons, announced the winners of the first round of the American-Made Solar Prize. The prize consists of a $3 million competition to revitalize U.S. solar manufacturing. Each prize winner received $500,000 for use at DOE National Laboratories. In addition to the aforementioned announcements, DOE also declared two initiatives led by EERE’s Solar Energy Technologies Office (SETO): the National...
September 27, 2019

Winners Of The 2019 Safer Choice Partner Of The Year Award Announced

By Lynn L. Bergeson On September 25, 2019, EPA’s Office of Pollution Prevention and Toxics (OPPT) recognized fourteen Safer Choice Partner of the Year award winners for their outstanding achievements in the design, manufacture, selection, and use of products with safer chemicals for use in households and facilities nationwide. Representing businesses, including woman-owned, small- and medium-sized, local government, and associations, winners from across 12 states and the District of...
September 27, 2019

DOE Announces RFI For Geothermal Field Research Applications

By Lynn L. Bergeson September 25, 2019, DOE EERE announced via the Federal Register a request for information (RFI) on the identification of wells of opportunity for critical geothermal field research applications. DOE’s RFI is directed to the geothermal community, seeking information about underutilized wells in known geothermal resource areas in the United States. Its aim is to obtain feedback on industry willingness to partner with DOE’s Geothermal Technologies Office (GTO) to...