September 16, 2019

September 16, 2019

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BRAG Biobased Products Blog: August 16, 2019

DOE Issues SBIR/STTR FOA

On August 12, 2019, the U.S. Department of Energy (DOE) announced its Fiscal Year (FY) 2020 Phase I Release 1 funding opportunity for the Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) programs. In its announcement, DOE encourages small businesses with strong research capabilities in science or engineering to apply. DOE’s Funding Opportunity Announcement (FOA) includes participation from its Advanced Scientific Computing Research, Basic Energy Sciences, Biological and Environmental Research, and Nuclear Physics program offices. On August 19, 2019, DOE will host a webinar to provide an overview of the SBIR/STTR technology areas, application process, and award process. Interested parties can register for the webinar here. Additional important dates are listed below.

  • September 3, 2019 -- Letters of Intent (LOI) Due

  • September 24, 2019 -- Non-responsive LOI Feedback Provided

  • October 15, 2019 -- Full Applications Due

  • January 6, 2020 -- Award Notification

  • February 18, 2020 -- Project Grant Start Date

The full FOA and its topics can be accessed on DOE’s Office of Science webpage.


EPA OIG Publishes Report On Its Compliance With The Law

On August 9, 2019, the U.S. Environmental Protection Agency (EPA) published a report on its compliance with the law titled EPA Exceeded the Deregulatory Goals of Executive Order 13771. Executive Order 13771, titled Reducing Regulation and Controlling Regulatory Costs, includes regulatory savings goals for FYs 2017 and 2018, EPA’s deregulatory actions, and its compliance with the Office of Management and Budget’s (OMB) goal-setting requirements. EO 13771 was issued to manage costs associated with existing and new regulations established by federal agencies. Commonly referred to as the “two-for-one” EO, it required that “for every one new regulation issued, at least two prior regulations be identified for elimination.” The report addresses EPA’s regulatory compliance with the aforementioned EO, stating that “in FYs 2017 and 2018, the EPA exceeded its deregulatory expectations” and exceeded the savings goal as well. EPA clearly adds in the report that it did not develop internal guidance or management controls to implement the EO. Instead, EPA relied solely on OMB guidance. In the report, EPA recommends the enhancement of transparency regarding EO 13771 decision-making and outreach.


FDA Announces Biosimilar User Fee Rates For FY 2020

On August 2, 2019, the U.S. Department of Health and Human Services (HHS)’s Food and Drug Administration (FDA) announced via the Federal Register the rates for biosimilar user fees for FY 2020. The Federal Food, Drug, and Cosmetic Act (FFDCA) authorizes FDA to assess and collect user fees for certain activities in connection with biosimilar biological product development; review of certain applications for approval of biosimilar biological products; and each biosimilar biological product approved in an application. The established fees will apply to the period from October 1, 2019, through September 30, 2020.


WBC To Host Small Business Awards Ceremony—Applications Open

On September 18, 2019, the D.C. Women’s Business Center (WBC) and the National Community Reinvestment Coalition (NCRC) will host the 2019 Just Ambitious Small Business Awards. The awards honor woman entrepreneurs who have demonstrated achievements, innovation, and vision in support of the District of Columbia’s small business community and economic vitality. WBC and NCRC are now accepting applications for the 2019 awards in the following categories:

  • NCRC Community Engagement of the Year

  • NCRC Youth Entrepreneur of the Year

  • Environmental Entrepreneur of the Year

  • Start-Up of the Year

  • Veteran Woman-Owned Business of the Year

  • Woman Empowerment Entrepreneur of the Year

  • Womanpreneur Under 40 of the Year

Businesses can be nominated for multiple awards. WBC and NCRC encourage self-nominations. To qualify for the award, applicants must either be or nominate a registered business entity that has been in business for at least one full year. The business must be at least 51 percent woman-owned. Non-profits that devote a significant portion of time to assisting entrepreneurs may also apply. The deadline for application submissions is September 4, 2019, by close of business.

©2019 Bergeson & Campbell, P.C.

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About this Author

Lynn Bergeson, Campbell PC, Toxic Substances Control Act Attorney, federal insecticide lawyer, industrial biotechnology legal counsel, Food Drug Administration law
Managing Partner

Owner of Bergeson & Campbell, P.C. (B&C®), Lynn L. Bergeson has earned an international reputation for her deep and expansive understanding of the Toxic Substances Control Act (TSCA), the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), European Union Registration, Evaluation, Authorization and Restriction of Chemicals (REACH), and especially how these regulatory programs pertain to nanotechnology, industrial biotechnology, synthetic biology, and other emerging transformative technologies. Her knowledge of and involvement in the policy...

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