By Lynn L. Bergeson and Ligia Duarte Botelho, M.A. On January 16, 2020, the U.S. Department of Agriculture (USDA) announced the issuance of a Request for Information (RFI) to assist with the creation of its new program called Higher Blends Infrastructure Incentive Program (HBIIP). A USDA Rural Development project, HBIIP is designed to expand the availability of domestic ethanol and biodiesel by incentivizing the expansion of sales of renewable fuels. Requesting feedback from all interested...
January 17, 2020
NFUS Pushes Scottish and UK Governments To Address Biofuel Issues
By Lynn L. Bergeson On January 10, 2020, the National Farmers’ Union of Scotland (NFUS) announced its pursuit for high level solutions to machinery problems linked to biofuel content. According to NFUS, many Scottish and UK farmers are experiencing issues because of the percentage of biofuel content in fuel for farming machinery. In December 2019, NFUS submitted a letter to Grant Shapps, Member of Parliament (MP) and Secretary of State for Transport, requesting long-term solutions for this...
January 17, 2020
DOE Announces Funding For Bioenergy Crops Research
By Lynn L. Bergeson On January 10, 2020, DOE announced that it will provide up to $75 million for research and development (R&D) of sustainable bioenergy crops within a period of five years. The bioenergy crops to be developed should be tolerant of environmental stress and resilient to changing environment conditions. Funded projects will focus on better comprehending the genetic and physiological mechanisms influencing plant productivity, resource use, and resilience, among other factors....
January 17, 2020
Congresswoman Axne Announces GAO Response To Investigation Report On EPA Misuse Of SREs
By Lynn L. Bergeson and Ligia Duarte Botelho, M.A. On January 13, 2020, U.S. Representative Cindy Axne announced that the Government Accountability Office (GAO) has responded to a bipartisan letter submitted by members of the House Biofuels Caucus (HBC) requesting an investigation into misuse of small refinery exemptions (SREs) by the U.S. Environmental Protection Agency (EPA). Submitted in August 2019, the bipartisan letter requested that GAO examine EPA’s review and approval of SRE...
January 10, 2020
Non-Profit Partners With Ukraine Ministry Of Education For Alternative Energy Competition
By Lynn L. Bergeson In late December 2019, CRDF Global, an independent non-profit focused on the global scientific community and alternatives to weapons research, announced a partnership with the Ministry of Education and Science of Ukraine (MES) in launching the 2020 U.S.-Ukraine Alternative Energy Research Competition. Currently accepting proposals from joint teams of U.S. and Ukrainian researchers, the competition will focus on the advancement of alternative energy sources. Intended to work...
By Lynn L. Bergeson On January 6, 2020, the American Chemical Society’s (ACS) Green Chemistry Institute opened its call for abstracts for the 24th Annual Green Chemistry & Engineering Conference (GC&E). This year, the conference will be held in Seattle, WA, from June 16 to June 18, 2020. Conference sessions will include a wide variety of topics, including biobased and renewable chemicals innovation, innovation in analytical chemistry applications, and making organic chemistry more...
January 10, 2020
Comments On Updated Version Of “Working Approach” Document For New Chemicals Review Due February 18,
By Lynn L. Bergeson On January 2, 2020, EPA published a Federal Register notice announcing the availability of the updated “Working Approach” document for a 45-day comment period. As reported in the Bergeson & Campbell, P.C. (B&C®) December 20, 2019, blog item, EPA released an updated version of the “Working Approach” document that builds upon EPA’s November 2017 “New Chemicals Decision-Making Framework: Working Approach to Making Determinations...
January 10, 2020
DOE Energy Storage Challenge Sets Goals For U.S. To Reach By 2030
By Lynn L. Bergeson On January 8, 2020, the U.S. Department of Energy (DOE) announced the launch of its Energy Storage Grand Challenge (the Grand Challenge). A comprehensive program to accelerate the development, commercialization, and utilization of next-generation energy storage technologies, the Grand Challenge builds on the $158 million Advanced Energy Storage Initiative announced in President Trump’s Fiscal Year (FY) 2020 budget request. U.S. Secretary of Energy Dan Brouillette states...
January 10, 2020
USDA, FDA, And EPA Announce Unified Website On Biotechnology
By Lynn L. Bergeson On January 9, 2020, also in recognition of National Biotechnology Month, the U.S. Department of Agriculture (USDA), the U.S. Food and Drug Administration (FDA), and the U.S. Environmental Protection Agency (EPA) announced the launch of a unified website for biotechnology regulation. Streamlining information about the three agencies in charge of overseeing agriculture biotechnology products, this website comes, in part, to fulfill President Trump’s Executive Order (EO)...
January 10, 2020
U.S. President Releases Message On Biotechnology Month
By Lynn L. Bergeson On January 1, 2020, U.S. President Donald Trump released a statement recognizing the beginning of National Biotechnology Month and the country’s “enormous potential” of biotechnology to improve lives in the United States and around the globe. Highlighting the benefits of biotechnology in different sectors, President Trump states that for every one job in biotechnology, nearly two other jobs are created in various sectors in the rural United States. In his...
January 3, 2020
NYSDEC Will Hold Public Meeting To Discuss Amendments to the Household Cleansing Product Regulations
The New York State Department of Environmental Conservation (NYSDEC) will hold a public meeting on February 24, 2020, at 1 p.m. (EST) in Albany, New York, “to discuss amendments to the household cleansing product rules that are being considered for adoption.” According to NYSDEC, amendments include specifying what information must be reported about covered products and their ingredients, how information should be shared with NYSDEC for the public record, the type of studies that must...
December 20, 2019
Implementation Of U.S. NBFDS To Begin In January 2020
By Lynn L. Bergeson and Ligia Duarte Botelho, M.A. The implementation date of the United States (U.S.) National Bioengineered Food Disclosure Standard (NBFDS) is January 1, 2020. Adopted in February 2019 by the U.S. Department of Agriculture’s (USDA) Agricultural Marketing Services (AMS), the NBFDS regulations (7 C.F.R. Part 66) directed USDA to establish a national mandatory standard for disclosing foods that are or may be bioengineered (BE). NBFDS requires food manufacturers, importers,...
December 20, 2019
EPA Publishes Final Rule On RFS Standards For 2020
By Lynn L. Bergeson On December 19, 2019, the U.S. Environmental Protection Agency (EPA) Administrator, Andrew Wheeler, signed the final rule on the Renewable Fuel Standard (RFS) program, setting the renewable fuel percentages for 2020. Titled Renewable Fuel Standard Program: Standards for 2020 and Biomass-Based Diesel Volume for 2021 and Other Changes, the final rule establishes the annual percentage standards for cellulosic biofuel, biomass-based diesel, advanced biofuel, and total renewable...
December 16, 2019
NAS Will Peer Review EPA’s TSCA Systematic Review Approach
The U.S. Environmental Protection Agency (EPA) announced on December 13, 2019, that it contracted the National Academies of Science (NAS) to conduct a peer review of its Application of Systematic Review in TSCA Risk Evaluations. According to EPA, this review will help provide it with important feedback on its approach to selecting and reviewing the scientific studies that are used to inform Toxic Substances Control Act (TSCA) risk evaluations. EPA states that “[i]ntegrating...
December 13, 2019
DOE Accepting Applicants For SBIR/STTR FY 2020 Phase I Release 2 Application Assistance
By Lynn L. Bergeson On December 6, 2019, DOE announced that the applications currently being accepted for free assistance preparing Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) FY 2020 Phase I Release 2 applications. There are a variety of eligibility criteria, and because space is limited, DOE Phase 0 applicants are admitted on a first-come, first-served basis. Each small business, however, is evaluated for selection to receive administrative and...
December 13, 2019
DOE Releases Notice Of Intent For Joint Funding Opportunity To Advance Plastics Innovation Challenge
By Lynn L. Bergeson On December 10, 2019, the U.S. Department of Energy (DOE) Office of Energy Efficiency and Renewable Energy (EERE) Bioenergy Technologies Office (BETO) published a notice of intent to issue a joint Funding Opportunity Announcement (FOA) with the Advanced Manufacturing Office (AMO), titled “BOTTLE: Bio-Optimized Technologies to Keep Thermoplastics out of Landfills and the Environment.” This FOA supports the Department’s Plastics Innovation Challenge, a...
By Lynn L. Bergeson On December 9, 2019, 22 Senate Democrats released a letter supporting the expansion of green energy tax credits. This letter was drafted in response to the Growing Renewable Energy and Efficiency Now (GREEN) Act discussion draft that was circulated in the U.S. House of Representatives on November 19, 2019. The Senators agree with the priorities of the GREEN Act and pledge to similarly prioritize and include: Offshore Wind Investment Tax Credit, Storage Investment Tax...
December 13, 2019
Sustainable Chemistry Research And Development Act Of 2019 Referred To Senate Committee On Commerce,
By Lynn L. Bergeson On December 9, 2019, the Sustainable Chemistry Research and Development Act of 2019 (H.R. 2051) was passed by the House of Representatives. H.R. 2051 establishes an interagency working group (IWG) led by the Office of Science and Technology Policy to coordinate Federal programs and activities in support of sustainable chemistry. The IWG will develop a roadmap for sustainable chemistry with a framework of attributes characterizing sustainable chemistry, assess the state of...
December 10, 2019
EPA Provides New Chemicals Meeting Materials and TSCA CBI Case List
The U.S. Environmental Protection Agency (EPA) announced on December 9, 2019, that in advance of the December 10, 2019, public meeting on new chemicals, it is providing the meeting materials and announcing the availability of a new web page detailing cases with completed confidential business information (CBI) determinations under the Toxic Substances Control Act (TSCA). Materials for the December 10, 2019, meeting include: Agenda; and Presentation. The new CBI web page includes a table of...
December 6, 2019
DOE To Host Workshop On Plastics For A Circular Economy
By Lynn L. Bergeson From December 11 through 12, 2019, DOE’s Office of Bioenergy Technologies Office will host a workshop titled “Plastics for a Circular Economy” in Denver, Colorado. The workshop will include discussions on technology solutions to address plastic waste and focus on the development of new recycling and degradation strategies. The objective of the workshop will be to identify early-stage applied research problems in the aforementioned area that need to be...
December 6, 2019
Iowa Governor Demonstrates Further Support For The Biofuels Industry
By Lynn L. Bergeson On December 3, 2019, Governor of Iowa, Kim Reynolds, signed an Executive Order that requires all new contracts for the purchase of state vehicles with diesel engines to have written support from the manufacturer to use B20 biodiesel (a mix of 20 percent biodiesel and 80 percent petroleum-based diesel) or more. The Iowa Department of Transportation (DOT) started using biodiesel blends in 1994. B20 is used for most of the year already, in most equipment with a diesel engine,...
By Lynn L. Bergeson and Ligia Duarte Botelho, M.A. First published last week, on November 25, 2019, the article titled “Consolidated Production of Coniferol and Other High-Value Aromatic Alcohols Directly from Lignocellulosic Biomass” has gained media attention across the globe. Given the finite geological oil reserves, the competition to identify alternative biobased and biorefinery processes continues to grow. According to the article, the aim in identifying such products is not...
November 22, 2019
FDA Acting Director Of Therapeutic Biologics And Biosimilars Provides Statement On Continued Efforts
By Lynn L. Bergeson On November 15, 2019, Sarah Yim, M.D., acting director of the Food and Drug Administration (FDA) Office of Therapeutic Biologics and Biosimilars in FDA’s Center for Drug Evaluation and Research, released a statement on FDA’s continued progress facilitating competition in the biologic marketplace with approval of its 25th biosimilar project. In her statement, Dr. Yim highlights FDA’s approval of one of nine new biosimilar products approved in 2019. Bringing...
November 22, 2019
EPA Announces OCSPP Meeting To Discuss TSCA New Chemicals Program
By Lynn L. Bergeson On November 20, 2019, the U.S. Environmental Protection Agency’s (EPA) Office of Chemical Safety and Pollution Prevention (OCSPP) announced a public meeting to engage with stakeholders interested on the implementation of the Toxic Substances Control Act (TSCA) New Chemicals Program. The meeting will be held on December 10, 2019, from 10:00 a.m. to 3:00 p.m. (EST), and will include: An overview of EPA’s updated “Working Approach” document that builds on...
By Lynn L. Bergeson On November 14, 2019, Senator Tom Udall (D-NM) and Representative Peter Welch (D-VT) introduced legislation seeking to reform the Renewable Fuel Standard (RFS) under the Clean Air Act (CAA). The Growing Renewable Energy through Existing and New Environmentally Responsible (GREENER) Fuels Act is intended to mitigate the “harmful environmental impacts of the corn ethanol mandate,” according to a press release issued by the lawmakers. The bill would phase out the...
November 15, 2019
EPA Holds Webinar on Green Chemistry Challenge Awards Program
By Lynn L. Bergeson On Wednesday, November 13, 2019, at 3:00 p.m. (EST), the U.S. Environmental Protection Agency (EPA) held a webinar on the Green Chemistry Challenge Awards Program. Participants learned about applying for the 2020 Green Chemistry Challenge Awards. The webinar presentation covered award eligibility, the application process, and evaluation criteria. There were also questions from the webinar participants. As reported in Bergeson &...
November 15, 2019
DOE Announces SBIR/STTR Phase I Release 2 Funding Opportunity
By Lynn L. Bergeson On November 12, 2019, DOE published a Funding Opportunity Announcement (FOA) for topics for its Fiscal Year (FY) 2020 Small Business Innovation Research (SBIR)/Small Business Technology Transfer (STTR) Phase I Release 2 funding. Participating in this FOA are the following DOE program offices: Office of Cyber Security, Energy Security, and Emergency Response (CESER); Office of Defense Nuclear Nonproliferation (NNSA); Office of Electricity (OE); EERE;...
November 15, 2019
DOE Announces Funding Opportunity To Address Plastics Recycling
By Lynn L. Bergeson On November 8, 2019, the U.S. Department of Energy (DOE) announced that $12 million will be available in funds for new projects to support research and development (R&D) and education and workforce development to increase plastics recovery, recycling, reuse, and remanufacturing. Designed for U.S. manufacturers, 12 to 18 exploratory and full R&D projects and four to eight education and workforce development projects will be funded by DOE’s Reducing Embodied...
The U.S. Environmental Protection Agency (EPA) announced on November 13, 2019, that it published “new, easily-searchable” web pages displaying information on: Premanufacture Notices (PMN), Significant New Use Notices (SNUN), Microbial Commercial Activity Notices (MCAN), and Test Market Exemption Applications (TMEA); Notices of Commencement of Manufacture or Import (NOC); and Test information submitted under Section 5 of the Toxic Substances Control Act (TSCA). EPA notes that it is required...
November 8, 2019
Biofuels Industry Supporters Come Together In Letter To Trump
By Lynn L. Bergeson On November 4, 2019, 60 organizations unified in an effort to urge U.S. President Donald Trump to reconsider EPA’s proposed amendments to the Renewable Fuel Standard (RFS) program. Signed by organizations such as the Biotechnology Innovation Organization (BIO), a Biobased and Renewable Products Advocacy Group (BRAG®) member, the letter to the President indicates flaws within the aforementioned proposal released on October 15, 2019. Arguing that the proposed...
By Lynn L. Bergeson On October 30, 2019, EPA announced that in response to an April 2019 court decision on the Toxic Substances Control Act (TSCA) Inventory Notification (Active-Inactive) Requirements Final Rule, EPA will publish a supplemental notice of proposed rulemaking that includes two additional questions about “reverse engineering” that manufacturers and processors would be required to answer when making confidential business information (CBI) claims. According to EPA, these...
By Lynn L. Bergeson On November 13, 2019, at 10:00 a.m. (EST), the House Committee on Science, Space, and Technology will hold a hearing on “Strengthening Transparency or Silencing Science? The Future of Science in EPA Rulemaking.” The Committee will hear from the following witnesses: Panel 1 Dr. Jennifer Orme-Zavaleta, Principal Deputy Assistant Administrator for Science, U.S. Environmental Protection Agency (EPA) Office of Research and Development (ORD); EPA Science Advisor. ...
November 1, 2019
Non-Profit Announces Opportunity For Start-Ups With Innovations To Address Plastic Waste In The Envi
By Lynn L. Bergeson and Ligia Duarte Botelho, M.A. On October 23, 2019, the Alliance to End Plastic Waste (AEPW) announced a partnership with innovation platform Plug and Play to develop an accelerator program focused on the plastics value chain to identify start-ups with innovative ideas addressing plastic waste. Named the End Plastic Waste Innovation Platform (EPWIP), this initiative will focus on solutions to lower the impact of plastic waste in the environment. Focus areas include but are...
November 1, 2019
ISU Hires CTO To Serve As A Bridge Between Research And Industry
By Lynn L. Bergeson On October 25, 2019, Iowa State University’s (ISU) Vice President for Research, Dan Kirkpatrick, announced that Sundeep Vani, Ph.D., has joined the team as the Chief Technology Officer (CTO) for Biobased Products, a newly created role. Announced in an ISU press release, Dr. Vani’s role will be to serve as a conduit between research and industry. Dr. Vani will work closely with the Biobased Product platform leader, Brent Shanks, his team, and the Iowa Innovation...
November 1, 2019
Industry Criticizes EPA Publication Of Supplemental Proposal On RFS
By Lynn L. Bergeson and Ligia Duarte Botelho, M.A. On October 28, 2019, the U.S. Environmental Protection Agency (EPA) published in the Federal Register a supplemental proposal on adjustments to the percentage standards for 2020 that result from the amended definitions of two terms used to calculate the percentage standards under the Renewable Fuel Standard (RFS). Signed and pre-published on October 15, 2019, by EPA Administrator Andrew Wheeler, the notice of the proposed rule is no surprise....
By Lynn L. Bergeson and Ligia Duarte Botelho, M.A. USDA Deputy Under Secretary Donald LaVoy and DOE Under Secretary of Energy Mark W. Menezes announced on October 24, 2019, a Memorandum of Understanding (MOU) signed between the two departments to promote rural energy and the development of technologies to support and advance rural and agricultural communities and domestic manufacturing. Required under Section 6501 of the 2018 Farm Bill, the MOU is meant to improve collaboration and coordination...
By Lynn L. Bergeson On October 30, 2019, the U.S. Department of Energy (DOE) Office of Energy Efficiency and Renewable Energy (EERE) announced open meetings of the Biomass Research and Development (R&D) Technical Advisory Committee. The first meeting is scheduled for November 19, 2019, from 8:00 a.m. to 5:00 p.m. (EST), and the second meeting will take place on November 20, 2019, from 8:00 a.m. to 1:30 p.m. (EST) in Washington, D.C. The purpose of the committee is to advise the Secretaries...
October 25, 2019
University Of Surrey Announces New Study On Microbial Organisms To Digest Plastic Waste
By Lynn L. Bergeson and Ligia Duarte Botelho, M.A. On October 16, 2019, the University of Surrey, United Kingdom, announced that its researchers have partnered with colleagues from France, Germany, and Spain to start working on a new technique to tackle plastic waste. According to the university’s article, this novel technique may revolutionize the recycling industry. The plan is to create engineered microbial communities that will digest two types of plastic polymers -- polyethylene...
October 25, 2019
House Committee Announces Legislative Hearing On EPA’s Mismanagement Of RFS Program
By Lynn L. Bergeson On October 22, 2019, Frank Pallone, Jr. (D-NJ), Energy and Commerce (E&C) Committee Chair, and Paul Tonko (D-NY), Environment and Climate Change Subcommittee (ECCS), announced that a legislative hearing will be held on October 29, 2019, at 10:30 a.m. (EDT) on Capitol Hill. Titled “Protecting the RFS: The Trump Administration’s Abuse of Secret Waivers,” the hearing will focus on the EPA’s mismanagement of the Renewable Fuel Standard (RFS) Program...
On October 17, 2019, the House Committee on Science, Space, and Technology unanimously approved the Sustainable Chemistry Research and Development Act (H.R. 2051), a companion bill to legislation introduced in the Senate by Senators Chris Coons (D-DE), Susan Collins (R-ME), Amy Klobuchar (D-MN), and Shelley Moore Capito (R-WV). Representative Dan Lipinski (D-IL) introduced the House bill on April 3, 2019. It is co-sponsored by Representative John Moolenaar (R-MI). The bill is intended to...
By Lynn L. Bergeson In response to EPA supplemental proposal outlined above, on October 15, 2019, U.S. Senator James Lankford (R-OK) issued a statement expressing his disappointment with EPA’s RFS mandates. Senator Lankford’s statement reads in part: The RFS has been a problem since day one, and the proposed increase to the mandate only further complicates a broken federal requirement to blend biofuels into gasoline. This proposal continues allowing exemptions for small refineries...
October 18, 2019
EPA Releases Its Supplemental Proposal On RFS
By Lynn L. Bergeson On October 15, 2019, EPA Administrator, Andrew Wheeler, signed a supplemental notice of the proposed rule on the Renewable Fuel Standard (RFS) that proposes to establish the cellulosic biofuel, advanced biofuel, and total renewable fuel volumes for 2020 and the biomass-based diesel volume for 2021. Although the rule does not change the volumes for 2020 and 2021 proposed in July 2019, it proposes and seeks comment on adjustments to the way that annual renewable fuel...
October 18, 2019
USDA Solicits Applications For Funds Under The Biorefinery, Renewable Chemical, And Biobased Product
By Lynn L. Bergeson On October 15, 2019, the U.S. Department of Agriculture (USDA) Rural Business-Cooperative Service (RBCS) announced via the Federal Register the solicitation of applications for funds under the Biorefinery, Renewable Chemical, and Biobased Product Manufacturing Assistance Program (the Program). Under the Program, USDA provides guaranteed loans to fund the development, construction, and retrofitting of commercial scale biorefineries using eligible technology. The loans are also...
October 11, 2019
EPA OIG Will Audit EPA’s Safer Choice Program
On September 23, 2019, the U.S. Environmental Protection Agency (EPA) Office of Inspector General (OIG) announced that it plans to begin fieldwork on EPA’s Safer Choice program. According to OIG, its objectives are to identify and assess the controls that EPA has in place to verify that the Safer Choice program meets its goals and achieves quality standards through its product qualification, renewal, and required audit process. OIG states that Safer Choice “is a voluntary labeling...
October 11, 2019
Governor Tim Walz Announces Applications For Seats On The Governor’s Biofuels Council
By Lynn L. Bergeson and Ligia Duarte Botelho, M.A. On October 2, 2019, the Governor of Minnesota, Tim Walz, announced that applications are now open for all 15 seats on the Governor’s Biofuels Council. Established in September 2019 by Governor Walz, the Governor’s Biofuels Council advises the Governor and cabinet on how best to support Minnesota’s biofuels industry. Council members will include representatives of agriculture, biofuels, and transportation industries and...
October 11, 2019
Green Party Of Canada Action Plan Calls For Plant Waste Biofuels
By Lynn L. Bergeson and Ligia Duarte Botelho, M.A. On October 2, 2019, the Green Party of Canada commented, via a press release, on its Green Climate Action Plan called “Mission: Possible.” Aiming to exceed the U.S. Green New Deal, under this plan, the Green Party outlines a 20-step action plan to achieve the goal of zero emissions by 2050. Part of the strategy outlined emphasizes the idea that heavy-duty industrial machinery will need to rely on biofuels. Although...
By Lynn L. Bergeson On October 2, 2019, the government of Quebec, Canada, published in its Official Gazette a notice of a draft regulation setting standards for the integration of renewable fuels into gasoline and diesel fuel. Under the draft regulation, the standards will apply on July 1, 2021, and will then increase. As of July 1, 2025, the integration of a minimum volume of ethanol of 15 percent into gasoline and a minimum volume of biobased diesel fuel of 4 percent into diesel fuel...
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...
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...