On October 30, 2020, the U.S. Food and Drug Administration (FDA) announced that it will host a virtual public meeting on the reauthorization of the Biosimilar User Fee Act (BsUFA) for fiscal years 2023 through 2027. Under BsUFA, FDA collects user fees to support its process for the review of biosimilar and biological products and the current legislative authority is set to expire in September 2022. At the aforementioned time, new legislation will be required for FDA to continue collecting user fees in future fiscal years. FDA requests public comments as it begins the process to reauthorize ... read more >

The Environmental Law Institute (ELI) recently released Environment 2021: What Comes Next?, a report that looks at the Trump Administration’s impact on environmental law and policy and what lies ahead. ELI states that the report is “a response to growing demand for analysis of how deregulatory initiatives by the Trump Administration will affect environmental protection, governance, and the rule of law with a focus on what might happen in a second Trump administration or a new administration.” According to ELI, the report: Assesses the Trump Administration’s steps to ... read more >

On August 4, 2020, the U.S. Food and Drug Administration (FDA) Department of Health and Human Services (DHHS) announced the rates for biosimilar user fees for fiscal year (FY) 2021. The fees assessed are used by FDA for certain activities in connection with biosimilar biological product development, review of applications for approval of biosimilar biological products, and approval of product applications. The established fees will apply from October 1, 2020, through September 30, ... read more >

On June 4, 2020, the Missouri Agricultural and Small Business Development Authority (MASBDA) announced the creation of the Biofuel Infrastructure Program (BIP). Designed to increase the availability of higher blends of ethanol and biodiesel in Missouri, BIP partners with private entities to support biofuel producers in applying for U.S. Department of Agriculture (USDA) Rural Development’s Higher Blends Infrastructure Investment Program (HBIIP) funding. The MASBDA Board of Directors has allocated up to $2 million statewide in grant funds. The maximum grant amount is $200,000 for each ... read more >

On March 4, 2020, FDA announced that it has issued in final a guidance for industry titled “The ‘Deemed to be a License’ Provision of the BPCI Act: Questions and Answers,” which addresses FDA’s “transition” provision of the BPCI Act. Established in 2009, the Biologics Price Competition and Innovation Act (BPCI Act) deemed applications for an approved biological product under Section 505 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) to be a license for the biological product under Section 351 of the Public Health Service Act (PHS Act) as ... read more >

On March 5, 2020, FDA opened a public docket for comments on its enhancement of the Purple Book, which is otherwise known as FDA’s “Database of FDA-Licensed Biological Products.” As reported in B&C’s biobased products blog on February 28, 2020, FDA is working to expand the Purple Book by transitioning from its current table list format to a searchable online database for all approved biosimilar products and their reference products. These upgrades will be released in multiple phases. FDA has now completed phase I, which consists of the full search functionality of ... read more >

The Iowa Economic Development Authority (IEDA) is offering the first Renewable Chemicals Production (RCP) Tax Credit in the United States. What does this mean? It means that the program provides an opportunity for industry stakeholders to advance Iowa’s economy through a focus on biomass as a feedstock for the production of renewable chemicals. As an attempt to incentivize the production of 30 high-value chemicals derived from biomass feedstocks, IEDA developed the RCP Tax Credit program to “capitalize on its resources and infrastructure and to capture the renewable chemical ... read more >

On February 21, 2020, the U.S. Food and Drug Administration (FDA) issued a final rule to amend its regulation that defines “biological product.” The new definition incorporates changes made by the Biologics Price Competition and Innovation Act of 2009 (BPCI Act) and the Further Consolidated Appropriations Act, 2020 (FCA Act). Under the final rule, the statutory term “protein” is interpreted to mean any alpha amino acid polymer with a specific, defined sequence that is greater than 40 amino acids in size. Intended to clarify the statutory framework under which such ... read more >

On February 24, 2020, FDA Commissioner Stephen M. Hahn, M.D., announced that FDA is upgrading its Purple Book, which is otherwise known as its “Database of FDA-Licensed Biological Products.” According to Dr. Hahn, FDA is working to expand the Purple Book by transitioning from its current list format to a searchable online database for all approved biosimilar products and their reference products. An upgrade planned to be released in multiple phases, the full search functionality is the first step. Subsequent phases will include the expansion of the number of FDA-licensed ... read more >

On February 10, 2020, the Governor of Wyoming, Mark Gordon, delivered his 2020 State of the State Address, which included a request to lawmakers of a $25 million investment to establish the Energy Commercialization Program. The program is designed to provide a coordinated approach to support research on technologies that advance zero or net-negative carbon uses for coal and other fossil fuels. Gordon stated: “Wyoming will always advocate for our industries, whether it be to protect against unconstitutional restraint of trade, or in their endeavors to deliver cleaner, more dependable, ... read more >