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, 2021.
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Bergeson & Campbell, P.C. (B&C®) is a Washington, D.C., law firm providing biobased and renewable chemical product stakeholders unparalleled experience, judgment, and excellence in bringing innovative products to market.
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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 business entity and can be used to fulfill up to 25 percent of the cash match obligation required for HBIIP. Eligible project costs include but are not limited to:
The application deadline for these grants is July 1, 2020. A non-refundable fee of $150 must accompany applications up to $25,000, and a fee of $300 for applications of $25,000 and over. For funded grants, an administrative fee of 10 percent of the grant amount will be assessed when the contract is executed. Further information can be accessed here, and the application here. MASBDA Executive Director, Jill Wood, expressed enthusiasm for the newly created BIP, stating that her team at MASBDA “is excited to stand in the financial gap that may help some agribusinesses from applying these federal funds.” By Lynn L. Bergeson and Ligia Duarte Botelho, M.A. 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 of March 23, 2020. Aiming to make the BPCI Act implementation process smoother, FDA has published the guidance for industry as part of the “transition” provision of the Act. The transition of biological products currently regulated under the FD&C Act to the PHS Act will allow for the submission and approval of marketing applications for new biosimilar or interchangeable biological products. The guidance follows FDA’s recent issue of the new definition of the term “biological product,” announced on February 21, 2020, per Bergeson & Campbell, P.C.’s (B&C®) February 28, 2020, blog item. By Lynn L. Bergeson and Ligia Duarte Botelho, M.A. 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 the database. Subsequent phases will include the expansion of the number of FDA-licensed biological products included in the Purple Book online database until the final release, which will include information about all FDA-licensed biological products. The first phase of the upgrade includes information about a product’s proprietary and proper names, the full product label, dosage form, route of administration, strength, and marketing status, among other information. Given its completion, FDA is now requesting comments from stakeholders until May 4, 2020. 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 manufacturing industry.” IEDA is offering tax credit of $0.05 per pound of renewable chemical produced. Start-ups can receive up to $1 million in credit, and established businesses can earn up to $500,000. Applications are open until March 15, 2020, for chemicals produced in 2019. 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 products are regulated, the final rule will be effective on March 23, 2020. 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 biological products included in the Purple Book online database until the final release, which will include information about all FDA-licensed biological products. The aim is to grow the data set to include data and information about all Center for Biologics Evaluation and Research (CBER) and Center for Drug Evaluation and Research (CDER) regulated products. The first phase of the upgrade includes information about a product’s proprietary and proper names, the full product label, dosage form, route of administration, strength, and marketing status, among other information. FDA plans to open a public docket to gather feedback from stakeholders on the new database with its enhanced functionality. In the announcement, Dr. Hahn stated that “[t]his expansion and digitization of the Purple Book will make more information about FDA-licensed biological products more accessible, increasing transparency for patients, industry users and other stakeholders.” 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, more affordable, and safer energy to our nation.” While supporting coal mines and preventing them from closing, Gordon seeks to build a carbon capture and sequestration facility in Wyoming. Criticizing states such as California, Oregon, and Washington, Gordon went as far as stating that Wyoming will require true carbon dioxide sequestration and “not just some artificial notion that wind and solar can cure climate change all by themselves.” The Wyoming Governor also urged lawmakers to support legislation that would require all new electric generation capacity in the state to be reliable, consistent, and reasonably net carbon negative. 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 be reported, and how confidential business information (CBI) should be handled. NYSDEC states that during the meeting, it “is looking for input on disclosure of nonfunctional ingredients, issues around confidential information, how to disclose when a product’s formulation temporarily changes, and any other regulatory concerns.” Registration is required to attend the meeting. NYSDEC notes that it “will hold a formal public comment period at a later date once it officially proposes the regulations.” As reported in Bergeson & Campbell, P.C.’s (B&C®) September 4, 2019, blog item, on August 27, 2019, the State of New York Supreme Court invalidated the Household Cleansing Product Information Disclosure Program (Disclosure Program). Information related to NYSDEC’s prior delay of its enforcement of its Disclosure Program is available here, and general information regarding the Program and its extensive requirements for manufacturers of certain consumer cleaning products to disclose information regarding the ingredients in those products is available here. The court found that the Disclosure Program was established in violation of the State Administrative Procedure Act (SAPA) and the New York State Constitution. In making this finding, the court held that the Program was a “rule” as argued by Petitioners and not “guidance” for which adherence to SAPA was not required, as argued by NYSDEC. A more detailed analysis and commentary are available in our August 30, 2019, memorandum, “NY Department of Environmental Conservation Household Cleansing Product Information Disclosure Program Ruled ‘Null and Void.’” 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, including motor graders and snowplows, among others. Largely contributing to Iowa’s job market and accounting for $568 million of the state’s gross domestic product (GDP), Iowa’s biodiesel plants increased their biodiesel production by 20 percent by the end of 2018. Governor Reynolds stated: “Ethanol and biodiesel remain essential to the health of the agricultural economy, sustainable environmental commitments and employ thousands of Iowans. I am proud to stand alongside Iowa Farm Bureau and key stakeholders in the renewable fuels industry to secure the continued demand for biofuels.” |
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