Biobased and Renewable Products News: Federal

November 9, 2018
Call For Candidate Chemicals For Equivalency Determinations
Is your company engaged in Class 2 chemistries that are similar to existing Class 2 chemicals but are derived from an innovative bio-source? We are looking for pioneering companies working on new biobased Class 2 chemicals to assist in advancing an important project with the U.S. Environmental Protection Agency (EPA).   ISSUE:  While EPA sustainability goals would seemingly include adoption of improved biobased technologies, EPA’s policies under the Toxic Substances Control Act (TSCA) mean that many novel, sustainable technologies are considered “new chemicals” ... read more >
August 16, 2019
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, ... read more >
August 9, 2019
Utility Workers Announce Apprenticeship Program In The Renewable Energy Sector
On August 6, 2019, the Utility Workers Union of America (UWUA) announced its partnership with The Power for America Training Trust Fund (P4A) for the launch of a renewable energy specialist apprenticeship program. Certified by the U.S. Department of Labor (DOL), the program aims at assisting individuals with a path to employment for highly demanded jobs in the renewable energy sector. Under this program, individuals will be taught specialized skills in the fields of solar generation, battery storage, and offshore and onshore wind. An earn-while-you-learn program, this two-and-a-half-year ... read more >
July 12, 2019
USDA To Amend Guidelines For Designating Biobased Products For Federal Procurement
On July 5, 2019, the U.S. Department of Agriculture (USDA) Office of Procurement and Property Management published a final rule that will amend the Guidelines for Designating Biobased Products for Federal Procurement (Guidelines) to add 30 sections designating the product categories within which biobased products would be afforded procurement preference by federal agencies and their contractors. These 30 product categories contain finished products that are made, in large part, from intermediate ingredients that have been designated for federal procurement preference. Additionally, USDA is ... read more >
May 24, 2019
HHS Announces Availability Of Draft Guidance On Therapeutic Protein Biosimilars
On May 22, 2019, the U.S. Food and Drug Administration’s (FDA) Department of Health and Human Services (HHS) announced via the Federal Register the availability of a draft guidance for industry titled “Development of Therapeutic Protein Biosimilars: Comparative Analytical Assessment and Other Quality-Related Considerations.” The draft guidance is a revision of the 2015 guidance titled “Quality Considerations in Demonstrating Biosimilarity of a Therapeutic Protein Product to a Reference Product.” It provides recommendations on the design and evaluation of ... read more >
March 29, 2019
FDA’s Premarket Voluntary Plant Biotechnology Consultation Program Provides Opportunity For Developers
In a recent statement prepared by U.S. Food and Drug Administration’s (FDA) Susan Mayne, Ph.D., Director of FDA’s Center for Food Safety and Applied Nutrition, and by Dennis Keefe, Ph.D, Director of FDA’s Office of Food Additive Safety, FDA highlights its commitment to assisting plant biotechnology developers to foster innovation and ensure that consumers can confidently trust FDA’s high safety standards.  Plant biotechnology consists of methods used to introduce new traits or characteristics to a plant (e.g., plants resistant to insect pests, plants with reduced ... read more >
March 15, 2019
FDA Commissioner Releases Statement On Biotechnology Innovations
On March 8, 2019, U.S. Food and Drug Administration (FDA) Commissioner Scott Gottlieb, M.D., released a statement on the continued efforts to advance safe biotechnology innovations, and the deactivation of an import alert on genetically engineered (GE) salmon.  In his statement, Dr. Gottlieb emphasized FDA’s mission to evaluate the safety of intentional genomic alterations (IGA) in animals that will ultimately be sold for consumption in the U.S.  According to FDA’s recent framework for the efficient development of safe biotechnology products, Plant and Animal ... read more >
August 3, 2018
Senators Collins, Coons Introduce Bipartisan Bill To Promote Innovation In Sustainable Chemistry
On July 30, 2018, Senators Susan Collins (R-ME) and Chris Coons (D-DE) reintroduced their sustainable chemistry bill, the Sustainable Chemistry Research and Development Act of 2018 (S. 3296).  This bill encourages the development of new and innovative chemicals, products and processes with an improved “environmental footprint” through efficient use of resources, reducing or eliminating exposure to hazardous substances, or otherwise minimizing harm to human health and the environment.  The legislation is intended to support new innovations in chemistry that benefit the ... read more >
June 29, 2018
FDA Withdraws Draft Guidance On Evaluation Of Analytical Similarity Between A Proposed Biosimilar Product And A Reference Product
On June 21, 2018, the U.S. Food and Drug Administration (FDA) announced it was withdrawing the draft guidance, “Statistical Approaches to Evaluate Analytical Similarity,” issued in September 2017.  The announcement states that the draft guidance, if issued in final as written, “was intended to provide advice for sponsors developing biosimilar products regarding the evaluation of analytical similarity between a proposed biosimilar product and the reference product.”  Further, comments submitted to the docket “addressed a range of issues that could impact ... read more >
December 15, 2017
DOC Postpones LTFV Final Determinations Related To Biodiesel From Argentina And Indonesia
On December 8, 2017, the U.S. Department of Commerce (DOC) issued in the Federal Register a notice on the postponement of final determinations of sales in less than fair value (LTFV) investigations into biodiesel from Argentina and Indonesia and the extension of provisional measures.  As reported in the Biobased and Renewable Products Advocacy Group (BRAG®) blog post “DOC Initiates Biodiesel Antidumping, Countervailing Investigation,” DOC initiated LTFV investigations of imports of biodiesel from Argentina and Indonesia on April 12, 2017.  DOC is postponing ... read more >
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