Biobased and Renewable Products News: Federal

March 6, 2020
Guidance On Biological Product Transition Issued By FDA
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 >
March 6, 2020
FDA Requests Comments On Its Licensed Biological Products Database
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 >
February 28, 2020
FDA Issues Final Rule Amending The Definition Of “Biological Product”
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 >
February 28, 2020
FDA Upgrades Its Database Of Licensed Biological Products
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 >
August 23, 2019
FDA Announces Collection Of Information Submission To OMB
On August 19, 2019, the U.S. Food and Drug Administration (FDA) announced in the Federal Register that a proposed collection of information on the Review Transparency and Communication in Reviews of 351(k) Biologics License Applications in Biosimilars User Fee Act has been submitted to the Office of Management and Budget (OMB) for review and approval. This information collection supports the review program under the Prescription Drug User Fee Act (PDUFA), which allows FDA to collect user fees for the review of human drug and biologics applications for fiscal years 2013 through 2021. OMB is ... 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 >
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 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 >
October 20, 2017
EPA Final Rule On Use Of TOFA Confirms Safety Of Unsaturated Fatty Acids
On October 10, 2017, the U.S. Environmental Protection Agency (EPA) published in the Federal Register its final rule establishing exemptions for a tolerance limit to use tall oil fatty acids (TOFA) as an inert ingredient “[‌i]n pesticide formulations applied to growing crops and raw agricultural commodities after harvest; in pesticides applied in/on animals, and in antimicrobial formulations for food contact surfaces.”  Pursuant to Section 408(c)(2)(A)(i) of the Federal Food, Drug, and Cosmetic Act (FFDCA), EPA has the authority to establish exemptions from the ... read more >
September 1, 2017
DOC Publishes Preliminary AD/CVD Determination For Argentina And Indonesia
On August 28, 2017, the U.S. Department of Commerce (DOC) announced in the Federal Register that a preliminary determination had been issued in the antidumping (AD) and countervailing duty (CVD) investigations on biodiesel from Argentina and Indonesia.  DOC preliminarily determined that countervailable subsidies are being provided to producers and exporters of biodiesel from Argentina and Indonesia. The period of investigation for both countries is January 1, 2016, through December 31, 2016.    Pursuant to Section 703(e)(1) of the Tariff Act of 1930, DOC preliminarily ... read more >
August 18, 2017
DOC Postpones Biodiesel AD/CVD Investigation Preliminary Determinations
On August 15, 2017, the U.S. Department of Commerce’s (DOC) International Trade Administration (ITA) announced in the Federal Register that the preliminary determination in the antidumping (AD) and countervailing duty (CVD) investigations on biodiesel from Argentina and Indonesia will be postponed.  A request to postpone the determinations was submitted by a petitioner on July 6, 2017, and, pursuant to Section 733(c)(1)(A) of the Tariff Act of 1930, ITA determined that there was no compelling reason to deny the request.  The preliminary determination will now be due by October ... read more >
January 13, 2017
White House Releases Updated Coordinated Framework for the Regulation of Biotechnology
On January 4, 2017, the White House announced the release of the 2017 Update to the Coordinated Framework for the Regulation of Biotechnology. The 2017 Update provides a comprehensive summary of the roles and responsibilities of the U.S. Environmental Protection Agency (EPA), the U.S. Food and Drug Administration (FDA), and the U.S. Department of Agriculture (USDA) with respect to regulating biotechnology products. Together with the National Strategy for Modernizing the Regulatory System for Biotechnology Products, published in September 2016, the 2017 Update offers a “complete picture ... read more >
December 28, 2016
Biobased Chemical, Fuel Makers Seek Parity For Their Products Under Trump
Lynn L. Bergeson was quoted in the December 28, 2016, Bloomberg BNA Daily Environment Report story "Biobased Chemical, Fuel Makers Seek Parity For Their Products Under Trump" (subscription required): Biobased chemical and fuel manufacturers want their products to be treated equally with their fossil fuel-based counterparts under the incoming administration's policies. [...]  Lynn Bergeson, managing partner of the Washington D.C.-based Bergeson & Campbell, P.C., which manages the Biobased and Renewable Products Advocacy Group (BRAG), said Pruitt’s alignment with ... read more >
October 28, 2016
BIO Writes Open Letter To Congress Encouraging Multi-Year Extension Of Biofuel Incentives
On October 18, 2016, the Biotechnology Innovation Organization (BIO) sent a letter to Congressional Leadership, the Senate Finance Committee Chairs, and the House Ways and Means Committee Chairs calling for the extension of expiring renewable energy tax credits.  The Second Generation Biofuel Producer Tax Credit, the Special Depreciation Allowance for Second Generation Biofuel Plant Property, the Biodiesel and Renewable Diesel Fuels Credit, and the Alternative Fuel Vehicle Refueling Property are set to expire at the end of 2016, with BIO urging congress for multi-year extensions.  ... read more >
September 30, 2016
Update To The Coordinated Framework For The Regulation Of Biotechnology Published In The Federal Register
On September 22, 2016,  Clarifying Current Roles and Responsibilities Described in the Coordinated Framework for the Regulation of Biotechnology (Update to the Coordinated Framework) was published in the  Federal Register . This proposed update provides a comprehensive summary of the roles and responsibilities of the U.S. Environmental Protection Agency (EPA), U.S. Food and Drug Administration (FDA), and U.S. Department of Agriculture (USDA) with respect to the regulation of biotechnology products. More information about what this means for the future of biotechnology and the ... read more >
September 23, 2016
Biotechnology: White House Releases Proposed Update To The Coordinated Framework And National Strategy For Modernizing The Regulatory System For Biotechnology Products
On September 16, 2016, the White House posted a blog item, "Building on 30 Years of Experience to Prepare for the Future of Biotechnology" and released two documents intended to modernize federal regulation of biotechnology products. In July 2015, the White House directed the U.S. Environmental Protection Agency (EPA), the U.S. Food and Drug Administration (FDA), and the U.S. Department of Agriculture (USDA) to develop a long-term strategy to ensure that the system is prepared for the future products of biotechnology, and commission an expert analysis of the future landscape of ... read more >
July 15, 2016
Senate Passes GMO Bill Creating A National Bioengineered Food Disclosure Standard With Federal Preemption And Exclusion Information
On July 7, 2016, the Senate passed a bill, An Act to Reauthorize and Amend the National Sea Grant College Program Act, and for Other Purposes (S. 764), through agreement to the House's amendment to S. 764, with further amendment. While the bill is being referred to as a genetically modified organism (GMO) labeling bill, there is no actual requirement to print GMO ingredients on labels. Instead, companies would be required to print information on the packaging (through text, a symbol such as a QR code, or an electronic link) directing consumers to a website or phone line for more ... read more >
April 8, 2016
Companies with Commercial Biofuels and Biobased Chemicals -- Get Ready For CDR
In less than two months, renewable fuel and biobased chemical companies that have successfully moved from research and development to commercialization will be required to respond to the U.S. Environmental Protection Agency's (EPA) Chemical Data Reporting (CDR) rule under the Toxic Substances Control Act (TSCA). This may come as a surprise to some biobased chemicals companies that are under the misperception that they are not regulated under TSCA. This is simply wrong. Unless otherwise regulated as a pesticide, food, food additive, drug, cosmetic, or nuclear material, biobased chemicals ... read more >
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