The Biobased and Renewable Products Advocacy Group (BRAG) helps members develop and bring to market their innovative biobased and renewable chemical products through insightful policy and regulatory advocacy. BRAG is managed by B&C® Consortia Management, L.L.C., an affiliate of Bergeson & Campbell, P.C.

By Lynn L. Bergeson

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 now accepting comments on the collection of information until September 18, 2019.


 

By Lynn L. Bergeson

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, through September 30, 2020.


 

By Lynn L. Bergeson

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 apprenticeship guarantees participants a job with a Michigan-based company. P4A is currently looking for more companies with which to form partnerships.

Tags: DOL

 

By Lynn L. Bergeson

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 amending the existing designated product categories of general purpose de-icers, firearm lubricants, laundry products, and water clarifying agents. The rule will be effective on August 5, 2019.
 
According to the final rule, when USDA designates by rulemaking a product category for preferred procurement under the BioPreferred Program, manufacturers of all products under the umbrella of that product category that meet the requirements to qualify for preferred procurement can claim that status for their products. To qualify for preferred procurement, a product must be within a designated product category and contain at least the minimum biobased content established for the designated product category. With the designation of these specific product categories, USDA invites manufacturers and vendors of qualifying products to provide information on the product, contacts, and performance testing for posting on its BioPreferred website. USDA states that procuring agencies will be able to use this website “as one tool to determine the availability of qualifying biobased products under a designated product category.”
 
For further information, see Bergeson & Campbell, P.C.’s memorandum on the final rule. In the memorandum, we link to the Biobased and Renewable Products Advocacy Group (BRAG®) and its interest in biobased products.


 

By Lynn L. Bergeson

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 comparative analytical studies that intend to demonstrate that a proposed therapeutic protein product is biosimilar to a reference product licensed under the Public Health Service Act (PHS Act). Additionally, the draft guidance makes recommendations to sponsors on the scientific and technical information for the chemistry, manufacturing, and controls (CMC) portion of a marketing application. Comments on the draft guidance are due on or prior to July 22, 2019.


 

By Lynn L. Bergeson

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 food waste, or plants with reduced levels of harmful elements, amongst others).  To assist developers in this field, FDA has a voluntary premarket Plant Biotechnology Consultation Program, which provides developers with the opportunity to engage with FDA to help navigate the appropriate regulatory pathways.  The program includes individualized advice from FDA’s biotechnology and food safety experts prior to a plant-based product being permitted to enter the market and allows for biotechnology developers to consult with these FDA experts throughout the entire development, data collection, and evaluation process.


 

By Lynn L. Bergeson

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 Biotechnology Innovation Action Plan, Dr. Gottlieb stated that FDA has taken important steps to help advance new products.
 
Part of these efforts includes FDA’s 2015 decision to approve an application related to GE salmon containing the first approved IGA in an animal meant for food consumption.  In 2016, however, the U.S. Congress directed FDA not to allow into commerce any food containing GE salmon until it issues final labeling guidelines for informing consumers of the GE salmon content in the food.  Consequently, in compliance with Congressional views, FDA implemented an import alert in that same year that prevented GE salmon from entering the U.S.  With the enactment of the National Bioengineered Food Disclosure Standard (NBFDS) by Congress, the U.S. Department of Agriculture (USDA) was made responsible for the implementation of a mandatory standard for disclosing foods that are bioengineered.  FDA was, therefore, divested of its authority over labeling GE content in human foods.  Given the Congressional enactment of NBFDS, Dr. Gottlieb stated that FDA believes this Congressional mandate on GE salmon has been satisfied by USDA’s issuance of final regulations implementing NBFDS.  NBFDS requires that human food containing GE salmon be labelled to indicate that it is bioengineered.  Therefore, FDA has deactivated the import alert that prevented GE salmon from entering the U.S.

Tags: Salmon, FDA, GE

 

By Kathleen M. Roberts

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” requiring EPA to conduct new chemical assessments.  If these new chemicals are converted to other substances by downstream customers, those substances are likely also new, requiring additional new chemical submissions and assessments.  Each new chemical submission and assessment represents a cost and a commercial delay and each is a barrier to adoption of what may be a promising sustainable technology.  These reviews can and do result in EPA applying risk management conditions on the production and distribution in commerce of the novel, renewable chemicals -- restrictions that may not apply to older chemistries even though they may be functionally identical in performance, hazard, and risk. Ironically, the new chemical may offer a more benign environmental footprint but nonetheless be subject to stricter controls.
 
POTENTIAL SOLUTION:  To address these issues, the Biobased and Renewable Products Advocacy Group (BRAG®) has submitted to EPA, in partnership with the Biotechnology Innovation Organization (BIO), a BRAG member, a White Paper proposing a TSCA Inventory representation and equivalency determinations for renewable and sustainable biobased chemicals. EPA’s initial response to the White Paper has been positive and staff has indicated a willingness to conduct equivalency determinations if submitted. 
 
REQUEST:  BRAG is now seeking companies interested in participating in a pilot project to prepare and submit such requests.  Specifically, we are looking for companies that manufacture or plan to manufacture a Class 2 chemical substance that is functionally equivalent to another Class 2 chemical, but due to existing naming conventions, the two chemicals are not listed as equivalent.  If your company fits this description and you wish to support an effort to alleviate commercial burden for yourself and others in the future, please consider working with BRAG on this important project so we present impactful equivalency cases to EPA.
 
BRAG and Bergeson & Campbell, P.C. (B&C®) are committed to this project.  As such, we will evaluate all candidate chemicals submitted, select what we believe is a good test case for the project, and prepare as a courtesy the necessary submission paperwork and equivalency arguments, in conjunction with the nominating company.
 
Please contact .(JavaScript must be enabled to view this email address) if your company is interested in submitting a nomination.

Tags: BRAG, Biobased

 

By Lynn L. Bergeson

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 economy, the environment, and human health.  The bill supports coordinated efforts in sustainable chemistry across federal agencies through research and development, technology transfer, commercialization, education, and training programs -- including partnerships with the private sector.  The bill does not include any regulatory components, nor does it authorize new spending.  Its goal, rather, is to coordinate better federal activities in sustainable chemistry and encourage industry, academia, nonprofits, and the general public to innovate, develop, and bring to market new sustainable chemicals, materials, products, and processes.


 

By Lynn L. Bergeson

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 the cost and efficiency of biosimilar development, including the number of reference product lots the draft guidance would recommend biosimilar developers sample in their evaluation of high similarity and the statistical methods for this evaluation.”  FDA states that after considering the public comments that were received on the draft guidance, it determined it would withdraw the draft guidance as it gives further consideration to the scientific and regulatory issues involved, and that it intends to “issue future draft guidance that will reflect state-of-the-art techniques in the evaluation of analytical data to support a demonstration that a proposed biosimilar product is highly similar to a reference product.”  FDA will communicate publicly when new draft guidance is issued.

Tags: FDA

 
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