By Lynn L. Bergeson and Carla N. Hutton
 
As part of the National Biotechnology and Biomanufacturing Initiative, the U.S. Department of Defense (DOD) announced in September 2022 an investment of $1.2 billion in bioindustrial domestic manufacturing infrastructure to catalyze the establishment of a domestic bioindustrial manufacturing base accessible to U.S. innovators. As reported in our March 30, 2023, blog item, on March 22, 2023, DOD released its Biomanufacturing Strategy to guide these investments, and its broader efforts in this critical technology field. According to the Biomanufacturing Strategy, as commercial use of new technologies expands, if the United States fails to invest in its domestic manufacturing capabilities, market forces could drive manufacturing overseas, often at the expense of the national economy and potentially creating vulnerabilities in the DOD supply of these products.
 
The Biomanufacturing Strategy is focused around three core principles:

• Establish DOD transition partners for early-stage innovations: Establishing DOD customers for biomanufactured capabilities will guide DOD technology investments. The core of the DOD Biomanufacturing Strategy is a culture shift throughout DOD that both recognizes and prioritizes, where applicable, biotechnology-based solutions to prevent strategic surprise.
• Develop the field of biomanufacturing through innovations in practice and application; According to the Biomanufacturing Strategy, research is required in scaling-up biomanufacturing to produce at a scale sufficient to prototype these products. The Biomanufacturing Strategy states although this is a hurdle in adopting biotechnology-based solutions to DOD mission needs, “it is also an incredible opportunity to develop biomanufacturing at home and with allies and partners to create a self-sustaining domestic biomanufacturing ecosystem.” It will also contribute to the United States remaining the “world leader in innovation,” guarantee DOD interests are protected, and ensure that U.S. global competitiveness in biotechnology is maintained.
• Map the domestic biomanufacturing ecosystem and the changes that occur over time for identification and tracking of metrics to support future implementation and refinement of the biomanufacturing strategy: According to the Biomanufacturing Strategy, for DOD to build enduring advantage through the implementation of the Biomanufacturing Strategy, DOD needs to address implementation risk. Concurrent with DOD’s need to prioritize where it places its resources in biomanufacturing, DOD “will support an upfront assessment of the biomanufacturing ecosystem, along with continued evaluation during and following early investments, allowing for more precise tailoring” of DOD resource allocation as the biomanufacturing ecosystem develops. The Biomanufacturing Strategy states that mapping the biomanufacturing ecosystem and establishing metrics to evaluate the bioeconomy “is central to mitigating implementation risk.”

In support of the Biomanufacturing Strategy, DOD issued a formal request for information (RFI) on biomanufactured products and process capabilities that could help address defense needs and whose development and commercialization could be addressed by DOD investment. The intent of the RFI is to gather information about U.S. national security industrial base shortcomings, risks, and opportunities that may be addressed by investments made under the provisions in Title III of the Defense Production Act (DPA). According to the RFI, biomanufactured products of interest include those that “enable capabilities within the following application and operational spaces of interest, and will bring revolutionary changes to military capabilities, the operations environment, and supply chain resiliency.” Such application and operational spaces may include, but are not necessarily limited to:

• Manufacture specialty chemicals and materials that are needed by DOD in an available and affordable manner (e.g., biomanufactured fuels and energetic precursors, biosynthetic fibers such as but not limited to spider silk, polymers, natural rubber/latex rubber, solvents);
• Enable reduced logistic costs, time, and energy through bio-composite and living materials (e.g., tunable materials with enhanced properties, self-healing materials);
• Maintain persistent sensing capabilities for sustained human and environmental intelligence (e.g., sensors for water quality monitoring, biobased energy harvesting in maritime systems);
• Augment human systems by impacting performance and protection (e.g., tailored proteins, but specifically excluding biopharma and probiotics); and
• Enable manufacturing defense relevant materials in a manner to reduce the impact on the environment while meeting or exceeding product performance requirements.

Responses are due by April 19, 2023, at 12:00 p.m. (EDT). The RFI notes that if late information is received, the government reviewers may consider it, depending on agency time constraints.

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By Lynn L. Bergeson

On September 10, 2020, DOE, the U.S. Department of Commerce (DOC), the U.S. Department of Defense (DoD), and the U.S. Department of State announced the launch of the Federal Consortium for Advanced Batteries (FCAB). FCAB was formed to accelerate the development of a secure, robust, domestic industrial base for advanced batteries. It provides a framework for cooperation and coordination among federal agencies that have a stake in developing such battery technology and establishing a domestic supply of lithium batteries.

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By Kathleen M. Roberts

On December 4, 2017, the U.S. Department of Defense (DOD), the General Services Administration (GSA), and the National Aeronautics and Space Administration (NASA) issued in the Federal Register a notice of request for public comment regarding an extension of a previously approved ICR regarding biobased procurements.  Pursuant to Federal Acquisition Regulation (FAR) clause 52.223-2, prime contractors are required to report annually the product types and dollar values of U.S. Department of Agriculture (USDA)-designated biobased products purchased to the System for Award Management (SAM) website, which supports annual reporting to the Office of Federal Procurement Policy (OFPP) concerning actions taken to implement and measure progress in carrying out the preference for biobased products required under Section 9002 of the Farm Security and Rural Investment Act of 2002. 
 
Public comments are invited specifically on:

• Whether the collection of information is necessary for the proper performance of functions of the FAR, and whether it will have practical utility;
• Whether the estimate of the public burden of this collection of information is accurate, and based on valid assumptions and methodology;
• Ways to enhance the quality, utility, and clarity of the information to be collected; and
• Ways in which we can minimize the burden of the collection of information on those who are to respond, through the use of appropriate technological collection techniques or other forms of information technology.
• ​​Comments are due by January 3, 2018.

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By Lauren M. Graham, Ph.D.

On August 21, 2017, the National Academies of Sciences, Engineering, and Medicine (NAS) released their interim report titled A Proposed Framework for Identifying Potential Biodefense Vulnerabilities Posed by Synthetic Biology.  The U.S. Department of Defense (DOD) asked NAS to develop the framework to:

• Guide an assessment of the security concerns related to advances in synthetic biology;
• Assess the level of concern warranted for various advances and identify areas of vulnerability; and
• Prioritize options to address these vulnerabilities.

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By Kathleen M. Roberts

On August 28, 2017, the U.S. Department of Defense (DOD), the General Services Administration (GSA), and the National Aeronautics and Space Administration (NASA) issued in the Federal Register a notice of request for public comment on an extension of a previously approved information collection requirement regarding Biobased Procurements.  Pursuant to the Federal Acquisition Regulation (FAR) Clause 52.223-2, Affirmative Procurement of Biobased Products Under Service and Construction Contracts, prime contractors are required to report annually the product types and dollar values of U.S. Department of Agriculture (USDA)-designated biobased products purchased to the System for Award Management (SAM) website.  Federal agencies use the submitted information to report annually to the Office of Federal Procurement Policy (OFPP) concerning actions taken to implement and measure progress in carrying out the preference for biobased products required under Section 9002 of the Farm Security and Rural Investment Act of 2002, codified at 7 U.S.C. § 8102.  
 
Comments are due by October 27, 2017.  Public comments are invited specifically on:

• Whether the collection of information is necessary for the proper performance of functions of the FAR, and whether it will have practical utility;
• Whether the estimate of the public burden of this collection of information is accurate, and based on valid assumptions and methodology;
• Ways to enhance the quality, utility, and clarity of the information to be collected; and
• Ways in which we can minimize the burden of the collection of information on those who are to respond, through the use of appropriate technological collection techniques or other forms of information technology.

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On January 19, 2017, the U.S. Air Force Research Laboratory issued a $55 million funding opportunity announcement (FOA) to establish additional Integrated Biofuel Production Enterprise (IBPE) capabilities to increase the domestic production capacity of advanced biofuels.  The U.S. Air Force anticipates granting one award of up to $55 million in funding with the recipients required to share at least 50 percent of the total project cost.  The project will include the design, construction and/or retrofit, operation, and qualification of a domestic IBPE with a capacity to produce at least ten million gallons of neat biofuel per year.  The FOA states that proposals can involve Brown Field expansion and/or modification of existing Pilot-scale facilities, commercial-scale facilities, or new Green Field construction.  Notice of intent to submit a proposal is due by April 25, 2017, with full proposals due by May 25, 2017.

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