CHEMICAL AND BIOLOGICAL DEFENSE PROGRAM
FY18.1: Small Business Innovation Research (SBIR)
Component Specific Proposal Submission Instructions
The approved FY18.1 topics included in the Chemical and Biological Defense (CBD) Small Business Innovation Research (SBIR) Program are listed below. Offerors responding to this Announcement must follow all general instructions provided in the Department of Defense (DoD) SBIR Program Broad Agency Announcement. Specific CBD SBIR requirements that add to or deviate from the DoD SBIR Program Announcement are provided below with references to the appropriate section of the DoD SBIR Announcement.
General Information
In response to Congressional interest in the readiness and effectiveness of U.S. Nuclear, Biological and Chemical (NBC) warfare defenses, Title XVII of the National Defense Authorization Act for Fiscal Year 1994 (Public Law 103-160) required the Department of Defense (DoD) to consolidate management and oversight of the Chemical and Biological Defense (CBD) Program into a single office – Office of the Assistant Secretary of Defense for Nuclear, Chemical and Biological Defense Programs. The Joint Science and Technology Office for Chemical and Biological Defense (JSTO-CBD), Defense Threat Reduction Agency (DTRA) provides the management for the Science and Technology portfolio of the Chemical and Biological Defense Program. Technologies developed under the CBD SBIR Program have the potential to transition to the Joint Program Executive Office for Chemical and Biological Defense (JPEO-CBD) if the appropriate level of technology maturity has been demonstrated. The JSTO-CBD Science & Technology (S&T) programs and initiatives are improving defensive capabilities against Chemical and Biological Weapons of Mass Destruction. The CBD SBIR portion of the CBD S&T Program is managed by the JSTO-CBD and is not part of the DTRA SBIR Program.
The mission of the Chemical and Biological Defense Program is to ensure that the U.S. military has the capability to operate effectively and decisively in the face of chemical or biological warfare threats at home or abroad. Numerous factors continually influence the program and its technology development priorities. Improved defensive capabilities are essential in order to mitigate the impact of Chemical and Biological Threats. The U.S. military requires the most up-to-date and state-of-the-art equipment and instrumentation to permit our Warfighters to detect to warn and avoid contamination, if possible, and to be able to sustain operations in a potentially compromised environment. Further information regarding the DoD Joint Chemical and Biological Defense Program is available at the DoD Counter-proliferation and Chemical Biological Defense homepage at
The overall objective of the CBD SBIR Program is to identify, obtain and provide technical solutions from small businesses and to improve the transition or transfer of innovative Chem-Bio technologies to the end user – the Warfighter – in addition to commercializing technologies within the private sector for mutual benefit. The CBD SBIR Program targets those technology efforts that maximize a strong defensive posture in a biological or chemical environment using passive and active means as deterrents. These technologies include chemical and biological detection for both point and stand-off capabilities; individual and collective protection; hazard mitigation (decontamination); information management, modeling, simulation, and analysis; medical pre-treatments (e.g., vaccine development and delivery); medical diagnostics and disease surveillance; and medical therapeutics (chemical countermeasures and biological countermeasures).
Submitting Your Phase I CBD SBIR Proposal
The entire SBIR proposal submission (consisting of a Proposal Cover Sheet, the Technical Volume, Cost Volume, and Company Commercialization Report) must be submitted electronically through the DoD SBIR/STTR Proposal Submission system located at .
The Proposal Technical Volume must be no more than 20 pages in length. The Cover Sheet, Cost Volume and Company Commercialization Report do not count against the 20-page Proposal Technical Volume page limit. Pages in excess of this length will not be evaluated and will not be considered for review. The proposal must not contain any type smaller than 10-point font size (except as legend on reduced drawings, but not tables).
If your proposal is selected for award, the technical abstract and discussion of anticipated benefits will be publicly released on the Internet; therefore, do not include proprietary information in these sections. Classified information is never permitted to be included in any SBIR proposal.
The CBD SBIR Program will fund a Phase I proposal up to $150,000 for a six-month period of performance (independent of Discretionary Technical Assistance funding, if requested). The CBD SBIR Program no longer uses a Phase I Option period and will not accept any Phase I proposals that include an option period. Additionally, the CBD SBIR Program will not accept Phase I proposals which exceed $150,000 (exclusive of Discretionary Technical Assistance; see below).
The CBD SBIR Program reserves the right to limit awards under any topic, and only those proposals of superior scientific and technical quality in the judgment of the Technical Evaluation Team will be funded. The offeror must be responsive to the topic requirements, as solicited.
Proposals not conforming to the terms of this Announcement, and any unsolicited proposals, will not be considered. Awards are subject to the availability of funding (subject to the Congressional Budget process) in addition to successful completion of contract negotiations. Note the Chemical and Biological Defense Program is not responsible for any funds expended by the offeror prior to contract award.
CBD Program Phase II Proposal Guidelines
Phase II is the demonstration of the technology that was found feasible in Phase I. Phase I awardees may submit a Phase II proposal without invitation; however, it is strongly encouraged that a Phase II proposal not be submitted until sufficient Phase I progress can be evaluated and assessed based on results of the Phase I proof-of-concept/feasibility study Work Plan and no earlier than a recommended five months from date of contract award. All Phase II proposal submissions must be submitted electronically through the DoD SBIR/STTR Proposal Submission system at . At the DoD SBIR Proposal Submission Web site, Phase II proposals MUST be submitted to ‘CBD SBIR’ regardless of which DoD contracting office negotiated and awarded the Phase I contract. Additional instructions regarding Phase II proposal submission process including submission key dates will be provided to Phase I awardees after Phase I contract award and also can be found at
CBD SBIR Phase II Cost Volumes must contain a budget for the entire 24-month Phase II period not to exceed the total maximum dollar amount of $1,000,000. These costs must be submitted using the Cost Volume format (accessible electronically on the DoD SBIR Proposal Submission Web site). The total proposed amount should be indicated on the Proposal Cover Sheet as the proposed cost with approximately 50% of the total Phase II budget for Year 1 and the balance of the funding budgeted for Year 2.
The CBD SBIR Program is committed to minimizing the funding gap between Phase I and Phase II activities. The CBD SBIR Program typically funds a cost-plus fixed-fee Phase II award, but may award a firm fixed price contract at the discretion of the Contracting Officer.
Discretionary Technical Assistance
In accordance with the Small Business Act (15 U.S.C. 632), the CBD SBIR Program Office will authorize the recipient of a Phase I and/or a Phase II SBIR award to purchase technical assistance services (Discretionary Technical Assistance, DTA), such as access to a network of scientists and engineers engaged in a wide range of technologies, or access to technical and business literature available through on-line databases, for the purpose of assisting such concerns as:
- making better technical decisions concerning such projects;
- solving technical problems which arise during the conduct of such projects;
- minimizing technical risks associated with such projects; and
- developing and commercializing new commercial products and processes resulting from such
projects.
If your small business firm is interested in proposing use of a vendor for Discretionary Technical Assistance, you must provide a cost breakdown in the Cost Volume under “Other Direct Costs (ODCs)” and provide a one-page description of the vendor you will use and the specific technical assistance services to be provided. The proposed amount may not exceed $5,000 for Phase I, and $5,000 for each year of a Phase II project. The DTA description should be included as the LAST page of the Technical Volume. This description will not count against the Phase I or Phase II proposal page limit and will NOT be assessed against SBIR proposal evaluation criteria. Approval of technical assistance is not guaranteed and is subject to review of the Contracting Officer.
CBD SBIR Projects Requiring Animal and Human Subjects
Companies should plan carefully for any research involving animal and/or human subjects in addition to the use of any chemical or biological warfare agents. The brief Phase I Period of Performance may preclude plans requiring the use of these materials as well as animal and/or human subjects prior to obtaining all necessary approvals.
The offeror is expressly forbidden to use or subcontract for the use of laboratory animals in any manner without the express written approval of the U.S. Army Medical Research and Material Command's (USAMRMC), Animal Care and Use Review Office (ACURO). Written authorization to begin research under the applicable protocol(s) proposed as part of the CBD SBIRprogram will be issued after contract award in the form of an approval letter from the USAMRMC ACURO to the recipient. Furthermore, modifications to already approved protocols require approval by ACURO prior to implementation.
Research under CBD SBIR awards involving the use of human subjects, to include the use of human anatomical substances or human data, shall not begin until the DTRA Research Oversight Board (ROB) provides authorization that the research protocol may proceed. Written approval to begin research protocol will be issued from the ROB, under separate notification to the recipient. Written approval from the ROB is also required for any sub-recipient that will use funds obtained from any CBD SBIR awards to conduct research involving human subjects.
Changes in research involving human subjects shall be conducted in accordance with the protocol submitted to and approved by the ROB. Non-compliance with any provision may result in withholding of funds and or termination of the award.
Key Dates
18.1 Announcement Pre-Release28 November 2017 – 7 January 2018
18.1Announcement Open/Close 8 January 2018 – 7 February 2018 (submission deadline:
8:00 pm Eastern Time on closing date)
Phase I EvaluationsFebruary– April 2018
Phase I Selections No Later Than 6 May 2018
Phase I Awards October 2018 (see Note 1)
Phase II Proposal Submission Recommend proposal submission no earlier than approximately five
monthsfrom date of Phase I contract award. Additional instructions
regarding Phase II proposal submission process including key dates will
be provided to Phase Iawardees after Phase I contract award and also can be found at
(Note 1) Subject to the Congressional Budget process.
CBD SBIRPROPOSAL CHECKLIST
This is a Checklist of Requirements for your proposal. Please review the checklist carefully to ensure that your proposal meets the CBD SBIR requirements. Failure to meet these requirements will result in your proposal not being evaluated or considered for award.
_____ 1. The Proposal Cover Sheet along with the Technical Volume, Cost Volume, and Company Commercialization Report were submitted via the Internet using the DoD SBIR Proposal Submission Web site at
_____ 2. The proposal cost adheres to the CBD SBIR Program criteria specified.
_____ 3. The proposal is limited to only ONESBIR topic. All required documentation within the proposal references the same topic number.
_____ 4. The proposal is responsive to the requirements addressed in the topic.
_____ 5. The Project Abstract and other content provided on the Proposal Cover Sheet does not contain any proprietary or classified information and is limited to the space provided.
_____ 6. The Technical Volume of the proposal includes the items identified in Section 5.3.c of the DoD SBIRProgram Announcement.
_____ 7. The Proposal Technical Volume must be 20 pages or less in length. The Cover Sheet, Cost Volume and Company Commercialization Report do not count against the 20-page Proposal Technical Volume page limit. Technical Volume pages in excess of 20-pages will not be evaluated and will not be considered for review.
_____ 8. The Company Commercialization Report is submitted online in accordance with Section 5.4.e of the DoD SBIR Program Announcement. This report is required even if the company has not received any prior SBIR funding.
_____ 9. The proposal must not contain any type smaller than 10-point font size (except as legend on reduced drawings, but not tables).
CBD SBIR 18.1 Topic Index
CBD181-001 / 3D Printed Manufacturing of Respiratory ProtectionCBD181-002 / Innovative Respiratory Protection for Low Threat Environments
CBD181-003 / Durable Stretch Barrier Materials
CBD181-004 / Extended Release Formulations for Fielded Nerve Agent Pretreatment
CBD181-005 / Dual Formulation of Atropine/Scopolamine with Enhanced Stability
CBD181-006 / Field Portable Mass Spectrometry for Small Molecule Drugs in Clinical Samples
CBD181-007 / Bi-specific Antibodies Targeting Disease Caused by Encephalitic Alphaviruses
CBD - 1
CBD SBIR 18.1 Topic Descriptions
CBD181-001 / TITLE: 3D Printed Manufacturing of Respiratory ProtectionTECHNOLOGY AREA(S): Chemical/Biological Defense, Materials/Processes
OBJECTIVE: Develop additive manufacturing processes to produce a fully functional Air Purifying Respirator (APR). Demonstrate advantages of 3D printed manufacturing to provide innovations such as custom sizing and use of multifunctional elastomeric composites.
DESCRIPTION: Many respiratory protection systems are designed for a high threat environment. These threat levels and quality assurance requirements posed upon respiratory protection devices currently drive the utilization of expensive and timely production processes such as rubber and plastic injection molding. Limitations of injection molding include cost, time, and an inability to produce multifunctional composite materials. Also, small run respirator modifications or customizations are typically cost prohibitive. Additive manufacturing allows for improvement in manufacturing cost and time but does not currently account for the production of materials that offer the strength or permeation resistance required for respiratory protection systems. Also, layered 3D printing techniques do not result in smooth surfacing and some resin based options do not have the print bed or working time requisite for a full facepiece respirator.
This effort seeks to overcome these challenges by pursuing a technological manufacturing innovation that is critical to a strong manufacturing sector in the U.S. economy. The focus of this effort is to develop a respiratory protective device utilizing innovative additive manufacturing technologies and processes. Innovative technologies and multifunctional elastomeric composite materials are needed to allow custom sized manufactured respirators to be produced at a cost effective price and in a timely manner. Additive manufacturing processes of composite elastomeric materials offer many potential advantages. Potential advantages could include a respirator facepiece consisting of a soft internal comfort layer near the face and a rugged threat agent resistant layer on the exterior. Even further, a composite layer providing ballistic, fire, or other operationally tailored levels protection could be achieved. Materials developed shall have threat agent permeation resistance characteristics required by the NIOSH Statement of Standard for Chemical, Biological, Radiological, and Nuclear (CBRN) Full Facepiece Air Purifying Respirator (APR). Durability and tensile requirements shall compare favorably to existing military respirator materials and shall comply with requirements set forth in MIL-STD 810G.
PHASE I: Investigate innovative elastomeric and/or composite materials and additive manufacturing processes that would result in eight vertically printed coupons (4” diameter; .05” thickness) that are resistant to chemical warfare agent materials as required by the NIOSH Statement of Standard for CBRN Full Facepiece Air Purifying Respirator APR. Provide eight coupons to the Government for testing. Perform and demonstrate in house durability and tensile strength testing of additional coupons of simple and complex geometries. Referencing Government-owned and provided M40 APR technical data, develop designs that illustrate in detail how these elastomeric and/or composite materials would be used to develop a full facepiece system. Show how the necessary production quality attributes can be met, especially those related to a good respirator to face seal. Assess materials chosen for human safety.
PHASE II: Refine the material and production technology chosen to develop a full elastomeric facepiece of size equivalent to the M40 APR. Technology demonstrated will be capable of printing a minimum of 10” (L) x 8” (W) x 8” (H) print volume and will exhibit smooth sealing surfaces. Exact APR face seal size and shape produced will be based on head and facial anthropometric characteristics of five test subjects. A full facepiece APR will be constructed using these custom facepieces and government provided M40 component hardware, to include the filter. The ability to co-print multiple materials to reduce hand assembly will be demonstrated. A preliminary laboratory respiratory protection level (LRPL) test of these five constructed APRs on the chosen test subjects will be performed at this stage. The LRPL of the APR shall be 2000 or greater, for 95% of trials, sampled in the breathing and ocular zone of the respirator. The APRs developed should comply with the NIOSH Statement of Standard for CBRN Full Facepiece Air Purifying Respirator APR.
PHASE III: Improve the APR design by demonstrating the incorporation of customized hardware, allowance for improved human factors, and operational tailoring. Demonstrate the scalability of the technology to print a NIOSH compliant APR in under 12 hours.
PHASE III DUAL USE APPLICATIONS: Potential alternative applications include industrial, pharmaceutical, healthcare, international, and other commercial respiratory protection uses as well as protection systems beyond the respirator.