Probabilistic Decompression Sickness Model Development

The purpose of this modification is to revise the FY21 deadline for submisions of pre-proposals from 11 November 2019 to no later than 3:00 PM EST, 12 November 2019. Naval Sea Systems Command (NAVSEA) is soliciting pre-proposals and proposals for applied Biomedical Research and Diving Equipment Development with a focus on Diver Health, Safety, and Performance, Deep Diving Advancements, and Submarine Escape and Rescue. The goals of this program are presented in more detail below. It is the intent that this Broad Agency Announcement (BAA) be open for a two-year period from the date of this publication. However, specified dates are given in paragraph 2.a. below for submission of pre-proposals and full proposals to be awarded within Fiscal Year (FY) 2020 and FY 2021. 1. Primary Areas of Interests This program's objectives are to focus research efforts on improving or developing diving equipment that can be rapidly transitioned to a fleet capability, and researching the biomedical aspects of Diver Health, Safety, and Performance, Deep Diving, and Submarine Escape and Rescue in order for procedures to be developed/improved to increase the levels of safety and effectiveness for Navy personnel. The typical project will be two years or less, although we will consider three year projects. a. Diving: This Area of Interest is comprised of five Lines of Effort (LOE) which relate to factors creating limitations on divers: Breathing Gas Supply; Human Performance; Protection from the Environment; Decompression; and Tools, Transportation and Training. Focus areas within each LOE are: (1) Breathing Gas Supply: Improved Portable Air Monitor that can test for all contaminants listed in Table 4-1 of the U.S. Navy Dive Manual in real time; Improved CO2 scrubbing material for both free-swimming and fixed systems; Development of portable, minimal power input, oxygen (O2) concentrators capable of working in conjunction with existing diving air compressors; Improved helium reclaim system to support mixed gas and saturation dive systems; Improved O2 sensor for use in closed-circuit Underwater Breathing Apparatuses (UBA); Development of High Pressure air flask, hose and regulators, with high pressure defined for this purpose as greater than 5,000 pounds per square inch (psi). (2) Human Performance: Improving understanding of the mechanisms of oxygen toxicity and development of mitigations; Developing pharmacological or other novel mitigations for preventing or delaying pulmonary and CNS Oxygen Toxicity; Identifying biomarkers to improve the diagnosis of oxygen toxicity and mitigate the impact thereof; Developing and/or refining noise protection strategies and exposure limits; Refining the understanding and mitigation of hypercapnia in divers; Improving understanding of gas (N2, O2, CO2) narcosis to include mitigations and predictions of equivalent narcotic depths; Improving understanding of effects on the human body from immersion, exertion, breathing resistance, and temperature in relation to working underwater; Improving understanding of and developing guidance for the prevention of immersion pulmonary edema; Developing breathing standards for resting and working personnel in dry hyperbaric environments to 6 Atmospheres Absolute (ATA); Developing a Diver Longitudinal Health Surveillance System/Program. (3) Protection from the Environment: Developing a diver-worn heater and/or chiller; Improving body temperature control for submerged divers in a wet submersible; Improving physical protection for divers in contaminated water; Improving the equipment and procedures used to decontaminate divers and diving gear; Improving the equipment and procedures to detect and quantify biologic and/or chemical contamination on-site prior to diving; Developing exposure limits for common biological contaminants; Improving understanding of heat loss/retention in the submerged body, in an effort to optimize heating/cooling of divers; Improving passive thermal protection for divers to include improved durability to support field/combat conditions; Improving diver performance in cold water by developing improved glove and boot systems; Developing a 1 atmosphere (ATM) diving capability that can accomplish 90% of a "wet diver's" tasks down to 1,000 feet of sea water (fsw). (4) Decompression: Developing/testing decompression models valid across the full spectrum of U.S. Navy diving, including diving to depths beyond 300fsw; Developing pharmacological or other novel mitigations for preventing or treating decompression sickness; Improving the diagnosis of decompression sickness through, but not limited to, the utilization of algorithms; Improving decompression profiles based on the use of alternate gas mixtures; Developing biomarkers to improve the accuracy of and speed to diagnosis of DCS and to mitigate the impact of DCS. (5) Tools, Transportation and Training: Developing a Transportable Recompression Chamber System (TRCS) replacement of similar or smaller size and functionality, using advanced materials (i.e. carbon fiber, or other lightweight material) to reduce system weight for easier transport in military and commercial aircraft; Improving diver communications, both wired and through-water; Improving the ability to track divers' location underwater from surface support craft; Improving through-water data communication for divers (text, navigation, biometrics); Improving diver propulsion devices to include diver worn and diver as passenger; Developing Heads-Up Display (HUD) for divers, both free-swimming and surface-supplied. HUDs need not be limited to life support data (e.g., text, navigation, diagrams/schematics for projects, etc); Improving low visibility vision enhancement for divers; Developing a system for electronic recording and archiving of operational dive profiles to create an operational dive data base. b. Submarine Escape and Rescue: This Area of Interest relates to optimizing submariner survival in a disabled submarine event. Focus areas are: Development of rapid, accurate methods of disabled submarine (DISSUB) atmosphere assessment, with focus on Submarine Escape Action Limit (SEAL) gases, to internal pressures up to 6 ATA; Development of novel means to mitigate oxygen toxicity (Pulmonary and CNS) aboard a pressurized disabled submarine; Development of novel means to accelerate or eliminate saturation decompression of pressurized DISSUB survivors, including but not limited to, greater oxygen use; Evaluation of the utility of pharmacologic interventions to prolong survival and accelerate decompression from a pressurized DISSUB; Evaluation of the impact of starvation, dehydration, sleep deprivation, and/or gas narcosis at 5 atmospheres absolute (ATA) on decision making in a pressurized DISSUB; Improved understanding and guidance for thermal stress (with focus on hyperthermia) and associated fluid loss in a pressurized DISSUB and rescue vehicles to 5 ATA by 1) development and evaluation of physiological heat stress limits based on time and environmental conditions, and 2) development and evaluation of heat mitigation measures (body cooling) under conditions of increased temperature, humidity, and elevated CO2 (2.5 - 3%); Improved understanding and guidance for mitigation of surface interval decompression sickness (DCS) risk associated with rescue using either the Pressurized Rescue Module (PRM) or the Submarine Rescue Chamber (SRC) after saturation dropout or aborted decompression, including, but not limited to, mitigation with various periods of oxygen pre-breathing and/or pharmacological interventions; Development of procedures to fully decompress pressurized rescuees within the PRM if needed; Improved guidance for hypothermia prevention in submarine escape scenarios using existing Submarine Escape and Surface Survival Personnel Equipment (SESSPE); Improved Guard Book guidance, procedures, and related senior survivor decision tools, to include reducing the risk of pulmonary oxygen toxicity for rescuees; Improving care of escape and rescue casualties within the U.S. Navy Submarine Rescue Diving and Recompression System (SRDRS), to include critical care and casualty assessment; Improvement of current concepts of rescuee triage, holding, and movement, including assessment of the adequacy of established procedures and available equipment, for rescues involving the PRM and the SRC. c. Of additional interest is any equipment, procedure, or medical treatment protocol, not specifically listed above, that could be used to improve the safety or effectiveness of Navy divers or submarine rescue operations. 2. Instructions for Preparation of Pre-proposal and Proposals a. Proposals to this BAA will be reviewed using a two-step process. To be considered for an award, first, respondents are required to submit a pre-proposal. (1) For FY20, the deadline for submission of pre-proposals is no later than 3:00 PM EST, 19 November 2018. The second step will be a request for full-proposals. The deadline for submission of full-proposals is no later than 3:00 PM EST, 11 March 2019. Proposals received after the due date will be considered only if funds remain available. These dates are applicable to work beginning in the funding cycle starting 1 October 2019. (2) For FY21, the deadline for submission of pre-proposals is no later than 3:00 PM EST, 12 November 2019. The second step will be a request for full-proposals. The deadline for submission of full-proposals is no later than 3:00 PM EST, 9 March 2020. Proposals received after the due date will be considered only if funds remain available. These dates are applicable to work beginning in the funding cycle starting 1 October 2020. b. This synopsis constitutes a Broad Agency Announcement (BAA) per FAR 6.102(d)(2)(i). The Step One pre-proposal should be three to five pages of text using the format provided with this BAA, and should include an estimate of overall costs (including indirect costs) for each year of the proposed effort. Pre-proposals will be evaluated based on the criteria specified below using a scale of 1 (lowest) to 10 (highest). c. The highest rated pre-proposal responses will be invited to submit a Step Two full technical and cost proposal on all or part of their pre-proposal submission. Any such invitation does not obligate the Government to make an award. Offerors are also advised all awards are subject to the Defense Contract Audit Agency (DCAA) contract audit process. A completed "animal use" protocol with supporting documentation is required before the awarding of a contract when animals are employed as required by SECNAVINST 3900.38C. Additionally, any proposal that involves human subject research must comply with the following requirements before a contract can be awarded: 32 CFR 219, DoDINST 3216.02, the SECNAVINST 3900.39 series, and all applicable sections of the 21 CFR. Each pre-proposal and full proposal must state that it is submitted in response to this BAA. This BAA provides no funding for pre-proposal or subsequent proposal development purposes. Proposals will be evaluated based on the criteria specified below. 3. Criteria for Scoring and Ranking Pre-proposals and Proposals, their Relative Importance, and the Method of Evaluation. a. Pre-proposal and full technical proposal submissions will be evaluated on: (1) the basis of innovation and scientific merit; (2) the relevance to diving and submarine escape and rescue; (3) the overall value to the Government and affordability of the proposal; (4) the likelihood of achieving success, based on the Offeror's abilities, capabilities, strengths, and weaknesses, all of which impact the ability to achieve the proposal objectives, and (5) the overall impression of the project by the expert reviewer. Selection of proposals for award will be based on the total evaluated score of the items above. b. This is to notify potential Offerors that each contract that may be placed under this announcement to an institution of higher education must include the following clause: "As a condition for receipt of funds available to the Department of Defense (DoD) under this award, the recipient agrees that it is not an institution that has a policy of denying, and that it is not an institution that effectively prevents the Secretary of Defense from obtaining for military recruiting purposes: (A) an entry to campuses or access to students on campuses; or (B) access to directory information pertaining to students. If the recipient is determined, using procedures established by the Secretary of Defense to implement Section 558 of Public Law 103-337 (1994), to be such an institution during the period of performance of this agreement, and therefore to be in breach of this clause, the Government will cease all payments of DoD funds under this agreement and all other DoD grants and cooperative payments unilaterally for material failure to comply with the terms and conditions of award. If your institution has been identified under the procedures established by the Secretary of Defense to implement Section 558, then: (1) no funds available to DoD may be provided to your institution through any contract, including any existing contract, (2) as a matter of policy, this restriction also applies to any cooperative agreement, and (3) your institution is not eligible to receive a contract or cooperative agreement in response to this solicitation." c. Historically Black Colleges and Universities (HBCU) and Minority Institutions (MI) are encouraged to submit pre-proposals or join others in submitting pre-proposals; however, no portion of this BAA will be set aside for HBCU and MI participation due to the impracticality of reserving discrete and severable areas of submarine escape and rescue, and diving for exclusive competition among these entities. This announcement constitutes a Broad Agency Announcement (BAA) as contemplated in FAR 6.102(d)(2)(i). The Government reserves the right to select for award all, some, or none of the proposals received in response to this announcement. 4. Pre-proposals and subsequent full proposals shall be submitted to: SEA00C_RD@supsalv.org Attn: BAA-18-G-01. Offerors are to follow the sample format for submission of pre-proposals and proposals as found in Enclosures (1) and (2) of this BAA. These templates can also be found at the Supervisor of Salvage and Diving website at: http://www.navsea.navy.mil/Home/SUPSALV/00C3-Diving/Diving-R-D-BAA-Submissions/. a. All pre-proposals and full-proposals will be acknowledged. Pre-proposals and full-proposals will not be returned after evaluation. General and technical questions regarding this announcement should be sent to SEA00C_RD@supsalv.org. The point of contact for information regarding contractual issues is Contracting Officer Mercedes Thurston at email: mercedes.thurston@navy.mil. The following additional information is provided: (1) Proposals may be submitted by any governmental agency, commercial firm, individual, non-profit, or institution of higher education. (2) Offerors must be current in System for Award Management (SAM). b. Phase II of the proposal selection process for non-government institutions (contractors) will consist of a request from the Government to the Offeror(s) for full technical and cost proposals to support the Navy in one or more of the primary areas of interest listed in paragraph 1 above. An Offeror can be considered for contract award only upon preparation and submittal of a fully compliant Phase II Proposal. In the event that a Phase II technical and cost proposal is requested, the applicable Request for Proposal will contain the terms and conditions and clauses to be incorporated in the potential contract. 5. Any contract(s) awarded based on responses to this BAA are considered to be the result of full and open competition (see FAR 6.102(d)(2)(i)) and in full compliance with the provisions of Public Law (PL) 98-369, "The Competition in Contracting Act of 1984."