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This Sources Sought opportunity from Department Of Defense was posted on April 8, 2022. The submission period has ended. Browse the details below for market research, or find similar active opportunities.

BAA-21-G-01 BIOMEDICAL RESEARCH AND DIVING EQUIPMENT DEVELOPMENT IN THE AREAS OF DIVER HEALTH, SAFETY, AND EFFECTIVENESS, AS WELL AS SUBMARINER SURVIVABILITY IN A DISABLED SUBMARINE

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N0002418R4328Federal

Contract Overview

Solicitation details, issuing organization, response deadlines, documents, and interested companies for this government contract opportunity.

Active Opportunities Like This One

NAICS: 541714
New
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The Capability Program Executive for Chemical, Biological, Radiological, and Nuclear Defense (CPE CBRND) is establishing the Chemical, Biological, Radiological, and Nuclear (CBRN) Medical Countermeasure (MCM) Participant Basic Agreement (PBA) ecosystem. This continuous, open announcement seeks to build a network of pre-qualified partners to accelerate the development, testing, and fielding of next-generation medical defense solutions. The program focuses on two primary pillars: host-targeted resilience, which targets critical host systems like neurological and respiratory pathways to enhance physiological protection, and threat-targeted neutralization, which focuses on broad-spectrum countermeasures for prophylaxis and acute treatment. Priority is given to candidates designed for austere environments, featuring environmental stability without cold-chain reliance and simplified administration routes such as oral or intranasal delivery. The government is inviting two types of participants: MCM Development Collaborators, ranging from Phase I products through FDA licensure, and MCM Development Support Collaborators, such as CROs and CDMOs specializing in preclinical testing, cGMP manufacturing, and regulatory submissions. Interested parties must submit a white paper of no more than five pages detailing their product descriptions, efficacy data, regulatory status, and manufacturing capabilities. Acceptance into the PBA enables the subsequent award of project orders under the authority of 10 U.S.C sections 4021, 4022, and 4023. These agreements are not subject to the Competition in Contracting Act of 1984. All prospective awardees must be registered in the System for Award Management (SAM) database to receive payment.
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NAICS: 541714
New
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AJ12--Development/Production - Kidney GEC-Specific AAV Vector
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The Department of Veterans Affairs is issuing a Sources Sought notice to identify capable vendors for the development and production of a kidney glomerular endothelial cell specific adeno-associated virus AAV vector. This project, funded by a VA ORD Merit award, aims to create a homing peptide enabled vector platform to target the glomerular endothelium to treat kidney injury and disease while reducing off target transduction. The scope of work is divided into three primary tasks: the engineering and incorporation of targeting peptides into the AAV capsid, testing vector binding and internalization in kidney tissue slices, and evaluating the specificity and efficiency of the modified vector through bioluminescence imaging and in vivo biodistribution studies. Qualified contractors must possess extensive onsite resources, including BSL 2 laboratories, specialized DNA and RNA facilities, and advanced instrumentation such as the Agilent Fragment Analyzer and various qPCR platforms. Vendors must demonstrate proven success in animal and human cell vector delivery and maintain full compliance with AAALAC and FELASA health standards. The government requires quarterly reporting, weekly videoconferences, and biannual face to face meetings. All generated data will be subject to Government Purpose Rights, and contractors must adhere to strict federal records management and information security protocols. Interested parties must submit a capability statement, relevant literature, and socio economic status details under NAICS 541714 by November 4, 2026.
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NAICS: 541714
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Translational Centers Using Microphysiological Systems for Infectious Diseases (U54 Clinical Trial Not Allowed)
Solicitation # RFA-AI-28-012
The National Institute of Allergy and Infectious Diseases (NIAID) has issued solicitation RFA-AI-28-012 to establish a consortium of Translational Centers Using Microphysiological Systems for Infectious Diseases (TCMID). The primary objective is to refine and validate human tissue models using Microphysiological Systems (MPS) to a level consistent with regulatory qualifications, thereby promoting their adoption by product developers and reducing reliance on laboratory animals. This initiative aligns with NIH and FDA guidance on New Approach Methodologies (NAMs) to accelerate the development of safer medical interventions by capturing human variability and patient-specific characteristics. The program is structured around an Administrative Core, a Qualification Core, and Scientific Cores, with a heavy emphasis on technical readiness, reproducibility, and regulatory acceptance. Key deliverables include the validation of assays for specific endpoints and the submission of regulatory packages. Applicants must be domestic entities, as foreign organizations and foreign subawards are strictly prohibited. Required personnel must possess deep expertise in infectious diseases, MPS platforms, bioinformatics, and FDA submission processes. Applications are due by January 29, 2027, and must be submitted via the NIH ASSIST system or approved institutional system-to-system solutions. Evaluation is based on an overall impact score considering the project's significance, the suitability of the investigators, and the quality of the institutional environment. Mandatory application components include a Data Management and Sharing Plan and a Benchmarks and Timeline PDF not exceeding six pages. Awardees must also adhere to strict cybersecurity incident reporting guidelines, notifying HHS within 48 hours of any discovery.
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NAICS: 541714
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Immune Tolerance Network (UM1 Clinical Trial Required)
Solicitation # RFA-AI-28-005
The National Institutes of Health, under the Department of Health and Human Services, is seeking applications through solicitation RFA-AI-28-005 to continue the Immune Tolerance Network (ITN). This cooperative agreement aims to develop tolerogenic therapies for immune-mediated disorders, specifically focusing on autoimmune diseases, allergic diseases and asthma, and the immune-mediated consequences of transplantation. The network operates through four integrated functional areas: Leadership, Clinical Operations, Core Laboratory, and Bioinformatics. Its primary objectives include designing and conducting clinical trials, performing integrated mechanistic studies, and sharing research results. Eligible applicants include small businesses and other for-profit organizations, though non-domestic entities are ineligible. Applications are evaluated based on scientific and technical merit, with a primary focus on significance and the likelihood of exerting a sustained influence on the research field. Key requirements include maintaining active registrations in SAM.gov, eRA Commons, and Grants.gov, as well as adhering to strict cybersecurity incident reporting and human subject protection protocols. The project requires a minimum effort of 3.6 person months per year for the PD/PI and mandates participation in a kick-off meeting in Bethesda, Maryland, and bi-annual steering meetings. Applications must follow specific page limits for the research strategy subsections and include detailed plans for clinical trial implementation, data management, and biorepository services.
National Institutes Of Health

POSTED

3 days ago

DEADLINE

in 3 months

General Info

NAICS

541714 - Research and Development in Biotechnology (except Nanobiotechnology)

Place of Performance

DC

Set-Aside

NONE

Documents

2

BAA+-+DSBD+and+Diving+Equipment+FY22+Encl+1+Preproposal+Format+%28Final%29.pdf

PDF

BAA+-+DSBD+and+Diving+Equipment+FY22+Encl+2+-+Full+Proposal+Format+%28Final%29.pdf

PDF

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Response deadline added: Mar 20, 2022.

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Submission Closed

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Organization & Contact Information

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AgencyDepartment Of Defense → Navsea Hq
Contacts2 people available
OfficeWASHINGTON NAVY YARD, DC, 20376-5000, USA
Office AddressWASHINGTON NAVY YARD, DC, 20376-5000, USA

Full Description

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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) 2022 and FY 2023. 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: Breathing Gas Supply: 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 and compact portable mix-making system for augmenting Fly Away Mixed Gas Diving System; Improved O2 sensor for use in closed-circuit Underwater Breathing Apparatuses (UBA); Development of innovative diluent gas solutions that combine the advantages of nitrogen's availability and helium's non-narcotic properties; 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) for SSD EGS and SCUBA/Rebreathers. Current diver worn EGS is not sufficient to recover from deepest depth if gas source is lost. 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); Development of portable bathymetric analysis systems capable of providing real-time quantification of environmental conditions including water depth, currents, bottom type and temperature at various depths; Improve current comprehension of the environmental and physiological mechanisms via which sound is perceived via wetted auditory interface; Develop permissible exposure limits (PEL) for typical broadband noise sources insonifying the aquatic mission environment; Develop compact, adaptive, wearable acoustic dosimetry technology for use in conjunction with PEL and in order to inform the comprehension of long term auditory hazards associated with underwater diving. (3) Protection from the Environment: Improving knowledge of body heat loss/retention to inform development of future heating/cooling systems; Improving heating/cooling methods for submerged divers/operators; Improving diver/operator performance by developing targeted heating/cooling systems; 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/chemical contaminants for risk mitigation planning; Improving understanding of heat loss/retention in the submerged body, in an effort to optimize heating/cooling of divers; Develop methods to assess and mitigate diver underwater sound/blast/implosion exposure; 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 300 fsw; 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. (5) Tools, Transportation and Training: 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; 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 non-hyperbaric 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: development and evaluation of physiological heat stress limits based on time and environmental conditions, and 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 other non-hyperbaric interventions e.g. pharmacological; 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; Improvement of current tracking of rescuee triage, holding, and movement. 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 FY22, the deadline for submission of pre-proposals is no later than 3:00 PM EST, 30 November 2020. 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, 30 March 2021. 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 2021. (2) For FY23, the deadline for submission of pre-proposals is no later than 3:00 PM EST, 30 November 2021. 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, 30 March 2022. 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 2022. 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. The technical proposal will be submitted using the format provided with this BAA and not be more than 20 pages excluding curriculum vitae and supporting documentation that would be included in the Appendix. 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. b. Selection of proposals for award will be based on the total evaluated score of the items above. c. 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." d. 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: NSSC_SUPSALVDSBD.fct@navy.mil Attn: BAA-21-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 NSSC_SUPSALVDSBD.fct@navy.mil. The points of contact for information regarding contractual issues is Contracting Officer CDR Jeffrey Carideo at email: jeffrey.w.carideo@navy.mil and Contracting Specialist LCDR Aaron Smith at email: aaron.k.smith3@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 198

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