Pharmaceutical Interventions for Noise-Induced Hearing Loss--Acute Exposure Treatment (PINIHL-AET)

08-AUG-2018, UPDATE TO NOTICE: The purpose of this notice amendment is to issue Solicitation Amendment W81XWH-18-R-0025-0003 for the PINIHL-AET requirement and upload the amendment (SF30), and amended RFP/Solicitation (SF33). 27-JUL-2018, UPDATE TO NOTICE: The purpose of this notice amendment is to issue Solicitation Amendment W81XWH-18-R-0025-0002 for the PINIHL-AET requirement and upload the amendment (SF30), amended RFP/Solicitation (SF33), and Attachment 6 (revised). 26-JUL-2018, UPDATE TO NOTICE: The purpose of this notice amendment is to issue Solicitation Amendment W81XWH-18-R-0025-0001 for the PINIHL-AET requirement and upload the amendment (SF30), amended RFP/Solicitation (SF33), Attachment 5 (revised), and Attachment 6 (new). The proposal due date is extended. 11-JUL-2018, UPDATE TO NOTICE: The purpose of this amendment is to issue Solicitation W81XWH-18-R-0025. 10-JUL-2018, UPDATE TO PRESOLICITATION NOTICE: The purpose of this amendment to the pre-solicitation notice is to provide the vendor community with updated projections regarding solicitation release, proposal submission, and award. 06-JUL-2018, UPDATE TO PRESOLICITATION NOTICE: The purpose of this amendment to the pre-solicitation notice is to provide the vendor community with updated projections regarding solicitation release, proposal submission, and award. Project Title: Pharmaceutical Interventions for Noise-Induced Hearing Loss-Acute Exposure Treatment (PINIHL-AET) The United States Army Medical Research Acquisition Activity (USAMRAA), in support of the United States Army Medical Materiel Development Activity (USAMMDA) Tissue Injury and Regenerative Medicine Project Management Office (TIRM PMO), intends to solicit for research and development (R&D) services to develop a pharmaceutical intervention for prevention of permanent noise-induced hearing loss (NIHL) for acute exposure treatment within seventy-two (72) hours of exposure to unanticipated noise hazards common to military operations (e.g., blasts, forgotten ear plugs while on patrol). The desired status at the end of this procurement action is completion of a Phase 2 clinical trial and an approved Phase 3 clinical study plan, both under an Investigational New Drug (IND) application. Hearing is a critical sense for Service Members (SMs). The inherently noise-hazardous environments common to military service make SMs particularly vulnerable to the vast subset of sensorineural hearing loss known as NIHL. Hearing injuries can threaten safety and fitness for duty by impeding communication, reducing situational awareness, hindering threat detection, and ultimately degrading mission effectiveness. In some cases, hearing loss may preclude redeployment or result in less optimal job assignment, and may permanently reduce their quality of life. There are currently no United States Food and Drug Administration (FDA)-approved pharmacological prevention strategies for NIHL. Several non-pharmacological strategies are available but these cannot alone, nor in concert, fully eliminate hearing loss. Strategies employed by the Department of Defense (DoD) include: noise-control engineering, hearing protective devices (HPDs), and administrative controls to limit times of exposure. Current US Military protocols for post-exposure treatment of acute acoustic trauma (AAT) include removing the patient from the noise hazard and maintaining the patient in an effectively quiet environment (ambient levels 70 dB or less) for twenty-one (21) days. Noise isolation provides some recovery from AAT, but removes SMs from duty for prolonged periods. The long term goal of the TIRM PMO is to make wounded warfighters whole by restoring form, function, and appearance. The outcome of this development will enable TIRM PMO to lead the development of products that will treat wounded warriors with NIHL in operational environments. According to PINIHL Integrated Product Team (IPT) market research, the developmental phases of these pharmacological interventions with potential to protect from or mitigate NIHL currently range from preclinical to start of Phase 2 clinical studies. Therefore, the Government released a request for proposals (RFP) to fulfill this requirement and promote innovation. The solicitation has been released via FedBizOpps (www.fbo.gov) to the vendor community and will close not earlier than 30 days after the issuance date. Specifications of the requirement have been provided in solicitation W81XWH-18-R-0025. Solicitation Release Date - 11 July 2018 Question Submission Date - 18 July 2018 Proposal Submission Date - 17 August 2018 Anticipated Award Date - 15 October 2018 The Government anticipates that the solicitation will result in the award of up to two (2) Cost Plus Fixed Fee (CPFF) contracts, each with up to sixty (60) months of performance. The Government intends to award the initial contract(s) for the completion of a Phase 2 (or later) clinical study. Subsequent optional tasks will be exercised if warranted. The Government's objectives will be outlined in the solicitation. The North American Industry Classification System (NAICS) Code selected for this acquisition is 541715-Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology); and the size standard is 1,000 employees. This is an unrestricted procurement. Award shall be made on a competitive basis, using the best value tradeoff process among cost/price and non-cost/-price factors described at FAR 15.101-1. The Government intends to evaluate offers and award a contract without discussions with Offerors. Therefore, the Offeror's initial offer should contain the Offeror's best terms from a cost/price and technical standpoint. However, the Government reserves the right to conduct discussions if later determined by the Contracting Officer to be necessary. The Government may reject any or all offers if such action is in the public interest; accept other than the lowest offer; and waive informalities and minor irregularities in offers received. Those interested in obtaining the solicitation can access it at the Federal Business Opportunities (FedBizOpps) website at www.fbo.gov and search for solicitation W81XWH-18-R-0025. Vendors wishing to submit an offer are responsible for downloading their own copy of the RFP and for frequently monitoring the site for any amendments. Requests made by phone will not be accepted. No solicitations will be provided by hard copy, fax, or e-mail. Failure to respond to the electronically posted RFP and associated amendments prior to the date and time set for receipt of proposals specified on the solicitation may render vendor offer non-responsive and result in rejection of the same. The Government is not responsible for any loss of internet connectivity or for an Offeror's inability to access the documents posted at the referenced website. To be eligible for an award or payment from any DoD activity, Offerors must provide registration information to the System for Award Management (SAM)*. All Offerors must be registered prior to receiving an award. The Offeror's SAM record must include the NAICS that has been selected for this procurement. Registration instructions may be obtained, and online registration may be accomplished at www.sam.gov. This includes the online representations and certifications located within SAM. * Registration of a new entity in SAM has changed as of 22 March 2018; the registrant must provide an original, signed notarized letter stating that you are the authorized Entity Administrator before your registration will be activated. Registration updates and renewals of existing entities in SAM has also changed as of 27 April. Please visit http://www.sam.gov and https://www.gsa.gov/about-us/organization/federal-acquisition-service/office-of-systems-management/integrated-award-environment-iae/sam-update to learn more about these process changes. Please note that international entities must follow a different process. It is recommended that Offerors allow sufficient time to complete the SAM registration process. An entity can be registered in SAM under multiple NAICS if they are applicable to the entity's business. EARLY REGISTRATION IS ADVISED.