SOURCES SOUGHT
A -- Pharmaceutical Interventions for Noise-Induced Hearing Loss
- Notice Date
- 11/21/2016
- Notice Type
- Sources Sought
- NAICS
- 541712
— Research and Development in the Physical, Engineering, and Life Sciences (except Biotechnology)
- Contracting Office
- Department of the Army, U.S. Army Medical Research Acquisition Activity, U.S. Army Medical Research Acquisition Activity, Attn: MCMR-AAA, 820 Chandler Street, Frederick, MD 21702-5014, Maryland, 21702-5014, United States
- ZIP Code
- 21702-5014
- Solicitation Number
- JD201601
- Archive Date
- 1/5/2017
- Point of Contact
- Jamie Diggs, Phone: 3016192663
- E-Mail Address
-
jamie.l.diggs.civ@mail.mil
(jamie.l.diggs.civ@mail.mil)
- Small Business Set-Aside
- N/A
- Description
- 1.0 RFI TITLE: Pharmaceutical Interventions for Noise-Induced Hearing Loss 2.0 AGENCY: United States Army Medical Research and Materiel Command 3.0 OFFICE: United States Army Medical Materiel Development Activity 4.0 LOCATION: Fort Detrick, Maryland 5.0 SUBJECT: The U.S. Army Medical Research and Materiel Command (USAMRMC) is working to develop U.S. Food and Drug Administration (FDA)-approved pharmaceutical interventions for noise-induced hearing loss (PINIHL) for Service Members to compliment current hearing protection strategies. This request is seeking information on pharmaceuticals which can, when administered before or after exposure to hazardous noise exposures, prevent or mitigate noise-induced hearing injury and, in turn, prevent permanent and irreversible hearing loss. 6.0 DISCLAIMER: This RFI is issued solely for information and planning purposes and does not constitute a solicitation. Neither unsolicited proposals nor any other kind of offers will be considered in response to this RFI. Responses to this notice are not offers and will not be accepted by the Government to form a binding contract. In keeping with the standards of FAR Part 10, the Government may request additional information from responders. Responders are solely responsible for all expenses associated with responding to this RFI or any follow-up information request. All information received in response to this RFI or any follow-up information request that is marked Proprietary will be handled accordingly. Responses to the RFI will not be returned. At this time, questions concerning the composition and requirements for a future request for proposal will not be entertained. 7.0 DESCRIPTION: The inherently noise-hazardous environments common to military service make Service Members particularly vulnerable to the vast subset of sensorineural hearing loss known as noise-induced hearing loss. Currently, there are 2.6 million Veterans receiving compensation for auditory body system conditions (largely tinnitus and hearing loss) and that number continues to climb every year despite over 70 years of hearing conservation efforts within the Department of Defense (DOD). Hearing protection strategies up to this point have included noise barrier devices (e.g., hearing protection devices) and noise reduction strategies. The latter include both engineering controls to reduce noise at the source as well as administrative controls such as limiting the amount of time Service Members spend in noisy environments. Inherent limitations to all of these strategies contribute to the broad gap in hearing protection capability the DOD can currently offer its Service Members. The DOD recognizes a need to identify alternative protective strategies, such as pharmaceutical agents designed to interrupt the biological pathways that cause permanent hearing injury and subsequent irreversible hearing loss. This request is seeking information from entities developing pharmaceuticals aligning with the following potential indications: i. Acute Exposure Prophylaxis: pre-loading with pharmaceutical supplementation prior to a known/anticipated short-term exposure (e.g., 3-day patrol, 1-30 days weapons training); ii. Chronic Exposure Prophylaxis: persistent regimen of pharmaceutical supplementation throughout a chronic exposure (e.g., 6-month shipboard deployment); iii. Acute Exposure Treatment: pharmaceutical treatment after acute change in hearing, within 72 hours of exposure to an unanticipated noise hazard (e.g., improvised explosive device blast, forgotten ear plugs on patrol); and/or iv. Chronic Exposure Treatment: chronic exposure across lifecycle resulting in permanent hearing loss; likely in need of rehabilitative device technologies and/or future regenerative medicine solutions. 8.0 SUBMISSION INSTRUCTIONS: Entities interested in submitting a response must furnish a white paper addressing the above capability (maximum of five pages, not including cover page, index or list of references). The subject header of the email for submission of questions and/or the RFI response shall be: USAMRMC/ USAMMDA Pharmaceutical Interventions for Noise-Induced Hearing Loss. All information regarding capabilities statements or any other proprietary information relative to this RFI shall be marked appropriately. Submission should include the following information: 8.1 A description of the technology (e.g., principle of operation, mechanism of action for achieving intended effect, route of administration, dosing regimen); 8.2 A description of all indications being sought to prevent or mitigate noise-induced hearing injury and, in turn, prevent permanent and irreversible hearing loss; 8.3 A summary of all completed and/or planned preclinical and clinical studies with current status; 8.4 A list of anticipated or known product side-effects; 8.5 A discussion of product storage, temperature, shipping, and shelf-life considerations; 8.6 A discussion of overall product regulatory strategy and current status in the US or other countries; 8.7 An estimate of pharmaceutical development timeline and cost through product deployment/launch and estimated cost per dose; 8.8 A discussion of commercial plans and manufacturing capability (e.g., production capacity, use of contract manufacturers, current Good Manufacturing Practice capability); 8.9 Information on the company's business size (based on the NAICS size standard), business status (i.e. small business, disadvantaged, HUB zone, woman owned, service disabled veteran owned); and 8.10 Responder's complete contact information (telephone, physical address, and email address). 9.0 SUBMISSION CONTACT INFORMATION: Interested entities shall forward submissions to Ms. Jamie Diggs at jamie.l.diggs.civ@mail.mil no later than 4:00 PM 21 December 2016. Telephonic communication will not be considered as submission nor receive response.
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