SPECIAL NOTICE
99 -- Request for Information (RFI)-PHARMACEUTICAL TREATMENTS FOR SENSORINEURAL HEARING LOSS (SNHL)
- Notice Date
- 3/29/2022 9:51:03 AM
- Notice Type
- Special Notice
- NAICS
- 32541
—
- Contracting Office
- W4PZ USA MED RSCH ACQUIS ACT FORT DETRICK MD 21702-5014 USA
- ZIP Code
- 21702-5014
- Solicitation Number
- W81XWH-22-BG-SNHL
- Response Due
- 5/16/2022 11:00:00 AM
- Point of Contact
- Bryan Heickman
- E-Mail Address
-
bryan.g.heickman.civ@mail.mil
(bryan.g.heickman.civ@mail.mil)
- Description
- REQUEST FOR INFORMATION (RFI) 1.0 RFI TITLE: Pharmaceutical Treatments FOR sensorineural hearing loss (SNHL) 2.0 AGENCY: US Army Medical Materiel Development Activity (USAMMDA) 3.0 OFFICE: Warfighter Expeditionary Medicine and Treatment Project Management Office (WEMT PMO) 4.0 LOCATION: FORT DETRICK, MD 5.0 SUBJECT: The WEMT PMO of the USAMMDA is conducting market research to determine whether a commercial solution or developmental item can meet requirements for the Pharmaceutical Intervention for Noise-Induced Hearing Loss (PINIHL) acquisition program. This market research may also assist with the further development and/or refinement of the requirements. 6.0 DISCLAIMER: In accordance with Federal Acquisition Regulation (FAR) 15.201 ""Exchange with industry before receipt of proposals,"" this RFI is for information and planning purposes only at this time, and shall not be construed as a solicitation or as an obligation on the part of the USAMRMC, or collaborative Department of Defense (DoD) activities. 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: WEMT PMO of USAMMDA has a requirement to develop a U.S. Food and Drug Administration (FDA) approved drug to treat sensorineural hearing loss in Service Members within 72 hours of acoustic trauma. The goal of this RFI is to canvas the research and market space for pharmaceuticals that treat sensorineural hearing loss. The acquisition program, Pharmaceutical Interventions for Noise Induced Hearing Loss (PINIHL), is interested in learning more about pharmaceutical efforts that are seeking approval for an FDA indication to treat sensorineural hearing loss. Information about the successes, challenges or best practices of completing successful Phase 2 or 3 clinical trials for sensorineural hearing loss treatments will help to inform the program objectives. 8.0 SUBMISSION INSTRUCTIONS: Entities interested in submitting a response must furnish brief answers to the following questions using a question and answer or table format. The subject header of the email for submission of questions and/or the RFI response shall be: SNHL Drug Treatment RFI. All information regarding capabilities statements or any other proprietary information relative to this RFI shall be marked appropriately. Submission should include the following information: Are you currently conducting a clinical trial for a treatment for sensorineural hearing loss? Are you re-purposing an already FDA-approved drug and planning or changing the drug indication to include an indication for sensorineural hearing loss? Are you developing a novel compound or pharmaceutical to treat sensorineural hearing loss? If any of the previous three questions are affirmative, please provide any relevant information requested�below: Brief description of clinical trial and NCT # Indication for use / Intended product label Anticipated timeline to obtain FDA approval and outline of regulatory path plan. Have you met with the FDA concerning a pharmaceutical seeking an indication for sensorineural hearing loss treatment? If yes, please provide summary of feedback from FDA regarding trial end points or other FDA communications What were successes, challenges, or best practices learned from trial. If trial has been completed, what were the results and was clinical significance met? Brief description of the mechanism of action and list of references that outline pre-clinical or clinical data supporting an FDA indication to treat sensorineural hearing loss. Brief description of communications with drug manufacturers. Do you have contracts in place from all manufacturing parties to produce Phase 3 materials as well as the first lots of FDA approved product? What are and who holds patents, intellectual property rights, data rights etc.? Brief outline of plan to manufacture and distribute pharmaceuticals. Have you been inspected by the FDA? If yes, were you issued a 483, for what, and how was it resolved? Please provide copies. Description of GMP systems in place or pending systems. Trial Master File (TMF) model used. Describe planned regulatory pathway for new indication � 505(b)(2) or 505(b)(1). If planning on using the 505(b)(2) pathway please describe what previous studies you will be relying on and how you will obtain the data. Additional considerations for preparing and completing a Phase 3 clinical trials for hearing loss. 8.1 Format response as question followed by the answer in paragraph form or using table format above. 8.2 Please use Arial 11 point font, at least 0.5� margins and do not exceed 5 pages. 9.0 SUBMISSION CONTACT INFORMATION:� Interested entities shall forward submissions to Bryan Heickman, bryan.g.heickman.civ@mail.mil no later than 2:00PM, EST 16 MAY 2022. Telephonic communication will not be considered as submission nor receive response. Responses shall be limited to five pages, answer the questions posed in Section 8 and submitted via e-mail only.� The font shall be Arial, size 11 point font, single space.� Electronic files shall not exceed 3 MB. All submissions become Government property and will not be returned.� 10.0 REQUIRED INFORMATION: Fill in the�information requested�below when responding to this RFI: RFI Number Company Name Company Address Point of Contact Phone Number E-mail Address Tax Identification Number (TIN) CAGE Code DUNS Number Company Web Page Company Location(s) Company is / is not a Small Business Company is / is not SAM Registered Other Socio-Economic Classifications (e.g. 8(a), HUB Zone, Woman-Owned, Veteran-Owned, Service- Disabled Veteran-Owned) If 8(a), date that the company graduates from the program �
- Web Link
-
SAM.gov Permalink
(https://sam.gov/opp/17debad86f7a40e89b98b5147e9c7812/view)
- Place of Performance
- Address: USA
- Country: USA
- Country: USA
- Record
- SN06282201-F 20220331/220329230100 (samdaily.us)
- Source
-
SAM.gov Link to This Notice
(may not be valid after Archive Date)
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