SOURCES SOUGHT
Q -- Ocular Drug Delivery Request For Information (RFI)
- Notice Date
- 6/30/2014
- Notice Type
- Sources Sought
- NAICS
- 339115
— Ophthalmic Goods Manufacturing
- Contracting Office
- US Army Medical Research Acquisition Activity, ATTN: MCMR-AAA, 820 Chandler Street, Frederick, MD 21702-5014
- ZIP Code
- 21702-5014
- Solicitation Number
- W81XWH-14-S-1003
- Response Due
- 7/30/2014
- Archive Date
- 8/29/2014
- Point of Contact
- Michael Ursone, 301-619-9525
- E-Mail Address
-
US Army Medical Research Acquisition Activity
(michael.a.ursone.civ@mail.mil)
- Small Business Set-Aside
- N/A
- Description
- THIS IS NOT A REQUEST FOR PROPOSALS (RFP) OR A REQUEST FOR QUOTATIONS; IT IS STRICTLY A REQUEST FOR INFORMATION (RFI). NEITHER UNSOLICITED PROPOSALS NOR ANY OTHER KINDS OF OFFERS WILL BE CONSIDERED IN RESPONSE TO THIS RFI. NO CONTRACT WILL BE AWARDED PURSUANT TO THIS ANNOUNCEMENT. 1.0 SUBJECT: The U.S. Army Medical Research Materiel Command is conducting market research on technology solutions for ocular drug delivery systems for the treatment of traumatic ocular injury. Responses to the RFI are due by 30 July 2014 at 3:00 pm E.S.T. See Section 5.0 for contact information. 2.0 DISCLAIMER: This RFI is issued solely for information and planning purposes only, 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. Responders are solely responsible for all expenses associated with responding to this RFI. All information received in response to this RFI 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 RFP will not be entertained. 3.0 BACKGROUND: The Joint Program Committee (JPC)-8 for Clinical/Rehabilitative Medicine (CRM) and the Telemedicine & Advanced Technology Research Center have an Ocular Therapies Research & Development Program research portfolio. These portfolios align with the Joint Force Health Protection Initial Capabilities Document, the CRM Initial Capabilities Document, and the capability gaps identified by the JPC-8 Vision Scientific Steering Committee. The capability gaps identified include; the need for drug delivery systems for the eye and adnexa in the mitigation/treatment of traumatic injuries, war-related injuries, and disease to ocular structures, as well as the visual system. This RFI is part of an ongoing effort to assess promising technologies that will fill this identified gap. The goal of the RFI is to identify candidate ocular drug delivery devices/platforms available on the market, or under development that can carry/deliver medications to provide ocular stability or treatment from as early as the point of injury, to the highest level of medical care available within the combat zone (Role 3) until definitive care can be provided. 4.0 MANDATORY SUBMISSION REQUIREMENTS: Manufacturer must provide: 1.A description of the ocular drug delivery platform technology and class of drug or specific drug tested to date (e.g., mode of loading and delivery, drugs to be delivered, composition or material, size specifications, drug delivery rate and duration, placement and removal methods, compatibility with other ocular drugs, etc.); 2.Indications for use applicable to treatment of traumatic injuries; 3.Status of FDA clearance, approval, or a feasible plan for FDA submission with proposed indication(s)-for-use or evidence of prior FDA approval or clearance and indication(s); 4.Status of license or approval for sale in foreign markets; 5.Proposed timeline for device development and deployment, if applicable, along with estimated product cost; 6.A description of any other device features in addition to primary role as a drug delivery platform (e.g., corneal patch); 7.Information on manufacturing capability; and 8.Evidence of device technology being sufficiently mature with demonstrated proof-of-concept work and completed development of functioning prototype. Responses should include a representative sample of the device for limited examination, if available. Manufacturers are encouraged to submit a response to this RFI even if a product does not meet all the requirements at this time. 5.0 CONTACT INFORMATION: Any and all questions related to this RFI shall be no more than five (5) pages or less in length, and shall be submitted via email to Michael Ursone, at Michael.a.ursone.civ@mail.mil, no later than 3:00 PM E.S.T. on 30 July 2014. All information regarding capabilities statements or any other proprietary information relative to this RFI shall be marked appropriately.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/USA/USAMRAA/DAMD17/W81XWH-14-S-1003/listing.html)
- Place of Performance
- Address: US Army Medical Research Acquisition Activity ATTN: MCMR-AAA, 820 Chandler Street Frederick MD
- Zip Code: 21702-5014
- Zip Code: 21702-5014
- Record
- SN03410267-W 20140702/140701023932-1d9e736d4da22b913466cafa9ebed8cc (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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