SPECIAL NOTICE
A -- Bioengineered Cornea for Transplation
- Notice Date
- 3/11/2015
- Notice Type
- Special Notice
- NAICS
- 541712
— Research and Development in the Physical, Engineering, and Life Sciences (except Biotechnology)
- Contracting Office
- US Army Medical Research Acquisition Activity, ATTN: MCMR-AAA, 820 Chandler Street, Frederick, MD 21702-5014
- ZIP Code
- 21702-5014
- Solicitation Number
- W81XWH15C0060
- Archive Date
- 3/10/2016
- Point of Contact
- Jamie Diggs, 301-619-2663
- E-Mail Address
-
US Army Medical Research Acquisition Activity
(jamie.l.diggs.civ@mail.mil)
- Small Business Set-Aside
- N/A
- Description
- This is a Notice of Intent to Award a Sole Source Bioengineered Cornea for Transplation The U.S. Army Medical Research Acquisition Activity (USAMRAA) in support of the U.S. Army Medical Materiel Development Activity (USAMMDA) is issuing a Notice of Intent to Award a Sole Source contract. USAMRAA intends to issue a firm-fixed price contract for the work addressing the Joint Warfighter Medical Research - Bioengineered Cornea for Transplation by utilizing the Joint Warfighter Medical Research Program (JWMRP). In this requirement, the contractor will develop a bioengineered cornea for keratoprosthesis and patch graft leading to Food and Drug Administration (FDA) approval. The proposed medical device is intended to improve or restore sight to Warfighters who are blind due to corneal injury. In accordance with Federal Acquisition Regulation (FAR) the statutory authority permitting other than full and open competition is 10 U.S.C. 2304 (c) (1). The FAR citation is 6.302-1(a)(2) with application at 6.302-1(b)(1)(ii). As directed by Congress in the Department of Defense Appropriations Bill, 2014 Report 113-85, page 190, $100M quote mark shall be used to augment and accelerate high priority Department of Defense (DoD) and Service medical requirements and to continue prior year initiatives that are close to achieving their objectives and yielding a benefit to military medicine. The funds shall not be used for new projects or for basic research. quote mark For this reason, the undersigned determined that the cited statutory authority permitting other than full and open competition is supported and required. This Bill essentially limits the competition to contractor's that have existing Congressional Special Interest Funded Research Projects (contracts or assistance agreements) and have a military relevance. The Bill also states that funds shall be awarded at the discretion of the Secretary of Defense following a review of medical research and development gaps. The strategy in executing the JWMRP was to find highly valued research efforts on a research grant or contract that could meet critical service requirements and that were not being continued through other appropriations. Based on a comparative analysis by the scientific and programmatic reviewers from USAMRMC, approximately 45 JWMRP research projects were selected for a follow-on effort to the previous effort (Contracts and Assistance Agreements.) Cellular Bioengineering, Inc.'s research is the only known research that can be considered when viewed in the context of the statutory mandated program described above. Cellular Bioengineering, Inc. was identified for its development of a FDA cleared/approved bioengineered cornea to improve or restore vision due to disease, trauma, or pathology of the cornea. The device has two intended uses, as an alternative to human corneal donor tissue and as a patch graft to stabilize the eye after corneal lacerations. As a corneal tissue alternative, the device lessens the dependence of human donor tissue that is limited in supply, histocompatibility, and shelf-life. It will be beneficial for both the military and civilian care for corneal transplantation where a long term artificial cornea is not available and the only option is human donor tissue. As a patch graft, the device is intended to seal severely damaged cornea that otherwise cannot be closed by conventional methods to provide stabilization of the eye (e.g., prevent vitreal leakage, maintain intraocular pressure) until definitive care. A capability gap to fulfill this need has been identified by the Requirements Adjudication Team of the Directorate of Combat & Doctrine Development for use in Role 3 and Forward Resuscitative and Surgical Team. Currently, there are no effective FDA cleared/approved products for this indication. To date, Cellular Bioengineering, Inc. has developed a bioengineered cornea material formulations and completed pilot preclinical studies with early prototypes. They are proposing to build on that work in refining the prototype, verify and validate device performance, and start a clinical study in order to achieve FDA clearance/approval for the final product. This sole source requirement at its advanced development stage is deemed to be available only from Cellular Bioengineering, Inc. as a follow-on effort. Competing this requirement would result in substantial duplication of costs and unacceptable delays. This notice of intent is for information purposes only, therefore, no solicitation will result from this announcement. All responsible sources may submit a capability statement, proposal or quotation, which shall be considered by the agency. A request for documentation will not be considered as an affirmative response. The action will be awarded without further notice. The Point of Contact (POC) for this action is jamie.l.diggs.civ@mail.mil.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/USA/USAMRAA/DAMD17/W81XWH15C0060/listing.html)
- Record
- SN03665328-W 20150313/150311235644-ffc83a7ed1d79bb7a2b70585e96c8ebf (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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