SPECIAL NOTICE
A -- Mass eye and ear
- Notice Date
- 2/26/2010
- Notice Type
- Special Notice
- NAICS
- 622110
— General Medical and Surgical Hospitals
- Contracting Office
- Department of Veterans Affairs;VA Boston Healthcare System;Contracting Officer (90C);940 Belmont Street;Brockton MA 02301
- ZIP Code
- 02301
- Archive Date
- 3/5/2010
- Point of Contact
- Robert O'Learyrobert.oleary@va.gov
- E-Mail Address
-
Contracting Specialist
(robert.oleary@va.gov)
- Small Business Set-Aside
- N/A
- Description
- The Department of Veterans Affairs, VA Boston Healthcare System has a requirement to utilize unique facilities and experienced personnel for continued retinal research. It is the Government's intention to solicite and negotiate only with this source. This is not a solicitation; it is a notice of intent to sole source a requirement. Inquires /information received after established deadline of March 5, 2010 at 1200P EST shall not be considered. The submission of any data for review shall not impede award of this contract as planned. the Government does not intend to pay for information solicited. This synopsis is issued pursuant to FAR 6.302-1. 1. Identification of the service/department and the transaction/requisition #: The VA Boston Healthcare System (VABHS) Center for Innovative Visual Rehabilitation (CIVR) is developing bioengineering therapies to improve the quality-of-life of visually impaired patients. The core mission of the CIVR is to develop an implantable retinal prosthesis that will be used to enhance vision in patients with retinitis pigmentosa or macular degeneration. 2. Nature and/or description of the action being approved: The CIVR is requesting a contract with the Massachusetts Eye and Ear Infirmary (MEEI) for specialized implantation surgeries and stimulation safety experiments, in support of the core CIVR mission, development of an implantable, configurable, biocompatible retinal prosthesis. The contract will enable CIVR, to collaborate with a highly skilled MEEI-based retinal surgeon to carry out approved experimental protocols at the VABHS. 3. Description of the supplies/services required to meet the agency's needs (including the estimated value): The long-term goal of the Center for Innovative Visual Rehabilitation is to implant our retinal prosthesis into the eyes of veteran patients. This will require FDA approval; an application is planned for 2014. It is required by the FDA that the CIVR first demonstrate the safety and efficacy of the retinal implant device in animal studies. This effort requires the development of surgical implantation techniques for subretinal electrode arrays in alternative retinal prosthesis designs. The purpose of this contract is to pay for the effort and support of a highly skilled and specialized retinal surgeon who is based at MEEI. The surgeon will carry out the development of new implantation techniques for subretinal electrode arrays according to approved animal surgical protocols at the VABHS. The ability to safely implant electrode arrays of sufficient size so as to allow a wide field of view and avoid tunnel vision in human patients receiving the prosthesis is of the utmost importance to the future development and clinical success of the CIVR. It is likely that future human recipients of the retinal implant will be most helped by restoration of both wide-field vision, and of moderate-acuity, more central vision, e.g. for the purpose of recognizing faces. The MEEI has developed surgical methods for implanting long but sparse stimulating electrode arrays in the subretinal space, and for implanting large arrays subtending a wide field of view and, for implanting both types of arrays simultaneously During the subsequent 4 Option Periods, trials must continue, to perfect and test the longevity of subretinal devices using the techniques developed. The value of this service to the CIVRs effort to develop a safe and functioning retinal implant lies in the highly specialized skills of the MEEI surgeon and the support personnel. The total cost for the Initial Contract Period (Apr. 1, 2010 Sept. 30, 2010) is expected to be over $25,000 and less than $75,000 The expected aggregate total of the base and all option periods will be over $350,000. 4. Identification of the statutory authority permitting other than full and open competition: FAR Part 6.302-1, Only One Responsible Source. 5. Demonstration that the proposed contractor's unique qualifications or the nature of the acquisition requires use of the authority cited: The purpose of this contract is to pay for the continued surgeries and experiments on the part of MEEI personnel, and to develop large subretinal electrode array implantation techniques at the VABHS under approved animal protocols. This effort is essential to the future success of the retinal prosthesis that is the core of the CIVR mission. The CIVR has worked with MEEI for over six years to develop these groundbreaking surgical techniques, and this has resulted in the implantation of very large electrode arrays using a minimally invasive, ab externo approach. This outstanding result has to our knowledge not been achieved by any of the other research groups working in the area of retinal prosthesis implantation. While vitreoretinal surgeons and their support teams are available in many locales, very few have attempted the CIVRs preferred surgical approach for subretinal implantation, and these skills take years to hone. The selection of any surgeon other than the one with whom the CIVR is currently collaborating would be a major setback for the CIVR and likely would eliminate the possibility of success for the CIVRs RR&D-funded project, due to the steep learning curve involved. For these reasons, no market survey was conducted. 6. Describe the efforts that have been made to ensure that offers are solicited from as many potential sources as is practicable, including whether a Federal Business Opportunities (FBO) notice was or will be publicized as required by Subpart 5.2 (copy attached) and, if not, which exception under 5.202 applies: As required by FAR Subpart 5.2, an intent to sole source notice was published in the FBO on Feb 26,2010. 7. Determination by the Contracting Officer that the anticipated cost to the Government will be fair and reasonable: Contracting officer will determine a price reasonableness finding. *8. Description of the market survey that was conducted (i.e. names of firms and the date(s) the firms were contacted) and the results or a statement of the reasons a market survey was not conducted: No market survey was conducted (see #5 and #6 above). *9. Any other facts supporting the use of other than full and open competition, such as - an explanation as to why technical data packages, specifications, engineering descriptions, statement of work, or purchase descriptions suitable for competition have not been developed or are not available. See # 5 above. * 10. A Iisting of the sources, if any, that expressed an interest in the acquisition: To be determined. *11. A statement of the actions, if any, that the department/service may take to remove or overcome any barriers to competition before any subsequent acquisition for the supplies/services is required in the future: The specialized nature of this requirement dictates the use of other than full and open competition. This department does not have barriers to competition. the researc focus of the department is highly specific. This contracting activity will continue to encourage full and open competition whenever possible. POC Robert O'leary contract specialist Email robert.oleary@va.gov Deadline Mar 5,2010 1200P EST
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