NEI Toxicity Studies to Support an IND Filing for Conducting Phase I Study of iPSC-Derived RPE on Scaffold

***Please note the following text change to the SOW***

SOW Page 1, Background and Description, Paragraph 3, last sentence is changed as follows:

FROM: "The investigational product consists of an iPSC differentiated RPE monolayer grown on a biodegradable scaffold and needs to be administered in the subretinal space of the eye of RNU rats."

TO: "The investigational product consists of an iPSC differentiated RPE monolayer grown on a biodegradable scaffold and needs to be administered in the subretinal space of the eye of RNU rats either as a monolayer tissue or as cell suspension (as required by the FDA)."

SOW Page 3, Task 2a, Bullet 4, is changed as follows:

FROM: "Tissue transplantation in required number of rats and follow up for several weeks to measure immediate toxicity of the transplant."

TO: "Tissue transplantation or cell injection (as required by the FDA) in required number of rats and follow up for several weeks to measure immediate toxicity of the transplant."

Q&As as of May 12, 2015 are posted.

The proposal due date is changed FROM: June 1, 2015 TO: June 10, 2015. 

Questions for Solicitation NIHEY2015002 will not be accepted after May 15, 2015, 4:00 PM EST.

Solicitation No. NIHEY2015002 is available.

Please note: the contract type has changed to firm fixed price.

This is a Pre-Solicitation Notice.  This is not a request for technical or cost proposals.  No solicitation is available at this time and requests for solicitation packages will not receive a response.

The National Eye Institute (NEI) of the National Institutes of Health (NIH) has a requirement for design and conduct pre-clinical toxicity studies to support an IND filing for a phase 1 clinical study in humans.  The investigational product consists of an iPSC differentiated RPE monolayer grown on a biodegradable scaffold and needs to be administered in the subretinal space of the eye of RNU rats.

A three year, cost reimbursement type contract is anticipated with an award made on or about June 12, 2015.  The anticipated contract will comprise one (1), one-year base period and two (2), one-year option periods which may be exercised unilaterally by the Government for a potential period of performance of 24 months.  The solicitation will be issued on or about April 14, 2015, in an electronic format only, on this web site (https://www.fbo.gov).  Offerors are responsible for routinely checking this web site for any amendments to the solicitation.  No individual notification of amendments will be provided.  Proposals will be due thirty days after the date of the issuance of the solicitation.  All responsible sources may submit a proposal which shall be considered.

The intended procurement will be classified under NAICS 541990.

A Sources Sought Notice was posted on FBO on March 3, 2015.

No collect telephone calls will be accepted.