MODIFICATION
99 -- NEI Toxicity Studies to Support an IND Filing for Conducting Phase I Study of iPSC-Derived RPE on Scaffold - Q&As as of May 12, 2015
- Notice Date
- 5/13/2015
- Notice Type
- Modification/Amendment
- NAICS
- 541990
— All Other Professional, Scientific, and Technical Services
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, Office of Administration, 6011 Executive Blvd, 5th Floor, Rockville, Maryland, 20852-3804, United States
- ZIP Code
- 20852-3804
- Solicitation Number
- HHS-NIH-OD-PS-15-001
- Archive Date
- 4/15/2015
- Point of Contact
- Louis A Kuta, Sr., Phone: 301-594-5782
- E-Mail Address
-
kutal@od.nih.gov
(kutal@od.nih.gov)
- Small Business Set-Aside
- N/A
- Description
- Q&As as of May 12, 2015 ***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.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/OoA/HHS-NIH-OD-PS-15-001/listing.html)
- Record
- SN03729494-W 20150515/150513234707-61b500454e287d61fbe5396bca09928a (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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