SOLICITATION NOTICE
A -- Natural History of BK Virus Infection in Renal Transplant Recipients
- Notice Date
- 9/13/2021 3:11:20 PM
- Notice Type
- Solicitation
- NAICS
- 541715
— Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology)
- Contracting Office
- FDA OFFICE OF ACQ GRANT SVCS Beltsville MD 20705 USA
- ZIP Code
- 20705
- Solicitation Number
- RFQ-FDA-SOL-21-1244304
- Response Due
- 9/20/2021 12:00:00 PM
- Archive Date
- 10/05/2021
- Point of Contact
- Jada Scott
- E-Mail Address
-
jada.scott@fda.hhs.gov
(jada.scott@fda.hhs.gov)
- Description
- The Contractor shall provide the existing Kidney Transplant Database being developed by the Critical Path Institute under an existing BAA contract with the Agency to collect multicenter, retrospective patient-level data regarding BKV management practices and clinical outcomes (Aim #1). These data will be summarized to fill in knowledge gaps, identify possible surrogate endpoints, and develop a model for predicting BKVN (Aim #2). It is hoped that the information garnered from this project will help establish a regulatory pathway to approval for BKV therapeutics and spur interest in developing drugs for this indication.
- Web Link
-
SAM.gov Permalink
(https://beta.sam.gov/opp/5481352104d54464b0c08a295ab9927c/view)
- Record
- SN06130404-F 20210915/210913230122 (samdaily.us)
- Source
-
SAM.gov Link to This Notice
(may not be valid after Archive Date)
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