AWARD
A -- Phase I Clinical Trials for Development of Neurotherapeutics
- Notice Date
- 7/7/2016
- Notice Type
- Award Notice
- NAICS
- 541712
— Research and Development in the Physical, Engineering, and Life Sciences (except Biotechnology)
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Institute of Neurological Disorders and Stroke, 6001 Executive Boulevard, Neuroscience Center, Suite 3287, MSC 9531, Bethesda, Maryland, 20892-9531
- ZIP Code
- 20892-9531
- Solicitation Number
- NIH-NINDS-15-01
- Point of Contact
- Annette Carter, Phone: (301) 496-5916, Kirkland L. Davis, Phone: (301) 496-1813
- E-Mail Address
-
cartera@mail.nih.gov, kd17c@nih.gov
(cartera@mail.nih.gov, kd17c@nih.gov)
- Small Business Set-Aside
- N/A
- Award Number
- HHSN271201600005I
- Award Date
- 7/1/2016
- Awardee
- PPD Development, LP, 929 North Front Street, Wilmington, North Carolina 28401, United States
- Award Amount
- $19,500,000
- Description
- The National Institute of Neurological Diseases and Stroke (NINDS), National Institute of Health (NIH), has made an Indefinite Delivery/Indefinite Quantity (ID/IQ) contract award under RFP No. NIH-NINDS-15-01. An ID/IQ contract has been awarded to PPD Development, LP, Wilmington, North Carolina, Contract No. HHSN271201600005I, on July 1, 2016. This contract is for performance of Phase I first in human clinical trials to determine the tolerated dose range, the dosing regimen, the safety profile and pharmacokinetic (PK) parameters and may include pharmacodynamics (PD), and evaluation of biological effects and early signs of efficacy in new potential therapeutics. The ID/IQ contract has been awarded with a ten (10) year ordering period of July 1, 2016 through June 30, 2026. The minimum award amount is $72,325; the maximum award amount under this program is $19,500,000. PPD, Development, LP has also been awarded a task order concurrent with the parent ID/IQ contract. This task order covers the first year of performance under the "Administrative and Overall Clinical Operations Support" component of the program. The period of performance of this task order award is July 1, 2016 through June 30, 2017 with an award amount of $72,325. The task order award also contains nine (9) additional 12-month term options which have been negotiated as follows: Option No. 1 - Clinical Operations Support for Year 02: 07/1/17- 06/30/18 - $48,656 Option No. 2 - Clinical Operations Support for Year 03: 07/1/18- 06/30/19 - $49,614 Option No. 3 - Clinical Operations Support for Year 04: 07/1/19- 06/30/20 - $50,594 Option No. 4 - Clinical Operations Support for Year 05: 07/1/20- 06/30/21 - $51,605 Option No. 5 - Clinical Operations Support for Year 06: 07/1/21- 06/30/22 - $52,649 Option No. 6 - Clinical Operations Support for Year 07: 07/1/22- 06/30/23 - $53,713 Option No. 7 - Clinical Operations Support for Year 08: 07/1/23- 06/30/24 - $54,821 Option No. 8 - Clinical Operations Support for Year 09: 07/1/24- 06/30/25 - $55,954 Option No. 9 - Clinical Operations Support for Year 10: 07/1/25- 06/30/26 - $57,119 Separate and distinct from the annual "Administrative and Overall Clinical Operations Support" task order, the NINDS will compete and award future Phase 1 clinical trial Task Orders from the ID/IQ awardees under the RFP.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/NINDS/NIH-NINDS-15-01/listing.html)
- Record
- SN04174937-W 20160709/160707235832-d374be52b19dc5f9906d40dda89a8b79 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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