GDNF
This is a notice of intent to award a sole source purchase order and is not a request for competitive proposals under the authority of 41.U.S.C. 253 (c)(1) as set forth in Federal Acquisition Regulation FAR 6.302-1(b)(1)(i). The government intends to enter into a firm fixed price award with Southern Research 2000 9th Avenue, S., Birmingham, AL 35205-2708, and DUNS Number 006900526.
The National Institute of Neurological Disorders and Stroke (NINDS) is a part of the National Institutes of Health (NIH), conducting research into the causes, treatment, and prevention of neurological disorders and stroke. The NINDS mission is to seek fundamental knowledge about the brain and nervous system and to use that knowledge to reduce the burden of neurological disease.
In 2013 a Purchase Order was awarded to perform assays for Protocol 12-N-0137, a Phase I clinical trial which infuses a gene therapy agent into the brain of patients with Parkinson's disease. The trial is FDA-approved under IND 14,996.
FDA and IRB approval of the protocol require assays of serum and cerebrospinal fluid for Anti-AAV2 antibody titers, GDNF protein levels, and anti-GDNF antibody levels. These assays are performed at baseline and at intervals up to five years following the gene therapy infusion, for a total of 10 time points per subject in 24 subjects.
Please refer to the attached Statement of Work for complete details and specifications.
Small businesses are encouraged to respond to this notice if they are capable to meet the needs of this requirement. Written responses to this notice shall contain sufficient documentation to establish a bonafide capability and compatibility to fulfill the requirement. A complete statement of work is attached for reference.
The intended procurement will be classified under North American Industry Classification System Code 541380 Testing Laboratories with a small business size standard of $14,000,000.00.
The period of performance for this requirement will be as follows:
Base Year - September 1, 2014 through August 30, 2015
Option Year One - September 1, 2015 through August 30, 2016
Option Year Two - September 1, 2016 through August 30, 2017
Option Year Three - September 1, 2017 through August 30, 2018
Option Year Four - September 1, 2018 through August 30, 2019
The Government shall consider all responses received prior to the close date of this announcement. All responses must be received no later than July 15, 2014 at 1:00PM, Eastern Standard Time. Please email Brian Lind, Contract Specialist, at [email protected] with technical questions or written responses pertaining to this notice. No phone calls will be accepted.
Brian Lind, Contract Specialist, Phone 3014021635, Email [email protected]
