SOLICITATION NOTICE
B -- Lyme Borreliosis Serum Bank - Lyme Carditis Panel
- Notice Date
- 8/14/2008
- Notice Type
- Combined Synopsis/Solicitation
- NAICS
- 541690
— Other Scientific and Technical Consulting Services
- Contracting Office
- Department of Health and Human Services, Centers for Disease Control and Prevention, Procurement and Grants Office (Atlanta), 2920 Brandywine Road, Room 3000, Atlanta, Georgia, 30341-4146
- ZIP Code
- 30341-4146
- Solicitation Number
- 000HCVHCC-2008-59517
- Archive Date
- 9/11/2008
- Point of Contact
- Linda F. Williams,, Phone: 770-488-2692, Nancy M. Norton,, Phone: 770-488-2056
- E-Mail Address
-
luw9@cdc.gov, ftg8@cdc.gov
- Small Business Set-Aside
- N/A
- Description
- The Centers for Disease Control and Prevention (CDC) intends to obtain specimens and supporting clinical information to establish a standardized national repository of control serum samples for the study of Lyme borreliosis. This repository and clinical information database will be maintained by staff at the CDC. Eventually this serum bank should have samples from patients with diverse manifestations of Lyme borreliosis, from healthy donors, and from patients with other illnesses (either within the differential diagnosis of Lyme disease or known to elicit cross-reacting antibodies) for use in evaluating improved serologic tests. (1) The vendor shall: Obtain and deliver to CDC acute and convalescent serum samples of approximately 15 mL each from 30 individuals with Lyme disease acquired in the United States that manifests as neuroborreliosis and/or Lyme carditis. Obtain and deliver to CDC clinical and laboratory information in support of the diagnosis of Lyme neuroborreliosis and/or Lyme carditis. The vendor will secure institutional and CDC Institutional Review Board (IRB) approval prior to collection of serum samples for this procurement and will obtain informed consent from each serum donor. Serum specimens will be coded by a unique number; direct personal identifiers will not be shared with CDC. The CDC will work with selected vendor to obtain CDC IRB Approval for serum sample collections. Receive deliverables, as specified. (2) The vendor shall perform the following tasks and complete them within two years of the award of this contract: a. Task I (prior to the start of the 2009 transmission season for Lyme borreliosis): Write a protocol and obtain institutional IRB approval for this serum acquisition. The protocol should include case definitions for Lyme neuroborreliosis and Lyme carditis. Coordinate efforts to obtain institutional IRB approval with the CDC project officer to facilitate CDC IRB approval of this protocol. Obtain CDC IRB approval before beginning serum acquisition. b. Task II (2009 and 2010 transmission seasons): Obtain positive control reference serum samples from 30 separate individuals presenting with neuroborreliosis and/Lyme carditis. Obtain a second sample from each individual at convalescence (10-30 days later). Each sample should be at minimum the serum resulting from the collection of three 10-mL vials of whole blood, that is, approximately 15 mL per patient, but up to 25 mL is desirable. c. Task III (2009 and 2010 transmission seasons): Develop and summarize clinical and laboratory information in support of the diagnosis of neuroborreliosis and/or Lyme carditis for each patient. Report the time intervals from onset of illness to collection of the serum samples. d. Task IV (2009 and 2010 transmission seasons): Store serum samples in 5 mL screw cap cryotubes at -70 degrees C. and ship them to CDC on dry ice. If a -70 degree freezer is not available, samples may be stored for up to two weeks at -20 degrees C. (3) The period of performance for this procurement shall be for two years from the date of award. (4) The vendor shall provide the following deliverables on or before the dates shown: 1. Written record of IRB approval of the protocol that includes the case definitions used (March 1, 2009). 2. Serum samples and supporting clinical and laboratory data as specified above that are acquired during each of two transmission seasons (September 30, 2009 and September 30, 2010, respectively). Serum samples received at CDC in good condition with no gross evidence of hemolysis, repeated freeze-thawing, or microbial contamination and accompanied by a document with data supporting the diagnosis of Lyme neuroborreliosis and/or Lyme carditis will be accepted for inclusion in the serum specimen bank. (5) MINIMUM VENDOR QUALIFICATIONS 1. Physican (MD or equivalent) project leader. 2. Access to a suitable patient population. 3. Experience in the diagnosis and treatment of Lyme borreliosis manifesting as Lyme neuroborreliosis and/or Lyme carditis, as demonstrated by publications in the peer-reviewed scientific literature. 4. Ability to support the clinical diagnosis of Lyme neuroborreliosis and/or Lyme carditis in each patient by a laboratory method or methods. 5. Previous experience obtaining IRB approval of a protocol that involved acquisition of clinical speciments and possession of an institutional FWA number. THIS IS A COMBINED SYNOPSIS/SOLICITATION FOR COMMERCIAL ITEMS PREPARED IN ACCORDANCE WITH THE FORMAT IN SUBPART 12.6, AS SUPPLEMENTED WITH ADDITIONAL INFORMATION INCLUDED IN THIS NOTICE. THIS ANNOUNCEMENT CONSTITUTES THE SOLICITATION; QUOTES ARE BEING REQUESTED ANDA SEPERATE WRITTEN SOLICITATION WILL NOT BE ISSUED. The following provision(s) apply to this acquisition: 52.212-1 Instructions to Offerors Commercial Items (MAR 2000) applies to this acquisition; 52.223-13 Certification of Toxic Chemical Release Reporting; 52.223-14 Toxic Chemical Release Reporting; 52.232-1 Payments; 52.233-3 Protest After Award; 52.201-1 Definitions; 52.203-5 Covenant Against Contingent Fees; 52.203-7 Anti-Kickback Procedures; 52.204-7 Central Contractor Registration; Contractor must be CCR Registered prior to submitting bid; The clause 52.212-4, Contract Terms & Conditions - Commercial Items (MAY 1999) applies to this acquisition. The following FAR Clauses are hereby added to this clause: 52.247-35 F.O.B. Destination; The clause at 52.212-5 - Contract Terms and Conditions Required to Implement Statutes or Executive Orders - Commercial Items applies to this acquisition. The following clauses listed in paragraph (b) of 52.212-5 apply to this acquisition: (1), (5), (7), (14), (15), (16), (17), (18), (22), (24), (29) and (30). 52.213-3 must be attached to bid. NAICS CODE: 424210, SIC: 5122 SIZE: 100, OFFERORS SHALL INCLUDE A COMPLETED COPY OF THE PROVISION AT 52.212-3, OFFERORS REPRESENTATIONS AND CERTIFICATIONS - COMMERCIAL ITEMS, WITH YOUR QUOTE. The best way to complete this certification is to download the FAR Clauses (Volume II) at http://www.arnet.gov/far, print out the clause 52.212-3, Offeror Representation and Certification, and fill in the appropriate blanks. Offers will be due August 29, 2008, by 12:00 P.M., EST at the Centers for Disease Control and Prevention; Procurements and Grants Office; Attn: Linda Williams; 2920 Brandywine Road, M/S K-14, Atlanta, GA, 30341. Offers will be accepted by email (luw9@cdc.gov). All quotes must be clearly marked on the envelope with the following: Solicitation# 000HCVHCC-2008-59517, Attn: Linda Williams. All responsible sources that can meet the above requirements may submit a quote, which may be considered by the Agency. ****
- Web Link
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- Place of Performance
- Address: 2920 Brandywine Road, Atlanta, GA 30341-3724, Atlanta, Georgia, 30341, United States
- Zip Code: 30341
- Zip Code: 30341
- Record
- SN01639967-W 20080816/080814221557-fa8ea32fbe53700638aa3449e0c1b75f (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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