SOLICITATION NOTICE
B -- Obtain Specimens From Physician-Diagnosed Fibromyalgia Patients Who Have Not Had Lyme Disease
- Notice Date
- 8/15/2008
- Notice Type
- Combined Synopsis/Solicitation
- NAICS
- 541990
— All Other Professional, Scientific, and Technical 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
- 00HCVHCC-2008-59537
- Archive Date
- 8/30/2008
- Point of Contact
- Linda M Young,, Phone: (770) 488-2655
- E-Mail Address
-
lml3@cdc.gov
- Small Business Set-Aside
- N/A
- Description
- The Centers for Disease Control and Prevention is offering contracts to obtain serum samples for a national repository. This specific requirement is to obtain specimens from physician-diagnosed fibromyalgia patients who have not had Lyme disease. These samples and supporting clinical information will be used for the study of Lyme disease. This is being advertised to determine what organizations may be willing and able to offer to obtain one or more types of serum samples that are needed for this serum bank. The bank will eventually contain positive and negative control samples, as well as serum from patients with illnesses within the differential diagnosis of Lyme disease or with conditions that elicit antibodies that may cross-react in laboratory tests. Please review the included Statement of Work (SOW) below. If you feel you can accomplish this requirement, please submit a brief proposal that addresses each item in the statement of work, plus a separate cost proposal, no later than close of business August 29, 2008. Since the end of the federal fiscal year is fast approaching, your prompt response is appreciated. We anticipate that this contract will be awarded in FY08. Statement of Work is as follows: Background: Serologic assays are the mainstay of laboratory testing for assessing exposure to Borrelia burgdorferi, the agent of Lyme borreliosis. CDC, NIH, and FDA currently recommend that serology be performed using a two-tiered algorithm. (This method consists of an enzyme immunoassay or, less commonly, an immunofluorescence assay as a first-tier test, followed by Western immunoblotting of samples that produce positive or indeterminate first-tier results.) Two-tiered testing performs well for determination of IgG antibodies after the first several weeks of infection, but works less well for determination of IgM responses. It would be desirable to improve serology in several ways: to increase the sensitivity of testing in early disease, to improve the specificity of IgM testing (or to make it unnecessary), and to develop alternatives to the two-tiered approach that are simpler, more objective, and less costly. Clinical decisions about the diagnosis of Lyme borreliosis could be better supported by improved serologic tests. A great impediment to these efforts is the lack of an adequate bank of serum samples from clinically well-characterized Lyme borreliosis patients and controls that can be used by the research community. The statutory authority permitting this procurement is 40 U.S.C. 759(g), as amended, and/or 41 U.S.C. *253-(c)(I). The purpose of this procurement is 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 Division of Vector-borne Infectious Diseases, 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. CDC will benefit from this procurement by being better able to serve its constituents by providing positive and negative control serum samples and anonymous clinical information to qualified investigators. It will also have resources to better perform in-house work to improve serology for Lyme disease. The scope of work for this requirement is as follows: Vendor shall obtain and deliver to CDC serum samples of approximately 15 mL each from 20 individuals with physician-diagnosed fibromyalgia and who have not had Lyme disease. Vendor shall obtain and deliver to CDC clinical and laboratory information (that excludes other diagnoses) to support the diagnosis of fibromyalgia. 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. CDC will work with selected vendor to obtain CDC IRB approval for serum sample collections and will receive deliverables, as specified. The vendor shall perform the following tasks and complete them within two years of the award of this contract: Task I: Write a protocol and obtain institutional IRB approval for this serum acquisition. The protocol should include the case definition used for fibromyalgia. 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. Task II: Obtain negative control reference serum samples from 20 separate individuals with fibromyalgia. 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. Task III: Develop and summarize clinical and laboratory information (that excludes other diagnoses) to support the diagnosis of fibromyalgia for each patient. Task IV: 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. The period of performance for this procurement shall be for two years from the date of award in fiscal year 2008. The vendor shall provide the following deliverables to the project officer on or before date indicated, or within two years from date of award. (1) Written record of IRB approval of the protocol that includes the case definition used (March 1, 2009). (2) Serum samples and supporting clinical and laboratory data as specified above (within two years from date of award). Serum samples received at CDC (DVBID, Fort Collins, CO) 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 fibromyalgia will be accepted for inclusion in the serum specimen bank. Forty percent of the contract amount will be paid after the protocol has been developed and IRB approvals have been obtained from both the vendor institution and CDC. Sixty percent of the contract amount will be paid after delivery of 20 samples from 20 patients when accompanied by supporting written documentation of fibromyalgia. Partial payments will be paid upon invoice at the rate of 3.0% of the contract amount for each qualifying serum sample. Delivery of samples in batches is preferred so that no more than 2-3 invoices are received per year. Minimum vendor qualifications for this project are as follows: (1) physician (MD or equivalent) project leader; (2) access to a suitable patient population; (3) experience in the diagnosis and treatment of fibromyalgia, preferably demonstrated by publications in the peer-reviewed scientific literature; (4) previous experience obtaining IRB approval of a protocol that involved acquisition of clinical specimens and possession of an institutional FWA number desirable. No other solicitation is being issued. Reminder: your cost proposal should be sent as separate documentation. Do not include any pricing reference in your technical proposal. If you intend to propose, please contact me via e-mail with the subject line “Fibromyalgia Panel” by close of business August 22, 2008. This procurement is not set-aside for small business. For contractual questions contact Linda M. Young.
- Web Link
-
FedBizOpps Complete View
(https://www.fbo.gov/?s=opportunity&mode=form&id=170d939c90a49393ae1e80423f91d483&tab=core&_cview=1)
- Place of Performance
- Address: Centers for Disease Control and Prevention, Division of Vector-Borne Infectious Diseases, 3150 Rampart Road, Fort Collins,, Colorado, 80522, United States
- Zip Code: 80522
- Zip Code: 80522
- Record
- SN01642019-W 20080817/080815224728-170d939c90a49393ae1e80423f91d483 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
| FSG Index | This Issue's Index | Today's FBO Daily Index Page |