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FBO DAILY - FEDBIZOPPS ISSUE OF MARCH 16, 2013 FBO #4130
DOCUMENT

65 -- Request for Information - Hydrocodone/Hydromorphone Reagnet Kit - Attachment

Notice Date

3/14/2013
 

Notice Type

Attachment
 

NAICS

325413 — In-Vitro Diagnostic Substance Manufacturing
 

Contracting Office

N62645 Naval Medical Logistics Command 693 Neiman Street Ft. Detrick, MD
 

Solicitation Number

N6264513RFI04
 

Response Due

5/14/2013
 

Archive Date

5/29/2013
 

Point of Contact

Nicholas Dankanich; Nicholas.Dankanich@med.navy.mil
 

E-Mail Address

N6264513RFI04 Hydros RFI
(Nicholas.Dankanich@med.navy.mil)
 

Small Business Set-Aside

N/A
 

Description

REQUEST FOR INFORMATION Immunoassay Reagent for the Detection of Hydrocodone and/or Hydromorphone in Urine Specimens Applicable for Use on the Hitachi / Roche Modular D and P High Speed Analyzer Systems THIS IS NOT A REQUEST FOR QUOTES. THIS IS A NOTICE OF THE GOVERNMENT ™S INTERST TO OBTAIN AN IMMUNOASSAY REAGENT FOR THE HIGHLY SPECIFIC DETECTION OF HYDROCODONE AND/OR HYDROMORPHONE IN URINE SPECIMENS AS OPPOSED TO OTHER OPIATES SUCH AS CODEINE, MORPHINE, OXYCODONE, OXYMORPHONE AND OTHER OPIATE ANALOGUES. THE IMMUNOASSAY REAGENT MUST BE SUITABLE FOR USE WITHOUT MODIFICATION ON THE ROCHE HITACHI MODDULAR- D AND P HIGH SPEED ANALYZER SYSTEMS This is a Request for Information (RFI), as defined by FAR 2.101, and the Government is not requesting offers or proposals at this time. Any responses to this RFI received by the Government will not be accepted to form a binding contract. This is a market survey for planning purposes and no award will be made as a result of this RFI. If a solicitation is issued, the Government does not guarantee that it will be issued to RFI respondents. The Government is also requesting that restrictive or proprietary markings not be used in response to the RFI. Responses to this RFI will not be returned. Not responding to this RFI does not preclude participation in any future solicitation, if one is issued. The Department of Defense (DoD) Drug Demand Reduction Program (DDRP) is conducting a market survey to determine current interest, capabilities, comments and questions regarding an immunoassay urine reagent kit for the detection of hydrocodone and/or hydromorphone abuse in urine to support the DoD DDRP Laboratories worldwide. Responses to this RFI must address the topic areas specified below. The DoD DDRP performs testing for a number of drugs of abuse to include codeine, morphine, oxycodone, and oxymorphone. In 2012, hydrocodone and hydromorphone was added to the testing panel. In order to maximize efficiency, the DoD DDRP started using a prescription medication database to compare positive service member test results with their medication to determine whether a valid prescription is the cause for the positive result. Due to the high cross-reactivity of existing opiate (codeine and morphine) immunoassay kits with hydrocodone and/or hydromorphone, it is not currently possible to validate a positive opiate screening result against the prescription database. The DoD DDRP is interested in seeing if a kit exists that can separate out the positive hydrocodone and/or hydromorphone specimens from the positive opiate (codeine and morphine) specimens. The DoD DDRP conducts testing at six Forensic Toxicology Drug Testing Laboratories (FTDTLs). Each location currently uses the Roche-Hitachi Modular (D and P) Analyzer System. The program has a mission critical requirement to conduct random urinalysis testing, not only for illicit drugs of abuse, but also for commonly prescribed opiate medications whose potential for misuse and addiction is recognized by the Drug Enforcement Administration scheduling of these medications. The salient characteristics desired by the DoD DDRP are: 1)The immunoassay must be highly specific for the detection of hydrocodone and/or hydromorphone as compared to other common opiate and opioid medications such as codeine, morphine, oxycodone, oxymorphone, 6-monoacetylmorphine, and other opiate / opioid analogues. 2)The immunoassay is for use in a urine based matrix. 3)The immunoassay reagent system must be compatible for use on the Roche Hitachi modular D and P high speed analyzer system without modification or interference with other testing systems in use on the analyzer system. 4)The immunoassay system must be able to sensitive to the detection of hydrocodone and/or hydromorphone when present alone or in combination at a calibration concentration of 100 nanograms per milliliter (ng/mL). The reagent must have a detection capability to reproducibly correctly discriminate urine specimens and controls with drug concentrations above and below the 100 ng/mL calibration concentration. Information Request The Government seeks informed input and questions from interested companies regarding technical requirements and contractual descriptions regarding an immunoassay urine reagent kit for the detection of hydrocodone and/or hydromorphone abuse in urine. Attachment 1 contains a sample, theoretical Statement of Work (SOW) which details the projected requirements interested responders shall base their submission upon. This sample does NOT indicate that the Government will contract for any of the supplies or services discussed within; it is merely a forecast of potential requirements to generate interest and feedback from companies in order to better inform the Government. Responses will not be rated but will be reviewed as part of an information gathering process. To ensure responses, including attachments, can be read and evaluated, please submit in Microsoft (MS) Word, MS Excel, or Adobe Acrobat format. Responses including attached files shall not exceed 10 MB in total. Responses exceeding 10 MB will not be transmitted through the Government server. Responses should include: (1) A cover letter on organizational letterhead including the Company name, CAGE code, DUNS code, point of contact, address, phone number, fax number, and e-mail address of the submitting agent; (2) A white paper, consisting of the requested information; and (3) Any attachments and supporting documentation felt to be relevant to a deeper investigation of the response. The white paper shall address the following two sections: Section 1 - Technical Requirements While responding directly to the sample Statement of Work (SOW) within Attachment 1, the white paper shall address the technical requirements based on the SOW provided within the Attachment. This should be a brief, informal section stating any specific interest, inquiries, capabilities, solutions, expertise, and past experience related to the technical requirements listed in the SOW. Comments and suggested revisions to the SOW are also requested. Section 2 - Questions 1)Is your company currently producing an immunoassay urine reagent kit for the detection of hydrocodone and/or hydromorphone abuse in urine that is able to meet the requirements based on the SOW provided in the Attachment 1? 2)If not, does your company plan on producing an immunoassay urine reagent kit for the detection of hydrocodone and/or hydromorphone? If so, how long would it take to be able to meet such requirement? 3)If your company is currently in the process of producing a hydrocodone and/or hydromorphone reagent kit, at what stage of production is the kit at? What is the predicted date of completion? No telephonic submissions will be honored. All responses shall be submitted at no cost or obligation to the Government. Interested parties should respond within 60 days of the posting date. Interested parties are requested to electronically send their response to the Naval Medical Logistics Command via e-mail to: Nicholas.Dankanich@med.navy.mil (SUBJECT: N6264513RFI04 Hydro's RFI). No phone calls please.
 

Web Link

FBO.gov Permalink
(https://www.fbo.gov/spg/DON/BUMED/N62645/N6264513RFI04/listing.html)
 

Document(s)

Attachment
 

File Name: N6264513RFI04_ATTACHMENT_1__SAMPLE_SOW.doc (https://www.neco.navy.mil/synopsis_file/N6264513RFI04_ATTACHMENT_1__SAMPLE_SOW.doc)

Link: https://www.neco.navy.mil/synopsis_file/N6264513RFI04_ATTACHMENT_1__SAMPLE_SOW.doc

 

Note: If links are broken, refer to Point of Contact above or contact the FBO Help Desk at 877-472-3779.
 

Record

SN03012452-W 20130316/130314235457-bc70ac09b95ab765c02399151c983070 (fbodaily.com)
 

Source

FedBizOpps Link to This Notice
(may not be valid after Archive Date)

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