SOLICITATION NOTICE
70 -- FDA 1146778-15 EAST MODULES AND LOGXACT
- Notice Date
- 3/17/2015
- Notice Type
- Combined Synopsis/Solicitation
- Contracting Office
- 5630 Fishers Lane, Rockville, MD 20857
- ZIP Code
- 20857
- Solicitation Number
- FDA1146778
- Response Due
- 3/19/2015
- Archive Date
- 9/15/2015
- Point of Contact
- Name: Deborah Hammond, Title: Contract Specialist, Phone: 3018277157, Fax: 3018277039
- E-Mail Address
-
dhammon1@oc.fda.gov;
- Small Business Set-Aside
- N/A
- Description
- This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in FAR Subpart 12.6, as supplemented with additional information included in this notice.The solicitation number is FDA1146778 and is issued as an invitation for bids (IFB), unless otherwise indicated herein.The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular FAC 2005-80. The associated North American Industrial Classification System (NAICS) code for this procurement is 334614 with a small business size standard of 750.00 employees.This requirement is unrestricted and only qualified offerors may submit bids.The solicitation pricing on www.FedBid.com will start on the date this solicitation is posted and will end on 2015-03-19 11:00:00.0 Eastern Time or as otherwise displayed at www.FedBid.com.FOB Destination shall be SILVER SPRING, MD 20993 The DHHS FDA Office of Acquisitions and Grants Services requires the following items, Brand Name or Equal, to the following: LI 001: BRAND NAME OR EQUAL FOR THE FOLLOWING ITEMS: EAST ESCALATE MODULE LICENSE - ESCALATE is an East module for the design, simulation, and monitoring of modern dose? escalation clinical trials. Evaluate and compare the operating characteristics of your designs under different assumptions about the dose?toxicity profile. Provide optimal dose recommendations for the next cohort of patients based on modeling accumulating data. Clearly communicate critical information to clinicians to guide dosing decisions. Model?based dose? escalation methods in this module include the Continual Reassessment Method (mCRM; Goodman et al., 1995), the Bayesian logistic regression model (BLRM; Neuenschwander et al., 2008), and the modified Toxicity Probability Interval (mTPI; Ji et al., 2010 )., 10, EA; LI 002: EAST PREDICT MODULE LICENSE - PREDICT is an East module that offers the ability to simulate and forecast the future course of the trial based on current data. Includes conditional simulations to assess expected treatment effects and associated repeated confidence intervals at future looks (also called Predicted Interval Plots or PIP; Li et al. 2009), as well as the probability of finishing with a successful trial (conditional power). Plan and simulate clinical trials with greater precision using different accrual patterns and response information for different regions/sites. Make probabilistic statements about accruals, events, and study duration using Bayesian models and accumulating data., 10, EA; LI 003: EAST ENDPOINTS MODULE - ENDPOINTS is an East module for the design, simulation, and analysis of studies that need to meet multiple objectives by testing multiple endpoints. Using a variety of multiple testing procedures, and including both serial and parallel gatekeeping procedures (Dmitrienko and Tamhane, 2007), ENDPOINTS ensures you have the right strategy to strongly control type?1 error while testing multiple endpoints. Optimize the testing strategy to obtain the best operating characteristics for meeting your goals., 10, EA; LI 004: LogXact 10 Perpetual License ? Qty: SITE ? Government Designated User All licenses and Maintenance should be valid for 1 Year, 10, EA; Solicitation and Buy Attachments ***Question Submission: Interested offerors must submit any questions concerning the solicitation at the earliest time possible to enable the Buyer to respond. Questions must be submitted by using the 'Submit a Question' feature at www.fedbid.com. Questions not received within a reasonable time prior to close of the solicitation may not be considered.*** For this solicitation, DHHS FDA Office of Acquisitions and Grants Services intends to conduct an online competitive reverse auction to be facilitated by the third-party reverse auction provider, FedBid, Inc. FedBid has developed an online, anonymous, browser based application to conduct the reverse auction. An Offeror may submit a series of pricing bids, which descend in price during the specified period of time for the aforementioned reverse auction. DHHS FDA Office of Acquisitions and Grants Services is taking this action in an effort to improve both vendor access and awareness of requests and the agency's ability to gather multiple, competed, real-time bids.All responsible Offerors that respond to this solicitation MUST submit the pricing portion of their bid using the online exchange located at www.FedBid.com. There is no cost to register, review procurement data or make a bid on www.FedBid.com.Offerors that are not currently registered to use www.FedBid.com should proceed to www.FedBid.com to complete their free registration. Offerors that require special considerations or assistance may contact the FedBid Helpdesk at 877-9FEDBID (877-933-3243) or via email at clientservices@fedbid.com. Offerors may not artificially manipulate the price of a transaction on www.FedBid.com by any means. It is unacceptable to place bad faith bids, to use decoys in the www.FedBid.com process or to collude with the intent or effect of hampering the competitive www.FedBid.com process.Should offerors require additional clarification, notify the point of contact or FedBid at 877-9FEDBID (877-933-3243) or clientservices@fedbid.com.Use of FedBid: Buyers and Sellers agree to conduct this transaction through FedBid in compliance with the FedBid Terms of Use. Failure to comply with the below terms and conditions may result in offer being determined as non-responsive. CCR Requirement - Company must be registered on Central Contractor Registration (CCR) before an award could be made to them. If company is not registered in CCR, they may do so by going to CCR web site at http://www.ccr.gov. The following FAR clauses in paragraph (b) of FAR clause 52.212-5, Contract Terms and Conditions Required To Implement Statutes or Executive Orders-Commercial Items, will apply: 52.222-21, 52.222-26, 52.222-35, 52.222-36, 52.222-37, 52.225-13, 52.232-34. The full text of a FAR clause may be accessed electronically at https://www.acquisition.gov/far/index.html. The selected Offeror must comply with the following commercial item terms and conditions. FAR 52.212-1, Instructions to Offerors - Commercial, applies to this acquisition. The selected Offeror must submit a completed copy of the provision at 52.212-3, Offeror Representations and Certifications - Commercial Items. FAR 52.212-4, Contract Terms and Conditions - Commercial Items, applies to this acquisition. In addition to providing pricing at www.FedBid.com for this solicitation, each offeror must provide any required, NON-PRICING responses (e.g. technical proposal, representations and certifications, etc.) directly to the point of contact in the FBO notice, so that they are received at that email address no later than the closing date and time for this solicitation.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/FDA/DCASC/FDA1146778/listing.html)
- Place of Performance
- Address: SILVER SPRING, MD 20993
- Zip Code: 20993
- Zip Code: 20993
- Record
- SN03670860-W 20150319/150317235912-87dbc872b429a7eb7b95b52807cc211e (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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