SOLICITATION NOTICE
66 -- Small Rodent Implantable Wireless Data Acquisition Telemetry System
- Notice Date
- 6/6/2012
- Notice Type
- Combined Synopsis/Solicitation
- NAICS
- 334516
— Analytical Laboratory Instrument Manufacturing
- Contracting Office
- Department of Health and Human Services, Food and Drug Administration, Office of Acquisitions and Grants Services, 5630 Fishers Lane, Room 2129, Rockville, Maryland, 20857-0001
- ZIP Code
- 20857-0001
- Solicitation Number
- 1104015
- Archive Date
- 6/30/2012
- Point of Contact
- James Scott Rawls, Phone: 8705437540
- E-Mail Address
-
james.rawls@fda.hhs.gov
(james.rawls@fda.hhs.gov)
- Small Business Set-Aside
- N/A
- Description
- This is a combined synopsis/solicitation for commercial items prepared in accordance with the Federal Acquisition Regulation (FAR) format in Subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; proposals are being requested and a written solicitation will not be issued. The government intends to issue a Purchase Order in accordance with FAR PART 13.106 for the below requirement under Simplified Acquisition Procedures. The solicitation number is 1104015. This solicitation is issued as a Request for Quote (RFQ). The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) 2005-58, May 18, 2012. The associated North American Industry Classification System (NAICS) Code is: 334516 - Analytical Laboratory Instrument Manufacturing; Small Business Size Standards is 500 employees. This combined synopsis/solicitation is set-aside for Small Business. Respondents are responsible for delivery in person, by e-mail, fax, mail or other delivery method their complete proposal and any additional documents before 9:00 am (Central Standard Time - Local Prevailing Time in Jefferson, Arkansas) on June 15, 2012 to james.rawls@fda.hhs.gov, Fax (870) 543-7990, or mail to the U. S. Food and Drug Administration (FDA), OO/OFBA/OAGS, Attention of James "Scott" Rawls, 3900 NCTR Road, Jefferson, AR 72079-9502. PLEASE NOTE - The above contact information is for the Contracting Office and not necessarily the delivery address. The delivery address is indicated in the FOB Destination section below. When appropriate, Respondents should consult with delivery providers to determine whether their documents will be delivered prior to the scheduled time. For information regarding this solicitation, please contact James "Scott" Rawls by e-Mail at james.rawls@fda.hhs.gov. Questions shall be submitted not later than 9:00 am CST on June 13, 2012. Any award resulting from this solicitation is contingent on the availability of funds within the 2012 Fiscal Year, and as such, prices shall be firm through September 30, 2012. Background Statement The FDA Center for Biologics Evaluation and Research (CBER), Laboratory of Biochemistry and Vascular Biology (LBVB), requires a remote implantable telemetry system for rodents and/or small animal models (i.e., mice and/or Guinea Pigs) that has the capability to record physiologic parameters from four (4) animal subjects continuously and simultaneously. More specifically, ongoing studies and experiments require the use of a method to evaluate pharmacodynamic parameters with the pharmacokinetic parameters currently collected. The pharmacokinetic parameters are acquired by micro-infusion pumps previously purchased from iPRECIO and are programmed by computer software; this software allows for synchronized constant and variable rate infusion of therapeutic molecules. As an additional component, this requirement for a remote wireless telemetry system shall have the capability to measure systemic blood pressure, pulmonary artery pressure, heart rate, EKG, and respiratory rate. The LBVB overarching goal for this requirement is to combine the new implantable wireless telemetry system with the existing iPRECIO infusion pump technology to better characterize the safety of biologics. This system will support multiple projects within the LBVB. Additionally, this system will be increasingly used in preclinical toxicology studies and the data generated requires new expertise in data evaluation and must insure public health. Overall Telemetry System Requirements Complete hardware and software telemetry system capable of monitoring four (4) rodents/small animals continuously and simultaneously (i.e., signal transmitters/receivers and data collection work station necessary for supporting the data collection in a lab environment). - Four (4) dual pressure transmitters: -- Compatible with existing iPRECIO therapeutic infusion pumps programmable for rodents (reference http://www.iprecio.com) -- A dual-pressure measurement capability (systemic and pulmonary) -- The ability to measure Biopotential, Temperature, and Activity -- Provide an independent measurement of ambient pressure -- Outer material made of silicone for sterilization -- Catheters to facilitate wireless transmitter implantation - Four (4) receivers for standard size plastic cages - Data collection workstation; minimum specifications: -- 32-bit operating system (OS)-Windows XP compatible -- 32-channel data acquisition system (allowing for experiment growth over time and compatible with a 32-bit OS) -- Post-acquisition analysis software (e.g., modules capable of measuring blood pressure, ambient pressure, electrocardiogram, etc.) -- Workstation hardware should include a minimum of 2 Gigabyte (GB) of RAM, 5 GB of free hard disk space, 21-inch monitor with a 1280 x 1024 resolution - One (1) day of on-site training - Free telephone/e-mail technical support Monday through Friday from 8:00am - 5:00pm CST (holidays excluded) Item #1 Small Rodent Wireless Telemetry System (while addressing all accessories, provide a single bundled price for a complete software and hardware system) Quantity - 1 *Unit Price: _____________________ * Price shall be inclusive of shipping costs GSA Contract Number (if applicable): ________________________ Item #2 Small Rodent Telemetry System On-Site Training (one (1) day) Quantity - 1 *Unit Price: _____________________ * Price shall be inclusive of travel costs GSA Contract Number (if applicable): ________________________ FOB Destination - U.S. FDA, Center for Biologics Evaluation and Research (CBER), 8800 Rockville Pike, Building 29, Rm. B24, Bethesda, MD 20892. Contract Type - Commercial Item - Firm fixed price. Simplified procurement procedures will be utilized. An official authorized to bind the Offeror must sign the terms and conditions of the offer. Offerors that fail to furnish required representations and certifications, or reject the terms and conditions of the solicitation, may be excluded from consideration. 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 provision at FAR 52.212-1 Instructions to Offerors - Commercial Items applies to this solicitation. The provision at FAR 52.212-2 Evaluation-Commercial Items is applicable to this solicitation. The specific evaluation criteria to be included in paragraph (1) of that provision are as follows: The government will award the purchase order to the responsible offeror whose offer conforming to the solicitation will be the most advantageous to the Government on a best value (tradeoff) evaluation basis, price and other factors considered. The following factors shall be used to evaluate offers: (i) Technical capability of the item(s) offered to meet the Government's requirement. (ii) Past Performance. (iii) Price. Technical capability and past performance are significantly more important when compared to price in determining the best value to the government; however, price remains a significant factor. Technical capability will be determined by review of information submitted by the quoter, which must provide a description in sufficient detail to show that the item(s) offered meet the Government's requirements LBVB's critical research addressed under the background statement. Past Performance will be determined by review of information submitted by the quoter, which must describe experience in meeting the above stated salient characteristics required for a small rodent wireless telemetry system and the ability to interface with the existing iPRECIO therapeutic infusion pumps (i.e., clearly demonstrate compatibility and interoperability). The Government reserves the right to look to other sources of information (e.g., the Past Performance Information Retrieval System (PPIRS), etc.) to support past performance evaluations. The government is not responsible for locating or securing any information, which is not identified in the proposal. To ensure information is available, vendors must furnish as part of their proposal all descriptive material necessary for the government to determine whether the service meets the technical requirements. Quotes shall include technical specifications, descriptive material, literature, brochures and other information corresponding to each minimum required item, which demonstrates the capabilities of the offeror. The Provision at FAR 52.212-3, Offerors Representations and Certifications-Commercial Items, applies to this acquisition. An offeror shall complete only paragraph (b) of the provision if the offeror has completed the annual representations and certification electronically at http://orca.bpn.gov. The clause at 52.212-4, Contract Terms and Conditions - Commercial Items, applies to this acquisition. The following addenda are incorporated by reference: All maintenance and repair activities (including warranty work) shall be accomplished in accordance with Original Equipment Manufacturer (OEM) specifications. Service Records and Reports: The Contractor shall, commensurate with the completion of each service call (inclusive of warranty service), provide the end-user of the equipment with a copy of a field service report/ticket identifying the equipment name, manufacturer, model number, and serial number of the equipment being serviced/repaired and detailing the reason for the service call, a detailed description of the work performed, the test instruments or other equipment used to affect the repair or otherwise perform the service, the name(s) and contact information of the technician who performed the repair/service, and for information purposes, the on-site hours expended and parts/components replaced. In addition, the Contractor shall provide monthly reports to the FDA COR and Contract Specialist, not later that the 5th work day following the end of each month, summarizing all maintenance and repair activities (including warranty work) for the previous month; negative reports are required. The clause at FAR 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders - Commercial Items (Mar 2012), applies to this acquisition. The following additional FAR clauses cited in this clause are applicable: 52.222-3, 52.222-19, 52.222-21, 52.222-26, 52.222-36, 52.225-3, 52.225-13, and 52.232-33. Clauses and provisions incorporated by reference can be obtained at http://www.arnet.gov.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/FDA/DCASC/1104015/listing.html)
- Place of Performance
- Address: FDA/CBER, 8800 Rockville Pike, Bldg. 29, Rm. B24, Bethesda, Maryland, 20892, United States
- Zip Code: 20892
- Zip Code: 20892
- Record
- SN02767523-W 20120608/120606235433-4122045ef33b396c87a0b53664fee157 (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 |