SOLICITATION NOTICE
99 -- HD-X11 TELEMTRY IMPLANTABLE CATHETER EXCHANGE - Sole Source
- Notice Date
- 7/20/2017
- 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 - Rockville, 5630 Fishers Lane, Room 2129, Rockville, Maryland, 20857-0001, United States
- ZIP Code
- 20857-0001
- Solicitation Number
- FDA-NOISS1185318
- Archive Date
- 8/12/2017
- Point of Contact
- Priscilla V. Harrison, Phone: 240-402-7609
- E-Mail Address
-
priscilla.harrison@fda.hhs.gov
(priscilla.harrison@fda.hhs.gov)
- Small Business Set-Aside
- Total Small Business
- Description
- FDA-NOISS1185318 July 20, 2017 Notice of Intent FDA-NOISS1185318 Title: HD-X11 TELEMETRY IMPLANTABLE CATHETER EXCHANGE The Food and Drug Administration intends to award a Sole Source firm-fixed price purchase order to Data Sciences International (DSI) 119-14th Street NW St. Paul, MD 55112 in the amount of $18,939 for the base. An additional three (3) option years are also being requested. In accordance with FAR part 6.302-1, the contractor is the only responsible source who can provide the required services as no other source has been identified who can provide the services and repairs needed to satisfy the agencies requirements. DSI HD-X11 implantable transmitters were purchased four years ago for an in vivo model for telemetry study to predict drug related adverse reactions. In order to expand the in vivo project with the upgraded HD-X11 transmitters and to advance analytical data. The upgraded implantable telemetry devices, HD-X11, are provided by DSI and the Institutional Animal Care and Use Committee (IACUC ) protocols have been established based on this device. The HD-X11 transducer is the advanced and improved version of PA-C10 and the ETA-F10. The advanced catheter in HD-X11 will provide upgraded sensitivity, which will further, accentuate the new parameters of blood pressure, temperature and animal activity to be monitored simultaneously. Additionally, the combined transducer will lower pressure channel drift and improve accuracy over the old version of PA-C10 in animal models. Expanded bio potential bandwidth over the former ETA-F10 will provide robust and advanced data analysis and further our study in better comprehending adverse drug reactions in hematological studies. Our lab has used the upgraded version HD-X11, and has been successful in generating excellent pilot study data. The North American Industrial Classification System (NAICS) Code is 334516 Analytical Laboratory Instrument Manufacturing Office of Medical Products and Tobacco, Center for Drug Evaluation and Research wants to exchange 22 telemetry implantable catheters that have the following technical specifications: 22 implantable telemetry HD-X11 probes from DSI with the following characteristics: a. Able to monitor the bio parameters : i) ECG, EEG and EMG ii) Systemic blood pressure via the carotid artery iii) Core and systemic body temperatures. iv) Animal activity b. Intuitive, easily understood/used software. c. Weighs no more than 2.5gms, transducer can't be no larger than 1.5 cc, must have ONE bio potential lead for ECG, temperature and animal activity. 2. Accessories, training, & warranty a. Proposal should include the following accessories or equivalent parts: b. Must include installation and delivery to: CDER-FDA Division of Biotechnology Products Research and Review II WO 52/72 RM#2206 10903 New Hampshire Avenue, Silver Spring, MD 20993 c. Warranty should cover all parts & installation for minimum of 1 year. 3. Three (3) Option years for service contract a. A service plan should be included after warranty expires (1) Plan to include necessary batteries re-charging and re-geling & all repairs for 1 calendar year (2) Must include all labor, & parts This notice is not a request for competitive proposals. However, any party that believes it is capable of meeting this requirement as stated herein may submit a written capability statement that clearly supports and demonstrates their ability to perform the requirement. Capability statements must be received by the response date and time of this notice. Submissions will be reviewed to determine if they can meet the requirement. A determination by the Government to compete this proposed contract based upon responses to this notice is solely within the discretion of the Government. It is anticipated that an award will be issued to Data Sciences International within approximately ten (10) days after the date of this notice unless the Government determines that any other organization has the capacity to meet this requirement.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/FDA/DCASC/FDA-NOISS1185318/listing.html)
- Record
- SN04587685-W 20170722/170720234642-d47111f56a473cfb34547c0b1ff2a49d (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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