SOLICITATION NOTICE
66 -- Smoking Machine
- Notice Date
- 6/2/2016
- 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-SOL-1164039
- Archive Date
- 6/25/2016
- Point of Contact
- Heather Kinsey, Phone: 2404027591
- E-Mail Address
-
heather.kinsey@fda.hhs.gov
(heather.kinsey@fda.hhs.gov)
- Small Business Set-Aside
- Total Small Business
- Description
- Notice Type: Combine Solicitation FDA-SOL-1164039 This is a combined synopsis/solicitation for a Smoking Machine, Plus 2 one year options. This is for commercial items prepared in accordance with the format in FAR Subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; quotes are being requested and a written solicitation will not be issued. a. Solicitation Number FDA-SOL-1164039 is being issued as a Request for Quotation (RFQ). b. Provisions and clauses are those in effect through Federal Acquisition Circular 2005-88, effective 16 May 2016 c. This procurement is a brand name or equal requirement, associated with NAICS Code 334516 and small business size employees 500. This acquisition is set aside 100% for small business concerns. d. Item Description: Smoking Machine, Plus 2 one year options Minimum Required Salient Characteristics of the Instrument The Contractor shall provide the following: 1. One Port Linear Smoking Instrument for Electronic Cigarettes •1 x 200ml Syringes •Fixed Puff Smoking •Graphical User Interface •Automated Port Leak Checking •GMP/GLP (21 CFR Part II) Compliant 2. Software •Data Stored in Relational Database with Full Audit Capability •Puff Volume - 5 -200cc •Puff Duration - 1 - 4 sec •Puff Interval - 10 - 9999 sec •Multiple puff profiles available 3. Additional Parts included •1 x Cambridge filter pad holder assemblies •Labyrinth seals and neoprene washers •1 x How to Instructions - electronically Minimal characteristics that should be met: 1)Maximum puff volume should be at least 200 mL 2)Multiple puff profiles should be available 3)The smoking machine should be flexible enough to accommodate the addition of four or more ports at a later time so multiple electronic cigarettes can generate smoke at the same time. 4) Should possess a dedicated human-machine interface (HMI) for inputting puff profile 5) The HMI should be able to control up to four or more electronic cigarette ports at the same time. 6) Servicing time should be about 2 weeks 7) Integration to aerosol analyzers for aerosol size and concentration measurements Criteria for coupling system with existing analyzers The company has to provide technical support for easy integration with existing aerosol instruments. 4. Warranty/Maintenance Agreement: Entire system must be warranted for parts and labor for 12 months from date of acceptance. Warranty service should be equivalent to the maintenance agreement requested in the next section. 5. Option Year Maintenance Agreement: As part of this purchase, CDRH seeks an option year maintenance agreement for two option years, beginning on the date of installation and acceptance. This shall not obligate CDRH to purchase the extended warranty. The specific requirements for this optional extended warranty are: a. Service contract coverage must include trouble-shooting capabilities based on complete knowledge of the entire instrument, immediate access to certified replacement parts, and immediate access to improvements and new procedures provided by the original vendor and manufacturer. b. Service must be provided by service engineers who are trained and certified by the original manufacturer of the instrument. Engineers should have access to the manufacturer's latest technical developments, repair procedures, application updates, diagnostic software, and planned maintenance procedures. c. The contract must enable the Project Officer or their designee to have access to the manufacturer's call center at regular business hours (8 am to 5 pm EST) for technical assistance, which is staffed by engineers who provide a high level of expertise for troubleshooting the instrument. d. The supplier must be able to guarantee that a service engineer will be able to work on site within four business days of receiving a call from CDRH. e. One (1) preventative maintenance inspection shall be performed during the 12 month period with all travel, labor, and parts included. This inspection shall include routine preventative maintenance of the instrument, calibration, electrical safety testing and any other preventative maintenance measures deemed necessary by the vendor. f. All software updates to the scientific instrument and/or system software and related installation of such instrument updates and/or system software during the Agreement Term g. Respond to requests for emergency on-site service and/or non-emergency requests (Monday-Friday, excluding vendor and Federal holidays) within 4 business days (96 hours) h. Upon the on-site visit, the contractor shall assess the scientific equipment and determine if the repairs needed to the scientific equipment are covered under the current service maintenance agreement. If the repairs are not covered under the service maintenance agreement, the contractor shall submit a quote to the Government for review and approval or negotiation, which shall include travel costs, parts costs and labor costs. Turnaround time for an emergency or non-emergency on-site visit to completion of repairs shall not exceed 4 business days (96 hours). For repairs up to $2,500, not covered by the Maintenance/Support Agreement, the Government shall pay the vendor (with proper Government approvals) with a Government Purchase Card For repairs over $2,500, not covered by the Maintenance/Support Agreement, the Government will issue a Purchase Order for the repairs Repair work that is not covered by the Maintenance/Support Agreement is not to be initiated by the vendor unless the Government has given the vendor proper authorization i. Service Records and Reports: The vendor shall, commensurate with the completion of each service call, provide the end user of the equipment with a copy of the 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, on-site hours expended and parts/components replaced. In addition, the vendor shall provide monthly reports to the FDA COR and Contract Specialist, not later than the 5th workday following the end of each month, summarizing all maintenance and repair activities (including warranty work) for the previous month; negative reports are required. 6. Training: The proposal must include a half day (four hour), on-site familiarization training for multiple users (the FDA estimates at least 2 users will attend this training session). This training session will take place at the CDRH location. This training session will be arranged by CDRH's project officer. Training session shall take place within 30 days after installation and acceptance by the FDA. This training session should include the following training objectives: a.Provide guidance to CDRH operators on the proper use of the instrument; b.Any routine maintenance required by the users; c.Any safety and related safeguards as deemed appropriate; d.Information on what the users should do if the unit is not functioning properly; and e.Other topics deemed necessary by the vendor 7.Prices must include all applicable fees including shipping and handling. f. FAR Provision 52.212-1 (Instructions to Offerors - Commercial Items) (Oct 2015) applies to this acquisition. Para (k) requires current registration in SAM at https://www.sam.gov. g. FAR Provision 52.212-2 Evaluation - Commercial Items (OCT 2014) applies to this acquisition. Award will be made to the Lowest Priced Technically Acceptable Offeror whose quote provides sufficient detail to evaluate compliance with the solicitation It is the responsibility of all interested offerors to review this site frequently for any updates/ amendments that may occur during the solicitation process. The posting of this requirement does not obligate the Government to award a contract nor does it obligate the Government to pay for any proposal preparation costs. The Government reserves the right to cancel this procurement/ solicitation either before or after the solicitation closing date, with no obligation to the offeror by the Government. The Government will issue a contract to the responsible, responsive offeror, with acceptable past performance, submitting the lowest price. All prospective contractors must be registered in the System for Award Management in order to be eligible for contract award. For registration, go to www.sam.gov and follow the instructions. h. Quotations must include a completed copy of FAR Provision 52.212-3 (Offeror Representations and Certifications - Commercial Items) (Apr 2016). Electronic submission is located at https://www.sam.gov. i. This order will include the following referenced clauses which may be accessed electronically at http://farsite.hill.af.mil. FAR 52.212-4 (Contract Terms and Conditions-Commercial Items) (May 2015) FAR 52.212-5 (Contract Terms and Conditions Required to Implement Statues Or Executive Orders-Commercial Items) (Mar 2016) FAR 52.219-8 (Utilization of Small Business Concerns and Small Disadvantage Business Concerns) (OCT 2014) FAR 52.232-33 (Payment by Electronic Funds-System for Award Management (JUL 2013) HHSAR 352.202-1 Definitions (JAN 2006) HHSAR 352.203-70 Anti-lobbying (JAN 2006) HHSAR 352.215-70 Late Proposals and Revisions (JAN 2006) HHSAR 352.233-71 Litigation and Claims (JAN 2006) HHSAR 352.242-73 Withholding of Contract Payments (JAN 2006) j. QUOTATIONS ARE DUE BY 2:00PM Eastern Standard Time on 10 June 2016 in order to be considered. Send quotation responses to Heather Kinsey @ Heather.Kinsey@fda.hhs.gov. Assistance or questions about this announcement may be sent to the above email.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/FDA/DCASC/FDA-SOL-1164039/listing.html)
- Place of Performance
- Address: Silver Spring, Maryland, 20993, United States
- Zip Code: 20993
- Zip Code: 20993
- Record
- SN04136559-W 20160604/160602235021-ee80c7be36b2ae1ded6ecd08571aced5 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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