SOLICITATION NOTICE
66 -- Linear Smoking Machine
- Notice Date
- 2/23/2015
- 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
- FDA-SOL-1145479
- Archive Date
- 3/25/2015
- Point of Contact
- Corina L Couch, Phone: 2404025352, Phillip Frame, Phone: 240-402-7578
- E-Mail Address
-
corina.couch@fda.hhs.gov, Phillip.Frame@fda.hhs.gov
(corina.couch@fda.hhs.gov, Phillip.Frame@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; quotes are being requested and a written solicitation will not be issued. The solicitation number is FDA-SOL-1145479. This solicitation is issued as a Request for Quote (RFQ), using the Simplified Acquisitions Procedures of FAR 13.5, Test Program for Certain Commercial Items. The solicitation documented and incorporated provisions and clauses in effect through the Federal Acquisition Circular (FAC) FAC 2005-78, dated December 26, 2014. The associated North American Industry Classification System (NAICS) Code is - 334516 - Analytical Laboratory Instrument Manufacturing; Small Business Size Standard is 500 in number of employees. The US Food & Drug Administration (FDA) intends to issue a Commercial Item Firm Fixed-Price purchase order that meets the following specifications below. SUPPLIES OR SERVICES AND PRICES/COSTS The contractor shall fill out the following pricing sheet: CLIN Description Qty Unit Price 0001 Linear Smoking Machine with required features 1 EA $________ 0002 Installation Operational Qualification Services 1 EA $________ 0003 Shipping 1 EA $________ 0004 Onsite Training and Installation 1 EA $________ 0005 Option Year 1 - Post Warranty Preventative Maintenance 1 EA $________ 0006 Option Year 2 - Post Warranty Preventative Maintenance 1 EA $________ 0007 Option Year 3 - Post Warranty Preventative Maintenance 1 EA $________ Total Amount $_______ I. Intro/Background The United States Food and Drug Administration (FDA), Office of Regulatory Affairs (ORA)'s Southeast Regional Laboratory (SRL) has a requirement to purchase one (1) automatic linear smoking machine with attachments for impingers and carbon monoxide detection. II. Objectives The Southeast Regional Laboratory (SRL) needs to purchase an automatic linear smoking machine for the purpose of generating smoke residues that will be used in chemical analyses to support regulatory work for the Center for Tobacco Products. The requested instrument is needed to expand SRL's regulatory sample throughout and to add additional capabilities are not present on our existing smoking machines. Without this purchase, SRL will not be able to provide the anticipated regulatory support to the Center for Tobacco Products for chemical testing and new tobacco product submissions. III. Scope The request is for a twenty (20) port, automatic linear smoking machine with attachments for impingers and carbon monoxide detection. The unit is used to simulate human cigarette smoking under a variety of conditions and to collect smoke residues for further regulatory chemical analysis. IV. Requirements All of the following are minimum requirements. Equivalent requirements that differ from these minimum requirements must be justified by the proposing vendor and evaluated by the Government. A. System specifications/ salient characteristics: The linear smoking machine system shall include the following components: • The linear smoking machine must be configurable to run on US 208-240 VAC electrical supply standards. • The linear smoking machine must be able to operate in a room with a maximum ceiling height of 89 inches. • The linear smoking machine must be supplied with all fitting and/or adapters to exhaust the smoke gases to a single (1) exhaust port of nominal internal diameter of 3.5 inches and external diameter of 3.75 inches. • All shipped components of the linear smoking machine must be able to fit through a doorway that is 33.5 inches wide and 77 inches tall. • The linear smoking machine shall have the ability to smoke twenty (20) cigarettes simultaneously with the ability to select different smoking regimes at each port. • The linear smoking machine must be able to smoke the following standard regimes used in regulatory testing: o ISO 3308 - Bell shaped profile, 35 mL puff volume, 2 second puff duration, 60 second puff frequency. o Canadian Intense - Bell shaped profile, 55 mL puff volume, 2 second duration, 30 second puff frequency. o Massachusetts Intense - Bell shaped profile, 45 mL puff volume, 2 second duration, 30 second puff frequency. • The linear smoking machine must have an automatic cigarette butt termination function that does not require the physical marking of cigarettes. • The linear smoking machine must have an automatic cigarette lighting function to minimize the user involvement in the lighting of cigarettes. • The linear smoking machine must have a smoke shield closure system that closes automatically once the smoking run has started. • The linear smoking machine shall be equipped with a system to detect leaks at each port. • The linear smoking machine must be supplied with an anemometer that can measure airflows of within the range of 160 to 300 millimeters/second with an accuracy of at least 10 millimeters/second. • The linear smoking machine shall be supplied with an anemometer and all necessary probes, fittings and attachments so that airflow measurement can be made at each of the twenty (20) cigarette ports. • If the anemometer is a self-contained unit that requires offsite, annual calibration, then the smoking machine must be supplied with a second anemometer and any necessary probes, cables or fittings to be used while the first is being calibrated. • The linear smoking machine shall be equipped with dual glass or Teflon impingers for each of the 20 smoking ports, including any racks and/or attachments needed on the smoking machine unit. • Each impinger set come equipped with all fittings, tubing and protection devices so that it can be used as-is for reactive carbonyl testing. • The linear smoking machine shall be equipped with twenty (20) Cambridge Filter Pad (CFP) holders, 1 for each of the 20 smoking ports. • The linear smoking machine shall have twenty (20) smoke collection bags, one for each port, so that online gas analysis can occur in the smoke bag. • The linear smoking machine must have an online, carbon monoxide (CO) detector so that CO levels can be measured for each of the twenty smoking ports. • The linear smoking machine must be supplied with all bags, tubing and fittings needed for CO gas calibrations. • The linear smoking machine shall come supplied with at least one (1) set of labyrinth seals per cigarette position for the following sizes: o 4.50 - 5.50 millimeters (mm), o 5.50 - 6.50 mm, o 6.50 - 7.50 mm, o 7.50 - 9.00 mm. • The linear smoking machine shall be controlled through a software interface that allows the user to select ISO3308, Canadian Intense and Massachusetts Intense smoke regimes as well as define customized smoke regimes for puff profiles, puff durations, puff volumes and puff numbers. • The linear smoking machine shall be controlled through a computer interface. If that interface is based on a Microsoft platform, then the underlying system must be at least Windows 7 or more recent operating system. • The linear smoking machine shall be supplied with all computers, monitors, user input devices, and a network capable laser printer. B. General Specifications The components and/or equipment shall be a newly manufactured, not used and refurbished, or previously used for demonstration. The systems shall be delivered with all necessary supplies and accessories required for installation and start-up. Installation and operator familiarization shall be included for the linear smoking machine system and all components. The vendor shall demonstrate upon installation that the item meets all performance specifications. The instrument will not be accepted until those performance specifications have been met. C. Service Maintenance Agreement: The system shall include a one (1) year full manufacturer's warranty on all parts, travel and labor, including software and hardware and shall include at a minimum: coverage on all non-consumable items and parts supplied including base instrument, computer, monitor, printer, and unlimited on-site service visits with a maximum 72-hour response time, factory-certified replacement parts, engineer labor and travel costs, software updates and notifications. In addition, the Government solicits three (3) 1-year Service and Maintenance Agreement Option Periods. The Service and Maintenance Agreement Option Periods shall meet the following technical requirements: - All manufacturer's required parts, consumables, supplies, labor and travel for repairs and maintenance are to be included. - Integrated service coverage for all of the modules that make up the analytical system. - Minimum of one (1) planned maintenance visit per year. - Maximum 72 hour response time to onsite repair requests. - Unlimited and priority telephone and e-mail access to instrument technical support. - All items utilized for repair and/or maintenance shall be new factory remanufactured OEM parts. - Service engineers shall be manufacturer certified and trained and have access to manufacturers' latest technical developments, repair procedures, application updates (including firmware and software) and planned maintenance procedures. - Pricing shall be inclusive of all labor, travel, parts, supplies, and other costs necessary to affect preventive maintenance and repairs and to otherwise accomplish all service herein. D. Training Services: Onsite training shall be provided at the installation location, for five people, on the operation and maintenance of the linear smoking machine, including software. Onsite training shall occur on a date determined by the COR during installation. Contractor will be given a minimum of 72 hours advance notice of requested date of training. E. Special instructions The contractor shall deliver and install Linear smoking machine that meets the above listed specifications, including equipment, software, essential documents and licenses. The contractor shall perform initial configuration of the system. The offeror shall include sufficient details on the technical specifications in order for a determination to be made as to whether the offeror meet all the technical requirements identified in the solicitation. Place of Delivery: US Food & Drug Administration ORA; Southeast Regional Laboratory 60 Eighth Street NE Atlanta, GA 30309 Delivery Period: Within sixty (60) days after contract award. Supplies and Equipment shall be delivered Monday - Friday between 9:00am - 3:00pm. The following FAR and HHSAR clauses apply to this acquisition. FAR clauses and provisions can be obtained at https://www.acquisition.gov/far/index.html. The provision at 52.212-1, Instructions to Offerors-Commercial Items (Apr 2014), applies to this acquisition with the following addenda to the provision. Period for Acceptance of Offers: The offeror agrees to hold the prices firm through September 30, 2015. The provision at 52.212-2, Evaluation-Commercial Items (Jan 1999), is applicable to this requirement. The specific evaluation criteria to be included in paragraph (a) of that provision are as follows: The Government will award a contract resulting from this solicitation to the responsible offeror whose proposal meets the specifications listed under Part 3 of this solicitation and is the lowest priced proposal received in response to this solicitation. Therefore, award will be made to offeror whose proposal is determined to be Lowest Price Technically Acceptable. A written notice of award or acceptance of an offer mailed or otherwise furnished to the successful offeror within the time for acceptance specified in the offer, shall result in a binding contract without further action by either party. Before the offer's specified expiration time, the Government may accept an offer (or part of an offer), whether or not there are negotiations after its receipt, unless a written notice of withdrawal is received before award. The Provision at FAR 52.212-3, Offeror Representations and Certifications-Commercial Items (May 2014), applies to this acquisition. An offeror should complete only paragraph (b) of this provision if the offeror has completed the annual representations and certifications electronically at http://orca.bpn.gov. The clause at 52.212-4, Contract Terms and Conditions-Commercial Items (Dec 2014), applies to this acquisition with the following addenda: Invoice Submission: A. The Contractor shall submit one original copy of each invoice to the address specified below: Office of Financial Services Food and Drug Administration W032- Second Floor MAIL HUB 2145 10903 New Hampshire Avenue Bldg 32, Rm# 2162, Mail Hub 2145 Silver Spring MD 20993-0002 Attn: Vendor Payments (301) 827-3742 or (866) 807-3742 fdavendorpaymentsteam@fda.gov B. Invoices submitted under this contract must comply with the requirements set forth in FAR Clauses 52.232-25 (Prompt Payment) and 52.232-33 (Payment by Electronic Funds Transfer - System for Award Management) and/or applicable Far Clauses specified herein. To constitute a proper invoice, the invoice must be submitted on company letterhead and include each of the following: (I) Name and address of the contractor; (II) Invoice Date and Invoice Number; (III) Purchase order/Award Number; (IV) Description, Quantity, Unit of Measure, Unit Price, and Extended Price Supplies Delivered or Services Performed, including: (a) Period of Performance for which costs are claimed; (b) Itemized travel costs, including origin and destination; and (c) Any other supporting information necessary to clarify questionable expenditures; (V) Shipping number and date of shipping, including the bill of lading number and weight of shipment if shipped on government bill of lading; (VI) Terms of any discount for prompt payment offered; (VII) Name and address of official to whom payment is to be sent (must be the same as that in the purchase order/award, or in a proper notice of assignment) (VIII) Name, title and phone number of person to notify in event of defective invoice; (IX) Taxpayer Identification Number (TIN); (X) Electronic Funds Transfer (EFT) banking information, including routing transit number of the financial institution receiving payment and the number of the account into which funds are to be deposited; (XI) Name and telephone number of the FDA Contracting Officer Representative (COR) or other program center/office point of contact, as referenced on the purchase order; and, (XII) Any other information or documentation required by the purchase order/award. C. QUESTIONS REGARDING INVOICES SHALL BE DIRECTED TO THE FDA AT THE TELEPHONE NUMBER PROVIDED ABOVE. The clause at 52.212-5, Contract Terms and Conditions Required To Implement Statutes or Executive Orders-Commercial Items (Dec 2014), applies to this acquisition. The following additional FAR clauses cited in the clause are applicable to the acquisition: (b) 52.203-13, Contractor Code of Business Ethics and Conduct (Apr 2010) (Pub. L. 110-252, Title VI, Chapter 1 (41 U.S.C. 251 note)). 52.222-21 Prohibition of Segregated Facilities (Feb 1999) 52.222-26 Equal Opportunity (Mar 2007) (E.O. 11246) 52.222-35 Equal Opportunity for Veterans (Jul 2014) (38 U.S.C. 4212) 52.222-36 Equal Opportunity for Workers with Disabilities (Jul 2014) (29 U.S.C. 793) 52.223-18 Encouraging Contractor Policies to Ban Text Messaging while Driving (Aug 2011) (E.O. 13513) 52.232-33 Payment by Electronic Funds Transfer- System for Award Management (Jul 2013) (31 U.S.C. 3332) FAR 52.217-5 Evaluation of Options (July 1990) FAR 52.217-9 Option to Extend the term of the Contract (Mar 2000) FAR 52.232-18 Availability of Funds (APR 1984) FAR 52.232-40 Providing Accelerated Payments to Small Business Subcontractors (Dec 2013) The following HHSAR clauses apply and can be obtained at the following website: http://farsite.hill.af.mil/VFHHSAR1.html 352.202-1 Definitions (Jan 2006) 352.203-70 Anti-lobbying (Jan 2006) 352.215-70 Late proposals and revisions (Jan 2006) 352.223-70 Safety and health (Jan 2006) 352.224-70 Privacy Act (Jan 2006) 352.228-7 Insurance--Liability to third persons (Dec 1991) 352.233-71 Litigation and claims (Jan 2006) 352.242-73 Withholding of contract payments (Jan 2006) 352.242-71 Tobacco-free Facilities (Jan 2006) 352.242-74 Final decisions on audit findings (Apr 1984) 352.270-1 Accessibility of meetings, conferences and seminars to persons with disabilities (Jan 2001) The supplies delivered hereunder shall be inspected and accepted at destination by the Contracting Officer's Representative (COR) specified at award. If the supplies or services are acceptable, the COR shall promptly forward a report of inspection and acceptance to the paying office. If the supplies or services are not acceptable, the COR shall document the nonconforming items/services and immediately notify the contracting officer. The COR name will be provided at time of award. The COR is responsible for: (1) monitoring the Contractor's technical progress, including the surveillance and assessment of performance and recommending to the Contracting Officer changes in requirements; (2) interpreting the Statement of Work and any other technical performance requirements; (3) performing technical evaluation as required; (4) performing technical inspections and acceptances required by this contract; and (5) assisting in the resolution of technical problems encountered during performance. The Contracting Officer is the only person with authority to act as agent of the Government under this contract. Only the Contracting Officer has authority to: (1) direct or negotiate any changes in the contract; (2) modify or extend the period of performance; (3) change the delivery schedule; (4) authorize reimbursement to the Contractor any costs incurred during the performance of this contract; or (5) otherwise change any terms and conditions of this contract. It is the offeror's responsibility to monitor the internet site for the release of an amendment to the combined synopsis/solicitation (if any). Offerors that fail to complete the required representations and certifications, or reject the terms and conditions of the solicitation, may be excluded from consideration. All responsible sources may submit a quote, which if timely received, shall be considered. The quote shall reference solicitation number FDA-SOL-1145479. The quotes are due by email to the point of contact listed below on or before March 10, 2015 by 10:00am ET. Please contact Corina Couch at (240) 402-5352 or email at Corina.Couch@fda.hhs.gov.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/FDA/DCASC/FDA-SOL-1145479/listing.html)
- Place of Performance
- Address: US Food & Drug Administration, ORA; Southeast Regional Laboratory, 60 Eighth Street NE, Atlanta, Georgia, 30309, United States
- Zip Code: 30309
- Zip Code: 30309
- Record
- SN03648740-W 20150225/150223234746-497dbb131b93fc422dae84dd89e4dd0a (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 |