Cigarette Paper Permeability Measurement Instrument for FDA

COMBINED SYNOPSIS/SOLICITATION FOR A CIGARETTE PAPER PERMEABILITY MEASUREMENT INSTRUMENT FOR FDA SOLICITATION NUMBER: FDA-SOL-1160787(2) 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-1160787(2). The solicitation documented and incorporated provisions and clauses in effect through the Federal Acquisition Circular (FAC) FAC 2005-85, Effective 04 Dec 2015. The associated North American Industry Classification System (NAICS) Code is - 334516 - Analytical Laboratory Instrument Manufacturing; Small Business Size Standard is 500 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 of Issue Price 1 Cigarette Paper Permeability Measurement Instrument 1 Each $ 2 Installation and Travel Expense 1 Each $ 3 IQ/OQ Service 1 Each $ 4 Shipping Charges 1 Each $ 5 Optional Year 1 - Cigarette Paper Instrument Preventative Maintenance Service 1 Each $ 6 Optional Year 2 - Cigarette Paper Instrument Preventative Maintenance Service 1 Each $ Total Amount $ STATEMENT OF WORK (SOW) I. BACKGROUND INFORMATION The Southeast Regional Laboratory (SRL) needs to purchase a Cigarette Paper Permeability measurement instrument for the purpose of developing and transferring methods in SRL to support regulatory work for the Center for Tobacco Products. This instrument will increase SRL Tobacco Group capabilities to analyze the permeability of cigarette paper as well as performing tests to market tobacco products. This instrument is designed to perform paper permeability analysis of cigarette paper, tipping paper, and plug wrap. Cigarette paper permeability testing is used by the tobacco industry as a quality control of their finish product. II. SALIENT CHARACTERISTICS 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 Project Advisory Group prior to purchase. **Offerors shall address each of the salient characteristics in order to be considered.** The system shall be a fully operational Paper Permeability Measurement instrument that will be used to analyze cigarette paper. The system shall have the following characteristics: - The instrument must be capable of performing paper permeability/Porosity as per CORESTA method No.40 and conform to ISO2965:2009 standard. - The instrument test piece holder must be capable of holding the cigarette paper without leaks. - The instrument test piece holder must be exchangeable to other sizes and at least include a rectangular test area of 2cm2. Different size holders must be included. - The instrument must be capable of providing accurate results within 2% and have a reproducibility of 2% above 10 CU (cm3 min-1 cm-2 at 1kPa) using the 2cm2 holder. For air porosity of less than 10 CU must be at least within 10% reproducible. - The instrument pressure range must be at least between 0-50 liter/minutes. - The instrument must measure permeability from 0 to 40,000 CU on the 2 cm2 clamp. - The instrument must include an integrated touch screen controller, keyboard or PC/monitor needed for operation and printer. - Training must be provided with the system installation. - The instrument installation must include IQ/OQ with documentation. - The instrument must be supplied with all necessary accessories to calibrate and run samples after installation. - The instrument power connection must be for a US power outlet with a voltage of 115V. - The system must be capable of performing the air permeability test by vacuum and positive pressure without the need to change parts or settings. It must change between methods by the computer operating system. - The instrument must be able to operate between temperature 18C to 33C and humidity of 20% to 80%. - The instrument must be benchtop size. - The system must include at least 1 year warranty that includes parts, travel and labor. Warranty All labor, replacement parts and components (excluding consumables) shall be guaranteed. III. PERIOD OF PERFORMANCE The period of performance shall be for a base period of twelve (12) months and two (2) twelve (12) month optional periods. IV. GOVERNMENT FURNISHED PROPERTY The Government shall provide visitor's access to the FDA facilities during the performance of the contract. A. Special instructions 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(s) of Delivery: Food and Drug Administration/SRL 60 8th Street NE Atlanta, Ga. 30309 Hours of Operation: The Contractor will be responsible for delivering equipment between the hours of 9:00 am - 3:00 pm Monday thru Friday except Federal Holidays. 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 (Mar 2015), 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 (May 2015), 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. The contractor shall submit one electronic copy of the invoice to each of the recipients listed below: Project Officer: TBD Email: Contract Specialist: Corina Genson Email: Corina.Couch@fda.hhs.gov 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 2015), 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)). 52.223-18 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 52.222-41 Service Contract Labor Standards (May 2014) FAR 52.217-5 Evaluation of Options (July 1990) FAR 52.217-9 Option to Extend the term of the Contract (Mar 2000) 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-1160787(2). The quotes are due by email to the point of contact listed below on or before March 22, 2016 by 1:00pm ET. Please contact Corina Genson at 240-402-5352 or email at Corina.Couch@fda.hhs.gov