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FBO DAILY - FEDBIZOPPS ISSUE OF JULY 10, 2015 FBO #4977
SOLICITATION NOTICE

66 -- Nano Tracking Analysis for FDA - Package #1

Notice Date

7/8/2015
 

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-1151147
 

Archive Date

8/4/2015
 

Point of Contact

Corina L Couch, Phone: 2404025352
 

E-Mail Address

corina.couch@fda.hhs.gov
(corina.couch@fda.hhs.gov)
 

Small Business Set-Aside

Total Small Business
 

Description

Solicitation for Nano Tracking System 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-1151147. This solicitation is issued as a Total Small Business Set, 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 2005-82, Effective 07 May 2015. 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. Please submit all quotes to be valid until September 30, 2015. SUPPLIES OR SERVICES AND PRICES/COSTS The contractor shall fill out the following pricing sheet: CLIN Description Qty Unit of Issue Price 0001 Brand Name or Equal to Malvern NS300 1 EA $ Total Amount $ I. Background/Intro The Forensic Chemistry Center (ORA/CER/FCC) requires a nanotracking analysis system for the characterization of nanoparticles. The incorporation of nanomaterial into medicine/medical devices, food contact surfaces, dietary supplements, and unapproved uses are becoming increasingly common. The ability to distinguish between nano and non-nano material and nanomaterial of different elemental composition are imperative because nanomaterials exhibit properties that greatly differ from their bulk counter material. Nanoparticle behavior can also be a function of size and concentration in its dilution matrix. A nanotracking analysis system will provide the FCC with the ability to differentially detect and enumerate nanoparticles composed of different material in the same solution in products that are being submitted for analysis. II. Minimum Characteristics A. General Characteristics: Elemental behavior and characteristics largely differ between nanomaterial and non-nano material of same composition. The number of products analyzed at the FCC containing nanomaterial (both for FDA approved and unapproved uses) has increased over the last several years. Acquisition of the nanotracking analysis system will allow fast, nondestructive characterization of nanomaterial in products submitted for analysis at the FCC. B. Salient Characteristics: • The system must be a newly manufactured unit, not used and refurbished or previously used for demonstration. • Software that allows for multi-users from set up through results and performs automated measurements using a microscope to visualize scattered light resulting from laser irradiation of nanoparticles in solution • The system must include a computer, monitor, keyboard, mouse, and appropriate cables/wires. • Software must include report designer. • One day on-site familiarization / training for up to two operators covering operation of the instrument, software use, and general maintenance must be supplied. • A one year warranty with the option to purchase up to three additional warranty years is required with the purchase and shall include at a minimum: coverage on all non-consumable items and parts supplied including base instrument, computer, and monitor, unlimited on-site service visits for warranty repairs, factory-certified replacement parts, engineer labor and travel costs, and software updates and notifications. • System must be network compatible for local laboratory data management system. • System must be able to be powered using 110v and without modifications to the in house electricity. Nanotracking analysis System • System must be able to perform nanoparticle size and counting analysis in a temperature controlled environment ranging between 5°C and 45°C • System must have sample introduction syringe pump to control injected effluent flow rate • Software must be able to provide real time visualization of the nanoparticles in the solution analyzed • System must be able to distinguish between nanoparticles of different composition in the sample solution. • System must have the capability to be used stand-alone • System must be capable of conducting particle size measurements from 20 nm to 2000 nm • System must include camera, green laser, and red laser • System must have footprint no more than 40 cm x 30 cm because of limited bench space • System must have integrated vibration compensation capability in order to be insensitive to vibration caused by building structure without compromising integrity of analysis or the need for additional equipment to absorb environmental vibration. • System must have filter wheel controlled by a computer • Must be able to analyze a minimum of 300 uL sample C. 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: US FDA, Forensic Chemistry Center, 6751 Steger Rd. Cincinnati, OH 45237-3097 The system must be delivered during normal business hours (M-F, 8:00AM - 4:30 PM EST), excluding government 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. 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 (May 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)). 52.219-6, Notice of Total Small Business Aside (Nov 2011) (15 U.S.C. 644 52.222-21 Prohibition of Segregated Facilities (Feb 1999) 52.222-26 Equal Opportunity (Apr 2015) (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 52.211-6 Brand Name or Equal (Aug 1999) 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-1151147. The quotes are due by email to the point of contact listed below on or before July 20, 2015 by 1:00pm ET. Please contact Corina Genson 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-1151147/listing.html)
 

Place of Performance

Address: US FDA, Forensic Chemistry Center, 6751 Steger Rd., Cincinnati, Ohio, 45237, United States

Zip Code: 45237
 

Record

SN03789964-W 20150710/150708235740-c82ba02b00d7b1706c6ffed1ffce0aef (fbodaily.com)
 

Source

FedBizOpps Link to This Notice
(may not be valid after Archive Date)

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