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FBO DAILY - FEDBIZOPPS ISSUE OF FEBRUARY 27, 2016 FBO #5209
SOLICITATION NOTICE

66 -- Brand Name or Equal - TA DHR-3 Discovery Hybrid Rheometer Upgrades - FDA-RFQ-1161860

Notice Date

2/25/2016
 

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-RFQ-1161860
 

Archive Date

3/25/2016
 

Point of Contact

Lisa K. Yaw, Phone: 2404024018, Sean Wybenga, Phone: 240-402-7629
 

E-Mail Address

lisa.yaw@fda.hhs.gov, sean.wybenga@fda.hhs.gov
(lisa.yaw@fda.hhs.gov, sean.wybenga@fda.hhs.gov)
 

Small Business Set-Aside

N/A
 

Description

Upgrades to an existing TA DHR-3 Discovery Hybrid Rheometer Part 1 - Description The U.S. Food and Drug Administration's (FDA) Center for Drug Evaluation and Research (CDER) has a requirement for a an upgrade to an existing TA DHR-3 Discovery Hybrid Rheometer, "Brand Name or Equal", which will be used for assessing critical quality attributes of complex semisolid pharmaceutical dosage forms. This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Federal Acquisition Regulation (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 separate written solicitation will not be issued. This solicitation is a Request for Quote (RFQ) using FAR Parts 12 and 13 procedures. The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) 2005-86. The North American Industry Classification System (NAICS) code for the proposed acquisition is 334516, Analytical Laboratory Instrument Manufacturing. The associated small business standard is 500 employees. This requirement is for full and open competition. Part 2 -Supplies or Service and Prices/Cost 2.1 Contract Type: Firm-Fixed Price 2.2 Pricing Table Base Pricing ManufacturerProduct CodeDescriptionQuantityPrice TA Instruments546810.901Modular Microscope Accessory (MMA) for the Discovery Hybrid Rheometer (DHR) (Brand Name or Equal)1 TA Instruments546814.901DHR Counter-Rotating Optics Plate Accessory (Brand Name or Equal) TA Instruments546800.901Optics Plate Accessory (OPA) (Brand Name or Equal) TA Instruments203274.001DHR MMA Fluorescence Splitter (Brand Name or Equal) TA Instruments533222.901DHR & AR-G2 / AR2000 SALS Accessory (Brand Name or Equal) TA InstrumentsShipping, Installation and Training TA InstrumentsOne (1) year warranty on parts and labor Total Firm-Fixed Price Option Pricing Option PeriodDescriptionPrice 1Service Agreement 2Service Agreement 3Service Agreement 4Service Agreement Total Firm Fixed Price The total price for the base and four option years is _______________. Part 3- Description/Specifications 3.1 Background The Division of Product Quality Research (DPQR) conducts research assessing the quality and safety of drug products. One of the on-going research activities is to develop in vitro quality matrix for semisolid ophthalmic drug products, for both human and veterinary use, using advanced rheometry. The division currently possesses a rheometer capable of performing basic rheological characterizations, and it has a modular design that can expand function by adding additional accessories. One of the areas DPQR seeks to improve the existing system is to combine rheological characterization with advanced imaging analysis to better determine the critical quality attributes of complex semisolid pharmaceutical dosage forms. In these products, drug substances commonly present as solid state particles and their stability and performance (e.g. drug release) likely influence the rheology of the semisolid system. By coupling advanced imaging analysis (e.g. optical microscopy, light scattering) with rheometry, DPQR anticipates to gain better understanding of complex semisolid dosage forms, ultimately providing insight and guidance with the regulation of these products. 3.2 Statement of Work DPQR's proposed upgrades to an existing rheometer will combine rheological characterization with advanced imaging analysis. These equipment enhancements will assist researchers with assessing critical quality attributes of complex semisolid pharmaceutical dosage forms. DPQR is requesting five (5) rheometer equipment upgrades and listed below with required technical specifications: 3.3 Salient Characteristics The contractor shall provide components for a Discovery Hybrid Rheometer (DHR) or equal which includes the following characteristics: A.Modular Microscope Accessory (MMA) for the Discovery Hybrid Rheometer (DHR): Provides complete microscopy capabilities during any rheological measurement in parallel plate or cone-plate geometries. The MMA is a self-contained system that should be able to mount directly to the DHR and does not require any additional stands, lifts, or other support. It should comprise a high resolution (640 × 480 px) camera that collects images at up to 90 fps coupled with industry-standard microscope objectives. The MMA should also include an x-y-z micrometer positioning system for selection of the observation location at any position along the sample radius. Illumination should be provided by a blue light LED. It should also include a cross-polarizer for polarized microscopy. B.DHR Counter-Rotating Optics Plate Accessory: Includes an optical stage that features an integrated motor for controlled rotation of the optics stage in coordination with the upper plate rotation producing a defined stagnation plane. The plate's rotational velocity should be software-controlled to maintain a user-defined velocity ratio relative to the upper plate allowing the user to select and adjust the depth of the stagnation plane. The open optical system should be able to integrate with any appropriate visualization system and should also be able to pair with the Modular Microscope Accessory (MMA). C.Optics Plate Accessory (OPA): Plugs into the DHR and comes equipped with a borosilicate glass plate that serves as the lower geometry and allows sample visualization from below the upper plate/cone geometry. The OPA's base should have 8 M2 tapped holes in a 2x4 grid (20 mm spacing) that can serve as a platform for integrating custom optics trains. The accessory should also include three replacement borosilicate glass plates and three nitrile O-rings. D.DHR MMA Fluorescence Splitter: This accessory should have the capability to be used in combination with the Modular Microscope Accessory (MMA) to permit fluorescence microscopy. E.DHR & AR-G2 / AR2000 SALS Accessory: Small Angle Light Scattering accessory (SALS) should be compatible with the DHR. It should include lower assembly with 635 nm 0.95 mW class 2 laser, stainless steel Peltier plate with temperature range of 5 to 95 °C, quartz window, and neutral density filter holder. Upper assembly should include variable depth focus optical tube, polarizer, and monochrome USB camera (1280 x 1024 pixels). The accessory should feature a light scattering angle range of approximately 6 to 26.8°, scattering vector q range of approximately 1.38 to 6.11μm-1. 3.4 Installation, Training and Warranty Requirements The offeror shall install the components at the location listed in Part 4 no later than three (3) months (3) after contract award. Installation, at a minimum, shall include uncrating/unpacking of all equipment, rigging, set-up and hook-up of the system, demonstration of all specifications, and removal of trash. The DHR system and components shall include an operations and maintenance manual covering proper operation, routine maintenance, and trouble shooting for the instrument and controlling software. All manuals and documentation on the instrument shall be provided in hard copy and electronic format. The offeror shall conduct one (1) training session for up to four (4) technical personnel at FDA CDER/OPQ location. The training shall provide a thorough demonstration of all system/solution functions, maintenance, data administration, basic troubleshooting and hardware/software operation. The training shall be completed the address listed below, immediately after installation/set-up and demonstration of performance specifications, but shall be completed no later than 90 days after installation. The US Food and Drug Administration White Oak Campus 10903 New Hampshire Avenue WO Building 64 Room 1083 Silver Spring, MD 20993 The offeror shall warrant the entire system for a period of at least one (1) year from acceptance by FDA. The warranty shall include: •unlimited telephone/e-mail support for questions regarding operation •onsite visits for diagnosis of problems and repairs inclusive of all parts, labor, and travel expenses at no additional cost to the FDA •onsite service rendered under the warranty shall be completed within 5 business days of request by Government, unless otherwise authorized 3.5 Optional Service Agreement The FDA shall have a unilateral right to exercise optional periods to continue the maintenance work described below. Maintenance and service shall include: •Software updates during the service agreement period •Technical phone support •Onsite visits for diagnosis of problem and repairs inclusive of all parts, labor, and travel expenses •Service rendered under agreement shall be completed within 5 business days of request by Government, unless otherwise authorized. The optional period of performance, if exercised, shall commence as follows: Option Period of Performance Option Period 1: Service AgreementTo begin 1st year following receipt of equipment Option Period 2: Service AgreementTo begin 2nd year following receipt of equipment Option Period 3: Service AgreementTo begin 3rd year following receipt of equipment Option Period 4: Service AgreementTo begin 4th year following receipt of equipment FAR 52.217-8, OPTION TO EXTEND SERVICES (NOVEMBER 1999) The Government may require continued performance of any services within the limits and at the rates specified in the contract. These rates may be adjusted only as a result of revisions to prevailing labor rates provided by the Secretary of Labor. The option provision may be exercised more than once, but the total extension of performance hereunder shall not exceed 6 months. The Contracting Officer may exercise the option by written notice to the Contractor within the period of performance of this contract. (End of clause) FAR 52.217-9, Option to Extend the Term of the Contract (March 2000) (a) The Government may extend the term of this contract by written notice to the Contractor within the period of performance of the contract; provided that the Government gives the Contractor a preliminary written notice of its intent to extend at least 30 days before the contract expires. The preliminary notice does not commit the Government to an extension. (b) If the Government exercises this option, the extended contract shall be considered to include this option clause. (c) The total duration of this contract, including the exercise of any options under this clause, shall not exceed five years. (End of clause) Part 4 - Deliveries or Performance All deliverables required under this contract shall be packaged, marked and shipped in accordance with Government specifications. At a minimum, all deliverables shall be marked with the contract number and contractor name. The Contractor shall guarantee that all required materials shall be delivered in immediate usable and acceptable condition. The spectrometer and all components shall be delivered to the address below no more than three (3) months after the effective date of the contract. Delivery Location: ATTN: Xiaoming Xu US Food & Drug Administration White Oak Campus 10903 New Hampshire Avenue WO Building 62 Loading Dock Silver Spring, MD 20993 The period of performance of shall one (1) year from the installation and acceptance of the equipment. Part 5 -Contract Administration 5.1 Representative's The following COR will represent the Government for the purpose of this order: Xiaoming Xu 301-796-5035 Xiaoming.Xu@fda.hhs.gov. The COR is responsible for the following as required by this order: (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 evaluations; (4) performing technical inspections and acceptances; and (5) assisting in the resolution of technical problems encountered during performance. The Contracting Officer is the only person with authority to act as an agent of the Government under this order. Only the Contracting Officer has authority to: direct or negotiate any changes in the order, including modifying or extending the period of performance, changing the delivery schedule, authorizing reimbursement to the Contractor for any costs incurred during the performance of this order, or otherwise change any terms and conditions of this order. The contact information for the Contracting Officer is the following: Sean Wybenga U.S. Food and Drug Administration Office of Acquisitions and Grants Services 5630 Fishers Lane Rockville, MD 20857 Sean.Wybenga@fda.hhs.gov; (240) 402-7629 The contact information for the Contract Specialist is the following: Lisa Yaw U.S. Food and Drug Administration Office of Acquisitions and Grants Services 5630 Fishers Lane Rockville, MD 20857 Lisa.Yaw@fda.hhs.gov; (240) 402-4018 The contact information for the Contractor is the following: (TBD) 5.2 Invoice Submission A.The Government will pay the Contractor only each respective deliverable's firm-fixed-price delineated in the table in Subpart 3.3 above, upon successful completion, as determined by the COR, and upon submission of a proper invoice. Proper invoice submission includes following the invoice instructions below. B.The Contractor shall submit all invoices in the manner specified below: The Contractor shall submit one original copy of each invoice to the address specified below: Office of Financial Services Food and Drug Administration 10903 New Hampshire Avenue W032-Second Floor Bldg. 32, Rm. 2162, Mail Hub 2145 Silver Spring MD 20993-0002 Attn: Vendor Payments Phone: (301) 827-3742 or (866) 807-3742 Email: fdavendorpaymentsteam@fda.gov Invoices submitted under this order must comply with the requirements set forth in FAR 52.232-33 (Payment by Electronic Funds Transfer - Central Contractor Registration) and the other 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 of 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 a 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 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. Questions regarding invoices shall be directed to the FDA at the telephone numbers provided above. Payment will only be made on a firm-fixed-price basis.
 

Web Link

FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/FDA/DCASC/FDA-RFQ-1161860/listing.html)
 

Place of Performance

Address: US Food & Drug Administration, White Oak Campus, 10903 New Hampshire Avenue, Silver Spring, MD 20993, United States

Zip Code: 20993
 

Record

SN04031473-W 20160227/160225235137-2fa95ce884035549fa8ebcb4a8008bdc (fbodaily.com)
 

Source

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

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