THIS IS FOR MARKET RESEARCH PURPOSES ONLY, NOT A REQUEST FOR QUOTE OR SOLICITATION. The Food and Drug Administration is seeking business sources, including 8(a) certified businesses, service-disabled veteran owned small businesses, HUB Zone small businesses, small disadvantaged business, veteran-owned small business, and women-owned small businesses. The following information is provided to assist the FDA in conducting Market Research to identify potential contractors for this effort: The government is looking to purchase Four (4) VK7025/8000/SP, 8Pos Dissolution System, 115V to include: • Paddle, Electropolished, V-Series • AccKit 7025, 8 Pos, SSBskt Std clip • AccKit 8000, 6/8 Vlv, 16x100mm Tray • Service IQOQPQ • IQOQPQ(combo)Qual guide VK7020/VK7025(Dup • Qual guide, IQOQ, 8000 PP/SP, App 1/2/3/7 • Bio-Dis, 42 Tube Capacity, 300ml, 115V Detailed Requirements for the Dissolution System: The Dissolution System is to comply with the USP requirements of the Apparatus from one to six. Apparatus 1 & 2 – Basic Dissolution System Basic system should include a full dissolution bath with paddles and baskets and be fully programmable with collection sample unit capable to run unattended for immediate and extended release runs. This system should include accessories such as sinkers, basket and suppositories baskets. USP Apparatus 3: Capable of running unattended for periods of up to six days. Seven sample tubes automatically traverse six rows of corresponding outer tubes filled with different media. Virtually any solid dosage form can be accommodated including pellets, tablets and transdermal patches. Mesh disks retain the samples in the tubes as they move through the medium. Media volume can vary from 100ml, 300ml (USP) or 1000ml. Features Include: • Allows you to fill up to six rows of vessels with different media • Bio-Dis transports each sample from one medium to the next automatically, without operator intervention. • Fully programmability – dip speed, time, hold time, drain time, etc. in each row • Stores up to 25 programs USP APPARATUS 3 (Bio-Dis III) Standard Seven Tube System Includes: • One microprocessor programmable drive unit with real time display of dips per minute • One Report Center II dot matrix printer • One 7-position manifold and three 7 x 2 outer tube cassette carriers • Seven inner tubes and evaporation caps for test samples • Seven upper and lower caps for inner tubes • 25 polypropylene, 20-mesh / 840-micron screens • 25 polypropylene, 40-mesh / 405-micron screens • 25 polypropylene, 78-mesh / 177-micron screens • 25 polypropylene, 100-mesh / 149-micron screens • 25 polypropylene, 160-mesh / 74-micron screens • 25 stainless steel type 316, 20-mesh / 840-micron screens for USP calibration • 42 USP outer tubes, 300ml • One acrylic water bath • One Thermistor probe for VK 750D • One VK 750D External Heater/Circulator • Bio Dis III Testing Station , 115V, 60HZ USP Apparatus 5: Accessories to be used with Basic Dissolution System to become Apparatus 5 to include: • Removable disposable 40-mesh screen and Teflon locking ring. • Type 316 stainless steel ring to retain screen in place • Paddle over disk assembly • Replacement Screens Type 316 s/s 40 mesh screens pkg/100 • Tool to disassemble disk assembly USP Apparatus 6: Accessories to be used with Basic Dissolution System to become Apparatus 6 to include: • Type 316 stainless steel with removable extension. The precision mechanical assembly provides surface area to both small and larger size patches. • Rotating Cylinder two piece assembly *****Shipping and Handling to: FDA, JAMAICA, NY 11433 FDA, IRVINE, CA 92612 FDA, BOTHELL, WA 98021 FDA, SAN JUAN, PR 00901 Each response should include the following Business Information: a. DUNS b. Company Name c. Company Address d. Current GSA Schedules appropriate to this Sources Sought. e. Do you have a Government approved accounting system? If so, please identify the agency that approved the system. f. Type of Company (i.e. small business, 8(a), woman owned, veteran owned, etc.) as validated via the Central Contractor Registration (CCR). All offerors must register on the CCR located at http://www.ccr.gov/index.asp g. Company Point of Contact, Phone and Email Address GENERAL INFORMATION This Sources Sought Notice is for information and planning purposes only and should not be construed as a commitment by the Government. This is not a solicitation announcement for proposals and no contract will be awarded from this Notice. No reimbursement will be made for any costs associated with providing information in response to this Notice. Respondents will not be notified of the results of this evaluation. The Government will not entertain questions regarding this Market Research. Interested Contractors are requested to provide information, brochures, literature, published price list, etc. Information can be submitted by mail, fax or email to Thomas Dumas, Contract Specialist, [email protected] not later than 3:00p.m. EST 29 November 2010.

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