SOURCES SOUGHT
66 -- Isothermal Titration Calorimeter
- Notice Date
- 7/22/2011
- Notice Type
- Sources Sought
- NAICS
- 334516
— Analytical Laboratory Instrument Manufacturing
- Contracting Office
- Department of Health and Human Services, Food and Drug Administration, Office of Acquisitions and Grants Services, Bldg 50 Room 422, Jefferson, Arkansas, 72079, United States
- ZIP Code
- 72079
- Solicitation Number
- 1089565
- Archive Date
- 8/10/2011
- Point of Contact
- Karen J. Moore, Phone: (870) 543-7479
- E-Mail Address
-
karen.moore@fda.hhs.gov
(karen.moore@fda.hhs.gov)
- Small Business Set-Aside
- N/A
- Description
- Notice Type: Sources Sought Set Aside: N/A Synopsis: This notice is for Market Research purposes only, not a request for proposal or solicitation. The Food and Drug Administration (FDA) is seeking sources, including service-disabled veteran-owned small business, Hubzone small businesses, 8(a) certified small business, woman owned small business, small disadvantaged businesses as well as small businesses. The following information is provided to assist the FDA in conducting Market Research to identify potential contractors for providing the items below. 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. BACKGROUND: Isothermal titration calorimetry (ITC) is a powerful tool for product characterization. ITC is a physical technique used to determine the thermodynamic parameters of interactions in solution. It is most often used to study the binding of small molecules (such as medicinal compounds) to larger macromolecules (proteins, DNA, etc.). ITC is primarily used to determine thermodynamic binding parameters such as binding affinity and dissociation constants, as well as stoichiometry, enthalpy, entropy, and Gibbs free energy of binding under isothermal conditions. It can also be used to determine heat capacity changes upon binding by performing experiments over a range of temperatures. ITC data supplies the thermodynamic parameters of protein unfolding, including the midpoint unfolding temperature, enthalpy, entropy, Gibbs free energy, and heat capacity changes upon unfolding. These thermodynamic parameters are commonly used to compare protein stability in different products, and/or to determine the relative stabilizing or destabilizing effect of the used excipients during product's development. REQUIREMENT: The Division of Product Quality Research (DPQR) within The Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) has a requirement for an Isothermal Titration Nanocalimeter System to promote the infrastructure of the FDA laboratory work and regulatory mission responsibilities. The required features of the instrument need to include: 1. Nanocalorimeter, 4 mL: The nanocalorimeter is a most sensitive calorimeter designed for use with the TAM III thermostat. Its twin-calorimeter design and integrated electronics should provide for operation in the heat flow or power compensation mode and in isothermal, step-isothermal or scanning experiments. The nanocalorimeter should accommodate all closed ampoules up to 4 mL with a similar ampoule containing an inert substance, as a reference. It should have exceptional baseline stability. 2. Ampoule, Titration, St. Steel, 1 mL, for Nanocalorimeter. 3. Titration Dummy, 1 mL, for Nanocalorimeter 4. Precision Syringe Pump with Control Module (115V / 230V): Dual position syringes pump to be used with the TAM III titration setup. The pump is used in titration studies and in experiments where an exact volume of a reactant is added as a single injection. It should include a single titration control slot module that plugs into the TAM Accessory Interface (P/N: 3801-1), the syringe pump, a 250 mL syringe with a stainless steel cannula, and cable connections. 5. Accessory Interface, TAM III, 115/230V, 50/60Hz: An interface module for communication and control of auxiliary equipment via TAM III and TAM Assistant software. Auxiliary equipment should include the Lund syringe pump, gas flow control kit, or pump control module. Potential contractors must indicate business size, proof of any set-aside certification and company's DUNS number and provide a contact name, the mailing address, phone number and email address of point of contact. Capability statement must provide enough information to determine if company can meet requirements stated above by including technical specifications, descriptive literature, brochures and other information that demonstrates the capabilities of the contractor to meet the requirements. Provide two contact names, email and phone numbers for user of the proposed system that may be contacted by the Government. Respondents are responsible for delivery in person, by email, fax, mail or other delivery method their responses on or before 1 August 2011 before 9:00 am (Central Standard Time - Local Prevailing Time in Jefferson, Arkansas), at the Food and Drug Administration, OC/OA/OAGS, ATTN: Karen J. Moore, 3900 NCTR Road Jefferson, AR 72079-9502. Reference: 1089565 Questions regarding this posting shall be submitted via email no later that 1:00PM CST on 27 July 2011. This notice does not obligate the Government to award a contract or otherwise pay for the information provided in response. The Government reserves the right to use information provided by the respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization's qualifications to perform the work. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. After a review of the responses received, a solicitation may be published in the Federal Business Opportunities. However, responses to this notice will not be considered adequate responses to a solicitation. No proprietary, classified, confidential or sensitive information should be included in your response. The Government reserves the right to use any non-proprietary technical information in a resultant solicitation that may result from this market survey. For information regarding this notice, contact Karen J. Moore Karen.moore@fda.hhs.gov phone, (870)543-7479, Fax (870) 543-7990.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/FDA/NCTR/1089565/listing.html)
- Place of Performance
- Address: The US Food and Drug Administration, 10903 New Hampshire Avenue, White Oak Campus, Bldg. 64, Silver Springs, Maryland, 20993, United States
- Zip Code: 20993
- Zip Code: 20993
- Record
- SN02507677-W 20110724/110723005904-f9ea0bb30e4cbfb9b324e7772ed40561 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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