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FBO DAILY ISSUE OF AUGUST 21, 2011 FBO #3557
MODIFICATION

66 -- Circular Dichroism Spectrometer

Notice Date

8/19/2011
 

Notice Type

Modification/Amendment
 

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

FDA-110-223-SOL-00184
 

Archive Date

9/6/2011
 

Point of Contact

Roy E. Mutch, Phone: 404-253-1258
 

E-Mail Address

roy.mutch@fda.hhs.gov
(roy.mutch@fda.hhs.gov)
 

Small Business Set-Aside

N/A
 

Description

The Food and Drug Administration intends to award a Purchase Order for a Circular Dichorism Spectrometer, "Subject to Availability of Funds". The requirements will be awarded using Simplified Acquisition Procedures in accordance with FAR 13.5. This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in FAR 12.6, as supplemented with additional information included in this notice. This announcement constitutes the solicitation: Proposals are being requested and a written solicitation will not be issued. The solicitation number is FDA-11-223-SOL-00179. This solicitation is issued as Request for Quote (RFQ). The associated North American Industry Classification System (NAICS) is 334516. Contract Type: Commercial Item-Firm Fixed Price. All responsible sources may submit a quote which shall be considered. The Food and Drug Administration is soliciting the following: 1. Circular Dichroism Spectrometer - 1 ea * Thermoelectric Sample Change * Automated Syring Pump System * pH Measurement System * Solid Sample Holder * Rectangular Cells 1mm Pathlength * Additional Cell Spacers Statement of Work In this project, we propose to intensively characterize using methods beyond those typically employed at lot release. For this purpose, we will use a model protein, protamine sulfate, from various sources. It is the only drug approved by FDA to reverse the anticoagulant effects of heparins. Protamine, isolated from sperm nuclei of fish, is a complex mixture of several similar peptides which are rich in arginine and positively charged. It is administered by IV routes. It has been suggested that the biological activities of protamines are primarily based upon the ability of these positively charged peptides present in the protamine to bind to other negatively charged biomolecules (e.g., polysaccharides). Structural attributes of protamine, such as molecular weight distribution, charge density, secondary structure, can have a significant impact on it binding to polysaccharides, and thus affect the safety and efficacy of the final drug product. These attributes have not been characterized extensively in any previously approved protamine sulfate injection products. Secondary and higher order structures of monoclonal antibodies and therapeutic proteins will be determined using Circular Dichroism which will aid in complete characterization of proteins and therefore, DPQR wishes to purchase this equipment. This collaborative project between Office of Testing and Research, Office of Biotech Products and Office of Generic Drugs will be able to delineate some of the critical quality attributes (CQAs) which are important for safety and efficacy. A comprehensive characterization will help build a regulatory framework for the incoming biosimilars which will enable reviewers to look proactively into characterizing similar molecules. FOB: Shipping Point - Origin. Company must be registered in Central Contractor Registration (CCR) before an award could be made to them. If the company is not registered in CCR, they may do so by going to CCR web site at http://www.ccr.gov. The provision at FAR 52.212-1 Instructions to Offeror-Commercial Items applies to this solicitation. The following addenda have been attached to this provision: None. The provision a FAR 52.212-2 Evaluation-Commercial Item is applicable to this solicitation. The specific evaluation criteria to be included in paragraph (1) of this provision are as follows: (i) Technical capability described to "Meet or Exceed the Requirement", (ii) Price. The Government will award a Purchase Order "Subject to Availibility of Funds" resulting from this solicitation to the responsible offeror whose offer conforming to the solicitation will be the most advantageous to the Government. Technical factors are more important than price. The Govenment is not responsible for locating or securing any information, which is not identified in the proposal. To ensure information is available, vendors must furnish as part of their proposal all descriptive materials necessary for the Government to determine whether their instrument meets the technical requirements. The Government reserves the right to make an award without discussions. The provision at FAR 52.212-3, Offeror Representation and Certification-Commercial Items, applies to this acquisition. The clause at 52.212-4, Contract Terms and Conditions-Commercial Items, applies to this acquisition. The clause at FAR 52.212-5, Contract Terms and Conditions Required to Implement Statutes of Excutive Orders-Commercial Items, applies to this acquisition. The following additional FAR clauses cited in this solicitation are applicable: 52.222-3; 52.222-19; 52.222.21; 52.222-26; 52.222.36; 52.225-1; 52.232-13; and 52.232-34. Clauses and provision can be obtained at http://www.acquisition.gov. Offers are due in person, by postal mail, by email or fax on or before August 22, 2011, 17:00pm Eastern Daylight Saving Time. Local Prevailing Time in Atlanta, GA at Food and Drug Administration OAGS/PB, Attn: Roy E. Mutch, 60 8th Street, NE, Atlanta, GA 30309. For information regarding this solicitation, please contact Roy E. Mutch @ (404) 253-1258, fax (404) 253-2256 or email roy.mutch@fda.hhs.gov.
 

Web Link

FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/FDA/NCTR/FDA-110-223-SOL-00184/listing.html)
 

Place of Performance

Address: FDA/CDER, Bldg 64, 10903 New Hamshire Avenue, Silver Spring, Maryland, 20993, United States

Zip Code: 20993
 

Record

SN02541974-W 20110821/110819235441-4c5bd9e24448fc472fee39a92f2fc6b4 (fbodaily.com)
 

Source

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

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