Added: Aug 01, 2008 11:50 am
THIS IS A SOLE / SINGLE SOURCE, NON-COMPETITIVE NOTICE. This notice of intent is not a request for competitive proposals. This sole/single source, non-competitive notice is prepared in accordance FAR Parts 5 and 13. This notice of intent is not a request for competitive proposals. FAR Part 6 Competition Requirements, is not applicable to contracts awarded using the simplified acquisition procedures of FAR Part 13.106-(b) (1).
This announcement constitutes the only notice; proposals are not being requested and a written solicitation will not be issued.
The resultant acquisition will be conducted in accordance with FAR Part 13, simplified acquisition procedures and the resultant purchase order will include all applicable provisions and clauses in effect through the Federal Acquisition Circular FAC 05-26 (as of June 12, 2008).
The intended procurement will be classified under North American Industry Classification System code 325413, and the business size standard is 500 .
THE NATIONAL INSTITUTES OF HEALTH (NIH), National Heart, Lung, and Blood Institute (NHLBI), Office of Acquisition (OA), on behalf of the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) intends to procure on a sole source basis, Human CNV370-Quad DNA Analysis Kits with Illumina Inc., 9885 Towne Center Drive, San Diego, California 92121.
Background:
Title: Genetics and Pathophysiology of familial mediterranean Fever and Related Disorders, (Behcet s Disease)
Protocol Number: 94-AR-0105
Summary: This study is designed to explore the genetics involved in diseases of intermittent fever, including familial mediterranean fever, TRAPS, hyper-IgD syndrome, and related diseases.
The following individuals may be eligible for this study: 1) patients 5 years of age and older with known or suspected familial mediterranean fever, TRAPS, hyper-IgD syndrome or related disorders; 2) relatives of these patients; 3) healthy, normal volunteers 18 years of age or older; and 4) healthy patients with gout 18 years of age or older who are taking colchicine.
Illumina Inc., has provided specific Human CNV370-Quad v3.0 DNA Analysis Kit (wg-311-1401 and catalog#wg-311-1403, for the National Institute of Arthritis and Musculoskeletal and Skin Diseases, entitled: Genetics and Pathophysiology of familial mediterranean Fever and Related Disorders for BEHCET S DISEASE under protocol Number: 94-AR-0105. (Since September 2007)
In addition, in order to satisfy the requirements of the Beh et's disease protocol and ensure the data generated can be incorporated into an extensive pre-existing datatbase derived using the Human CNV370-Quad DNA Analysis Kits, the proposed project must adhere to the conditions, genomic DNA, the purposed protocol must adhere to the conditions, quality of needed supplies required ofr intergity of experiment. The purpose of this requirement is to process the next 800 samples of genomic DNA as a continuation our genome-wide complex genetics analysis of Behcet s disease. Through this process data is combined with data already collected; therefore, the product and platform cannot be changed. Only the Illumina beadstation automated processing robotics and automated sample scanning, for which this product can be used. Changing variable would disrupt the outcome of the experiment under protocol #94-AR-0105.
Researchers are exploring possible genetic, bacterial, and viral causes of Beh et's disease as well as improved drug treatment. For example, genetic studies show strong association of the gene HLA-B51 with the disease, but the exact role of this gene in the development of Beh et's is uncertain. Researchers hope to identify genes that increase a person's risk for developing Beh et's disease. Studies of these genes and how they work may provide new understanding of the disease and possibly new treatments.
1. Researchers are also investigating factors in the environment, such as bacteria or viruses, that may trigger Beh et's disease. They are particularly interested in whether Streptococcus, the bacterium that causes strep throat, is associated with Beh et's disease. Many people with Beh et's disease have had several strep infections. In addition, researchers suspect that herpesvirus type 1, a virus that causes cold sores, may be associated with Beh et's disease.
Finally, researchers are identifying other medicines to better treat Beh et's disease. TNF inhibitors are a class of drugs that reduce joint inflammation by blocking the action of a substance called tumor necrosis factor. Although serious side effects have been reported for TNF inhibitors, they have shown some promise in treating Beh et's disease. Examples of TNF inhibitors include etanercept and infliximab. Also, interferon alpha, a protein that helps fight infection, has shown promise in treating Beh et's disease. Thalidomide, which is believed to be a TNF inhibitor, appears effective in treating severe mouth sores, but its use is experimental and side effects are a concern. Thalidomide is not used to treat women of childbearing age because it causes severe birth defects.
Market Research conducted by the Government in accordance with the Federal Acquisition Regulations (FAR) Part 10, Market Research, has determined that only Illumina Inc., can perform the requisite services specified herein.
This notice of intent is not a request for competitive proposals. The resulting acquisition will be entered into pursuant to the acquisition authority set forth in FAR 6.302-1 and 41 U.S.C. 253(c)(1) and HHSAR 306-302-1. Only one responsible source and no other supplies or services will satisfy agency requirements.
The sole source determination is based on the need to continue on-going experiment; changing variable would disrupt the outcome of the experiment. Therefore an award to any other source is not feasible nor practical.
Interested parties may identify their interest and capability to respond to the requirement or submit proposals. This notice of intent is not a request for competitive proposals. However, all proposals received within 15 days after publication of this synopsis will be considered by the Government.
A determination by the Government not to compete this proposed contract based upon responses to this notice is solely within the discretion of the Government. Information received will normally be considered solely for the purpose of determining whether to conduct a competitive procurement.
Inquires to this notice, referencing number NHLBI-PB-(AR)2008-213-RCO may be submitted to the National Heart, Lung and Blood Institute, Office of Acquisition, Procurement Branch, 6701 Rockledge Drive, Suite 6128, Bethesda, Maryland 20892-7902, Attention: Rosie C. Owens, Contract Specialist. Response may be submitted electronically to rowens@nhlbi.nih.gov or marsdenk@hlbi.nih.gov and by fax to (301) 480-3345. Responses will only be accepted if dated on or before August 15, 2008; and 5:00pm, Eastern Standard Time signed by an authorized company representative.
