SOLICITATION NOTICE
Q -- Testing Services for Anti-Schistosomiasis Therapeutics
- Notice Date
- 5/18/2010
- Notice Type
- Combined Synopsis/Solicitation
- NAICS
- 622110
— General Medical and Surgical Hospitals
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Heart, Lung and Blood Institute, Rockledge Dr. Bethesda, MD, Office of Acquisitions, 6701 Rockledge Dr RKL2/6100 MSC 7902, Bethesda, Maryland, 20892-7902
- ZIP Code
- 20892-7902
- Solicitation Number
- NHLBI-PB-(HG)-2010-175-DLM
- Archive Date
- 6/12/2010
- Point of Contact
- Dorothy Maxwell, Phone: 301-435-0352
- E-Mail Address
-
maxwelld@mail.nih.gov
(maxwelld@mail.nih.gov)
- Small Business Set-Aside
- N/A
- Description
- 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 only solicitation and a separate written solicitation will not be issued. The solicitation number is NHLBI-PB-(HG)-2010-175-DLM and is issued as a Request for Quotation (RFQ). The solicitation/contract will include all applicable provisions and clauses in effect through Federal Acquisition Circular 2005-41 (May 13, 2010). Period of Performance: The proposed performance for this service will consist on a one year contract period. (July 1, 2010 – June 30, 2011) The estimated level of effort is 3700 direct labor hours. The North American Industry Classification (NAICS) Code is 622110 and the business size standard is $34.5M. This acquisition is being conducted using Simplified Acquisition Procedures in accordance with FAR Part 13. It is the intent of the National Institutes of Health (NIH) National Heart, Lung and Blood Institute (NHLBI) on behalf of The NIH Chemical Genomics Center (NCGC) and the Therapeutics for Rare and Neglected Disease program (TRND) of the National Human Genome Research Institute to negotiate and award an order to Rush University Medical Center, 1653 West Congress Parkway, Chicago, Illinois 60612-3833 for assaying of compounds in multiple assays associated with Anti-Schistosomiasis activity. The sole source determination is based on the fact the National Institute of Health (NIH) is the nation’s medical research agency and the primary Federal agency conducting and supporting making medical discoveries that improve people’s health and save lives. The NIH Chemical Genomics Center (NCGC) and the Therapeutics for Rare and Neglected Disease program (TRND) of the National Human Genome Research Institute has developed an oxadiazole-2-oxide class of compounds identified agents capable of killing all species of the parasite Schistosomiasis in both ex vivo and in vivo models. To continue to further our understanding of the structure activity relationships surrounding this class of compounds and establish a mechanistic link between the NO (Nitric Oxide) donation by these agents and the down-regulation of key reductases in both species. One of the key goals is for the research results to be used as the basis for the filing of an investigational new drug application (IND) for phase 0/1 clinical evaluation of advanced agent(s) as a therapy by NCGC and/or TRND. Therefore, TRND needs the following tasks to be carried out by the Contractor: 1) synthesize newer analogues of this molecule 2) examine selected pharmacokinetic properties of these agents (including plasma and microsomal stability and the ability of these agents to cross membranes) 3) additional testing of these agents anti-hookworm properties including the assaying of compounds for NO donation, for ex vivo worm killing, a pulse worm killing assay, LD50 determinations, worm killing in plasma shift environments, and in vivo worm clearance assays. The NIH Chemical Genomics Center and the NIH Therapeutics for Rare and Neglected Diseases laboratories (referred to as NCGC and TRND, respectively) have discovered agents capable of inhibiting thioredoxin glutathione reductase (TGR), a reductase required by the parasites causing schistosomiasis and other helminth parasites to maintain proper cellular redox balance. Gratifyingly, these agents are capable of inhibiting this enzyme and have subsequently been found to be active anti-schistosomal and anti-hookworm agents in both ex vivo and in vivo models. Starting in July of 2010 TRND will initiate a comprehensive effort to expand on these discoveries in order to develop small molecule therapeutics for Schistosomiasis infection either as a single agent or in combination with prazequantil. The administration of this contract will be responsible for the accurate and timely of all data in regards to activities only as requested and directed by the TRND Project Officer and may not conduct work on the contract without receiving advanced approval from TRND. The decision of which animal species to be used and any requirements for specific pathogen free (SPF) animals shall be made jointly by the TRND and concerns scientific leadership with TRND having final approval authority. The Contractor will use state-of-the-art techniques and technologies in evaluating promising therapeutics and will incorporate new and improved techniques and technologies into the contract activities The objective of this agreement is to establish a set of mutually agreeable research parameters and anticipated contract terms all of which can be incorporated into a future fee-for-service contract executed between the qualified agency’s and/or small business concerns and TRND. Under this contract the Contractor will be responsible for all analyses associated with novel small molecules versus all species of Schistosomiasis. There is compelling data that suggests that these agents would be appropriate for clinical use and the primary purpose of this contract is to assess new small molecules versus a battery of tests associated with anti-Schistosomiasis activity. The major functions to be carried out by this contract are: -- Assaying of compounds for ex vivo worm killing -- Assaying of compounds for pulse worm killing assay -- Assaying of compounds for LD50 determinations -- Assaying of compounds for worm killing in plasma shift -- Assaying of compounds for in vivo worm clearance assays -- Analysis of compounds for animal GI effects --Analysis of plasma for exposure to compound All data associated with this program will be handled and disseminate in accordance to guidelines set by the TRND Project Officer. The Contractor may not disseminate data associated with this project without receiving advanced approval from TRND. -- The Contractor shall conduct an assessment the quality of all assays and submit data in a timely fashion. -- No data will be sent without the minimal amount of quality requirements that meet the accepted standards for advancement of the project as determined by the TRND staff. -- The Contractor shall identify the biological techniques that are not previously recorded in the published literature and forward such methods and record all alterations to experimental procedures. -- The primary task is the determination of activities of new compounds in all assays and timely delivery of this data. -- The Contractor shall provide the both final data and raw data. FAR Provisions apply to this acquisition are:1) FAR Clause 52.212-1 Instructions to Offerors Commercial Items (JUN 2008) 2) As stated in FAR Clause 52.212-2 (a), The Government will award a contract resulting from this solicitation to the responsible offeror whose offer conforming to the solicitation will be most advantageous to the Government, price and other factors considered. Commercial Items; 3) FAR Clause 52.212-4, (SEPT 2009) Contract Terms and Conditions Required To Implement Statues or Executive Orders Commercial Items, Contract Terms and Conditions Commercial Items; and 4) FAR Clause 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders Commercial Items Deviation for Simplified Acquisitions. Only one responsible source and no other supplies or services will satisfy agency requirement. Interested parties may identify their interest and capability to respond to the requirement or submit proposals. A determination by the Government not to compete this proposed acquisition is based upon responses to this notice and is solely for the purpose of determining whether to conduct a competitive acquisition. The offeror must include in their quotation, hourly rate, the unit price, the list price, shipping and handling costs, the delivery period after contract award, the prompt payment discount terms, the F.O.B. Point (Destination or Origin), the Dun & Bradstreet Number (DUNS), the Taxpayer Identification Number (TIN), and the certification of business size. Note: In order to receive an award from the NHLBI contractors must have a valid registration in the Central Contractor Registration (CCR) www.ccr.gov. The clauses are available in full text at http://www.arnet.gov/far. Interested vendors capable of furnishing the government with the item specified in this synopsis should submit their information to the below address and will be due ten (10) calendar days from the publication date of this synopsis or by May 28, 2010, 7:30 a.m., Eastern Standard Time. The quotation must reference Solicitation number NHLBI-PB-(HG)-2010-175-DLM. Information must be submitted in writing to the National Heart, Lung, and Blood Institute, 6701 Rockledge Drive, Room 6149, Bethesda, Maryland 20892-7902, Attention: Dorothy Maxwell. Responses may be submitted electronically to maxwelld@mail.nih.gov. Responses will only be accepted if dated and signed by an authorized company representative.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/NHLBI/NHLBI-PB-(HG)-2010-175-DLM/listing.html)
- Place of Performance
- Address: NIH, Bethesda, Maryland, 20892-7902, United States
- Zip Code: 20892-7902
- Zip Code: 20892-7902
- Record
- SN02152490-W 20100520/100518234801-4c5650598aea9f6f8f44b94a49e98601 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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