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FBO DAILY ISSUE OF AUGUST 20, 2012 FBO #3922
SOURCES SOUGHT

B -- Gene Expression Signatures of Cancer-Prevention Activities of Si-Wu-Tang in an in-vitro cell culture system

Notice Date

8/18/2012
 

Notice Type

Sources Sought
 

NAICS

541380 — Testing Laboratories
 

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

1110020
 

Archive Date

8/22/2012
 

Point of Contact

Nicholas E Sartain, Phone: 870-543-7370
 

E-Mail Address

nick.sartain@fda.hhs.gov
(nick.sartain@fda.hhs.gov)
 

Small Business Set-Aside

N/A
 

Description

MARKET RESEARCH PURPOSES ONLY NOT A REQUEST FOR PROPOSAL OR SOLICITATION The U.S. Food and Drug Administration (FDA), is conducting market research to support the National Center for Toxicological Research (NCTR) requirement for gene expression signatures of cancer-prevention activities of Si-Wu-Tang in an in-vitro cell culture system. The FDA is seeking business sources, including total small businesses, service-disabled veteran-owned small businesses, HUBZone small businesses, 8(a) certified companies and other than 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 seeking capability statements from businesses capable of performing the gene expression signatures of cancer-prevention activities of Si-Wu-Tang in an in-vitro cell culture system. Background: The project is part of the on-going Microarray Quality Control (MAQC-III) project, which is also called Sequencing Quality Control (SEQC), Which aims to assess the technical performance of Next-Generation sequencing technology (Next-Gen) by generating benchmark datasets with reference samples and evaluating advantages and limitation of various bioinformatics strategies in RNA and DNA analysis. Microarrays and Next-Gen sequencing represent core technologies in pharmacogenomics and toxicogenomics; however before these technologies can successfully and reliably be used in clinical practice and regulatory decision-making, standards and quality measures need to be developed. The MAQC series of projects are helping improve the microarray and Next-Gen sequencing technologies and foster their proper applications in discovery, development and review of FDA regulated products. 1. The Tasks: The contractor shall investigate a potentially new role for the traditional oriental medicine Si-Wu-Tang in cancer chemoprevention. Si-Wu-Tang has been used in Eastern Asia for about one thousand years for various women's diseases and ranks first as the most frequently used Chinese medicines in several surveys. Our previous study using gene expression microarray and Connectivity Map analysis has discovered new mechanisms for this old drug and suggests its potential activity in cancer prevention (Wen, et al. PLoS ONE, e18278, 2011). Its chemoprevention potential will be further assessed in a cancer development model in cell culture. An estimated total of 18 samples (the vehicle control group, the tumor promoter group, the positive control group and the Si-Wu-Tang groups in three concentrations, all in triplicate) samples will be analyzed so that the Government can compare the effect of Si-Wu-Tang with known chemopreventive agents. The tumor promoter is the epidermal growth factor (EGF) (10 ng/ml). The chemopreventive agent serving as the positive control is (-)-epigallocatechin gallate (EGCG), the most abundant and potent antioxidant in green tea. The Si-Wu-Tang water extract will be tested for its effect on EGF-induced cell transformation in non-cancerous mouse epidermal cell line JB6. Both Si-Wu-Tang and the positive control EGCG will be evaluated on the efficacy in suppressing EGF-induced colony formation in soft agar (anchorage-independent growth assay). Dose-dependent effect and IC50 values will be obtained for EGCG and Si-Wu-Tang. As the JB6 assay has the positive predictive value for in vivo efficacy of chemopreventive agents (Steele et al., J Cell Biochem Suppl 26, 29-53, 1996), the in vitro assay is expected to provide compelling evidence to support our hypothesis. To investigate the potential cancer preventing mechanism, gene expression profiles of Si-Wu-Tang on the JB6 cells using a whole-genome microarray will be compared with previously obtained microarray profiles on MCF-7 cells. Ultimately, the gene expression changes will be used as biomarkers of efficacy of the chemopreventive agents. The government reserves the right to change the quantity of analyses required. 2. Performance standards. The endpoint of the soft agar assay is the number of colonies that grow on each well of the soft agar in a 96-well plate in comparison with the vehicle control and tumor promoter groups. Only cells with carcinogenic properties can form soft agar colonies. The effects of Si-Wu-Tang on suppression of carcinogenesis will be also compared with the positive control EGCG (10 µM) (expect to reduce ~ 60% of colonies). 3. Samples to be analyzed, what will be sent and when the Government will provide them: An estimated total of 18 samples (the vehicle control group, the tumor promoter group, the positive control group and the Si-Wu-Tang groups in three concentrations, all in triplicate) will be provided by the Government for the Contractor to analyze. Sources of materials and methods of extraction of the raw herbs have been reported previously (Wang et al., J Pharm Biomed Anal 50, 232-244, 2009). FOB Point Destination. FOB Point of Delivery for Services and Supplies will be the FDA/NCTR located at 3900 NCTR Road, Jefferson, AR 72079. Payment terms net 15 days after government acceptance of the supplies/services. Period of Performance: This work will be accomplished by the contractor within three months upon receipt of the samples from the Government. The Government will provide all samples by September 15, 2012. The contractor shall run all samples and return results no later than December 15, 2012. The offeror shall furnish sufficient technical information necessary for the Government to conclusively determine that the offered instrument and components meet the technical requirements identified above. Firms believing they can meet the requirements to the above specifications are encouraged to respond electronically with no less than the following information: • Business name, DUNS number, business address, business website, business size status (i.e., SB, VOSB, SDVOSB, HUBZone SB, SDB, WOSB, LB), point of contact name, mailing address (if different from business address), phone number and email address; • Sufficient descriptive literature that unequivocally demonstrates that offered products and services meet or exceed above specifications. • At a minimum provide the following: All descriptive material necessary for the government to determine whether the service/product offered meets the technical requirements including: technical specifications, descriptive material, literature, brochures and other information, which demonstrates the capabilities of the contractor to meet the requirement. Include the amount of total RNA required for each sample. • The offeror includes documentation of technical competency of the sequencing • Provide a list of prior similar experience in Next-Gen sequencing work and contact information on at least two references that can be contacted that the contractor has provided similar services within the last two years. Name, telephone number, email address, contract number and description of services with dollar amount. • If applicable, identification of the firm's GSA Schedule contract(s) by Schedule number and SINs that are applicable to this potential requirement are also requested. • Provide information if any of these specifications are too restrictive. No response will be considered that the listed specifications are adequate in a competitive environment. • If a large business, provide if subcontracting opportunities exist for small business concerns. • Though this is not a request for quote, informational pricing must be submitted. The government is not responsible for locating or securing any information, not identified in the response. The associated North American Industry Classification System (NAICS) Code is- 541380- Testing laboratories; Small Business Size Standard is $14 million. Interested Contractors must respond with capability statements which are due in person, by postal mail or email to the point of contact listed below on or before August 21, 2012 by 13:00 hours (Central Time in Jefferson, Arkansas) at the Food and Drug Administration, OC/OA/OAGS, Attn: Nick Sartain, 3900 NCTR Road, HFT-320, Jefferson, AR 72079-9502 or email nick.sartain@fda.hhs.gov. Reference FDA1110020. Notice of Intent Responses to this sources sought announcement will assist the Government in determining whether or not any future requirement similar to this one should be set aside for small business, made available to full and open competition or procure through sole-source acquisition procedures. Disclaimer and Important Notes 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 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 pre-solicitation synopsis and solicitation may be published in FedBizOpps. However, responses to this notice will not be considered adequate responses to a solicitation. Confidentiality 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 any resultant solicitation(s).
 

Web Link

FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/FDA/NCTR/1110020/listing.html)
 

Place of Performance

Address: 3900 NCTR Road, Jefferson, Arkansas, 72079, United States

Zip Code: 72079
 

Record

SN02845902-W 20120820/120818233506-1e730acae9180ef8fca1143d237e5d7f (fbodaily.com)
 

Source

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

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