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FBO DAILY ISSUE OF MARCH 03, 2012 FBO #3752
SOURCES SOUGHT

65 -- DNA Methylation Microarrays, Labeling and Hybridization Reagents

Notice Date

3/1/2012
 

Notice Type

Sources Sought
 

NAICS

325413 — In-Vitro Diagnostic Substance 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

FDA1100668
 

Archive Date

3/29/2012
 

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 DNA Methylation Microarrays, Labeling and Hybridization Reagents. 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 providing the supplies/services contained herein. Rat DNA methylation microarrays for 90 samples (1 x 3 inch glass slides in a kit) with accompanying enzyme labeling and hybridization reagents and array processing accessories. The Center for Functional Genomics requires rat DNA methylation microarrays and reagents for high quality and sensitive detection of DNA methylation changes to meet the research projects and protocols needs of the Center. The project is for genetic and epigenetic mechanisms for sex differences in the kidney of a rat model system: developing safety biomarkers for FDA regulated products. This study requires that data obtained by microarrays be of highest quality to determine DNA methylation changes in the kidney of a rat model over the 2 year period to assist the FDA in evaluating drug research. Various sex differences in renal disease, renal disease progression, and susceptibility to acute renal failure following surgery have been noted, including age of onset and severity. There is an urgent and unmet need for mechanistic insight to understand and address these sex differences in clinical renal injury and any potential interaction of age with sex. Understanding these differences will aid in the development of biomarkers and therapeutic interventions, as well as identify potential safety issues. Sex- and age-associated differences in gene expression patterns, as well as expression regulatory elements such as microRNA and DNA methylation, will be examined in the kidney in both sexes throughout the life cycle in the rat model system. The arrays with enzyme labeling hybridization reagents, array processing and accessories must meet the following requirements: • The DNA methylation microarrays must contain at least 385,000 unique probes in order to provide comprehensive coverage throughout the rat genome. • These DNA methylation microarrays must have high sensitivity and specificity in order to readily detect as low as two methylated CpGs in a 500 base pair (bp) fragment. • The DNA methylation array reagents must allow low sample input of 10 ng (nanogram) or less genomic DNA per labeling reaction without amplification bias. • The microarray reagents must utilize a dye source for direct labeling method and hybridization for optimal microarray performance. • These arrays must be compatible with the Government's existing G2505C Agilent microarray scanner and the Government's long-term experience with the glass-slide based microarray format. The slides must fit a 1"x3" glass slide format for fluorescent image scanning with barcode labels. • The manufacturer must provide quality kits for the conduct of these experiments and, in addition, provide detailed experimental protocols 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 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. Indicate whether the organization is the manufacturer of the items or authorized reseller. If reseller, include the manufacturer's name, address and DUNS number. • 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 or brand specific. 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- 325413- In-Vitro Diagnostic Substance Manufacturing; Small Business Size Standard is 500 employees. 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 March 14, 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 FDA1100668. 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, seek a SBA non-manufacturer rule waiver or procure through sole-source acquisitions 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/FDA1100668/listing.html)
 

Place of Performance

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

Zip Code: 72079
 

Record

SN02686748-W 20120303/120301234856-1180c9358c1ee0dd44fe7d7a3afbbab8 (fbodaily.com)
 

Source

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

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