SOURCES SOUGHT
B -- mRNA Sequencing
- Notice Date
- 6/29/2015
- Notice Type
- Sources Sought
- NAICS
- 541690
— Other Scientific and Technical Consulting Services
- Contracting Office
- Department of Health and Human Services, Food and Drug Administration, Office of Acquisitions and Grants Services, 3900 NCTR Road, HFT-320, Bldg 50 | Rm 421, Jefferson, Arkansas, 72079, United States
- ZIP Code
- 72079
- Solicitation Number
- FDA1151695
- Archive Date
- 7/21/2015
- 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 Center for Biologics Evaluation and Research (CBER) requirement for ribosomal profiling analyses services. The FDA is seeking small business sources to determine the availability and capability of small businesses capable of providing the required services. Other than small business concerns are also encouraged to submit capability statements. The following information is provided to assist the FDA in conducting Market Research to identify potential contractors for this effort: The associated North American Industry Classification System (NAICS) Code is-541690- Other Scientific and Technical Consulting Services; Small Business Size Standard is $15 million. Part I: General Information A. Introduction The Center for Biologics Evaluation and Research requires series of ribosomal profiling analyses in order to characterize the distribution of ribosomes along messenger RNA (mRNA). The Government will provide samples that are prepared from cultured cells expressing the target protein, coagulation factor IX and coagulation regulator a disintegrin and metalloproteinase with a thrombospondin type 1 motif, member 13 (ADAMTS13). These analyses will allow the Government to assess the translational activities along mRNA and compare among various genetic variants/mutants of these proteins. B. Background The Laboratory of Hemostasis (LH), within the Division of Hematology at the Center for Biologics Evaluation and Research has been investigating the effect of genetic variations on the functionality of factor IX and ADAMTS13. LH conducts experimental life-science/biomedical research on various proteins involved in blood coagulation. One essential component of such research is the investigation of genetic variations in coagulation factor IX and coagulation regulator ADAMTS13 genes, and their effects on protein function. LH have generated a panel of gene sequences and expressed selected variants/mutants as recombinant proteins. Especially for the synonymous variants/mutants, information regarding the translational activities in the cells expressing these genes could be essential in explaining observed differences in protein levels. This information can be obtained by characterizing the distribution of ribosomes along the mRNA using ribosome profiling. This method would provide LH with sequences for short mRNA fragments, unbounded to the ribosomal protein complex. By using powerful data analysis algorithms, these sequences would be annotated and aligned, allowing for the identification of mRNA regions bound to the translational machinery (i.e. actively translated mRNA regions). Synonymous variants/mutants are commonly seen in therapeutic proteins. The purpose of this contract is to determine whether these synonymous mutations alter the distribution of ribosomes along the mRNA. C. Scope To reliably characterize the distribution of ribosomes along mRNA of coagulation factors, such as factor IX and ADAMTS13, using ribosome profiling technology. Part II: Work Requirements A. Technical Requirements • Contractor shall have the capability of, and perform sequencing with the following conditions using HiSeq2500 system: o 1x50 bp single read o "rapid run" mode o loading 6 samples (6 libraries) per lane using 2- lane flowcell • Shall perform ribosomal profiling sequencing and primary data processing for 132 library samples (correspond to 22 variants) furnished by the government. The Government will provide 14 variants (84 samples) of coagulation factor IX and 8 variants (48 samples) of coagulation regulator ADAMTS13. • The Government will provide the samples within 60 calendar days after contract award. Government will provide a minimum10nM in ≥15 uL EB buffer for each sample. B. Deliverables Electronic Dataset of the results of characterization analyses for 132 samples. FastQ file. Electronic Dataset shall include a report in Word format describing the most important findings, a presentation in Power Point visually presenting the results, and an Excel file with the row data. Supportive material may be delivered in TIF or PDF format. B. Place of Performance Work shall take place at the Contractor's facility. Deliver to: Attn: to be complete at time of award. FDA CBER 10903 New Hampshire Ave. WO52/72 - 4144 (Lab) Silver Spring, MD 20993-0002 C. Period of Performance Delivery shall be within 30 calendar days of receipt of government furnished samples. FOB Point destination. All items shall include delivery to the destination identified herein. The offeror shall furnish sufficient technical information necessary for the Government to conclusively determine that the offered products/services and components meet the technical requirements identified above. Though the target audience is small business manufacturers or small businesses capable of supplying a U.S. made product of a small business manufacturer or producer all interested parties may respond. At a minimum, responses shall include the following: • 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 (Provide this same information if responding to provide a product manufactured by another firm); • Sufficient descriptive literature that unequivocally demonstrates that offered services can meet the above requirements. 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. • Three (3) years of past performance information for the manufacture and/or sale in which the offeror has provided same or substantially similar service solutions and used for same or near-same applications as set forth herein. For each past performance reference include the date of sale, description, dollar value, client name, client address, client point of contact name, client point of contact mailing address (if different from that provided for client), client point of contact phone number, client point of contact email address, and name of the manufacturer (to include DUNS number and size status) if not the respondent. • If applicable, identification of the firm's GSA Schedule contract(s) by Schedule number and SINs that are applicable to this potential requirement. • 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, identify the subcontracting opportunities that would exist for small business concerns; • Standard commercial warranty and payment terms; and • Though this is not a request for quote, informational pricing is encouraged. The government is not responsible for locating or securing any information, not identified in the response. The Government encourages any comments and/or suggestions from any interested party, regarding the specifications. While the Government will not respond directly to your comments and/or suggestions; we will consider them as we finalize the specifications in preparation for the forthcoming solicitation. Interested Parties shall respond with capability statements which are due in person, by postal mail or email to the point of contact listed below on or before July 6, 2015 by 13:00 hours (Central Time in Jefferson, Arkansas) to nick.sartain@fda.hhs.gov, or mail to the Food and Drug Administration, OO/OFBA/OAGS/DAP, Attn: Nick Sartain, 3900 NCTR Road, Building 50, Room 422, Jefferson, AR 72079-9502. Reference FDA1151695. 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/FDA1151695/listing.html)
- Place of Performance
- Address: 10903 New Hampshire Ave., Silver Spring, Maryland, 20993, United States
- Zip Code: 20993
- Zip Code: 20993
- Record
- SN03778993-W 20150701/150629234346-c7776be05162c31bf71f43ec49dc927a (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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