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FBO DAILY ISSUE OF AUGUST 28, 2009 FBO #2834
SOURCES SOUGHT

A -- NHLBI DNA Resequencing and Genotyping Service - Laboratory Center

Notice Date
8/26/2009
 
Notice Type
Sources Sought
 
NAICS
541712 — Research and Development in the Physical, Engineering, and Life Sciences (except Biotechnology)
 
Contracting Office
Department of Health and Human Services, National Institutes of Health, National Heart, Lung and Blood Institute, NIAMS, Bethesda, MD, Office of Acquisitions, 6701 Rockledge Dr RKL2/6100 MSC 7902, Bethesda, Maryland, 20892-7902
 
ZIP Code
20892-7902
 
Solicitation Number
HHS-NIH-NHLBI-SBSS-HV-10-22
 
Archive Date
9/25/2009
 
Point of Contact
Kimberly Goodwin, Phone: 3014350334
 
E-Mail Address
goodwink2@nhlbi.nih.gov
(goodwink2@nhlbi.nih.gov)
 
Small Business Set-Aside
N/A
 
Description
Introduction This is a posting of a Small Business Sources Sought Notice to clarify the capabilities of interested small businesses. This is NOT a solicitation for proposals, proposal abstracts, or quotations. The purpose of this notice is to obtain information regarding: (1) the availability and capability of qualified small business sources; (2) whether they are small businesses, HUBZone small businesses; service-disabled, veteran-owned small businesses; 8(a) small businesses; veteran-owned small businesses; woman-owned small businesses; or small disadvantaged businesses; and (3) their size classification relative to the North American Industry Classification System (NAICS) code for the proposed acquisition. Your response to this information requested will assist the Government in determining the appropriate acquisition method, including whether a set-aside is possible. An organization that is not considered a small business under NAICS code 541712 should not submit a response to this notice. Background The NHLBI is seeking a small business with the ability to serve as a Laboratory Center (LC) for a renewal of a five-year program, NHLBI DNA Resequencing and Genotyping (RS&G) Service. The purpose of this renewal is to continue to provide high quality, high-volume resequencing and genotyping for investigators to discover and type DNA variations needed to elucidate the genetic components involved in the cause, variable outcome and progression of heart, lung, and blood diseases and disorders. The RS&G Service will consist of two to five Laboratory Centers capable of performing both massively high throughput, large-scale DNA resequencing and high throughput genotyping for heart, lung, and blood investigators; and one Administrative Coordinating Center (ACC) to provide the logistical support for the entire RS&G Service. Project Requirements Each LC will provide resequencing and genotyping to investigators involved in heart, lung, and blood research approved to use the RS&G Service. The LC will need to be able to accommodate a variety of project sizes. The projects will focus on the genomic regions of potential importance in the disease pathways of heart, lung, and blood disorders. Specific research is dependent upon the requests from investigators. The LC should expect to receive applications for resequencing candidate genes and regions, and for custom genotyping and genotyping using specialized chips for disease specific questions (vascular disease, lung disease, etc). In addition, they will be expected to provide support for some animal projects and to incorporate technological advances in resequencing and genotyping as appropriate. During the entire period of performance, the LC will: (1) provide personnel with expertise and experience in massively parallel DNA resequencing, high throughput genotyping, database management, informatics, general laboratory management, and quality control (QC - used here and throughout encompassing quality assurance and quality control activities); (2) on an annual basis, propose a Performance Assessment Scheme (PAS) for the upcoming period and submit information for evaluation of performance under the applicable PAS to include production, QC for laboratory method, databases, informatics, turn-around times, amount of data submitted to public databases, and increases in production and decreases in cost; (3) provide materials and information promptly and communicate with the ACC frequently and regularly; (4) attend and contribute to Steering Committee meetings (twice a year), monthly conference calls, and subcommittee meetings or conference calls; (5) attend Oversight Committee meetings, provide requested information in a timely manner, facilitate Oversight Committee activities, and respond to comments and suggestions of Oversight Committee; (6) provide in a timely manner technical input to the NHLBI regarding projects submitted for use of the RS&G Service including possible approaches to accommodate varying project designs and to overcome potential complications; (7) communicate frequently and regularly with NHLBI regarding LC activities including any concerns or barriers to performance and work to develop and implement prompt solutions; and (8) assist the ACC as needed to inform the research community of the availability of the RS&G Service, in addition to contributing ideas and information for the RS&G Service website. During the Transition Period/Start-up and Early Production (up to 3 months), the LC will: (1) perform tasks 1-8 from the above list; (2) produce a laboratory-specific detailed Manual of Operations to include production pipelines, rationale for each method/platform with strengths and weaknesses, sensitivity and accuracy, methods for optimizing and evaluating methods and platforms, sample preparation, false positive rate, problem sequences or SNPs, instrumentation and robotics, methods for incorporating technology development to increase capacity and production, informatics with methods for processing raw data, filters to remove poor-quality data, assessment of bias in procedures, procedures for data analysis, final data processing and steps to prepare the data for transmission to the investigators and to public databases, sample receipt and handling/tracking systems, sample and data security, laboratory QC procedures including methods to reduce or eliminate systematic errors, methods to reduce or eliminate errors in computational and informatics aspects, procedures for identifying and implementing corrective actions based on QC information; (3) work collaboratively with other RS&G Service LCs and the ACC to develop and implement RS&G Service-wide protocols, guidelines and procedures for the renewal period; (4) work collaboratively to prepare RS&G Service-wide and laboratory-specific materials for review by the Oversight Committee, and promptly revise materials in response to recommendations for implementation; (5) following written approval by the Contracting Officer’s Technical Representative (COTR), implement the approved laboratory-specific and RS&G Service-wide protocols and procedures for resequencing or genotyping, informatics, sample handling and tracking, QC, and data submission; (6) finalize the laboratory Manual of Operations by incorporating the RS&G Service-wide minimum quality control procedures agreed upon by the Steering Committee, recommended by the Oversight Committee, and approved by the NHLBI, in addition to revising or updating the manual as necessary only with approval from the NHLBI; (7) obtain from the Principal Investigator for each study a copy of the Institutional Review Board approval for each study referred for use of the LC prior to accepting samples for DNA resequencing or genotyping; (8) perform resequencing or genotyping of candidate genes, candidate gene regions, or important regions in DNA samples for projects assigned to the LC following recommendation by the Evaluation Panel and approval for access to the service by the NHLBI; (9) produce at least 0.1 Gb of usable sequence (number to be determined based on the technical proposal) with an error of 1 in 10,000 bases or less and at least 10 M genotypes (number to be determined based on the technical proposal) with an error of less than or equal to 1%; (10) except as explicitly authorized by the NHLBI, maintain the confidentiality of the resequencing or genotyping data; and (11) provide secure backup of all data essential to the RS&G Service, including but not limited to all resequencing or genotyping data generated, sample tracking and storage information, and QC information. During Production phase (months 4 – 36), the LC will: (1) perform tasks 1-8 from the list provided for the entire period of performance and finalize any tasks remaining from the Transition Period/Start-up and Early Production phase (months 1-3); (2) provide information and reports to the ACC in a complete and timely manner to expedite its role as facilitator for the RS&G Service committees and panels; (3) obtain from the PI for each study a copy of the Institutional Review Board approval for each study referred for use of the LC prior to accepting samples for DNA resequencing or genotyping; (4) perform resequencing or genotyping of candidate genes, candidate gene regions, or important regions in DNA samples for projects assigned to the LC following recommendation by the Evaluation Panel and approval for access to the service by the NHLBI; (5) produce at least 0.5 Gb of usable sequence (number to be determined based on the technical proposal) with an error of 1 in 10,000 bases or less and at least 60 genotypes (number to be determined based on the technical proposal) with an error of less than or equal to 1% per genotype; (6) work collaboratively to prepare RS&G Service-wide and laboratory-specific materials for review by the Oversight Committee, and promptly revise materials in response to recommendations for implementation; (7) implement recommendations from the Steering Committee and the Oversight Committee as approved by the NHLBI to maximize the RS&G Service’s effectiveness; (8) submit the Monthly Status Report electronically to the ACC summarizing overall performance of the LC including an updated table with projects assigned, current status of samples received, data provided to investigators and public databases, monthly QC data, production, error rate, problems encountered and resolution, summary of interactions/communications with investigators and ACC; (9) provide information for the RS&G Service public website as maintained by the ACC; (10) provide technical expertise to assist investigators approved and assigned to use the RS&G Service to finalize the project; (11) except as explicitly authorized by NHLBI, maintain the confidentiality of the resequencing or genotyping data; (12) provide secure backup of all data essential to the RS&G Service, including but not limited to all resequencing or genotyping data generated, sample tracking and storage information, and QC information; (13) return or destroy all DNA from investigators approved for use of the RS&G Service within 90 days of completing the project or as agreed upon by the Steering Committee and approved by the NHLBI; (14) develop and incorporate new technologies and methodological advancements for resequencing or genotyping to maintain a state-of-the-art service, reduce per unit costs, and increase production, while maintaining or improving consistently high product quality, including maintaining or improving sequence quality in accordance with RS&G Service standards and procedures; and (15) submit detailed summary materials for the Oversight Committee to review at about month 30. During the High Production phase (months 37 – 60), the LC will: (1) continue all tasks from the entire period of performance; and (2) produce resequencing or genotyping at a level double or quadruple the initial level of production and (3) provide suggested plans for close-out and implement the NHLBI approved plan for close-out of the RS&G Service. Capability Statement Small business concerns that believe they possess the capabilities necessary to undertake this study should submit complete documentation of their capabilities to the Contracting Officer. The capabilities statement should specifically address each project requirement separately. Additionally, the capability statement should include: (1) the total number of employees, (2) the professional qualifications of scientists, medical experts, and technical personnel as it relates to the above outlined requirements, (3) a description of general and specific facilities and equipment available, including computer equipment and software, (4) an outline of previous research projects that are similar to the RS&G Service project requirements in which the organization and proposed personnel have participated; and (5) any other information considered relevant to this program. The capability statement must not exceed 15 single sided or 7.5 double sided pages in length and using a 12-point font size minimum. Interested small business organizations are required to identify their size standards in accordance with the Small Business Administration. The government requests that no proprietary or confidential business data be submitted in a response to this notice. However, responses that indicate the information therein is proprietary will be properly safeguarded for Government use only. Capability statements must include the name and telephone numbers of a point of contact having authority and knowledge to discuss responses with Government representatives. Capability statements in response to this market survey that do not provide sufficient information for evaluation will be considered non-responsive. When submitting this information, please reference the solicitation notice number. All capability statements sent in response to this Sources Sought Notice must be submitted electronically (via email) to Kimberly Goodwin, Contract Specialist, at goodwink2@nhlbi.nih.gov and Deborah Applebaum-Bowden, Contracting Officer Technical Representative, at applebad@nhlbi.nih.gov in either MS Word or Adobe Portable Document Format (PDF), within 10 calendar days of the date of this announcement. All responses must be received by the specified due date and time in order to be considered. This notice does not obligate the Government to award a contract or otherwise pay for the information provided in response. No proprietary, classified, confidential, or sensitive information should be included in your 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 review of the responses received, pre-solicitation and solicitation notices may be published in Federal Business Opportunities. However, responses to this notice will not be considered adequate responses to a solicitation. The solicitation release date is pending. The Government intends to negotiate four (4) cost plus reimbursement contract for a period of five years with an approximate award date of September 30, 2010.
 
Web Link
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/NHLBI-DEMO/HHS-NIH-NHLBI-SBSS-HV-10-22/listing.html)
 
Place of Performance
Address: Department of Health and Human Services, National Institutes of Health, National Heart, Lung and Blood Institute (NHLBI), Office of Acquisitions 6701 Rockledge Dr RKL2/6016 MSC 7902, Bethesda, Maryland, 20892-7902, United States
Zip Code: 20892-7902
 
Record
SN01927597-W 20090828/090827001031-3f0b49233343b36feb5b97313abc8517 (fbodaily.com)
 
Source
FedBizOpps Link to This Notice
(may not be valid after Archive Date)

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