SOLICITATION NOTICE
B -- Whole-genome sequence analysis of Salmonella enterica serovars
- Notice Date
- 2/19/2009
- Notice Type
- Modification/Amendment
- NAICS
- 541380
— Testing Laboratories
- Contracting Office
- Department of Health and Human Services, Food and Drug Administration, Office of Acquisitions and Grants Services, 5630 Fishers Lane, Room 2129, Rockville, Maryland, 20857-0001
- ZIP Code
- 20857-0001
- Solicitation Number
- FDA-SOL-09-00002
- Response Due
- 2/27/2009 5:00:00 PM
- Archive Date
- 3/14/2009
- Point of Contact
- Dominique H Malone,, Phone: (301) 827-7227, Patricia M Pemberton,, Phone: 301-827-1022
- E-Mail Address
-
dominique.malone@fda.hhs.gov, patricia.pemberton@fda.hhs.gov
- Small Business Set-Aside
- N/A
- Description
- A. General Information: In accordance with FAR 15.201(e), this request is for planning purposes only, and does not constitute an Invitation for Bids, a Request for Proposals, a Solicitation, a Request for Quotes, or an indication the Government will contract for the items contained in the announcement. This is a Sources Sought regarding potential sources. The Food and Drug Administration (FDA) requires Professional Services to provide consultation, advisory and project management services to Whole-genome sequence analysis of Salmonella enterica serovars commonly associated with foodborne outbreaks from processed foods, fresh-cut produce, and poultry. The intent of this SOURCES SOUGHT announcement is to conduct market research to identify sources to support informed decisions to procure for the required services, i.e., a total small business set-aside action (e.g., SBA Certified 8(a), Service-Disabled Veteran Owned, HUBZone, Small Disadvantaged, Veteran-Owned, Women-Owned,), GSA task order, etc. Our intention is to specifically identify small businesses. This notice is a Request for Information (SOURCES SOUGHT) for all interested qualified small businesses that meet the requirements for this effort. The North American Industrial Classification System (NAICS) code is 541380 with a small business size standard of $12 million. This is not an invitation for bid, request for quote or other solicitation. B. Statement of Work Base Contract: The contractor shall: Independently, and not as an agent of the Government, furnish the necessary personnel, services, and otherwise do all things necessary for, or incident to, the performance of the work. The contractor shall provide staff (contract staff) to be trained and capable of performing the tasks as described in this contract providing quality of work. Ensuring the American public that their food supply is safe to the consumer is a paramount mission of the US Food and Drug Administration. The Center for Food Safety and Applied Nutrition, in conjunction with ORA, has the responsibility to provide the technology and methods for the analysis of foods. The emphasis of this contract is to focus on obtaining data that will reflect a broader scope of the frequency and levels of bacteriological human pathogens that have historically been associated with fresh produce commodities and a variety of ready-to-eat (RTE) foods. Since the United States government has been advocating that the American public consume more fresh produce so Americans can lead longer and healthier lives, it is incumbent on all the players in this field, from the grower, processor, transporter, and grocer to the government agencies that provide an oversight on food production, to ensure that foods are safe to consume. This should apply to produce commodities grown and processed domestically and to imported foods as well, since the United States imports much of its food supply. All commodities that enter this country should also be devoid of any biological or chemical agent that can be deleterious to health. Since the late 1990’s, there have been an average of 16 foodborne outbreaks annually attributed to fresh produce. In many cases, the source of the outbreak is unknown; however, some, such as the recent Salmonella outbreak associated with jalapeno peppers, made national and international news. Although the Food and Drug Administration in 1998 (final guidance in 2007) issued its “Guide to Minimize Microbial Food Safety Hazards for Fresh Fruits and Vegetables” (Good Agricultural Practices and Good Manufacturing Practices), the Agency has had to respond to several major produce-related outbreaks over the past few years. The potential risks, from either zoonotic or human sources, to contamination with either a viral, protozoan or bacterial human pathogen can be traced to specific commodities, locations (domestic and imports), water sources and perhaps equipment used in processing and collection. For instance, examples of contaminated commodities include leafy greens (EHEC, Salmonella), tomatoes (Salmonella), green onions (HAV, Shigella), cantaloupe (Salmonella), parsley, cilantro, culantro (Salmonella, Shigella). In order to better understand how pervasive microbial pathogens are in fresh produce commodities the objective of this contract is to analyze selected foods for the presence of Salmonella, Shigella, and Escherichia coli O157:H7. As for RTE foods, our focus will be on Listeria monocytogenes. Our plans include the generation of a database for these select produce as to the frequency of isolation/detection of the aforementioned pathogens in each commodity as it relates to its geographical location and growing season. The impact of such data collection could have an affect on any Produce Safety Regulatory Options Developed by FDA with the following parameters: Consistent across the U.S., based on sound science, overarching (most commonly consumed fresh produce), accommodate specifics (commodity, region, operations, practices, size of establishment), and allow the U.S. to meet its obligations under WTO SPS. All data collected as part of this contract will be evaluated for potential posting at www.FoodRisk.org is an online information resource providing data, tools, and resources for risk analysis professionals. The site is hosted by the Joint Institute for Food Safety and Applied Nutrition (JIFSAN) which is a partnership between FDA and the University of Maryland. FoodRisk.org has agreed to host the formatted data and make it available through the website. Having the data of this study from surveying environmental and food samples in regard to the presence of Listeria monocytogenes in RTEs, purchased from supermarkets data accessible through JIFSAN will help FDA and others refine existing food safety risk assessment models, build improved models, and develop appropriate consumer education and outreach campaigns. FDA supports the need to reformat the data and make it widely available through the internet. C. Project Background: The US Food and Drug Administration and The Center for Food Safety and Applied Nutrition’s (CFSAN) mission is to promote and protect the public’s health by ensuring that the nation’s food supply is safe, wholesome, sanitary, and labeled in earnest. Ensuring the American public that their food supply is safe to consumers is a paramount mission of the US Food and Drug Administration. The Center for Food Safety and Applied Nutrition, in conjunction with ORA, has the responsibility to develop, apply, and provide the necessary technology and methods for the effective screening, detection, and identification of foodborne pathogens from foods. This analysis often requires the application of facile molecular genetic methods in order to allow for a rapid and highly accurate genetic trace back of a foodborne pathogen to a particular food source, pathogen cluster, or locale. Such techniques often rely heavily on the genetic information provided from the genome-wide sequence analysis of these strains. That is, the use of fully sequenced genome information often provides the starting point for identifying and applying unique genetic signatures in the form of SNPs (single nucleotide substitutions) for the differentiation and clustering of closely related pathogenic strains. To this end, massive collaborative efforts are now in place between several genomic institutes which provide rapid throughput whole genome sequencing and federal and state public health laboratories which exploit the nascent sequence data to develop rapid subtyping methodologies based on SNP detection technology. As examples, several of these technologies include the Luminex SNP detection platform (Bio-Rad), Pyrosequencing (Corbett), and the IBIS T-5000 EIS-TOF SNP detection (IBIS) platforms. In recent times, numerous Salmonella serovars have been associated with a number of foodborne outbreaks in the U.S. Many of these outbreaks have come from Salmonella strains isolated from tomatoes, sprouts, cantaloupes, and derivative juices. Foodborne illness from Salmonella Newport, for example, has been associated with consumption of tomatoes cultivated on the Eastern Shore of Virginia. In 2002 (512 cases), 2005 (71 cases), and 2006 (107 cases), S. Newport was found to have sickened consumers who ingested raw tomatoes from several Eastern shore farms. The epidemiological complexity of Salmonella-induced outbreaks is manifold and includes: (i) potentially numerous natural reservoirs of Salmonella in the ecosystem, (ii) a lack of suspect isolates actually found on tomato, and (iii) a widely-dispersed area of affected individuals to name but a few aggravating circumstances. Salmonella, in general, appears to be a prominent and rising pathogen associated with produce and increased foodborne illness. In addition, Salmonella poses a substantial health risk since numerous strains appear to be resistant to at least one antibiotic with many strains displaying multi-drug resistant phenotypes. Salmonella has been shown to persist in certain niches for long periods of time. For example, recent reports have demonstrated long-term survival of S. Newport in the gut of free-living nematodes. Other studies have shown these serovars to be effective colonizers of living plant tissues that would help to account for the persistence of Salmonella on tomatoes and tomato plants. The ecological complexities of this recurrent contamination of tomato by Salmonella mandate the development of more effective and more sensitive DNA sequence-based subtyping methodologies. These methods are important for more rapid and effective responses to these Salmonella-induced foodborne outbreaks as they should provide important information about the origins of an outbreak including the produce commodity, the geographic locales, and the genetic/epidemiological lineage of the Salmonella involved. This project is intended to provide CFSAN with a detailed nucleotide-sequence based survey of the complete genomic structure of a significant number of those current and specific Salmonella pathogens associated with produce-borne outbreaks of salmonellosis among the American public. Outbreaks due to the contamination of produce have received a heightened interest from the American public, public health agencies, and regulatory bodies. The first task order that will be issued will provide significant data on the specific DNA sequence-based genetic structures of several of the most common Salmonella strains to associated with human illness caused by the consumption of fresh produce. These data will facilitate the design of specific diagnostic tests for effective detection, identification, and differentiation of foodborne outbreak strains of Salmonella. That is, the full-length genomic data harvested from this project will allow for the identification of effective nucleic-acid based targets for uniquely and unambiguously identifying a specific strain or serovar of Salmonella. All data generated, including all of the raw nucleotide sequence files generated will be sent to the project officer and encompass a comprehensive genomic database of Salmonella pathogens within CFSAN that are commonly associated with foodborne outbreaks originating from fresh-cut produce and undercooked poultry and eggs. D. Contract period of performance The period of performance for the base year of this contract will be on or about June 1, 2009 thorough July 31, 2010. This contract will have a base year and four option years. E. Procurement/Contract Strategy: It is anticipated that an indefinite delivery, indefinite quantity (IDIQ) contract will be awarded. The contract will have a period of performance of 1 base year with 4 option years. This is a new requirement. The (NAICS) code is 541380 with a small business size standard of $12 million. F. Capability Statement Requirements: Interested small business potential offerors are encouraged to respond to this notice. However, be advised that generic capability statements are not sufficient for effective evaluation of respondents’ capacity and capability to perform the specific work as required. Responses must directly demonstrate the company’s capability, experience, and/or ability to marshal resources to effectively and efficiently perform each of the tasks described above at a sufficient level of detail to allow definitive numerical evaluation; and evidence that the contractor can satisfy the minimum requirements listed above while in compliance with FAR 52.219-14 (“Limitations on Subcontracting”). Failure to definitively address each of these factors will result in a finding that respondent lacks capability to perform the work. Respondents must address their capability, experience and knowledge directly correlated to the Statement of Work. Interested offerors should submit their capability statement not exceeding fifteen (15) pages in length, excluding standard brochures. SUBMISSIONS ARE DUE on or before 5:00pm, Eastern Time, February 27, 2009. The capabilities response shall be e-mailed to: Dominique.Malone@fda.hhs.gov. Responses to the notice will not be returned. Information provided in response to this notice will be used to assess alternatives available for determining how to proceed in the acquisition process. G. Additional Requirements/ Instructions for Submitting SOURCES SOUGHT Responses to FDA: 1.Company name, mailing address, e-mail address, telephone and FAX numbers, website address (if available), and the name, telephone number, and e-mail address of a point of contact having the authority and knowledge to clarify responses with Government representatives. 2.Name, title, telephone number, and e-mail addresses of individuals who can verify the demonstrated capabilities identified in the responses. 3.Business size for 541380, size standard $12 mil and status, if qualified as an 8(a) firm (must be certified by SBA), Small Disadvantaged Business (must be certified by SBA), Woman-Owned Small Business, HUBZone firm (must be certified by SBA), and/or Service-Disabled Veteran-Owned Small Business (must be listed in the VetBiz Vendor Information Pages). 4.DUNS number, CAGE Code, Tax Identification Number, and company structure (Corporation, LLC, partnership, joint venture, etc.). Companies also must be registered in the Central Contractor Registry (CCR, at www.ccr.gov) to be considered as potential sources. 5.Identification of the firm's GSA Schedule contract(s) by Schedule number and contract number and SINs that are applicable to this potential requirement are also requested. 6.If the company has a Government approved accounting system, please identify the agency that approved the system. Please submit copies of any documentation such as letters or certificates to in Teaming arrangements are acceptable, and the information required above on the company responding to this announcement, should also be provided for each entity expected to be teammates of the respondent for performance of this work. To the maximum extent possible, please submit non-proprietary information. Any proprietary information submitted should be identified as such and will be properly protected from disclosure. This notice is for planning purposes only, and does not constitute an Invitation for Bids, a Request for Proposals, a Solicitation, a Request for Quotes, or an indication the Government will contract for the items contained in this announcement. This request is not to be construed as a commitment on the part of the Government to award a contract, nor does the Government intend to pay for any information submitted as a result of this request. The Government will not reimburse respondents for any cost associated with submission of the information being requested or reimburse expenses incurred to interested parties for responses to this announcement. a.Responses to this notice must be received by the Contract Specialist, Dominique.Malone@fda.hhs.gov on or before 5:00pm, Eastern Time, February 27, 2009 b.Responses to this announcement will not be returned, nor will there be any ensuing discussions or debriefings of any responses. However, information obtained as a result of this announcement may be reflected in the subsequent solicitation, and FDA may contact one or more respondents for clarifications and to enhance the Government’s understanding. This announcement is Government market research, and may result in revisions in both its requirements and its acquisition strategy based on industry responses. c.All transmitted information marked proprietary shall be treated as such. Therefore, businesses should identify any proprietary information in their SOURCES SOUGHT response. Proprietary materials will neither be distributed, nor discussed with, any other organization. Information submitted in response to this SOURCES SOUGHT will be used at the discretion of the Government. Further, the information submitted will remain confidential insofar as permitted by law, including the Freedom of Information and Privacy Acts. H. Other Information: The Government does not reimburse respondents for any cost associated with submission of the information being requested or reimburse expenses incurred to interested parties for responses to this announcement. Any responses received will not be used as a proposal. FDA does reserve the right to utilize any non-proprietary technical information in the anticipated SOW or solicitation. Information received will be considered solely to make informed decisions regarding a potential procurement. Responses to the SOURCES SOUGHT will not be returned and will not be accepted after the due date. All communications shall be by email. Respondents will not be notified of the results of the review of the responses. On behalf of the Food and Drug Administration, thank you for your interest.
- Web Link
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- Place of Performance
- Address: CPK1 RM3D039 HFS-710, 5100 Paint Branch, College Park, Maryland, 20740, United States
- Zip Code: 20740
- Zip Code: 20740
- Record
- SN01753105-W 20090221/090219220047-ed1e24caa7186b54c949ab01b556c236 (fbodaily.com)
- Source
-
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