SOURCES SOUGHT
B -- Egg Baseline Study
- Notice Date
- 10/26/2015
- 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 - Rockville, 5630 Fishers Lane, Room 2129, Rockville, Maryland, 20857-0001, United States
- ZIP Code
- 20857-0001
- Solicitation Number
- FDA-SS-1158324
- Archive Date
- 12/2/2015
- Point of Contact
- Lisa K. Yaw, Phone: 240-402-4018, Sean Wybenga, Phone: 240-402-7629
- E-Mail Address
-
lisa.yaw@fda.hhs.gov, sean.wybenga@fda.hhs.gov
(lisa.yaw@fda.hhs.gov, sean.wybenga@fda.hhs.gov)
- Small Business Set-Aside
- N/A
- Description
- SMALL BUSINESS SOURCES SOUGHT NOTICE Egg Baseline Study: A Survey on the Incidence of Salmonellae in Eggs NOTE: This is a Small Business Sources Sought notice. 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, which is 541380, Testing Laboratories, which has an associated Small Business size standard of $15 Million. Your responses to the 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 the applicable NAICS code should not submit a response to this notice. 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 it submits. After a review of the responses received, a pre-solicitation synopsis and solicitation may be published in Federal Business Opportunities. However, responses to this notice will not be considered adequate responses to a solicitation. 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). Background The primary microbiological concern in shell-eggs is contamination with Salmonella Entertidis (SE) and the potential human illness that results from consumption of contaminated eggs. Despite SE being the primary concern, other serovars have become an increasing concern. The United States Food and Drug Administration (FDA) regulates shell-eggs under the Egg Safety Rule (21 CFR 118). This regulation requires various SE prevention measures and testing requirements aimed at eliminating SE in the egg production environment and keeping contaminated eggs from human consumption channels. One component required to measure performance of the egg safety rule is an accurate, up to date, measure of the incidence of SE in eggs. Given the increasing concern with other serovars, an accurate incidence rate for all salmonellae would also be extremely beneficial. The currently accepted rate for SE positive eggs is 1 in 20,000. This rate is far outdated and numerous parties question the validity of this rate, particularly as it relates to the current production environments. Much change has occurred in the management practices, strain of birds, and layer house types used for production since the currently accepted rate was established. There is a clear need to determine what the true incidence rate is. In addition to SE, there are over 2,500 serovars of salmonella, all of which are human pathogens. The presence of any salmonella in an egg would be considered an adulterant under the Food, Drug and Cosmetic Act. There is a pronounced lack of data on the incidence rate of all salmonellae in eggs, most data, although outdated, has been concentrated on SE. This type of data is necessary for inclusion in future risk assessments, for consideration of any potential future expansion of the egg safety rule, for other agencies (such as CDC) to update their attrition models and to the industry itself to help identify serovars of future concern before they become major public health issues. Data on the incidence rate of all salmonellae, along with data on SE specifically would also serve the Health and Human Services (HHS) to achieve the HHS Priority Goal of reducing foodborne pathogens in the population. HHS has set a goal of reducing SE associated illness from the 2007-09 baseline levels of 2.6 cases/100,000 population to 1.9 cases/100,000 population by December 31, 2015. Completion of this egg baseline study will represent a major benefit to multiple entities. Objectives To determine the true incident rate of SE and other serovars in eggs by: • Collecting egg samples at egg production farms; • Analyzing egg samples collected to determine the presence of Salmonella and other SE's in accordance with the FDA Bacteriological Analytical Manual (BAM). Scope The egg baseline study will involve collection of egg samples across the country from multiple egg producers registered in the Shell Egg Producer Registration Module (SEPRM). Registration in SEPRM is required for any producer selling eggs to the table egg market with 3,000 or greater laying hens at a specific farm. Egg samples will be collected at egg production farms of all sizes, small and large. All productions systems will be included in the study, including but not limited to traditional caged production, cage-free production, organic and non-organic production. Subsequent to collection, egg samples will be analyzed for the presence of all salmonella, in accordance with methodology outlined in FDA Bacteriological Analytical Manual (BAM, Chapter 5: Salmonella). The resulting data will be analyzed with the end goal of determining the incidence rate of all salmonella in eggs, in addition to the incidence of SE in eggs.. Task Areas: 1. The Contractor shall develop, in conjunction with the COR, a detailed sampling scheme/schedule and conduct the physical collection of 3,000 composite samples of 20 eggs each from layer houses (pre-processing) of 200 farms. The Contractor shall strictly adhere to FDA biosecurity policies during sample collections, including a complete change of personal protective equipment between layer houses. 2. The Contractor shall coordinate shipment of samples to the analyzing laboratory and conduct a microbiological assessment for the presence of all salmonella serovars in accordance with methodology cited in FDA egg safety rule (21 CFR 118.8(b)). 3. The Contractor shall analyze the data to report the incidence rate of all salmonella in eggs, in addition to reporting the specific incidence rate of SE in eggs. 4. The Contractor shall assemble a detailed report on relevant findings, including a breakdown of the overall incidence of salmonella in eggs in addition to the incidence rate of SE, a breakdown of the incidence rate by geographic region, by season of the year, by size of producer, and by type of production system. ANTICIPATED PERIOD OF PERFORMANCE One (1) year from the effective date of contract. OTHER IMPORTANT CONSIDERATIONS Lead Researcher Qualifications: The candidate must have a PhD and a minimum of five (5) years working experience in the areas of experimental design/development, sample collection, and microbiological analysis of samples. They must have extensive knowledge of egg industry and have specific knowledge of the production practices of various types of egg production facilities. They must have experience in the biosecurity practices common to the egg production industry, experience in coordination, execution, and management of large scale scientific studies. They must have extensive knowledge on the specific microbiological protocols used for isolation, identification, and serotyping of salmonellae in various food samples. Place of Performance: Egg sample collection will take place at multiple farm locations across the United States. Analysis of the samples will occur at the Contractor's designated laboratory. The contractor shall be responsible for providing its own functioning laboratory facility. Pricing and Payment: This requirement is anticipated to be a firm-fixed-price order, inclusive of all costs, such as labor, materials, shipping, and travel costs, with firm-fixed-price payment upon completion of specified deliverables. CAPABILITY STATEMENT/INFORMATION SOUGHT The FDA is requesting interested qualified small businesses to provide a capability statement showing their ability and willingness to complete this requirement electronically to Lisa Yaw at Lisa.Yaw@fda.hhs.gov in a commonly used format, such as Microsoft Word or pdf. This capability statement shall be no more than five pages, excluding a cover page and table of contents, and shall include examples of successfully completing relevant similar work, including a description of the similar work and client contact information. The FDA will be determining capability based on the ability to perform the tasks delineated above. Interested eligible small businesses shall also include company information to determine eligibility, including their contact information, Dun and Bradstreet (DUNS) number and size and business type (e.g. 8(a), HUBZone, etc.) based on the applicable NAICS code for the proposed acquisition 541380, Testing Laboratories which has an associated Small Business size standard of $15 Million. Entities have until 2 pm ET, Wednesday, November 17, 2015 to respond to the FDA.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/FDA/DCASC/FDA-SS-1158324/listing.html)
- Record
- SN03930055-W 20151028/151026233946-ed88ca948592143917e84044044def76 (fbodaily.com)
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