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This notice is issued to help determine the availability and type of qualified Small Business companies technically capable of meeting this potential government requirement and to determine the method of acquisition. It is not to be construed as a commitment by the Government to issue a solicitation or ultimately award a contract. Responses will not be considered as proposals or quotes. No award will be made as a result of this notice. The Government will NOT be responsible for any costs incurred by the respondents to this notice. The notice is strictly for research and information purposes only.
The information requested will assist the Government in determining the appropriate acquisition method including small business socio-economic set-aside possibilities and to determine the availability of qualified Small Business companies technically capable of meeting the Government's potential requirement. All Small Business companies with the capability and availability to perform the requirement under the applicable NAICS code are invited to submit a response to this notice.
The NAICS code applicable to this requirement is 334516 Analytical Laboratory Instrument Manufacturing with size standard 1000 employees.
BACKGROUND
Evaluating microbial contamination associated with medical devices is multi-faceted in the complexity of biology between the host, microorganism, and device/device-material(s) associated with infections. Evaluating the compatibility of device materials and their potential to support microbes requires intense laboratory analysis of microbial growth with multi-factorial conditions to optimize and evaluate conditions that promote pathogenic behavior. Analysis of these conditions requires evaluating samples across time points, commonly, between 12, 24, and 48 hours at a schedule of 1-3-hour intervals. Currently, the intense schedule and nature of this type of analysis prohibits proper experimentation due to a lack of necessary equipment to perform these procedures.
To evaluate microbial growth and pathogenesis, the FDA needs instrumentation that accommodates evaluating multiple growth conditions with automated measurements of cell growth under specified controlled conditions. The need of this instrument includes ongoing collaborative projects that are currently funded to review microbial growth associated to wound dressings and emerging studies by newly acquired principal investigators studying biofilms, microbial virulence, and antibiotic resistance associated to orthopedic leachables and material polymers. Cell growth is quantified by measuring turbidity via optical density (OD) of the cell medium over time at different wavelengths. The OD curve reflects the growth (increased concentration) of the organism of interest.
Currently there is one (1) temperature-controlled shaker-incubator and one (1) spectrophotometer to perform microbial cell growth and measure turbidity, but these instruments are limited to a single individual or project creating extensive lags in experiments among researchers and across multiple research projects that extend into weeks and months of delay.
Additionally, the Food and Drug Administration (FDA) does not have instrumentation that is comparable to conduct microbial growth analysis allowing multiple experimental and biological conditions, simultaneously or separately. This requirement is for the purpose of an Automated Growth Curve Analysis System that can process many samples, measuring the turbidity in each sample over time using multiple wavelengths of light to evaluate the microbial growth. The system shall be capable of programming a wide range of time and temperature with ether anaerobic or aerobic conditions. It shall be able to slow-down or inhibit growth (commonly at 4˚C) at various specified time periods. It shall also include a method to maintain sample uniformity, normally done using a shaker device
PURPOSE AND OBJECTIVE
This SBSS notice seeks to determine eligible sources capable of achieving the essential features of this potential requirement, which is to obtain an automated growth curve analysis system with the following salient characteristics.
At a minimum, the system shall have the following capabilities:
1. Allow user to create multiple growing conditions.
2. Temperature range: ~1°C (above freezing) to +50 °C (or better) in 0.1 °C steps.
3. Temperature stability +/- 0.1 degree.
4. Programmable for various sequence runs as follows:
a. various set temperatures
b. various time periods
c. various shaker periods
d. various measurement periods
5. Capable of running experiments up to 1500 hours. Allows parameters to be modified mid-run. Ability to start the system and comeback when it has completed the programed sequence or be able to modify the sequence, if needed.
6. User-controlled "sample" shaker (used to maintain uniformity of samples for measurements), the vibration from the shaker must NOT be transmitted outside the instrument to the workbench.
7. Uses "Well Plate Format" to hold samples (96 wells or greater, prefer 100 wells).
8. Accommodates ether anaerobic or aerobic conditions.
9. Uses optical density (OD) to measure the turbidity of the sample to evaluate the microbial growth. Ability to select from multiple wavelengths to optimize microorganism. measurements. Ability to program various measurement periods.
10. Protects test samples from: evaporation, condensation, and sample carry-over.
11. The system controller can be built in or external computer (prefer the use of IBM compatible computer).
12. Ability to export test results in: Text, CSV, XLS or HTML formats.
13. Preference will be given for system that can run 2 Well Plates at the same time.
14. One-year warranty, parts and labor, from date of acceptance.
NOTE: The following system specifications must be met to ensure compatibility with FDA infrastructure:
1. Power requirements: 120 VAC 60 Hz (less than 7.5 Amps)
2. Equipment Size (Dimensions) and weight:
a. Width: 30" (~75 cm)
b. Depth: 24" (~60 cm)
c. Height: 12" (~30 cm)
d. Weight: 50 pounds (20-25 kg)
CAPABILITY STATEMENTS/INFORMATION SOUGHT
Offerors submitting a response to this SBSS notice shall possess the ability to achieve the essential government features specified herein. Products offered must include those salient physical, functional, or other characteristics which are deemed essential in meeting the government's needs. Interested parties are expected to review this notice to familiarize itself with the requirements of this project. Failure to do so will be at your firm's own risk.
Respondents must provide, as part of their response: (a) product, catalog, model, and/or part number(s); (b) product description; (c) all relevant information and documentation that the item(s) offered meets the salient physical, functional, or performance characteristics as specified in this announcement; (d) quantity; (e) shipping, handling, and/or installation instructions, and/or any special delivery conditions after receipt of an order.
The respondent must also provide their DUNS number, organization name, address, point of contact, and size and type of business (e.g., 8(a), HubZone, etc.) pursuant to the applicable NAICS code and any other information that may be helpful in developing or finalizing the acquisition requirements.
The information submitted must be in outline format that addresses each of the elements of this requirement. A cover page and an executive summary may be included but is not required.
The response is limited to ten (10) pages. The 10-page limit does not include the cover page, executive summary, or references, if requested.
The response must include the respondents' technical and administrative points of contact, including names, titles, addresses, telephone and fax numbers, and e-mail addresses.
Respondents must reference the subject announcement number on all correspondence related to this SBSS notice. The response must be submitted to Yvette Brown electronically, at [email protected], and be received prior to the closing date specified in this announcement.
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 Federal Business Opportunities. 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).