75F401-22-SSN-I111913.pdf

THIS IS A SOURCES SOUGHT ANNOUNCEMENT, A MARKET SURVEY FOR

WRITTEN INFORMATION ONLY. THIS IS NOT A SOLICITATION

ANNOUNCEMENT FOR PROPOSALS AND NO CONTRACT WILL BE AWARDED

FROM THIS ANNOUNCEMENT. NO REIMBURSEMENT WILL BE MADE FOR

ANY COSTS ASSOCIATED WITH PROVIDING INFORMATION IN RESPONSE TO

THIS ANNOUNCEMENT OR ANY FOLLOW-UP INFORMATION REQUESTS. NO

TELEPHONE CALLS WILL BE ACCEPTED REQUESTING AN RFQ PACKAGE OR

SOLICITATION. THERE IS NO RFQ PACKAGE OR SOLICITATION. IN ORDER TO

PROTECT THE PROCUREMENT INTEGRITY OF ANY FUTURE PROCUREMENT,

IF ANY, THAT MAY ARISE FROM THIS ANNOUNCEMENT, INFORMATION

REGARDING THE TECHNICAL POINT OF CONTACT WILL NOT BE GIVEN AND

NO APPOINTMENTS FOR PRESENTATIONS WILL BE MADE.

The U.S. Food and Drug Administration (FDA), Office of Acquisitions and Grants Services (OAGS) issues this Sources Sought announcement on behalf of the National Center for Toxicological Research (NCTR)’s Division of Neurotoxicology in order to determine if there are existing small business sources capable of providing a JESS Simple-Western or equal instrument for use in its studies, plus a one-year post-warranty “Silver Service” or equal maintenance plan.

If your firm is considered a small business source under North American Industry Classification System (NAICS) 334516 – Analytical Laboratory Instrument Manufacturing; with a Small Business Size Standard of 1,000 employees, and you believe that your firm would be able to provide the FDA with the system described below, please submit an email to suzanne.martella@fda.hhs.gov. The vendor shall include information about the company and demonstrate that it can meet all of the minimum performance requirements.

Background: The US FDA, NCTR’s Division of Neurotoxicology is currently working on quantitative analyses of protein samples extracted from various sources including postmortem human brains, monkey brains, rat brains, mouse brains, and zebrafish embryos. The purpose of these studies is to determine protein level changes of specific signaling proteins caused by neurotoxicity and/or neurodegeneration, leading to a better understanding of molecular mechanisms underlying neurotoxicity and neurodegeneration. Because signaling proteins are usually low abundant compared to structural proteins, we need an instrument that could quantify protein at the lowest level possible.

In addition, brain samples from humans (Alzheimer’s disease and age-matched controls) and monkeys are precious and should be maximally utilized with smallest loading volume possible, so that more target proteins in each brain sample could be examined. To our knowledge, only Simple-Western systems have the lowest detection sensitivity (in picogram range) and lowest loading volume (3 µL) on the market. To perform these studies, the laboratory currently utilizes a WES Simple-Western instrument which can run 24 lanes in a single experiment. However, to quantify protein amount, a reference protein such as beta-actin from each tissue sample needs to be used to run in parallel in order to normalize the target protein. Because the Simple-Western systems are super-sensitive, the parallel run of a reference protein could add a variable error source as the lab has observed. Therefore, mailto:suzanne.martella@fda.hhs.gov the lab is looking for an instrument that can detect chemiluminescence and fluorescence, one for the reference and one for the target protein, simultaneously within the same lane to avoid lane-to-lane variations. The FDA has identified an instrument that meets its requirements: the Jess Simple-Western or equal instrument.

This Sources Sought is for a Brand Name or Equal solution. Proposed equal needs to meet all the Technical Requirements listed below to be deemed technically acceptable.

Instrument Technical Requirements:

1. The system shall be able to run simple western blot assays, as well as fluorescence (NIR and IR), chemiluminescence, and protein normalization assays. The protein sample required for assays shall be between 0.3–1.2 μg for total protein; 0.6–1.2 μg for chemiluminescence; 2–4 μg for fluorescence; and 0.6–3.6 μg for protein normalization.

2. The molecular weight ladder of sample proteins shall range between 2 – 400 kDa.

3. System shall be capable of completing two immunoassays at the same time (RePlex capabilities).

4. Sample loading volume per well shall be 3 μL.

5. Capable of running no less than 12 samples per run or more than 25 samples per run.

6. Assay runtimes shall not exceed 3 hours for protein specification, chemiluminescence, fluorescence specification; or 4 hours for protein normalization assays.

7. Intra-assay variation shall not vary more than 15% for total protein, chemiluminescence, and fluorescence assay and 20% for protein normalization. Inter-assay variation should 20% for any assays. Quantitation variation shall not exceed 20% for any assays.

8. Instrument shall be covered by a standard 12-month manufacturer’s warranty

9. The vendor shall be capable of accepting the following pre-owned equipment as a trade-in on the purchase of the new equipment:

• Manufacturer: ProteinSimple, a Bio-Techne brand

• Instrument: Simple Western system

• Model: WES

• Serial Number: WS-2383

Post Warranty Maintenance Agreement Requirements (“Silver Service” or equal plan):

1. The Contractor shall provide unlimited service for the instrument at a depot repair facility;

plan shall include all labor and materials required for repairs, plus all costs for shipping/packaging to and from factory.

2. Plan shall include one annual PM performed at a depot facility, to include all parts and supplies, labor and materials required for servicing, plus all costs for shipping to and from factory

3. The Contractor shall provide access to the Original Equipment Manufacturer (OEM) technical developments, repair procedure bulletins, hardware and software application updates and revisions.

4. The maintenance and/or repair activities shall be performed by formally trained and certified technicians/engineers. All repairs and PM services shall be performed following Original Equipment Manufacturer (OEM) specifications, manuals, and service bulletins, using OEM replacement parts, components, subassemblies, etc.

5. The Contractor shall include unlimited priority access to software and firmware updates during the coverage period(s).

6. The Contractor shall provide unlimited technical support Mondays - Fridays (excluding Federal Holidays) between the hours of 8:00 AM - 5:00 PM Central Time and shall begin working on a solution to the problem within 8 business hours of contact for assistance. (e.g., telephone-based, email-based, website-based, etc.)

Deliverables: Service Records and Reports: The Contractor shall, commensurate with the completion of each preventive maintenance service visit, provide the end-user of the equipment with a copy of a field service report/ticket identifying the equipment name, manufacturer, model number, and serial number of the equipment being serviced, a detailed description of the work performed, the test instruments or other equipment used to perform the service, the name(s) and contact information of the technician who performed the service, and for information purposes, the on-site hours expended, and parts/components replaced. In addition, the Contractor shall provide a written report to the FDA COR and Contract Specialist, summarizing all maintenance activities (including warranty work) each time service is performed.

Delivery/Period(s) of Performance:

Expected delivery for the equipment is within 30 days of contract award. There is no requirement for installation or training.

Period of performance for the optional year of post-warranty maintenance is estimated as:

(Warranty Period: 07/29/2022 – 07/28/2023) Option Year 1: 07/29/2023 – 07/28/2024

Place of Delivery/Performance

US FDA/NCTR

3900 NCTR Rd.

BLDG 53, Room 216 Jefferson AR 72079

Responses to this Sources Sought shall unequivocally demonstrate that the respondent is regularly engaged in the sale of same or substantially similar service. Though the target audience is small business vendors or small businesses capable of supplying a U.S. product/service of a small business vendor or producer, all interested parties may respond. At a minimum, responses shall include the following:

• Business name and bio, UEI 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 again if responding to provide a service offered by another firm.

• Past Performance (within the last 3 years) information for the sale of same or substantially similar product/service to include date of sale, description, dollar value, client name, client address, client 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 UEI number and size status) if not the respondent.

• Descriptive literature, brochures, marketing material, etc. detailing the nature of the service the responding firm is regularly engaged in manufacturing or selling.

• The offeror shall furnish sufficient technical information necessary for the Government to conclusively determine that the offered products/services meet the technical requirements identified above.

• If applicable, identification of the firm's GSA Schedule contract(s) by Schedule number and SINs that are applicable to this potential requirement are also requested.

• If applicable, identification of Best in Class (BIC) contract information or other Government-wide or HHS-wide contracts that the equipment/service is available on.

• If a large business, provide whether subcontracting opportunities exist for small business concerns.

• Standard commercial warranty and payment terms.

• Provide place of product manufacture or service performance and any other applicable information to enable review and analysis pertaining to the Buy American statute and requirements relating to Made in America in the event a nonavailability waiver request through the MIAO Digital Waiver Portal is needed.

• Though this is not a request for quote, informational pricing for the equipment/service would be helpful for market research purposes.

The Government is not responsible for locating or securing any information, not identified in the response.

Interested Contractors must respond with capability statements which are to be submitted by email only to the point of contact listed below on or before 2:30 pm (Central Time in Jefferson AR) on May 31, 2022 to Suzanne Martella at email suzanne.martella@fda.hhs.gov. Reference: 75F401-22-

SSN-111913.

Disclaimer and Important Notes

This notice does not obligate the Government to award a contract or otherwise pay for the mailto:suzanne.martella@fda.hhs.gov 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 SAM.gov – Contracting Opportunities. However, responses to this notice will not be considered adequate responses to a solicitation.

Confidentiality and Proprietary Information

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).

Additional Notes:

If the stated requirements appear restrictive, please submit comments detailing the concern. Though this is not a request for quote, informational pricing for the service would be helpful.