75F40122Q00072_1254417_SSN.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) has issued this sources sought announcement on behalf of the Center for Biologics Evaluation and Research (CBER) in order to determine if there are existing small business sources capable of providing an automated Deoxyribonucleic acid (DNA)/ Ribonucleic acid (RNA) Extraction System with viral nucleic acid kits.

If your firm is considered a small business source under North American Industry Classification System (NAICS) Code 334516 – Analytical Laboratory Instrument Manufacturing; with a Small Business Size Standard of 1000 employees, and believe that your firm would be able to provide the FDA with the supplies/services described below, please submit an email to Yolanda.rankin@fda.hhs.gov. The vendor should include information about the company and demonstrate that it can meet all of the minimum performance requirements.

Background: The U.S. Food and Drug Administration (FDA)/Center for Biologics Evaluation and Research (CBER) has a need for an automated Deoxyribonucleic acid (DNA)/ Ribonucleic acid (RNA) Extraction System with viral nucleic acid kits. The laboratory of Molecular Virology has developed a panel of Human immunodeficiency viruses (HIV) representing all the strains detected to date. DNA sequencing is part of HIV characterization work. The CBER lab receives samples from these endemic regions, and they must be characterized before releasing into the FDA HIV-1 panel. The CBER HIV panel studies need thousands of RNA extraction from HIV-1 samples (cultured supernatant or plasma). The automatic DNA/RNA extraction system is needed to purify high-quality nucleic acid materials from thousands of supernatant and plasma samples that are collected to help the FDA mission-relevant projection for HIV-1 panel development.

Minimum Technical Requirements for an automated Deoxyribonucleic acid (DNA)/ Ribonucleic acid (RNA) Extraction System with viral nucleic acid kits:

• Shall allow for extracting both DNA/RNA from various sample types: - Protocols for the isolation of DNA and RNA from Blood, Saliva, FFPE, Cell-Free Plasma, Cells, Stool, Urine, Bacteria, viruses, Plants, and Forensic Samples.

• Shall be fully Automated Walk away DNA/RNA extraction system, no manual intervention required - including formalin-fixed, paraffin-embedded (FFPE).

• Shall have bar code scanning and laboratory information system (LIS) interfacing for full traceability of samples and kits

• Shall have real-time Mobile/App monitoring.

• Shall have ability to process from 1-16 samples per batch.

• Shall have a test volume 0.5 – 2.0 ml.

• Shall produces high-quality nucleic acid ideal for downstream use

• Shall have built-in ultra violet (UV)-Decontamination

• Shall include an uninterruptible power supply (UPS).

• Shall include a 12-month warranty, which covers the cost of repair or replacement, including labor or any defect in quality or parts.

Viral Nucleic Acid Kits Requirements:

• Shall include: Viral Nucleic Acid Extraction – 96 preps

• Shall include: Viral Nucleic Acid Extraction Kit (Low PCR Inhibition) – 96 preps

• Shall include: Viral Nucleic Acid Extraction Kit (High Sensitivity – SARS-CoV-2) – 96 preps

• Shall include: Viral Nucleic Acid Large Volume Extraction Kit (2.4ml) – 96 preps

• Shall include: Viral Nucleic Acid Large Volume Extraction Kit (1.2ml) – 96 preps

Estimated Delivery Date: 30 days after award

Delivery Location:

Food and Drug Administration Center for Biologics Evaluation and Research 10903 New Hampshire Avenue Building 72, Room 4318B Silver Spring, MD 20993

Though the target audience is small business vendors or small businesses capable of supplying a U.S.

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, unique entity identification (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 information for the manufacturer and/or sale of same or substantially similar product and service or similar brand instruments 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 product and service the responding firm is regularly engaged in manufacturing and/or selling.

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

• The offeror shall advise if the product and/or service is on a Best in Class contract.

• If applicable, the offeror shall clearly identify where the offered product is made.

• 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 a large business, provide if 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.

• Informational pricing is desired.

• 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 due by email to the point of contact listed below on or before May 10, 2022 by 13:00 hours (Central Time in Dallas, Texas) at the Food and Drug Administration, Field Operations Branch, FDA|OO|OFBA|OAGS|DAP, Attn: Yolanda Rankin, email yolanda.rankin@fda.hhs.gov. Reference: 75F40122Q00072_1254417.

Disclaimer and Important Notes 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 sam.gov. 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).

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.