75F40123Q00033_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 a “Brand Name or Equal” Filtration Device (Item Number: SYMBLFH01US) with 4 (1-year Post-Warranty Maintenance option periods).

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 FDA/CBER Division of Biological Standards and Quality Control (DBSQC) serves as a Standards Preparation and Testing laboratory of CBER and an ISO 17025 accredited testing laboratory of CBER. The center is in need of a “Brand Name or Equal” closed filtration device and onsite Qualification (IQ/OQ) for the testing of vaccines and other biologics for confirming sterility. This instrument is critical for the conduct of official testing by DBSQC.

IQ/OQ (Installation Qualification/Operation Qualification) of an equipment is required for the use of the instrumentation to determine suitability for intended purpose in accordance with cGMP and

ISO 17025.

Minimum Technical Requirements for a “Brand Name or Equal” closed filtration device and onsite Qualification (IQ/OQ) for the testing of vaccines and other biologics for confirming sterility:

• Shall include a user interface liquid-crystal display (LCD) screen.

• Shall include a Canister style that is compatible with all EMDMillipore Steritest™ models. (Model: Steritest Symbio).

• Shall include Two (2) pressure detection modes.

• Shall include Reliable splitting of the liquid sample and verify precision by qualification.

• Shall include an adjustable bottle holder height and tiltable display.

• Shall include a pump rotation speed: up to 240 rpm.

• Shall include a timer: 0.5 to 999.

• Shall include the following power requirements: 100 to 240 Volts AC.

• Shall include Frequency of: 50–60 Hz.

• Shall include Pump equipped with all the accessories required to perform testing.

• Shall be able to fit within the following dimensions: 628(W) + 372(D) + 410(H) in mm or close.

Onsite Qualification (IQ/OQ/PQ) Installation, Training and Warranty Requirements:

• The system and its associated accessories shall include operations and maintenance manuals covering proper operation, routine maintenance, and trouble shooting for the instrument and controlling software. All manuals and documentation on the instrument shall be provided in hard copy and/or electronic format.

• The offeror shall provide qualification protocol for FDA to review and address comments and/or suggestions.

• The offeror shall execute qualification by manufacturer trained technicians and reagents based on an approved protocol.

• The offeror shall use calibrators with current NIST and/or other national traceable calibration.

• The offeror shall address any non-conformances occurred during execution of the qualification protocol in accordance with cGMP regulations.

• The offeror shall provide qualification report for FDA review and address any comments/ suggestions.

• The offeror shall install the equipment and provide all labor, travel, kits and tools, etc, to install the equipment at the address provided below, to include inside delivery.

• The offeror shall provide training for proper operation of the instrument.

• The offeror shall warrant the entire system for a period of at least one (1) year from acceptance by FDA. The warranty shall include: unlimited telephone/e-mail support for questions regarding operation, onsite visits for diagnosis of problems and repairs inclusive of all parts, labor, and travel expenses at no additional cost to the FDA.

Minimum Performance Requirements for 4 (1-year Post Warranty Maintenance Option Periods):

• The Contractor shall provide one (1) scheduled on-site planned preventive maintenance visit per year.

• The Contractor shall provide unlimited On-Site Corrective Maintenance/Repairs within 3 business days of call for service where problems cannot be resolved remotely after 2 business days.

• The Maintenance and Repair activities shall be performed following the Original Equipment

Manufacturer (OEM) specifications, manuals, and service bulletins, using OEM-certified replacement parts, components, subassemblies, etc.

• The Contractor shall include unlimited software and firmware updates during the coverage period(s).

• The Contractor shall include unlimited technical support Monday through Friday (excluding Federal Holidays) 8:00AM – 5:00PM Eastern Time.

• All maintenance/repair pricing shall be inclusive of labor, travel, replacement parts, components, subassemblies, etc.

• Invoice for the equipment and qualification will be approved after approval of successful qualification report and complete training.

• Invoice for the option year will be approved once a year after receiving onsite preventative maintenance.

Estimated Delivery Date: 30 days after award

Option Year 1: 02/20/2023 thru 02/19/2024 Option Year 2: 02/20/2024 thru 02/19/2025 Option Year 3: 02/20/2025 thru 02/19/2026 Option Year 4: 02/20/2026 thru 02/19/2027

Delivery Location:

Food and Drug Administration Center for Biologics Evaluation and Research 10903 New Hampshire Ave Building 75, Room G672 Silver Spring, MD 20993

Service Records and Reports The Contractor shall, commensurate with the completion of each service call (inclusive of warranty service), 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/repaired and detailing the reason for the service call, a detailed description of the work performed, the test instruments or other equipment used to affect the repair or otherwise perform the service, the name(s) and contact information of the technician who performed the repair/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 Technical Representative and Contract Specialist, summarizing all maintenance and repair activities (including warranty work) each time service and/or repair is performed.

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, DUNS 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 DUNS 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.

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

• Informational pricing is desired.

Interested Contractors must respond with capability statements which are due by email to the point of contact listed below on or before December 30, 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: 75F40123R00033.

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.