75F40122_SSN1251947.pdf

U.S. FDA SOURCES SOUGHT NOTICE (SSN)

Preventive maintenance for scientific lab equipment

SSN #: FDA_SSN_1251243

Posted Date: March 10, 2022 Response Date: March 20, 2022 Classification: J066 - Maint/Repair/Rebuild of Equipment- Instruments and Laboratory

Equipment NAICS Code: 811219 - Other Electronic and Precision Equipment Repair and

Maintenance

MARKET RESEARCH PURPOSES ONLY - NOT A REQUEST FOR PROPOSAL OR SOLICITATION

This is a Sources Sought notice to determine the availability of Small Businesses capable of supplying the preventive maintenance and calibration services for the instruments and lab equipment described both herein below, and on the document attached to this Notice labeled ATTACHMENT !: List of Equipment. This notice is for planning purposes only, and does not constitute an Invitation for Bids, Request for Proposal, Request for Quotation, or an indication the Government intends to award a contract, nor does the Government intend to pay for any information submitted as a result of this notice. Your response to the information requested will assist the Government in determining the appropriate acquisition method, including whether a Small Business Set-Aside is possible.

The appropriate NAICS code for the acquisition is 811219 - Other Electronic and Precision Equipment Repair and Maintenance, Small Business Size Standard – $22 million.

Requirement and Background The U.S. Food and Drug Administration (FDA) Center for Biologics Evaluation and Research (CBER), Division of Biological Standards and Quality Control (DBSQC) serves as a Standards Preparation and Testing laboratory of CBER, and is also an ISO 17025 accredited testing laboratory of CBER. The samples deposited by industry providers (Sponsors) for licensing and lot release approvals are tested in the laboratories of DBSQC/OCBQ/ CBER.

The current requirement is for the purchase of onsite preventive maintenance, calibration and certification services for a broad spectrum of scientific instruments and lab equipment such as refrigerators, freezers, refrigerator/freezer combination units, CO2 incubators, ovens, water baths, centrifuges, digital thermometers, hygrometers, and chart recorders (please see ATTACHMENT 1: List of Equipment). The equipment is physically located across several research areas – Microbiology, Analytical Chemistry Lab (ACS), Immunology, Virology, Blood Products, and Product Release Branch (PRB). For the purposes of responding to a solicitation and future invoicing procedures, service for all of the equipment on the attached has been loosely grouped into four annual periods of performance (June, September, November, and December) but some service for particular instruments may fall outside those months listed.

Minimum Technical Requirements are as follows for a base period and four (4) option periods of onsite preventive maintenance, calibration and certification services for the instruments and scientific lab equipment listed on ATTACHMENT 1:

*Shall include at least one (1) planned on-site preventive maintenance visit for routine preventive maintenance, certification and/or calibration per contract year for each instrument listed on ATTACHMENT 1;

*Access by the FDA Technical Representative (TR) and system operator personnel to the manufacturer’s call center for technical assistance, which is staffed by senior engineers to provide a high level of expertise for troubleshooting a particular instrument or piece of lab equipment;

*Priority access to technical support (e-mail and telephone) Mondays - Fridays (excluding Federal Holidays) between the hours of 7:00 AM - 5:00 PM Eastern (Prevailing) Time;

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

*All preventive maintenance service pricing shall be inclusive of labor, travel, replacement parts, components, subassemblies, etc.

Service Records and Reports *The Contractor shall, commensurate with the completion of each preventive maintenance or repair service visit (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, 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 Technical Point of Contact (TPOC) and Contract Specialist, summarizing all maintenance activities (including warranty work) each time service is performed.

Preventive maintenance shall not be scheduled during Federal Holidays or Federal Closures as determined by Executive Orders or opm.gov. Federal Holidays are as follows:

New Year’s Day Martin Luther King, Jr.’s Birthday Washington’s Birthday Memorial Day Juneteenth Day Independence Day Labor Day

Columbus Day Veterans Day Thanksgiving Day Christmas Day

Contract Type: Commercial Item-Firm Fixed Price

Period(s) of Performance (Estimated) Base Period: 12 consecutive months from date of award;

Option Year 1: 12 consecutive months commencing from expiration of base period;

Option Year 2: 12 consecutive months from expiration of Option Year 1;

Option Year 3: 12 consecutive months from expiration of Option Year 2.

Option Year 4: 12 consecutive months from expiration of Option Year 3.

Delivery Address U.S. Food and Drug Administration Center for Biologics Evaluation and Research Bldg. 52/72, Bldg. 75 10903 New Hampshire Avenue Silver Spring, MD 20993-0002

Responses to this Sources Sought notice shall unequivocally demonstrate the respondent is currently engaged in providing the onsite preventive maintenance, calibration and certification services for a broad spectrum of scientific instruments and lab equipment such as refrigerators, freezers, refrigerator/freezer combination units, CO2 incubators, ovens, water baths, centrifuges, digital thermometers, hygrometers, and chart recorders, as described herein and meeting all technical requirements set forth above. Although the target audience for this Notice are small businesses or small businesses capable of providing these stocks from another small business, all interested parties may respond. At a minimum, responses in the form of a Capability Statement shall include the following:

1. 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 with the capability of providing virus stocks offered by another firm;

2. Descriptive literature, brochures, marketing material, etc. detailing the multi-parameter spectral analyzing cell sorter instrument system and preventive-corrective maintenance services which the responding firm is regularly engaged in providing. Capability statements must provide sufficient information that unequivocally demonstrates that the technical requirements and delivery time identified above can be met;

3. Provide recent (within the last three (3) years) and relevant past performance information for the manufacture and/or sale in which the offeror has provided same or substantially similar cell sorter instrument systems and preventive-corrective maintenance services. For each past performance reference include the date of sale, description, dollar value, client name, client address, client point of 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;

4. If applicable, standard commercial warranty and payment terms;

5. If applicable, identification of the firm's GSA Schedule contract(s) by Schedule number and

SIN’s that are applicable to this potential requirement are also requested;

6. If a large business, provide documentation of any subcontracting opportunities which exist for small business concerns;

7. Though this is not a request for quote, informational pricing is encouraged;

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

9. Respondent shall advise if the services required is currently available on a “Best in Class” or other Government-wide or HHS-wide contract.

10. If applicable, respondent shall provide place (country) of product/service manufacture or performance and any other applicable information to enable review and analysis pertaining to the requirements under the Buy American Act and requirements relating to Executive Order 14005 Ensuring the Future is Made in All of America by All of America’s Workers, in the event that a nonavailability waiver request submitted through the Made in America Office (MIAO) Digital Waiver Portal is required.

Interested parties shall respond with Capability Statements as described above by e-mail only, before 2:00 pm (Central Daylight Time - Local Prevailing Time in Jefferson, Arkansas) on March 20, 2022, to Tim Walbert, Contract Specialist, at the following address:

timothy.walbert@fda.hhs.gov.

Notice of Intent Responses to this Sources Sought announcement will assist the Government in determining whether or not any future requirement similar to this one should be set aside for small business, made available to full and open competition or procure through sole-source acquisition procedures.

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/or combined synopsis-solicitation may be published on SAM/Federal Contract mailto:timothy.walbert@fda.hhs.gov

Opportunities (formerly FBO) at https://sam.gov/content/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).

https://sam.gov/content/opportunities