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 on-site certification, testing, calibration, and decontamination services described below. 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 541990 - All Other Professional, Scientific, and Technical Services, Small Business Size Standard – $16.5 million. Requirement and Background The U.S. Food and Drug Administration (FDA) National Center for Toxicological Research (NCTR) requires on-site certification, testing, calibration, and decontamination services for Biological Safety Cabinets (BSC’s). BSC’s are critical to the safe environment of facility-wide research and studies where researchers work with materials contaminated with pathogens and cytotoxic substances requiring a defined biosafety level. The requirement is for a base period and four (4) option years of services. The service provider shall furnish all necessary labor, supervision, personal protective equipment, materials and supplies to perform the on-site services described above for the following type of cabinets and quantity of each: *Class 100 – Laminar Flow Units (LFU), 2 units; *Laminar Flow Units (LFU) animal care change stations and clean benches, 3 units; *Class IIA1, 0 units; *Class IIA2, HA/B3, 66 units; *Class IIB2, 23 units. Minimum Technical Requirements are as follows for a base period and four (4) option years of on-site certification, testing, calibration, and decontamination services for Biological Safety Cabinets (BSC’s).: *Firm shall provide proof of ISO 17025:2017 accreditation; *Shall conform to NSF 49-2019 International Standard for Biosafety Cabinetry protocols for all testing techniques; *Shall include at least one (1) planned on-site certification, testing, calibration, (and/or decontamination service as required) for each BSC (including new installation or relocation), and shall include the following: (1) leak testing (with no dispersed oil particles) of HEPA and HEPA-equivalent filters; leak testing shall be performed in accordance with NSF/ANSI 49-2008 (see 12a); (2) measurement of velocity profile and inflow velocity as it applies to Class I BSC’s, Class II (Type A and B) BSC’s, laminar flow clean air cabinets (Class 100) and laminar flow animal care modules (change stations); (3) cabinet exhaust quantity measurement; (4) testing of ground fault interrupters (GFI’s) and ground continuity; (5) lighting intensity measurements in accordance with National Sanitation Foundation, Standard #49; (6) leveling for Class II, Type A and Type B BSC’s. *Shall include, where required, assemble or disassembly of BSC’s. *All testing, certification, and decontamination activities shall conform to, and be in accordance with, the following standards: (1) NSF 49-2019 International Standard for Biosafety Cabinetry; (2) Laboratory Safety Monograph, A Supplement to the NIH Guidelines for recombinant DNA Research, US, DHEW, PHS, NIH, January 3, 1979; (3) Biosafety in Microbiological and Biomedical Laboratories, CDC-NIH, December 2009; (4) Occupational Safety & Health Administration (OSHA) 29 CFR 1910.1450-Occupational exposure to hazardous chemicals in laboratories; (5) NCTR Center Safety Manual (Attachment 1). Service Records and Reports *The Contractor shall, commensurate with the completion of each certification/testing, 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. Testing, certification, and decontamination activities 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 National Center for Toxicological Research 3900 NCTR Road Jefferson, AR 72079-9501 Responses to this Sources Sought notice shall unequivocally demonstrate the respondent is currently engaged in providing the onsite testing, calibration and certification services for the BSC’s, LFU’s, animal care change stations, and clean benches as described herein. 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: Business name and bio, SAM Unique Entity Identifier (UEI), 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; Descriptive literature, brochures, marketing material, etc. detailing the BSC 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; Provide recent (within the last three years) and relevant past performance information where the offeror has provided same or substantially similar 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 and phone number, and e-mail address (if different from that provided for client); If applicable, standard commercial warranty and payment terms; 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; If a large business, provide documentation of any subcontracting opportunities which exist for small business concerns; Though this is not a request for quote, informational pricing is encouraged; The Government is not responsible for locating or securing any information, not identified in the response; Respondent shall advise if the services required is currently available on a “Best in Class” or other Government-wide or HHS-wide contract. 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 April 28, 2022, to Tim Walbert, Contract Specialist, at the following address:
[email protected]. 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 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).