Pre-made Custom Standards

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This is a combined synopsis/solicitation for commercial items prepared in accordance with the Federal Acquisition Regulation (FAR) format in Subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; quotes are being requested and a written solicitation will not be issued. The solicitation number is FDA-RFQ-24Q1276629. This requirement is issued as Request for Quote (RFQ). The solicitation is issued as a Full and Open competition.

The solicitation documented and incorporated provisions and clauses in effect through the Federal Acquisition Circular (FAC) FAC-2024-05, Effective 05/22/2024. The associated North American Industry Classification System (NAICS) Code is 325199 with a small business size standard of 1250 employees. The US Food & Drug Administration (FDA) intends to issue a Commercial Item Firm Fixed-Price purchase order that meets the requirements herein.

BACKGROUND Arkansas (ARLHAF), Atlanta (ATLHAF), and Denver (DENHAF) are the three servicing laboratories within the Office of Regulatory Affairs (ORA) that are responsible for running the analysis of nitrofurans and chloramphenicol in aquaculture species of shrimp, tilapia, eel, lobster, crab, crawfish, frog legs, barramundi, cobia, croaker, and hybrid striped bass per ORS SOP-000584.

Chloramphenicol and nitrofurans are a group of veterinary antibiotics commonly used to treat protozoan and bacterial infections in a variety of aquaculture species, if ingested, these can cause a variety of acute and serious reactions. On an annual basis, Arkansas receives approximately 550 aquaculture samples per year, Atlanta receives approximately 300, and Denver receives approximately 450 samples.

More than seventy-five percent of received aquaculture samples are analyzed for nitrofuran and chloramphenicol metabolites by each laboratory to protect public health. To achieve the goals of screening and confirmation, each batch of analyzed samples must be matrix matched to the aquaculture species and contain a continuous calibration verification standard (CCV) and an initial calibration verification standard (ICV).

In accordance with the Office of Regulatory Science (ORS) SOP-000584, standards may be purchased as a custom mixture from two different vendors or from the same vendor with different lots. This is an ongoing analysis that is expected to continue for up to five (5) years or more. OBJECTIVE Three FDA workgroups within the Office of Regulatory Affairs (ARLHAF, ATLHAF, and DENLHAF) need custom prepared stock standards for use in regulatory analysis.

Purchasing custom prepared multi-component standards for multiple laboratories enhances the reliability of results, enhances accuracy, reduces variability, saves time, and is more cost effective than three different laboratories individually purchasing their own mixes or separate standards. This is a one-year contract. REQUIREMENTS The contractor shall provide the minimum requirements under this contract: The contractor shall be an accredited ISO 17025 laboratory and be ISO Guide 34 certified.

The standards shall be sent to the shipping destination, using priority shipping. The contractor shall preserve the integrity of the standards during shipment, i.e., in appropriate protective packaging on cold packs or dry ice. Standards shall be dissolved in appropriate liquid chromatography mass spectrometry (LCMS) grade solvents and sealed in volumes of 1mL in glass ampules. The contractor shall provide two (2) mixes of standards (CCV and ICV) containing each set of compounds.

Each mix shall be made of different lot numbers from each other. For example, if standard mix 1 is made with US Pharmacopeia (USP) Lot U, then standard mix 2 must be made either from a different manufacturer or from USP with a different valid lot code.

If another lot number or manufacturer is not available, it is acceptable to prepare the solution from the same lot number, provided it is prepared by a different analyst and on a different day from mix 1. A certificate of analysis (COA) shall accompany or be available online for all compounds.

At a minimum, the COA shall contain/provide the component name, lot number, chemical abstract service number (CAS), uncertainty level, expiration date, solvent used to prepare the standard material, certified value, and how the certified value was obtained (i.e., GC/MS, HPLC). All compounds which are in the hydrochloride form shall have final concentrations as free base. The required groups of compounds, concentration levels, Chemical Abstracts Service (CAS) number, and minimum shelf-life are listed in the table below:

INSPECTION/ACCEPTANCE CRITERIA Inspection and acceptance shall be in accordance with the base clause 52.212-4(a). Contracting officer’s representative (COR) is responsible for the inspection and acceptance of the deliverables for this requirement. CONTRACT TYPE This is firm fixed price. PERIOD OF PERFORMANCE The period of performance (POP) is one year. PLACE OF DELIVERY AND PERFORMANCE U. S. FDA Winchester Engineering and Analytical Center Attn: POC to be identified at time of award.

109 Holton Street Winchester, MA 01890 POC: POC to be identified at time of the award. HOURS OF OPERATION Work/Deliveries shall typically be performed/delivered during normal business hours (typically between 8AM and 5PM Eastern) Mondays through Fridays. FEDERAL HOLIDAYS The Government will not require support for the Federal Holidays listed below. Specific dates can be found on https://www.opm.gov/. New Year's Day Birthday of Martin Luther King, Jr.

Washington’s Birthday Memorial Day Juneteenth National Independence Day Independence Day Labor Day Columbus Day Veterans Day Thanksgiving Day Christmas Day GOVERNMENT CLOSURES Government operating statuses for offices nationwide can be found on https://www.opm.gov/. Aside from Federal holidays, the contractor shall contact the COR or Contracting Officer to determine work status in the event of Government closures.

If a contractor staff has been approved to work at an alternate work site, the Government anticipates that the contractor staff will continue to perform their tasks as assigned at the order level. In the event of inclement weather, contractor staff that work on-site at a Federal facility shall be responsible for checking the operating status.

If the facility is closed and the contractor staff is telework ready, the contractor staff may be required to work at the direction of the COR or CO. This is a combined synopsis/solicitation for commercial items prepared in accordance with the Federal Acquisition Regulation (FAR) format in Subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; quotes are being requested and a written solicitation will not be issued.

The solicitation number is FDA-RFQ-24Q1276629. This requirement is issued as Request for Quote (RFQ). The solicitation is issued as a Full and Open competition. The solicitation documented and incorporated provisions and clauses in effect through the Federal Acquisition Circular (FAC) FAC-2024-05, Effective 05/22/2024. The associated North American Industry Classification System (NAICS) Code is 325199 with a small business size standard of 1250 employees.

The US Food & Drug Administration (FDA) intends to issue a Commercial Item Firm Fixed-Price purchase order that meets the requirements herein.

BACKGROUND Arkansas (ARLHAF), Atlanta (ATLHAF), and Denver (DENHAF) are the three servicing laboratories within the Office of Regulatory Affairs (ORA) that are responsible for running the analysis of nitrofurans and chloramphenicol in aquaculture species of shrimp, tilapia, eel, lobster, crab, crawfish, frog legs, barramundi, cobia, croaker, and hybrid striped bass per ORS SOP-000584.

Chloramphenicol and nitrofurans are a group of veterinary antibiotics commonly used to treat protozoan and bacterial infections in a variety of aquaculture species, if ingested, these can cause a variety of acute and serious reactions. On an annual basis, Arkansas receives approximately 550 aquaculture samples per year, Atlanta receives approximately 300, and Denver receives approximately 450 samples.

More than seventy-five percent of received aquaculture samples are analyzed for nitrofuran and chloramphenicol metabolites by each laboratory to protect public health. To achieve the goals of screening and confirmation, each batch of analyzed samples must be matrix matched to the aquaculture species and contain a continuous calibration verification standard (CCV) and an initial calibration verification standard (ICV).

In accordance with the Office of Regulatory Science (ORS) SOP-000584, standards may be purchased as a custom mixture from two different vendors or from the same vendor with different lots. This is an ongoing analysis that is expected to continue for up to five (5) years or more. OBJECTIVE Three FDA workgroups within the Office of Regulatory Affairs (ARLHAF, ATLHAF, and DENLHAF) need custom prepared stock standards for use in regulatory analysis.

Purchasing custom prepared multi-component standards for multiple laboratories enhances the reliability of results, enhances accuracy, reduces variability, saves time, and is more cost effective than three different laboratories individually purchasing their own mixes or separate standards. This is a one-year contract. REQUIREMENTS The contractor shall provide the minimum requirements under this contract: The contractor shall be an accredited ISO 17025 laboratory and be ISO Guide 34 certified.

The standards shall be sent to the shipping destination, using priority shipping. The contractor shall preserve the integrity of the standards during shipment, i.e., in appropriate protective packaging on cold packs or dry ice. Standards shall be dissolved in appropriate liquid chromatography mass spectrometry (LCMS) grade solvents and sealed in volumes of 1mL in glass ampules. The contractor shall provide two (2) mixes of standards (CCV and ICV) containing each set of compounds.

Each mix shall be made of different lot numbers from each other. For example, if standard mix 1 is made with US Pharmacopeia (USP) Lot U, then standard mix 2 must be made either from a different manufacturer or from USP with a different valid lot code.

If another lot number or manufacturer is not available, it is acceptable to prepare the solution from the same lot number, provided it is prepared by a different analyst and on a different day from mix 1. A certificate of analysis (COA) shall accompany or be available online for all compounds.

At a minimum, the COA shall contain/provide the component name, lot number, chemical abstract service number (CAS), uncertainty level, expiration date, solvent used to prepare the standard material, certified value, and how the certified value was obtained (i.e., GC/MS, HPLC). All compounds which are in the hydrochloride form shall have final concentrations as free base. The required groups of compounds, concentration levels, Chemical Abstracts Service (CAS) number, and minimum shelf-life are listed in the table below:

INSPECTION/ACCEPTANCE CRITERIA Inspection and acceptance shall be in accordance with the base clause 52.212-4(a). Contracting officer’s representative (COR) is responsible for the inspection and acceptance of the deliverables for this requirement. CONTRACT TYPE This is firm fixed price. PERIOD OF PERFORMANCE The period of performance (POP) is one year. PLACE OF DELIVERY AND PERFORMANCE U. S. FDA Winchester Engineering and Analytical Center Attn: POC to be identified at time of award.

109 Holton Street Winchester, MA 01890 POC: POC to be identified at time of the award. HOURS OF OPERATION Work/Deliveries shall typically be performed/delivered during normal business hours (typically between 8AM and 5PM Eastern) Mondays through Fridays. FEDERAL HOLIDAYS The Government will not require support for the Federal Holidays listed below. Specific dates can be found on https://www.opm.gov/. New Year's Day Birthday of Martin Luther King, Jr.

Washington’s Birthday Memorial Day Juneteenth National Independence Day Independence Day Labor Day Columbus Day Veterans Day Thanksgiving Day Christmas Day GOVERNMENT CLOSURES Government operating statuses for offices nationwide can be found on https://www.opm.gov/. Aside from Federal holidays, the contractor shall contact the COR or Contracting Officer to determine work status in the event of Government closures.

If a contractor staff has been approved to work at an alternate work site, the Government anticipates that the contractor staff will continue to perform their tasks as assigned at the order level. In the event of inclement weather, contractor staff that work on-site at a Federal facility shall be responsible for checking the operating status.

If the facility is closed and the contractor staff is telework ready, the contractor staff may be required to work at the direction of the COR or CO. Shipping Destination for Arkansas (ARLHAF): Arkansas Regional Laboratory U.S. Food and Drug Administration 3900 NCTR Rd., Bldg. 26 Jefferson, AR 72079 Shipping Destination for Atlanta (ATLHAF): FDA Southeast Food and Feed Laboratory 60 8th Street Atlanta, GA 30309 Shipping Destination for Denver (DENLHAF): FDA Denver Laboratory 6th Avenue & Kipling St, Bldg. 20, Door W10 Denver, Colorado, 80225 8. GOVERNMENT POINTS OF CONTACT Contract Specialist Warren Jackson U.S. Food and Drug Administration Office of Acquisitions and Grants Services 4041 Powder Mill Road, STE 400 Beltsville, MD 20705 Phone:

301-796-7376 Email: warren.jackson@fda.hhs.gov Contracting Officer’s Representative/Technical Point of Contact (TPOC) To be determine after award. All shipments shall be made F.O.B. Destination.

Shipping Destination for Arkansas (ARLHAF): Arkansas Regional Laboratory U.S. Food and Drug Administration 3900 NCTR Rd., Bldg. 26 Jefferson, AR 72079 Shipping Destination for Atlanta (ATLHAF): FDA Southeast Food and Feed Laboratory 60 8th Street Atlanta, GA 30309 Shipping Destination for Denver (DENLHAF): FDA Denver Laboratory 6th Avenue & Kipling St, Bldg. 20, Door W10 Denver, Colorado, 80225 8. GOVERNMENT POINTS OF CONTACT Contract Specialist Warren Jackson U.S. Food and Drug Administration Office of Acquisitions and Grants Services 4041 Powder Mill Road, STE 400 Beltsville, MD 20705 Phone:

301-796-7376 Email: warren.jackson@fda.hhs.gov Contracting Officer’s Representative/Technical Point of Contact (TPOC) To be determine after award.