75F40121Q-1244563.pdf

Third Party Retail Shrimp Sampling Collection & Chemical Analysis Combined Synopsis Solicitation

75F40121Q-1244563

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; proposals are being requested and a written solicitation will not be issued. The solicitation is being issued in conjunction with FAR Part

13.5 - Simplified Procedures for Certain Commercial Items.

The solicitation number is 75F40121Q-1244563. This solicitation is issued as a Request for Quote (RFQ).

As a result of this solicitation, the government intends to award an IDIQ contract with firm-fixed price tasks.

The guaranteed minimum amount for this IDIQ is $10,000.00 which will be satisfied through the issuance of one or more Task Orders. The maximum IDIQ amount (ceiling) is estimated not to exceed $500,000.00. The estimate ceiling can be increased via mutual agreement of the parties.

The solicitation document and incorporated provisions and clauses in effect through the Federal Acquisition Circular 2021-06 dated July 12, 2021. All Task Orders issued are subject to the terms and conditions of this IDIQ contract. This contract shall take precedence in the event of conflict with any Task Order.

The associated North American Industry Classification System (NAICS) code is 541380 Testing Laboratories; Small Business Size standards – $16.5. This requirement is being competed Unrestricted/Full and Open Competition.

Statement of Work

1.0 Purpose:

The purpose of this requirement to obtain sample collection and analysis services to determine current levels of specific chemical contaminant and drug residues in seafood.

2.0 Background/Statement of Need:

Congress, through the 2021 Appropriation has directed the Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs (Commissioner), has directed the agency to develop and, if it determines feasible, implement a number of options for regulating the export of shrimp to the United States from other countries, including the three largest exporting countries by volume to the United States over the last three calendar years, such as sampling of products prior to export to the United States, increasing foreign inspections of export facilities, increased seafood importer inspections, foreign surveillance inspections at overseas manufacturing sites, enhanced import screening, higher rates of examination and sampling, use of third-party audits, and formal seafood arrangements with foreign competent authorities. Congress further directed that priority consideration to the following (1) that appropriate controls are applied to shrimp feed and production ponds, processing plants, and facilities throughout the chain of distribution to determine compliance with seafood safety requirements; (2) dedicate its inspectional effort to determine compliance with seafood arrangements, once established, from any dedicated funds; (3) provide an annual report to the Committee before the end of fiscal years 2021, 2022, and 2023 with the reporting requirement goal being to provide the Committee information related to FDA’s oversight of the safety of shrimp products imported into the United States.

The U. S. Food and Drug Administration, Center for Food Safety and Applied Nutrition (CFSAN) requires third party retail shrimp sampling collection and chemical analysis services to determine current levels of specific chemical contaminant and drug residues in seafood.

3.0 Scope:

Independently and not as an agent of the Government, the Contractor shall furnish the necessary personnel, materials, services, facilities, and otherwise do all things necessary for or incidental to the performance of the work.

Contractor shall collect and analyze samples of imported farm-raised or aquaculture shrimp to determine the levels of chemical contaminants and drug residues. The number of samples and analyses to be performed will be provided by FDA as needs arise within the performance period of the contract.

4.0 Minimum Performance Requirements/Specific Tasks:

The Contractor shall collect and analyze samples of imported farm-raised or aquaculture shrimp. The reliability of the results shall be supported by specified quality assurance/quality control processes within the study. The types of samples to be collected for these studies shall include farm-raised or aquaculture shrimp from India, Indonesia, Ecuador and other countries to be identified. The analytical methodology for this requirement will be defined by the FDA and will include methods based on widely available and recognized methodology.

4.1 Task 1 – Kick Off Meeting

The Contractor shall conduct a Kickoff Meeting with the FDA Technical Point of Contact, Program Staff and the FDA Contracting Officer Representative (COR) within ten (10) calendar days after award.

4.2 Task 2 – Sample Purchase, Collection and Shipping

The Contractor shall collect samples of raw or cooked, frozen farm-raised or aquaculture shrimp samples imported from specified countries as outlined in the following requirements:

The Center for Food Safety and Applied Nutrition (CFSAN) will specify the types of samples, quantities , analytical methodology and data reporting requirements with each specified task.

1. Sample collection:

a. Collect raw or cooked, frozen farm-raised or aquaculture shrimp from a sample collection list generated by the FDA. Samples shall be acquired from major “brick and mortar” national chains, local retail chain locations and local independent stores and markets in two (minimum) major United States cities. Cities chosen shall be representative of major geographic regions (Eastern, Midwest, West) and may include the metropolitan areas of Atlanta, Chicago, Dallas, Denver, Los Angeles, New York, San Francisco, Seattle and Washington, DC. FDA will specify the brand distribution, lot number and import date distribution, country of origin, quantity and geographic location of the samples. The ability to obtain samples from major metropolitan areas throughout the U.S. is required. In addition, the capability to respond to specific requests to collect samples in specific locations is an added capability of importance.

b. Types of samples to be collected: Raw or cooked, frozen aquaculture or farm-raised shrimp samples imported from specified countries.

c. Sample collection costs: Sample collection costs are to be priced in a way that the cost per sample is known at the time the task is awarded; the sample list will be presented to the contractor prior to the final task order and the contractor shall be expected to produce an estimate of the cost of sample collection:

i. Cost of product: the best possible estimate of product cost shall be given at the time of the sample collection cost estimate, but it is recognized that there will be some fluctuation in the expected purchase price.

ii. Personnel costs for sample collection, including hourly rates and expected number of hours for each type of personnel.

iii. Costs per mile for physical collection of samples.

iv. Cost of any shipping involved on a per item basis.

d. Contractor shall also provide pricing for cases in which samples are requested to be collected by the contractor but shipped to FDA laboratories and include this as a separate sample collection line item if the pricing structure is different.

e. Information required to be kept when logging collected samples:

i. Sample identification number assigned by the contractor.

ii. Name of the product and size of the package.

iii. Date and location of sample collection.

iv. Readable digital photographs or photocopies of the product packaging, as purchased, to include front of package, and all additional label information including ingredient list. The contractor shall retain all product packages for the analyzed products until FDA deems the digital photographs to be acceptable.

1. Collected item shall be assigned a sample identification number which shall be carried throughout the entire analysis process.

2. Photographs shall be taken of the front of the item so that the specific item and brand are clearly identifiable.

3. Photographs shall be taken of the ingredients panel and the Nutrition Facts or

Supplement Facts label, as well as the uniform product code (UPC).

4. Photographs shall be taken of preparation instructions, if the samples are to be prepared by the vendor.

5. All digital photographs are to be available in BMP, JPG or similar digital format.

Each digital photograph shall be named in such a way that the sample identification number occurs at the beginning of the file name.

6. Contractor must be able to upload the digital photographs to an FDA-selected site using FTP or similar protocol.

v. Record of lot numbers/production codes and expiration dates (where applicable).

f. Destination of collected samples:

i. Most samples shall be collected and analyzed by the Contractor. However, in some case, samples or duplicates of samples shall be sent to FDA laboratories for analysis by the FDA (Center for Food Safety and Applied Nutrition, College Park, MD) or FDA Regulatory Laboratories (Irvine, CA; San Francisco, CA; Bothell, WA;

Jefferson, AR; Kansas City, KS; Jamaica, NY; Atlanta, GA; Denver, CO).

g. Receipt of samples collected by other entities:

i. In some cases, FDA will arrange for samples to be collected by FDA or other third-party entities and shipped to the Contractor’s laboratory for analysis.

ii. In such cases, all of the above logged information shall be collected, with the exception of date and location of item purchased.

4.3 Task 3 – Chemical Analysis Testing

The Contractor shall provide a method and perform the analysis of samples for chloramphenicaol and nitrofuran metabolites. The method must be one of the following:

a. Determination of Chloramphenicol and Nitrofuran Metabolites in Cobia, Croaker, and

Shrimp Using Microwave-Assisted Derivatization, Automated SPE, and LC-MS/MS; FDA Foods Program Compendium of Analytical Laboratory Methods: Chemical Analytical Manual (CAM): Method C-011.01 (https://www.fda.gov/food/laboratory-methods-food/foods-program-compendium-analytical-laboratory-methods)

1. Veach, B. T.; Baker, C. A.; Kibbey, J. H.; Fong, A.; Broadaway, B. J.; Drake, C.

P. Quantitation of Chloramphenicol and Nitrofuran Metabolites in Aquaculture Products Using Microwave-Assisted Derivatization, Automated SPE, and LC- MS/MS. J. AOAC Int. 2015, 98(3): 588-594.

2. Veach, B. T. Determination of Chloramphenicol and Nitrofuran Metabolites in Cobia, Croaker, and Shrimp Using Microwave-Assisted Derivatization, Automated SPE, and LC-MS/MS–Results from a U.S. Food and Drug Administration Level Three Inter-Laboratory Study. J. AOAC Int. 2020, 103(4):

1043-1051.

3. Equivalent method, either cited in literature or developed by the contractor.

The Contractor shall provide an SOP of the method used in their facility. If the method is a contractor-developed method, the level of detail shall be sufficient to allow FDA to establish equivalence to the above cited methods.

Target analytes for the analysis:

LC-MS/MS Quantitative Analysis:

1-aminohydantoin (AHD) 3-amino-5-morpholinomethyl-2-oxazolidinone (AMOZ) 3-amino-2-oxazolidinone (AOZ) semicarbazide (SC) chloramphenicol (CAP)

Performance characteristics:

1. Method limit of quantitation (LOQ): Contractor shall specify the method LOQ (not instrument LOQ) and the process by which the LOQ was determined. (Note: All analytes must have at least a signal-to-noise ratio of 10 at the LOQ in the selected ion chromatogram.)

2. Quantification approach must be specified by the contractor and may include:

a. Interpolation from a non-matrix matched calibration curve if demonstrated recoveries are between 80% and 120% for the analytes in the subject food matrix.

b. Interpolation from a matrix-matched calibration curve made from the same type of matrix.

c. Method of standards addition (spike two different amounts and average result).

3. Recoveries: Spike recoveries for each analyte in shrimp must be 80%-120%. Provide validation data table.

4. Identification Criteria:

a. Retention time match that of a standard to within (1) ± 0.2 min or (2) within ± 2.5%

(not to exceed 0.5 minutes).

b. Mass spectral confirmation as appropriate to the specific method (e.g. GC-MS, LC-

MS/MS), as defined by the method or in CVM 118, FDA Exact Mass Guidance Document.

5. Chromatographic baseline resolution for all target analytes.

• Validation/Verification o Validation: The Contractor shall specify how the method was validated. This can include:

https://www.fda.gov/food/laboratory-methods-food/foods-program-compendium-analytical-laboratory-methods https://www.fda.gov/food/laboratory-methods-food/foods-program-compendium-analytical-laboratory-methods

• Validation by an external study (e.g. AOAC); include citation.

• Internal validation. Briefly describe internal validation process and provide figures of merit as would be included in a study as outlined in the FDA Validation Guidelines, by an organization such as AOAC or provide evidence that the method falls under a scope of accreditation and provide a link to the validation requirements for the accrediting organization.

6. Verification: The Contractor shall submit verification data, which will include:

a. Selected ion chromatograms for each matrix spike and matrix blank extraction.

Submitted chromatograms should demonstrate chromatographic baseline resolution for all analytes.

b. Demonstrate lack of carryover with consecutive chromatograms of a matrix spike and a blank.

c. Replicate (n=3) spikes of each analyte into shrimp matrix (blank) at two fortification concentrations. See Table 1 below

i. Recoveries must be 80-120%.

ii. Repeatability should be less than ± 20% relative standard deviation of the mean

(RSD).

Table 1: Chloramphenicol and Nitrofuran Metabolites

4.4 Task 4 – Multiclass Veterinary Drug Analysis

The Contractor shall provide a method and perform the analysis of samples to confirm the presence of multiple classes of veterinary drugs in shrimp samples. Contractor must submit a method SOP or citation to the method used. The method used must be one of the following:

Current methodology in the literature includes some, but not all of the analytes in Table 2.

Recommended methodology utilized by FDA can be provided upon request.

1. Turnipseed, S.B.; Storey, J.M.; Lohne, J.J.; Andersen, W.C.; Burger, R.; Johnson, A.S.;

Madson, M.R. Wide-Scope Screening Method for Multiclass Veterinary Drug Residues in Fish, Shrimp, and Eel Using Liquid Chromatography–Quadrupole High-Resolution Mass Spectrometry. J. Agric. Food Chem. 2017. 65(34): 7252-7267.

2. LIB 4562: Analysis of sulfonamides, trimethoprim, fluoroquinolones, quinolones, triphenylmethane dyes (and their leuco metabolites) and methyl testosterone in fish and

Analyte Fortification Level 1(n=3)

Fortification Level 2 (n=3)

1-aminohydantoin

(AHD)

0.50 ng/g 1.0 ng/g

3-amino-5-morpholinomethyl- 2-oxazolidinone

(AMOZ)

0.50 ng/g 1.0 ng/g

3-amino-2-oxazolidinone

(AOZ)

0.50 ng/g 1.0 ng/g semicarbazide

(SC)

0.50 ng/g 1.0 ng/g chloramphenicol

(CAP)

0.15 ng/g 0.30 ng/g shrimp using liquid chromatography mass spectrometry. Revision 02 (03-2018).

https://www.fda.gov/media/111599/download

3. Gibbs, R.S.; Murray, S.L.; Watson, L.V.; Nielsen, B.P.; Potter, R.A.; Murphy C.J.

Development and Validation of a Hybrid Screening and Quantitative Method for the Analysis of Eight Classes of Therapeutants in Aquaculture Products by Liquid Chromatography– Tandem Mass Spectrometry. J. Agric. Food Chem. 2018. 66(20): 4997-5008.

4. Veach, B. T.; Kibbey, J. H.; Barnes, P. J.; Broadaway, B. J.; Storey, J. M.; Turnipseed, S. B.;

Baker, C. A. LIB 4653: Multiclass Veterinary Drug Residue Method for Aquaculture Products using LC-MS/MS.

5. Equivalent method, either cited in literature or developed by the contractor.

Contractor shall provide an SOP of the method used in their facility. If the method is a contractor-developed method, the level of detail must be sufficient to allow FDA to establish equivalence to the above cited methods.

Target analytes for analyses:

LC-MS/MS Quantitative Analysis: See Table 2.

Table 2: Veterinary drugs to be included in the multi-analyte LC-MS/MS method.

Analyte

Class Level of Interest (ng/g)

Amoxicillin Beta Lactam 10 Ampicillin Beta Lactam 10 Chlortetracycline Tetracycline 50 Ciprofloxacin Fluoroquinolone 5 Cloxacillin Beta Lactam 10 Danofloxacin Fluoroquinolone 5 Difloxacin Fluoroquinolone 5 Doxycycline Tetracycline 50 Enrofloxacin Fluoroquinolone 5 Erythromycin Macrolide 50 Florfenicol Amine Phenicol 50 Flumequine Quinolone 10 Gentian Violet Triphenylmethane Dye 1 Hydroxy Mebendazole Anthelmintic 5 Leuco Gentian Violet Triphenylmethane Dye 1 Leuco Malachite Green Triphenylmethane Dye 1 Lincomycin Lincosamide 50 Malachite Green Triphenylmethane Dye 1 Mebendazole Anthelmintic 5 Mebendazole Amine Anthelmintic 5 Nalidixic Acid Quinolone 10 Norfloxacin Fluoroquinolone 5 Oxolinic Acid Quinolone 10 Oxytetracycline Tetracycline 50 Sarafloxacin Fluoroquinolone 5 https://www.fda.gov/media/111599/download

Sulfacetamide Sulfonamide 10 Sulfachlorpyridazine Sulfonamide 10 Sulfadiazine Sulfonamide 10 Sulfadimethoxine Sulfonamide 10 Sulfadoxine Sulfonamide 10 Sulfaethoxypyridazine Sulfonamide 10 Sulfamerazine Sulfonamide 10 Sulfamethazine Sulfonamide 10 Sulfamethoxazole Sulfonamide 10 Sulfamethoxypyridazine Sulfonamide 10 Sulfamonomethoxine Sulfonamide 10 Sulfapyridine Sulfonamide 10 Sulfaquinoxaline Sulfonamide 10 Sulfathiazole Sulfonamide 10 Tetracycline Tetracycline 50 Thiamphenicol Phenicol 1 Trimethoprim Potentiator 10

Target Matrix: Shrimp

Performance characteristics:

• Method limit of quantitation (LOQ): Contractor shall specify the method LOQ (not instrument LOQ) and the process by which the LOQ was determined. (Note: All analytes must have at least a signal-to-noise ratio of 10 at the LOQ in the selected ion chromatogram.)

• Quantification approach must be specified by the Contractor and may include:

o Interpolation from a non-matrix matched calibration curve if demonstrated recoveries are between 80% and 120% for the analytes in the food matrix in question.

o Interpolation from a matrix-matched calibration curve made from the same type of matrix.

o Method of standards addition (spike two different amounts and average result).

• Recoveries: Spike recoveries for each analyte in shrimp must be 80%-120% for 95% of analytes listed in Table 2. All analytes must demonstrate spike recovery performance between 60-120%. Provide validation data table.

• Identification Criteria:

o Retention time match that of a standard to within (1) ±0.2 min or (2) within ± 2.5%

(not to exceed 0.5 minutes) o Mass spectral confirmation as appropriate to the specific method (e.g. GC-MS, LC-

MS/MS), as defined by the method or in CVM 118, FDA Exact Mass Guidance Document.

Validation/Verification:

• Validation: The Contractor shall specify how the method was validated. This can include:

o Validation by an external study (e.g. AOAC); include citation o Internal validation; briefly describe internal validation process and provide figures of merit as would be included in a study as outlined in the FDA Validation Guidelines, by an organization such as AOAC, or provide evidence that the method falls under a scope of accreditation and provide a link to the validation requirements for the accrediting organization.

• Verification: The Contractor shall submit verification data, which will include:

o Selected ion chromatograms for all analytes in a matrix blank extraction and a matrix spike at 0.5X (or LOQ, whichever is larger) or 1.5X, where X = Level of Interest (Table 3).

o Demonstrate lack of carryover with consecutive chromatograms of a matrix spike and a blank.

o Replicate (n=3) spikes of 11 analytes (minimum; one compound per class) into shrimp matrix (blank) at two fortification concentrations: 0.5X (or LOQ, whichever is larger) and 1.5X ,where X = Level of Interest). See Table 3.

Analyte selection should cover chromatographic range of separation.

Recoveries: Spike recoveries for each analyte in shrimp must be 80%-120% for

95% of analytes listed in Table 2. All analytes must demonstrate spike recovery performance between 60-120%.

Repeatability should be less than +/- 20% relative standard deviation of the mean

(RSD).

Table 3: Recommended fortification concentrations for target veterinary drugs.

Analyte

Class Level of Interest (ng/g)

Fortification Level 1 (ng/g) 0.5X;

n=3

Fortification Level (ng/g) 1.5X; n=3

Amoxicillin Beta Lactam 10 5.0 15 Ampicillin Beta Lactam 10 5.0 15 Chlortetracycline Tetracycline 50 25 75 Ciprofloxacin Fluoroquinolone 5 2.5 7.5 Cloxacillin Beta Lactam 10 5.0 15 Danofloxacin Fluoroquinolone 5 2.5 7.5 Difloxacin Fluoroquinolone 5 2.5 7.5 Doxycycline Tetracycline 50 25 75 Enrofloxacin Fluoroquinolone 5 2.5 7.5 Erythromycin Macrolide 50 25 75 Florfenicol Amine Phenicol 50 25 75 Flumequine Quinolone 10 5.0 15

Gentian Violet Triphenylmethane Dye 1 0.5 1.5

Hydroxy Mebendazole Anthelmintic 5 2.5 7.5

Leuco Gentian Violet Triphenylmethane Dye 1 0.5 1.5

Leuco Malachite Green Triphenylmethane Dye 1 0.5 1.5

Lincomycin Lincosamide 50 25 75

Malachite Green Triphenylmethane Dye 1 0.5 1.5

Mebendazole Anthelmintic 5 2.5 7.5 Mebendazole Amine Anthelmintic 5 2.5 7.5 Nalidixic Acid Quinolone 10 5.0 15

Norfloxacin Fluoroquinolone 5 2.5 7.5 Oxolinic Acid Quinolone 10 5.0 15 Oxytetracycline Tetracycline 50 25 75 Sarafloxacin Fluoroquinolone 5 2.5 7.5 Sulfacetamide Sulfonamide 10 5.0 15 Sulfachlorpyridazine Sulfonamide 10 5.0 15 Sulfadiazine Sulfonamide 10 5.0 15 Sulfadimethoxine Sulfonamide 10 5.0 15 Sulfadoxine Sulfonamide 10 5.0 15 Sulfaethoxypyridazine Sulfonamide 10 5.0 15 Sulfamerazine Sulfonamide 10 5.0 15 Sulfamethazine Sulfonamide 10 5.0 15 Sulfamethoxazole Sulfonamide 10 5.0 15 Sulfamethoxypyridazine Sulfonamide 10 5.0 15 Sulfamonomethoxine Sulfonamide 10 5.0 15 Sulfapyridine Sulfonamide 10 5.0 15 Sulfaquinoxaline Sulfonamide 10 5.0 15 Sulfathiazole Sulfonamide 10 5.0 15 Tetracycline Tetracycline 50 25 75 Thiamphenicol Phenicol 1 0.5 1.5 Trimethoprim Potentiator 10 5.0 15

Deliverables:

The Contractor shall meet with the FDA Technical Point of Contact, Program Staff and FDA Contracting Officer Representative at least once to discuss sample collection and method requirements.

Collect samples of raw or cooked, frozen farm-raised or aquaculture shrimp samples imported from specified countries as outlined in the requirements.

1. Chemical Analysis Testing of samples.

2. Multiclass Veterinary Drug Analysis of samples.

Delivery Schedule:

Task Deliverable Estimated Quantity

Frequency Required Format Due Date

Task 1 Kick Off Meeting

Once Conference Call/Webex/Zoom

Within ten

(10) calendar days after award

Task 2 Sample Purchase, Collection and Shipping

500 –

Variable Sample log is to be provided in Microsoft Word or Excel.

Photographs of packaging and/or labels is to be provided in PNG or JPEG format.

Within thirty (30)days after receiving information from FDA regarding the types of samples and countries to be obtained.

Task 3 Chemical Analysis Testing subsamples tested

Variable Results to be provided in Microsoft Word, Excel, or maybe printouts from scientific equipment used to perform the analysis.

Within thirty

(30) days after sample has been collected.

Task 4 Multiclass Veterinary Drug Analysis subsamples analyzed

Variable Results to be provided in Microsoft Word, Excel, or maybe printouts from scientific equipment used to perform the analysis.

Within thirty

(30) days after sample has been collected.

Contractor Provided Special Material Requirements:

1. Laboratories must have ISO 17025 accreditation or a similar accreditation from a recognized accreditation body (submit documentation).

2. Laboratories must provide documentation of the quality control measures that are instituted during batch runs of multiple samples as part of their standard operating procedures. These could include:

a. Independent Calibration Control (e.g. calibration standard)

b. Standard reference material (SRM)

c. Blank matrix spike

3. In addition, the FDA will include the requirement to run (at FDA cost) additional quality control analyses within sample sets. A typical Quality Control scheme is described below, however, the scheme will be adjusted at the time a final task order is submitted based on the Contractor’s typical QA scheme.

a. Spike recoveries will be performed by addition of analytes to the product matrix every 20th sample. If less than 20 samples are run in a batch, a spike should be run on at least one sample for each batch run. Given the large range of analyte concentrations, it is acceptable to perform an initial analysis of the unfortified sample, prior to performing and analyzing the spike recovery procedure. For samples that do not contain quantifiable concentrations of analyte, they can be fortified at 2-10x the LOQ of the method. For samples that do contain analyte, they should be fortified with 50-100% of the native concentration. For example, a sample that contains 10 ng/g of “X” may be fortified with an additional 5-10 ng/g, giving a final spiked concentration of 15 to 20 ng/g. These fortification amounts will allow recoveries to be calculated with only minor influences from the precision of the method. The value calculated for the recovery should be within ± 25% of the expected recovery. If the recoveries are not acceptable, appropriate actions should be taken and the spike recovery should be re-run. The mass or concentration and volume of analyte added to the sample must be reported with the results in order to allow an independent determination of the recovery.

b. Duplicate or triplicate analysis of a sample will be performed every 20th sample within the category. If less than 20 samples are run for a category, duplicates or triplicates should be run on at least one sample in the category for each batch run. For duplicate samples, they should agree to within 30%. For triplicate samples, the relative standard deviation should the same or better than the precision of the method itself (as relative standard deviation), or 20%, whichever is larger. Replicate analysis requires a new aliquot to be carried through the entire

c. method (sample preparation and analysis).

d. A method blank, which can be from a known blank matrix (chosen from among the matrix/product types above), must be prepared with every sample preparation batch. It is also recommended that a solvent or method blank be analyzed throughout a run to monitor contamination and carryover.

e. An independent calibration check standard shall be analyzed every 10th sample to monitor retention time and quantitative accuracy. (Calibration check samples must fall within the 95% confidence limits determined from the standard curve.) The calibration check standard should be run at a level that is near the mid-point of the analytical calibration curve. If there is a failure to meet this criterion, appropriate actions should be taken, and the standard should be re-analyzed. Additional failures require that a new calibration curve be prepared and all samples prior to the QC failure to be re-run. The true value (i.e., expected value) of the calibration check should be reported with the results to allow for an independent determination of the QC result.

4. Failure of any of QA/QC samples to meet method performance measures may require an explanation of what was done to correct the method and shall require reanalysis of the samples analyzed prior to loss of method control measures.

All deliverables shall be developed using Microsoft Office products that are compatible with the versions currently utilized by the FDA (i.e., MS 2016) and are 508 compliant. Quarterly reports shall be provided by e-mail from the Contractor.

The Contractor shall deliver all products to the TPOC/COR. The COR or other technical staff will notify the Contractor of deliverable acceptance regarding overall compliance with the guideline’s requirements of the task.

Section 508:

• Electronic content must be accessible to HHS acceptance criteria. Checklist for various formats are available at http://508.hhs.gov/, or from the Section 508 Coordinator listed at https://www.hhs.gov/web/section-508/additional-resources/section-508-contacts/index.html.

Materials that are final items for delivery should be accompanied by the appropriate checklist, except upon approval of the Contracting Officer or Representative.

Schedule of Supplies or Services and Prices/Costs (all costs shall be included in the unit price including but not limited to sample purchase, collection, analysis, shipping, overhead, travel, profit). No other prices/costs will be allowed to be added when task orders are issued:

Line Item Description Estimated

Quantity

Unit of

Issue

Unit Price

Extended Price http://508.hhs.gov/ https://www.hhs.gov/web/section-508/additional-resources/section-508-contacts/index.html

Task 1 - Kick Off Meeting in accordance the Statement of Work & Minimum Performance Requirements set forth above and herein.

GSA Contract #, if applicable__________

Each

Task 2 - Sample Purchase, Collection and Shipping in accordance the Statement of Work & Minimum Performance Requirements set forth above and herein. *For the purposes of pricing evaluations, 500 is the requested quote quantity.

Task 3 - Chemical Analysis Testing in accordance the Statement of Work & Minimum Performance Requirements set forth above and herein.

Sub samples tested

Task 4 - Multiclass Veterinary Drug Analysis in accordance the Statement of Work & Minimum Performance Requirements set forth above and herein

Sub samples analyze

Total Amount for CLIN 0001 - 0004 $ __________

Period of Performance:

The period of performance shall be twelve (12) months from contract award date.

Place of Performance:

Work under this contract shall be conducted at the contractor’s facilities.

Government-Furnished Property, Material, Equipment, or Information (GFP, GFM, GFE, or GFI) If requested, method of analysis recommended by FDA.

Security:

No unique security requirements are associated with the contract performance

Travel:

Contractor shall travel to major “brick and mortar” national chains, local retail chain locations and local independent stores and markets in two (minimum) major United States cities. Cities chosen shall be representative of major geographic regions (Eastern, Midwest, West) and may include the metropolitan areas of Atlanta, Chicago, Dallas, Denver, Los Angeles, New York, San Francisco, Seattle and Washington, DC. Travel shall be included in the unit price of the schedule of items above.

Solicitation Clauses:

FAR 52.212-4 Contract Terms and Conditions—Commercial Items (Deviation 2017-02) (Oct 2018) applies to this acquisition. Paragraph “r” is changed as follows:

“(r) Compliance with laws unique to Government contracts. The Contractor agrees to comply with 31 U.S.C.

1352 relating to limitations on the use of appropriated funds to influence certain Federal contracts; 18 U.S.C.

431 relating to officials not to benefit; 40 U.S.C. chapter 37, Contract Work Hours and Safety Standards; 41 U.S.C. chapter 87, Kickbacks; 10 U.S.C. 2409 relating to whistleblower protections; 49 U.S.C. 40118, Fly American; and 41 U.S.C. chapter 21 relating to procurement integrity.”

The following addenda to FAR 52.212-4 applies:

The following FAR and HHSAR provisions and clauses, incorporated by reference, apply to this acquisition and can be obtained at:

https://www.acquisition.gov/far/ and http://www.hhs.gov/grants/contracts/contract-policies-regulations/hhsar/index.html

FAR Clause:

52.204-13 System for Award Management and Maintenance (Oct 2018) 52.204-18 Commercial and Government Entity Code Maintenance (Aug 2020) 52.216-18 Ordering (OCT 1995)

For the purposes of this clause the blank(s) is/are completed as follows:

“(a)…issued from the date of contract award through one (1) year from contract award…”

52.216-19 Order Limitations (Oct 1995) For the purposes of this clause the blank(s) is/are completed as follows:

“(a) Minimum order. …amount less than 50 Sample Purchase, Collection and Shipping …” “(b) Maximum order.

(1) Any order for a single item in excess of 1,000 Sample Purchase, Collection and Shipping…;

(2) Any order for a combination of items in excess of 1,000 Sample Purchase, Collection and Shipping;

(3) A series of orders from the same ordering office within 5 calendar days…” “(d)… unless that order (or orders) is returned to the ordering office within 5 calendar days...”

52.216-22 Indefinite Quantity (Oct 1995) For the purposes of this clause the blank(s) is/are completed as follows:

“(d)… “… contract after the date of final payment under this.”

52.217-7 Option for Increased Quantity-Separately Priced Line Item This clause may be issued on subsequent task orders with applicable fill-in information https://www.acquisition.gov/far/ http://www.hhs.gov/grants/contracts/contract-policies-regulations/hhsar/index.html completed at that time.

52.222-49 Service Contract Labor Standards-Place of Performance Unknown (May 2014) For the purposes of this clause the blank(s) is/are completed as follows:

“(a)…none.”; “within 10 days of the issuance of this solicitation.”

HHSAR Clause:

352.222-70 Contractor Cooperation in Equal Employment Opportunity Investigations (Dec 2015) 352.239-74 Electronic and Information Technology Accessibility (Dec 2015)

Paragraph (c). The Section 508 standards applicable to this contract are:

• Must meet WCAG 2.0 A and AA

• E101.2 Equivalent Facilitation (Appendix A, Application and Scoping Requirements)

• E203 Access to Functionality (Appendix A, Application and Scoping Requirements)

• E204 Functional Performance Criteria (Appendix A, Application and Scoping

Requirements)

• E205 Electronic Content (Appendix A, Application and Scoping Requirements)

• 302 Functional Performance Criteria (Appendix C, Functional Performance Criteria and Technical Requirements)

• E208 Support Documentation and Services (Appendix A, Application and Scoping

Requirements)

• Electronic content must be accessible to HHS acceptance criteria. Checklist for various formats are available at http://508.hhs.gov/, or from the Section 508 Coordinator listed at https://www.hhs.gov/web/section-508/additional-resources/section-508-contacts/index.html. Materials that are final items for delivery should be accompanied by the appropriate checklist, except upon approval of the Contracting Officer or Representative.

• Chapter 6 Support Documentation and Services (Appendix C, Functional Performance Criteria and Technical Requirements)

Inspection/Acceptance:

The supplies and/or services delivered hereunder shall be inspected and accepted at destination by the Governments TPOC specified at award. If the supplies or services are acceptable, the TPOC shall promptly forward a report of inspection and acceptance to the paying office. If the supplies or services are not acceptable, the TPOC shall document the nonconforming items/services and immediately notify the Contracting Officer.

Contract Administration:

The Contracting Officer is the only person with authority to act as agent of the Government under this contract. Only the Contracting Officer has authority to: (1) direct or negotiate any changes in the contract; (2) modify or extend the period of performance; (3) change the delivery schedule; (4) authorize reimbursement to the Contractor any costs incurred during the performance of this contract; or (5) otherwise change any terms and conditions of this contract.

The following individual is the Contracting Officer for this contract:

Jennifer L. Johnson Phone: (870) 543-7830 Email Address: jennifer.johnson3@fda.hhs.gov

The TPOC is responsible for: (1) monitoring the Contractor's technical progress, including the surveillance and assessment of performance and recommending to the Contracting Officer changes in requirements; (2) interpreting the Statement of Work and any other technical performance requirements;

(3) performing technical evaluation as required; (4) performing technical inspections and acceptances http://508.hhs.gov/ https://www.hhs.gov/web/section-508/additional-resources/section-508-contacts/index.html https://www.hhs.gov/web/section-508/additional-resources/section-508-contacts/index.html mailto:jennifer.johnson3@fda.hhs.gov required by this contract; and (5) assisting in the resolution of technical problems encountered during performance.

The following individual has been identified as the Technical Point of Contact (TPOC) for this contract: (To be provided upon contract award) Name:

Phone:

Email address:

Contractor Performance Evaluation(s):

In accordance with Federal Acquisition Regulation (FAR) Subpart 42.15 – Contractor Performance Information, the FDA will complete annual and final contractor performance evaluations. Annual evaluations will be prepared to coincide with the anniversary date of the contract. Additional interim performance evaluations may be prepared at the CO’s discretion, as necessary. Final performance evaluations will be completed upon contract expiration.

FDA will utilize the Contractor Performance Assessment Reporting System (CPARS) to execute annual and final contractor performance evaluations. CPARS is a secure internet website located at https://www.cpars.gov/main/cparsmain.htm. FDA will register the contractor in CPARS upon receipt of the name and email address of two (2) individuals who will be responsible for serving as the Contractor’s primary and alternate CPARS contacts. Once FDA registers the contractor in CPARS, the Contractor will receive an automated CPARS email message which contains User IDs and instructions for creating a password.

Once a performance evaluation is issued, the Contractor’s primary and alternate CPARS contact will receive an email instructing them to logon to CPARS to review the performance evaluation. The Contractor has 14 calendar days from the date of performance evaluation issuance in which to review the evaluation. If the Contractor agrees with the performance evaluation outcome, the evaluation becomes final. Should the Contractor disagree with the performance evaluation outcome, rebuttal comments must be submitted via the CPARS within 14 days from date the evaluation was issued by FDA. Any disagreement between the CO and the Contractor will be referred to a contracting official one level above the CO, whose decision will be final.

Copies of each performance evaluation and contractor responses, if any, will be retained as part of the official contract file and will be used to support future award decisions. Evaluations will also be stored for a 3-year period (6 years for construction) in the https://www.cpars.gov/ system.

Contractors may obtain CPARS training material and register for on-line training at https://www.cpars.gov/main/cparsmain.htm . There is no fee for registration or use of the CPARS system.

Reporting Matters Involving Fraud, Waste, and Abuse Anyone who becomes aware of the existence or apparent existence of fraud, waste and abuse in FDA-funded programs is encouraged to report such matters to the HHS Inspector General’s Office in writing or to the Inspector General’s Hotline. The toll free number is 1-800-HHS-TIPS (1-800-447-8477). All telephone calls will be handled confidentially. The email address is HHStips@oig.hhs.gov and the mailing address is:

Office of Inspector General Department of Health and Human Services Attn: HOTLINE P.O. Box 23489 Washington, D.C. 20026 Information regarding procedural matters is contained on the HHS/OIG website at http://oig.hhs.gov/hotline.html

Organizational Conflicts of Interest (Simplified):

http://www.cpars.gov/main/cparsmain.htm.

https://www.cpars.gov/ https://www.cpars.gov/main/cparsmain.htm mailto:HHStips@oig.hhs.gov http://oig.hhs.gov/hotline.html

a. The Contractor warrants that, to the best of its knowledge and belief, and except as otherwise disclosed to the Contracting Officer, he or she does not have any actual or potential conflict of interests pertaining to the subject contract, as defined in Federal Acquisition Regulation (FAR) Subpart 9.5.

b. The Contractor agrees that, if after award he or she discovers an organizational conflict of interest with respect to this contract, he or she shall make an immediate and full disclosure in writing to the Contracting Officer.

c. The Government reserves the right to exercise any remedy available at law or equity, including termination of the contract for cause or convenience, should the Government determine that remedial action is necessary to address any identified actual or potential conflicts of interests.

d. All contractor personnel involved in this requirement shall abide by the FDA’s Form FDA 3398 – Commitment to Protect Non-Public Information Employee Agreement included at Attachment 1.

FDA Data Disclosure Procedures Dissemination, Publication and Distribution of Information Data and information either provided to the Contractor, or to any subcontractor or generated by activities under this contract or derived from research or studies supported by this contract, shall be used only for the purposes of the contract. It shall not be duplicated, used or disclosed for any purpose other than the fulfillment of the requirements set forth in this contract. This restriction does not limit the Contractor’s right to use data or information obtained from a non-restrictive source. Any questions concerning “privileged information” shall be referred to the Contracting Officer.

Any questions about use or release of the data or information or handling of material under this contract shall be referred to the COR who must render a written determination to the Contracting Officer (CO). The COR’s determination will reflect the results of internal coordination with appropriate program and legal officials. After receipt of the COR’s written determination, the CO will make a final decision authorizing the release of information.

Invoices:

FDA Three-Way Invoicing Procedures:

A. The contractor shall submit all invoices to:

U.S. FOOD AND DRUG ADMINISTRATION

Attn: Vendor Payments Division of Payment Services 10903 New Hampshire Ave WO32 - Second Floor

MAIL HUB 2145

Silver Spring, MD 20993-0002

(301) 827-3742 E-mail: FDAVendorPaymentsTeam@fda.hhs.gov *** Acceptable methods of delivery include: E-mail (preferred) and Standard Mail.

Provide a copy marked courtesy to the COR or Technical Point of Contact (TPOC). The COR/TPOC is:

To be provided upon contract award.

B. Invoices submitted under this contract must comply with the requirements set forth in FAR Clauses 52.232-25 (Prompt Payment) and 52.232-33 (Payment by Electronic Funds Transfer – System for Award mailto:FDAVendorPaymentsTeam@fda.hhs.gov

Management) and/or other applicable FAR clauses specified herein. To constitute a proper invoice, the invoice must be submitted on company letterhead and include each of the following:

(i) Name and address of the contractor;

(ii) Invoice date and invoice number;

(iii) Contract/Order number (including a reference to any base award for Indefinite-Delivery/Indefinite- Quantity Contracts or Blanket Purchase Agreements);

(iv) Description, quantity, unit of measure, unit price, and extended price supplies delivered or services performed, including:

(a) period of performance for which costs are claimed;

(b) itemized travel costs, including origin and destination;

(c) any other supporting information necessary to clarify questionable expenditures;

(d) the contractor shall include the Contract Line Item/Funding line item for each description, quantity, unit of measure, unit price, and extended price supplies delivered or services performed;

(v) Shipping number and date of shipment, including the bill of lading number and weight of shipment if shipped on government bill of lading;

(vi) Terms of any discount for prompt payment offered (Prompt Payment terms other than NET 30);

(vii) Name and address of official to whom payment is to be sent (must be the same as that in the purchase order/award, or in a proper notice of assignment)

(viii) Name, title, and phone number of person to notify in event of defective invoice;

(ix) Taxpayer Identification Number (TIN);

(x) Electronic funds transfer (EFT) banking information, including routing transit number of the financial institution receiving payment;

(xi) Name and telephone number of the FDA Contracting Officer Representative (COR) or other Program Center/Office point of contact, as referenced on the award;

(xii) For all Time-and-Materials and Labor-Hour Awards, Contractor is required to attach an invoice log addendum to each invoice which shall include, at a minimum, the following information for contract administration and reconciliation purposes:

(a) list of all invoices submitted to date under the subject award, including the following:

(1) invoice number, amount, & date submitted

(2) corresponding payment amount & date received

(b) total amount of all payments received to date under the subject contract or order

(c) and, for definitized contracts or orders only, total estimated amounts yet to be invoiced for the current, active period of performance;

(xiii) Any other information or documentation required by the award.

C. An electronic invoice is acceptable if submitted in adobe acrobat (PDF) format. All items listed in (i) through (xiii) of this clause must be included in the electronic invoice. Electronic invoices must be on company letterhead and must contain no ink changes and be legible for printing.

D. Questions regarding invoice payments should be directed to the Employee Resource and Information Center (ERIC) Helpdesk at 301-827-ERIC (3742) or toll-free 866-807-ERIC (3742); or, by email at ERIC@fda.hhs.gov. Refer to the Call-in menu options and follow the phone prompts to dial the option that corresponds to the service that's needed. All ERIC Service Now Tickets will either be responded to or resolved within 48 hours (2 business days) of being received. When emailing, please be sure to include the contract number, invoice number and date of invoice, as well as your name, phone number, and a detailed description of the issue.

Be advised that FDA does not accept documents which contain the use of macros. Document submissions required throughout the award period(s) shall not have macro enabled functionality and any document delivered having that functionality will be deemed delinquent, if not corrected prior to the due date.

Payments Terms:

mailto:ERIC@fda.hhs.gov

Net 30 days after government acceptance. No advance payment will be made.

52.212-5 -- Contract Terms and Conditions Required to Implement Statutes or Executive Orders -- Commercial Items (Jul 2021) (Deviation Apr 2020) and (Deviation 2020-05 Oct 2020) (Deviation 2017-02, Jun 2017).

(a) The Contractor shall comply with the following Federal Acquisition Regulation (FAR) clauses, which are incorporated in this contract by reference, to implement provisions of law or Executive orders applicable to acquisitions of commercial items:

(1) 52.203-19, Prohibition on Requiring Certain Internal Confidentiality Agreements or Statements (Jan 2017) (section 743 of Division E, Title VII, of the Consolidated and Further Continuing Appropriations Act, 2015 (Pub. L. 113-235) and its successor provisions in subsequent appropriations acts (and as extended in continuing resolutions)).

(2) 52.204-23, Prohibition on Contracting for Hardware, Software, and Services Developed or Provided by Kaspersky Lab and Other Covered Entities (Jul 2018) (Section 1634 of Pub. L. 115-91).

(3) 52.204-25, Prohibition on Contracting for Certain Telecommunications and Video Surveillance Services or Equipment. (Aug 2019) (Section 889(a)(1)(A) of Pub. L. 115-232).

(4) 52.209-10, Prohibition on Contracting with Inverted Domestic Corporations (Nov 2015).

(5) 52.233-3, Protest After Award (Aug 1996) (31 U.S.C.3553).

(6) 52.233-4, Applicable Law for Breach of Contract Claim (Oct 2004) (Public Laws 108-77 and 108-78 (19 U.S.C. 3805 note)).

(b) The Contractor shall comply with the FAR clauses in this paragraph (b) that the Contracting Officer has indicated as being incorporated in this contract by reference to implement provisions of law or Executive orders applicable to acquisitions of commercial items:

__ (1) 52.203-6, Restrictions on Subcontractor Sales to the Government (Sept 2006), with Alternate I (Oct 1995) (41 U.S.C.4704 and 10 U.S.C.2402).

__ (2) 52.203-13, Contractor Code of Business Ethics and Conduct (Oct 2015) (41 U.S.C. 3509)).

__ (3) 52.203-15, Whistleblower Protections under the American Recovery and Reinvestment Act of 2009 (June 2010) (Section 1553 of Pub. L. 111-5). (Applies to contracts funded by the American Recovery and Reinvestment Act of 2009.)

_X_ (4) 52.203-17, Contractor Employee Whistleblower Rights and Requirement to Inform Employees of Whistleblower Rights (Jun 2020) (41 U.S.C. 4712) relating to whistleblower protections) __ (5) 52.204-10, Reporting Executive Compensation and First-Tier Subcontract Awards (Oct 2018) (Pub. L. 109-282) (31 U.S.C. 6101 note).

__ (6) [Reserved].

__ (7) 52.204-14, Service Contract Reporting Requirements (Oct 2016) (Pub. L. 111-117, section 743 of Div. C).

__ (8) 52.204-15, Service Contract Reporting Requirements for Indefinite-Delivery Contracts (Oct 2016) (Pub. L. 111-117, section 743 of Div. C).

_X (9) 52.209-6, Protecting the Government’s Interest When Subcontracting with Contractors Debarred, Suspended, or Proposed for Debarment. (Oct 2015) (31 U.S.C. 6101 note).

__ (10) 52.209-9, Updates of Publicly Available Information Regarding Responsibility Matters (Oct 2018) (41 U.S.C. 2313).

__ (11) [Reserved].

__ (12) (i) 52.219-3, Notice of HUBZone Set-Aside or Sole-Source Award (Mar 2020) (15 U.S.C. 657a).

__ (ii) Alternate I (Mar 2020) of 52.219-3.

__ (13) (i) 52.219-4, Notice of Price Evaluation Preference for HUBZone Small Business Concerns (Mar 2020) (if the offeror elects to waive the preference, it shall so indicate in its offer) (15 U.S.C. 657a).

__ (ii) Alternate I (Mar 2020) of 52.219-4.

__…