FDA-SB-1244563.pdf

FDA-SB-1244563

Title: Third Party Retail Shrimp Sampling

DESCRIPTION

This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Federal Acquisition Regulation (FAR) Subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; quotes are being requested, and a separate written solicitation shall not be issued.

This solicitation is a Request for Quote (RFQ) using FAR Parts 12 and 13 procedures. The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) 2021-03. The North American Industry Classification System (NAICS) code for the proposed acquisition is 541380 Testing Laboratories, 541690 Other Scientific and Technical Consulting Services.

The solicitation is set aside for small business.

BACKGROUND

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.

OBJECTIVE

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.

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 approximately 500-100 samples of imported farm-raised or aquaculture shrimp to determine the levels of chemical contaminants and drug residues.

TASKS

The Contractor shall collect and analyze approximately 500-1000 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.

Task 1-Kick Off Meeting

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

Task 2 – Sample Purchase, Collection and Shipping

Task 2 – Sample Purchase, Collection and Shipping

The Contractor shall collect 500 – 1000 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 (between 500 and 1000), 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.

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 detailshall be sufficient to allow FDA to establish equivalence to the above cited methods.

Target analytes for the analysis:

1. LC-MS/MS Quantitative Analysis:

a. 1-aminohydantoin (AHD)

b. 3-amino-5-morpholinomethyl-2-oxazolidinone (AMOZ)

c. 3-amino-2-oxazolidinone (AOZ)

d. semicarbazide (SC)

e. chloramphenicol (CAP) 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

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:

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

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 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.

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

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 Interes t (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 Sulfacetamide Sulfonamide 10 Sulfachlorpyridazine Sulfonamide 10 Sulfadiazine Sulfonamide 10 Sulfadimethoxine Sulfonamide 10 Sulfadoxine Sulfonamide 10 Sulfaethoxypyridazi ne Sulfonamide 10 Sulfamerazine Sulfonamide 10 Sulfamethazine Sulfonamide 10 Sulfamethoxazole Sulfonamide 10 Sulfamethoxypyrida zine Sulfonamide 10 Sulfamonomethoxin e 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 Interes t (ng/g)

Fortificati on Level 1 (ng/g) 0.5X; n=3

Fortificati on Level 2 (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 Sulfaethoxypyridazi ne Sulfonamide 10 5.0 15 Sulfamerazine Sulfonamide 10 5.0 15 Sulfamethazine Sulfonamide 10 5.0 15 Sulfamethoxazole Sulfonamide 10 5.0 15 Sulfamethoxypyrida zine Sulfonamide 10 5.0 15 Sulfamonomethoxin e 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

DELIVERABLE(s)

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 500 – 1000 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

GOVERNMENT-FURNISHED PROPERTY, MATERIAL, EQUIPMENT, OR INFORMATION

(GFP, GFM, GFE, OR GFI)

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:

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

Task

Deliverable Quantity Frequency Required Format Due Date

Task 1 Kick Off Meeting Once Conference Call/Webex/Zoom

Within ten

(10) days after award

Task 2 Sample Purchase, Collection and Shipping

500 – 1000 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.

Task 3 Chemical Analysis Testing subsamples tested

Variable Results to be provided in Microsoft Word, Excel, or ????

Task 4 Multiclass Veterinary Drug Analysis subsamples analyzed

Variable Results to be provided in Microsoft Word, Excel, or?????

2. Standard reference material (SRM)

3. 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.

1. Spike recoveries will be performed by addition of analytes to the 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.

2. 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 method (sample preparation and analysis).

3. 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.

4. 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.

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.

SECTION 508 COMPLIANCE

Section 508 of the Rehabilitation Act of 1973 (29 U.S.C. 794d) requires Federal agencies to purchase electronic and information technologies (EIT) that meet specific accessibility standards. This law helps to ensure that federal employees with disabilities have access to, and use of, the information and data they need to do their jobs. Furthermore, this law ensures that members of the public with disabilities have the ability to access government information and services.

There are three regulations addressing the requirements detailed in Section 508. The Section 508 technical and functional standards are codified at 36 CFR Part 1194 and may be accessed through the Access Board’s Web site at http://www.access-board.gov. The second regulation issued to implement Section 508 is the Federal Acquisition Regulation (FAR). FAR Part 39.2 requires that agency acquisitions of Electronic and Information Technology (EIT) comply with the Access Board’s standards. The entire FAR is found at Chapter 1 of the Code of Federal Register (CFR) Title 48, located at http://www.acquisition.gov. The FAR rule implementing Section 508 can be found at http://www.section508.gov. The third applicable regulation is the HHS Acquisition Regulation (HHSAR).

Regardless of format, all Web content or communications materials produced for publication on or delivery via HHS Web sites - including text, audio or video - must conform to applicable Section 508 standards to allow federal employees and members of the public with disabilities to access information that is comparable to information provided to persons without disabilities. All contractors (including subcontractors) or consultants responsible for preparing or posting content intended for use on an HHS-funded or HHS-managed Web site must comply with applicable Section 508 accessibility standards, and where applicable, those set forth in the referenced policy or standards documents below. Remediation of any materials that do not comply with the applicable provisions of 36 CFR Part 1194 as set forth in the SOW, shall be the responsibility of the contractor or consultant retained to produce the Web-suitable content or communications material.

Unless an agency exception to this requirement exists, the Contractor must conform to applicable Section 508 standards and must apply best practices associated with Section 508 compliance during the application design, development, and testing phases. The Contractor shall utilize FDA approved tools to verify the compliance with the Section 508 standards and ensure the delivery of the fully compliant products.

The following Sections apply to this procurement:

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, Application and Scoping Requirements) E208 Support Documentation and Services (Appendix A, Application and Scoping Requirements) http://www.access-board.gov/ http://www.acquisition.gov/ http://www.section508.gov/

Chapter 6 Support Documentation (Appendix C, Application and Scoping

OTHER CONSIDERATIONS

a. Quality Assurance: All Methods

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

ii. 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:

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

2. Standard reference material (SRM)

3. Blank matrix spike

iii. 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.

1. Spike recoveries will be performed by addition of analytes to the 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.

2. 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 method (sample preparation and analysis).

3. 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.

4. 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.

iv. 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.

PLACE OF PERFORMANCE

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

PERIOD OF PERFORMANCE

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

CONTRACT ADMINISTRATION

The Contracting Officer’s Representative (COR) will perform inspection and acceptance of equipment, installation and services to be provided.

The COR is responsible for the following as required by this order: (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 evaluations; (4) performing technical inspections and acceptances; and (5) assisting in the resolution of technical problems encountered during performance.

The Contracting Officer is the only person with authority to act as an agent of the Government under this order. Only the Contracting Officer has authority to: direct or negotiate any changes in the order, including modifying or extending the period of performance, changing the delivery schedule, authorizing reimbursement to the Contractor for any costs incurred during the performance of this order, or otherwise change any terms and conditions of this order.

The contact information for the FDA Contracting Officer’s Representative is: TBD

The contact information for the FDA Contracting Officer is: TBD

The contact information for the FDA Contract Specialist is the following: TBD

The contact information for the contractor is: TBD

CONTRACT CLAUSES

FAR Clauses Incorporated by Reference:

52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998)

This contract incorporates one or more clauses by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. Also, the full text of a clause may be accessed electronically at: www.acquisition.gov/far/index.html

52.204-18 Commercial and Government Entity Code Maintenance (Jul 2016) 52.202-1 Definitions (November 2013) 52.203-5 Covenant Against Contingent Fees (May 2014) 52.203-7 Anti-Kickback Procedures (May 2014) 52.212-4 Contract Terms and Conditions-Commercial Items (Oct 2018) 52.232-39 Unenforceability of Unauthorized Obligations (Jun 2013) 52.232-40 Providing Accelerated Payments to Small Business Subcontractors (Dec 2013) 52.233-4 Applicable Law for Breach of Contract Claim (Oct 2004)

FAR Clauses in Full Text:

52.212-3 Offeror Representations and Certifications-Commercial Items

As prescribed in 12.301(b)(2), insert the following provision:

OFFEROR REPRESENTATIONS AND CERTIFICATIONS-COMMERCIAL ITEMS (JAN 2021)

The Offeror shall complete only paragraph (b) of this provision if the Offeror has completed the annual representations and certification electronically in the System for Award Management (SAM) accessed through https://www.sam.gov. If the Offeror has not completed the annual representations and certifications electronically, the Offeror shall complete only paragraphs (c) through (v)) of this provision.

(a) Definitions. As used in this provision— "Covered telecommunications equipment or services" has the meaning provided in the clause 52.204-

25, Prohibition on Contracting for Certain Telecommunications and Video Surveillance Services or Equipment.

Economically disadvantaged women-owned small business (EDWOSB) concern means a small business concern that is at least 51 percent directly and unconditionally owned by, and the management and daily business operations of which are controlled by, one or more women who are citizens of the http://www.acquisition.gov/far/index.html https://www.acquisition.gov/sites/default/files/current/far/html/52_212_213.html#wp1179194 https://www.acquisition.gov/far/part-12#FAR_12_301 https://www.sam.gov/ https://www.acquisition.gov/far/part-52#FAR_52_204_25

United States and who are economically disadvantaged in accordance with 13 CFR part 127. It automatically qualifies as a women-owned small business eligible under the WOSB Program.

Forced or indentured child labor means all work or service—

(1) Exacted from any person under the age of 18 under the menace of any penalty for its nonperformance and for which the worker does not offer himself voluntarily; or

(2) Performed by any person under the age of 18 pursuant to a contract the enforcement of which can be accomplished by process or penalties.

Highest-level owner means the entity that owns or controls an immediate owner of the offeror, or that owns or controls one or more entities that control an immediate owner of the offeror. No entity owns or exercises control of the highest level owner.

Immediate owner means an entity, other than the offeror, that has direct control of the offeror.

Indicators of control include, but are not limited to, one or more of the following: ownership or interlocking management, identity of interests among family members, shared facilities and equipment, and the common use of employees.

Inverted domestic corporation, means a foreign incorporated entity that meets the definition of an inverted domestic corporation under 6 U.S.C. 395(b), applied in accordance with the rules and definitions of 6 U.S.C. 395(c).

Manufactured end product means any end product in product and service codes (PSCs) 1000-9999, except—

(1) PSC 5510, Lumber and Related Basic Wood Materials;

(2) Product or Service Group (PSG) 87, Agricultural Supplies;

(3) PSG 88, Live Animals;

(4) PSG 89, Subsistence;

(5) PSC 9410, Crude Grades of Plant Materials;

(6) PSC 9430, Miscellaneous Crude Animal Products, Inedible;

(7) PSC 9440, Miscellaneous Crude Agricultural and Forestry Products;

(8) PSC 9610, Ores;

(9) PSC 9620, Minerals, Natural and Synthetic; and

(10) PSC 9630, Additive Metal Materials.

Place of manufacture means the place where an end product is assembled out of components, or otherwise made or processed from raw materials into the finished product that is to be provided to the Government. If a product is disassembled and reassembled, the place of reassembly is not the place of manufacture.

Predecessor means an entity that is replaced by a successor and includes any predecessors of the predecessor.

Reasonable inquiry has the meaning provided in the clause 52.204-25, Prohibition on Contracting for Certain Telecommunications and Video Surveillance Services or Equipment.

Restricted business operations means business operations in Sudan that include power production activities, mineral extraction activities, oil-related activities, or the production of military equipment, as those terms are defined in the Sudan Accountability and Divestment Act of 2007 (Pub. L. 110-174).

Restricted business operations do not include business operations that the person (as that term is defined in Section 2 of the Sudan Accountability and Divestment Act of 2007) conducting the business can demonstrate—

(1) Are conducted under contract directly and exclusively with the regional government of southern Sudan;

http://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title6-section395&num=0&edition=prelim http://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title6-section395&num=0&edition=prelim

(2) Are conducted pursuant to specific authorization from the Office of Foreign Assets Control in the Department of the Treasury, or are expressly exempted under Federal law from the requirement to be conducted under such authorization;

(3) Consist of providing goods or services to marginalized populations of Sudan;

(4) Consist of providing goods or services to an internationally recognized peacekeeping force or humanitarian organization;

(5) Consist of providing goods or services that are used only to promote health or education; or

(6) Have been voluntarily suspended."Sensitive technology"— Sensitive technology—

(1) Means hardware, software, telecommunications equipment, or any other technology that is to be used specifically—

(i) To restrict the free flow of unbiased information in Iran; or

(ii) To disrupt, monitor, or otherwise restrict speech of the people of Iran; and

(2) Does not include information or informational materials the export of which the President does not have the authority to regulate or prohibit pursuant to section 203(b)(3)of the International Emergency Economic Powers Act (50 U.S.C. 1702(b)(3)).

Service-disabled veteran-owned small business concern—

(1) Means a small business concern—

(i) Not less than 51 percent of which is owned by one or more service-disabled veterans or, in the case of any publicly owned business, not less than 51 percent of the stock of which is owned by one or more service-disabled veterans; and

(ii) The management and daily business operations of which are controlled by one or more service-disabled veteransor, in the case of a service-disabled veteran with permanent and severe disability, the spouse or permanent caregiver of such veteran.

(2) Service-disabled veteran means a veteran, as defined in 38 U.S.C. 101(2), with a disability that is service connected, as defined in 38 U.S.C. 101(16).

Small business concern—

(1) Means a concern, including its affiliates, that is independently owned and operated, not dominant in the field of operation in which it is bidding on Government contracts, and qualified as a small business under the criteria in 13 CFR part 121 and size standards in this solicitation.

(2) Affiliates, as used in this definition, means business concerns, one of whom directly or indirectly controls or has the power to control the others, or a third party or parties control or have the power to control the others. In determining whether affiliation exists, consideration is given to all appropriate factors including common ownership, common management, and contractual relationships.

SBA determines affiliation based on the factors set forth at 13 CFR 121.103.

Small disadvantaged business concern, consistent with13 CFR 124.1002, means a small business concern under the size standard applicable to the acquisition, that—

(1) Is at least 51 percent unconditionally and directly owned (as defined at 13 CFR 124.105) by—

(i) One or more socially disadvantaged (as defined at13 CFR 124.103) and economically disadvantaged (as defined at 13 CFR 124.104) individuals who are citizens of the United States; and

(ii) Each individual claiming economic disadvantage has a net worth not exceeding $750,000 after taking into account the applicable exclusions set forth at 13 CFR124.104(c)(2); and

(2) The management and daily business operations of which are controlled (as defined at 13.CFR

124.106) by individuals, who meet the criteria in paragraphs (1)(i) and (ii) of this definition.

Subsidiary means an entity in which more than 50 percent of the entity is owned—

(1) Directly by a parent corporation; or http://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title38-section101&num=0&edition=prelim http://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title38-section101&num=0&edition=prelim

(2) Through another subsidiary of a parent corporation Successor means an entity that has replaced a predecessor by acquiring the assets and carrying out the affairs of the predecessor under a new name (often through acquisition or merger). The term "successor" does not include new offices/divisions of the same company or a company that only changes its name. The extent of the responsibility of the successor for the liabilities of the predecessor may vary, depending on State law and specific circumstances.

Veteran-owned small business concern means a small business concern—

(1) Not less than 51 percent of which is owned by one or more veterans (as defined at 38 U.S.C.

101(2)) or, in the case of any publicly owned business, not less than 51 percent of the stock of which is owned by one or more veterans; and

(2) The management and daily business operations of which are controlled by one or more veterans.

Women-owned small business (WOSB) concern eligible under the WOSB Program (in accordance with 13 CFR part 127), means a small business concern that is at least 51 percent directly and unconditionally owned by, and the management and daily business operations of which are controlled by, one or more women who are citizens of the United States.

Women-owned small business concern means a small business concern—

(1) That is at least 51 percent owned by one or more women; or, in the case of any publicly owned business, at least51 percent of the stock of which is owned by one or more women; and

(2) Whose management and daily business operations are controlled by one or more women.

(b)

(1) Annual Representations and Certifications. Any changes provided by the Offeror in paragraph (b)(2) of this provision do not automatically change the representations and certifications in SAM

(2) The offeror has completed the annual representations and certifications electronically in SAM accessed through http://www.sam.gov. After reviewing SAM information, the Offeror verifies by submission of this offer that the representations and certifications currently posted electronically at FAR 52.212-3, Offeror Representations and Certifications-Commercial Items, have been entered or updated in the last 12 months, are current, accurate, complete, and applicable to this solicitation (including the business size standard(s) applicable to the NAICS code(s) referenced for this solicitation), at the time this offer is submitted and are incorporated in this offer by reference (see FAR 4.1201), except for paragraphs ______________.

[Offeror to identify the applicable paragraphs at (c) through (v) of this provision that the offeror has completed for the purposes of this solicitation only, if any.

These amended representation(s) and/or certification(s) are also incorporated in this offer and are current, accurate, and complete as of the date of this offer.

Any changes provided by the offeror are applicable to this solicitation only, and do not result in an update to the representations and certifications posted electronically on SAM.]

(c) Offerors must complete the following representations when the resulting contract will be performed in the United States or its outlying areas. Check all that apply.

(1) Small business concern. The offeror represents as part of its offer that it □ is, □ is not a small business concern.

(2) Veteran-owned small business concern. [Complete only if the offeror represented itself as a small business concern in paragraph (c)(1) of this provision.] The offeror represents as part of its offer that it □ is, □ is not a veteran-owned small business concern.

(3) Service-disabled veteran-owned small business concern. [Complete only if the offeror represented itself as a veteran-owned small business concern in paragraph (c)(2) of this provision.] The http://www.sam.gov/ https://www.acquisition.gov/far/part-52#FAR_52_212_3 https://www.acquisition.gov/far/part-4#FAR_4_1201 offeror represents as part of its offer that it □ is, □ is not a service-disabled veteran-owned small business concern.

(4) Small disadvantaged business concern. [Complete only if the offeror represented itself as a small business concern in paragraph (c)(1) of this provision.] The offeror represents, that it □ is, □ is not a small disadvantaged business concern as defined in 13 CFR124.1002.

(5) Women-owned small business concern. [Complete only if the offeror represented itself as a small business concern in paragraph (c)(1) of this provision.] The offeror represents that it □ is, □ is not a women-owned small business concern.

(6) WOSB concern eligible under the WOSB Program. [Complete only if the offeror represented itself as a women-owned small business concern in paragraph (c)(5) of this provision.] The offeror represents that-

(i) It □ is, □ is not a WOSB concern eligible under the WOSB Program, has provided all the required documents to the WOSB Repository, and no change in circumstances or adverse decisions have been issued that…