sEval Criteria.docx

INSTRUCTIONS FOR SUBMISSION OF THE TECHNICAL PROPOSAL

Ill.Technical Quote Requirements

This section contains specific technical proposal requirements, which must be addressed in detail, as set forth below. This section is critical to the technical evaluation process.

The offeror shall submit a Technical Quote that includes plans and procedures for conducting the testing and analysis of ingredients in dietary supplements (DSs). Quotes must include details for the analysis of ingredients and tests in the DSs listed in Appendix A, but the offeror is not required to bid on every test and ingredient listed.

The offeror may submit prices on all or some• of the tests and ingredient assays listed in Appendix A using one of the following options:

Option 1: Tests and Assays in all sections listed in Attachment A (Sections 1, 2, 3, 4 and 5) Option 2: Tests and Assays in all sections except Botanicals (Sections 1, 2, 4 and 5) Option 3: Tests and Assays in all sections except Physical Testing (Sections 1, 2, 3 and 5) Option 4: Assays in sections: Vitamins and Botanicals (Sections 1 and 3) Option 5: Assays in section: Botanicals (Section 3)

*The offeror is required to submit prices for all (or at least 80-90%) of the required tests and assays in each section, based on the five options above. For the Vitamins, Minerals, Botanicals and Proximates sections, there are additional optional assays listed. The offeror may submit prices for all or some of the optional assays in these sections only if the offeror also submits prices on at least 80-90% of the required ingredients in that section. The offeror may not submit prices for just Proximates or Physical Testing (sections 4 and 5) or for just a few ingredients in Attachment A.

The offeror must provide supporting documentation about their experience and/or demonstrated expertise. The offeror must include details about which ingredients can be analyzed with methods already validated in their lab (and used routinely) for DS matrices. The offeror shall also describe the process by which they will assure method performance. The technical quote shall, at a minimum, address the following:

A. Technical Approach

The technical approach shall identify specific methods and procedures that the offeror will use to complete each task. The discussion shall include: description of number of samples and amount of material which can be handled; procedures for sample weighing, grinding, lyophilization and homogenization; lab equipment to be used; any precautionary measures to prevent contamination and deterioration; sample handling and storage conditions, including temperature; and procedures for identifying, labeling and tracking samples.

For analytical or test methods, provide the title of the method, AOAC, Int. or USP method number if relevant, or a complete reference for any other proposed method. A detailed description is only

DRAFT April 2, 2020 necessary if the method has been developed in-house. Document any modifications for specific matrices; the limit of detection; limit of quantification; and analytical sample size for levels typically found in DSs. Provide method verification and validation procedures.

Specific information is needed on the following methods and ingredients:

· Indicate whether any or all of the following methods will be used for folate analysis: HPLC, single enzyme or tri-enzyme microbiological methods.

· Specify if folic acid, methylfolate and folinic acid (calcium folinate) can be quantified in the same method or require separate methods of analysis in your laboratory. Specify what OS forms (capsules, tablets, soft gels, liquids, powders, gummies, chews, etc.) are validated for these ingredients.

· The vitamin D methods used must be able to separate vitamin 02 from vitamin 03•

· Iodine analysis must use an ICP-MS method.

· Analytical assays that are part of dissolution testing must be performed in the same location as the dissolution test.

In addition, provide information on the following topics:

· Indicate whether any ingredients listed in Appendix A are subcontracted on a regular basis. If yes, detailed information on the subcontractor should be given, including how sample integrity will be maintained during transit.

· OS manufacturers and distributors are currently transitioning to new FDA labeling requirements for Supplement Facts panels. The offerer shall provide information about how they have modified methods and reporting procedures to take these changes into account, especially for vitamins A, D and E. The offerer may be required to report results in both the old and new labeling units.

· Indicate in table form the number of times a particular test or assay has been done monthly during the past one or two years. Please specify which of the tests were for food matrices and which were for dietary supplement matrices.

B. Quality Control Plan

The quote shall include a detailed Quality Control Plan (QC Plan), that is, a set of procedures by which the accuracy and precision of the generated data are determined and maintained. This discussion should include descriptions and results from Standard and Certified Reference Materials (SRMs, CRMs) and in house QC materials, in addition to spike recoveries. Representative QC charts or reports for tests specified and for ingredients in dietary supplements run within the last twelve months shall be included.

C. Project Management

The offeror shall submit a staffing and management plan indicating how the proposed work will be managed and performed. Furnish curriculum vitae for key members of the proposed project team.

IV. Timeline/Schedule

DRAFT April 2, 2020

The delivery schedule is based on an anticipated start date of October 1, 2020 The following activities/deliverables are required under this contract:

Turnaround

receipt

The same schedule applies for each option year and task order.

V. Price Quotation

The offerer must furnish a comprehensive price quotation for performing the analysis of ingredients and other tests using validated analytical methods and reporting the results according to the instructions in the Statement of Work. The award will be based on the determination of best value to the government.

Technical Evaluation Criteria: In relative Order of Importance

Technical Approach

The technical approach shall identify methods and procedures required to complete each task. The offerer can choose to bid on all ingredients and tests in Attachment A or on a more limited selection. See Attachment A or Section Ill of the SOW for information on the options for bidding.

For each ingredient or test or ingredient category (e.g., ICP minerals), the proposal shall include information about the analytical method(s) to be used.

Elements of evaluation Analytical Methods. If a published/compendium method is used, note the reference and any modifications made by the offerer. If the method was developed in-house, describe the method in detail, including extraction, separation, and quantitation and noting unique or critical steps. For all methods, list the ingredient forms and sample matrices, and list the limits of detection and quantification. Identify ingredient forms and DS forms (tablet, capsule, etc.) that can be analyzed with each method. list the number of samples that your laboratory can perform per batch and per day.

Validation Procedures. Identify how analytical methods were validated for use in your laboratory to assure accurate results.

Sample Preparation. Include descriptions of specific procedures for weighing, homogenizing, and preparing various forms of dietary supplements (i.e., tablets, capsules, softgels, gummies, liquids, etc.) and the extraction of labile and microencapsulated ingredients. Describe the equipment used. Describe steps to prevent contamination and deterioration of ingredients.

Sample identification, Storage and Tracking. Include a description of the entire storage period (before and after sample preparation and sample retention, storage of re-test samples). Detail specific equipment for storage (# of freezers, temperatures and monitoring). Indicate how samples will be identified, tracked, monitored and managed.

Test Frequency. Include the number of times each assay or test was performed in your laboratory during the course of the past one - two years and whether it was tested in a DS or food.

Analytical Quality Control

The proposal shall include a detailed discussion of quality control procedures by which the reliability of the generated data is determined.

Elements of evaluation Method Validation. Discuss how the laboratory uses spikes, recoveries, blanks, blind duplicates, standard curves, internal standards, certified reference materials and in house control materials to validate methods.

Quality Control Materials and Monitoring. Specify how in-house materials are developed, validated and stored and how they are used to monitor quality control. Discuss how quality is monitored on a day-to-day basis. Frequency of use for each QC measure, action level, and the action to be taken if the results are out of specification.

Laboratory and staff affiliations with proficiency testing programs and methods development and certification organizations. Detail how your involvement improves the quality of your assays and tests.

QC Charts. Representative quality control charts or reports for ingredients in dietary supplements run within the last twelve (12) months shall be included for review with this proposal.

Past Performance. Contracts

Offerors shall provide information on past performance on contracts for the same or closely similar work called for in this solicitation, which demonstrate an ability to meet the contract objectives. Companies will be evaluated on the extent and quality of past-related experience and demonstrated competence. Offerors shall include the following information, as a minimum, regarding their past performance:

Elements of evaluation Past performance of personnel identified in criterion number 4, below. Include names and phone numbers of client project officers who would be able to comment on individuals' past performance.

A reference list of at least five previous contracts along with individuals who can verify capabilities ofthe organization's performance on specific projects related to the analysis of dietary supplements. The list shall consist of the name and address of the organization, or agency, for which the offerer has held or presently holds contracts. The narrative shall include.

i. the size of the contract,

ii. when started and completed, and

iii. a description of the testing provided. List the the ingredients/components analyzed in dietary supplements, any additional tests run and the number of samples tested.

Reports of specific expertise developed by the offerer, such as development of specific methods, special equipment, and/or validation procedures pertaining to dietary supplements.

Organizational Qualifications. Laboratory Experience and Organization of Proposal

The organization will be evaluated on its capability to successfully complete the project, on the overall quality of the proposal and additional information about experience not related to

DRAFT

April 2, contracted work. The principal investigator and other key staff shall be identified. In the event specific individuals (other than the principal investigator) cannot be identified, job descriptions for positions appropriate to each task shall be supplied. Also, training procedures and criteria for assuring competency of individuals in each area shall be included.

Elements of evaluation Previous Experience conducting research in ingredient analyses of dietary supplements shall be identified. Provide information about experience adapting methods to dietary supplement matrices. Identify pertinent publications as well as specific projects analyzing ingredients/components in dietary supplements and testing DS dosage forms for quality.

Ownership of organization and/or facilities and if there have been any recent changes or if any changes are anticipated Equipment and facilities available to be utilized for the research shall be specifically identified, along with any expansion plans and/or facility relocations Identification of Principal Investigator and other key staff, with expertise in managing the testing and ingredient analysis of dietary supplements and related tasks (preparing reports and quality control, customer service, project liaison), including the percentage of time devoted to this project for key personnel. Provide resumes with educational background of key personnel, pertinent experience and publications.

Proposal. The proposal shall include a table of contents, numbered pages, and a brief introductory statement to indicate the offerer's understanding of the purpose and significance of this project. The proposal shall be well organized and cover all pertinent information without being verbose or introducing irrelevant information.

Task Completion. An outline of the timeframe for task completion shall be included. Discuss the capacity of the lab to handle USDA samples along with those of other clients

An individual who will be responsible for check sample receipt (refer to criterion 5) shall be named. A phone number, email address and street address for receipt of check samples shall be provided.

Performance Evaluation Criteria

Accuracy of Analytical Performance-Check Samples - Pass/Fail

Any offerer whose written proposal is evaluated to be technically acceptable under the four criteria listed above shall have three (3) weeks to analyze, at no cost to the government, check samples, in triplicate, and report the results or the ingredient content as specified. Check samples will be sent for some of tests and ingredients/components listed in Appendix A. All tests and ingredient/component analyses shall be considered of equal importance.

Analyses shall be conducted by the methods listed in the offerer's proposal. All analyses shall be performed by the personnel listed in the offerer's proposal. Check samples will be provided by USDA, Methods and Application of Food Composition Laboratory (MAFCL) or its designee in amounts considered to be adequate for the analyses and tests. No additional sample material will be available.

The results for check samples will be evaluated against a range already established by the MAFCL. Results shall be reported in the units and number of decimals as specified in the Statement of Work, Attachment A unless otherwise specified in the work order accompanying the analytical samples. Both individual values and means shall be reported. Results are to be sent via email to Sushma Savarala, and Karen Andrews (Sushma.Savarala@ usda.gov and Karen.Andrews@ usda.gov ). Any questions should be sent by email to both of these MAFCL personnel.