Inactive Total Small Business Set-Aside (FAR 19.5)

(See attachment for full Satement of Work) STATEMENT OF WORK Background NIH ODS has collaborated with the National Institute of Standards and Technology (NIST) since 2002 to cumulatively produce over ... (See attachment for full Satement of Work) STATEMENT OF WORK Background NIH ODS has collaborated with the National Institute of Standards and Technology (NIST) since 2002 to cumulatively produce over 40 reference materials for dietary supplement ingredients and products derived from botanicals and other natural products. A reference material or RM is a material that is homogenous and stable with respect to one or more specified properties, and for food and dietary supplement RMs issued by NIST the specified properties are often quantified values with uncertainties for select macro- and micronutrients, marker compounds, toxins, contaminants, and/or adulterants. NIST’s analytical determinations of botanical RMs predominantly focus on the material’s composition of vitamins, minerals, toxic elements, and potentially bioactive phytochemicals/organic compounds. Additional chemical characterization beyond individual and often unique constituents, including determinations for fat, protein, and carbohydrate content, will support more comprehensive comparisons of available botanical RMs and expand their value as an experimental resource for dietary supplement researchers and industry scientists. SCOPE The National Institutes of Health Office of Dietary Supplements (NIH ODS) seeks proposals from testing laboratories for proximate analyses (i.e., moisture, total fat, total protein, total carbohydrate) of reference materials for common botanical and other natural product derived dietary supplement ingredients. Objectives NIH ODS seeks a testing laboratory to provide proximate analyses for a collection of NIST dietary supplement ingredient reference materials. For the purposes of this project, proximate analysis means gravimetric determinations (mass/mass) of water (moisture [for the purpose of determining dry mass basis]), total fat, crude protein, and total carbohydrate. The full listing of NIST RMs intended for proximate determination is provided in Table 1 under Requirements. NIH ODS will use the resulting proximate determinations to complement existing analytical characterizations and expand the quantitative information provided for the RMs in a publicly accessible online database. Requirements NIH ODS seeks a vendor with demonstrated capabilities to perform chemical analyses necessary for the determination of total fat, total protein, and total carbohydrate for all RMs listed in Table 1. Offeror shall propose analytical test methods that are scientifically validated, for example published compendial methods from AOAC International, United States Pharmacopeia, or other internationally recognized consensus standard setting organizations, or provide documentation for an otherwise fully validated methodology. Offeror shall demonstrate up-to-date ISO 17025 accreditation that covers all proposed analytical test methods. Offeror shall make all proximate determinations for each material based on 4 measurement replicates (i.e., 19 natural product RM matrices x 4 measurement replicates = 76 sample measurements). In addition, a certified reference material with reference values for the proximates to be assigned (NIST SRM 3232 Kelp Powder (Thallus laminariae)), shall be included as a control material in measurement runs with a regularity specified by the offeror. NIST natural product RM matrices include powdered plant parts (e.g., leaves, rhizome/root, fruit, aerial parts), protein isolates, and oil extracts. As such, offeror shall demonstrate capabilities and experience in quantitative chemical analyses of the matrix types and preparations listed in Table 1. Offerors should describe available alternative or orthogonal analytical testing methods which would be used in the event that the requisite analytes/matrices prove challenging for their standard in-house methods. Table 1. Dietary Supplement RMs to Undergo Proximate Analysis NIST RM # Source Material Material Matrix / Preparation NA Ashwagandha (Withania somnifera) Powdered rhizomes NA Black cohosh (Actaea racemosa) Powdered leaves NA Black cohosh (Actaea racemosa) Powdered rhizomes RM 8662 Eleuthero (Eleutherococcus senticosus) Powdered root NA Red clover (Trifolium pratense) Powdered flowers SRM 3246 Ginkgo biloba Powdered leaves SRM 3398 Ginger (Zingiber officinale) Powdered rhizomes SRM 3384 Asian Ginseng (Panax ginseng) Powdered rhizomes SRM 3254 Green Tea (Camellia sinensis) Powdered leaves RM 8650 Kudzu (Pueraria montana var. lobata) Powdered rhizomes SRM 3299 Turmeric (Curcuma longa L.) Powdered rhizomes RM 8037 Krill Oil Oil extract RM 8183 Omega-3 and Omega-6 Fatty Acids in Botanical Oils Oil extract SRM 3275 Omega-3 and Omega-6 Fatty Acids in Fish Oil Oil extract SRM 3250 Saw Palmetto (Serenoa repens) Powdered fruit SRM 3237 Soy Protein Concentrate Powder RM 8186 Soy Protein Isolate Powder SRM 3262 St. John's Wort (Hypericum perforatum L.) Powdered aerial parts SRM 3253 Yerba Mate (Ilex paraguariensis) Powdered leaves SRM 3232 Kelp (Thallus laminariae) Powder PERIOD OF PERFORMANCE Work is to be completed within 6 months after NTP is approved. PERFORMANCE SCHEDULE Performance Schedule: Monday through Friday Work Hours: 0700 to 1630 (7:00 a.m. to 4:30 p.m.) PLACE OF PERFORMANCE The work may be performed at the offeror’s location of choice. NIH ODS shall provide to the awarded vendor the requisite number of RM samples (and their accompanying NIST Certificates of Analysis documentation) needed for proximate analyses. Deliverables The offeror will generate data for accurate, precise, and reliable measurements of moisture, total fat, total protein, and total carbohydrate, for the 17 RMs listed in Table 1, using scientifically validated analytical methods. Offeror will deliver a comprehensive report to NIH ODS that describes all experimental procedures (including methodology, materials, reagents) and all raw data replicate measurement values (including means and standard deviations of replicates) for the RM samples and control material(s) in order to prepare a final proximate value determination for the purpose of incorporation into a publicly accessible online database to be hosted on the NIH ODS website (https://ods.od.nih.gov/). Contractor Traits ODS seeks the following qualities and qualifications of the offeror: 1. U.S. based vendor preferred. 2. Offeror shall demonstrate up-to-date ISO 17025 accreditation that covers all proposed analytical test methods. 3. Offeror shall propose analytical test methods that are scientifically validated. Offeror should possess experience in contract-testing services for the food and dietary supplements industry GOVERNMENT FURNISHED PROPERTY/EQUIPMENT/INFORMATION Not Applicable (N/A) CONSIDERATIONS • Maintain communication with the COR (and immediately inform the COR of any unforeseen issues or problems that arise). • Inform COR of any anticipated disruption in services for construction at least three (3) days in advance. CLOSE OUT • The contractor shall provide a signed warranty of any damage, defective material and improper workmanship on any material provided in this contract. • Materials and labor to be warranted for one year after installation, and equipment to be warranted per manufacturer. END OF SOW SECTION 2 – PROVISIONS 52.252-01 – Provisions Incorporated by Reference (FEB 1988) This solicitation incorporates one or more solicitation provisions 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. The offeror is cautioned that the listed provisions may include blocks that must be completed by the offeror and submitted with its quotation or offer. In lieu of submitting the full text of those provisions, the offeror may identify the provision by paragraph identifier and provide the appropriate information with its quotation or offer. Also, the full text of a solicitation provision may be accessed electronically at this/these address(es): http://acquisition.gov/far/current/html/FARTOCP52.html Clause Title Date 52.212-1 Instructions to Offerors-Commercial Products and Commercial Services NOV 2021 52.212-2 Evaluation-Commercial Products and Commercial Services NOV 2021 52.212-3 Offerors Representations and Certifications-Commercial Products and Commercial Services MAY 2022 52.214-34 Submission of Offers in the English Language APRIL 1991 52.214-35 Submission of Offers in U.S. Currency APRIL 1991 Provisions Incorporated by Full Text 52.212 -1 Instructions of Offerors-Commercial Products and Commercial Services— Addendum (NOV 2021) o Ensure organization’s Entity Information is registered on System for Award Management (SAM). See www.SAM.gov o This is a notice that the procurement is a total set-aside for Small Business o Only quotes submitted by Small Business will be accepted by the government o Any quote submitted by a vendor not a Small Business will not be considered for award • Submission of Proposals The proposal shall identify labor categories, rates, and total amount. The proposal shall not exceed five (5) pages. Interested offerors that submit proposal packages via e-mail to emmanuel.riddle@nih.gov are encouraged to request a delivery receipt and reference Solicitation No. 75N98023Q00023 Testing Laboratories for Proximate Analyses (Note: If needed, offerors should .zip file proposals to keep the attachment size under 25 MB). An official having the authority to contractually bind the offeror's company must complete blocks 17a, 30a, 30b and 30c the Standard Form (SF) 1449 Solicitation/Contract/Order for Commercial Items in accordance with the procedures prescribed in FAR 4.102. • Acceptable Offerors The proposal package must be in English and not exceed 5 pages. Quotes received in another language other than English will be rejected. The proposals shall include the font size 12 and the font style Times New Roman. Telegraphic offers (submitted by telegram or mailgram) will not be accepted. Any proposal received after the time and date specified will not be considered. • Late Offers Offers or modifications of offers received at the address specified for receipt of offers after the exact time specified for receipt of offers in Block 8 of Standard Form 1449 will not be considered. • Estimated Date of Contract Award The Government intends to evaluate and award a contract without discussions with offerors. Therefore, the offerors initial offer should contain the offerors best terms from a price and technical standpoint. However, the Government reserves the right to conduct discussions if later determined by the Contracting Officer to be necessary. The Government may reject any or all offers if such action is in the public interest and waive informalities and minor irregularities in the offers received. • Communication The offeror is instructed to contact only the solicitation Issuing Office for information about any aspect of the solicitation. All communication regarding this solicitation should directed to the Agency Point of Contact, Emmanuel Riddle, at emmanuel.riddle@nih.gov. Communication is preferred via email. The offeror must confirm receipt of communication submitted by these methods. The offeror is cautioned against contacting Government technical personnel regarding this solicitation prior to award of this procurement. ALL QUESTIONS regarding this solicitation must be forwarded to emmanuel.riddle@nih.gov via email by 2:30PM March 16, 2023. Responses to all questions/comments will be posted as an amendment to the solicitation in https://www.SAM.gov/. If questions are received after the cut-off date, the solicitation response due date may not be extended. The Government will make reasonable attempts to respond to questions/comments. • Contract Administration All contract administration matters will be handled by the National Institute of Health (HQ) Office of Acquisition located in Bethesda Maryland. 52.217-5 Evaluation of Options – (July 1990) Offeror should be aware that the Government shall perform a “best value analysis” using lowest priced technically acceptable selection. The selection for award shall be made to the Offeror whose proposal is most advantageous to the Government, taking into consideration the technical factors listed below and the total proposed price across all contract periods. Factor 1 - Technical The offeror must submit a written technical proposal for evaluation which provides sufficient provides sufficient information to demonstrate the capabilities to satisfactorily perform the work. The proposal must address the following: o Qualifications/experience o Staffing plan (Note: Address available resources) o Identify any potential problems and/or critical issues that will relate to the successful completion of the project. Factor 2 – Price Offeror(s) cost/price proposal will be evaluated for reasonableness. For a price to be reasonable, it must represent a price to the government that a prudent person would pay when consideration is given to prices in the market. The Offeror shall submit firm fixed prices for all items listed on the SOW (including options). Factor 3 – Past Performance The Offeror’s experience will be evaluated on the degree of relevance to the requirement on the basis of similarity in size, scope, complexity, technical difficulty, contract type, and period of performance. Only recent experience will be evaluated. Evaluations may include interviews with previous clients of the prime contractor and subcontractors and may include interviews with previous clients of proposed personnel. The Offeror’s experience with and knowledge of issues and problems of large organizations will be evaluated. The Offeror’s past performance will be evaluated on the basis of information contained in the Offeror's proposal and the information that the Government obtains through other means. The past performance evaluation will assess the Offeror’s record of providing high quality services of a similar nature in a manner that ensures maximum accuracy, throughput, cost effectiveness and overall client satisfaction. If some of the Offeror’s experience is relevant and the rest is not, only the relevant experience will be evaluated for purposes of past performance. If no experience is relevant or the experience that is relevant cannot be evaluated due to a reference’s failure to respond, a rating of neutral will be assigned for past performance as defined below. The Government will evaluate the Past Performance Factor using the following adjectival ratings. Rating Symbol Definition Neutral N No past performance available for evaluation. Offeror has asserted that it has no directly related or similar relevant past performance experience. Proposal receives no merit or demerit for this factor. Outstanding O Based on the Offeror’s record of past performance, no issues, concerns, or risks are associated with receiving timely services and contract performance. Past performance surveys and the Offeror’s experiences indicate that the Offeror is capable of exceeding the requirements of the delivery order. The Contractor has demonstrated significant experience with and knowledge of the issues and problems of large organizations. Good G The Offeror’s record of past performance indicates there is very little risk associated with receiving quality products, timely services and full contract performance. Past performance surveys and the Offeror’s experience indicate the Offeror will meet or exceed the requirements of the delivery order. The Contractor has demonstrated experience with and knowledge of the issues and problems of large organizations. Acceptable A The Offer’s record of past performance indicates that there is some potential risk associated with receiving quality products, timely services, and contract performance. Past performance surveys and the Offeror’s experience indicate the Offeror may have some problems during performance of the delivery order. The Contractor has demonstrated limited experience with and knowledge of the issues and problems of large organizations. Unsatisfactory U The Offeror’s record of past performance indicates it will be unable to perform successfully on the delivery order. Relative Importance of Evaluation Factors Pricing is significantly important than past performance and technicality. Basis for Award: Offeror should be aware that the Government shall perform a “best value analysis” using lowest priced technically acceptable selection. The selection for award shall be made to the Offeror whose proposal is most advantageous to the Government, taking into consideration the technical factors listed above and the total proposed price across all contract periods Before award can be made to the potential successful offeror: a. The offeror must be deemed “responsible”, as defined in Federal Acquisition Regulation (FAR) 9.1, meets all standards contained therein, and is otherwise eligible to receive an award; b. The offeror’s proposal must comply with the requirements of law, regulation and conditions set forth in the solicitation; c. The offeror’s evaluated price must be determined to be fair and reasonable; and d. The offeror and individuals proposed to provide services under the contract must be determined to be free of any conflicts of interest that cannot be waived or mitigated. 52.212-3 Offeror Representations and Certifications – Commercial Products and Commercial Services--Addendum (MAY 2022) An offeror should complete the representations and certifications online via www.SAM.gov.