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.

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(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.