FDA RFQ: CBD Collection and Assessment

Solicitation Number: RFQ_75F40120R00020
Collection and Analysis of Products Containing CBD and Cannabinoids - IDIQ
This is a ccombined synopsis/solicitation for commercial services prepared in accordance with the
format in FAR 12.6 as supplemented with FAR 13 and additional information included in this notice.
The incorporated provisions and clauses are those in effect through Federal Acquisition Circular
(FAC) 2020-07.
THIS ANNOUNCEMENT CONSTITUTES THE ONLY SOLICITATION AND A SEPARATE

SOLICITATION WILL NOT BE ISSUED. The solicitation number for this acquisition is
RFQ_75F40120R00020 and is being issued as a Request for Quote (RFQ).
This will be awarded as a hybrid Indefinite Delivery, Indefinite Quantity contract and Full and Open
competitive. Prospective Offerors are responsible for downloading the solicitation and any
amendments from beta.Sam.gov. The Government reserves the right to award a contract without
discussions if the Contracting Officer determines that the initial offer is providing the Best Value and
discussions are not necessary.
The Government intends to issue an Indefinite Delivery, Indefinite Quantity contract.
The associated North American Industrial Classification System (NAICS) Code is 541380: Testing
Laboratories.
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PART I – THE SCHEDULE
SECTION B - SUPPLIES OR SERVICES AND PRICES/COSTS
B.1 Brief Description of Supplies or Services

The Food and Drug Administration (FDA) and its various components, including the Office of the
Commissioner, the Office of Regulatory Affairs, the Center Food Safety and Applied Nutrition
(CFSAN), the Center for Veterinary Medicine (CVM), the Center for Drug Evaluation and Research
(CDER) and the Center for Tobacco Products (CTP), has the need to obtain information about the
amounts of cannabidiol (CBD) and various related cannabinoids, in a wide variety of consumer
products, through the collection of food, cosmetic, and other samples, and their subsequent analysis
by chemical analytical methods to be specified by the FDA.
To accomplish the FDA strategic goals, the FDA must also obtain information about the occurrence
of other possible chemical contaminants and adulterants that may be present in the products, and
therefore is also interested in information about the presence of toxic elements, pesticides and
industrial chemicals and residual processing solvents.
In performing the work as described in detail in Section “C” the Offeror shall consider the following:
This is an Indefinite Delivery, Indefinite Quantity (IDIQ) task order contract. This IDIQ will consist
of hybrid task order contract types which include: firm-fixed price (FFP), time and materials (T&M),
or Labor Hour (LH).
As the need for services covered by this contract arises, the Government will issue a Task Order (TO)
to the Offeror with all the necessary documentation of project requirements, under cover of a written
request for quote to perform the required services.
B.2 Commitment of Public Funds
The Contracting Officer is the only individual who can legally commit the Government to the
expenditure of public funds in connection with the proposed acquisition. Any other commitment,
either explicit or implied, is invalid.
B.3 Communications Prior To Award
Offerors shall direct all communications to the attention of:
Nicole, Contract Specialist

CC: Monifa Coleman, Contracting Officer
nicole.craig@fda.hhs.gov
monifa.coleman@fda.hhs.gov
All communication shall be submitted in writing. Communications with other officials may
compromise the competitiveness of this acquisition and result in cancellation of the requirement. No
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phone calls will be accepted.
B.4 Preparation Costs
This RFQ does not commit the Government to pay for the preparation and submission of a quotation.
B.5 Potential Award without Discussions
The Government reserves the right to award the IDIQ without discussions if the Contracting Officer
(CO) determines that the initial quotation(s) provide the Best Value and discussions are not
necessary.
B.6 Pricing / Equipment Schedule

The Task Areas is in spreadsheet form which contains all information about each task under this
contract. See Attachment J-2 Pricing Table. All requirements must be supported with detailed
narratives in quote submission. Attachment J-2 supports Attachment J-1 Statement of Work.
(End of Section B)
SECTION C – STATEMENT OF WORK
C.1 Background
The FDA Cannabidiol (CBD) Policy Working Group has developed a two-phase strategy for
obtaining the information by performing a sampling study of the current CBD marketplace to
understand CBD and related cannabinoid content, and possible contaminants, in a range of products.
The near-term plan involved a small sampling and analysis study (~200 samples) conducted by the
Center for Food Safety and Applied Nutrition, Office of Regulatory Science (CFSAN/ORS). The
long-term sampling plan will involve a much larger 1000-3000 sample survey1 of the CBD
marketplace conducted over the remainder of this fiscal year and the beginning of the next fiscal year.
In addition to the use of agency resources, it will be necessary to implement a contract for the
collection and analysis of samples to complete this much larger study and report the findings.
The overall goal of the long-term portion of the study, obtained through a contract laboratory, will be
the collection of CBD-containing products of various types, including foods and cosmetics, from
geographic locations throughout the U.S., and the analysis of these products for CBD content, for
related cannabinoid content and profiles, as well as for chemical and microbiological contaminants
that could be present in CBD products. Chemical contaminants of interest would include toxic
elements (e.g. lead, mercury, arsenic and cadmium), pesticides and industrial chemicals, and residual
processing solvents. Microbiological contaminants of interest would include Salmonella spp, Listeria
monocytogenes (Lm), and Shiga toxin-producing Escherichia coli (STEC), as well as aerobic plate
count. These studies and the analytical information they obtain will not only be reported to Congress,
1
For the purposes of this solicitation, “survey” is defined as the collection of a general or specific sub group of products and analysis for specific
chemical or microbiological constituents. For example, to determine the concentration of acrylamide in snack food products produced in the US.
Surveys are undertaken in order to acquire information about constituents in food outside of direct regulatory action.
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but will also be used to guide the development of future policy.
C.2 Business Objectives

The purpose of this Indefinite-Delivery-Indefinite-Quantity (IDIQ) contract is to obtain a capability
to support FDA by assessing the quantities of CBD and related cannabinoids, as well as potential
associated contaminants such as toxic elements, pesticides, industrial chemicals, and processing
solvents, in foods and cosmetics through surveys of these commodities. The purpose of these studies
will be to develop a better understanding of the quantities of CBD and associated cannabinoids and
their distribution.
C.3 Statement of Work Specifications

FDA is seeking a Contractor who shall provide support to the FDA by collecting samples and
assessing the quantities of CBD and related cannabinoids, as well as potential associated contaminants
such as toxic elements, pesticides, industrial chemicals, processing solvents and microbial
contaminants, in foods and cosmetics through surveys of these commodities. The purpose of these
studies will be to develop a better understanding of the quantities of CBD and associated cannabinoids
and their distribution.
The goal will be to collect and analyze a statistically relevant number of samples, between 1000-
3000. The reliability of the results will be supported by specified quality assurance/quality control
processes within the study. The types of samples to be collected for these studies will include food
and cosmetic products from across the United States, mainly including CBD-containing packaged and
processed foods such as beverages, water, candy, baked goods, oils and tinctures that can be added to
human or animal foods, including pills, capsules, gel caps, gummies and other forms. The analytical
methodology for this contract will be defined by the FDA and will include methods based on widely
available and recognized methodology.
All items requested herein shall comply with the requirement specifications to include the Statement
of Work. See Attachment J-1 Statement of Work.
C.4 Technical Requirements
The Contractor shall provide support services throughout performance period. The IDIQ COR will
specify the types of samples, quantities (between 50 and 3000), analytical methodology and data
reporting requirements with each specified task. See Attachment J-1 Statement of Work.
C.5 Reporting Requirements and Deliverables
The Contractor shall provide Quarterly Status Reports to the (QSR) to include a summary of sample
collection information, a summary of data from the analyses, a summary of certificates of analysis
that have been issued, work planned, issues to be addressed, project risks, and problems that could
impact schedules. In addition to the quarterly reports, the Contractor shall also report data as it is
obtained for review by the IDIQ COR on a weekly basis. Sample collection information (in
spreadsheet format), results spreadsheets and certificates of analysis will be delivered on a weekly
basis, or on less frequent intervals as established by the COR. The contractor must be able to deliver
these items via an electronic transfer process that will be established and provided by the FDA
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(equivalent to secure file transfer protocol).
The Contractor may be requested by the Contracting Officer Representative (COR) or Contracting
Officer (CO) to provide special reports on as needed basis.
Within the first 30 calendar days after IDIQ award, the COR and the Contractor shall design and
agree upon a standard reporting format and timeframe.
C.6 Description of Task Areas
The Contractor shall work with the IDIQ COR to ensure that tasks stay on track and important
milestones are met.
The Contractor shall identify, report, and address for resolution to the Government any issues that
prevent the Contractor from performing the work activities in any individual order that the Contractor
is unable to resolve independently.
(End of Section C)
SECTION D - PACKAGING AND MARKING
D.1 Marking Instructions for Reports
Unless otherwise specified in future individual orders, all reports or copies of reports shall be
delivered to the IDIQ COR.
D.2 Payment of Postage and Fees
All postage and fees related to distribution of deliverables including forms, reports, etc., shall be paid
by the Contractor.
(End of Section D)
SECTION E - INSPECTION AND ACCEPTANCE
E.1 Inspection and Acceptance (Feb 1998)
For the purpose of this section, the COR is the authorized representative of the CO. The Government
reserves the right to an Inspection period of 30 calendar days, unless a different time period is stated
when (task orders/elsewhere in the contract). The receiving report, completed and signed by the
appropriate official, constitutes acceptance and shall be acknowledged to the payment office (OFM).
a. The COR shall perform inspection and acceptance of materials and services to be provided.
b. Invoices shall be submitted for review and approval (see invoicing instructions).
c. For the purpose of this section, the COR is the authorized representative of the CO.
d. Acceptance is communicated in writing unless otherwise indicated in writing by the CO, COR
or the duly authorized representative within 30 days of receipt.
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(End of Section E)
SECTION F - DELIVERIES OR PERFORMANCE
F.1 Period of Performance
Performance of this contract shall begin on September 10, 2020 and shall not extend beyond
September 9, 2021 plus two (1) year option periods which may be exercised at the Government’s
discretion.
Option Years Option Periods

Option Year 1 September 10, 2021 to September 9, 2022
Option Year 2 September 10, 2022 to September 9, 2023

Six (6) months extension September 10, 2023 to February 9, 2024
F.2 Place of Performance
The places of performance for this contract shall be the Contractor’s site unless otherwise specified.
All meetings between the Contractor and FDA staff will be held virtually as agreed upon by IDIQ
COR and the Contractor.
(End of Section F)
SECTION G - CONTRACT ADMINISTRATION DATA
G.1. Contracting Officer’s Representative (COR)
The COR is responsible for the acceptance of work provided hereunder will be designated by separate
correspondence. The term ‘‘COR’’ means the person who monitors the technical aspects of contract
performance. The COR is not authorized to issue any instructions or directions which cause any
increase or decrease in the scope of work which would result in the increase or decrease in the price
of this contract, or changes in the delivery schedule or period of performance of this contract. The
COR is not authorized to receive or act upon any notification or revised cost estimate provided by the
Contractor in accordance with the Limitation of Cost or Limitation of Funds clauses of this contract.
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G.2 Invoice Submission Requirements (Three-Way Match)
FDA Three-Way Match Invoicing Procedures
A. The contractor shall submit all invoices to:
U.S. FOOD AND DRUG ADMINISTRATION
Attn: Vendor Payments

Division of Payment Services
10903 New Hampshire Ave
WO32 - Second Floor
MAIL HUB 2145
Silver Spring, MD 20993-0002
301-827-3742
FDAVendorPaymentsTeam@fda.hhs.gov
*** Acceptable methods of delivery include: E-mail (preferred) and Standard Mail. Provide a copy
marked courtesy to the COR.
B. Invoices submitted under this contract must comply with the requirements set forth in FAR
Clauses 52.232-25 (Prompt Payment) and 52.232-33 (Payment by Electronic Funds Transfer -
System for Award Management) and/or other applicable FAR clauses specified herein. To constitute
a proper invoice, the invoice must be submitted on company letterhead and include each of the
following:
(i) Name and address of the contractor;
(ii) Invoice date and invoice number;
(iii) Contract/Order number (including a reference to any base award for Indefinite-
Delivery/Indefinite-Quantity Contracts or Blanket Purchase Agreements);
(iv) Description, quantity, unit of measure, unit price, and extended price supplies delivered or
services performed, including:
(a) period of performance for which costs are claimed;
(b) itemized travel costs, including origin and destination;
(c) any other supporting information necessary to clarify questionable expenditures;
(d) the contractor shall include the award item number for each description, quantity, unit of measure,
unit price, and extended price supplies delivered or services performed;
(v) Shipping number and date of shipment, including the bill of lading number and weight of
shipment if shipped on government bill of lading;
(vi) Terms of any discount for prompt payment offered (Prompt Payment terms other than NET 30);
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(vii) Name and address of official to whom payment is to be sent (must be the same as that in the
purchase order/award, or in a proper notice of assignment);
(viii) Name, title, and phone number of person to notify in event of defective invoice;
(ix) Taxpayer Identification Number (TIN);
(x) banking routing transit number of the financial institution receiving payment for Electronic funds
transfer (EFT);
(xi) Name and telephone number of the FDA Contracting Officer Representative (COR) or other
Program Center/Office point of contact, as referenced on the award;
(xii) Contractor is required to attach an invoice log addendum to each invoice which shall include, at
a minimum, the following information for contract administration and reconciliation purposes:
(a) list of all invoices submitted to date under the subject award, including the following:
(1) invoice number, amount, & date submitted
(2) corresponding payment amount & date received
(b) total amount of all payments received to date under the subject contract or order
(c) and, for definitized contracts or orders only, total estimated amounts yet to be invoiced for the
current, active period of performance;
(xiv) Any other information or documentation required by the award.
C. An electronic invoice is acceptable if submitted in Adobe Acrobat (PDF) format. All items
listed in (i) through (xiii) of this clause must be included in the electronic invoice. Electronic invoices
must be on company letterhead and must contain no ink changes and be legible for printing.
D. Questions regarding invoice payments should be directed to the Employee Resource and
Information Center (ERIC) Helpdesk at 301-827-ERIC (3742) or toll-free 866-807-ERIC (3742); or,
by email at ERIC@fda.hhs.gov. Refer to the Call-in menu options and follow the phone prompts to
dial the option that corresponds to the service that's needed. All ERIC Service Now Tickets will
either be responded to or resolved within 48 hours (2 business days) of being received. When
emailing, please be sure to include the contract number, invoice number and date of invoice, as well
as your name, phone number, and a detailed description of the issue.
G.3 Invoice Payment
Payment will be made after performance of lump sum services on a monthly basis. It is the
requirement of the Government to obtain complete and satisfactory performance in accordance with
the terms of the specifications and quality standards of this contract. The Government is contracting
for satisfactory performance of all work identified in the performance work statement, and deductions
will, therefore, be made for any service not provided.
It is agreed that failure to: accomplish any work required under this contract; to satisfactorily
accomplish such work; or to comply with any provisions of this contract, where due to the
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carelessness, neglect, or fault of the contractor, shall constitute a deficiency for which a permanent
reduction of payment will be made in accordance with the provisions of this contract.
Payment for Task Orders will be made upon inspection and acceptance of each individual order as
evidenced by the submission of Form GSA 220 with the monthly invoice.
G.4 Key Personnel
The contractor shall provide the resumes of key personnel for this contract. Key personnel are:
Project Manager
Lead Chemical Analyst (or Lead Scientist)
Lead Microbiology Analyst (or Lead Scientist)
Lead Sample Collection coordinator (if not Project Manager)
HHSAR 352.237-75 Key Personnel (Dec 2015)
The key personnel specified in this contract are considered to be essential to work performance. At
least 30 days prior to the contractor voluntarily diverting any of the specified individuals to other
programs or contracts the Contractor shall notify the Contracting Officer and shall submit a
justification for the diversion or replacement and a request to replace the individual. The request must
identify the proposed replacement and provide an explanation of how the replacement's skills,
experience, and credentials meet or exceed the requirements of the contract. If the employee of the
contractor is terminated for cause or separates from the contractor voluntarily with less than thirty
days notice, the Contractor shall provide the maximum notice practicable under the circumstances.
The Contractor shall not divert, replace, or announce any such change to key personnel without the
written consent of the Contracting Officer. The contract will be modified to add or delete key
personnel as necessary to reflect the agreement of the parties.
(End clause)
Related experience may be substituted for education. Education and experience requirements will be
determined jointly by the contractor and the Government based on task requirements at the order level
G.5 Contract Administration
a. Nicole Craig
Contracting Specialist
Email: nicole.craig@fda.hhs.gov
Monifa Coleman
Contracting Officer
Email: monifa.coleman@fda.hhs.gov
b. Contractor Representative Officer

To be completed at Award.
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G.6 Post Award Evaluation of Offeror Performance
Offeror Performance Evaluations
Interim and final evaluations of Offeror performance will be prepared on this contract in accordance
with FAR 42.15. The final performance evaluation will be prepared at the time of completion of
work. In addition to the final evaluation, interim evaluation(s) shall be submitted within 14 calendar
days following the anniversary date of the contract if any options are exercised pursuant to the Option
Provision provided under Section H of the contract.
Interim and final evaluations will be provided to the Contractor as soon as practicable after
completion of the evaluation. The Contractor will be permitted thirty days to review the document
and to submit additional information or a rebuttal statement. If agreement cannot be reached between
the parties, the matter will be referred to an individual one level above the Contracting Officer, whose
decision will be final.
Copies of the evaluations, Contractor responses, and review comments, if any, will be retained as part
of the contract file, and may be used to support future award decisions.
(End of Section G)
SECTION H - SPECIAL CONTRACT REQUIREMENTS
H.1 Smoke Free Environment
The Department of Health and Human Services is the Federal Governments principal agency for
furthering the health of Americans and providing them with essential human services. The health
risks of smoking and exposure to smoke are clearly documented by reports of the Surgeon General.
It is essential that the Department, in the accomplishment of its mission, provide a smoke-free
environment in all HHS owned and leased building space.
It is, therefore, the Departments policy to establish a smoke-free environment in all HHS building
space. All HHS owned and leased building space is designated as no-smoking areas. This policy
applies to Government employees as well as Contractor employees who are assigned to work at HHS
owned or leased building space.
H.2 Restriction on Employment of Unauthorized Alien Workers
The Offeror shall not use contract funds to employ workers described in section 274A(h)(3) of the
Immigration and Nationality Act, which reads as follows:
"(3) Definition of unauthorized alien. - As used in this section, the term 'unauthorized alien' means,
with respect to the employment of an alien at a particular time, that the alien is not at that time either
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(A) an alien lawfully admitted for permanent residence, or (B) authorized to be so employed by this
Act or by the Attorney General."
H.3 Government Furnished Equipment (GFE) Government Furnished Information (GFI)
No Government Furnished Information (GFI) and/or Government Furnished Equipment (GFE) will
be provided during the period of performance of this IDIQ contract.
All materials developed by the Contractor shall not include copyright material and will be copied and
distributed for the Government. All materials developed or created shall become property of the U.S.
Government.
H.4 Observance of Legal Holidays
A. The Government hereby provides “NOTICE” and the Contractor hereby acknowledges
“RECEIPT” that government personnel observe the listed days as holidays:
(1) New Year's Day (6) Labor Day

(2) Martin Luther King's Birthday (7) Columbus Day
(3) President’s Day (8) Veterans' Day
(4) Memorial Day (9) Thanksgiving Day
(5) Independence Day (10) Christmas Day
B. In addition to the days designated as holidays, the Government observes the following
days:
(1) Any other day designated by Federal Statute

(2) Any other day designated by Executive Order
(3) Any other day designated by the President’s Proclamation
C. When any such day falls on a Saturday, the following Monday is observed. Except for
designated around-the-clock or emergency operations, Contractor personnel will not be able to
perform on-site under this contract on holidays set forth above. The Contractor will not charge
any holiday as direct charge to the contract. In the event Contractor personnel work during a
holiday observed by the Contractor other than those above, no form of holiday or other
premium compensation will be reimbursed as either a direct or indirect cost. This provision
does not preclude reimbursement for authorized overtime work if applicable to this contract.
D. The Government reserves the right to close the facilities due to weather conditions, safety,
health, or medical emergencies as necessary. The Contractor personnel may be required to
remain on duty to maintain the facility in the event of adverse weather conditions or
emergencies. During these times, the Contractor program manager, or designee, must be
available (on-site or by cell phone and email) to address FDA operational shutdowns or
emergencies. Contractor personnel should refer to the COR for early dismissal and closure
procedures.
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E. It is understood and agreed between the Government and the Contractor that observance of such
days by Government personnel shall not otherwise be a reason for an additional period of
performance, or entitlement of compensation except as set forth within the contract.
F. Nothing in this clause abrogates the rights and responsibilities of the parties relating to stop
work provisions as cited in other sections of this contract.
G. The Contractor shall perform work in a manner that does not interfere with normal occurrence
of Government business.
H.5 Employee Conduct
The Contractor shall be responsible for maintaining satisfactory standards of employee competency,
conduct, appearance, and integrity at all times and shall be responsible for the employee’s
performance and the quality of the employees’ services.
H.6 Travel
The Government will not reimburse the Contractor for travel related expenses.
(End of Section H)
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Part II – Contract Clauses
SECTION I - CONTRACT CLAUSES
I.1. FAR 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 this/these address (es):
[https://www.acquisition.gov/far/]
HHS Acquisition Regulation (HHSAR)
[https://www.acquisition.gov/hhsar]
GENERAL
FAR Clause Title and Date
52.202-1 Definitions (Jun 2020)
52.203-3 Gratuities (Apr 1984)
52.203-5 Covenant Against Contingent Fees (May 2014)
52.203-7 Anti-Kickback Procedures (Jun 2020)
52.203-8 Cancellation, Rescission, and Recovery of Funds for Illegal or Improper
Activity. (May 2014)
52.203-12 Limitation on Payments to Influence Certain Federal Transactions (Jun 2020)
52.203-17 Contractor Employee Whistleblower Rights and Requirement To Inform
Employees of Whistleblower Rights (Jun 2020)
52.204-4 Printed or Copied Double-Sided on Postconsumer Fiber Content Paper
Over the Simplified Acquisition Threshold) (May 2011)
52.204-7 System for Award Management (Oct 2018)
52.204-13 System for Award Management Maintenance (Oct 2018)
52.215-8 Order of Precedence-Uniform Contract Format (Oct 1997)
52.216-7 Allowable Cost and Payment
52.216-32 Task-Order and Delivery -Order Ombudsman (Sep 2019)
52.222-1 Notice to the Government of Labor Disputes (Feb 1997)
52.222-2 Payment for Overtime Premiums (Jul 1990)
52.222-4 Contract Work Hours and Safety Standards Act – Overtime
Compensation. (Mar 2018)
52.222-20 Contracts for Materials, Supplies, Articles and Equipment Exceeding $15,000 (
(Jun 2020)
52.222-41 Service Contract Labor Standards (Aug 2018)
52.223-6 Drug-Free Workplace (May 2001)
52.227-1 Authorization and Consent (Jun 2020)
52.227-2 Notice and Assistance Regarding Patent and Copyright Infringement (Jun
2020)
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52.227-11 Patent Rights-Ownership by the Contractor (May 2014)

52.229-3 Federal, State, and Local Taxes (Feb 2013)
52.232-1 Payments (Apr 1984)
52.232-8 Discounts for Prompt Payment (Feb 2002)
52.232-9 Limitation on Withholding of Payments (Apr 1984)
52.232-11 Extras (Apr 1984)
52.232-17 Interest (May 2014)
52.232.39 Unenforceability of Unauthorized Obligations (Jun 2013)
52.232-40 Providing Accelerated Payments to Small Business Subcontractors (Dec 2013)
52.237-2 Protection of Government Buildings, Equipment, and Vegetation
(Apr 1984)
52.237-3 Continuity of Services (Jan 1991)
52.242-13 Bankruptcy (Jul 1995)
52.246-6 Inspection – Time and Materials and Labor Hours (May 2001)
52.246-20 Warranty of Services (May 2001)
52.247-35 F.O.B. Destination Within Consignee’s Premises (Apr 1984)
52.253-1 Computer Generated Forms (Jan 1991)
TIME AND MATERIAL / LABOR HOURS

FAR Clause Title and Date
52.216-31 Time-and-Materials/Labor-Hour Proposal Requirements—Commercial Item
Acquisition (Feb 2007)
HHSAR Clauses
352.203-70, Anti-Lobbying (Dec 2015)

352.208-70, Printing and Duplication (Dec 2015)
352.211-3, Paperwork Reduction Act (Dec 2015)
352.222-70, Contractor Cooperation in Equal Employment Opportunity Investigations (Dec 2015)
352.224-70, Privacy Act (Dec 2015)
352.224-71, Confidential Information (Dec 2015)
352.227-70, Publications and Publicity (Dec 2015)
352.231-70, Salary Rate Limitation (Dec 18, 2015)
352.233-71, Litigation and Claims (Dec 2015)
352.239-73, Electronic and Information Technology Accessibility Notice (Dec 2015)
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I. 2 Clauses Incorporated in Full Text
52.212-4 -- Contract Terms and Conditions -- Commercial Items. Contract Terms and Conditions
-- Commercial Items (Oct 2018): Is hereby incorporated by reference.
52.212-5 -- Contract Terms and Conditions Required to Implement Statutes or Executive Orders --
Commercial Items (Jul 2020)
(a) The Contractor shall comply with the following Federal Acquisition Regulation (FAR) clauses,
which are incorporated in this contract by reference, to implement provisions of law or Executive
orders applicable to acquisitions of commercial items:
52.203-19, Prohibition on Requiring Certain Internal Confidentiality Agreements or

Statements (Jan 2017) (section 743 of Division E, Title VII, of the Consolidated and Further
Continuing Appropriations Act 2015 (Pub. L. 113-235) and its successor provisions in
subsequent appropriations acts (and as extended in continuing resolutions)).
52.209-10, Prohibition on Contracting with Inverted Domestic Corporations (Nov 2015)
52.233-3, Protest After Award (Aug 1996) (31 U.S.C. 3553).
52.233-4, Applicable Law for Breach of Contract Claim (Oct 2004) (Public Laws 108-77,
108-78 (19 U.S.C. 3805 note)).
(b) The Contractor shall comply with the FAR clauses in this paragraph (b) that the contracting
officer has indicated as being incorporated in this contract by reference to implement provisions of
law or Executive orders applicable to acquisitions of commercial items:
52.203-6, Restrictions on Subcontractor Sales to the Government (Jun 2020), with Alternate I
(Oct 1995) (41 U.S.C. 4704 and 10 U.S.C. 2402).
52.203-13, Contractor Code of Business Ethics and Conduct (Jun 2020) (41 U.S.C. 3509).
52.204-10, Reporting Executive compensation and First-Tier Subcontract Awards (Jun 2020) (Pub. L.
109-282) (31 U.S.C. 6101 note).
52.204-15, Service Contract Reporting Requirements for Indefinite-Delivery Contracts (Oct

2016) (Pub. L. 111-117, section 743 of Div. C).
52.209-6, Protecting the Government’s Interest When Subcontracting with Contractors

Debarred, Suspended, or Proposed for Debarment (Jun 2020) (31 U.S.C. 6101 note).
52.219-8, Utilization of Small Business Concerns (Oct 2018) (15 U.S.C. 637(d)(2) and (3)).
52.219-9, Small Business Subcontracting Plan (Jun 2020) (15 U.S.C. 637 (d)(4)).
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52.219-16, Liquidated Damages—Subcontracting Plan (Jun 2020) (15 U.S.C.

637(d)(4)(F)(i)).
52.219-28, Post Award Small Business Program Rerepresentation (May 2020) (15 U.S.C.
632(a)(2)).
52.222-3, Convict Labor (Jun 2003) (E.O. 11755).
52.222-19, Child Labor—Cooperation with Authorities and Remedies (Jan 2020) (E.O.
13126).
52.222-21, Prohibition of Segregated Facilities (Apr 2015).
52.222-26, Equal Opportunity (Sep 2016) (E.O. 11246).
52.222-35, Equal Opportunity for Veterans (Jun 2020) (38 U.S.C. 4212).
52.222-36, Equal Opportunity for Workers with Disabilities (Jun 2020) (29 U.S.C. 793).
52.222-37, Employment Reports on Veterans (Jun 2020) (38 U.S.C. 4212).
52.222-40, Notification of Employee Rights Under the National Labor Relations Act (Dec
2010) (E.O. 13496).
52.222-50, Combating Trafficking in Persons (Jan 2019) (22 U.S.C. chapter 78 and E.O.
13627).
52.222-54, Employment Eligibility Verification (Oct 2015). (E. O. 12989). (Not applicable to
the acquisition of commercially available off-the-shelf items or certain other types of
commercial items as prescribed in 22.1803.)
52.223-18, Encouraging Contractor Policies to Ban Text Messaging while Driving (Jun 2020)
(E.O. 13513).
52.225-1, Buy American--Supplies (May 2014) (41 U.S.C. chapter 83).
52.225-13, Restrictions on Certain Foreign Purchases (Jun 2008) (E.O.’s, proclamations, and
statutes administered by the Office of Foreign Assets Control of the Department of the
Treasury).
52.232-33, Payment by Electronic Funds Transfer— System for Award Management (Oct
2018) (31 U.S.C. 3332).
52.239-1, Privacy or Security Safeguards (Aug 1996) (5 U.S.C. 552a).
Page 16 of 95
52.242-5, Payments to Small Business Subcontractors (Jan 2017) (15 U.S.C. 637(d)(12)).
(c) The Contractor shall comply with the FAR clauses in this paragraph (c), applicable to commercial
services, that the Contracting Officer has indicated as being incorporated in this contract by reference
to implement provisions of law or executive orders applicable to acquisitions of commercial items:
52.222-41, Service Contract Labor Standards (Aug 2018) (41 U.S.C. chapter 67.).
52.222-43, Fair Labor Standards Act and Service Contract Labor Standards -- Price
Adjustment (Multiple Year and Option Contracts) (Aug 2018) (29 U.S.C.206 and 41 U.S.C.
chapter 67).
52.222-44, Fair Labor Standards Act and Service Contract Labor Standards -- Price
Adjustment (May 2014) (29 U.S.C. 206 and 41 U.S.C. chapter 67).
(d) ) Comptroller General Examination of Record. The Contractor shall comply with the provisions
of this paragraph (d) if this contract was awarded using other than sealed bid, is in excess of the
simplified acquisition threshold, as defined in FAR 2.101, on the date of award of this contract, and
does not contain the clause at 52.215-2, Audit and Records-Negotiation.
(1) The Comptroller General of the United States, or an authorized representative of the
Comptroller General, shall have access to and right to examine any of the Contractor’s
directly pertinent records involving transactions related to this contract.
(2) The Contractor shall make available at its offices at all reasonable times the records,
materials, and other evidence for examination, audit, or reproduction, until 3 years after final
payment under this contract or for any shorter period specified in FAR Subpart 4.7,
Contractor Records Retention, of the other clauses of this contract. If this contract is
completely or partially terminated, the records relating to the work terminated shall be made
available for 3 years after any resulting final termination settlement. Records relating to
appeals under the disputes clause or to litigation or the settlement of claims arising under or
relating to this contract shall be made available until such appeals, litigation, or claims are
finally resolved.
(3) As used in this clause, records include books, documents, accounting procedures and
practices, and other data, regardless of type and regardless of form. This does not require the
Contractor to create or maintain any record that the Contractor does not maintain in the
ordinary course of business or pursuant to a provision of law.
(e) (1) Notwithstanding the requirements of the clauses in paragraphs (a), (b), (c) and (d) of this
clause, the Contractor is not required to flow down any FAR clause, other than those in this paragraph
(e)(1) in a subcontract for commercial items. Unless otherwise indicated below, the extent of the flow
down shall be as required by the clause—
Page 17 of 95
(i) 52.203-13, Contractor Code of Business Ethics and Conduct (Jun 2020) (41 U.S.C.
3509).
(ii) 52.203-19, Prohibition on Requiring Certain Internal Confidentiality Agreements

or Statements (Jan 2017) (section 743 of Division E, Title VII, of the Consolidated and
Further Continuing Appropriations Act, 2015 (Pub. L. 113-235) and its successor
provisions in subsequent appropriations acts (and as extended in continuing
resolutions)).
(iii) 52.219-8, Utilization of Small Business Concerns (Oct 2018) (15 U.S.C. 637(d)(2)
and (3)), in all subcontracts that offer further subcontracting opportunities. If the
subcontract (except subcontracts to small business concerns) exceeds the applicable
threshold specified in FAR 19.702(a) on the date of subcontract award, the
subcontractor must include 52.219-8 in lower tier subcontracts that offer
subcontracting opportunities..
(v) 52.222-21, Prohibition of Segregated Facilities (Apr 2015).
(vi) 52.222-26, Equal Opportunity (Sep 2015) (E.O. 11246).
(vii) 52.222-35, Equal Opportunity for Veterans (Jun 2020) (38 U.S.C. 4212).
(viii) 52.222-36, Equal Opportunity for Workers with Disabilities (Jun 2020) (29
U.S.C. 793).
(ix) 52.222-37, Employment Reports on Veterans (Jun 2020) (38 U.S.C. 4212).
(x) 52.222-40, Notification of Employee Rights Under the National Labor Relations
Act (Dec 2010) (E.O. 13496). Flow down required in accordance with paragraph (f) of
FAR clause 52.222-40.
(xi) 52.222-41, Service Contract Labor Standards (Aug 2018), (41 U.S.C. chapter 67).
(xii) (A) 52.222-50, Combating Trafficking in Persons (Jan 2019) (22 U.S.C. chapter
78 and E.O. 13627).
(B) Alternate I (Mar 2015) of 52.222-50 (22 U.S.C. chapter 78 E.O. 13627)
(xiii) 52.222-51, Exemption from Application of the Service Contract Labor Standards
to Contracts for Maintenance, Calibration, or Repair of Certain Equipment--
Requirements (May 2014) (41 U.S.C. chapter 67.)
(xiv) 52.222-53, Exemption from Application of the Service Contract Labor Standards
to Contracts for Certain Services--Requirements (May 2014) (41 U.S.C. chapter 67)
Page 18 of 95
(xv) 52.222-54, Employment Eligibility Verification (Oct 2015) (E. O. 12989).
(xvi) 52.222-55, Minimum Wages Under Executive Order 13658 (Dec 2015).
(xviii) 52.222-60, Paycheck Transparency (Executive Order 13673) (Oct 2016).
(xix) 52.222-62, Paid sick Leave Under Executive Order 13706 (Jan 2017) (E.O.
13706).
(xx) (A) 52.224-3, Privacy Training (Jan 2017) (5 U.S.C. 552a).
(B) Alternate I (Jan 2017) of 52.224-3.
(xxi) 52.225-26, Contractors Performing Private Security Functions Outside the

United States (Oct 2016) (Section 862, as amended, of the National Defense
Authorization Act for Fiscal Year 2008; 10 U.S.C. 2302 Note).
(xxii) 52.226-6, Promoting Excess Food Donation to Nonprofit Organizations. (Jun

2020) (42 U.S.C. 1792). Flow down required in accordance with paragraph (e) of FAR
clause 52.226-6.
(xxiii) 52.247-64, Preference for Privately-Owned U.S. Flag Commercial Vessels (Feb
2006) (46 U.S.C. Appx 1241(b) and 10 U.S.C. 2631). Flow down required in
accordance with paragraph (d) of FAR clause 52.247-64.
(2) While not required, the Contractor may include in its subcontracts for commercial items a
minimal number of additional clauses necessary to satisfy its contractual obligations.
(End of clause)
52.216-18 Ordering (Oct 1995)
(a) Any supplies and services to be furnished under this contract shall be ordered by issuance of
delivery orders or task orders by the individuals or activities designated in the Schedule. Such orders
may be issued up to thirty-six (36) months from date of award.
(b) All delivery orders or task orders are subject to the terms and conditions of this contract. In the
event of conflict between a delivery order or task order and this contract, the contract shall control.
(c) If mailed, a delivery order or task order is considered “issued” when the Government deposits the
order in the mail. Orders may be issued orally, by facsimile, or by electronic commerce methods only
if authorized in the Schedule.
Page 19 of 95
52.216-19 Order Limitations (Oct 1995)
(a) Minimum order. When the Government requires supplies or services covered by this contract in
an amount of less than $3,000.00, the Government is not obligated to purchase, nor is the Contractor
obligated to furnish, those supplies or services under the contract.
(b) Maximum order. The Contractor is not obligated to honor—
(1) Any order for a single item in excess of $300,000;
(2) Any order for a combination of items in excess of $700,000.00; or
(3) A series of orders from the same ordering office within 30 days that together call for quantities
exceeding the limitation in paragraph (b)(1) or (2) of this section.
(c) If this is a requirements contract (i.e., includes the Requirements clause at subsection 52.216-21 of
the Federal Acquisition Regulation (FAR)), the Government is not required to order a part of any one
requirement from the Contractor if that requirement exceeds the maximum-order limitations in
paragraph (b) of this section.
(d) Notwithstanding paragraphs (b) and (c) of this section, the Contractor shall honor any order
exceeding the maximum order limitations in paragraph (b), unless that order (or orders) is returned to
the ordering office within 3 days after issuance, with written notice stating the Contractor’s intent not
to ship the item (or items) called for and the reasons. Upon receiving this notice, the Government may
acquire the supplies or services from another source.
52.216-22 Indefinite Quantity (Oct 1995)
(a) This is an indefinite-quantity contract for the supplies or services specified and effective for the
period stated, in the Schedule. The quantities of supplies and services specified in the Schedule are
estimates only and are not purchased by this contract.
(b) Delivery or performance shall be made only as authorized by orders issued in accordance with the
Ordering clause. The Contractor shall furnish to the Government, when and if ordered, the supplies or
services specified in the Schedule up to and including the quantity designated in
the Schedule as the “maximum.” The Government shall order at least the quantity of supplies or
services designated in the Schedule as the “minimum.”
(c) Except for any limitations on quantities in the Order Limitations clause or in the Schedule, there is
no limit on the number of orders that may be issued. The Government may issue orders requiring
delivery to multiple destinations or performance at multiple locations.
(d) Any order issued during the effective period of this contract and not completed within that period
shall be completed by the Contractor within the time specified in the order. The contract shall govern
the Contractor’s and Government’s rights and obligations with respect to that order to the same extent
as if the order were completed during the contract’s effective period; provided, that the Contractor
shall not be required to make any deliveries under this contract after forty-two (42) months.
Page 20 of 95
52.217-8 Option to Extend Services. (Nov 1999)
The Government may require continued performance of any services within the limits and at the rates
specified in the contract. These rates may be adjusted only as a result of revisions to prevailing labor
rates provided by the Secretary of Labor. The option provision may be exercised more than once, but
the total extension of performance hereunder shall not exceed 6 months. The Contracting Officer may
exercise the option by written notice to the Contractor any time before the contract expires.
52.217-9 Option to Extend the Term of the Contract (Mar 2000)
(a) The Government may extend the term of this contract by written notice to the Contractor within
five (5) days provided that the Government gives the Contractor a preliminary written notice of its
intent to extend at least 1 day before the contract expires. The preliminary notice does not commit the
Government to an extension.
(b) If the Government exercises this option, the extended contract shall be considered to include this
option clause.
(c) The total duration of this contract, including the exercise of any options under this clause, shall
not exceed forty-two (42) months.
(End of Section I)
Page 21 of 95
SECTION J – LIST OF ATTACHMENTS
The following attachments are incorporated into this solicitation/ contract:
Attachment J-1 Statement of Work.

Attachment J-2 Pricing Table
Attachment J-3 Example Task Order
Attachment J-4 Small Business Subcontracting Plan
Attachment J-5 FDA Personnel Security Services Requirements Forms
Attachment J-6 Offeror Representations and Certifications-Commercial Items
(End of Section J)
-ATTACHMENTS ARE LOCATED BEHIND SECTION M OF THIS DOCUMENT-
Page 22 of 95
PART IV - RESPRESENTATIONS AND INSTRUCTIONS
SECTION K - REPRESENTATIONS, CERTIFICATIONS, AND OTHER STATEMENTS

OF OFFERORS OR QUOTERS
K.1. Representations and Certifications
To be Completed by the Offeror/Bidder: (The Representations and Certifications must be executed by

an individual authorized to bind the offeror/bidder.)
The offeror/bidder makes the following Representations and Certifications as part of its quote (check
or complete all appropriate boxes or blanks on the following pages).
_________________________________
Solicitation No.
_________________________________
Name of Offeror/Bidder
_________________________________
Signature of Authorized Individual
_________________________________
Typed Name of Authorized Individual
__________________________________
Date
NOTE: The penalty for making false statements in offers or bids is prescribed in 18 U.S.C. 1001.
Page 23 of 95
K.2. FAR Solicitation Provisions Incorporated by Reference (Feb 1998)
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): [https://www.acquisition.gov/far/]
52.212-3 Offeror Representations and Certifications-Commercial Items (Jun 2020)

Please reference Attachment J-6 for the full text.
52.222-52 Exemption From Application Of The Service Contract Labor Standards To Contracts
For Certain Services--Certification (May 2014)
Parties responding to this solicitation may submit their offer in accordance with their standard
commercial practices (e.g. on company letterhead, formal quote form, etc.) but shall include the
following information: 1) company’s complete mailing and remittance addresses 2) discounts for
prompt payment if applicable; 3) Dun & Bradstreet number; 4) Taxpayer ID number; 5) Catalog or
Published Price Listing applicable to the service; 6) Offerors shall meet specifications as noted in the
synopsis. Offerors shall include a completed copy of the provision at 52.212-3, Offeror
Representations and Certifications/Commercial Items with their offer. Note: Contractor shall be
registered and active in the System for Award Management (SAM) prior to the award of a contract.
You may register by going to www.beta.sam.gov.
(End of Section K)
Page 24 of 95
SECTION L - INSTRUCTIONS, CONDITIONS, AND NOTICES TO OFFERORS
L.1. General Information
A. The Offeror is requested to submit a quote, which will be considered if received by the due
date. The subject line shall read: RFP_75F40120R00020: Collection and Analysis of
Products Containing CBD and Cannabinoids and a statement from the Offeror verifying
that they are SAM/CCR Registered under NAICS Code: 541380: Testing Laboratories.
Quotes shall be clearly indexed and logically assembled. All pages of the written quotation
shall be appropriately numbered and identified by the complete company name, date and RFQ
number in the header and/or footer. A Table of Contents should be created. A standard, 12-
point minimum font size applies shall be used. Arial or New Time Roman fonts are required.
Tables and illustrations may be used. A faxed quote shall not be accepted.
Offerors that fail to submit all required documentation, or do not complete the required
representations and certifications, or reject the terms and conditions of the RFQ, shall be
considered non-responsive.
A complete quote must consist of: i) Cover Letter, ii) Technical Quote (which, in
accordance with FAR 52.212-1 (b) (4)) must be a technical description of the items being
offered in sufficient detail to evaluate compliance with the requirements in the solicitation).
Incomplete quotes shall be considered non-responsive and shall not be evaluated.
B. 52.216-1 Type of Contract

The Government contemplates award of a Hybrid IDIQ Contract. This IDIQ will consist of
firm-fixed price (FFP), time and materials (T&M), or Labor Hour (LH) Task Order type
contract with a base year of 12 months and two (2), one-year option periods.
C. Preparation Costs
This RFQ does not commit the Government to pay for the preparation and submission of a
quote.
D. Service of Protest (Sep 2006) - FAR 52.233-2

(a) Protests, as defined in section 33.101 of the Federal Acquisition Regulation, that are filed
directly with an agency, and copies of any protests that are filed with the Government
Accountability Office (GAO), shall be served on the Contracting Officer (addressed as
follows) by obtaining written and dated acknowledgment of receipt from Monifa
Coleman, via email monifa.coleman@fda.hhs.gov.
Page 25 of 95
(b) The copy of any protest shall be received in the office designated above within one day of
filing a protest with the GAO.
L.2. Quote Instructions
The Contractor shall indicate, with detailed narratives for each section of the SOW, if the minimum
solicitation requirements have been met to be considered responsive for this requirement. Just
restating the SOW will not be considered responsive.
Evaluation of offers to this solicitation will be based upon written quotes responding to maximum
requirements, supported by detailed documentation, as well as written price and past performance
information provided in response to the requirements stated herein.
All quotes must be prepared in accordance with the solicitation and the attached Statement of Work.
The following instructions establish the acceptable minimum requirements for the format and content
of quotes.
Offer must submit all questions concerning this solicitation shall be submitted electronically to
nicole.craig@fda.hhs.gov CC: monifa.coleman@fda.hhs.gov no later than 4:00 PM Eastern
Standard Time, August 19, 2020 and the following must be listed in the subject line “Questions –
RFQ_75F40120R00020”.
The penalty for making false statements in offers is prescribed in 18 USC 1001.
Note: Offerors are hereby advised that the Government will acquire the right to use, duplicate, or
disclose in any manner and for any purpose whatsoever, and have or permit others to do so, all
subject data required to be delivered under any contract resulting from this solicitation.
**Quote shall be in 2 volumes**: 1 Technical and 2 Price. The volumes shall be separate and
complete. The volumes shall be separate and complete, so that evaluation of one may be
accomplished independently of, and concurrently with, the evaluation of the other. No pricing
information shall be provided in volume 1.
Volume 1 (Technical) shall include the following information:
Factor 1: Technical Capability
Offerors shall provide a detailed narrative that clearly and completely demonstrates its
technical capability to execute the specified activities in the J-1 Statement of Work (SOW)
that is comprehensive, feasible, and likely to be effective. The Offeror shall provide the resumes of
Key Personnel. Each resume shall clearly display academic qualifications, professional certifications,
technical skills, and length and variety of experience relevant to the SOW labor categories and
demonstrate that the proposed Key Personnel has/have the appropriate qualifications,
certifications, skills, experience and demonstrated success for meeting the requirements in the
Page 26 of 95
SOW. Offerors shall provide signed commitment letters for the Key Personnel. The Government
will not evaluate resumes that do not include a commitment letter signed by the Key Personnel.
Offerors shall not provide resumes for personnel that are not deemed Key Personnel and the
Government will only evaluate one resume per Key Personnel position.
Factor 2: Relevant Past Performance
The Offeror shall provide a narrative describing three (3) efforts that are most like this effort in
terms of scope, complexity and size. Two of the three efforts must be J-1 SOW attachment efforts
where the Offeror was the Prime. The Offeror shall not provide more than three (3) relevant
experience references. The narrative shall describe the Offeror’s current or previous experience
within the past three (3) years. The Offeror shall identify other Government organizations in which it
has performed similar tasks including the degree of its involvement (prime or subcontractor), the size
of the client’s organization, and other information to describe its expertise and performance in the
subject areas, highlighting the organization’s demonstrated successes. Relevant experience may
include a mix of the Prime and proposed teammates information. When considered together, the
relevant experience references cited should cover the entire scope of the J-1 SOW attachment
requirements.
The administrative data, scope, complexity and size are described as:
Administrative Data:
1. Contract Number
2. Type of Contract (e.g., BPA/IDIQ/Task or Delivery Order)
3. Period of Performance (within last 3 years)
4. Whether Prime/ Teaming Partner performed the work as a Prime/Subcontractor for this effort
5. Size of the client’s organization
Scope: Identifies the aspects of the scope that are the same or like the work requirements as
listed in the J-1 SOW attachment. The Offeror must identify that it was the Prime on work performed
that is the same or similar.
Complexity: Describes the complex and specialized nature of the engagement, i.e. varied staffing
levels, provision of subject matter experts, more than ten (10) labor categories, two or more
concurrent task orders and/or IDIQ TOs, and nationwide support of laboratories.
Size: Identifies the total dollar value of the contract and the number of personnel involved.
Factor 3: Subcontracting Plan
The Offeror shall provide a complete subcontracting plan that is comprehensive, feasible, and clearly
reflects stated goals.
Page 27 of 95
Volume 2 (Price) shall include the following information:
Factor 4: Price
Quotes shall contain a total price with a breakdown showing cost elements that make up the total
price, i.e. labor breakdown, and tasks/deliverables breakdown in accordance with J-2 Pricing Table
attachment.
Quotes shall be submitted electronically to nicole.craig@fda.hhs.gov CC:

monifa.coleman@fda.hhs.gov no later than 10:00AM Eastern Standard Time on August 31,
2020.
Confidentiality: No proprietary, classified, confidential, or sensitive information should be included

in your response. The Government reserves the right to use any non‐proprietary technical
information in any resultant solicitation(s).
(End of Section L)
Page 28 of 95
SECTION M - EVALUATION FACTORS FOR AWARD
M.1. Basis for award
The Government intends to evaluate proposals and, if necessary conduct discussions with all
responsible Offerors within the competitive range. The award will be made to the Offeror whose
proposal conforms to the terms and conditions of the solicitation and award may be made to other
than the lowest priced or the highest technically rated offer.
Relative importance and trade-offs. The Government will base the determination of best value on
performance, and the other evaluation factors identified elsewhere in this solicitation. The
determination of best value also considers the relative importance of the evaluation factors.
Technical factors and past performance when combined are significantly more important than price.
It is pointed out; however, should technical competence between Offerors be considered
approximately the same, then price could become primary.
FDA will base its award decision using a best value analysis that results in the most advantageous
acquisition for the Government. FDA’s acquisition strategy used to obtain best value may result in an
award to other than the lowest priced, technically rated Offeror. Best value analysis spans a
continuum from the lowest priced, technically acceptable proposal to those proposals in which
tradeoffs between price, past performance, and each Offeror’s technical solution is evaluated. This
tradeoff process depends on the Government’s assessment of quality factors, including but not limited
to past performance, compliance with solicitation requirements, technical excellence, management
capability, personnel qualifications and prior experience, and price.
The Government reserves the right to award without discussions if the Contracting Officer determines
that the initial quote is/are providing the best value and discussions are not necessary.
Selection of an Offeror for contract award will be based on an evaluation of quotes against these
factors:
Volume I: Technical Quote
FACTOR 1: TECHNICAL CAPABILITY
A. Sample Collection:
The Government will evaluate the quality of: 1) the plan for collection and transportation of
food and cosmetics samples; 2) the ability to sample throughout the U.S. in the areas specified
(or geographically and demographically similar to those areas) as identified in the statement
of work; 3) the ability to identify the locations and collect samples of the specific types (e.g.
Page 29 of 95
baked goods, gummies) and brand names; 4) the plan for collecting and recording the
necessary sample information; and 5) the plan and process for estimating the expected sample
collection pricing (price of product, price of collection personnel, mileage) once a sample
collection request is presented.
B. Proposed Methodology:
1. The Government will evaluate the Offeror’s proposed methodology to be used in
conducting quantitative and qualitative analyses of foods (cosmetics will be excluded from
analysis) for each of the analytes specified in the statement of work. The Government will
evaluate: 1) the equivalence of the proposed method to that identified in the SOW and its
ability to measure the specified analytes; 2) the ability to use that method to conduct
analysis of the specific matrices identified for that method (not all matrices are required
for each method); 3) the ability to meet the performance characteristics of the method; 4)
the validation/verification evidence provided for the method.
2. The Government will evaluate the Offeror’s experience in conducting quantitative and
qualitative analysis of foods with the methods listed in the statement of work. A tabula
format must be provided to FDA wherein the title of the project, contracting agency,
agency contact, dollar amount, and type of analysis (cost estimate) are presented.
3. The Government will evaluate that the Offeror has available personnel with experience in
collecting food samples with proper techniques, experience in transporting samples to the
laboratory, ability to analyze foods with the methods specified in the Statement of Work
and to properly catalogue all data as specified in the Statement of Work.
4. The Government will evaluate the Offeror’s awareness of compliance with all laws and
regulations of the regulated industries, their trade associations, and consumer
organizations and demonstrate knowledge of Government and other data sources, as well
as demonstrate primary data collection capabilities (such as previous experience with
national projects
FACTOR 2: RELEVANT PAST PERFORMANCE
The Government will evaluate the past experience in analysis of foods with methods cited in the
below table extent to which the Offeror’s quote is comprehensive and demonstrates successful
performance on similar projects and/or past government contracts over the past three (3) years which
are relevant to the IDIQ Statement of Work.
FACTOR 3: SUBCONTRACTING PLAN
FDA shall evaluate subcontracting plan for adequacy, ensuring that the required information, goals,
and assurances are included that has contained at a minimum the HHS current subcontracting goals if
applicable.
Page 30 of 95
Volume II: Business Quote
FACTOR 4: PRICE
Quotes shall contain a total price with a breakdown showing cost elements that make
up the total price, i.e. labor breakdown, and tasks/deliverables breakdown. The Government will
evaluate the Offeror’s quote to determine if the proposed price is fair and reasonable. This factor
will be evaluated to ensure that the price is reasonable, complete and balanced. In this regard, the
Government will evaluate price for the overall IDIQ SOW in accordance with J-2 Pricing Table
attachment. Prices that are determined to be either unreasonably high or unrealistically low in
relation to the proposed work may result in the overall quote being considered unacceptable. In terms
of “completeness”, the Government will consider whether the price covers all of the work identified
in the SOW and address all of the items in the Pricing Table, Attachment J-2 (which must be used
for evaluation).
The Government will evaluate the Offeror’s labor rates, level of effort, staffing pricing,
and other prices necessary for operations such as deliverables and Other Direct Costs, for the
program. The Government will review Line Item Numbers (LINs) for reasonableness and
affordability to determine whether they reflect an understanding of Government tasks or contain
apparent mistakes.
Options. The Government will evaluate offers for award purposes by adding the total
price for the base year and all options periods to determine the total price for the requirement.
Evaluation of options shall not obligate the Government to exercise the option(s).
A. The quote shall represent the Offeror’s response to the requirements solicitation for the
methods and sample collection processes, as cited in the Attachment J-1 SOW.
B. For purposes of evaluation, the price of product will be evaluated as an estimate, with the
recognition that price of products will fluctuate with time, place and brand. It cannot be
known exactly until the time of purchase what the price will be; however, supporting
information should be provided to explain how estimated purchase price for the various
product types were derived.
FAR 52.217-5 Evaluation of Options (Jul 1990)
(End of Section M)
Page 31 of 95
Attachment J-1 Statement of Work
Scope
The principal objective of this contract will be to obtain a capability to support FDA by assessing
the quantities of CBD and related cannabinoids, as well as potential associated contaminants
such as toxic elements, pesticides, industrial chemicals and processing solvents, in foods and
cosmetics through surveys of these commodities. The purpose of these studies will be to develop
a better understanding of the quantities of CBD and associated cannabinoids and their
distribution. The goal will be to collect and analyze a statistically relevant number of samples,
between 1000-3000. The reliability of the results will be supported by specified quality
assurance/quality control processes within the study. The types of samples to be collected for
these studies will include food and cosmetic products from across the United States, mainly
including CBD-containing packaged and processed foods such as beverages, water, candy, baked
goods, oils and tinctures that can be added to human or animal foods, including pills, capsules,
gel caps, gummies and other forms. The analytical methodology for this contract will be defined
by the FDA and will include methods based on widely available and recognized methodology.
Table 1. Indefinite Delivery Indefinite Quantity Line Items

Sampling Sampling Shipping Types of samples Estimated
locations destinations number of
samples
1. Sample On-line Offeror’s Baked goods and snacks, 1000-2000
purchase/collecti purchasing or laboratory; Chocolate, Candy, Oils,
on and shipping from site visits College Park, Extracts/Concentrates/Tinct
to analysis in two cities MD (FDA ures marketed for human
destination (see from each of the CFSAN and animal use, Pills
Technical major Laboratories); (capsules, tablets, gel caps)
Requirements, geographic FDA marketed for human and
Section 1 below) regions Regulatory animal use, Gummies,
(Eastern, Labs (see Water/Beverages, Pet treats
Midwest, West) below)1 ; and cosmetics
and may include Oxford, MS
the metropolitan (National
areas of Atlanta, Center for
Chicago, Dallas, Natural
Denver, Los Products
Angeles, New Research)
York, San
Francisco,
Seattle and
Washington,
DC.
Page 32 of 95
ATTACHMENT J‐1 Statement of Work
Analysis Basis of method Method Matrices Estimated

(see listed Analytes number of
sections below samples
for
recommended
methods or
equivalents)
2. Cannabinoid Liquid Qualitative: Baked goods and snacks, All survey
profile with chromatography Cannabinoid Chocolate, Candy, Oils, samples (1000-
quantitation with UV, diode profile (section Extracts/Concentrates/Tincture 2000)
of CBD, array or 2,b,ii below) s marketed for human use,
Pills (capsules, tablets, gel
CBDA, THC fluorescence Quantitative:
caps) marketed for human use,
and THCA detection (see CBD, CBDA, Gummies, Water/Beverages,
(see section Section 2,a,i THC, THCA products marketed for animal
2, a below) below) use, including pet foods, pet
treats and Oils, Extracts,
Concentrates and Tinctures
3. Confirmation Derivatization CBD, CBDA, Baked goods and snacks, 10% of survey
of gas THC, THCA Chocolate, Candy, Oils, samples (100-
cannabinoids chromatography Extracts/Concentrates/Tincture 200)
with mass s marketed for human use,
quantitation spectrometry or
of CBD, liquid Gummies, Water/Beverages,
CBDA, THC chromatography products marketed for animal
and THCA tandem mass use, including pet foods, pet
spectrometry treats and Oils, Extracts,
(LC-MS/MS) or Concentrates and Tinctures
liquid
chromatography
high-resolution
mass
spectrometry
(LC-HRMS)
(section 2,b, i
below)
4. Toxic Inductively Pb, Cd, total Baked goods and snacks, All survey
elements coupled plasma Hg and total Chocolate, Candy, Oils, samples (1000-
mass As Extracts/Concentrates/Tincture 2000)
spectrometry s marketed for human use,
(ICP-MS)
(section 2,c,i Gummies, Water/Beverages,
below) products marketed for animal
use, including pet foods, pet
treats and Oils, Extracts,
Page 33 of 95

5. Pesticides Liquid See analyte list Oils, 20% of survey

chromatography in Table 2 Extracts/Concentrates/Tinct samples (200-
tandem mass ures marketed for human 400)
spectrometry use, Pills (capsules, tablets,
(LC/MS/MS) gel caps) marketed for
and/or gas human use
chromatography
mass
spectrometry
(GC/MS)
(section 2,d,i
below)
6. Residual Gas Class 1 and Chocolate, Oils, 20% of survey
solvents chromatography Class 2 Extracts/Concentrates/Tinct samples (200-
with flame solvents ures marketed for human 400)
ionization (section 2,f,ii use, Pills (capsules, tablets,
detection below) gel caps) marketed for
(section 2,e,i human use, Gummies,
below) Water/Beverages, products
marketed for animal use,
including pet foods, pet treats
and Oils, Extracts,
7. Microbiologi Bacteriological Salmonella spp Baked goods and snacks, 10% of samples
cal analysis: Analytical pills (capsules, tablets, gel (100-200)
detection and Manual (BAM) caps) marketed for human
identification Method or use, products marketed for
of equivalent animal use, including pet
Salmonella (section 2,f,i foods, pet treats and Oils,
spp below) Extracts, Concentrates and
Tinctures
8. Microbiologi qPCR per FDA Salmonella spp Baked goods and snacks, 10% of samples
cal Analysis: Foods Program pills (capsules, tablets, gel (100-200)
Confirmation Compendium caps) marketed for human
per positive method or use, products marketed for
Salmonella equivalent animal use, including pet
spp. (section 2,g,i foods, pet treats and Oils,
below) Extracts, Concentrates and
Tinctures
9. Microbiologi Bacteriological Listeria Baked goods and snacks, 10% of samples
cal analysis: Analytical monocytogenes pills (capsules, tablets, gel (100-200)
Detection Manual (BAM) caps) marketed for human
and Method or use, products marketed for
Identification equivalent animal use, including pet
of Listeria (section 2,h,i foods, pet treats and Oils,
monocytogen below) Extracts, Concentrates and
es Tinctures
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10. Microbiologi Bacteriological Listeria Baked goods and snacks, 10% of samples
cal Analysis- Analytical monocytogenes pills (capsules, tablets, gel (100-200)
Confirmation Manual (BAM) caps) marketed for human
per Listeria Method or use, products marketed for
Monocytoge equivalent animal use, including pet
nes positive (section 2,h,i foods, pet treats and Oils,
Tinctures
11. Microbiologi Bacteriological Shiga toxin- Baked goods and snacks, 10% of samples
cal analysis: Analytical producing E. pills (capsules, tablets, gel (100-200)
detection and Manual (BAM) coli (STEC) caps) marketed for human
identification Method or use, products marketed for
of Shiga equivalent animal use, including pet
toxin- (section 2,h,i foods, pet treats and Oils,
producing E. below) Extracts, Concentrates and
coli (STEC) Tinctures
12. Microbiologi Bacteriological Shiga toxin- Baked goods and snacks, 10% of samples
cal Analysis: Analytical producing E. pills (capsules, tablets, gel (100-200)
Confirmation Manual (BAM) coli (STEC) caps) marketed for human
per positive Method or use, products marketed for
Shiga toxin- equivalent animal use, including pet
producing E. (section 2,h,i foods, pet treats and Oils,
coli (STEC) below) Extracts, Concentrates and
Tinctures
13. Microbiologi Bacteriological Aerobic Baked goods and snacks, 10% of samples
cal analysis- Analytical bacteria pills (capsules, tablets, gel (100-200)
total aerobic Manual (BAM) caps) marketed for human
plate count Method or use, products marketed for
equivalent animal use, including pet
(section 2,i,i foods, pet treats and Oils,
Tinctures
1
FDA regulatory laboratory locations: Jefferson, AR; Lakewood, CO; Cincinnati, OH; Lenexa, KS; New York, NY; Bothell, WA; Alameda,
CA; Atlanta, GA; Irvine, CA.
Technical Requirements
Chemical Analysis: CFSAN will specify the specific samples (or types of samples), quantities
(between 50 and 2000), analytical methodology and data reporting requirements with each
specified task.
1. Sample collection
a. Collect processed/package foods and cosmetics from a sample collection list
generated by the FDA. FDA will provide instructions about procedures to be
followed if items on the list cannot be found (e.g. substitution, consultation with
FDA). Samples will be acquired from internet-based retailers, major “brick and
mortar” national chains, local retail chain locations and local independent stores
and markets in at least two major United States cities. Cities chosen will be
representative of major geographic regions (Eastern, Midwest, West) and may
Page 35 of 95

include the metropolitan areas of Atlanta, Chicago, Dallas, Denver, Los Angeles,
New York, San Francisco, Seattle and Washington, DC. FDA will specify the
type of commodity, the brand distribution, lot number and manufacturing date
distribution, quantity and geographic location of the samples. While the
geographic distribution is not expected to be extensive, the ability to obtain
samples from major metropolitan areas 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
1. Baked goods and snacks, chocolate, candy
2. Oils, Extracts, Concentrates, Tinctures marketed for human
3. Pills (capsules, tablets, gel caps) marketed for human use
4. Gummies (may be limited due to analytical difficulty)
5. Water/Beverages (including coffee grounds/instant coffee)
6. Products marketed for animal use, including pet foods, pet treats
and Oils, Extracts, Concentrates and Tinctures
7. Cosmetics
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 should 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. Information required to be kept when logging collected samples (contractor shall
be asked to provide the following information in a spreadsheet format as agreed
upon at the time a task order is issued)
i. Sample number assigned by FDA (on samples shipped to the contractor)
or 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 will be assigned a sample ID #, which will be
carried throughout the entire analysis process
Page 36 of 95

2. Photographs will be taken of the front of the item so that the

specific item and brand are clearly identifiable
3. Photographs will be taken of the ingredients panel and the
Nutrition Facts or Supplement Facts label, as well as the uniform
product code (UPC)
4. Photographs will 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 will be named in such a
way that the sample identification number occurs at the beginning
of the file name
6. Contractor shall be able to upload the digital photographs to an
FDA-selected site using FTP or similar protocol
v. Record of lot numbers/batch numbers, production codes (UPC) and
expiration dates (where applicable)
vi. Information from product label, including Serving Size Value, Serving
Size Units, Alternate Serving Size Value, Alternate Serving Size Units,
Other Ingredients, Minimum Recommended Servings Daily, Maximum
Recommended Servings Daily, Warnings, Allergens
vii. Other information as requested by FDA in the task order, including:
Manufacturer Name, Manufacturer City, Manufacturer State,
Manufacturer Telephone, Product Name, Hemp Food Additive Category,
Net Quantity Value, Net Quantity Units, Hemp Ingredient Name, Hemp
Ingredient Value, Hemp Ingredient Units, Hemp Extraction Method, CBD
Claim (Y/N), CBD Amount Claim (mg/serv), THC Claim (Y/N), THC
Claim Category, Pet Category, Pet Body weight category (BWC) Name,
BWC Value, BWC Units
e. Destination of collected samples
i. Most samples will be collected and analyzed by the contractor. However,
in some case, samples or duplicates of samples will be sent to FDA
laboratories for analysis by the FDA (Center for Food Safety and Applied
Nutrition, College Park, MD), FDA Regulatory Laboratories (Irvine, CA;
San Francisco, CA; Bothell, WA; Jefferson, AR; Kansas City, KS;
Jamaica, NY; Atlanta, GA; Denver, CO), or FDA Centers of Excellence
(National Center for Natural Products Research, Oxford, MS)
f. 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 should be collected,
with the exception of date and location of item purchased
2. Chemical Analysis Testing Required: The contractor shall be required to perform the
following analyses and provide separate pricing, on a per sample basis, for each of the
specified methods. Associated criteria and additional details are listed below
Page 37 of 95

a. Cannabidiol (CBD) and cannabinoid profiling: The contractor shall provide a

method and perform the analysis of samples for cannabidiol and related cannabinoids
i. Method: Liquid chromatography (HPLC) with UV detection; liquid
chromatography (HPLC) with diode array detection; liquid chromatography
(HPLC) with fluorescence detection; for example, “Commercial cannabis
consumer products part 2: HPLC-DAD quantitative analysis of cannabis
cannabinoids”; Laura A. Ciolino*, Tracy L. Ranieri, Allison M. Taylor ;
Forensic Science International 289 (2018) 438–447 or equivalent. Offeror
must submit method SOP or citation to the method used for review prior to
product analysis.
ii. Target analytes:
1. Qualitative identification:
a. CBD
b. ∆9-THC (∆9-tetrahydrocannabinol) (THC)
c. ∆8-THC (∆8-tetrahydrocannabinol)
d. THCA (Tetrahydrocannabinolic acid-A)
e. THCV (Tetrahydrocannabivarin)
f. CBC (Cannabichromene)
g. CBDA (Cannabidiolic acid)
h. CBG (Cannabigerol)
i. CBGA (Cannabigerolic acid)
j. CBN (cannabinol)
k. CBDV (Cannabidivarin)
2. Quantitative analysis:
a. CBD
b. ∆9-THC (∆9-tetrahydrocannabinol)
c. THCA (Tetrahydrocannabinolic acid-A)
d. CBDA (Cannabidiolic acid; quantitative analysis to determine
“Total CBD”)
iii. Target matrices: Baked goods and snacks, chocolate, candy, oils,
extracts/concentrates/tinctures marketed for human and animal use, pills
(capsules, tablets, gel caps) marketed for human and animal use, gummies,
water/beverages, pet treats
iii. Performance characteristics:
1. Method limit of quantitation (LOQ): Offeror must specify the method
LOQ and the process by which the LOQ was determined. The LOQ
should be 10 micrograms/gram (ppm) or less for CBD, CBDA, THC
and THCA.
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 70% and 130% for the
analytes in the food matrix in question
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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 CBD, CBDA, THC and THCA in the
matrices listed above should be 70%-130%
4. All cannabinoids in the profile must be baseline resolved in the
chromatogram
iv. Validation/Verification
1. Validation: The offeror must specify how the method was validated.
This can include:
a. Validation by an external study (e.g. AOAC study, etc);
include citation
b. Internal validation; briefly describe internal validation process
2. Verification: The offeror must submit verification data, which will
include:
a. Chromatograms demonstrating baseline resolution of the
cannabinoid profile by spiking into a blank baked food and
blank ground coffee matrix.
b. Replicate spikes into a blank baked food and blank gummy
matrix
i. Three replicate spikes of CBD, CBDA, THC and
THCA into each matrix at each of two concentrations
that assess the performance at relevant concentrations.
For example, one concentration may be most relevant
for CBD in a typical sample, while a lower
concentration spike would be relevant for CBDA, THC
and THCA (typically present at lower levels)
ii. Recoveries must be 70-130%
iii. Repeatability in each matrix should be less than +/-
20% relative standard deviation of the mean (RSD)
iv. Submit chromatograms from each spike and blank
extraction
c. Demonstrate lack of carryover with consecutive
chromatograms of a spike and a blank
b. Cannabidiol and cannabinoid confirmation: The contractor shall provide a
method and perform the analysis of samples to confirm the presence of CBD,
CBDA, THC and THCA with a mass spectrometry-based method. The method
must also quantitate CBD, CBDA, THC and THCA. Offeror must submit a
method SOP or citation to the method used. Confirmatory testing will be
performed on all products that exceed alert levels provided by the FDA, and on
any products where the analytical result is outside the range of 80-150% of the
label claim. In addition, at least 10% of the products in a category will undergo
confirmatory testing
Page 39 of 95

i. Method:
1. Liquid chromatography-resolution mass spectrometry (LC/HRMS):
“Quantitation of Cannabinoids in Cannabis Dried Plant Materials,
Concentrates, and Oils Using Liquid Chromatography-Diode Array
Detection Technique with Optional Mass Spectrometric Detection:
Single-Laboratory Validation Study, First Action 2018.11.”Vaclavik et
al.: Journal of AOAC International Vol. 102, No. 6, 2019 (sequential
diode array detection not required) or similar method
2. Liquid chromatography-tandem mass spectrometry (LC/MS/MS):
Adaptation of Vaclavik et al method (sequential diode array detection
not required) cited in previous section (section 2,b,i,1) or similar
method.
3. Derivatization gas chromatography mass spectrometry (GC/MS):
Commercial cannabis consumer products part 1: GC–MS qualitative
analysis of cannabis cannabinoids; Laura A. Ciolino*, Tracy L.
Ranieri, Allison M. Taylor; Forensic Science International 289 (2018)
429–437 or similar method.
ii. Target analytes: CBD, CBDA, THC and THCA
(capsules, tablets, gel caps) marketed for human and animal use, gummies ,
iv. Performance characteristics:
1. Recoveries: Spike recoveries for CBD, CBDA, THC and THCA in
the matrices listed above should be 70%-130%
2. All cannabinoids in the profile must be baseline resolved in the
chromatogram
3. Qualitative identification of CBD, CBDA, THC, and THCA: See the
following guidance documents for details on confirmation
requirements; CVM 118: Guidance for Industry Mass Spectrometry
for Confirmation of the Identity of Animal Drug Residues;
(https://www.fda.gov/regulatory-information/search-fda-guidance-
documents/cvm-gfi-118-mass-spectrometry-confirmation-identity-
animal-drug-residues) or Acceptance Criteria for Confirmation of
Identity of Chemical Residues using Exact Mass Data for the FDA
FVM Program (FDA Exact Mass)
(https://www.fda.gov/media/96499/download). The identity of the
compounds must be confirmed by:
a. Retention time match that of a standard to within (1) ≤ 0.2 min;
or (2) within ±2.5% (not to exceed 0.5 min)
b. MS criteria
i. LC/MS/MS: for two structurally-specific ions
(precursor fully dissociated) relative abundance ratio
Page 40 of 95

matches a standard to +/- 10%; see CVM 118 for other

acceptable criteria
ii. LC/HRMS: Measured accurate mass of the
quasimolecular ion is within 5 ppm of the calculated
exact mass; see FDA Exact Mass Criteria for more
details
iii. GC/MS: The spectrum should contain three
structurally-specific ions that match the relative
abundance ratio for the standard to within +/- 20%.
Other criteria, as defined in CVM 118 may be used
depending on the method
4. Quantitative determination of CBD, CBDA, THCA, and THCA
a. Method limit of quantitation (LOQ): Offeror must specify the
method LOQ and the process by which the LOQ was
determined. The LOQ should be 10 micrograms/gram (ppm)
or less for CBD, CBDA, THC and THCA
b. Compounds may be quantified using interpolation from a
three-point external calibration curve, which does not need to
be matrix-matched assuming recoveries meet the above
specified requirements; two-point standards addition may also
be used
c. If the quantitative result for CBD, CBDA, THC, or THCA
disagrees with the result obtained in the HPLC/UV method
above by a difference of 30%, the offeror will be required to
re-run the sample and verify the concentration by two-point
standards addition
v. Validation/Verification
1. Validation: The offeror must specify how the method was validated.
This can include:
include citation
2. The offeror must submit verification data, which will include:
a. Chromatograms showing a blank and a spike at 100 ppm for
the four compounds in either a baked food or gummie matrix
(chosen by the offeror); submit the summed mass spectra over
the chromatographic peak for the spiked sample
c. Toxic Element Analysis: The contractor shall provide a method for quantitation of
toxic elements in the matrices identified above. Offeror must submit method SOP or
citation to the method used
i. Method: Microwave assisted digestion ICP-MS as defined in FDA method
EAM 4.7 (see listing in https://www.fda.gov/food/laboratory-methods-
food/foods-program-compendium-analytical-laboratory-methods) or similar
method
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ii. Target analytes:

1. total arsenic (As)
2. total mercury (Hg)
3. lead (Pb)
4. cadmium (Cd)
(capsules, tablets, gel caps) marketed for human and animal use, gummies,
iv. Performance specifications
1. Limits of quantitation: as specified in table 1 of EAM 4.7 and
determined as defined in EAM 4.7(equivalent approaches can be used,
if explained); if LOQs are higher than EAM 4.7 table 1, explain reason
and provide approach for determining the LOQ if different than EAM
4.7
2. Repeatability at LOQ: +/- 10% Relative standard deviation of the
mean (RSDmean)
v. Validation/verification:
1. Validation: If using other than EAM 4.7, cite validation study. If
internal method, describe validation approach and cite relevant
validation data.
2. Verification: Select a relevant NIST Certified Reference Material and
run the material 3 times.
a. Accuracy: Average result must within +/- 20% of the CRM
value.
b. Repeatability: Replicates must have a precision of less than or
equal to 20% (relative standard deviation of the mean)
d. Pesticides analysis: The contractor shall provide a method to analyze for
pesticides in selected matrices (oils and capsules containing botanical materials).
Offeror must submit method SOP or citation to the method used
i. Method: LC-MS/MS and/or GC-MS per Multiresidue Method of Analysis
of Pesticides in Medical Cannabis Moulins et al. 2018, J AOAC Int
101(6) 1948-1960 or AOAC Official Method 2007.01, Pesticide Residues
in Foods by Acetonitrile Extraction and Partitioning with Magnesium
Sulfate (Gas Chromatography/Mass Spectrometry and Liquid
Chromatography/Tandem Mass Spectrometry), Sack, et al. 2011, J Ag.
Food Chem. 59, 6383-6411
ii. Target analytes: Per Table 2
iii. Target matrices: Oils, Extracts/Concentrates/Tinctures marketed for
human and animal use, Pills (capsules, tablets, gel caps) marketed for
human and animal use
1. Recoveries: Spike recoveries should be 60-120% in one oil (high fat)
and one botanical (low-moisture) matrix
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2. Qualitative identification of pesticides. The identity of the compounds

must be confirmed by:
a. Retention time match that of a standard to within (1) ≤ 0.2 min;
or (2) within ±2.5% (not to exceed 0.5 min)
b. Mass spectral confirmation as appropriate to the specific
method (e.g. GC/MS, LC/MS/MS, etc), as defined in CVM 118
or FDA Exact Mass
3. Quantitative determination of pesticides
a. Method limit of quantitation (LOQ): LOQs should be 20 parts-
per-billion (ug/kg) or less, or otherwise specified by the
offeror. Offeror must specify the method LOQ and the process
by which the LOQ was determined
b. Compounds may be quantified using interpolation from a
three-point external calibration curve, which does not need to
be matrix-matched assuming recoveries meet the above
specified requirements; two-point standards addition may also
be used
v. Validation/Verification:
1. Validation: the offeror must specify how the method was validated.
This can include:
include citation
include:
a. Mass selected chromatograms showing the results for a spike
of all 60 pesticides at one concentration (50-100 ppb) in each
of two matrices, one oil (high fat) and one botanical (low-
moisture) matrix. Provide averaged mass spectrum or ion-
abundance ratios over chromatographic peak for each analyte.
The same information for a blank matrix, chosen by the
offeror, should be included.
Table 2. Pesticides to be included in the pesticide analysis method

Pesticide
Abamectin Fenthion Spirotetramat
Acephate Fenvalerate Spiroxamine
Acequinocyl Fipronil Tebuconazole
Acetamiprid Flonicamid Tebufenozide
Aldicarb Fludioxonil Teflubenzuron
Allethrin Fluopyram Tetrachlorvinphos
Azadirachtin Hexythiazox Tetramethrin
Azoxystrobin Imazalil Thiacloprid
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Benzovindiflupyr Imidacloprid Thiamethoxam

Bifenazate Iprodione Thiophanate-methyl
Bifenthrin Kinoprene Trifloxystrobin
Boscalid Kresoxim-methyl Spirotetramat
Buprofezin Malathion Spiroxamine
Carbaryl Metalaxyl Tebuconazole
Carbofuran Methiocarb Tebufenozide
Chlorantraniliprole Methomyl Teflubenzuron
Chlorphenapyr Methoprene Tetrachlorvinphos
Chlorpyrifos Mevinphos Tetramethrin
Clofentezine MGK-264 Thiacloprid
Clothianidin Myclobutanil Thiamethoxam
Coumaphos Naled Thiophanate-methyl
Cyantraniliprole Novaluron Trifloxystrobin
Cyfluthrin Oxamyl
Cypermethrin Paclobutrazol
Cyprodinil Parathion-methyl
Daminozide Permethrin
Deltamethrin Phenothrin
Diazinon Phosmet
Dichlorvos Piperonyl butoxide
Dimethoate Pirimicarb
Dimethomorph Prallethrin
Dodemorph Propiconazole
Endosulfan sulfate Propoxur
Endosulfan-alpha Pyraclostrobin
Endosulfan-beta Pyrethrins
Ethoprophos Pyridaben
Etofenprox Quintozene
Etoxazole Resmethrin
Etridiazole Spinetoram
Fenoxycarb Spinosad
Fenpyroximate Spirodiclofen
Fensulfothion Spiromesifen
e. Residual Solvents: The offeror must provide a method for the analysis of
residual Class 1 and Class 2 solvents
i. Method: USP 30 <467> Residual Solvents (Headspace Gas
chromatography with flame ionization detection) or similar method
ii. Target analytes: Class 1 solvents: Benzene, Carbon tetrachloride, 1,2-
Dichloroethane, 1,1-Dichloroethene, 1,1,1-Trichloroethane; Class 2
solvents: Acetonitrile, Chlorobenzene, Chloroform, Cyclohexane, 1,2-
Dichloroethene, 1,2-Dimethoxyethane, N,N-Dimethylacetamide, N,N-
Dimethylformamide, 1,4-Dioxane, 2-Ethoxyethanol, Ethylene glycol,
Formamide, Hexane, Methanol, 2-Methoxyethanol, Methylbutylketone,
Page 44 of 95

Methylcyclohexane, Methylene chloride, N-Methylpyrrolidone,

Nitromethane, Pyridine, Sulfolane, Tetrahydrofuran, Tetralin, Toluene,
Trichloroethylene, Xylene
iii. Target matrices: Chocolate, Oils, Extracts/Concentrates/Tinctures
marketed for human and animal use, Pills (capsules, tablets, gel caps)
marketed for human and animal use, Gummies, Water/Beverages, pet
treats
1. Recoveries: Spike recoveries should be 60-120% in one oil (high
fat) and one botanical (low-moisture) matrix
2. Qualitative identification of pesticides. The identity of the
compounds must be confirmed by:
a. Retention time match that of a standard to within (1) ≤ 0.2
min; or (2) within ±2.5% (not to exceed 0.5 min)
3. Quantitative determination of residual solvents
a. Method limit of quantitation (LOQ): LOQs should be less
than or equal to the concentration limits specified in Table
1 of USP 30 <467> for class 1 solvents (e.g. 2 ppm for
benzene, 4 ppm for CCl4), and less than or equal to the
concentration limits in Table 2 of USP 30 <467> for class 2
solvents. Offeror must specify the process by which the
LOQ was determined
b. Compounds may be quantified using the approach in USP
30 <467> or equivalent
v. Validation/Verification:
1. Validation: If using other than USP 30 <467>, the offeror should
specify the validation process. This can include:
include citation
b. Internal validation; briefly describe internal validation
process
include,
a. Measurement of recoveries for spikes of a class 1 solvent at
two concentrations in a relevant matrix; along with a matrix
blank. Recoveries must be 60-120%
f. Microbiological analysis: Detection, identification and confirmation of
Salmonella spp.
i. Method:
1. Isolation and Identification. Salmonella analysis shall be
performed using the method described in the BAM
(http://www.fda.gov/Food/ScienceResearch/LaboratoryMethods/B
acteriologicalAnalyticalManualBAM/UCM070149) or any
appropriate Salmonella method found in the Official Methods of
Page 45 of 95

Analysis (OMA: Official Methods of Analysis of AOAC

INTERNATIONAL, 18th Ed., Revision 4, 2011. AOAC
INTERNATIONAL, Gaithersburg, MD).
2. Confirmation (positives from isolation and identification): FDA
Foods Program Compendium of Analytical Laboratory Methods:
Microbiological methods (https://www.fda.gov/food/laboratory-
methods-food/foods-program-compendium-analytical-laboratory-
methods) “Confirmation of Salmonella Isolates by Real-time
Polymerase Chain reaction”, or equivalent method
ii. Target analytes: Salmonella spp
iii. Target Matrices: Baked goods and snacks, pills (capsules, tablets, gel
caps) marketed for human and animal use, pet treats
iv. Performance specifications: Methods must be equivalent to cited methods
v. Validation/verification: the offeror must specify how the method was
validated. This can include:
include citation
process; validation process should be equivalent to FDA
Foods Program Guidelines for the Detection of Microbial
Pathogens in Foods and Feeds
(https://www.fda.gov/food/laboratory-methods-food/foods-
program-methods-validation-processes-and-guidelines)
2. Verification: None required
g. Microbiological analysis: Detection, identification and confirmation of
Listeria monocytogenes
i. Method:
1. Isolation and identification: L. monocytogenes analysis shall be
performed using the method described in the BAM
acteriologicalAnalyticalManualBAM/UCM071400) or any
appropriate L. monocytogenes method found in the Official
Methods of Analysis (OMA: Official Methods of Analysis of
AOAC INTERNATIONAL, 18th Ed., Revision 4, 2011. AOAC
INTERNATIONAL, Gaithersburg, MD)
2. Confirmation (positives from isolation and identification): L.
monocytogenes confirmation shall be performed using the method
described in the BAM
acteriologicalAnalyticalManualBAM/UCM071400), any
appropriate L. monocytogenes method found in the Official
Methods of Analysis (OMA: Official Methods of Analysis of
AOAC INTERNATIONAL, 18th Ed., Revision 4, 2011. AOAC
INTERNATIONAL, Gaithersburg, MD), or an equivalent method.
Page 46 of 95

ii. Target analytes: Listeria monocytogenes

iii. Target matrices: Baked goods and snacks, pills (capsules, tablets, gel
include citation
2. Verification: None required.
h. Microbiological analysis: Detection , identification and confirmation of
Shiga toxin-producing Escherichia coli (STEC)
i. Method:
1. Isolation and identification: STEC analysis shall be performed
using the method described in the BAM
appropriate STEC method found in the Official Methods of
2. Confirmation (positives from isolation and identification): STEC
confirmation should be performed by methods described in the
BAM
appropriate STEC method found in the Official Methods of
ii. Target analytes: STEC
include citation
Page 47 of 95


2. Verification: None required
i. Microbiological analysis: Aerobic Plate Count (APC)
i. Method: Aerobic Plate Count may be determined by using the method
described in the BAM
(http://www.fda.gov/Food/ScienceResearch/LaboratoryMethods/Bacteriol
ogicalAnalyticalManualBAM/UCM071400) Chapter 3, or any appropriate
method found in the Official Methods of Analysis (OMA: Official
Methods of Analysis of AOAC INTERNATIONAL, 18th Ed., Revision 4,
2011. AOAC INTERNATIONAL, Gaithersburg, MD), e.g. AOAC 996.23
or 977.27
ii. Target analytes: aerobic bacteria
iv. Performance specifications: Methods must be equivalent to cited
methods.
include citation
2. Verification: None required.
j. Quality Assurance for 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
Page 48 of 95

at the time a final task order is submitted based on the offeror’s typical QA
scheme.
1. For each separate product category (e.g. tincture, oil, food, pet
treat) spike recoveries will be performed by addition of CBD and
THC standards to the product matrix every 20th sample. If less
than 20 samples are run for a category, spikes should be run on at
least one sample in the category 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 sample types 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
mg/kg of CBD may be fortified with an additional 5-10 mg/kg,
giving a final spiked concentration of 15 to 20 mg/kg. 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. The same product and aliquot may
be used for both CBD and THC spike studies.
2. For each separate product category, 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, 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
Page 49 of 95

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.
Page 50 of 95

ATTACHMENT J-3 Example Task Order
Analysis of Food for CBD and Related Cannabinoids

Introduction
To better protect the U.S. food supply, the Food and Drug Administration (FDA) and its various
components, including the Office of the Commissioner, the Office of Regulatory Affairs, the Center Food
Safety and Applied Nutrition (CFSAN), the Center for Veterinary Medicine (CVM), the Center for Drug
Evaluation and Research (CDER) and the Center for Tobacco Products (CTP), has the need to obtain
information about the amounts of cannabidiol (CBD) and various related cannabinoids, in a wide variety
of foods and cosmetics, through the collection of food and cosmetic samples and their subsequent analysis
by chemical analytical methods to be specified by the FDA. The FDA also has need to obtain
information about the occurrence of other possible chemical contaminants and adulterants that may be
present in the aforementioned products, and therefore is also interested in information about the presence
of toxic elements, pesticides and industrial chemicals and residual processing solvents.
Scope
The principal objective of this task order will be to support FDA by assessing the quantities of CBD and
related cannabinoids, as well as potential associated contaminants such as toxic elements, pesticides,
industrial chemicals and processing solvents, in foods through surveys of these commodities. In addition,
this task order will be used to collect cosmetic samples for shipment to a third party for analysis. The
purpose of these studies will be to develop a better understanding of the quantities of CBD and associated
cannabinoids and their distribution. The goal will be to collect and analyze a statistically relevant number
of samples. The reliability of the results will be supported by specified quality assurance/quality control
processes within the study. The types of samples to be collected for these studies will include food and
cosmetic products from two major cities in the United States (Seattle and Dallas). The samples will be
collected at large retailers (national or regional), small independent local retailers, and through internet
sales. The sample lists will be provided in detail, with specific product type and brand. The product
types will mainly include CBD-containing packaged and processed foods such as beverages, water,
candy, baked goods, oils and tinctures that can be added to human or animal foods and including pills,
capsules, gel caps, gummies and other forms. As noted, cosmetics will also be collected. All samples
will be analyzed for cannabinoid profile with quantitation of CBD, CBDA, THC and THCA. All samples
will also be analyzed for toxic elements. After initial evaluation of all samples, CFSAN will select a
subset of samples (typically those that exceed a pre-set quantitative threshold) for analysis by an MS-
based method to confirm identification and confirm measured CBD, CBDA, THC and THCA
concentrations. Selected samples will also be analyzed for pesticides, residual solvents, Salmonella spp.,
Listeria monocytogenes, Shiga toxin-producing E. coli (STEC) and total aerobic plate count, and positive
confirmation will be required for cases where the three foodborne pathogens are detected and identified.
Sample Collection
The following table defines the samples that will be collected in this task order. Samples will be defined
as a single item purchased at retail. Sample collection will occur in two major U.S. cities (Dallas and
Seattle), or through internet sales. Sample types and quantity of samples to be collected are outlined in
the table. Detailed product lists, identifying product types, brands within that type, and retail outlets
selling those types and brands will be provided with as much detail as possible at the time of task order
issuance, and will include instructions about potential substitutions should the targeted items be difficult
Page 51 of 95
to find. However, where specific product/retailer information is not available, the contractor will need to
assess possible sources through in-person visits to retail outlets directly. All samples will be shipped to
the contractor’s laboratories for analysis, with the exception of cosmetics samples. Cosmetics samples
will be shipped to the National Center for Natural Products Research at Oxford, MS. Perishable samples
should be shipped to minimize spoilage and bacterial growth, if it is likely to occur during shipping.
Sample type Samples Samples Samples Samples Internet Total

collected: collected: collected: collected: Purchases Collected
City 1 (e.g. City 1 (e.g. City 2 City 2 (e.g.
Seattle) Seattle) (e.g. Dallas)
Major Independent Dallas) Independent
retailers retailers and Major retailers and
shops retailers shops
Baked goods and snacks 35 35 35 35 35 175
Chocolate 35 35 35 35 35 175
Oils 35 35 35 35 35 175
Extracts/Concentrates 35 35 35 35 35 175
and lysates/Tinctures
marketed for human and
animal use
Pills (capsules, tablets, 35 35 35 35 35 175
gel caps) marketed for
human and animal use
Gummies 35 35 35 35 35 175
Water/Beverages 35 35 35 35 35 175
Pet treats and Pet foods 35 35 35 35 35 175
Cosmetics 60 60 60 60 60 300
Totals 340 340 340 340 340 1700
The following information must collected about each sample.

A. Sample number assigned by FDA (on samples shipped to the contractor) or by the contractor
B. Name of the product and size of the package
C. Date and location of sample collection
D. Readable digital photographs or photocopies of the food packaging, as purchased, to include front of
package, and all additional label information including ingredient list. The contractor will retain all
product packages for the analyzed products until FDA deems the digital photographs to be
acceptable.
a. Collected item will be assigned a sample ID #, which will be carried throughout the entire
analysis process
b. Photographs will be taken of the front of the item so that the specific item and brand are
clearly identifiable
c. Photographs will be taken of the ingredients panel and the Nutrition Facts label, as well as the
uniform product code (UPC)
d. Photographs will be taken of preparation instructions, if the samples are to be prepared by the
vendor
e. All digital photographs are to be available in BMP, JPG or similar digital format. Each
digital photograph will be named in such a way that the sample identification number occurs
at the beginning of the file name.
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f. Contractor must be able to upload the digital photographs to an FDA-selected site using FTP
or similar protocol
E. Record of lot numbers/production codes and expiration dates (where applicable)
F. Serving size from product label (where applicable)
Chemical and Microbiological Analysis
Samples (which will not include cosmetics samples) will be analyzed according to the chemical analysis
and microbiological analysis methods outlined in the base contract. The following table includes a
summary of the analysis method, the target analytes, the matrices (product types) that will be analyzed
with that method, and the number of analyses that will be conducted. The number of analyses will not
match the number of samples in every case because the specified quality control/quality assurance regime
will require the inclusion (at FDA cost) of additional analyses (see below). All samples will be analyzed
for cannabinoid profile, including quantitation of CBD, CBDA, THC and THCA. All samples will also
be analyzed for toxic elements (Total As, Cd, Hg, and Pb). A selected subset of the samples, as
determined by CFSAN after the initial analytical results from the CBD profile are received, will then be
analyzed using the remainder of the specified methods, with the probable number of analysis listed in the
table below. In the case of microbiological confirmation, the expected number of analyses is based on the
expected number of positives.
Analysis Basis of method Method Analytes Matrices Number of
(see SOW) listed analyses
sections below for (where less
than the total
recommended sample set is
methods or indicated,
equivalents) samples will be
selected by
CFSAN after
initial CBD
profiling)
1. Cannabinoid Liquid Qualitative: Baked goods and snacks, 1750
profile with chromatography Cannabinoid Chocolate, Candy, Oils,
quantitation of with UV, diode profile (section Extracts/Concentrates/Tinctures
CBD, CBDA, array or 2,b,ii below) marketed for human and animal
THC and fluorescence Quantitative: use, Pills (capsules, tablets, gel
THCA (see detection (see CBD, CBDA, caps) marketed for human and
section 2, a in Section 2,a,i in THC, THCA animal use, Gummies,
SOW) SOW) Water/Beverages, Pet treats
2. Confirmation of Derivatization gas CBD, CBDA, Baked goods and snacks, 175
cannabinoids chromatography THC, THCA Chocolate, Candy, Oils,
with mass spectrometry Extracts/Concentrates/Tinctures
quantitation of or liquid marketed for human and animal
CBD and THC chromatography use, Pills (capsules, tablets, gel
tandem mass caps) marketed for human and
spectrometry (LC- animal use, Gummies,
MS/MS) or liquid Water/Beverages, Pet treats
chromatography
high-resolution
mass spectrometry
(LC-HRMS)
(section 2,b, i in
SOW)
3. Toxic elements Inductively coupled Pb, Cd, total Hg Baked goods and snacks, 1750
plasma mass and total As Chocolate, Candy, Oils,
spectrometry (ICP- Extracts/Concentrates/Tinctures
MS) (section 2,c,i marketed for human and animal
in SOW) use, Pills (capsules, tablets, gel
Page 53 of 95
caps) marketed for human and
animal use, Gummies,
Water/Beverages, Pet treats
4. Pesticides Liquid See analyte list Oils, 175
chromatography in Table 2 Extracts/Concentrates/Tinctures
tandem mass (SOW) marketed for human and animal
spectrometry use, Pills (capsules, tablets, gel
(LC/MS/MS) caps) marketed for human and
and/or gas animal use
chromatography
mass spectrometry
(GC/MS) (section
2,d,i in SOW)
5. Residual Gas Class 1 and Chocolate, Oils, 350
solvents chromatography Class 2 solvents Extracts/Concentrates/Tinctures
with flame (section 2,f,ii marketed for human and animal
ionization detection below) use, Pills (capsules, tablets, gel
(section 2,e,i in caps) marketed for human and
SOW) animal use, Gummies,
Water/Beverages, Pet treats
6. Microbiological Bacteriological Salmonella spp Baked goods and snacks, pills 350
analysis: Analytical Manual (capsules, tablets, gel caps)
detection and (BAM) Method or marketed for human and animal
identification of equivalent (section use, pet treats
Salmonella spp 2,f,i in SOW)
7. Microbiological qPCR per FDA Salmonella spp Baked goods and snacks, pills 20
Analysis: Foods Program (capsules, tablets, gel caps)
Confirmation Compendium marketed for human and animal
per positive method or use, pet treats
Salmonella spp. equivalent (section
2,g,i in SOW)
8. Microbiological Bacteriological Listeria Baked goods and snacks, pills 350
analysis: Analytical Manual monocytogenes (capsules, tablets, gel caps)
Detection and (BAM) Method or marketed for human and animal
Identification of equivalent (section use, pet treats
Listeria 2,h,i in SOW)
monocytogenes
9. Microbiological Bacteriological Listeria Baked goods and snacks, pills 20
Analysis- Analytical Manual monocytogenes (capsules, tablets, gel caps)
Confirmation (BAM) Method or marketed for human and animal
per Listeria equivalent (section use, pet treats
Monocytogenes 2,h,i in SOW)
positive
10. Microbiological Bacteriological Shiga toxin- Baked goods and snacks, pills 350
analysis: Analytical Manual producing E. coli (capsules, tablets, gel caps)
detection and (BAM) Method or (STEC) marketed for human and animal
identification of equivalent (section use, pet treats
Shiga toxin- 2,h,i in SOW)
producing E.
coli (STEC)
11. Microbiological Bacteriological Shiga toxin- Baked goods and snacks, pills 20
Analysis: Analytical Manual producing E. coli (capsules, tablets, gel caps)
Confirmation (BAM) Method or (STEC) marketed for human and animal
per positive equivalent (section use, pet treats
Shiga toxin- 2,h,i in SOW)
producing E.
coli (STEC)
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12. Microbiological Bacteriological Aerobic bacteria Baked goods and snacks, pills 350
analysis- total Analytical Manual (capsules, tablets, gel caps)
aerobic plate (BAM) Method or marketed for human and animal
count equivalent (section use, pet treats
2,i,i in SOW)
Quality Assurance
In addition to the general quality assurance requirements defined in the base contract, the following
procedures will be performed. These procedures are summarized in the table below, and they are
described in detail following the table.
Action Acceptance Criterion Frequency

Spike Recovery at 50-100% of +/- 25% of the expected Once out of every 20 analyses of
native concentration, or 2-10X recovery the same product type
LOQ for blank matrices
Replicate analysis (duplicate, or Duplicates agree within 30% Once out of every 20 analyses of
triplicate if specified) Triplicates: relative standard the same product type
deviation (RSD) =20%, or RSD
equal to method RSD for
matrices with high RSD
Independent calibration check Must fall within 95% confidence Once out of every 10 analyses of
interval of calibration curve the same product type
Method blank No detectable analyte Every sample preparation batch
The FDA will include the requirement to run (at FDA cost) additional quality control analyses within
sample sets. A typical Quality Control scheme would be as follows, though it will be adjusted at the time
a final task order is submitted based on the offeror’s typical QA scheme.
1. For each separate product category (e.g. tincture, oil, food, pet treat) spike recoveries will be
performed by addition of CBD and THC standards to the product matrix every 20th sample. If less
than 20 samples are run for a category, spikes should be run on at least one sample in the category 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 sample types 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 mg/kg of CBD may be
fortified with an additional 5-10 mg/kg, giving a final spiked concentration of 15 to 20 mg/kg. 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. In the event of consistent failures, CFSAN will be consulted about
the need for possible verification with different products in the same matrix category. 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. The same product and aliquot may be used for
both CBD and THC spike studies.
2. For each separate product category, 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, 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
Page 55 of 95
larger. Replicate analysis requires a new aliquot to be carried through the entire method (sample
preparation and analysis). No more than 10% of replicate samples should be performed on products
without quantifiable concentrations of target analyte.
3. A method blank, which can be from a known blank matrix from one of the sample categories cited
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. The calibration check standard can be analyzed more often to evaluate
for carryover or instrument deviations. (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.
5. 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.
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U.S. DEPARTMENT OF HEALTH & HUMAN SERVICES Office of the Secretary
Washington, D.C. 20201
ATTACHMENT J-4
OFFICE OF SMALL AND DISADVANTAGED BUSINESS UTILIZATION
SMALL BUSINESS SUBCONTRACTING PLAN – 17-223-SOL-1179416
The following outline meets the minimum requirements of section 8(d) of the Small Business Act, as
amended, and implemented by the Federal Acquisition Regulations (FAR) Subpart 19.7. The U.S.
Department of Health and Human Services (HHS), Office of Small and Disadvantaged Business
Utilization (OSDBU) recommend offerors use the following format to submit proposed Individual
Subcontracting Plans, including modifications. It is not intended to replace any existing
Corporate/Commercial Plan that is more extensive. A subcontracting Plan is required if the
estimated cost of the contract may exceed $700,000 ($1,500,000 for construction) Small
businesses are excluded. Questions should be forwarded to the Contracting Officer or Operating
Division (OPDIV) Small Business Specialist.
HHS Operating Division (OPDIV): _______________________________
SOLICITATION OR CONTRACT NUMBER: ______________________________
DATE OF PLAN: ___________________________________________________
CONTRACTOR: ____________________________________________________
ADDRESS: ________________________________________________________
STATE/ZIP CODE___________________________________________________
DUNN & BRADSTREET NUMBER: _____________________________________
ITEM/SERVICE (Description): _______________________________________
__________________________________________________________________
__________________________________________________________________
__________________________________________________________________
__________________________________________________________________
__________________________________________________________________
Page 57 of 95
NEW/INITIAL CONTRACT
PERIOD OF CONTRACT PERFORMANCE (MM/DD/YYYY – MM/DD/YYYY):________ __________
Base (if options apply) $___________________ Performance Period/Quantity ____________
Option 1: $___________________ Performance Period/Quantity ____________
$___________________ Total Contract Cost
CONTRACT MODIFICATION (if applicable)
NEW PERIOD OF CONTRACT PERFORMANCE (MM/DD/YYYY – MM/DD/YYYY):__________________
Original/Base $___________________ Performance Period/Quantity _________
Modification $___________________ Performance Period/Quantity _________
Task Order $___________________ Performance Period/Quantity _________
$___________________ Modified Total Contract Cost
Failure to include the essential information of FAR Subpart 19.7 may be cause for either a delay in
acceptance or the rejection of a bid or offer when a subcontracting plan is required.
“SUBCONTRACT,” as used in this clause, means any agreement (other than one involving an
employer-employee relationship) entered into by a Federal Government prime contractor or
subcontractor requesting supplies or services required for performance of the contract or
subcontract.
If assistance is needed to locate small business sources, contact the Small Business
Specialist (SBS) supporting the OPDIV. SBS contact information is located on the OSDBU
website (http://www.hhs.gov/about/smallbusiness/osdbustaff.html) or you may contact the
OSDBU headquarters at (202) 690-7300.
HHS current subcontracting goal is 33.0% for Small Business (hereafter referred to as SB),
5.00% for Small Disadvantaged Business, including 8(a) Program Participants, Alaska
Native Corporations (ANC) and Indian Tribes (hereafter referred to as SDB), 5.00% for
Women-Owned Small Business and Economically Disadvantaged Women-Owned Small
Business (hereafter referred to as WOSB), 3.00% HubZone business (hereafter referred to
as HUBZone), 3.00% Veteran Owned Small Business (hereafter referred to as VOSB) and
3.00% Service Disabled Veteran-Owned Small Business (hereafter referred to as SDVOSB)
concerns for Fiscal Year (FY) 2016. For this procurement, HHS expects all proposed
subcontracting plans to contain at a minimum the aforementioned percentages.
Revised November 2015
Page 58 of 95
These percentages shall be expressed as percentages of the total estimated subcontracting
dollars.
1. Type of Plan (check one)
_____ Individual plan (all elements developed specifically for this contract and
applicable for the full term of this contract).
_____ Master plan (goals developed for this contract) all other elements
standardized and approved by a lead agency Federal Official; must be renewed every
three years and contractor must provide copy of lead agency approval.
_____ Commercial products/service plan (goals are negotiated with the initial
agency on a company-wide basis rather than for individual contracts) this plan
applies to the entire production of commercial service or items or a portion thereof.
The contractor sells commercial products and services customarily used for non-
government purposes. The plan is effective during the offeror’s fiscal year (attach a
copy). The Summary Subcontracting Report (SSR) must include a breakout
of subcontracting prorated for HHS and other Federal agencies.
2. Goals
Below indicate the dollar and percentage goals for Small Business (SB), Small
Disadvantaged (SDB) including Alaska Native Corporations and Indian Tribes,
Women-owned and Economically Disadvantaged Women-Owned (WOSB), Historically
Underutilized Business Zone (HUBZone), Veteran Owned Small Business (VOSB), Service-
Disabled Veteran-Owned (SDVOSB) Small Businesses and “Other than Small Business”
(Other) as subcontractors. Indicate the base year and each option year, as specified in FAR
19.704 or project annual subcontracting base and goals under commercial plans. If any
contract has more four options, please attach additional sheets which illustrate dollar
amounts and percentages. PLEASE NOTE: Zero dollars is not an acceptable goal for
the SB, SDB, WOSB, HUBZone, VOSB or SDVOSB categories since this does not
demonstrate a good faith effort throughout the period of performance of the
contract. Formula for below: 2.b. + 2.h. = 2.a.
a. Total estimated dollar value of ALL planned subcontracting, i.e., with ALL
types of concerns under this contract is _____ ____ (Base Period - if options apply).
FY ___1st Option FY ___2nd Option FY ___3rd Option FY ___4th Option
$ _____________ $ _____________ $ _____________ $ _____________
b. Total estimated dollar value and percent of planned subcontracting with

SMALL BUSINESSES (including SDB, WOSB, HUBZone, VOSB and SDVOSB): (% of
“a”)
$ ________________ and ________________% (Base Period - if options apply)
$ _____________ $ _____________ $ _____________ $ _____________

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c. Total estimated dollar value and percent of planned subcontracting with SMALL
DISADVANTAGED BUSINESSES: (% of “a”) $ ________________ and
________________% (Base Period - if options apply)
$ _____________ $ _____________ $ _____________ $ _____________
d. Total estimated dollar value and percent of planned subcontracting with

WOMEN-OWNED SMALL BUSINESSES: (% of “a”) $ ________________ and
$ _____________ $ _____________ $ _____________ $ _____________
e. Total estimated dollar and percent of planned subcontracting with HUBZone SMALL
BUSINESSES:
(% of “a”) $ ________________ and _________% (Base Period - if options apply)
$ _____________ $ _____________ $ _____________ $ _____________
f. Total estimated dollar and percent of planned subcontracting with VETERAN-

OWNED SMALL BUSINESSES: (% of “a”) $ ____________and
$ _____________ $ _____________ $ _____________ $ _____________
g. Total estimated dollar and percent of planned subcontracting with SERVICE-

DISABLED VETERAN-OWNED SMALL BUSINESSES: (% of “a”) $
________________ and ________________% (Base Period - if options apply)
$ _____________ $ _____________ $ _____________ $ _____________
h. Total estimated dollar and percent of planned subcontracting with “OTHER THAN
SMALL BUSINESSES” (As defined by the Small Business Administration as “any entity
that is not classified as a small business. This includes large businesses, state and local
governments, non-profit organizations, public utilities, educational institutions and
foreign-owned firms.) (% of “a”) $ ________________ and ________________%
(Base Period - if options apply)
$ _____________ $ _____________ $ _____________ $ _____________

Page 60 of 95
i. Provide a description of ALL the products and/or services to be subcontracted under
this contract, and indicate the size and type of business supplying them (check all
that apply):
Small
Products and/or Services Other SDB WOSB Hubz VOSB SDVOSB
Business
1
2
3
4
5
6
7
8
9
10
j. Provide a description of the method used to develop the subcontracting goals for SB,
SDB, WOSB, HUBZone and SDVOSB concerns. Address efforts made to ensure that
maximum practicable subcontracting opportunities have been made available for
those concerns and explain the method used to identify potential sources for
solicitation purposes. Explain the method and state the quantitative basis (in
dollars) used to establish the percentage goals. Also, explain how the areas to be
subcontracted to SB, WOSB, HUBZone, VOSB and SDVOSB concerns were
determined, how the capabilities of these concerns were considered contract
opportunities and how such data comports with the cost proposal. Identify any
source lists or other resources used in the determination process. (Attach additional
sheets, if necessary.)
_____________________________________________________________
_____________________________________________________________
k. Indirect costs have ____ have not ____ been included in the dollar and percentage
subcontracting goals above (check one).
Page 61 of 95
l. If indirect costs have been included, explain the method used to determine the
proportionate share of such costs to be allocated as subcontracts to SB, SDB, WOSB,
HUBZone, VOSB and SDVOSB concerns:
_________________________________________________________________
_________________________________________________________________
__________________________________________________________
3. Program Administrator:
NAME: ______________________________________________
TITLE: ______________________________________________
ADDRESS: ______________________________________________
______________________________________________
TELEPHONE: ______________________________________________
E-MAIL: ______________________________________________
Duties: Does the individual named above have general overall responsibility for the
company’s subcontracting program, i.e., developing, preparing, and executing
subcontracting plans and monitoring performance relative to the requirements of those
subcontracting plans and perform the following duties? (If NO is checked, please who in
the company performs those duties, or indicate why the duties are not performed in your
company on a separate sheet of paper and submit with the proposed subcontracting plan.)
a. Developing and promoting company-wide policy initiatives that demonstrate the

company’s support for awarding contracts and subcontracts to SB, SDB, WOSB,
HUBZone, VOSB and SDVOSB concerns; and for assuring that these concerns are
included on the source lists for solicitations for products and services they are
capable of providing; __yes __ no
b. Developing and maintaining bidder source lists of SB, SDB, WOSB, HUBZone, VOSB
and SDVOSB concerns from all possible sources; __yes __ no
c. Ensuring periodic rotation of potential subcontractors on bidder’s lists; __ yes __ no
d. Assuring that SB, SDB, WOSB, HUBZone, VOSB and SDVOSB businesses are included
on the bidders’ list for every subcontract solicitation for products and services that
they are capable of providing. __ yes __ no
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e. Ensuring that Requests for Proposals (RFPs) are designed to permit the maximum
practicable participation of SB, SDB, WOSB, HUBZone, VOSB and SDVOSB concerns.
__ yes __ no
f. Reviewing subcontract solicitations to remove statements, clauses, etc., which might

tend to restrict or prohibit small, 8(a), SDB, WOSB, HUBZone, VOSB and SDVOSB
small business participation. __ yes __ no
g. Accessing various sources for the identification of SB, SDB, WOSB, HUBZone, VOSB
and SDVOSB concerns to include the System for Award Management (http://sam.gov
), local small business and minority associations, local chambers of commerce and
Federal agencies’ Small Business Offices; ___ yes ___ no
h. Establishing and maintaining contract and subcontract award records; __ yes __ no
i. Participating in Business Opportunity Workshops, Minority Business Enterprise

Seminars, Trade Fairs, Procurement Conferences, etc; __ yes __ no
j. Ensuring that SB, SDB, WOSB, HUBZone, VOSB and SDVOSB concerns are made
aware of subcontracting opportunities and assisting concerns in preparing responsive
bids to the company; __ yes __ no
k. Conducting or arranging for the conduct of training for purchasing personnel

regarding the intent and impact of Section 8(d) of the Small Business Act, as
amended; __ yes __ no
l. Monitoring the company’s subcontracting program performance and making any

adjustments necessary to achieve the subcontract plan goals; ___yes ___ no
m.Preparing and submitting timely, required subcontract reports; ___ yes ___ no
n. Conducting or arranging training for purchasing personnel regarding the intent and
impact of 8(d) of the Small Business Act on purchasing procedures; __ yes __ no
o. Coordinating the company’s activities during the conduct of compliance reviews by

Federal agencies; and __ yes __ no
p. Other duties: ________________________________________________________
________________________________________________________
________________________________________________________
4. Equitable Opportunity
Describe efforts the offeror will undertake to ensure that SB, SDB, WOSB, HUBZone, VOSB
and SDVOSB concerns will have an equitable opportunity to compete for subcontracts.
These efforts include, but are not limited to, the following activities:
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a. Outreach efforts to obtain sources:
1. Contact minority and small business trade associations; 2) contact business

development organizations and local chambers of commerce; 3) attend SB,
SDB, WOSB, HUBZone, VOSB and SDVOSB procurement conferences and
trade fairs; 4) review sources from the System for Award Management
(http://www.sam.gov); 5) review sources from the Small Business
Administration (SBA), Dynamic Small Business Search database (DSBS)
http://dsbs.sba.gov/); 6) Consider using other sources such as the
National Institutes of Health (NIH) e-Portals in Commerce, (e-PIC),
(http://epic.od.nih.gov/). The NIH e-PIC is not a mandatory source;
however, it may be used at the offeror’s discretion; and 7) Utilize
newspaper and magazine ads to encourage new sources.
b. Internal efforts to guide and encourage purchasing personnel:
1. Conduct workshops, seminars and training programs;
2. Establish, maintain, and utilize SB, SDB, WOSB, HUBZone, VOSB and SDVOSB
source lists, guides, and other data for soliciting subcontractors; and
3. Monitor activities to evaluate compliance with the subcontracting plan.
Additional efforts:
_____________________________________________________________
_____________________________________________________________
5. Flow Down Clause
The contractor agrees to include the provisions under FAR 52.219-8, “Utilization of Small
Business Concerns,” in all acquisitions exceeding the simplified acquisition threshold that
offers further subcontracting opportunities. All subcontractors, except small business
concerns, that receive subcontracts in excess of $700,000 ($1,500,000 for construction)
must adopt and comply with a plan similar to the plan required by FAR 52.219-9, “Small
Business Subcontracting Plan.” Note: In accordance with FAR 52.212-5(e) and 52.244-
6(c) the contractor is not required to include flow-down clause FAR 52.219.-9 if it is
subcontracting commercial items.
6. Reporting and Cooperation
The contractor gives assurance of 1) cooperation in any studies or surveys that may be
required; 2) submission of periodic reports which illustrate compliance with the
subcontracting plan; 3) submission of its Individual Subcontracting Report (ISR) and
Summary Subcontract Report (SSR); and 4) subcontractors submission of ISRs and SSRs.
ISRs and SSRs shall be submitted via the Electronic Subcontracting Reporting
System (eSRS) website https://esrs.symplicity.com/index?_tab=signin&cck=1
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Reporting Period Report Due Due Date
Oct 1 - Mar 31 ISR 4/30
Apr 1 - Sept 30 ISR 10/30
Oct 1 - Sept 30 SSR 10/30
Contract Year End SDB 30 days after

Completion Report completion
Please refer to FAR Part 19.7 for instruction concerning the submission of a Commercial
Plan: SSR is due on 10/30 each year for the previous fiscal year ending 9/30.
a. Submit ISR (bi-annually) for the awarding Contracting Officer’s review and
acceptance via the eSRS website.
b. Currently, SSR (annually) must be submitted for the HHS eSRS Agency
Coordinator review and acceptance via the eSRS website. (Note: Log onto the
OSDBU website to view the HHS Agency Coordinator contact information
(http://www.hhs.gov/grants/small-business-programs/index.html)
Note: The Request for Proposal (RFP) will indicate whether a subcontracting plan is
required. Due to the nature and complexity of many HHS contracts, particularly the
Centers for Medicare and Medicaid (CMS), the contractor may not be required to submit its
subcontracting reports through the eSRS. The Contracting Officer will confirm reporting
requirements prior to the issuance of an award. For more information, contact Agency
Coordinator-eSRS on 202-690-7300.
7. Record keeping
FAR 19.704(a) (11) requires a list of the types of records your company will maintain to
demonstrate the procedures adopted to comply with the requirements and goals in the
subcontracting plan. The following is a recitation of the types of records the contractor will
maintain to demonstrate the procedures adopted to comply with the requirements and
goals in the subcontracting plan. These records will include, but not be limited to, the
following:
a. SB, SDB, WOSB, HUBZone, VOSB and SDVOSB source lists, guides and other
data identifying such vendors;
b. Organizations contacted in an attempt to locate SB, SDB, WOSB, HUBZone, VOSB

and SDVOSB sources;
c. On a contract-by-contract basis, records on all subcontract solicitations over

$100,000, which indicate for each solicitation (1) whether SB, SDB, WOSB,
HUBZone, VOSB and/or SDVOSB concerns were solicited, if not, why not and the
reasons solicited concerns did not receive subcontract awards;
Page 65 of 95
d. Records to support other outreach efforts, e.g., contacts with minority and small
business trade associations, attendance at small and minority business
procurement conferences and trade fairs;
e. Records to support internal guidance and encouragement provided to buyers

through (1) workshops, seminars, training programs, incentive awards; and (2)
monitoring performance to evaluate compliance with the program and
requirements; and
f. On a contract-by-contract basis, records to support subcontract award data

including the name, address, and business type and size of each subcontractor.
(This is not required on a contract–by–contract basis for commercial plans.)
g. Other records to support your compliance with the subcontracting plan: (Please
describe)
_____________________________________________________________
_____________________________________________________________
_____________________________________________________________
8. Timely Payments to Subcontractors
FAR 19.702 requires your company to establish and use procedures to ensure the timely
payment of amounts due pursuant to the terms of your subcontracts with SB concerns,
SDB, WOSB, HUBZone, VOSB and SDVOSB concerns.
Your company has established and used such procedures: ________ yes _________ no
9. Description of Good Faith Effort
Maximum practicable utilization of SB, SDB, WOSB, HUBZone, VOSB and SDVOSB concerns
as subcontractors in Government contracts is a matter of national interest with both social
and economic benefits. When a contractor fails to make a good faith effort to
comply with a subcontracting plan, these objectives are not achieved, and 15
U.S.C. 637(d) (4) (F) directs that liquidated damages shall be paid by the
contractor. In order to demonstrate your compliance with a good faith effort to achieve
the SB, SDB, WOSB, HUBZone, VOSB and SDVOSB small business subcontracting goals,
outline the steps your company plans to take. These steps will be negotiated with the
contracting official prior to approval of the plan.
____________________________________________________________________
____________________________________________________________________
____________________________________________________________________
Page 66 of 95
SIGNATURE PAGE
Signatures Required:
This subcontracting plan was submitted by:
Signature: __________________________________________________
Typed/Print Name: __________________________________________________
Title: __________________________________________________
Date: __________________________________________________
This plan was reviewed by:
Signature: __________________________________________________
Typed/Print Name: __________________________________________________
Title: Contracting Officer Date: ______________
Signature: __________________________________________________
Typed/Print Name: __________________________________________________
Title: HHS Small Business Specialist Date: ______________
Signature: __________________________________________________
Typed/Print Name: __________________________________________________
Title: Small Business Administration Procurement Center Representative
Date: __________________________________________________
This plan was approved by:
Signature: __________________________________________________
Typed/Print Name: __________________________________________________
Title: Contracting Officer Date: ______________

Page 67 of 95
ATTACHMENT J-5
FDA 1335 Personnel Security Clearance Requirements
1. BACKGROUND
The Office of the Assistant Secretary for Management and Budget, Department of Health and
Human Services (DHHS), requires that DHHS employees and contractor employees (including
subcontractors) who will be working in a DHHS-owned or leased space and/or who will have
access to DHHS equipment, and non-public privileged, proprietary, or trade secret information,
undergo a background investigation of some type.
Contractor employees who will be in DHHS-owned or lease space for less than thirty (30) days are
exempted from the background investigation requirement. These contractor employees must be
escorted at all time while in DHHS-owned or leased space.
2. GENERAL
The contractor shall submit the following items to the Contracting Officer, ten (10) calendar days
prior to commencement of work under this contract:
Certification that all required security form packets and a list of contractor employees names for
whom the requisite security information has been provided to Division of Security Operations,
Policy and Planning, Personnel Security Staff.
a. "Contractor's Commitment to Protect Non-public Information Agreement" forms

signed by each employee named in the paragraph above.
With the exception of costs associated with fingerprinting Contractor employees outside of the
FDA Personnel Security Office, the Government will conduct all required background
investigations at no cost to the contractor. The cost of fingerprinting Contractor employees at any
location other than the FDA Personnel Security Office will be borne by the Contractor.
Contractor employees shall obtain security badges in order to access to DHHS-owned or leased
property without an escort. (See Section 3 for details on the badging process) However, in the event
that work must commence before security badges can be issued, contractor employees will be
allowed onto DHHS-owned or leased property, but must be escorted at all times.
All Contractor employees who undergo a background investigation are required to log onto the
Office of Personnel Management’s (OPM’s) Electronic Questionnaire for Investigation Processing
(e-QIP) system to complete the forms necessary to initiate their background investigations. The
forms required vary with the position risk levels for the contract.
1
The position risk levels for this contract are ______________.
There are two (2) potential position risk levels, which are:
Page 68 of 95
Non-Sensitive Positions (Level 1) (SEE CHART A) - Positions which involve the lowest degree of
adverse impact on the efficiency of the Agency. The forms set forth by CHART A are required for
Non-Sensitive Positions (Level 1). Contractor employees assigned to Level 1 who receive a
security badge will be required to provide additional security information for a background
investigation as specified in Paragraph 5 below.
b. Public Trust Positions (Levels 5 or 6) (SEE CHART B) - Positions in which the incumbent's
actions or inaction could diminish public confidence in the integrity, efficiency, or effectiveness of
assigned Government activities, whether or not actual damage occurs. The forms set forth by
CHART B are required for Public Trust Positions (Levels 5 or 6). Contractor employees assigned
Levels 5 or 6 must receive security badge as well as a background investigation.
In order to access the e-QIP system, Contractor employees must provide the appropriate Personnel
Security Specialist with the following information: (a) full name; (b) position title; (c) social
security number; (d) date of birth; (e) place of birth; (f) email address; and (g) phone number. The
Personnel Security Specialist will use this information to initiate each Contractor employee into the
e-QIP system. Once this is done, each Contractor employee will receive an email that contains a
web link to access the e-QIP system, as well as instructions and additional forms needed to initiate
the suitability background investigation. The Project Officer for the contract will provide the name
of the appropriate Personnel Security Specialist to the Contractor.
A Contractor’s failure to comply with the e-QIP processing guidelines will result in that
Contractor’s employees being denied access to FDA property until all security processing has been
completed.
3. BADGING PROCESS
The FDA Project Officer will sponsor Contractor employees on the FDA Form 3391 for the
purpose of obtaining an FDA Security Access Card. In order to obtain one, a contractor employee
must receive a "favorable" fingerprint return. Fingerprints must be submitted to the Personnel
Security Office at least ten (10) days prior to the commencement of work. Fingerprints will be
submitted in one of two ways, depending on where the contract will be performed:
Contractor employees who will work in the Washington D.C. metro area will, at the direction of the
FDA Project Officer or his/her designee, contact the Personnel Security Branch to schedule a
fingerprinting appointment, or
b. Contractor employees who will work in a field office will submit fingerprints to:
Food and Drug Administration

Fingerprinting and Personnel Security Office
10903 New Hampshire Avenue, Building 1, Room 1201
Silver Spring, MD 20993
Upon the receipt of a "favorable" fingerprint return, each Contractor employee must present two
forms of identification in order to receive his or her badge. One form of identification must be a
Page 69 of 95
government-issued photo identification document. Acceptable forms of photo identification are
referenced on the FDA Form 3391. Acceptable forms of secondary identification are listed on the
back of the I-9 Form. This form can be obtained at http://uscis.gov/graphics/formsfee/forms/files/i-
9.pdf
An individual who receives an unfavorable report may appeal that finding by submitting a written
request to the Personnel Security Staff.
4. BACKGROUND INVESTIGATIONS
The Government shall conduct an additional background investigation for those individuals named
to risk Levels 1, 5 and 6 serving under this contract.
Required background investigations may include, but not be limited to:
Review of prior Government/military personnel records;

Review of FBI records and fingerprint files;
Searches of credit bureaus;
Personal interviews; and
Written inquiries covering the subject's background.
Background investigations will be conducted by the Office of Personnel Management (OPM).
The Contractor is responsible for ensuring that the integrity of contract performance is maintained
pending completion of all appropriate background investigations of contractor employees.
The Contractor shall submit the information required for eQIP access and other requisite forms for
the risk level(s) specified. In addition, the contractor shall provide a cover letter which includes: the
Contractor's name, the contract number, the name of the Contracting Officer administering the
contract, the names of all Contractor employees' for whom a background check is required and
those employees’ social security numbers, dates of birth, and former names. This cover letter and
all completed forms shall be transmitted, in a separate sealed envelope marked, "TO BE OPENED
BY ADDRESSEE ONLY," to:

Badging and Credentialing Office
10903 New Hampshire Avenue, Building 1, Room 1201
The contractor shall send a separate letter to the Contracting Officer that includes the contract
number and employee names.
The contractor shall advise its prospective employees that all standard forms submitted to the FDA
will be forwarded to the Office of Personnel Management (OPM) for scheduling background
investigations.
Page 70 of 95
Personnel Security Staff will resolve with the contract employee any issues arising out of
inaccurate or incomplete forms.
Employees who have been previously granted a Government security clearance shall advise
Personnel Security Staff of the details of such clearances to determine if a previous clearance level
is suitable for the current FDA position.
At any time, if a contractor employee for whom security forms have been submitted is terminated
or otherwise ceases work under the contract, the contractor shall immediately notify Personnel
Security Staff, in writing, with copies to the respective FDA Project and Contracting Officers.
The OPM background investigation will take approximately 120 days. The Contracting Officer will
notify the Contractor in writing if an employee is denied a clearance. Those individuals who have
been cleared by Personnel Security Staff may continue to work under the contract. Those who are
not cleared must cease work on the contract immediately.
If a Contractor employee changes job responsibilities under this contract, the contractor shall notify
the Contracting Officer, and the Government will make a determination whether an additional
security clearance is required.
In the event that a cleared individual is replaced, the contractor shall notify the Contracting Officer
and comply with all requirements of this clause, as specified herein, prior to the commencement of
work by the replacement individual.
The Contractor shall be responsible for the return of any Government issued security badges to the
Project Officer.
6. NON-PUBLIC DATA PROTECTION
The contractor shall protect the privacy of all information reported by or about contract employees
and shall protect against unauthorized disclosure.
CHARTS A & B ARE APPENDED TO THIS CLAUSE
For clarification purposes and to facilitate the flow of all required security forms, the following
matrix is provided:
Page 71 of 95
CHART A
Mandatory for all on-site contract employees
NON-SENSITIVE
POSITIONS - LEVEL 1
OBTAIN SUBMIT
WHEN REQUIRED DATE REQUIRED
FORM NAME FROM TO

Attn: Badging and Credentialing Office
Project Officer. Sponsorship 10903 New Hampshire Avenue
FDA Form 3391 - FDA Security All positions on DHHS Form must be received prior to
must be provided by FDA Building 1, Room 1201
Card Access Request property or leased space making fingerprint appointment.
Project Officer. Silver Spring, MD 20993
**Form must be submitted by Security
Rep.
All positions with access

Contractor’s Commitment to
to non-public privileged, Contracting Officer for retention Ten (10) calendar days prior
Protect Non-Public Information Contracting Officer
proprietary, or trade secret in contract file to commencement of work
(NPI) Agreement form
information
*Food and Drug Administration

Listing of all contractor employee
names, social security #s, gender, All positions, including
10903 New Hampshire Avenue Ten (10) calendar days prior to
dates of birth, former names, and a Contractor generated intermittent, per diem or
Building 1, Room 1201 commencement of work
completed Fair Credit Reporting temporary
Act Release
(301) 796-4592
SF 85 - Questionnaire for Online via OPM’s Non-Sensitive Positions – *Submit to OPM online via the e-QIP Ten (10) calendar days upon
Non-Sensitive Positions e-QIP system Level 1 Clearance system request of the Contracting Officer

FD 258 - Fingerprint Chart (2
Fingerprinting & Personnel Security Office
Charts Required) Ten (10) calendar days prior to
Non-Sensitive Positions - L 10903 New Hampshire Avenue
Fingerprinting services available Contracting Officer commencement of work
Clearance Building 1, Room 1201
by appointment only.
Call (301) 827-9527
(301) 796-4607
*In addition to the submission of these forms, the contractor shall provide a cover letter that
includes: contractor’s name, contract number, contractor employees’ names, and name of
Contracting Officer.
*Upon favorable fingerprint return, contractor will be notified to respond to the badging
office for their building pass.
Page 72 of 95
CHART B

Public Trust Positions - Levels 5

or 6
OBTAIN SUBMIT
WHEN REQUIRED DATE REQUIRED
FORM NAME FROM TO
SF 85P - Questionnaire for Public T Online via OPM’s

Public Trust Positions – *Submit to OPM online via the e-QIP Ten (10) calendar days prior
Positions e-QIP system
Level 5 or 6 Clearance system to Commencement of work

FD 258 - Fingerprint Chart
Fingerprinting & Personnel Security Office
(2 Charts Required)
Public Trust Positions – 10903 New Hampshire Avenue Ten (10) calendar days prior
Fingerprinting services available Contracting Officer
Level 5 or 6 Clearance Building 1, Room 1201 to commencement of work
by appointment only.
Call (301) 827-9527
(301) 796-4607

10903 New Hampshire Avenue
Building 1, Room 1201 Form must be received prior
FDA Form 3391 - FDA Security Project Officer. Sponsorsh All positions on DHHS
Silver Spring, MD 20993 to making fingerprinting
Card Access Request provided by FDA Project O property or leased space
appointment.
**Form must be submitted by Security Rep.
Contractor’s Commitment to All positions with access to n

Contracting Officer for retention Ten (10) calendar days prior
Protect Non-Public Information Contracting Officer privileged, proprietary,
in contract file to commencement of work
(NPI) Agreement form or trade secret information

Listing of all contractor employee n Attn: Badging and Credentialing Office
All positions, including
security #s, gender, dates of birth, f 10903 New Hampshire Avenue Ten (10) calendar days prior
Contractor generated intermittent, per diem or
names, and a completed Fair Credit Building 1, Room 1201 to commencement of work
temporary
Act Release Silver Spring, MD 20993
(301) 796-4592

8:00 a.m. – 11:00 a.m. and 1:00 p.m. – 3:00 p.m.
10903 New Hampshire Avenue
Building 1, Room 1201
No appointment necessary
(301) 796-4592
*Upon favorable fingerprint return, contractor will be notified to respond to the badging
office for their building pass.
Page 73 of 95
*In addition to the submission of these forms, the contractor shall provide a cover letter that
includes: contractor’s name, contract number, contractor employees’ names, and name of
Contracting Officer.
Page 74 of 95
Attachment J-6 Offeror Representations and Certifications-Commercial Items.
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 (JUN 2020)
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 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).
Page 75 of 95
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.
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;
(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;
Page 76 of 95
(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 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.
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—
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(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
(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)
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(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 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.
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(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 affects its eligibility; and
(ii) It □ is, □ is not a joint venture that complies with the requirements of 13 CFR
part 127, and the representation in paragraph (c)(6)(i) of this provision is accurate for each
WOSB concern eligible under the WOSB Program participating in the joint venture. [The offeror
shall enter the name or names of the WOSB concern eligible under the WOSB Program and
other small businesses that are participating in the joint venture: __________.] Each WOSB
concern eligible under the WOSB Program participating in the joint venture shall submit a
separate signed copy of the WOSB representation.
(7) Economically disadvantaged women-owned small business (EDWOSB) concern.

[Complete only if the offeror represented itself as a WOSB concern eligible under the WOSB
Program in (c)(6) of this provision.] The offeror represents that-
(i) It □ is, □ is not an EDWOSB concern, has provided all the required documents to
the WOSB Repository, and no change in circumstances or adverse decisions have been issued
that affects its eligibility; and
(ii) It □ is, □ is not a joint venture that complies with the requirements of 13 CFR
part 127, and the representation in paragraph (c)(7)(i) of this provision is accurate for each
EDWOSB concern participating in the joint venture. [The offeror shall enter the name or names
of the EDWOSB concern and other small businesses that are participating in the joint
venture: __________.] Each EDWOSB concern participating in the joint venture shall submit a
separate signed copy of the EDWOSB representation.
Note: Complete paragraphs (c)(8) and (c)(9) only if this solicitation is expected to
exceed the simplified acquisition threshold.
(8) Women-owned business concern (other than small business concern). [Complete
only if the offeror is a women-owned business concern and did not represent itself as a small
business concern in paragraph (c)(1) of this provision.] The offeror represents that it □ is a
women-owned business concern.
(9) Tie bid priority for labor surplus area concerns. If this is an invitation for bid, small
business offerors may identify the labor surplus areas in which costs to be incurred on account of
manufacturing or production (by offeror or first-tier subcontractors) amount to more than 50
percent of the contract price:____________________________________
(10) HUBZone 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–
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(i) It □ is, □ is not a HUBZone small business concern listed, on the date of this
representation, on the List of Qualified HUBZone Small Business Concerns maintained by the
Small Business Administration, and no material changes in ownership and control, principal
office, or HUBZone employee percentage have occurred since it was certified in accordance
with 13 CFR Part 126; and
(ii) It □ is, □ is not a HUBZone joint venture that complies with the requirements
of 13 CFR Part 126, and the representation in paragraph (c)(10)(i) of this provision is accurate
for each HUBZone small business concern participating in the HUBZone joint venture. [The
offeror shall enter the names of each of the HUBZone small business concerns participating in
the HUBZone joint venture: __________.] Each HUBZone small business concern participating
in the HUBZone joint venture shall submit a separate signed copy of the HUBZone
representation.
(d) Representations required to implement provisions of Executive Order11246-
(1) Previous contracts and compliance. The offeror represents that-
(i) It □ has, □ has not participated in a previous contract or subcontract subject to the
Equal Opportunity clause of this solicitation; and
(ii) It □ has, □ has not filed all required compliance reports.
(2) Affirmative Action Compliance. The offeror represents that-
(i) It □ has developed and has on file, □ has not developed and does not have on file,
at each establishment, affirmative action programs required by rules and regulations of the
Secretary of Labor (41 CFR parts 60-1 and 60-2), or
(ii) It □ has not previously had contracts subject to the written affirmative action
programs requirement of the rules and regulations of the Secretary of Labor.
(e) Certification Regarding Payments to Influence Federal Transactions

(31 http://uscode.house.gov/ U.S.C. 1352). (Applies only if the contract is expected to exceed
$150,000.) By submission of its offer, the offeror certifies to the best of its knowledge and belief
that no Federal appropriated funds have been paid or will be paid to any person for influencing
or attempting to influence an officer or employee of any agency, a Member of Congress, an
officer or employee of Congress or an employee of a Member of Congress on his or her behalf in
connection with the award of any resultant contract. If any registrants under the Lobbying
Disclosure Act of 1995 have made a lobbying contact on behalf of the offeror with respect to this
contract, the offeror shall complete and submit, with its offer, OMB Standard Form LLL,
Disclosure of Lobbying Activities, to provide the name of the registrants. The offeror need not
report regularly employed officers or employees of the offeror to whom payments of reasonable
compensation were made.
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(f) Buy American Certificate. (Applies only if the clause at Federal Acquisition Regulation
(FAR) 52.225-1, Buy American-Supplies, is included in this solicitation.)
(1) The offeror certifies that each end product, except those listed in paragraph (f)(2) of
this provision, is a domestic end product and that for other than COTS items, the offeror has
considered components of unknown origin to have been mined, produced, or manufactured
outside the United States. The offeror shall list as foreign end products those end products
manufactured in the United States that do not qualify as domestic end products,i.e., an end
product that is not a COTS item and does not meet the component test in paragraph (2) of the
definition of “domestic end product.” The terms “commercially available off-the-shelf (COTS)
item” “component,” “domestic end product,” “end product,” “foreign end product,” and “United
States” are defined in the clause of this solicitation entitled “Buy American-Supplies.”
(2) Foreign End Products:
Line Item No. Country of Origin
______________ _________________
______________ _________________
______________ _________________
[List as necessary]
(3) The Government will evaluate offers in accordance with the policies and procedures
of FAR part 25.
(g)
(1) Buy American-Free Trade Agreements-Israeli Trade Act Certificate. (Applies only if the
clause at FAR 52.225-3, Buy American-Free Trade Agreements-Israeli Trade Act, is included in
this solicitation.)
(i) The offeror certifies that each end product, except those listed in paragraph
(g)(1)(ii) or (g)(1)(iii) of this provision, is a domestic end product and that for other than COTS
items, the offeror has considered components of unknown origin to have been mined, produced,
or manufactured outside the United States. The terms “Bahrainian, Moroccan, Omani,
Panamanian, or Peruvian end product,” “commercially available off-the-shelf (COTS) item,”
“component,” “domestic end product,” “end product,” “foreign end product,” “Free Trade
Agreement country,” “Free Trade Agreement country end product,” “Israeli end product,” and
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“United States” are defined in the clause of this solicitation entitled “Buy American-Free Trade
Agreements–Israeli Trade Act.”
(ii) The offeror certifies that the following supplies are Free Trade Agreement
country end products (other than Bahrainian, Moroccan, Omani, Panamanian, or Peruvian end
products) or Israeli end products as defined in the clause of this solicitation entitled “Buy
American-Free Trade Agreements-Israeli Trade Act”:
Free Trade Agreement Country End Products (Other than Bahrainian, Moroccan,
Omani, Panamanian, or Peruvian End Products) or Israeli End Products:
______________ _________________
______________ _________________
______________ _________________
[List as necessary]
(iii) The offeror shall list those supplies that are foreign end products (other than
those listed in paragraph (g)(1)(ii) of this provision) as defined in the clause of this solicitation
entitled “Buy American-Free Trade Agreements-Israeli Trade Act.” The offeror shall list as other
foreign end products those end products manufactured in the United States that do not qualify as
domestic end products, i.e., an end product that is not a COTS item and does not meet the
component test in paragraph (2) of the definition of “domestic end product.”
Other Foreign End Products:
______________ _________________
______________ _________________
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______________ _________________
[List as necessary]
(iv) The Government will evaluate offers in accordance with the policies and
procedures of FAR part 25.
(2) Buy American-Free Trade Agreements-Israeli Trade Act Certificate, Alternate I. If

Alternate I to the clause at FAR 52.225-3 is included in this solicitation, substitute the following
paragraph (g)(1)(ii) for paragraph (g)(1)(ii) of the basic provision:
(g)(1)(ii) The offeror certifies that the following supplies are Canadian end products as
defined in the clause of this solicitation entitled “Buy American-Free Trade Agreements-Israeli
Trade Act”:
Canadian End Products:
Line Item No.
_______________________________________
_______________________________________
_______________________________________
[List as necessary]
(3) Buy American-Free Trade Agreements-Israeli Trade Act Certificate, Alternate II. If
Alternate II to the clause at FAR 52.225-3 is included in this solicitation, substitute the following
(g)(1)(ii) The offeror certifies that the following supplies are Canadian end products or
Israeli end products as defined in the clause of this solicitation entitled “Buy American-Free
Trade Agreements-Israeli Trade Act”:
Canadian or Israeli End Products:
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______________ _________________
______________ _________________
______________ _________________
[List as necessary]
(4) Buy American-Free Trade Agreements-Israeli Trade Act Certificate, Alternate III.
If Alternate III to the clause at 52.225-3 is included in this solicitation, substitute the following
(g)(1)(ii) The offeror certifies that the following supplies are Free Trade Agreement
country end products (other than Bahrainian, Korean, Moroccan, Omani, Panamanian, or
Peruvian end products) or Israeli end products as defined in the clause of this solicitation entitled
“Buy American-Free Trade Agreements-Israeli Trade Act”:
Free Trade Agreement Country End Products (Other than Bahrainian, Korean,
Moroccan, Omani, Panamanian, or Peruvian End Products) or Israeli End Products:
______________ _________________
______________ _________________
______________ _________________
[List as necessary]
(5) Trade Agreements Certificate. (Applies only if the clause at FAR 52.225-5, Trade
Agreements, is included in this solicitation.)
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(i) The offeror certifies that each end product, except those listed in paragraph
(g)(5)(ii) of this provision, is a U.S.-made or designated country end product, as defined in the
clause of this solicitation entitled “Trade Agreements.”
(ii) The offeror shall list as other end products those end products that are not U.S.-
made or designated country end products.
Other End Products:
_______________ __________________
_______________ __________________
_______________ __________________
[List as necessary]
(iii) The Government will evaluate offers in accordance with the policies and
procedures of FAR part 25. For line items covered by the WTO GPA, the Government will
evaluate offers of U.S.-made or designated country end products without regard to the
restrictions of the Buy American statute. The Government will consider for award only offers of
U.S.-made or designated country end products unless the Contracting Officer determines that
there are no offers for such products or that the offers for such products are insufficient to fulfill
the requirements of the solicitation.
(h) Certification Regarding Responsibility Matters (Executive Order 12689). (Applies only
if the contract value is expected to exceed the simplified acquisition threshold.) The offeror
certifies, to the best of its knowledge and belief, that the offeror and/or any of its principals–
(1) □ Are, □ are not presently debarred, suspended, proposed for debarment, or declared
ineligible for the award of contracts by any Federal agency;
(2) □ Have, □ have not, within a three-year period preceding this offer, been convicted
of or had a civil judgment rendered against them for: commission of fraud or a criminal offense
in connection with obtaining, attempting to obtain, or performing a Federal, state or local
government contract or subcontract; violation of Federal or state antitrust statutes relating to the
submission of offers; or commission of embezzlement, theft, forgery, bribery, falsification or
destruction of records, making false statements, tax evasion, violating Federal criminal tax laws,
or receiving stolen property;
Page 86 of 95
(3) □ Are, □ are not presently indicted for, or otherwise criminally or civilly charged by
a Government entity with, commission of any of these offenses enumerated in paragraph (h)(2)
of this clause; and
(4) □ Have, □ have not, within a three-year period preceding this offer, been notified of
any delinquent Federal taxes in an amount that exceeds $3,500 for which the liability remains
unsatisfied.
(i) Taxes are considered delinquent if both of the following criteria apply:
(A) The tax liability is finally determined. The liability is finally determined if it
has been assessed. A liability is not finally determined if there is a pending administrative or
judicial challenge. In the case of a judicial challenge to the liability, the liability is not finally
determined until all judicial appeal rights have been exhausted.
(B) The taxpayer is delinquent in making payment. A taxpayer is delinquent if the

taxpayer has failed to pay the tax liability when full payment was due and required. A taxpayer is
not delinquent in cases where enforced collection action is precluded.
(ii) Examples.
(A) The taxpayer has received a statutory notice of deficiency, under I.R.C. §6212, which
entitles the taxpayer to seek Tax Court review of a proposed tax deficiency. This is not a
delinquent tax because it is not a final tax liability. Should the taxpayer seek Tax Court review,
this will not be a final tax liability until the taxpayer has exercised all judicial appeal rights.
(B) The IRS has filed a notice of Federal tax lien with respect to an assessed tax
liability, and the taxpayer has been issued a notice under I.R.C. §6320 entitling the taxpayer to
request a hearing with the IRS Office of Appeals contesting the lien filing, and to further appeal
to the Tax Court if the IRS determines to sustain the lien filing. In the course of the hearing, the
taxpayer is entitled to contest the underlying tax liability because the taxpayer has had no prior
opportunity to contest the liability. This is not a delinquent tax because it is not a final tax
liability. Should the taxpayer seek tax court review, this will not be a final tax liability until the
taxpayer has exercised all judicial appeal rights.
(C) The taxpayer has entered into an installment agreement pursuant to I.R.C.
§6159. The taxpayer is making timely payments and is in full compliance with the agreement
terms. The taxpayer is not delinquent because the taxpayer is not currently required to make full
payment.
(D) The taxpayer has filed for bankruptcy protection. The taxpayer is not
delinquent because enforced collection action is stayed under 11 U.S.C. §362 (the Bankruptcy
Code).
(i) Certification Regarding Knowledge of Child Labor for Listed End Products (Executive
Order 13126). [The Contracting Officer must list in paragraph (i)(1) any end products being
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acquired under this solicitation that are included in the List of Products Requiring Contractor
Certification as to Forced or Indentured Child Labor, unless excluded at 22.1503(b).]
(1) Listed end products.
Listed End Product Listed Countries of Origin
___________________ ___________________
___________________ ___________________
(2) Certification. [If the Contracting Officer has identified end products and countries
of origin in paragraph (i)(1) of this provision, then the offeror must certify to either (i)(2)(i) or
(i)(2)(ii) by checking the appropriate block.]
(i) The offeror will not supply any end product listed in paragraph (i)(1) of this
provision that was mined, produced, or manufactured in the corresponding country as listed for
that product.
(ii) The offeror may supply an end product listed in paragraph (i)(1) of this provision
that was mined, produced, or manufactured in the corresponding country as listed for that
product. The offeror certifies that it has made a good faith effort to determine whether forced or
indentured child labor was used to mine, produce, or manufacture any such end product
furnished under this contract. On the basis of those efforts, the offeror certifies that it is not
aware of any such use of child labor.
(j) Place of manufacture. (Does not apply unless the solicitation is predominantly for the
acquisition of manufactured end products.) For statistical purposes only, the offeror shall indicate
whether the place of manufacture of the end products it expects to provide in response to this
solicitation is predominantly-
(1) □ In the United States (Check this box if the total anticipated price of offered end
products manufactured in the United States exceeds the total anticipated price of offered end
products manufactured outside the United States); or
(2) □ Outside the United States.
(k) Certificates regarding exemptions from the application of the Service Contract Labor
Standards (Certification by the offeror as to its compliance with respect to the contract also
constitutes its certification as to compliance by its subcontractor if it subcontracts out the exempt
services.) [The contracting officer is to check a box to indicate if paragraph (k)(1) or (k)(2)
applies.]
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(1) Maintenance, calibration, or repair of certain equipment as described in
FAR 22.1003-4(c)(1). The offeror □ does □ does not certify that–
(i) The items of equipment to be serviced under this contract are used regularly for
other than Governmental purposes and are sold or traded by the offeror (or subcontractor in the
case of an exempt subcontract) in substantial quantities to the general public in the course of
normal business operations;
(ii) The services will be furnished at prices which are, or are based on, established
catalog or market prices (see FAR 22.1003-4(c)(2)(ii)) for the maintenance, calibration, or repair
of such equipment; and
(iii) The compensation (wage and fringe benefits) plan for all service employees
performing work under the contract will be the same as that used for these employees and
equivalent employees servicing the same equipment of commercial customers.
(2) Certain services as described in FAR 22.1003-4(d)(1). The offeror □ does □ does
not certify that-
(i) The services under the contract are offered and sold regularly to non-
Governmental customers, and are provided by the offeror (or subcontractor in the case of an
exempt subcontract) to the general public in substantial quantities in the course of normal
business operations;
(ii) The contract services will be furnished at prices that are, or are based on,
established catalog or market prices (see FAR 22.1003-4(d)(2)(iii));
(iii) Each service employee who will perform the services under the contract will
spend only a small portion of his or her time (a monthly average of less than 20 percent of the
available hours on an annualized basis, or less than 20 percent of available hours during the
contract period if the contract period is less than a month) servicing the Government contract;
and
(iv) The compensation (wage and fringe benefits) plan for all service employees
performing work under the contract is the same as that used for these employees and equivalent
employees servicing commercial customers.
(3) If paragraph (k)(1) or (k)(2) of this clause applies–
(i) If the offeror does not certify to the conditions in paragraph (k)(1) or (k)(2) and
the Contracting Officer did not attach a Service Contract Labor Standards wage determination to
the solicitation, the offeror shall notify the Contracting Officer as soon as possible; and
(ii) The Contracting Officer may not make an award to the offeror if the offeror fails
to execute the certification in paragraph (k)(1) or (k)(2) of this clause or to contact the
Contracting Officer as required in paragraph (k)(3)(i) of this clause.
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(l) Taxpayer Identification Number (TIN) ( 26 U.S.C. 6109, 31 U.S.C. 7701). (Not
applicable if the offeror is required to provide this information to the SAM to be eligible for
award.)
(1) All offerors must submit the information required in paragraphs (l)(3) through (l)(5)
of this provision to comply with debt collection requirements of 31 U.S.C. 7701(c) and 3325(d),
reporting requirements of 26 U.S.C. 6041, 6041A, and 6050M, and implementing regulations
issued by the Internal Revenue Service (IRS).
(2) The TIN may be used by the Government to collect and report on any delinquent
amounts arising out of the offeror’s relationship with the Government (31 U.S.C. 7701(c)(3)). If
the resulting contract is subject to the payment reporting requirements described in FAR 4.904,
the TIN provided hereunder may be matched with IRS records to verify the accuracy of the
offeror’s TIN.
(3) Taxpayer Identification Number (TIN).
TIN: ________________________________.
TIN has been applied for.
TIN is not required because:
Offeror is a nonresident alien, foreign corporation, or foreign partnership that does

not have income effectively connected with the conduct of a trade or business in the United
States and does not have an office or place of business or a fiscal paying agent in the United
States;
Offeror is an agency or instrumentality of a foreign government;
Offeror is an agency or instrumentality of the Federal Government.
(4) Type of organization.
Sole proprietorship;
Partnership;
Corporate entity (not tax-exempt);
Corporate entity (tax-exempt);
Government entity (Federal, State, or local);
Foreign government;
International organization per 26 CFR1.6049-4;
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Other ________________________________.
(5) Common parent.
Offeror is not owned or controlled by a common parent;
Name and TIN of common parent:
Name ________________________________.
TIN _________________________________.
(m) Restricted business operations in Sudan. By submission of its offer, the offeror
certifies that the offeror does not conduct any restricted business operations in Sudan.
(n) Prohibition on Contracting with Inverted Domestic Corporations.
(1) Government agencies are not permitted to use appropriated (or otherwise made available)
funds for contracts with either an inverted domestic corporation, or a subsidiary of an inverted
domestic corporation, unless the exception at 9.108-2(b) applies or the requirement is waived in
accordance with the procedures at 9.108-4.
(2) Representation. The Offeror represents that–
(i) It □ is, □ is not an inverted domestic corporation; and
(ii) It □ is, □ is not a subsidiary of an inverted domestic corporation.
(o) Prohibition on contracting with entities engaging in certain activities or transactions

relating to Iran.
(1) The offeror shall e-mail questions concerning sensitive technology to the Department of
State at CISADA106@state.gov.
(2) Representation and Certifications. Unless a waiver is granted or an exception

applies as provided in paragraph (o)(3) of this provision, by submission of its offer, the offeror-
(i) Represents, to the best of its knowledge and belief, that the offeror does not
export any sensitive technology to the government of Iran or any entities or individuals owned or
controlled by, or acting on behalf or at the direction of, the government of Iran;
(ii) Certifies that the offeror, or any person owned or controlled by the offeror, does
not engage in any activities for which sanctions may be imposed under section 5 of the Iran
Sanctions Act; and
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(iii) Certifies that the offeror, and any person owned or controlled by the offeror,
does not knowingly engage in any transaction that exceeds the threshold at FAR 25.703-2(a)(2)
with Iran’s Revolutionary Guard Corps or any of its officials, agents, or affiliates, the property
and interests in property of which are blocked pursuant to the International Emergency
Economic Powers Act (et seq.) (see OFAC’s Specially Designated Nationals and Blocked
Persons List at https://www.treasury.gov/resource-center/sanctions/SDN-
List/Pages/default.aspx).
(3) The representation and certification requirements of paragraph (o)(2) of this

provision do not apply if-
(i) This solicitation includes a trade agreements certification (e.g., 52.212-3(g) or a

comparable agency provision); and
(ii) The offeror has certified that all the offered products to be supplied are
designated country end products.
(p) Ownership or Control of Offeror. (Applies in all solicitations when there is a

requirement to be registered in SAM or a requirement to have a unique entity identifier in the
solicitation).
(1) The Offeror represents that it □ has or □ does not have an immediate owner. If the
Offeror has more than one immediate owner (such as a joint venture), then the Offeror shall
respond to paragraph (2) and if applicable, paragraph (3) of this provision for each participant in
the joint venture.
(2) If the Offeror indicates “has” in paragraph (p)(1) of this provision, enter the
following information:
Immediate owner CAGE code: ____________________.
Immediate owner legal name: _____________________.
(Do not use a “doing business as” name)
Is the immediate owner owned or controlled by another entity: □ Yes or □ No.
(3) If the Offeror indicates “yes” in paragraph (p)(2) of this provision, indicating that
the immediate owner is owned or controlled by another entity, then enter the following
information:
Highest-level owner CAGE code: __________________.
Highest-level owner legal name: ___________________.
(Do not use a “doing business as” name)
Page 92 of 95
(q) Representation by Corporations Regarding Delinquent Tax Liability or a Felony
Conviction under any Federal Law.
(1) As required by sections 744 and 745 of Division E of the Consolidated and Further
Continuing Appropriations Act, 2015 (Pub. L. 113-235), and similar provisions, if contained in
subsequent appropriations acts, The Government will not enter into a contract with any
corporation that–
(i) Has any unpaid Federal tax liability that has been assessed, for which all judicial
and administrative remedies have been exhausted or have lapsed, and that is not being paid in a
timely manner pursuant to an agreement with the authority responsible for collecting the tax
liability, where the awarding agency is aware of the unpaid tax liability, unless an agency has
considered suspension or debarment of the corporation and made a determination that suspension
or debarment is not necessary to protect the interests of the Government; or
(ii) Was convicted of a felony criminal violation under any Federal law within the
preceding 24 months, where the awarding agency is aware of the conviction, unless an agency
has considered suspension or debarment of the corporation and made a determination that this
action is not necessary to protect the interests of the Government.
(2) The Offeror represents that–
(i) It is □ is not □ a corporation that has any unpaid Federal tax liability that has been
assessed, for which all judicial and administrative remedies have been exhausted or have lapsed,
and that is not being paid in a timely manner pursuant to an agreement with the authority
responsible for collecting the tax liability; and
(ii) It is □ is not □ a corporation that was convicted of a felony criminal violation

under a Federal law within the preceding 24 months.
(r) Predecessor of Offeror. (Applies in all solicitations that include the provision
at 52.204-16, Commercial and Government Entity Code Reporting.)
(1) The Offeror represents that it □ is or □ is not a successor to a predecessor that held a
Federal contract or grant within the last three years.
(2) If the Offeror has indicated “is” in paragraph (r)(1) of this provision, enter the
following information for all predecessors that held a Federal contract or grant within the last
three years (if more than one predecessor, list in reverse chronological order):
Predecessor CAGE code: (or mark “Unknown”).
Predecessor legal name: ____.
(Do not use a “doing business as” name).
(s) [Reserved].
Page 93 of 95
(t) Public Disclosure of Greenhouse Gas Emissions and Reduction Goals. Applies in all
solicitations that require offerors to register in SAM (12.301(d)(1)).
(1) This representation shall be completed if the Offeror received $7.5 million or more
in contract awards in the prior Federal fiscal year. The representation is optional if the Offeror
received less than $7.5 million in Federal contract awards in the prior Federal fiscal year.
(2) Representation. [Offeror to check applicable block(s) in paragraph (t)(2)(i) and (ii)].
(i) The Offeror (itself or through its immediate owner or highest-level owner) □ does, □ does
not publicly disclose greenhouse gas emissions, i.e., makes available on a publicly accessible
website the results of a greenhouse gas inventory, performed in accordance with an accounting
standard with publicly available and consistently applied criteria, such as the Greenhouse Gas
Protocol Corporate Standard.
(ii) The Offeror (itself or through its immediate owner or highest-level

owner) □ does, □ does not publicly disclose a quantitative greenhouse gas emissions reduction
goal, i.e., make available on a publicly accessible website a target to reduce absolute emissions
or emissions intensity by a specific quantity or percentage.
(iii) A publicly accessible website includes the Offeror's own website or a

recognized, third-party greenhouse gas emissions reporting program.
(3) If the Offeror checked “does” in paragraphs (t)(2)(i) or (t)(2)(ii) of this provision,
respectively, the Offeror shall provide the publicly accessible website(s) where greenhouse gas
emissions and/or reduction goals are reported:_________________.
(u)
(1) In accordance with section 743 of Division E, Title VII, of the Consolidated and Further
Continuing Appropriations Act, 2015 (Pub. L. 113-235) and its successor provisions in
subsequent appropriations acts (and as extended in continuing resolutions), Government agencies
are not permitted to use appropriated (or otherwise made available) funds for contracts with an
entity that requires employees or subcontractors of such entity seeking to report waste, fraud, or
abuse to sign internal confidentiality agreements or statements prohibiting or otherwise
restricting such employees or subcontractors from lawfully reporting such waste, fraud, or abuse
to a designated investigative or law enforcement representative of a Federal department or
agency authorized to receive such information.
(2) The prohibition in paragraph (u)(1) of this provision does not contravene
requirements applicable to Standard Form 312 (Classified Information Nondisclosure
Agreement), Form 4414 (Sensitive Compartmented Information Nondisclosure Agreement), or
any other form issued by a Federal department or agency governing the nondisclosure of
classified information.
Page 94 of 95
(3) Representation. By submission of its offer, the Offeror represents that it will not
require its employees or subcontractors to sign or comply with internal confidentiality
agreements or statements prohibiting or otherwise restricting such employees or subcontractors
from lawfully reporting waste, fraud, or abuse related to the performance of a Government
contract to a designated investigative or law enforcement representative of a Federal department
or agency authorized to receive such information (e.g., agency Office of the Inspector General).
(v) Covered Telecommunications Equipment or Services-Representation. Section

889(a)(1)(A) of Public Law 115-232.
(1) The Offeror shall review the list of excluded parties in the System for Award
Management (SAM) (https://www.sam.gov) for entities excluded from receiving federal awards
for “covered telecommunications equipment or services”.
(2) The Offeror represents that it □ does, □ does not provide covered
telecommunications equipment or services as a part of its offered products or services to the
Government in the performance of any contract, subcontract, or other contractual instrument.
(End of Provision)
Page 95 of 95

FDA RFQ: CBD Collection and Assessment

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Solicitation Number: RFQ_75F40120R00020

Collection and Analysis of Products Containing CBD and Cannabinoids - IDIQ

THIS ANNOUNCEMENT CONSTITUTES THE ONLY SOLICITATION AND A SEPARATE

The Government intends to issue an Indefinite Delivery, Indefinite Quantity contract.

PART I – THE SCHEDULE

SECTION B - SUPPLIES OR SERVICES AND PRICES/COSTS

B.1 Brief Description of Supplies or Services

B.2 Commitment of Public Funds

B.3 Communications Prior To Award

Offerors shall direct all communications to the attention of:

Nicole, Contract Specialist

phone calls will be accepted.

B.4 Preparation Costs

B.5 Potential Award without Discussions

B.6 Pricing / Equipment Schedule

SECTION C – STATEMENT OF WORK

but will also be used to guide the development of future policy.

C.2 Business Objectives

C.3 Statement of Work Specifications

C.4 Technical Requirements

C.5 Reporting Requirements and Deliverables

(equivalent to secure file transfer protocol).

SECTION D - PACKAGING AND MARKING

D.1 Marking Instructions for Reports

D.2 Payment of Postage and Fees

SECTION E - INSPECTION AND ACCEPTANCE

E.1 Inspection and Acceptance (Feb 1998)

SECTION F - DELIVERIES OR PERFORMANCE

F.1 Period of Performance

Option Years Option Periods

Option Year 2 September 10, 2022 to September 9, 2023

F.2 Place of Performance

SECTION G - CONTRACT ADMINISTRATION DATA

G.1. Contracting Officer’s Representative (COR)

G.2 Invoice Submission Requirements (Three-Way Match)

FDA Three-Way Match Invoicing Procedures

A. The contractor shall submit all invoices to:

U.S. FOOD AND DRUG ADMINISTRATION

Attn: Vendor Payments

(i) Name and address of the contractor;

(ii) Invoice date and invoice number;

(ix) Taxpayer Identification Number (TIN);

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

G.3 Invoice Payment

G.4 Key Personnel

HHSAR 352.237-75 Key Personnel (Dec 2015)

G.5 Contract Administration

b. Contractor Representative Officer

G.6 Post Award Evaluation of Offeror Performance

Offeror Performance Evaluations

Provision provided under Section H of the contract.

SECTION H - SPECIAL CONTRACT REQUIREMENTS

H.1 Smoke Free Environment

H.2 Restriction on Employment of Unauthorized Alien Workers

H.3 Government Furnished Equipment (GFE) Government Furnished Information (GFI)

H.4 Observance of Legal Holidays

(1) New Year's Day (6) Labor Day

(1) Any other day designated by Federal Statute

H.5 Employee Conduct

Part II – Contract Clauses

SECTION I - CONTRACT CLAUSES

I.1. FAR 52.252-2 Clauses Incorporated by Reference (Feb 1998)

52.227-11 Patent Rights-Ownership by the Contractor (May 2014)