A28 - RFQ for beta.sam - D-20-DC-0018.pdf

REQUEST FOR QUOTATIONS This RFQ is is not a Small Business-Small PAGE OF PAGES (THIS IS NOT AN ORDER) Purchase Set Aside 1 31

1. REQUEST NO. 3. REQUISITION/PURCHASE REQUEST NO. 4. CERT. FOR NAT. DEF.

UNDER BDSA REG. 2

AND/OR DMS REG. 1

RATING

D-20-DC-0018

2. DATE ISSUED

4-1-2020

5A. ISSUED BY 6. DELIVER BY (Date)

DRUG ENFORCEMENT ADMINISTRATION

OFFICE OF ACQUISITION AND RELOCATION MGMT

8701 MORRISSETTE DRIVE

SPRINGFIELD, VA 22152

04/15/2020

7. DELIVERY

FOB

DESTINATION OTHER

(See Schedule)5B. FOR INFORMATION CALL: (No collect calls)

NAME TELEPHONE NUMBER 9. DESTINATIONAREA CODE & NUMBER

Jennifer Jordan 202-598-2497 DEA Headquarters 600 Army Navy Dr Arlington VA 22202

8. TO:

To all interested offerors

10. PLEASE FURNISH QUOTATIONS TO THE

ISSUING OFFICE IN BLOCK 5A ON OR

BEFORE CLOSE OF BUSINESS (Date)

IMPORTANT: This is a request for information, and quotations furnished are not offers. If you are unable to quote, please so indicate on this form and return it to the address in Block 5A. This request does not commit the Government to pay any costs incurred in the preparation of the submission of this quotation or to contract for supplies or services. supplies are of domestic origin unless otherwise indicated by quoter. Any representations and/or certifications attached to this Request for Quotations must be completed by the quoter.

4/15/2020 at 10:00AM ET

11. SCHEDULE (Include applicable Federal, State, and local taxes)

ITEM NO.

(a)

SUPPLIES/SERVICES

(b)

QUANTITY

(c)

UNIT

(d)

UNIT PRICE

(e)

AMOUNT

(f)

Study reports and results from the scientific investigation of the in vivo analgesic effects

10 1 0.00 and drug discrimination of 10 synthetic opioid compounds (for a total of 20 reports/results)

0.00

Period of performance is 12 months.

0.00

0.00

GRAND TOTAL $0.00

12. DISCOUNT FOR PROMPT PAYMENT - -

a. 10 CALENDAR DAYS b. 20 CALENDAR DAYS c. 30 CALENDAR DAYS d. CALENDAR DAYS

NUMBER PERCENTAGE

NOTE: Additional provisions and representations are are not attached.

13. NAME AND ADDRESS OF QUOTER 14. SIGNATURE OF PERSON AUTHORIZED TO

SIGN QUOTATION

15. DATE OF QUOTATION

Interested Offerors shall provide the following information:

DUNS Number:

Cage Code Number:

16. SIGNER

a. NAME (Type or Print) b. TELEPHONE

AREA CODE & NUMBER

c. TITLE (Type or Print)

AUTHORIZED FOR LOCAL REPRODUCTION

PREVIOUS EDITION NOT USABLE

STANDARD FORM 18 (REV. O6-95)

Prescribed by GSA FAR (48 CFR) 53.215-1(a)

10am EST.

DEA/DC/DOE 1

Statement of Work

Evaluation of Synthetic Opioid Substances using the Analgesia and Drug Discrimination Assay

I. Background

The Drug and Chemical Evaluation Section (DOE) of the Drug Enforcement Administration’s (DEA) Diversion Control Division (DC) is responsible for evaluating drugs and chemicals to determine whether these substances have abuse potential. Pharmacological, medical, epidemiological, and other scientific data for these drugs are needed to evaluate the abuse potential of these substances. DOE uses these evaluations to initiate the administrative procedure to place these substances under regulatory control according to the guidelines of the Controlled Substances Act (CSA).

Recently, numerous synthetic substances with opioid-like activity have been abused in the United States and pose a significant risk to the public safety. Law enforcement and forensic laboratory data have reported increased encounters of new synthetic opioid substances. Abuse of these synthetic opioid substances has been associated with overdoses and deaths. Due to the immediate public health threat associated with these synthetic opioid substances, several of them have been placed under schedule I pursuant to temporary scheduling provision of the CSA.

Temporary scheduling status lasts for a period of up to 3 years. In order to place these synthetic opioid substances under permanent control, pharmacological data is required.

Analgesia is a pharmacological property that is associated with opioid drugs. Evaluating the discriminative stimulus properties of drugs of abuse including synthetic opioids is highly important in determining their abuse potential. Studies on the analgesic and discriminative stimulus effects of new synthetic opioids in comparison to established opioid drugs such as morphine or fentanyl will help to determine opioid-like effects and abuse potential of these substances. As such, DEA would like the vendor to assess analgesic and discriminative stimulus properties of selected synthetic opioids. Due to the time-sensitivity of this work, DEA is requesting that the pharmacological studies be initiated and completed in an expedited manner.

II. Brief Description of Work

For this project, DEA will provide the synthetic opioid substances to the potential vendor.

Most of these substances are Schedule I substances. Therefore, the vendor should have a Schedule I researcher registration with DEA. The vendor shall conduct preclinical evaluation of analgesic and discriminative stimulus effects of these substances in comparison to appropriate controls and reference standard opioid substances (i.e. morphine and fentanyl). The vendor will provide DEA with investigational study results and a description of the methodology used to

DEA/DC/DOE 2

conduct the investigation in the form of a formal study report (one for analgesia study and one for drug discrimination study) as per the timelines specified in this statement of work (SOW), if not earlier. The vendor will evaluate 10 synthetic opioid substances in the aforementioned studies. Upon award of the purchase order, DEA will notify the vendor the names of these test substances. DEA will provide the vendor these substances in sufficient quantities to complete the proposed pharmacological studies. It is the vendor’s responsibility to purchase all necessary substances other than the test substances for the analgesia studies and drug discrimination assays.

III. Specific Tasks to be Performed

Task 1. Drug source, storage and recordkeeping.

I. Drug Source: DEA will provide the vendor the test substances only. The vendor is responsible for obtaining the training drug (morphine), reference substances (fentanyl), and antagonists (naltrexone) or any other substances needed to complete the studies.

II. Record Keeping: The vendor shall maintain electronic and paper copies of a chronological log of the test substance receipt and evaluation using Microsoft Excel spreadsheet software.

When each substance is received, the following shall be recorded :

a) test substance's name;

b) date of authorization for testing of the test substance;

c) date of receipt of the test substance (If provided by DEA);

d) amount of test substance received (if provided by DEA);

e) pharmacological studies authorized by DEA for the test substance (e.g. analgesia and drug discrimination);

f) date of initiation of each study authorized by DEA;

g) amount of test substance used for each authorized study;

h) date of completion of each authorized study;

i) date of the submission of each study report to DEA.

These records shall be kept up to date and forwarded to the DEA representative upon request.

III. Drug Storage and Schedule I Researcher Registration Requirement: Some of the test substances may be in schedule I of the CSA. Such schedule I test substances shall be stored in accordance with the regulatory requirements as specified by the CSA. The vendor shall be registered with DEA as a Schedule I researcher. Some reference drugs are in schedule II of the CSA. The vendor shall adhere to appropriate CSA regulatory requirements (appropriate registration, storage etc.) related to such substances. In cases of non-controlled test substances, drug storage and handling shall be maintained as per the Good Laboratory Practices (GLP) or GLP-like conditions.

Task 2. Protocols of in vivo pharmacological studies (analgesia and drug discrimination) in laboratory rodents

DEA/DC/DOE 3

The vendor’s proposal shall include the general protocols that are used for in vivo analgesia and drug discrimination studies including a description of these studies (i.e., preferred methodology).

Upon acceptance of the award and as specified in the deliverables, the vendor shall provide DEA the detailed study protocols. The study protocols shall contain a description of the methodology and apparatus used to conduct the experiments, maintenance of the animals to be used in the tests, data analysis including proposed statistical methods, and proposed presentations of the data and study results. Specifically, the study protocol should conform to the following standards:

I. The vendor shall provide a study protocol for each in vivo pharmacological study. For example, one protocol should be provided for analgesia and one protocol for drug discrimination.

II. The study protocols must be specifically written to meet the protocol preferences as listed in this SOW under Tasks 3, 4, 5, and 6.

III. The study protocol should closely follow the format of the materials and methods section of scientific journal articles. If the vendor has previously published these methods in a scientific journal, such information should be included as part of the study protocol and shall not be submitted as a separate file (i.e., submitting the example paper with the study protocol would not be considered acceptable). Details including the animal species and strain, number of animals, animal care, experimental design, data analysis including statistical methods and generation of results (e.g., %MPE, ED50, 95% confidence limit values, and repeated measures ANOVA, as appropriate) shall be included.

IV. The study protocol shall include examples of data presentation format. For example, representative dose-response curves, tables, and statistical analyses should be included.

V. Signature lines shall be included on each study protocol. The protocol that is approved by both DEA and the vendor will be signed by the respective representatives. The original signed document will remain with DEA. A copy of the signed protocol will be provided to the vendor. The signed protocols will serve as an official record.

Following receipt of the standard protocols by DEA representative, a phone conversation may be scheduled to discuss the study protocols and SOPs. Any significant deviations or modifications from the protocol by the vendor must be authorized by DEA. The vendor must provide a modified protocol (e.g., change in time points, change in vehicle used, modification needed based on a specific test substance, etc.), the amended or modified protocol must be submitted in writing to DEA representative for review and approval. The DEA representative must approve the protocol with each new assay modifications.

NOTE: The DEA representative must approve work with each new test method prior to its initiation. Only those test substances specified by DEA shall be evaluated using the new modified method. For the most part, standard substances (known drugs of abuse such as morphine and fentanyl) shall be used. Special reports and data summaries shall adhere to the format determined by DEA.

Task 3. Evaluation of test substances for analgesic effects

DEA/DC/DOE 4

I. Objective: The goal of this in vivo pharmacological study is to understand whether administration of test substances can result in an analgesic effect using the approved protocol as specified in Task 2.

II. Experimental Design: Analgesia assays shall be conducted in mice or rats. The vendor and DEA shall agree on the strain of rodent to be used for each of the studies. The vendor shall follow DEA-approved in vivo analgesia protocol for conducting these studies. Briefly, analgesia study will be conducted using the warm-water tail withdrawal assay (this is the preferred method for the opioid drug class; however, other anti-nociceptive assays can be considered if a protocol and justification is provided).

Selection of the appropriate study shall be agreed upon by both DEA and the vendor. The preferred route of administration of substances for this study is subcutaneous injection.

To determine the opioid receptor mediated effect, the analgesic effect of these compounds shall be evaluated in the presence of appropriate dose(s) of standard receptor antagonist(s) (e.g., naltrexone). Experimental groups for evaluating each test substance shall consist of appropriate number of doses and statistically appropriate number of animals per group (at least 8 animals). Data from the proposed experiments shall be summarized in terms of ED50 (median effective dose; a dose producing the analgesic effect by 50%) as well as inclusion of the %MPE. Dose response curves from the studies shall also be included. Dose response studies using appropriate reference drugs (i.e.

fentanyl and morphine) shall be included in the proposed study. ED50 values may be presented as mean ± SEM. A 95% confidence interval or an equivalent data reporting measurement should be calculated from the dose-response curves. A statistical analysis of data collected from all tests for comparing different treatment groups with vehicle control should be performed and the resulting data should be presented. It is the responsibility of the vendor to determine the pharmacologically effective dose range for each test substance for this study. Total cost to conduct the study should be inclusive of any costs associated with such determination of pharmacologically effective dose ranges.

DEA may have in vitro opioid receptor binding and functional data for some of the test substances and in such cases DEA will share these data with the vendor to facilitate the determination of appropriate doses for the test substances.

III. Potential Experimental Issues and Reporting: In the event that any experimental issues arise (e.g., inability to dissolve test compound, unexpected results, animal lethality, deviation or departure from the agreed protocol, statistics issue due to experimental constrains ), the vendor shall immediately notify the DEA representative, in writing (email) with the issue and if it was resolved. Based on the issue noted by the vendor, the DEA representative may schedule a phone conversation or respond by email. All experimental issues that arise and the resolutions shall be documented in writing even if the issue and resolutions are discussed in a phone conversation.

Study Report: Following completion of the in vivo analgesia study for each test substance, the results in the form described in Task 5 (e.g. ED50 and 95% confidence limit values, %MPE, dose response curves) shall be provided to the DEA representative for review and acceptance. The DEA representative may contact vendor if there are any notable issues with the results.

DEA/DC/DOE 5

Task 4. Evaluation of test substances in in vivo drug discrimination assay

I. Objective: The objective of this in vivo pharmacological study is to determine whether the test substances are similar to known drugs of abuse with regard to their discriminative-stimulus effects.

IV. Experimental Design: Drug discrimination studies shall be conducted in rats. If alternative animal species are selected, the vendor will provide to DEA a comprehensive rationale for selecting a different animal species. The vendor and DEA shall agree on the strain of rodent to be used for each of the studies. The vendor shall maintain groups of animals trained to discriminate the stimulus effects of a given training drug (morphine) from its vehicle. It is expected that drug discrimination training for the animals commence within a week after the protocol is approved. The dose-response studies for training and reference (fentanyl) drugs should be repeated periodically and the resulting dose-response curves should be included in the study reports (see Task 5). The vendor shall have the equipment available for drug discrimination testing procedures such that the experiments can be conducted in a relatively expedient manner for this assay.

Additionally, it is encouraged to have multiple and/or automated apparatus for evaluating the discriminative stimulus effects in order to complete the experiments in a timely manner. DEA may have in vitro opioid receptor binding and functional data for some of the test substances and in such cases DEA will share these data with the vendor. Such data may be of use in selecting the appropriate doses for this study.

Potential Experimental Issues and Reporting: In the event that any experimental issues arise (e.g. inability to dissolve test compound, unexpected results, animal lethality, deviation or departure from the agreed protocol, statistics issue due to experimental constrains ), the vendor shall immediately notify the DEA representative, in writing (email) with the issue and if the issue was resolved. Based on the issue noted by the vendor, the DEA representative may schedule a phone conversation or respond by email.

All experimental issues that arise and the resolutions shall be documented in writing even if the issue and resolutions are discussed in a phone conversation. To rule out the possibility of false negative data, the DEA may request the vendor to repeat the testing using different testing conditions such as change in drug pretreatment time or route of drug administration.

II. Study Report: Following completion of the in vivo drug discrimination study for each test substance, the results in the form described in Task 5 (e.g. ED50 and 95% confidence limit values, dose response curves) shall be provided to the DEA representative for review and acceptance. The DEA representative may contact vendor if there are any notable issues with the results.

DEA/DC/DOE 6

Task 5. Final study report for each substance tested

Following completion of the experiments in Task 3 and 4, a final study report containing the complete methodology, data analysis, and study results for each test substance shall be provided in electronic format to DEA.

i) Study Reports: A final study report containing the complete methodology, data analysis, and study results for each compound/assay in comparison to reference standard drugs shall be provided to DEA. The study report should include dose-response curves for the test drug, the training and reference drugs. The DEA representative will provide an example of a Final Study Report for the vendor to use in preparation of the report. Where feasible, data shall be presented in tables and figures and the results shall be described in a textual format. Raw data should also be included in an appendix to the report. The vendor shall first submit a draft report in using Microsoft word to the DEA Representative. Upon review by the DEA Representative, revisions may need to be made. Once revisions are completed or the draft is cleared by the DEA Representative, final copies of the report shall be provided to the DEA Representative in electronic MS word version as well as a portable document file (PDF) format. Each report shall be due no later than thirty

(30) calendar days after the study completion date. The format shall be as follows:

ii.) Front cover to contain: Date, title (to include compound name), researcher (name/address/phone number, email), contract number.

iii.) Main body to contain: (1) A brief (one or two paragraph) summary of the findings

(2) detailed methods, and (3) results organized as text, tables, and/or figures, as agreed upon by vendor and DEA representative.

iv.) Appendix: Raw data as agreed upon by the vendor and DEA representative.

Task 6. Reporting Requirements

All reports required herein shall be submitted in electronic format to the DEA representative as detailed in the following subsections. The preparation and submission of regularly recurring Technical Progress Reports will be required for this agreement. These reports shall require descriptive information about the activities undertaken during the reporting period and will require information about planned activities for future reporting periods. The frequency and specific content of these reports will be determined by the DEA Representative.

a. Monthly reports: On or before the 5th working day following the end of each period of performance year, the vendor shall submit one electronic copy in PDF format of a report on activities during the month. In the report, vendor shall include (1) all study reports completed during the month (2) a table, or set of tables, of all compounds tested in the contract, with the main results so far, and

(3) entries for the compounds next in line for testing as specified above.

DEA/DC/DOE 7

b. Study Reports: See task 5 for details on these reports.

c. Annual Progress Report: On or before the 5th working day following the end of the period of performance, the vendor shall submit a report on activities during the year. One electronic copy in Microsoft Word or PDF format shall be sent to the DEA representative. In the report, vendor shall include: section 1 – a summary of the overall results generated on all substances during the past 12 months;

section 2 – a brief summary of any problems encountered while conducting the established experimental assays and, if applicable, a description of how those problems were resolved, as well as a brief summary of progress in any experimental assay development; section 3 – the log of all substances purchased;

section 4 – any other information required. The summary of overall findings (section 1) should not be an all-inclusive summary of data generated on standard substances but, rather a summary of highlights.

Task 7. Level of Effort

The DEA Representatives reserve the right to visit the laboratory where testing is being conducted.

a) Meetings between DEA and vendor:

i. Monthly conference calls: After submission of the monthly report, the vendor and the DEA representative shall have a teleconference meeting once a month. Other DEA and contract staff may participate if necessary. These meetings may be waived at the discretion of the DEA representative. Specific items for discussion shall be subject to the approval of the DEA representative.

ii. In-person meetings: DEA representatives may set-up a meeting with the vendor for the purpose of reviewing past, current, and/or proposed work under this agreement. These meetings may be waived at the discretion of the DEA representative. Specific items for discussion shall be subject to the approval of the DEA representative.

iii. Pre-Meeting Materials: Three weeks before each meeting, the vendor shall prepare "pre-meeting packets" summarizing all data on test compounds to be presented and describing relevant assay methods. This packet shall also include summaries of: (1) proposals for optimizing existing assays; (2) progress in ongoing assay development; (3) proposals for new assay development; (4) problems encountered in implementing tasks required in the agreement; and (5) proposed solutions to problems encountered. The vendor shall deliver this information to the DEA representative at least 3 weeks in advance of the meeting for approval, and after approval has been obtained, to each consultant at least 2 weeks prior to the meeting.

DEA/DC/DOE 8

iv. Post-Meeting Materials: After the meeting, the vendor shall prepare a post- Meeting report, summarizing the recommendations and comments of the attending consultants and DEA staff. The report shall include recommendations for optimizing specific assays and suggestions for incorporating new assays into DEA testing program. The Post- Meeting Report shall be sent to the DEA representative within three (3) weeks of the meeting.

v. Meeting Location(s): The site of the meeting shall be either at the annual scientific meetings of professional associations such as the College on Problems of Drug Dependence and the Society for Neuroscience, DEA headquarters or other locations as specified by DEA. This agreement shall not be responsible for the payment of DEA consultants' expenses. Meetings via video teleconference to discuss status and other issues may be held, but could be cancelled at DEA’s discretion.

IV. Deliverables:

If a report on any of the requested studies cannot be provided by the specified timelines, the vendor must notify DEA immediately upon obtaining this knowledge. This notification shall be followed up by a letter to DEA stating the reason for the delay, the anticipated date of completion of investigations, and the anticipated delivery of the study.

ITEM DELIVERABLE DELIVERY SCHEDULE

1 Project kick-off meeting to discuss overall project expectations, timelines, and deliverables.

Agreed protocols of the in vivo analgesia and drug discrimination assays

Within 2 working days following receipt of protocol.

Initial protocols to be provided to DEA within 30 calendar days after start of the agreement period.

Modified or revised protocols to be provided to DEA for review within 7 calendar days of discussion/notification by either party that the protocol must be modified

DEA/DC/DOE 9

or revised.

2 Monthly Status Reports 30 days from contract award date and monthly thereafter.

3 Study Reports To DEA no later than 30 calendar days after study completion date.

4 Annual Progress Report To DEA on or before the 5th working day following each year.

5 Laboratory Records and Test Substances To DEA on or before the expiration of the agreement period.

V. Use of Data

All documents, data, materials, records, and information sources provided to the vendor, developed or maintained by the vendor in the performance of this contract under this SOW are deemed to be the property of DEA. All data collected, generated, manipulated or otherwise processed under this agreement are confidential information unless or until DEA authorizes its release. None of these data may be used at any time for any purpose except to generate reports or other requirements specified in the Statement of Work, without prior written approval of DEA. The vendor and DEA will mutually agree to discuss matters of Freedom of Information Act (FOIA) policy before each agency independently discloses requested information.

On or before the agreement year expiration, the vendor shall deliver (or otherwise dispose per DEA) all data, including raw databases (electronic or hard copies), tapes, software programs used to interpret or manipulate data, weight calculation files, data collection forms, file definitions, and various edited databases generated under this contract to DEA (except for data necessary only to comply with other Federal data retention requirements, such as requirements pertaining to clinical trials or the Food and Drug Administration's rules pertaining to drug applications).

During or after the agreement, no data may be released, presented or published except upon prior approval of DEA. All requests which the vendor will receive from third parties for access to the data must be referred to DEA.

VI. Retention of Information

DEA/DC/DOE 10

The vendor shall retain, for 5 years beyond the duration of this agreement, all laboratory notebooks (which shall include paper copies of raw data) and electronic data files. Electronic data files shall be labeled and recorded in a manner that allows their association with corresponding laboratory notebook entries and paper copies of raw data. On or before the expiration date of this agreement, if so instructed by DEA, the vendor shall ship these items to the DEA representative in Arlington, VA.

VII. Period of Performance As outlined in this SOW, the period of performance for the Statement of Work shall be from May 1, 2020 – April 30, 2021 based on the timelines provided for the deliverables for each task.

VIII. Security Requirements

All contractor personnel supporting this procurement are entrusted with a certain level of trust due to the nature of DEA’s mission. The Government expects the vendor will employ persons of integrity and trustworthiness. To ensure this, DEA reserves the right to conduct background screening or a full background investigation on all employees if a need arises. While all services provided on this contract will be performed outside of DEA, all contractors must be escorted if entering a DEA facility. DEA reserves the right to modify the security requirements found in this contract at anytime. The Diversion Control Division has agreed to accept all programmatic risk for the loss of any data as a result of the request to waive the U.S. citizenship requirement. The U.S. citizenship requirement has been waived for this effort only.

DEA Representative (Scientific and Technical Contact): Will be provided at time of award

DEA PROVISION & CLAUSE MATRIX – COMMERCIAL ITEMS

Updated through FAC 2020-04

February 2020 Page 1 of 19

SOLICITATION #: D-20-DC-0018

52.252-1 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 address:

https://www.acquisition.gov/far-smart-matrix.

(End of provision)

CONTRACTING OFFICER: Check the corresponding box for the provisions and clauses applicable to this procurement.

52.204-6 UNIQUE ENTITY IDENTIFIER (OCT 2016)

52.204-7 SYSTEM FOR AWARD MANAGEMENT (OCT 2018)

52.204-7 ALT I SYSTEM FOR AWARD MANAGEMENT (OCT 2018) WITH ALTERNATE I OCT 2018)

52.204-16 COMMERCIAL AND GOVERNMENT ENTITY CODE REPORTING (JUL 2016)

52.204-24 REPRESENTATION REGARDING CERTAIN TELECOMMUNICATIONS AND VIDEO SURVEILLANCE SERVICES OR EQUIPMENT (AUG 2019)

The Offeror shall not complete the representation in this provision if the Offeror has represented that it “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” in the provision at 52.204-26, Covered Telecommunications Equipment or Services-Representation, or in paragraph (v) of the provision at 52.212-3, Offeror Representations and Certifications-Commercial Items.

(a) Definitions. As used in this provision—

“Covered telecommunications equipment or services”, “critical technology”, and “substantial or essential component” have the meanings provided in clause 52.204-25, Prohibition on Contracting for Certain Telecommunications and Video Surveillance Services or Equipment.

(b) Prohibition. Section 889(a)(1)(A) of the John S. McCain National Defense Authorization Act for Fiscal Year 2019 (Pub. L. 115-232) prohibits the head of an executive agency on or after August 13, 2019, from procuring or obtaining, or extending or renewing a contract to procure or obtain, any equipment, system, or service that uses covered telecommunications equipment or services as a substantial or essential component of any system, or as critical technology as part of any system. Contractors are not prohibited from providing—

(1) A service that connects to the facilities of a third-party, such as backhaul, roaming, or interconnection arrangements; or

(2) Telecommunications equipment that cannot route or redirect user data traffic or permit visibility into any user data or packets that such equipment transmits or otherwise handles.

(c) Procedures. 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”.

(d) Representation. The Offeror represents that it will, will not provide covered telecommunications equipment or services to the Government in the performance of any contract, subcontract or other contractual instrument resulting from this solicitation.

(e) Disclosures. If the Offeror has represented in paragraph (d) of this provision that it “will” provide covered telecommunications equipment or services”, the Offeror shall provide the following information as part of the offer—

(1) A description of all covered telecommunications equipment and services offered (include brand; model number, such as original equipment manufacturer (OEM) number, manufacturer part number, or wholesaler number; and item description, as applicable);

(2) Explanation of the proposed use of covered telecommunications equipment and services and any factors relevant to determining if such use would be permissible under the prohibition in paragraph (b) of this provision;

(3) For services, the entity providing the covered telecommunications services (include entity name, unique entity identifier, and Commercial and Government Entity (CAGE) code, if known); and

(4) For equipment, the entity that produced the covered telecommunications equipment (include entity name, unique entity identifier, CAGE code, and whether the entity was the OEM or a distributor, if known).

(End of provision)

52.204-26 COVERED TELECOMMUNICATIONS EQUIPMENT OR SERVICES-REPRESENTATION (DEC 2019)

(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.

(b) Procedures. 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”.

https://www.acquisition.gov/far-smart-matrix https://www.acquisition.gov/content/52204-6-unique-entity-identifier https://www.acquisition.gov/content/52204-7-system-award-management https://www.acquisition.gov/content/52204-7-system-award-management https://www.acquisition.gov/content/52204-7-system-award-management https://www.acquisition.gov/content/52204-24-representation-regarding-certain-telecommunications-and-video-surveillance-services#id1989I600I4C https://www.acquisition.gov/content/52204-26-covered-telecommunications-equipment-or-services-representation#id19CAC0P0ESS https://www.acquisition.gov/content/52212-3-offeror-representations-and-certifications-commercial-items#i1060550 https://www.acquisition.gov/content/52204-25-prohibition-contracting-certain-telecommunications-and-video-surveillance-services-or-equipment#id1989I600I4C https://www.sam.gov/ https://www.acquisition.gov/content/52204-25-prohibition-contracting-certain-telecommunications-and-video-surveillance-services-or-equipment#id1989I600I4C https://www.sam.gov/

February 2020 Page 2 of 19

SOLICITATION #: D-20-DC-0018

(c) Representation. 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)

52.211-6 BRAND NAME OR EQUAL (AUG 1999)

52.212-1 INSTRUCTIONS TO OFFERORS—COMMERCIAL ITEMS (OCT 2018)

52.212-2 EVALUATION—COMMERCIAL ITEMS (OCT 2014)

(a) The Government will award a contract resulting from this solicitation to the responsible offeror whose offer conforming to the solicitation will be most advantageous to the Government, price and other factors considered. The following factors shall be used to evaluate offers:

Technical Capability Past Performance

[Contracting Officer shall insert the significant evaluation factors, such as (i) technical capability of the item offered to meet the Government requirement; (ii) price; (iii) past performance (see FAR 15.304); and include them in the relative order of importance of the evaluation factors, such as in descending order of importance.]

Technical and past performance, when combined, are [Contracting Officer state, in accordance with FAR 12.602]

(b) Options. The Government will evaluate offers for award purposes by adding the total price for all options to the total price for the basic requirement. The Government may determine that an offer is unacceptable if the option prices are significantly unbalanced. Evaluation of options shall not obligate the Government to exercise the option(s).

(c) A written notice of award or acceptance of an offer, mailed or otherwise furnished to the successful offeror within the time for acceptance specified in the offer, shall result in a binding contract without further action by either party. Before the offer’s specified expiration time, the Government may accept an offer (or part of an offer), whether or not there are negotiations after its receipt, unless a written notice of withdrawal is received before award.

(End of provision)

52.212-3 OFFEROR REPRESENTATIONS AND CERTIFICATIONS—COMMERCIAL ITEMS (DEC 2018)

Attention is drawn to paragraph (b) of provision 52.212-3, which requests offeror-provided fill-in information in (b)(2), when applicable:

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

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

***Paragraph (i) contracting officer fill-in information***

Note: Paragraph (i)(1): The end products being acquired under this solicitation that are included in the List of Products Requiring Contractor Certification as to Forced or Indentured Child Labor are listed by Schedule of Supplies/Services Item Number as follows:

[when applicable, enter item numbers with country of origin in parentheses and separated by commas]

***Paragraph (k) contracting officer fill-in information***

Contracting officer — select applicable item when an exemption to the Service Contract Labor Standards statute applies.

Paragraph k(1) is applicable. Paragraph k(2) is applicable.

https://www.acquisition.gov/content/52211-6-brand-name-or-equal https://www.acquisition.gov/content/52212-1-instructions-offerors-commercial-items https://www.acquisition.gov/content/52212-2-evaluation-commercial-items https://www.acquisition.gov/content/15304-evaluation-factors-and-significant-subfactors#i1108563 https://www.acquisition.gov/content/part-12-acquisition-commercial-items#i1112620 https://www.acquisition.gov/content/52212-3-offeror-representations-and-certifications-commercial-items http://www.sam.gov/ https://www.acquisition.gov/content/52212-3-offeror-representations-and-certifications-commercial-items https://www.acquisition.gov/content/part-4-administrative-matters#i1121876

February 2020 Page 3 of 19

SOLICITATION #: D-20-DC-0018

Offerors – Paragraph (v) was added to provision 52.212-3 by FAC 2020-03. If the DEC 2019 version of provision 52.212-3 is not included in your annual representations and certifications, you must either update your annual representations and certifications or complete paragraph (v) below.

(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.

52.225-7 WAIVER OF BUY AMERICAN STATUTE FOR CIVIL AIRCRAFT AND RELATED ARTICLES (FEB 2016)

DEA-2852.209-75 NATIONAL SECURITY RISK ASSESSMENT (JUN 2014)

(a) Any offeror responding to this solicitation acknowledges that before acquiring information technology equipment or software, the U.S. Department of Justice and its component entities will assess the supply chain risk of cyber-espionage or sabotage associated with the acquisition of such equipment or software, including any risk associated with such equipment or software being produced, manufactured, or assembled by one or more entities identified as posing a cyber-threat, including but not limited to, those that may be owned, directed, or subsidized by the People’s Republic of China.

(b) By submitting an offer to this solicitation, the Offeror understands and agrees that the Government retains the right to reject any offer or response to this solicitation made by the Offeror, without any further recourse by, or explanation to, the Offeror, if the Government determines the Offeror or the equipment or software offered by the Offeror, in whole or in part, presents an unacceptable risk to national security.

(c) To assist the Government in assessing whether the acquisition poses a national security risk, offerors are required to complete and submit with its offer or quotation the National Security Acquisition Risk Assessment Questions, which are attached to this solicitation. Offerors must answer all questions completely and accurately to the best of their knowledge and belief. All answers are to be reflective of the parent and subsidiary levels of an organization.

(d) Offerors are also required to request, collect, and forward with its offer or quotation completed National Security Acquisition Risk Assessment Questions from all subcontractors that will provide any equipment or software in performance of the contract or order. Offerors are responsible for the thoroughness and completeness of each subcontractor's submission.

(e) Failure to provide any such requested information may render a proposal unacceptable.

(End of provision)

CONTINUED ON NEXT PAGE

https://www.acquisition.gov/content/52225-7-waiver-buy-american-statute-civil-aircraft-and-related-articles

February 2020 Page 4 of 19

SOLICITATION #: D-20-DC-0018

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 address: https://www.acquisition.gov/far-smart-matrix.

(End of clause)

CONTRACTING OFFICER: Check the appropriate box only for clauses that are applicable to this procurement.

52.203-16 PREVENTING PERSONAL CONFLICTS OF INTEREST (DEC 2011)

52.203-19 PROHIBITION ON REQUIRING CERTAIN INTERNAL CONFIDENTIALITY AGREEMENTS OR STATEMENTS (JAN 2017)

52.204-4 PRINTED OR COPIED DOUBLE-SIDED ON POSTCONSUMER FIBER CONTENT PAPER (MAY 2011)

52.204-9 PERSONAL IDENTITY VERIFICATION OF CONTRACTOR PERSONNEL (JAN 2011)

52.204-12 UNIQUE ENTITY IDENTIFIER MAINTENANCE (OCT 2016)

52.204-13 SYSTEM FOR AWARD MANAGEMENT MAINTENANCE (OCT 2018)

52.204-18 COMMERCIAL AND GOVERNMENT ENTITY CODE MAINTENANCE (JUL 2016)

52.204-19 INCORPORATION BY REFERENCE OF REPRESENTATIONS AND CERTIFICATIONS (DEC 2014)

52.204-21 BASIC SAFEGUARDING OF COVERED CONTRACTOR INFORMATION SYSTEMS (JUN 2016)

52.204-23 PROHIBITION ON CONTRACTING FOR HARDWARE, SOFTWARE, AND SERVICES DEVELOPED OR PROVIDED BY KASPERSKY LAB AND OTHER

COVERED ENTITIES, IN ALL SOLICITATIONS AND CONTRACTS (JUL 2018)

52.204-25 PROHIBITION ON CONTRACTING FOR CERTAIN TELECOMMUNICATIONS AND VIDEO SURVEILLANCE SERVICES OR EQUIPMENT (AUG 2019)

52.207-5 OPTION TO PURCHASE EQUIPMENT (FEB 1995)

52.212-4 CONTRACT TERMS AND CONDITIONS—COMMERCIAL ITEMS (OCT 2018)

52.212-4 ALT I CONTRACT TERMS AND CONDITIONS—COMMERCIAL ITEMS (JAN 2017) WITH ALTERNATE I (JAN 2017)

52.212-5 CONTRACT TERMS AND CONDITIONS REQUIRED TO IMPLEMENT STATUTES OR EXECUTIVE ORDERS—COMMERCIAL ITEMS (JAN 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:

(1) 52.203-19, Prohibition on Requiring Certain 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)).

(2) 52.204–23, Prohibition on Contracting for Hardware, Software, and Services Developed or Provided by Kaspersky Lab and Other Covered Entities (Jul 2018) (Section 1634 of Pub. L. 115–91).

(3) 52.204-25, Prohibition on Contracting for Certain Telecommunications and Video Surveillance Services or Equipment. (Aug 2019) (Sec.889(a)(1)(A) of Pub. L. 115-232)

(4) 52.209-10, Prohibition on Contracting with Inverted Domestic Corporations (Nov 2015) (Executive Order 13658).

(5) 52.233-3, Protest After Award (Aug 1996) (31 U.S.C. 3553).

(6) 52.233-4, Applicable Law for Breach of Contract Claim (Oct 2004)(Public Laws 108-77 and 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:

[Contracting Officer: Check the corresponding box for each clause that applies to this order.]

(1) 52.203-6, Restrictions on Subcontractor Sales to the Government (Sept 2006), with Alternate I (Oct 1995) (41 U.S.C. 4704 and 10 U.S.C. 2402).

(2) 52.203-13, Contractor Code of Business Ethics and Conduct (Oct 2015) (Pub. L. 110-252, Title VI, Chapter 1 (41 U.S.C. 3509)).

(3) 52.203-15, Whistleblower Protections under the American Recovery and Reinvestment Act of 2009 (June 2010) (Section 1553 of Pub. L. 111-5).

(Applies to contracts funded by the American Recovery and Reinvestment Act of 2009.)

(4) 52.204-10, Reporting Executive Compensation and First-Tier Subcontract Awards (Oct 2018) (Pub. L. 109-282) (31 U.S.C. 6101 note).

(5) [Reserved]

(6) 52.204-14, Service Contract Reporting Requirements (Oct 2016) (Pub. L. 111-117, section 743 of Div. C).

(7) 52.204-15, Service Contract Reporting Requirements for Indefinite-Delivery Contracts (Oct 2016) (Pub. L. 111-117, section 743 of Div. C).

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