B01. Combined Synopsis_Solicitation W81XWH22Q0173.pdf

W81XWH22Q0173

COMBINED SYNOPSIS_SOLICITATION

COMBINED SYNOPSIS/SOLICITATION INSTRUCTIONS

1. Issue Date: 21 September 2022

2. Close Date: 25 September 2022 11:59PM Eastern Time

3. Contracting Activity: U.S. Army Medical Research Acquisition Activity (USAMRAA) located at 820 Chandler Street, Fort Detrick, MD 21702.

4. Requiring Activity: U.S. Army Public Health Center (APHC)

5. Subject: Unbiased External Scientific Peer Reviews of Wildlife Toxicity Assessments (WTAs)

6. Solicitation Number: W81XWH22Q0173

7. Description of Requirement: The APHC has a requirement for eight annual unbiased external peer reviews of Wildlife Toxicity Assessments (WTAs).

7.1. This is a combined synopsis/solicitation (issued as a Request for Quotation (RFQ)) for commercial items prepared in accordance with FAR 12.6, Streamlined Procedures for Evaluation and Solicitation for Commercial Items, in conjunction with the policies and procedures for solicitation, evaluation and award prescribed in FAR Part 13-Simplified Acquisition Procedures, as supplemented with additional information included in this notice.

This announcement constitutes the only solicitation; quotes are being requested and no other solicitation will be issued.

7.2. This solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) 2022-07; effective 10 August 2022.

7.3. This acquisition is being competed using full and open competition. The North American Industry Classification System (NAICS) code is: 541620, Special Studies/Analysis- Environmental Assessments, with a size standard of $16.5M. All capable vendors are encouraged to submit a quote.

7.4. Contract award shall be made on a competitive best-value basis using the “Lowest Price, Technically Acceptable (LPTA)” approach.

7.5 Offerors responding to this combined synopsis/solicitation shall include a completed copy of the provision at 52.212-3 Offeror Representations and Certifications – Commercial Items with its quote.

7.6. Offerors responding to this combined synopsis/solicitation shall complete and return self-certification from FAR 52.204-24 and 52.204-26.

8. Preparation and Submission of Quotes

8.1. To be eligible for award, Offeror’s must have a valid registration in the Government’s System for Award Management (SAM) at https://www.sam.gov. Offerors will not be considered for award if registration has not been completed prior to the close of this solicitation.

8.2. Quotes shall be prepared in accordance with (IAW) this solicitation and FAR provision 52.212-1, Instructions to Offerors – Commercial Items including the Addendum.

8.3. All quotes shall be evaluated in accordance with the Evaluation Criteria identified in the Addendum to FAR 52.212-2 Evaluation – Commercial Items within the Contract Clauses Section.

8.4. The FAR clause 52.212-4 Contract Terms and Conditions – Commercial Items applies to this acquisition.

Additional contract requirements and terms and conditions are identified in this RFQ.

8.5. The FAR clause 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders – Commercial Items, applies to this acquisition. See the clause for additional FAR clauses cited and marked which are applicable to this acquisition.

8.6. The Government reserves the right to reject any or all quotes, and to award no contract at all, depending on the quality of the quotes(s) submitted and the availability of funds.

ITEM NO SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT

0001 8 Each Scientific Peer Reviews of WTAs

FFP

Scientific Peer Reviews of Wildlife Toxicity Assessments (WTAs) FOB: Destination

PURCHASE REQUEST NUMBER: 0011788886

PSC CD: B510

NET AMT

1001 8 Each OPTION Scientific Peer Reviews of WTAs

FFP

Scientific Peer Reviews of Wildlife Toxicity Assessments (WTAs) FOB: Destination

2001 8 Each OPTION Scientific Peer Reviews of WTAs

FFP

Scientific Peer Reviews of Wildlife Toxicity Assessments (WTAs)

3001 8 Each OPTION Scientific Peer Reviews of WTAs

FFP

Scientific Peer Reviews of Wildlife Toxicity Assessments (WTAs)

4001 8 Each OPTION Scientific Peer Reviews of WTAs

FFP

Scientific Peer Reviews of Wildlife Toxicity Assessments (WTAs)

PWS

PERFORMANCE WORK STATEMENT (PWS)

Title: U.S. Army Public Health Center Toxicology Directorate PWS for Wildlife Toxicity Assessments Scientific Peer Review

Requiring Activity Name: U.S. Army Public Health Center (APHC)

1. INTRODUCTION

This is a non-personal services contract to provide unbiased scientific peer review of APHC Wildlife Toxicity Assessments (WTAs). The Government will not exercise any supervision or control over the contract service providers performing the services herein. Such contract service providers shall be accountable solely to the Contractor who, in turn, is responsible to the Government.

The Contractor shall provide all personnel, equipment, supplies, facilities, transportation, tools, materials, supervision, and other items and non-personal services necessary to perform scientific peer review of APHC WTAs as defined in this PWS. The Contractor shall perform to the standards described in this contract.

2. PURPOSE AND BACKGROUND

The mission of the APHC is to “Enhance Army readiness by identifying and assessing current and emerging health threats; developing and communicating public health solutions; and assuring the quality and effectiveness of the Army’s Public Health Enterprise.”

An integral component of a wildlife ecological risk assessment is the development of some quantitative measure of the toxicity of a chemical to the animals of concern. This measure is often referred to as a toxicity reference value (TRV). APHC has developed and is implementing a revised standard method for developing toxicological profiles and TRVs for military-related substances that may potentially pose risks to wildlife. The TRVs and information supporting those values are documented in APHC’s WTAs. These chemical-specific documents address the potential toxicity of individual chemicals associated with exposure to all classes of wildlife.

The values that are derived are intended to act as screening toxicity values for risk assessment purposes. Since assumptions, professional judgment, and variability in the data are considered, it is necessary that these documents are peer-reviewed by other expert toxicologists, ecologists and risk assessment professionals. These defensible values undergo rigorous review internally and externally to APHC.

For external peer-review, each WTA is requested to be reviewed by a minimum of three subject matter experts (SMEs).

3. SCOPE

The APHC requests that the work described for the contractor shall be:

- Identification and solicitation of SMEs for external review of the WTAs

- Assignment and coordination of three external reviewers for each WTA

- Compilation of reviews to be sent to APHC

4. PERIOD OF PERFORMANCE

This will be a five (5) year contract, consisting of one (1) 12-month base period, and four (4) 12-month option periods.

The periods of performance for this contract are as follows:

Base period 29 Sept 2022 – 28 Sept 2023 Option period 1 29 Sept 2023 – 28 Sept 2024 Option period 2 29 Sept 2024 – 28 Sept 2025 Option Period 3 29 Sept 2025 – 28 Sept 2026 Option Period 4 29 Sept 2026 – 28 Sept 2027

5. WORK SCHEDULE AND LOCATION

5.1. Work Location

The work locations for this requirement are performed at the Contractor’s location.

6. PERFORMANCE REQUIREMENTS

6.1. Objectives

Objective 1 – Complete eight annual scientific peer reviews for all Wildlife Toxicity Assessments (WTA’s) and complete the following tasks as stated under Section 6.2 below:

6.2. Specific Tasks / Requirements

Objective 1: Key Task 1 – Identify, recruit and assign a minimum of three (3) scientific reviewers to evaluate WTA’s. The reviewers shall provide objectivity to review these Assessments and provide confidence that regulatory and non-government organizations require in order to endorse the derivation of the values provided in these documents.

Objective 1: Key Task 2 – The scientific reviewers shall be experts in the chemical class and be capable of reviewing the WTA’s based on their expertise in the field.

Objective 1: Key Task 3 – Evaluate each WTA for accuracy and completeness. Review appropriate literature to ensure accuracy.

Objective 1: Key Task 4 – Collect, compile and collate the reviewers’ comments into one consolidated draft report of each chemical for each WTA (Deliverable 1). The draft reports shall be due to the APHC scientist within three months of the initiation of each WTA’s external review process.

Objective 1: Key Task 5 – Upon approval from the APHC scientist, finalize each report and deliver to the Contracting Officer’s Representative (COR) and Project Manager by September 30th of that Fiscal Year (FY) (Deliverable 2).

Objective 1: Key Task 6 – The contractor shall provide a draft Quality Control Plan (QCP) no later than 15 days after contract award. The contractor shall prepare and adhere to a QCP describing how the contractor intends to manage the contract to achieve the established standards set forth in the Performance Standards Summary Matrix and the contractor’s QCP. At a minimum, the QCP must include a self- inspection plan, an internal staffing plan, and an outline of the procedures the Contractor shall use to maintain quality, timeliness, responsiveness and customer satisfaction (Deliverable 3).

Objective 1: Key Task 7 – Organizational Conflict of Interest (OCI) Certification. The Contractor shall complete the OCI Certification at time of quote submission. (Deliverable 4).

Objective 1: Key Task 8 – Non-Disclosure Statement. The Contractor shall sign the Non-Disclosure Statement and ensure that all staff including all employees, subcontractors, and consultants assigned to or performing under the contract, execute, sign, and adhere to the terms of the Non-Disclosure Statement. (Deliverable 5).

6.3. Management Reports and Plans

Quality Control Plan (Deliverable 3). The contractor shall provide a draft Quality Control Plan (QCP) no later than 15 days after contract award. The contractor shall prepare and adhere to a QCP describing how the contractor intends to manage the contract to achieve the established standards set forth in the Performance Standards Summary Matrix and the contractor’s QCP. At a minimum, the QCP must include a self- inspection plan, an internal staffing plan, and an outline of the procedures the Contractor shall use to maintain quality, timeliness, responsiveness and customer satisfaction.

7. DELIVERABLES

The contractor shall complete and submit deliverables in accordance with the “Deliverables Table” below. Unless specified in the PWS within the description of the deliverable, all deliverables will be made to the COR electronically.

DELIVERABLES TABLE

PWS Ref. Number Title/Description Due

6.2 Objective 1:

Key Task 4

Collect, compile and collate the reviewers’ comments into one consolidated draft report of each chemical for each WTA.

The draft reports shall be due to the APHC scientist within 3 months of the initiation of each WTA’s external review process.

6.2 Objective 1:

Key Task 5

Upon approval from the APHC scientist, finalize each report and deliver to the COR and Project Manager.

By 9/30 of that FY

6.2 Objective 1:

Key Task 6

Quality Control Plan - how the contractor intends to manage the contract to achieve the established standards set forth in the Performance Standards Summary Matrix and the contractor’s QCP. At a minimum, the QCP must include a self- inspection

No later than 15 days after contract award

PWS Ref. Number Title/Description Due plan, an internal staffing plan, and an outline of the procedures the Contractor shall use to maintain quality, timeliness, responsiveness and customer satisfaction.

6.2 Objective 1:

Key Task 7

4 OCI Certification

The Contractor shall complete the OCI Certification at time of quote submission.

6.2 Objective 1:

Key Task 8

5 Non-Disclosure Statement

The Contractor shall sign the Non-Disclosure Statement and ensure that all staff including all employees, subcontractors, and consultants assigned to or performing under the contract, execute, sign, and adhere to the terms of the Non-Disclosure Statement.

7.1. Reports and Documents

Reports and documents delivered by the contractor in the performance of this contract shall be considered Technical Data. All documentation shall reflect the latest version of the work product or activity, unless specifically directed otherwise by the Government. All documentation shall be prepared in accordance with (IAW) standard industry practices, ensuring electronically produced documents, which reflect logical flow of material, tables of contents indexes and page numbering. Where applicable, the contractor’s attention is called to the availability of commercial, industry, federal, and military guides, instructions, and standards for many of the topics addressed in this PWS and under this contract.

7.2. Inspection and Acceptance

The COR that is delegated oversight of specific technical, functional and oversight responsiblities is responsible for inspection and acceptance of all services, incoming shipments, documents, and services.

Certification by the Government of satisfactory services provided is contingent upon the Contractor performing in accordance with the performance standards contained in the Performance Work Statement and all terms and conditions of this order, including all modifications.

7.3. COR Information

To Be Determined (TBD)

8. Contract Management

8.1. Government Management

The COR for this contract will be appointed by the Contracting Officer (KO). The COR will serve as the primary point of contact for all activities and issues that occur under this contract. Only the KO has the authority to enact changes to this award.

8.2. Subcontract management

8.2.1. The contractor is responsible for any subcontract management necessary to integrate services performed on this contract.

8.2.2. The contractor is responsible and accountable for subcontractor performance on this contract

8.2.3. The contractor is responsible to manage task distribution to ensure there are no OCI considerations

8.2.4. Contractor may add subcontractors to their team after notification and written approval from the

KO.

8.3. Performance Requirements Summary Matrix

The Government intends to utilize a Quality Assurance Surveillance Plan (QASP) to monitor the quality of the Contractor’s performance in relation to performance objectives. The Government will finalize the QASP immediately following award, and the COR will provide a copy of the final QASP to the contractor. The QASP is a living document and may be updated by the Government as necessary.

The Government will use the following performance requirements to measure the performance of the contractor.

The contractor shall meet the Performance Objective(s) and Acceptable Quality Level(s) within the “Performance Requirements Summary Matrix” (PRS Matrix).

PERFORMANCE REQUIREMENTS SUMMARY MATRIX

PWS

Ref.

Performance Objective

Performance Standard Acceptable

Quality Level

Performance Measurement

1 6.2

Collect, compile and collate the reviewers’ comments into one consolidated draft report of each chemical for each WTA.

The draft reports shall be due to the APHC scientist within 3 months of the initiation of each WTA’s external review process.

95% Receipt of reports within the specified timeframe.

2 6.2 Finalize each report and deliver to the COR and Project Manager.

By 30 September of that fiscal year`

95% Receipt of finalized reports within the specified timeframe.

3 6.2

Provide a QCP regarding how the contractor intends to manage the contract to achieve the established standards. At a minimum, the QCP must include a self-inspection plan, an internal staffing plan, and an outline of the procedures the Contractor shall use to maintain quality, timeliness, responsiveness and customer satisfaction.

No later than 15 days after contract award.

100% Receipt of QCP

9. COMPLIANCE DOCUMENTS

9.1. General Compliance

9.1.1. Federal Law

The services provided under this contract must be conducted in accordance with all Federal law, Department of Defense (DOD), Department of the Army (DA) and Medical Command (MEDCOM) laws and command laws, regulations, policies, and procedures that govern the conduct of regulated research.

Federal regulations governing regulations for human subject’s protection are found in 45 Code of Federal Regulations (CFR) 46. The International Convention on Harmonization Guidelines for Good Clinical Practice is the standard governing the conduct of research trials. References for military regulations and policies governing regulated research may be found at https://mrmc.amedd.army.mil/rodorphrpo.asp.

9.1.2. DOD Compliance Documents

A complete list of Department of Defense compliance documents providing specifications, standards, or guidelines can be found at http://www.dtic.mil/whs/directives/corres/dir.html

A complete list of Department of Defense compliance documents providing specifications, standards, or guidelines can be found at http://www.dtic.mil/whs/directives/corres/dir.html

a) Army Regulation 340-21, Army Privacy Program.

http://www.army.mil/usapa/epubs/340_Series_Collection_1.html

b) Army Regulation 25-2, Information Assurance.

c) Title 21, CFR Part 11 Electronic Records: Electronic Signature.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=11

9.2. Medical and Laboratory Compliance

9.2.1. Army Regulation 340-21, Army Privacy Program

Compliance information regarding Army Privacy program may be found at:

http://www.army.mil/usapa/epubs/340_Series_Collection_1.html

10. OTHER TERMS, CONDITIONS, AND PROVISIONS

10.1. Non-Personal Services

This PWS identifies services that are strictly non-personal in nature, as defined by Federal Acquisition Regulation (FAR) Part 37, Service Contracting. To ensure there is no appearance of any personal services, the Government shall neither supervise contractor personnel nor control the method by which the contractor performs the required tasks. Under no circumstances shall the Government assign tasks or prepare work schedules for individual contractor personnel. It shall be the responsibility of the contractor to manage its personnel and to guard against any actions that give the perception of personal services. If the contractor believes that any actions constitute, or are perceived to constitute personal services, it shall be the contractor's responsibility to notify the Contractor Officer (KO) immediately.

10.2. Severable / Non-Severable Services

This award identifies services that are severable in nature.

10.3. Inherently Governmental Functions

This requirement has been reviewed and contains no services that are inherently governmental functions.

10.4. Organizational Conflict of Interest

U.S. Army Public Health Center (APHC) has categorized all service procurements into one of the following three categories as defined below, for the purpose of identifying, avoiding, or mitigating Organizational Conflicts of Interest (OCI) IAW Federal Acquisition Regulation (FAR) Subpart 9.5. These categories are defined as follows:

Category 1: Command Wide Internal Support: Services which, by their very nature, give the Contractor access to non-public procurement sensitive data about the contract requirements, other contractors’ proprietary information, or put the contractor in a position to influence the award decision on a contract in which they are participating. Services would be characterized as having access to Command Wide procurement sensitive information, or work that could likely have an influence over follow-on awards or contracts with subordinate directorates/Commands.

Category 2: Program Management Support: Services which assist APHC in planning and managing an organization’s activities and programs. These include, for example: requirements analysis, acquisition support, budget planning and management, business process reengineering, program planning and execution support, and independent technical management support. Services would be characterized as having access to only Directorate or Subordinate Command level procurement sensitive information or work that would have little influence on follow-on requirements or requirements of other directorates/Subordinate Commands.

Category 3: Product Support. Services or end items required to meet the mission requirements of the organization’s activities and programs. These include, for example: concept exploration and development, system design, system development and integration, COTS procurement and integration, internal development testing, deployment, installation, operations, and maintenance. Services can be characterized as having little or no access to procurement sensitive information other than the immediate requirement and little chances of follow-on work that can be influenced by the immediate requirement.

OCI Certification. APHC OCI Category 3 is applicable for this acquisition. The Contractor shall perform a thorough comparative analysis of the potential new work against all current and previous works performed in support of the APHC organization and ascertain whether they have a possible conflict of interest. If there is a conflict of interest or the appearance of a conflict of interest, the Contractor shall provide a comprehensive OCI Mitigation Plan. The Contractor shall complete the OCI Certification at time of quote submission.

The FAR Part 9.5 prescribes responsibilities, general rules, and procedures for identifying, evaluating, and resolving Organizational Conflict of Interest (OCI), provides examples to assist Contracting Officers in applying these rules and procedures to individual contracting situations; and implements section 8141 of the 1989 Department of Defense Appropriation Act. The two (2) underlying principles which the FAR seeks to avoid are preventing the existence of conflicting roles that might bias a Contractor's judgment and preventing unfair competitive advantage. An unfair competitive advantage exists where a Contractor competing for award of any Federal contract possesses --

(1) Proprietary information that was obtained from a Government official without proper authorization; or

(2) Source selection information (as defined in FAR 2.101) that is relevant to the contract but is not available to all competitors, and such information would assist that Contractor in obtaining the contract.

The following subsections prescribe certain limitations on contracting as the means of avoiding, neutralizing or mitigating organizational conflicts of interest.

It is the Contractor’s responsibility to notify the Contracting Officer of any potential OCI. In the event that an OCI exists the Contractor shall propose a Mitigation Plan that shall be reviewed and accepted by the Contracting Officer prior to continuance of the work that presents an OCI. Should the proposed Mitigation Plan not be accepted by the Contracting Officer, the Government may terminate this contract, disqualify the Contractor from subsequent related contractual efforts, and pursue any remedies as may be permitted by the law or this contract.

Contractors shall sign a Non-Disclosure Agreement (Deliverable 6) at the start of their performance on the contract.

If, under this contract, the Contractor will provide systems engineering and technical direction for a system, but does not have overall contractual responsibility for its development, integration, assembly, checkout or production, the Contractor shall not be awarded a subsequent contract to supply the system or any of its major components, or to act as consultant to a supplier of any system, subsystem, or major component utilized for or in connection with any item or other matter that is (directly or indirectly) the subject of the systems engineering and technical direction. The term of this prohibition shall endure for the entire period of this contract and for two (2) years thereafter.

If, under this contract, the Contractor will prepare and furnish complete specifications covering non-developmental items, to be used in a competitive acquisition, the Contractor shall not be permitted to furnish these items, either as a prime or subcontractor. The term of this prohibition shall endure for the entire period of this contract performance and for either two (2) years thereafter or the duration of the initial production contract whichever is longer. This rule shall not apply to Contractors who furnish specifications or data at Government request or to situations in which Contractors act as Government representatives to help Government agencies prepare, refine or coordinate specifications, provided this assistance is supervised and controlled by Government representatives.

If, under this contract, the Contractor will prepare or assist in preparing a work statement to be used in competitively acquiring a system or services, the Contractor shall not supply the system, its major components, or the service unless the Contractor is the sole source, the Contractor has participated in the development and design work, or more than one Contractor has been involved in preparing the work statement. The term of this prohibition shall endure for the length of this contract.

If, under this contract, the Contractor will provide technical evaluation of products or advisory and assistance services, the Contractor shall not provide such services if the services relate to the Contractor's own or a competitor's products or services unless proper safeguards are established to ensure objectivity.

If, under this contract, the Contractor gains access to proprietary or source selection information of other companies in performing advisory assistance services for the Government, the Contractor agrees to protect this information from unauthorized use or disclosure and to refrain from using the information for any purpose other than that for which it was furnished. A separate agreement shall be entered into between the Contractor and the company whose proprietary information is the subject of this restriction. A copy of this agreement shall be provided to the Contracting Officer.

The Contracting Officer has significant discretion as to the acceptability of any mitigation plan offered.

Contractors are encouraged to present their best strategy for mitigation of any potential OCI under this contract.

Contractors shall submit a mitigation plan at the Contract level and update it as often as necessary throughout the life of the Contract.

The Contracting Officer (and when applicable the appropriate program office, acquisition manager, and legal counsel) will review the comparative analysis and, if provided, the Avoidance or Mitigation Plan, in accordance with the requirements of FAR Subpart 9.5 (Organizational Conflict of Interest) to determine whether award to that Offeror would be consistent with those requirements and review as necessary throughout the life of the contract. If it is unilaterally determined by the Contracting Officer that no OCI would arise or that the OCI Avoidance or Mitigation Plan adequately protects the interests of the government in the event of award to that Offeror, the Offeror will be determined eligible for award. If the Contracting Officer reasonably determines that a Contractor has not provided either a comparative analysis or avoidance/mitigation plan, or both, or that the analyses or plan provided is inadequate, sanctions including elimination from the award process, or termination of the related contract effort already awarded, as well as other appropriate sanctions will be considered.

If the Offeror/Contractor knows of no OCI in accepting work under this contract, it shall certify its OCI status and submit the certification with its quote and any later award, if awarded the contract. The Contractor shall also obtain a similar certification of OCI status from all sub-Contractors, teaming partners or consultants prior to tasking any such party under this contract.

For breach of any of the above restrictions or for nondisclosure or misrepresentation of any relevant facts required to be disclosed concerning this contract, the Government may terminate this contract, disqualify the Contractor from subsequent related contractual efforts, and pursue any remedies as may be permitted by law or this contract.

Prior to a contract modification involving a change to the Performance Work Statement, or an increase in the level of effort or extension of the term of the contract, the Contractor shall submit any applicable organizational conflict of interest disclosure or an update of the previously submitted disclosure or representation.

10.5. Invoices

The contractor shall submit invoices to Wide Area Work Flow (WAWF) with sufficient documentation to provide certification of invoice.

10.6. Dissemination of Information/Publishing

There shall be no dissemination or publication, except within and between the Contractor and any Sub Contractors or specified Integrated Product/Process Team (IPT) members who have a need to know, of information developed under this order or contained in the reports to be furnished pursuant to this order without prior written approval of the COR or the Contracting Officer.

10.7. Contractor Identification

The Contractor shall ensure that Contractor personnel identify themselves as Contractors when attending meetings, answering Government telephones, providing any type of written correspondence, or working in situations where their actions could be construed as official Government acts. Contractors may not use or allude to former or current military rank during the performance of this work.

10.8. Attendance at Meetings

Contractor personnel may be required to attend meetings or otherwise communicate with Government and/or other contract or assistance agreement representatives to meet the requirements of this contract. Contractor personnel shall make their contractor status known during introductions.

10.9. Data Rights

All data received, processed, evaluated, loaded, and created as a result of this contract shall remain the sole property of the Government and shall be returned to the Government at the conclusion of the contract, unless the KO grants a specific exception.

11.0 ACRONYMS LIST

Acronym Definition

APHC Army Public Health Center

CFR Code of Federal Regulations

CLIN Contract Line Item Number

COR Contracting Officer Representative

DA Department of the Army

DOD Department of Defense

FAR Federal Acquisition Regulation

IAW In Accordance With

KO Contracting Officer

MEDCOM Medical Command

OCI Organizational Conflict of Interest PWS Performance Work Statement

QCP Quality Control P

SME Subject Matter Expert

TRV Toxicity Reference Value

WAWF Wide Area Work Flow

WTA Wildlife Toxicity Assessment

ADMINISTRATIVE INFORMATION

Contracting Officer (KO):

U.S. Army Medical Research Acquisition Activity (USAMRAA) ATTN: Ayi J. Ayayi 820 Chandler Street Fort Detrick, MD 21702 ayi.j.ayayi.civ@health.mil

Contract Specialist (CS):

USAMRAA

ATTN: Jesse D. Nisley 820 Chandler Street Fort Detrick, MD 21702 Jesse.d.nisley.civ@health.mil

Contracting Officer’s Representative (COR):

Army Public Health Center (APHC) ATTN: To be Determined

Vendor Information Contact (VIC):

To be Determined

INSPECTION AND ACCEPTANCE TERMS

Supplies/services will be inspected/accepted at:

CLIN INSPECT AT INSPECT BY ACCEPT AT ACCEPT BY

0001 Destination Government Destination Government 1001 Destination Government Destination Government 2001 Destination Government Destination Government 3001 Destination Government Destination Government 4001 Destination Government Destination Government

DELIVERY INFORMATION

CLIN DELIVERY DATE QUANTITY SHIP TO ADDRESS DODAAC /

CAGE

0001 POP 29-SEP-2022 TO

28-SEP-2023

N/A W03H USA PUBLIC HEALTH COMMAND

(PHC)

W03H USA PUBLIC HEALTH COMMAND

(PHC

5158 BLACKHAWK ROAD

ABERDEEN PROVING GROUND MD 21010

W23MWP

1001 POP 29-SEP-2023 TO

28-SEP-2024

N/A (SAME AS PREVIOUS LOCATION)

2001 POP 29-SEP-2024 TO

28-SEP-2025

N/A (SAME AS PREVIOUS LOCATION)

3001 POP 29-SEP-2025 TO

28-SEP-2026

N/A (SAME AS PREVIOUS LOCATION)

4001 POP 29-SEP-2026 TO

28-SEP-2027

N/A (SAME AS PREVIOUS LOCATION)

CLAUSES INCORPORATED BY REFERENCE

52.203-12 Limitation On Payments To Influence Certain Federal

Transactions

JUN 2020

52.204-7 System for Award Management OCT 2018 52.204-13 System for Award Management Maintenance OCT 2018 52.204-16 Commercial and Government Entity Code Reporting AUG 2020 52.204-18 Commercial and Government Entity Code Maintenance AUG 2020

52.212-1 Instructions to Offerors--Commercial Products and Commercial Services

NOV 2021

52.217-5 Evaluation Of Options JUL 1990 52.232-39 Unenforceability of Unauthorized Obligations JUN 2013 52.232-40 Providing Accelerated Payments to Small Business

Subcontractors

NOV 2021

252.201-7000 Contracting Officer's Representative DEC 1991 252.203-7000 Requirements Relating to Compensation of Former DoD

Officials

SEP 2011

252.203-7002 Requirement to Inform Employees of Whistleblower Rights SEP 2013 252.203-7005 Representation Relating to Compensation of Former DoD

Officials

NOV 2011

252.204-7003 Control Of Government Personnel Work Product APR 1992 252.204-7006 Billing Instructions 252.204-7008 Compliance With Safeguarding Covered Defense Information

Controls

252.204-7012 Safeguarding Covered Defense Information and Cyber Incident Reporting

252.204-7015 Notice of Authorized Disclosure of Information for Litigation Support

MAY 2016

252.204-7018 Prohibition on the Acquisition of Covered Defense Telecommunications Equipment or Services

JAN 2021

252.204-7019 Notice of NIST SP 800-171 DoD Assessment Requirements MAR 2022 252.225-7012 Preference For Certain Domestic Commodities APR 2022 252.225-7048 Export-Controlled Items JUN 2013 252.225-7055 Representation Regarding Business Operations with the

Maduro Regime

MAY 2022

252.225-7056 Prohibition Regarding Business Operations with the Maduro Regime

MAY 2022

252.225-7972 (Dev) Prohibition on the Procurement of Foreign-Made Unmanned Aircraft Systems (DEVIATION 2020-O0015)

MAY 2020

252.225-7973 (Dev) Prohibition on the Procurement of Foreign-Made Unmanned Aircraft Systems - Representation (DEVIATION 2020- O0015)

MAY 2020

252.227-7015 Technical Data--Commercial Items FEB 2014 252.227-7037 Validation of Restrictive Markings on Technical Data APR 2022 252.232-7010 Levies on Contract Payments DEC 2006 252.232-7017 Accelerating Payments to Small Business Subcontractors--

Prohibition on Fees and Consideration

APR 2020

252.237-7010 Prohibition on Interrogation of Detainees by Contractor Personnel

JUN 2013

252.244-7000 Subcontracts for Commercial Items JAN 2021 252.247-7023 Transportation of Supplies by Sea FEB 2019

CLAUSES INCORPORATED BY FULL TEXT

52.204-24 REPRESENTATION REGARDING CERTAIN TELECOMMUNICATIONS AND VIDEO

SURVEILLANCE SERVICES OR EQUIPMENT (NOV 2021)

The Offeror shall not complete the representation at paragraph (d)(1) of 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 paragraph (c)(1) in the provision at 52.204-26, Covered Telecommunications Equipment or Services--

Representation, or in paragraph (v)(2)(i) of the provision at 52.212-3, Offeror Representations and Certifications- Commercial Products and Commercial Services. The Offeror shall not complete the representation in paragraph (d)(2) of this provision if the Offeror has represented that it "does not use covered telecommunications equipment or services, or any equipment, system, or service that uses covered telecommunications equipment or services" in paragraph (c)(2) of the provision at 52.204-26, or in paragraph (v)(2)(ii) of the provision at 52.212-3.

(a) Definitions. As used in this provision-

Backhaul, covered telecommunications equipment or services, critical technology, interconnection arrangements, reasonable inquiry, roaming, and substantial or essential component have the meanings provided in the clause 52.204-25, Prohibition on Contracting for Certain Telecommunications and Video Surveillance Services or Equipment.

(b) Prohibition.

(1) 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. Nothing in the prohibition shall be construed to--

(i) Prohibit the head of an executive agency from procuring with an entity to provide a service that connects to the facilities of a third-party, such as backhaul, roaming, or interconnection arrangements; or

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

(2) Section 889(a)(1)(B) 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, 2020, from entering into a contract or extending or renewing a contract with an entity that uses 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. This prohibition applies to the use of covered telecommunications equipment or services, regardless of whether that use is in performance of work under a Federal contract. Nothing in the prohibition shall be construed to--

(i) Prohibit the head of an executive agency from procuring with an entity to provide a service that connects to the facilities of a third-party, such as backhaul, roaming, or interconnection arrangements; or

(ii) Cover telecommunications equipment that cannot route or redirect user data traffic or cannot 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) Representations. The Offeror represents that--

(1) 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. The Offeror shall provide the additional disclosure information required at paragraph (e)(1) of this section if the Offeror responds "will" in paragraph (d)(1) of this section; and

(2) After conducting a reasonable inquiry, for purposes of this representation, the Offeror represents that--

It [ ___ ] does, [ ___ ] does not use covered telecommunications equipment or services, or use any equipment, system, or service that uses covered telecommunications equipment or services. The Offeror shall provide the additional disclosure information required at paragraph (e)(2) of this section if the Offeror responds "does" in paragraph (d)(2) of this section.

(e) Disclosures.

(1) Disclosure for the representation in paragraph (d)(1) of this provision. If the Offeror has responded "will" in the representation in paragraph (d)(1) of this provision, the Offeror shall provide the following information as part of the offer:

(i) For covered equipment--

(A) The entity that produced the covered telecommunications equipment (include entity name, unique entity identifier, CAGE code, and whether the entity was the original equipment manufacturer (OEM) or a distributor, if known);

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

(C) Explanation of the proposed use of covered telecommunications equipment and any factors relevant to determining if such use would be permissible under the prohibition in paragraph (b)(1) of this provision.

(ii) For covered services--

(A) If the service is related to item maintenance: A description of all covered telecommunications services offered (include on the item being maintained: Brand; model number, such as OEM number, manufacturer part number, or wholesaler number; and item description, as applicable); or

(B) If not associated with maintenance, the Product Service Code (PSC) of the service being provided; and explanation of the proposed use of covered telecommunications services and any factors relevant to determining if such use would be permissible under the prohibition in paragraph (b)(1) of this provision.

(2) Disclosure for the representation in paragraph (d)(2) of this provision. If the Offeror has responded "does" in the representation in paragraph (d)(2) of this provision, the Offeror shall provide the following information as part of the offer:

(i) For covered equipment--

(A) 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);

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

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

(ii) For covered services--

(A) If the service is related to item maintenance: A description of all covered telecommunications services offered (include on the item being maintained: Brand; model number, such as OEM number, manufacturer part number, or wholesaler number; and item description, as applicable); or

(B) If not associated with maintenance, the PSC of the service being provided; and explanation of the proposed use of covered telecommunications services and any factors relevant to determining if such use would be permissible under the prohibition in paragraph (b)(2) of this provision.

(End of provision)

ADDENDUM TO 52.212-1

**52.212-1 ADDENDUM FOR INSTRUCTIONS TO OFFERORS**

1.1 Size Standard

The NAICS code and small business size standard for this acquisition is 541620 ($16.5M).

1.2 Point of Contact

The Contract Specialist, Jesse Nisley, is the point of contact (POC) for this acquisition. Any questions or concerns regarding this acquisition shall be submitted electronically via email to jesse.d.nisley.civ@health.mil. All questions and documents shall be submitted electronically via email. The Offeror is responsible for verifying receipt by the

POC.

1.3 Quote Questions

Questions pertaining to the solicitation requirements shall be submitted no later than 3:30 PM Eastern Time, 22 September 2022 to the Contract Specialist at jesse.d.nisley.civ@health.mil. The Offeror shall submit one set of questions only; multiple e-mails will not be accepted. Questions not submitted electronically will not be answered;

telephone inquiries will not be accepted or acknowledged. Follow up/additional questions will not be accepted after this date. Answers to all relevant and appropriate questions will be issued via amendment to the solicitation.

1.4 Quote Due Date: No later than 11:59 PM, Eastern Time 25 Sep 2022.

1.5 Electronic Submission of Offers

The Offeror’s quote shall be electronically submitted to the POC above and as set forth below. Failure to submit all documents concurrently and in accordance with these instructions may be a reason to reject the quote. The Offeror’s quote shall consist of two separate volumes. The Volumes are:

- Volume I: Technical Approach

- Volume II: Price

Files shall not contain classified data.

1.6 Quote Content and Format Instructions

The Government intends to evaluate quotes and award a contract without exchanges with offerors. Therefore, the Offeror’s initial quote should contain the Offeror’s best terms from a price and non-price standpoint.

The Offeror’s submission shall be submitted electronically to the Contract Specialist listed above by the deadline and include two (2) separate volumes: a Technical Approach Volume and a Price Volume.

1.6.1 The quote shall be submitted in MS Word, MS Excel, and/or searchable PDF format. The firewall utilized by the Government contracting office does not authorize or accept zip files. Quote files shall be limited to 8MB per email (files can be submitted via multiple emails if necessary).

1.6.2 The submission shall include a table of contents and be logically assembled. Each volume shall be clearly identified and shall begin at the top of a page. All pages of each volume shall be appropriately numbered and identified by the complete company name, date and Request for Quote (RFQ) number in the header and/or footer.

Each file shall be labeled with the date and offeror’s name.

MS Word (doc) files shall use the following page setup parameters:

Margins - Top, Bottom Left, Right - 1" Gutter - 0" From Edge - Header, footer - 0.5" Page Size, Width - 8.5" Page Size, Height - 11" Each file shall be labeled with the date and offeror’s name.

1.6.3 Electronic File Packaging: All of the quote files shall be separate uploads in their native format, i.e. doc, xls, Adobe etc. All price breakdown information to aide in the price evaluation shall be submitted in Microsoft Office Word and/or Excel. Each file shall be labeled with the volume number, date and the offeror’s name. Note:

Self extracting exe files are not acceptable.

1.6.4 Content Requirement: All information shall be confined to the appropriate file. The Offeror shall confine submissions to essential matters, sufficient to define the quote in a concise manner to permit a complete and accurate evaluation of each quote. The quote shall fully document and substantiate a cross-mapping of the Offeror’s price approach as it equates to the non-priced quote. Proprietary information shall be clearly marked.

The quote shall follow the following page limits:

Volume Number Page Limitation Volume I – Technical Approach 5 single-sided pages total (does not include page limits for required quote attachments) Volume II – Price No Limit

Pages should be numbered consecutively throughout the document and not by sections. For any volume with a defined page limit, any pages exceeding the specified limit will be removed and not forwarded for evaluation. The following sections of the quote (if present) are not counted towards the page limit(s):

- Table of Contents

- Title Page

- Offeror’s POC Cover Page

- Organizational Conflict of Interest Certification (Signed)

- OCI Mitigation Plan (if OCI is identified)

- Completed FAR and Defense Federal Acquisition Regulation Supplement (DFARS) Provisions

1.6.4.1 Volume I – Technical Approach:

The quote shall include in Volume I:

- Representations and Certifications at FAR 52.204-24, FAR 52.212-3 Alternate I, DFARS 252.204-7016, and

DFARS 252.204-7017.

- CAGE Code and Tax Identification Number (TIN).

- A stipulation that the quote is predicated upon all terms and conditions of this RFQ.

In addition, the Offeror shall submit a technical approach which effectively demonstrates:

- The Offeror’s capabilities, technical expertise, techniques, strategies, methodologies, and flexibility to be applied to the task objectives as outlined in the PWS;

- A thorough understanding of all requirements listed in the PWS;

- Knowledge and understanding as well as a plan of action for performing all the PWS requirements, including how the Offeror plans to mitigate bias in their peer review.

Required Attachments to Volume I: Technical Approach of the quote:

Attachments listed below do not count towards the overall page limit for Volume I.

Attachment A: Organizational Conflict of Interest (OCI) Certification: The contractor shall submit an OCI certification (see template via Attachment 1 of the solicitation) with their quote. Attachment A has a page limit of 5 pages.

Attachment B: Organizational Conflict of Interest (OCI) Mitigation Plan: The Offeror shall submit an OCI Mitigation Plan in response to any actual or potential conflict of interest associated with performance of this requirement. If no actual or potential conflict of interest is identified, a Mitigation Plan is not required. If provided, Attachment B has a page limit of 10 pages.

1.6.4.2 Volume II – Price: The Price Volume shall be submitted separately from the Technical Approach; however, the Price quote shall be consistent with the Technical Approach. Discrepancies between Volumes I and II may be viewed as a lack of understanding of this requirement.

The price quote information shall include completed pricing for all Contract Line Item Numbers (CLINs). The Offeror shall ensure mathematical computations are correct.

(a) Offerors shall propose on all contract line items, either by price or “NSP” (Not Separately Priced). A line item price left blank will be considered incomplete and may not be considered for award.

(b) Offerors’ quote shall remain valid for a minimum of 30 days from the date of submission.

CLAUSES INCORPORATED BY FULL TEXT

52.212-2 EVALUATION--COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES (NOV 2021)

(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 Government intends to award a single contract as a result of this RFQ.

The following factors shall be used to evaluate offers:

Evaluation Factor I – Technical Approach Evaluation Factor II – Price

A Firm Fixed Price (FFP) contract shall be made on a competitive best value basis, using a “Lowest Priced Technically Acceptable” method among price and non-price factors.