Combined Synopsis_Solicitation Amendment 0001.pdf

W81XWH22R0106-0001

COMBINED SYNOPSIS/SOLICITATION – AMENDMENT 0001

This amendment provides responses to questions received regarding this solicitation. As a result, the PWS, estimated start dates, FAR 52.209-7, FAR 52.212-1, and FAR 52.212-3 have been updated. DFARS 252.204-7019 has been removed. The proposal submission due date has been extended from 07 September 2022 to 12 September

2022. All revisions to the combined synopsis/solicitation are in a red font.

RESPONSES TO QUESTIONS

1. Is this a brand new contract or is there an incumbent currently performing these services?

Response: This is a new contract. There is currently no incumbent performing this requirement.

2. The RFP mentions analysis of tissues and eggs. Which kinds of tissues and eggs are these?

Response: Tissues will be from laboratory mice (CD1) and kestrels (and their eggs).

3. Are the eggs in the shell or have they been broken and transferred into a container?

Response: It is believed the eggs will have been broken and transferred into a container. If there is another preferable format, offerors are encouraged to specify the preferred method within their proposal.

4. Is it possible to extend the due date to September 14th?

Response: The proposal due date has been extended to September 12th, 2022.

5. It was not clear which format(s) are requested for the final reports. Our standard format is a level 2 report (sample results plus basic analytical QC) in PDF format. Our other options are a basic excel EDD and a Level 4 report (includes all raw data necessary to re-construct/validate the final results). Please specify which formats are required.

Response: The Government will require a final report that contains all raw data necessary to validate the final results. The PWS (pages 9-10) have been updated to include this information.

6. On page 27 [now 30], there are page limit specifications. It is not clear to us if the 20 page limit applies to each individual volume or if it applies to the total number of pages in volumes 1-3 combined. Can you please clarify?

Response: The 20 page limit applies to the total number of pages in volumes 1-3 combined.

7. Do attachments like method SOPs and reporting limits count against our page limit total specifications?

Response: Attachments, such as method SOPs and reporting limits, will count against the page limit specifications since they are not required to be provided by the solicitation.

8. Can you tell us what your expected volume (in mL) will be for mouse plasma and serum samples?

Response: For everything besides the 6:2 semi-quant analysis, APHC will have 100-200uL/animal. If pooling is required, APHC can do that prior to shipment, but Offerors shall specify the quantities on analysis adjusted.

9. Will plasma and serum samples be spun down and separated prior to shipping to the laboratory for analysis by 1633?

Response: Yes, plasma and serum samples will be spun down and separated prior to shipping to the laboratory for analysis by EPA Method 1633.

10. Our lab has not implemented NIST SP 800-171 and currently has no plans to do so. Would this fact make [offerors] ineligible for an award for this solicitation?

Response: DFARS 252.204-7019, Notice of NIST SP 800-171 DoD Assessment Requirements, has been removed from the solicitation.

11. Will samples for the base year be delivered to the lab in one large shipment or in multiple shipments over the course of the first year? If multiple shipments are expected, can you give us anticipated delivery dates for each proposed shipment?

Response: For the base year, one large shipment is expected to be delivered by approximately 28 October 2022.

12. In support of our submission for Volumes I, II, and III, the inclusion of additional documents, such as the resumes of certain key technical staff, would add value to USAMRAA's review of our response. If provided, will those resumes be included in the total page count maximum of 20 pages for Volumes I, II and III or would they not be counted towards the page limit(s) in the same way as the other items noted on page 27 [now page 30] of the solicitation (Table of Contents, Title Page, Offeror’s POC Cover Page, Organization Conflict of Interest, Completed FAR and DFARS Provisions)?

Response: Inclusion of additional documents, such as resumes of certain technical staff, will count against the page limit specifications since they are not required to be provided by the solicitation.

13. Regarding the Homogenization and Analysis of eggs for 40 PFAS listed under item numbers 1001 and 1002, who will be providing the eggs?

Response: Eggs will be taken from exposed kestrels. That is being conducted by a collaborator at the U.S.

Geological Survey (USGS).

14. Will they be albumin only or with yolk?

Response: It is believed that the entire egg (with yolk) will be provided. If there is another preferable format, offerors are encouraged to specify the preferred method within their proposal.

15. If a water source is required, who will supply it?

Response: The Government will supply a water source.

16. Additional Revisions for the Combined Synopsis/Solicitation:

- Estimated start dates have been revised due to the updated proposal due date.

- FAR 52.209-7 has been changed from “Incorporated by reference” to being shown in full text.

- DFARS 252.239-7009 has been removed from the list of provisions in FAR 52.212-1.

- FAR 52.212-3 has been revised to be FAR 52.212-3 Alternate I.

COMBINED SYNOPSIS/SOLICITATION INSTRUCTIONS

This is a combined synopsis/solicitation 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; proposals are being requested and no other solicitation will be issued.

The NAICS code is 541380, Testing Laboratories, with a size standard of $16.5M. This is a requirement issued under full and open competition. All capable vendors are encouraged to submit a proposal.

The US Army Medical Research Acquisition Activity (USAMRAA) requests responses from qualified sources capable of determining the concentration of per- and polyfluoroalkyl substances (PFAS) analytes in various matrices via Environmental Protections Agency (EPA) Draft Method 1633.

ITEM NO SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT

0001 400 Each Analysis of mouse serum for 40 PFAS

FFP

Analysis of mouse serum for 40 PFAS

FOB: Destination

PURCHASE REQUEST NUMBER: 0011788617

PSC CD: Q301

NET AMT

0002 30 Each Analysis of dosing solutions for 40 PFAS

FFP

Analysis of dosing solutions for 40 PFAS

FOB: Destination

0003 300 Each Homogenization of whole bodies

FFP

Homogenization of whole bodies (prior to services on CLIN 0004)

FOB: Destination

0004 300 Each Analysis of whole bodies for 40 PFAS

FFP

Analysis of whole bodies for 40 PFAS (after services on CLIN 0003)

FOB: Destination

0005 100 Each Analysis of mouse serum, 6:2 FTCA/FTUCA

FFP

Analysis of mouse serum for 6:2 FTCA and FTUCA

FOB: Destination

0006 1 Job Shipping

COST

Shipping

FOB: Destination

ESTIMATED COST

0007 1 Job Service Contracting Reporting (SCR)

COST

FOB: Destination

1001 30 Each OPTION Homogenization of eggs

FFP

Homogenization of eggs (prior to services on CLIN 1002)

1002 30 Each OPTION Analysis of eggs for 40 PFAS

FFP

Analysis of eggs for 40 PFAS (after services on CLIN 1001)

1003 180 Each OPTION Analysis of plasma for 40 PFAS

FFP

Analysis of plasma for 40 PFAS

1004 282 Each OPTION Homogenization of tissues

FFP

Homogenization of tissues (prior to services on CLIN 1005)

1005 282 Each OPTION Analysis of tissues for 40 PFAS

FFP

Analysis of tissues for 40 PFAS (after services on CLIN 1004)

1006 7 Each OPTION Analysis of dosing solutions

FFP

Analysis of dosing solutions

1007 1 Job OPTION Shipping

COST

Shipping

1008 1 Job OPTION Service Contracting Reporting (SCR)

COST

PERFORMANCE WORK STATEMENT

PERFORMANCE WORK STATEMENT (PWS)

Title: Multi-Matrix Sample Analysis Services

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

1. INTRODUCTION

The U.S. Army Public Health Center (APHC) is part of the U.S. Army Medical Command (MEDCOM) and focuses on epidemiology, laboratory sciences, occupational health sciences, public health information and toxicology to enhance Army readiness and assure the quality and effectiveness of Army’s Public Health

Enterprise. Ensuring high-quality services is an imperative of MEDCOM as it strives to become a high-reliability organization (HRO).

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.” The purpose of this contract is to provide analysis of the concentration of per- and polyfluoroalkyl substances (PFAS) in various matrices collected from toxicological studies. Data from this contract is used to identify potential health hazards in the operational environment and occupational exposures.

3. SCOPE

The scope of this Contract includes (1) shipment, receipt, handling, and processing, (2) homogenization of tissue and body samples, (3) determining the concentration of 40 PFAS analytes in various matrices via

Environmental Protection Agency (EPA) Draft Method 1633, and (4) providing data, final reports, and any samples not completely consumed during analysis to APHC within 45 business days from the completion of sample analysis.

4. PERIOD OF PERFORMANCE

The estimated periods of performance for this contract are as follows:

Base period 21 September 2022 – 20 September 2023

Option period 1 21 September 2023 – 20 September 2024

5. WORK SCHEDULE AND LOCATION

5.1. Work Location

The work locations for this requirement will be performed at the Contractor’s facility. There is no onsite support for this requirement.

PERFORMANCE REQUIREMENTS

5.2. Objectives

Objective 1 – Provide appropriate containers, shipment, receipt, handling, and storage of samples when the samples arrive at the contractor facility.

Objective 2 – Determine the concentration of 40 PFAS analytes in various matrices via EPA Draft Method 1633.

Homogenize tissue and whole body samples prior to analysis. A subset of serum samples will also need semi-quant analysis for potential biotransformation products of 6:2 fluorotelomer sulfonate (FTS), including 6:2 fluorotelomer carboxylic acid (FTCA) and 6:2 fluorotelomer unsaturated carboxylic acid (FTUCA). Contractor shall analyze 830 samples during the base year and 499 samples during Option Year 1.

Objective 3 – Provide data, final report (containing all raw data), and any samples not completely consumed during analysis, to APHC within 45 business days from the completion of sample analysis.

5.3. Specific Tasks / Requirements

Objective 1:

Key Task 1 – The Contractor shall provide sample containers and shipment containers (i.e., coolers) that meet the contractor’s laboratory’s standards (size, shape, material, cleanliness, etc.). (Deliverable 1)

U.S. Army Public Health Center (APHC)

8242 Blackhawk Road

Building E-5165

APG, MD 21010-5403

Key Task 2 – The Contractor shall provide paid priority shipping labels and instructions for the Government to ship coolers to the Contract laboratory. (Deliverable 2)

Key Task 3 – The Contractor shall immediately process samples or store them in accordance with parameters set forth in EPA Draft Method 1633 for processing later. Notify APHC upon receipt of samples via email no later than

48 hours after receiving shipment. (Deliverable 3)

Objective 2:

Key Task 1 – The Contractor shall homogenize whole body (mus musculus) and tissue samples.

Key Task 2 – The Contractor shall determine the concentration of PFAS analytes in various matrices (whole body, serum, and/or water) via EPA Draft Method 1633. A subset of serum samples will also need semi-quantitative analysis for potential biotransformation products of 6:2 FTS, including 6:2 FTCA and 6:2 FTUCA. Email notification of preliminary data quality to APHC study director no later than 14 days after sample analysis.

(Deliverable 4)

Objective 3:

Key Task 1 – The Contractor shall send a final report containing all raw data to the COR within 45 business days after APHC study director concurrence with the report. (Deliverable 5).

Key Task 2 – The Contractor shall return any samples not completely consumed during analysis to APHC via paid express air shipping (Deliverable 6) within 45 business days from the completion of sample analysis.

8242 Blackhawk Road

Building E-5165

APG, MD 21010-5403

6. 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 Contracting

Officer’s Representative (COR) electronically.

DELIVERABLES TABLE

PWS Ref. Number Title/Description Due

6.2 1 Sample collection containers and coolers for shipping.

No later than 14 days after request.

6.2 2 Paid priority shipping labels and instructions.

No later than 14 days after request.

6.2 3 Receipt/handling of samples. Email notification to APHC study director.

No later than 48 hours after receiving shipment.

6.2 4

Sample analysis. Email notification of homogenization of whole body and tissue samples, and preliminary analysis data quality to

APHC study director.

No later than 14 days after sample analysis.

6.2 5

Data management. Send final report to COR for each of the two sample batches analyzed (first batch in base year and second batch in Option

Year 1).

No later than 45 days after study director concurrence with report.

6.2 6 Return of all samples not completely consumed during analysis to APHC.

No later than 45 days from the completion of sample analysis.

Attachment 2 7 Organizational Conflicts of Interest (OCI)

Certification

The Contractor shall complete the OCI

Certification at time of proposal submission.

6.1. 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.

6.2. Inspection and Acceptance

The COR 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.

6.3. COR Information

TBD

8. 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

Sample collection containers and coolers for shipping.

No later than 14 days after contract award.

95% Receipt of supplies within specified timeframe

2 6.2

Paid priority shipping labels and instructions.

No later than 14 days after contract award.

95% Receipt of labels and instructions within specified timeframe

3 6.2

Receipt/handling of samples: Email notification to

APHC study director.

No later than 48 hours after receiving shipment.

95% Confirmation of email received within specified timeframe

4 6.2

Sample analysis and homogenization of whole body and tissue samples:

Email notification of preliminary data quality to APHC study director.

No later than 14 days after sample analysis.

95% Confirmation of email received within specified timeframe

5 6.2

Data management:

Send final report to

COR.

No later than 45 days after study director concurrence with report.

95% Receipt of report within specified timeframe

6 6.2

Return of all samples not completely consumed during analysis to APHC.

No later than 45 days from the completion of sample analysis.

95% Receipt of samples within specified timeframe

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.

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. Occupational Safety and Health Administration

The contractor shall comply with Occupational Safety and health Administration Standard Number

1904.32. The contractor shall deliver the 300A by February 1 of each year (Deliverable XX).

9.1.3. 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) in accordance with (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.

10.4.1 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 proposal submission.

10.5. Invoices

The contractor shall submit invoices monthly 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 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. ATTACHMENTS

Attachment 1 – Acronyms List

Attachment 2 – Organizational Conflict of Interest

ATTACHMENT 1 – ACRONYMS LIST

Acronym Definition

APHC Army Public Health Center

CFR Code of Federal Regulations

COR Contracting Officer Representative

DoD Department of Defense

FAR Federal Acquisition Regulation

OCI Organizational Conflict of Interest

PWS Performance Work Statement

QASP Quality Assurance and Surveillance Plan

US United States

WAWF Wide Area Work Flow

ATTACHMENT 2: ORGANIZATIONAL CONFLICT OF INTEREST

The APHC has categorized all service procurements into one of the following three categories as defined below, for the purpose of identifying, avoiding or mitigating against Organizational Conflicts of Interests (OCI) in accordance with (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.

Contractor participation in more than one of these areas may give rise to an unfair competitive advantage resulting from access to advance acquisition planning, source selection sensitive or proprietary information. Furthermore, Contractor participation in more than one area may give rise to a real or apparent loss of Contractor impartiality and objectivity where its advisory or planning assistance in one area potentially affects its present or future participation in another area.

The purpose of this categorization is to accomplish the following three objectives: (1) to inform prospective Offerors that APHC presumes that award of a contract or order in the subject category will give rise to real or apparent OCIs with respect to requirements in the other two categories; (2) to assist current Contractors and prospective Offerors in developing their own business strategies regarding participation in APHC requirements and in identifying and, where possible, avoiding or mitigating against OCIs; and (3) to ensure that all current Contractors and prospective

Offerors are afforded the maximum practicable opportunity to compete for all USAMRMC requirements consistent with the restrictions required under FAR Subpart 9.5 and sound business practices.

For purposes of identifying, avoiding and / or mitigating against OCIs, APHC will examine all its non-purchased care requirements and acquisitions regardless of the cognizant contracting activity (e.g., USAMRAA, GSA, other agency Multiple Award Schedules, etc.) or the type of contract vehicle used (e.g., FSS order, Fair Opportunity competitive order under Multiple Award ID/IQ Contracts, competitively negotiated awards under FAR Part 15, etc.).

Each APHC non-purchased care solicitation will therefore be designated as falling within one of the three above defined categories. The work called for under this contract / order has been determined by APHC to fall within the following non-purchased care OCI category:

Category 2: Program Management Support

APHC will administer this clause for purposes of award eligibility for each solicitation as follows:

An Offeror that has never provided support to APHC in any of the categories is eligible for award in any category without any further action required under this clause.

An Offeror that provides or has provided support to APHC in only one category of work and has never supported

APHC in any other category (a single-category Contractor) is eligible for award for any future requirement in that single category without further action under this clause.

A single-category Offeror/Contractor wishing to submit an offer in a different category, or any Offeror/Contractor which now provides or previously has provided support in more than one category, must include the following as part of its offer:

• Perform a comparative analysis of the potential new work against all current and previous work performed in support of APHC in any category other than that of the new work being offered. The comparative analysis must be included in the proposal for the new work, and must include a statement certifying whether the Contractor believes that its performance of the proposed new work would create a real or apparent OCI. If the Contractor believes that no real or perceived OCI will result from an award of the proposed work, no additional action by the

Contractor is required.

• If the Offeror/Contractor believes that a real or apparent OCI may exist as a result of an award, the

Contractor shall also submit an OCI Avoidance or Mitigation Plan with its proposal.

Inclusion of the comparative analysis and OCI Avoidance or Mitigation Plan will not be counted against any offer page limitations otherwise stated in the solicitation.

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. 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, for purposes of this clause, to be 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 at the end of this clause with its proposal and any later award, if awarded the contract. The

Contractor shall also obtain a similar certification of OCI status from all subcontractors, teaming partners or consultants prior to tasking any such party under this contract. The Contractor shall appropriately modify and include this clause, including this paragraph, in all consulting agreements and subcontracts of any tier to preserve the rights of the Government.

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 Statement of Work, 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.

The Offeror/Contractor should review the considerations below in determining whether or not a conflict of interest exists.

• Does the Offeror or any intended subcontractors, teaming partners, proposed employees, or affiliates have

Unequal Access to Information? Would award to the Offeror result in the Offeror having the opportunity to access nonpublic information that may give the Offeror a competitive advantage in a later competition for a government contract? Specifically, will the Offeror/Contractor have access to any of the following information:

o Budget(s), or Budget Information?

o Acquisition Sensitive Information related to the procurement process to include, but not limited to

Acquisition Plans, Requirements, Statements of Work, or Evaluation Criteria?

• Does the Offeror or any intended subcontractors, teaming partners, proposed employees, or affiliates have

“impaired objectivity” because the Offeror’s ability to render impartial judgments may be compromised because of its conflicting role(s) on this effort and other government contracts?

• Do “biased ground rules” exist? Most commonly, this would include a situation where the Offeror has, as a government Contractor, written specifications or a statement of work for this effort, which could skew competition in favor of itself?

• Is the Offeror aware of any other information relating to this proposed contract/order, which could reasonably be construed as creating an OCI?

The Offeror/Contractor hereby certifies to the best of its knowledge its OCI status below:

(Offeror: Choose one of the following two statements. Indicate which one applies by placing an X in the box to the left of the statement.)

No real or perceived OCI, as defined in FAR 2.1 and discussed in FAR 9.5, will result from an award of the proposed work (there are no ‘Yes’ responses to the questions above).

A real or apparent OCI may exist as a result of an award and therefore an appropriate OCI Avoidance or

Mitigation Plan is attached (Offeror shall include an appropriate OCI Avoidance or Mitigation Plan, as required by this clause, with its proposal to the Contracting Officer).

Upon award the Contractor agrees that it will provide timely OCI training to all employees and subcontractor employees working on this effort, which will include emphasis on how work performed by Contractor employees

(either prime Contractor, subcontractor, or other teaming partners) under one APHC OCI category can exclude the

Contractor as well as its teaming partners from performing related tasks under a different OCI category of work.

____________________________ (Signature) ____________________ (Date)

____________________________ (Printed Name) ____________________ (Title)

ADMINISTRATIVE INFORMATION

Contracting Officer (KO):

U.S. Army Medical Research Acquisition Activity (USAMRAA)

ATTN: Erin J. Maddox

820 Chandler Street

Fort Detrick, MD 21702

Erin.j.maddox.civ@health.mil

Contract Specialist (CS):

USAMRAA

mailto:Erin.j.maddox.civ@health.mil

ATTN: Jesse D. Nisley

820 Chandler Street

Fort Detrick, MD 21702

Jesse.d.nisley.civ@health.mil

Administrative Information Contact (AIC):

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

0002 Destination Government Destination Government

0003 Destination Government Destination Government

0004 Destination Government Destination Government

0005 Destination Government Destination Government

0006 Destination Government Destination Government

0007 Destination Government Destination Government

1001 Destination Government Destination Government

1002 Destination Government Destination Government

1003 Destination Government Destination Government

1004 Destination Government Destination Government

1005 Destination Government Destination Government

1006 Destination Government Destination Government

1007 Destination Government Destination Government

1008 Destination Government Destination Government

DELIVERY INFORMATION

CLIN DELIVERY DATE QUANTITY SHIP TO ADDRESS DODAAC /

CAGE

0001 POP 21-SEP-2022 TO

20-SEP-2023

N/A W03H USA PUBLIC HEALTH COMMAND

(PHC)

W03H USA PUBLIC HEALTH COMMAND

(PHC

5158 BLACKHAWK ROAD

ABERDEEN PROVING GROUND MD 21010

FOB: Destination

W23MWP

mailto:Jesse.d.nisley.civ@health.mil

0002 POP 21-SEP-2022 TO

N/A (SAME AS PREVIOUS LOCATION)

0003 POP 21-SEP-2022 TO

N/A (SAME AS PREVIOUS LOCATION)

0004 POP 21-SEP-2022 TO

N/A (SAME AS PREVIOUS LOCATION)

0005 POP 21-SEP-2022 TO

N/A (SAME AS PREVIOUS LOCATION)

0006 POP 21-SEP-2022 TO

N/A (SAME AS PREVIOUS LOCATION)

0007 POP 21-SEP-2022 TO

N/A (SAME AS PREVIOUS LOCATION)

1001 POP 21-SEP-2023 TO

20-SEP-2024

N/A (SAME AS PREVIOUS LOCATION)

1002 POP 21-SEP-2023 TO

N/A (SAME AS PREVIOUS LOCATION)

1003 POP 21-SEP-2023 TO

N/A (SAME AS PREVIOUS LOCATION)

1004 POP 21-SEP-2023 TO

N/A (SAME AS PREVIOUS LOCATION)

1005 POP 21-SEP-2023 TO

N/A (SAME AS PREVIOUS LOCATION)

1006 POP 21-SEP-2023 TO

N/A (SAME AS PREVIOUS LOCATION)

1007 POP 21-SEP-2023 TO

N/A (SAME AS PREVIOUS LOCATION)

1008 POP 21-SEP-2022 TO

N/A (SAME AS PREVIOUS LOCATION)

CLAUSES INCORPORATED BY REFERENCE

52.202-1 Definitions JUN 2020

52.203-3 Gratuities APR 1984

52.203-6 Alt I Restrictions On Subcontractor Sales To The Government

(JUN 2020) -- Alternate I

NOV 2021

52.203-12 Limitation On Payments To Influence Certain Federal

Transactions

JUN 2020

52.204-4 Printed or Copied Double-Sided on Postconsumer Fiber

Content Paper

MAY 2011

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

52.204-19 Incorporation by Reference of Representations and

Certifications.

DEC 2014

52.209-7 Information Regarding Responsibility Matters OCT 2018

52.212-4 Contract Terms and Conditions--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

252.203-7000 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

252.204-7015 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

252.215-7007 Notice of Intent to Resolicit JUN 2012

252.215-7008 Only One Offer JUL 2019

252.225-7012 Preference For Certain Domestic Commodities APR 2022

252.225-7048 Export-Controlled Items JUN 2013

252.225-7052 Restriction on the Acquisition of Certain Magnets, Tantalum, and Tungsten.

OCT 2020

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

252.226-7001 Utilization of Indian Organizations and Indian-Owned

Economic Enterprises, and Native Hawaiian Small Business

Concerns

APR 2019

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

252.243-7002 Requests for Equitable Adjustment DEC 2012

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)

52.209-7 INFORMATION REGARDING RESPONSIBILITY MATTERS (OCT 2018)

(a) Definitions. As used in this provision--

Administrative proceeding means a non-judicial process that is adjudicatory in nature in order to make a determination of fault or liability (e.g., Securities and Exchange Commission…