W81XWH17T0135.pdf

SEE ADDENDUM

(No Collect Calls)

W81XWH-17-T-0135 16-Feb-2017

b. TELEPHONE NUMBER

(301) 619-2845

8. OFFER DUE DATE/LOCAL TIME

01:00 PM 08 Mar 2017

5. SOLICITATION NUMBER 6. SOLICITATION ISSUE DATE

AUTHORIZED FOR LOCAL REPRODUCTION

PREVIOUS EDITION IS NOT USABLE

STANDARD FORM 1449 (REV. 2/2012)

Prescribed by GSA – FAR (48 CFR) 53.212

(TYPE OR PRINT)

(SIGNATURE OF CONTRACTING OFFICER)

ADDENDA X ARE

26. TOTAL AWARD AMOUNT (For Gov t. Use Only )

23.

CODE 10. THIS ACQUISITION IS

SUCH ADDRESS IN OFFER

17b. CHECK IF REMITTANCE IS DIFFERENT AND PUT

BELOW IS CHECKED

TELEPHONE NO.

W81XWH9. ISSUED BY

18b. SUBMIT INVOICES TO ADDRESS SHOWN IN BLOCK 18a. UNLESS BLOCK

7. FOR SOLICITATION

INFORMATION CALL:

a. NAME

DAVID R. DANIEL

2. CONTRACT NO. 3. AWARD/EFFECTIVE DATE 4. ORDER NUMBER

(TYPE OR PRINT)

30b. NAME AND TITLE OF SIGNER 30c. DATE SIGNED 31b. NAME OF CONTRACTING OFFICER

30a. SIGNATURE OF OFFEROR/CONTRACTOR 31a.UNITED STATES OF AMERICA

1 27a. SOLICITATION INCORPORATES BY REFERENCE FAR 52.212-1. 52.212-4. FAR 52.212-3. 52.212-5 ARE ATTACHED.X

25. ACCOUNTING AND APPROPRIATION DATA

1. REQUISITION NUMBER

20.

ADDITIONAL SHEETS SUBJECT TO THE TERMS AND CONDITIONS SPECIFIED.

OFFEROR TO COMPLETE BLOCKS 12, 17, 23, 24, AND 30

SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL ITEMS

ARE NOT ATTACHED

27b. CONTRACT/PURCHASE ORDER INCORPORATES BY REFERENCE FAR 52.212-4. FAR 52.212-5 IS ATTACHED. ADDENDA ARE ARE NOT ATTACHED

(BLOCK 5), INCLUDING ANY ADDITIONS OR CHANGES WHICH ARE

SET FORTH HEREIN, IS ACCEPTED AS TO ITEMS:

. YOUR OFFER ON SOLICITATION

28. CONTRACTOR IS REQUIRED TO SIGN THIS DOCUMENT AND RETURN

% FOR:SET ASIDE:UNRESTRICTED ORX

SMALL BUSINESS

17a.CONTRACTOR/ CODE FACILITY

OFFEROR CODE

USA MED RESEARCH ACQ ACTIVITY

820 CHANDLER ST

FORT DETRICK MD 21702-5014

18a. PAYMENT WILL BE MADE BY CODE

RATED ORDER UNDER

DPAS (15 CFR 700)

13a. THIS CONTRACT IS A

13b. RATING

CODE15. DELIVER TO CODE 16. ADMINISTERED BY

SEE SCHEDULE

12. DISCOUNT TERMS11. DELIVERY FOR FOB DESTINA-

TION UNLESS BLOCK IS

MARKED

SEE SCHEDULE

14. METHOD OF SOLICITATION

RFQ IFB RFPX

FAX:

TEL: SERVICE-DISABLED

VETERAN-OWNED

SMALL BUSINESS

8(A)

HUBZONE SMALL

BUSINESS

SIZE STANDARD:

1,000

NAICS:

541712

X

OFFER DATED

29. AWARD OF CONTRACT: REF.

DELIVER ALL ITEMS SET FORTH OR OTHERWISE IDENTIFIED ABOVE AND ON ANY

COPIES TO ISSUING OFFICE. CONTRACTOR AGREES TO FURNISH AND

EMAIL:

TEL:

31c. DATE SIGNED

SEE SCHEDULE

SCHEDULE OF SUPPLIES/ SERVICESITEM NO. QUANTITY UNIT UNIT PRICE AMOUNT

24.22.21.19.

WOMEN-OWNED SMALL BUSINESS (WOSB)

ELIGIBLE UNDER THE WOMEN-OWNED

SMALL BUSINESS PROGRAM

EDWOSB

32g. E-MAIL OF AUTHORIZED GOVERNMENT REPRESENTATIVE

SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL ITEMS

(CONTINUED)

ACCEPTED, AND CONFORMS TO THE CONTRACT, EXCEPT AS NOTED: ______________________________________________________

32a. QUANTITY IN COLUMN 21 HAS BEEN

RECEIVED INSPECTED

32b. SIGNATURE OF AUTHORIZED GOVERNMENT

REPRESENTATIVE

32c. DATE 32d. PRINTED NAME AND TITLE OF AUTHORIZED GOVERNMENT

REPRESENTATIVE

32e. MAILING ADDRESS OF AUTHORIZED GOVERNMENT REPRESENTATIVE 32f . TELEPHONE NUMBER OF AUTHORIZED GOVERNMENT REPRESENTATIVE

37. CHECK NUMBER

FINALPARTIALCOMPLETE

36. PAYMENT35. AMOUNT VERIFIED

CORRECT FOR

34. VOUCHER NUMBER

FINAL

33. SHIP NUMBER

PARTIAL

38. S/R ACCOUNT NUMBER 39. S/R VOUCHER NUMBER 40. PAID BY

41a. I CERTIFY THIS ACCOUNT IS CORRECT AND PROPER FOR PAYMENT 41b. SIGNATURE AND TITLE OF CERTIFYING OFFICER 41c. DATE

42a. RECEIVED BY (Print)

42b. RECEIVED AT (Location)

42c. DATE REC'D (YY/MM/DD) 42d. TOTAL CONTAINERS

STANDARD FORM 1449 (REV. 2/2012) BACK

Prescribed by GSA – FAR (48 CFR) 53.212

AUTHORIZED FOR LOCAL REPRODUCTION

PREVIOUS EDITION IS NOT USABLE

SEE SCHEDULE

20.

SCHEDULE OF SUPPLIES/ SERVICES

21.

QUANTITY UNIT

22. 23.

UNIT PRICE

24.

AMOUNT

19.

ITEM NO.

W81XWH-17-T-0135

Section SF 1449 - CONTINUATION SHEET

ITEM NO SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT

0001 12 Months

GENOME SEQUENCING AND ANALYSES

FFP

Contractor shall provide support services in accordance with (IAW) the Performance Work Statement (PWS) for Genome Sequencing and Anayses R&D Support Services.

FOB: Destination

NET AMT

0002 1 Each

CONTRACTING MANPOWER REPORTING

FFP

The contractor shall report ALL contractor labor hours (including subcontractor labor hours) required for performance of services provided under this contract for the US Army Institute of Surgical Research via a secure data collection site. The contractor is required to completely fill in all required data fields using the following web address: http://www.ecmra.mil/. Reporting inputs will be for the labor executed during the period of performance during each Government fiscal year (FY), which runs October 1 through September 30. While inputs may be reported any time during the FY, all data shall be reported no later than October 31 of each calendar year, beginning with 2017. Contractors may direct questions to the help desk at help desk at: http://www.ecmra.mil.

1001 12 Months

OPTION GENOME SEQUENCING AND ANALYSES

FFP

Contractor shall provide support services in accordance with (IAW) the Performance Work Statement (PWS) for Genome Sequencing and Anayses R&D Support Services.

1002 1 Each

OPTION CONTRACTING MANPOWER REPORTING

FFP

The contractor shall report ALL contractor labor hours (including subcontractor labor hours) required for performance of services provided under this contract for the US Army Institute of Surgical Research via a secure data collection site. The contractor is required to completely fill in all required data fields using the following web address: http://www.ecmra.mil/. Reporting inputs will be for the labor executed during the period of performance during each Government fiscal year (FY), which runs October 1 through September 30. While inputs may be reported any time during the FY, all data shall be reported no later than October 31 of each calendar year, beginning with 2017. Contractors may direct questions to the help desk at help desk at: http://www.ecmra.mil.

PWS

PERFORMANCE WORK STATEMENT (PWS)

Chronic wound metagenomics and metatranscriptomics studies

Vision Statement (United States Army Institute of Surgical Research) (USAISR)

The USAISR Dental and Craniofacial Trauma Research and Tissue Regeneration Directorate mission is to provide militarily relevant research and solutions for the prevention and rehabilitation of craniofacial trauma and infections dental diseases.

1.0. Introduction

The U.S. Army Institute of Surgical Research (USAISR) Dental and Craniofacial Trauma Research and Tissue Regeneration Directorate. The goal of this study is to apply a high-resolution metagenomics strategy in conjunction with metatranscriptomics approach towards tissue specimens from chronic human wound debridement to understand the microbial ecosystem (virulence profile) present in healing-impaired wounds at the genomic and transcriptomic level.

Next, the microbial profile of these chronic wound specimens, which are classified as ulcer pressure, diabetic foot ulcer, and venous leg ulcer, will be computationally correlated with the wound etiology and other clinically relevant metadata (e.g., comorbidity). Better defining the microbial composition and genotypic profile of chronic wound residents including bacteria, fungi, and viruses (microbial metagenome) via high-throughput deep sequencing will aid in defining the molecular crosstalk and interplay between different chronic wound inhabitants that result in changes in survival, fitness, or virulence; thus providing the foundation for understanding the homeostatic state and mechanisms contributing to development of chronic wounds. Moreover, identifying the genotypic features of a diverse collection of chronic wounds can ultimately lead to novel therapeutic strategies (e.g., probiotics).

Metatranscriptomics profiling of the microbiota that reside in different types of chronic wounds will provide the mechanistic insight to better understand the functional characteristics of the human wound microbiome and its susceptibility to treatment.

1.2. Background

The U.S. Army Institute of Surgical Research (USAISR) Dental and Craniofacial Trauma Research and Tissue Regeneration Directorate has a need for Next Generation Sequencing (NGS) services using latest deep-sequencing, high-throughput, HiSeq NGS technology for whole-genome shotgun sequencing (metagenome) and RNA-sequencing (metatranscriptome) of viral, fungal and bacterial communities residing in the microbiome of major classes of chronic wounds. Prior expertise and proficiency is required to utilize the proper library prep and NGS sequencing chemistry (e.g., low-input versus high-input) for each task to generate high-quality sequenced reads with sufficient sequenced read length and coverage for statistically sound downstream computational analysis. A proficient bioinformatics group that provides expertise in assembly, annotation, and analysis of fungal, viral, and bacterial sequences is needed for the timely completion of downstream computational analyses for the different tasks described below.

1.3. Scope of Work

1.3.1. This PWS contains no services that are inherently governmental functions, as defined in FAR Part 2.1. The Government shall neither supervise contractor employees nor control the method by which the contractor performs the required tasks. Under no circumstances shall the Government assign tasks to, or prepare work schedules for, individual contractor employees. It shall be the responsibility of the contractor to manage its employees and to guard against any actions that are of the nature of personal services, or 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 Contracting Officer (KO) immediately.

2.0 Performance Requirements.

First Year of the Wound Microbiome Project

2.1 Metagenomics Study. Use the latest deep-sequencing high-throughput NGS technology, conduct whole-genome shotgun sequencing (WGS) technology to capture and characterize microbial residents of chronic wounds including fungi, bacteria, and viruses (ssDNA and dsDNA). The details of the capabilities and approaches for library preparation and NGS sequencing will be provided by the vender and discussed with ISR investigators

2.2 DNA Library Preparation

2.2.1 Offer capability and skills to utilize the appropriate strategy based on microbial DNA concentration and findings from our microbial survey data (previous study):

2.2.2 Capture DNA sequences of both ssDNA and dsDNA present in the wound metagenome; which is necessary for detection of the wound’s viral community, the virome, using technology such as the Accel-NGS 1S DNA system.

2.2.3 Capture microbial DNA present at very low concentrations as low as10pg using systems such as Accel-NGS 2S to detect rare and low abundant wound microbial residents.

2.3 Whole-metagenome sequencing

2.3.1 Use Ultra-High-throughput and deep sequencing technologies to include but not limited to the HiSeq 3000 or HiSeq 4000 sequencing systems for paired-end (PE) sequencing of chronic wound samples that provides us with sequenced reads of at least 300 million reads from a single sequencing run.

2.3.2 Any modifications or adjustments to the parameters of sequencing run will be in accordance to the microbial biodiversity and species richness of each specimen.

2.4 DNA Bioinformatics Analysis

2.4.1 Trim and filter output sequenced read files followed by reference-based and de novo assembly.

2.4.2 Remove any human DNA carryover.

2.4.3 Conduct gene prediction and annotation of assembled contigs for fungi, bacteria, and viruses.

2.4.4 Conduct comparative genomics of the fungal, viral, and bacterial sequences within and across the wound samples.

2.4.5 Conduct genotypic profiling and pathogenome characterization of the sequenced data for the presence of known genotypes or genetic features that are associated with factors including virulence, survival, and host-immune evasion.

2.4.6 Perform metagenomic-related analyses including the well-established features of Biobakery and CloVR-metagenome.

Second Year of the Microbiome Project

2.5 Metatranscriptomics Study. Capture transcripts produced by bacteria and fungi while also detecting the presence of RNA viruses. Use RNA-Seq technology to generate a total transcriptome profile (metatranscriptome) of wound specimens to investigate dynamics of gene expression, overall pathway landscape, and the metabolome profile of the wound’s microbial community. The details of the capabilities and approaches offered for library preparation and RNA-sequencing will be detailed and provided by the vender and discussed with ISR investigator.

2.6 cDNA Library Preparation

2.6.1 Develop cDNA libraries from human wound specimens that is based on factors including metagenomics findings as well as concentration of each RNA sample.

2.6.2 Deplete rRNA using yeast- and bacterial- specific kits (RiboZero rRNA Removal kit for yeast and bacteria).

2.6.3 If early RNA sequencing runs reveals significant loss of microbial RNA during mammalian RNA depletion steps, alternative library prep and sequencing approach is required to increase microbial sequencing coverage and improve downstream bioinformatics analysis.

2.6.4 SMARTer Low Input RNA system is needed for low RNA concentrations (200pg to 10ng) to capture presence of fungi, bacteria, and viral RNA transcripts from wound specimens.

2.7 RNA-Sequencing of microbiome metatranscriptome

2.7.1 Capture the total transcriptome profile of fungi, bacteria, and RNA viruses present in each wound RNA extract at ultra-high-throughput and deep sequencing coverage with at least 300 million reads per sequencing run to facilitate accurate and robust downstream sequence analysis. Such ultra-high-throughput sequencing technology may include but is not limited to the HiSeq 3000 or the HiSeq 4000 sequencing systems.

2.8 RNA Bioinformatics Analysis

2.8.1 The human RNA reads are removed using human reference genome and the remaining reads are normalized (e.g., RPKM for microbial and VPMM for viral) and assembled using the metagenomics findings for referenced assembly.

2.8.2 For RNA-based virome studies, viral reads need to undergo De novo and reference-based assembly, as applicable, followed by normalization of reads (e.g.,VPMM, viral reads per million per unique mapped reads).

2.8.3 Create a separate comprehensive gene expression profile for fungal and bacterial wound residents.

2.8.4 Characterize the metabolome and describe the pathway landscape using metabolic flux analysis (MFA), in dynamic and/or static mode, as applicable.

Deliverables. Deliverables must meet accepted industry standards and meet the requirements set forth in contractual documentation. The contractor will be responsible for delivering/accomplishing all end items specified.

Number Deliverable Title Due Date

Provide output sequenced reads (fasta, fastq, BAM) of metagenomic sequencing data in raw and processed/assembled format. Sequenced read files stored and delivered on Hard drive.

Within first year of contract

Conduct assembly, annotation, and computational analysis of metagenomics sequenced read files using tools appropriate for each sample microbial population. Figures, Stats, and results depicting the progress of sequence analysis can be shared via email.

Within first year of contract

Provide ISR investigators with finalized, polished, publication ready results and figures. The figures will present data pertaining to comparative metagenomics, genetic profiling, and microbiome characterization in appropriate formats (e.g., PDF, SVG, CSV). The analysis result files and figures will be stored and delivered on a hard drive.

Within first year of contract

Provide output of transcript reads of RNA-sequencing (fasta, fastq, BAM) in the raw and processed format that is stored and delivered on a hard drive.

Within second year of contract

05 Conduct assembly, annotation, and computational analysis of Within second year of contract the metatranscriptome sequenced read files using tools appropriate for each sample microbial population makeup.

Figures, Stats, and results depicting the progress of transcriptomic sequence analysis can be shared via email.

Provide ISR investigators with finalized, polished, publication ready results and figures. The figures will present data pertaining to comparative metatranscriptomics, metabolomics profiling, and microbiome gene expression characterization in appropriate formats (e.g., PDF, SVG, CSV). The analysis result files and figures will be stored and delivered on a hard drive.

Within second year of contract

3.0 The Government shall neither supervise contractor employees nor control the method by which the Contractor performs the required tasks. Under no circumstances shall the Government assign tasks to, or prepare work schedules for, individual Contractor employees. It shall be the responsibility of the Contractor to manage its employees and to guard against any actions that are of the nature of personal services, or 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 Contracting Officer (KO) immediately.

4.0. Government Data. The Contractor shall manage all data created for Government use or legally controlled by the Government, in support of the functional activity or required by AF publication, IAW with the records management procedures in Air Force Instruction (AFI) 33 - 322, Records Management Program, Air Force Manual (AFMAN) 33-363, Management of Records, and the Air Force Records Disposition Schedule (AF RDS) located at https://www.my.af.mil/gcss-af61a/afrims/afrims/rims.cfm.

4.1.. Reporting Requirements. The Contractor shall comply with AFI 71-101, Volume 1, Criminal Investigations and Volume-2, Protective Service Matters and AFI 31-401 (Chapter 8). Contractor shall report to Security Forces any information or circumstances which may pose a threat to DoD or Contractor personnel, resources, or DoD information.

4.2. 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 specific exception.

4.3. All products including files, software, and other information, which are created, produced or developed during the period of performance is the property of the Government and shall be returned unless the Government grants the contractor permission to retain the materials and products for continued development or publication.

4.4.The Contractor shall sign one copy of the non-disclosure statement on behalf of their company and shall also ensure that all staff including all employees, subcontractors and consultants assigned to or performing on that order execute, sign, and adhere to the terms of the following non-disclosure statement. Assignment of staff who has not executed this statement or failure to adhere to this statement shall constitute default on the part of the Contractor.

4.5. Organizational Conflicts of Interest (OIC). The USAMRMC has categorized all service procurements into one of the following three, mutually exclusive categories, regardless of the contract vehicle used to procure the services:

Category 1 - Program and/or Administrative 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 within subordinate directorates/Commands.

Category 2 - Program and/or Administrative Support. Services which assist 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. This requirement specifically excludes – Category 1 – Program and/or Administrative Support and Category 3 Product Support.

4.6. For Information Assurance (IA)/Information Technology (IT) certification. Per DoD 8570.01-M , DFARS

252.239.7001 and AR 25-2, the contractor employees supporting IA/IT functions shall be appropriately certified upon contract award. The baseline certification as stipulated in DoD 8570.01-M must be completed upon contract award.

4.6.1. The Contractor shall protect all data in the strictest confidence; prevent the unauthorized duplication, use and disclosure of information that is subject to the Privacy Act of 1974, Health Insurance Portability and Accountability Act (HIPAA) IAW applicable statutory, regulations, local policies and procedures.

4.6.2. All technical data created as a result of this CONTRACT shall be handled in accordance with DFARS

252.227-7013, DFARS 252.227-7015.

4.6.3. The Contractor is prohibited from appropriation, disclosure, or unauthorized use of proprietary information that is acquired in the execution of this CONTRACT.

4.6.4. All products including files, software, and other information, which are created, produced or developed during the period of performance is the property of the Government and shall be returned unless the Government grants the Contractor permission to retain the materials and products for continued development or publication.

4.6.5. Information Assurance

5.1. General Security Requirements. The Contractor shall establish appropriate administrative, technical, and physical safeguards to protect any and all Government data, to ensure the confidentiality, integrity, and availability of Government data. At a minimum, this shall include provisions for personnel security, electronic security and physical security as listed in the sections that follow:

5.2. Health Insurance Portability And Accountability Act (HIPAA). The Contractor shall comply with the Health Insurance Portability and Accountability Act of 1996 (HIPAA) (P.L. 104-191) requirements, specifically the administrative simplification provisions of the law and the associated rules and regulations published by the Secretary, Health and Human Services (HHS). This includes the Standards for Electronic Transactions and the Standards for Privacy of Individually Identifiable Health Information. It is expected that the Contractor shall comply with all HIPAA-related rules and regulations as they are published and as HCE requirements are defined (including security standards, identifiers for providers, employers, health plans, and individuals, and standards for claims attachment transactions).

5.2.6. Personnel Security and Information Assurance

5.2.6.1. The Contractor shall comply with DoD Directive 8500.1, Information Assurance, DoD Instruction 8500.2, Privacy Act Program Requirements (DoD 5400.11), DoD Health Information Privacy Regulation (DoD 6025.18-R) and Personnel Security Program Requirements (5200.2-R).

5.2.6.2. Contractor responsibilities for ensuring personnel security include, but are not limited to, meeting the following requirements:

a. Immediately report to the appointed COR if any Contractor employee filling a sensitive position receives an unfavorable National Agency Check (NAC) adjudication, or if information that would result in an unfavorable NAC becomes available. Notify the USAMRAA Contracting Office within five (5) working days if, at any time, a Contractor employee has privileges revoked to a DoD data or system data because of security concerns.

b. Immediately deny access to any automated information system (AIS) or network, to the Contractor employee if, at any time, the individual receives an unfavorable NAC adjudication, or if directed to do so by the appropriate government representative for security reasons.

c. Ensure that all Contractor personnel receive information assurance (AI) training before being granted access to DoD AISs or networks.

6.2.7. Electronic Security. Department of Defense Information Assurance Certification and Accreditation Process (DIACAP). The Contractor shall acquire, develop and maintain the DIACAP documentation to ensure both initial and continued DIACAP for all Contractor systems and networks with a physical or logical connection to a DIACAP certified network. The Contractor shall also put in place processes that provide and ensure an acceptable level of security protection for any Contractor Owned, Contractor Operated – includes outsourced IT services networks that process DoD-owned Sensitive Informations (ISs) and DoD-controlled ISs. These requirements are further defined in DoD Instruction (DoDI) 8510.01, DIACAP dated 28 November 2007 (http://www.dtic.mil/whs/directives/corres/pdf/851001p.pdf).

6.2.8. Public Key Infrastructure and Encryption. The Contractor shall follow the DoD standards, policies, and procedures for the use of Public Key Infrastructure (PKI) certificates and biometrics for positive authentication.

Where interoperable PKI is required for the exchange of unclassified information between DoD and its vendors and Contractors, industry partners shall obtain all necessary certificates. The Contractor must turn over to the Government all encryption keys for deployed systems, backdoor algorithms, and procedures for their use in remote support. The Contractor must provide a written report detailing all of the above, prior to TASK ORDER expiration, regardless of modifications or extensions.

6.2.9. Information Systems (IS)/Networks Physical Security. The Contractor shall employ physical security safeguards for IS/Networks involved in processing or storage of Government Data to prevent the unauthorized access, disclosure, modification, destruction, use, etc., and to otherwise protect the confidentiality and ensure use conforms with DoD regulations.

7.0 Contractor Manpower Reporting

"The contractor shall report ALL contractor labor hours (including subcontractor labor hours) required for performance of services provided under this contract for the US Army Institute of Surgical Research via a secure data collection site. The contractor is required to completely fill in all required data fields using the following web address: http://www.ecmra.mil/ Reporting inputs will be for the labor executed during the period of performance during each Government fiscal year (FY), which runs October 1 through September 30. While inputs may be reported any time during the FY, all data shall be reported no later than October 31 of each calendar year, beginning with 2016. Contractors may direct questions to the Help Desk at at http://www.ecmra.mil.

GOV POCS

Contracting Officer (KO) (Authorized official to bind the Government in Contracts) http://www.ecmra.mil/ http://www.ecmra.mil/

U.S. Army Medical Research Acquisition Activity (USAMRAA) ATTN: MCMR-AAA-SE (Mr. David A Rader) Contracting Officer 820 Chandler Street Fort Detrick, MD 21702-5014 Email: david.a.rader2.civ@mail.mil

Contract Administrative Information Contact (AIC):

Mr. David R. Daniel Contract Specialist US Army Medical Research Acquisition Activity (USAMRAA) 820 Chandler Street Fort Detrick, MD 21702-5014 Phone: 301-619-2845 Email: david.r.daniel27.civ@mail.mil

ADMINISTRATIVE INSTRUCTIONS

Contractor Performance Assessment Reporting System (CPARS)

A CPAR assesses a contractor's performance and provides a record, both positive and negative, on a given contractor during a specific period of time. Each assessment is based on objective facts and supported by program and contract management data, such as cost performance reports, customer comments, quality reviews, technical interchange meetings, financial solvency assessments, construction/production management reviews, contractor operations reviews, functional performance evaluations, and earned contract incentives. Performance evaluations are transmitted into the Past Performance Information Retrieval System (PPIRS) which is used by government agencies to assess contractor past performance for future acquisitions. The contractor shall appoint a Contractor Representative (CR) and provide this information to the Contracting Officer (KO) within 10 calendar days of award.

The contractor POC shall have the authority to comment on the CPAR assessment on behalf of their company and within the timeframes established.

A CPARS assessment must be completed within 120 calendar days after the evaluation. Evaluations are sent to PPIRS within 14 calendar days after the government Assessing Official (AO) has submitted the rating. If the CR has not concurred/non-concurred with the rating; PPIRS will show the government evaluation as “Contractor Comment Pending Review”. The CR has a total of 60 calendar days to concur/non-concur with the assessment. After 60 days, the CR can either concur/non-cur. The CR has the authority to: access the Government evaluation;

review/comment/concur or non-concur with the assessment within 60 calendar days after notification of the government’s assessment. The CR has the right to request a meeting (in writing) with the government within 7 calendar days of notification of an assessment. Once the government and the CR complete the evaluation; an automatic update will be sent to PPIRS and visible for Source Selection. If the CR fails to respond within 60 days, the assessment will be finalized. Training for CPARS can be found on the CPARS website:

https://www.cpars.gov/index.htm.

To access CPARS, the contractor must have a Public Key Infrastructure (PKI). It is suggested an ECA certificate of Medium Assurance should be purchased. This should be a Department of Defense identity certificate, not an e-mail certificate.

EXHIBIT / ATTACHMENT TABLE

Exhibit/Attachment Table of Contents:

Document Type Description Pages Date mailto:david.a.rader2.civ@mail.mil mailto:david.r.daniel27.civ@mail.mil

Attachment 1 Organizational Conflicts of Interest 3 30 November 2016 Attachment 2 Non-Disclosure Statement 1 30 November 2016 Attachment 3 Quality Assurance Surveillance Plan (QASP) 4 30 November 2016 Attachment 4 Wage Determination Attachment 1 30 November 2016 Attachment 5 Pricing Sheet 1 30 November 2016

INSTRUCTIONS TO OFFERORS

INSTRUCTIONS TO OFFEROR

L.1. PROPOSAL SUBMISSION INSTRUCTIONS.

L.1.1. POINT OF CONTACT (POC): David R. Daniel at david.r.daniel27.civ@mail.mil . Due to the difficulties in receipt of mail through normal postal services, questions and proposals shall be sent via E-mail to the POC for RFP. The Offeror is responsible for ensuring receipt by the POC.

L.1.2. PROPOSAL QUESTIONS: Questions and Comments may be submitted to the POC via email No Later Than 28 February 2017 at 1:00 PM Eastern Standard Time (EST). Follow-up/additional questions will not be accepted after this date unless deemed in the best interest of the government.

L.1.3. PROPOSAL DUE DATE: No Later Than 08 March 2017 at 1:00 PM Eastern Standard Time.

L.1.4. ELECTRONIC SUBMISSION: Proposals shall be electronically submitted to the POC above. Your submission should include two separate parts: a Price proposal and a Non-Price proposal. The Non-Price proposal shall be submitted in MS Word or searchable PDF format. The price proposal shall be submitted in MS Excel 2000 or higher, but not greater than MS Excel 2007 format. The firewall utilized by the Government contracting office does not authorize or accept zip files.

L.2. PROPOSAL CONTENT AND FORMAT INSTRUCTIONS.

The Offeror’s submission shall include two separate parts: a Price proposal and a Non-Price proposal.

L.3. ADMINISTRATIVE FORMAT INSTRUCTIONS:

L.3.1. PAGE LIMITS: Non- price proposals are limited to 20 single-sided pages. Pages should be numbered consecutively throughout the document and not by sections. For any sections of a proposal with a defined page limit, pages exceeding the specified limit will be removed and not forwarded for evaluation. The following sections are not subject to page limits:

• Table of Contents

• Title page

• Exhibit Table of Contents

• Contractor POC Cover Page,

• Quality Control Plan (QCP),

• OCI Certification

• Non-Disclosure Statement

• Resumes or Curriculum Vitae

L.3.2. FORMATTING: Proposal content shall be no smaller than Times New Roman font 12 pitch.

Exhibits, graphics, charts, captions, etc., shall be no smaller than 10 pitch.

mailto:david.r.daniel27.civ@mail.mil

L.3.3. PROPOSAL’S VOLUMES: Proposals shall be submitted in two separate volumes. One is for non-price proposal and one is for cost/price proposal.

L.4.1 NON- PRICE PROPOSAL CONTENT INSTRUCTIONS: The Offeror’s non- price proposal shall not mention cost/price. Proposal shall clearly reflect the Offeror’s approach to execute and comply with the performance requirements identified in the PWS, regardless of the Government’s estimated effort. Your non-price proposal, including any supporting documentation, should be clear and concise. The level of effort proposed must be consistent with the proposed solution outlined in your non-price proposal. The proposal must fully document and substantiate a cross mapping of your cost/price approach as it equates to the non- price proposal. If you intend to use any labor categories that you feel are consistent in duties with the level of effort labor categories but are titled differently, in accordance with your cost accounting procedures, you must cross map those labor categories to the Government’s PWS to ensure your proposal receives a proper evaluation. Any use of subject matter experts or other labor categories shall be explained in full as to why the suggested labor category is impractical to use or the proposal shall be deemed noncompliant. All items should be addressed in the evaluation criteria.

The Offeror’s non-price proposal shall contain the following:

Factor 1 - Technical Approach

Factor 2 – Past Performance

Factor 3 – Price

L.4.1.1 Technical Approach – The Offeror’s proposal shall demonstrate an understanding of the PWS and of the functional and technical tasks to be performed. The Offeror’s proposal shall state how the proposed Technical Approach will yield the required results as stated in the request for proposal’s required time frame. The Offeror should discuss the methodology and flexibility that will be used in performing the requirements.

L.4.1.2 Past Performance – The Offeror, as the prime, shall submit NO MORE THAN three (3) past performance references of relevant CONTRACTS in scope, magnitude of effort, and complexities with this requirement. The Offeror shall also submit NO MORE THAN one (1) reference for each subcontractor proposed as defined in L.4.3.1.3. below. The CONTRACTS may be past or current as long as the recent performance did not end more than three (3) years prior to the due date for the submission of the Offeror’s proposal, and the referenced CONTRACTS may have been with Federal, State, or City agencies and commercial customers.

L.4.1.2.1. Offerors are reminded the Government may elect to consider data obtained from other sources.

Other sources available to the Government include, but are not limited to, the Past Performance Information Retrieval System (PPIRS), Federal Awardee Performance and Integrity Information System (FAPIIS), and Contractor Performance Assessment Reporting System (CPARS) and interviews with Program Mangers and Contracting Officers. The Government may elect to obtain past performance information from questionnaires tailored to the circumstances of this requirement. The burden of demonstrating relevancy of the past performance rests with the Offeror.

L.4.1.2.2. The Offeror shall provide a Past Performance Narrative that discusses the Offeror’s ability to perform all the requirements identified in the PWS. The narrative shall include the following information:

(1) Customer's name, address and current telephone number and e-mail address provided for one (1) point of contact.

(2) Contract number, type and total original and present or final CONTRACT value.

(3) Date of CONTRACT, place(s) of performance, and period of performance.

(4) Brief description of CONTRACT work and comparability to the proposed effort. It is not sufficient to state that it is comparable in magnitude and scope. Rationale must be provided to demonstrate that it is comparable as set forth above.

(5) Method of acquisition: competitive or noncompetitive.

(6) Discuss any major technical problems and how they were overcome. List major deviations or waivers to technical requirements granted by the customer.

(7) Whether delivery was on time and, if not, why; adherence to program schedules, incentive performance

(e.g., schedule and technical) history, if applicable.

(8) Cost and price management history, cost overruns and underruns, and cost and price increase modifications and the reasons, if applicable.

(9) List any CONTRACTS cancelled or terminated (partial or complete) within the past five (5) years and basis for termination (convenience or default). Include the CONTRACT number, name, address and telephone number of the terminating Contracting Officer. Include CONTRACTS “descoped" by the customer because of performance or cost problems.

(10) Average number of personnel on the CONTRACT per year and the percent turnover of personnel per year.

L.4.1.2.3. If the Offeror proposes to use subcontractors/teaming arrangements to perform 30 percent or more of the scope and objectives of this requirement, the Offeror is to provide the above information for each of the subcontractors/teaming arrangements. The Offeror must address this item in sufficient detail to evidence an understanding of the requirement and identify the Offeror’s plan and approach to meet key performance requirements.

L.4.2 PRICE PROPOSAL

L.4.2.1. Offeror shall submit the following:

L.4.2.2. The Offeror shall complete Exhibit 1 Pricing Sheet and the customer shall provide any further information they feel necessary to explain how they came up with their proposed pricing for this requirement.

L.4.2.3. All percentages and rates shall be rounded to two decimal places. The Offeror shall ensure any mathematical computations are correct. Errors in addition or multiplication may be considered a reason to be removed from consideration for award.

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 N/A N/A N/A Government 1001 N/A N/A N/A Government 1002 N/A N/A N/A Government

DELIVERY INFORMATION

CLIN DELIVERY DATE QUANTITY SHIP TO ADDRESS DODAAC

0001 N/A N/A N/A N/A

0002 N/A N/A N/A N/A

1001 N/A N/A N/A N/A

1002 N/A N/A N/A N/A

CLAUSES INCORPORATED BY REFERENCE

52.202-1 Definitions NOV 2013 52.203-3 Gratuities APR 1984 52.203-6 Restrictions On Subcontractor Sales To The Government SEP 2006 52.203-6 Alt I Restrictions On Subcontractor Sales To The Government

(Sep 2006) -- Alternate I

OCT 1995

52.203-12 Limitation On Payments To Influence Certain Federal Transactions

OCT 2010

52.203-17 Contractor Employee Whistleblower Rights and Requirement To Inform Employees of Whistleblower Rights

APR 2014

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

MAY 2011

52.204-7 System for Award Management OCT 2016 52.204-13 System for Award Management Maintenance OCT 2016 52.204-16 Commercial and Government Entity Code Reporting JUL 2016 52.204-18 Commercial and Government Entity Code Maintenance JUL 2016 52.204-19 Incorporation by Reference of Representations and

Certifications.

DEC 2014

52.209-6 Protecting the Government's Interest When Subcontracting With Contractors Debarred, Suspended, or Proposed for Debarment

OCT 2015

52.209-10 Prohibition on Contracting With Inverted Domestic Corporations

NOV 2015

52.212-1 Instructions to Offerors--Commercial Items JAN 2017 52.212-4 Contract Terms and Conditions--Commercial Items JAN 2017 52.217-5 Evaluation Of Options JUL 1990 52.222-21 Prohibition Of Segregated Facilities APR 2015 52.222-26 Equal Opportunity SEP 2016 52.222-34 Project Labor Agreement MAY 2010 52.222-34 Alt I Project Labor Agreement (May 2010) Alternate I MAY 2010 52.222-35 Equal Opportunity for Veterans OCT 2015 52.222-36 Equal Opportunity for Workers with Disabilities JUL 2014 52.222-37 Employment Reports on Veterans FEB 2016 52.222-40 Notification of Employee Rights Under the National Labor

Relations Act

DEC 2010

52.222-41 Service Contract Labor Standards MAY 2014 52.222-43 Fair Labor Standards Act And Service Contract Labor

Standards - Price Adjustment (Multiple Year And Option Contracts)

MAY 2014

52.222-44 Fair Labor Standards And Service Contract Labor Standards- Price Adjustment

MAY 2014

52.222-50 Combating Trafficking in Persons MAR 2015 52.222-55 Minimum Wages Under Executive Order 13658 DEC 2015 52.223-18 Encouraging Contractor Policies To Ban Text Messaging

While Driving

AUG 2011

52.225-1 Buy American--Supplies MAY 2014 52.225-13 Restrictions on Certain Foreign Purchases JUN 2008 52.227-14 Rights in Data--General MAY 2014 52.232-2 Payments Under Fixed-Price Research And Development

Contracts

APR 1984

52.232-8 Discounts For Prompt Payment FEB 2002 52.232-11 Extras APR 1984 52.232-17 Interest MAY 2014 52.232-24 Prohibition of Assignment of Claims MAY 2014 52.232-25 Prompt Payment JAN 2017 52.232-33 Payment by Electronic Funds Transfer--System for Award

Management

JUL 2013

52.232-39 Unenforceability of Unauthorized Obligations JUN 2013 52.232-40 Providing Accelerated Payments to Small Business

Subcontractors

DEC 2013

52.233-1 Disputes MAY 2014 52.233-3 Protest After Award AUG 1996 52.233-4 Applicable Law for Breach of Contract Claim OCT 2004 52.242-13 Bankruptcy JUL 1995 52.242-15 Stop-Work Order AUG 1989 52.243-1 Alt V Changes--Fixed-Price (Aug 1987) - Alternate V APR 1984 52.244-5 Competition In Subcontracting DEC 1996 52.246-4 Inspection Of Services--Fixed Price AUG 1996 52.246-9 Inspection Of Research And Development (Short Form) APR 1984 52.246-16 Responsibility For Supplies APR 1984 52.246-25 Limitation Of Liability--Services FEB 1997 52.247-17 Charges APR 1984 52.247-27 Contract Not Affected by Oral Agreement APR 1984 52.249-4 Termination For Convenience Of The Government (Services)

(Short Form)

APR 1984

52.249-5 Termination For Convenience Of The Government (Educational And Other Nonprofit Institutions)

AUG 2016

52.249-8 Default (Fixed-Price Supply & Service) APR 1984

52.249-9 Default (Fixed-Priced Research And Development) APR 1984 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

252.204-0001 Line Item Specific: Single Funding SEP 2009 252.204-7000 Disclosure Of Information OCT 2016 252.204-7003 Control Of Government Personnel Work Product APR 1992 252.204-7004 Alt A System for Award Management Alternate A FEB 2014 252.204-7006 Billing Instructions OCT 2005 252.204-7008 Compliance With Safeguarding Covered Defense Information

Controls

OCT 2016

252.204-7012 Safeguarding Covered Defense Information and Cyber Incident Reporting

OCT 2016

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

MAY 2016

252.209-7004 Subcontracting With Firms That Are Owned or Controlled By The Government of a Country that is a State Sponsor of Terrorism

OCT 2015

252.215-7007 Notice of Intent to Resolicit JUN 2012 252.215-7008 Only One Offer OCT 2013 252.225-7012 Preference For Certain Domestic Commodities DEC 2016 252.225-7048 Export-Controlled Items JUN 2013 252.227-7022 Government Rights (Unlimited) MAR 1979 252.232-7003 Electronic Submission of Payment Requests and Receiving

Reports

JUN 2012

252.232-7010 Levies on Contract Payments DEC 2006 252.235-7011 Final Scientific or Technical Report JAN 2015 252.237-7010 Prohibition on Interrogation of Detainees by Contractor

Personnel

JUN 2013

252.243-7001 Pricing Of Contract Modifications DEC 1991 252.243-7002 Requests for Equitable Adjustment DEC 2012 252.244-7000 Subcontracts for Commercial Items JUN 2013

CLAUSES INCORPORATED BY FULL TEXT

52.204-8 ANNUAL REPRESENTATIONS AND CERTIFICATIONS (JAN 2017)

(a)(1) The North American Industry Classification System (NAICS) code for this acquisition is 541712.

(2) The small business size standard is 1,000.

(3) The small business size standard for a concern which submits an offer in its own name, other than on a construction or service contract, but which proposes to furnish a product which it did not itself manufacture, is 500 employees.

(b)(1) If the provision at 52.204-7, System for Award Management, is included in this solicitation, paragraph (d) of this provision applies.

(2) If the provision at 52.204-7 is not included in this solicitation, and the offeror is currently registered in System for Award Management (SAM), and has completed the Representations and Certifications section of SAM electronically, the offeror may choose to use paragraph (d) of this provision instead of completing the corresponding individual representations and certifications in the solicitation. The offeror shall indicate which option applies by checking one of the following boxes:

( ) Paragraph (d) applies.

( ) Paragraph (d) does not apply and the offeror has completed the individual representations and certifications in the solicitation.

(c) (1) The following representations or certifications in SAM are applicable to this solicitation as indicated:

(i) 52.203-2, Certificate of Independent Price Determination. This provision applies to solicitations when a firm-fixed-price contract or fixed-price contract with economic price adjustment is contemplated, unless—

(A) The acquisition is to be made under the simplified acquisition procedures in Part 13;

(B) The solicitation is a request for technical proposals under two-step sealed bidding procedures; or

(C) The solicitation is for utility services for which rates are set by law or regulation.

(ii) 52.203-11, Certification and Disclosure Regarding Payments to Influence Certain Federal Transactions. This provision applies to solicitations expected to exceed $150,000.

(iii) 52.203-18, Prohibition on Contracting with Entities that Require Certain Internal Confidentiality Agreements or Statements--Representation. This provision applies to all solicitations.

(iv) 52.204-3, Taxpayer Identification. This provision applies to solicitations that do not include the provision at 52.204-7, System for Award Management.

(v) 52.204-5, Women-Owned Business (Other Than Small Business). This provision applies to solicitations that—

(A) Are not set aside for small business concerns;

(B) Exceed the simplified acquisition threshold; and

(C) Are for contracts that will be performed in the United States or its outlying areas.

(vi) 52.209-2; Prohibition on Contracting with Inverted Domestic Corporations--Representation.

(vii) 52.209-5; Certification Regarding Responsibility Matters. This provision applies to solicitations where the contract value is expected to exceed the simplified acquisition threshold.

(viii) 52.209-11, Representation by Corporations Regarding elinquent Tax Liability or a Felony Conviction under any Federal Law. This provision applies to all solicitations.

(ix) 52.214-14, Place of Performance--Sealed Bidding. This provision applies to invitations for bids except those in which the place of performance is specified by the Government.

(x) 52.215-6, Place of Performance. This provision applies to solicitations unless the place of performance is specified by the Government.

(xi) 52.219-1, Small Business Program Representations (Basic & Alternate I). This provision applies to solicitations when the contract will be performed in the United States or its outlying areas.

(A) The basic provision applies when the solicitations are issued by other than DoD, NASA, and the Coast Guard.

(B) The provision with its Alternate I applies to solicitations issued by DoD, NASA, or the Coast Guard.

(xii) 52.219-2, Equal Low Bids. This provision applies to solicitations when contracting by sealed bidding and the contract will be performed in the United States or its outlying areas.

(xiii) 52.222-22, Previous Contracts and Compliance Reports. This provision applies to solicitations that include the clause at 52.222-26, Equal Opportunity.

(xiv) 52.222-25, Affirmative Action Compliance. This provision applies to solicitations, other than those for construction, when the solicitation includes the clause at 52.222-26, Equal Opportunity.

(xv) 52.222-38, Compliance with Veterans' Employment Reporting Requirements. This provision applies to solicitations when it is anticipated the contract award will exceed the simplified acquisition threshold and the contract is not for acquisition of commercial items.

(xvi) 52.222-57, Representation Regarding Compliance with Labor Laws (Executive Order 13673). This provision applies to solicitations expected to exceed $50 million which are issued from October 25, 2016 through April 24, 2017, and solicitations expected to exceed $500,000, which…