RFI_Attachment.docx

Contents

STATEMENT OF WORK

MILITARY MALARIA RESEARCH PROGRAM

TRIAZINE DRUG MANUFACTURING SERVICES

Title: Triazine Drug Manufacturing

Requiring Activity Name: Walter Reed Army Institute of Research (WRAIR)

1. BACKGROUND

The Experimental Therapeutics (ET) Branch of the Walter Reed Army Institute of Research (WRAIR) focuses on the development of new drugs to prevent and treat malaria, leishmaniasis, antibiotic-resistant bacteria, and other infectious disease threats to US Service members. The ET branch is currently developing anti-malarial drugs to address current and projected unmet medical needs (requirements). Technical

2. SCOPE

The scope of work includes all activities required for current Good Manufacturing Practices (cGMP) compliant synthesis, formulation, fill/finish, and analytical testing of one selected triazine anti-malarial agent. The selected vendor will be responsible for the following: development of the synthetic method of a triazine compound API and placebo, formulation and packaging of capsules (optional: alternate solid dosage form) for oral administration in clinical testing, and investigational product release and stability testing (to include analytical method validation). Each stage of the project will be performed through collaborative interaction with the WRAIR Integrated Product Team (IPT) scientists.

The selected vendor must comply with all applicable cGMP and other regulations, and ensure it has adequate resources and staffing to complete the project. Quantities of bulk drug substances (BDS) and drug products listed in the following tasks are current estimates. These quantities will be adjusted as development proceeds based on preclinical, clinical, and manufacturing and testing data and FDA requirements for preclinical, clinical, and chemistry, manufacturing, and controls (CMC)-related testing. Specific technical requirements and deliverables will be listed in the Specific Requirements and Deliverables sections of this SOW.

3. OBJECTIVES

The primary objective of this requirement is to successfully manufacture, label, package, and test a triazine compound in accordance with the manufacturing process, product specification, and analytical test methods specified under each of the following tasks:

Task 1 – Final Quality Agreement/Plan with WRAIR and USAMMDA

Task 2 – Analytical Test Methods

Task 3 – Phase 1 & 2a Manufacture BDS, formulated into capsules for oral dosing Manufacture a placebo BDS, formulated into capsules for oral dosing Shipping & Storage

Task 4 – (Optional) Phase 2b Manufacture BDS, formulated into capsules for oral dosing Manufacture a placebo BDS, formulated into capsules for oral dosing Shipping & Storage

Task 5 – (Optional) Phase 3 Manufacture BDS, formulated into capsules for oral dosing Manufacture a placebo BDS, formulated into capsules for oral dosing Shipping & Storage

Task 6 – (Optional) Formulation of triazine and placebo BDS into an alternate solid oral dosage form.

Shipping & Storage

Task 7 – Technical Data Package (TDP)

Task 8 – eCTD-compliant Module 2 summaries and Module 3 Quality sections

4. PERIOD OF PERFORMANCE

The period of performance is 15 June 2017- 14 June 2019.

This requirement will include a base period of two (2) years for Phase 1 & 2a followed by optional tasks with the following period of performances:

(Optional) Phase 2b- One (1) year (Optional) Phase 3- Two (2) years (Optional) Task 6- Six (6) months

5. REQUIRED TASKS

5.1. Task 1 - Quality Control Plan with WRAIR and USAMMDA (Deliverable 1)

The contractor shall establish a final Quality Control Plan with WRAIR and USAMMDA that outlines roles and responsibilities of the Quality components of each organization, and the Quality standards to which the contractor will adhere. This agreement will include timeframes for receipt of contract deliverables.

5.2. Task 2 - Analytical Test Methods (Deliverable 11)

The contractor shall develop and validate analytical test methods to determine purity, related substances, and strength per the FDA Guidance for Industry “Analytical Procedures and Methods Validation for Drugs and Biologics” and the International Conference on Harmonisation (ICH) guidance 28 Q2(R1) Validation of Analytical Procedures: Text and Methodology (Q2(R1)) for developing and validating analytical methods.

5.3. Task 3 – Phase 1 & 2a (Deliverables 3 and 4)

5.3.1. Manufacture BDS

The contractor shall manufacture BDS to support IND-enabling preclinical and Phase 1 and 2a clinical testing, fill into capsules (at a strength to be determined based on preclinical and clinical data), label, package and test under 21CFR312 and cGMP regulations 21CFR210 & 211 following already established Master Batch Production Records and validated analytical testing methods. The actual quantity will be determined and finalized based on preclinical, clinical, manufacturing and testing data resulting from previous phases. Product release test methods, specifications and required stability testing schedules are provided in Tables A, B, C, and D respectively under Attachment B— Technical Specifications for Specific Requirements.

5.3.2. Manufacture a placebo BDS

The contractor shall manufacture a placebo BDS, to support Phase 1 and 2a clinical testing, fill into capsules, label, package and test under 21CFR312 and cGMP regulations 21CFR210 & 211 following established Master Batch Production Records and validated analytical testing methods. The actual quantity will be determined and finalized based on preclinical, clinical, manufacturing and testing data resulting from previous phases and will be the same amount as Task 5.3.1. Product release test methods, specifications and required stability will be determined after the formulation of an acceptable placebo has been agreed upon. The placebo will be used in a blinded study; therefore the capsule used during fill/finish will need to be identical to the capsule used to fill/finish the triazine final drug product.

5.3.3. Shipping & Storage

The contractor shall provide cGMP storage of all product samples retained at the manufacturing site and/or testing laboratory, and provide cGMP-compliant refrigerated shipping of drug products to the Government’s storage facility in Rockville, MD.

5.4. Task 4 – (Optional) Phase 2b (Deliverables 3 and 4)

5.4.1. Manufacture BDS

The contractor shall manufacture BDS to support further preclinical testing and/or Phase 2b clinical testing, fill into capsules (at a strength to be determined based on preclinical and clinical data), label, package and test under 21CFR312 and cGMP regulations 21CFR210 & 211 following already established Master Batch Production Records and validated analytical testing methods. The actual quantity will be determined and finalized based on preclinical, clinical, manufacturing and testing data resulting from previous phases. Product release test methods, specifications and required stability testing schedules are provided in Tables A, B, C, and D respectively under Attachment B— Technical Specifications for Specific Requirements.

5.4.2 Manufacture a placebo BDS

The contractor shall manufacture a placebo BDS, to support Phase 2b clinical testing, fill into capsules, label, package, and test under 21CFR312 and cGMP regulations 21CFR210 & 211 following established Master Batch Production Records and validated analytical testing methods. The actual quantity will be determined and finalized based on preclinical, clinical, manufacturing and testing data resulting from previous phases and will be the same amount as Task 5.4.1. Product release test methods, specifications and required stability will be determined after the formulation of an acceptable placebo has been agreed upon. The placebo will be used in a blinded study; therefore the capsule used during fill/finish will need to be identical to the capsule used to fill/finish the triazine final drug product.

5.4.3 Shipping & Storage

The contractor shall provide cGMP storage of all product samples retained at the manufacturing site and/or testing laboratory, and provide cGMP-compliant refrigerated shipping of drug products to the Government’s storage facility in Rockville, MD.

5.5. Task 5 - (Optional) Phase 3 (Deliverables 3 and 4)

5.5.1. Manufacture BDS

The contractor shall manufacture BDS to support Phase 3 clinical testing and a New Drug Application (NDA) submission to FDA, fill into capsules (at a strength to be determined based on preclinical and clinical data), label, package and test under 21CFR312 and cGMP regulations 21CFR210 & 211 following already established Master Batch Production Records and validated analytical testing methods. The actual quantity will be determined and finalized based on preclinical, clinical, manufacturing and testing data resulting from previous phases. Product release test methods, specifications and required stability testing schedules are provided in Tables A, B, C, and D respectively under Attachment B— Technical Specifications for Specific Requirements.

5.5.2. Manufacture a placebo BDS

The contractor shall manufacture a placebo BDS, to support Phase 3 clinical testing, fill into capsules, label, package and test under 21CFR312 and cGMP regulations 21CFR210 & 211 following established Master Batch Production Records and validated analytical testing methods. The actual quantity will be determined and finalized based on preclinical, clinical, manufacturing and testing data resulting from previous phases and will be the same amount as Task 5.5.1. Product release test methods, specifications and required stability will be determined after the formulation of an acceptable placebo has been agreed upon. The placebo will be used in a blinded study; therefore the capsule used during fill/finish will need to be identical to the capsule used to fill/finish the triazine final drug product.

5.5.3. Shipping & Storage

The contractor shall provide cGMP storage of all product samples retained at the manufacturing site and/or testing laboratory, and provide cGMP-compliant refrigerated shipping of drug products to the Government’s storage facility in Rockville, MD.

5.6. Task 6 - (Optional) Formulation of triazine and placebo BDS into an alternate solid oral dosage form. (Deliverables 3 and 4)

The contractor shall formulate the triazine and placebo BDS into an alternate solid oral dosage form (e.g. tablets or caplets), should clinical and/or stability testing indicate that the capsule is not optimal to meet Army requirements. BDS will be formulated into oral dosage (actual quantity and strength will be determined based on previous testing data), labeled, packaged and tested under 21CFR312 and cGMP regulations 21CFR210 & 211 following already established Master Batch Production Records and validated analytical testing methods. Product release test methods, specifications and required stability testing schedules are provided in Tables A, B, C, and D respectively under Attachment B— Technical Specifications for Specific Requirements. The placebo tablets or caplets will be used in blinded clinical studies; therefore the placebo final drug product will need to be identical to the triazine final drug product. The actual quantity will be determined and finalized based on preclinical, clinical, manufacturing and testing data resulting from previous phases

5.6.1 Shipping & Storage

The contractor shall provide cGMP storage of all product samples retained at the manufacturing site and/or testing laboratory, and provide cGMP-compliant refrigerated shipping of drug products to the Government’s storage facility in Rockville, MD.

5.7. Task 7 - Technical Data Package (TDP) (Deliverables 2, 5, 6, 7, 8, 9, 10, 11, and 12)

In order to support assembly and participate in writing of Module 3 (Chemistry, Manufacturing, and Controls) of the Investigational Drug Application (IND) to the US FDA, the contractor shall prepare and maintain currency of a Technical Data Package (TDP) that includes all necessary documentation and technical data and reports collected and prepared during each phase of the development effort funded by the Government. The TDP shall contain, but is not limited to the following documents:

· Master production records (Deliverables 7 & 8 )

· Batch production records (Deliverable 5)

· Stability study protocol and data reports (Deliverable 10)

· Certificates of analysis of raw materials and finished products (Deliverable 9)

· Testing methods

· Validation protocols and data reports (Deliverable 11)

· Shipping documentation (Deliverable 12)

· Out of specification (OOS) results/OOS investigations

· Necessary Standard Operating Procedures (SOPs) (Deliverable 2)

· Environmental assessments

5.8. Task 8 - eCTD-compliant Module 2 summaries and Module 3 Quality sections (Milestone 1)

The contractor shall assist in writing eCTD-compliant Module 2 summaries and Module 3 Quality sections for 2 Bulk Drug Substances and 2 Final Drug Products using USAMMDA-provided templates, AMA (10th ed) style manual, and the USAMMDA electronic document management system.

6. DELIVERABLES

The contractor shall complete and submit deliverables in accordance with the “Deliverables Table.” All deliverables should comply with regulatory or other authority listed, in order to allow inclusion in regulatory submissions to the US FDA. Documentation deliverables are to be provided to the COR in an electronic format compatible with incorporation and appropriate annotation in the Electronic Common Technical Document (eCTD).

DELIVERABLES TABLE

6.1. 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.

6.2. Acceptance Criteria

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

7. 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).

5.3, 5.4, 5.5, 5.6

8. QUALITY CONTROL

The Contractor shall prepare and adhere to a Quality Control Plan (QCP) (Deliverable 1). The final QCP will be submitted upon award. The QCP shall document how the Contractor will meet and comply with the requirements and performance objectives. At a minimum, the QCP must include a self-inspection plan, an internal staffing plan, and an outline of the procedures that the Contractor will use to maintain quality, timeliness, responsiveness, and customer satisfaction

9. WORK SCHEDULE AND LOCATION

All work associated with this effort shall be performed and completed at the contractor’s facility.

9.1. Federal Holidays

The following are Federal Holidays:

· New Year’s Day

· Birthday of Martin Luther King, Jr.

· Washington’s Birthday

· Memorial Day

· Independence Day

· Labor Day

· Columbus Day

· Veterans Day

· Thanksgiving Day

· Christmas Day

10. COMPLIANCE DOCUMENTS

10.1. General Compliance

10.1.1. 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 Research and Material Command (USAMRMC) 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 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.

10.1.2. DoD Compliance Documents

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

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

a) Army Regulation 340-21, Army Privacy Program. http://www.army.mil/usapa/epubs/340_Series_Collection_1.html

b) Army Regulation 25-1, Information Technology. http://armyhpubs.army.mil/epubs/25_Series_Collection_1.html

c) Army Regulation 25-2, Information Assurance.

d) Department of Defense (DoD) Instruction 3216.02, Protection of Human Subjects and Adherence to Ethical Standards in DoD-Supported Research, dated November 2011. http://www.dtic.mil/whs/directives/corres/pdf/321602p.pdf

e) Department of Defense (DOD) 6025.18 Regulation, DOD Health Information Privacy Regulation, 24 January 2003.

f) DOD Instruction 3210.7, Research Integrity and Misconduct, 14 May 2004.

g) Department of Defense (DOD) Instruction 8500.01 Cybersecurity

h) Department of Defense (DOD) Instruction 8510.01 Risk Management Framework (RMF) For DOD Information Technology (IT Department of Defense (DoD) Instructions 5400.11-R, Privacy Program http://www.dtic.mil/whs/directives/corres/pdf/540011p.pdf

i) Army Regulation (AR) 70-25: Use of Volunteers as Subjects of Research, Headquarters, Department of the Army, dated 25 January 1990 – currently under revision

j) Clinical Laboratory Improvement Amendments, 2013. https://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/CLIA_Regulations_and_Federal_Register_Documents.html. Specific guidance: http://www.ecfr.gov/cgi-bin/text-idx?SID=1248e3189da5e5f936e55315402bc38b&node=pt42.5.493&rgn=div5

k) Clinical Laboratory Improvement Program (CLIP) Manual, May 29, 2014. http://www.dtic.mil/whs/directives/corres/pdf/64402m.pdf (this document is codified Title 42 Part 493 under Memorandum of Agreement between the US Department of Defense and Health and Human Services.

l) College of American Pathologists Inspection Checklists. http://www.cap.org

m) Clinical Laboratory Standards Institute. Standards and Guides for Laboratories: http://clsi.org/standards

n) Title 42 Part 493 Laboratory Requirements, 1 October 2011 https://www.gpo.gov/fdsys/granule/CFR-2011-title42-vol5/CFR-2011-title42-vol5-part493/content-detail.html

o) National Institutes of Allergy and Infectious Diseases, DAIDS Guidelines for Good Clinical Laboratory Practice Standards, https://www.niaid.nih.gov/LabsAndResources/resources/DAIDSClinRsrch/Documents/gclp.pdf

p) ICH Guideline for Good Clinical Practice, Consolidated Practice (E6) http://www.ich.org/products/guidelines/efficacy/efficacy-single/article/good-clinical-practice.html

q) Title 21, CFR Part 11 Electronic Records: Electronic Signature. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=11

r) Title 21, CFR Part 50 Protection of Human Subjects https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?CFRPart=50&showFR=1

s) Title 21 CFR Part 54 Financial Disclosure by Clinical Investigators https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=54

t) Title 21 CFR Part 56, Institutional Review Boards https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=56

u) Title 21 CFR Part 812, Investigational Device Exemptions, April 1, 2014 http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRsearch.cfm?CFRPart=812

v) Title 32 CFR Part 219, National Defense, Protection of Human Subjects, http://www.ecfr.gov/cgi-bin/text-idx?tpl=/ecfrbrowse/Title32/32cfr219_main_02.tpl

w) Title 45 CFR 46, Protection of Human Subjects, April 1, 2014, http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html#

x) Title 29 Part 1910.1030 Bloodborne Pathogens; 1910.1200, Hazard Communication; 1910.132 Personal Protective Equipment https://www.osha.gov/pls/oshaweb/owastand.display_standard_group?p_toc_level=1&p_part_number=1910

y) Title 42 CFR 72.3 Transportation of Materials Containing Certain Etiologic Agents; Minimum Packaging Requirements. https://www.gpo.gov/fdsys/granule/CFR-2007-title42-vol1/CFR-2007-title42-vol1-sec72-3

z) Title 49 CFR Part 173.199 Category B Infectious Substances https://www.gpo.gov/fdsys/pkg/CFR-2015-title49-vol2/pdf/CFR-2015-title49-vol2-sec173-199.pdf

aa) Dangerous Goods Regulations of the International Air Transport Association.

http://www.iata.org/Pages/default.aspx

ab) Title 5, U.S.C section 5A, Records Maintained on Individuals https://www.gpo.gov/fdsys/granule/USCODE-2010-title5/USCODE-2010-title5-partI-chap5-subchapII-sec552a/content-detail.html

10.2. Information Technology Compliance

10.2.1. Army Regulation 25-1, Information Technology

Compliance information regarding Army Information Technology may be found at: http://armyhpubs.army.mil/epubs/25_Series_Collection_1.html

10.2.2. Army Regulation 25-2, Information Assurance

Compliance information regarding Army Information Assurance may be found at: https://ia.signal.army.mil/docs/AR25-2.pdf

10.2.3. Cyber-security

Department of Defense (DOD) Instruction 8500.01 Cybersecurity

10.2.4. Risk Management Framework

Department of Defense (DOD) Instruction 8510.01 Risk Management Framework (RMF) For DOD Information Technology (IT Department of Defense (DoD) Instructions 5400.11-R, Privacy Program http://www.dtic.mil/whs/directives/corres/pdf/540011p.pdf

11. REFERENCE DOCUMENTS

a) Department of Defense Directive 6485.01, Human Immunodeficiency Virus, June 7, 2013. http://www.dtic.mil/whs/directives/corres/pdf/648501p.pdf

b) Department of Defense Instruction 6440.02, Clinical Laboratory Improvement Program (CLIP) Manual, May 29, 2014. http://www.dtic.mil/whs/directives/corres/pdf/644002p.pdf

c) Department of Defense Instruction 3216.02, Protection of Human Subjects and Adherence to Ethical Standard in D00D-Supported Research. http://www.dtic.mil/whs/directives/corres/pdf/321602p.pdf

d) Army Regulation 600-110, Identification, Surveillance, and Administration of Personnel Infected with Human Immunodeficiency Virus, 22 April 2014. http://www.apd.army.mil/pdffiles/r600_110.pdf

e) Army Regulation 40-501, Standards of Medical Fitness

f) US Medical Entrance Processing Command Regulation 40-1, Medical Processing and Examinations http://www.mepcom.army.mil/ASP/pubnform.asp?topic=Regulations&sort=pubNo

g) US Medical Entrance Processing Command Regulation 40-8, Department of Defense (DOD) Human Immunodeficiency Virus (HIV) Testing Program and Drug and Alcohol Testing (DAT) Program http://www.mepcom.army.mil/ASP/pubnform.asp?topic=Regulations&sort=pubNo

12. OTHER TERMS, CONDITIONS, AND PROVISIONS

12.1. Non-Personal Services

This award identifies services that are strictly non-personal in nature.

12.2. Severable / Non-Severable Services

This award identifies services that are severable in nature.

12.3. Inherently Governmental Functions

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

12.4. Organizational Conflict of Interest

Walter Reed Army Institute of Research (WRAIR) has categorized its requirements into two broad categories, as defined below, for purposes of identifying, avoiding or mitigating against OCIs in accordance with FAR Subpart 9.5. These categories apply to all enterprise laboratories (Armed Forces Research Institute of Medical Sciences (AFRIMS), United States Medical Research Directorate – Kenya (USAMRD-K), and United States Medical Research Directorate – Georgia (USAMRD-G). These categories are defined as follows:

Global Support: Where 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. These services are identified as those having a direct impact to the operations of the greater WRAIR enterprise.

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.

Mitigation strategies may include: avoidance (non-participation), firewalls between existing personnel and new requirement.

Isolated Support: Services which have focused impact on a specific Branch/ Department/ Program of WRAIR rather than the WRAIR enterprise.

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.

Mitigation Strategies: Contractor can provide a mitigation plan or acceptable self-certification that no OCI exists.

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 WRAIR presumes that award of a contract or order in the subject category will give rise to real or apparent OCI’s with respect to requirements in the other category and or may give rise to an CCI in the same category; (2) to assist current Contractors and prospective Offerors in developing their own business strategies regarding participation in WRAIR 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 WRAIR requirements consistent with the restrictions required under FAR Subpart 9.5 and sound business practices.

For purposes of identifying and/or mitigating against OCIs, WRAIR will examine all its services 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 WRAIR services solicitation will therefore be designated as falling within one of the above defined categories. The applicable OCI category will be set forth in each award.

This requirement is categorized as GLOBAL SUPPORT.

Organizational and consulting conflicts of interest may arise by performing advisory or consulting support services. Organizational conflicts of interest include providing services or performing advisory or consulting work for private companies that participate or will participate in future services or contract activities (solicitations and award). See FAR subpart 9.5.

12.5. Invoices

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

The contractor is responsible for properly preparing and forwarding to the appropriate Government official, the invoice and receiving report for payment. The contractor shall attach back up information to receiving reports for direct labor and Other Direct Costs (ODCs). Direct labor backup information shall reflect the person’s name, job title and quantity of hours worked for each pay period at a minimum. Backup information for ODCs shall list all elements of costs, such as travel breakout backup, including itinerary, dates of travel, name of employees traveling plus per diem costs shall accompany the receiving report. All ODCs exceeding $3,000 requires that the contractor conduct appropriate competition and obtain approval from the COR prior to purchase. Equipment purchases are not authorized under this contract. The Wide Area Workflow – Receipt and Acceptance application is the required method of submission.

12.6. Dissemination of Information/Publishing

There shall be no dissemination or publication, except within and between the Contractor and any Sub Contractors or specified Integrated Product/Process Team (IPT) members who have a need to know, of information developed under this order or contained in the reports to be furnished pursuant to this order without prior written approval of the COR or the Contracting Officer. Business Program Management Office (PMO) approval for publication will require provisions that protect the intellectual property and patent rights of both Business PMO and the Contractor.

12.7. 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.

12.8. 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 order. Contractor personnel shall make their contractor status known during introductions.

12.9. Use of Military Rank by Contractor Personnel

Contractors may not use or allude to former or current military rank during the performance of this work.

12.10. Data Rights

The Government will retain rights to all data produced in the course of developing, deploying, training, using and supporting WRAIR or other federal agencies that utilize this order.

12.11. Section 508 Requirement

The Contractor shall comply with Section 508 of the Rehabilitation Act of 1973 (29 U.S.C. 794d). Specifically, the procurement, development, maintenance, or integration of electronic and information technology (EIT) under this contract must comply with the applicable accessibility standards issued by the Architectural and Transportation Barriers Compliance Board at CFR part 1194.

12.12. 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 WRAIR support 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); this 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 help desk at: http://www.ecmra.mill.

Register under the "All Other Defense Components" module. The Walter Reed Institute of Research (WRAIR) Unit Identification Code (UIC) is W03KAA. The Federal Supply Code (FSC) is R499.

12.13. Anti-Terrorism and Operational Security

<Update this section based on response to AT OPSEC Questionnaire from Security Office>

12.13.1. AT Level I Training.

All contractor employees, including subcontractor employees, requiring access to Army installations, facilities, and controlled access areas shall complete AT Level I awareness training within 30 calendar days after contract start date or effective date of incorporation of this requirement into the contract, whichever is applicable.

The contractor shall submit certificates of completion for each affected contractor employee and subcontractor employee to the COR or to the contracting officer, if a COR is not assigned, within 30 calendar days after completion of training by all employees and subcontractor personnel. AT Level I awareness training is available at the following website: http://jko.jten.mil.

12.13.2. AT Awareness Training for Contractor Personnel Traveling Overseas.

Contractor and all associated subcontractor employees shall provide all information required for background checks to meet installation access requirements to be accomplished by the installation Provost Marshal Office, Director of Emergency Services, or Security Office.

Contractor workforce must comply with all personal identity verification requirements (CFR clause 52.204-9, Personal Identity Verification of Contract Personnel) as directed by DoD, HQDA and/or local policy. In addition to the changes otherwise authorized by the changes clause of this contract, should the Force Protection Condition (FPCON) at any individual facility or installation change, the Government may require changes in contractor security matters or processes.

a) For contractors requiring CAC. Before CAC issuance, the contractor employee requires, at a minimum, a favorably adjudicated National Agency Check with Inquiries (NACI) or an equivalent or higher investigation in accordance with Army Directive 2014-05. The contractor employee will be issued a CAC only if duties involve one of the following: (1) both physical access to a DoD facility and access, via logon, to DoD networks on-site or remotely; (2) remote access, via logon, to a DoD network using DoD-approved remote access procedures; or (3) physical access to multiple DoD facilities or multiple non-DoD federally controlled facilities on behalf of the DoD on a recurring basis for a period of 6 months or more. At the discretion of the sponsoring activity, an initial CAC may be issued based on a favorable review of the FBI fingerprint check and a successfully scheduled NACI at the Office of Personnel Management.

b) For contractors that do not require CAC, but require access to a DoD facility or installation. Contractor and all associated subcontractor employees shall comply with adjudication standards and procedures using the National Crime Information Center Interstate Identification Index (NCIC-III) and Terrorist Screening Database (Army Directive 2014-05/AR 190-13); applicable installation, facility and area commander installation and facility access and local security policies and procedures (provided by Government representative); or, at OCONUS locations, in accordance with status-of-forces agreements and other theater regulations.

12.13.3.

This standard language requires U.S.-based contractor employees and associated subcontractor employees to make available and to receive Government-provided area of responsibility (AOR)–specific AT awareness training as directed by AR 525-13. Specific AOR training content is directed by the combatant commander, with the unit ATO being the local point of contact.

12.13.4. iWATCH Training. This standard language is for contractor employees with an area of performance within an Army-controlled installation, facility, or area.

The contractor and all associated subcontractors shall brief all employees on the local iWATCH program (training standards provided by the requiring activity ATO). This locally developed training will be used to inform employees of the types of behavior to watch for and instruct employees to report suspicious activity to the COR. This training shall be completed within XX calendar days of contract award and within YY calendar days of new employees commencing performance, with the results reported to the COR NLT XX calendar days after contract award.

12.13.5. Army Training Certification Tracking System (ATCTS) registration for contractor employees who require access to Government information systems.

All contractor employees with access to a Government info system must be registered in the ATCTS at commencement of services and must successfully complete the DoD Information Assurance Awareness prior to access to the information system and annually thereafter.

12.13.6. For Contracts That Require an OPSEC Standing Operating program.

The contractor shall develop an OPSEC Standing Operating Procedure (SOP)/Plan within 90 calendar days of contract award, to be reviewed and approved by the responsible Government OPSEC officer. This plan will include a process to identify critical information, where it is located, who is responsible for it, how to protect it, and why it needs to be protected. The contractor shall implement OPSEC measures as ordered by the commander. In addition, the contractor shall have an identified certified Level II OPSEC coordinator per AR 530-1.

12.13.7. For Contracts That Require OPSEC Training.

Per AR 530-1, Operations Security, the contractor employees must complete Level I OPSEC Awareness training. New employees must be trained within 30 calendar days of their reporting for duty and annually thereafter.

12.13.8. For IA/IT training.

All contractor employees and associated subcontractor employees must complete the DoD IA awareness training before issuance of network access and annually thereafter. All contractor employees working IA/IT functions must comply with DoD and Army training requirements in DoDD 8570.01, DoD 8570.01-M, and AR 25-2 within six months of appointment to IA/IT functions.

12.13.9. 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.

12.13.10. For Contractors Authorized to Accompany the Force.

DFARS Clause 252.225-7040, Contractor Personnel Authorized to Accompany U.S. Armed Forces Deployed Outside the United States, shall be used in solicitations and contracts that authorize contractor personnel to accompany U.S. Armed Forces deployed outside the U.S. in contingency operations; humanitarian or peacekeeping operations; or other military operations or exercises, when designated by the combatant commander. The clause discusses the following AT/OPSEC-related topics: required compliance with laws and regulations, pre-deployment requirements, required training (per combatant command guidance), and personnel data required.

12.13.11. For Contract Requiring Performance or Delivery in a Foreign Country.

DFARS Clause 252.225-7043, Antiterrorism/Force Protection for Defense Contractors Outside the US, shall be used in solicitations and contracts that require performance or delivery in a foreign country. This clause applies to both contingencies and non-contingency support. The key AT requirement is for non-local national contractor personnel to comply with theater clearance requirements and allows the combatant commander to exercise oversight to ensure the contractor’s compliance with combatant commander and subordinate task force commander policies and directives.

12.13.12. For Contracts That Require Handling or Access to Classified Information.

Contractor shall comply with FAR 52.204-2, Security Requirements. This clause involves access to information classified “Confidential,” “Secret,” or “Top Secret” and requires contractors to comply with (1) the Security Agreement (DD Form 441), including the National Industrial Security Program Operating Manual (DoD 5220.22-M); (2) any revisions to DoD 5220.22-M, notice of which has been furnished to the contractor.

12.13.13. Threat Awareness Reporting Program.

For all contractors with security clearances. Per AR 381-12 Threat Awareness and Reporting Program (TARP), contractor employees must receive annual TARP training by a CI agent or other trainer as specified in 2-4b.

12.13.14. Sexual Harassment / Assault Response and Prevention (SHARP) The contractor shall comply with OTSG/MEDCOM Policy Memo 16-033, Policy for Reporting Incidents of Sexual Assault and Sexual Harassment under the Sexual Assault Prevention and Response Program (SHARP). The SHARP reporting requirements apply only to knowledge obtained by contractor personnel while performing services under this contract.

The contractor shall require all contractor personnel with knowledge of an incident of sexual assault or sexual harassment occurring on a Government facility, to include a Government leased facility, where the contractor is providing services under this contract, to report the incident to the contractor who shall immediately (within 24 hours) report the incident in writing to the Government's COR or Contracting Officer. All incidents shall be reported whether they involve contractor personnel or Government personnel, or other individuals.

The contractor shall ensure all service providers receive Sexual Harassment/Assault Response and Prevention (SHARP) training not later than 60 calendar days after contractor personnel begin performance under this contract and annually thereafter. Training can be self study using the attached slides, obtained online for contractor personnel with an Army Knowledge On-line (AKO) account or in person. In-person training through USAMRAA can be scheduled by contacting 301-619-8937 for class date/time and availability. If the employee has an AKO account, they can access training online at Army AKO https://www.us.army.mil/. Once in AKO:

Under the "Self Service" tab, click on "My Training"; once that page comes up, in the center of the page, click on the ALMS logo or the "Access the ALMS" option. On the left hand side of the page that launches, click on “Search”, and enter “SHARP Standing Strong” in the Search option (in about the middle of the page that opens).

Sexual Harassment/Assault Response and Prevention Standing Strong Training (Version: FY15) will appear as one of your options. Under that option, click on the “Begin Registration” option.

12.14. Business Associate

12.14.1. General Provisions

The Contractor meets the definition of Business Associate, and DHA meets the definition of a covered entity under the HIPAA Rules and the DoD HIPAA Issuances. Therefore, a Business Associate Agreement (BAA) between the Contractor and DHA is required to comply with the HIPAA Rules and the DoD HIPAA Issuances. This paragraph 8 serves as the required BAA. As a Business Associate, the Contractor shall comply with the HIPAA Rules and the DoD HIPAA Issuances applicable to a business associate performing under this Contract.

12.14.2. Catch-All Definition

The following terms used, but not otherwise defined in paragraph 9.1, shall have the same meaning as those terms have in the DoD HIPAA Issuances: Data Aggregation, Designated Record Set, Disclosure, Health Care Operations, Individual, Minimum Necessary, Notice of Privacy Practices (NoPP), Protected Health Information (PHI), Required By Law, Secretary, Security Incident, Subcontractor, Unsecured Protected Health Information (Unsecured PHI), and Use.

12.14.3. PHI Disclosure

The Contractor shall not use or further disclose PHI other than as permitted or required by the Contract or as Required by Law.

12.14.4. Safeguards

The Contractor shall use appropriate safeguards, and comply with the HIPAA Security Rule with respect to electronic PHI, to prevent use or disclosure of PHI other than as provided for by the Contract.

12.14.5. Breach

The Contractor shall report to DHA any breach of which it becomes aware, and shall proceed with breach response steps as required by Paragraph 9. With respect to electronic PHI, the Contractor shall also respond to any security incident of which it becomes aware in accordance with any Information Assurance provisions of this Contract. If at any point the Contractor becomes aware that a security incident involves a breach, the contractor shall immediately initiate breach response as required by paragraph 9.

12.14.6. Subcontractors

In accordance with 45 CFR 164.502(e)(1)(ii)) and 164.308(b)(2), respectively, as applicable, the Contractor shall ensure that any subcontractors that create, receive, maintain, or transmit PHI on behalf of the Contractor agree to the same restrictions, conditions, and requirements that apply to the Contractor with respect to such PHI.

12.14.7. Subcontractors

With respect to individual rights of access to PHI, the Contractor shall make available PHI in a designated record set to the individual or the individual’s designee as necessary to satisfy DHA’s obligations under the DoD HIPAA Issuances and the corresponding 45 CFR 164.524. If the Contractor intends to deny the individual’s request, the Contractor shall forward it (within seven working days of receipt) to the CO. The CO shall make a determination within 20 calendar days (50 calendar days for justified delays) of the request. The CO shall notify the individual, with a copy to the Contractor, of any approved or denied access determinations and the reason for any denial. The individual may appeal the denial determination to the DHA Privacy Office.

12.14.8. Amendments

The Contractor shall make any amendment(s) to PHI in a designated record set as directed or agreed to by DHA, or take other measures as necessary to satisfy DHA’s obligations under the DoD HIPAA Issuances and the corresponding 45 CFR 164.526.

12.14.9. Disclosures

The Contractor shall maintain and make available to the Government the information required to provide an accounting of disclosures to the MHS or to the individual as necessary to satisfy DHA’s obligations under the DoD HIPAA Issuances and the corresponding 45 CFR 164.528.

12.14.10. HIPAA Rules

To the extent the Contractor is to carry out one or more of DHA’s obligation(s) under the HIPAA Rules, the Contractor shall comply with the requirements…