Request for Information -Plasmodium Mosquitos.docx

Request for Information (RFI)

Entomology Branch: Walter Reed Army Institute of Research

This is an RFI as defined in FAR 15.201(e) to ascertain whether a commercial item exists that provides the capabilities described herein.

This RFI is issued solely for information and planning purposes and does not constitute a solicitation. All information received in response to this RFI will be treated as business confidential information. Nonetheless, submitters should properly mark their responses if the information is confidential. Responses to the RFI will not be returned. Responses to this notice are not offers and cannot be accepted by the Government to form a binding contract. Responders are solely responsible for all expense associated with responding to this RFI.

RFI Response and due date: 26 June 2023 10:00AM ET

Instructions to Responders:

Responses from all capable and qualified sources are encouraged to respond to this request.

White papers should adhere to the following formatting and outline instructions:

1. All submissions shall be made electronically and be in one of the following formats: Microsoft Word or Adobe PDF.

2. Cover Page (1page)

· Title

· Organization

· Responders technical and administrative points of contact (names, addresses, phone, fax number and email addresses)

· Topic area(s) addressed

3. Please note that the response shall provide sufficient technical data to determine how you fully meet the requirements as specified in the DRAFT Performance Work Statement.

Please note that responses are due no later than 26 June 2023 10:00AM ET. The preferred method of submission is via email. The point of contact for this action is Ms. Flodean Billings, Contract Specialist flodean.p.billings.civ@health.mil . Only electronic responses are requested. No evaluation letters and/or results will be issued to the respondents. At this time no solicitation exists; therefore, please do not request a copy of the solicitation.

DRAFT STATEMENT OF WORK

Contents:

Title: Plasmodium Mosquitoes

Requiring Activity Name: Walter Reed Army Institute of Research (WRAIR), Experimental Therapeutics (ET)

1. INTRODUCTION

Since 1893, the Walter Reed Army Institute of Research (WRAIR) has been a leader in solving the most significant threats to Soldier readiness and lethality such as disease and battle injury. WRAIR’s broad research capabilities at its Washington, D.C., area, and expeditionary laboratories function in concert to afford Soldiers the best medical protection and support possible before, during, and after deployment by addressing both longstanding and emerging threats. Though WRAIR’s research is focused on Soldier health, its products have important civilian applications, saving countless lives around the world.

In 2018, WRAIR began a major reorganization. The new Center for Enabling Capabilities (CEC) streamlines existing platforms to allow WRAIR to quickly and effectively innovate: the Veterinary Services Program, with a newly modernized vivarium to support preclinical research; the Clinical Trials Center, capable of conducting Phase 1 and 2 clinical trials; and the Pilot Bioproduction Facility, renovated with an expanded capacity to manufacture vaccines and therapeutics to meet a DOD-wide need. Other new groups, such as the Research Programs Office and Research Transition Office, streamlined WRAIR’s ability to work closely with partners in the federal government, academia and industry and operationalize new techniques and therapeutics. WRAIR is built to detect, mitigate, and eliminate medical threats to Soldiers, allowing them to face any enemy, anywhere in the world.

1. PURPOSE AND BACKGROUND

Experimental Therapeutics (ET) is a drug discovery and development enterprise created to protect military personnel from death, disease, and injury and meet Army and DOD mission requirements. While its historical focus has been radioprotection and parasitic disease, ET applies its core competencies of medicinal, synthetic, and analytical chemistry as well as clinical pharmacology to all therapeutic areas within the Medical Research and Development Command's portfolio.

The mission of ET has a 75-year legacy of excellence in small molecule drug development, with over 65 Investigational New Drug (IND) applications submitted to the U.S. Food and Drug Administrations (FDA). ET is a world leader in malaria drug development—every malaria prophylaxis drug was either created by ET scientists or transited ET test systems on its way to FDA approval. ET recently established a robust antibacterial product development effort mandated by the Presidential Combating Antibiotic Resistant Bacteria (CARB) initiative.

1. SCOPE

Experimental Therapeutics (ET) requires three variants of Mosquitoes (berghei, cynomolgi, and viviax) to support in vivo studies over the next five years. This requirement is to be variable throughout each year as to the quantity of purchase. The purchase will be executed through delivery orders off a fixed price IDIQ contract.

1. PERIOD OF PERFORMANCE

The periods of performance for this contract are as follows:

1. PERFORMANCE REQUIREMENTS

4. Minimum Essential Characteristics

Product:

1. Plasmodium cynomolgi infected Mosquitoes

1. The specific breed of mosquito is Anopheles Dirus

1. The specific Plasmodium species is Plasmodium cynomolgi B/M strain

1. Upon delivery, viability of live mosquitoes will be at least 90%

1. The composition of male and female mosquitoes is 100% females

1. Plasmodium vivax infected Mosquitoes

1. The specific breed of mosquito is Anopheles Dirus

1. The specific Plasmodium species is Plasmodium vivax

1. Upon delivery, viability of live mosquitoes will be at least 90%

1. The composition of male and female mosquitoes is 100% females

1. Plasmodium berghei infected Mosquitoes

1. The specific breed of mosquito is Anopheles stephensi – Pb-luciferase strain.

1. Upon delivery, viability of sporozoite count/mosquito will be >10,000 spz/mosquito and will be at least 90% viable.

1. The composition of male and female mosquitoes is 100% female.

Quality Control and Shipping:

1. The mosquitos will be delivered using FedEx air, overnight shipping.

1. Packaging Requirements: The prescribed packaging for transporting Plasmodium cynomolgi-infected Anopheles dirus mosquitoes must comply with Part 4, Chapters 1 and 2 and Part 4, Chapter 8, Section 8.1, Packing Instruction 620 of the ICAO TI and CFR 49 Part 173 to include, but not be limited to, § 173.196 and consists of the triple packaging and two over pack layers as described below:

1. The leak-proof primary receptacle consists of the following:

0. A one-pint (0.57 L) cardboard container measuring 3.5 inches in diameter by 3.5 inches in height, which contains the Plasmodium cynomolgi-infected Anopheles dirus mosquitoes. The cardboard container may contain up to a maximum of 200 Plasmodium cynomolgi-infected Anopheles dirus mosquitoes.

0. The top of the cardboard container must be covered with flame-proof nylon mesh that is secured with two rubber bands and tape. A 1-inch cardboard band that fits securely over the opening of the container must be placed over the mesh. This cardboard band and the exposed mesh fabric must be secured with tape.

0. The cardboard container has a ¾-inch diameter access port in its side, which must be covered with two sheets of green latex rubber. The access port must be covered securely by tape during transportation.

0. A cotton ball moistened with sugar water solution (approximately 0.002 L; a food source for the Anopheles dirus mosquitoes) must be placed on the fabric mesh and must be held in place by an inverted petri dish.

0. The cardboard container must be placed and sealed via a self-sealing adhesive strip within a leak-proof plastic biohazard bag. (i.e., a LABTITE specimen transport Bag).

1. The leak-proof secondary packaging consists of the following:

1. The leak-proof primary receptacle as described in paragraph (1) must be placed within an EXAKT-PAK Technologies plastic screw-cap canister with an O-ring seal that measures 5 inches in diameter by 8.5 inches in height and must be rated to not less than 95 kPa.

1. The EXAKT-PAK Technologies screw-cap canister whichever is used, must be labeled with a Biohazard label conforming to 29 CFR § 1910.1030(g)(1)(i)

1. The quantity of leak-proof primary receptacles as described in paragraph (1) permitted within the leak-proof secondary packaging may not exceed two.

1. The rigid outer packaging consists of the following:

2. The leak-proof secondary packaging as described in paragraph (2) must be placed within an UN 4G, Class 6.2 fiberboard box that measures up to 12.5 cm. x 12.5 cm. x 24 cm. (i.e., Bio-Bottle fiberboard box). This fiberboard box must be sealed with 2-inch clear plastic tape.

2. An itemized list of the contents enclosed between the leak-proof secondary packaging as described in paragraph (2) and the rigid outer packaging must be placed within the rigid outer packaging.

2. The quantity of leak-proof secondary packaging as described in paragraph (2) permitted within the rigid outer packaging may not exceed one.

2. The gross weight of mosquitoes permitted within the rigid outer packaging may not exceed 50 g.

1. The two overpack layers consist of the following:

3. The rigid outer packaging as described in paragraph (3) must be placed within the thermal parcel box (i.e., GTC56L) that measures up to 65 cm x 65 cm x 66 cm.

3. The quantity of rigid outer packaging as described in paragraph (3) permitted within the thermal parcel box may not exceed nine.

3. The thermal parcel box must be placed within a cardboard box (e.g., U-Line or similar). This cardboard box must be sealed along all edges with reinforced packaging tape (e.g., Scotch “Extreme Application Packaging Tape” or an equivalent) in an “H”- shaped pattern that extends 6 inches over the ends of the cardboard box.

3. All required permits, along with itemizing the container contents must be enclosed between the thermal parcel box (i.e., GTC56L) and the rigid outer cardboard box.

3. The gross weight of the thermal parcel box and cardboard box plus its contents must not exceed 60 kg

1. DELIVERABLES

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

DELIVERABLES TABLE

5. Inspection and Acceptance

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

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

5. COR Information

TBD

1. COMPLIANCE DOCUMENTS

0. General Compliance

0. 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.

0. 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

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

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

1. Army Regulation 25-2, Information Assurance.

1. Department of Defense (DOD) Instruction 8500.01 Cybersecurity

1. 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

1. OTHER TERMS, CONDITIONS, AND PROVISIONS

1. Invoices

The contractor shall submit invoices monthly and/or annually 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. Invoices submitted for payment, which do not contain Contract Line-Item Number (CLIN) and the Accounting Classification Reference Number (ACRN) information, will be rejected. Equipment purchases and ODCs are not authorized under this contract. The Wide Area Workflow – Receipt and Acceptance application is the required method of submission.

1. Anti-Terrorism and Operational Security

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.

DFARS 204.7202 Contractor personnel who, as a condition of contract performance, require routine physical access to a Federally controlled facility or military installation are required to complete Level I antiterrorism awareness training within 30 days of access and annually thereafter.

Include the clause at DFARS 252.204-7004 DoD Antiterrorism Awareness Training for Contractors, in solicitations and contracts, including solicitations and contracts using FAR part 12 procedures for the acquisition of commercial items, when contractor personnel require routine physical access to a Federally controlled facility or military installation.

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.

1. Compliance with Relevant DoD, Service, and Institutional Policy Regulations.

The Contractor shall comply with HIPAA and all relevant DoD/USG regulations for collection, storage, and transfer of sensitive data and PHI. In addition, the Contractor will comply with all requirements for communication of findings and publication in the scientific peer reviewed literature (e.g., Public Affairs clearance and Operational Security clearance for dissemination).

1. Personally Identifiable Information (PII) and Protected Health Information (PHI)

The contractor shall comply with the DHA Procedures, and Information (PGI) 224 – Protection of Privacy and Freedom of Information, revised 17 May 2015. The contractor may access PII during task response to the requirements of this contract, as such the contractor shall comply with the document entitled “Personally Identifiable Information (PII), Protected Health Information (PHI) and Federal Information Requirements”.

The Contractor shall establish appropriate administrative, technical, and physical safeguards to protect all Government data. The Contractor shall also ensure the confidentiality, integrity, and availability of Government data in compliance with all applicable laws and regulations, including data breach reporting and response requirements, in accordance with DFAR Subpart 224.1 (Protection of Individual Privacy), which incorporates by reference DoDD 5400.11, “DoD Privacy Program,” May 8, 2007, and DoD 5400.11-R, “DoD Privacy Program,” May 14, 2007. The contractor shall also comply with federal laws relating to freedom of information and records management. The Contractor shall comply with all requirements of the Health Insurance Portability and Accountability Act of 1996 (HIPAA) (Pub. L. 104-191), as implemented by the HIPAA Privacy and Security Rules codified at 45 CFR Parts 160 and 164, and as further implemented within the Military Health System (MHS) by DoD 6025.18-R, "DoD Health Information Privacy Regulation," January 24, 2003, and DoD 8580.02-R, “DoD Health Information Security Regulation, July 12, 2007.

IT services that collect, maintain, use, or disseminate personally identifiable information must be managed in a manner that protects privacy, in accordance with section 552a of Title 5, U.S.C., DoD 5400.11 and DoD 5400.11-R. DoDI 5400.16 established the guidance for development, review, and approval of Privacy Impact Assessments, in accordance with chapter 36 of Title 44, U.S.C.