RFI_addendum_Log_Med_REV1.pdf

Additional Request under W911QY-18-R-0001 If you have not responded to this RFI previously, details of the government’s request can be found in the paragraphs below and the final paragraph of this Request for information (RFI).

If you already responded to the original RFI, we request an addendum specifically addressing your ability to provide, hire, train, and place approximately 100 logistics and 60 medical support professionals nationwide within 30 days of notification of successful offer. This additional response is requested as this has been identified as a major risk to program success.

The government is interested in how your company can staff a requirement for approximately 100 Logistics and 60 Medical support professionals within 30 days of notification of successful offer because this is a significant risk to successfully achieving contract performance objectives. Specifically, how would your company provide existing employees, hire new employees, subcontract, and train these professionals at diverse locations across the country? What recruitment methods would you utilize and can you demonstrate that you have done this in the past? If this acquisition is a Set Aside for Small Business, it will be subject to FAR 52.219-14 –Limitations on Subcontracting, therefore Task Order holders shall be required to provide at least 50% of the cost of contract performance from employees of the company.

If you have not responded to this RFI previously, details of the government’s request can be found in the paragraphs below and the final paragraph of this Request for information (RFI).

The US Army Contracting Center, Aberdeen Proving Ground, Natick Contracting Division (NCD) on behalf of Joint Program Executive Office for Chemical and Biological Defense (JPM-CBD) is looking for interested vendors to compete for a Multi Award Firm Fixed Price Indefinite Delivery, Indefinite Quantity Professional Services Contract (MA IDIQ). The team is especially interested in learning more about businesses of all sizes who believe they can fulfill these requirements. The MA IDIQ ordering period will be six (6) years, including all option years, and one additional year of performance. After the award of the IDIQ, individual Task Orders (TOs) will be competed Fair Opportunity under FAR 16.5. Please be advised this is for informational purposes only and does not constitute a Request for Proposal (RFP) or Request for Quotation (RFQ). The Government is not responsible for any cost incurred in providing this information.

Scope of Work:

The Joint Program Executive Office for Chemical and Biological Defense (JPEO-CBD) and its chartered Joint Project Managers (JPMs), lead, manage and direct the development, acquisition, production/procurement, fielding and sustainment of Chemical, Biological, Radiological and Nuclear (CBRN) defense systems and equipment used by the military services within the Department of Defense (DOD) and by various Other Government Agencies (OGAs). These systems, capabilities and items of equipment provide critical force protection against CBRN threats world-wide.

Services needed are for Acquisition, Program Management, Systems Engineering and Technical Assistance (SETA) support and to provide chemical, biological, radiological and Nuclear (CBRN) subject matter experts. JE-OPETS services span the Portfolio Groups (Taxonomy for the Acquisition of Services and Supplies & Equipment) of: Research and Development (R & D); Knowledge Based Services (KBS); and Logistics Management Services (LMS).

The predominate portfolios are: (R & D) Systems and Operational Systems Development; (KBS) Engineering and Technical, Program Management and Professional Services; (LMS) Logistics Support Services.

Under the Federal Procurement Data System, Product and Services Manual, the predominate services being purchased are identified by codes:

• AD94 - R & D, Other Defense, Engineering Development;

• AD95 - R & D, Other Defense, Operational Systems Development;

Additional (supporting) codes are identified as:

• D314: ADP Acquisition Support Services

• R408: Program management Support – Professional Program Management/Support (“…where the Contractor provides program management support to a Government Program Manager.”);

• R425: Support – Professional: Engineering /Technical Services which includes systems engineering, technical assistance and other services used to support the Program Office during the (DoDI 5000.02) Acquisition Cycle

• R706: Logistics Support Services (Less 4 Army LOGCAP Contacts)

Applicable North American Industry Classification System (NAICS) Codes for the Medical and Logistics Business area are indicated below:

• 541330 Engineering Services

JPOE-CBD is seeking contracted team members to support various programs under both the Logistical and Medical Business Areas. The contracted personnel must be able to interact with both military and civilian leaders in each of the business focus areas at several locations across the United States.

Contracted team members will be co-located with government leadership in government facilities and others will be off site at contractor provided location(s). On Site locations include but are not limited to:

Aberdeen MD, San Diego CA, Bedford MA, and Stafford VA. Contractors are expected to make personnel available at all of the required locations based on requirements articulated in each Task Order. In addition, a need for contracted personnel exists in Afghanistan, Kuwait, and the Republic of Korea.

Since various requirements and skills are required the government anticipates 6 different skill levels approximately commensurate with federal pay scales GS 5 through 15 under the labor categories listed below in the Logistical and Medical Business:

Fielding Coordinator, Logistics Management Specialist, Staff Logistician, Program Logistician, Property Accountability Officer, Quality Assurance Specialists, Sustainment Manager, Transition Manager, Bioengineer, Bio-Medical Technician, Nonclinical Advisor, Process Advisor, Regulatory Affairs Manager, Scientist.

Skill sets associated with these two areas are as follows:

• Acquisition – Logistics & Medical

• Logistics Analysis

• Technical Documentation & Validation

• Sustainment and Maintainability

• Drug Development Policies & Procedures

• Management, Organization & Businesses Improvement

• Affordability & Costing

• Specialized Analysis

• Training Services

• Special Technical Studies

For illustration purposes, the estimated breakdown of required support is as follows:

Logistics Management Specialist (27 needed). The offeror shall serve as a logistician, providing all acquisition logistics support functions (i.e., planning, development, implementation, and management of support concepts and strategies) for programs within the JPEO-CBD portfolio. Using performance-based logistics, the offeror shall plan and develop effective product support strategies, ensuring they meet established goals for operational effectiveness and readiness. The offeror shall manage, as required, review and comment on Contractor technical manuals, validation efforts, provisioning data, training packages, and other logistics-related deliverables. The offeror shall determine level of maintenance, review system parts lists, and make recommendations on the table of allowance.

In addition, the offeror shall perform other tasks including, but not limited to, the following:

Lead the IPT on all multi-service support issues

Lead the Government team during Contractor logistics support review sessions

Monitor supportability requirements in relation to the established requirements for cost, schedule and performance

Ensure integration of all support elements to maximize system deployment, supportability and mobility

Develop fielding plans and logistics demonstration plans, and coordinate them with stakeholders

Quality Assurance Specialist (17 needed). The offeror shall provide quality assurance oversight and support to programs within the JPEO-CBD portfolio and external agencies, such as prime Contractor sites and government laboratories, as required. Such support includes, but is not limited to, the following:

Performing quality planning

Conducting quality assurance audits and reviews

Developing and documenting quality control policies and procedures

Administering quality control activities

The offeror shall plan, organize, and conduct such quality assurance activities relating to the design, development, fabrication, installation, modification, sustainment, and analysis of systems or system components for a functional specialty (i.e., reliability and maintainability, systems safety, materials, avionics, structures, propulsion, chemical/biological, human systems interfaces, weapons, etc.).

Staff Logistician (15 needed). The offeror shall design and implement systems to collect, maintain and analyze data; generate progress reports and other logistics tracking information related to programs within the JPEO-CBD portfolio.

Program Logistician (17 needed). The offeror shall serve as the program-level point of contact for all logistics requirements. The offeror shall be responsible for developing, updating, and/or reviewing and providing comment to all logistics-related documentation (e.g., Life Cycle Sustainment Plan, Logistics Requirement and Funding Strategy), the LCCE, and the Joint Independent Logistics Assessment. The offeror shall perform logistics engineering and management studies and analyses, as required. In addition, the offeror shall provide input and participate in program milestone reviews with the Milestone Decision Authority. The offeror shall also assist in the development and implementation of logistics policies and procedures, as required.

Technical Documentation Specialist (TBD). The offeror shall serve as a technical documentation specialist, responsible for collecting, organizing, reviewing, and providing comment to the customer’s technical documentation; which includes, but is not limited to, system specifications, user manuals, software products and special reports. The offeror shall proofread and edit these technical documents, maintaining version control and consistency in naming conventions. In addition, the offeror shall be responsible for all distribution and duplication of technical documentation.

Transition Manager (1 needed). The offeror shall serve as a transition manager for fielded systems within the JPEO-CBD portfolio. The offeror shall provide daily technical and service-level transitional support, which includes, but is not limited to, the following:

Contractor oversight during installation and checkout

Coordination with the installation to ensure that the system fielded best meets its requirements

Sustainment Manager (9 needed). The offeror shall perform the research, logistical analysis, and planning necessary for sustaining all CBRN-related COTS equipment fielded across the JPEO-CBD portfolio.

Fielding Coordinator (12 needed). The offeror shall provide total package fielding support to programs within the JPEO-CBD portfolio, which includes, but is not limited to, the following:

Supporting fielding IPTs

Updating support strategies, fielding documentation and provisioning plans

Developing and updating training material and user guides in preparation for transition of fielded systems

Conducting NET and refresher training to deploying forces, as required

Negotiating the fielding schedule with gaining commands and coordinating shipment of systems

Preparing issue documents and fielding reports

Maintaining an electronic library of contract deliverables and ensuring that the deliverable review process is completed monthly

Tracking and reporting the status on all Integrated Logistics Support (ILS) documentation (e.g., ILS Plans, Materiel Fielding Plans and Logistics Analyses)

Initiating and resolving Product Quality Deficiency Reports (PQDRs)

Conducting surveillance testing

Assessing reliability of fielded systems based on maintenance or field surveys

Equipment Specialist (TBD). The offeror shall serve as an equipment specialist, advising on the preproduction, production, usage, and disposal of chemical and biological defense protective equipment.

Property Accountability Officer (3 needed). The offeror shall maintain property books, hand receipts and accountability for all standard and non-standard equipment transferred to the customers within the JPEO-CBD portfolio. The offeror shall be responsible for researching, cataloging, posting, editing, and filing all property book documentation.

The Medical domain includes all support associated with the product concept and design, and policy and protocol development of all JPEO-CBD systems relating to biologics, vaccines and pharmaceuticals. To facilitate this support requirement, the JPEO-CBD has identified the following areas of interest to categorize the Engineering & Technical domain:

Drug Development Policies & Procedures

Science, Pharmaceutical, Vaccine/Biologics, Management

Support within the Medical domain is required by JPEO-CBD Headquarters and the Joint Project Managers for Chemical and Biological Medical Systems, Information Systems, Medical Countermeasures Advanced Development and Manufacturing, and Transformational Medical Technologies.

Drug Development Policies & Procedures

Nonclinical Advisor (3 needed). The offeror shall serve as an advisor on the nonclinical protocols used during development of CBRN pharmaceutical products. The offeror shall provide recommendations on regulatory matters concerning good laboratory practices for nonclinical studies. Additionally, the offeror shall provide oversight on formulation development, assay qualification and validation, International Conference of Harmonization stability protocols, and FDA regulations and guidelines for good manufacturing practices.

Clinical Advisor (TBD). The offeror shall serve as an advisor on the clinical protocols used during development of CBRN pharmaceutical products, including, but not limited to, the following:

Informed consent

Clinical monitoring

Regulations and guidelines for good clinical practice established by the FDA and the International Conference of Harmonization

Process Advisor (9 needed). The offeror shall provide scientific and technical support during the development or transfer of new biologics and other medical technologies. The offeror shall assist in determining strategic direction of the project office by proposing and implementing actionable strategies to address critical issues. The offeror shall review pertinent correspondence and related documents for scientific and medical content, and evaluate all aspects of the clinical study protocol.

Additionally, the offeror shall provide insight on current good laboratory and manufacturing processes, as well as the following FDA requirements:

Animal rule application and implementation

Investigational New Drugs (INDs) and biologic license application (conformance to new drug regulations and the submission, approval, and licensure process)

Preparation for and conduct during Type A, B, and C meetings

Qualification of drug development tools

The offeror shall advise the client on the impact of changing trends in the pharmaceutical industry and FDA policies and requirements, and recommend courses of action. The offeror shall provide advice on the impact of legislative changes and directives from higher echelons and recommend courses of action, as well as ensure application of pertinent inter-state and foreign commerce laws and regulations governing manufacturing and shipment. In addition, the offeror shall facilitate communication and coordination with the FDA, as required.

Regulatory Affairs Manager (8 needed). The offeror shall assist in the organization, planning, assessment, and management of regulatory affairs (i.e., FDA) and quality assurance activities to support the research, development, and acquisition of JPEO-CBD medical systems. This support includes, but is not limited to, the following:

Participating on IPTs

Preparing, reviewing, and coordinating regulatory documentation; researching, troubleshooting, and communicating solutions to resolve technical issues related to regulatory documentation; and ensuring that regulatory documentation is compliant and consistent within the DoD Acquisition Framework

Supporting development of POM recommendations and Congressional and Office of the Secretary of Defense briefings

Maintaining relationships with the FDA and other Federal agency personnel, as necessary

Providing coordination and staff support for regulatory, pharmaceutical, and portfolio integration chiefs

Science, Pharmaceutical, Vaccine/Biologics, Management

Bioengineer (31 needed). The offeror shall serve as an advisor on all aspects of bioengineering, medical countermeasures, drug development, and portfolio management, to include bioengineering efforts, industry best practices, strategic relations, and medical transition activities. The offeror shall perform support and oversight functions from product conceptualization through implementation, including, but not limited to, the following:

Understanding capability gaps and assisting in setting project- and product-level strategy and priorities, ensuring portfolios are mapped to program goals

Providing expert analysis and engineering support of the design and development, installation and qualification, operation and validation of flexible, modular, single use system technologies in relation to biopharmaceutical manufacturing

Directing the activities of other bioengineers, as required

Advising the program team on risk assessment and risk management, technology portfolio and pipeline management, business and contracting strategies, technology transfers, and intellectual property management

Implementing and tracking EVM systems appropriate for pharmaceutical development within the constraints of the FDA approval process

Reviewing and assessing documentation (e.g., Alignment Charts; Research, Development and Acquisition Plans; Technology Development Strategy; TEMP; Life Cycle Management Plan;

Acquisition Strategy; Modernization Plans, etc.)

Participating in Integrated Capability Teams and serve as technical point of contact, as required

Attending medical technical conferences (e.g., Medical Research Institute of Chemical Defense and Armed Forces Radiological Research Institute)

Performing discrete, special interest efforts to solve problems and complete studies

Participating in medical Focus Innovative Technologies (FITs), Solicitations for Efforts Exploratory Development (SEEDs), and related efforts with Joint Science and Technology Office (JSTO) and other agencies

The offeror shall establish and maintain relationships with relevant internal and external stakeholders in the CBD community (i.e., combat and materiel developers, systems engineers, test and evaluation entities, Industry, DoD, Department of Health and Human Services Biomedical Advanced Research and Development Authority, JSTO, FDA, and academic partners in order to evaluate current and emerging medical technologies and facilitate cross-communication regarding program priorities and courses of action. In addition, the offeror shall assist in determining the strategic direction of the organization, participating in technology demonstrations and directing Science and Technology (S&T) transitions.

Scientist (4 needed). The offeror shall provide scientific oversight and technical knowledge in the areas of bioengineering, biology, chemistry, and vaccine development. The offeror shall support and analyze the development of medical technologies, including, but not limited to, the following:

Developing, overseeing, and reviewing proposals, protocols, and study designs to support nonclinical (i.e., immunogenicity, toxicity, and efficacy) and clinical testing, assay development, and manufacturing efforts

Assessing technology readiness levels

Ensuring test protocols conform with FDA requirements

The offeror shall author and edit documents, reports, and briefings; interpret technical data, specifications, and requirements; and assist in development of risk management efforts. Additionally, the offeror shall work closely with the product team to solve problems and ensure application of appropriate scientific principles to meet technical requirements.

Licensed Healthcare Provider (TBD). The offeror shall serve as a licensed healthcare provider, offering insight to JPEO-CBD program offices on medical/healthcare informatics and biosurveillance efforts. The offeror shall review and provide input to requirements and acquisition documentation.

The offeror shall participate in meetings and activities, and maintain relationships with Tricare Management Activities (TMAs), Armed Forces Health Longitudinal Technology Application (AHLTA), Veteran’s Administration (VA), Office of the Surgeon General (OTSG), Center for Disease Control (CDC), Health and Human Services (HHS), Biomedical Advanced Research and Development Authority (BARDA), and JSTO.

Bio-Media Technician (1 needed). The offeror shall evaluate and maintain awareness of news media reports and emerging trends in bioengineering, pharmaceutical development, and bio-surveillance. The offeror shall develop, proofread, and edit technical documentation intended for public release. In addition, the offeror shall manage public affairs issues and concerns, and prepare and submit stakeholder responses.

Medical Systems Cost Modeler (TBD). The offeror shall develop and apply cost models suitable for prediction and analysis of budgetary requirements for medical product development, inclusive of costs associated with FDA processes and regulatory compliance, clinical trials, drug manufacturing, laboratory testing, and development of drugs leading to FDA approval and licensure. The offeror shall understand and extrapolate the cost of medical product development in the civilian sector to the development of medical countermeasures for bio-defense. Additionally, the offeror shall assist with the DoD PPBE process, assisting in budget formulation matters and the justification, presentation, and execution of program budgets.

Interested parties shall demonstrate their ability to meet the requirements of this scope of work and shall describe their expertise at recruiting, hiring, and retaining contracted personnel in both the Logistic and Medical Business areas. A brief explanation of your company’s financial ability to accomplish these task orders is required. Please include your CAGE code and any and all socioeconomic detail based on the NAICS codes listed above. Responses to this RFI should be in the form of a capabilities document of no more than three (3) pages in length and sent to the Contracting Officer, Brian Murphy, via email only at brian.f.murphy20.civ@mail.mil.

mailto:brian.f.murphy20.civ@mail.mil