W911QY21R0007.pdf

W911QY21R0007

Combined Synopsis Solicitation

ID/IQ for Regulatory Consultant, Non-Personal Services

This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in FAR Subpart 12.6 supplemented by FAR Subpart 13.5 with additional information included in this notice. This announcement constitutes the only solicitation; proposals are being requested and a separate written solicitation will not be issued. The solicitation number is W911QY21R0007 and is issued as a Request for Proposal (RFP), unless otherwise indicated herein.

The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 2020-09. The associated North American Industrial Classification System (NAICS) code for this procurement is 541714 with a small business size standard of 1,000 employees. This requirement is being solicited using full and open competition. Both small and other than small businesses may respond.

The Government requires the ability to engage senior regulatory experts to provide consultation and reporting on projects related to FDA regulations, quality auditing, FDA package submissions and other task areas. Please see the attached solicitation document for the Performance Work Statement, ID/IQ CLIN schedule, response requirements, evaluation criteria and all terms and conditions.

All contractors must be actively registered in the System for Award Management without exclusions to be eligible for award.

The Contractor shall not be reimbursed for any costs incurred prior to the effective date of the contract.

Information contained in the successful or unsuccessful Offeror's Management or Price proposal must be released under the Freedom of Information Act (5 U.S.C. 552) upon request from the public after contract award, except to the extent it contains trade secrets and privileged or confidential commercial or financial information. If the Offeror's proposal contains material meeting this description which is customarily maintained in confidence in the course of the Offeror's business and is not otherwise publicly available, and if the Offeror does maintain this information in confidence and it is not otherwise publicly available, and if the Offeror does not want it disclosed to the public, the title page shall be marked with the legend that follows.

"This proposal, furnished in response to Solicitation No. W911QY-21-R-0007 contains trade secrets and/or privileged or confidential commercial or financial information. This information is maintained in confidence in the course of the Offeror's business and is not otherwise publicly available. The Offeror submits this information to the Government in confidence and understands that it is received with that intent. This information shall not be released or disclosed outside the Government under the Freedom of Information Act (5 U.S.C. 552) or under any other circumstances."

Proposals so marked will be accepted by the Government in confidence and will not be released provided that the Offeror and/or the Government can show, upon request under the Freedom of Information Act, that disclosure would either (1) impair the Government’s ability to obtain necessary information in the future or (2) cause substantial harm to the competitive position of the Offeror.

Responses shall be submitted electronically to scott.i.hoffman2.civ@mail.mil, no later than the time and date specified in this notice. A courtesy copy shall be provided to susan.e.ruzicka2.civ@mail.mil no later than the time and date specified in this notice.

Questions regarding this solicitation shall be sent to scott.i.hoffman2.civ@mail.mil and a courtesy copy provided to susan.e.ruzicka2.civ@mail.mil, no later than 11:00 am Eastern time on 30 November 2020.

Section B - Supplies or Services and Prices

ITEM NO SUPPLIES/SERVICES MAX

QUANTITY

UNIT UNIT PRICE MAX AMOUNT

0001 UNDEFINED Job Work Under PWS Task Area 1

FFP

Orders issued under this CLIN shall be to advise, provide input, and assist in developing FDA package submissions IAW Performance Work Statement section 3.1.

FOB: Destination

PSC CD: AN15

MAX

NET AMT

UNIT UNIT PRICE MAX AMOUNT

0002 UNDEFINED Job Work Under PWS Task Area 2

FFP

Orders issued under this CLIN shall be to perform regulatory assessments of medical product development efforts IAW Performance Work Statement section 3.2.

UNIT UNIT PRICE MAX AMOUNT

0003 UNDEFINED Job Work Under PWS Task Area 3

FFP

Orders issued under this CLIN shall be to conduct third party independent audits using certified quality auditors to evaluate a specific medical product developer’s level of compliance with respect to facility, manufacturing, QC testing and QA support consistent with current Good Manufacturing Practices (cGMPs), Good Clinical Practice (GCP), and Good Laboratory Practice (GLP) regulatory and quality requirements for manufacturing and testing MCM products IAW Performance Work Statement section 3.3.

UNIT UNIT PRICE MAX AMOUNT

0004 UNDEFINED Job Work Under PWS Task Area 4

FFP

Orders issued under this CLIN shall be to provide regulatory and quality support on-site for a specified duration to provide regulatory and quality oversight on manufacturing tasks IAW Performance Work Statement section 3.4.

UNIT UNIT PRICE MAX AMOUNT

0005 UNDEFINED Job Base Year Travel

COST

Travel requirements shall be specified in the task order. All travel will be invoiced according to the Federal Travel Regulations.

MAX COST

UNIT UNIT PRICE MAX AMOUNT

0006 UNDEFINED Job Base Year Contractor Manpower Reporting

FFP

The contractor and all subcontractors, at all levels/tiers, providing direct labor under this contract shall report complete and accurate data for the labor executed during the period of performance during each Government fiscal year (FY), which runs from October 1 to September 30. The Contractor shall input the data into the appropriate Services Contract reporting tool, which can be accessed via a secure web site at http://sam.gov. Contractors may direct technical questions to the system for award management helpdesk.

UNIT UNIT PRICE MAX AMOUNT

1001 UNDEFINED Job OPTION Work Under PWS Task Area 1

FFP

Orders issued under this CLIN shall be to advise, provide input, and assist in developing FDA package submissions IAW Performance Work Statement section 3.1.

UNIT UNIT PRICE MAX AMOUNT

1002 UNDEFINED Job OPTION Work Under PWS Task Area 2

FFP

Orders issued under this CLIN shall be to perform regulatory assessments of medical product development efforts IAW Performance Work Statement section 3.2.

UNIT UNIT PRICE MAX AMOUNT

1003 UNDEFINED Job OPTION Work Under PWS Task Area 3

FFP

Orders issued under this CLIN shall be to conduct third party independent audits using certified quality auditors to evaluate a specific medical product developer’s level of compliance with respect to facility, manufacturing, QC testing and QA support consistent with current Good Manufacturing Practices (cGMPs), Good Clinical Practice (GCP), and Good Laboratory Practice (GLP) regulatory and quality requirements for manufacturing and testing MCM products IAW Performance Work Statement section 3.3.

UNIT UNIT PRICE MAX AMOUNT

1004 UNDEFINED Job OPTION Work Under PWS Task Area 4

FFP

Orders issued under this CLIN shall be to provide regulatory and quality support on-site for a specified duration to provide regulatory and quality oversight on manufacturing tasks IAW Performance Work Statement section 3.4.

UNIT UNIT PRICE MAX AMOUNT

1005 UNDEFINED Job OPTION Option Year 1 Travel

COST

Travel requirements shall be specified in the task order. All travel will be invoiced according to the Federal Travel Regulations.

UNIT UNIT PRICE MAX AMOUNT

1006 UNDEFINED Job OPTION Opt Yr 1 Contractor Manpower Reporting

FFP

The contractor and all subcontractors, at all levels/tiers, providing direct labor under this contract shall report complete and accurate data for the labor executed during the period of performance during each Government fiscal year (FY), which runs from October 1 to September 30. The Contractor shall input the data into the appropriate Services Contract reporting tool, which can be accessed via a secure web site at http://sam.gov. Contractors may direct technical questions to the system for award management helpdesk.

UNIT UNIT PRICE MAX AMOUNT

2001 UNDEFINED Job OPTION Work Under PWS Task Area 1

FFP

Orders issued under this CLIN shall be to advise, provide input, and assist in developing FDA package submissions IAW Performance Work Statement section 3.1.

UNIT UNIT PRICE MAX AMOUNT

2002 UNDEFINED Job OPTION Work Under PWS Task Area 2

FFP

Orders issued under this CLIN shall be to perform regulatory assessments of medical product development efforts IAW Performance Work Statement section 3.2.

UNIT UNIT PRICE MAX AMOUNT

2003 UNDEFINED Job OPTION Work Under PWS Task Area 3

FFP

Orders issued under this CLIN shall be to conduct third party independent audits using certified quality auditors to evaluate a specific medical product developer’s level of compliance with respect to facility, manufacturing, QC testing and QA support consistent with current Good Manufacturing Practices (cGMPs), Good Clinical Practice (GCP), and Good Laboratory Practice (GLP) regulatory and quality requirements for manufacturing and testing MCM products IAW Performance Work Statement section 3.3.

UNIT UNIT PRICE MAX AMOUNT

2004 UNDEFINED Job OPTION Work Under PWS Task Area 4

FFP

Orders issued under this CLIN shall be to provide regulatory and quality support on-site for a specified duration to provide regulatory and quality oversight on manufacturing tasks IAW Performance Work Statement section 3.4.

UNIT UNIT PRICE MAX AMOUNT

2005 UNDEFINED Job OPTION Option Year 2 Travel

COST

Travel requirements shall be specified in the task order. All travel will be invoiced according to the Federal Travel Regulations.

UNIT UNIT PRICE MAX AMOUNT

2006 UNDEFINED Job OPTION Opt Yr 2 Contractor Manpower Reporting

FFP

The contractor and all subcontractors, at all levels/tiers, providing direct labor under this contract shall report complete and accurate data for the labor executed during the period of performance during each Government fiscal year (FY), which runs from October 1 to September 30. The Contractor shall input the data into the appropriate Services Contract reporting tool, which can be accessed via a secure web site at http://sam.gov. Contractors may direct technical questions to the system for award management helpdesk.

UNIT UNIT PRICE MAX AMOUNT

3001 UNDEFINED Job OPTION Work Under PWS Task Area 1

FFP

Orders issued under this CLIN shall be to advise, provide input, and assist in developing FDA package submissions IAW Performance Work Statement section 3.1.

UNIT UNIT PRICE MAX AMOUNT

3002 UNDEFINED Job OPTION Work Under PWS Task Area 2

FFP

Orders issued under this CLIN shall be to perform regulatory assessments of medical product development efforts IAW Performance Work Statement section 3.2.

UNIT UNIT PRICE MAX AMOUNT

3003 UNDEFINED Job OPTION Work Under PWS Task Area 3

FFP

Orders issued under this CLIN shall be to conduct third party independent audits using certified quality auditors to evaluate a specific medical product developer’s level of compliance with respect to facility, manufacturing, QC testing and QA support consistent with current Good Manufacturing Practices (cGMPs), Good Clinical Practice (GCP), and Good Laboratory Practice (GLP) regulatory and quality requirements for manufacturing and testing MCM products IAW Performance Work Statement section 3.3.

UNIT UNIT PRICE MAX AMOUNT

3004 UNDEFINED Job OPTION Work Under PWS Task Area 4

FFP

Orders issued under this CLIN shall be to provide regulatory and quality support on-site for a specified duration to provide regulatory and quality oversight on manufacturing tasks IAW Performance Work Statement section 3.4.

UNIT UNIT PRICE MAX AMOUNT

3005 UNDEFINED Job OPTION Option Year 3 Travel

COST

Travel requirements shall be specified in the task order. All travel will be invoiced according to the Federal Travel Regulations.

UNIT UNIT PRICE MAX AMOUNT

3006 UNDEFINED Job OPTION Opt Yr 3 Contractor Manpower Reporting

FFP

The contractor and all subcontractors, at all levels/tiers, providing direct labor under this contract shall report complete and accurate data for the labor executed during the period of performance during each Government fiscal year (FY), which runs from October 1 to September 30. The Contractor shall input the data into the appropriate Services Contract reporting tool, which can be accessed via a secure web site at http://sam.gov. Contractors may direct technical questions to the system for award management helpdesk.

UNIT UNIT PRICE MAX AMOUNT

4001 UNDEFINED Job OPTION Work Under PWS Task Area 1

FFP

Orders issued under this CLIN shall be to advise, provide input, and assist in developing FDA package submissions IAW Performance Work Statement section 3.1.

UNIT UNIT PRICE MAX AMOUNT

4002 UNDEFINED Job OPTION Work Under PWS Task Area 2

FFP

Orders issued under this CLIN shall be to perform regulatory assessments of medical product development efforts IAW Performance Work Statement section 3.2.

UNIT UNIT PRICE MAX AMOUNT

4003 UNDEFINED Job OPTION Work Under PWS Task Area 3

FFP

Orders issued under this CLIN shall be to conduct third party independent audits using certified quality auditors to evaluate a specific medical product developer’s level of compliance with respect to facility, manufacturing, QC testing and QA support consistent with current Good Manufacturing Practices (cGMPs), Good Clinical Practice (GCP), and Good Laboratory Practice (GLP) regulatory and quality requirements for manufacturing and testing MCM products IAW Performance Work Statement section 3.3.

UNIT UNIT PRICE MAX AMOUNT

4004 UNDEFINED Job OPTION Work Under PWS Task Area 4

FFP

Orders issued under this CLIN shall be to provide regulatory and quality support on-site for a specified duration to provide regulatory and quality oversight on manufacturing tasks IAW Performance Work Statement section 3.4.

UNIT UNIT PRICE MAX AMOUNT

4005 UNDEFINED Job OPTION Option Year 4 Travel

COST

Travel requirements shall be specified in the task order. All travel will be invoiced according to the Federal Travel Regulations.

UNIT UNIT PRICE MAX AMOUNT

4006 UNDEFINED Job OPTION Opt Yr 4 Contractor Manpower Reporting

FFP

The contractor and all subcontractors, at all levels/tiers, providing direct labor under this contract shall report complete and accurate data for the labor executed during the period of performance during each Government fiscal year (FY), which runs from October 1 to September 30. The Contractor shall input the data into the appropriate Services Contract reporting tool, which can be accessed via a secure web site at http://sam.gov. Contractors may direct technical questions to the system for award management helpdesk.

CONTRACT MINIMUM/MAXIMUM QUANTITY AND CONTRACT VALUE

The minimum quantity and contract value for all orders issued against this contract shall not be less than the minimum quantity and contract value stated in the following table. The maximum quantity and contract value for all orders issued against this contract shall not exceed the maximum quantity and contract value stated in the following table.

MINIMUM

MINIMUM

AMOUNT

MAXIMUM

QUANTITY

MAXIMUM

AMOUNT

$100,000.00 $7,043,000,000.00

Section C - Descriptions and Specifications

PERFORMANCE WORK STATEMENT

Senior Regulatory and Quality Consultants

1.0 Background

The Defense Threat Reduction Agency Research and Development Chemical and Biological Technologies Directorate (DTRA CB) is dual-hatted as the Joint Science and Technology Office for Chemical and Biological Defense (JSTO-CBD). DTRA CB is responsible for the development and integration of Science and Technology (S&T) programs, support for DoD CB Defense S&T international programs, management and integration of CB Defense Advanced Concept Technology Demonstrations, and working with the JPEO-CBRND to ensure effective transition of S&T efforts to advanced development.

The Joint Program Executive Office for Chemical, Biological, Radiological, and Nuclear Defense (JPEO-CBRND) mission is to provide Research, Development, Acquisition Fielding and Life-Cycle Support of Chemical, Biological, Radiological and Nuclear Defense Equipment, Medical Countermeasures (MCM) and Installation and Force Protection Integrated Capabilities Supporting the National Strategies.

Both the JSTO-CBD and JPEO-CBRND fall under the Department of Defense Chemical and Biological Defense Program (CBDP). The One Network of Excellence for Regulatory Affairs and Quality Assurance (ONE-RAQA) was established in 2018 to address regulatory and quality issues across MCM development lifecycle to augment current acquisition system decision making. The Senior Director Medical Regulatory (SDMR) / Senior Regulatory Advisor reports directly to the Director, JSTO-CBD and the JPEO-CBRND Milestone Decision Authority. The Senior Medical Regulatory Director leads a multidisciplinary group of regulatory subject matter experts that fall within ONE-RAQA. ONE-RAQA provides independent assessments of regulatory risk and regulatory risk mitigation strategies and serves as the regulatory voice to DoD leadership and FDA for MCMs.

Per DoDI 6200.02, unapproved medical products may be administered or used as part of Force Health Protection programs, when in compliance with DoDI 6200.02, with the approval of the Assistant Secretary of Defense for Health Affairs (ASD(HA)) under an FDA regulatory mechanism for emergency use. The Secretary of the Army is the Lead Component for development of medical protocols and regulatory submissions to the FDA in coordination with ASD (Health Affairs) for such products. This authority is delegated to the Medical Research and Development Command (MRDC) to serve on behalf of the Surgeon General as the sponsor's representative and the Office of Regulated Activities serves the role to ensure Sponsor’s Responsibilities for the Office of the Surgeon General-sponsored FDA regulated products. Since there are instances where CBRND medical products are OTSG-sponsored, the SDMR and ONE- RAQA provide advice and consultation to MRDC ORA and MRDC ORA provides operational regulatory and quality support to CBRN medical countermeasure development.

2.0 Objective

The objective of this contract is to provide very senior regulatory and quality consultation services to ONE-RAQA to support its mission in development, delivery and maintenance of medical capabilities across the CBDP that are aligned to U.S. Food and Drug Administration regulations, guidance, and policies. The consultation services shall support regulatory and quality assessments and site visits/audits to cover a range of regulatory and quality components across the phases of medical product development activities from discovery through post-marketing, as well as enabling tools (i.e. non-clinical/clinical trial designs, animal model development, assay models, unique statistical analyses) that support the development of medical products. Medical products include drugs, biologics, medical devices, platform technologies, and consideration of enabling tools necessary for the development of medical products. The assessments and audits may include a single SME involvement or a blue-ribbon panel of SMEs and include all or some of the following components: domestic and international regulatory intelligence, programmatic strategic planning, product regulatory and quality analysis, outreach and awareness, and workshop planning/execution and workshop synopsis.

Specific details of task assignments, deliverables, documentation, applicable government/department standards, and other supporting information, will be provided at the task order level. Below are the task areas for this contract and examples of the types of services that may be obtained under each technical area task.

3.0 Tasks Areas

The contractor shall be responsible for providing qualified personnel and program management for Task Orders issued under the following main task areas. Specific tasks, travel, deliverables and timelines will be detailed in each Task Order Performance Work Statement, Statement of Work or Statement of Objectives.

3.1 Task Area 1. Developing, providing input and advisement on FDA package submissions Task Orders under this area shall require the contractor to develop, provide input and advice on medical countermeasure product documents required for complete submission packages to the FDA (i.e., pre-EUA, EUA, p-IND, IND, BLA/NDA). This may include but no be limited to advising and developing response to questions from the FDA, and developing the table of contents (TOCs), summary sections (CTD, eCTD) and a draft cover letter for FDA submissions. For Orders issued under this task area, the contractor shall provide expert level input to non-clinical study designs, human clinical trial study designs for medical product safety and efficacy assessments at all phases of clinical development and post-market.

3.2 Task Area 2. Regulatory and/or Quality Assessments/Summaries Task Orders under this area shall require the contractor to perform regulatory assessments of medical product development efforts. The scope of orders may include tasks such as reviewing specific animal model pathways for the development of medical countermeasures or evaluating regulatory strategies for medical countermeasures.

Deliverables provided under orders issued in this task area will be used as part of the Medical Portfolio Asset Stage-Gate Structure (MEDPASS) review to JPEO-CBRND senior leaders. The MEDPASS is used as a decision supporting framework for MCM development with defined decision gates where progress towards a common goal

(fielding a product) is assessed. The ONE-RAQA Portfolio Manager leads the technical and regulatory assessment team.

Assessment includes reviewing completed and planned development activities and providing decision makers supportive regulatory and technical risk assessments to make an informed decision on the path forward for a particular candidate. Tasks for assessments shall include but not limited to comprehensive literature searches (i.e., peer-reviewed scientific research literature) and technology surveys, reviews of test data to determine alignment with Service requirements, clinical practice guidelines, independent technology readiness level assessments, responses/comments from the FDA, Chemistry, Manufacturing, Controls (CMC) assessment, Target Product Profiles and Regulatory Strategies.

3.3 Task Area 3. Site Visits/Audits

Task Orders issued under this task area require the contractor to conduct third party independent audits using certified quality auditors to evaluate a specific medical product developer’s level of compliance with respect to facility, manufacturing, QC testing and QA support consistent with current Good Manufacturing Practices (cGMPs), Good Clinical Practice (GCP), and Good Laboratory Practice (GLP) regulatory and quality requirements for manufacturing and testing MCM products (herein after referred to as the “Quality Audit”). Audits shall identify potential gaps in the Quality System. Each Task Order issued under this area will include specific language regarding audit capabilities, and a description of Government coordination with the developer to ensure that all information necessary to accomplish this task shall be made available to the contractor assisting with the audit. Kick-off meeting - Certified quality auditor(s) shall attend a teleconference kick-off meeting with the Government to discuss the purpose of the Quality Audit, define the scope of audit, define the audit team, define the roles and responsibilities of each member of the audit team, and project the number of days auditors will be on-site to perform the audit. The certified quality auditor who is determined to be lead auditor shall capture and deliver minutes from the kick-off meeting, prepare an audit plan and provide to the Government for review and approval.

Kick off meeting minutes within 5 business days of the kick-off meeting.

a. Quality Audit Plan - The lead certified auditor shall create a draft Quality Audit Plan based on discussions during the kick-off meeting. At a minimum, the Quality Audit Plan shall identify the purpose, scope, schedule, regulation and standards which shall be used when conducting the audit, and identify the supporting documentation required for review during the audit. The draft Quality Audit Plan shall be delivered to the Government for concurrence. Upon concurrence, the final Quality Audit Plan will be sent to the performer prior to Quality Audit. The contractor shall provide a draft Quality Audit Plan within 10 business days of the kick-off meeting. The contractor shall provide the final quality audit plan within 3 business days of receiving Government comments on the draft plan.

b. Execute Quality Audit - The certified quality auditor(s), accompanied by two (2) JPEO-CBRND regulatory subject matter experts, will perform the audit in accordance with the Quality Audit Plan at the performer facilities. Any deviations to the Quality Audit Plan shall be identified, risk assessed to the overall integrity of conducting a complete evaluation of the facility and opportunities the deviated requirement from the Quality Audit Plan may yield (i.e. increased scrutiny to achieve a more detailed assessment of the observation).

c. Quality Audit Report - Lead certified auditor(s) shall prepare and submit a draft Quality Audit Report to the Government for review, comment and concurrence.

The draft Quality Audit Report shall also take into consideration any observations and findings by the JPEO-CBRND regulatory subject matter experts. The finalized Quality Audit Report shall be submitted to the Government. Additional time for the lead certified auditor may be required to clarify findings with the performer once the final Quality Audit Report is sent to the performer.

3.4 Task Area 4: Subject Matter Expert on-site

Task Orders issued under this task area shall require the contractor to provide regulatory and quality support on-site for a specified duration to provide regulatory and quality oversight on manufacturing tasks. The contractors assigned to task orders shall be responsible for working with the product regulatory Sponsor to assist with new process/product implementations and for providing regulatory and quality support during specific phases of product development to be detailed in future task orders. An example would be to have the contractor on-site during an engineering run that is employing a new process to provide real-time expertise and regulatory risk management in coordination with the JPEO-CBRND/JSTO Senior Director Medical Regulatory.

4.0 PERSONNEL EXPERIENCE AND QUALIFICATIONS

The contractor shall provide personnel with qualifications meeting or exceeding the qualification requirements listed below, capable of performing each Task Order issued under this ID/IQ contract. Each Task Order will specify requirements for personnel experience and qualifications necessary for each task order. Each Task Order SOW/PWS/SOO will contain specific descriptions of qualifications and experience required. Previous regulatory and quality efforts to support the Senior Director Medical Regulatory included senior consultants that demonstrated some, but not all, of the following skillsets/experience:

Clinical Development Project Manager/Leader Experience in development of clinical development plans and implementing protocols through oversight of Clinical Research Organizations or identifying, executing and managing a clinical research program from Phase 1 to Phase 3. Implementation and execution or oversight of Phase IV clinical studies desired.

Experience with the development of multiple animal model plans to successfully guide development and approval of a drug or biologics with the FDA. Experience with developing and providing consultation in the execution of regulatory strategies for vaccines, orphan drugs, new mechanisms of action, rare diseases a plus.

Demonstrated experience in leading, developing and managing cross-functional Translational Teams in the execution of a development plan.

Demonstrated working knowledge of project management software (i.e. MS Project, Visio) to develop integrated development plans

Experience in conducting decision analytics and conducting risk analyses and probabilities of technical and regulatory success

Experience developing internal processes and procedures for the execution/oversight of sponsor responsibilities identified in 21 CFR, writing/reviewing/editing work objectives for clinical research organizations, developing/executing/overseeing clinical protocols

Regulatory Affairs Experience in development and execution of Regulatory strategies and Operations from late S&T through FDA approval Experience in formulating regulatory strategies and communicating with FDA both in written submissions, regulatory meetings; experience as a panel member with FDA and FDA/pharmaceutical/academia representatives

Experience in FDA drug submissions, approvals and launches, both as a regulatory SME writing submissions and as a strategic leader guiding the program

Supervisory experience of high level regulatory personnel who manage individual projects/programs that have successfully achieved FDA approval/clearance/authority.

Experience as a regulatory advisor to senior management Experience in creating and managing teams comprised of decision analysts using best practice methods of decision analytics Knowledgeable in data warehousing capabilities used to create a longitudinal comparison of portfolio and corporate history; capability of developing a web-based portfolio analysis tool for drug discovery, as well as early and advanced drug development, with enabled viewing for senior management.

Animal Rule Technical Expert Experience in development and execution of non-clinical, toxicology and pharmacology studies, including animal model drug development plans pursuant to regulatory guidelines Experience in functional and drug development project leadership Experience in animal model development that lead to successful drug submissions, approvals Experience with assessing appropriateness of animal models and appropriate application of the models in relation to the MCM maturity as well as the MCM intended end use, associated regulatory risks, realism of animal model timeline, cost realism, anticipated FDA guidance, interpretation of FDA guidance and animal model non-pivotal and pivotal animal studies risk management strategies, appropriate for the level of development.

Pharmaceutical Chemistry, Manufacturing, Controls (CMC) Regulatory Leader Experience in providing expertise regarding current Good Manufacturing Practice (cGMP) and Good Laboratory Practice (cGLP) for MCM product development; regulatory strategy;

regulatory compliance; quality assurance; regulatory risks; realism of regulatory and manufacturing timelines; cost realism; and of FDA regulatory processes, requirements, and guidance for drafting, submitting, and receiving acceptable review of CMC submissions by the FDA.

Experience with the development of thoroughly referenced documents and briefs demonstrating capability of conducting independent analysis and advisement of products’ CMC regulatory: compliance, regulatory associated risks, risk management strategies and outstanding questions, issues and options that should be discussed or considered.

Experience in all phases of manufacturing development from bench top to commercial with appropriate quality by design experience, inclusive of process, analytical development to validated state.

Medical Device Expert Experience in providing regulatory and quality oversight including successful submission applications to the FDA for pre-market clearance/approval/CLIA waiver and/or emergency use authorization

Experience with companies involved with pre-market and post market compliance for devices used to aid in the diagnosis of infectious diseases

Experience in working with interdisciplinary teams across the spectrum environmental detection, bio surveillance, and diagnostic testing.

Experience in designing and developing study protocols for the conduct of clinical evaluations for new and improved diagnostic and screening assays to detect infectious diseases

Expert level understanding of FDA regulation of novel products such as wearable medical devices

Expert level understanding of design capability, design controls, design verification, device history files, Human Factors studies, reliability as determined by Fault Tree analysis/tolerance interval methods and others to achieve five-nines reliability.

5. Deliverables Required Deliverables and delivery timeline requirements shall be defined in each issued task order.

6.0 Training and Information Access

Task orders requiring access to Government information systems shall specify the required training and access requirements in the task order requirements documents.

7.0 Contractor Manpower Reporting

Each Task Order issued under this ID/IQ shall require Contractor Manpower Reporting in accordance with the ID/IQ Contract Line Item Schedule.

Section E - Inspection and Acceptance

INSPECTION AND ACCEPTANCE TERMS

Supplies/services will be inspected/accepted at:

CLIN INSPECT AT INSPECT BY ACCEPT AT ACCEPT BY

0001 Destination Government Destination Government 0002 Destination Government Destination Government 0003 Destination Government Destination Government 0004 Destination Government Destination Government 0005 Destination Government Destination Government 0006 Destination Government Destination Government 1001 Destination Government Destination Government 1002 Destination Government Destination Government 1003 Destination Government Destination Government 1004 Destination Government Destination Government 1005 Destination Government Destination Government 1006 Destination Government Destination Government 2001 Destination Government Destination Government 2002 Destination Government Destination Government 2003 Destination Government Destination Government 2004 Destination Government Destination Government 2005 Destination Government Destination Government 2006 Destination Government Destination Government 3001 Destination Government Destination Government 3002 Destination Government Destination Government 3003 Destination Government Destination Government 3004 Destination Government Destination Government 3005 Destination Government Destination Government 3006 Destination Government Destination Government 4001 Destination Government Destination Government 4002 Destination Government Destination Government 4003 Destination Government Destination Government 4004 Destination Government Destination Government 4005 Destination Government Destination Government 4006 Destination Government Destination Government

Section F - Deliveries or Performance

DELIVERY INFORMATION

CLIN DELIVERY DATE QUANTITY SHIP TO ADDRESS DODAAC /

CAGE

0001 1 yr. ADC 0 JPEO-CBRND ONE RAQA

CHRIS DORSEY

110 THOMAS JOHNSON DRIVE

FREDERICK MD 21702

301-660-0368

W56XNH

0002 1 yr. ADC 0 (SAME AS PREVIOUS LOCATION)

0003 1 yr. ADC 0 (SAME AS PREVIOUS LOCATION)

0004 1 yr. ADC 0 (SAME AS PREVIOUS LOCATION)

0005 1 yr. ADC 1 (SAME AS PREVIOUS LOCATION)

0006 1 yr. ADC 0 (SAME AS PREVIOUS LOCATION)

1001 1 yr. AOE 1 (SAME AS PREVIOUS LOCATION)

1002 1 yr. AOE 1 (SAME AS PREVIOUS LOCATION)

1003 1 yr. AOE 1 (SAME AS PREVIOUS LOCATION)

1004 1 yr. AOE 1 (SAME AS PREVIOUS LOCATION)

1005 1 yr. AOE 1 (SAME AS PREVIOUS LOCATION)

1006 1 yr. AOE 0 (SAME AS PREVIOUS LOCATION)

2001 1 yr. AOE 1 (SAME AS PREVIOUS LOCATION)

2002 1 yr. AOE 1 (SAME AS PREVIOUS LOCATION)

2003 1 yr. AOE 1 (SAME AS PREVIOUS LOCATION)

2004 1 yr. AOE 1 (SAME AS PREVIOUS LOCATION)

2005 1 yr. AOE 1 (SAME AS PREVIOUS LOCATION)

2006 1 yr. AOE 0 (SAME AS PREVIOUS LOCATION)

3001 1 yr. AOE 1 (SAME AS PREVIOUS LOCATION)

3002 1 yr. AOE 1 (SAME AS PREVIOUS LOCATION)

3003 1 yr. AOE 1 (SAME AS PREVIOUS LOCATION)

3004 1 yr. AOE 1 (SAME AS PREVIOUS LOCATION)

3005 1 yr. AOE 1 (SAME AS PREVIOUS LOCATION)

3006 1 yr. AOE 0 (SAME AS PREVIOUS LOCATION)

4001 1 yr. AOE 1 (SAME AS PREVIOUS LOCATION)

4002 1 yr. AOE 1 (SAME AS PREVIOUS LOCATION)

4003 1 yr. AOE 1 (SAME AS PREVIOUS LOCATION)

4004 1 yr. AOE 1 (SAME AS PREVIOUS LOCATION)

4005 1 yr. AOE 1 (SAME AS PREVIOUS LOCATION)

4006 1 yr. AOE 0 (SAME AS PREVIOUS LOCATION)

Section G - Contract Administration Data

CLAUSES INCORPORATED BY REFERENCE

52.232-20 Limitation Of Cost APR 1984 52.232-22 Limitation Of Funds APR 1984 252.201-7000 Contracting Officer's Representative DEC 1991 252.204-7006 Billing Instructions OCT 2005 252.231-7000 Supplemental Cost Principles DEC 1991 252.232-7003 Electronic Submission of Payment Requests and Receiving

Reports

DEC 2018

252.232-7007 Limitation Of Government's Obligation APR 2014

CLAUSES INCORPORATED BY FULL TEXT

52.216-18 ORDERING. (AUG 2020)

(a) Any supplies and services to be furnished under this contract shall be ordered by issuance of delivery orders or task orders by the individuals or activities designated in the Schedule. Such orders may be issued from the day of contract award through the date of contract expiration.

(b) All delivery orders or task orders are subject to the terms and conditions of this contract. In the event of conflict between a delivery order or task order and this contract, the contract shall control.

(c) A delivery order or task order is considered "issued" when--

(1) If sent by mail (includes transmittal by U.S. mail or private delivery service), the Government deposits the order in the mail;

(2) If sent by fax, the Government transmits the order to the Contractor's fax number; or

(3) If sent electronically, the Government either--

(i) Posts a copy of the delivery order or task order to a Government document access system, and notice is sent to the Contractor; or

(ii) Distributes the delivery order or task order via email to the Contractor's email address.

(d) Orders may be issued by methods other than those enumerated in this clause only if authorized in the contract.

**Addendum to 52.216-18** Ordering Instructions For each order contemplated under this ID/IQ, the Government will issue a request for quote accompanied by a performance work statement/statement of work/statement of objectives that describes, at a minimum, the technical nature of the task and all deliverables.

The contractor shall provide a response to the Government’s request within five days of receipt of the request, unless otherwise granted an extension. The response shall contain the following:

1) A discussion on the approach to complete the task(s)

2) A project timeline to complete the task(s)

3) Proposed personnel to complete the task(s). Personnel shall be proposed according to the labor categories agreed to under this ID/IQ. Information such as resumes or discussions on proposed personnel should provide enough information for the Government to determine that the personnel meet the qualifications and experience listed in the ID/IQ labor category descriptions and that they are likely to successfully complete the task(s).

4) A price proposal which states a breakout of the labor categories proposed, fully burdened labor rates according to the information listed in this ID/IQ, hours per category, and travel if applicable. Travel costs must be supported with data showing how the proposed travel was calculated including quotes, GSA per diem rates, and other data as necessary.

The Government will review the data provided under each task order to determine if it is reasonable and likely to result in successful performance.

A task order will be issued in accordance with the terms stated above only at that time in which the Government has found the technical approach and personnel to be sound and the price fair and reasonable.

(End of clause)

52.216-19 ORDER LIMITATIONS (OCT 1995)

(a) Minimum order. When the Government requires supplies or services covered by this contract in an amount of less than 10,000.00 (insert dollar figure or quantity), the Government is not obligated to purchase, nor is the Contractor obligated to furnish, those supplies or services under the contract.

(b) Maximum order. The Contractor is not obligated to honor -

(1) Any order for a single item in excess of $7,000,000.00;

(2) Any order for a combination of items in excess of $7,000,000.00; or

(3) A series of orders from the same ordering office within 2 days that together call for quantities exceeding the limitation in paragraph (b) (1) or (2) of this section.

(c) If this is a requirements contract (i.e., includes the Requirements clause at subsection 52.216-21 of the Federal Acquisition Regulation (FAR)), the Government is not required to order a part of any one requirement from the Contractor if that requirement exceeds the maximum-order limitations in paragraph (b) of this section.

(d) Notwithstanding paragraphs (b) and (c) of this section, the Contractor shall honor any order exceeding the maximum order limitations in paragraph (b), unless that order (or orders) is returned to the ordering office within 1 day after issuance, with written notice stating the Contractor's intent not to ship the item (or items) called for and the reasons. Upon receiving this notice, the Government may acquire the supplies or services from another source.

252.232-7006 WIDE AREA WORKFLOW PAYMENT INSTRUCTIONS (DEC 2018)

(a) Definitions. As used in this clause—

“Department of Defense Activity Address Code (DoDAAC)” is a six position code that uniquely identifies a unit, activity, or organization.

“Document type” means the type of payment request or receiving report available for creation in Wide Area WorkFlow (WAWF).

“Local processing office (LPO)” is the office responsible for payment certification when payment certification is done external to the entitlement system.

“Payment request” and “receiving report” are defined in the clause at 252.232-7003, Electronic Submission of Payment Requests and Receiving Reports.

(b) Electronic invoicing. The WAWF system provides the method to electronically process vendor payment requests and receiving reports, as authorized by Defense Federal Acquisition Regulation Supplement (DFARS) 252.232- 7003, Electronic Submission of Payment Requests and Receiving Reports.

(c) WAWF access. To access WAWF, the Contractor shall—

(1) Have a designated electronic business point of contact in the System for Award Management at https://www.sam.gov; and

(2) Be registered to use WAWF at https://wawf.eb.mil/ following the step-by-step procedures for self-registration available at this web site.

(d) WAWF training. The Contractor should follow the training instructions of the WAWF Web-Based Training Course and use the Practice Training Site before submitting payment requests through WAWF. Both can be accessed by selecting the “Web Based Training” link on the WAWF home page at https://wawf.eb.mil/.

(e) WAWF methods of document submission. Document submissions may be via web entry, Electronic Data Interchange, or File Transfer Protocol.

(f) WAWF payment instructions. The Contractor shall use the following information when submitting payment requests and receiving reports in WAWF for this contract or task or delivery order:

(1) Document type. The Contractor shall submit payment requests using the following document type(s):

(i) For cost-type line items, including labor-hour or time-and-materials, submit a cost voucher.

(ii) For fixed price line items—

(A) That require shipment of a deliverable, submit the invoice and receiving report specified by the Contracting Officer.

(Contracting Officer: Insert applicable invoice and receiving report document type(s) for fixed price line items that require shipment of a deliverable.)

(B) For services that do not require shipment of a deliverable, submit either the Invoice 2in1, which meets the requirements for the invoice and receiving report, or the applicable invoice and receiving report, as specified by the Contracting Officer.

(Contracting Officer: Insert either “Invoice 2in1” or the applicable invoice and receiving report document type(s) for fixed price line items for services.)

(iii) For customary progress payments based on costs incurred, submit a progress payment request.

(iv) For performance based payments, submit a performance based payment request.

(v) For commercial item financing, submit a commercial item financing request.

(2) Fast Pay requests are only permitted when Federal Acquisition Regulation (FAR) 52.213-1 is included in the contract.

[Note: The Contractor may use a WAWF “combo” document type to create some combinations of invoice and receiving report in one step.]

(3) Document routing. The Contractor shall use the information in the Routing Data Table below only to fill in applicable fields in WAWF when creating payment requests and receiving reports in the system.

Routing Data Table will be filled out for each task order issued under this ID/IQ*

Field Name in WAWF Data to be entered in WAWF

Pay Official DoDAAC ____

Issue By DoDAAC ____

Admin DoDAAC** ____

Inspect By DoDAAC ____

Ship To Code ____

Ship From Code ____

Mark For Code ____

Service Approver (DoDAAC) ____

Service Acceptor (DoDAAC) ____

Accept at Other DoDAAC ____

LPO DoDAAC ____

DCAA Auditor DoDAAC ____

Other DoDAAC(s) ____

(*Contracting Officer: Insert applicable DoDAAC information. If multiple ship to/acceptance locations apply, insert “See Schedule” or “Not applicable.”)

(**Contracting Officer: If the contract provides for progress payments or performance-based payments, insert the DoDAAC for the contract administration office assigned the functions under FAR 42.302(a)(13).)

(4) Payment request. The Contractor shall ensure a payment request includes documentation appropriate to the type of payment request in accordance with the payment clause, contract financing clause, or Federal Acquisition Regulation 52.216-7, Allowable Cost and Payment, as applicable.

(5) Receiving report. The Contractor shall ensure a receiving report meets the requirements of DFARS Appendix F.

(g) WAWF point of contact.

(1) The Contractor may obtain clarification regarding invoicing in WAWF from the following contracting activity’s WAWF point of contact.

(Contracting Officer: Insert applicable information or “Not applicable.”)

(2) Contact the WAWF helpdesk at 866-618-5988, if assistance is needed.

Section I - Contract Clauses

CLAUSES INCORPORATED BY REFERENCE

52.203-18 Prohibition on Contracting With Entities That Require Certain

Internal Confidentiality Agreements or Statements-- Representation

JAN 2017

52.204-13 System for Award Management Maintenance OCT 2018 52.212-4 Contract Terms and Conditions--Commercial Items OCT 2018 52.216-22 Indefinite Quantity OCT 1995 52.217-5 Evaluation Of Options JUL 1990 52.229-12 Tax on Certain Foreign Procurements JUN 2020 52.232-40 Providing Accelerated Payments to Small Business

Subcontractors

DEC 2013

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 252.204-7003 Control Of Government Personnel Work Product APR 1992 252.204-7008 Compliance With Safeguarding Covered Defense Information

Controls

OCT 2016

252.204-7012 Safeguarding Covered Defense Information and Cyber Incident Reporting

DEC 2019

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

MAY 2016

252.205-7000 Provision Of Information To Cooperative Agreement Holders DEC 1991 252.209-7004 Subcontracting With Firms That Are Owned or Controlled By

The Government of a Country that is a State Sponsor of Terrorism

MAY 2019

252.219-7003 Small Business Subcontracting Plan (DOD Contracts) DEC 2019 252.222-7006 Restrictions on the Use of Mandatory Arbitration Agreements DEC 2010 252.225-7001 Buy American And Balance Of Payments Program-- Basic DEC 2017 252.225-7002 Qualifying Country Sources As Subcontractors DEC 2017 252.225-7012 Preference For Certain Domestic Commodities DEC 2017 252.225-7048 Export-Controlled Items JUN 2013 252.226-7001 Utilization of Indian Organizations and Indian-Owned

Economic Enterprises, and Native Hawaiian Small Business Concerns

APR 2019

252.232-7010 Levies on Contract Payments DEC 2006 252.232-7017 Accelerating Payments to Small Business Subcontractors--

Prohibition on Fees and Consideration

APR 2020

252.235-7011 Final Scientific or Technical Report DEC 2019 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 OCT 2020

CLAUSES INCORPORATED BY FULL TEXT

52.204-22 ALTERNATIVE LINE ITEM PROPOSAL (JAN 2017)

(a) The Government recognizes that the line items established in this solicitation may not conform to the Offeror's practices. Failure to correct these issues can result in difficulties in acceptance of deliverables and processing payments. Therefore, the Offeror is invited to propose alternative line items for which bids, proposals, or quotes are requested in this solicitation to ensure that the resulting contract is economically and administratively advantageous to the Government and the Offeror.

(b) The Offeror may submit one or more additional proposals with alternative line items, provided that alternative line items are consistent with subpart 4.10 of the Federal Acquisition Regulation. However, acceptance of an alternative proposal is a unilateral decision made solely at the discretion of the Government. Offers that do not comply with the line items specified in this solicitation may be determined to be nonresponsive or unacceptable.

(End of provision)

52.204-24 REPRESENTATION REGARDING CERTAIN TELECOMMUNICATIONS AND VIDEO

SURVEILLANCE SERVICES OR EQUIPMENT (OCT 2020)

The Offeror shall not complete the representation at paragraph (d)(1) of this provision if the Offeror has represented that it "does not provide covered telecommunications equipment or services as a part of its offered products or services to the…