Sol Doc_A1_SOW_1223623.pdf

FDA-RFP-20-1223623 – Attachment 1 - SOW

Center for Drug Evaluation and Research

Office of Compliance

Center of Excellence on Compounding for Outsourcing Facilities

Statement of Work (SOW)

FDA-RFP-20-1223623 – Attachment 1

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Table of Contents

1 Introduction _________________________________________________________________ 4

1.1 Background ____________________________________________________________________ 4

1.2 Objective ______________________________________________________________________ 5

2 Description of Work - Scope ____________________________________________________ 6

2.1 Tasks For Period Of Performance _________________________________________________ 6

2.1.1 Task 1: Project Management Support, Planning, and Outreach __________________________________ 6

2.1.2 Task 2: In-Person Practical Training _______________________________________________________ 7

2.1.2.1 Lab-Based Training __________________________________________________________________ 8

2.1.2.2 Training on Investigations and CAPA ___________________________________________________ 9

2.1.3 Task 3: Web-based Training for External Stakeholders _______________________________________ 10

2.1.4 Task 4: Annual Outsourcing Facility Conference ___________________________________________ 10

2.1.5 Task 5: Evaluation and Assessment ______________________________________________________ 11

2.1.6 Task 6: Continuation of Training Roadmap ________________________________________________ 12

2.1.7 Task 7: Follow-on Environmental Scan and Analysis ________________________________________ 13

2.1.8 Task 8: Advancement of the Center of Excellence___________________________________________ 13

2.2 Deliverables and Schedule _______________________________________________________13

2.2.1 Deliverables and Schedule – Specified in Table 1 ___________________________________________ 13

2.2.2 Inspection and Acceptance _____________________________________________________________ 17

2.3 Tasks For Option Years _________________________________________________________18

2.3.1 Task 1: Project Management Support, Planning, and Outreach _________________________________ 18

2.3.2 Optional Task 2: In-Person Practical Training ______________________________________________ 19

2.3.2.1 Lab-Based Training _________________________________________________________________ 19

2.3.2.2 Classroom-based training ____________________________________________________________ 20

2.3.3 Optional Task 3: Web-based Training for External Stakeholders _______________________________ 21

2.3.4 Optional Task 4: Annual Outsourcing Facility Conference ____________________________________ 22

2.3.5 Optional Task 5: Evaluation and Assessment _______________________________________________ 23

2.3.6 Optional Task 6: Follow-on Environmental Scan and Analysis ________________________________ 24

2.3.7 Optional Task 7: Continuation of Training Roadmap ________________________________________ 25

2.3.8 Optional Task 8: Advancement of the Center of Excellence ___________________________________ 25

3 Period of Performance _______________________________________________________ 26

4 Place and Time of Performance ________________________________________________ 27

5 Government Furnished Equipment and Vendor Supplied Equipment __________________ 28

5.1 Key Personnel / Staffing _________________________________________________________29

5.2 Key Personnel Position Description _______________________________________________30

5.2.1 Senior Project Manager ________________________________________________________________ 30

5.2.2 Training Expert ______________________________________________________________________ 31

5.2.3 Survey and Research Expert ____________________________________________________________ 31

5.2.4 Pharmaceutical Manufacturing and Quality Expert __________________________________________ 32

6 Technical Leads _____________________________________________________________ 33

7 Security ____________________________________________________________________ 34 A. Baseline Security Requirements _________________________________________________________ 34 B. Training ____________________________________________________________________________ 38

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C. Rules of Behavior ____________________________________________________________________ 38 D. Incident Response ____________________________________________________________________ 38 E. Position Sensitivity Designations __________________________________________________________ 40 F. Homeland Security Presidential Directive (HSPD)-12 _________________________________________ 40 G. Contract Initiation and Expiration ________________________________________________________ 40 H. Records Management and Retention ______________________________________________________ 41

8 Access To Non-Public Information _____________________________________________ 42

9 Conformance with Applicable Laws, Regulations, Policies, and Standards ______________ 43

9.1 Contractor Compliance _________________________________________________________43

9.2 Section 508 Standard Compliance _________________________________________________43

10 Contracting Administration __________________________________________________ 44

10.1 Appendix A: List of Acronyms __________________________________________________44

10.2 Appendix B: Electronic and Information Technology Accessibility ____________________44

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1 INTRODUCTION

1.1 BACKGROUND

The U.S. Food and Drug Administration (FDA) is responsible for protecting the public health by assuring the safety, efficacy and security of human and veterinary drugs, biological products, medical devices, the nation’s food supply, cosmetics and products that emit radiation. The FDA is also responsible for advancing the public health by helping to speed innovations that make biologics, medicines and foods more effective, safer and more affordable; and helping the public access accurate science-based information for drug products and foods. The FDA’s mission is to ensure the safety purity, potency, and effectiveness of all regulated products. The agency is committed to providing the public with accurate, timely and easy to understand information on agency policies, programs and actions.

The Center for Drug Evaluation and Research’s (CDER) mission is to protect and promote public health by helping to ensure that human drugs are safe and effective for their intended use, meet established quality standards and are available to patients.

CDER’s Office of Compliance (OC) plays a critical role in protecting and promoting public health by shielding patients from poor quality, unsafe and ineffective drugs. The complexity of the human drug supply and development pipeline and the global nature of the regulated industry present unprecedented challenges to effective regulatory oversight. CDER’s Office of Compliance encompasses five offices who collectively support FDA’s overall mission:

• Office of Manufacturing Quality (OMQ)

• Office of Unapproved Drug Labeling and Compliance (OUDLC)

• Office of Drug Security, Integrity and Response (ODSIR)

• Office of Scientific Investigations (OSI)

• Office of Program and Regulatory Operations (OPRO)

• Program Management and Analysis Staff (PMAS)

CDER’s Office of Compliance, as well as other offices in CDER (such as the Office of Pharmaceutical Quality) and other offices at the FDA (such as the Office of Regulatory Affairs) work together to advance FDA’s work related to drug compounding.

Drug compounding is generally the practice of combining, mixing, or altering ingredients of a drug or active pharmaceutical ingredient (bulk drug substance) to create a medication tailored to the needs of an individual patient. Although compounded drugs can serve an important medical need for certain patients when an approved drug is not medically appropriate, they also present a risk to patients.

Compounded drugs are not FDA-approved. Therefore, they do not undergo premarket review by FDA for safety, effectiveness, and quality. Since compounded drugs are subject to a lower regulatory standard than approved drugs, Federal law places conditions on compounding that are designed to protect the public health.

The Drug Quality and Security Act of 2013 created “outsourcing facilities” – a new industry sector of drug compounders held to higher quality standards to protect patient health. Outsourcing facilities are intended to offer a more reliable supply of compounded drugs needed by hospitals, clinics, and

P a g e 5 | 46 other providers. Five years since its creation, this domestic industry is still relatively small (approximately 70 entities) and is experiencing growth and market challenges. FDA continues to find concerning quality and safety problems during inspections.

To help this industry meet its intended function, FDA intends to engage in a number of initiatives to address challenges and support advancement. These include the development and provision of practical and virtual training, as well as focused research to better understand barriers that impede growth and formulate potential solutions.

1.2 OBJECTIVE

The objective of the SOW is to conduct multiple specialized virtual trainings, develop web-based educational modules, gather intelligence on the outsourcing community, and continue the groundwork to establish and operationalize a Center of Excellence for engagement with Compounding Outsourcing Facilities. Training will initially be provided in a virtual environment, but may transition to in-person, onsite training at a later date at the FDA’s discretion when the COVID-19 related issues subside. FDA’s focus on product quality is the agency’s top priority to mitigate the risks of compounded drugs, including those produced by outsourcing facilities. The foundation of these trainings and educational opportunities for outsourcing facilities and state partners will focus on the principles of current good manufacturing practice requirements. All task areas will contribute to the development and operationalization of FDA’s first Center of Excellence model for the outsourcing community.

The key objectives of this effort shall be to:

• Conduct two instructor-led, live, virtual practical trainings on a sterile drug processing or environmental control-related topics TBD, and investigations and CAPA. Training will initially be provided in a virtual environment, but may transition to in-person, onsite training at a later date at the FDA’s discretion when the COVID-19 related issues subside;

• Create public-facing web-based training content for three training areas and post to an FDA designated web-based training application, following 508-compliance standards;

• Develop a roadmap for future online training modules with possible wireframes and mock-ups, as well as future in-person practical trainings;

• Analyze external data sources, and conduct focus groups, interviews, and survey(s) to execute a focused environment scan (landscape study) of the outsourcing facility sector, to clarify findings from previous studies and better understand barriers to market entry and opportunities associated with both the outsourcing facility industry and FDA/outsourcing facility interactions;

• Develop recommendations for ways that FDA might address any barriers identified from the environmental scan (landscape study), focus groups, interviews and survey(s);

• Plan and execute a two-day year-end conference for information sharing between FDA and Outsourcing Facilities and;

• Develop a charter and five-year strategic plan for the Compounding Quality Center of Excellence.

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2 DESCRIPTION OF WORK - SCOPE

The Office of Compliance (OC) will be overseeing this contract and will work in collaboration with other FDA entities including OPQ and ORA. FDA’s commitment to outsourcing facilities is a testament to its public health mission in keeping drugs safe. This important effort requires the expertise and support of experienced consultants to conduct and develop training content, advise on framework and governance models for Center of Excellence (CoE), strategic planning for future phases of the CoE, planning of a year-end conference, Environmental Scan and research on the compounding industry, logistical support, and project management for trainings and year-end educational conference, services for web-based trainings and communications support for all of these work areas. All tasks areas within this order will collectively establish the foundation for building a sustainable CoE model for the FDA. Lessons learned from each sub task will be leveraged to create a final CoE instance for the Outsourcing Facilities.

The Contractor shall participate in FDA meetings in a variety of training, project management, strategic planning, and consulting-related capacities, as needed and directed by the FDA Contracting Officer’s Representative (COR) The tasks in this Statement of Work (SOW) are structured around clearly defined activities but allow for flexibility and innovation to rapidly address new and emerging issues, FDA’s strategic priorities, and priorities of HHS.

2.1 TASKS FOR PERIOD OF PERFORMANCE

This SOW seeks support for the following tasks: instructor led, live virtual training and content development, developing web-based trainings and content development, planning a year-end conference, conducting a follow-on study to a previously conducted environmental scan on the compounding outsourcing facility industry, laying the groundwork for a Center of Excellence (CoE), project management support, communications and outreach, and strategic planning for the next phase of FDA’s engagement with outsourcing facilities. Training will initially be provided in a virtual environment, but may transition to in-person, onsite practical and lab-based training at a later date at the FDA’s discretion when the COVID-19 related issues subside.

2.1.1 Task 1: Project Management Support, Planning, and Outreach The task requires an experienced project management team to oversee parallel workstreams throughout the contract year. Ongoing tasks may include the development of training content, planning a year-end conference, event logistics and registration for virtual (or, if applicable in-person) trainings and the year-end conference, strategic planning for the Center of Excellence, outreach to training and conference attendees, travel coordination, administering evaluations after each training, incorporating feedback into future sessions, development and execution of outsourcing facility market research, planning and executing an overarching communications and outreach plan, and continuous communications with the FDA COR and project team. The contractor shall provide frequent operational support across all workstreams. Specifically, the contractor shall:

• Develop a draft comprehensive project management plan, describing the tasks to be accomplished, projected timelines/schedule, proposed working processes as well as change

P a g e 7 | 46 management, work product review by technical and project leads, and how the work plan fits into the larger scope of the award. The Contractor shall submit this plan to the COR within 15 business days of the effective date of this contract. Contractor shall submit a final plan within five (5) business days after the Government’s review of the draft is provided, and shall update project management plan on a weekly basis to reflect, as relevant, the real-time progress of the project and reflect any changes to timelines and schedules that may become necessary;

• Delineate which project manager is responsible for overseeing each task. The project managers shall work directly with Project and Technical Leads;

• Ensure a robust process for quality control for work products provided under each task;

• In consultation with Drug Manufacturing Quality Expert described in Key Personnel below, identify and secure appropriately qualified subject matter experts that will provide ongoing support and specialized expertise that aligns with the technical areas applicable to each individual technical course. The Contractor shall ensure a sufficient number of such experts to provide substantial support, including expert review, editing and, as need, drafting, for each specialized training course offered under this contract. The qualifications and experience of the experts will be reviewed by the FDA to ensure appropriate subject matter expertise;

• Develop and update on a monthly basis, a Staffing Roster document identifying all personnel (including subcontracted) working on the contract and their assigned functions.

• Establish a schedule for practical virtual (or, as applicable, in-person) trainings and develop and execute an outreach plan to communicate, in conjunction with FDA, training opportunities to outsourcing facility participants and, when seats are available, to state regulator participants or other stakeholders;

• Develop, in conjunction with FDA subject matter experts, an outreach plan to encourage outsourcing facility and stakeholder attendance at a two-day year-end in-person or virtual conference as well as handling registration and logistics;

• Facilitate strategic planning for the Center of Excellence and;

• Develop an overarching outreach and internal/external communications plan geared toward increased positive engagement with the outsourcing facility sector.

2.1.2 Task 2: Instructor-Led, Live Virtual Practical Training The Contractor shall conduct two instructor-led, live virtual trainings on topics to be determined, including one new lab-based training developed during the contract period as well as sessions of existing lab-based trainings, and one lecture-focused course on corrective and preventative actions and investigations. The contractor shall offer multiple sessions of each course as described below.

Training will initially be provided in a virtual environment, but may transition to in-person, onsite training at a later date at the FDA’s discretion when the COVID-19 related issues subside. Course topics will be finalized based on a previously developed roadmap geared toward training for outsourcing facilities.

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The contractor shall maintain a roster to track all participants and their organizations. Priority seating will be offered to outsourcing facilities and remaining spots will be offered to state and federal regulators and other stakeholders at FDA’s discretion through a lottery process developed by the contractor. Attendees will not be charged a fee to attend the trainings.

The contract shall include limited travel funds for state and federal regulatory workers, should the courses move to an in-person format, to be distributed through the previously mentioned lottery. If additional travel funds are remaining, they may be offered to outsourcing facilities through the same lottery process. The contractor shall maintain accurate accounting of travel for each training. Virtual trainings will also be recorded, to afford FDA future use of training content, as appropriate.

2.1.2.1 Virtual Lab-Related Training

The Contractor shall conduct instructor-led, live virtual training using a combined teaching approach of lab-based, videotaped demonstration and virtual instruction methods. Training will initially be provided in a virtual environment, but may transition to in-person, onsite training at a later date at the FDA’s discretion when the COVID-19 related issues subside. These trainings shall include one new lab-related training developed during the contract period as well as sessions of existing courses on sterile drug compounding, environmental monitoring, or cleanroom design. The projected time frame for each training is 4.5 days. Training shall be conducted by FDA-reviewed industry experts specializing in such training or subject matter. Specifically, the contractor shall:

• Develop one new instructor-led, live lab-related course utilizing existing materials as available and modify to accommodate FDA’s regulatory requirements and policies specific to outsourcing facilities utilizing a subject matter expert external to FDA with knowledge and experience in the specific technical areas applicable to the course;

facilitate direct working sessions between FDA and these SMEs to develop the course;

• Host three (3) separate virtual training sessions of this new course, staggered throughout the period of performance serving at least 50 students total. Training will initially be provided in a virtual environment, but may transition to in-person, onsite training at a later date at the FDA’s discretion when the COVID-19 related issues subside;

• Host six (6) separate instructor-led, virtual lab-related training sessions of existing courses staggered throughout the period of performance (including sterile drug compounding, environmental monitoring, or cleanroom design as determined by FDA) serving at least 100 students total. Training will initially be provided in a virtual environment, but may transition to in-person, onsite training at a later date at the FDA’s discretion when the COVID-19 related issues subside;

• Administer and produce an evaluation report after each session 15 business days after the end of each session;

• If applicable, identify and utilize an interactive web-based platform to facilitate virtual training;

• Ensure CE credit is available to participants for the training, prior to any course launch;

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• Manage training logistics including outreach, invitations, travel (when applicable) and communication throughout the process;

• Make travel accommodations for up to 20 travelers, including airfare, ground transportation and up to 5 nights of lodging in accordance with GSA rates;

• Generate lessons learned, including consideration of FDA feedback, for inclusion into the CoE model and;

• Report evaluation results to FDA.

2.1.2.2 Training on Investigations and CAPA

The Contractor shall conduct instructor-led, live virtual trainings using a combined teaching approach of videotaped demonstration and virtual instruction methods. Training will initially be provided in a virtual environment, but may transition to in-person, onsite training at a later date at the FDA’s discretion when the COVID-19 related issues subside; This training will focus on the function of the quality unit, how to conduct investigations of complaints and out-of-specification results, root cause analysis, and corrective and preventative actions (CAPA). The projected time frame for this training is 4.5 days. Training shall be conducted by FDA-reviewed industry experts specializing in how to conduct investigations of complaints, out-of-date specifications results, conducting root cause analysis, as well as inspections and corrective and preventive actions. Specifically, the contractor shall:

• Utilize existing investigations, CAPA and quality training materials and modify to accommodate FDA’s regulatory requirements and policies specific to outsourcing facilities utilizing a subject matter expert external to FDA with knowledge and experience in the specific technical areas applicable to the course; facilitate direct working sessions between FDA and these SMEs to develop the course;

• Host two (2) separate investigations and CAPA training sessions, staggered throughout the contract period of performance serving at least 70 students total;

• If applicable, identify and utilize an interactive web-based platform to facilitate virtual training;

• Ensure CE credit is available to participants for the training, prior to any course launch;

• Administer and produce an evaluation report after each session 15 business days after the end of each session;

• Manage training logistics including outreach, invitations, travel (when applicable) and communication throughout the process;

• Make travel accommodations for up to 15 travelers, including airfare, ground transportation and up to 3 nights of lodging;

• Generate lessons learned, including consideration of FDA feedback, for inclusion into the

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2.1.3 Task 3: Web-based Training for External Stakeholders

The Contractor shall develop content utilizing existing FDA material for three (3) web-based trainings sessions. The trainings shall be open-access and intended for use by outsourcing facilities, other compounders, state regulators, and other interested stakeholders. Each training session shall require multiple modules, as determined by the training consultant and FDA’s subject matter experts. The FDA will leverage the TRAIN Learning Network as the training platform for external stakeholders.

All training work products shall comply with 508-compliance regulations and other appropriate access guidelines. Specifically, the contractor shall:

• Develop three web-based courses on topics to be determined likely based upon roadmap developed in a previous contract and; Develop and execute an outreach plan to communicate availability of web-based trainings to outsourcing facilities, other compounders, state regulators, and other interested stakeholders and;

• Develop the course utilizing FDA staff as well as utilizing a subject matter expert(s) external to FDA with knowledge and experience in the specific technical areas applicable to the course; facilitate direct working sessions between FDA and these SMEs to develop the course;

• Ensure CE credit is available to participants for the training, prior to any course launch and;

• Assist with the establishment and assignment of role-based privileges and permissions for each training type.

2.1.4 Task 4: Annual Outsourcing Facility Conference

The Contractor shall develop and execute a year-end conference for outsourcing facilities to engage the sector on issues related to outsourcing facilities and drug production as well as educate the sector on relevant policy matters and FDA oversight approaches. Conference length, location, in-person vs virtual format, content and topics are to be determined; however, the size and scope shall be similar to the previous conference. If the previous conference was by virtual format, the size and scope for the current conference may need to be changed for an in-person format.

Approximately 350 attendees from current and prospective outsourcing facilities, state/federal regulators, as well as other potential stakeholder groups may participate. As part of the FDA’s commitment to educating the outsourcing community, the FDA shall host a conference to engage the sector on issues related to outsourcing facilities and drug production as well as to educate the sector on relevant policy matters and FDA oversight approaches. In-person vs virtual format of the conference will be determined based on conditions related to the COVID-19 pandemic or similar event during the period of performance and with approval of FDA.

Content topics may include, but are not limited to, key and recent policies related to compounding issued by FDA; CGMP for outsourcing facilities; process design and use of automation technology by outsourcing facilities; FDA inspectional process for outsourcing facilities; interactions with FDA during and after inspections, including responses to FDA Form 483s and warning letters, and pre-operational meetings with FDA; additional potential opportunities for increased feedback and engagement; COVID-19, and other topic areas that are identified through other contract tasks. Details

P a g e 11 | 46 gathered from training sessions and interviews with outsourcing facilities, state regulators and other stakeholders will be used to solidify the conference agenda and format.

Specifically, the contractor shall:

• Identify key conference topics, develop an agenda, identify presenters (including FDA presenters and external presenters)

• Design interactive sessions such as breakout sessions and tabletop discussions, or equivalent virtual sessions, as applicable;

• If applicable, identify and utilize an interactive web-based platform to facilitate a virtual conference;

• Develop and execute a communication and outreach plan to promote the conference to outsourcing facilities and other stakeholders, manage invitations and RSVPs;

• Ensure CE credit is available to participants for the training, prior to any course launch;

• If applicable, manage travel accommodations for up to 25 travelers, including presenters, consultants, and potentially other stakeholders. This shall include airfare, ground transportation and up to 2 nights of lodging;

• Prepare outward-facing conference materials, including final agenda, participant list, background materials. Provide materials in digital form to participants, as well as certain printed materials;

• Facilitate conference sessions as needed, take notes, record and prepare summaries of discussions;

• Administer an evaluation after the conference session;

• Generate lessons learned, including consideration of FDA feedback, for inclusion into the

2.1.5 Task 5: Evaluation and Assessment

The Contractor shall gather measurements of the level of participation in each in-person or virtual training such as the number of outsourcing facilities represented, or other relevant measures identified by the contractor and agreed upon by FDA. In addition, the Contractor shall administer an evaluation/assessment at the end of each training. The results of each training session shall be summarized individually subsequent to each training to assess for any issues requiring near-term action and into one final evaluation/assessment report for future reference, decision making on future trainings, metrics generation, and enhancing FDA’s interactions with external stakeholders. Lastly, the Contractor shall recommend additional methods for measuring increases in engagement between FDA and the outsourcing facility community.

Metrics generated from these evaluations/assessments shall be used for reporting to senior leaders and congressional audiences. Measurement shall occur at timepoints throughout the contract period that are relevant to each collected measure.

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As soon as FDA’s web-based content development is completed in TRAIN and made available to the training community, the Contractor shall also evaluate the level of participation of the web-based training modules such as the number of “hits” received by each training website, or other relevant measures identified by the contractor and agreed upon by FDA. To the extent possible, audit features and capabilities of the training platform should be leveraged as much as possible. Web-based trainees shall receive an assessment after each online session, after the training sessions have been created and deployed. The Contractor shall measure all methods of trainings administered during the period of performance.

Specifically, the contractor shall:

• Refine and implement methods for measuring the level of participation of outsourcing facilities and other entities for in-person or virtual trainings, online trainings, any surveys/focus groups/interviews, and the end of year conference;

• Create a final summary report submitted to the COR that includes the participation measures;

• Refine as needed methods for measuring increases in engagement between FDA and the outsourcing facility community;

• Create a final summary report submitted to the COR that includes the FDA-outsourcing facility engagement measures;

• Refine as needed questions for post-training evaluations/assessments for both in-person and web-based training;

• Refine and utilize the best instrument, such as a short survey or evaluation form, for post-training evaluations/assessments;

• Administer these instruments after each training and create a consolidated report and;

• Create a final summary report that includes details from all training session metrics, summary of accomplishments, and other quantified and qualified details for senior leadership and congressional reporting 15 days prior to end of award period to include the number of participants trained during each session, stakeholder category (e.g. state, outsourcing facilities, federal, other) and identifies key themes in written feedback from participants, including any challenges that may merit immediate action. The report should also include all accomplishments during the contract period of performance.

All web-based courses developed during this contract period of performance shall follow applicable standards of Enterprise Performance Life Cycle (EPLC), as appropriate for agile development. All web-based training shall be appropriately tested before going live. A modified user acceptance testing shall also be conducted to accommodate the agile nature of this task.

2.1.6 Task 6: Continuation of Training Roadmap

The Contractor shall continue development, in consultation with FDA, of a strategic roadmap describing future web-based and in-person practical trainings for outsourcing facilities informed by experiences in the execution of trainings under this contract, feedback obtained by participants, and landscape studies three months before the end of the contract period of performance.

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Specifically, the roadmap shall describe:

• Specific web-based trainings recommended for future development and execution, including outlines, and learning objectives;

• Specific virtual trainings recommended for future deployment, including outlines, and learning objectives. Trainings should be adaptable to in-person format so the course can be provided either virtually or in-person as circumstances related to COVID-19 allow;

• Other specific web-based or in-person educational opportunities that are recommended for ongoing, meaningful education for the outsourcing facility sector and compounders that are considering registration as outsourcing facilities.

2.1.7 Task 7: Follow-on Environmental Scan and Analysis

The Contractor shall conduct follow-on research based on previous Environmental Scan findings in areas of research as specified by the COR. Specifically, the contractor may:

• Engage in additional analysis of data gathered for previous Environmental Scans;

• Identify new or follow-on areas of research interest in conjunction with FDA;

• Analyze existing data in research areas of interest;

• Conduct focus groups, interviews, and survey(s) in research areas of interest;

• Develop a document analyzing and summarizing findings and;

• Synthesize findings and develop recommendations as well as potential program areas for the CoE, if applicable.

2.1.8 Task 8: Advancement of the Center of Excellence

The Contractor shall assist FDA in advancing the operations within the Center of Excellence. This shall include, facilitating strategic planning, and developing a charter. Specifically, the contractor shall:

• Development a three-year strategic plan for the Center of Excellence and;

• Development of a charter for the Center of Excellence in conjunction with FDA.

2.2 DELIVERABLES AND SCHEDULE

2.2.1 Deliverables and Schedule – Specified in Table 1

All deliverables as defined by this SOW shall be provided to FDA in draft electronic form for FDA’s review and comment. The FDA will review and only the Contracting Officer may request changes to the deliverable(s). Once the recommended changes are incorporated into the document, a determination will be made by the FDA COR as to if the deliverable is acceptable.

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The COR will closely monitor contractor performance through use of measures contractually in place to be able to evaluate progress and deliverables. This includes bi-weekly status reports from the Contractor, sign off on deliverables by the COR, and close examination of monthly invoices against the work performed.

Table 1: Deliverables and Schedule

Deliverable Due Date

General Contract Administration

1. Project Kick-off Meeting Within 5 business days after the contract period of performance starts

2. Government Furnished Inventory Issued after award; returned prior to end of contract

3. Meeting Agendas and Presentation Material

2 business days prior to meetings

4. Meeting Minutes 2 business days after meetings

5. Project Closeout Meeting Within 5 business days before the contract period of performance ends

Task 1: Project Management Support, Planning & Outreach

6. Draft Project Management Plan Within 15 business days after the contract period of performance starts

7. Final Project Management Plan Within 5 business days after COR review

8. Weekly Project Management Plan Update

Beginning 15 business days after the contract period of performance starts

9. Biweekly Status Reports Beginning 15 business days after the contract period of performance starts

10. Weekly Status Meetings (when required by FDA)

Beginning 15 business days after the contract period of performance starts

11. Staffing Roster, identifying all available staff and their functional responsibilities

Updated and provided to the COR monthly

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Task 2: Practical In-Person Trainings

12. Host four (4) separate sterile processing or environmental control or related topic training sessions

Staggered throughout the contract period of performance

13. Administer and produce an evaluation report after each session

15 business days after the end of each session

14. Host two (2) separate investigations and CAPA training sessions

Staggered throughout the contract period of performance

15. Administer and produce an evaluation report after each session

15 business days after the end of each session

Task 3: Annual Outsourcing Facilities Conference

16. Conference invitations sent Six months prior to conference

17. Final agenda and confirmed speakers Two months prior to conference

18. Hold end-of-year conference By end of the contract period of performance period

19. Consolidate feedback from attendees 3 days after end of conference

Task 4: Web-Based Training

20. Develop three (3) web-based courses related to drug compounding - topics TBD by FDA

Staggered throughout contract period of performance

Task 5: Evaluation and Assessment

21. Develop assessment questions for evaluations

15 business days prior to the start of the training session

22. Create a final report to include: training metrics, summary of accomplishments, and other quantified and qualified details for senior leadership and congressional reporting.

15 days prior to end of the contract period of performance

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Task 6: Continuation of Training Roadmap

23. Develop roadmap for future trainings 3 months before end of the contract period of performance

Task 7: Follow-on Environmental Scan and Analysis

24. Develop a research plan for the Environmental Scan that includes:

• Final set of research questions

• Plan for analysis of available data sources

• Plan and methodology for obtaining new data through use of interviews, focus groups and surveys.

• Draft survey instrument(s) ready for OMB review and clearance

45 days after the contract period of performance starts

25. Analyze outsourcing facility market using available data sources and develop a report of findings.

Draft: 4 months after the contract period of performance starts.

Final: 5 months after the contract period of performance starts

26. Conduct Interviews, Focus Groups, and Surveys based on questions developed in research plan.

9 months after the contract period of performance starts

27. Presentation and written summary of results and key findings from interviews, focus group discussions, and surveys

10 months after award.

28. Develop a report that: synthesizes and summarizes all research for the Environmental Scan including data analysis, surveys, focus groups, and interviews; highlights any significant barriers or other issues identified as a result of the research; makes recommendations for addressing the issues; and identifies potential program

Draft: 45 days before contract period of performance ends Final: 15 days before contract period of performance ends

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Task 8: Advancement of the Center of Excellence

29. Develop a Charter for the Compounding Quality Center of Excellence

6 months after contract period of performance starts

30. Develop a three-year strategic plan for the Compounding Quality Center of Excellence.

1 month before end of the contract period of performance

DELIVERABLE DELIVERY ADDRESS

Unless otherwise specified, all deliverables shall be delivered to:

FDA, CDER, Office of Compliance ATTN: Mark Agnello 10903 New Hampshire Ave Silver Spring, MD 20993 Bldg. 51, Room 5261 Telephone: (301) 348-1833 Email: Mark.Agnello@fda.hhs.gov

2.2.2 Inspection and Acceptance

The Government shall review all reporting requirement deliverables in accordance with specifications and standards identified in the statement of work or any directives issued by the Contracting Officer Representative (COR). Reporting Requirements/Deliverables shall be submitted to the COR or government designee in accordance to the delivery schedule. The acceptance of deliverables and satisfactory work performance, required herein, shall be based upon the timeliness and accuracy of the deliverables.

The Contractor shall share information and provide full access to documentation while delivering integrated, cohesive business and technology services. Work products developed under this contract shall be owned by the Government and shall not be labeled ‘copyright’ or ‘proprietary’ or anything similar that might preempt the desired environment of fluid sharing and partnership.

Acceptance is only by indication in writing by the Contracting Officer, COR or the duly authorized representative within 10 business days of receipt.

The Contractor shall implement necessary changes within 10 business days, or a mutually agreed upon period, from the day of change notification.

The COR or the duly authorized representative shall perform inspection and acceptance of materials and services.

mailto:Mark.Agnello@fda.hhs.gov

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Inspection and acceptance shall be performed at: 10903 New Hampshire Avenue, Silver Spring, Maryland 20993.

2.3 TASKS FOR OPTION YEARS

At the end of the initial contract period of performance FDA may elect to exercise option year(s).

The option year would involve extending and expanding upon the work conducted in the initial contract period of performance. Specifically, the contractor could be involved in any or all of the following: project management support, planning, and outreach; conducting in-person practical training; planning and executing a year-end outsourcing facility conference; developing a web-based training for external stakeholders; and advancement of the Center of Excellence. Training will initially be in-person, but may be converted to and delivered in a virtual format at any time during the period of performance at FDA’s discretion depending upon current conditions related to the COVID-19 pandemic. With the exception of Project Management Support, Planning and Outreach, all tasks in this section are optional, and subject to change prior to the start of each option year.

2.3.1 Task 1: Project Management Support, Planning, and Outreach The task requires an experienced project management team to oversee parallel work streams throughout the option year. Ongoing tasks may include the development of training content, planning a year-end conference, event logistics and registration for in person or virtual trainings and the year-end conference, strategic planning for the Center of Excellence, outreach to training and conference attendees, travel coordination, administering evaluations after each training, incorporating feedback into future sessions, development and execution of outsourcing facility market research, planning and executing an overarching communications and outreach plan, and continuous communications with the FDA COR and project team. The contractor shall provide frequent operational support across all work streams. Specifically, the contractor shall:

• Develop a draft comprehensive project management plan, describing the tasks to be accomplished, projected timelines/schedule, proposed working processes as well as change management, and how the work plan fits into the larger scope of the effort. This plan shall be submitted to the COR within 15 business days of the effective date of this contract. A final plan shall be submitted within five (5) business days after the Government’s review of the draft is provided, and shall update work plan on a weekly basis to reflect as relevant, the real-time progress of the project and reflect any changes to timelines and schedules that may become necessary;

• Delineate which project manager is responsible for overseeing each task. The project managers will work directly with Project and Technical Leads;

• Ensure robust process for quality control for work products provided under each task;

• In consultation with Drug Manufacturing Quality Expert described in Key Personnel below, identify and secure appropriately qualified subject matter experts that will provide ongoing support and specialized expertise that aligns with the technical areas applicable to each individual technical course. The Contractor shall ensure a sufficient number of such experts to provide substantial support, including expert review, editing and, as need, drafting, for each specialized training course offered under this contract. The qualification and experience of the experts will be reviewed by the FDA to ensure appropriate subject-matter expertise;

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• Develop and update on a monthly basis, a Staffing Roster document identifying all personnel (including subcontracted) working on the contract and their assigned functions.

• As applicable, establish a schedule for practical in-person or virtual trainings and develop and execute an outreach plan to communicate, in conjunction with FDA, training opportunities to outsourcing facility participants and, when seats are available, to state regulator participants or other stakeholders;

• Develop, in conjunction with FDA subject matter experts, an outreach plan to encourage outsourcing facility and stakeholder attendance at a two-day year-end conference as well as handling registration and logistics. Conference may be virtual or in-person. Virtual vs in-person format will be decided within the first months of each option year at FDA’s discretion depending upon circumstances related to COVID-19;

• As applicable, facilitate strategic planning for the Center of Excellence and;

• Develop an updated overarching outreach and internal/external communications plan geared toward increased positive engagement with the outsourcing facility sector.

2.3.2 Optional Task 2: In-Person Practical Training

The Contractor shall conduct on-site trainings with multiple sessions on topics TBD, including one new lab-based training developed during the contract year as well as sessions of existing lab-based trainings, and one classroom-focused course. The contractor shall offer multiple sessions of each course as described below. Course topics will be finalized based on the roadmap developed in the initial contract period of performance and geared toward outsourcing facilities. Trainings may be converted to and delivered in an instructor-led, live virtual format at any time during the period of performance at FDA’s discretion based on current conditions related to COVID-19.

The contractor shall maintain a roster to track all participants and their organization. Priority seating will be offered to outsourcing facilities and remaining spots will be offered to state and federal regulators and other stakeholders at FDA’s discretion through a lottery process developed by the contractor. Attendees will not be charged a fee to attend the trainings.

The contract shall include limited travel funds for state and federal regulatory workers and other stakeholders, to be distributed through the previously mentioned lottery. If additional travel funds are remaining, they may be offered to outsourcing facilities through the same lottery process. The contractor shall maintain accurate accounting of travel for each training. Virtual trainings will be recorded, to afford FDA future use of training content, as appropriate.

2.3.2.1 Lab-Based Training

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The Contractor shall conduct on-site training using a combined teaching approach of lab-based and classroom methods. These trainings shall include one new lab-related training developed during the contract period as well as sessions of existing courses on sterile drug compounding, environmental monitoring, or cleanroom design. The projected time frame for each training is 4.5 days. Training shall be conducted by FDA reviewed industry experts specializing in such training or subject matter.

Trainings may be converted to and delivered in an instructor-led, live virtual format at any time during the period of performance at FDA’s discretion based on current conditions related to COVID-19.

• Develop one new in-person lab-based course utilizing existing training materials as available and modify to accommodate FDA’s regulatory requirements and policies specific to outsourcing facilities utilizing a subject matter expert with knowledge and experience in the specific technical areas applicable to the course; facilitate direct working sessions between FDA and these SMEs to develop the course. Course may be converted to and delivered in an instructor-led, live virtual format at any time during the period of performance at FDA’s discretion based on current conditions related to COVID-19;

• Host three (3) separate lab-based training sessions of this new course, staggered throughout the period of performance serving at least 50 students total. If courses changed to an instructor-led, live virtual format, virtual course sessions accommodating an equivalent total number of students will be conducted;

• Host six (6) separate lab-based training sessions of existing courses staggered throughout the period of performance (including sterile drug compounding, environmental monitoring, or cleanroom design as determined by FDA) serving at least 100 students total.