Draft BTEC SOW.pdf

Statement of Work for the Biomanufacturing Principles and Processes Curriculum Contract

B ackground

The Office of Regulatory Affairs (ORA), an Office of the U.S. Food and Drug Administration (FDA), coordinates domestic and foreign inspectional, quality and investigational activities across the field and at headquarters. In addition, ORA works closely with the Center for Drug Evaluation & Research (CDER) and the Center for Veterinary Medicine (CVM) on compliance and enforcement activities and to implement policies related to the Pharmaceutical program.

The Office of Training, Education, and Development (OTED), within ORA, trains field and headquarter investigators and analysts to conduct inspections of biopharmaceutical and pharmaceutical manufacturing processes and practices for compliance with good manufacturing practices (GMP) regulations. The trainees for the Biomanufacturing Principles and Processes Curriculum will typically have 5 or more years of agency experience and hold a Bachelor of Science degree. Some will have a background in chemistry, biochemistry, microbiology or engineering.

OTED worked with an outside vendor to create a set of courses to provide investigators additional biological therapeutic drug training with the objective of exposing course participants to:

o Product o Product development o Facility and equipment design o Technology transfer o Manufacturing processes o Analytical testing methods

The four courses developed for this series are:

o Quality Control/Analytical Testing o Upstream Bioprocessing o Downstream Bioprocessing o Aseptic Processing

Students must complete all four courses within 12 months. The courses included web-based, classroom, and hands-on training.

Each course allowed for a maximum enrollment of 15 students, took place over a five-week period, and required 32 contact hours. A total of eight contact hours were provided via online instruction over the first four weeks of the course. The remaining 24 hours of instructional time took place over three days onsite at the contractor’s facility in the fifth and final week of the course.

Objective

OTED is interested in working with an institution that does not create/produce products that are or will be regulated by the FDA and/or marketed or introduced to the market and thus regulated by FDA. The objective of this project is for a contractor to deliver the four-course training curriculum, developed under a different contract by a different source, to Food and Drug Administration (FDA) investigators. The curriculum is designed to give investigators a greater understanding of biomanufacturing principles and processes, to include facility equipment design, product manufacturing processes, and analytical testing methods.

The curriculum shall be delivered via distance learning technologies, classroom instruction coupled with practical experience in the vendor’s facilities. Multiple contracts may be awarded and students will complete the entire 4 course series from an individua l contractor.

Scope

The contractor shall deliver c u r r i c u l u m s via distance learning, followed by classroom instruction, coupled with practical experience. Course delivery shall consist of asynchronous web-based, synchronous web-based, synchronous classroom and laboratory training and the development of comprehensive instructor and participant guides to go with the delivery of the synchronous classroom and laboratory training with respect to the manufacture of biological l therapeutic drugs. ORA employees will have access to the web from their desktop. ORA employees will travel to the vendor’s facilities for the on-site portion of the training.

Tas ks

The biomanufacturing principles and processes curriculum will be comprised of asynchronous web-based training, synchronous web-based training, and classroom training. The contractor shall perform each of the following tasks within the parameters outlined in this section.

The scope of work section details the overall requirements for delivering the biomanufacturing principles and processes curriculum and developing the accompanying instructor and participant guides for that curriculum. The instructional areas to be covered in four courses include, but are not limited to:

o Quality Control o Analytical Testing o Upstream Bioprocessing o Downstream Bioprocessing o Aseptic Processing

The contractor will deliver web-based modules and classroom training which will allow FDA inspectors to experience the production of biological therapeutic drug products thereby enabling them to better understand the manufacturing processes and provide them with the skills and knowledge to determine areas of highest risk. The contractor shall develop instructional and participant guides for the curriculum.

The Contractor shall furnish the necessary personnel, materials, services, and facilities, to perform the work described herein. Instructors and contract personnel must be experienced in the development and presentation of adult education. In addition, instructors must possess both academic and workplace experience in biotechnology/pharmaceutical production and development that prepared them for teaching in a university environment.

The contractor shall organize, coordinate, and control all program activities to ensure compliance with the contract requirements and the timely delivery of the required product and services specified herein. The Contractor shall provide the necessary qualified personnel to provide instructional courses in Biotechnology/Pharmaceutical Training. The contractor shall provide the necessary system engineering, design engineering, hardware, software, personnel, supervision, management, materials, services, equipment, facilities, testing, technical, logistics, safety and clerical support necessary to perform the tasks described in this

SOW.

Kick-off Meeting The project kick-off meeting will be held at 11919 Rockville Pike in Rockville, MD 20852, but can be attended virtually. The contractor, Project COR, Project Manager, and OTED will attend the kick-off meeting to discuss the Project Management Plan, the courseware review process, instructional design strategies, project schedule, and the roles and responsibilities of all parties involved to ensure all personnel share the same level of understanding with respect to the goals, requirements, and complexities of the project. This conference will be held within 15 working days after contract award. The meeting will not exceed one day in duration.

Project Management Plan (PMP)

The contractor shall develop and electronically deliver a Project Management Plan (PMP). The PMP shall detail processes, schedules, and milestones for the contract deliverables for review by OTED. The PMP shall describe in detail how work will be accomplished and explain the management and technical processes, procedures, methodologies and tools for contract performance. The PMP shall include a risk management plan that describes risk minimization and control. The PMP shall detail the schedule for developing and implementing the curriculum in a “phased-in” approach.

If the government enters into option years of the contract, the class schedule shall be gradually adjusted to allow the final class to complete all of the 4-course series in biomanufacturing principles and processes before the contract is finished at the end of the last option year.

The contractor will implement a process that allows OTED to review and comment on the implementation of the web-based and classroom materials. When the first course is completed, it will be available for student enrollment while the remaining courses are still in their various phases of implementation. The review and comment capabilities will allow the government to view and comment on the following course elements:

o Agenda o Classroom handouts o Instructional strategies for web-based, classroom, and laboratory instruction o Assessment strategy o Course evaluation strategy o Alpha version of all web-based and classroom materials

Course Materials

The contractor shall utilize the course materials given to them by OTED personnel to design the look of the course materials. The contractor shall meet with appropriate OTED personnel to clarify any information in the given course materials. In the analysis section of the project, the contractor may perform several different types of analyses depending upon the specific objectives of a given project. The analysis phase will include a review of the content, instructional objectives, and development of the instructional strategies for each topic. OTED and the contractor will review the proposed course schedule and agendas and determine if additional topics will be added to the curriculum and existing topics updated or deleted.

The visual design of training materials shall involve the development of templates for the online training materials. The contractor shall submit template designs and prototype content to OTED for approval prior to the final deliverable. The contractor shall screen capture and print examples of all images and templates to be used in the final courses.

For the synchronous web-based component of the curriculum, the given course materials will describe the following:

o Webinar objectives o Interface design for the webinar o Webinar course outline o Sample visual aids o Webinar schedule

For the classroom component of the curriculum, the information provided will describe the following:

o Course objectives o Classroom exercises guides and instructions o List of materials to be used

For the hands-on component of the curriculum, OTED will provide:

o Objectives o Outline of the instructional activities o Hands-on activities o Schedule of events

The contractor will review the course materials implemented under the guidance of the course guides with OTED prior to the courses beginning.

Training Materials and Multimedia Assets

The contractor shall provide all assets necessary for performance that are not provided by OTED (i.e., photographs, graphics, animation, video, audio, etc.). The contractor will ensure compliance with all copyright laws for all assets used. The contractor shall provide release forms for copyrighted materials to OTED for all content not developed by OTED. Personnel release forms must be obtained for the use of images for personnel who appear in the course materials.

Photos or media obtained from the Internet or stock media galleries must be identified by website/software/company, file name, and permission granted. The contractor should not assume that media files appearing on FDA sites or other media sources are “owned” by the FDA and are free of copyright restrictions.

HTML Requirements

- The courseware will conform to HTML5 or the most recent version of HTML on the date the contract is awarded. Sharable Content Objects (SCOs) will be produced and tagged at the unit, module, lesson, and topic level and all media assets will be tagged to include:

video, graphics, animation, and audio when used as or to support content.

Meta-data Tagging

- The contractor shall tag electronic assets and SCOs that are capable of being reused or repurposed. The contractor shall produce the required metadata files for all training products.

Browser and Mobile Data Compatibility

- All web-based components shall be developed to operate with Internet Explorer version

11and Firefox version 60.0.2.

Reusable Learning Objects

- All new courseware developed for this contract will be structured in the form of Reusable

Learning Objects (RLOs). The web-based courses shall include, but are not limited to, the following features:

o Report whether the student has completed the topic when “Exit Topic” (or similar text) is activated.

o If a student has not completed the topic upon exiting, the RLO should report bookmarking data to the Learning Management System (LMS).

o When the student re-enters the RLO, the RLO should query the LMS for the bookmarking data.

o Upon receipt of the bookmarking data from the LMS, the user should be directed to the topic and screen he/she last visited before exiting the lesson.

Prototype

- The prototype for the asynchronous web-based component will be a topic from one of the courses. Included in the prototype will be a demonstration of screen layouts and templates, interface design, instructional strategies, question items, and other major functional components. All features and functions of the final course shall be demonstrated, including transitions, remediation, and feedback.

- The contractor shall deliver the courseware prototype via a test website to OTED for review. The website must be accessible to OTED personnel. The date of posting materials on the website shall be considered the date of delivery.

- The prototype must follow and demonstrate adherence to Section 508 compliance guidelines. The contractor must provide 508 test logs for the prototype that verify compliance to Section 508 requirements.

- All prototype assets (e.g., graphics, audio files, video files, etc.) will be delivered with the finished prototype.

- A prototype of the participant guide that will be used for the classroom component will be submitted for review. The prototype will be a topic from one of the courses. Included in the prototype will be a demonstration of page layouts, instructional strategies, instructional graphics/photos, and question items.

- The contractor may make changes to material in the prototypes to reflect the equipment used in the contractor’s facilities that is different from past facilities equipment.

Preliminary and Final Course Material

Upon OTED approval of the prototype, the contractor shall commence work on the development of the asynchronous web-based modules for the synchronous web-based component and the classroom training based on already developed course training. The schedule for this development and review will be outlined in the contractor’s Project Management Plan. The contractor shall incrementally deliver electronic preliminary modules for each completed lesson and revised content to OTED for review.

- As shown in the provided curriculum materials, the modules for the web-based courses must contain the following instructional screens and descriptions:

o Introduction o Objectives o Screen text (course content) o Summary o Description of the visuals that will be used o Assessment items o Description of interactive elements o Section 508 instructions o Navigation information o Programmer instructions o Artist instructions

- As shown in the provided curriculum materials, each classroom script must contain the following:

o Objectives o Content o Descriptions of visuals o Instructional activities o Test items

- The contractor will subject all preliminary modules to a copy edit review to ensure proper grammar, punctuation, continuity, and content clarity.

- All accompanying assets (e.g., graphics, audio files, video files, etc.,) will be delivered with the finished course.

- All assessment questions, answer keys and scoring systems will be delivered with the finished course.

Content Integrity

The Contractor shall ensure that the developed content functions as designed within the policies and restrictions of the FDA network and FDA issued computers and is free of elements that might be detrimental to the secure operation of the resource operating system, including those listed below:

o Malicious code o Trojans, worms, logic bombs, and other computer viruses o Backdoors o Ad-ware, Spy-ware, or web bugs that have the ability to track user behavior o Code that permits functions that are beyond the actual publicized intent of application capability o Software that will not function properly with the operating system configured securely o Code that permits functions that are beyond the actual publicized intent of application capability

The alpha version of the web-based courses will be tested on computers configured to FDA standards and delivered via the FDA network. The vendor is not to develop the courseware to exceed FDA standards or develop the courseware in a way that requires students to view it on computers that exceed the minimum technical requirements.

Implementing and Evaluating Courseware

During the development, implementation, and evaluation phases of the project, the Contractor will notify OTED of any bugs or defects in the courseware. The contractor shall develop an Implementation and Evaluation Plan that specifies the process to be used by the contractor to oversee the implementation of the web-based courseware. The Implementation and Evaluation Plan will be included in the PMP.

On-site Classroom Training

- This course’s on-site portion will take place at one location. The contractor must have a learning space large enough to teach between 10-25 students per course each year.

- The contractor must develop a comprehensive instructor guide and participant guide to go with the provided curriculum of the synchronous classroom and laboratory training. The contractor will implement a process that allows OTED to review and comment on the development of the participant and instructor guide.

- The contractor will provide instruction that addresses the manufacturing of biological therapeutic drugs as per the provided curriculum. It is the expectation that the curriculum delivered by the contractor reflects the current knowledge base in the field of biomanufacturing. Contractor is requested to provide updates to curriculum if current practices are out of date. The contractor is permitted to change the curriculum to reflect the equipment, materials and specialties of the contractor’s facilities.

Curriculum Maintenance

The contractor will perform an annual review of the curriculum content and ensure that it reflects the current science that is being taught in the areas of biomanufacturing principles and processes.

The content review will also incorporate student feedback.

The contractor will perform an annual review of the hardware, software, SCORM and Section 508 requirements needed to deliver the curriculum.

After the curriculum is implemented, the contractor will maintain, revise, and update all electronic and classroom materials. All content revisions and updates will be coordinated through the OTED Project Manager.

Registration

- After students register for classes with OTED, their names and email addresses will be forwarded to the contractor. The contractor will provide the students with the web address and necessary information for accessing the online components of the c u r r i c u l u m . It is the contractor’s responsibility to track the attendance of the students attending the classroom component of the curriculum and forward that information to the Project Manager at OTED.

Web Based Training

OTED will provide the contractor with all pre-course web modules, past webinars, hand- outs, slides and any other developed course materials. The contractor will write the instructor and participant guides based on the already developed course content that will be provided.

The contractor shall provide practical experience (manufacturing and laboratory environments) that leverages and reinforces the knowledge gained through the web-based training. After the student completes the curriculum, the student should be able to apply the knowledge and skills gained to the inspection of a biopharmaceutical manufacturing facility.

The contractor’s laboratory facilities s h a l l include equipment that reflects the current science in the biomanufacturing industry.

Course Assessments

- The contractor will be responsible for implementing assessments for the web-based and classroom components of the curriculum. Assessments for the web-based asynchronous component will be implemented at the module level and may offer multiple attempts at the correct answer before moving on to the next topic. The questions developed for the assessments will be related directly to the learning outcomes. Students must obtain the set minimum score (to be determined by the contractor) for each of the web-based modules in order to move forward and attend the instructor-led classroom sessions. Students must obtain the set minimum score (to be determined by the contractor) for the classroom component in order to receive a certificate of completion. If students do not pass the course tests, a remediation plan will be implemented pulling information from the assessments to help students work to comprehend the concepts and information with which they are struggling.

- The government will provide the computers and network access for students to attend web-based learning.

- OTED will track student course completion using the attendance records supplied by the contractor.

On-site Instructor Led Training

This section identifies the types of content that will be incorporated into the on-site portion of the biomanufacturing principles and processes curriculum. The contractor will develop a participant guide and instructor guide and implement other training materials such as interactive laboratory activities, handouts, and slide shows.

- All materials developed and/or used in the on-site courses will be made available to participants upon completion of the course (CD, DVD, downloadable from website, etc.).

Electronic resource materials include participant guides, video clips, visual aids, photographs technical manuals, graphics, video clips and other miscellaneous classroom resource materials.

- OTED will review delivery design for on-site training and provide comments to the contractor.

- The contractor shall supply necessary qualified personnel to provide practical, hands-on instructional services in the manufacturing environment.

- The classroom component of the curriculum will contain a final assessment for determining the students’ level of mastery of the learning outcomes. Each test item will utilize an assessment strategy that is appropriate for measuring comprehension of the knowledge/skills needed for each objective. This might necessitate the development of both knowledge-based and performance-based assessments. If students do not pass the final course assessment, the contractor will implement a remediation plan to help students obtain the necessary knowledge for meeting the minimum competency requirements. The assessment strategies used for determining the minimum passing scores and student remediation will be detailed in the document and will be reviewed by OTED for acceptance.

- Depending on the course content, the contractor shall provide classroom training coupled with practical manufacturing experience. The practical component of the instruction should provide ORA employees with a setting that better prepares them to conduct inspections of biological therapeutic drug manufacturing firms.

- The Government will provide funding for student travel, lodging, and meals for the on-site component of the course.

Web Based Training

- The contractor will post and maintain the web-based components on a web server accessible by the government for the duration of the contract. As course materials are completed, they will be posted on this site for OTED to review in accordance with the approved schedule. In-Progress Reviews (IPRs) will be held via web conference to review to-be-implemented courseware components.

- The contractor shall supply necessary qualified personnel to provide instructional services in the design and delivery of web-based component of the curriculum.

- The contractor shall supply knowledgeable IT person to define the requirements for accessing the web-based training and to further work with FDA IT once the contract is awarded. OTED will provide the contractor with FDA IT contact information. The contractor shall work with FDA IT personnel to address security and delivery issues of the web-based components.

- Web-based components of the course shall be delivered in a synchronous/asynchronous fashion to the student’s personal computers.

- During the quality assurance process, the contractor will notify OTED of any bugs or defects in the courseware and updates on when the issues were resolved.

Asynchronous Web-Based Training

- The contractor will present asynchronous web-based courses for each of the courses in the curriculum. Each web-based course will be comprised of multiple modules. The approximate seat time for each module is 2 hours. The estimated seat time for each web-based course is 6-8 hours. Each module will be available anytime of the day within a specified calendar period. For example, modules will be available from June 20th, 2020 – June 24th,2020 if the classroom course takes place from June 24-28,2020.

- The asynchronous web-based component will be implemented a t a Level II interactivity category. Standard navigation controls (e.g., Back, Next, Glossary, Menu, etc.) are not considered interactive elements. Types of interactive elements may include but are not limited to: links that review additional content; animation control buttons, submenu links that branch to additional information, test questions, and “click-and-see” activities. The contractor can provide additional options as to the types, and location, of interactive activities.

- The web-based courseware shall be presented in an open architecture, non-proprietary environment. The courseware will be HTML-based (e.g., XHTML), will meet Levels 1 and 2 interactivities, and will apply the Shareable Content Object Reference Model to ensure that it is (SCORM) conformant. Metadata will be generated to provide the LMS with additional information about each RLO (topic) and multimedia asset.

- OTED will review content, layout, and delivery mechanism for distance learning courses and provide comments to the contractor.

- The contractor will deliver the hierarchy of web-based courses so that the content is divided into logical chunks of information (e.g., course, module, lesson, topic). The contractor will design the web-based course(s) so that users are not required to view every screen within the topics. Users will also have the option of skipping over screens that contain branching to several sub-topic sections. The curriculum will be programmed to make the Next button available at all times while within a topic. Students will have the option of selecting individua l modules and lessons within each course.

- The expectation is that the student will be able exit the asynchronous course and upon re-entry be directed to the screen last viewed.

- Graphics and photographs of an instructional nature will be used to clarify complex concepts and to show manufacturing processes. These graphics and photographs should reflect the equipment and processes at the contractor’s biotech facility.

- The courseware must contain a glossary section.

- The help section of the courseware will provide students with network assistance as well as additional navigational instruction, assistance with the course website, and courseware guidance.

- Each module within a course will include an assessment activity. Students will be given two opportunities to pass the online tests with an established minimum score. If a student fails to pass after two attempts, the instructor who will teach the same content for the classroom component will contact the student to provide coaching, remediation and/or clarification. If the instructor believes the student has grasped the concepts of the module, he/she will be permitted to attend the classroom component. Another objective of the online assessments is to assist students with their learning plan by identifying areas of weakness and recommending topics for remediation prior to attending the classroom component. Users will have the option to not view each lesson within a module, or each topic within a lesson, before taking the assessments. Assessment results will include feedback for each answer.

Synchronous, Instructor-Led Web-Based Training

- The contractor will implement and present a synchronous, instructor-led webinar for each course based on OTED’s course guide. The synchronous portion of the web-based training will take place within a week after the time allotted for completion of the asynchronous web-based modules. This session will allow participants to discuss course content and ask questions related to the previously-completed asynchronous session in preparation for the face-to-face portion of each unit. The web-based synchronous (webinar) component of the curriculum will be held one week before the classroom component. The web-based synchronous component shall be offered at several different times during the week to accommodate the work schedules of the participants.

508 Compliance

352.239-74 Electronic and Information Technology Accessibility.

As prescribed in HHSAR 339.203-70(b), insert the following clause:

Electronic and Information Technology Accessibility (December 18, 2015)

(a) Pursuant to Section 508 of the Rehabilitation Act of 1973 (29 U.S.C. 794d), as amended by the Workforce Investment Act of 1998, all electronic and information technology (EIT) supplies and services developed, acquired, or maintained under this contract or order must comply with the “Architectural and Transportation Barriers Compliance Board Electronic and Information Technology (EIT) Accessibility Standards” set forth by the Architectural and Transportation Barriers Compliance Board (also referred to as the “Access Board”) in 36 CFR part 1194. Information about Section 508 is available at http://www.hhs.gov/web/508. The complete text of Section 508 Final Provisions can be accessed at http://www.access-board.gov/guidelines-and-standards/communications-and-it/about-the-section- 508-standards.

(b) The Section 508 accessibility standards applicable to this contract or order are identified in the Statement of Work or Specification or Performance Work Statement. The contractor must provide any necessary updates to the submitted HHS Product Assessment Template(s) at the end of each contract or order exceeding the simplified acquisition threshold (see FAR 2.101) when the contract or order duration is one year or less. If it is determined by the Government that EIT supplies and services provided by the Contractor do not conform to the described accessibility standards in the contract, remediation of the supplies or services to the level of conformance specified in the contract will be the responsibility of the Contractor at its own expense.

(c) The Section 508 accessibility standards applicable to this contract are:

• Must meet WCAG 2.0 A and AA

• E101.2 Equivalent Facilitation (Appendix A, Application and Scoping Requirements)

• E203 Access to Functionality (Appendix A, Application and Scoping Requirements)

• E204 Functional Performance Criteria (Appendix A, Application and Scoping Requirements)

• E205 Electronic Content (Appendix A, Application and Scoping Requirements)

• 302 Functional Performance Criteria (Appendix C, Functional Performance Criteria and Technical

Requirements)

• Electronic content must be accessible to HHS acceptance criteria. Checklist for various formats are available at http://508.hhs.gov/, or from the Section 508 Coordinator listed at https://www.hhs.gov/web/section-508/additional-resources/section-508-contacts/index.html.

Materials that are final items for delivery should be accompanied by the appropriate checklist, except upon approval of the Contracting Officer or Representative.

• E208 Support Documentation and Services (Appendix A, Application and Scoping Requirements)

• Chapter 6 Support Documentation and Services (Appendix C, Functional Performance Criteria and

Technical Requirements)

(d) In the event of a modification(s) to this contract or order, which adds new EIT supplies or services or revises the type of, or specifications for, supplies or services, the Contracting Officer may require that the contractor submit a completed HHS Section 508 Product Assessment Template and any other additional information necessary to assist the Government in determining that the EIT supplies or services conform to Section 508 accessibility standards. Instructions for documenting accessibility via the HHS Section 508 Product Assessment Template may be found under Section 508 policy on the HHS website:

(http://www.hhs.gov/web/508). If it is determined by the Government that EIT supplies and services provided by the Contractor do not conform to the described accessibility standards in the contract, https://www.hhs.gov/grants/contracts/contract-policies-regulations/hhsar/part-339-acquisition-information-technology/index.html#339.203-70 https://www.hhs.gov/web/508 http://www.access-board.gov/guidelines-and-standards/communications-and-it/about-the-section-508-standards http://www.access-board.gov/guidelines-and-standards/communications-and-it/about-the-section-508-standards http://www.ecfr.gov/cgi-bin/text-idx?node=pt48.1.2#se48.1.2_1101 http://508.hhs.gov/ https://www.hhs.gov/web/section-508/additional-resources/section-508-contacts/index.html https://www.hhs.gov/web/508 remediation of the supplies or services to the level of conformance specified in the contract will be the responsibility of the Contractor at its own expense.

(e) If this is an Indefinite Delivery contract, a Blanket Purchase Agreement or a Basic Ordering Agreement, the task/delivery order requests that include EIT supplies or services will define the specifications and accessibility standards for the order. In those cases, the Contractor may be required to provide a completed HHS Section 508 Product Assessment Template and any other additional information necessary to assist the Government in determining that the EIT supplies or services conform to Section 508 accessibility standards. Instructions for documenting accessibility via the HHS Section 508 Product Assessment Template may be found at http://www.hhs.gov/web/508. If it is determined by the Government that EIT supplies and services provided by the Contractor do not conform to the described accessibility standards in the provided documentation, remediation of the supplies or services to the level of conformance specified in the contract will be the responsibility of the Contractor at its own expense.

(End of clause)

In-Progress Reviews (IPR)

In-Progress Reviews (IPRs) will be held via web conference to review the to-be-implemented course materials, etc. Initially one to two-hour reviews will be held bi-weekly for the first six months of the project until the all the components of the first course is released. In-Progress Reviews will be held monthly for the remainder of the 6 months. The IPRs will be stated in the PMP and will be included in the project timeline. Each IPR will be held on a date and time mutually agreeable to the Government and contractor. The IPRs will last no longer than two hours in duration.

Contractors Progress, Status, and Management Report Development

The Contractor shall be required to provide monthly progress reports to the OTED COR and Project Manager. The Government will be given 2 workdays to review the monthly progress reports. The report shall contain:

o A summary of how much of the project budget has been used o The budget estimate for each task and how much was actually spent o A summary as to how well the production schedule is being adhered to o The contract numbers o General summary information about the tasks specified in the Project Management Plan o Explanations for any dates or milestones that are not met o Other problems of contract interest

Any progress report which includes information concerning changes in contract requirements, standards, or specifications does not constitute Government Agreement to those changes. Only by direction of the Contracting Officer can such changes be made.

De live rable s

1. Instructor and Participant Guides

This deliverable includes approved instructor and participant guides and all multimedia assets used within them. Instructor and participant guides will include approved scripts, https://www.hhs.gov/web/508 approved prototype layout and all visuals needed to support them.

Listed below are the review periods for reviewing the instructor and participant guides:

o Instructor guide review – 10 business days for review o Participant guide review – 10 business days for review

2. Web Based Modules and Webinars

This includes approved web-based course modules and layout for pre-on-site course webinar.

For each of the web-based courses (i.e. alpha and beta), the contractor will develop and upload a copy of the courseware onto their server for review by OTED. Listed below are the review periods for each type of review:

o Alpha review – 2 days for each course module o Beta Review – 2 day for each course module

3. Annual Delivery of Full Couse Sequence

Contractor must annually deliver all four courses in the Biomanufacturing Principles and Processes curriculum.

4. Other Deliverables

Other deliverables include the Project Management Plan, courseware prototypes, all multimedia assets that were used to implement the web-based and classroom courses for this contract, the Quality Assurance Report, Section 508 test logs and all final course materials for this project.

This includes all source and document files used in the planning, design, development, and testing processes of the product to include but not limited to programming source code, branching/mapping files of the product, etc. This does not include pre-existing training materials that were not revised/updated to meet the terms of this contract.

All course materials need to be in accordance with the contractor’s facility and appropriate for an FDA audience.

The contractor shall deliver final courseware materials that may be easily maintained by OTED. Instructions for developing assets and making changes to the courseware for its life cycle maintenance shall be provided in the form of a “Train the Trainer” package.

Deliverable Timelines

The contractor will notify OTED’s COR as soon as possible if requested changes are unreasonable in time or scope.

The following shall be submitted by the contractor to the Project Officer at the time specified or as negotiated with the COR and/or project officer:

1. Within two (2) weeks from award of contract, the contractor and OTED will meet to discuss delivery of already developed courses. IT personnel will attend this meeting to determine FDA access to web-based training and explain FDA policies and restrictions to the contractor.

2. Within three (3) weeks from award of contract, the contractor shall consult with FDA IT to determine connectivity to contractor's web-based training and to verify that the technologies used do not conflict with FDA IT policies.

3. Within the first two (2) months of award of contract OTED will conduct an on-site visit to the contractor's facility to verify it meets all the requirements as outlined by OTED and stated in the contractor’s technical proposal.

4. Within two (2) months from award of contract, contractor shall present a schedule for

OTED concurrence for presentation of distance learning modules and classroom courses for the training of FDA inspectors.

5. Within four (4) months from award of contract, the contractor shall present for review to

OTED, the prototypes for one web-based course and one participant guide.

6. Within six (6) months from award of contract, contractor shall make available for FDA employees all components (asynchronous and synchronous web-based training, on-site training materials and lesson plans) for one course in the biomanufacturing principles and processes curriculum.

7. Within twelve (12) months from award of contract, contractor shall make all the web-based courses and classroom courses available to FDA employees.

8. Within twelve (12) months from award of contract, contractor shall supply OTED with evaluation data of all components (web-based and on-site) for all courses that have been completed by students.

Evaluation Factors

Vendor proposals in this course will be evaluated by several factors, listed below.

1. Retention of Contractor Personnel: The vendor will inform OTED of their retention rates for personnel involved in biomanufacturing principles and processes in the last 5 years.

2. Qualifications of Project Personnel: All personnel involved in the project (course design, delivery, management) must submit a CV for review by OTED staff. Couse delivery and design personnel must detail their work experience in the biotechnology and biomanufacturing field. Instructional designers and other support staff may submit a standard CV.

3. Vendor Biotechnology Experience: The vendor will inform OTED of their past experiences designing and delivering Biomanufacturing curricula. If possible, the vendor will provide samples of past work in this field.

4. Vendor Qualifications: The vendor will explain the qualifications that their institute or organization has that qualifies the vendor to design and deliver this curriculum. The vendor will document the successes of a past program with similar content and structure to OTED.

5. Emergency Turnaround: The vendor will provide a detailed plan to OTED laying out the vendor’s plan if there is an emergency on campus or with a staff member resulting in a change in class schedule or personnel.

Pe riod of Pe rformance

The period of performance is 6/1/2020 through 6/30/2021 for the base option year. This contract will also include 4 one-year option periods. The dates for the 4 one option year periods are listed below:

First option year: /1/2020 through 6/30/2022

Second option year: 6/1/2022 through 6/30/2023 Third option year: 6/1/2023 through 6/30/2024 Fourth option year: 6/1/2024 through 6/30/2025

The entire curriculum must be available for student enrollment by the end of the base year. The first course must be finalized and ready for student enrollment within 6 months from award of contract. The first cohort must complete at least half of the curriculum before the end of the base year of the contract. By the end of the fourth option year, 5 separate cohorts will have completed the entire curriculum.

Approval Autho rity

Overall coordination, final approval, and authority for this project are the responsibility of OTED and the contracting office (i.e., Office of Acquisition & Grants Services (OAGS)). OTED will serve as an integral part of the review, acceptance, and rejection process to ensure that quality training materials are delivered and installed in accordance with the defined requirements. The Contracting Officer will be the administrative point of contact at OAGS for all official correspondence and information concerning this contract. Final acceptability or unacceptability of all deliverables and tasks performed by the contractor is the responsibility of the OAGS Contracting Officer. A Contracting Officer’s Representative (COR) will be the technical lead supporting the Contracting Officer and the OTED Project Manager (PM). The PM will make performance, cost, and schedule decisions based on technical input from the COR.

Se le ction of Contractor

The selection of the contractor to perform the work of this SOW will be made according to FDA selection procedures. The final selection will be made with the concurrence and approval of

OTED.

The potential contractors will be required to submit a Technical Proposal to OAGS in response to this SOW.

OAGS will contact the contractor who has been awarded the contract. The Contracting Officer’s Representative (COR) will coordinate with the contractor and OTED to schedule the date for the Kick-Off Meeting, which will be held at 11919 Rockville Pike, North Bethesda, MD 20852, but may be attended via web conference.

Gove rnme nt Furnis he’d Prope rty

Government Furnished Material (GFM), such as existing outlines and objectives, will be furnished by OTED and will be required for the successful completion of the project. The contractor shall have use of the GFM for the duration of this delivery order. If available, OTED will provide the contractor with applicable resource and reference material. If not available, it will be the responsibility of the contractor to obtain the content necessary to develop the curriculum. The contractor will be responsible for ensuring that all images are not under copyright protection and have been legally cleared for use in biomanufacturing principles and processes curriculum.

All items provided as GFP will be marked as such and will have the name and phone number of providers on each document or item as a reference for the developer. Upon completion of the contract, the contractor shall deliver all source code, a Train the Trainer package containing all developmental source material necessary for life cycle support and return all provided GFM to the government.

Data Rights

Unlimited Rights Agreement

The Government shall receive an Unlimited Rights License in all deliverable technical data, computer software and computer software documentation. The Unlimited Rights License shall be irrevocable, fully paid up, perpetual and world-wide. For example, the Government will not pay royalties, recurring license fees, or run-time fees, use taxes, or any similar additional payments to the contractor for the approved and final content generated under this contract. Furthermore, the contractor may not use any multimedia software packages for production, authoring, or presentation to produce, modify, view or execute the content – whether in progress or final – if such software requires that the Government pay a royalty after delivery including any running or recurring royalty, special license fee, run-time fee, use tax, or any similar additional payment to any organization including but not limited to the contractor, any third-party provider, including a provider of commercial computer software. Any third-party license that is procured must be irrevocable, fully paid-up, perpetual, and world-wide and must be authorized by the Contracting Officer.

The Government shall receive an Unlimited Rights License in all metadata-tagged assets within the developed content and the required source files (unlocked or fully layered and with the creation software identified) which are necessary for lifecycle management of the assets and any other data used or needed to design, develop, display, deliver, or manage the final and approved content. The Unlimited Rights License shall be irrevocable, fully paid up, perpetual and world- wide.

All materials created under this contract will become the property of the U.S. Government. All materials should be provided in Microsoft Office 2003 format (i.e., Excel, Word, PowerPoint, etc.) or using current Government standard software products.

Licensing/Ownership Rights

All technical data and computer software, including but not limited to source files, 2D and 3D imagery, 3D models and wire-frames, video, audio, animations, design documentation, other support documentation and content, developed by the contractor under this contract are contemplated to be developed with Government funding and not private funding. Therefore, the Government shall obtain an Unlimited Rights License to all such technical data and computer software. If the contractor is involved in any future efforts with the Government, pursuant to the Government’s Unlimited Rights as provided for under this Contract, the contractor warrants that the Government shall not be charged again for the technical data and computer software developed under this contract when provided to, or expected to be used by, or for the use by any Government agency, organization including, but not limited to any modifications, including derivative works, and any integrated products created through a non-segregable interface to the technical data or computer software.

Delivery of Training Materials and Files

No proprietary software will be developed that prevents OTED from using/repurposing any training materials or files developed under the terms of this contract. At the conclusion of the contract, OTED will own and take delivery (supplied via CD-ROMs and DVDs) of all project files and training materials developed and delivered under this contract. Included in this delivery are all instructional materials, source files used in the development of the web-based and classroom courses in both original layers and compressed file types, as well as all files used in the planning, design, development, and production processes of the courseware to include but not limited to programming source code, branching/mapping files of the courseware, and storyboards, etc. The contractor shall deliver to the government any as well as all design and development materials that may contain information necessary for future updates to the courseware. These materials shall be delivered in the form of a Life Cycle Manager’s notebook for management and archival storage upon completion of this project. Pre-existing courses and training materials that are not revised for this contract are not considered to be government property.

Appe ndice s

Appendix A: Example of Synchronous Instructor-Led Web-Based Training (pre-course webinar) Appendix B: Example of Asynchronous Web-Based Training for Aseptic Processing course Appendix C: Slides from On-Site Course Training with accompanying laboratory hand-out assignment (Endotoxins from the Aseptic Processing course) Appendix D: Agenda for Aseptic Processing course