FDA_RFI_SOW_75F40124Q00013.docx

Center for Drug Evaluation and Research Office of Compliance: Office of Unapproved Drugs and Labeling Compliance

Reducing Risks of Compounded Drugs: Online Training Support

Statement of Work (SOW)

Table of Contents

Introduction 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, they meet established quality standards and that they are available to patients.

CDER’s Office of Compliance (OC) plays a critical role in protecting and promoting public health in shielding patients from poor quality, unsafe and ineffective drugs. The complexity of the human drug supply and development pipeline and the global nature of regulated industry present unprecedented challenges to effective regulatory oversight. CDER’s Office of Compliance encompasses six 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 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 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 several initiatives to address challenges and support advancement. These include the development and provision of practical and virtual training, as well as in-depth research to better understand barriers that impede growth and potential solutions.

Objective This contract is a companion contract to the Reducing Risks of Compounded Drugs: Engagement with Outsourcing Facilities contract. Under the Reducing Risks of Compounded Drugs: Engagement with Outsourcing Facilities contract, that contractor shall be tasked with creating FDA-centric, public-facing web-based training content for at least 6 training areas and post to an FDA designated web-based training application, following 508-compliance standards. The contractor under this task order shall provide services to host, manage, and administer this web-based training.

Description of Work - Scope A learning management system (LMS) is a software application for the administration, documentation, tracking, reporting, and delivery of educational courses, training programs, or learning and development programs. The LMS procured under this task order shall be designed with a primary focus on working with government agencies to deliver training in public health and/or health science-related disciplines.

Tasks For Period Of Performance Task 1: Host, Manage and Administer Web-based Training To host and manage the web-based content created under the Reducing Risks of Compounded Drugs: Engagement with Outsourcing Facilities contract, CDER OC will procure access to a commercial web-based learning management system.

This web-based learning management system shall have the following characteristics:

· Ability for CDER OC staff to post courses visible to all users of the learning management system or a specific group of users.

· Entirely web-based with no need for users to install extra software or plug-ins.

· Ability to host both SCORM-compliant and non-SCORM compliant content.

· Ability to migrate data, including existing user, content, or course data to the LMS.

· The LMS shall be housed outside the FDA’s internal network to allow external (non-governmental) users access.

· Ability to host an unlimited number of separate courses and manage an unlimited number of users and allow for nearly 24/7 user access to those courses.

· Ability to track individual learner progress, course attendance and create detailed student transcripts with a complete learning history.

· An interface to create custom reports to monitor and track user progress, course completions and course evaluations.

· Create, assign, and manage pre- and post-assessments and evaluations.

· Ability to communicate with LMS users through targeted email announcements.

· Create an CDER/OC-branded portal.

· Ability to provide detailed student transcripts with complete learning history.

· Manage LMS users through designated subgroups.

· Ability to assign admin roles to CDER OC users.

· Create and assign training plans for learners and groups of learners.

· Ability to provide continuing education credits.

· Availability of technical support through email or phone.

· Ability to provide recovery of data and all course content due to the occurrence of a malfunction, power outage, or other event leading to loss of electronic files /redundancy of electronic file storage Deliverables and Schedule Deliverables and Schedule There are no deliverables under this contract.

Period of Performance The Contract Period of Performance for this task order is:

one (1) twelve (12) month base with four (4) twelve (12) month option years.

Place and Time of Performance The place of performance for this contract will be at the contractor’s primary work location.

Government Furnished Equipment and Vendor Supplied Equipment There will be no Government Furnished Equipment for this task order.

Key Personnel / Staffing There are no individuals designated in this contract that are considered essential.

Access To Non-Public Information

All Contractor and subcontractor employees are required to sign the Contractor's Commitment to Protect Non-Public Information (NPI) Agreement (Form FDA 3398). If a person who has signed this agreement resigns, is dismissed, or is otherwise no longer working on this contract, the Contractor shall notify the FDA COR and the Contracting Officer. Any new Contractor or subcontractor employee assigned to this contract shall sign the form, and the Contractor shall hand- deliver it to the COR ten (10) days prior to said new employee's commencement of work on this contract.

The prime Contractor, subcontractors, and consultants shall not be provided nor possess non-public information in any form unless written approval has been granted, nor shall they have unaccompanied access to an FDA facility unless a facility clearance has been granted.

Conformance with Applicable Laws, Regulations, Policies, and Standards Contractor Compliance The Contractor shall be responsible for knowledge of, and compliance with all applicable federal information technology and information management laws, regulations, policies, and standards at the government-wide, HHS, and FDA levels. At the government-wide level, these include Office of Management and Budget (OMB), National Institute of Standards and Technology (NIST), and Government Accountability Office (GAO). These can be primarily found at or through the Federal CIO Council website at: http://www.cio.gov/. HHS documents are found at: http://www.hhs.gov/oirm/ Section 508 Standard Compliance Section 508 of the Rehabilitation Act of 1973 (29 U.S.C. 794d), as amended by the Workforce Investment Act of 1998, requires that all electronic and information technology (EIT) products and services developed, acquired, maintained, or used under this contract/order must comply with the “Electronic and Information Technology Accessibility Provisions” 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.section508.gov/. The complete text of Section 508 Final Provisions can be accessed at http://www.access-board.gov/sec508/provisions.htm Appendix A: List of Acronyms

Appendix B: Electronic and Information Technology Accessibility

HHSAR Clause352.239-74: Electronic and Information Technology Accessibility.

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:

· 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 RepresentativeE208 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, 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.

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