Requirements Document - Clean_08162024.docx

STATEMENT OF WORK

FOOD AND DRUG ADMINISTRATION (FDA)

STUDIO VIDEO MEDIA PRODUCTION SERVICES

STATEMENT OF WORK (SOW)

CENTER FOR DEVICES AND RADIOLOGICAL HEALTH (CDRH)

FOOD AND DRUG ADMINISTRATION (FDA)

STUDIO VIDEO MEDIA PRODUCTION SERVICES

DATE: August 1, 2024

Table of Contents

1 Background The 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, our 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 medicines and foods more effective, safer, and more affordable, and helping the public get the accurate, science-based information they need to use medicines and foods to improve their health.

The mission of the Center for Devices and Radiological Health (CDRH) is to protect and promote the public health. CDRH assures that patients and providers have timely and continued access to safe, effective, and high-quality medical devices and safe radiation-emitting products. We provide consumers, patients, caregivers, and medical professionals with understandable and accessible science-based information about the products we oversee. We facilitate medical device innovation by advancing regulatory science, providing industry with predictable, consistent, transparent, and efficient regulatory pathways, and assuring consumer confidence in devices marketed in the U.S.

In an effort to minimize cost, inform and educate the largest audience, and use technology to the fullest extent possible, the FDA’s webcasts, video productions, remote hosting and content creation initiatives have become a vital public health communication and educational tool for the FDA and other agencies throughout the federal government.

Historically, these initiatives have provided education at significantly reduced cost, and much of the content produced by the FDA Studio has been used to help communicate important information to health care professionals, patients and consumers, industry and other key stakeholders with a role to play in public health.

2 Objective The objective of this contract is to provide multimedia support and management services required by CDRH’s Digital Communication Media Staff (DCMS) in the Office of Communication and Education (OCE). The multimedia support is needed for the delivery of Ultra-High Definition (4K) video production, remote hosting, content development, live webcasting/broadcasting, system design and engineering services for the FDA and other government agencies.

3 Scope The overall scope of work for this effort will consist of multiple deliverables over the course of the performance period with a varying degree of involvement from the contractor as requested by the FDA. Contractor requirements include providing:

· Video production and engineering staff to assist and supplement FDA staff engaged in production at FDA facilities or other off-site production locations under the technical guidance of the FDA;

· Multimedia production in response to and as agreed to by specific FDA work requests; and,

· Management and maintenance of the acquisition and delivery of equipment, supplies, services, travel and any other item or personnel needs required in support of multimedia productions as directed by the FDA.

4 Tasks

4.1 Task One: Project Management

The Contractor shall provide project management to establish control, management, monitoring, and notification mechanisms, ensuring that contracted tasks and costs stay on track while milestones, and performance measures are met. Additionally, the Contractor shall provide a contact person(s) available 24/7 to discuss and respond to FDA work requests and requests from other government agencies.

The Contractor shall conduct a Kickoff Meeting, Provide Monthly Status Reports, and Participate in Monthly Project Management Team Meetings.

4.1.1 Subtask One: Kickoff Meeting

The Contractor shall conduct a kickoff meeting with FDA (OCE and Studio leadership) within seven (7) business days of contract award. The kickoff meeting shall be conducted to introduce the Contractor team, discuss roles and responsibilities, workflow logistics- such as approvals, individual job documentation, invoices and monthly reports, discuss the contract objectives, and address other relevant issues. The Contractor must provide meeting minutes within three (3) business days of the meeting.

4.1.2 Subtask Two: Monthly Status Report

The Contractor shall submit monthly status reports to the FDA Project Manager (PM) and Contracting Officer’s Representative (COR). The report shall identify and summarize progress toward completion of each work request individually and identify any problems requiring management attention. Monthly Reports shall track to specific task requirements as stated in the SOW or “steady state” activities. The Contractor shall submit the Monthly Status Report no later than the fifth (5th) day of each month. The monthly report shall include a minimum of the following information:

· A brief narrative of each ongoing project and the personnel used for that project.

· Limitation on Subcontracting

· Material Ceiling on the contract The Contractor shall inform the COR of challenges or issues as soon as the Contractor is aware of the matter.

4.1.3. Subtask Three: Monthly Project Management Team Meetings The Contractor shall participate in monthly Project Management Team meetings by phone with the COR and other identified members from CDRH. The purpose of meetings shall be to discuss upcoming work, progress toward completion of work and to discuss any problems and mitigation strategies. The Contractor must provide meeting minutes within three (3) business days of the meeting.

4.2 Task Two: Ad-Hoc Studio Support Projects

The FDA requires that the contractor provide video production personnel to supplement FDA video production staff on an “as needed” basis. Contractor staff will be located in the Washington, DC area and shall report to work at the FDA studio in Gaithersburg, MD or shall report to locations as directed by FDA work requests. Contractor staff shall receive technical guidance from the FDA CDRH Digital Communication Media Staff. Contractor personnel shall provide technical and engineering services, satellite time, and video production crew services in the creation of video productions and webcasts. Contractor personnel may only perform duties that fall withing the scope of the contract. Production work may require work beyond the standard 8-hour day, in order to provide set-up, production and strike of production. Work beyond the traditional 8-hour day will be paid at an overtime rate of time and a half.

The (FDA will provide full production facilities and equipment for producing, recording, and editing the video footage (including captioning), and staging (rehearsal and performance) of the video production within its television studio or designated off-site location. The Contractor shall support additional needs identified by the FDA for staffing, equipment, equipment maintenance, satellite time, and television studios of appropriate size and technical capability. The FDA requires production of education, communication and training materials. This requires additional staffing, for example copywriters, animators, instructional designers, creation of internet-based information and training tools (websites), and other supporting materials that coincide with overall FDA project needs. The contractor shall support the FDA with personnel and materials as needed by the FDA.

The contractor shall manage the acquisition and delivery of equipment and service purchases identified by the FDA as needed.

4.2.1. Contractor Work Proposal

The contractor shall provide a Contractor Cost Proposal within 5 Calendar days of receipt of an Estimate Rate Card (work requests) (Attachment A-Process Timeline Summary).

Upon receipt, the Contractor reviews the Estimate Rate Card and uses it to inform contractor cost proposal, which includes:

· Center/Entity Name and Office

· Title that briefly describes the work to be completed

· Job number for reference, which should be referenced in related invoices and monthly reports to track work and costs.

· Detailed cost breakout in line with the labor categories, rates and hours as outlined in the contract.

· NOTE: When include in a proposal the “On-Site Full-Time Support Staff” listed within the contract should be included with their established labor category and rate under that heading for the appropriate period of performance.

· If a request for equipment or materials is included in a request, the contractor shall provide quote(s) for review.

· If a subcontractor is proposed in response to CDRH’s request, the contractor shall submit a full package in compliance with FAR Clause 52.244-2, as referenced in the contract.

4.3 Task Three: Transition

Transition activities take place to efficiently transition all activities from the incumbent Contractor to the new Contractor. As tasked, the Contractor shall develop transition plans and conduct transition activities as applicable.

4.3.1 Subtask One: Transition-Out

As directed by FDA, the Contractor shall facilitate the transition-out of contracted activities and services to the Government or, to a successor contractor by the end of the period of performance. The Contractor shall provide support for transition-out activities. During this period, the Contractor shall ensure that no degradation in service or support is experienced. Between the turnover date designated by the CO and the end of the contract period of performance, the Contractor shall ensure all activities are closed-out and provide sustainment support to complete the transition.

Representative activities include, but are not limited to:

· Develop and submit a Transition-Out Plan and Schedule to the CO and COR within 45 days of performance end date or within 20% of contract ceiling price, whichever occurs first.

· Provide the Government with current versions of all documentation (i.e., electronic and hardcopies).

· Provide the Government with a current inventory of all Government-Furnished Equipment (GFE) and Government Furnished Information (GFI) utilized by the Contractor along with full support in the reconciliation of this inventory.

Provide the successor contractor with the ability to “shadow” and participate in technical exchange meetings and opportunities to facilitate the transfer of information, processes, and data needed to continue the services being performed by the Contractor.

5. Deliverables

5.1 Format Of Deliverables

Deliverables shall be provided by email to the government in soft copy format using MS Office products as specified below. Weekly, interim, informal, and working-copy products shall be provided by e-mail to the COR. Final soft copies of deliverables shall be developed using the current FDA version of Microsoft Office products and/or other standard application software. Be advised that the FDA does not accept documents which contain the use of macros. Document submissions required through the period of performance of this contract must not have micro-enabled functionality, and any document delivered having that functionality will be deemed delinquent, if not corrected prior to the due date.

Deliverables Submission Procedure The Contractor shall submit all deliverables to the COR and PM, unless otherwise stated. The COR and PM will be responsible for the review of all deliverables to ensure accuracy, functionality, completeness, professional quality, and overall compliance with the requirements of the task. The Contractor shall ensure the accuracy and completeness of all deliverables in accordance with referenced policy, regulations, laws, and directives. Reports and presentations shall be concise and clearly written; errors, misleading or unclear statements, incomplete or irrelevant information, and/or excessive rhetoric, repetition, and "padding,” or excessive length if a page limit is imposed, shall be considered deficiencies and will be subject to correction by the Contractor at no additional cost to the government. Unless specified otherwise, the government shall have ten (10) working days to complete the review and approve the deliverables. If the government does not approve the deliverable within ten (10) business days the deliverable is considered accepted. If deficiencies are found or areas require modification, the Contractor will be notified and shall have five (5) calendar days to correct the deficiencies. Upon re-submission by the Contractor, the government will reapply the same acceptance criteria. If the deliverable does not meet the acceptance criteria a second time, the government may consider the Contractor as having deficient performance with respect to the subject task.

Summary Of Deliverables Table 1: Deliverables

Within forty-five (45) days of performance end date

COR

Contract Type This requirement is for a competitive Time-and-Materials (T&M) type contract awarded to an 8(a).

Period Of Performance The anticipated dates of performance are:

Option Year 3: TBD Option Year 4: TBD 8 Place of Performance

TBD

Services shall be provided both on and off-premises.

Remote work will be permitted for work that can be performed with minimal negative impact to the operating efficiency of the FDA Studio operation (e.g. script writing, graphics, animation or instructional design projects, etc.

9 Government Furnished Property Government furnished property (materials, equipment, and/or information) is to be provided in conjunction with required performance under this contract as determined by mutual agreement between FDA and the Contractor.

When the Government provides equipment, then the Contractor shall maintain a detailed inventory accounting system for Government Furnished Property (GFP) following contract award. The inventory accounting system must specify, at a minimum:

· Product description (make, model)

· Government tag number

· Date of receipt

· Name of receipt

· Location of receipt

· Current location

· Contract/order number under which the equipment is being used The Contractor shall attach an update inventory report to each MPR unless otherwise specified by the COR. In either case, the Contractor’s inventory listing must be available for Government review within one (1) business day of COR request. The Contractor shall remain responsible and accountable for all GFP for the duration of the contract and ensure the return of the property upon completion of all work required under this contract.

CDRH Property Custodian:

Name: Provided at time of award U.S. Food and Drug Administration White Oak Campus, Building 66 10903 New Hampshire Ave Silver Spring, MD 20993c Amey Phone: TBD Email: TBD 10 Invoicing Procedures Invoices should distinctly and separately track the studio “steady state” or the work on the On-Site Full-Time Support Staff while not working on a specific task requirement specified in the contract. The invoice should also track each specific task requirement separately.

Invoices should match Contractor Cost Proposals and include:

· Labor categories, hours and rates for prime and subcontractors (consistent with the contract)

· Subcontractors should be noted as such

11 508 Standard Requirements Section 508 of the Rehabilitation Act of 1973 (29 U.S.C. 794d) requires Federal agencies to purchase information and communication technologies (ICT) that meet specific accessibility standards. This law helps to ensure that federal employees with disabilities have access to, and use of, the information and data they need to do their jobs. Furthermore, this law ensures that members of the public with disabilities have the ability to access government information and services.

There are three regulations addressing the requirements detailed in Section 508. The Section 508 technical and functional standards are codified at 36 CFR Part 1194 and may be accessed through the Access Board’s Web site at http://www.access-board.gov. The second regulation issued to implement Section 508 is the Federal Acquisition Regulation (FAR). FAR Part 39.2 requires that agency acquisitions of information and communication technology (ICT) comply with the Access Board’s standards. The entire FAR is found at Chapter 1 of the Code of Federal Register (CFR) Title 48, located at http://www.acquisition.gov. The FAR rule implementing Section 508 can be found at http://www.section508.gov. The third applicable regulation is the HHS Acquisition Regulation (HHSAR).

Regardless of format, all Web content or communications materials produced for publication on or delivery via HHS Web sites - including text, audio or video - must conform to applicable Section 508 standards to allow federal employees and members of the public with disabilities to access information that is comparable to information provided to persons without disabilities. All contractors (including subcontractors) or consultants responsible for preparing or posting content intended for use on an HHS-funded or HHS-managed Web site must comply with applicable Section 508 accessibility standards, and where applicable, those set forth in the referenced policy or standards documents below. Remediation of any materials that do not comply with the applicable provisions of 36 CFR Part 1194 as set forth in the SOW, shall be the responsibility of the contractor or consultant retained to produce the Web-suitable content or communications material.

Unless an agency exception to this requirement exists, the Contractor must conform to applicable Section 508 standards and must apply best practices associated with Section 508 compliance during the application design, development, and testing phases. The Contractor shall utilize FDA approved tools to verify the compliance with the Section 508 standards and ensure the delivery of the fully compliant products.

The following Section 508 standards apply to this Statement of Work (SOW):

· 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)

· 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)

· 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 https://www.hhs.gov/web/section-508/making-files-accessible/index.html, 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.