RFQ_FDA-75F40124Q00493.pdf

REQUEST FOR QUOTE (RFQ)

FY24 ThinkTrends Software Support

FDA – 75F40124Q00493

The Request for Quote (RFQ) FDA-75F40124Q00493 is a combined synopsis/solicitation issued under FAR Part 12 and Subpart 13.5 procedures. This RFQ is for FY24 ThinkTrends Software Support. This will be a single Firm Fixed Price (FFP) award with a one-year period of performance and will be solicited as a Total Small Business set-aside under NAICS code 541519.

The Government is in no way obligated to make an award, nor to pay any costs incurred by the Contractor in preparing and submitting its quote.

1. BACKGROUND

The Food and Drug Administration (FDA) is responsible for protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices; and by ensuring the safety of our nation's food supply, cosmetics, and products that emit radiation. The FDA also has responsibility for regulating the manufacturing, marketing, and distribution of tobacco products to protect the public health and to reduce tobacco use by minors. Additionally, the FDA is responsible for advancing the public health by helping to speed innovations that make medical products more effective, safer, and more affordable and by helping the public get the accurate, science-based information they need to use medical products and foods to maintain and improve their health.

The organization sponsoring and supporting this requirement is the Office of Computational Science (OCS) in the (super) Office of Translational Sciences (OTS) under the Center for Drug Evaluation and Research

(CDER).

The Center for Drug Evaluation and Research (CDER) performs an essential public health task by making sure that safe and effective drugs are available to improve the health of people in the United States. As part of the U.S. Food and Drug Administration (FDA), CDER regulates over-the-counter and prescription drugs, including biological therapeutics and generic drugs.

The Office of Translational Sciences empowers a diverse, collaborative, and high performing workforce to champion innovation and advance global human drug development. The vision of this super office is to drive advancements in human health through scientific and regulatory innovation. A summary of current work being done includes:

• Promoting scientific collaboration and innovation in drug regulatory review across CDER

• Assuring the validity of clinical trial design and analysis in regulatory decision making

• Developing and applying quantitative and statistical approaches to decision making in regulatory review process

• Ensuring alignment of CDER research with CDER goals

• Serving the CDER scientific community in establishing technology transfer agreements that are vital to collaboration with the broader scientific community

• Maintaining knowledge management databases that can be the basis of improvements in the regulatory review process

• Overseeing bioequivalence inspections to ensure the availability of safe and effective generic equivalents of investigational drugs

The mission of the Office of Computational Science is to provide CDER reviewers innovative and reliable solutions that improve and strengthen the scientific review process by integrating data, tools, and training. The focus of OCS’s current efforts include:

• Building solutions that drive New Drug Modernization, promote access to quality data, and optimize data analysis capabilities

• Processing Study Data for rapid use

• Delivering effective tools, technologies, services, and training to meet CDER’s mission

• Delivering solutions that streamline Bioresearch Monitoring (BIMO) workflow for reviewers and inspectors

• Spearheading the CDER Innovation Board to harness subject matter expertise across FDA

• Offering cloud-enabled innovation space for tools, technologies, and data exploration

• Connecting CDER staff to the scientific computing resources and technology needed to drive efficient analysis and cost-effective solutions

• Collaborating with industry, academia, and other external partners through our work with PHUSE, CDISC and BioCelerate

The OCS is comprised of approximately 30 staff of medical officers, information technology project managers (IT PMs), regulatory information specialists (RISs), statisticians, and variety of science-related PhDs.

OCS plays an integral role in CDER’s mission to perform an essential public health task by making sure that safe and effective drugs are available to improve the health of people in the United States. Our work is aligned with CDER’s efforts to modernize the New Drugs Regulatory and Inspections & Compliance programs. Our primary focus is to enhance and modernize data management and analytical processes for a variety of CDER stakeholders, including reviewers, inspectors, and researchers. OCS provides stakeholders with innovative, reliable solutions to improve and strengthen the scientific review process by integrating data, tools, and training. One of such solutions is the Bioresearch Monitoring Evaluation Support Tools (BEST), which is for performing remote inspections activities to enforce compliance of federal regulatory states at sponsor sites.

BEST is a platform that currently consists of two applications to help facilitate the inspection needs of OSIS inspection activities. The BEST platform replaces a manual inspection practice of comparing sponsor site data to FDA submitted data, to make the inspection activities more streamlined and accelerated. The applications are Data Comparison module and Audit Trail Review module.

o Data Comparison module provides OSIS inspectors the ability to compare one or more site data sets with one or more datasets which is in the submission and loaded to the SDP database. The key function of the application is to discover data discrepancies.

o Audit Trail Review module provides a way for OSIS and other CDER offices’ inspectors to:

- View the audit logs for instrument, project, and results files for a study in one

- Drill down on regulatory findings of interest by interacting with a fully featured table that contains events and allows for sorting by columns, flagging, etc.

2. OBJECTIVE

As part of the BEST platform, the contractor shall provide an AI-based OCR (Optical Character Recognition) function that provides a PDF extraction solution. The solution shall be able to extract data tables from bioanalytical reports in a PDF format at greater than 90% accuracy level to allow for reviewers to access data in a format which is amenable to filtering specific data sets, performing calculations, and other analyses that are critical to their processes. The government should be able to leverage this solution for other projects that are part of the Remote Regulatory Assessment (RRA) initiatives. RRA allows FDA investigators to perform FDA-regulated sponsor site inspections remotely. It includes voluntary interactive evaluations (such as remote livestreaming video of operations, teleconferences and screen sharing) in addition to requests to review records and other information under existing statutory or regulatory authority. Throughout the pandemic, the FDA has used these tools, domestically and abroad, to help the agency conduct oversight, mitigate risk, and meet critical public health needs. The BEST platform described above is an example of RRA.

3. OPERATING ENVIRONMENT/COMPIBILITY REQUIREMENTS

The operating environments of ThinkTrends have already been deployed across two distinct environments: pre-production and production.

In the pre-production environment, there are two instances. One of them is GPU instance, used for running machine learning tasks. The other instance is for proxy and front facing services.

Production environments is set up similarly to pre-production environments with two instances.

ThinkTrends has also been deployed to establish a connection with OCS Data Central even though this connection is not being used by any application as of now.

4. REQUIREMENTS - SPECIFIC TASKS AND DELIVERABLES

The Contractor shall perform project management activities to ensure control, management, monitoring, and notification mechanisms to meet the requirements of this procurement.

4.1 TASK AREA 1: Project Management (Firm-Fixed Price)

4.1.1 Kick-Off Meeting

The Contractor shall conduct and provide an agenda and Kick-off Presentation for a task order Kick-off Meeting at the FDA facilities in Silver Spring, MD to introduce the Contractor team to additional stakeholders, present the COR approved kick-off presentation, review the scope of work and technical approach, and delivery schedule and facilitate questions and discussions. The Kick-off Meeting shall be scheduled within ten (10) business days of task order award.

The Contractor shall coordinate with the task order COR to determine date, time, location and attendees for the Kick-off Meeting.

The Contractor shall submit meeting minutes for the Kick-off Meeting within two (2) business days of the meeting and upload them to the FDA’s project repository (e.g., SharePoint), along with other meeting materials (e.g., slide deck used for the kick-off presentation).

MEETINGS

Meeting/ Description Location(s) Estimated Activity Frequency

Task Order Kick-off Meeting.

Stakeholder meeting for staff introductions and contract review of content within 10 business days of award.

FDA White Oak 1

DELIVERABLES

Deliverable Frequency/Due Date Delivered To

Kick-off Presentation. DRAFT: Within 5 business days of award.

FINAL: Within 1 business day of Kick-off Meeting.

COR

Kick-off Meeting Agenda and Minutes.

Agenda – 1 business day prior to meetings; Minutes – 2 business days post meeting.

COR and Attendees

4.1.2 Task Order Project Management (Firm-Fixed Price)

The Contractor shall establish control, management, monitoring, and notification mechanisms to ensure that tasks stay on track to meet the important milestones and performance measures within the awarded task order.

The Contractor shall perform the following task management and project management (PM) activities:

A. Provide a final Task Order Management Plan to the Contracting Officer Representative (COR) within 45 business days of award describing the technical approach, organizational resources, risk management and other management controls to be employed to meet the cost, performance and schedule requirements.

B. Prepare project artifacts, EPLC documentation, and other PM materials for and participate in meetings related to project reviews, stage gate reviews, team meetings, management briefings, stakeholder presentations, cross‐agency information exchanges and other similar meetings. The COR or COR designee will provide the dates, time, and location of the meetings at a minimum of three (3) business days prior to the meeting.

C. Ensure completion and submission of information required for the on-boarding of contractor employees who will be working on this task order immediately following task order award as well as compliance with security clearance requirements for management of PIV cards provided to contractor staff.

D. Provide ad‐hoc COR‐requested documentation needed for data calls, management decisions and requests, conferences, and reporting. The COR will provide direction, details and timelines to the Contractor. The Contractor shall consult with the COR or COR designee for clarification of the documentation requirements. Examples of documentation shall include:

1. Release Notes

2. Requests for Change

3. Help Desk Ticket Summaries

4. Posters for FDA Scientific Computing Days Conference

E. Submit Government Furnished Equipment (GFE) Inventory Report. The Contractor shall prepare and provide the COR or their designee an inventory of government furnished equipment (GFE) and FDA‐provided software licenses in MS‐Excel format. The Contractor shall ensure that the Contractor GFE Inventory is updated when resources are added or removed from the project. At a minimum, the Inventory Report shall include the following:

1. Serial Numbers

2. FDA Property Codes

3. Model Numbers

4. Licensed Software Name and License Number

5. Item Description

6. Person Assigned To

7. Location

F. Provide Monthly Task Order Status Report to the COR and COR designee for all tasks awarded under the IDIQ. This Status Report shall include:

1. Task Order Status

2. Earned Value Management (EVM) reporting to include cost and schedule progress and variances against the Project Schedule.

3. Significant risks to scheduled deliverables and plans to mitigate them

4. Issues and recommendations for escalation

5. Status of tickets and metrics

6. Recommendations for changes or additional activities

G. Maintain required EPLC documents in accordance with the EPLC. The project team has a full set of EPLC documentation. The Contractor shall use the Project Process Agreement (PPA) (EPLC document) to determine what documentation should be updated with each release.

H. Identify, create, submit and track through completion approximately 15‐20 requests for change and/or provision requests for maintenance, releases, integration, and enhancements. Change and provisions requests use the RQST‐IT system. RQST‐IT is an FDA system that supports the business process for evaluating and tracking all new projects, provisioning and software and hardware configuration changes, requests, assessments of new software and software versions. The Change processes are managed by FDA’s ServiceNow application.

I. Attend Change Control Boards (CCBs) such as infrastructure, desktop, firewall and application

CCBs when changes requests have been submitted that impact the application or hardware. The

Contractor shall complete all required forms and present changes to the board in accordance with the FDA CCB Charter. This charter is located at:

http://inside.fda.gov:9003/downloads/ProgramsInitiatives/CommitteesWorkgroups/ITChangeC ontrolBoard/UCM444319.pdf

It is anticipated that the Contractor shall participate in 4‐6 CCB meetings per year.

J. Create and maintain required support documents that include User Guides and Customer Support

Operations to ensure accurate information after each release.

K. Conform to FDA specific guidance, applicable laws, regulations, policies and standards included in the underlying IDIQ, including those included in this requirement under Technical Standards and Conformance Guidelines.

MEETINGS

Meeting/ Description Location(s) Estimated Activity Frequency

Project Team Meetings.

Project Status Meeting. Remote and at FDA. Weekly until directed by COR to move to bi‐ monthly.

Stage Gate Reviews. Independent confirmation by Critical Partners to the IT governance organization that all EPLC documents and task order deliverables are satisfactorily produced and adequately met all exit criteria for the phase to permit advancement to the next phase.

Remote. 2‐3 times per year.

Ad‐Hoc meetings (briefings, presentations, information exchanges).

Additional meetings as necessary to communicate status, technologies, analyses, capabilities.

Remote and at FDA. Maximum of 6 times per year.

ATO Annual Review. Meetings with Information System Security Officer (ISSO) and assessors to review the technical security features of the system and identify security bugs and vulnerabilities.

Remote and at FDA. 3‐5 meetings July/August.

IT Change Control Boards.

Board that approves changes to any production system.

Remote. 4‐6 times per year.

http://inside.fda.gov:9003/downloads/ProgramsInitiatives/CommitteesWorkgroups/ITChangeControlBoard/UCM444319.pdf http://inside.fda.gov:9003/downloads/ProgramsInitiatives/CommitteesWorkgroups/ITChangeControlBoard/UCM444319.pdf

Deliverable Frequency/Due Date Deliver To

Management Plan. Draft due 30 business days after task order award. Final due 45 business days after task order award.

COR or COR Designee.

GFE Inventory Report. Within 30 days after award, and updated when inventory or staff change.

COR.

Task Order Monthly Status Report.

Due the 10th of each month for prior month. COR or COR Designee.

CPIC Reporting / Earned Value Reporting.

Due the 10th of each month for prior month. COR or COR Designee.

EPLC Documents. Updates are determined during project schedule development.

Typically updated in preparation for new application releases (two‐three (2‐3) per year).

COR or COR Designee.

User Guides, Customer Support Operations.

Review and update prior to each release (twice per year). COR, COR Designee.

4.2 TASK AREA 2: ThinkTrends Software Support for OCR PDF Extraction (Firm-Fixed Price) Thinktrends is a data mining and AI workflow automation platform that allows users to create custom AI models that allow detection of objects from images with minimal coding. This technology may significantly improve the accuracy of OCR text and table extraction. ThinkTrends OCR API and ThinkTrends PDF AI are the ThinkTrends products to facilitate PDF extraction, conversion, verification, and automation from bioanalytical reports.

The OCR PDF extraction requirements for the government’s remote inspection activities are:

• Maintain the Integration of OCR tool with Study Data Platform (SDP) loading module. The integration should be using:

o real-time API calls o build a batch process o create an end-to-end workflow

• Maintain API call to populate SDP with extracted data from the bioanalytical reports.

• Maintain ability to integrate with downstream systems to BEST and RRA.

• OCR data extraction process shall be able to extract table, table titles/names, page numbers and other elements from PDF files.

• Extraction of tables from Bio-Analytical Reports.

• On-Demand (Real-Time) and Batch processing of files need to be supported.

• As part of batch processing, scan for input PDF files and process them.

• Generate extracted output files and place them in output location.

• As part of real-time processing, maintain a means of initiating processing and write data to a specified location through an API Tagging of files to particular applications and studies.

• Maintain directory structure as needed for identification of extracted files.

• Frequency of file processing shall be twice a day; frequency may change based on user needs.

• Extract data from text and tables with greater than 90% accuracy.

• Provide processing results for batch processing within 24-hour turnaround time.

• Generate and share detailed error reports in case of any failure for both on demand and batch processing.

• Send notification/status for both on-demand and batch processing.

• Share daily status on files scanned, files processed, pending files and any errors.

• Make provision for other tools and systems to leverage this OCR extraction set up.

The ThinkTrends vendor shall clarify requirements by conducting requirements gathering sessions with the government and other relevant contractors as needed.

A summary of deliverables of this task includes, but not limited to:

• Continuous stakeholder interaction and requirements gathering.

• Software installation and configuration in cloud environment (being performed in current period of performance) shall be maintained in the upcoming period of performance.

• Initial model configured shall be maintained in the upcoming period of performance.

• Model training and algorithm release shall be maintained in the upcoming period of performance.

• Customer support.

• Continuous support of extracted data from unstructured bioanalytical report files to support BEST by (1) API calls and (2) Batch processing.

• Maintain a streamlined and efficient flow of extracted data from source to destination using the OCR technologies.

The following are additional details of deliverables that shall be completed during the period of performance:

Deliverable Name Application/ Use Case

Configuration

- Maintain configuration of FDA GovCloud production server o This is a shared server where other

OCS applications are currently being hosted.

BEST and RRA Initiatives

Initial Model Customization The contractor shall maintain a model/algorithm in ThinkTrends for OCR (Optical Character Recognition) functionality that provides a PDF extraction solution and train the model using FDA data including but not limited to submission data for BEST (audit trail review) and RRA (site data).

Initial model development included the following:

• Set up the AI model accurately based off the (greater than 90%) accuracy level needed for the most beneficial use of BEST and RRA.

• Facilitate the requirements gathering discussions with project team and Study Data Platform contractor.

• Develop the initial tool AI model within two weeks after configuration on FDA GovCloud.

• The solution shall be able to extract data tables, table titles, and page numbers from bioanalytical reports in a PDF format.

• The solution shall allow reviewers to access data in a format which is amenable to filtering specific data sets, performing calculations, and other analyses that are critical to their processes.

• Perform identification and custom extractions of data tables from bioanalytical report.

• Build an API call and batch process solution to retrieve reports for data extraction.

o Provide documentation and technical support for API and batch processing. This should support the accuracy tuning, performance enhancements, and technical questions.

o Provide data visualization and validation.

• Develop a front-end dashboard to monitor the volume of data extracted, flagging any data that cannot be accurately converted to text.

Model Training and Algorithm Release For all subsequent model iteration releases, the contractors shall:

• Retrain the model to learn from the previous iteration errors as well as refined use case requirements captured during discussions, email notifications, and backlog items.

• Facilitate the requirements gathering discussions with project team and Study Data Platform contractor.

• Work collaboratively and provide development support to the vendor providing support for the Study Data Platform program.

• Provide release notes for each algorithm update that includes anomalies and updates.

• The outputs shall include the results in human readable (e.g. excel) and machine readable (e.g. JSON) formats with greater than 90% accuracy level.

• The solution shall collect and provide statistics for performance and accuracy of the tool.

5. INSPECTION AND ACCEPTANCE

In accordance with the inspection and acceptance clauses of the contract, all work under this task order is subject to inspection and final acceptance by the Contracting Officer or duly authorized representative of the Government. The Government’s Contracting Officer’s Representative (COR) is a duly authorized representative of the Government and is responsible for inspection and acceptance of all items to be delivered under this task order. The general quality measures, as set forth below, will be applied to each work product received from the Contractor for requirement.

• Accuracy: Work products shall be accurate in presentation, technical content, and adherence to accepted elements of style with minimum number of bugs and issues.

• Clarity: Work products shall be clear and concise. Diagrams shall be easy to understand and be relevant to the supporting narrative.

• Consistency to Requirements: All work products must satisfy the requirements of this statement of objective.

• Timeliness: Work products shall be submitted by the due date specified in the task orders Statements of Work or submitted in accordance with a later scheduled date determined by the Government.

• File Editing: All text and diagrammatic files shall be editable by the Government.

• Format: Work products shall be submitted in hard copy (where applicable) and in media as approved by the COR prior to submission.

Non‐conforming products or services will be rejected. Deficiencies will be corrected, by the Contractor, within ten (10) business days. If the deficiencies cannot be corrected within the specified time period in the task order, the Contractor will immediately notify the FDA COR and CO of the reason for the delay and provide a proposed corrective action plan within ten (10) business days.

The Contractor shall provide a copy of each deliverable under this task order in draft format to the COR and other program personnel as instructed by the COR. Within ten (10) business days of receipt, the COR or designee will review the deliverable and suggest any changes and/or accept or reject the deliverable.

In the event the Government rejects any deliverable, the COR shall notify the Contractor in writing explaining the specific reason(s) for the rejection. If the Government suggests changes, or rejects, the Contractor shall resubmit the revised deliverable within ten (10) business days after receiving the Government’s input.

If the Contractor does not receive suggestions or comments within ten (10) business days of submitting a deliverable, the Government has accepted the deliverable unless stated otherwise by the COR.

The Contractor shall make all documentation available in a designated area that is accessible to the COR or their designee.

Deliverables are scalable relative to the risk, size and complexity of the project. The Contractor shall work with the Government to determine the appropriate level of deliverables and milestones to ensure a successful outcome.

All deliverables and other contract work products shall be considered to be solely owned by the Government and shall not be labeled ‘copyright’, ‘proprietary’ or anything similar that might preempt the desired environment of fluid sharing and partnership. The Contractor shall provide to the Government access to all work products including but not limited to: research, designs, code, constructs, databases, and documentation.

Inspection and acceptance shall be performed at 10903 New Hampshire Avenue, Silver Spring, Maryland 20993, any other FDA facility, or remotely.

6. TECHNICAL STANDARDS AND CONFORMANCE GUIDELINES

All work shall be accomplished in accordance with the FDA, Department of Health and Human Services (HHS), and Office of Management and Budget (OMB) standards described below. In the event the Contractor is unable to meet the standards, they shall immediately notify the COR. The Contractor shall comply with applicable federal information technology and information management laws, regulations, policies, and standards at the government‐wide, HHS, and FDA levels, pursuant to guidance and instruction from the COR and as provided in this IDIQ. At the government‐wide level, these include OMB, National Institute of Standards and Technology (NIST), and General Accounting Office (GAO). These can be primarily found at or through the Federal CIO Council website at: https://www.cio.gov. See the underlying IDIQ for all technical and conformance guidelines. The below standards and guidelines have been included in this task order for quick reference.

6.1 SOFTWARE DEVELOPMENT LIFECYCLE STANDARDS

The Contractor shall follow the standard development lifecycle for FDA IT systems and modules.

Currently, the FDA follows the HHS Enterprise Performance Life Cycle (EPLC) management process, which includes both waterfall and agile methodologies. FDA expects the use of agile methodologies.

This process‐driven IT lifecycle management approach emphasizes enterprise integration based on development of sound business and technical requirements. The framework will evolve over time in response to changes in technology and business needs and, therefore, the Contractor is expected to adapt accordingly to comply with the most current framework methodology in performance of work under this IDIQ. The Contractor shall consult with the COR and/or COR designee to clarify the EPLC artifacts required for an individual project or system. The required artifacts depend on the release type and are tailored through the Project Process Agreement (PPA). Furthermore, the Contractor shall ensure that updated artifacts are maintained in the appropriate repositories.

Additional requirements for IT application design, development, or support include the following:

A. The Contractor (and/or any subcontractor) shall ensure IT applications designed and developed for end users (including mobile applications and software licenses) run in the standard user context without requiring elevated administrative privileges.

B. The Contractor (and/or any subcontractor) shall follow secure coding best practice requirements, as directed by United States Computer Emergency Readiness Team (US-CERT) specified standards and the Open Web Application Security Project (OWASP), that will limit system software vulnerability exploits.

C. The Contractor (and/or any subcontractor) shall ensure that computer software developed on behalf of HHS/FDA or tailored from an open-source product, is fully functional and operates correctly on systems configured in accordance with government policy and federal configuration standards. The contractor shall test applicable products and versions with all relevant and current updates and patches updated prior to installing in the HHS/FDA environment. No sensitive data shall be used during software testing.

D. The Contractor (and/or any subcontractor) shall protect information that is deemed sensitive from unauthorized disclosure to persons, organizations, or subcontractors who do not have a need to know the information. Information which, either alone or when compared with other reasonably-available information, is deemed sensitive or proprietary by HHS/FDA shall be protected as instructed in accordance with the magnitude of the loss or harm that could result from inadvertent or deliberate disclosure, alteration, or destruction of the data. This language also applies to all subcontractors that are performing under this contract.

6.2 RELEASE MANAGEMENT

The Contractor shall work within the FDA guidelines for Release Management and Coordination. This process provides application and service teams a shared solution for planning releases. The Release Management and Coordination meeting will complement the Change Control and Configuration Management process by:

• Forecasting and communicating upcoming releases,

• Assisting with the resource confirmation process, and

• Expediting the Change Control Board meetings.

The Release Management activities occur before requests for change are submitted to the Change Control Board.

6.3 CHANGE CONTROL AND CONFIGURATION MANAGEMENT

The FDA has a Change Control, Configuration and Release Management Team who is responsible for managing the process of formally changing the FDA IT Infrastructure by facilitating the Change Control Board and Configuration Items database. Documentation and procedures will be provided by COR at task order award.

The team performs the following key functions:

• Facilitate the Change Control Board (CCB).

• Is Process Champion for Configuration and Change Management, including EPLC artifacts.

• Administers the automated Configuration Management Tools.

The FDA’s Configuration Management process is used to control changes within the functional and physical aspects of FDA systems, thus ensuring the proper maintenance of integrity and traceability throughout the system development life cycle.

6.4 REQUEST QUALITY SERVICES AND TECHNOLOGY FROM IT (RQST-IT TRACKER)

The FDA has instituted the RQST‐IT process to track projects, provisioning, technologies and configuration changes across the agency. The introduction of a new technology or IT project, version change of an already approved technology, or change to the configuration of the system requires the submission and approval of an RQST‐IT request. The Contractor shall be responsible for supporting the RQST‐IT process including writing and submitting requests and tracking them from inception through completion.

The FDA Center IT Investment Review Boards (ITIRBs) may need to be included in a coordinated review process. The RQST‐IT process is also used to request the provisioning of new servers in both data centers.

6.5 DATA QUALITY STANDARDS

FDA has approved data standards for e‐submissions and their regulatory review process. For example, CDER data standards references and resources can be found at the following site:

https://www.fda.gov/forindustry/datastandards/studydatastandards

The CDER Data Standards Program does the following:

• Identifies data standard needs.

• Determines priorities for these needs.

• Works with organizations that develop standards, industry, and other stakeholders to find or develop the necessary standards.

Where current standard specifications are unavailable or inadequate, CDER plans to engage appropriate Standards Development Organizations (SDOs), as well as industry and other stakeholders, to develop new standards through SDO processes.

7. CONTRACT TYPE

The contract type of this order is firm-fixed price (FFP).

8. PERIOD OF PERFORMANCE

The anticipated period of performance will consist of one 12-month period of performance running from 9/29/2024 – 9/28/2025.

9. PLACE OF PERFORMANCE

The place of performance for this task order will be primarily the Contractor’s site. The Contractor shall be responsible for providing internet access so contractor‐assigned laptops can connect to the FDA network via VPN. Training, on‐site support, and meetings shall be performed at 10903 New Hampshire Avenue, Silver Spring, Maryland 20993, where office space may be provided; however, the Contractor should also be prepared to work offsite at their facility if sufficient space is not available. Given the space limitations and the FDA White Oak Campus, the Contractor should anticipate a 20/80 split between time spent on the FDA campus and time spent at the Contractor’s facility.

All training will be conducted at an FDA location within the Washington, DC Metro area, with most training conducted at the FDA White Oak Campus, 10903 New Hampshire Avenue, Silver Spring, Maryland, 20993.

https://www.fda.gov/forindustry/datastandards/studydatastandards

10. HOURS OF OPERATION

For the purposes of this contract, normal business hours will be Monday through Friday, between the hours of 8:30 AM and 5:00 PM ET.

The following are exceptions to normal business hours:

• Emergency responses and releases after hours will be determined on a case‐by‐case basis.

• Friday night, weekend, and holiday release implementations shall not be considered overtime.

• The Contractor shall make every effort to modify their work week to incorporate any evening, weekend, or holiday work into their normal 40-hour week.

• The Contractor shall typically not work holidays.

• The Contractor shall typically not work more than 10 hours in one (1) day. For Government closures due to inclement weather:

o When possible, the Contractor Project Manager shall submit via email a high-level plan to the COR, detailing staff locations and planned work to be completed.

o The COR or their designee will deliver and/or approve of the format and detail level to be used in the high-level plan.

During inclement weather and Government offices are open:

• The Contractor shall use good judgment to get to the FDA provided work environment.

• If the Contractor needs to work from an alternate work site, the same procedures apply to the Contractor as during the office closures due to inclement weather section.

• In addition, if meetings are scheduled, the Contractor shall be prepared and call in to meetings that are scheduled.

• The Contractor may request changes for these work conditions which must be approved by the

COR.

For any other unscheduled closings, the contracting employees shall seek guidance from the COR.

11. HOLIDAYS

The Contractor is not required to provide on‐site services on Federal holidays. The Government is closed on the holidays listed below. Specific dates for these holidays can be found at the Office of Personnel Management (OPM) website located at: https://www.opm.gov/policy-data-oversight/snow-dismissal-procedures/federal-holidays/

• New Year’s Day

• Birthday of Martin Luther King, Jr.

• Washington’s Birthday

• Memorial Day

• Juneteenth Day

• Independence Day

• Labor Day

• Columbus Day

• Veterans Day

• Thanksgiving Day

• Christmas Day

For this task order, the Contractor shall take into consideration the above holidays when developing project plans/schedules. In addition, the Contractor shall obtain additional blackout dates from the COR.

12. GOVERNMENT POINTS OF CONTACT

Contracting Officer (CO):

(To be entered at time of award)

Contracting Specialist (CS):

Terina Hicks Terina.Hicks@fda.hhs.gov

Contracting Officer’s Representative (COR):

(To be entered at time of award)

13. CONTRACTING OFFICER’S AUTHORITY

The Contracting Officer (CO) is the only person with authority to act as agent of the Government under this order. Only the Contracting Officer has authority to: (1) direct or negotiate any changes in the RFQ;

(2) modify or extend the period of performance; (3) change the delivery schedule; (4) authorize reimbursement to the Contractor any costs incurred during the performance of this order; or (5) otherwise change any terms and conditions of this order.

No statement, whether oral or written, by anyone other than the Contracting Officer, shall be interpreted as modifying the terms and conditions of this order. It is the Contractor’s responsibility to contact the CO immediately if there is even the appearance of any technical direction that is or may be outside the scope of the order. The Government will not reimburse the Contractor for any work not authorized by the Contracting Officer, including work outside the scope of the order.

The Contracting Officer’s Representative (COR) is responsible for: (1) monitoring the Contractor's technical progress, including the surveillance and assessment of performance and recommending to the Contracting Officer changes in requirements; (2) interpreting the order and any other technical performance requirements; (3) performing technical evaluation as required; (4) performing technical inspections and acceptances required by this order; and (5) assisting in the resolution of technical problems encountered during performance.

The Government may unilaterally change its COR designation.

14. ORDER OF PRECEDENCE

The Contractor shall follow the terms and conditions of this contract. Should the Contractor include any additional terms and conditions resulting in conflicts between this document and the Contractor’s document, the Order of Precedence shall be as specified in FAR Clause 52.212-4. The Contractor shall not auto-renew any subscriptions, licenses, maintenances and services not authorized under this contract.

Any auto-renewals are at the risk of the Contractor, and the Government will not reimburse the Contractor.

15. TECHNICAL DIRECTION

Performance of the work under this task order shall be subject to the technical direction of the COR and.

The term “technical direction” is defined to include, without limitation, the following:

• Directions to the Contractor which redirect the contract effort, shift work emphasis between work areas or tasks, require pursuit of certain lines of inquiry, fill in details or otherwise serve to accomplish the contractual statement of work.

• Provision of information to the Contractor which assists in the interpretation of drawings, specifications, or technical portions of the work description.

• Review and, where required by the contract, approval of technical reports, drawings, specifications, and technical information to be delivered by the Contractor to the Government under the contract.

Technical direction must be within the scope of work stated in the task order. The COR does not have the authority to and may not issue any technical direction which:

• Constitutes an assignment of additional work outside the scope of work of the task order.

• Constitutes a change as defined in the applicable contract clause FAR 52.212‐4 (c)–Changes.

All technical direction shall be issued in writing by the COR or shall be confirmed by him/her in writing within five (5) business days after issuance.

16. INVOICING INSTRUCTIONS

FDA Electronic Invoicing and Payment Requirements - Invoice Processing Platform (IPP) (Jan 2022)

(a) All Invoice submissions for goods and or services must be made electronically through the U.S.

Department of Treasury’s Invoice Processing Platform System (IPP).

http://www.ipp.gov/vendors/index.htm

(b) Invoice Submission for Payment means any request for contract financing payment or invoice payment by the Contractor. To constitute a proper invoice, the payment request must comply with the requirements identified in in FAR 32.905(b), “Content of Invoices” and the applicable Payment clause included in this contract, or the clause 52.212-4 Contract Terms and Conditions – Commercial Items included in commercial items contracts. The IPP website address is: https://www.ipp.gov

(c) The Agency will enroll the Contractors new to IPP. The Contractor must follow the IPP registration email instructions for enrollment to register the Collector Account for submitting invoice requests for payment. The Contractor Government Business Point of Contact (as listed in SAM) will receive Registration email from the Federal Reserve Bank of St. Louis (FRBSTL) within 3 – 5 business days of the contract award for new contracts or date of modification for existing contracts.

(1) Registration emails are sent via email from ipp.noreply@mail.eroc.twai.gov. or phone (866)

973-3131. Contractor assistance with enrollment can be obtained by contacting the IPP Production Helpdesk via email to IPPCustomerSupport@fiscal.treasury.gov or phone (866) 973-3131.

(2) The Contractor POC will receive two emails from IPP Customer Support, the first email contains the initial administrative IPP User ID. The second email, sent within 24 hours of mailto:IPPCustomerSupport@fiscal.treasury.gov receipt of the first email, contains a temporary password. You must log in with the temporary password within 30 days.

(3) If your company is already registered to use IPP, you will not be required to re-register.

(4) If the Contractors unable to comply with the requirement to use IPP for submitting invoices for payment as authorized by HHSAR 332.7002, a written request must be submitted to the Contracting Officer to explain the circumstances that require the authorization of alternate payment procedures.

(d) Invoices that include time and materials, or labor hours Line Items must include supporting documentation to (1) substantiate the number of labor hours invoiced for each labor category, and

(2) substantiate material costs incurred (when applicable).

(e) Invoices that include cost-reimbursement Line Items must be submitted in a format showing expenditures for that month, as well as contract cumulative amounts.

(1) At a minimum the following cost information shall be included, in addition to supporting documentation to substantiate costs incurred.

- Direct Labor-include all persons, listing the person's name, title, number of hours worked, hourly rate, the total cost per person and a total amount for this category;

- Indirect Costs (i.e., Fringe Benefits, Overhead, General and Administrative, Other Indirect)-show rate, base and total amount;

- Consultants (if applicable)-include the name, number of days or hours worked, daily or hourly rate, and a total amount per consultant;

- Travel-include for each airplane or train trip taken the name of the traveler, date of travel, destination, the transportation costs including ground transportation shown separately and the per diem costs. Other travel costs shall also be listed;

- Subcontractors (if applicable)-include, for each subcontractor, the same data as required for the Prime Contractor;

- Other Direct Costs-include a listing of all other direct charges to the contract, i.e., office supplies, telephone, duplication, postage; and-

- Fee–amount as allowable in accordance with the Schedule and FAR52.216-8 if applicable.

(f) Contractor is required to attach an invoice log addendum to each invoice which shall include, at a minimum, the following information for contract administration and reconciliation purposes:

(1) list of all invoices submitted to date under the subject award, including the following:

- invoice number, amount, & date submitted

- corresponding payment amount &date received

- total amount of all payments received to date under the subject contractor order

- and, for definitized contracts or orders only, total estimated amounts yet to be invoiced for the current, active period of performance.

(g) Payment of invoices will be made based upon acceptance by the Government of the entire task or the tangible product deliverable(s) invoiced. Payments shall be based on the Government certifying that satisfactory services were provided, and the Contractor has certified that labor charges are accurate.

(h) If the services are rejected for failure to conform to the technical requirements of the task order, or any other contractually legitimate reason, the Contractor shall not be paid, or shall be paid an amount negotiated by the CO.

(i) Payment to the Contractor will not be made for temporary work stoppage due to circumstances beyond the control of U.S. Food and Drug Administration such as acts of God, inclement weather, power outages, and results thereof, or temporary closings of facilities at which Contractor personnel are performing. This may, however, be justification for excusable delays.

(j) The Contractor agrees that the submission of an invoice to the Government for payment is a certification that the services for which the Government is being billed, have been delivered in accordance with the hours shown on the invoices, and the services are of the quality required for timely and successful completion of the effort.

(k) Questions regarding invoice payments that cannot be resolved by the IPP Helpdesk should be directed to the FDA Employee Resource and Information Center (ERIC) Helpdesk at 301-827- ERIC (3742) or toll-free 866-807-ERIC (3742); or, by email at ERIC@fda.hhs.gov. Refer to the Call-in menu options and follow the phone prompts to dial the option that corresponds to the service that's needed. All ERIC Service Now Tickets will either be responded to or resolved within 48 hours (2 business days) of being received. When emailing, please be sure to include the contract number, invoice number and date of invoice, as well as your name, phone number, and a detailed description of the issue.

(END OF CLAUSE)

17. PAYMENT TERMS

Payment terms Net 30 days after government acceptance of the supply item / service. Payments shall not be made more frequently than monthly in arrears. Advance payments will not be made.

18. SECTION 508 STANDARDS

Section 508 of the Rehabilitation Act of 1973 (29 U.S.C. 794d) requires Federal agencies to purchase electronic and information technologies (EIT) 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. These 508 standards were revised in January 2018.

These revised standards, which consist of 508 Chapters 1 and 2 (Appendix A), along with Chapters 3 through 7 (Appendix C), contain scoping and technical requirements for information and communication technology (ICT) to ensure accessibility and usability by individuals with disabilities. Compliance with these standards is mandatory for Federal agencies subject to Section 508 of the Rehabilitation Act of 1973, as amended (29 U.S.C. 794d).

The following Section 508 standards apply to this 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)

• 302 - Functional Performance Criteria (Appendix C, Application and Scoping 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.

19. GOVERNMENT FURNISHED EQUIPMENT AND INFORMATION

Following receipt of FDA badges, FDA will provide personal computers, network accounts, laptops, network access, necessary software, and access to relevant FDA data systems to the Contractor employees. Additional access and property may be granted on a case‐by‐case basis, (e.g., mobile devices, hardware to test) as required per individual task order requirement. The FDA will provide the Development, Test, Pre‐production, Production and any other server‐based environments necessary to accomplish the stated work.

Item Description PIV Badge PIV badge will be issued by security office, upon successful

Level‐5 security clearance.

Laptop Computer An FDA laptop, with standard FDA “image” will be provided.

Laptop can only be accessed using PIV Badge.

Desk and Chair A desk and chair will be provided, in an office, cubicle or open area, at the government’s discretion. The FDA uses hoteling and therefore the desk/chair may rotate daily.

Printer/Photocopier Services will be provided in a “networked” configuration, accessible from the provided laptop computer.

Government Furnished Information (GFI) will be accessible through the FDA network and paper copies, as needed. The following will be provided to the Contractor upon arrival and obtaining badging and access to FDA network:

• Access to document repositories and file shares.

http://508.hhs.gov/ https://www.hhs.gov/web/section-508/additional-resources/section-508-contacts/index.html

• System‐related artifacts.

• Production system documentation.

• Access to FDA tools.

• System software and code.

• Other relevant…