FDA_SourcesSought.pdf

REQUEST FOR INFORMATION #FDA-RFI-75F40124R00011

FOR: Center for Drug Evaluation and Research (CDER)

DEPT/AGENCY INFORMATION: Department of Health and Human Services U.S. Food and Drug Administration (FDA)

Requiring Offices: Office of Surveillance and Epidemiology (OSE)

GENERAL INFORMATION

The U.S. Food and Drug Administration (FDA) is issuing this request for information (RFI) as a means of conducting market research, pursuant to FAR Part 10 Market Research, to identify potential parties from the marketplace capable of providing access to human poison exposure data that target segment of the population who rely exclusively on the internet for health information, to improve reporting and accountability of its missioned program areas.

This is a REQUEST FOR INFORMATION ONLY, not a Request for Quote (RFQ) and does not commit the Government to award a contract now or in the future. The purpose of this sources sought is to identify sources with the capabilities to provide the services stated herein. Submission of any information in response to this market survey is purely voluntary and FDA welcomes responses from all interested parties;

the Government assumes no financial responsibility for any costs incurred. Small business are encouraged to submit a response.

The FDA will use the results of the market research to determine if sources capable of satisfying the agency's requirements exist based on its response to the objectives described in this notice. The FDA does not intend to make a selection decision or award a contract on the basis of responses.

Acknowledgement of receipt of responses will not be made, nor will respondents be notified of the outcome of the FDA's review of the information received. Additionally, the FDA does not intend to hold discussions concerning this RFI with any interested parties. However, FDA reserves the right to contact vendors if additional information is required.

INSTRUCTIONS

Responses should not exceed 15 pages in length. A complete response should include answers to all the questions below. Please note that a respondent's failure to provide a complete response to a question will be interpreted to mean that it does not understand the question and does not demonstrate the capability to provide services required. Responses should demonstrate capability, not merely affirm the respondent's capability (i.e., the response must go beyond the statement that, "XYZ company can provide technical support").

Respondents will not receive individualized feedback on any suggestions. No basis for claims against the United States government shall arise as a result of a response to this request for information or from the United States government's use of such information. Proprietary, classified, confidential, or sensitive information should not be included in your response. The Federal Government reserves the right to use any non-proprietary technical information in any resultant solicitation(s).

While the Government anticipates establishing a contract for human poison exposure data which requires contractual support, A SOLICITATION IS NOT CURRENTLY AVAILABLE. The Government is not obligated and will not pay for any information received from potential sources as a result of this sources sought.

Companies are encouraged to respond if they have the capability and capacity to provide the identified services. Interested small business potential Offerors are encouraged to respond to this notice.

However, be advised that generic capability statements are not sufficient for effective evaluation of respondents' capacity and capability to perform the specific work as required.

Responses should be emailed to Brian Wodzisz, Contract Specialist, at Brian.Wodzisz@fda.hhs.gov by 2pm ET, May 6th, 2024.

Please include the RFI number FDA-RFI- 75F40124Q00218 Human Poison Exposure Data in the subject line.

No phone calls will be accepted for this notice.

CAPABILTY STATEMENTS

Interested, capable vendors (parties) shall submit a Capability Statement in response to this notice with the following information:

1) Contact information:

1) Company Name

2) Mailing Address

3) Name, telephone number, and e-mail address of a point of contact having the authority and knowledge to clarify responses with Government representatives.

4) UEI

5) Business size for NAICS 541990 with size limitation standards of $19,500,000.00 and status, if qualified as an 8(a) firm (must be certified by the Small Business Administration (SBA), Small Disadvantaged Business (must be certified by SBA), Woman-Owned Small Business, HUBZone firm (must be certified by SBA), and/or Service-Disabled Veteran Owned Small Business (must be listed in the VetBiz Vendor Information Pages).

6) Company structure (Corporation, LLC, partnership, joint venture, etc.). Companies also must be registered in the SAM (www.sam.gov) to be considered as potential sources.

7) Any Governmentwide Acquisition contract number(s) with period of performance to include option periods.

8) If a small business, demonstrate the firm’s capability to meet the requirements of FAR 52.219-14, Limitations on Subcontracting.

9) If a large business, identify the subcontracting opportunities that would exist for small business concerns.

10) Proposed NAICS for this effort

2) Please provide responses to the following questions regarding capability/experience relevant to providing Human Poison Exposure Data:

1. Can you provide a brief narrative to demonstrate your company’s experience providing this type of product (commercial or Government)?

2. Does your company have the capability to provide access to a nation-wide human poison exposure data captured entirely through a well-structured web-based platform that targets population who relies on the internet for health information?

a. If yes, address the following questions:

i. Are the data available for user friendly visualization and analysis?

ii. Do the data collection method provide comprehensive triage? Are the follow-up of cases fully automated and allow adjustment of recommendations based on specific symptoms at follow-up?

3. Real Time Data Access

a. Does your company have the capability to provide real time or near real time data access and analysis? If yes, please explain.

b. If a case is entered more than once, will the duplicate entry be excluded from the case counts and real time data analysis?

c. Can an alerting system be created for the surveillance of specific drugs or products?

4. Number of Cases Managed

a. What is the number of cases received on a daily, monthly, and annual basis?

5. Quarterly Download and Search Capabilities

a. Can your company provide a customized report download?

b. If so, can a sample quarterly report of poison data be provided, that details the overall distribution of adverse event for drugs/biologics? Can a similar report be provided for overdose cases?

6. Enhanced Data Collection

a. Does your company adhere to standardized evidence-based algorithms to maintain an online tool for collection of exposure data, provide access to an analytic platform to visualize and to analyze the collected data? If yes, please describe the capability.

BACKGROUND

The Food and Drug Administration (FDA)/Center for Drug Evaluation and Research (CDER) is interested in obtaining access to human poison exposure data collected exclusively online. This data targets a segment of the population who may exclusively rely on the internet for health information. The primary objective of securing access to exposure data targeting this population, is to complement the existing data in support of the agency’s public health surveillance activities.

The FDA continues to seek data stream that provide additional information to complement agency’s currently available data to inform regulatory and routine surveillance activities.

FDA considers risks from accidental exposure in its overall assessment of drug safety. For example, regulatory actions to mitigate this risk include requiring a black-box warning in drug labeling for testosterone topical gel1 and requiring risk evaluation and mitigation strategies for sufentanil and the transmucosal immediate-release fentanyl medicines, respectively. As the FDA continues assessing adverse events associated with use of drugs in the post-market setting, FDA seeks to increase its coverage of data on accidental exposures to drugs by supplementing existing data with access to an analytic platform that offer exposure data gathered from segment of the population that rely solely on the internet for health information. We anticipate public’s use of internet-based health information will expand the role in the prevention, triage, and treatment of human poison exposures in the United States.

OBJECTIVE

The Sources Sought is to broaden FDA’s understanding of the market’s capability to conduct safety surveillance of adverse events including poison exposure information reported solely through the internet. The FDA perceives that the Contractor shall have the capabilities to provide the following:

1) Access to a nationwide poison exposure data that targets segment of the population who may rely exclusively on the internet for health information.

2) Access to a user-friendly analytic platform that allow data analysis

3) Access to robust data such as routes of exposure (e.g., eye, inhalation, injection, multiple routes, etc.), demographics (e.g., weight, specific age) captured through evidenced based web-portal and automated follow-up of cases

Description of Work & Task Areas

The Contractor shall furnish the required personnel, operations, maintenance, enhancements, analytic and technical capabilities, facilities, and all other aspects of the statement of work delivery and administration necessary for the performance of the work, as described below. The Contractor shall ensure end user is kept informed and trained on how to use the system and the available features.

Description of Tasks

The Contractor shall perform the following tasks under this Scope of Work.

Task 1: Access to the Web-based Poison Data

a. User Access FDA User Access is the ability of authorized FDA users to conduct data analysis and generate reports on any products or substances, to share retrieved poison data across the FDA, and publicize the data in support of public health issues tracked and regulated by the FDA in accordance with the license agreement between FDA and the Contractor. Access Structure shall provide the following representative features and functionalities:

Access to comprehensive poison data dating back to the available data years through user friendly analytic platform

Enterprise access rights for unlimited number of FDA users, including third-party users (i.e., FDA's contractors who are bound by confidentiality requirements at least as strict as those

1 Testosterone Gel Drug Label. Available at:

https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/205781Orig1s000lbl.pdf [Accessed 31 October 2023] https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/205781Orig1s000lbl.pdf applicable to FDA employees). Access to the web-based poison data shall be limited to only those individuals as determined by FDA.

Maximum of 50 number of concurrent users at any given time shall be allowed.

b. Activities FDA users shall have the ability to perform following activities:

Search, visualize, and download poison data from user friendly analytic platform Run reports with high level aggregate data and accompanying graphs and tables Run complex reports that may include granular detailed information about each case Filter cases based on a specific set of products or substances taken during a user defined time period Create surveillance definitions for automated alerts Extract data and download available reports in the following formats: CSV, PDF, Excel, Word

c. Task 1 Deliverables

Web-Based Poison Data Platform with searchable functionality Enterprise user accounts with unlimited number of user access Reports with aggregate and granular data Surveillance definitions based on user selections Downloaded reports

Task 2: Products and Services

The Contractor shall provide the following products and services.

a. Training

The contractor shall coordinate and manage at least three (3) training sessions annually to ensure FDA users become familiar with the data system. Contractor shall provide up to five (5) additional ad hoc training sessions annually when requested.

Training shall include instructions on how to query, how to interpret the retrieved data, how to set up surveillance alerts, and other information on optimal use of the data and the data system.

Of note, surveillance alerts when set up may allow a system to generate reports at set intervals triggered by predefined criteria to enable users to monitor cases or volume of exposures to one or more products or substances.

Training and/or tutorial videos on how to use the data platform Updated user manual with clear instructions

b. Professional Consulting Services

The Contractor shall provide services for data management, customized data searches and reports, risk assessment and analysis, data quality improvements, and effective use and interpretation of the data.

These services include:

Supporting FDA with specific information and in categories of specific interest to FDA o This may include detailed information request for analysis of internal data and resources, and creation of tables and reports to accommodate user requests o Respond to ad hoc data call as requested

Surveillance reports – reports generated at set intervals triggered by predefined criteria to enable FDA to monitor cases or volume of exposures to one or more products or substances. Search parameters will be agreed upon between FDA and the Contractor

Ad hoc and emergency requests associated with current public health safety issues adverse events, and/or market analysis for specific categories of FDA regulated products or substances

The Contractor shall be available to support emergency requests 7 days a week due to urgencies related to outbreaks involving FDA regulated products, advisory meetings, congressional testimony, etc. These activities may include specific data collection (e.g., follow-ups), data retrieval, data integration, and data analysis activities.

If the Contractor recognizes any concerning trends related to FDA regulated products, Contractor shall promptly notify FDA’s key personnel

Data Analysis and Subject Matter Expertise Service

The Contractor shall provide subject matter expertise (SME) services which may include:

Support and collaboration on web-based poison data used by FDA Support for utility/usability of collected data for analysis to address complex data needs Triage, diagnosis, medical management, and continuing care of patients by clinical/medical toxicologist health care professionals to provide direction on any patient-care related aspects of data collection/use or possibilities for patient management directives based on established algorithms

Advise and develop new data collection algorithms to meet FDA’s specific data needs not currently met

c. Technical Support and Services

The Contractor shall provide technical support that shall be available Monday–Friday, 9:00 am–6:00 pm ET. Representative activities include: phone, online, or email support on system access issues; respond to general inquiries on how to use the system and run reports; address and resolve system availability and functionality issues; track issues and usage; follow escalation procedures; and respond to any other general technical issues.

Technical services shall include system configuration, development, customization, and on-going enhancements to meet FDA’s business needs

d. Surveillance Definition Maintenance Services

The Contractor shall create and maintain surveillance definitions on behalf of the FDA user. This service also includes technical support.

Task 2 Deliverables

Three (3) required training sessions during the contract performance period Up to five (5) ad hoc training sessions as needed User manual, training materials and recorded tutorials for the web-based poison data platform Professional consultation services outlined in the SOW Data analysis support Subject matter expertise services Technical Support and Services

Surveillance definition maintenance services

Task 3: Program and Project Management

The Contractor shall provide technical support and project management (PM) for the outlined requirements. These requirements shall include what is necessary to plan, structure, coordinate, schedule, manage, communicate, report, and steward all respective tasks orders and activities to meet the scope of work during the performance period. Additionally, the Contractor shall work with all relevant government contracting personnel and subject matter experts (SMEs) to ensure the outlined scope of work stay on track and important milestones are met. The Contractor shall provide government necessary feedback regarding progress.

Activities may include but not limited to the following tasks.

a. Kickoff Meeting

Within thirty (30) government business days of the award of this contract or as directed by the Contracting Officer’s Representative (COR), the Contractor shall conduct an orientation meeting and briefing. The completion of this briefing will result in, but not be limited to, the following:

• Brief overview of contract administration and reporting

• Discussion of substantive risks and issues that may impact the delivery of the project

• Joint determination of the contents of a work plan to detail the specific activities and tasks to be associated with the period of performance specified in the SOW

• Plan to deliver to the Contractor any Government-Furnished Equipment, Information, or

Materials (GFE/I/M) unless specifically provided at contract award

• Review by the Contractor of its understanding of the work to be accomplished under this

SOW so that all parties have a common understanding of the work to be performed and of the respective responsibilities and obligations of the parties to that end

b. Project Management Plan

The Contractor shall develop a proposed schedule and high-level Project Management Plan

(PMP).

The Contractor shall identify the resources that FDA needs to provide for this effort.

FDA will approve the PMP or provide comments for revision within ten (10) government business days of delivery.

The PMP may be revised as needed throughout the period of delivery; however, an updated version of the PMP shall be delivered a least once a month.

c. Instructions - Management Plan

• Describe the administrative infrastructure required of the contractor to ensure efficient planning, initiation, implementation, and timely completion of the project;

• Describe the responsibility for overall project management including communication plan, timelines, status reports, report format, etc.;

• Include coordination of activities carried out under subcontractors, if applicable;

• Throughout the period of performance, the Contractor shall maintain, modify, and update the

PWP that may include risk management, staffing, and quality assurance plans, Standard Operating Procedures (SOP), protocols, and manual of procedures;

d. Progress Reports

The Contractor shall provide monthly progress and financial reports that show the expenditure of resources is consistent with and will lead toward successful completion of all tasks within projected cost and schedule limitations. In coordination with FDA and pending the content approval of the government COR, the monthly status reports may take the form of a PowerPoint briefing to expedite the identification and resolution of issues.

Additionally, the progress reports shall include but not limited to: (1) information on maximum number of FDA users of the web-based poison data system per week to gauge usage pattern; (2) previous month’s progress, deviance from previous month’s planned progress (either positive and negative); (3) Issue and recommendations; (4) Overall updates and enhancements

e. Meetings The Contractor shall coordinate, conduct, and participate in the following meetings as mutually agreed to in the PMP: status update meetings, progress meetings, facility meetings, training meetings, performance meetings, program/project reviews, management briefings, stakeholder presentations, demonstration meetings, transition meetings, and / or COR site visits.

f. Transition Plan

The Contractor shall assist FDA in developing a plan for commercialization and any other appropriate transition activities.

g. Executive Report-Out

The Contractor shall provide an executive-level summary of the goals, activities, and findings of this work.

This may take the form of a document and/or a briefing, as mutually agreed to with FDA.

Task 3 Deliverables

Kickoff Meeting Project Management Plan Progress Reports Meetings Transition Plan Executive Report-Out