SOL_RFQ (75F40125Q00401) SafeMedUse.docx

COMBINED SYNOPSIS/SOLICITATION FOR SafeMedUse

SOLICITATION NUMBER: 75F40125Q00401

i. This is a combined synopsis/solicitation for commercial items prepared in accordance with the Federal Acquisition Regulation (FAR) format in Subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; quotes are being requested and a written solicitation will not be issued.

This procurement is being conducted under simplified acquisitions procedures in accordance with FAR Parts 12 in conjunction with Part 13.

ii. The solicitation number is 75F40125Q00401. This requirement is issued as a request for quotation (RFQ)

The solicitation is issued as a Full and Open Competition.

iii. The solicitation documented and incorporated provisions and clauses in effect through the Federal Acquisition Circular (FAC) FAC-2025-05, Effective 08/07/2025.

iv. The associated North American Industry Classification System (NAICS) Code is 541990 All other Professional, Scientific and Technical Servcies with a small business size standard of $19.5 million.

v. The US Food & Drug Administration (FDA) intends to issue a Commercial Item Firm Fixed-Price purchase order that meets the requirements herein.

A list of line item number(s) and items, quantities, and units of measure are provided in the schedule below and can also be found in sections vi and vii of the solicitation.

vi. Description of Requirement - Safe Medication Use - Access to Medication Error Data, Products, and Services and vii. Order Administration Information

BACKGROUND

The Food and Drug Administration (FDA) / Center for Drug Evaluation and Research (CDER) is interested in obtaining products, services, and access to medication error[footnoteRef:1] data collected from across the United States to inform regulatory and mission critical surveillance activities. [1: The National Coordinating Council for Medication Error Reporting and Prevention defines a medication error as, “any preventable event that may cause or lead to inappropriate medication use or patient harm while the medication is in the control of the health care professional, patient, or consumer. Such events may be related to professional practice, health care products, procedures, and systems, including prescribing, order communication, product labeling, packaging, and nomenclature, compounding, dispensing, distribution, administration, education, monitoring, and use." Available at: https://www.nccmerp.org/about-medication-errors [accessed 2025 Jan 28].]

FDA considers risks from medication errors in its overall assessment of drug safety. For example, regulatory actions to minimize medication error risks include requiring a boxed warning in the Prescribing Information to prevent dosing errors, changing a proprietary name to prevent wrong drug errors, and revising container labels to prevent wrong route of administration errors.[footnoteRef:2],[footnoteRef:3],[footnoteRef:4] As the FDA continues assessing adverse events associated with the use of drug products in the postmarketing setting, FDA seeks to enhance data coverage through available products, services, and access to medication error data associated with FDA regulated drug products that is gathered nationwide from healthcare providers, consumers, patient safety organizations, published literature, and other sources of safety information. [2: Methadone hydrochloride oral solution Prescribing Information. Available at: https://fdalabel.fda.gov:8443/fdalabel/services/spl/set-ids/8c363f90-c378-48ae-abbc-aeb25c9bf5cb/spl-doc [accessed 2024 Oct 1]. ] [3: FDA Drug Safety Communication: FDA approves brand name change for antidepressant drug Brintellix (vortioxetine) to avoid confusion with antiplatelet drug Brilinta (ticagrelor). 2016 May 2. Available at: https://www.fda.gov/drugs/drug-safety-and-availability/fda-drug-safety-communication-fda-approves-brand-name-change-antidepressant-drug-brintellix [accessed 2024 Oct 1]. ] [4: FDA Alerts Healthcare Professionals About the Risk of Medication Errors with Tranexamic Acid Injection Resulting in Inadvertent Intrathecal (Spinal) Injection. 2020 Dec 3. Available at: https://www.fda.gov/drugs/drug-safety-and-availability/fda-alerts-healthcare-professionals-about-risk-medication-errors-tranexamic-acid-injection-resulting [accessed 2025 Jan 28].]

OBJECTIVES

FDA’s objective is to acquire:

· Medication error case reports collected from across the U.S. population (including pediatrics and adults) throughout the medication use process[footnoteRef:5] with sufficient granularity to understand the type of error, where the error originated, specific product(s) involved in the error, causes or contributing factors for the error, actions taken or recommended to prevent the error from occurring, adverse events and outcomes associated with the error. [5: For the purposes of this document, the medication use process includes selection and procurement, storage, prescribing and transcribing, preparing and dispensing, administering, and monitoring. ]

· Unlimited, multi-user access to medication error data from an existing web-based analytics platform[footnoteRef:6] that contains at least 5 years of medication error case reports from across the United States to support surveillance activities for identifying and tracking medication error safety related issues. [6: For the purposes of this document, an analytics platform includes software, databases and other systems to receive, store, manage, and analyze collected medication error data.]

· Medication error data to inform appropriate responses to emerging public health safety concerns to ensure the safety of FDA-regulated drug products.

· Advanced subject matter expertise, training, and education to increase existing knowledge and experience within FDA on medication error prevention and analysis, including medication error risks, incidence trends, causes, and mitigation strategies.

SCOPE/WORK STATEMENT AND TASK AREAS

Scope of Work (SOW) 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.

SOW Task Areas Table

Task 1: Medication Error Case Report Data Technical Requirements and Services

MEDICATION ERROR CASE REPORT DATA REQUIREMENTS

The Contractor shall collect voluntarily submitted medication error case reports from various sources (e.g., healthcare providers, consumers, hospitals, outpatient pharmacies, long term care facilities) across the United States that are associated with FDA-regulated drug products (including prescription and nonprescription drug products). Case reports collected should include those that describe “near misses” or circumstances that could have led to a medication error (i.e., “potential error”).

The Contractor shall allow the use of various types of media (e.g., web-based, paper, telephone, fax) for the sources to submit medication error case reports to the Contractor.

The Contractor shall provide copies of their collected medication error case reports on a monthly basis to the FDA Adverse Event Reporting System (FAERS).

The Contractor shall upon request from the FDA provide medication error case reports within 48 hours in support of evaluating an urgent medication error safety issue.

The Contractor shall redact any patient identifiable information (e.g., name, address, etc.) when providing FDA medication error case reports and adhere to regulations involving confidential information.

The Contractor shall attempt to obtain detailed information through the use of reporting forms and follow up methods that are necessary to assess each medication error case report, including:

· Patient demographics (e.g., age, weight)

· A description of the circumstances that led to the medication error (including “near misses”) or could have led to a medication error (i.e., “potential error”).

· Specific products involved in the medication error, including proprietary (if applicable) and nonproprietary drug names, manufacturer, product characteristics (e.g., dosage form, strength) and National Drug Code (NDC).

· Type of error (e.g., wrong drug, improper dose, wrong route of administration)

· Stage in the medication error process (e.g., prescribing, dispensing, administration) where the error originated.

· Setting where the error occurred (e.g., hospital, patient home).

· Causes and contributing factors for the error (e.g., lookalike container labels, soundalike drug names, unclear preparation instructions).

· Actions taken or recommended to prevent the error from occurring.

· Whether the medication error did or could have resulted in patient harm.

· Outcome (e.g., death, hospitalization) related to the medication error(s)

· Images of the products involved in the error.

The Contractor shall use industry standard dictionaries and terminologies to code information provided in the medication error case reports, including the product name, type of error, and contributing factors.

DATA ANALYSIS AND SUBJECT MATTER EXPERTISE SERVICE

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

· Support for the medication error data provided by the Contractor that is used by FDA, including medication error risk identification and mitigation strategies.

· Support for utility/usability of Contractor-collected data for analysis to address complex data needs

· Collaboration with FDA on medication error safety issues

· Advise and develop new medication error data collection and surveillance methods and alerts to meet FDA’s specific data needs.

PROFESSIONAL CONSULTING SERVICES

The Contractor shall provide professional and consultative services for data management, customized data searches and reports, risk assessment and analysis, data quality improvements, and effective use and interpretation of the data. Contractor shall provide consultative services via email or through virtual meetings as requested. These services include:

· Promptly notifying FDA’s key personnel if the Contractor recognizes any emerging medication error safety issues or other concerning trends.

· Supporting FDA with specific information and in categories of specific interest to FDA. This may include detailed information requests for analysis of the Contractor’s collected medication error data and creation of custom tables and reports to accommodate user requests.

· Supporting FDA ad hoc data calls during normal business hours (8 AM to 6 PM ET, weekdays) to provide medication error case reports and data.

· Providing surveillance reports, generated at set intervals triggered by predefined criteria to enable FDA to monitor cases and trends. Search parameters will be agreed upon between FDA and the Contractor.

· Responding to ad hoc and emergency requests associated with current medication error safety issues.

· Participating in virtual monthly meetings with FDA to discuss medication error safety concerns as requested by FDA.

DELIVERABLES – MEDICATION ERROR DATA TECHNICAL REQUIREMENTS AND SERVICES

· Case reports collected through various types of media for reporting medication errors

· Copies of medication error case reports provided to FDA

· Medication error reports with detailed information as specified in the scope of work

· Medication error data coded with standardized dictionaries and terminologies

· Notify and collaborate on emerging safety issues.

· Support for complex data needs

· Advise and develop new medication error data collection and surveillance methods

Professional Consulting Services

· Notify FDA’s key personnel of emerging medication error safety issues or other concerning trends

· Supporting FDA with specific information and in categories of specific interest to FDA.

· Supporting FDA ad hoc data calls to provide medication error case reports and data.

· Provide surveillance reports

· Responding to ad hoc and emergency requests associated with current medication error safety issues.

· Participating in virtual monthly meetings with FDA to discuss medication error safety concerns as requested by FDA.

Task 2: Web-based Analytics Platform Data Requirements

USER ACCESS

FDA access to medication error data shall include the capability for authorized FDA users to conduct data analysis and generate reports on drug products, to share medication error data across the FDA, and publicize the data in support of public health issues tracked by the FDA. User access shall provide the following representative features and functionalities:

· Access to comprehensive medication error data dating back to the available data years (at a minimum of 5 years) through an analytics platform.

· Access rights to the analytics platform for up to 25 FDA users, with user accounts determined by FDA.

· Access to the analytics platform shall be in real-time and accessible via a secure Internet connection permitting multi-user access through a user-friendly data query interface tool.

· Access to the analytics platform shall be to the most current version, including all upgrades, enhancements, and modifications to the analytics platform and include associated training on how to use the platform and new features.

· Access shall allow for a maximum of 10 concurrent users at any given time.

FEATURES AND FUNCTIONALITY

FDA users shall have the ability to perform the following activities:

· Search, visualize, and download medication error data from the analytics 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 specific products, medication error types, product characteristics, contributing factors, or outcomes during a user defined time period.

· Perform text searches of medication error case report narratives.

· Create surveillance definitions for automated alerts. The surveillance alerts when set up shall allow a system to generate reports at set intervals triggered by predefined criteria to enable users to monitor cases or large data sets involving one or more products and or type of medication error.

· Extract data and download available reports in the following formats: CSV, PDF, Excel, Word in an automated method without any intervention required by the Contractor.

TRAINING SERVICES

The contractor shall coordinate and manage at least two virtual training sessions annually to ensure FDA users become familiar with the collected medication error data and analytics platform; and provide up to three additional ad hoc training sessions annually as requested.

· Training shall include instructions on how to request or perform data queries, how to interpret the retrieved data, how to request or set up surveillance alerts, and other information on optimal use of the medication error data and analytics platform.

· Training tutorial videos on how to use the analytics platform that are in a format mutually agreed upon with the FDA.

· User training (including updated training user manuals, training materials, and recorded tutorials) will be updated to reflect any upgrades, enhancements, and modification to the analytics platform available electronically.

· Training shall be initiated within 30 days of award and continue throughout the duration of contract.

DELIVERABLES - WEB-BASED DATA RESOURCE DATA REQUIREMENTS

· Access to the analytics platform for up to 25 FDA users

· Real-time access to the analytics platform via a secure Internet connection permitting multi-user access through a user-friendly data query interface tool.

· Upgrades, enhancements, and modifications to the analytics platform

· Capability to run complex reports

· Capability to filter cases based on data criteria

· Capability to create surveillance definitions for automated alerts

· Capability to extract data and download reports

· Up to three virtual additional ad-hoc training sessions annually

· User training associated with upgrades, enhancement, and modifications

· Electronic user manual, training materials, and recorded tutorials

Task 3: Technical Support and Services

TECHNICAL SUPPORT PACKAGE

The Contractor shall provide a support package comprised of written documentation that includes technical and analytical support throughout the length of the contract and shall address:

· Frequency of data resource platform upgrades, enhancements, modifications, and the potential need of customization for FDA business needs

· Provide technical support that shall be available Monday–Friday, 8:00 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.

OPTIONAL SERVICES:

Technical services shall include system configuration, development, customization, and on-going enhancements to the existing data resource platform to meet FDA’s business needs.

DELIVERABLES – TECHNICAL SUPPORT AND SERVICES

· Customizable to FDA needs

· Support via phone, email or online

Task 4: Program and Project Management, Performance Evaluation Plans The Contractor shall provide Program and Project Management Plans (P/PMP) to manage the cost, schedule, and quality of services for the scope of work (SOW) requirements. The P/PMPs may be revised as needed throughout the period of performance; however, the P/PMPs shall be reviewed a maximum of once a month.

PROGRAM MANAGEMENT PLAN

· The Program Management section of the plan shall include a Quality Planning (QP), Quality Control (QC), Quality Assurance (QA), Risk Management (RM) to support the overall contract to ensure FDA access to medication error data, including the analytics platform. The plan shall detail the procedures, methods and guidelines used to ensure the required performance and services meet the SOW requirements.

PROJECT MANAGEMENT PLAN

· The Project Management section of the plan shall include a staffing plan, communication plan, quality assurance, and risk management plan for the purpose to plan, staff, coordinate, schedule, manage, communicate, report, and steward all respective tasks, activities, and deliverables to meet the day-to-day operations of SOW during the performance period of the contract.

· The Contractor shall work with all relevant government contracting personnel, Contracting Officer’s Representative (COR), Project Manager (PM) and subject matter experts (SMEs) to ensure the outlined scope of work requirements are met.

· The Project Management Plan may be revised as needed throughout the period of delivery; however, an updated version of the plan shall be delivered at Monthly Progress Meetings.

PERFORMANCE EVALUATION PLAN

Performance shall be evaluated to determine whether the contractor meets the threshold of the agreement. When the performance threshold is not met, the FDA COR shall notify the Contract Specialist/Officer. The Contractor shall reply to all performance inquiries listed below with a resolution within 15 business days of receipt. Failure to meet the Acceptable Quality Level shall be captured as non-performance and provided to the Contracting Officer for action.

DELIVERABLES – PROGRAM AND PROJECT MANAGEMENT PLANS

· Revise as needed and deliver updated Plan at the Monthly Progress Meetings

Task 5: Project Management

KICKOFF MEETING

Within thirty (30) government business days of contract award the Contractor shall facilitate and conduct a kickoff meeting to address transition-in activities, contract administration activities, and review of the contract task areas to ensure all parties have a common understanding of the tasks to be performed, and the respective responsibilities and obligations of the parties.

The completion of this kickoff meeting will result in, but not be limited to, the following:

· Introductions

· Contract Administration Activities:

· Contractor Roster (Employee Information: Roles and Responsibilities List)

· Government Integrated Project Team (IPT) (Employee Information: Roles and Responsibilities)

· Discussion of contract task areas, deliverables and associated timelines, risks and/or issues that may impact delivery

· Contract Overview/Invoice Processing Platform (IPP)/Instructions/Invoicing/Monthly Reporting

· Meeting Schedule

· Mandatory Contractor Training

MONTHLY PROGRESS MEETINGS

The Contractor shall provide a Monthly Progress Report in the form of a PowerPoint briefing and shall include but not limited to the following items with the goal of expediting the identification and resolution of issues:

· Staffing Updates – scheduled personal time off (PTO), key personnel changes

· Financial reporting – burn rate of expenditure of resources to ensure the level is consistent with successful completion of all tasks within the projected cost and schedule limitations

· Task Area Status Updates – to include any upgrades, enhancements, and modifications to software and data

· Training Scheduled

USAGE AND CLEARANCE REPORTING

The Contractor shall provide monthly usage reports by each individual FDA user noting deviance from previous month’s usage (positive or negative) of the web-based data resource platform to gauge usage patterns.

The Contractor shall provide a monthly report on the clearances for use of the data in a public forum detailing the date, audience, data disclosed, and public meeting (see Disclosure Clearance sub-heading).

DISCLOSURE CLEARANCE FOR AGGREGATED DATA OUTSIDE THE AGENCY

As part of its regulatory activities, FDA shall, at times, require disclosure of scientific and technical articles, study results, presentations, public health advisories, and similar works involving medication error data to entities outside the Agency including the general public. For activities that require disclosure of medication error data, the Contractor shall accept and adhere to the FDA Data Disclosure Clearance Procedures as mutually agreed .

The FDA shall continue to require the ability to release medication error data through the agreed upon FDA Data Disclosure Clearance process for data obtained during the contract period of performance.

· Clearance after ordering period during option years: the FDA shall notify the contractor of the medication error data release and accept the Contractor’s requested revisions but shall not require formal approval for release.

· Clearance after Conclusion of Contract: the FDA shall continue to require, after the conclusion of the contract, the ability to release medication error data through the FDA Data Disclosure Clearance process for data obtained for analyses during the contract period. After Year 5, the FDA shall notify the Contractor of the medication error data release and accept the Contractor’s requested revisions but shall not require formal approval for release.

MEETINGS

The Contractor shall schedule, coordinate, conduct, and participate in the following meetings to be conducted remotely unless determined at the discretion of FDA COR/PM to be in-person at the FDA White Oak facility in Silver Spring, MD:

· Monthly (or mutually agreed upon frequency) Progress Meetings

· Training Sessions

· Technical and/or Analytic Meetings as needed

· Demonstrations on any upgrade, enhancement, or modification to data resource platform

· Transition meetings associated with Key Personnel changes

· Optional Annual Meeting - conduct an annual meeting to discuss scientific issues of interest to the Agency and relevant work that the contractor has performed, as well as discussing FDA satisfaction with all deliverables.

MEETING AGENDA

The Contractor shall prepare meeting agendas, consulting with the FDA COR/PM in advance, to include meeting notes, issues, risks, and action items; and submit via email to the COR/PM at least two (2) business days prior to the meeting

MEETING NOTES

The contractor shall take formal meeting notes at all meetings (except for training sessions). No later than two (2) business days after the meeting, the contractor shall submit via email to the COR/PM, detailing the discussion, and listing any risks, actions, and/or issues identified with an owner and target date for decision, resolution, or a mitigation strategy agreed upon during the meeting.

DELIVERABLES – PROGRAM AND PROJECT MANAGEMENT PLANS

SCHEDULE OF DELIVERABLES

The Contractor shall propose a schedule of deliverables based on its proposed technical approach and incorporate the final agreed-upon deliverable schedule into the Management Plan.

TABLE 1. Deliverables and Schedule

(e.g., Reports with aggregate and granular data; Downloadable reports) At the time of award and throughout the contract period of performance

Throughout the contract performance period

Up to three ad hoc training sessions as needed First training session within 30 government business days of award date and throughout the contract performance period

CONTRACT ADMINISTRATION

Type of Contract The Government anticipates awarding one (1) Firm Fixed Price type contract.

Contract Administration Point of Contacts (POCs) Contracting Officer Representative (COR): TBD at time of award

Contracting Officer (CO): Phillip Frame

Inspection and Acceptance of Deliverables Within twenty-five (25) business days of receipt of an official deliverable, the COR will review the deliverable and indicate any required changes and/or accept or reject the deliverable. In the event the Government rejects any deliverable(s), the COR will notify the Contractor in writing explaining the specific reason(s) for the rejection, and the Contractor shall resubmit the revised deliverable within ten (10) business days after receiving the Government’s input. If the Contractor cannot correct the deficiencies within this timeframe, the Contractor shall immediately notify the COR of the reason for the delay and provide a proposed corrective action plan within ten (10) business days.

Period of Performance The anticipated period of performance consists of one (1), 12-month base period and four (4), 12‑month option period, as follows:

The actual period of performance will be determined at the time of award.

Place of Performance The Contractor shall work primarily in facilities provided by the Contractor or remote facilities approved by the Contractor.

As approved by FDA, the Contractor may participate in conferences and meetings where relevant project issues are discussed. As requested by the COR, site visits to sponsor locations may be required to meet with the Contractor or other FDA and HHS staff experts.

In the event of a Government Shutdown, the Contractor shall follow the rules as follows:

When the Government facility is closed due to local or national emergences, administrative closings, or similar Government directed facility closing, for other than firm fixed prices contract, the Contractor will not be reimbursed when the Government facility is closed for the above reasons. For unscheduled closing, (e.g., weather emergencies, Executive Orders, etc.) the Contractor shall seek guidance from the COR.

Travel All travel costs incurred by the Contractor within the Washington, DC metropolitan area is considered local travel and will not be reimbursed. If travel is required, all requests for travel shall be submitted to the FDA COR and CO for approval at least 10 days in advance of the projected travel. All costs shall be in accordance with the Federal Travel Regulations (http://www.gsa.gov /portal/content/l 02886) and FAR 31.205-46. FDA doesn’t anticipate travel under this contract, however if it is the case the above terms will apply.

Advance Understanding Notwithstanding any of the above requirements, under certain circumstances, the Government may be required to share data or information it obtains under this contract with Congress, with a Federal court, or with another governmental body of competent jurisdiction. If it intends to share data or information obtained under this contract with Congress, with a Federal court, or with another governmental body of competent jurisdiction, the Government shall take appropriate measures within its control to ensure that the information shall be shared in a manner intended to protect the information from public disclosure.

The Contractor shall ensure the protection of the information and data they receive under this contract from unauthorized use or disclosure and shall treat the information as confidential or otherwise privileged.

Government Furnished Equipment/Information This contract will not require Government Furnished Equipment (GFE).

The Government shall retain all rights and privileges, including those of patent and copy, to all Government-furnished data and materials. The Contractor shall neither retain nor reproduce for private or commercial use any data or other materials furnished under this contract. The Contractor agrees not to assert any rights at common law or in equity or establish any claim to statutory copyright in such data. These rights are not exclusive and are beyond any other rights and remedies to which the Government is otherwise entitled elsewhere in this contract.

Section 508 Compliance The Contractor shall be familiar with Section 508 requirements as described at http://www.section508.gov/ in order to ensure that the deliverables generated as part of this contract shall be compliant with Section 508.

HHS Mandated Contractor Training HHS mandates that all prime contractors and sub-contractors that are performing work under a government contract regardless of having direct access to the agency’s network are required to complete annually the HHS mandated contractor training courses within thirty (30) business days after contract award; and any other newly mandated training as required by the FDA within ten (10) business after training notification as follows:

· FDA Information Security Awareness – contractors without direct access to the FDA network, may use the HHS publicly available training site: https://www.hhs.gov/about/agencies/asa/ocio/cybersecurity/security-awareness-training/

· Training completed at this site is not tracked, therefore keep the HHS training certificates for your records and provide as a separate deliverable to the CO and/or COR.

· Regular users should complete the following:

· Cybersecurity Awareness Training – Module 1

· Cybersecurity Awareness Training – Module 2

· Rules of Behavior Overview – Module 3

· If there is a system administrator on the contract, the contractors shall complete the HHS https://www.hhs.gov/sites/default/files/hhs-etc/rbt-it-training/index.html and provide certificates to the CO and/or COR.

· FDA Records Management – contractors without access to the FDA network but are on an FDA contract and who are creating records on behalf of FDA shall complete the .pdf version of the FDA annual Records Management training and the certificate of completion (see Attachment A- 2023 FDA Annual Records Management Training_v.1.pdf and Attachment B – FDA Records Management Training Certification-2023.pdf) and provide that deliverable to the CO and/or COR.

· Emergency Preparedness – the Administration for Strategic Preparedness and Response (ASPR) requires contractors without FDA Network access to complete the mandatory training via the following link: Emergency Preparedness Training

· The Contractor PM shall provide to the FDA COR/PM a training completion report via email within five (5) business days before the required FDA Training deadline. The report shall consist of all active contractor employee’s names per the Roster, name of the training and documenting training certification.

DELIVERABLES – HHS MANDATORY CONTRACTOR TRAINING

· Documentation of completion submitted to the COR/PM

FDA Access to Non-Public Information

All Contractor and subcontractor employees are required to sign the Contractor’s Commitment to Protect Non-Public Information (NPI) Employee Agreement (Form FDA 3398), provided as Attachment D to this Purchase Order. 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 Contracting Officer’s Representative (COR) and the Contracting Officer. Any new Contractor or subcontractor employee assigned to this contract shall sign the form, and the Contractor shall electronically deliver it to the Contracting Officer 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.

CONTRACTING OFFICER AUTHORITY

The Contracting Officer (CO) is the sole person authorized to make or approve any changes in any of the requirements of this order and notwithstanding any provisions contained elsewhere in the order, the said authority remains solely with the CO. In the event the Contractor makes any changes at the direction of any person other than the CO, the change shall be considered to have been made without authority and no adjustment will be made in the delivery order terms and conditions, including price. The CO shall be the only individual authorized to accept nonconforming work, waive any requirement of the order and modify any term or condition of the order. The CO is the only individual who can legally obligate Government funds.

The Contracting Officer’s Representative (COR) or Project Officer is not authorized to make any commitments or otherwise obligate the Government or authorize any changes which affect the order price, terms or conditions. The COR/Project Officer is responsible for the technical aspects of the project and serves as technical liaison with the contractor and is responsible for the final inspection and acceptance, and such other responsibilities as may be specified in the order.

INVOICING INSTRUCTIONS

Instructions for invoicing are indicated below.

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 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.

i. 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.

ii. Registration emails are sent via email from ipp.noreply@mail.eroc.twai.gov. 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.

iii. 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 receipt of the first email, contains a temporary password. You must log in with the temporary password within 30 days.

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

v. If the Contractor is 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. 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 Indirects)- 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 FAR 52.216-8 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:

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

(1) invoice number, amount, & date submitted

(2) corresponding payment amount & date received

(b) total amount of all payments received to date under the subject contract or order

(c) 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.

viii. The provision at 52.212-1 (SEP 2023), Instructions to Offerors-Commercial Products and Commercial Services, applies to this acquisition and with the addenda below.

Submission of offers: The quoter shall submit all quotes to the point(s) of contact listed below by the due date and time indicated in the solicitation.

Period for Acceptance of Quotes: The quoter agrees to hold the prices firm until Septermber 30, 2025.

Quote Submission: All quotes shall be submitted with the following –

a) Pricing, period of performance and type of subscription for all line items with the total price

b) Description of services included in the unlimited users subscription.

c) The information requested under section x of this solicitation.

Quotes that do not provide the requested information may be deemed non-responsive.

The quoter shall submit all electronic documents for Microsoft Office suite products without the use of “macros”. When submitting proposals via email, DO NOT include .exe, .mso, or any other executable file types that could potentially trigger email security protections (i.e. email blocks, quarantine). If the offeror or applicant submits documents that contain macros, macro referenced files, and/or executable files, the Government will not be able to view or open such documents and the submission will be considered non-responsive to the solicitation. No additional time will be given to an quoter to correct the document submission and the Government will not inform the quoter that their submission is non-responsive prior to award. It is the quoter’s responsibility to ensure all electronic documents are submitted without the use of macros.

RFQ Attachments

Proposal Instructions The technical proposal shall be submitted electronically via e-mail to the Contract Specialist, Phillip Frame, at 301-796-7578, Phillip.Frame@fda.hhs.gov. The technical proposal described below shall be limited to 50 pages not including resumes or bibliographies, with no less than an 11-point font. Resumes or CVs are only required for key personnel; brief biographical sketches of other personnel may be provided.

Responses to all evaluation criteria are essential to this evaluation. Omissions will result in a poor rating for that technical criterion.

Proposals shall be submitted in three separate volumes:

Volume 1 – Technical Proposal The Offeror’s proposal shall present sufficient information to reflect a thorough understanding of the work requirements and a detailed plan for achieving the objectives as detailed in Section C. Technical proposals shall not merely paraphrase the requirements of the Agency’s scope of work or parts thereof or use of phrases such as “will comply” or “standard techniques will be employed.”

The technical proposal must include a detailed description of the techniques and procedures to be used in achieving the proposed end results in compliance with the Agency’s requirements as detailed in Section C. A successful technical proposal shall have all of the following sections.