RFQ_75F40125Q00101.docx

Request for Quote

RFQ Title: Drug Utilization: Hospital Inpatient & Emergency Dept. Data

RFQ Issue Date:

March 21, 2025 RFQ Close Date: 04/16/2025 4:00 pm ET

Delivery Location:

Food and Drug Administration Center for Drug Evaluation and Research 10001 New Hampshire Ave, Silver Spring, MD 20903 NAICS Code - 541690 - Other Scientific and Technical Consulting Services (PT)

Access to Hospital Inpatient and Emergency Department Drug Utilization Data

Table of Contents

DRUG UTILIZATION PROGRAM: ACCESS TO HOSPITAL INPATIENT AND EMERGENCY DEPARTMENT DRUG UTILIZATION DATA

Procurement Sensitive

SECTION 2: DESCRIPTION OF REQUIREMENTS

STATEMENT OF WORK

Note: All italicized terms are defined in the Glossary (Attachment 1)

2.1. Background

A vital part of the U.S. Food and Drug Administration (FDA) and Center for Drug Evaluation and Research (CDER) mission is to protect public health. The mission of the Office of Surveillance and Epidemiology (OSE) is to evaluate drug risks and promote the safe use of drugs by the American people. The statutory provisions of the Federal Food, Drug, and Cosmetic Act as amended by the Food and Drug Administration Modernization Act (FDAMA, Section 406), Title 21 Code of Federal Regulations, Section 310.305, and Title 21 Code of Federal Regulations, Section 314.80 require FDA to ensure the safety and effectiveness of regulated marketed products.

https://www.govinfo.gov/content/pkg/PLAW-105publ115/pdf/PLAW-105publ115.pdf The Office of Surveillance and Epidemiology (OSE) contributes to this effort by evaluating drug risks and promoting the safe use of drugs by the American people. Under PDUFA (Prescription Drug User Fee Act) IV, specific provisions in Title IX of the Food and Drug Administration Amendments Act of 2007 (FDAAA 2007) contains numerous provisions related to post-marketing safety and communication of safety information. A subset of those provisions calls for enhanced authorities for accessing disparate data sources as well as establishing and improving procedures to identify drug use data trends on a national level in the hospital setting.

https://www.gpo.gov/fdsys/pkg/PLAW-110publ85/pdf/PLAW-110publ85.pdf

In furtherance of these efforts, the recent enactment of PDUFA VII in 2022 under Section I (Ensuring the effectiveness of the human drug review program) includes a provision for the agency to enhance and modernize FDA’s Drug Safety System. This new act authorizes FDA (under Section IV (Information technology and bioinformatics goals) to “enhance transparency and leverage modern technology” to continue the Agency’s efforts on the standards-based information systems to support how FDA obtains and analyzes post-market drug safety data as well as manage emerging drug safety information. These statutory provisions provide FDA the authority to obtain and expand database resources that will enhance FDA’s post-market surveillance capabilities.

https://www.fda.gov/industry/prescription-drug-user-fee-amendments/pdufa-vii-fiscal-years-2023-2027 The ability of FDA to respond expeditiously to the increasing number of drug safety issues is crucial to overall public safety. Continuous access to these data complements and strengthens the utility of the passive reporting system currently in place by providing estimates of the numbers of adult and pediatric patients exposed to drugs nationwide in the hospital setting. These data resources provide a denominator, or context, for understanding adverse event reports; for modeling drug risk based on usage patterns; and for calculating patient-based reporting rates for drugs used in the hospital setting. Access to these data also increases FDA’s ability to request regulatory impact studies to better understand the usefulness of drug labeling to healthcare providers. This can be done by examining actual use of products in hospitals in accordance with the recommended labeling. Finally, direct access to these data in real time enhances and accelerates the pace of FDA's regulatory decision-making process.

The funding of "Access to Hospital Drug Utilization Data" would serve as a mechanism for FDA to respond expeditiously to serious public health concerns, regulatory issues, and legislative mandate. FDA is not interested in developing this database and expects any qualified organization to own the data as well as the means to access the data.

2.2. PURPOSE AND OBJECTIVES

This requirement seeks to obtain direct access to commercially available hospital drug utilization data and services that support regulatory drug utilization activities. Specifically, the objectives are to:

A. Provide FDA personnel with immediate automated access to a currently existing, commercially available data resource for adult and pediatric drug utilization data in short-stay hospitals including pediatric specialty hospitals and Emergency Departments (ED) and treatment procedures and diagnostic information in pediatric patients with the capability of providing counts of discharges and patients utilizing drugs and diagnosis data;

B. Provide FDA personnel with the ability to use these data to describe national patterns of drug utilization and diagnosis data in the adult and pediatric hospital settings through the use of projection or other appropriate methodologies that are scientifically sound and transparent to FDA personnel;

C. Provide FDA personnel with direct, unlimited internet, or network-based access via an interface tool to the entire data resource for adult and pediatric hospital data in a multi-user environment and in real time; and, D. Provide FDA personnel with the ability to download (or obtain in a timely manner using other means) large datasets as needed, for the purpose of conducting epidemiological drug safety studies.

2.3. SCOPE

Independently, and not as an agent of the Government, the Contractor shall furnish the required personnel, materials, services, databases, facilities, and otherwise to do all things required for or incident to the performance of the work as described in this Statement of Work.

2.4. DATA REQUIREMENTS FOR UNLIMITED ACCESS TO HOSPITAL DRUG UTILIZATION AND DIAGNOSIS DATA

A. The Contractor shall provide continuous access to data resources on hospital drug product usage in adult and pediatric patients throughout the length of the contract. For the purpose of this contract, these data shall meet the need of FDA to access discharge-level and patient-level data describing adult and pediatric hospital drug use, in short-stay hospitals.

B. The Contractor shall provide information on the size and characteristics (such as age, gender, ethnicity, etc.) of the population of hospitals from which the data are derived since these can affect the quality and usefulness of the data and the validity of national projections from the data. The data shall not include the identity of any patient, provider, or hospital. It shall be solely the Contractor’s responsibility to de-identify the data for FDA use, but the methods used to de-identify the data shall be described in the proposal.

C. In addition, the following information shall be provided to FDA: the number of years of valid data available overall and online in real time to FDA personnel; the procedures for accessing data that are no longer on-line; the lag time between the date of service for the hospitalization and on-line availability of the data; and data collection and management procedures.

D. The Contractor shall also provide a description of the data acquisition status for all data streams for the adult and pediatric hospital drug utilization and diagnosis data resource. All data flow and management procedures shall be described, including data acquisition, cleaning, and editing procedures, specification and description of all coding systems used for diagnoses and drugs, methods for coding data, percentage of missing, unspecified, uncategorized, or incomplete information, including strategies to minimize missing or incomplete information and method of coding missing data, availability of raw/sample numbers, as well as projected numbers, and the frequency with which data are updated and methods for updates.

E. The Contractor shall provide a description of quality control measures that will ensure access to valid data that is technically correct and conforms to contract requirements. The description shall include methods and timelines of quality control measures to be conducted by the Contractor. This requirement applies to data procured from subcontractors, as well as the data generated or processed by the Contractor.

F. The data resource shall include access to hospital data that shall be amenable to analysis at the discharge-level and patient-level. Age and gender of the patient during the hospital visit shall be required. Hospital episode data shall be required and include the dates of the hospital visit, the length of stay, all diagnoses, discharge date and disposition. Data related to all drugs administered during the hospital visit shall be required and include the generic and established name for the drug, drug identifier codes (e.g., NDCs), strength, dosage form, route of administration, date and time of drug administration, treatment dose and treatment duration. Data related to diagnoses shall be required for all procedures performed during the hospital visit and shall include the diagnoses coded in the International Classification of Diseases (ICD).

G. The Contractor shall provide access to information relating to the hospital episode, for example, utilization data for drugs used during operations/procedures (anesthetics, contrast agents, etc.), and information on diagnosis, drugs at admission, and drugs at discharge. A description of data available on diagnosis and drugs administered shall be provided and shall be accompanied by how this information is combined or associated with other data and any limitations on the usefulness of these data in making national estimates.

H. FDA requires the ability to use these data to estimate drug utilization and diagnosis patterns for the total U.S. hospital population, or for specific national sub-populations of interest (e.g., children, women of child-bearing age, elderly). This shall require the use of a projection methodology or other appropriate methodology which shall be valid, reliable, and robust with regard to drug utilization and diagnosis codes specifically, and the methods shall be fully disclosed. Demographics (e.g., age, gender, race/ethnicity, etc.) and other relevant characteristics for discharges and patients included in the sample to be used for projection, as well as for the proposed universe, shall be included.

2.5. REGULATORY DRUG UTILIZATION SERVICES

The Contractor shall provide Drug Utilization Services as specified in individual task orders. These services may include:

A. Feasibility studies – studies that are conducted as initial pilot studies to determine if the scope of a study is practical, achievable and likely to require a large population size in order to determine the significance of the association between exposure and outcome;

B. Customized Studies – Provision of datasets that can answer a specific question requiring additional tools and resources beyond the current interface tool provided by the database including data from standalone pediatric hospitals; The Contractor shall provide FDA personnel with the ability to have access to detailed hospital data (including drug utilization and medical diagnostic data) that can be linked with other datasets such as outpatient data;

C. Risk management studies – studies that can ascertain if a specific risk management program is effective in ensuring that the benefits of the drug outweigh the risks;

D. Validation studies – studies conducted to establish the validity of exposure or outcome ascertainment method, e.g., establishing the validity of specific diagnoses recorded in the database as discharge claims as compared to the diagnoses recorded in medical record data from hospitals;

E. Active Surveillance – Inclusion of dataset as part of a data warehouse for active surveillance with prior approval from data provider;

F. Training services – training staff from whom a specific service is required. For example, training medical records abstractors on the pertinent information required for abstracting medical record data based on medical record abstraction form;

G. Ad-Hoc Analyses – The Contractor shall provide additional hours of ad-hoc data analyses or custom queries not available through the data tool.

2.6. TECHNICAL REQUIREMENTS AND CAPABILITIES

The Contractor shall provide drug utilization data that meets the following technical requirements and capabilities:

A. Access to a data resource for hospital data for adult and pediatric patients shall be through a currently existing, commercially-available, HIPAA-compliant interface tool with immediate automated access and the capability of providing counts of discharges and patients utilizing specific drug products in the hospital setting, as well as characterizing the hospital episode in short-stay hospitals nationwide. The Contractor shall provide FDA personnel with the capability to access detailed hospital data (including drug utilization and diagnosis data) that are linked with detailed outpatient data (including drug utilization and diagnosis data);

B. Access to the data resource shall commence immediately after award;

C. Access to the data shall be immediate, unlimited, direct, attainable via desktop and in real-time. Access shall include all up-to-date upgrades, enhancements, and modifications to interface software and data;

D. Access shall be via secure internet or network-based methods and shall be in a multi-user environment. The network-based methods shall not necessitate any additions to the FDA communications infrastructure. Methods for access in order of preference are: 1) secure internet access, and 2) firewall-to-firewall virtual private network (VPN). FDA shall not support modem-based or dial-up access. Additionally, FDA shall not support or maintain Contractor’s equipment or personnel on premises;

E. Access shall be through an interface which shall be user-friendly (easy to understand and methods fully disclosed), transparent and flexible for conducting data queries. The interface shall provide both predefined (e.g., canned) and custom reports. The interface shall also include access to national estimates of adult and pediatric discharges and patients stratified by patient demographics [including age in months for pediatric patients <2 years old], primary and secondary diagnoses, length of stay, length of therapy, and time period (e.g., month, quarter, year, moving annual total, aggregate time). Location of service and hospital characteristics (e.g., region, teaching status, bed size, urban vs. rural) shall be available. Data related to the drug product shall display the generic and established name of the drug (if available), dose, strength, dosage form, route of administration, frequency and NDC (if available);

F. Full disclosure of data collection, construction, coding and configuration as well as quality control procedures as required by FDA staff to appropriately interpret findings and understand the construction and application of the projection or other appropriate methodology;

G. A complete data dictionary shall be provided to FDA in an electronic format. An updated dictionary shall be provided within 30 days of any changes which affect the data elements contained within the tools or data streams accessed by FDA;

H. The Contractor shall notify FDA within five business days of any changes in their business agreements with their data suppliers. This notification shall include details of the impact of these changes on data quality, data quantity, and overall data characteristics;

I. For regulatory requirements, the Contractor shall provide FDA with the ability to download (or obtain in a timely manner using other means mutually agreed upon between the database vendor and FDA) and archive data and the means (e.g., via query file or search logic) used to create it. FDA requires that datasets shall be available on demand and without intervention by the Contractor;

J. The Contractor shall provide additional analytical and programming support to enable FDA personnel to obtain data for patients, discharges, and any other utilization metrics not available through the online data tools. The Contractor shall provide up to 100 hours ad-hoc hours annually, with option for additional ad-hoc hours as required in individual task orders and provide criteria for the level of effort and the billing against the bank of hours.

K. The Contractor shall ensure that all data are HIPAA-compliant. No patient, practitioner, or health plan-specific identifiers will be required by FDA. It shall be solely the Contractor’s responsibility to de-identify the data for FDA use;

L. 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 aggregated data to entities outside the Agency including the general public. For activities that require disclosure of aggregated data, the Contractor shall accept and adhere to the FDA Data Disclosure Clearance Procedures and Form found in Attachment 7 and Attachment 8, unless a different Data Disclosure Clearance Procedure process proposed by the Contractor is approved in advance by FDA;

M. As part of its regulatory activities, FDA shall, at times engage in collaborative research projects with third parties outside of FDA for specific research projects of public health importance that are initiated by and for the benefit of FDA. These collaborations shall require FDA to have the ability to share project specific aggregated or raw data with third parties for collaborative research projects. For activities that require disclosure of aggregated data, the Contractor shall accept and adhere to the FDA Data Disclosure Clearance Procedures and Form found in Attachment 7 and Attachment 8, unless a different Data Disclosure Clearance Procedure process proposed by the Contractor is approved in advance by FDA. These procedures include terms and conditions for third-party collaborations;

N. FDA shall require continuation of services to release aggregated data through the FDA Data Disclosure Clearance process for data obtained during the task order period. After Ordering Period 4, FDA will notify the Contractor of the aggregated data release and accept the Contractor’s requested revisions, however, will not require formal approval for release;

O. The Contractor shall provide a kick-off meeting within 14 days upon award of the Indefinite delivery, indefinite quantity (IDIQ) contract. In addition, at the discretion of the FDA, the Contractor shall conduct an annual meeting either virtual or on-site at the FDA campus in Silver Spring, Maryland. The purpose of the annual meeting is 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.

P. The Contractor shall provide two virtual or on-site training sessions at the FDA campus (Silver Spring, MD) per year. Training shall be provided for users of the data, as well as training for FDA personnel who will support the use of the data (e.g., technical users). Live or web-based training of FDA personnel shall be required for any modifications, enhancements, or upgrades to the data source. Course outlines and written documentation related to using the data shall be provided. Options for additional “on-demand” sessions via web-based methods shall be provided, up to a maximum of ten (10) training sessions per year. The training shall be initiated 30 days after receipt of award and continues throughout the duration of the contract;

Q. The Contractor shall provide a support package comprised of written documentation that includes technical, analytical, and clinical support throughout the length of the contract. The support package shall include any modifications, enhancements, or upgrades to the data source. The support shall be provided by phone or by e-mail for all certified users of the data during business hours (9:00 am -5:00 pm EST) Monday through Friday excluding federal holidays throughout the length of the contract in accordance with the service levels established in the contract. To ensure effective communication and access to needed resources, the Contractor shall have a dedicated client support personnel to serve as a liaison between FDA and the Contractor;

R. The Contractor shall be required to conduct on-site annual meetings for the purposes of discussing contract performance, product enhancements, annual updates (data characteristics, data elements) to the data source, and FDA satisfaction with all deliverables;

S. The Contractor’s software and interface tools shall be in full conformance or FDA- satisfactory level of conformance with Section 508 standards (See HHSAR 352.239-74).

The required mechanism for data access is via internet. FDA has direct, desktop access to the Internet. The system shall be web-based and be compatible with commonly used web browsers including Microsoft Edge and above, Firefox 23 and above, Chrome, and Safari 4 or higher. The Contractor’s proposal shall specify any additional software and/or hardware (name and version) necessary to access the data.

2.7.2. Number of Users

FDA may purchase a range of seat licenses, a minimum of 5 to a maximum of 30 for direct, unlimited access to the data. The unit price for 1 base lot (20 seat licenses) shall be established in the IDIQ, with an additional line item for an additional 10 users. The specific number of seat licenses required will be specified in individual task orders.

2.7.3. Data Downloading

FDA uses standard statistical and data management software, such as SAS, Access and Excel, PDF, ASCII, and shall require the ability to download or export data in formats that are compatible with these packages.

2.7.4. Local Area Network (LAN) Configuration

FDA uses a central-server network model. The configuration is a wide area network with transmission control protocol/Internet protocol (TCP/IP) running on a 10/1000 Mbs network. FDA shall not provide a diagram of the network.

2.7.5. Software Security

Any client software that is required to be installed on any FDA computers for the purposes of accessing the data shall not use key-logging and/or network capturing functionality to transmit any data from the FDA system, except for login information specific to the data and data (e.g., SQL queries or similar methods) accessing the Contractor’s application data sets. Such software add-ons or plugin shall be approved prior and must be approved by the FDA IT department. The contractor is responsible for providing the needed documentations to assist in the approval process. The license shall include postproduction maintenance that includes patches, upgrades, and bug fixes if required.

2.7.6. Virtual Private Network (VPN)

FDA utilizes the virtual private network to establish a trusted, encrypted TCP/IP tunnel for accessing data from a remote location. The VPN shall be a firewall-to-firewall encrypted tunnel utilizing commercially available software and industry standard Internet Protocol Security (IPSEC) protocols.

2.7.7. Custom Programming and Analytical Support

The Contractor shall provide analytical and programming support, to enable FDA personnel to obtain prescriptions, patients, claims and any other utilization metrics not available through the online data tools.

As tasked, the Contractor shall provide Program Management support services. These Program Management responsibilities shall include what is necessary to plan, structure, coordinate, schedule, manage, communicate, report, and steward all respective task orders and activities throughout the period of performance. The Contractor shall provide end-to-end program management services to support all programmatic activities.

The PMP shall provide written processes and procedures describing the interactions with FDA stakeholders (e.g.,COR, CO and users of the data)

Representative requirements include but are not limited to:

The Contractor shall provide at a minimum the following key requirements for the Program Management services:

Program Management Plan (PMP)

a. The Contractor shall lead and organize a kick-off meeting at the FDA White Oak campus or virtual with the COR and Government staff within 14 business days of task order award. The purpose of the kick-off meeting is to introduce the Contractor staff to the Government and discuss the Contractor’s approach to meeting the requirements of the SOW.

b. Prepare a Program Management Plan (PMP) that addresses all program and individual task order project management issues and overall approach for meeting FDA needs over the course of the IDIQ contract. The PMP shall be a comprehensive, high-level overview on how the Contractor plans to maintain overall management and insight of all contract studies, tasks, reports, and deliverables.

c. Within ten (14) business days after the post-award kick-off meeting, the Contractor shall submit a draft PMP that addresses all program and project management issues. This draft PMP shall reflect updates or revisions discussed prior to or during the kick-off meeting, including all relevant issues involved in completing the contract, such as challenges to timelines. The PMP shall also delineate contingencies and alternate work strategies in response to unexpected challenges. The final PMP shall be due ten (14) business days after the Contractor receives FDA’s comments on the draft PMP.

d. Establish a program coordinating team to manage and coordinate all the management and operations included in the PMP.

e. PMP shall include both program-level management services and task order-level project management services to establish control, management, monitoring and notification mechanisms for the program requirements.

f. Provide a Monthly Report including but not limited to program updates, project status, workload and program performance metrics, and other program management planned requirements.

g. Documentation that the contactor shall work with the Government Contracting Officer (CO), Contracting Officer’s Representative (COR), and subject matter experts (SMEs) to ensure that tasks stay on track and important milestones are met.

The PMP shall also include the following operations and management plans to be maintained and updated at a minimum annually:

Sub-Task 1: Quality Management Plan The Contractor shall provide a Quality Assurance (QA) Plan detailing procedures and guidelines to ensure the required performance standards or services levels are met throughout the life of this contract. The QA Plan shall describe the systematic methods used by the Contractor to monitor performance, identify required documentation, and allocate resources. The Government reserves the right to alter or change the surveillance methods in the QA Plan at its own discretion.

Sub-Task 2: Risk Management Plan

a. Awardees are required to have an operational Management Plan that continually monitors project risks and provide mitigation/resolution in the areas of:

I. Qualified project support staff II. Establishing clear quality control measures to ensure valid data streams and provide consistent, timely deliverables.

III. Management of data loss or discrepancies IV. Maintaining open communication and transparency.

b. Each individual task order shall have a comprehensive RMP including a risk registry that is monitored as specified in the individual task order and include at a minimum the following:

i. Risk Identification (issue number, description, dates)

ii. Potential Risk Assessment (severity, likelihood, consequences)

iii. Mitigation and Contingency plans (solution or workaround)

iv. Implementation (actions to resolve issue)

v. Resolution (actions taken) Sub-Task 3: Communication Management Plan

a. Develop a Communication Management Plan that facilitates scientific and technological collaboration with FDA COR and users of the data. The Communication Management Plan shall:

i. Promote collaboration with FDA stakeholders by utilizing the innovative methods.

ii. Identify key stakeholders and roles.

iii. Ensure feedback loops as needed with various stakeholders to ensure understanding, increase buy-in, and avoid duplication of effort.

iv. Scheduled biweekly and annual meetings and develop a day-to-day communications strategy.

Sub-Task 4: Staffing Plan

a. Develop a Staffing Plan that identifies sufficient subject matter experts and appropriately skilled personnel that collectively possess all the required knowledge and experience essential to perform the tasks in the SOW.

b. Provide an organization chart mapping the key personnel and other designated personnel with the tasks in the SOW and include any assumptions or constraints.

c. Each individual task order shall include a staffing plan designating key personnel and other designated personnel’s the percentage of time, level of effort and contribution to the project.

Representative standards include but are not limited to:

a. Within fourteen (14) business days after the post-award kick-off meeting, the Contractor shall submit a draft Program Management Plan. The draft shall reflect updates or revisions discussed prior to or during the kick-off meeting, including all relevant issues involved. The final Program Management Plan shall be due 14 business days after the Contractor receives FDA’s comments on the draft.

b. The Contractor shall provide Monthly Usage Reports by the 20th of each month for the previous month’s data detailing use of the resource by individual FDA users and type of use, clearances, third party agreements, number of ad-hoc programming hours used, and project title.

1. The Monthly Usage Report shall include the number and type of data queries by individual FDA user;

2. Clearance Requests shall include type of data submitted, project title, FDA requestor, date of request, and approval date;

3. Third-Party Agreement Requests shall include third-party collaborator, project title, FDA principal investigator, date of request, approval date, and expiration date.

4. Ad-hoc Dataset Requests shall include the number of technical supports; programming hours used, project title, FDA requestor, date of request, and date received

5. Notifications of any circumstances resulting in loss or lack of data streams, or any data enhancements or data errors that would impact access to data from the data resource(s).

Representative quality assurance tasks include but are not limited to:

For the Program Management Plans Quality Assurance Task, the Contractor shall ensure that the Program Management Plan’s outlined align with the Requirements and Standards for the Program Management Plans.

2.8.2. Performance Evaluation

Performance shall be evaluated to determine whether the Contractor meets the threshold of the agreement. When the performance threshold is not met, the FDA Contracting Officers Representative (COR) will 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. Failure to meet the described performance standards will directly affect the Contractor’s annual performance evaluation and may result in a poor performance rating and influence potential future contract award decisions.

The successful Contractor shall provide Disclosure Clearance and Third-Party Agreement Service

The successful Contractor shall provide Unlimited Direct Access to Data Resource and Services

The Contractor shall notify FDA 48 hours in advance of any circumstances resulting in loss of access to the data source due to planned downtime.

The Contractor shall notify FDA within 30 minutes (Monday-Friday, 9:00 AM – 5:00 PM Eastern Time) from the onset of unplanned downtime with an estimate of-time as to restoration of access

The contractor shall provide a resolution plan and shall include a timeline for resolving any circumstances resulting in loss of, or lack of, access to data or any data errors/loss from the database(s)

Within five business days of Contractor’s knowledge of the loss or lack of access to data or any data errors/loss from the database(s) and shall be documented in the Monthly Report

Standard shall be fully met at 100%

COR and staff review of data quality (i.e., variance in data runs)

The Contractor shall guarantee timely access to hospital analytical datasets

The mutually agreed upon dataset parameters (max. size, data elements) and turnaround time to be negotiated at the time of award

Standards shall be fully met for access to all analytical datasets

COR and staff review of dataset quality and turnaround times

2.9. LABOR CATEGORY DESCRIPTIONS

Program/Project Manager:

· Leads team on large projects or significant segment of large complex projects

· Analyzes new and complex project related problems and creates innovative solutions involving finance, scheduling, technology, methodology, tools, and solution components

· Project manager shall have a minimum of a master’s degree or an equivalent certification and at least 5 years of experience managing projects.

Senior Computer Analyst:

· Analyze science, engineering, business, and other data processing problems to implement and improve computer systems. Analyze user requirements, procedures, and problems to automate or improve existing systems and review computer capabilities, workflow, and scheduling limitations. May analyze or recommend commercially available software.

· The individual shall have the required certification with a minimum of 8 years of experience in the field.

Application Programmer:

· Devises or modifies procedures to solve complex problems considering computer equipment capacity and limitations, operating time, and form of desired results

· Designs, codes, tests, debugs, and documents

· Application programmer shall have the required certification with a minimum of 5 years of experience in the field Statistician:

· At least ten years of experience and training in economics, finance, statistics, or related areas. Demonstrated record of supporting development and delivery of presentations, publications, and reports on specific programs or technically complex subjects

· An Economist/Statistician is responsible for performing work of a technically complex nature in the areas of economics and statistics, including cost-benefit and regulatory impact analysis, financial analysis, risk assessment, statistical analysis, sampling, survey design and implementation; and for reviewing the work of other staff Pharmacist:

· Dispense drugs prescribed by physicians and other health practitioners and provide information to patients about medications their use. May advise physicians and other health practitioners on the selection, dosage, interactions, and side effects of medications

· The pharmacist shall be a registered in any state with a minimum of ten years of experience in the field Senior Training Specialist:

· Assesses, designs, and conceptualizes training scenarios, approaches, objectives, plans, tools, aids, curriculums, and other state of the art technologies related to training and behavioral studies

· Identifies the best approach training requirements to include, but not limited to hardware, software, simulations, course assessment and refreshment, assessment centers, oral examinations, interviews, computer assisted and adaptive testing, behavior-based assessments and performance, and team and unit assessment and measurement

· Develops and revises training courses. Prepares training catalogs and course materials

· Trains personnel by conducting formal classroom courses, workshops, and seminar

· Training Specialist Senior shall have a minimum of eight (8) years of experience in the field or in a related area.

· Educational requirement is a Bachelor's degree in a related area or equivalent.

Epidemiologist:

· Epidemiologists are public health professionals who investigate patterns and causes of disease and injury in humans. They seek to reduce the risk and occurrence of negative health outcomes through research, community education, and health policy.

· The epidemiologist shall be a registered in any state with a minimum of ten years of experience in the field.

2.10 G.6 HHSAR 352.237-75 KEY PERSONNEL (DEC 2015)

The key personnel specified in this contract are considered to be essential to work performance.

At least 30 days prior to the contractor voluntarily diverting any of the specified individuals to other programs or contracts the Contractor shall notify the Contracting Officer and shall submit a justification for the diversion or replacement and a request to replace the individual. The request must identify the proposed replacement and provide an explanation of how the replacement's skills, experience, and credentials meet or exceed the requirements of the contract (including, when applicable, Human Subjects Testing requirements). If the employee of the contractor is terminated for cause or separates from the contractor voluntarily with less than thirty days notice, the Contractor shall provide the maximum notice practicable under the circumstances. The Contractor shall not divert, replace, or announce any such change to key personnel without the written consent of the Contracting Officer. The contract will be modified to add or delete key personnel as necessary to reflect the agreement of the parties.

The Key Personnel under this contract is to be provided at the time of award.

SECTION 3: DELIVERY AND ACCEPTANCE

PRICING TERMS

The Contractor shall comply with FAR 52.232-7, Payments Under Time-and-Materials and Labor-Hour Contracts (Nov 2021), with regard to the ceiling price for each labor-hour or time-and-materials type task order.

The total amount specified in Firm-Fixed Price (FFP) task orders shall be fixed for the task order period of performance and shall not be subject to adjustment; except, as a result of a direct action or inaction by the Government which delays the Contractor from completing the task order within the time specified in the order. The Contractor shall comply with FAR Clause 52.232-1 Payments (Apr 1984) in regards to the firm-fixed-price for the individual task orders.

CONTRACT TYPE

It is anticipated that a single-award Indefinite Delivery-Indefinite Quantity (IDIQ) type Contract will be awarded as a result of this solicitation. The quantities of services ordered under this contract shall be accomplished by the issuance of task orders that will describe the contract type, objectives, scope, period of performance, and deliverables. All task orders are subject to the terms and conditions in the IDIQ base contract. Authorized contract types under this IDIQ are: Labor-Hour (LH), Time-and-Materials (T&M), and Firm-Fixed-Price (FFP). Option periods may be included in task order awards.

B. Reports not submitted electronically shall be delivered Free on Board (F.O.B.) Destination, as set forth in FAR Clause 52.247-35, F.o.b. Destination, Within Consignee’s Premises, and as specified in the delivery schedule.

3.3. PERIOD OF PERFORMANCE

The effective date of contract through twelve (12) months and four one-year options as follows:

Base Year: May 12, 2025 – May 11, 2026 Option Year #1: May 12, 2026 – May 11, 2027 Option Year #2: May 12, 2027 – May 11, 2028 Option Year #3: May 12, 2028 – May 11, 2029 Option Year #4: May 12, 2029 – May 11, 2030

3.4. PLACE OF PERFORMANCE

The place of performance will be identified in individual task orders but is expected to occur primarily at the Contractor’s facility. Onsite meetings and trainings shall take place at FDA’s main campus, located at 10903 New Hampshire Avenue, Silver Spring, Maryland 20993, or other FDA locations in the Washington, DC metropolitan area or virtually as designated by the COR.

3.5. DELIVERABLES

Specific deliverables and schedule of deliverables shall be identified in each task order. Satisfactory performance of this contract shall be deemed to occur upon performance of the work and upon delivery and acceptance by the COR or the duly authorized representative.

The Contractor shall provide unlimited additional quantities of Services via the issuance of firm fixed priced or time and materials Delivery Orders at the unit price negotiated for each Order within the description of work. The performance period/delivery date(s) for services ordered shall be specified on each Order. The combined price of all IDIQ Orders shall not exceed $5,000,000 over the total period of performance (base and option periods).

3.5.1 Deliverable Items

Program Management Plans Sub-Task 1: Quality Management Plan Sub-Task 2: Risk Management Plan Sub-Task 3: Communication Management Plan Sub-Task 4: Staffing Plan

3.6. OBSERVANCE OF GOVERNMENT CLOSURES

The Contractor may not bill the Government for any hours that Contractor employees did not work due to any Government closure under this contract or any task orders under this contract that include labor hour or time-and-materials contract type. In the event Contractor personnel work during a holiday observed by the Contractor other than those below, no form of holiday of premium compensation will be reimbursed as either a direct or indirect cost. However, this does not preclude reimbursement for authorized overtime work.

Recognized Federal Holidays: Contractor coverage is expected during all Federal workdays. Except for designated around-the-clock or emergency operations and after-hour courier services, Contractor personnel shall not perform on-site under this contract on Federal holidays or any other day designated as a Federal holiday for the Washington, DC area. No services or deliveries shall be performed at Federal sites on Federal holidays unless specifically requested by the CO.

July – Independence Day Inclement Weather and Other Government Closures: The Contractor is not required to provide on-site service on days when the Federal Government is closed due to inclement weather, government closures or other emergencies. The COR will notify the Contractor of Government Closures due to inclement weather, government closure or emergencies (man-made or otherwise). Specific inclement weather plans shall be specified at the task order level.

In the event the Federal Government is closed by order of the President of the United States or the U.S. Office of Personnel Management (OPM) for any reason, the agency is closed, or the center or FDA building is closed for administrative or safety reasons, the Contractor shall follow directives issued by responsible officials concerning reporting for work.

3.7. HHS MANDATORY 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 three (3) 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 no tracked, therefore keep the HHS training certificates for your records and provided as a separate deliverable to the CO and/or COR.

· Regular users should complete the following:

· Cybersecurity Awareness Training – Module 1