RFP-23-115584.pdf

FDA-RFP-23-115584

ACCESS TO HEALTH CARE PRACTITIONER PRESCRIBING DATA

PART 1- Description

Solicitation number is issued as a Request for Proposal (RFP).

This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Subpart 12.6, as supplemented with additional information from FAR Part 13.5 and included in this notice. The resultant task orders will include all applicable provisions and clauses in effect through the Federal Acquisition Circular 05-96. The North American Industrial Classification System (NAICS) code for this procurement is 541990, All Other Professional, Scientific, and Technical Services.

1.2 Type of Contract

The Government intends to award a Indefinite Delivery/Indefinite Quantity (IDIQ) contract vehicle for a duration of five (5) years, consisting of one (1) base year, and four (4) optional periods. The IDIQ contract intends to issue Firm-Fixed-Price, and Labor Hour Task Orders.

The IDIQ guaranteed minimum amount will be the amount of the awarded fixed price line items. The contract maximum ceiling amount for the IDIQ is anticipated to be $5,000,000.00 over five (5) years, inclusive of options. The Task Order minimum ordering amount is $150,000.00 and the maximum ordering amount is $1,000,000.00.

PART 2- SUPPLIES OR SERVICES AND PRICES/COSTS

2.1 Description of Services and Supplies

The Food and Drug Administration’s Center for Drug Evaluation and Research has a need for access to Healthcare Practitioner Prescribing Practices Data.

2.2 Pricing Schedule

BASE YEAR

CLIN Description of Supplies/Service Qty. Unit Total Price

0001 Access to Healthcare Practitioner Prescribing Practices Data (Unlimited Access License) 70 Users

Month

0002 Kick Off/On-site Annual Meeting 1 Lot

0003 Disclosure Clearance Service/Third Party Agreement Services.

0004 Acceptable Projection or Other Appropriate Methodology 1 Lot

0005 Current and complete Data Dictionary, including updates 1 Lot

0006 On-site training programs and training materials 2 Lot

0007 Technical Support: to include Notification of and Access to Upgrades and/or New Releases of the Data and Software

0008 Monthly Usage Reports 12 Month

0009 Ad hoc Analyses: Custom reporting and product customization.

Hour

Base Year: Total Firm Fixed Price

OPTION YEAR 1

Supplies/Service Qty. Unit Total Price

1001 Access to Healthcare Practitioner Prescribing

1002 Kick Off/On-site Annual

1003 Disclosure Clearance

1004 Acceptable Projection or Other

1005 Current and complete Data Dictionary, including updates 1 Lot

1006 On-site training programs and training materials 2 Lot

1007 Technical Support: to include Notification of and Access to

1008 Monthly Usage Reports 12 Month

1009 Ad hoc Analyses: Custom

Option Year 1: Total Firm Fixed Price

OPTION YEAR 2

Supplies/Service Qty. Unit Total Price

2001 Access to Healthcare Practitioner Prescribing

2002 Kick Off/On-site Annual

2003 Disclosure Clearance

2004 Acceptable Projection or Other

2005 Current and complete Data Dictionary, including updates 1 Lot

2006 On-site training programs and training materials 2 Lot

2007 Technical Support: to include Notification of and Access to

2008 Monthly Usage Reports 12 Month

2009 Ad hoc Analyses: Custom

Option Year 2: Total Firm Fixed Price

OPTION YEAR 3

Supplies/Service Qty. Unit Total Price

3001 Access to Healthcare Practitioner Prescribing

3002 Kick Off/On-site Annual

3003 Disclosure Clearance

3004 Acceptable Projection or Other

3005 Current and complete Data Dictionary, including updates 1 Lot

3006 On-site training programs and training materials 2 Lot

3007 Technical Support: to include Notification of and Access to

3008 Monthly Usage Reports 12 Month

3009 Ad hoc Analyses: Custom

Option Year 3: Total Firm Fixed Price

OPTION YEAR 4

Supplies/Service Qty

Unit Total Price

4001 Access to Healthcare Practitioner Prescribing

4002 Kick Off/On-site Annual Meeting

1 Lot

4003 Disclosure Clearance

4004 Acceptable Projection or Other Appropriate Methodology

1 Lot

4005 Current and complete Data Dictionary, including updates

1 Lot

4006 On-site training programs and training materials

2 Lot

4007 Technical Support: to include Notification of and Access to

4008 Monthly Usage Reports 12 Month

4009 Ad hoc Analyses: Custom

Option Year 4: Total Firm Fixed Price

TOTAL CONTRACT VALUE

BASE PERIOD TOTAL PRICE

OPTION YEAR 1 TOTAL PRICE

OPTION YEAR 2 TOTAL PRICE

OPTION YEAR 3 TOTAL PRICE

OPTION YEAR 4 TOTAL PRICE

TOTAL FIRM FIXED PRICE

Labor Rate Pricing Chart: Labor

Category Hourly Rate Estimated # of

Hours per Year

Total Rate X #Hours

Project Manager Base Year $ 1040 $

Option Year 1 $ 1040 $ Option Year 2 $ 1040 $ Option Year 3 $ 1040 $ Option Year 4 $ 1040 $ Senior Computer Analyst Base Year $ 1040 $

Option Year 1 $ 1040 $ Option Year 2 $ 1040 $ Option Year 3 $ 1040 $ Option Year 4 $ 1040 $

Application Programmer Base Year $ 1040 $

Option Year 1 $ 1040 $ Option Year 2 $ 1040 $ Option Year 3 $ 1040 $ Option Year 4 $ 1040 $ Statistician Base year $ 1040 $

Option Year 1 $ 1040 $ Option Year 2 $ 1040 $ Option Year 3 $ 1040 $ Option Year 4 $ 1040 $

Pharmacist Base Year $ 1040 $

Option Year 1 $ 1040 $ Option Year 2 $ 1040 $ Option Year 3 $ 1040 $ Option Year 4 $ 1040 $ Senior Training Specialist Base Year $ 1040 $

Option Year 1 $ 1040 $ Option Year 2 $ 1040 $ Option Year 3 $ 1040 $ Option Year 4 $ 1040 $ Computer Programmer Base Year $ 1040 $

Option Year 1 $ 1040 $ Option Year 2 $ 1040 $ Option Year 3 $ 1040 $ Option Year 4 $ 1040 $

TOTAL IDIQ PRICING

PART 3 - DESCRIPTIONS/SPECIFICATIONS/STATEMENT OF WORK

Note: All italicized terms are defined in the Glossary (Appendix A)

3.1 Background

A vital part of Food and Drug Administration (FDA) and Center for Drug Evaluation and Research (CDER) mission is to protect the public health. The mission of the Office of Surveillance and Epidemiology (OSE) is to evaluate post marketing drug risks and promote the safe use of drugs for 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.

In response to reports from the Institute of Medicine (IOM), FDA is authorized by the FDA Amendments (2007)1 Act to expand database resources for providing advanced analyses of drug safety data to improve the quality of post-market risk/benefit analyses and enhance the ability of FDA to make timely assessments of drug safety data. In addition, a sub-section of the Act calls for enhanced authorities for accessing disparate data sources, establish and improve procedures to identify data trends and prescribing patterns for health care practitioners on a national-level in the outpatient setting.

The 21st Century Cures Act2 which was enacted in December 2016 also contains provisions for the FDA to increase surveillance and monitoring of certain medications such as opioids which aligns with CDER’s mission. This section of the Act encourages the use of real-world evidence in the analysis of post market surveillance data to enable the Agency to respond promptly to serious public health issues.

The ability of FDA to respond expeditiously to the increasing number of drug safety issues is crucial to the overall public safety. Continuous access to healthcare practitioner prescribing practice data (e.g., physician survey and e-prescribing data) will complement and strengthen the utility of FDA's Adverse Event Reporting System (FAERS) currently in place. Access to these data also increases the FDA’s ability to perform regulatory impact studies; in particular, those studies that assess the effectiveness of product labeling in influencing prescribing behavior. 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 Data on Prescribing Practices of Health Care Practitioners" would serve as a mechanism for FDA to respond expeditiously to serious public health or regulatory issues.

1 https://www.gpo.gov/fdsys/pkg/PLAW-110publ85/pdf/PLAW-110publ85.pdf 2 https://www.congress.gov/114/bills/hr34/BILLS-114hr34enr.pdf https://www.gpo.gov/fdsys/pkg/PLAW-110publ85/pdf/PLAW-110publ85.pdf https://www.congress.gov/114/bills/hr34/BILLS-114hr34enr.pdf

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.

FDA's authority to fund research projects is outlined in section 301 of the Public Health Service Act (PHSA 42 U.S.C. 241).

3.2 Program Research Goals and Objectives:

A. The Contractor shall provide FDA personnel with access to currently existing, commercially available data resource on health care practitioner prescribing practices including but not limited to patient demographics, and indications for treatment in the outpatient setting.

B. This data source shall have the ability of providing national-level estimates of health care practitioner prescribing patterns in the outpatient setting through the use of projection or other appropriate methodologies based on a nationally representative sample that are scientifically sound and transparent to FDA personnel.

C. The Contractor shall provide FDA personnel with data that has a maximum of 3-month lag time, i.e., time between the date of prescriber/patient encounter and date of data availability for FDA use.

D. The Contractor shall provide FDA personnel with immediate, direct, unlimited, Internet or network-based access to all HIPAA-compliant data in a multi-user, desktop environment and in real time.

3.3 Scope of Work

The Contractor shall provide the required personnel, materials, services, facilities, and otherwise to do all things required for, or incident to the performance of the work as described below.

3.3.1 Access to Healthcare Practitioner Prescribing Practices Data Requirement;

The Contractor shall provide continuous automated access to data resources on health care practitioner prescribing practices for seventy (70) users including, but not limited to drug treatment patterns, patient demographics, and indications for treatment in the outpatient setting. The source data can be obtained from either a survey or Electronic Medical Records (EMR) excluding claims data that provides insight into healthcare practitioner prescribing practices. FDA requires access to such data to obtain national estimates or counts. The FDA has no interest in knowing the identity of any patient, provider, or health plan included in the data. It shall be solely the Contractor’s responsibility to de-identify the data for FDA use.

For the prescriber data, the Contractor shall project the data to the national-level using an FDA approved projection or other appropriate methodology. Results from projections shall be comparable to estimates obtained from national benchmarks such as the National Center for Health Statistics’ National Ambulatory Medical Care Survey (NAMCS). The data resource(s) shall have raw and projected numbers.

These data resources shall be accessible via a secure Internet or network-based method permitting simultaneous, multi-user access through a user-friendly data query tool(s).

The healthcare practitioners (e.g., physicians, physician assistants, nurse practitioners, dentists) prescribing practices data shall include visits and patients; characterization of individual health care practitioners in terms of number, specialty, practice setting, age, gender, race/ethnicity, and four U.S. Census regions (see Appendix B). Additionally, these data shall provide health care practitioner prescribing practices data in terms of type of facility (e.g., surgical-centers, staff model HMOs, clinics) and where possible, the Contractor shall provide a comparison to national estimates.

The patient-specific population data shall include the number and percentage of patient populations of special interest to FDA, including children (ages ≤ 17 years), infants (age <1 year), women of childbearing age, and elderly (ages ≥ 65 years); the health care practitioner turnover rate for participation in the data resource; and the demographic distribution of patients (age and sex are required;

race/ethnicity, if available).

The patient-specific basic data elements at the visit-level shall include (but are not limited to): patient demographics such as age (specify method on how age is obtained and how it is displayed in canned reports, i.e. standard age groups or customized age groups, , gender and specify if other data elements are available which would include race/ethnicity; height and weight; clinical measures, such as blood pressure, cholesterol, smoking status; type of insurance; and U.S Census region.

The drug-specific basic data elements shall include drug class, molecule(s)/active pharmaceutical ingredient(s), generic/trade name of drug(s); linkage between generic and established name; strength;

dosage form; new vs. continued therapy; days’ supply; prescriber specialty; quantity prescribed;

directions for use; indication(s) for use, concurrent or concomitant drug or diagnosis, and source of drug (sample provided, prescription given, product administered).

The diagnosis-specific basic data element shall describe the patient’s condition as identified by the health care practitioner during the time of office-visit; as well as visit-specific basic data elements with the time of visit (month, year); the type of visit, e.g., first vs. subsequent visit; and the type of outpatient setting and the health care practitioner-specific basic data elements shall include the type of practitioner; specialty; age; sex; and U.S. Census region.

The data resource shall include a drug coding system that consists of drug, clinical, or medical coding levels for FDA data analyses, quantify the prescribing of drug or biologic products in the outpatient setting by healthcare professionals. For examining visit-level prescribing data for products, the data resource shall link clinical or medical data to indication in detail. For examining data on visits for specified disease or medical conditions, and associated treatments (if any), the data resource shall capture the drugs prescribed to treat the same diagnosis as well as all drugs mentioned during the visit regardless of diagnosis.

The Contractor shall provide the total number of years of data available overall, the number of years available online and accessible in real time to FDA personnel. The lag time between the dates of service for data and on-line availability of the data shall be provided. For historical data that is no longer online, the Contractor shall propose methods to obtain historical data in a timely manner.

3.4 Technical Requirements and Capabilities of the Data Source

The Contractor shall provide patient-level and/or visit-level data that is current and commercially available. The data shall be provided in a HIPAA-compliant product that shall provide immediate automated access with the capability of providing characterization of health care practitioner prescribing practices including but not limited to patient demographics, and indications for treatment in the outpatient setting; and shall provide immediate automated access with the capability of providing both current and a minimum of six (6) years historical national-level prescribing practice information.

Access to the data shall be immediate, unlimited, direct, desktop and in real time. Direct access shall include all upgrades, enhancements, and modifications to software and data. 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. Preferred 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. Access shall be through an existing interface and this interface shall be user-friendly, transparent (e.g., clarity of details, limitations and assumptions), and flexible enough to meet the FDA’s needs. Minimally, the interface shall provide both predefined (e.g., canned) and custom reports.

FDA requires the ability to make national estimates of visit-based and/or patient-based outpatient health care practitioner prescribing practices using projection or other appropriate methodologies, which shall be valid, reliable, and robust regarding prescribing practices specifically, and the methods fully disclosed.

The FDA shall have the ability to archive and analyze historical data in a timely manner. The FDA shall have the ability to download (or obtain in a timely manner using other means) and analyze patient-level data. FDA’s preference is that unrestricted access to datasets shall be available on demand and without intervention by the Contractor.

All data shall be 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.

In the event of changes to the Contractor’s business or agreements with their data suppliers, the FDA shall be notified within 5 business days of the Contractor becoming aware of such changes.

This notification shall include details of the impact of these changes on data quality, data quantity, and overall data characteristics.

The Contractor shall conform to Section 508 standards (see Appendix C).

3.4.1 Training Programs and Training Materials

The Contractor shall provide training for users of the data, as well as training for FDA personnel who will support use of the data (e.g., technical users). The Contractor shall provide a minimum of two onsite or virtual training sessions per year. Live or web-based training of FDA personnel shall be required for any modifications, enhancements, or upgrades to the data source.

The Contractor shall provide course outlines for all levels of training offered and options for additional “on-demand” sessions either in person at FDA (Silver Spring, MD) or via web-based methods. The training shall be initiated within 30 days of award and continue throughout the duration of contract.

3.4.2 Kick-Off and Annual Meetings

The Contractor shall participate in a kick-off meeting within two weeks of award and shall conduct an annual meeting virtual or on-site at the FDA campus in Silver Spring, MD. 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.

3.4.3 Technical Support

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 Contractor shall be required to provide ongoing technical, analytical, and clinical support by phone or e-mail for all certified users of the data during business hours (9:00am to 5:00pm EST) Monday through Friday, excluding federal holidays throughout the length of the contract in accordance with the service levels established in the Quality Assurance Surveillance Plan (QASP) of the contract.

To ensure effective communication and access to needed resources, the Contractor shall have dedicated client support personnel to serve as a liaison between the FDA and the Contractor.

3.4.4 Monthly Usage Reports

The Contractor shall provide Monthly Usage Reports detailing use of the resource by individual FDA users and type of use (see Appendix F), Example of Monthly Usage Report).

The Contractor shall provide Monthly Usage Reports by 20th of each month for the previous month 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 (see Appendix F, Example of Monthly Usage Report).

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

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

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

d. Ad hoc Dataset Requests shall include the number of technical support programming hours used, project title, FDA requestor, date of request, and date received.

e. 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).

3.4.5 Progress Reports

The Contractor shall submit one (1) electronic copy of the Progress Report monthly to the COR and Contracts Specialist. The report shall include a status update on each task worked on and deliverables submitted, any problems encountered, and suggestions for addressing problems each period. If the tasks are cost reimbursable in nature, an accounting of applicable staff who worked on the tasks as well as any deviations from the original projection of hours planned vs. actually incurred shall be required.

3.4.6 Trial Subscription Period

The FDA requires a 30-day trial subscription. The trial subscription shall include direct access, documentation, and technical support for a maximum of seven FDA researchers on the technical evaluation panel. The FDA will not pay for this subscription as access will be used solely to evaluate the Offeror’s product, and not for any analysis, public disclosure or regulatory decision making. The Offeror shall provide telephonic or web-based training session that lasts a maximum of 2 hours at the start of the trial subscription period. Trial subscription shall include online access (usernames and passwords).

The Offeror’s proposal shall include a point of contact for FDA to call to set up the trial subscription and the Trial Subscription Agreement (Appendix H). The FDA shall only use the data for the purposes of understanding the systems data resources. FDA shall not use the data, nor any analyses derived from the data, for public disclosure or regulatory decision making.

3.4.7 Disclosure Clearance Services

3.5.1 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 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 Appendices D and E unless a different Data Disclosure Clearance Procedure process proposed by the Offeror is approved in advance by the FDA. The FDA shall continue to require the ability to release aggregated data through the FDA Data Disclosure Clearance process for data obtained during the contract period for the period of Option Year 4 (year 5 of the contract). After Option Year 4, FDA will not require data access service, but will require the services of processing clearance requests.

After option year 4, the FDA will notify the Contractor of the aggregated data release and accept the Contractor’s requested revisions for a maximum of one year but will not require formal approval for release.

3.5.2 Clearance for Third Party Collaborations:

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 these collaborations that require sharing of aggregated or raw data, the Contractor shall accept and adhere to the Data Disclosure Clearance Procedures and form found in Appendices D and E unless a different Data Disclosure Clearance Procedure process proposed by the Offeror is approved in advance by the FDA. These Procedures include terms and conditions for third party collaborations.

3.5.3 Ad Hoc Analyses:

The Contractor shall provide additional ad hoc data analyses or custom queries or product customization not available through the data tools and in increments of 50 hours but not to exceed 100 man-hours per year.

3.6 Indefinite Delivery, Indefinite Quantity (IDIQ) Services Associated with the Scope of Work

The Contractor shall provide additional quantities of Services via the issuance of firm fixed price 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 orders shall not exceed $500,000.00 over the total period of performance (base and option periods).

The type of additional services and associated maintenance would include:

• Validation studies- studies that are conducted to establish soundness or validity of the method used, for example to validate indications for treatment in the database against the survey or claims data.

• Projection methodology studies- Developing methods that will allow projecting the number of patients/visits or use based on the sample size for drugs associated with specific diseases, conditions, or indications.

• Concomitant drug reports – Reports on the concomitant use of two or more drugs from the same therapeutic class or different therapeutic classes used to treat the same diagnosis

• Feasibility studies- studies that are conducted as initial pilot studies to determine if the scope of a study is practical, achievable and likely to involve a large population size to determine a significant association or non-significance association between exposure and outcome

• Customized analysis – Analysis of data to answer a specific question that require additional tools beyond the current interface tool that is provided by the database

• Customized metrics/questions – Ability to issue a customized query outside of the prespecified drug-specific basic data captured in the tool. For example, if pre-specified surveys are used in data collection, the ability to add a defined custom question to the survey for a limited period of time.

• Risk management studies – studies to ascertain if a specific risk management program is effective to ensure that benefits of the drug outweigh the risks.

• Ad Hoc Analyses – The Contractor shall provide additional hours of ad hoc data analyses or custom queries not available through the data tool and in increments of 50 hours but not to exceed 100 man-hours per year.

3.7.1 Labor Category Descriptions

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 (for example, a PMP) and/or 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 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 in the form of desired results.

• Designs, codes, tests, debugs, and documents.

• Application programmer shall have a minimum of 5 years of experience in the field.

Statistician:

• At least 10 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 healthcare practitioners and provide information to patients on use of medications. May advise physicians and other healthcare practitioners on the selection, dosage, interactions, and side effects of medications.

• Pharmacist shall be registered in any state with a minimum of 10 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 seminars.

• Senior training specialist shall have a minimum of eight (8) years of experience.

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

4 - Contracts Management Requirements

Performance Evaluation Plan:

1. Performance shall be evaluated to determine whether it meets the threshold of the agreement. When the performance threshold is not met, the FDA Contracting Officer 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.

Performance Requirements Summary Table (PRST): The purpose of this section is to define performance evaluation procedures.

Required Service Standard Acceptable Quality Level (AQL)

Method of Surveillance

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

The turnaround time for urgent clearance requests is 24 hours; 48 hours for standard clearance requests; and 72 hours for third-party agreements

Standard shall be fully met at 100%

COR and FDA staff shall maintain a clearance tracking log with turnaround times

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

The Contractor shall notify the 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 the 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

Standard shall be fully met at 100%

COR and FDA staff shall monitor database access, notification and restoration times

The Contractor shall provide an acceptable Quality Assurance Surveillance Plan

(QASP)

The Contractor Shall provide a QASP with a description of quality control measures that will ensure access to valid data that is technically correct and conforms to contract requirements.

Standard shall be met at 100%

COR and FDA staff shall monitor receipt of and adherence to acceptable

QASP

The Contractor shall provide Ad-hoc Analyses: custom reporting and product customization

The Contractor shall provide the FDA ad-hoc data results within 15 business days of receipt

Standard shall be fully met at 100%

COR and FDA staff shall monitor turnaround times from the Contractor’s monthly report

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) the Contractor shall notify FDA and shall be documented in the Monthly Progress 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 healthcare practitioner’s prescribing data

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

PART 4- INSPECTION AND ACCEPTANCE

The FDA Contracting Officers Representative (COR) will perform inspection and acceptance of all OTC services in the SOW, including the IDIQ Ad-Hoc Analyses - Regulatory Drug Utilizations Services via the issuance of task orders and shall include the closure of all activities and associated deliverables within the established period of performance.

Inspection will include verifying all services were rendered and in place. The Government will accept services only if they conform to all the terms and conditions of the contract/task order.

PART 5- DELIVERABLES AND PERFORMANCE

IDIQ Deliverables shall be established with the issuance of each task order. All deliverables shall be delivered F.O.B Destination to the COR for acceptance.

52.247-34 FOB Destination (NOV 1991)

PART 6- FDA TECHNICAL ENVIRONMENT

6.1: Internet Access

Description of Deliverables Qty Unit Delivery Date

Access to Healthcare Practitioner Prescribing Practices Data (Unlimited Access License) 70 Users; Monthly Usage Reports (by the 20th of each month for the previous month); Disclosure Clearance and Third Party Agreement Services; Technical Support; Acceptable Projection or Other Appropriate Methodology; Current and complete Data Dictionary, including updates

1 Monthly Initiated at time of award

Ad hoc Analyses: custom reporting and product customization 50 Hours Lot As specified by the Government

Kick Off/On-site Annual Meeting 1 Annual Within 2 weeks of the award date

Quality Assurance Surveillance Plan 1 Annual Initiated at time of award and updated as needed thereafter.

Technical Support: to include Notification of and Access to Upgrades and/or New Releases of the Data and Software

Unlimited 12 months Length of Contract

Program Management Plan Annual Initiated at time of award and updated as needed thereafter.

http://sharepoint.fda.gov/orgs/CDER/ContractManagementTeam/OUTPATIENT%20RECOMPETE%20%202018/MON_SOW%202_28_18/SOW.docx#Projection

The required mechanism for data access is via internet. The FDA has direct, desktop access to the Internet. The system shall be web-based and be compatible with commonly used web browsers including Internet Explorer 10 and above, Firefox 23 and above, Chrome, Microsoft Edge, 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.

6.2: Number of Users

The FDA shall purchase one site license for 70 certified users.

6.3: Data Downloading

The Contractor shall provide the FDA the ability to export data in SAS, MS Excel, or MS Access, in addition to ASCII format, from the Contractor’s interface to FDA’s external storage device and/or directly to the FDA server.

6.4: Local Area Network Configuration

The Contractor shall provide access to the data resource(s) via a secure Internet or network-based method permitting simultaneous, multi-user access through a user-friendly data query tool(s).

Access to the data resource(s) shall be through a wide area network with transmission control protocol/Internet protocol (TCP/IP) running on a 10/1000 Mbs network. The network-based methods shall not necessitate any additions to the FDA communications infrastructure. FDA shall not support modem-based or dial-up access. Additionally, FDA shall not support or maintain Contractor’s equipment or personnel on premises.

6.5: Security

The Contractor shall specify any additional software and/or hardware (name and version) necessary to access the data. Any client software installed on 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 dataset and requests (e.g SQL queries or similar methods) for accessing the offeror’s application data sets. This client software shall also not transmit any data to the FDA system other than that needed for developing, transmitting, and reviewing the output of requests (such as documentation and a querying interface).

6.6: Virtual Private Network (VPN)

The Contractor shall participate in the CDER secure electronic mail system to protect any sensitive data which may be transmitted electronically between the data vendor and the FDA.The FDA utilizes the virtual private network (VPN) 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 IPSEC protocols.

PART 7- PERIOD OF PERFORMANCE

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

Base Year: May 2023 – May 2024 Option Year #1: May 2024 – May 2025 Option Year #2: May 2025 – May 2026 Option Year #3: May 2026 - May 2027 Option Year #4: May 2027- May 2028

The period of performance for the IDIQ portion of this contract shall be extended through the associated periods above, if exercised.

PART 8- CONTRACT ADMINISTRATION DATA

8.1 Place of Performance:

The Contractor shall perform services off-site at the contractor’s facility except where the Kick-Off Meeting, Annual Meetings, and Training programs are directed by the COR to be onsite.

8.2 Hours of Operation:

Unless otherwise specified in the individual task order, Contractor staff must be available during normal FDA business hours, from 8:00 am – 5:00 pm Eastern Time (ET), Monday through Friday, except on Government Closures.

The Contractor may be required to deliver documents and records materials outside of normal FDA business hours. If working outside of normal business hours, the Contractor will have the flexibility to use management tools (i.e., swing shifts) to successfully meet individual task order requirements. Any overtime incurred must be approved in advance.

Normal FDA business hours are defined as being from 8:00 am – 5:00 pm ET, Monday through Friday, with deliveries on some weekends and holidays.

8.3 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 types. In the event Contractor personnel work during a holiday observed by the Contractor other than those below, no form of holiday or 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 Contracting Officer.

January – New Year’s Day September – Labor Day January – Martin Luther King, Jr. Day October – Columbus Day February – President’s Day November – Veterans Day May – Memorial Day June – Juneteenth July – Independence Day November – Thanksgiving Day December – Christmas 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).

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.

If adverse weather conditions develop after the Federal Government has opened for normal business, upon notification of early release from OPM, the COR and/or CO will notify the Contractor of Facility closings and specify the time for a final document pickup.

Additional specific inclement weather plans may be specified at the task order level.

8.2 Transition Out:

FDA will provide instructions to the contractor for securely transferring or destroying any agency records that are in the contractor’s [or any subcontractor’s] custody or control.

8.3 Management Plan:

The Contractor shall provide the FDA with a project management plan that covers the six

(6) major components of this project in the areas of an Executive Summary, Policy and Procedures, Schedules, Timeline Plans, Budget, and the Quality Assurance Surveillance Plan.

8.4 Quality Assurance Surveillance Plan:

The Contractor shall provide a Quality Assurance Surveillance Plan (QASP) plan detailing procedures and guidelines to ensure the required performance standards or services levels are met throughout the life of this contract. The

QASP shall describe the systematic methods used to monitor performance, identify required documentation, and allocate resources. The Government reserves the right to alter or change the surveillance methods in the QASP at its own discretion.

8.5 Ordering Processes and Procedures

Ordering services under this contract shall be accomplished by the issuance of written task orders specifying the types of services being ordered. All task orders issued under this contract shall conform to the provisions of the contract clause in Part 8 entitled “Ordering.” The only office authorized to process task orders through the Office of Acquisitions & Grants Services is the Food and Drug Administration (FDA) Contracting Officer.

8.6 Task Order Procedures

The process for awarding tasks orders will be as follows:

FDA’s Office of Acquisitions & Grants Services Contracting Officer will issue an RTOP (Request for Task Order Proposal) via email. The RFTOP will include at a minimum a SOW, the period of performance, the anticipated order type (FFP, LH, etc.), reporting requirements and deliverables, and any special terms and conditions applicable to the Task Order.

The Contractor shall prepare and submit a task proposal addressing all areas of the requirement.

The Contractor shall submit the task proposal within the time specified in the RFTOP and adhere to the ceiling rates established in the contract. No separate payment will be made to the contractor for the cost to prepare, submit and/or negotiate a task order proposal.

1. Within ten (10) business days (unless another time frame is specified in writing), the contractor will provide a proposal to the Contracting Officer. The proposal will include a brief description of the technical approach and a price build up.

The price build up shall include the labor categories to be used, the number of hours within each labor category, extended pricing for each labor category and a bottom line price /ceiling.

2. FDA will evaluate the task order proposal for technical acceptability and price reasonableness. FDA will consider the following technical factors: technical approach, whether the labor mix is appropriate; and whether the level of effort is sufficient. If the FDA has questions or concerns the Contracting Officer will contact the contractor, and may ask for a revised proposal.

3. After the proposal is acceptable, the Contracting Office will issue the task order.

4. Orders will include the following:

a. Task Order Number

b. Date

c. Accounting Information

d. Statement of Work (SOW)

e. Price/Ceiling

f. Period of Performance

g. Any terms, conditions, or instructions unique to the order

Any work that the Contractor undertakes prior to receiving a fully executed task order signed by the Contracting Officer is undertaken at risk.

8.7 Contracting Officer Representative

The following COR will represent the Government for the purpose of this contract:

(COR To be determined at the time of contract award)

Contracting Officer’s Authority: The Contracting Officer is the only individual who has the authority to enter into, administer, or terminate this contract and is the only person authorized to approve changes to any of the requirements under this contract. It is the Contractor’s responsibility to contact the CO immediately if there is even the appearance of any technical direction that is, or may be, outside the scope of the contract. In the event the Contractor effects any changes to this contract or contracts at the direction of any person other than the CO, the changes will be considered to have been made without authority and no adjustment will be made in the contract price to cover any increase in costs incurred as a result thereof. The CO will be the only individual authorized to accept nonconforming work, waive any requirement of the contract/task order and modify any term or condition of the contract/task order. The Contracting Officer is the only individual who can legally obligate Government funds. No costs chargeable to the proposed contract can be incurred before receipt of a fully executed contract or specific authorization from the Contracting Officer.

The COR is responsible for: (1) monitoring the Contractor's technical progress, including The surveillance and assessment of performance and recommending changes in requirements to the Contracting Officer; (2) interpreting the Statement of Work and any and all other technical performance requirements; (3) performing technical evaluations as required; (4) performing technical inspections and acceptances required by this contract; and (5) assisting in the resolution of technical problems encountered during performance of the contract. The Government may unilaterally change its COR designation.

8.8 The contact information for the Contracting Specialist is:

Sheila Brown

OFBA/OO/OAGS

4041 Powder Mill Road Calverton, MD 20705 E-Mail: Sheila.Brown1@fda.hhs.gov Phone: (301) 796-0827

8.9 The contact information for the Contracting Officer is:

Ian Weiss

OFBA/OO/OAGS

4041 Powder Mill Road Calverton, MD 20705 Phone: (301) 796-5782 Email: Ian.Weiss@fda.hhs.gov

8.10 Key Personnel

The Contractor shall provide the names and qualifications of the key personnel assigned to this contract. The individuals cited below are key personnel.

Name Title

Project Manager _______________

If any of the personnel listed as key personnel are unable to perform because of health, resignation from the Contractor’s employ, or any other reasons, the Contractor shall promptly submit to the Contract Specialist, a detailed written explanation of the situation, the proposed substitution, complete resumes for the proposed substitute, and any other information necessary for the approval of the substitution. No substitutions shall be made without prior written approval of the Contract Specialist. No increase in contract pricing will be allowed when substitutions are authorized by the government.

8.11 INVOICE SUBMISSION

mailto:Sheila.Brown1@fda.hhs.gov mailto:Ian.Weiss@fda.hhs.gov

1. The following clauses are incorporated into the contract:

a. 352.232-71 Electronic Submission of Payment Requests (FEB 2022)

(a) Definitions. As used in this clause—

Payment request means a bill, voucher, invoice, or request for contract financing payment with associated supporting documentation. 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.

(b) Except as provided in paragraph (c) of this clause, the Contractor shall submit payment requests electronically using the Department of Treasury Invoice Processing Platform (IPP) or successor system. Information regarding IPP, including IPP Customer Support contact information, is available at www.ipp.gov or any successor site.

(c) The Contractor may submit payment requests using other than IPP only when the Contracting Officer authorizes alternate procedures in writing in accordance with HHS procedures.

(d) If alternate payment procedures are authorized, the Contractor shall include a copy of the Contracting Officer's written authorization with each payment request.

(END OF CLAUSE)

b. 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…