DRAFT STATEMENT OF WORK FDASS12212022 FINAL.pdf

ATTACHMENT: DRAFT STATEMENT OF WORK (for FDASS12212022)

BACKGROUND

A vital part of FDA and Center for Drug Evaluation and Research (CDER’s) mission is to protect the 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.

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, establish and improve procedures to estimate the number of patients exposed to drugs nationwide.

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 “Enhancement and Modernization of the FDA Drug Safety System”, Section IV (Information technology and bioinformatics goals) authorizes the FDA to “enhance transparency and leverage modern technology” continue the Agency’s efforts on the standards-based information systems to support how FDA obtains and analyzes post-market drug safety data and manages 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 of paramount importance to the overall public safety. Continued access to Over-the-Counter (OTC) drug utilization data will complement and strengthen the utility of FDA Adverse Event Reporting System (FAERS) currently in place. Access to these data will also increase the FDA’s ability to perform regulatory impact studies; in particular, those studies that assess the impact of prescription to OTC drug switches, and also allow the FDA to continue to evaluate the effectiveness of the Acetaminophen Safe Use Initiative by monitoring acetaminophen utilization https://www.gpo.gov/fdsys/pkg/PLAW-110publ85/pdf/PLAW-110publ85.pdf https://www.fda.gov/industry/prescription-drug-user-fee-amendments/pdufa-vii-fiscal-years-2023-2027 https://www.fda.gov/industry/prescription-drug-user-fee-amendments/pdufa-vii-fiscal-years-2023-2027 patterns. Finally, direct access to these data enhances and accelerates the pace of FDA's regulatory decision-making process. The funding of "Access to Over-the-Counter (OTC) Drug Utilization Data" will serve as a mechanism for FDA to respond expeditiously to serious public health or regulatory issues related to OTC drug products. FDA’s Authority to fund research and projects is set out in Section 301 of the Public Health Service Act (PHSA 42 U.S.C. 241).

PROGRAM RESEARCH GOALS AND OBJECTIVES

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

1. Provide Access to OTC Drug Utilization Data as follows:

a. Provide FDA personnel with access to a currently existing, commercially available data resource for OTC data

b. Provide FDA personnel with the ability to use these data to describe national patterns of OTC drug utilization through the use of projection or other appropriate methodologies that are scientifically sound and transparent to FDA personnel.

c. 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.

SCOPE OF WORK

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

National Level Over-the-Counter (OTC) Drug Utilization Data - Data Requirements (Firm-Fixed Price (FFP)

a. The Contractor shall provide access to de-identified, HIPAA-compliant data resources on OTC drug product sales from U.S. retail outlets to consumers. FDA requires access to current and historical data to obtain national patterns of OTC drug product utilization. The data shall have a maximum of a 6-month lag time between the date of OTC drug product purchase and date of data availability for FDA use. (approx. between 20- 25 users).

https://www.google.com/url?sa=t&rct=j&q=&esrc=s&source=web&cd=&ved=2ahUKEwjZ7bLS3p_7AhU1MVkFHWG9AkcQFnoECAkQAQ&url=https%3A%2F%2Fwww.govinfo.gov%2Fcontent%2Fpkg%2FCOMPS-8773%2Fpdf%2FCOMPS-8773.pdf&usg=AOvVaw2FXCaFQEw86mW2wM5v4yni

b. The OTC drug-specific basic data elements shall include brand and generic drug product names; drug active ingredients; unit price code (UPC) and/or national drug code (NDC) number; strength of active ingredients; dosage form; size of drug product by milliliter (mL), number of tablets/capsules and/or total doses available; manufacturer and/or re-packager; date of purchase; indication(s) for use or ailment(s) intended to treat or an acceptable surrogate such as therapeutic sub-categories. In response to the RFP and as needed during the period of performance of the contract, the Contractor shall provide the percentage of missing or incomplete data for each of these OTC drug-specific basic data elements and how it is handled.

Of note, specific store names for store name brand products are not required but data on store name brand products, such as drug active ingredients, shall be included for analysis by the elements listed above.

c. The treatment-specific basic data elements shall describe the marketing category.

d. The data resource shall include a coding system that consists of drug and ailment coding levels for FDA data analyses and the percentage of missing or incomplete information for each data element.

e. The Contractor shall provide FDA staff the ability to select OTC drugs and market categories, and perform data reports at the active ingredient level, product level, and any other data elements that may become available.

f. The Contractor shall de-identify the data for FDA use, and the methods used to de-identify the data shall be described in the proposal and shall be HIPAA-compliant.

g. The Contractor shall provide national estimates using FDA-approved and appropriate projection methodology. These estimates shall be comparable to estimates obtained from national benchmarks such as the U.S. National Census Data. The data resource(s) shall have projected numbers. The Contractor shall provide the frequency with which data are updated and methods for updates.

h. The Contractor shall provide full disclosure of data collection, construction, coding, and configuration to allow FDA staff to appropriately interpret findings and understand the construction and application of the projection or other appropriate methodology.

i. The Contractor shall provide OTC drug utilization data that is currently existing and commercially available. Access to the data shall be through monthly reports via an online interface and/or excel format

Ad-Hoc Analyses - Regulatory Drug Utilizations Services – Labor Hour

When directed by the Contracting Officer via the issuance of Task Orders, on a Labor Hour basis at the rates negotiated in this base IDIQ, the Contractor shall provide ad-hoc Regulatory Drug Utilization Services. The performance period/delivery date(s) for services ordered shall be specified on each order. The types of task orders would include:

a. Concomitant drug reports – reports on the concomitant purchases of an OTC product(s) or class of products with another product(s) or class of products used to treat an ailment.

b. 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.

c. Customized analysis – analysis of data that endeavor to answer a specific question that require additional tools beyond the current interface tool that is provided by the database (e.g., data to include but not limited to household and/or intended/patient demographic data and patient specific data elements such as age, gender, height, weight; income level; race/ethnicity).

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

e. The Contractor shall provide for configuration and inclusion of drug categories that were either not included in the dataset or not completely coded. The performance period/delivery date(s) for services ordered shall be specified on each order. These drug categories shall include, but shall not be limited to, the following drug categories: smoking cessation products, female contraceptives, oral pain products, weight loss products, cannabis/hemp products, acne products, ear care products, and motion sickness/anti-emetic products.

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

Key Personnel and Staffing

The Offeror shall have key personnel employed and available for duty before the commencement of contract performance. The Offeror is responsible for proposing qualified staff, including the required key personnel, that meet the requirements of the SOW. Key personnel shall be evaluated in accordance with the evaluation factors. Any subsequent changes to key personnel must meet these criteria and be approved in writing by the Contracting Officer. The following position is designated as a Key Personnel position under this contract and is subject to HHSAR 352.237.75 – Key Personnel (Dec 2015):

Project Manager/Research Director (Key Personnel):

• 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.

The following positions are not designated Key Personnel positions however, the Offeror shall propose staffing meeting the qualifications and position descriptions as follows:

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 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 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.

• Pharmacist shall be a registered in any state with a minimum of 10 years of experience in the field.

Survey Scientist:

• Trains personnel by conducting formal classroom courses, workshops, and seminars.

• Survey Scientist shall be a registered in any state with a minimum of 10 years of experience in the field.

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.

Epidemiologist shall be a 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.

• 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.

• The Contractor shall provide staffing, qualified in accordance with this section of the

SOW, dedicated to delivering the services required under this contract.

Complete Data Dictionary for OTC Drug Utilization Data Resource

The Contractor shall provide a current and complete data dictionary, including updates, and a description of their data resource(s), type of data, the data collection methodology, and the data elements demonstrating that the data resource(s) can evaluate OTC drug utilization data at the national level.

Monthly Reports

The Contractor shall provide a Monthly Report by the 20th of each month for the previous month data detailing, clearances, third party agreements, number of ad-hoc programming hours used and project title.

a. Ad-Hoc Dataset Requests shall include the number of technical support programming hours used

b. Clearance Requests shall include data submitted, project title, purpose (publication, presentation, research, or other), FDA requestor, and approval date

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

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

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. 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 of performance. After option year 4, the FDA shall notify the contractor of the aggregated data release and accept the Contractor’s requested revisions, but shall not require formal approval for release.

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 forms.

These Procedures include terms and conditions for third party collaborations.

Clearance after Conclusion of Contract:

The FDA shall continue to require, after the conclusion of the contract, the ability to release aggregated data through the FDA Data Disclosure Clearance process for data obtained during the contract period. After option Year 4 when the contract has ended, the FDA may not use data extracted during the contract period of performance for any other purpose, beyond the release of aggregated data for analyses completed prior to the end of the contract through the FDA Data Disclosure Clearance process, without vendor’s approval in writing.

Technical Environment Security

Any client software that is required to be installed on any FDA computers for the purposes of accessing the data shall not use keylogging 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 post-production maintenance that includes patches, upgrades, and bug fixes, if required.

Virtual Private Network (VPN)

The 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 IPSEC protocols.

Custom programming and analytical support

The Contractor shall provide analytical, clinical, and programming support, to enable FDA personnel to obtain OTC drug utilization metrics not available in the monthly deliverables.

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.

The training sessions shall include an instructor-led overview of the OTC data resource to the FDA staff with the ability to project via web-based presentation. A hands-on computer-based training for a maximum of 25 FDA staff members shall be provided on the use of the data and interface tool(s). The hands-on sessions shall include exercises with data queries with FDA content. The Contractor shall work with FDA COR to develop exercises with data queries relevant to FDA work.

The Contractor shall provide options for additional “on-demand” sessions, limited to a maximum 10 training sessions per year, either in person or via web-based methods, as requested. Training shall be initiated within 30 days of award and shall continue throughout the duration of the contract.

The Contractor shall provide course outlines to include a detailed training agenda (pre-approved by FDA) for the overview of the OTC data resource(s) and the hands-on computer-based training offered. Training manuals and course outlines shall be provided in hard copy at the time of training.

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 on-site at the FDA campus in Silver Spring, MD or virtually once a year. 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.

Technical Support

The Contractor shall provide a support package comprised of web-based written documentation that includes technical, analytical, and clinical support throughout the length of the contract.

The Contractor shall provide ongoing technical, analytical, and clinical support, by phone or by e- mail, to all certified users of the data during business hours (9:00 am to 5:00 pm, EST), throughout the length of the contract in accordance with the service levels established in the contract.

The support package shall include all upgrades, enhancements, and modifications to the software and data.

Contract Management Requirements

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.

Type of Contract The type of contract contemplated for the OTC services is a fixed price and/or labor hour type of contract.

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

Base Year: September 28, 2023 – September 27 , 2024 Option Year #1: September 28, 2024 – September 27, 2025 Option Year #2: September 28, 2025 – September 27, 2026 Option Year #3: September 28, 2026 – September 27, 2027 Option Year #4: September 28, 2027 – September 27, 2028

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

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.

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.

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.

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.

Performance Evaluation Plan:

Performance shall be evaluated to determine whether it meets the threshold of the agreement.

When the performance threshold is not met, the FDA 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.

ADVANCE UNDERSTANDING

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

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

Required Service Standard ceptable 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 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 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 guarantee timely access to OTC 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

Deliverables

Description of Deliverables Unit Delivery Date Monthly updates to national level Over-the-Counter (OTC) Drug Utilization Data /Services; Monthly Usage Reports (by the 30th of each month); Disclosure Clearance and Third-Party Agreement Services; Technical Support; Projection or other appropriate Methodologies; Current and complete Data Dictionary, including updates

Monthly Initiated at time of award

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

Kick Off/On-site Annual Meeting Annual As specified by the Government

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

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