Solicitation No. 7540123R00015 Amendment 0001.pdf

Offers must acknowledge receipt of this amendment prior to the hour and date specified in the solicitation or as amended, by one of the following methods:

(a) By completing items 8 and 15, and returning or (c) By separate letter or electronic communication which includes a reference to the solicitation and amendment numbers. FAILURE OF YOUR ACKNOWLEDGMENT TO BE

RECEIVED AT THE PLACE DESIGNATED FOR THE RECEIPT OF OFFERS PRIOR TO THE HOUR AND DATE SPECIFIED MAY RESULT IN REJECTION OF YOUR OFFER. If by virtue of this amendment you desire to change an offer already submitted, such change may be made by letter or electronic communication, provided each letter or electronic communication makes reference to the solicitation and this amendment, and is received prior to the opening hour and date specified.

E. IMPORTANT: Contractor is not is required to sign this document and return copies to the issuing office.

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT

1. CONTRACT ID CODE

2. AMENDMENT/MODIFICATION NUMBER 3. EFFECTIVE DATE 4. REQUISITION/PURCHASE REQUISITION NUMBER 5. PROJECT NUMBER (If applicable)

7. ADMINISTERED BY (If other than Item 6) CODE

STANDARD FORM 30 (REV. 11/2016)

Prescribed by GSA FAR (48 CFR) 53.243

FACILITY CODE

9A. AMENDMENT OF SOLICITATION NUMBER

9B. DATED (SEE ITEM 11)

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11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS

The above numbered solicitation is amended as set forth in Item 14. The hour and date specified for receipt of Offers is extended. is not extended.

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IT MODIFIES THE CONTRACT/ORDER NUMBER AS DESCRIBED IN ITEM 14.

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Except as provided herein, all terms and conditions of the document referenced in Item 9A or 10A, as heretofore changed, remains unchanged and in full force and effect.

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14. DESCRIPTION OF AMENDMENT/MODIFICATION (Organized by UCF section headings, including solicitation/contract subject matter where feasible.)

PAGE OF PAGES

6. ISSUED BY CODE

8. NAME AND ADDRESS OF CONTRACTOR (Number, street, county, State and ZIP Code) (X)

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16B. UNITED STATES OF AMERICA

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Previous edition unusable

DAO

James G. Whitt

The purpose of this Amendment 0001 is to:

1. Provide answers to questions received from interested vendors;

2. Provide revised Attachments A, B, I, and J in response to questions received; and

3. Provide revisions to the solicitation document.

**Please see "10. INSTRUCTIONS TO OFFERORS AND EVALUATION/AWARD CRITERIA" for revised submission Schedule.

Phase I proposals due January 25, 2023, 3:00 PM EST.

DHHS/FDA/OAGS/DAO

ATTN: Nicholas Bisher 4041 Powder Mill Road Beltsville MD 20705

1263203

75F40123R00015

1 111

01/18/2023

01/18/2023

RFP Number: 75F40123R00015 FDA Adverse Event Reporting System (FAERS) Data Management Program (DMP) Support Services

Food and Drug Administration (FDA)

FDA Adverse Event Reporting System (FAERS) Data Management Program (DMP) Support Services

Request for Proposals #: 75F40123R00015

Single-Award IDIQ Contract -- 8(a) Competition

1. SOLICITATION INFORMATION

1.1 Notice of Combined Synopsis/Solicitation

This is a combined synopsis/solicitation in which the FDA will issue a single award IDIQ contract for commercial items prepared in accordance with (IAW) the format in FAR Subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation;

proposals are being requested and a written solicitation will not be issued. This is a request for proposals (RFP) for commercial items IAW the procedures of FAR Part 12 – Acquisition of Commercial Items, in conjunction with FAR Part 15 – Contracting by Negotiation.

1.2 Notice of FAC

This solicitation document incorporates provisions and clauses in effect through Federal Acquisition Circular FAC 2022-08, effective October 28, 2022. The applicable North American Industry Classification System (NAICS) code is 518210—Computing Infrastructure Providers Data Processing, Web Hosting, and Related Services. The small business size standard is $40 million.

2. CONTRACT TYPE

This competitive 8(a) requirement will be an Indefinite Delivery-Indefinite Quantity (IDIQ) type contract with a five (5) year ordering period, and is being processed under a Partnership Agreement (PA) between the Department of Health and Human Services (HHS) and the Small Business Administration (SBA), under which the SBA has delegated to HHS, authority to enter into 8(a) contracts directly with eligible 8(a) firms in accordance with Section 8(a) of the Small Business Act (15 U.S.C. 637(a)).

FDA has chosen to pursue an IDIQ contract to reduce lead time to award orders and maximize the flexibility of selecting contract types appropriate to the specific tasks under consideration. At the discretion of the Contracting Officer, the Government may utilize Firm-Fixed-Price (FFP), Labor-Hour (LH), and Time and Materials contract types, or a combination thereof, for the orders. Each Request for Task Order Proposal (RFTOP) issued under this contract will identify the Government’s determination of contract type.

3. DESCRIPTION OF REQUIREMENTS / PERFORMANCE WORK STATEMENT (PWS)

1.0 Introduction

1.1 Food and Drug Administration (FDA) Mission

The mission of the FDA is to protect the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices; and by ensuring the safety of our nation's food supply, cosmetics, and products that emit radiation.

FDA is responsible for:

1) Regulating the manufacturing, marketing, and distribution of tobacco products to protect the public health and to reduce tobacco use by minors.

2) Advancing the public health by helping to speed innovations that make medical products more effective, safer, and more affordable and by helping the public get the accurate, science-based information they need to use medical products and foods to maintain and improve their health.

3) Playing a significant role in the Nation's counterterrorism capability. FDA fulfills this responsibility by ensuring the security of the food supply and by fostering development of medical products to respond to deliberate and naturally emerging public health threats.

1.2 Center for Drug Evaluation and Research (CDER); Office of Surveillance and Epidemiology (OSE) Mission

The mission of the FDA/CDER/OSE performs an essential public health task by making sure that safe and effective drugs are available to improve the health of people in the United States. CDER regulates over the counter and prescription drugs, including biological therapeutics and generic drugs. works to detect, assess, prevent, and manage the risks of medications so that they can be relied upon to treat disease and improve health. All medicines have risks as well as benefits; the risks of medicines are the chances that something unwanted or unexpected could happen when consumers use them. OSE participates in the safety analysis of drugs before they are marketed to patients and consumers. After the drugs are marketed, we utilize risk assessment tools to identify and assess adverse events and medication errors that did not appear during the drug development process as well as to understand better those risks observed in clinical trials. OSE also provides expertise on risk mitigation strategies to prevent medication errors, to improve the safe use of products, and to manage the risks associated with medicines after they are marketed.

2.0 FAERS DMP Background

The FDA’s CDER and the FDA’s Center for Biologics Evaluation and Research (CBER) perform a crucial part of FDA's mission, specifically review and analysis of pre-market and post-market safety and efficacy assessments of human drugs and biologics. In this context, CDER and CBER perform safety surveillance, to include the recording of mandatory and voluntary submission of adverse event reports, product problem and medication error reports (referred to in this PWS as “safety reports”) by the FDA’s Adverse Event Reporting System (FAERS).

Mandatory safety reports are submitted electronically by manufacturers to the FDA. The mandatory reports are either expedited (i.e., submitted within 15 days after the manufacturer became aware of the adverse event for their product) or non-expedited (i.e., submitted within 90 days after the manufacturer became aware of the adverse event for their product). These reports are XML files that follow the International Council of Harmonisation (ICH) E2B (R2) format and are submitted to the FDA’s Electronic Submission Gateway (ESG) also referred in this document as eSubs. Since these reports are electronic in nature, they typically get processed by FAERS without any human intervention. Of the 2.2 million reports submitted by the manufacturer only about 2% of these reports stop for human intervention due to issues with the name of the product or the manufacturer.

Safety reports submitted by consumers and healthcare professionals are sent directly to the FDA and are voluntary in nature. These reports are also referred to as “direct reports”. Approximately 100,000 reports per year are direct reports and have to be triaged and routed to appropriate Centers within FDA.

Of the 100,000 direct reports, 70% are processed via the FAERS system and made available for the reviewers. These direct reports come using the MedWatch form and some variation of the MedWatch form. The MedWatch form itself has two variations: i) MedWatch Form 3500 (https://www.fda.gov/media/76299/download) for healthcare professional; and ii) MedWatch Form 3500B (https://www.fda.gov/media/85598/download) for consumers. The form may be sent in by US postal mail, to a special electronic fax line or an electronic version can be filled out using the MedWatch Online website (Https://www.accessdata.fda.gov/scripts/medwatch/index.cfm). For certain FDA regulatory products, the MedWatch Form 3500A (https://www.fda.gov/media/69876/download) is submitted by the manufacturer.

Additionally, there are reports processed by DMP that are received by CDER’s Office of Pharmaceutical Quality (OPQ) that are related to product quality defects. These reports include MedWatch Product Complaints, Consumer Complaints, Field Alert Reports (FARs) and Biologic Product Deviation Reports (BPDRs) of the post-marketing safety surveillance data for all regulated human medical products including drugs and combination products (drug/biologic, drug/device). The Field Alert Reports (FARs) Form 3331a (https://www.fda.gov/media/85567/download) are mandatory reports submitted by the manufacturer that are used to quickly identify quality defects in distributed drug products that may present a potential safety threat. More than 9,000 FARs per year are submitted to FDA, approximately 95% are submitted in XML format and uploaded directly into the FAERS system similar to post-market eSubs and the remaining 5% come as pdf documents. The BPDRs Form 3486 (https://www.fda.gov/media/70604/download) are mandatory reports that are submitted by manufacturers of human cells, tissues and cellular and tissue-based product (HCT/Ps) to report biological product deviations (BPD) to FDA that may affect the safety, purity, or potency of a distributed products.

Approximately 300 BPDRs are received per year in both PDF and XML format. The Product Complaint reports are submitted by consumers or healthcare professional using the MedWatch Form 3500 and 3500B and are voluntary reports. As stated above, the Product Complaint reports contains complaints about the quality of an FDA regulated product that require review and analysis by FDA Consumer Safety Officers (CSOs).

Compared to these CDER OPQ product quality reports, a substantially smaller number of CBER product quality reports are received annually. These reports are not currently processed into FAERS but FDA standard operating procedures may change in the future to accommodate these reports in the FAERS database. New types of safety reports may be added as required by FDA regulations and policies.

In the future, FDA intends to process Investigational New Drug (IND) Safety Reports into FAERS because of changing regulations and to monitor the full drug safety lifecycle. Approximately 40,000 IND Safety

Reports are received per year will be processed in FAERS. Of the 40,000 reports, approximately 5% of the reports are submitted on non-commercial IND as MedWatch 3500A form in PDF format which are not mandated to report electronically and the remaining 95% are on commercial INDs which will be mandated to submit safety reports electronically. There will be a transition period where IND safety reports on commercial INDs will continue to be submitted on a MedWatch 3500A form in PDF format until the manufacturer submits XML files electronically via eSub.

The DMP contract is supported by a separate support contract to maintain the FAERS software system which is managed by the FDA CDER’s Office of Business Informatics (OBI). This separate contract is responsible for the enhancement and maintenance of the FAERS software system along with the integration of third-party tools. The DMP contract is not responsible for the operations and maintenance of the FAERS software system.

For the DMP contract, the FDA allows for innovation in managing the task areas defined in Section 6.0 below.

2.1 A Broad Overview of Data Entry

The processing of the safety reports is a crucial part of the safety surveillance mission critical program.

Below is the high-level view (Figure 1) of the data entry process that enables the reports to pass through multiple activities and finally are made available to the safety reviewers to review and analyze them.

Figure 1: Case Processing of Safety reports

Reports are received by U.S. Postal Mail, special designated fax lines, dedicated websites or through an FDA electronic gateway which can receive electronic messages in the E2B R2 format from manufacturers.

Postal mail, fax, and MedWatch Online website reports come from consumers and health care providers. The postal mail reports are picked up by a courier and sent to the Central Triage Unit (CTU) to be scanned and registered into First Look at Reports (FLARe). FLARe is a computer system that support the registration, triaging and disposition of all voluntary reports. Reports received via fax and MedWatch Online are automatically registered into FLARe. Approximately ten fields with basic information are entered into FLARe from the postal mail and the fax reports. The reports from MedWatch Online are electronic and no data entry is required. Reports then go to the Triage processing step where each report is reviewed by a pharmacist to make sure it has the four necessary elements of a valid report.

Reports that are not valid are logically deleted and no additional data entry is performed. Reports are also reviewed to ensure that the products they describe are regulated by CDER and CBER. FDA products that are regulated by other Centers are routed to them and no further data entry is required. After the reports are triaged and marked as CDER or CBER reports based on the products, they are dispositioned by FLARe as an electronic XML file to the case processing software tool called LifeSphere MultiVigilance (LSMV) which is part of the FAERS system.

Reports that are sent to FAERS undergo the Data Entry activity step where approximately 50 different fields are entered into the FAERS system. After data entry these reports are sent to undergo Product and Manufacturer Coding. The Product and Manufacturer Coding activity step ensures that the drug product names, and the names of any manufacturer and/or firm are validated using the FAERS Product and Manufacturer dictionary systems respectively. At this point the eSubs sent by the manufacturers may also enter the system if their drug name or manufacturer name is not automatically matching in our dictionaries.

Specialists in these areas ensure that all reports have validated drug and manufacturers names associated with each report. The reports are then routed to the MedDRA Coding activity step. All reports have a “narrative” (section B5 of the MedWatch Form 3500) free form text box that asks the reporter to “Describe the Event or Problem”. The narrative is read by the MedDRA coder and the appropriate adverse event term, medication error term or defect terms in case of product quality reports is coded into the report in FAERS using the MedDRA dictionary. This “MedDRA coding step” is done by highly trained specialist who normally have backgrounds as doctor, nurse, pharmacist, dentist, or other licensed health care providers. These defined terms are from an international standard called MedDRA.

MedDRA stands for Medical Dictionary for Regulatory Activities (https://www.meddra.org) used to code adverse events/medication error/defect terms. After the completion of MedDRA Coding the reports are now ready for evaluation. At this point the report has all data values available entered and each report is coded to FDA dictionaries on drug product name, manufacturer/firm, and a controlled vocabulary for adverse events/medication error/defect terms using MedDRA. Reports that have undergone all data entry activity step can now be efficiently searched by FDA safety reviewers for analysis, identify issues and trends which may result in regulatory actions.

The above process and activity steps are also applicable for processing product quality reports.

3.0 Overview of the Acquisition

What is it: This acquisition is for data management services in support of the FDA Adverse Event Reporting System (FAERS) Data Management Program (DMP), in support of the FDA/CDER/RSS office use only.

Why it is needed: Data management services are used in capturing and processing safety reports which includes human adverse events data, medication errors, and product complaints reported by the general public, healthcare companies and organizations.

Who needs it: The safety reports are reviewed by the FDA safety evaluators to make regulatory decisions and allow the FDA to respond to public health crises. These reports are also made available for the public use.

For What Purpose: DMP services are important for FDA to identify safety issues to protect the public health by capturing and processing safety reports to ensure that all data entry activities are completed with timeliness and accuracy.

4.0 Objective

The overall objective of this requirement is for the contractor to process the reports, submitted by the public, by entering and coding the reports in a timely manner. This process is critical to ensure that the data can be reviewed by the FDA safety evaluation team to identify safety issues and respond to public health incidents to meet its regulatory mission.

As a result, the FAERS data management services are required to achieve the results as follows:

1) Collect, receive and process mandatory and voluntary safety reports to make it available to the FDA Safety Evaluation Teams.

2) Establish quality assurance and training programs for the data entry process and management of coding services to enhance the quality of data for the FDA review and analysis.

3) Ongoing review of case processing activities for process improvement and program efficiency.

The task requirements below are reflective of the tasks and effort to be associated with the first task order.

5.0 Scope of Work

The contractor shall perform these functional DMP services as follows:

1) Performing services within the FDA Standard Operating Procedures (SOP) requirements.

2) Development and enhancement of SOPs.

3) Program management services for the oversight of data management operations, contractor staff training, records management, courier services and regular metrics reports.

4) Receiving data in a variety of physical and electronic formats.

5) Scanning physical documents into electronic formats, reviewing electronic submissions, and making the required corrections.

6) Entering, registering, and processing data into the FDA computer system.

7) Performing data analysis on case processing metrics, tracking services, and stakeholder/user support.

8) Sorting and routing this data to the correct work area or correct FDA Center that regulates the product described.

9) Medical coding of reports using various taxonomies (e.g., MedDRA).

10) Performing quality assurance and quality control on data.

11) Participating in the testing and validation of new software systems used to support new and more efficient data entry systems.

6.0 DMP Task Areas

The contractor shall meet the following performance-based objectives within each of these functional task areas and further described below.

Task Area 1: Case Processing Services Following the Standard Operating Procedures (SOP)

Task Area 2: Management of the SOPs

Task Area 3: Case Processing Management

Task Area 4: Systems & Management Support

Task Area 5: Document Delivery (Local Courier Services)

Task Area 6: Program Management Services

Task Area 7: Data Quality Assurance and Training

Task Area 8: Support of FAERS DMP Program Enhancements and Efficiencies

All of the below sections are divided into the requirements which are the tasks along with the associated standards which define the minimum task level for the contractor to perform.

6.1 Task Area 1: Case Processing Services Following the Standard Operating Procedures (SOP)

Requirement:

The contractor shall perform case processing services, which are written in the SOPs listed below, and utilizing the FLARe and FAERS software systems. The Direct MedWatch ICSR handling SOP, the FAERS Case Processing SOP, and the Drug Quality Reporting System (DQRS) SOP, are referenced in the below task areas (Task Area 3: Case Processing Management) and the attached appendices.

Standard:

Title SOP file Description of SOP

FAERS Case Processing Case Processing and Data Management in FAERS

Direct MedWatch ICSR Handling Processing Individual Case Safety Reports Submitted Directly to MedWatch

Drug Quality Reporting System Case Processing of Drug Quality Reports

Deliverable(s): As Specified in Each Individual Task Order.

6.2 Task Area 2: Management of the SOPs

Requirement:

The contractor shall develop and update existing Data Management SOPs or create new SOPs in coordination with the FDA as follows:

Standard:

1) Update, review, create new, and post SOPs as needed according to FDA enterprise records management policies.

2) Create detailed Work Guides based on SOPs for FAERS activities, as needed.

3) Maintain a change history of all SOPs related to this contract and assure that only current

SOPs are posted on the FDA provided intranet.

4) Ensure that appropriate FDA personnel review and approve all SOPs prior to issuance.

5) Perform SOP revisions within twenty-one (21) days from notification by COR.

6) Ensure that up-to-date SOPs are available electronically in the FDA SharePoint site to all contractor personnel and FDA/CDER internal users.

7) Ensure that all hyperlinks used within SOPs are maintained and up to date.

8) Review SOPs on an annual basis and provide COR with a summary of changes needed.

The FDA COR/PM and FDA On-Site Representatives shall review and approve all new and updated SOPs.

Deliverable(s):

Revised and/or Reviewed DMP SOPs/Work Guides, and other deliverables that may be specified in each individual task order.

6.3 Task Area 3: Case Processing Management

Requirement:

Per the process in the above Figure 1: Case processing of Safety reports, the contractor shall provide FAERS data entry support services for reports commonly known as Individual Case Safety Reports (ICSRs) to include tasks such as: scanning, registering (logging), triaging, data entry, coding of manufacturer and product(s), MedDRA coding as described in the two SOPs in Task Area 1: SOP Services above and in the detailed sections describing each FAERS process step below. Additional case processing management activities include updating of data records, reviewing, editing, filing, quality control, and quality assurance.

All reports shall be processed according to approved SOPs and business rules. The contractor shall seek assistance from the FDA On-site Representative with issues not covered by the SOPs.

Standard:

Each ICSR shall be legible, and shall contain at least one identifiable suspect product, an identifiable reporter, identifiable patient, and a minimum of one identifiable event converted by the contractor to a MedDRA term to be entered into FAERS.

The contractor shall, at a minimum, maintain the performance guidelines per the below table on the volume of direct reports (70% of the 100,000 direct reports) and electronic reports (2% of the 2.2 million from manufacturers) that require human intervention due to coding issues with products and/or manufacturers.

The table below lists the different process steps and the average number of reports processed by one (1) person in one (1) hour (per hour/per person) in each specific step.

FAERS Process Step Average Reports Per Hour/Per Person

Registration 20

Triage 30*

Data Entry 6.0

Product/Manufacturer Coding 7.0

MedDRA Coding 8.0

*All reports received before noon shall complete the triage process step each business day.

The table below lists the different report types and the average days to process those report types.

Report Type Average “Business ” Days to Process

Direct Reports 5* (1-2 days for urgent issues/products of concern identified by FDA)

Expedited - Paper 2

Non-expedited - Paper 2

Expedited E2B 1

Non-expedited E2B 1

*Within the average business days to process for the report type “Direct Reports”, all postal mail direct reports shall be “scanned” into the FLARe system within one (1) business day upon receipt.

6.3.1 Receipt and Handling of Reports

Requirement:

The contractor shall establish a courier service to collect the mail according to the currently established mail stops (See Appendix Courier Routes). The reports received shall be scanned and sent via email to the FDA established email to the FLARe system. Fax and MedWatch Online (MWO) reports will flow directly into the FLARe system.

Standard:

The physical copy of the scanned reports shall be retained at the FDA White Oak location for at least ninety (90) calendar days prior to shredding.

6.3.2 Central Triage Unit (CTU) FLARe – Registration and Triage

The contractor shall establish and operate a CTU that performs the following activities: (1) Registration,

(2) Triage/Routing reports to the appropriate Center(s) and (3) send Acknowledgement letters for paper voluntary reports.

The contractor shall perform the following activities:

1) Registration steps:

i. Manually scan the paper reports into FLARe. Note that fax and Medwatch online reports are pulled into FLARe automatically. The FLARe system generates a unique receipt number for each report and automatically attaches the scanned report to the unique receipt number as the source document.

ii. Only reports in the English language shall be processed through FLARe or LSMV.

Non-English language reports shall be assigned to the FDA representative for translation or required handling before being further processed in FLARe or LSMV as required.

iii. Enter approximately 10 data fields in the FLARe system from the source document.

2) Triaging step:

i. Review, Triage, and route all reports along with any source document to the appropriate responsible Center(s) listed in the Direct MedWatch ICSR Handling

SOP.

ii. Reports triaged to CDER and CBER are automatically disposed to LSMV for Case Data Entry which now generates a Case ID in LSMV.

iii. Seek assistance from the FDA Onsite Representative, as necessary, when encountering unfamiliar reports or products in the report.

3) Acknowledgement Letter steps:

i. Prepare labels and mail acknowledgement letters once a week to reporters who submitted paper direct reports.

Standard:

The contractor shall generate metrics reports available in FLARe system that provides metrics on all CTU activities to monitor workload. These metrics shall be reported on the “Weekly Summary Report of Case Processing Activities”.

6.3.3 Case Data Entry of Individual Case Safety Reports (ICSRs)

Requirement:

The contractor shall process all reports other than E2B (ESG or SRP) submissions received directly from the manufacturers.

Standard:

The contractor shall perform the activities as follows:

1) Enter the verbatim data for the voluntary case in the LSMV tool by looking at the source document.

2) Complete data entry of reports containing high priority drugs as specified by the FDA within 24 hours after receipt.

3) Route the report to the Product/Manufacturer Coding activity in LSMV after data entry is complete.

Note: During case data entry in LSMV, data checks are performed in the tool.

6.3.4 Product/Manufacturer Coding and Dictionary Maintenance

Requirement:

The contractor shall ensure that the Product/Manufacturer coders resolve discrepancies between the data entered in the FAERS database and information submitted on the actual report form. The coders shall also validate the report data for each primary and secondary suspect drug product.

Standard:

The contractor shall perform the Product/Manufacturer Coding activity as follows:

1) Review the product name(s) and/or “National Drug Code (NDC)” in the report that does not auto-code to the product dictionary and choose the appropriate name from the product dictionary to code the product name(s).

2) Review the manufacturer name and/or “Firm Establishment Identifier (FEI)” in the report that do not auto-code to the manufacturer dictionary and choose the appropriate name from the manufacturer dictionary to code the manufacturer/firm name.

3) Support FDA with updates and corrections to the FAERS product dictionary by working closely with the FDA MedDRA Dictionary Team who maintain the Product/Manufacturer dictionary.

a. The contractor shall be responsible for researching and including new drug names into the product dictionary and correcting and updating entries.

b. The contractor’s employees assigned to support dictionary maintenance shall report to the FDA’s product dictionary group and assist with researching and updating manufacturer dictionary entries

4) Route the report to MedDRA Coding once all product name(s) and the manufacturer name(s) are coded.

6.3.5 MedDRA Coding

Requirement:

The contractor shall ensure that the MedDRA Coding is performed by reviewing the narratives and using the MedDRA dictionary.

Standard:

The contractor shall perform the MedDRA Coding activity as follows:

1) MedDRA coder(s) certification via MedDRA coding training and testing.

2) Code MedDRA lowest level terms (LLTs) and MedDRA version discrepancies, which includes:

a. Reading the narrative section of the report to identify the reported adverse events/medication errors/product defects.

b. Searching MedDRA for an appropriate term that corresponds to the identified reported term in the report or key in the identified reported term directly into the appropriate data field.

c. Verify that all adverse events/medication errors/product defects are coded to a term in the MedDRA dictionary according to the coding guidelines.

d. Seeking assistance from the FDA MedDRA Dictionary Specialists Team when unable to identify and/or code a reported verbatim term.

3) Utilize MedDRA in the FAERS database to capture and code reported adverse events, indications, medication errors, product defects, and other fields required coding, as needed.

4 ) Route the MedDRA coded report to the final status “Evaluation Ready”, to allow the report to be available to the Safety Reviewer.

6.3.6 Processing of Drug Quality Reports

Requirement:

The contractor shall process the Post Market Product Quality Reports that includes FAR, BPDR, 3500, 3500B and Consumer Complaint reports. These reports are processed into the DQRS system according to the DQRS SOP.

Standard:

In addition to the above process, the contractor shall perform a few additional process activities as follows:

1) Send Information Requests (IRs) to reporters or product manufacturers to collect specific product details that are sometimes missing on the report (e.g., NDC number, Lot number, etc.)

2) Route the MedDRA coded report to the CSO Review activity to be reviewed by the CSO.

3) The table below lists the different report types and the average days to process those report types.

Report Type Average “Business ” Days to Process

Post Market Product Quality Reports 3

Deliverables:

ICSRs delivered via completed case available in LSMV; Weekly Performance Report; and MedDRA Coding Competency Certificate, and other deliverables that may be specified in each individual task order.

6.4 Task Area 4: Systems & Management Support

The contract shall assist the FDA during the enhancement and/or replacement of FAERS, FLARe, and Optical Character Recognition (OCR) software systems that support all DMP requirement activities.

Standard:

These DMP support activities include:

1) Perform testing and validation of the new or existing systems during the implementation phase of the software.

2) Perform User Acceptance Testing (UAT).

3) Train contractor employees on existing, new, and updated software.

4) Create new SOPs.

5) Update current SOPs.

6) Assist FDA in elaborating use cases and requirements on new or existing systems.

Deliverable(s):

Monthly Performance Report, and other deliverables that may be specified in each individual task order.

6.5 Task Area 5: Document Delivery (Local Courier Services)

Requirement:

The contractor shall provide local courier services to collect and deliver MedWatch reports and physical media from companies sent through the U. S. Postal Service, FDA/CDER reports that were sent to other FDA Centers and re-route non-FDA CDER/CBER reports that were received per the courier route appendix.

Standard:

The contractor shall provide local courier service as follows:

1) Up to two (2) routings per day, as needed

2) Oversight of these courier services.

3) Multiple routes to FDA facilities each weekday, as tasked.

4) Expedited delivery services of FDA materials within the specified timeframes.

5) All documents shall be picked up and delivered on the same day.

6) No documents shall be retained by the courier overnight.

7) Back- up courier/driver services.

8) Distributing mail and stored files between off-site and on-site locations.

9) Adhere to the government’s local courier route appendix.

The contractor shall develop an oversight plan and provide a monthly courier log report, i.e., excel spreadsheet, to the COR/PM. The plan shall include backup courier services, if the primary courier is not available, and a method to track and ensure that all locations are serviced each day. The courier shall wear their FDA security badge at all times. The COR/PM shall be notified via email in a timely manner (no later than the next business day) if any service cannot be performed as scheduled.

Deliverable(s):

Monthly Performance Report, and other deliverables that may be specified in each individual task order.

6.6 Task Area 6: Program Management Services

6.6.1 Program Management Activities

The contractor shall provide program and project management services.

Standard:

The contractor shall provide program management activities as follows:

1) Within thirty (30) days of contract award, provide to the COR/PM a project management plan (PMP) to manage cost, schedule, and quality of services (i.e., latest ISSO-9000 ISO-9000/9001;

CMMI CMMI; PMI/PMBOK PMI/PMBOK best practices) for all tasks and deliverables to meet the contract objectives.

2) Address FDA operational shutdowns or emergency situations and be available (on-site or cell phone) 24 hours/7 days/week, as required. Note: These hours are inclusive of the estimated number of hours stated in the task order pricing table.

3) Provide all management services required to plan, staff, coordinate, schedule, manage, communicate, report, and steward all tasks, activities, and deliverables for the contract throughout the period of performance in accordance with all the task areas as follows:

a) Case Management Process Activities (Inclusive of SOP Services)

b) System & Management Support Program

c) Document Delivery (Local Courier Services)

d) Date Entry Quality Assurance Program

e) MedDRA Coding Quality Assurance Program

f) Training Program

g) Support of Updated Software for Greater Program Efficiencies

4) Provide monthly performance reports in the below task areas, to include, at a minimum, the performance activities that may be specified in each individual task order as follows:

a) Task Area 4: Systems & Management Support

b) Task Area 5: Document Delivery (Local Courier Services)

c) Task Area 6: Program Management Services

d) Task Area 7: Data Quality Assurance and Training

e) Task Area 8: Support of FAERS DMP Program Enhancements and Efficiencies

f) 7.0 Meetings

6.6.2 Weekly Summary Report of Case Processing Activities

In accordance with the above Task Area 3, Case Processing Management, the contractor shall provide a Weekly Summary Report of Case Processing Activities as defined by the COR/PM.

The contractor shall run reports in the FLARe and LSMV systems and contain a collection of detailed metrics and counts outlining the reports received, those that are in-process, and those that were completed per week. The report shows the different report types and includes the days it took to process each type.

Note: These metrics are used by the contractor and FDA for monitoring staff productivity, planning, resource allocation, continuous process/quality improvement, and contractor performance against contract objectives. These metrics contain historical numerical report counts to help predict monthly and yearly reporting trends.

Deliverable(s):

PMP; Updates to the PMP; Monthly Performance Report; Weekly Summary Report of Case Processing Activities, and other deliverables that may be specified in each individual task order.

6.7 Task Area 7: Data Quality Assurance and Training

6.7.1 Data Entry and MedDRA Coding Quality Assurance

Requirement:

Within thirty (30) calendar days of contract award, the contractor shall provide a Data Entry and MedDRA Coding Quality Assurance Plan to monitor data quality of the ICSRs. The plan shall include these sections and the contractor shall perform these services according to the plan as follows:

1) Gather data entry and coding errors by running FAERS reports, and front-end queries designed for this purpose.

2) Collect feedback from the FDA on data quality issues and correct them.

3) Collect feedback from the FDA Quarterly Data Extract (QDE) Quality Control Group that verifies the ICSR data quality and publishes FAERS data to the public.

4) Collect feedback from FDA MedDRA Dictionary Team any issues noted with MedDRA coding.

5) Document in a Data Quality Report:

i. The data entry and coding errors collected

ii. Any correlation among the errors

iii. Any trends among the errors

iv. Corrective and preventive action taken to address the data entry or coding errors

6) Deliver the Data Quality Report to the COR/PM at the monthly meetings and discuss with the FDA the findings and outcome.

7) Contractor host weekly data quality meetings with the contractor’s staff to go over trends in data entry and coding errors to assist with improving the accuracy of data.

8) Ensure that all new FAERS DMP contractor employees are initially trained and verified by the contractor on a pre-production system before starting to process reports on the production system.

9) Receive feedback from the FDA MedDRA Dictionary Team on updates and changes in the MedDRA coding standard. The contractor shall acknowledge the FDA feedback, train their staff, and update the SOPs, if necessary.

10) Ensure that the scanned reports are available and complete when viewed in the database as per the SOP.

6.7.2 Training

The contractor shall conduct ongoing comprehensive training for all newly hired and existing contractor employees to ensure that all contractor employees are performing their assigned duties in accordance with the SOPs. Additionally, the contractor shall provide a virtual tour of the entire case management process (See Paragraph 6.7.2.2).

6.7.2.1 Training Plan

Within thirty (30) calendar days after contract award; and updated as needed. The training plan shall consist of data entry, product/manufacturer coding, MedDRA coding training procedures, including their proficiency standards, which is subject to the approval by the COR/PM.

The training plan shall also include the following:

a. Evaluation of Competency for Subject Matter Expert (Medical) II, III and IV (MedDRA Coders)

The contractor shall develop a qualification for new or existing contractor employees to document the progress of MedDRA coding. The contractor shall double check all MedDRA coding performed during the training period. A MedDRA coder shall be considered qualified only if, in addition to the training requirements for all employees, the employee:

1) Passes a written test developed by the contractor based on the training performed.

2) Performs accurately on a simulation test of actual coding.

b. Training Progress Reporting

The contractor shall provide a training progress report within the monthly performance report indicating that the contractor employees have successfully completed the training, along with the training completion date, and are ready to work in the FAERS production environment. The contractor shall maintain a record of the training test results and produce the results if requested by the COR/PM.

c. On-going Maintenance of Competency

The contractor shall perform on-going assessments of competency for triaging, data entry, product/manufacturer coding, and MedDRA Coding personnel. The contractor shall conduct proficiency maintenance training based on:

1. Triaging and data entry errors derived from FAERS reports and front-end queries

2. Feedback from the FDA FAERS data quality workgroup and users

3. Feedback from the FDA Quarterly Data Extract quality control group

4. Feedback from the FDA Dictionary Team on coding errors

6.7.2.1.1 Conduct of Training

The contractor shall use the SOPs and more in-depth User Training Guides to assist new employees in understanding individual field level job activities. The contractor shall provide orientation to new employees on the different reporting forms, such as: MedWatch 3500, 3500A and 3500B, Field Alert Report, and the Biologic Product Deviation Report.

The contractor shall conduct training in the FAERS pre-production environment, which is a copy of the production environment.

Deliverables:

Data Entry and MedDRA Coding Quality Assurance Plan; Data Quality Report; Training Plan;

Training Progress Reporting in the Monthly Performance Report, and other deliverables that may be specified in each individual task order.

6.8 Task Area 8: Support of FAERS DMP Program Enhancements and Efficiencies

The contractor shall understand that the FDA is constantly trying to improve the process of data entry, which includes enhancements to the FAERS software system, and analyzing and evaluating contractor workload needs.

Requirement:

The contractor shall be part of this change management process that supports enhancements to the FAERS software system, by performing User Acceptance Testing (UAT). The contractor shall perform comparative economic analysis of how different scenarios will affect the contractor workload, DMP labor and costs, and performance guidelines as stated above in Section 6.3

Task Area 3: Case Processing Management.

Comparative Economic Analysis Factors Include:

Personnel Resource Management (Labor)

Data Quality Management (Quality)

Contract Costs (Labor Hours)

The contractor shall be involved in requirements gathering and User Acceptance Testing (UAT) of any software and/or processes including creating and analyzing data sets. The contractor shall communicate UAT script execution results to the designated FDA POC and report these activities in the monthly performance report.

Deliverable(s):

UAT script execution results in the Monthly Performance Report; FAERS Change and Enhancement Request(s) reviewed and cleared by the DMP contractor; Documents Generated from the Comparative Economic Analysis, and other deliverables that may be specified in each individual task order.

Meetings

Requirement:

The contractor shall actively participate in all FAERS DMP related meetings such as technical and business-related meetings, such as: government-led discussions, participation in discussions, contributing questions and answers, raising issues, risks, and concerns, developing, and giving presentation, to include providing input, as necessary.

Standard:

7.1 Meeting Agenda

The contractor shall prepare meeting agendas, to include any meeting notes, issues, risks, and action items; and submit them via email to the COR/PM at least two (2) business days prior to the meeting.

7.2 Meeting Notes

The contractor shall take formal meeting notes at all meetings described below. No later than two (2) business days after the meeting, the contractor shall submit via email to the COR/PM, detailing the discussion, and listing any risks, actions, and/or issues identified during the meeting. Each risk, action, and issue shall have an owner and a target date for decision, resolution, or mitigation strategy. The meeting notes shall also identify any decisions that need to be made as a result of the meeting and who has to make the decision.

7.3 Ad-Hoc Meetings

The contractor may be required to participate in ad-hoc meetings remotely, as needed, to discuss and resolve any contract and/or technical issues upon written notice by the COR/PM.

7.4 Monthly Status and Review Meetings

The contractor shall participate in monthly status and review meetings to go over the invoice, budget, and quality metrics.

7.5 Program Review Meetings

The contractor shall conduct a formal program review meeting every six months either on-site at the FDA White Oak facility in Silver Spring, MD, and/or remotely at the discretion of the COR/PM, to brief key stakeholders and FDA leadership of accomplishments and trends. Local or out of state travel is not authorized under this contract.

Deliverables:

Meeting Agenda; Meeting Notes (Including Ad-hoc Meetings); Monthly Status and Review Meetings in the Monthly Performance Report; Program Review Meetings, and other deliverables that may be specified in each individual task order.

8.0 FDA DMP Tour Activities

Requirement:

In support of the FDA’s Staff Orientation, at the direction of the FDA, the contractor shall conduct a virtual tour, on a monthly basis, if required. The contractor shall also update the content of the tour information, as required.

Standard:

The virtual tour shall consist of the following:

PowerPoint Slide Presentation

Audio/Video Tour Presentations

Question and Answer Session

Deliverables:

PowerPoint Slides; Audio/Video Presentation, and other deliverables that may be specified in each individual task order.

9.0 FDA Mandated Contractor Training

Requirement:

The contractor shall complete all required contractor employee training, to include FDA-mandated contractor training courses, for example: FDA Records Management Training, Computer Security Awareness Training, IT Security Recertification, and Emergency Preparedness Training and other newly mandated training as required by the FDA within ten (10) business after training notification.

Standard:

All contractor employees shall upload all training certificates into the FDA/CDER/OSE/RSS Training Tracker app. The contractor PM shall provide to the COR/PM a training completion report via email within five (5) business days before the required FDA Training deadline. The report shall consist of all active contractor employee’s names per the Roster, name of the training and the training certificate upload date. COR/PM will provide the link to the app upon contract award.

Deliverables:

Contract Roster; Training Completion Report, and other deliverables that may be specified in each individual task order.

10.0 Government Furnished Property (GFP)/Government Furnished Equipment (GFE)/Government Furnished Information (GFI)

Requirement:

The FDA may provide GFP/GFE such as laptops and the associated PIV card badges, scanning equipment, fax machines, security badges, computer monitors, FDA adverse event reports, SOPs/Work Guides, and courier route diagram for the performance of work under this contract/task order.

Laptops shall not be used for any other work outside this contract/task order. All documents produced by the contractor shall be owned by the government and shall not be copyrighted by the contractor. The contractor’s company name shall not appear on any documents that are produced for the government.

Contractor employees shall identify themselves as “contractor” on all oral and written correspondence.

All software used on the project shall be owned by the government.

Standard:

The Contractor shall be responsible for safeguarding all GFP/GFE/GFI provided for Contractor use. At the close of each work period, FDA facilities, equipment, and materials shall be secured. The Contractor shall take all necessary action needed to protect the GFP/GFE/GFI against catastrophic events such as major or unusual weather conditions.

Within 90 days prior to the completion date of the final task order under…