Computerized Labeling Tool RFI
Computerized Labeling Review Tool: Request for Information
1.0 Purpose
This Request for Information (RFI) is being issued by the Food and Drug Administration (FDA) in accordance with Federal Acquisition Regulation Part 10, Market Research. It is for information, planning and market research purposes only and shall not be construed as either a solicitation or obligation on the part of the FDA or its Centers. The purpose of this RFI is to broaden FDA's understanding of the market's capability, either as solutions requiring potential development of a technology or existing commercially-available applications, to provide a Computerized Labeling Review Tool that uses computer programming and artificial intelligence technology to automate portions of the drug product labeling review process used by the Division of Medication Error Prevention and Analysis (DMEPA), in the Office of Surveillance and Epidemiology (OSE), CDER/FDA.
FDA will not award a contract based on responses nor otherwise pay for the preparation of any information submitted or FDA's use of such information. Responses to this notice are not offers and cannot be accepted by the Federal Government to form a binding contract. Information obtained because of this notice may be used by the FDA for program planning on a non-attribution basis.
Eligibility in participating in a future acquisition does not depend upon a response to this notice. Responses will be reviewed only by FDA personnel and will be held in a confidential manner.
Requests for a solicitation will not receive a response.
Notice to Small Businesses: One purpose of this RFI/Sources Sought Notice is to seek declarations of technical capabilities and various information, data, and materials from qualified small business concerns [including 8A Businesses, Small Disadvantaged Businesses (SDB), Woman-owned Small Businesses (WOSB), Historically Underutilized Business Zone (HUBZone), Small Businesses, Veteran-Owned Small Businesses (VOSB), and Service-Disabled Veteran-owned Small Businesses (SDVOSB)]. FDA intends to provide maximum practicable opportunities in its acquisitions to small business, veteran-owned small business, service-disabled veteran-owned small business, HUBZone small business, and small disadvantaged business.
2.0 Background
DMEPA is the scientific lead for medication error prevention and analysis for CDER-regulated drug products. DMEPA's responsibilities include premarket and postmarket reviews of drug product labeling (e.g., container labels, carton labeling, prescribing information, Medication Guides, and Instructions for Use) to minimize the risk of medication errors. An overview of DMEPA's missions and responsibilities can be found on the FDA website: https://www.fda.gov/drugs/drugsafety/medicationerrors/.
As part of the drug product labeling review process, DMEPA manually evaluates proposed drug product labeling submitted by applicants, sponsors, or manufacturers against applicable regulations, United States Pharmacopeia (USP) standards, FDA guidance for industry, best practices promoted by patient safety organizations, and experience gained through FDA's postmarket surveillance program for medication errors. This process helps to identify potential areas of the labeling that may contribute to medication errors, ensure drug products meet regulatory requirements, and standardize DMEPA labeling reviews across multiple types of drug products. If DMEPA's labeling review identifies potential deficiencies or inconsistences, then the drug product applicant, sponsor, or manufacturer is notified to consider revisions and resubmit the labeling.
Drug product labeling reviews are labor- and time-intensive; analysts are required to consider current regulations, standards, guidance, and best practices for medication error prevention; identify and evaluate potential look-alike features with marketed products; and track labeling revisions. Therefore, FDA anticipates the need to computerize the labeling review process, which will increase efficiency, and standardization and harmonization across multiple product types.
3.0 Technical Information
Drug product applicants, sponsors, and manufacturers submit proposed labeling (e.g., container labels, carton labeling, prescribing information, Medication Guides, and Instructions for Use) electronically to FDA using various file formats (e.g., Word, PDF, XML, JPEG). The submitted proposed labeling contains confidential and proprietary information. Following FDA approval of a drug product, the final (approved) labeling is available to the public on the FDA website (e.g., https://labels.fda.gov/), and the electronic labeling files can be downloaded from the National Library of Medicine's DailyMed website (https://dailymed.nlm.nih.gov/dailymed/index.cfm).
Applicable regulations, standards, guidances, and best practices for medication error prevention include: Code of Federal Regulations-Title 21 (available from: https://www.ecfr.gov/cgi-bin/text- idx?SID=3ee286332416f26a91d9e6d786a604ab&mc=true&tpl=/ecfrbrowse/Title21/21tab_02.tpl), USP labeling and packaging standards (available from https://www.uspnf.com/), FDA guidance for industry on medication error prevention (available from http://www.fda.gov/RegulatoryInformation/Guidances/default.htm), and best practices from patient safety organizations, including the Institute for Safe Medication Practices (available from: https://www.ismp.org/).
4.0 Information Requested
FDA anticipates the need to increase the efficiency, and standardization and harmonization of DMEPA's labeling reviews across multiple product types. One such need is a tool that incorporates computer programming and artificial intelligence to automate portions of DMEPA's manual labeling review process. DMEPA safety evaluators would apply the tool to proposed drug product labeling submitted to FDA by applicants, sponsors, and manufacturers. The tool would analyze the proposed labeling for error-prone abbreviations, look-alike labeling for currently marketed products, product strength differentiation, prominence of the product name, appropriate packaging, presence of a barcode and National Drug Code (NDC) number, and other features in accordance with applicable regulations, standards, FDA guidance for industry, and best practices promoted by patient safety organizations. The tool would also generate a report of the review findings, including identification of labeling areas that are acceptable, deficient or inconsistent, and uncertain (tool was unable to assess).
5.0 Anticipated High-Level Functionalities and Requirements
The FDA anticipates the need for a computerized labeling tool that is capable of computerizing DMEPA's manual review process to increase efficiency, and enhance standardization and harmonization across multiple drug product types as follows:
1. Allow the user to upload labeling submitted in various file formats, including Word, PDF, CSV, XML and JPEG or other image files.
2. Allow the user to name and organize submitted files in folders within the tool (e.g., folder named 'NDA 12345 Drug A' contains the submitted container labels, prescribing information, and carton labeling for Drug A).
3. Allow document check-in and check-out functionality, retain versions, and provide multiple users review and edit features of the labeling materials.
4. Allow the user to select one or more labeling materials for review (e.g., folder contains the container label, carton labeling, and prescribing information, but the user wants to select only the container label for review).
5. Allow the user to select the entire or specific section(s) of the prescribing information for review (e.g., the prescribing information contains 17 sections, but the user will review only sections 2 (DOSAGE AND ADMINISTRATION) and 16 (HOW SUPPLIED)).
6. Allow the user to apply the entire or portions of the tool (e.g., the user will apply only the portion of the tool related to the NDC number and barcode regulations).
7. Allow the user to generate a report of the labeling review findings in a file format that allows the user to copy and paste the findings into a separate Word or pdf document. The tool shall also highlight deficiencies or inconsistencies in the reviewed labeling (e.g., yellow-highlight error- prone abbreviations in the prescribing information that were identified by the tool).
8. Allow the user to upload revised labeling, perform an additional labeling, and generate a data comparison report that compares the revised labeling with the initial or previously submitted labeling.
9. Allow the use of computer programming, algorithms, and machine learning as needed to perform labeling reviews.
10. Incorporate revisions based on updates to regulations, standards, guidance, best practices, and experience gained through postmarketing surveillance for medication errors.
11. Identify look alike container labels or carton labeling from a repository of labeling.
12. Run from a cloud computing environment.
13. Provide robust security enable environment to protect proprietary and confidential information.
14. Enable with API capabilities to connect with other potential data sources for comparison.
6.0 RFI Submission Instructions
Responses should be submitted to Melanie Suris-Rodriguez, Contract Specialist, via email at Melanie.Suris-Rodriguez@fda.hhs.gov, and cc Tzeleong.chang@fda.hhs.gov. Please include the RFI number in the response. Do not send information that requires a non-disclosure agreement or sensitive business information. Telephone inquiries will not be accepted or acknowledged, and no feedback or evaluations will be provided to companies regarding their submissions. Appendix A below provides a use case that interested parties can consider when responding to this RFI. Interested companies must submit a Capability Statement limited to 10 pages that provides responses to the following requested information. Capability statements will not be returned and will not be accepted after the due date.
Note that FDA reserves the right to contact one or more of the respondents if additional information is required or to request demonstrations of available systems.
• RFI number: FDA-RFI-19-1208214
• RFI response date: February 13, 2019 by 3:00 pm
• Point of Contract email: Melanie Suris-Rodriguez
Interested parties to this RFI, please respond to all questions below.
1. Does your company have the capabilities to meet the "High-level Functionalities and Requirements" described above? If yes, explain. Your response should include a description of the tool to be developed or commercial application that currently exists, and whether your company is interested in demonstrating the capabilities to FDA.
2. Does your company have experience with artificial intelligence technology? If yes, explain. Include specific experience with image recognition and developing systems with machine learning capabilities.
3. Describe your company's approach for using best practices for software development. Include your company's use of agile methodology, certified project management professionals, and your Capability Maturity Model Level if applicable.
4. Does your company have experience in providing IT training and support services, including revisions and upgrades for a software application or tool in production, for a commercial industry or government? If yes, explain.
5. Does your company have expertise in user experience design to ensure the usability of the proposed tool and user satisfaction? If yes, explain.
6. Does your company have knowledge of FDA regulations and guidances, and United States Pharmacopeia (USP) standards that pertain to drug product labeling and medication errors or adverse events? If yes, please explain.
7. Is your company able to provide a technical overview and cost estimates for possible scaling of the tool that would have the capability of analyzing labeling simultaneously for large numbers of users?
8. Is the proposed tool capable of complying with Section 508 of the Rehabilitation Act? Please specify meet, partially meet or do not meet for each Section 508 standard. (i.e. E101.2 - Meet)
See link for Section 508 standards: https://www.access-board.gov/guidelines-and-standards/communications-and-it/about-the-ict-refresh/final-rule/text-of-the-standards-and-guidelines
9. Please provide the following business information:
• DUNS Number
• Company Name
• Company Address
• Company Point of Contact, phone number and email address
• Type of company under NAICS, as validated via the System for Award Management (SAM). Additional information on NAICS codes can be found at www.sba.gov. Any potential government contract must be registered on the SAM located at http://www.sam.gov/index.asp.
• Small Business Socioeconomic program, if applicable
• Corporate structure (corporation, LLC, sole proprietorship, partnership, limited liability partnership, professional corporation, etc.)
• Current GSA Schedules appropriate to this Sources Sought
• Current Government Wide Agency Contracts (GWACs)
• Point of Contact, phone number and email address of individuals who can verify the demonstrated capabilities identified in the response.
• Please provide a cost estimate in accordance with FAR Part 10 or a copy of your commercial price catalog as market research.
Appendix A. Use Case - Computerized Labeling Review Tool for Drug Product Reviews
A company submits a new drug application for an injectable drug product. The application includes the proposed prescribing information in both a Word file and XML file, and images of the proposed carton label and container labeling in a pdf file.
The DMEPA safety analyst downloads the files containing the proposed prescribing information and images of the container label and carton labeling. The analyst reviews the prescribing information and images against regulations, standards, guidance documents, postmarket medication error cases submitted to FAERS, and best practices to identify proposed content that may contribute to medication errors (e.g., error prone abbreviations, unclear preparation and dosing instructions, discordant product strength and units of measure, confusing packaging, lack of prominence for the product name, missing storage information, no differentiation for product strengths, missing or uninterpretable lot numbers, National Drug Code [NDC] numbers or linear barcodes). The analyst also compares the proposed container label and carton labeling against currently marketed products to avoid look alike labeling that may contribute to medication errors.
After reviewing the proposed prescribing information and images of the container label and carton labeling, the analyst lists the identified deficiencies and inconsistencies, and provides written recommendations to the company. The company then considers DMEPA's recommendations and submits revised labeling to address the deficiencies and inconsistencies. The analyst compares the revised labeling with the original or previously submitted labeling, reviews the revised labeling, and notifies the company if the revised labeling is acceptable or if additional revisions are needed.
DMEPA management periodically runs a report that lists identified labeling deficiencies or inconsistencies, analyst recommendations, and other metrics for the reporting period, and determines if revisions should be made to regulations, standards, guidance documents, or the labeling review process.
Melanie Suris-Rodriguez, Contract Specialist, Phone 2404027532, Email mela.suris-rodriguez@fda.hhs.gov - Steven Chang, Supervisory Contract Specialist, Email Tzeleong.Chang@fda.hhs.gov
