Access to Food and Cosmetic Product and Packaging Databases

The scope of this contract is to acquire the full range of technical, management and support services necessary to obtain and maintain access to US food and cosmetic products.

The contract is divided into the following task areas:

• Project Management
• Data Access
• Data Collection
• Training Support

6.1 Technical Requirements

6.1.1 Datasets

The processed food and cosmetic products and their package data (as well as menu data) shall be from a currently existing, commercially available database(s) that shall provide immediate automated access.  The data shall include products from all regions of the US (Appendix B indicates the US Census regions) and be accurate, quality-assured, and easily-validated; well organized; stored as relationally searchable information for trend and other analyses; and fully exportable.  The database(s) shall be regularly updated and maintained in a current state throughout the base and option periods. 

Information will be required for the following product types:

1. Processed, and retail food products (e.g. foods, infant formula, etc.; minimum 400,000 products that are selling on the market in the contract year) and thus, over 2 million historical products;
2. (Optional) Restaurant food products/menu items (minimum 50,000 products from top chains)
3. Dietary supplements (minimum 100,000 products); shall be categorized according to the definition in Appendix A
4. Cosmetics (minimum 300,000 products)

The following attributes (as shown on the package) shall be required:

• Package images (legible images of all surfaces (e.g. sides, top, bottom) of product packaging, including internal and external packaging
• Count of available images per product
• Information contained on and in product packaging – shall include the following at minimum (each data entry line in the database must be quality assured and -controlled (QA/QC’d) for accuracy as the database is populated)
  • GTIN/UPC/Barcode
  • Nutrition Facts label, including single and dual columns and including multi-packs (shall be displayed in format according to 21 CFR 101.9) and Supplement Facts label (shall be displayed in format according to 21 CFR 101.36(e)(10) (i), (ii), (iii), and (iv))
  • Additional nutrients presenting on package labels
  • Indication of added sugars
  • Ingredients list (e.g. food additives, active ingredients for dietary supplements)
  • Allergen labeling information (Contains/may contain) and advisory statements
  • Pack size and weight
  • Number of servings per package
  • Brand
  • Manufacturer
  • Location of manufacturer, packer, or distributor
  • Written and/or pictorial statements signaling the presence of one or more allergens (according to the Food Allergen Labeling and Consumer Protection Act (FALCPA) of 2004; e.g. “Contains”) and/or caution statements about the product (e.g. “warning statements”)
  • Insignificant amounts for certain nutrients
  • Claims on package (e.g., regulated, health, nutrition, efficacy, marketing, and all other types) including indication of “healthy” on package
  • Statements/icons/signages and similar information that features the nutrition, health, organoleptic, processing, suggested usages (e.g., recipes), and other properties of the product (e.g., written and/or pictorial statements that feature nutrient content claim languages, front-of-pack language/icons)
  • Certifications on package
  • GE/Bioengineered/GMO language on package
  • Verbatim language of all text (e.g. product description, instructions, etc.) and icons from product packaging
• Product source where collected
• Product category
• Dates of when product information is a) released to the market and on shelf, b) collected, c) published, d) updated, and e) discontinued
• Indication of “previous” or “new” nutrition facts label
• FNDDS 8-digit and 7-digit food codes; SR 5-digit sub codes (8-digit food code shall be linked to food products and ingredients;7-digit food codes are mapped to 8-digit at the product level; 5-digit SR sub codes are mapped to 8-digit food codes at the ingredient level) through 2019
• GSFA (General Standard for Food Additives) categories through 2019
• Food packaging types (primary and secondary) and codes
• Food content type

Moreover, the data shall provide additional valid and verifiable information on the product ingredients; at a minimum, the data shall provide all available synonym name(s), allergen status, and technical or functional effect descriptors in a usable format.  Additionally, FDA shall have access to other Mintel products, such as Mintel Leap, Mintel Food & Drink, Mintel Reports, Mintel Trends, Comperemedia Direct, Market Dynamics, and Global Consumer Research.

6.1.2 Product Requirements

Overarching product requirements:

• Unlimited access for up to 200 FDA personnel;
• Located external to FDA network (access via weblink);
• Universal access from any FDA computer hardware (desktops, laptops with docking stations and/or scientific workstations) using internet browsers compatible with FDA current standards;
• Product access shall not be restricted according to product price;
• Capability to perform relational searching and analyses of the food and cosmetic product labeling and packaging datasets and menu datasets in functional environments using appropriate methodologies, which shall be valid, reliable, and robust;
• Ability to support 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;
• High resolution, readable images for all sides of the package labels (and optionally, menu images) for validation and other research purposes. Images shall be displayed with product data from all sides of the package so that information may be easily verifiable by the user.
• Accurate data reflective of verbatim language and icons of product labels (and menus).
• Verification that products are still being sold in the US marketplace.
• Users shall be able to analyze and summarize their searches into summary reports and all available data and search results and outputs shall be downloadable and exportable within an accepted timeframe into Microsoft Excel Spreadsheets and Access Data Base Software, SAS Business Analytics Software, and other common formats.
• Regular, updated, extracted bulk/batch raw data of the full dataset shall be available by API and in MS Excel compatible format (e.g. single pipe delimited txt, csv) and shall be accessible in a secure FTP or cloud service acceptable by FDA.
• In addition to the product label (and menu) database(s), all sales data, other accompanying databases, and market research reports, when available, shall be provided. This information shall apply to food, dietary supplement, restaurant, and cosmetic products when available
• Data and UI status updates shall be posted on the system website main page and identified users shall be notified via email
• System usage statistics (including statistics regarding individual login usage and length of time logged in) shall be available in monthly reports and upon request
• All data and files shall undergo quality control checks prior to accessibility/delivery to FDA.
• Documentation on quality control procedures shall be provided (at the onset and with any changes over time) for all data and image collection and data processes (e.g. ingestion of data, quality assurance of data in different formats, etc.) as noted below.

Web Interface

A user-friendly and data comprehensive interface that is transparent and flexible and allows both predefined (i.e., canned) and custom reports shall be provided. The user should be able to conduct a multi-variable search (i.e. searching a combination of factors concurrently). The user should be able to search and filter according to product category, year, product name, UPC, brand, company, claims, ingredients, allergens, other product attributes, and user-entered keywords in any and all fields.

Raw Data Files

Raw files (e.g. MS Excel compatible, single pipe-delimited txt, csv) for all data (food, supplements, cosmetics, etc.) shall be delivered a minimum of quarterly as defined by FDA or downable without file size restriction.  The file sizes should be appropriate so that they can be opened and readily used.  Files shall be accessible in a secure FTP or cloud service acceptable by FDA and organized based on FDA specifications. All files shall also be available by API with fields as specified by FDA.

The database(s) shall be scientific based on FDA’s definition: able to verify the data entry line(s) via product images, and the product’s contents may be analyzed, if the user chooses to have the item purchased and analyzed, to verify the accuracy/truthfulness of the product label, the offeror(s) shall provide this as a purchasable service.  

System maintenance during the base and all option periods, if exercised, shall be provided.  Maintenance shall include upgrades and updates to the software and data, continued use of and access to the database system and data, and updates to technical and analytical documentation.

6.1.3 Documentation

The Contractor shall compile and submit full documentation to the Contracting Officer Representative (COR) and Project Officer (PO) within 14 days of the beginning of the contract as well as any updated documentation through the contract years. After approval by the COR, all documentation shall be available to access online in the database(s) system with downloadable format into MS Word.  The Contractor shall provide documentation on the following:

• All data collection and acquisition processes so that the source data is clearly understood
• Documentation on the status of all products found in the databases relative to what is selling on the market each year of the contract (e.g., is the product verified as being available in retail for purchase and/or is it discontinued).
• The methodologies used for any data cleaning and ingestion processes and those used to develop the data as well as information on pertinent software used as part of the process
• Data dictionary and a code book defining all data elements/fields that are included in the data package, which includes information on how calculations are performed relative to certain data fields
• Documentation on the process of standardizing and cleaning data from different sources as well as information on UPCs that are duplicated (e.g. historical vs, duplicated)
• Any related technical specifications on the technologies or software that is used
• Information on how to access and use the data in all formats
• Written methodology regarding quality control procedures for all data and images collected, ingested into a database, exported, and categorized, including information on the oversight of quality control to ensure above 98% accuracy
• Interface documentation and user guides
• Any updates to general processes, methodologies, data sources, QC processes,
• Documentation on limitations of database, errors in the database, and plans for mitigation and/or resolution of issues
• Full-disclosure

6.1.4 Support / Training

A. Support: Ongoing technical and analytical support by phone or by e-mail shall be provided to all certified users of the data during business hours (9:00 a.m. to 5:00 p.m. Eastern Time) throughout the period of performance (POP) in accordance with the service levels established in the contract. The Contractor shall notify the COR regarding any issues as they relate to Acceptable Quality Level (AQL) standards. All technical related issues would need to be addressed and resolved in 5 business days or within a reasonable timeframe agreement upon with COR and TCOR.

B. Training: The Contractor shall provide up to two (2) one-day training sessions per year (on-site or via web-based methods).  This training can be divided into shorter time periods. Additional options for additional “on-demand” sessions either in person or via web-based methods shall be made available under the IDIQ portion of the award.

6.1.5 Data Disclosure Clearance

As part of its regulatory activities, FDA shall, at times, require disclosure of scientific and technical articles, study results, presentations, public health advisories, and similar works involving aggregated data to entities outside the Agency including the general public.  For activities that require disclosure of aggregated data the Contractor shall accept and adhere to the FDA Data Disclosure Clearance Procedures and form found in Appendices D.

The FDA shall continue to require the ability to release aggregated data through the FDA Data Disclosure Clearance process for data obtained during the contract period for the period of all Option Periods.   The FDA will require the services of processing clearance requests.

As part of its regulatory activities, FDA shall, at times engage in collaborative research projects with third parties outside of FDA for specific research projects of public health importance that are initiated by and for the benefit of FDA. These collaborations shall require FDA to have the ability to share project specific aggregated or raw data with third parties for collaborative research projects. For these collaborations that require sharing of aggregated or raw data, the Contractor shall accept and adhere to the Data Disclosure Clearance Procedures and form to be found in Appendices D.  These Procedures include terms and conditions for third party collaborations.

6.2 Project Management

The Contractor shall be responsible for creating, managing and updating project plans, schedules and managing resources for the project. 

6.2.1 Quality Control

The Contractor shall ensure that quality control procedures are conducted prior to providing FDA access to data. The Contractor shall provide written methodology on quality control procedures for all data and images collected, ingested into a database, exported, and categorized, including information on the oversight of quality control to ensure above 98% accuracy. The Contractor shall notify the COR should any issues with the data be noticed and shall flag it in the interface. Should FDA notice issues with the data, the Contractor shall address and fix the issues immediately within an agreed upon timeframe with the COR.  

6.2.2 Reporting

The Contractor shall provide a brief work plan outlining the strategy for supporting each of the areas outlined in Section 4 of the SOW to the COR within 10 days of award.   Each month the Contractor shall provide a status report giving brief descriptions of activities performed. The monthly status report shall, at minimum, contain the following: usage statistics for databases and other resources; usage statistics of technical support feature by FDA staff; technical issues reported by FDA staff; other technical issues (ex. log of times when database(s)/resources were inaccessible), data ingestion success and failure rates with mitigation plans should issues be present. 

The Contractor shall conduct yearly face-to-face presentation meetings with the COR and other FDA staff as well as deliver final written progress reports about contract performance for the preceding period of performance.  The Contractor shall submit to the COR a final report which documents and summarizes the results of the contract work 10 days prior to the end of each period of performance.  The final report shall include tables, graphs, diagrams, curves, sketches, photographs and drawings as necessary and in sufficient detail to comprehensively explain the results achieved under this contract.

6.3 Contract Services Requirements

The Contractor shall perform the following types of tasks as needed:

• Contractor shall collect information for selected products. The list of products and data fields to be collected shall be defined by the COR.
• Contractor shall conduct search(es) for products using search criteria defined by the COR.
• The option shall be available to purchase identified products.
• Contractor shall conduct exports for products using search criteria defined by the COR as needed.

Please view the attached Request for Quote (RFQ) RFQ_FDA-SOL-75F40126Q00341 document for additional information.