RFQ_FDA-SOL-75F40126Q00341.pdf

REQUEST FOR QUOTE

Access to Food and Cosmetic Product and Packaging Databases

FDA-SOL-75F40126Q00341

This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Federal Acquisition Regulation (FAR) 12.6 and 13.1 as supplemented with additional information in this notice. Quotes are being requested, and this announcement constitutes the only solicitation. It is the Government’s intent to issue a firm fixed-price purchase order resulting from this solicitation. The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 2026-01, effective 13 March 2026. FAR and HHSAR provisions and clauses referenced in this RFQ can be found on the following website:

https://www.acquisition.gov/browse/index/far .

The solicitation number is FDA-SOL-75F40126Q00341.The associated North American

Industrial Classification System (NAICS) code for this procurement is 518210 – Computing

Infrastructure Providers, Data Processing, Web Hosting, and Related Services, with an associated size standard of $40.0 million. This requirement is being issued as a total Other Than Full and

Open Competition.

The Government is in no way obligated to make an award, nor to pay any costs incurred by the

Contractor in preparing and submitting its quote.

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

1. PURPOSE

The purpose of the contract is to meet the US Food and Drug Administration and Human Foods

Program’s business objectives, constraints, applicable scope and task areas and acquire the full range of technical, management and support services necessary to develop and maintain access to food and cosmetic product and packaging databases.

2. BACKGROUND

The US Food and Drug Administration (FDA) has a continuing need for current (e.g. available now for sale in retail and food establishments) and historical, cost effective, and accurate data on the exposure of consumers to food products and the information about those food products, including processed food products sold in stores and menu items sold in foodservice establishments that are either manufactured for sale or imported for sale into the United States

(US) marketplace and presumed consumed by the US population. Any food other than a raw agricultural commodity, dietary supplements, infant formula, bottled water, chewing gum, and pet https://www.acquisition.gov/browse/index/far food are examples of food items included in the definition of processed foods. Entrees, side dishes, desserts, and beverages offered by restaurants are examples of menu items. Additionally, FDA has a continuing need for current and historical, cost effective, and accurate data on the exposure of consumers to food and color chemicals/ingredients/additives, generally recognized as safe

(GRAS) substances and food allergens in processed food products; to color additives and other substances in cosmetic products; and to processed food and cosmetic packaging sold in US retail stores, online as mail order or door-to-door and presumed consumed by the US population.

FDA needs to continue to gather such data to have a complete and comprehensive knowledge of these products, their ingredients, and the exact wording used on labels and packaging and on menus at food service establishments in order to better assess how they may affect human exposure as part of the agency’s ongoing mission to promote and protect public health. FDA has devoted considerable resources to continuously monitor the safety of food and food ingredients, dietary supplements, infant formula, and cosmetics. FDA has determined that the most effective means to advance the agency’s objectives is to obtain accurate, quality-assured, easily validated, past and currently existing, commercially available product, packaging and menu information, including high resolution viewable product images from all surfaces (all sides and bottom) and/or menu images. These data, information, and images shall be available in various ways depending on the dataset:

1) in a well-organized, standardized, searchable interfaces that includes images and that allow reliable data exports

2) as comprehensive “raw” files (e.g. txt, csv, mdb, etc.) with specified fields/variables determined by FDA (including image links when possible) that include all categories of foods in the US market

3) as API’s (that includes historical data)

4) as newly collected processed food and cosmetic product information and images as specified by FDA

3. OBJECTIVES

FDA is seeking to purchase a license, providing unlimited access for up-to-200 users to a robust, valid and reliable database or databases containing information on processed food and cosmetic products sold in the United States (U.S.) marketplace as well as menu items sold in foodservice establishments. To meet FDA’s research mission and for the purpose of this acquisition, these multiple, interlinked, compatible databases shall be accurate, comprehensive, representing regionally and nationally, processed food and cosmetic products manufactured or imported for sale in the United States (US) retail market for both stores and food service establishments. The database(s) shall contain current and historical data for products from the 1990s-to-the-present that are valid, verified, and re-verifiable and shall represent greater than 80% of each of processed food and cosmetic products sold in the current US marketplace (for each year of the contract such that

2020 data would represent greater than 80%, etc.). Additionally, the database shall contain menu, nutrition, and allergen data when possible for US restaurant food products from 2010-to-the-present that are valid, verified, and re-verifiable representing at least the top 100 national food chains when available.

However, for the purpose of this acquisition these databases are not expected to be wholly-complete, meaning containing absolutely all products ever manufactured or imported for sale in the US since the 1990s to-the-present. These interlinked databases may have some commonality

(general overlap in the products or product lines they each contain); however, these databases, for the most part, shall be divergent, representing unique niches or regional areas of the U.S.

marketplace rather than containing identical or largely duplicative information. The user shall have the capability to perform relational searching and analyses of the product datasets using appropriate methodologies, which shall be valid, reliable, and robust. Also, FDA will require services in which specified products are procured and/or product information collected on an as needed basis.

4. SCOPE

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

5. SUPPLIES / SERVICES

SOFTWARE AND/OR DATA

CLIN Task Description Qty. Unit Unit Price Price

0001 6.1.1 Gladson (Syndigo) license - Food segment

1 12 Months $ $

0002 6.1.1 Gladson (Syndigo) license - Cosmetics segment

1 12 Months $ $

0003 6.1.1 Gladson (Syndigo) - Coding images annual delivery

1 12 Months $ $

0004 6.1.1 Gladson (Syndigo) data integration into multi-tenant system

1 12 Months $ $

0005 6.1.1 Mintel License -GNPD (including Premium Cosmetic products), Food&Drink

1 12 Months $ $

0006 6.1.1 Mintel License - Cosmetic Market resources

1 12 Months $ $

0007 6.1.1 Mintel data integration into multi-tenant system

1 12 Months $ $

0008 6.1.1 NeilsonIQ data license 1 12 Months $ $

0009 6.1.1 NeilsonIQ-Mintel-Gladson mult-tenant system license

1 12 Months $ $

0010 6.1.1 NeilsonIQ - Enhancements to data 1 12 Months $ $

LABOR

CLIN Task Description Qty. Unit Unit Price Price

0011 6.1.2 Maintenance:

Upgrades/Modifications to databases

1 12 Months $ $

0012 6.1.3 Maintenance:

Upgrades/Modifications to documentation

1 12 Months $ $

0013 6.2.2 Monthly Status Reports 12 12 Months $ $

0014 6.1.4 Ongoing technical and analytical support by phone or email

1 12 Months $ $

0015 6.1.4 Training for FDA scientists 2 12 Months $ $

0016 6.2.2 Yearly face-to-face meeting and final progress report

1 12 Months $ $

TOTAL $

6. SPECIFIC TASKS

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) o GTIN/UPC/Barcode o 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)) o Additional nutrients presenting on package labels o Indication of added sugars o Ingredients list (e.g. food additives, active ingredients for dietary supplements) o Allergen labeling information (Contains/may contain) and advisory statements o Pack size and weight o Number of servings per package o Brand o Manufacturer o Location of manufacturer, packer, or distributor o 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”) o Insignificant amounts for certain nutrients o Claims on package (e.g., regulated, health, nutrition, efficacy, marketing, and all other types) including indication of “healthy” on package o 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) o Certifications on package o GE/Bioengineered/GMO language on package o 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.

7. DELIVERABLES

Task Deliverable Due Date

Access to all databases (6.1.1)

FDA staff are able to access all databases licensed under the contract

Within 14 days after award

Documentation

(6.1.3)

Documentation specified in section 6.1.3 made available to COR and online

Within 14 days after award

System

Maintenance

(6.1.2)

System maintenance shall include all upgrades and updates to software and data.

Ongoing

Support

(6.1.4/A)

Technical and analytical support available according to 6.1.4 /A

Ongoing

Training

(6.1.4/B)

Training for FDA staff 2 sessions

Monthly Reports

(6.2.2)

Monthly status reports on database systems, including any upgrades, modifications, issues, usage statistics

Ongoing

Yearly report and presentation

(6.2.2)

Yearly on-site presentation with COR and

FDA technical staff, as well as deliver final written progress report for preceding contract Performance Period.

Draft report due 15 days prior to end of POP; Presentation due 10 days prior to end of

POP

Deliverable format and timing shall be determined by the COR at the assignment of each task.

Deliverable options include incorporation of collected information into the database(s).

Criteria for Acceptance

FDA will review contractor deliverables in accordance with specifications and standards stated in the criteria stated above and in table below.

Acceptable Quality Level Standards

Standard Acceptable Quality

Level (AQL)

Method of Surveillance

Accuracy of information contained in datasets shall be maintained by Contractor.

Standard shall be met at

>95%.

COR and staff shall review and document.

Contractor shall notify COR and flag in UI regarding 1) circumstances impacting accessibility of data systems, or

2) circumstances resulting in loss or lack of data from data systems within one business day.

Standard shall be met at

100%.

COR and staff shall monitor dataset access and quality.

Contractor shall respond to support requests from FDA staff within one business day.

Standard shall be met at

>95%.

COR and staff shall monitor.

8. CONTRACT TYPE

This is a Firm-Fixed-Price Contract.

9. PERIOD OF PERFORMANCE

The anticipated period of performance for this order will consist of one 12-month period of performance running from 09/29/2026 – 09/28/2027.

10. PLACE OF PERFORMANCE

U.S. Food and Drug Administration

ATTN: (To be entered at time of award)

5001 Campus Drive

College Park, MD 20740

11. GOVERNMENT POINT OF CONTACTS

Contracting Officer:

(To be entered at time of award)

Contract Specialist:

Terina Hicks terina.hicks@fda.hhs.gov

Contracting Officer’s Representative:

(To be entered at time of award)

12. CONTRACTING OFFICER’S AUTHORITY

The Contracting Officer (CO) is the only person with authority to act as agent of the Government under this contract. Only the Contracting Officer has authority to: (1) direct or negotiate any changes in the RFQ; (2) modify or extend the period of performance; (3) change the delivery schedule; (4) authorize reimbursement to the Contractor any costs incurred during the performance of this contract; or (5) otherwise change any terms and conditions of this contract. No statement, whether oral or written, by anyone other than the Contracting Officer, shall be interpreted as modifying the terms and conditions of this award. It is the Contractor’s responsibility to contact the CO immediately if there is even the appearance of any technical direction that is or may be outside the scope of the award. The Government will not reimburse the Contractor for any work not authorized by the Contracting Officer, including work outside the scope of the award.

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

mailto:terina.hicks@fda.hhs.gov

13. IPP INVOICING REQUIREMENTS

FDA Electronic Invoicing and Payment Requirements - Invoice Processing Platform (IPP)

(Jan 2022)

(a) All Invoice submissions for goods and or services must be made electronically through the

U.S. Department of Treasury’s Invoice Processing Platform System (IPP).

http://www.ipp.gov/vendors/index.html

(b) Invoice Submission for Payment means any request for contract financing payment or invoice payment by the Contractor. To constitute a proper invoice, the payment request must comply with the requirements identified in in FAR 32.905(b), “Content of Invoices” and the applicable Payment clause included in this contract, or the clause 52.212-4 Contract Terms and

Conditions

– Commercial Items included in commercial items contracts. The IPP website address is:

https://www.ipp.gov.

(c) The Agency will enroll Contractors new to IPP. The Contractor must follow the instructions in the IPP registration email, to properly register the Collector Account for submitting invoice requests for payment by the FDA. The Contractor Government Business Point of Contact

(as listed in System for Award Management (SAM)) will receive a Registration email from the

Federal Reserve Bank of St. Louis (FRBSTL) within 3 to 5 business days of the contract award for new contracts or date of modification for existing contracts.

(1) Registration emails are sent via email from ipp.noreply@mail.eroc.twai.gov or phone

(866) 973-3131. Contractor assistance with enrollment can be obtained by contacting the IPP

Production Helpdesk via email to IPPCustomerSupport@fiscal.treasury.gov or phone (866) 973-

3131.

(2) The Contractor POC will receive two emails from IPP Customer Support, the first email contains the initial administrative IPP User ID. The second email, sent within 24 hours of receipt of the first email, contains a temporary password. You must log in with the temporary password within 30 days of receipt.

(3) If your company is already registered to use IPP, you will not be required to re-register.

(4) If the Contractors unable to comply with the requirement to use IPP for submitting invoices for payment as authorized by HHSAR 332.7002, a written request must be submitted to the

Contracting Officer to explain the circumstances that require the authorization of alternate payment procedures.

(d) Invoices that include time and materials, or labor hours Line Items must include supporting documentation to (1) substantiate the number of labor hours invoiced for each labor category, and

(2) substantiate material costs incurred (when applicable).

(e) Invoices that include cost-reimbursement Line Items must be submitted in a format showing expenditures for that month, as well as contract cumulative amounts.

(1) At a minimum the following cost information shall be included, in addition to supporting documentation to substantiate costs incurred.

- Direct Labor-include all persons, listing the person's name, title, number of hours worked, hourly rate, the total cost per person and a total amount for this category.

http://www.ipp.gov/vendors/index.html https://www.ipp.gov/ mailto:ipp.noreply@mail.eroc.twai.gov mailto:IPPCustomerSupport@fiscal.treasury.gov

- Indirect Costs (i.e., Fringe Benefits, Overhead, General and Administrative, Other)-show rate, base and total amount;

- Consultants (if applicable)-include the name, number of days or hours worked, daily or hourly rate, and a total amount per consultant.

- Travel-include for each airplane or train trip taken the name of the traveler, date of travel, destination, the transportation costs including ground transportation shown separately and the per diem costs. Other travel costs shall also be listed;

- Subcontractors (if applicable)-include, for each subcontractor, the same data as required for the Prime Contractor.

- Other Direct Costs-include a listing of all other direct charges to the contract, i.e., office supplies, telephone, duplication, postage; and-Fee–amount as allowable in accordance with the

Schedule and FAR52.216-8 if applicable.

(f) Contractor is required to attach an invoice log addendum to each invoice which shall include, at a minimum, the following information for contract administration and reconciliation purposes:

(1) list of all invoices submitted to date under the subject award, including the following:

- invoice number, amount, & date submitted

- corresponding payment amount & date received

- total amount of all payments received to date under the subject contractor order

- and, for definitized contracts or orders only, total estimated amounts yet to be invoiced for the current, active period of performance.

(g) Payment of invoices will be made based upon acceptance by the Government of the entire task or the tangible product deliverable(s) invoiced. Payments shall be based on the Government certifying that satisfactory services were provided, and the Contractor has certified that labor charges are accurate.

(h) If the services are rejected for failure to conform to the technical requirements of the task order, or any other contractually legitimate reason, the Contractor shall not be paid, or shall be paid an amount negotiated by the CO.

(i) Payment to the Contractor will not be made for temporary work stoppage due to circumstances beyond the control of U.S. Food and Drug Administration such as acts of God, inclement weather, power outages, and results thereof, or temporary closings of facilities at which

Contractor personnel are performing. This may, however, be justification for excusable delays.

(j) The Contractor agrees that the submission of an invoice to the Government for payment is a certification that the services for which the Government is being billed, have been delivered in accordance with the hours shown on the invoices, and the services are of the quality required for timely and successful completion of the effort.

(k) Questions regarding invoice payments that cannot be resolved by the IPP Helpdesk should be directed to the FDA Employee Resource and Information Center (ERIC) Helpdesk at 301-827-

ERIC (3742) or toll-free 866-807-ERIC (3742); or, by email at ERIC@fda.hhs.gov . Refer to the

Call-in menu options and follow the phone prompts to dial the option that corresponds to the service that's needed. All ERIC Service Now Tickets will either be responded to or resolved within

48 hours (2 business days) of being received. When emailing, please be sure to include the contract mailto:ERIC@fda.hhs.gov number, invoice number and date of invoice, as well as your name, phone number, and a detailed description of the issue. (End of Clause)

14. PAYMENT TERMS

Payment terms Net 30 days after government acceptance of the supply item/service. Payments shall not be made more frequently than monthly in arrears. Advance payments will not be made.

15. INSPECTION AND ACCEPTANCE

Inspection and acceptance will be performed at the delivery location. The Contracting Officer

Representative (COR) will perform inspection and acceptance of the materials delivered.

Acceptance is communicated in writing unless otherwise indicated by the COR within 30 days of receipt of the deliverable(s). If a rejection is issued, the Contractor shall correct any deficiencies within fifteen (15) days from the time the Government issues the rejection notice. If the Contractor cannot correct the deficiencies within this time frame, the contractor shall immediately notify the

COR of the reason for the delay and provide a proposed corrective action plan within three (3) business days.

16. SPECIAL CONTRACT REQUIREMENTS

Section 508 Compliance

The following standards are always required to be applied for contracts:

• Must meet WCAG 2.0 A and AA

• E101.2 Equivalent Facilitation (Appendix A, Application and Scoping Requirements)

• E203 Access to Functionality (Appendix A, Application and Scoping Requirements)

• E204 Functional Performance Criteria (Appendix A, Application and Scoping

Requirements)

• E205 Electronic Content (Appendix A, Application and Scoping Requirements)

• E208 Support Documentation and Services (Appendix A, Application and Scoping

Requirements)

• Chapter 6 Support Documentation and Services (Appendix C, Functional Performance

Criteria and Technical Requirements)

• 302 Functional Performance Criteria (Appendix C, Functional Performance Criteria and

Technical Requirements)

• Electronic content must be accessible to HHS acceptance criteria. Checklist for various formats are available at https://www.hhs.gov/web/section-508/accessibility-checklists/index.html, or from the Section 508 Coordinator listed at https://www.hhs.gov/web/section-508/additional-resources/section-508-contacts/index.html. Materials that are final items for delivery should be accompanied by the appropriate checklist, except upon approval of the Contracting Officer or

Representative

• E206 Hardware (Appendix A, Application and Scoping Requirements)

• E207 Software (Appendix A, Application and Scoping Requirements) https://www.hhs.gov/web/section-508/accessibility-checklists/index.html https://www.hhs.gov/web/section-508/accessibility-checklists/index.html https://www.hhs.gov/web/section-508/additional-resources/section-508-contacts/index.html https://www.hhs.gov/web/section-508/additional-resources/section-508-contacts/index.html

PROCEDURES:

These clearance procedures do not apply to disclosure of information, including of Limited Rights

Data and/or Aggregated Limited Rights Data, made in response to an authorized request of

Congress or any other government body of competent jurisdiction (see [section of primary agreement in which such disclosures are discussed] [Database System] (“Agreement”).

1. FDA and Contractor shall complete the Clearance Procedure Cover Sheet (Appendix D is a blank copy) upon execution of the Agreement. This form provides the names and contact information for individuals who shall serve as the primary contact (Contact) for each party. Each party must update the Cover Sheet any time any of its contact information or its Contact changes.

2. For each proposed disclosure, FDA shall submit a Clearance Request Form (Appendix E is a blank copy), a copy of the materials to be disclosed, and a copy of the source data files cited in those materials.

3. FDA shall identify Contractor as the data source when disclosing Aggregated Limited Rights

Data or Limited Rights Data.

4. Within 24 hours of receipt by the Contractor's Contact of the Clearance Request Form, Contractor shall provide a clearance decision for the requested Public Release of Aggregated

Limited Rights Data.

5. Within 48 hours of receipt by the Contractor's Contact of the Clearance Request Form, the

Contractor shall provide a clearance decision for disclosure of Limited Rights Data to a third party in accordance with the following conditions:

a. The third party must be actively engaged in a project initiated by FDA;

b. Clearance to share the data with the third party shall be granted only for purposes of the FDA initiated project and shall not extend beyond the duration of the third party's active engagement in that project;

c. The third party must execute in a timely manner the required Contractor Third Party Access agreement and agree in writing to return any copies of the data provided to, or made by, that party when the third party is no longer actively engaged in such project or at such earlier time as FDA may request in writing; and

d. The third party must agree in writing not to release the Limited Rights Data to any additional party.

6. If a third party that received Limited Rights Data in accordance with paragraph 5 seeks to disclose materials that include Aggregated Limited Rights Data, the third party must submit an electronic copy of those materials and of the source data files relied upon to FDA for submission to Contractor for clearance approval.

7. Clearance to use Limited Rights Data and/or Aggregated Limited Rights Data does not grant any third party rights to use the (Name of Contractor) (Contractor) [Database Systems] software tools.

TERM:

This policy shall be in effect for the calendar year for the length of the contract and thereafter until either party notifies the other of its termination or Contractor provides to the FDA a different policy.

Data Disclosure Forms (Third Party)

i. COVER SHEET

Date: __________ Contractor's Address: Client’s Address:

Food and Drug Administration

5100 Paint Branch Parkway

College Park, MD 20740

Contact Name: Contact Name:

Telephone: Telephone:

E-mail: E-mail:

17. FAR / HHSAR CLAUSES & PROVISIONS

FAR 52.252-2 – Clauses Incorporated by Reference (Feb 1998)

This purchase order incorporates one or more clauses by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. Also, the following FAR and HHSAR provisions and clauses, incorporated by reference, apply to this acquisition and can be obtained in full text at: https://www.acquisition.gov/far/ and http://www.hhs.gov/grants/contracts/contract-policies-regulations/hhsar/index.html

FAR Clauses:

52.203-19 Prohibition on Requiring Certain Internal Confidentiality Agreements or Statements

(Jan 2017)

52.204-13 System for Award Management - Maintenance (Apr 2026) (Deviation)

52.212-4 Terms and Conditions—Commercial Products and Commercial Services (Apr 2026)

(Deviation)

52-232-18 Availability of Funds (Apr 1984)

52.232-39 Unenforceability of Unauthorized Obligations (Jun 2013)

52.232-40 Providing Accelerated Payments to Small Business Subcontractors (Mar 2023)

FAR 52.222-54 Employment Eligibility Verification (Apr 2026) (Deviation)

(a) Definitions. As used in this clause-

Commercially available off-the-shelf (COTS) item— https://www.acquisition.gov/far/ http://www.hhs.gov/grants/contracts/contract-policies-regulations/hhsar/index.html

(1) Means any item of supply that is—

(i) A commercial product (as defined in paragraph (1) of the definition of “commercial product” at Federal Acquisition Regulation (FAR) 2.101);

(ii) Sold in substantial quantities in the commercial marketplace; and

(iii) Offered to the Government, without modification, in the same form in which it is sold in the commercial marketplace; and

(2) Does not include bulk cargo, as defined in 46 U.S.C. 40102(4), such as agricultural products and petroleum products. Per 46 CFR 525.1 (c)(2), "bulk cargo" means cargo that is loaded and carried in bulk onboard ship without mark or count, in a loose unpackaged form, having homogenous characteristics. Bulk cargo loaded into intermodal equipment, except LASH or

Seabee barges, is subject to mark and count and, therefore, ceases to be bulk cargo.

Employee assigned to the contract means an employee who was hired after November 6, 1986

(after November 27, 2009 in the Commonwealth of the Northern Mariana Islands), who is directly performing work, in the United States, under a contract that is required to include the clause prescribed at 22.1802-2. An employee is not considered to be directly performing work under a contract if the employee-

(1) Normally performs support work, such as indirect or overhead functions; and

(2) Does not perform any substantial duties applicable to the contract.

Subcontract means any contract, as defined in 2.101, entered into by a subcontractor to furnish supplies or services for performance of a prime contract or a subcontract. It includes but is not limited to purchase orders, and changes and modifications to purchase orders.

Subcontractor means any supplier, distributor, vendor, or firm that furnishes supplies or services to or for a prime Contractor or another subcontractor.

United States, as defined in 8 U.S.C. 1101(a)(38), means the 50 States, the District of Columbia, Puerto Rico, Guam, the Commonwealth of the Northern Mariana Islands, and the U.S. Virgin

Islands.

(b) Enrollment and verification requirements.(1) If the Contractor is not enrolled as a Federal

Contractor in E-Verify at time of contract award, the Contractor must-

(i) Enroll. Enroll as a Federal Contractor in the E-Verify program within 30 calendar days of contract award;

(ii) Verify all new employees. Within 90 calendar days of enrollment in the E-Verify program, begin to use E-Verify to initiate verification of employment eligibility of all new hires of the

Contractor, who are working in the United States, whether or not assigned to the contract, within

3 business days after the date of hire (but see paragraph (b)(3) of this section); and

(iii) Verify employees assigned to the contract. For each employee assigned to the contract, initiate verification within 90 calendar days after date of enrollment or within 30 calendar days of the employee’s assignment to the contract, whichever date is later (but see paragraph (b)(4) of this section).

(2) If the Contractor is enrolled as a Federal Contractor in E-Verify at time of contract award, the

Contractor must use E-Verify to initiate verification of employment eligibility of-

(i) All new employees.(A) Enrolled 90 calendar days or more. The Contractor must initiate verification of all new hires of the Contractor, who are working in the United States, whether or not assigned to the contract, within 3 business days after the date of hire (but see paragraph (b)(3) of this section); or

(B) Enrolled less than 90 calendar days. Within 90 calendar days after enrollment as a Federal

Contractor in E-Verify, the Contractor must initiate verification of all new hires of the Contractor, who are working in the United States, whether or not assigned to the contract, within 3 business days after the date of hire (but see paragraph (b)(3) of this section); or

(ii) Employees assigned to the contract. For each employee assigned to the contract, the Contractor must initiate verification within 90 calendar days after date of contract award or within 30 days after assignment to the contract, whichever date is later (but see paragraph (b)(4) of this section).

(3) If the Contractor is an institution of higher education (as defined at 20 U.S.C. 1001(a)); a State or local government or the government of a Federally recognized Indian tribe; or a surety performing under a takeover agreement entered into with a Federal agency pursuant to a performance bond, the Contractor may choose to verify only employees assigned to the contract, whether existing employees or new hires. The Contractor must follow the applicable verification requirements at (b)(1) or (b)(2) respectively, except that any requirement for verification of new employees applies only to new employees assigned to the contract.

(4) Option to verify employment eligibility of all employees. The Contractor may elect to verify all existing employees hired after November 6, 1986 (after November 27, 2009, in the

Commonwealth of the Northern Mariana Islands), rather than just those employees assigned to the contract. The Contractor must initiate verification for each existing employee working in the

United States who was hired after November 6, 1986 (after November 27, 2009, in the

Commonwealth of the Northern Mariana Islands), within 180 calendar days of-

(i) Enrollment in the E-Verify program; or

(ii) Notification to E-Verify Operations of the Contractor’s decision to exercise this option, using the contact information provided in the E-Verify program Memorandum of Understanding

(MOU).

(5) The Contractor must comply, for the period of performance of this contract, with the requirements of the E-Verify program MOU.

(i) The Department of Homeland Security (DHS) or the Social Security Administration (SSA) may terminate the Contractor’s MOU and deny access to the E-Verify system in accordance with the terms of the MOU. In such case, the Contractor will be referred to a suspending and debarring official.

(ii) During the period between termination of the MOU and a decision by the suspending and debarring official whether to suspend or debar, the Contractor is excused from its obligations under paragraph (b) of this clause. If the Contractor is not suspended, debarred, or subject to a voluntary exclusion, then the Contractor must reenroll in E-Verify.

(c) Web site. Information on registration for and use of the E-Verify program can be obtained via the Internet at the Department of Homeland Security Web site: https://www.e-Verify.gov.

(d) Individuals previously verified. The Contractor is not required by this clause to perform additional employment verification using E-Verify for any employee-

(1) Whose employment eligibility was previously verified by the Contractor through the E-Verify program;

(2) Who has been granted and holds an active U.S. Government security clearance for access to confidential, secret, or top secret information in accordance with the National Industrial Security

Program Operating Manual; or

(3) Who has undergone a completed background investigation and been issued credentials pursuant to Homeland Security Presidential Directive (HSPD)-12, Policy for a Common

Identification Standard for Federal Employees and Contractors.

(e) Subcontracts. The Contractor must include the requirements of this clause, including this paragraph (e) (appropriately modified for identification of the parties), in each subcontract that-https://www.e-verify.gov/

(1) Is for—(i) Services (except for commercial services that are part of the purchase of a COTS item (or an item that would be a COTS item, but for minor modifications), performed by the COTS provider, and are normally provided for that COTS item); or

(ii) Construction;

(2) Has a value of more than $3,500; and

(3) Includes work performed in the United States.

(End of clause)

This contract incorporates one or more HHSAR clauses by reference, with the same force and effect as if they were given in full text. The full text of the HHSAR clauses may be accessed electronically at this address: https://www.hhs.gov/grants-contracts/contracts/contract-policies-regulations/hhsar/index.html

HHSAR Clauses:

352.222-70 Contractor Cooperation in Equal Employment Opportunity…