FDA-21-RFQ-1238432_Amendment1.pdf

FDA-21-RFQ-1238432 Page 1 of 40 Access to Food and Cosmetic Product & Packaging Database

Offeror Name DUNS

PART 1 – GENERAL INFORMATION

This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in 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. The Government contemplates issuing 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 FAC 2021-05 dated March 10, 2021.

The associated North American Industrial Classification System (NAICS) code for this procurement is 518210 – Data Processing, Hosting, and Related Services, with an associated size standard of $35.0 million. This requirement is being solicited as a total Small Business set-aside, in accordance with FAR 19.5.

PART 2 – SUPPLIES OR SERVICES AND PRICES/COSTS

Contract Type: This is a restricted procurement and the government anticipates awarding a single-award Indefinite Delivery, Indefinite Quantity (IDIQ) Contract with Firm-Fixed Price Delivery Orders resulting from this solicitation.

2.1 Pricing

Pricing: Base Year

CLIN Description and Task Quantity Unit of Issue Unit Price Total

0001 Maintenance: Upgrades/Modifications to databases and documentation (Task 3.1.2) 1 LS

0002 Monthly Status Reports (Task 3.2.1) 12 EA

0003 Ongoing technical and analytical support by phone or email (Task 3.1.4) 1 LS

0004 Training for FDA scientists (Task 3.1.4) 2 EA

0005 Yearly face-to-face meeting and final progress report (Task 3.2.1) 1 EA

Total Base Period

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Pricing: Option Year 1

Issue Unit Price Total

1000 Maintenance: Upgrades/Modifications to databases and documentation (Task 3.1.2) 1 LS

1001 Monthly Status Reports (Task 3.2.1) 12 EA

1002 Ongoing technical and analytical support by phone or email (Task 3.1.4) 1 LS

1003 Training for FDA scientists (Task 3.1.4) 2 EA

1004 Yearly face-to-face meeting and final

Total Option Year 1

Pricing: Option Year 2

Issue Unit Price Total

2000 Maintenance: Upgrades/Modifications to databases and documentation (Task 3.1.2) 1 LS

2001 Monthly Status Reports (Task 3.2.1) 12 EA

2002 Ongoing technical and analytical support by phone or email (Task 3.1.4) 1 LS

2003 Training for FDA scientists (Task 3.1.4) 2 EA

2004 Yearly face-to-face meeting and final

Total Option Year 2

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Pricing Option Year 3:

Issue Unit Price Total

3000 Maintenance: Upgrades/Modifications to databases and documentation 1 LS

3001 Monthly Status Reports 12 EA

3002 Ongoing technical and analytical support by phone or email 1 LS

3003 Training for FDA scientists 2 EA

3004 Yearly face-to-face meeting and final progress report 1 EA

Pricing: Option Year 4

Issue Unit Price Total

4000 Maintenance: Upgrades/Modifications to databases and documentation (Task 3.1.2) 1 LS

4001 Monthly Status Reports (Task 3.2.1) 12 EA

4002 Ongoing technical and analytical support by phone or email (Task 3.1.4) 1 LS

4003 Training for FDA scientists (Task 3.1.4) 2 EA

4004 Yearly face-to-face meeting and final

Total Option Year 4

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2.2 IDIQ Pricing

Software and/or Data Costs:

Gladson: Base Period Option Year 1 Option Year 2 Option Year

Option Year

Gladson license - Food segment $ $ $ $ $

Gladson license - Cosmetics segment $ $ $ $ $

Gladson - Coding images annual delivery

Gladson data integration into multi-tenant system

Mintel:

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

License - Cosmetic Market resources $ $ $ $ $

Mintel data integration into multi-tenant system

Mintel annotation project (Food Codes)

FoodEssentials:

FoodEssentials data license $ $ $ $ $

FoodEssentials- Mintel-Gladson multi-tenant system license

Enhancements to data $ $ $ $ $

Total Software and/or Data Costs

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Payment Schedule:

Unless otherwise agreed to by the Technical POC, the Contractor shall submit invoices subsequent to the delivery of the required equipment. Installation and training shall be invoiced after installation and training has been completed.

PART 3 – DESCRIPTION OF REQUIREMENT

Background The US Food and Drug Administration (FDA) has a continuing need for current, cost effective, and accurate data on the exposure of consumers to processed food products and food ingredients that are either manufactured for sale or imported for sale into the United States (US) marketplace and presumed consumed by the US population. Dietary supplements, infant formula, bottled water, chewing gum, and pet food are examples of food items included in the definition of processed foods. Additionally, FDA has a continuing need for current, cost effective, and accurate data on the exposure of consumers to food and color 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 manufactured products, their ingredients, labeling and packaging in order to better assess how they may affect human exposure as part of the agency’s ongoing mission to protect public health. FDA has devoted considerable resources to continuously monitor the safety of food ingredients, dietary supplements, infant formula, and cosmetics. FDA has determined that the most cost-effective means to advance the agency’s objectives is (1) to obtain accurate, quality-assured, easily-validated processed food and cosmetic product and ingredient information and coding images, which has been well-organized within one or more relationally searchable database(s) for trend and other analyses; and/ or 2) to collect processed food and cosmetic product and ingredient information as tasked.

Purpose The purpose of the contract is to issue to meet CFSANs 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 ingredient information.

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. To meet FDA’s research mission and for the purpose of this acquisition, these multiple, interlinked, compatible databases should be comprehensive, representing regionally and nationally, processed food and cosmetic products manufactured or imported for sale in the United States (US) marketplace. The database(s) shall contain current and historical data for products from the 1990s-to-the-present that are valid, FDA-21-RFQ-1238432 Page 6 of 40 verified, and re-verifiable and shall represent greater than 50% of products sold in the U.S.

marketplace.

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 data bases may have some commonality (general overlap in the products or product lines they each contain); however, these databases, for the most part, should be divergent, representing unique niches or regional areas of the US 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.

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 food and cosmetic product and ingredient information.

The contract is divided into the following task areas:

• Project Management

• Data Access

• Data Collection

• Training Support

Specific Tasks Technical Requirements (Task 3.1)

Datasets: (Task 3.1.1) The processed food and cosmetic products and their ingredients 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); accurate, quality-assured, and easily-validated; well organized; and stored as relationally searchable information for trend and other analyses. 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:

• Processed food products (minimum 250,000 products); Possible change number

• Dietary supplements (minimum 15,000 products); shall be categorized according to the definition in Appendix A

• Infant formula;

• Cosmetics (minimum 120,000 products);

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The following attributes shall be required:

• Coding images (legible images of all sides of product packaging) possible add bottom/all surfaces

• Information contained on 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 Nutrition Facts label (shall be displayed in format according to 21 CFR 101.9) o Ingredients o Food Additives o Price o pack size and weight o Number of servings per package o Brand o Name and place of business of manufacturer, packer, or distributor o Warning statements/icons?

o Detailed product description on packaging o Statements/icons/signages and similar information that features the nutrition, health, organoleptic, processing, and other properties of the product (e.g., nutrient content claim languages, front-of-pack language).

o Verbatim language from product packaging (if available) o Warning Icon

• Product source where collected

• Date collected or published

• 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)

• GSFA (General Standard for Food Additives) categories

• Food packaging types(primary and secondary)

• Food content type

• Allergen labeling (contains/may contain)

Moreover, the successful Contractor also shall provide additional valid and verifiable information on the product ingredients; at a minimum, the successful Contractor should provide synonym name(s), allergen status, and technical or functional effect descriptors.

Product Requirements (Task 3.1.2) Overarching product requirements:

• Unlimited access for up to 200 FDA personnel;

• Located external to FDA network (access via weblink);

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• 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 processed food and cosmetic product labeling and packaging datasets 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;

• Coding images for all the labels for validation and other research purposes. Images shall be displayed with product data so that information may be easily verifiable by the user.

• Means to verify that products are still being sold in the US marketplace (ex. sales data).

• All searches shall be downloadable and exportable into Microsoft’s Excel Spreadsheet and Access Data Base Software, SAS Business Analytics Software, and other common formats. Users shall be able to analyze and summarize their searches into summary reports using pivot tables.

• Data status updates shall be posted on the system website

• System usage statistics (including statistics regarding individual login usage) available in monthly reports and upon request

A user-friendly interface is required for that is transparent and flexible and that shall provide both predefined (i.e., canned) and custom reports. The user shall be able to conduct a multi-variable search (i.e. searching a combination of factors concurrently). The user shall be able to search according to product category, name, brand, company, claims, ingredients, product attributes, and user-entered keywords in any and all fields.

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. (may need the last sentence)

In addition to the product label database(s), offeror shall provide all sales data and market research reports when available. This information shall apply to processed food and cosmetic products.

The Contractor shall provide system maintenance during the base and all option periods, if exercised. Maintenance includes 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.

Documentation (Task 3.1.3) The methodologies used by the Contractor and contained in the software shall be fully revealed in the required documentation. The Contractor shall develop and complete Limitations & Restrictions, data dictionary, technical specifications, full-disclosure, and interface documents

FDA-21-RFQ-1238432 Page 9 of 40 and provide them to the Contracting Officer Representative (COR) at the time of final installation of the database system. After approval by COR, all documentation shall be available to access online in the database(s) system.

Documentation shall include 1) comprehensive methodology of product data collection and assignments, and 2) user guides for system use.

Support/Training (Task 3.1.4)

A. Support: Ongoing technical and analytical support by phone or by e-mail shall be required for 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.

B. Training: The Contractor shall provide two (2) one-day training sessions per year (on-site or via web-based methods). 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.

Data Disclosure Clearance (Task 3.1.5) 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 C and 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 C and D. These Procedures include terms and conditions for third party collaborations.

Project Management (Task 3.2) The Contractor shall be responsible for creating, managing and updating project plans, schedules and managing resources for the project.

Reporting (Task 3.2.1) 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

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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).

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 4 copies of 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.

Deliverables

Task Deliverable Due Date

Access to all databases (3.1.2)

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

Within 14 days after award

Documentation (3.1.3)

Documentation specified in section 3.2.4 made available to COR and online

Within 14 days after award

System Maintenance (3.1.2)

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

Ongoing

Support (3.1.4.A)

Technical and analytical support available according to 3.2.5.A

Ongoing

Training (3.1.4.B)

Training for FDA staff 2 sessions per BASE year;

2 sessions per Option year

Monthly Reports (3.2.1)

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

Ongoing

Yearly report and presentation (3.2.1)

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

PART 4 – 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

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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.

PART 5 – DELIVERIES OR PERFORMANCE

Place of Performance

Planning meetings and progress reports with agency staff may be held at the FDA offices in College Park, Maryland or by remote communication. Meeting locations will depend on the business need and will be specified by the COR. The majority of the work shall be performed from a secured network connection to the FDA network from the contractor’s location utilizing government furnished laptops.

Please note that FDA will not provide office space to the Contractor to maintain the processed food and cosmetic product and packaging database system. The database system, once implemented, should be operable by FDA scientists who have been trained in its use without the ongoing physical presence of the contractor at FDA.

Period of Performance

The period of performance shall be for a base period of one year with four one-year option periods for Data processing Services. The actual POP for the contract shall be finalized at the time of award, but for planning purposes the anticipated performance period for the contract is as follows.

BASE YEAR - 9/01/2021 – 8/31/2022

OPTION YEAR 1 – 9/01/2022 – 8/31/2023

OPTION YEAR 2 – 9/01/2023 – 8/31/2024

OPTION YEAR 3 – 9/01/2024 – 8/31/2025

OPTION YEAR 4 – 9/01/2025 – 8/31/2026

Unless otherwise specified, services shall be performed Monday through Friday (excluding Federal Holidays) between the hours of 8:00 a.m. and 4:30 p.m. EST. Supplies or services scheduled for delivery on a Federal holiday shall be made the next business day.

The following personnel shall represent the Government for the purpose of this contract:

Contracting Officer Representative (COR):

The following COR will represent the Government for the purpose of this order: (TBD at time of award)

The 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 Statement of Work and any other technical

FDA-21-RFQ-1238432 Page 12 of 40 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.

Contracting Officer (CO): Contract Specialist (CS):

Gary Klaff Rodney D. Aytch 4041 Powder Mill Road 4041 Powder Mill Road Beltsville, MD 20705 Beltsville, MD 20705 Gary.Klaff@fda.hhs.gov rodney.aytch@fda.hhs.gov Tel: (240) 402-7555 Tel: (240) 402-7514

The Contracting Officer 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 order.

FDA Three-Way Match Invoicing Procedures:

A. The contractor shall submit all invoices to:

U.S. FOOD AND DRUG ADMINISTRATION

Attn: Vendor Payments Division of Payment Services 10903 New Hampshire Ave WO32 - Second Floor

MAIL HUB 2145

Silver Spring, MD 20993-0002 301-827-3742 FDAVendorPaymentsTeam@fda.hhs.gov

*** Acceptable methods of delivery include: E-mail (preferred) and Standard Mail.

B. Invoices submitted under this contract must comply with the requirements set forth in FAR Clauses 52.232-25 (Prompt Payment) and 52.232-33 (Payment by Electronic Funds Transfer - System for Award Management) and/or other applicable FAR clauses specified herein. To constitute a proper invoice, the invoice must be submitted on company letterhead and include each of the following:

(i) Name and address of the contractor;

(ii) Invoice date and invoice number;

(iii) Contract/Order number (including a reference to any base award for Indefinite- Delivery/Indefinite-Quantity Contracts or Blanket Purchase Agreements);

(iv) Description, quantity, unit of measure, unit price, and extended price supplies delivered, or services performed, including:

(a) period of performance for which costs are claimed;

(b) itemized travel costs, including origin and destination;

mailto:Gary.Klaff@fda.hhs.gov

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(c) any other supporting information necessary to clarify questionable expenditures;

(d) the contractor shall include the award item number for each description, quantity, unit of measure, unit price, and extended price supplies delivered, or services performed;

(v) Shipping number and date of shipment, including the bill of lading number and weight of shipment if shipped on government bill of lading;

(vi) Terms of any discount for prompt payment offered (Prompt Payment terms other than NET 30);

(vii) Name and address of official to whom payment is to be sent (must be the same as that in the purchase order/award, or in a proper notice of assignment);

(viii) Name, title, and phone number of the person to notify in event of defective invoice;

(ix) Taxpayer Identification Number (TIN);

(x) banking routing transit number of the financial institution receiving payment for Electronic funds transfer (EFT);

(xi) Name and telephone number of the FDA Contracting Officer Representative (COR) or other Program Center/Office point of contact, as referenced on the award;

(xii) For all Inspections, Time-and-Materials and Labor-Hour Awards, 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:

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

(1) invoice number, amount, & date submitted

(2) corresponding payment amount & date received

(b) total amount of all payments received to date under the subject contract or order

(c) and, for definitized contracts or orders only, total estimated amounts yet to be invoiced for the current, active period of performance;

(xiii) Any other information or documentation required by the award.

C. An electronic invoice is acceptable if submitted in Adobe Acrobat (PDF) format. All items listed in (i) through (xiii) of this clause must be included in the electronic invoice.

Electronic invoices must be on company letterhead and must contain no ink changes and be legible for printing.

D. Questions regarding invoice payments should be directed to the 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 number, invoice number and date of invoice, as well as your name, phone number, and a detailed description of the issue.

PART 6 – SPECIAL CONTRACT REQUIREMENTS

508 Standards 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)

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• 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)

10. Security A. Baseline Security Requirements

1) Applicability. The requirements herein apply whether the entire contract or order (hereafter

“contract”), or portion thereof, includes either or both of the following:

2) Access (Physical or Logical) to Government Information: A Contractor (and/or any subcontractor) employee will have or will be given the ability to have, routine physical (entry) or logical (electronic) access to government information.

a. Operate a Federal System Containing Information: A Contractor (and/or any subcontractor) will operate a federal system and information technology containing data that supports the HHS mission. In addition to the Federal Acquisition Regulation (FAR) Subpart 2.1 definition of “information technology” (IT), the term as used in this section includes computers, ancillary equipment (including imaging peripherals, input, output, and storage devices necessary for security and surveillance), peripheral equipment designed to be controlled by the central processing unit of a computer, software, firmware and similar procedures, services (including support services), and related resources.

Safeguarding Information and Information Systems. In accordance with the Federal Information

3) Processing Standards Publication (FIPS)199, Standards for Security Categorization of Federal Information and Information Systems, the Contractor (and/or any subcontractor) shall:

a. Protect government information and information systems in order to ensure:

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

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• Confidentiality, which means preserving authorized restrictions on access and disclosure, based on the security terms found in this contract, including means for protecting personal privacy and proprietary information;

• Integrity, which means guarding against improper information modification or destruction, and ensuring information non-repudiation and authenticity; and

• Availability, which means ensuring timely and reliable access to and use of information.

b. Provide security for any Contractor systems, and information contained therein, connected to an FDA network or operated by the Contractor on behalf of FDA regardless of location. In addition, if new or unanticipated threats or hazards are discovered by either the agency or contractor, or if existing safeguards have ceased to function, the discoverer shall immediately, within one (1) hour or less, bring the situation to the attention of the other party. This includes notifying the FDA Systems Management Center (SMC) within one (1) hour of discovery/detection in the event of an information security incident.

c. Adopt and implement the policies, procedures, controls, and standards required by the HHS/FDA Information Security Program to ensure the confidentiality, integrity, and availability of government information and government information systems for which the Contractor is responsible under this contract or to which the Contractor may otherwise have access under this contract. Obtain the FDA Information Security Program security requirements, outlined in the FDA Information Security and Privacy Policy (IS2P), by contacting the CO/COR or emailing your ISSO.

d. Comply with the Privacy Act requirements and tailor FAR clauses as needed.

4) Information Security Categorization. In accordance with FIPS 199 and National Institute of Standards and Technology (NIST) Special Publication (SP) 800-60, Volume II: Appendices to Guide for Mapping Types of Information and Information Systems to Security Categories, Appendix C, and based on information provided by the ISSO or other security representative, the risk level for each Security Objective and the Overall Risk Level, which is the highest watermark of the three factors (Confidentiality, Integrity, and Availability) of the information or information system are the following:

Confidentiality: [ X ] Low [ ] Moderate [ ] High Integrity: [ X ] Low [ ] Moderate [ ] High Availability: [ X ] Low [ ] Moderate [ ] High Overall Risk Level: [ X] Low [ ] Moderate [ ] High

Based on information provided by the Privacy Office, system/data owner, or other privacy representative, it has been determined that this solicitation/contract involves:

[ X ] No PII [ ] Yes PII

Complete this section using the information obtained from the Security and Privacy Checklist in Appendix A, parts A and B.

http://csrc.nist.gov/publications/nistpubs/800-60-rev1/SP800-60_Vol2-Rev1.pdf

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Personally Identifiable Information (PII). Per the OMB Circular A-130, “PII is information that can be used to distinguish or trace an individual's identity, either alone or when combined with other information that is linked or linkable to a specific individual.” Examples of PII include, but are not limited to the following: Social Security number, date and place of birth, mother’s maiden name, biometric records, etc.

PII Confidentiality Impact Level has been determined to be: [ X] Low [ ] Moderate [ ] High

5) Controlled Unclassified Information (CUI). CUI is defined as “information that laws, regulations, or Government-wide policies require to have safeguarding or dissemination controls, excluding classified information.” The Contractor (and/or any subcontractor) must comply with Executive Order 13556, Controlled Unclassified Information, (implemented at 3 CFR, part 2002) when handling CUI. 32 C.F.R. 2002.4(aa). As implemented the term “handling” refers to “…any use of CUI, including but not limited to marking, safeguarding, transporting, disseminating, re-using, and disposing of the information.” 81 Fed. Reg. 63323. All sensitive information that has been identified as CUI by a regulation or statute, handled by this solicitation/contract, shall be:

a. marked appropriately;

b. disclosed to authorized personnel on a Need-To-Know basis;

c. protected in accordance with NIST SP 800-53, Security and Privacy Controls for Federal Information Systems and Organizations applicable baseline if handled by a Contractor system operated on behalf of the agency, or NIST SP 800-171, Protecting Controlled Unclassified Information in Nonfederal Information Systems and Organizations if handled by internal Contractor system; and

d. returned to FDA control, destroyed when no longer needed, or held until otherwise directed.

Destruction of information and/or data shall be accomplished in accordance with NIST SP 800- 88, Guidelines for Media Sanitization and the FDA IS2P Appendix T: Sanitization of Computer- Related Storage Media.

6) Protection of Sensitive Information. For security purposes, information is or may be sensitive because it requires security to protect its confidentiality, integrity, and/or availability. The Contractor (and/or any subcontractor) shall protect all government information that is or may be sensitive in accordance with OMB Memorandum M-06-16, Protection of Sensitive Agency Information by securing it with a FIPS 140-2 validated solution.

Confidentiality and Nondisclosure of Information. Any information provided to the contractor (and/or any subcontractor) by FDA or collected by the contractor on behalf of FDA shall be used only for the purpose of carrying out the provisions of this contract and shall not be disclosed or made known in any manner to any persons except as may be necessary in the performance of the contract. The Contractor assumes responsibility for protection of the confidentiality of Government records and shall ensure that all work performed by its employees and subcontractors shall be under the supervision of the Contractor. Each Contractor employee or any of its subcontractors to whom any FDA records may be made available or disclosed shall

FDA-21-RFQ-1238432 Page 17 of 40 be notified in writing by the Contractor that information disclosed to such employee or subcontractor can be used only for that purpose and to the extent authorized herein.

The confidentiality, integrity, and availability of such information shall be protected in accordance with HHS and FDA policies. Unauthorized disclosure of information will be subject to the HHS/FDA sanction policies and/or governed by the following laws and regulations:

a. 18 U.S.C. 641 (Criminal Code: Public Money, Property or Records);

b. 18 U.S.C. 1905 (Criminal Code: Disclosure of Confidential Information); and

c. 44 U.S.C. Chapter 35, Subchapter I (Paperwork Reduction Act).

7) Internet Protocol Version 6 (IPv6). All procurements using Internet Protocol shall comply with

OMB Memorandum M-05-22, Transition Planning for Internet Protocol Version 6 (IPv6).

8) Government Websites. All new and existing public-facing government websites must be securely configured with Hypertext Transfer Protocol Secure (HTTPS) using the most recent version of Transport Layer Security (TLS). In addition, HTTPS shall enable HTTP Strict Transport Security (HSTS) to instruct compliant browsers to assume HTTPS at all times to reduce the number of insecure redirects and protect against attacks that attempt to downgrade connections to plain HTTP. For internal-facing websites, the HTTPS is not required, but it is highly recommended.

9) Contract Documentation. The Contractor shall use FDA-provided templates, policies, forms and other agency documents to comply with contract deliverables as appropriate.

10) Standard for Encryption. The Contractor (and/or any subcontractor) shall:

a. Comply with the HHS Standard for Encryption of Computing Devices and Information to prevent unauthorized access to government information.

b. Encrypt all sensitive federal data and information (i.e., PII, protected health information [PHI], proprietary information, etc.) in transit (i.e., email, network connections, etc.) and at rest (i.e., servers, storage devices, mobile devices, backup media, etc.) with FIPS 140-2 validated encryption solution.

c. All devices (i.e.: desktops, laptops, mobile devices, etc.) that store, transmit, or process non-public FDA information should utilize FDA-provided or FDA information security authorized devices that meet HHS and FDA-specific encryption standard requirements. Maintain a complete and current inventory of all laptop computers, desktop computers, and other mobile devices and portable media that store or process sensitive government information (including PII).

d. Verify that the encryption solutions in use are compliant with FIPS 140-2. The Contractor shall provide a written copy of the validation documentation to the COR.

e. Use the Key Management system on the HHS Personal Identification Verification (PIV) card or establish and use a key recovery mechanism to ensure the ability for authorized personnel to encrypt/decrypt information and recover encryption keys. Encryption keys (PIV card) shall be http://csrc.nist.gov/publications/fips/fips140-2/fips1402.pdf

FDA-21-RFQ-1238432 Page 18 of 40 provided to the COR upon request and at the conclusion of the contract. Upon completion of contract, contractor ensures that COR is able to access and read any encrypted data.

11) Contractor Non-Disclosure Agreement (NDA). Each Contractor (and/or any subcontractor) employee having access to non-public government information under this contract shall complete the FDA non-disclosure agreement (3398 Form), as applicable. A copy of each signed and witnessed NDA shall be submitted to the CO and/or COR prior to performing any work under this acquisition.

12) Privacy Threshold Analysis (PTA)/Privacy Impact Assessment (PIA) – The Contractor shall assist the procuring activity representative, program office and the FDA SOP or designee with conducting a PTA for the information system and/or information handled under this contract to determine whether or not a full PIA needs to be completed.

a. If the results of the PTA show that a full PIA is needed, the Contractor shall assist procuring activity representative, program office and the FDA SOP or designee with completing a PIA for the system or information after completion of the PTA and in accordance with HHS and FDA policy and OMB M-03-22, Guidance for Implementing the Privacy Provisions of the E- Government Act of 2002. The PTA/PIA must be completed and approved prior to active use and/or collection or processing of PII and is a prerequisite to agency issuance of an authorization to operate (ATO).

b. The Contractor shall assist the procuring activity representative, program office and the FDA SOP or designee in reviewing and updating the PIA at least every three years throughout the Enterprise Performance Life Cycle (EPLC) /information lifecycle, or when determined by the agency that a review is required based on a major change to the system, or when new types of PII are collected that introduces new or increased privacy risks, whichever comes first.

B. Training

1) Mandatory Training for All Contractor Staff. All Contractor (and/or any subcontractor) employees assigned to work on this contract shall complete the applicable FDA Contractor Information Security Awareness, Privacy, and Records Management training (provided upon contract award) before performing any work under this contract. Thereafter, the employees shall complete FDA Information Security Awareness, Privacy, and Records Management training at least annually, during the life of this contract. All provided training shall be compliant with HHS and FDA training policies.

2) Role-based Training. All Contractor (and/or any subcontractor) employees with significant security responsibilities (as determined by the program manager) must complete role-based training annually commensurate with their role and responsibilities in accordance with HHS and FDA policy and FDA Role-Based Training (RBT) of Personnel with Significant Security Responsibilities Standard Operating Procedures (SOP).

3) Training Records. The Contractor (and/or any subcontractor) shall maintain training records for all its employees working under this contract in accordance with HHS and FDA policy. A http://inside.fda.gov:9003/downloads/administrative/forms/fda/ucm013733.pdf

FDA-21-RFQ-1238432 Page 19 of 40 copy of the training records shall be provided to the CO and/or COR within 30 days after contract award and annually thereafter or upon request.

C. Rules of Behavior

1) The Contractor (and/or any subcontractor) shall ensure that all employees performing on the contract comply with the HHS Information Technology General Rules of Behavior.

2) All Contractor employees performing on the contract must read and adhere to the Rules of Behavior (ROB) before accessing HHS and FDA data or other information, systems, and/or networks that store/process government information, initially at the beginning of the contract and at least annually thereafter, which may be done as part of annual FDA Information Security Awareness Training. If the training is provided by the contractor, the signed ROB must be provided as a separate deliverable to the CO and/or COR per defined timelines.

D. Incident Response

The Contractor (and/or any subcontractor) shall respond to all alerts/Indicators of Compromise (IOCs) provided by HHS Computer Security Incident Response Center (CSIRC)/FDA SMC /Incident Response Team (IRT) teams within 24 hours, whether the response is positive or negative.

FISMA defines an incident as “an occurrence that (1) actually or imminently jeopardizes, without lawful authority, the integrity, confidentiality, or availability of information or an information system; or (2) constitutes a violation or imminent threat of violation of law, security policies, security procedures, or acceptable use policies.” The HHS Policy for IT Security and Privacy Incident Reporting and Response further defines incidents as events involving cybersecurity and privacy threats, such as viruses, malicious user activity, loss of, unauthorized disclosure or destruction of data, and so on.

A privacy breach is a type of incident and is defined by FISMA as the loss of control, compromise, unauthorized disclosure, unauthorized acquisition, or any similar occurrence where

(1) a person other than an authorized user accesses or potentially accesses personally identifiable information or (2) an authorized user accesses or potentially accesses personally identifiable information for an other than authorized purpose. The HHS Policy for IT Security and Privacy Incident Reporting and Response further defines a breach as “a suspected or confirmed incident involving PII.”

In the event of a suspected or confirmed incident or breach, the Contractor (and/or any subcontractor) shall:

1) Protect all sensitive information, including any PII created, stored, or transmitted in the performance of this contract to avoid a secondary sensitive information incident with FIPS 140-2 validated encryption.

FDA-21-RFQ-1238432 Page 20 of 40

2) NOT notify affected individuals unless so instructed by the Contracting Officer or designated representative. If so instructed by the Contracting Officer or representative, the Contractor shall send FDA approved notifications to affected individuals as directed by FDA’s SOP.

3) Report all suspected and confirmed information security and privacy incidents and breaches to the FDA Systems Management Center, COR, CO, and other stakeholders, (Recommend adding the FDA Senior Official for Privacy with contact information and either defining or deleting “other stakeholders.”) including incidents involving PII, in any medium or form, including paper, oral, or electronic, as soon as possible and without unreasonable delay, no later than one (1) hour of discovery/detection, and consistent with the applicable FDA and HHS policy and procedures, NIST standards and guidelines, as well as US-CERT notification guidelines. The types of information required in an incident report must include at a minimum: company and point of contact information, contract information, impact classifications/threat vector, and the type of information compromised. In addition, the Contractor shall:

a. cooperate and exchange any information, as determined by the Agency, necessary to effectively manage or mitigate a suspected or confirmed breach;

b. not include any sensitive information in the subject or body of any reporting e-mail; and

c. encrypt sensitive information in attachments to email, media, etc.

4) Comply with OMB M-17-12, Preparing for and Responding to a Breach of Personally Identifiable Information and HHS and FDA incident response policies when handling PII breaches.

5) Provide full access and cooperate on all activities as determined by the Government to ensure an effective incident response, including providing all requested images, log files, and event information to facilitate rapid resolution of sensitive information incidents. This may involve disconnecting the system processing, storing, or transmitting the sensitive information from the Internet or other networks or applying additional security controls. This may also involve physical access to contractor facilities during a breach/incident investigation demand.

E. Position Sensitivity Designations

All Contractor (and/or any subcontractor) employees must obtain a background investigation commensurate with their position sensitivity designation that complies with Parts 1400 and 731 of Title 5, Code of Federal Regulations (CFR). The following position sensitivity designation levels apply to this solicitation/ contract: [See the FDA Security Article, entitled Contractor Personnel Security Clearance Standards and Residency Requirements for the Position Risk Designation Tier(s) (i.e., 1, 2, and/or 4”) that apply to this award.]

F. Homeland Security Presidential Directive (HSPD)-12

The Contractor (and/or any subcontractor) and its employees shall comply with Homeland Security Presidential Directive (HSPD)-12, Policy for a Common Identification Standard for Federal Employees and Contractors; OMB M-05-24; FIPS 201, Personal Identity Verification

FDA-21-RFQ-1238432 Page 21 of 40

(PIV) of Federal Employees and Contractors; HHS HSPD-12 policy; and Executive Order 13467, Part 1 §1.2.

Roster. The Contractor (and/or any subcontractor) shall submit a roster by name, position, e-mail address, phone number and responsibility, of all staff working under this acquisition where the Contractor will develop, have the ability to access, or host and/or maintain a government information system(s). The roster and any revisions to the roster as a result of staffing changes shall be submitted to the COR and/or CO per the COR or CO’s direction. Any revisions to the roster as a result of staffing changes shall be submitted within a timeline as directed by the COR and/or CO. The COR will notify the Contractor of the appropriate level of investigation required for each staff member.

If the employee is filling a new position, the Contractor shall provide a position description and the Government will determine the appropriate suitability level.

G. Contract Initiation and Expiration

1) General Security Requirements. The Contractor (and/or any subcontractor) shall comply with information security and privacy requirements, Enterprise Performance Life Cycle (EPLC) processes, HHS Enterprise Architecture requirements to ensure information is appropriately protected from initiation to expiration of the contract.