RFQ_75F40126Q00171.pdf

Center for Tobacco Products (CTP) Advertising Data Monitoring Subscription and Training

75F40126Q00171

CTP Advertising Data Monitoring Subscription and Training

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TABLE OF CONTENTS

CONTINUATION OF SOLICITATION FOR COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES

1. Supplies or Services and Prices/Costs

2. Description/Specifications/Statement of Work

3. Packaging and Marking

4. Inspection and Acceptance

5. Deliveries or Performance

6. Contract Administration Data

7. Special Contract Requirements

CONTRACT CLAUSES

8. Contract Clauses

CONTRACT DOCUMENTS, EXHIBITS OR ATTACHMENTS

9. List of Attachments

SOLICITATION PROVISIONS

10. Representations, Certifications, and Other Statements of Offerors or Respondents

11. Instructions, Conditions, and Notices to Offerors or Respondents

12. Evaluation Factors for Award

CONTINUATION OF SOLICITATION FOR COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES

1. SUPPLIES OR SERVICES AND PRICES/COSTS

This is a solicitation for commercial products or commercial services prepared in accordance with Federal Acquisition Regulation (FAR) Part 12. This announcement constitutes the only solicitation. Offers are being requested and a separate written solicitation will not be issued.

Solicitation number 75F40126Q00171 is issued as a Request for Quotation (RFQ) for CTP Advertising Data Monitoring Subscription and Training. Simplified procedures are being utilized in accordance with FAR 12.201-1.

This acquisition is not set-aside for small business concerns. This solicitation incorporates provisions and clauses by reference. The full text of provisions and clauses may be accessed electronically at www.acquisition.gov.

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 a small business size standard of $40 million. The product or service code is DH10 (IT and Telecom - Platform As A Service: Database, Mainframe, Middleware). The Government will award a Firm-Fixed Price (FFP) Purchase Order (PO) resulting from this solicitation to the responsible offeror whose offer, conforming to the solicitation, will be most advantageous to the Government (as determined by the solicitation evaluation criteria).

If an item in this solicitation is identified as "brand name or equal," the purchase description reflects the characteristics and level of quality that will satisfy the Government’s needs. The salient physical, functional, or performance characteristics that "equal" products must meet are specified in the solicitation.

All interested companies must provide quotations for the following:

Firm-Fixed-Price Type Purchase Order

BASE YEAR

Deliverable Unit of Measure Frequency Quantity Unit Price Total Price

Subscription and Trainings Up to 4 users Annually 1 $ $

Base Year Firm-Fixed-Price Total $

OPTION YEAR I

Deliverable Unit of Measure Frequency Quantity Unit Price Total Price

Subscription and Trainings Up to 4 users Annually 1 $ $

Option Year I Firm-Fixed-Price Total $

OPTION YEAR II

Deliverable Unit of Measure Frequency Quantity Unit Price Total Price

Subscription and Trainings Up to 4 users Annually 1 $ $

Option Year II Firm-Fixed-Price Total $ http://www.acquisition.gov/

OPTION YEAR III

Deliverable Unit of Measure Frequency Quantity Unit Price Total Price

Subscription and Trainings Up to 4 users Annually 1 $ $

Option Year III Firm-Fixed-Price Total $

OPTION YEAR IV

Deliverable Unit of Measure Frequency Quantity Unit Price Total Price

Subscription and Trainings Up to 4 users Annually 1 $ $

Option Year IV Firm-Fixed-Price Total $

GRAND TOTAL FIRM-FIXED-PRICE (ALL YEARS) $

2. DESCRIPTION/SPECIFICATIONS/STATEMENT OF WORK

A description of requirements for the items and/or services to be acquired is provided below.

2.1. Background Information and Purpose of the Project

The Family Smoking Prevention and Tobacco Control Act grants the U.S. Food and Drug Administration (FDA) the authority to regulate tobacco products. The FDA established the Center for Tobacco Products (CTP) to regulate the manufacture, marketing, and distribution of tobacco products to protect public health and to reduce tobacco use by youth. CTP oversees the implementation of the Family Smoking Prevention and Tobacco Control Act. To inform tobacco regulatory activities, CTP’s Office of Science implements and supports various internal and external research activities designed to provide mission-critical data and information to support tobacco product application review and other tobacco regulatory activities.

The purpose of this fixed price contract is to provide CTP with advertising data (including actual ads and estimated media spend [i.e., estimated money spent by industry to purchase ad placements]) in traditional and non-traditional media channels. Tobacco advertising data provides information on tobacco product attributes (e.g., flavors, flavor descriptors, colors, nicotine content), and product claims. Tobacco advertising data can also provide information to help understand which audiences (e.g., youth) may be exposed to certain tobacco ads. Tobacco advertising data includes advertisements in traditional (e.g., TV, radio, and print) and non-traditional media (e.g., social media, mobile display) channels.

For purposes of this SOW, tobacco products include cigarettes; cigars; dissolvables; hookah tobacco;

nicotine gels; pipe tobacco; roll-your-own tobacco; nicotine pouches; heated tobacco products;

smokeless tobacco products, including dip, snuff, snus, and chewing tobacco; and vapes, e-cigs, hookah pens, and other Electronic Nicotine Delivery Systems (ENDS). For additional information on types of tobacco products, see: https://www.fda.gov/tobacco-products/products-guidance-regulations.

Specifically, the Contractor shall: 1) provide CTP with ongoing online access to its existing advertising data monitoring platform and 2) provide technical assistance in setting up and maintaining the online subscription so that it can be used by CTP for tobacco regulatory science purposes. The platform shall include tobacco industry advertising creative (i.e., actual ads) as well as estimated media spend (i.e., https://www.fda.gov/tobacco-products/products-guidance-regulations https://www.fda.gov/tobacco-products/products-guidance-regulations estimated money spent by industry to purchase ad placements) for traditional and non-traditional media channels.

CTP may publish results in peer-reviewed journals based on research conducted using the advertising data obtained through this data monitoring platform.

2.2. Scope

The Contractor shall provide CTP online access to and support for its advertising data monitoring platform – MediaRadar Magnifier (or equal product) – which shall include tobacco industry advertising creative (i.e., actual ads) as well as estimated media spend (i.e., estimated money spent by industry to purchase ad placements) in the U.S. for specified media channels. The sampling frame shall include the most popular outlets within each media channel. The estimated media spend shall be calculated based on the cost to purchase ad placements as well as an audience factor (dependent on media type). The estimated media spend shall be reported by individual ad occurrence, for all channels where this information is available. The platform shall have the ability to track and report on the following media channels: TV, radio, print, out-of-home, online display, online video, mobile ads, and social media advertisements.

The services for this requirement, listed below, will provide information to the CTP Office of Science to monitor tobacco industry advertising of tobacco products and to inform tobacco regulatory activities.

2.2.1. SALIENT CHARACTERISTICS

The Contractor shall ensure that the proposed solution meets the following salient characteristics:

• The Contractor shall provide CTP with a subscription or license where CTP can log on via a website to view tobacco advertising data collected by the existing platform.

• The Contractor shall ensure that a minimum of four users can access the system via user name and password authentication.

• The Contractor shall ensure that the platform allows for tracking tobacco ads. For purposes of this SOW, tobacco products include cigarettes; cigars; dissolvables; hookah tobacco; nicotine gels; pipe tobacco; roll-your-own tobacco; nicotine pouches; heated tobacco products; smokeless tobacco products, including dip, snuff, snus, and chewing tobacco; and vapes, e-cigs, hookah pens, and other Electronic Nicotine Delivery Systems (ENDS). For additional information on types of tobacco products, see:

https://www.fda.gov/tobacco-products/products-guidance-regulations.

• The platform shall provide creative data (i.e., actual ads) as well as estimated media spend data (i.e., estimated money spent by industry to purchase ad placements). The estimated media spend shall be calculated based on the cost to purchase ad placements as well as an audience factor (dependent on media type). The estimated media spend shall be reported by individual ad occurrence, including details on brand advertised, date of ad occurrence, and outlet in which the ad appeared. The estimated media spend shall be reported for all channels where this information is available, e.g., TV, radio, print, online display, online video, and mobile ads.

• The Contractor shall ensure that the platform reports on all advertising elements, including image, text, and sound, depending on the type of ads.

• The platform shall have the ability to track and report on the following media channels:

TV, radio, print, out-of-home, online display, online video, mobile ads, and social media advertisements.

• The platform shall allow for creative data to be downloaded.

• The Contractor shall ensure that the estimated media spend can be viewed in Microsoft

Excel using either .xls or .csv file format.

• The platform shall have the ability to provide access to historical data starting from 2012 or as soon thereafter as available; and provide access to the most recent data.

• The Contractor shall provide technical support, and training, as specified in Section 2.2.2, Requirements.

2.2.2. REQUIREMENTS

2.2.2.1. LICENSE / USER ACCOUNTS

The Contractor shall provide access to MediaRadar Magnifier subscription (or equal) and support services for a minimum of four users.

2.2.2.2. PLATFORM

The interface and data shall be web-hosted and shall be accessible 24 hours a day, 7 days a week with a user ID/password.

2.2.2.3. TECHNICAL SUPPORT

The Contractor shall assign a Project Manager to answer CTP’s questions and assist with system issues. The Project Manager shall answer all methodological questions and provide CTP accompanying documentation in the form of written email responses. The Project Manager shall notify CTP of any changes to the platform’s sampling frame (i.e., the media channels tracked and reported by the platform) via email within five business days of the change. The Project Manager (or an alternative staff person with knowledge of CTP’s account) shall answer CTP’s email and telephone inquiries within two business days. Administrative support shall be available eight hours per day, 40 hours per week. In addition, technical customer support or service shall be available from 8:00 AM to 5:00 PM Monday through Friday, US Eastern Time.

2.2.2.4. TRAINING

The Project Manager shall provide initial training to familiarize a minimum of four CTP staff with the platform, and up to five additional trainings via teleconference per year as needed, with topics to be approved by the Government. The initial training shall consist of a maximum of 8 hours (i.e., one day) and shall be held by webinar. The Contractor shall provide a written user guide on how to use the platform for distribution within CTP.

2.3. Deliverables

Task Deliverable Due Date Format

2.3.1 Kickoff Meeting Within 5 days after award Teleconference

Task Deliverable Due Date Format

2.3.1 Kickoff Meeting Notes Within 3 days after kickoff meeting Electronically

2.2.2.1 Provide User Accounts Within 5 days after kickoff meeting Electronically

2.2.2.4 User Guides Within 60 days of contract award Electronically

2.2.2.4 Initial Training Within 60 days of contract award Teleconference

2.2.2.4 Up to 5 Additional Trainings As needed, per year Teleconference

2.3.1. KICKOFF MEETING

Within five (5) business days after award, the Contractor shall meet with the Government via teleconference for a maximum of 90 minutes to discuss contract administration and the process for providing user names to gain access to the website. The Contractor shall take notes at the kickoff meeting and provide them to the Government within three (3) business days after the kickoff meeting.

User Accounts

Within five (5) business days after kickoff meeting, the Contractor shall provide user accounts for web access to the COR.

2.3.2. TRAINING

Within 60 days of contract award, the Contractor shall provide user guides/manuals and initial training (up to one day) to the CTP team.

3. PACKAGING AND MARKING

None.

4. INSPECTION AND ACCEPTANCE

None.

5. DELIVERIES OR PERFORMANCE

5.1. Period of Performance

The period of performance is anticipated to be one (1) twelve-month Base Year and four (4) twelve-month Option Years, as follows:

Base Year: July 1, 2026 through June 30, 2027 Option Year I: July 1, 2027 through June 30, 2028 Option Year II: July 1, 2028 through June 30, 2029 Option Year III: July 1, 2029 through June 30, 2030 Option Year IV: July 1, 2030 through June 30, 2031

Each Option Year has the same tasks as the Base Year.

5.2. Place of Performance

The requirement is a cloud/web-based subscription with no physical place of performance. Trainings shall take place by webinar.

5.3. Method of Delivery

Be advised that FDA does not accept documents which contain the use of macros. When submitting documents via email, DO NOT include .exe, .mso, or any other executable file types that could potentially trigger email security protections (i.e. email blocks, quarantine). Document submissions required throughout the award period(s) shall not have macro enabled functionality and any document delivered having that functionality will be deemed delinquent, if not corrected prior to the due date.

6. CONTRACT ADMINISTRATION DATA

6.1. Government Points of Contact

The following are the names, emails, and telephone numbers of the individuals to contact for information.

6.1.1. CONTRACTING OFFICER

Noah Wills Noah.Wills@fda.hhs.gov

Only Contracting Officers have authority to enter into, administer, or terminate contracts and make related determinations and findings. Only Contracting Officers acting within the scope of their authority are empowered to execute contract modifications on behalf of the Government.

Contracting Officers may designate and authorize, in writing and in accordance with agency procedures, a Contracting Officer’s Representative.

6.1.2. CONTRACTING OFFICER’S REPRESENTATIVE

To be determined at award

The Contracting Officer’s Representative has no authority to make any commitments or changes that affect price, quality, quantity, delivery, or other terms and conditions of the contract nor in any way direct the contractor or its subcontractors to operate in conflict with the contract terms and conditions. The Contracting Officer’s Representative shall be designated in writing, with copies furnished to the contractor and the contract administration office: specifying the extent of the Contracting Officer’s Representative’s authority to act on behalf of the contracting officer;

identifying the limitations on the Contracting Officer’s Representative’s authority; specifying the period covered by the designation; stating the authority is not redelegable; and stating that the Contracting Officer’s Representative may be personally liable for unauthorized acts.

mailto:Noah.Wills@fda.hhs.gov

The Contracting Officer’s Representative may be changed at any time by the Government without prior notice to the Contractor by a unilateral modification that is signed only by the Contracting Officer in accordance with FAR 43.103(b).

6.2. Type of Contract/Order

Firm-Fixed-Price

6.3. Invoicing

The Contractor shall comply with FAR 52.212-4, Contract Terms and Conditions—Commercial Products and Commercial Services, with regard to Firm-Fixed-Price tasks/deliverables. The Contractor may submit invoices for one or more individual quantities of a deliverable after the successful delivery and acceptance of that individual quantity, not to exceed the individual unit Firm-Fixed-Price of each deliverable and not to exceed the total Firm-Fixed-Price of each period of performance.

The Contractor shall include the payment address, if it is different from that shown for the Contractor.

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.htm

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 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.

1. The Agency will enroll the Contractors new to IPP. The Contractor must follow the IPP registration email instructions for enrollment to register the Collector Account for submitting invoice requests for payment. The Contractor Government Business Point of Contact (as listed in SAM) will receive Registration email from the Federal Reserve Bank of St. Louis (FRBSTL) within 3

- 5 business days of the contract award for new contracts or date of modification for existing contracts.

2. Registration emails are sent via email from ipp.noreply@mail.eroc.twai.gov. 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.

3. 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.

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

5. If the Contractor is 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.

http://www.ipp.gov/vendors/index.htm https://www.ipp.gov/

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. 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;

• Indirect Costs (i.e., Fringe Benefits, Overhead, General and Administrative, Other Indirects)-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 FAR 52.216-8 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:

(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.

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 number, invoice number and date of invoice, as well as your name, phone number, and a detailed description of the issue.

6.4. Availability of Funds

The Government’s obligation for performance of this contract is contingent upon the availability of appropriated funds from which payment for contract purposes can be made. No legal liability on the part of the Government for any payment may arise for performance under this contract until funds are made available to the Contracting Officer for performance and until the Contractor receives notice of availability, to be confirmed in writing by the Contracting Officer.

6.5. Government Property

Government-furnished property is not anticipated.

Independently, and not as an agent of the Government, the Contractor shall furnish the necessary services, personnel, materials, equipment, and facilities, not otherwise provided by the Government, as needed to perform this contract.

Government Furnished Equipment (GFE) for Foreign Travel. FDA personnel are prohibited from taking GFE when participating in personal, unofficial travel to foreign countries. FDA personnel are strictly prohibited from teleworking using GFE in foreign countries. FDA personnel must also request loaner GFE from the FDA Foreign Travel program for official travel to any foreign country. Please see the FDA IS2P, Appendix T Government Furnished Equipment for Foreign Travel.

6.6. Conflict of Interest

The Contractor warrants that, to the best of its knowledge and belief, and except as otherwise disclosed to the Contracting Officer, it does not have any actual, potential, or apparent conflict of interests pertaining to the subject contract, as defined in FAR subpart 9.5 and HHS and FDA policies, for its organization, employees, or subcontractors working or proposed to be working under this contract.

The Contractor agrees that, if after award, it discovers a conflict of interest with respect to this contract, it shall make an immediate and full disclosure in writing to the FDA Contracting Officer for this contract.

The Government reserves the right to exercise any remedy available at law or equity, including termination of the contract for cause or convenience, should the Government determine remedial action is necessary to address any actual, potential, or apparent conflict of interest.

7. SPECIAL CONTRACT REQUIREMENTS

The following are additional contract requirements and terms and conditions determined to be necessary for this acquisition and consistent with customary commercial practices.

7.1. Procurements Requiring Information Security and/or Physical Access

1. Baseline Security Requirements

a. Applicability. The requirements herein apply whether the entire contract or modification (hereafter "contract"), or portion thereof, includes either or both of the following:

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

ii. 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 FDA 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.

b. Safeguarding Information and Information Systems. All government information and information systems must be protected in accordance with FDA policies and level of risk.

At a minimum, the Contractor (and/or any subcontractor) must:

i. Protect the:

▪ 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.

ii. Categorize all information owned and/or collected/managed on behalf of FDA and information systems that store, process, and/or transmit FDA information 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. Based on information http://csrc.nist.gov/publications/nistpubs/800-60-rev1/SP800-60_Vol2-Rev1.pdf http://csrc.nist.gov/publications/nistpubs/800-60-rev1/SP800-60_Vol2-Rev1.pdf http://csrc.nist.gov/publications/nistpubs/800-60-rev1/SP800-60_Vol2-Rev1.pdf http://csrc.nist.gov/publications/nistpubs/800-60-rev1/SP800-60_Vol2-Rev1.pdf provided by the System/Data Owner, ISSO, privacy representative, or other POC, the impact level for each Security Objective (Confidentiality, Integrity, and Availability) and the Overall Impact Level, which is the highest watermark of the three factors of the information or information system are the following:

▪ Confidentiality: [ ] Low [X] Moderate [ ] High

▪ Integrity: [ ] Low [X] Moderate [ ] High

▪ Availability: [ ] Low [X] Moderate [ ] High

▪ Overall Impact Level: [ ] Low [X] Moderate [ ] High

iii. Based on the agreed-upon level of impact, implement the necessary safeguards to protect all information systems and information collected and/or managed on behalf of FDA regardless of location or purpose.

iv. Report any discovered or unanticipated threats or hazards by either the agency or contractor, or if existing safeguards have ceased to function immediately after discovery, within one (1) hour or less, to the government representative(s). This includes notifying the FDA Cybersecurity and Infrastructure Operations Coordination Center (CIOCC) within one (1) hour of discovery/detection in the event of a cybersecurity or privacy incident.

v. Adopt and implement all applicable policies, procedures, controls, and standards required by the 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 Protection (IS2P) policy, by contacting the CO/COR or emailing your ISSO.

c. Privacy Act. Comply with the Privacy Act requirements (when applicable), and tailor FAR and HHSAR clauses as needed.

d. Privacy Compliance. Comply with the E-Government Act of 2002, NIST SP 800-53, and applicable FDA privacy policies and complete all the requirements below:

i. Per the Office of Management and Budget (OMB) Circular A-130, Personally

Identifiable Information (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.

ii. Based on information provided by the ISSO, System/Data Owner, or other security or privacy representative, it has been determined that this solicitation/contract involves:

[ ] No PII [X] PII

iii. The Contractor must support the agency with conducting a Privacy Threshold Analysis

(PTA) for the information system and/or information handled under this contract to determine whether or not a full Privacy Impact Assessment (PIA) needs to be completed.

▪ If the results of the PTA show that a full PIA is needed, the Contractor must support the agency 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).

▪ The Contractor must support the agency in reviewing the PIA at least every three years throughout the system development lifecycle (SDLC)/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.

e. Controlled Unclassified Information (CUI). Executive Order 13556 defines CUI 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. The requirements below apply only to nonfederal systems that process, store, or transmit CUI, or that provide security protection for such components. All sensitive information that has been identified as CUI by a regulation or statute, handled by this solicitation/contract, must be:

i. Marked appropriately;

ii. Disclosed to authorized personnel on a Need-To-Know basis;

iii. Protected in accordance with NIST SP 800-53, Security and Privacy Controls for

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

iv. Returned to FDA control, destroyed when no longer needed, or held until otherwise directed. Information and/or data must be disposed of in accordance with NIST SP

800-88, Guidelines for Media Sanitization.

f. 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) must protect all government information that is or may be sensitive by securing it with a solution that is validated with current FIPS 140 validation certificate from the NIST CMVP.

g. Government Furnished Equipment (GFE) for Foreign Travel. FDA personnel are prohibited from taking GFE when participating in personal, unofficial travel to foreign countries. FDA personnel are strictly prohibited from teleworking using GFE in foreign countries. FDA personnel must also request loaner GFE from the FDA Foreign Travel program for official travel to any foreign country. Please see the FDA IS2P, Appendix T Government Furnished Equipment for Foreign Travel.

h. 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 must be used only for the purpose of carrying out the provisions of this contract and must 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 must ensure that all work performed by its employees and subcontractors must 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 must 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 must be protected in accordance with HHS and FDA policies. Unauthorized disclosure of information will be subject to the HHS and FDA sanction policies and/or governed by the following laws and regulations:

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

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

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

i. Internet Protocol Version 6 (IPv6). All procurements using Internet Protocol must comply with OMB Memorandum M-05-22, Transition Planning for Internet Protocol Version 6 (IPv6).

j. Information and Communications Technology (ICT). ICT products and services from prohibited entities/sources must not be used/acquired in compliance with Public Law 115- 232, Section 889 Parts A and B, FAR 4.21, FAR 52.204.23, FAR 52.204.24, and FAR

52.204.25. The contractor (and/or any subcontractor) must notify the government if they identify prohibited ICT products and/or services are used during the contract performance.

k. 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 must 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, HTTPS is not required, but it is highly recommended. Consult the HHS Policy for Internet and Email Security for additional information.

l. Contract Documentation. The Contractor must use provided templates, policies, forms, and other agency documents to comply with contract deliverables as appropriate.

m. Standard for Encryption. The Contractor (and/or any subcontractor) must:

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

ii. 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 an encryption solution that is validated with current FIPS 140 validation certificates from the NIST CMVP.

iii. Secure all devices (i.e.: desktops, laptops, mobile devices, etc.) that store and process government information and ensure devices 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).

iv. Verify that the encryption solutions in use have been validated under the

Cryptographic Module Validation Program to confirm compliance with current FIPS 140 validation certificates from the NIST CMVP. The Contractor must provide a written copy of the validation documentation to the COR.

v. 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 http://csrc.nist.gov/publications/. Encryption keys must be provided to the COR upon request and at the conclusion of the contract.

n. Contractor Non-Disclosure Agreement (NDA). Each Contractor (and/or any subcontractor) employee having access to non-public government information under this contract must complete the FDA non-disclosure agreement (3398 Form)], as applicable.

Contractors (and/or subcontractors) must submit a copy of each signed and witnessed NDA to the Contracting Officer (CO) and/or CO Representative (COR) prior to performing http://csrc.nist.gov/publications/ any work under this acquisition.

2. Training Requirements

a. Mandatory Training for All Contractor Staff. All Contractor (and/or any subcontractor) employees assigned to work on this contract must complete the applicable FDA information security awareness, privacy, and records management training (provided upon contract award) before performing any work under this contract. Thereafter, the employees must complete FDA information security awareness, privacy, and records management training at least annually, during the life of this contract. All provided training must be compliant with HHS training policies.

b. 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.

c. Training Records. The Contractor (and/or any subcontractor) must maintain training records for all its employees working under this contract in accordance with HHS and FDA policy. A copy of the training records must be provided to the CO and/or COR within 30 days after contract award and annually thereafter or upon request.

3. Rules of Behavior

a. The Contractor (and/or any subcontractor) must ensure that all employees performing on the contract comply with the HHS Information Technology General Rules of Behavior, HHS Rules of Behavior for Privileged Users, and FDA policies and standards.

b. All Contractor employees performing on the contract must read and adhere to the Rules of Behavior before accessing Agency 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 above.

4. Incident Response

a. The Contractor (and/or any subcontractor) must respond to all alerts/Indicators of

Compromise (IOCs) provided by HHS Computer Security Incident Response Center (CSIRC)/FDA CIOCC /Incident Response Team 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. In accordance with OMB

M-17-12, Preparing for and Responding to a Breach of Personally Identifiable Information (PII), an incident is "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" and a privacy breach is "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." For additional information on the HHS breach response process, please see the FDA IS2P Appendix F: Incident Response and the HHS Policy and Plan for Preparing for and Responding to a Breach of Personally Identifiable Information (PII)."

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

i. Protect all sensitive information, including any PII created, stored, or transmitted in the performance of this contract, with encryption solution that is validated with current FIPS 140 validation certificates from the NIST CMVP.

ii. 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 must send FDA approved notifications to affected individuals as directed by FDA’s SOP.

iii. Report all suspected and confirmed information security and privacy incidents and breaches to the FDA CIOCC, COR, CO, FDA SOP (or his or her designee), and other stakeholders, including breaches 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, 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, contact information, impact classifications/threat vector, and the type of information compromised. In addition, the Contractor must:

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

▪ Not include any sensitive information in the subject or body of any reporting e-mail; and

▪ Encrypt sensitive information in attachments to email, media, etc.

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

v. 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 on demand.

5. 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 (e.g. tier 1, 2, or 4): Tier 1.

6. Homeland Security Presidential Directive (HSPD)-12 The Contractor (and/or any subcontractor) and its employees must comply with Homeland Security Presidential Directive (HSPD)-12, Policy for a Common Identification Standard for Federal Employees and Contractors; OMB M-05-24; OMB M-19-17; FIPS 201, Personal Identity Verification (PIV) of Federal Employees and Contractors; HHS HSPD-12 policy; and Executive Order 13467, Part 1 §1.2.

7. Roster The Contractor (and/or any subcontractor) must 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 must 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 must 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 must provide a position description and the Government will determine the appropriate suitability level.

8. Contract Initiation and Expiration

a. General Security Requirements. The Contractor (and/or any subcontractor) must 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. All information systems development or enhancement tasks supported by the contractor must follow the FDA EPLC framework and methodology in accordance with the FDA EPLC Project documentation, located here:

http://sharepoint.fda.gov/orgs/DelMgmtSupport/IntakeProc/EPLCv2/SitePages/v2/EPL CHome.aspx and in accordance with the HHS Contract Closeout Guide (2012).

b. System Documentation. Contractors (and/or any subcontractors) must follow and adhere to HHS System Development Life Cycle requirements, at a minimum, for system http://sharepoint.fda.gov/orgs/DelMgmtSupport/IntakeProc/EPLCv2/SitePages/v2/EPL development and provide system documentation at designated intervals (specifically, at the expiration of the contract) within the EPLC that require artifact review and approval.

c. Sanitization of Government Files and Information. As part of contract closeout and at expiration of the contract, the Contractor (and/or any subcontractor) must provide all required documentation in accordance with SMGs published by FDA’s Office of Acquisitions and Grant Services (OAGS) to the CO and/or COR to certify that, at the government's direction, all electronic and paper records are appropriately disposed of and all devices and media are sanitized in accordance with NIST SP 800-88, Guidelines for Media Sanitization.

d. Notification. The Contractor (and/or any subcontractor) must notify the CO and/or COR and system ISSO as soon as it is known that a contract employee will stop working under this contract.

e. Contractor Responsibilities upon Physical Completion of the Contract. The contractor (and/or any subcontractors) must return all government information and IT resources (i.e., government information in non-government-owned systems, media, and backup systems) acquired during the term of this contract to the CO and/or COR. Additionally, the Contractor must provide a certification that all government information has been properly sanitized and purged from Contractor-owned systems, including backup systems and media used during contract performance, in accordance with HHS and FDA policies.

f. The Contractor (and/or any subcontractor) must perform and document the actions identified in the FDA eDepart system http://inside.fda.gov:9003/EmployeeResources/NewEmployee/eDepartDepartureSyste m/default.htm as soon as it is known that a contract an employee will terminate work under this contract.