FDA-SOL-21-1238491C_08092021-REVISED.docx

REVISED -- FDA-21-RFQ-1238491C

News Release/Consumer Information Distribution and Media Contact Management Services

1. DESCRIPTION/COMMERCIAL ITEM PROCUREMENT

This is a combined synopsis/solicitation for commercial items prepared in accordance with the Federal Acquisition Regulation (FAR) format in Subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; quotes are being requested and a written solicitation will not be issued. This is a Request for Quotes (RFQ) for commercial items in accordance with the procedures of FAR Part 12 - Acquisition of Commercial Items, and Part 13.5 - Simplified Procedures for Certain Commercial Items.

The associated North American Industry Classification System (NAICS) Code is 541820 – Public Relations Services.

This solicitation is unrestricted.

2. NOTICE OF FAC

This solicitation document incorporates provisions and clauses in effect through Federal Acquisition Circular FAC 2021-06, effective July 12, 2021.

FAR provisions and clauses referenced in this solicitation can be found on the following website: www.acquisition.gov. HHSAR provisions and clauses referenced in this solicitation can be found on the following website: https://www.hhs.gov/grants/contracts/contract-policies-regulations/hhsar/index.html

3. CONTRACT REQUIREMENTS

See Section 6, Statement of Work, for a full description of the supplies/services to be acquired.

4. CONTRACT TYPE

The Government anticipates awarding one (1) Firm-Fixed-Price (FFP) type contract. The total contract period of performance consists of a base year and four (4) option years.

5. PRICING

Services shall be provided in accordance with the services described in the Statement of Work.

PERFORMANCE PERIOD: Base Year – September 15, 2021 through September 14, 2022

DESCRIPTION

QUANTITIES

UNIT PRICE

EXTENDED PRICE

Text-only distributions to English national newslines via wire (unlimited length) & analytics

PERFORMANCE PERIOD: Option Year 1 – September 15, 2022 through September 14, 2023

Text-only distributions to English national newslines via wire (unlimited length) & analytics

PERFORMANCE PERIOD: Option Year 2 – September 15, 2023 through September 14, 2024

Text-only distributions to English national newslines via wire (unlimited length) & analytics

PERFORMANCE PERIOD: Option Year 3 – September 15, 2024 through September 14, 2025

Text-only distributions to English national newslines via wire (unlimited length) & analytics

PERFORMANCE PERIOD: Option Year 4 – September 15, 2025 through September 14, 2026

Text-only distributions to English national newslines via wire (unlimited length) & analytics

Text-only distributions to national Hispanic newslines (Spanish-language media) via wire (unlimited length) & analytics

Multimedia distributions (English/Spanish) via wire & analytics

Text-only email distribution to FDA English private media and internal list (unlimited length)

6. STATEMENT OF WORK

Project Title: NEWS RELEASE/CONSUMER INFORMATION DISTRIBUTION AND MEDIA CONTACT MANAGEMENT SERVICES

Background

The U.S. Food and Drug Administration (FDA), an agency within the U.S. Department of Health and Human Services (HHS), protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation and for regulating tobacco products.

The FDA’s Office of External Affairs (OEA) coordinates the FDA’s communication to the news media, health professionals, patient advocates, industry, advocacy groups, and the general public and includes the Office of Media Affairs (OMA) and the Office of Editorial and Creative Services (OECS). The OMA serves as the agency focal point for preparing, clearing, and disseminating news announcements and consumer information representing agency policy and responding to news media inquiries. The OECS serves as the agency’s focal point for communicating with the general public and produces the agency’s flagship updates for consumers and FDA Voices articles for stakeholders.

The FDA seeks to continue to ensure timely and effective dissemination of information to news media and other stakeholder groups including those representing industry and patients through a web-based communication platform that: distributes, tracks and houses all agency news announcements and other communication, including Consumer Updates and FDA Voice stakeholder contacts to be automatically updated.

Scope

The Contractor shall perform the distribution of news announcements and consumer-oriented editorial and multimedia content (i.e., visual, audio and video) via an established and reliable wire service and PR network to specified lists of print, broadcast, and online media that includes the most prominent news outlets. Distribution services shall be required on a 24-hour basis. Distribution lists must include top tier news outlets, local, national, multicultural, and international print and broadcast journalists, trade media, social media influencers, bloggers, online sites interested in FDA issues, including but not limited to: Public Interest/Consumer Issues; Medical Product Safety; Food Safety; Health; Nutrition; Tobacco Health Issues. Distribution of select content shall be provided to Spanish-speaking/Hispanic news media outlets.

Specific Tasks:

1. Access to a web-based media relations database and distribution tool

1.1 The Contractor shall provide access to a secure web-based system that allows for simultaneous multiple-user access at any given time for an unlimited number of users, and if possible, be accessible by a mobile app or other electronic handheld devices. The system shall have the ability to quickly add and subtract the number of users and control the levels of access to the system.

1.2 FDA users must have the ability to configure on-screen dashboards or report visualizations and analytics in a defined time-period.

1.3 Web-based tool shall be able of distributing press releases, including multimedia content in a responsive email template.

2. Distribution

2.1 The Contractor shall use a secured web-based communication system that disseminates via established and reliable news wire distribution channels up to 360 news releases in English and 100 news releases in Spanish or multicultural, including Consumer Updates, FDA Voice articles, and other editorial and multimedia content (i.e., visual, audio and video) per year to news media and other stakeholders.

2.2 The Contractor shall disseminate up to 30-40 press announcements and consumer health information/stakeholder updates per month.

2.3 The Contractor shall publish and distribute news announcements within 30 minutes to one hour after an FDA order was received.

2.4 The Contractor shall also have an established system for the distribution of multimedia content in formats required for the immediate use by newspapers, wire services, the broadcast media and Web sites. The FDA will provide all editorial and multimedia content (e.g. video, images, photos, infographics, audio or other) for dissemination.

2.5 The Contractor shall provide responsive email templates for distribution.

2.6 The Contractor shall manage and update OEA’s private media and other contact lists, by removing outdated contacts, updating and adding new contacts on a biweekly basis.

2.7 The Contractor shall provide support for distribution of news announcements and consumer information in English and Spanish and media contact management service.

2.8 All Contractor staff must review and sign the HHS/FDA Form 3398, entitled, “Commitment to Protect Non-Public Information Employee Agreement” prior to commencing with performance under this contract.

3. Searchable Database

3.1 The Contractor shall use a web-based system to manage all news media and other stakeholder databases which allow for an up-to-date searchable director of major U.S. and international news media organizations, reporters, influencers, and other news media including updated contact information, such as e-mail addresses.

3.2 Users should be able to build media lists easily by type, audience and geography.

3.3 Users should have the ability to create and manipulate media lists by importin or exporting contacts.

3.4 If possible, the system should include contacts for trade associations, advocacy groups, and other stakeholders.

3.5 If possible, the web-based system should automatically sync to the system’s contact database section and be routinely updated to stay current.

3.6 The searchable directory shall have the ability to create contact lists that can be automatically synched to the system’s contact database.

3.7 The Contractor shall have a unique and routinely updated database of distribution lists and not rely on the use of free Websites to distribute FDA content.

4. Reporting/Analytics Requirements

4.1 The Contractor shall track the use of the FDA content by print, broadcast, social and online media, as well as, specific websites, online communities, and blogs in “real time,” and provide the FDA with regular media monitoring reports (measurement and analytics) after each distribution.

4.2 The Contractor shall track and provide FDA with a report which summarizes the reach of the disseminated material after each media distribution is completed. These reports shall include detailed data on the number and reach of each individual outlet using the disseminated press announcements and FDA consumer health information. Each report shall be delivered with 24 hours of each distribution.

4.3 The Contractor shall provide a monthly consumption report to the COR or other designated representative.

5. Technical Support

5.1 The Contractor shall provide customer support 24 hours per day and 7 days per week.

5.2 The Contractor shall attend three (3) on-site/virtual meetings: one (1) prior to production and dissemination of the first item and two (2) additional meetings at the discretion of the Contracting Officer’s Representative (COR) during the duration of the contract. The purpose of these meetings will be to discuss expectations, deliverables, and any necessary adjustments.

5.3 Contractor shall provide kickoff meeting agenda and notes following the meeting. As well as trainings and reference materials for the use of the media relations web-based platform and its distribution services.

6. Deliverables/reporting requirements

6.1 The Contractor shall provide a system and services as described in the specific tasks above, including but not limited to technical assistance and training in those systems.

6.2 The Contractor shall submit to the COR the following deliverables.

6.3 Kick-Off Meeting:

The Contractor and the OMA Project Officer shall meet within the first week of award to go over the scope of the contract.

Base Year – September 15, 2021 – September 14, 2022

Option Year 1 – September 15, 2022 – September 14, 2023

Option Year 2 – September 15, 2023 – September 14, 2024

Option Year 3 – September 15, 2024 – September 14, 2025

Option Year 4 – September 15, 2025 – September 14, 2026

SECURITY CONSIDERATIONS

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:

a. 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.

b. 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 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:

· 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.

2) 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:

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

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

3) 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.

4) 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 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).

5) 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).

6) 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.

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

8) 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 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.

9) 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.

10) 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 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.

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 (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. All information systems development or enhancement tasks supported by the contractor shall 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/EPLCHome.aspx HHS EA requirements may be located here: https://www.hhs.gov/about/agencies/asa/ocio/index.html

2) System Documentation. Contractors (and/or any subcontractors) must follow and adhere to NIST SP 800-64, Security Considerations in the System Development Life Cycle, at a minimum, for system development and provide system documentation at designated intervals (specifically, at the expiration of the contract) within the EPLC that require artifact review and approval.

3) Sanitization of Government Files and Information. As part of contract closeout and at expiration of the contract, the Contractor (and/or any subcontractor) shall provide all required documentation in accordance with FDA OAGS SMGs 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 and FDA IS2P Appendix T: Sanitization of Computer-Related Storage Media

4) Notification. The Contractor (and/or any subcontractor) shall notify the CO and/or COR as soon as it is known that an employee will stop working under this contract.

5) Contractor Responsibilities Upon Physical Completion of the Contract. The contractor (and/or any subcontractors) shall 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 shall 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/or FDA policies.

6) The Contractor (and/or any subcontractor) shall coordinate with the COR via email, copying the Contract Specialist, to ensure that the appropriate person performs and documents the actions identified in the FDA eDepart system http://inside.fda.gov:9003/EmployeeResources/NewEmployee/eDepartDepartureSystem/default.htm as soon as it is known that an employee will terminate work under this contract within days of the employee’s exit from the contract. All documentation shall be made available to the CO and/or COR upon request.

H. Records Management and Retention

The Contractor (and/or any subcontractor) shall maintain all information in accordance with Executive Order 13556 -- Controlled Unclassified Information, National Archives and Records Administration (NARA) records retention policies and schedules and HHS/FDA policies and shall not dispose of any records unless authorized by HHS/FDA.

In the event that a contractor (and/or any subcontractor) accidentally disposes of or destroys a record without proper authorization, it shall be documented and reported as an incident in accordance with HHS/FDA policies.

PERSONNEL

The Contractor shall ensure that all Contractor support are adequately trained, possess the requisite experience, and are otherwise fully qualified to provide the high level of support required by this contract and provide the required services. Personnel must have demonstrable experience in the work areas described herein. The Contractor shall provide current staffing plans, bios, and organizational charts to the FDA project manager during the term of this contract.

PERIOD OF PERFORMANCE

The period of performance is anticipated to be twelve (12) months from the contract effective date, with four (4) option years.

PLACE OF PERFORMANCE

Work shall take place at the Contractor’s facilities and on-line

CONTRACT TYPE

The resulting order is anticipated to be a Firm-Fixed-Price order.

TRAVEL:

No travel paid.

CONTRACT ADMINISTRATION

Contract Specialist/Contracting Officer:

Alice Mihill Office of Operations, Office of Finance Budget & Acquisitions Office of Acquisitions and Grants Services Tel: 301-796-3247 Alice.Mihill@fda.hhs.gov

Contracting Office Representative (COR)

TBD

FDA Office of Media Affairs Tel: TBD

Technical Experts

TBD

FDA Office of Media Affairs Tel: TBD

NON-PERSONAL SERVICES

The Government and the Contractor understand and agree that the services delivered by the Contractor to the Government are non-personal services. The parties also recognize and agree that no employer-employee relationship will exist between the Government and the Contractor. The Contractor and the Contractor’s employees are not employees of the Federal Government and are not eligible for entitlement and benefits given Federal employees.

Contractor personnel under this contract shall not:

· Be placed in a position where there is an appearance that they are employed by a Federal Officer, or are under the supervision, direction, or evaluation of a Federal Officer.

· Be placed in a position of command, supervision, administration or control over personnel or personnel of other Government contractors, or become a part of the Government organization.

· Be used in administration or supervision of procurement activities.

INSPECTION AND ACCEPTANCE

All work under this contract is subject to inspection and final acceptance by the Contracting Officer or the duly authorized representative of the Government. The Government’s Contracting Officer’s Representative (COR) is a duly authorized representative of the government and is responsible for inspection and acceptance of all items to be delivered under this contract.

· Accuracy: Work products shall be accurate in presentation, technical content, and adherence to accepted elements of style.

· Technical Soundness: Work products, especially digital work products, shall exhibit no technical flaws.

· Comprehensiveness: Work products, especially qualitative and quantitative research, shall have sufficient strength to make the research sufficiently measurable and therefore meaningful.

· Clarity: Work products shall be clear and concise. Diagrams shall be easy to understand and be relevant to the supporting narrative.

· Creative: Work products shall exhibit fresh, new ideas and innovative tools and materials that effectively reach and engage target audiences.

· Consistency to Requirements: All work products must satisfy the requirements of the statement of work.

· Timeliness: Work products shall be submitted by the due date specified in this statement of work or submitted in accordance with a later scheduled date determined by the Government.

· File Editing: All text and diagrammatic files shall be editable by the Government.

· Format: Work products shall be submitted electronically and in the format mutually agreed upon prior to submission.

All services delivered to the COR will be deemed to have been accepted 30 calendar days after date of delivery, except as otherwise specified in this contract, if written approval or disapproval has not been given within such period. The COR’s approval or revision to the services delivered shall be within the general scope of work stated in this contract.

FEDERAL ACQUISITION REGULATION (FAR) PROVISIONS AND CLAUSES:

FAR Provisions Incorporated by Reference:

FAR 52.203-18 Prohibition on Contracting with Entities that Require Certain Internal Confidentiality Agreements or Statements-Representation (Jan 2017)

FAR 52.204-24 Representation Regarding Certain Telecommunications and Video Surveillance Services or Equipment (OCT 2020)

FAR 52.204-26 Covered Telecommunications Equipment or Services – Representation (OCT 2020)

FAR 52.212-1 Instructions to Offerors—Commercial Items (JUL 2021) is applicable to this solicitation.

FAR 52.212-3 Offeror Representations and Certifications—Commercial Items (FEB 2021)

○ This provision applies to this solicitation. Offerors shall provide the required data with their quotations in accordance with FAR 52.212-3. (Please include completed representations and certifications, not already completed in SAM.gov.)

Federal Acquisition Regulation (FAR) Clauses

FAR 52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998)

This contract incorporates one or more clauses by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. Also, the full text of a clause may be accessed electronically at this/these address(es):

FAR: https://www.acquisition.gov/ HHSAR: https://www.hhs.gov/grants/contracts/contract-policies-regulations/hhsar/index.html (End of clause)

FAR 52.204-18 Commercial and Government Entity Code Maintenance (AUG 2020) FAR 52.204-23 Prohibition on Contracting for Hardware, Software, and Services Developed or Provided by Kaspersky Lab and Other Covered Entities (JUL 2018) FAR 52.204-25 Prohibition on Contracting for Certain Telecommunication and Surveillance Services or Equipment (AUG 2020) FAR 52.212-4 Contract Terms and Conditions—Commercial Items (OCT 2018) FAR 52.219-14 Limitations on Subcontracting (MAR 2000) FAR 52.227-14 Rights in Data—General (MAY 2014) FAR 52.232-40 Providing Accelerated Payments to Small Business Contractors (DEC 2013) FAR 52.242-15 Stop-Work Order (AUG 1989) FAR 52.245-1 Government Property (JAN 2017)

FAR 52.212-5 Contract Terms and Conditions Required to Implement Statutes or Executive Orders—Commercial Items (JUL 2021)

The additional FAR Clauses cited in this clause that have an “X” next to them are applicable to this solicitation. Full text of this clause is provided in (Attachment G).

FAR Clauses in Full Text

FAR 52.203-19 Prohibition on Requiring Certain Internal Confidentiality Agreements or Statements (JAN 2017)

(a) Definitions. As used in this clause– “Internal confidentiality agreement or statement” means a confidentiality agreement or any other written statement that the contractor requires any of its employees or subcontractors to sign regarding nondisclosure of contractor information, except that it does not include confidentiality agreements arising out of civil litigation or confidentiality agreements that contractor employees or subcontractors sign at the behest of a Federal agency.

“Subcontract” means any contract as defined in subpart 2.1 entered into by a subcontractor to furnish supplies or services for performance of a prime contract or a subcontract. It includes but is not limited to purchase orders, and changes and modifications to purchase orders.

“Subcontractor” means any supplier, distributor, vendor, or firm (including a consultant) that furnishes supplies or services to or for a prime contractor or another subcontractor.

(b) The Contractor shall not require its employees or subcontractors to sign or comply with internal confidentiality agreements or statements prohibiting or otherwise restricting such employees or subcontractors from lawfully reporting waste, fraud, or abuse related to the performance of a Government contract to a designated investigative or law enforcement representative of a Federal department or agency authorized to receive such information (e.g., agency Office of the Inspector General).

(c) The Contractor shall notify current employees and subcontractors that prohibitions and restrictions of any preexisting internal confidentiality agreements or statements covered by this clause, to the extent that such prohibitions and restrictions are inconsistent with the prohibitions of this clause, are no longer in effect.

(d) The prohibition in paragraph (b) of this clause does not contravene requirements applicable to Standard Form 312 (Classified Information Nondisclosure Agreement), Form 4414 (Sensitive Compartmented Information…