FDA_RFQ_130905.pdf

REQUEST FOR

QUOTE

Web-Based Communications Platform

FDA-RFQ - 130905

DATE POSTED: August 15, 2025

RESPONSE DATE: August 26, 2025, by 1:00PM EST

CLASSIFICATION CODE: R708 – Support Management Public Relations

NAICS CODE: 541820 – Public Relations Agencies

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; proposals are being requested and a written solicitation will not be issued. It is the Government's intent to issue a Firm Fixed Priced Purchase Order in accordance with FAR Part 13.

The solicitation number is FDA-SOL-75F40125Q00280. This solicitation is issued as a Request for Quote (RFQ). This is a Full and Open Competition.

The solicitation document and incorporated provisions and clauses in effect through the Federal Acquisition Circular 2025-05, effective 07 August 2025. FAR and HHSAR provisions and clauses referenced in this RFQ can be found on the following website:

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

1. Statement of Need __________________________________________________________

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.

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

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.

2. Objective__________________________________________________________________

The objective of this award is to provide a web-based communication platform that enables timely and effective dissemination of information such as agency news announcements and other communications to news media and other stakeholder groups including those representing industry and patients, through integrated media distribution services, monitoring and analytics services, and comprehensive media management.

3. Scope______________________________________________________________________ The objective of this award is to provide a web-based communication platform that enables timely and effective dissemination of information such as agency news announcements and other communications to news media and other stakeholder groups including those representing industry and patients, through integrated media distribution services, monitoring and analytics services, and comprehensive media management.

4. Tasks _____________________________________________________________________

4.1 Task One: Project Management

The Contractor shall provide project management to establish control, management, monitoring, and notification mechanisms, ensuring that contracted tasks and costs stay on track while milestones, and performance measures are met. Additionally, the Contractor shall provide a contact person(s) available 24/7 to discuss and respond to FDA work requests.

Services / Supplies and Total Price

Item Hours/Month Rate Total Price Project Manager (0.2 FTE) Subtotal

4.1.1 Sub-Task One: Kick-off Meeting

Within five (5) business days after the effective date of the award, the Contractor shall participate in a Kick-Off Meeting with OC management and the COR. The Contractor shall provide meeting materials and the agenda two (2) days prior to the Kick-off meeting. The Contractor shall prepare summary meeting minutes detailing the discussion held. The Contractor shall provide a copy of the minutes to the COR within five (5) business days after the meeting.

4.1.2 Sub-Task Two: Monthly Status Reports

The Contractor shall submit monthly status reports to the FDA Project Manager and COR. The report shall summarize progress toward completion of work requests and identify any problems requiring management attention. The Contractor must submit the Monthly Status Report no later than the fifth (5th) day of each month.

4.2 Task Two: Media Relations Database and Distribution tool

The Contractor shall provide access to a secure web-based system that allows for simultaneous multiple-user access at any given time for up to 5 users, be accessible by a mobile app or other electronic handheld devices. The system shall have the ability to quickly provision and deprovision users and control the levels of access to the system.

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

The web-based platform shall be able of distributing press releases, including multimedia content in a responsive email template.

The system shall comply with federal security requirements including data encryption, secure authentication, and audit trail capabilities.

Services / Supplies and Total Price

Item Qty / Unit Total Price Platform licensing (mid-tier) 12 / Months System configuration - Streamlined setup User administration - Basic provisioning

4.3 Task Three: Distribution

The Contractor shall provide a secured web-based communication system that disseminates news releases and other editorial and multimedia content (i.e., visual, audio and video) to news media and other stakeholders via established and reliable news wire distribution channels.

The Contractor shall provide a system to disseminate up to 40 press announcements and consumer health information/stakeholder updates per month.

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

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.

The Contractor shall provide responsive email templates for distribution.

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.

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

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.

Item Qty / Unit Total Price

Wire service distribution - 360 releases Multimedia distribution - 120 items Email template management - 12 months

4.4 Task Four: Searchable Database

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

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

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

The system should include contacts for trade associations, advocacy groups, and other stakeholders.

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

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

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.

Item Qty / Unit Total Cost Database licensing - Standard media database Biweekly updates - 26 updates × $154 Basic import/export - Standard functionality

4.5 Task Five: reporting/analytics requirement

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.

The Contractor shall provide a media monitoring capability across print, online, broadcast, and podcasts based on key works or user entered criteria.

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 within 24 hours of each distribution.

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

Services / Supplies and Total Price

Item Qty / Unit Total Cost Standard monitoring - Continuous Distribution reports - 360 reports Monthly reports - 12 reports Dashboard access - Annual

4.6 Task Six: technical support

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

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.

Contractor shall provide training and reference materials for the use of the media relations web-based platform and its distribution services.

Item Qty / Unit Total Cost Business hours support + on-call Training sessions (3) Basic documentation

4.7 Format Of Deliverables

The Contractor shall deliver all products to the FDA COR, various programmatic staff, and/or CO, where applicable. Electronic transmission shall be the primary delivery mechanism. Electronic copies must be in a format compatible with Office 365 and Adobe Acrobat (version 10 or later).

Be advised that the FDA does not accept documents which contain the use of macros. Document submissions required throughout the period of performance of this contract must not have macro-enabled functionality, and any document delivered having that functionality will be deemed delinquent, if not corrected prior to the due date.

4.8 Deliverables Submission Procedure

The Contractor shall submit all deliverables to the COR, unless otherwise stated. The COR will be responsible for the review of all draft and final deliverables to ensure accuracy, functionality, completeness, professional quality, and overall compliance with the requirements of the task. The Contractor shall ensure the accuracy and completeness of all deliverables in accordance with referenced policy, regulations, laws, and directives. Reports and presentations shall be concise and clearly written; errors, misleading or unclear statements, incomplete or irrelevant information, and/or excessive rhetoric, repetition, and "padding,” or excessive length if a page limit is imposed, shall be considered deficiencies and will be subject to correction by the Contractor at no additional cost to the government.

Unless specified otherwise, the government shall have ten (10) working days to complete the review and approve the deliverables. If deficiencies are found or areas require modification, the Contractor will be notified and shall have five (5) calendar days to correct the deficiencies. Upon re-submission by the Contractor, the government will reapply the same acceptance criteria. If the deliverable does not meet the acceptance criteria a second time, the government may consider the Contractor as having deficient performance with respect to the subject task.

4.9 Summary of Deliverables

Task Deliverables Frequency Due Date

4.1.1 Kick-off meeting agenda 1 Within five (5) business days after the effective date of the award.

4.1.1 Kick-off meeting minutes 1 Within five (5) business days after the kick-off meeting

4.1.2 Monthly Status Reports 12 (one per month) No later than the fifth (5th) business day of the following month

4.5 Media monitoring reports

(measurement and analytics) As needed Within 24 hours after each distribution

4.5 Report which summarizes the reach of the disseminated material

As needed Within 24 hours after each distribution

4.6 Initial group training and

reference materials 1 1st week after award

4.6 Supplemental group trainings

and reference materials 2 As needed

5. Period of performance_______________________________________________________ The Period of Performance is a base period, (9/30/2025 – 9/29/2026). Work shall take place at the Contractor’s facilities.

6. Contract Type_______________________________________________________________ This order is a firm-fixed-price order.

7. Conformance with Applicable Laws, Regulations, Policies, and Standards____________ Contractor Compliance The Contractor shall be responsible for knowledge of, and compliance with all applicable federal information technology and information management laws, regulations, policies, and standards at the government-wide, HHS, and FDA levels. At the government-wide level, these include Office of Management and Budget (OMB), National Institute of Standards and Technology (NIST), and General Accounting Office (GAO). These can be primarily found at or through the Federal CIO Council website at:

http://www.cio.gov/. HHS documents are found at: http://www.hhs.gov/oirm/

Section 508 Standard Compliance Section 508 of the Rehabilitation Act of 1973 (29 U.S.C. 794d), as amended by the Workforce Investment Act of 1998, requires that all electronic and information technology (EIT) products and services developed, acquired, maintained, or used under this order must comply with the “Electronic and Information Technology Accessibility Provisions” set forth by the Architectural and Transportation Barriers Compliance Board (also referred to as the “Access Board”) in 36 CFR part 1194. Information about Section 508 is available at http://www.section508.gov/. The complete text of Section 508 Final Provisions can be accessed at http://www.access-board.gov/sec508/provisions.htm

Special Notice and Agreement Regarding Software EULA/TOS

Computer software and services are often subject to license agreements, referred to as End User License Agreements (EULA), Terms of Service (TOS), or other similar legal instruments or agreements. Many of these agreements contain indemnification clauses that are inconsistent with Federal law and unenforceable, but which could create a violation of the Anti-Deficiency Act (31 U.S.C. 1341) if agreed to by the Government.

Therefore, by submitting a quotation the all offeror shall agree that the inclusion of any Limitation of Liability, Indemnification, and any other clauses that conflict with Federal law or regulation in any EULA or TOS are NULL AND VOID. The offeror agrees that any EULA/TOS clauses conflicting with Federal law or regulation and are not agreed to by the Government if included with the submission of a quotation.

Additionally, by submission of the quotation the offeror shall agree to the inclusion of FAR 52.232-39 Unenforceability of Unauthorized Obligations in any resulting contract or order, if awarded.

8. Inspection and Acceptance______________________________________________________

The Contracting Officer’s Representative (COR) will verify that the software is functioning properly. The Government shall have 10 working days to inspect and verify that the software is operational, functional, and compatible with FDA server and software.

Completion of all deliverables, quality, and timeliness of delivery, as well as incidents and types of defects, will be used to evaluate the Contractor’s progress and suitability.

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.

http://www.cio.gov/ http://www.hhs.gov/oirm/ http://www.section508.gov/ http://www.access-board.gov/sec508/provisions.htm

- 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.

9. Government Furnished Equipment/Information____________________________________

Government furnished property (materials, equipment, and/or information) is to be provided in conjunction with required performance under this contract as determined by mutual agreement between FDA and the Contractor.

When the Government provides equipment, then the Contractor shall maintain a detailed inventory accounting system for Government Furnished Property (GFP) following contract award. The inventory accounting system must specify, at a minimum:

• Product description (make, model)

• Government tag number

• Date of receipt

• Name of receipt

• Location of receipt

• Current location

• Contract/order number under which the equipment is being used

The Contractor shall attach an update inventory report to each MPR unless otherwise specified by the COR.

In either case, the Contractor’s inventory listing must be available for Government review within one (1) business day of COR request. The Contractor shall remain responsible and accountable for all GFP for the duration of the contract and ensure the return of the property upon completion of all work required under this contract.

Government Furnished Information / Reference Material

The Government will furnish information as needed for the Contractor to fulfill the obligations of the contract. The contractor shall not release any information concerning the contract or any information gained due to such work without the advance, written consent of the contracting officer. Much of the work performed shall be considered management confidential and may at times be subject to the Privacy Act.

All contractor work product produced by the contractor while under contract with the FDA shall be considered the property of the Federal Government.

10. Key Personnel_________________________________________________________________ The key personnel specified in this contract is essential to work performance. Pursuant to Health and Human Services Acquisition Regulation (HHSAR) Clause 352.237-75, Key Personnel (December 2015), the following positions are key personnel for this Task Order. Proposed changes to staffing or changes to level of key personnel support shall be coordinated with the COR to ensure the change or diversion will not negatively impact the contract.

Project Manager: Responsible for oversight of one or several complex projects. Responsible for problem solving, innovative solutions involving schedule, technology, methodology, tools, solution components, and financial management/tracking of the project.

11. Travel _______________________________________________________________________ Local travel may be required to attend training or meetings in the DC Metro area under this Contract. The Contractor shall not be reimbursed for local travel costs. The Contractor shall comply with all Federal Travel Regulation (FTR) regulations when engaging in travel. The FTR is available at http://www.gsa.gov

12. Contract Administration________________________________________________________

Contracting Officer (CO):

Roosevelt Walker Email: roosevelt.walker@fda.hhs.gov

Contracting Officer’s Representative (COR): (To be entered at time of award)

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

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

14. IPP Invoicing Instructions_______________________________________________________

(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 in FAR 32.905(b), “Content of Invoices” and the applicable Payment clause included in this contract, or the clause 52.212-4 Contract Terms and Conditions – Commercial Items included in commercial items contracts. The IPP website address is:

https://www.ipp.gov.

(c) The Agency will enroll 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 http://www.gsa.gov/ mailto:roosevelt.walker@fda.hhs.gov

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.

(1) Registration emails are sent via email from ipp.noreply@mail.eroc.twai.gov. or phone (866)

973- 3131. Contractor assistance with enrollment can be obtained by contacting the IPP Production Helpdesk via email to IPPCustomerSupport@fiscal.treasury.gov or phone (866) 973-3131.

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

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

(4) If the Contractors unable to comply with the requirement to use IPP for submitting invoices for payment as authorized by HHSAR 332.7002, a written request must be submitted to the Contracting Officer to explain the circumstances that require the authorization of alternate payment procedures.

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

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

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

(1) At a minimum the following cost information shall be included, in addition to supporting documentation to substantiate costs incurred. -Direct Labor-include all persons, listing the person's name, title, number of hours worked, hourly rate, the total cost per person and a total amount for this category.

-Indirect Costs (i.e., Fringe Benefits, Overhead, General and Administrative, Other Indirect)-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– amountasallowableinaccordancewiththeScheduleandFAR52.216-8ifapplicable.

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

(1) list of all invoices submitted to date under the subject award, including the following: invoice number, amount, & date submitted-corresponding payment amount &date received -totalamountofallpaymentsreceivedtodateunderthesubjectcontractororder-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.

mailto:IPPCustomerSupport@fiscal.treasury.gov

(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.

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

16. Inspection & Acceptance_______________________________________________________ Inspection and acceptance will be at destination in accordance with FAR clause 52.212-4(a). In accordance with FAR 52.212-4(a), the Government has the right either to reject or to require correction of nonconforming supplies. Supplies are nonconforming when they are defective in material or workmanship or are otherwise not in conformity with contract requirements. The Government may reject nonconforming supplies with or without disposition instructions.

The COR will perform inspection and acceptance of all products and services. The performance criteria for these products shall be timely delivery and closure of all activities and deliverables listed above and within the established Period of Performance.

Inspection and acceptance will occur at the place of delivery. Inspection will include verifying all parts were received and warranties and services are in place. The Government will accept goods and services only if they conform to all terms and conditions of this order. The Government will provide written notification of acceptance or rejection within ten (10) business days of receiving the delivery.

The Government will reject non-conforming products and services. The Contractor shall correct any deficiencies within thirty (30) days of when the Government issues the rejection notice. If the Contractor cannot correct the deficiencies within this time frame, the Contractor shall immediately notify the COR or technical POC of the reason for the delay and provide a proposed corrective action plan within ten (10) business days.

All quoter’s shall be Authorized reseller and/or servicing agent shall identify and/or provide documentation to confirm their claim as an authorized reseller and/or servicing agent.

All Offerors quote shall clearly state license number, product description, quantity, price, and period of performance for each product. The quotation shall include and match license number, product description, quantity, and period of performance. Offerors are advised that should their quotation conflict with or does not clearly reflect the specified product and requirement of this solicitation, their quotation may be deemed as technically unacceptable and may not be considered for award.

Price: Provide detailed price quote for each item proposed to meet the Schedule of Items. Include the firm’s Unique Entity Identifier (UEI) number with quote. The option year periods will not be funded at time of award. If exercised, funding will be obligated individually each year for the option period exercised via contract modification; the option periods shall be priced accordingly.

The offeror or applicant shall submit all electronic documents for Microsoft Office suite products without the use of macros. If the offeror or applicant submits documents that contain macros the Government will not be able to view or open such documents and the submission will be considered non-responsive to the solicitation. No additional time will be given to an offeror or applicant to correct the document submission and the Government will not inform the offeror or applicant that their submission is non-responsive prior to award. It is the offerors or applicant’s responsibility to ensure all electronic documents are submitted without the use of macros.

17. 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.

2) 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 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 and/or COR Designee or emailing your ISSO.

3) Comply with the Privacy Act requirements and tailored FAR clauses. Information

Security Categorization. In accordance with FIPS 199 and National Institute of Standards and Technology (NIST) Special Publication (SP) 800-60, Volume II:

Appendices to Guide for Mapping Types of Information and Information Systems to Security Categories, Appendix C, and based on information provided by the ISSO or other security representative, the risk level for each Security Objective and the Overall Risk Level, which is the highest watermark of the three factors (Confidentiality, Integrity, and Availability) of the information or information system are the following:

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

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

[] No PII [X] 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

4) 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.

5) 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 anysubcontractor) 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).

6) 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).

7) 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.

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

9) 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 and/or COR Designee upon request and at the conclusion of the contract.

Upon completion of contract, contractor ensures that COR and/or COR Designee is able to access and read any encrypted data.

10) 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 and/or COR Designee prior to performing any work under this acquisition.

11) Privacy Threshold Analysis (PTA)/Privacy Impact Assessment (PIA) – The Contractor shall assist the procuring activity representative, program office and the FDA Senior Official for Privacy (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 PTAfor 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.

3 Training

12) 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.

13) 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).

14) 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 and/or COR Designee within 30 days after contract award and annually thereafter or upon request.

4 Rules of Behavior

15) 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.

16) 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 and/or COR Designee per defined timelines.

5 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…