2026-01-26 RFQ 75F40126Q00019 Ergonomics.pdf

FDA Nationwide Ergonomic Services Request for Quotation (RFQ) No. 75F40126Q00019

1. DESCRIPTION/COMMERICAL SERVICES PROCUREMENT

This is a combined synopsis/solicitation for commercial services prepared in accordance with the format set forth at Department of Health and Human Services (HHS) Federal Acquisition Regulation (FAR) Class Deviation (CD) No. 2025-09, Amendment 1 (Nov. 3, 2025), Revolutionary FAR Overhaul (RFO) FAR 12.202(b)(1) (Aug. 14, 2025). This announcement constitutes the only solicitation. Quotations are being requested, and a separate written solicitation will not be issued. Solicitation number 75F40126Q00019 is issued as a request for quotation (RFQ) for nationwide ergonomic services.

This acquisition is a total set-aside for small business concerns in accordance with HHS FAR CD No. 2026-01 (Nov. 21, 2025), RFO FAR 19.104-1 (Sept. 26, 2025). The associated North American Industry Classification System (NAICS) code is 541690- Other Scientific and Technical Consulting Services. The associated small business size standard is $19 million.

2. NOTICE OF FAC

This solicitation document incorporates FAR provisions and clauses in effect through Federal Acquisition Circular (FAC) 2025-06, effective October 1, 2025. This solicitation incorporates provisions and clauses by reference. The full text of provisions and clauses may be accessed electronically at www.acquisition.gov.

The Department of Health and Human Services (HHS) Acquisition Regulation (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. PURCHASE ORDER REQUIREMENTS

See Section 7, Statement of Work, for a full description of the services to be acquired.

4. ORDER TYPE

The Government anticipates awarding one (1) Time-and-Materials (T&M) type Purchase Order.

5. PERIOD OF PERFORMANCE

The anticipated period of performance consists of one (1) Base Year and four (4) Option Years, as set forth below, and a 6-month Option to Extend Services per FAR 52.217-8:

• Base Year: March 30, 2026, through March 29, 2027

• Option Year 1: March 30, 2027, through March 29, 2028

• Option Year 2: March 30, 2028, through March 29, 2029

• Option Year 3: March 30, 2029, through March 29, 2030

• Option Year 4: March 30, 2030, through March 29, 2031 http://www.acquisition.gov/ https://www.hhs.gov/grants/contracts/contract-policies-regulations/hhsar/index.html

• 6-Month Option to Extend Services: March 30, 2031, through September 29, 2031

The actual period of performance will be determined at time of award.

6. PRICING

Anticipated Period of Performance: Base Year (March 30, 2026, through March 29, 2027)

LABOR PRICES

Labor Category Est. Number of Labor

Hours Government Site Hourly Rate

Extended Price

Ergonomist 2,564 $ $ Project Manager 400 $ $ Total Labor Price $

MATERIALS PRICES

Other Direct Costs (ODCs)

Not to Exceed (NTE) Price

Travel $40,000.00 Total Materials Price $40,000.00 Base Year Time-and-Materials (T&M) Ceiling Price $

Anticipated Period of Performance: Option Year 1 (March 30, 2027, through March 29, 2028)

LABOR PRICES

Labor Category Est. Number of Labor

Hours Government Site Hourly Rate

Extended Price

Ergonomist 2,564 $ $ Project Manager 492 $ $ Total Labor Price $

Travel $42,000.00 Total Materials Price $42,000.00 Option Year 1 Time-and-Materials (T&M) Ceiling Price $

Anticipated Period of Performance: Option Year 2 (March 30, 2028, through March 29, 2029)

LABOR PRICES

Labor Category Est. Number of Labor

Hours Government Site Hourly Rate

Extended Price

Ergonomist 2,564 $ $ Project Manager 492 $ $ Total Labor Price $

Travel $44,000.00 Total Materials Price $44,000.00 Option Year 2 Time-and-Materials (T&M) Ceiling Price $

Anticipated Period of Performance: Option Year 3 (March 30, 2029, through March 29, 2030)

LABOR PRICES

Labor Category Est. Number of Labor

Hours Government Site Hourly Rate

Extended Price

Ergonomist 2,564 $ $ Project Manager 492 $ $ Total Labor Price $

Travel $46,000.00 Total Materials Price $46,000.00 Option Year 3 Time-and-Materials (T&M) Ceiling Price $

Anticipated Period of Performance: Option Year 4 (March 30, 2030, through March 29, 2031)

LABOR PRICES

Labor Category Est. Number of Labor

Hours Government Site Hourly Rate

Extended Price

Ergonomist 2,564 $ $ Project Manager 492 $ $ Total Labor Price $

Travel $47,000.00 Total Materials Price $47,000.00 Option Year 4 Time-and-Materials (T&M) Ceiling Price $

Anticipated Period of Performance: 6-Month Option to Extend (March 30, 2031, through September 29, 2032)

LABOR PRICES

Labor Category Est. Number of Labor

Hours Government Site Hourly Rate

Extended Price

Ergonomist 1,282 $ $ Project Manager 246 $ $ Total Labor Price $

Travel $23,500.00 Total Materials Price $23,500.00 6-Month Option Time-and-Materials (T&M) Ceiling Price $

Total Purchase Order T&M Ceiling Price $

The rate, or rates, set forth above cover all expenses, including report preparation, salaries, overhead, general and administrative expenses, and profit. The labor categories and numbers of hours listed in the Pricing Table above comprise the Government’s best estimate of the labor mix required for successful performance of the Purchase Order. While actual performance staffing requirements may vary, the total amount obligated for award will comprise the Ceiling Amount for each Period of Performance and is not anticipated to change after award.

7. STATEMENT OF WORK

STATEMENT OF WORK (SOW)

U.S. FOOD AND DRUG ADMINISTRATION (FDA)

OFFICE OF THE CHIEF SCIENTIST (OCS)

OFFICE OF OCCUPATIONAL SAFETY AND HEALTH (OOSH)

NATIONWIDE ERGONOMIC SERVICES

BACKGROUND

The Occupational Safety and Health Act of 1970 requires employers to furnish to each of their employees a place of employment which is free from recognized hazards that are causing or likely to cause death or serious physical harm.

At the Food and Drug Administration (FDA), the Office of Occupational Safety and Health (OOSH) provides a comprehensive ergonomics program with focus on a proactive approach to increase productivity, through the prevention of musculoskeletal disorders (MSDs), while reducing the FDA’s liability for workers’ compensation related costs.

OOSH continues to have an enterprise-wide ergonomics program with continuous process and support methods to support modernization. Coupled with supporting organization office moves, hiring new FDA employees, and conducting laboratory assessment needs, OOSH has requirements that need to support the well-being of the current workforce, ensure that the onsite offices and laboratories are conducive to productive work, and support reasonable accommodation requests.

The mission of the FDA’s Ergonomics Program is to minimize or eliminate potential harm to employees caused by repetitive motions. Each ergonomic assessment educates FDA workers on posture and behavior awareness.

PURPOSE

The purpose of this Purchase Order is to obtain Contractor support to assist the FDA’s Office of Occupational Safety and Health (OOSH) in facilitating a safe and healthy work environment for FDA employees through ergonomic consultative services. The FDA seeks Contractor support to provide a wide range of nationwide ergonomic services including, but not limited to: ergonomic assistance in office workstations; ergonomic equipment handling; and laboratory, vivarium, and support space ergonomic consultations.

SCOPE OF WORK

This Statement of Work (SOW) describes the requirements, level of effort, services and expected outcomes for the contractor to provide certified ergonomists for ergonomic consultative services for FDA’s workforce. This SOW covers support that will enhance/augment OOSH by providing overarching integrated support in the areas of ergonomics.

The Contractor shall provide the FDA with the following services: (1) ergonomic education presentations, trainings, and participation at FDA or OOSH sponsored health fairs or similar events held periodically; (2) ergonomic consultation regarding the selection of furniture and equipment as needed; and (3) staffing for the ergonomics assessments needed at FDA facilities such as White Oak, College Park, and Rockville in Maryland, and at other FDA regional offices located throughout the United States.

TASKS

Ergonomic Assessment:

To support the program mission and reinforce the concept that ergonomics is behavior, not products, the ergonomic assessment shall be comprehensive to ensure the customer has learned proper body positioning to 1) increase worker productivity, 2) include adjustments to current office furniture/equipment to prevent or correct current work practices that increase their risk for musculoskeletal disorders (MSD), and 3) educate customers on posture/behavior modifications that will aid them in continuing their ergonomic health.

The Contractor shall perform the following tasks:

Receive appointment notifications for ergonomic assessments for assessments using the Ergonomic Appointments calendar that is coordinated with FDA’s Employee Resource and Information Center (ERIC) administrative system, or direct contact. Systems knowledge such as FDA’s administrative scheduling and tracking systems is preferred.

The Contractor shall respond to ergonomic inquires received in the FDA Ergonomics email account and/or from ERIC Safety Coordination Agency Ergonomics tickets, to include scheduling those requesting an ergonomic assessment. No later than three (3) business days from the date of receiving the ERIC ticket request, ergonomic assessments will be scheduled on the internal ergonomics calendar.

Conduct ergonomic assessments, submit detailed written ergonomic reports with evaluation findings and recommendations to reduce the risk of musculoskeletal injuries in staff who work in a variety of environments, including office/computing workstations, materials handling, laboratory, vivarium, and associated support spaces.

The ergonomic report should provide a justification for any recommended ergonomic equipment that the FDA customer’s office would need to purchase if it is reasonable accommodation-required assessment. The Ergonomics Program does not suggest FDA’s purchase of furniture or equipment if it is not a reasonable accommodation-required assessment.

Due to the vast diversity of FDA workers each ergonomic assessment is inherently unique to each worker and their requirements and workstation environments. Experience with performing a variety of ergonomic assessments is necessary.

Examples of the various ergonomic assessment types are, but not limited to:

Health Assessment These evaluations are a concise, yet effective approach to controlling workplace-related musculoskeletal disorders (MSD) and providing ergonomic education to the customer for health reasons. These types of evaluations would be best applied when going into a new workstation, returning to office, renovating workspaces, relocating customers, or as part of a new hire onboarding. A detailed written report of overall ergonomic conditions within workstations and work areas shall be provided, with recommendations for remediation of risk factors and topics covered with the customer that promoted ergonomic education.

Reasonable Accommodations (Medical Necessity) Assessments These evaluations are more extensive and shall be performed for those workers experiencing or attempting to alleviate MSD symptoms, or those who have had a physician referral, and may or may not be initiated in response to a reasonable accommodation request received through HHS/FDA’s Reasonable Accommodations Office. In addition to the work site consultation, the Contractor shall provide a detailed written report of overall ergonomic conditions within workstations and work areas, including recommendations for remediation of risk factors and discussion of any items that a physician may have prescribed for the customer.

Post-Injury Assessments These evaluations shall be performed for those workers with pre-existing MSD or those who have had a physician referral for an injury. A detailed written report of overall ergonomic conditions within workstations and work areas shall be provided, with recommendations for remediation of risk factors and discussion of any items that a physician may have prescribed for the customer.

Assistive Technology Assessments These evaluations shall be performed for those workers with a need for assistive technology equipment recommendations or to better understand how to use their assistive technology (e.g., Dragon Speech, Microsoft Speech). A detailed written report of overall ergonomic conditions within workstations and work areas shall be provided, with recommendations for remediation of risk factors and discussion of any items that a physician may have prescribed for the customer.

Virtual Assessments These evaluations shall be performed for FDA workers using both audio and visual government furnished property for any FDA worker requesting an ergonomic assessment, at the discretion of the COR. A detailed written report of overall ergonomic conditions within workstations and work areas shall be provided, with recommendations for remediation of risk factors and discussion of any items that a physician may have prescribed for the customer.

Follow-Up Assessments These evaluations are designed to ensure that workstation recommendations and equipment modifications previously performed have been implemented properly. The visit shall include: 1) answering questions, 2) reviewing with staff the proper positioning and adjustment features of the new equipment, 3) obtaining feedback on customer application of the behavior/posture changes they implemented since having their initial ergonomic assessment 4) addressing any customer challenges or new ergonomic concerns.

All ergonomic reports (drafts/finals reports) are to be created and stored on the FDA’s internal network, to record ergonomic assessment findings, recommendations and subsequent actions.

Ergonomic reports will be written using proper grammar/punctuation and written in a clear manner with terms that the average person would be able to comprehend or an explanation of the terminology used. Customer service, and quality assurance are a priority, therefore, the contractor must proofread all reports prior to dissemination.

Provide in-service training, regarding ergonomics and providing information to the customer that can be used to augment their safety and comfort at work while reducing their risk of MSDs. This training may be created by the Contractor or provided by the Contracting Officer’s Representative (COR) and the content will be FDA location specific. All created visual aids such as Power Point and demonstration items (e.g., diagrams and workstation set-up) elements shall be stored on the internal FDA network. All created trainings will be FDA property.

DELIVERABLES

The following deliverables shall be delivered electronically utilizing the Government-furnished laptop:

Deliverable Due Date Recipient Delivery Method Ergonomic Assessment Report (that may include both before and after photos)

– secure locations will be the exception.

Within seven (7) calendar days from the completed ergonomic consultation.

FDA

Employee

1. Email

2. Saved and stored to the FDA Network via the designated Ergo Program shared drive

Ergonomic Equipment Recommendation(s) Report.

If applicable, within seven (7) calendar days from the completed ergonomic consultation.

FDA

Employee

1. Email

2. Saved and stored to the FDA Network via the designated Ergo Program shared drive

CONTRACTOR PERSONNEL

The Contractor shall provide necessary personnel to maintain performance standards and accomplish required services. Contractor personnel shall possess:

1. Legal citizenship of the United States.

2. All contractor employees shall be literate in the English language to the extent of being able to read and understand all work processes, orders, regulations, safety, health, and security regulations, and traffic signs posted on Government property. English shall be used for all correspondence, deliverables, and presentations.

3. Ability to communicate orally to effectively present information groups or individuals.

4. Ability to communicate recommendations in writing, prepare reports of ergonomic assessments, prepare and deliver in-service training, and to recommend a specific course of action.

5. Proficient at the level of “advanced” in information technology including, but not limited to, Microsoft Office: Outlook, Word, Excel, and PowerPoint.

6. Ability to analyze information and form reasonable conclusions from complex sets of facts when customers provide human factors information on their ergonomic needs.

7. Certification by a professional organization, such as the Board of Certification in Professional Ergonomics (BCPE). Acceptable examples of applicable certifications include: Certified Professional Ergonomist®, Certified Human Factors Professional (CHFP)®, and Certified Users Experience Professional

(CUXP)®.

Associate certifications from the BCPE are acceptable; provided the individual will complete certification as a CPE/CHFP/CUXP within 11 months from the contract award date.

Acceptable examples of applicable certifications include: Associate Ergonomics Professional (AEP)®, Associate Human Factors Professional (AHFP)®, Associate User Experience Professional (AUXP)®, Certified Ergonomics Associate (CEA)®, or a Certified Ergonomic Assessment Specialist (CEAS).

OR

8. Certification by a professional organization, such as the Oxford Research Institute (ORI). Acceptable examples of applicable certifications include: Certified Industrial Ergonomist (CIE), and Certified Human Factors Engineering Professional (CHFEP).

Associate certification from the ORI are acceptable; provided the individual will complete certification as a CIE/CHFEP within 11 months from the contract award date. Acceptable examples of applicable certifications include: Certified Associate Ergonomist (CAE), or Certified Assistant Ergonomist (CAsE).

9. Alternatively, a Human Factors Engineering Bachelor’s Degree from an accredited university is an acceptable equivalent necessary to effectively fulfill contract obligations and objectives provided the individual will complete certification as a BCPE (see above acceptable examples) within 11 months from the contract award date. Or a Human Factors Engineering/Ergonomics degree at the Master’s or Ph.D. level, from a Human Factors and Ergonomics Society (HFES) accredited university is an acceptable equivalent necessary to effectively fulfill contract obligations and objectives. The Government reserves the right to request and review documentation (e.g., degrees, certificates, training records, work records) certifying the personnel filling positions.

10. The Government reserves the right to refuse to permit any contractor employee to perform services under this SOW.

11. Thorough knowledge of applicable federal, state, and local standards.

12. Possess the skill and ability to apply applicable health, safety, occupational health standards, laws, regulations, and practices to FDA operations.

13. Ability to evaluate situations to determine whether there is compliance with applicable health and safety requirements.

KICK-OFF MEETING

Within ten (10) business days after the award of the Purchase Order, the Contractor shall conduct a kick-off meeting to introduce the Contractor team, discuss roles and responsibilities, discuss the Purchase Order objectives, and address other relevant issues.

PLACE OF PERFORMANCE

The main location for these efforts is in Silver Spring, Maryland at the FDA White Oak Campus;

however, there may be a need to provide in-person assessments to customers located within the Washington, D.C. metropolitan area and other FDA facility locations in the United States.

GOVERNMENT-FURNISHED PROPERTY (GFP)

The Government will furnish a laptop computer, computer hardware, and Personal Identity Verification (PIV) cards (badges) for Contractor employee usage in support of the work completed on this Purchase Order. All duties/tasks in this Purchase Order are to be performed using Government laptops and internal systems.

No software external to the FDA’s internal network will be considered, used, or accepted. The Contractor shall only use FDA’s provided platforms.

The Government reserves the right to request an inventory of Government provided equipment items at any time. The Contractor shall return provided GFP at the request of the government, prior to Contractor employee resignation and/or termination from this Purchase Order.

TRAVEL

Travel shall be in accordance with the Federal Travel Regulations (FTR).

GOVERNMENT POINTS OF CONTACT

Contracting Officer (CO)

• Name and Position: Nicholas Bisher, Lead Contract Specialist

• Office: Office of Operations (OO)/ Office of Finance, Budget, and Acquisitions (OFBA)/

Office of Acquisitions and Grants Services (OAGS)/ Division of Acquisition Operations (DAO)/ Service Contracts Branch (SCB)

• Phone: 240-402-2773

• Email: Nicholas.Bisher@fda.hhs.gov

Contract Specialist (CS)

• Name and Position: Melinda Kim, Contract Specialist

• Office: OO/OFBA/OAGS/DAO/SCB

• Phone: 301-796-0607

• Email: Melinda.Kim@fda.hhs.gov

Contracting Officer’s Representative (COR)

• Name and Position: To be completed at time of award

• Office: Office of the Commissioner (OC)/ Office of the Chief Scientist (OCS)/ Office of

Occupational Safety and Health (OOSH)

• Phone: To be completed at time of award

• Email: To be completed at time of award

Contracting Officer’s Authority

The Contracting Officer (CO) identified above has responsibility for ensuring the performance of all necessary actions for effective contracting, ensuring compliance with the terms of the Purchase Order, and safeguarding the interests of the United States in its contractual relationships. The CO is the only individual who has the authority to enter into, administer, or terminate this Purchase Order and is the only person authorized to approve changes to any of the requirements under this Purchase Order; notwithstanding any provision contained elsewhere in this Purchase Order, this authority remains solely with the CO.

No statement, whether oral or written, by anyone other than the CO, shall be interpreted as modifying the terms and conditions of the Purchase Order. 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 Purchase Order. The Government will not reimburse the Contractor for any work not authorized by the CO.

COMPLIANCES

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 mailto:Nicholas.Bisher@fda.hhs.gov mailto:Melinda.Kim@fda.hhs.gov 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/

GOVERNMENT CLOSURES AND FEDERAL HOLIDAYS

Recognized Federal Holidays – The Contractor is not required to provide on-site services on the following days that are Federal Holidays or on any other day designated as a Federal holiday for the Washington, D.C. area:

New Year’s Day Martin Luther King, Jr.’s Birthday Washington’s Birthday

Memorial Day Juneteenth National Independence Day Independence Day

Labor Day Columbus Day

Veterans Day Thanksgiving Day

Christmas Day

Inclement Weather – The Contractor is not required to provide on-site service on days when the Federal Government is closed due to inclement weather. The Contractor is required to follow, as a minimum, other directives issued by the U.S. Office of Personnel Management (OPM) or other such official for late arrivals due to inclement weather (unless otherwise specified in the Purchase Order).

In the event the Federal Government is closed by order of the President of the United States or OPM for any reason, or the agency, the Center or the building is closed for administrative or safety reasons, the Contractor shall follow directives issued by the COR or Contracting Officer concerning reporting for work. In the event of early closings, the Contractor may be approved to leave early at the discretion of the COR and/or local policy.

INVOICING INSTRUCTIONS AND REQUIREMENTS

Department of Health and Human Services (HHS) Acquisition Regulation (HHSAR) 352.232-71 - Electronic Submission of Payment Requests (FEB 2022)

(a) Definitions. As used in this clause-

Payment request means a bill, voucher, invoice, or request for contract financing payment with associated supporting documentation. The payment request must comply with the requirements http://www.hhs.gov/ identified in FAR 32.905(b), "Content of Invoices" and the applicable Payment clause included in this contract.

(b) Except as provided in paragraph (c) of this clause, the Contractor shall submit payment requests electronically using the Department of Treasury Invoice Processing Platform (IPP) or successor system. Information regarding IPP, including IPP Customer Support contact information, is available at www.ipp.gov or any successor site.

(c) The Contractor may submit payment requests using other than IPP only when the Contracting Officer authorizes alternate procedures in writing in accordance with HHS procedures.

(d) If alternate payment procedures are authorized, the Contractor shall include a copy of the Contracting Officer's written authorization with each payment request.

FDA Electronic Invoicing and Payment Requirements - Invoice Processing Platform (IPP) (Jan 2022)

a. All Invoice submissions for goods and or services must be made electronically through the U.S. Department of Treasury’s Invoice Processing Platform System (IPP).

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

b. Invoice Submission for Payment means any request for contract financing payment or invoice payment by the Contractor. To constitute a proper invoice, the payment request must comply with the requirements identified in FAR 32.905(b), “Content of Invoices” and the applicable Payment clause included in this contract, or the clause FAR 52.212-4 Contract Terms and Conditions - Commercial Items included in commercial items contracts. The IPP website address is: https://www.ipp.gov.

c.

1. The Agency will enroll the Contractors new to IPP. The Contractor must follow the IPP registration email instructions for enrollment to register the Collector Account for submitting invoice requests for payment. The Contractor Government Business Point of Contact (as listed in SAM) will receive Registration email from the Federal Reserve Bank of St. Louis (FRBSTL) within 3 - 5 business days of the contract award for new contracts or date of modification for existing contracts.

2. Registration emails are sent via email from ipp.noreply@mail.eroc.twai.gov. Contractor assistance with enrollment can be obtained by contacting the IPP Production Helpdesk via email to IPPCustomerSupport@fiscal.treasury.gov or phone (866) 973-3131.

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

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

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

d. Invoices that include time and materials or labor hours Line Items must include supporting http://www.ipp.gov/ http://www.ipp.gov/vendors/index.htm documentation to (1) substantiate the number of labor hours invoiced for each labor category, and (2) substantiate material costs incurred (when applicable).

e. Invoices that include cost-reimbursement Line Items must be submitted in a format showing expenditures for that month, as well as contract cumulative amounts. At a minimum the following cost information shall be included, in addition to supporting documentation to substantiate costs incurred:

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

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

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

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

• Subcontractors (if applicable) - include, for each subcontractor, the same data as required for the prime Contractor;

• Other Direct Costs - include a listing of all other direct charges to the contract, i.e., office supplies, telephone, duplication, postage; and

• Fee - amount as allowable in accordance with the Schedule and FAR 52.216-8 if applicable.

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

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

(1) invoice number, amount, & date submitted

(2) corresponding payment amount & date received

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

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

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

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

i. Payment to the Contractor will not be made for temporary work stoppage due to circumstances beyond the control of U.S. Food and Drug Administration such as acts of God, inclement weather, power outages, and results thereof, or temporary closings of facilities at which Contractor personnel are performing. This may, however, be justification for excusable delays.

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

k. Questions regarding invoice payments that cannot be resolved by the IPP Helpdesk should be directed to the FDA Employee Resource and Information Center (ERIC) Helpdesk at 301-827- ERIC (3742) or toll-free 866-807-ERIC (3742); or, by email at ERIC@fda.hhs.gov. Refer to the Call-in menu options and follow the phone prompts to dial the option that corresponds to the service that's needed. All ERIC Service Now Tickets will either be responded to or resolved within 48 hours (2 business days) of being received. When emailing, please be sure to include the contract number, invoice number and date of invoice, as well as your name, phone number, and a detailed description of the issue.

PROCUREMENTS REQUIRING INFORMATION SECURITY AND/OR PHYSICAL

ACCESS SECURITY

1. Baseline Security Requirements

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

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

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

b. Safeguarding Information and Information Systems. All government information and information systems must be protected in accordance with FDA policies and level of risk. At a minimum, the Contractor (and/or any subcontractor) must:

i. Protect the:

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

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

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

ii. Categorize all information owned and/or collected/managed on behalf of FDA and information systems that store, process, and/or transmit FDA information in accordance with FIPS 199 and National Institute of Standards and Technology (NIST) Special Publication (SP) 800-60, Volume II: Appendices to Guide for Mapping Types of Information and Information Systems to Security Categories.

Based on information provided by the System/Data Owner, ISSO, privacy representative, or other POC, the impact level for each Security Objective (Confidentiality, Integrity, and Availability) and the Overall Impact Level, which is the highest watermark of the three factors of the information or information system are the following:

• Confidentiality: [ ] Low [ ] Moderate [ ] High [X] N/A

• Integrity: [ ] Low [ ] Moderate [ ] High [X] N/A

• Availability: [ ] Low [ ] Moderate [ ] High [X] N/A

• Overall Impact Level: [ ] Low [ ] Moderate [ ] High [X] N/A

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

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

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

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

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

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

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

[ ] No PII [ X ] PII

iii. The Contractor must support the agency with conducting a Privacy Threshold Analysis (PTA) for the information system and/or information handled under this contract to determine whether or not a full Privacy Impact Assessment (PIA) needs to be completed.

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

• The Contractor must support the agency in reviewing the PIA at least every three years throughout the system development lifecycle (SDLC)/information lifecycle, or when determined by the agency that a review is required based on a major change to the system, or when new types of PII are collected that introduces new or increased privacy risks, whichever comes first.

e. Controlled Unclassified Information (CUI). Executive Order 13556 defines CUI as "information that laws, regulations, or Government-wide policies require to have safeguarding or dissemination controls, excluding classified information." The Contractor (and/or any subcontractor) must comply with Executive Order 13556, Controlled Unclassified Information, (implemented at 3 CFR, part 2002) when handling CUI. 32 C.F.R. 2002.4(aa) As implemented the term "handling" refers to "…any use of CUI, including but not limited to marking, safeguarding, transporting, disseminating, re-using, and disposing of the information." 81 Fed. Reg. 63323. The requirements below apply only to nonfederal systems that process, store, or transmit CUI, or that provide security protection for such components. All sensitive information that has been identified as CUI by a regulation or statute, handled by this solicitation/contract, must be:

i. Marked appropriately;

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

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

iv. Returned to FDA control, destroyed when no longer needed, or held until otherwise directed. Information and/or data must be disposed of in accordance with NIST SP 800-88, Guidelines for Media Sanitization.

f. Protection of Sensitive Information. For security purposes, information is or may be sensitive because it requires security to protect its confidentiality, integrity, and/or availability. The Contractor (and/or any subcontractor) must protect all government information that is or may be sensitive by securing it with a solution that is validated with current FIPS 140 validation certificate from the NIST CMVP.

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

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

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

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

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

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

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

j. Information and Communications Technology (ICT). ICT products and services from prohibited entities/sources must not be used/acquired in compliance with Public Law 115-232, Section 889 Parts A and B, FAR 4.21, FAR 52.204.23, FAR 52.204.24, and FAR 52.204.25. The contractor (and/or any subcontractor) must notify the government if they identify prohibited ICT products and/or services are used during the contract performance.

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

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

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

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

ii. Encrypt all sensitive federal data and information (i.e., PII, protected health information [PHI], proprietary information, etc.) in transit (i.e., email, network connections, etc.) and at rest (i.e., servers, storage devices, mobile devices, backup media, etc.) with an encryption solution that is validated with current FIPS 140 validation certificates from the NIST CMVP.

iii. Secure all devices (i.e.: desktops, laptops, mobile devices, etc.) that store and process government information and ensure devices meet HHS and FDA-specific encryption standard requirements. Maintain a complete and current inventory of all laptop computers, desktop computers, and other mobile devices and portable media that store or process sensitive government information (including PII).

iv. Verify that the encryption solutions in use have been validated under the Cryptographic Module Validation Program to confirm compliance with current FIPS 140 validation certificates from the NIST CMVP. The Contractor must provide a written copy of the validation documentation to the COR.

v. Use the Key Management system on the HHS personal identification verification (PIV) card or establish and use a key recovery mechanism to ensure the ability for authorized personnel to encrypt/decrypt information and recover encryption keys http://csrc.nist.gov/publications/. Encryption keys must be provided to the COR upon request and at the conclusion of the contract.

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

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

2. Training Requirements

a. Mandatory Training for All Contractor Staff. All Contractor (and/or any subcontractor) employees assigned to work on this contract must complete the applicable FDA information security awareness, privacy, and records management training (provided upon contract award) before performing any work under this contract.

Thereafter, the employees must complete FDA information security awareness, privacy, and records management training at least annually, during the life of this contract. All provided training must be compliant with HHS training policies.

b. Role-based Training. All Contractor (and/or any subcontractor) employees with significant security responsibilities (as determined by the program manager) must complete role-based training annually commensurate with their role and responsibilities in accordance with HHS and FDA policy.

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

3. Rules of Behavior

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

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

4. Incident Response

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

FISMA defines an incident as "an occurrence that (1) actually or imminently jeopardizes, without lawful authority, the integrity, confidentiality, or availability of information or an information system; or (2) constitutes a violation or imminent threat of violation of law, security policies, security procedures, or acceptable use policies. In accordance with OMB M-17-12, Preparing for and Responding to a Breach of Personally Identifiable Information (PII), an incident is "an occurrence that (1) actually or imminently jeopardizes, without lawful authority, the integrity, confidentiality, or availability of information or an information system; or (2) constitutes a violation or imminent threat of violation of law, security policies, security procedures, or acceptable use policies" and a privacy breach is "the loss of control, compromise, unauthorized disclosure, unauthorized acquisition, or any similar occurrence where (1) a person other than an authorized user accesses or potentially accesses personally identifiable information or (2) an authorized user accesses or potentially accesses personally identifiable information for an other than authorized purpose." For additional information on the HHS breach response process, please see the FDA IS2P Appendix F: Incident Response and the HHS Policy and Plan for Preparing for and Responding to a Breach of Personally Identifiable Information

(PII).

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

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

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

iii. Report all suspected and confirmed information security and privacy incidents and breaches…