2024-08-19 Final RFQ 75F40124Q00466 Ergonomic.pdf

Nationwide Ergonomic Consultative Services Request for Quotation (RFQ) no. 75F40124Q00466

1. DESCRIPTION/COMMERICAL SERVICES PROCUREMENT

This is a combined synopsis/solicitation for commercial services prepared in accordance with the format in Federal Acquisition Regulation (FAR) Subpart 12.6- Streamlined Procedures for Evaluation and Solicitation for Commercial Products and Commercial Services, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; quotations are being requested and a written solicitation will not be issued. This is Request for Quotation (RFQ) no. 75F40124Q00466 for commercial services in accordance with the procedures of FAR Part 12- Acquisition of Commercial Products and Commercial Services, and FAR Subpart 13.5- Simplified Procedures for Certain Commercial Products and Commercial Services.

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 provisions and clauses in effect through Federal Acquisition Circular (FAC) 2024-05, effective May 22, 2024.

The FAR provisions and clauses referenced in this solicitation can be found on the following website: 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) Firm-Fixed Price (FFP) type Purchase Order.

5. PERIOD OF PERFORMANCE

The anticipated period of performance consists of a 12-month base and four (4), 12-month options, as set forth below:

• Base Year: September 30, 2024, through September 29, 2025 (12 months)

• Option Year 1: September 30, 2025, through September 29, 2026 (12 months)

• Option Year 2: September 30, 2026, through September 29, 2027 (12 months)

• Option Year 3: September 30, 2027, through September 29, 2028 (12 months)

• Option Year 4: September 30, 2028, through September 29, 2029 (12 months) http://www.acquisition.gov/ https://www.hhs.gov/grants/contracts/contract-policies-regulations/hhsar/index.html

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

6. PRICING

The Purchase Order will utilize fixed rates for services. The following fixed rates shall apply for payment purposes for the duration of the purchase order.

Anticipated Period of Performance: Base Year (September 30, 2024, through September 29, 2025) Item Description Quantity Unit Unit Price Extended Price HQ and the National Capital Region (NCR): In-person Ergonomic Assessments; including if applicable, ergonomic equipment recommendations

3,500 EA $ $

FIELD SITES/RESIDENT POSTS:

In-person Ergonomic Assessments;

including if applicable, ergonomic equipment recommendations

4,500 EA $ $

VIRTUAL: Ergonomic Assessments; including if applicable, ergonomic equipment recommendations

5,000 EA $ $

Base Year Firm-Fixed Price $

Anticipated Period of Performance: Option Year 1 (September 30, 2025, through September 29, 2026) Item Description Quantity Unit Unit Price Extended Price HQ and the National Capital Region (NCR): In-person Ergonomic Assessments; including if applicable, ergonomic equipment recommendations

3,500 EA $ $

FIELD SITES/RESIDENT POSTS:

In-person Ergonomic Assessments;

including if applicable, ergonomic equipment recommendations

4,500 EA $ $

VIRTUAL: Ergonomic Assessments; including if applicable, ergonomic equipment recommendations

5,000 EA $ $

Option Year 1 Firm-Fixed Price $

Anticipated Period of Performance: Option Year 2 (September 30, 2026, through September 29, 2027) Item Description Quantity Unit Unit Price Extended Price HQ and the National Capital Region (NCR): In-person Ergonomic Assessments; including if applicable, ergonomic equipment recommendations

3,500 EA $ $

FIELD SITES/RESIDENT POSTS:

In-person Ergonomic Assessments;

including if applicable, ergonomic equipment recommendations

4,500 EA $ $

VIRTUAL: Ergonomic Assessments; including if applicable, ergonomic equipment recommendations

5,000 EA $ $

Option Year 2 Firm-Fixed Price $

Anticipated Period of Performance: Option Year 3 (September 30, 2027, through September 29, 2028) Item Description Quantity Unit Unit Price Extended Price HQ and the National Capital Region (NCR): In-person Ergonomic Assessments; including if applicable, ergonomic equipment recommendations

3,500 EA $ $

FIELD SITES/RESIDENT POSTS:

In-person Ergonomic Assessments;

including if applicable, ergonomic equipment recommendations

4,500 EA $ $

VIRTUAL: Ergonomic Assessments; including if applicable, ergonomic equipment recommendations

5,000 EA $ $

Option Year 3 Firm-Fixed Price $

Anticipated Period of Performance: Option Year 4 (September 30, 2028, through September 29, 2029) Item Description Quantity Unit Unit Price Extended Price HQ and the National Capital Region (NCR): In-person Ergonomic Assessments; including if applicable, ergonomic equipment recommendations

3,500 EA $ $

FIELD SITES/RESIDENT POSTS:

In-person Ergonomic Assessments; 4,500 EA $ $ including if applicable, ergonomic equipment recommendations VIRTUAL: Ergonomic Assessments; including if applicable, ergonomic equipment recommendations

5,000 EA $ $

Option Year 4 Firm-Fixed Price $

Total Purchase Order Firm-Fixed Price (Base Year and Option Years 1-4)

The rate, or rates, set forth above cover all expenses, including report preparation, salaries, overhead, general and administrative expenses, and profit.

7. STATEMENT OF WORK

STATEMENT OF WORK (SOW)

U.S. FOOD AND DRUG ADMINISTRATION (FDA)

OFFICE OF FACILITIES ENGINEERING AND MISSION SUPPORT (OFEMS)

EMPLOYEE SAFETY AND OCCUPATIONAL HEALTH (ESOH)

NATIONWIDE ERGONOMIC CONSULTATIVE SERVICES

BACKGROUND

At the U.S. Food and Drug Administration (FDA), the Employee Safety and Occupational Health (ESOH) team within the FDA’s Office of Facilities Engineering and Mission Support (OFEMS) offers a comprehensive ergonomics program. The Occupational Safety and Health Act of 1970 mandates that employers furnish to each of their employees a place of employment free from recognized hazards that are causing or are likely to cause death or serious physical harm.

The ergonomics program focuses on a proactive approach to increasing productivity through the prevention of musculoskeletal disorders (MSDs) while simultaneously reducing the Agency’s liability for workers' compensation-related costs.

ESOH provides leadership, oversight, and service for the overarching Occupational Health and Safety Program which proactively ensures safe and healthy workplaces at FDA worksites for FDA employees, and contractors. ESOH promotes proactive health and safe work practices to prevent injury and illness, as well as provides direct support services to employees at all levels within the FDA, while assuring compliance with all the applicable federal, state, and local health, safety and environmental laws and regulations.

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 Employee Safety and Occupational Health (ESOH) in facilitating a safe and healthy work environment for FDA employees through ergonomic assessment services. The FDA seeks an ergonomist to provide a wide range of ergonomic services nationwide, including U.S. territories such as Puerto Rico. These services are to include, but are not limited to, ergonomic assistance for office workstations, and ergonomic equipment handling (with instruction/education provided on the equipment’s proper use).

Additionally, the contractor shall provide the FDA with ergonomists to deliver:

• Individual in-person ergonomic assessments (nationwide)

• Individual virtual ergonomic assessments (nationwide)

• Staffing for the Ergonomics Resource Center (ERC) located at the Federal Research

Center at White Oak in Silver Spring, Maryland

Staffing at the Ergonomics Resource Center (ERC) will start with up to two days per week and may increase in frequency as the program expands.

The FDA has a population of 22,000 employees, across approximately 350 FDA facilities nationwide.

SCOPE OF WORK

This SOW outlines the requirements, level of effort, services, and expected outcomes for the contractor to provide ergonomists for ergonomic services to FDA workers. This SOW aims to enhance and augment the Office of Employee Safety and Occupational Health (ESOH) by delivering comprehensive and integrated support in ergonomics.

TASKS

Ergonomic Services:

The contractor shall provide ergonomic services, including, but not limited to:

• Individual or group assessments

• Basic/preventative assessments

• Reasonable accommodation assessments

• Office assessments

• Return-to-work assessments

• Post-injury assessments

• Assistive technology assessments

• Follow-up assessments

• Virtual home office assessments

• Equipment recommendations

Assessment Scheduling:

The contractor shall:

• Utilize FDA's internal scheduling and tracking system to manage all ergonomic assessment requests and completed assessments.

• Respond to ergonomic inquiries received via the FDA Ergonomics email account or the ERIC Safety Coordination Agency Ergonomics ticketing system within 24 hours of request submission.

• Schedule ergonomic assessments using the internal ergonomics calendar, at the recipient's convenience and within their normal working hours or at the government's discretion.

• Perform assessments by the preferred delivery method(s), in-person or virtual, as indicated on the internal ergonomics calendar or as directed by the Contracting Officer’s Representative (COR).

• Understand that appointment notifications for ergonomic assessments may be provided by the Contracting Officer’s Representative (COR). The COR has full discretion to adjust or alter the Ergonomics appointment calendar to fit the needs of the government and the ergonomics program.

Ergonomic Assessment(s):

• Conduct ergonomic assessments tailored to the unique needs of FDA workers, following the U.S. Department of Labor, Occupational Safety and Health Administration evaluation checklist.

• Perform virtual assessments using FDA-furnished laptops and internal video conferencing platforms (e.g., Teams or Zoom).

• Provide comprehensive ergonomic assessments that include real-time adjustments, education on proper postures, behavior modifications, and work practices.

• Support FDA’s Ergonomics program mission by reinforcing that ergonomics is behavior modification(s) and education, over equipment implementation.

• Understand that ergonomic equipment is not the outcome desired for the ergonomic assessment, worker understanding of repetitive injury reduction is the priority.

• The ergonomic assessment includes drafting the ergonomic assessment report and if applicable the ergonomic equipment recommendations report.

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

Basic (Injury Preventative) Assessment/Return to Work

Reasonable Accommodations (Medical Necessity) Assessments

Post-Injury Assessments

Assistive Technology Assessments

Virtual Assessments

Follow-Up Assessments

These evaluations are a concise, yet effective approach to controlling workplace-related musculoskeletal disorders (MSD) and providing ergonomic education to the customer. These evaluations are typically best suited to symptom-free workers and those considered at low MSD risk. These types of evaluations would be best applied when requesting ergonomic assistance adjusting existing office equipment, relocating customers, customers seeking ergonomic education, or as part of a new hire onboarding.

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 the Office of Equal Employment Opportunity

These evaluations shall be performed for those workers with pre-existing MSD, self-reported pain/injury, or those who have had a physician referral

These evaluations shall be performed for those workers with a need for assistive technology equipment recommendations or to better understand how to use their current assistive technology (e.g., Dragon Speech, Microsoft speech, telephone hearing aid pairing, foot mouse, etc.).

These evaluations shall be performed for FDA workers using government furnished property that allow both audio and video capabilities to provide the assessment for any FDA worker requesting a virtual ergonomic assessment.

These evaluations are designed to ensure that workstation recommendations and equipment modifications previously evaluated have been implemented properly. The visit shall include:

1) answering questions

2) re-reviewing with FDA workers the proper positioning and if applicable, 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

• Basic/Follow-Up/Return-to-work Assessments: up to 30 minutes each

• Medical-Related (RA/Post-injury/Assistive Technology) Assessments: up to 1 hour each

In-Person Assessments:

The contractor shall provide:

• Ergonomists for in-person assessments at FDA sites nationwide, including U.S. territories such as Puerto Rico.

• Up to 3,500 assessments per contract year at Headquarters and the National Capital Region.

• Up to 4,500 assessments per contract year at Nationwide Field Offices/Resident Posts.

Virtual Assessments:

The contractor shall provide:

• Up to 5,000 virtual assessments per each 12-month base and option years.

Ergonomic Resource Center (ERC):

• Provide an ergonomist in-person at the FDA ERC site in Silver Spring, MD, up to two days per week.

• Follow the COR’s adjusted appointment schedule to meet ergonomic program needs and assessment requests.

• Use FDA-furnished ergonomic equipment for demonstrations, consultations, and guided selection.

• Ensure all ergonomic equipment remains FDA property and is not removed from the ERC without COR direction.

Ergonomic Equipment:

• Submit any personal ergonomic equipment preferences or suggestions to the COR for approval before recommending or discussing them with customers.

• Maximize the use of existing furniture before recommending new equipment.

• Update recommendations based on COR’s discretion.

• Provide written justification for recommended ergonomic equipment, ensuring alignment with FDA policies and Ergonomics program best practices, if equipment is recommended as an ergonomic correction.

Ergonomic Report(s):

• Use FDA’s internal platforms to prepare, revise, and store written reports of each ergonomic evaluation.

• Ensure all reports are clear, error-free, and comprehensible to laypersons, with explanations for technical terminology.

• Prioritize customer service and quality assurance, by proofreading all reports before dissemination.

• Include overall ergonomic conditions within workstations and work areas noting both positive aspects and risk factors of current workstation.

• Include recommendations for remediation of risk factors or reasons remediation was not accomplished.

• Include topics covered with the customer that promoted ergonomic education.

• Include, when applicable, ergonomic equipment recommendations and a justification for the purchase of the equipment.

• Include, when applicable, discussion of any physician prescribed information (if medical information is volunteered by the customer).

• Include, when conducting a follow-up assessment, the ergonomic recommendations that the customer implemented in their work practices from the original assessment.

• Include, when conducting a follow-up assessment, any new ergonomic concerns that were addressed.

• Include, when conducting a follow-up assessment, if the previously recommended equipment (if applicable) was procured/installed, or any hindering factors for delay in procurement.

The FDA owns all rights to all ergonomic reports, the contents in the reports and in all forms (draft, final, revised, etc.).

CONTRACTOR PERSONNEL

The Contractor shall provide qualified key personnel for the below position:

Ergonomists:

The Contractor shall:

• Provide all personnel necessary to maintain performance standards and accomplish required services with qualified ergonomists during the hours of operation, even when regularly scheduled ergonomists are absent.

• Ensure all personnel certifications and license are kept current for the duration of the contract and provided to the COR in a timely manner.

• Provide the COR with evidence of unexpired/renewal of certification(s). Failure to provide evidence of renewals shall cause removal of the ergonomist from the contract.

• Ensure personnel are literate in the English language to the extent of being able to read and understand all work processes, orders, regulations, safety, health, security regulations, and traffic signs posted on Government property. English shall be used for all correspondence and deliverables.

• Possess the ability to analyze information and form reasonable conclusions from complex sets of facts when customers provide human factors information on their ergonomic needs.

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

• Ensure personnel meet one of the following qualifications:

1. Certification by a professional organization, such as the Board of

Certification in Professional Ergonomics (BCPE). Acceptable examples of applicable certifications include Certified Professional Ergonomist (CPE)®, Certified Human Factors Professional (CHFP)®, and Certified Users Experience Professional (CUXP)®.

2. BCPE Associate Certification and Experience: Associate certifications from the BCPE and three years of full-time equivalent human factors/ergonomics (HFE) related work experience, including performing office assessments.

Acceptable examples of applicable certifications include Associate Ergonomics Professional (AEP)®, Associate Human Factors Professional (AHFP)®, Associate User Experience Professional (AUXP)®, Certified Ergonomics Associate (CEA)®.

3. Bachelor’s Degree and Experience: Bachelor’s degree in Human Factors or Ergonomics, and three years full-time equivalent human factors/ergonomics (HFE) related work experience, including performing office assessments.

4. Graduate Degree (Masters) and Experience: Master’s degree in Human Factors or Ergonomics, from a Human Factors and Ergonomics Society HFES-listed graduate program or accredited university, and three years full-time equivalent human factors/ergonomics (HFE) related work experience, including performing office assessments.

5. Graduate Degree (PhD) and Experience: PhD in Human Factors or Ergonomics, and two years full-time equivalent human factors/ergonomics (HFE) related work experience, including performing office assessments.

6. Graduate Degree in Related Field and Experience: Graduate degree in Physiotherapy, Kinesiology, Human Factors Psychology, or Occupational Therapy from an accredited university, and three years full-time equivalent human factors/ergonomics (HFE) related work experience, including performing office assessments.

7. Certification by Oxford Research Institute (ORI) and Experience:

Certification by a professional organization, such as the Oxford Research Institute (ORI) and three years full-time equivalent human factors/ergonomics (HFE) related work experience, including performing office assessments. Acceptable examples of applicable certifications include Certified Industrial Ergonomist (CIE), and Certified Human Factors Engineering Professional (CHFEP).

8. ORI Associate Certification and Experience: Associate certification from the ORI and three years full-time equivalent human factors/ergonomics (HFE) related work experience, including performing office assessments. Acceptable examples of applicable certifications include Certified Human Factors Engineering Professional (CHFEP), and Certified Associate Ergonomist (CAE).

The Government reserves the right to request and review documentation (e.g., degrees, certificates, training records, work records, etc.) certifying the personnel filling positions. The Government reserves the right to refuse to permit any contractor employee to perform services under this SOW.

Key Personnel The contractor shall:

• Identify all key personnel in the proposal. Assign Key Personnel whose names were identified in the quote and who are integral to the performance of the task requirements.

• Notify the Contracting Officer in writing at least 30 days prior to diverting any of the specified individuals to other programs or contracts and submit comprehensive justification for the diversion or replacement request (including proposed substitutions for key personnel). This advanced notification will permit evaluation by the Government of the impact on performance under this Order.

• Not divert or replace any key personnel without the written consent of the Contracting Officer.

The Government may modify the Order to add or delete key personnel at the request of the contractor or Government.

Substitution of Key Personnel Do not substitute key personnel during the first ninety (90) days of the Order performance period.

After the initial 90-day period, submit to the COR and CO all proposed substitutions at least 30 days in advance. All requests for approval of substitutions must be in writing and provide a detailed explanation of the circumstances necessitating the proposed substitution(s). Requests must contain a complete resume for the proposed substitute, who shall meet the personnel requirements outlined in this SOW, and any other information requested by the Contracting Officer to approve or disapprove the proposed substitution. The Contracting Officer and COR will evaluate such requests and promptly notify the Contractor of approval or disapproval in writing.

Removal of Personnel The Contracting Officer may require, in writing, that the Contractor remove from work any employee the Contracting Office deems inappropriate, careless, otherwise objectionable.

DELIVERABLES

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

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 contract objectives, and address other relevant issues.

Deliverable Due Date Recipient(s) Delivery Method Ergonomic Assessment Provided based on FDA’s

Ergonomic Appointment Calendar

• FDA Worker 1. Virtual or In-person assessment (method of delivery pre-determined by the

FDA)

Ergonomic Assessment Report (that includes, if necessary, both before and after photos) – FDA secure locations will be the exception for photos

Within 7 calendar days from the completed ergonomic consultation.

• FDA Worker

• FDA

Ergonomics Program

1. Email (using FDA’s internal email)

2. Report saved & stored to the FDA Network via the designated Ergo Program shared drive

Ergonomic Equipment Recommendation(s) Report (if equipment is recommended this is applicable. A separate report based on the individual’s ergonomic situation providing equipment recommendations)

Within 7 calendar days from the completed ergonomic consultation.

• FDA Worker

• FDA Center

Safety Officer

• FDA

Ergonomics Program

1. Email (using FDA’s internal email)

2. Saved & Stored to the FDA Network via the designated Ergo Program shared drive

Monthly Summary Report – including FDA’s internal ticketing number (INC#) with each assessment provided per ergonomist and the date performed

To be submitted with the monthly invoice.

• COR

• FDA Vendor

Payments

1. Invoice Processing Platform (IPP)

PLACE OF PERFORMANCE

The FDA locations for these efforts are nationwide, including U.S. territories such as Puerto Rico, and will encompass both virtual and in-person assessments for FDA customers.

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. FDA shall cover the cost to ship the return of any provided GFP.

TRAVEL

Any travel costs incurred would be at cost to the contractor.

GOVERNMENT POINTS OF CONTACT

Contracting Officer (CO)

• Name and Position: Nicholas Bisher, Lead Contract Specialist

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

(OFBAP)/ 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/OFBAP/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 Operations (OO)/ Office of Facilities Engineering and Mission Support

(OFEMS)/ Employee Safety and Occupational Health (ESOH)

• Phone: To be completed at time of award

• Email: To be completed at time of award mailto:Nicholas.Bisher@fda.hhs.gov mailto:Melinda.Kim@fda.hhs.gov

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 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/

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 http://www.hhs.gov/oirm/ 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

Health and Human Services 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 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.

(End of Clause)

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

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