SOW Sequel2e ORS-22-C2625_75F40122R00080.pdf

75F40122R00080

Offeror Name Unique Entity ID (UDI)

GENERAL INFORMATION

This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Federal Acquisition Regulation (FAR) Subparts 12.6 AND 13.501(A), as supplemented with additional information included in this notice. Quotes are being requested and this announcement constitutes the only solicitation. The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) 2022-07 dated August 10, 2022.

THIS ANNOUCEMENT CONSTITUTES THE ONLY SOLICITATION AND A SEPARATE

SOLICITATION WILL NOT BE ISSUED. The solicitation number for this acquisition is 75F40122R00080 and is being issued as a Request for Quotation (RFQ). The NAICS Code for this solicitation is 811219, Description: Other Electronic and Precision Equipment Repair and Maintenance, and the Small Business Size Standard is $12 Million in millions of dollars. This will be awarded as Firm- Fixed Price. Prospective Offerors are responsible for downloading the solicitation and any amendments.

The Government reserves the right to award without discussions if the Contracting Officer determines that the initial offer is providing the Best Value and discussions are not necessary.

https://www.acquisition.gov/far/part-12#FAR_Subpart_12_6

SECTION 1 - SUPPLIES OR SERVICES/PRICES

1.0 LINE ITEMS AND PRICES

The Government contemplates awarding a firm-fixed priced contract resulting from this solicitation.

Offerors are requested to provide a fixed price quote.

Line Item Number Description Qty Price

0001 Base Period

Comprehensive Sequel™ II Service Contract without Insight.

Covers all parts, labor, and consumables required for the repair and recommended preventative maintenance of an installed system with priority service.

0002 Option Period 1

Comprehensive Sequel™ II Service Contract without Insight.

Covers all parts, labor, and consumables required for the repair

0003 Option Period 2 Comprehensive Sequel™ II Service Contract without Insight.

Covers all parts, labor, and consumables required for the repair

0004 Option Period 3

Covers all parts, labor, and consumables required for the repair

0005 Option Period 4

Covers all parts, labor, and consumables required for the repair

SECTION 2 - Statement of Work

Title: Sequel 2e Service Contracts

Title: Procurement of Service Contract for a Sequel 2e long-read sequencer

I. Purpose The Office of Regulatory Science (ORS), Division of Division of Microbiology requires the purchase of a service contract for an existing Sequel 2e long-read sequencer to maintain the instrument to perform at optimum specifications and ensure data generated is consistent and of high quality to resolve outbreaks of foodborne disease.

II. Background III. The Sequel 2e machine purchased in September 2021 with a one-year warranty, needs to be maintained in a manner that does not void the warranty provided by the manufacturing company, Pacific Biosciences. The sequencer needs to perform at optimum specifications to ensure that all data generated is consistent and of high enough quality to resolve outbreaks of foodborne disease. This is a contract to include one base year and four option years.

IV. Objectives The vendor shall

• Provide service contract that will cover any parts and labor that is required to perform preventative maintenance annually for the Sequel 2e long-read sequencer.

• Includes full coverage of all service parts and labor.

• Includes critical and non-critical hardware and software updates. These may be done during a scheduled preventive maintenance visit.

• Replacement parts must be Pacific Biosciences-supplied and may not void any remaining warranties.

• Replacement parts must be warranted to conform to Pacific Biosciences’s specifications

• Must be equal to or better than Pacific Biosciences’s Standard Pacific Biosciences Sequel

Service plan.

• Repairs must be performed by a Pacific Biosciences approved and certified technician.

• On-site:

• Preventive maintenance – at least on preventive maintenance on-site visit per year.

• Includes all travel, labor and parts/materials associated with Pacific Biosciences’s prescribed preventative maintenance.

• Corrective maintenance/repairs as needed – on-site response should be within 5 business days.

• Off-site:

• Includes comprehensive email and telephone support for instrument, applications and bioinformatics issues.

• Includes access to online training support modules

• Includes discounts for optional advanced training programs

• Service contract shall provide 50% faster onsite response time with 30-40% reduced downtime compared to billable customers. Priority access shall be provided by more than 2,000 field service professionals with an average of eighteen (18) years of experience.

• The vendor shall provide field service engineer labor, travel, and parts required for corrective maintenance visits within three (3) business days of receiving a call from CFSAN. Priority status shall be given for technical support inquiries with a targeted immediate response time. A certified service engineer from the vendor shall conduct diagnosis and corrective maintenance procedures using the latest digital support tools.

• One (1) scheduled preventative maintenance visit shall be performed during the twelve (12) month period with all travel, labor, and parts included. This inspection shall include routine preventative maintenance of the instrument, calibration, and any other preventative maintenance measurements deemed necessary by the vendor. Any additional preventative maintenance needed shall be provided at a discount.

• The vendor shall provide software and firmware updates that can improve performance upon request and in conjunction with a scheduled preventative maintenance or corrective maintenance visit.

V. Scope Independently, and not as an agent of the Government, furnish the necessary personnel, services, and otherwise do all things necessary for, or incident to, the performance of the work. Due to the persistent degraded performance of the Sequel 2e and the vendor not being able to determine a specific cause, a service contract is needed in order to replace expensive parts and labor.

Troubleshooting without a service contract would be an unnecessary use of time and resources. A highly skilled and trained field service engineer is needed to perform a thorough inspection of the instrument. Once the cause has been determined, the appropriate corrective action(s) will be performed to resolve the issue. If the cause cannot be determined, service and labor will be covered under the service contract to replace multiple parts at once.

VI. Specific Tasks The vendor shall perform the tasks below:

4.1 Task 1 – Corrective Maintenance

As part of the service contract, the vendor shall provide on-site corrective maintenance visits to rectify the Sequel 2 sequencer degraded performance issues. This service will take place at the Center for Food Safety and Applied Nutrition (CFSAN), 5001 Campus Drive, College Park, MD, where the Sequel 2 sequencer is located. This service shall take place within 30 days after the coverage start date and shall be provided anytime deemed necessary within the twelve (12)-month coverage period. This service shall include the field service engineer’s labor, travel, and any parts required.

4.2 Task 2 – Preventative Maintenance

The vendor shall provide one (1) scheduled annual preventative maintenance visit with all travel, labor and parts included. This inspection shall include routine preventative maintenance of the instrument, calibration and any other preventative maintenance measures deemed necessary by the vendor to ensure optimal performance of the Sequel 2 sequencer.

VII. Deliverables

• The vendor shall provide service contract that will cover any parts and labor needed to repair and maintain a Sequel 2 sequencer.

o This shall be delivered immediately after the contract award date.

o Field service engineer labor, travel, and parts required for corrective maintenance visits within three (3) business days of receiving a call from CFSAN. Priority status shall be given for technical support inquiries with a targeted immediate response time. A certified service engineer from the vendor shall conduct diagnosis and corrective maintenance procedures using the latest digital support tools.

o One (1) scheduled preventative maintenance visit shall be performed during the 12-month period with all travel, labor, and parts included. This inspection shall include routine preventative maintenance of the instrument, calibration, and any other preventative maintenance measurements deemed necessary by the vendor. Any additional preventative maintenance needed shall be provided at a discount.

o The vendor shall provide software and firmware updates that can improve performance upon request and in conjunction with a scheduled preventative maintenance or corrective maintenance visit.

Government-Furnished Property, Material, Equipment, or Information (GFP, GFM, GFE, or GFI) N/A

VIII. Travel To be determined by government based on work to be covered under the service contract.

V. Section 508 Compliance

Section 508 of the Rehabilitation Act of 1973 (29. U.S.C. 794d), as amended by the Workforce Investment Act 1998, requires that all electronic and information technology (EIT) products and services developed, acquired, maintained, or used under this award must comply with the “Electronic and Information Technology Accessibility Provisions” set forth by the Architectural and Transportation Barriers Compliance Board (also referred to as the “Access Board”) in 36 CFR part 1194. Information about Section 508 is available at http://www.access-board.gov/guidelines-andstandards/commications-and-it/about-the-section-508-standards. This requirement is shall comply with the following standards.

• E101.2 Equivalent Facilitation (Appendix A, Application and Scoping Requirements)

• E203 Access to Functionality (Appendix A, Application and Scoping Requirements)

• E204 Functional Performance (Appendix A, Application and Scoping Requirements)

• E205 Electronic Content (Appendix A, Application and Scoping Requirements) http://www.access-board.gov/guidelines-andstandards/commications-and-it/about-the-section-508-standards http://www.access-board.gov/guidelines-andstandards/commications-and-it/about-the-section-508-standards

• 302 Functional Performance (Appendix C, Functional Performance Criteria and Technical Requirements)

• Electronic content must be accessible to HHS acceptance criteria. Checklist for various formats are available at http://508.hhs.gov/, or from the Section 508 Coordinator listed a https://www.hhs.gov/web/section-508/additional-resources/section-508-contacts/index.html.

Materials that are final items for delivery should be accompanied by the appropriate checklist, except up approval of the Contract Officer or Representative.

• E207 Software (Appendix A, Application and Scoping Requirements)

• E208 Support Documentation and Services (Appendix A, Application and Scoping Requirements)

• Chapter 5 Software (Appendix C, Functional Performance Criteria and Technical Requirements)

• Chapter 6 Support Documentation and Services (Appendix C, Functional Performance Criteria and

Technical Requirements)

All EIT must meet the applicable accessibility standards at 36 CFR 1194, unless an agency exception to this requirement exists. 36 CFR 1194 implements Section 508 of the Rehabilitation Act of 1973, as amended, and is viewable at: https://www.section508.gov/.

http://508.hhs.gov/ https://www.hhs.gov/web/section-508/additional-resources/section-508-contacts/index.html https://www.section508.gov/

SECTION 3 - INSPECTION AND ACCEPTANCE

3.0 INSPECTION AND ACCEPTANCE

Inspection and acceptance will be performed at the delivery location. The Technical Point of Contact will perform inspection and acceptance of the materials delivered. Acceptance is communicated in writing unless otherwise indicated by the Contracting Officer of Technical POC within 30 days of receipt of the deliverable(s). If a rejection is issued, the Contractor shall correct any deficiencies within fifteen (15) days from the time the Government issues the rejection notice.

If the Contractor cannot correct the deficiencies within this time frame, the contractor shall immediately notify the Technical POC of the reason for the delay and provide a proposed corrective action plan within three (3) business days.

SECTION 4 - DELIVERIES OR PERFORMANCE

4.0 PERIOD OF PERFORMANCE

Service contract agreement will span twelve (12) months from coverage award date and four (4) twelve (12) months option periods.

4.1 PLACE OF PERFORMANCE

Work covered under the service contract will be performed at FDA’s CFSAN’s (Center for Food Safety and Applied Nutrition) facility located at: 5001 Campus Drive, College Park, Maryland, 20740.

Work covered under the service contract shall be conducted Monday through Friday, excluding federal holidays. Unless otherwise directed, the Contractor shall adhere to standard work hours, working no more than forty (40) hours per week, and observe all U.S. Government holidays. The on-site Contractor shall maintain continuous service during the hours at the facility identified above on an as-needed basis.

4.2 GOVERNMENT- FURNISHED PROPERTY AND INFORMATION

No Government-furnished property will be provided.

SECTION 5 - CONTRACT ADMINISTRATION DATA

5.0 CONTRACT ADMINISTRATION DATA

The following personnel shall represent the Government to this contract:

Technical Representative:

To be determined upon contract award

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

Contracting Officer (CO): Contract Specialist (CS):

Madeline Bryant Pamela T. Lee 4041 Powder Mill Rd 4041 Powder Mill Rd Beltsville, MD 20705 Beltsville, MD 20705 Madeline.Bryant@fda.hhs.gov Pamela.Lee@fda.hhs.gov

The Contracting Officer is the only person with authority to act as agent of the Government under this contract. Only the Contracting Officer has authority to: (1) direct or negotiate any changes in the RFQ; (2) modify or extend the period of performance; (3) change the delivery schedule; (4) authorize reimbursement to the Contractor any costs incurred during the performance of this contract; or, (5) otherwise change any terms and conditions of this contract.

5.1 CONTRACTING OFFICER'S REPRESENTATIVE (COR) AUTHORITY

(a) Performance of work under this contract must be subject to the technical direction of the Contracting Officer's Representative identified above, or a representative designated in writing.

The term "technical direction" includes, without limitation, direction to the contractor that directs or redirects the labor effort, shifts the work between work areas or locations, fills in details and otherwise serves to ensure that tasks outlined in the work statement are accomplished satisfactorily.

(b) Technical direction must be within the scope of the specification(s)/work statement.

The Contracting Officer's Representative does not have authority to issue technical direction that:

(1) Constitutes a change of assignment or additional work outside the specification(s)/statement of work;

(2) Constitutes a change as defined in the clause entitled "Changes";

(3) In any manner causes an increase or decrease in the contract price, or the time required for contract performance;

(4) Changes any of the terms, conditions, or specification(s)/work statement of the contract;

(5) Interferes with the contractor's right to perform under the terms and conditions of the contract; or

(6) Directs, supervises or otherwise controls the actions of the contractor's employees.

(c) Technical direction may be oral or in writing. The Contracting Officer's Representative shall confirm oral direction in writing within five work days, with a copy to the Contracting Officer.

(d) The contractor shall proceed promptly with performance resulting from the technical direction issued by the Contracting Officers, Representative. If, in the opinion of the contractor, any direction of the Contracting Officers, Representative, or his/her designee, falls within the limitations in (b), above, the contractor shall immediately notify the Contracting Officer no later than the beginning of the next Government work day.

(e) Failure of the contractor and the Contracting Officer to agree that technical direction is within the scope of the contract shall be subject to the terms of the clause entitled "Disputes."

SECTION 6 - SPECIAL CONTRACT REQUIREMENTS

6.0 CONTRACTOR PERFORMANCE EVALUATION(S)

During the life of this contract, Contractor performance will be evaluated on an interim and final basis pursuant to FAR Subpart 42.15. The Contractor Performance Assessment Reporting System (CPARS) will be utilized for these reviews. Information on CPARS can be located at http://www.cpars.gov.

6.1 GENERAL INVOICING INSTRUCTIONS

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

a. All Invoice submissions for goods and or services must be made electronically through the U.S.

Department of Treasury's Invoice Processing Platform System (IPP).

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

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

https://www.ipp.gov.

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 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.

SECTION 7 – CLAUSES

7.0 52.252-2 Clauses Incorporated by Reference (FEB 1998) This contract incorporates one or more clauses by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. Also, the full text of a clause may be accessed electronically at this/these address(es):

1) http://www.acquisition.gov/far/:

52.202-1 Definitions (Jun 2020) 52.212-4 Contract Terms and Conditions-Commercial Items (Nov 2021) 52.224-1 Privacy Act Notification. (APR 1984) 52.224-2 Privacy Act. (APR 1984) 52.232-39 Unenforceability of Unauthorized Obligations (Jun 2013) 52.232-40 Providing Accelerated Payments to Small Business Subcontractors. (NOV 2021) 52.233-4 Applicable Law for Breach of Contract Claim (Oct 2004) and,

2) http://www.hhs.gov/policies/hhsar/:

352.203-70 Anti-Lobbying. (DEC 2015) 352.204-70 Prevention and Public Health Fund Reporting Requirements. (DEC 2015) 352.208-70 Printing and Duplication. (DEC 2015) 352.211-1 Public Accommodations and Commercial Facilities. (DEC 2015) 352.211-3 Paperwork Reduction Act. (DEC 2015)

7.1 FAR 52.217-8 Option To Extend Services. (NOV 1999)

The Government may require continued performance of any services within the limits and at the rates specified in the contract. These rates may be adjusted only as a result of revisions to prevailing labor rates provided by the Secretary of Labor. The option provision may be exercised more than once, but the total extension of performance hereunder shall not exceed 6 months. The Contracting Officer may exercise the option by written notice to the Contractor within 30 days.

(End of clause)

7.2 FAR 52.217-9 Option To Extend the Term of the Contract. (MAR 2000)

(a) The Government may extend the term of this contract by written notice to the Contractor within [insert the period of time within which the Contracting Officer may exercise the option];

provided that the Government gives the Contractor a preliminary written notice of its intent to extend at least [60 days unless a different number of days is inserted]days before the contract expires. The preliminary notice does not commit the Government to an extension.

(b) If the Government exercises this option, the extended contract shall be considered to include this option clause.

(c) The total duration of this contract, including the exercise of any options under this clause, shall not exceed 66 months.

(End of clause)

7.3 HHSAR 352.239-74 Electronic and Information Technology Accessibility. (DEC 2015)

(a) Pursuant to Section 508 of the Rehabilitation Act of 1973 (29 U.S.C. 794d), as amended by the Workforce Investment Act of 1998, all electronic and information technology (EIT) supplies and services developed, acquired, or maintained under this contract or order must comply with the "Architectural and Transportation Barriers Compliance Board Electronic and Information Technology (EIT) Accessibility Standards" set forth by the Architectural and Transportation Barriers Compliance Board (also referred to as the "Access Board") in 36 CFR part 1194.

Information about Section 508 is available at http://www.hhs.gov/web/508. The complete text of Section 508 Final Provisions can be accessed at http://www.access-board.gov/guidelines-and-standards/communications-and-it/about-the-section-508-standards.

(b) The Section 508 accessibility standards applicable to this contract or order are identified in the Statement of Work or Specification or Performance Work Statement. The contractor must provide any necessary updates to the submitted HHS Product Assessment Template(s) at the end of each contract or order exceeding the simplified acquisition threshold (see FAR 2.101) when the contract or order duration is one year or less. If it is determined by the Government that EIT supplies and services provided by the Contractor do not conform to the described accessibility standards in the contract, remediation of the supplies or services to the level of conformance specified in the contract will be the responsibility of the Contractor at its own expense.

(c) The Section 508 accessibility standards applicable to this contract are: []

(d) In the event of a modification(s) to this contract or order, which adds new EIT supplies or services or revises the type of, or specifications for, supplies or services, the Contracting Officer may require that the contractor submit a completed HHS Section 508 Product Assessment Template and any other additional information necessary to assist the Government in determining that the EIT supplies or services conform to Section 508 accessibility standards. Instructions for documenting accessibility via the HHS Section 508 Product Assessment Template may be found under Section 508 policy on the HHS Web site: (http://www.hhs.gov/web/508). If it is determined by the Government that EIT supplies and services provided by the Contractor do not conform to the described accessibility standards in the contract, remediation of the supplies or services to the level of conformance specified in the contract will be the responsibility of the Contractor at its own expense.

(e) If this is an Indefinite Delivery contract, a Blanket Purchase Agreement or a Basic Ordering Agreement, the task/delivery order requests that include EIT supplies or services will define the specifications and accessibility standards for the order. In those cases, the Contractor may be required to provide a completed HHS Section 508 Product Assessment Template and any other additional information necessary to assist the Government in determining that the EIT supplies or services conform to Section 508 accessibility standards. Instructions for documenting accessibility via the HHS Section 508 Product Assessment Template may be found at http://www.hhs.gov/web/508. If it is determined by the Government that EIT supplies and services provided by the Contractor do not conform to the described accessibility standards in the provided documentation, remediation of the supplies or services to the level of conformance specified in the contract will be the responsibility of the Contractor at its own expense.

(End of clause)

SECTION 8 - INSTRUCTIONS, CONDITIONS, AND NOTICES TO QUOTERS

8.0 FAR 52.252-1 Solicitation Provisions Incorporated by Reference. (FEB 1998)

This solicitation incorporates one or more solicitation provisions by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. The offeror is cautioned that the listed provisions may include blocks that must be completed by the offeror and submitted with its quotation or offer. In lieu of submitting the full text of those provisions, the offeror may identify the provision by paragraph identifier and provide the appropriate information with its quotation or offer. Also, the full text of a solicitation provision may be accessed electronically at this/these address(es):

1) http://www.acquisition.gov/far/:

52.212-1 Instructions to Offerors—Commercial Products and Commercial Services (Nov. 2021) FAR 52.212-3 Offeror Representations and Certifications—Commercial Products and Commercial Services (Nov 2021)

2) http://www.hhs.gov/policies/hhsar/

HHSAR 352.215-70 Late Proposals and Revisions. (DEC 2015) HHSAR 352.270-4 a Notice to Offerors, Protection of Human Subjects. (DEC 2015)

8.1 HHSAR 352.239-73 Electronic Information and Technology Accessibility Notice. (DEC 2015)

(a) Section 508 of the Rehabilitation Act of 1973 (29 U.S.C. 794d), as amended by the Workforce Investment Act of 1998 and the Architectural and Transportation Barriers Compliance Board Electronic and Information (EIT) Accessibility Standards (36 CFR part 1194), require that when Federal agencies develop, procure, maintain, or use electronic and information technology, Federal employees with disabilities have access to and use of information and data that is comparable to the access and use by Federal employees who are not individuals with disabilities, unless an undue burden would be imposed on the agency. Section 508 also requires that individuals with disabilities, who are members of the public seeking information or services from a Federal agency, have access to and use of information and data that is comparable to that provided to the public who are not individuals with disabilities, unless an undue burden would be imposed on the agency.

(b) Accordingly, any offeror responding to this solicitation must comply with established HHS EIT accessibility standards. Information about Section 508 is available at http://www.hhs.gov/web/508. The complete text of the Section 508 Final Provisions can be accessed at http://www.access-board.gov/guidelines-and-standards/communications-and-it/about-the-section-508-standards.

(c) The Section 508 accessibility standards applicable to this solicitation are stated in the clause at 352.239-74, Electronic and Information Technology Accessibility.

In order to facilitate the Government's determination whether proposed EIT supplies meet applicable Section 508 accessibility standards, offerors must submit an HHS Section 508 Product Assessment Template, in accordance with its completion instructions. The purpose of the template is to assist HHS acquisition and program officials in determining whether proposed EIT supplies conform to applicable Section 508 accessibility standards. The template allows offerors or developers to self-evaluate their supplies and document-in detail-whether they conform to a specific Section 508 accessibility standard, and any underway remediation efforts addressing conformance issues. Instructions for preparing the HHS Section 508 Evaluation Template are available under Section 508 policy on the HHS Web site http://www.hhs.gov/web/508.

In order to facilitate the Government's determination whether proposed EIT services meet applicable Section 508 accessibility standards, offerors must provide enough information to assist the Government in determining that the EIT services conform to Section 508 accessibility standards, including any underway remediation efforts addressing conformance issues.

(d) Respondents to this solicitation must identify any exception to Section 508 requirements. If a offeror claims its supplies or services meet applicable Section 508 accessibility standards, and it is later determined by the Government, i.e., after award of a contract or order, that supplies or services delivered do not conform to the described accessibility standards, remediation of the supplies or services to the level of conformance specified in the contract will be the responsibility of the Contractor at its expense.

(End of provision)

8.2 RFP INQUIRIES AND QUESTIONS DUE DATE

All questions regarding the solicitation, of a contractual nature or technical nature, must be submitted in writing and sent via email to Pamela.Lee@fda.hhs.gov by 2:00 P.M., September 8, 2022, Easter Daylight Savings Time (EDT). The Government may not consider any questions received after this date and time. All questions received and any amendments to this solicitation will be answered and posted on sam.gov.

8.3 PROPOSAL SUBMISSION

Offerors who are interested in this RFP must submit their proposal by September 13, 2022 no later than 1:00 P.M. EDT. Offerors shall submit one (1) electronic copy to Pamela.Lee@fda.hhs.gov.

All electronic submissions must contain the RFP solicitation number and titled in the subject of the electronic submission email.

8.4 TECHNICAL VOLUME INSTRUCTIONS

The Technical volume shall be limited to 10 pages, with 1-inch margins, and using not less than 12 point font. Quoters are encouraged to be succinct and economical in their presentation. Excessive volume and elaborate presentation are unnecessary. Tables of contents, and works cited and the Technical Appendix are not included in the page count.

The technical volume must not contain references to price; however, resource information, such as data concerning labor hours and categories, materials, subcontracts, etc., must be contained in the technical volume so that the Quoter's understanding of the scope of work may be evaluated.

The quoter's technical approach must be disclosed in sufficient detail to provide a clear and concise presentation that includes, but is not limited to, the requirements of the technical volume instructions. The Quoter must provide clear responses, including objectives and outcomes, to each

Task addressing the work to be performed in the Description/Specifications section. The technical volume must reflect a clear understanding of the nature of the work being undertaken. Quotes which merely offer to conduct a project in accordance with the requirements of the Government's requirements will not be eligible for award.

Technical Appendices:

The quoter shall include a Technical Appendix (as applicable) that will include all attachments, such as transcripts, resumes, letters of commitment.

8.5 PRICE/BUSINESS VOLUME INSTRUCTIONS

The Quoter shall prepare a price volume that contains all information necessary to allow for a comprehensive evaluation of the prices quoted. The price quote shall consist of pricing discounts, the proposed labor categories and hours, as applicable.

The pricing information shall include the following:

• A completed Pricing Table.

This is a firm-fixed price requirement. So being, your price volume must include a payment plan tied to the deliverables schedule and reflecting an amount equal to the value of the deliverable being invoiced for. Please express the prices under the quoted payment plan on a per deliverable basis.]

The price/business volume should also include all other information required by this RFQ in these instructions such as the Quoter Representations and Certifications.

Other Proposal instructions:

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

It is the offeror’s responsibility to ensure all electronic documents are submitted without the use of macros.

The following language will be included in the resultant contract award:

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

8.6 ORGANIZATIONAL CONFLICT OF INTEREST DISCLOSURE/MITIGATION

Offerors are required to identify actual and potential organizational conflicts of interest (OCI) related to the services described in the statement of work for itself, as well as employees, consultants and subcontractors proposed. This includes, but is not limited to:

- The existence of conflicting roles that might bias judgment; and

- Access to nonpublic information that will give the offeror an unfair competitive advantage.

Offerors shall include an explanation of the process used to identify OCIs. If an actual or potential OCI is identified, the offeror shall submit a mitigation plan as part of its proposal.

Offerors shall submit with their proposal an OCI affirmation, using the following language:

"I, (Name and Title), warrant that: 1) I am an official authorized to bind the entity; and 2) to the best of my knowledge and belief , actual and potential organizational conflicts of interest have been identified, and disclosed to the Contracting Officer (identify section of proposal) as of (Date)."

SECTION 9 - EVALUATION FACTORS FOR AWARD

9.0 GENERAL EVALUATION INSTRUCTIONS

Quotes must be prepared in accordance with and in compliance with the instructions given in this RFQ. The Government does not anticipate requesting revisions to quotes, so Quoters should provide their best solution and price in its response to the RFQ.

The agency will assess the evaluation factors in accordance with FAR Part 12 and in accordance with the evaluation criteria stated within this solicitation. After this assessment, the Contracting Officer may award a contract to the quoter representing the best value, or may contact the quoter (or multiple quoters) and request quote revisions that seek additional price discounts, provide revisions to the technical quote or explain aspects of the quote to improve the terms of the deal reflected in the quote. In the event quote revisions are requested, the Government will not necessarily be seeking revisions from all quoters, and will not be conducting "discussions" as defined in FAR Part 15.

9.1 PRICE EVALUATION

Quoters, at a minimum, shall submit price quotes in sufficient detail for the Government to determine that the proposed price is consistent with the proposed technical approach. The government will consider the level of effort and the mix of labor proposed for the work to be performed for determining whether the price is reasonable. The quoted price is not a numerically weighted factor.

In evaluating the Quoter’s price/business volume, the total evaluated price will include all option periods/items.

9.2 BASIS FOR AWARD

FAR 52.212-2 Evaluation—Commercial Products and Commercial Services (Nov 2021)

(a) The Government will award a contract resulting from this solicitation to the responsible offeror whose offer conforming to the solicitation will be most advantageous to the Government, price and other factors considered. The following factors shall be used to evaluate offers:

(i) technical capability of the item offered to meet the Government requirement; (ii) price; (iii) past performance.

Technical and past performance, when combined, are significantly less important than cost or price.

(b) Options. The Government will evaluate offers for award purposes by adding the total price for all options to the total price for the basic requirement. The Government may determine that an offer is unacceptable if the option prices are significantly unbalanced. Evaluation of options shall not obligate the Government to exercise the option(s).

(c) A written notice of award or acceptance of an offer, mailed or otherwise furnished to the successful offeror within the time for acceptance specified in the offer, shall result in a binding contract without further action by either party. Before the offer’s specified expiration time, the Government may accept an offer (or part of an offer), whether or not there are negotiations after its receipt, unless a written notice of withdrawal is received before award.

(End of provision)