RFQ_2024-130334.docx

RFQ FDA_2025130334

The U.S. Food and Drug Administration (FDA)’s Office of Laboratory Operations and Applied Science (OLOAS), Office of Applied Microbiology and Technology (OAMT) Division of Food Safety Genomics (DFSG) intends to award a contract on a sole source basis to Biolog, Inc. upon the basis of the authority provided at FAR 13.106-1(b).

Biolog, Inc. was identified as the only source reasonably available to meet all technical requirements of the Government because of the proprietary hardware and software systems in place. Annual calibration and maintenance is required to maintain the standards level which were originally established for the equipment at the time of purchase.

This Notice is not a request for competitive quotations. However, interested parties may identify their interest and capability to respond to this requirement. Any interested party that believes they can fulfill this requirement should submit a capability statement to be reviewed. All submissions will be considered, however there is no guarantee that submissions in response to this notice will in any way alter the Government's acquisition strategy.

Note: In order to be eligible for award of a Government contract, vendors must be actively registered in the System for Award Management (SAM), have no active exclusions, and complete the FAR and DFARS representations and certifications.

1. Contracting Office Address:

DHHS/FDA/OAGS/DAP

ATTN: Pamela Lee 11601 Lansdown Street 3WFN/13th Floor North Bethesda, MD 20852 Email: Pamela.Lee@fda.hhs.gov Telephone: 240- 402-3847

2. Solicitation Number: FDA-RFQ-2025130334

3. Subject: The U.S. Food and Drug Administration (FDA)’s Office of Laboratory Operations and Applied Science (OLOAS), Office of Applied Microbiology and Technology (OAMT) Division of Food Safety Genomics (DFSG) has requirement for a once-a-year preventative maintenance service contract for the Omnilog systems in order to keep the instruments functioning properly so that it can take accurate and reproducible readings

4. Classification Code: J066

5. NAICS Code: 811310

6. Response Date: September 12, 2025, 10:00 A.M. Eastern time due via email to the Primary Point of Contact listed in the sam.gov webpage for this combined synopsis-solicitation.

7. Name and Telephone Number of the Individual to Contact for Information Regarding the Solicitation: POC: Contract Specialist: Pamela Lee, pamela.lee@fda.hhs.gov Phone: 240-402-3847 Alternate POC: Contracting Officer: Madeline Bryant. Email address: Madeline,Bryant@fda.hhs.gov. Telephone: (240) 402-7611

8. Description: FDA is seeking the services of a contractor capable of

(i) This is a solicitation for commercial items prepared in accordance with the format in FAR Subpart 12.6, as supplemented with additional information included below.

(ii) This acquisition is issued as a Request for Quote.

(iii) The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 2025-05, August 7, 2025.

(iv) Evaluation Criteria - All evaluation factors other than cost or price, when combined, are approximately equal to cost or price.

OAMT Statement of Work (SOW)

Purchase of Preventative Maintenance Service for Biolog/Omnilog Instruments at FDA/OAMT

1. Purpose

· The purpose of this requirement is to acquire preventative maintenance (PM) service on the existing Government-owned Biolog Omnilog instruments serial number (SN) 193 and SN 191, which are installed at Food and Drug Administration (FDA), Module 1 (MOD1). FDA requires PM service for the existing instruments. The PM service shall include service on both instruments. This acquisition is for a new PM service purchase order (P/O) for the SN 193 and SN 191, to begin on 09/23/25, after current PO 75F40124P00489 ends.

· The PM service shall include:

· All labor, travel, and expenses for one (1) preventative maintenance visit per year for the SN 191 and SN 193.

· Telephone/Email technical support and routine troubleshooting.

2. Background

· FDA’s Office of Laboratory Operations and Applied Science (OLOAS), Office of Applied Microbiology and Technology (OAMT) Division of Food Safety Genomics (DFSG) has two existing Government-owned Omnilog Biolog systems to conduct phenotypic microarray (PM) experiments. DFSG requires once a year PM service for instrument SN 193 and SN 191 to keep the instruments functioning according to the Original Equipment Manufacturer (OEM)’s specifications. PM service is required to ensure that the SN 193 and SN 191 can take accurate and reproducible readings for DFSG.

· A PM service is required on instruments SN 193 and SN 191. Both instruments are located at FDA 8301 Muirkirk Rd, Laurel MD 20708 and are operating normally. The new PO will provide PM service on both SN 193 and SN 191 during the period of performance of 09/23/2025 to 09/22/2026.

· In an effort to ensure accurate research at OAMT, DFSG has maintained PM service on instruments SN 193 and SN 191 to ensure quality of data output and analysis since FY19. Without yearly PM and routine service by the OEM, Biolog Inc, instruments SN 193 and S 191 may lose their capacity to perform at OEM standards, which could compromise mission critical research for DFSG. PM service on SN 193 and SN 191 is needed to keep the instruments at OEM standards so that it can take accurate and reproducible readings. The required PM service provides performance verification of the covered components. Therefore, maintenance on SN 193 and SN 191 is necessary to ensure proper performance of phenotypic microarray equipment within OAMT.

3. Specific Tasks

The Government requires the following:

· Task 1: One-year (12 months) PM service for Omnilog Biolog instruments SN 193 and for SN 191. If Biolog allows option years, DFSG would like to include four option years. In the past, Biolog did not allow for optional years.

Task 1:

Maintenance Requirements for the Preventative Maintenance Service: (for the Omnilog Biolog Instruments, SN193 and SN191)

The Contractor shall:

• Perform one (1) planned on-site PM visit annually, to include all associated labor, travel, and expenses at a date and time approved by the Contracting Officer’s Representative

• Perform all maintenance activities by formally trained and certified technicians and/or engineers. All maintenance activities shall follow OEM specifications, manuals, and service bulletins. The Contractor shall only use OEM replacement parts, components, subassemblies, etc.

• Provide telephone technical support and routine troubleshooting.

• Response time within three (3) to five (5) business days after receipt of service call if issue cannot be corrected remotely within eight (8) hours from call for service

Project Milestones/Completion Dates

Milestones Projected Completion Date

4. Deliverables

· The Contractor shall deliver: Preventative maintenance service on Biolog Omnilog instruments, SN 193 and SN19.

· Receipt of the field service report/ticket identifying the equipment name, manufacturer, model number, and serial number of the equipment being serviced, a detailed description of the work performed, the contact information of the technician who performed the service, and for information purposes, the hours expended, and parts/components replaced.

· The Contractor shall provide a written report to the FDA COR and contract specialist, summarizing all the maintenance activities (including warranty work) after each service.

Deliverable Table

Deliverable Title (Brief description)

Recipient

5. Security

Government shall provide escort of the service engineer for maintenance on the instruments. The engineer shall not be provided access to any material that involves Non-Public positions and involves the lowest degree of adverse impact on the efficiency of the Agency. This position does not require a badge or access to FDA’s network.

6. Travel

Travel by the vendor is included in the cost of the preventative maintenance service.

7. Place of Performance

The location of the Biolog Instruments:

FDA

8301 Muirkirk Road Laurel, MD 20708 Attn: TBD

8. Holidays and Government Closures

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, DC area:

New Year’s Day Martin Luther King Day President’s Day Memorial Day Juneteenth Independence Day Labor Day Columbus Day Veteran’s Day Thanksgiving Day Christmas Day

In the event of inclement weather when the Federal government is closed, the Contractor is not required to provide on-site service. The Contractor is required to follow, as a minimum, other directives issued by the U.S. Office of Personnel Management or other such official for late arrivals due to inclement weather (unless otherwise specified in the Contract).

In the event the Federal Government is closed by order of the President of the United States or the U.S. Office of Personnel Management 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 responsible officials concerning reporting for work.

The Contractor may not bill the Government for any hours that contractor employees did not work due to any Government closure (e.g. applicable under a Labor Hour contract).

For on-site support at the FDA facility, unless otherwise directed, the Contractor should adhere to standard work hours, working no more than forty (40) hours per week. If more than 40 hours per week are required, then the hours should be billed at normal rates/straight time. Any necessary overtime shall be authorized in advance by the Contracting Officer.

9. Period of Performance

The period of performance is 09/23/2025-09/22/2026.

10. Contract Administration

The FDA Contracting Officer Representative (COR) The following COR will represent the FDA for the purpose of this contract: TBD

Technical Point of Contact (TPOC): TBD

11. Additional Conditions, Provisions and Clauses

1. The Government intends to award a single, firm-fixed price order resulting from this RFQ.

2. The provision at 52.212-1, Instructions to Offerors-Commercial Products and Commercial Services (Sep 2023), applies to this acquisition.

3. The provision at FAR 52.212-3, Offeror Representations and Certification – Commercial Products and Commercial Services (May 2024)(DEVIATION FEB 2025). (and Alternate I – Feb 2024),

4. The clause at 52.212-4, Contract Terms and Conditions – Commercial Products and Commercial Services (JAN 2025)(DEVIATION FEB 2025), applies to this acquisition.

5. The clause at 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders - Commercial Products and Commercial Services (JAN 2025) (DEVIATION FEB 2025) applies to this acquisition. The following additional FAR clauses cited in this clause are applicable:

52.204-27, Prohibition on a ByteDance Covered Application (Jun 2023) 52.219-11, Special 8(a) Contract Conditions (Jan 2017) 52.219-12, Special 8(a) Subcontract Conditions (Oct 2019) 52.219-28, Post Award Small Business Program Representation (Jan 2025) 52.222-3, Convict Labor (Jun 2003) 52.222-19, Child Labor-Cooperation with Authorities and Remedies (Jan 2025) 52.222-21, Prohibition of Segregated Facilities (Apr 2015) 52.222-36, Equal Opportunity for Workers with Disabilities (Jun 2020) 52.222-50, Combating Trafficking in Persons (Nov 2021) 52.224-3, Privacy Training (Jan 2017) 52.225-13, Restrictions on Certain Foreign Purchases (Feb 2021) 52.232-33 Payment by Electronic Funds Transfer-System for Award Management (Oct 2018)

6. The following additional contract requirement(s) or terms and conditions apply:

a) https://www.acquisition.gov/far:

52.204-7, System for Award Management (Nov 2024) 52.204-13, System for Award Management Maintenance (Oct 2018) 52.204-16, Commercial and Government Entity Code Reporting (Aug 2020) 52.204-18, Commercial and Government Entity Code Maintenance (Jul 2016) 52.204-24, Representation Regarding Certain Telecommunications and Video Surveillance Services or Equipment (Nov 2021) 52.232-40, Providing Accelerated Payments to Small Business Subcontractors (Dec 2013)

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

352.203-70, Anti-Lobbying (Dec 2015) 352.208-70, Printing and Duplication (Dec 2015) 352.211-3, Paperwork Reduction Act (Dec 2015) 352.222-70, Contractor Cooperation in Equal Employment Opportunity Investigations (Dec 2015) 352.223-70, Safety and Health (Dec 2015) 352.224-70, Privacy Act (Dec 2015) 352.224-71, Confidential Information (Dec 2015) 352.227-70, Publications and Publicity (Dec 2015) 352.233-70, Choice of Law (Overseas), (Dec 2015) 352.237-70, Pro-Children Act (Dec 2015) 352.237-71, Crime Control Act – Reporting of Child Abuse (Dec 2015) 352.237-72, Crime Control Act - Requirement for Background Checks (Dec 2015) 352.237-74, Non-Discrimination in Service Delivery (Dec 2015) 352.239-73, Electronic and Information Technology Accessibility Notice (Dec 2015) 352.239-74, Electronic and Information Technology Accessibility Notice (Dec 2015)

12. 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.

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

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

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

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

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

d. Invoices that include time and materials or labor hours Line Items must include supporting 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.

13. DEPARTMENT OF HEALTH AND HUMAN SERVICES ACQUISITION

REGULATION (HHSAR) (48 CFR CHAPTER 3) CONTRACT CLAUSES

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)

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 requirements (ability to meet all salient requirements); and, (ii) price. Technical, is significantly less important than 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)