Automated DNA Extraction System

(i) This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in FAR Subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; quotes are being requested and a written solicitation will not be issued.

(ii) The solicitation number is CVM-2025-129685 and is issued as a Request for Quote (RFQ).

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

(iv) This acquisition is Full and Open competition. The associated NAICS code is 334516 with a size standard of 1,000 employees.

(v) Contract Line Items (CLINs):

• CLIN 0001 Automated DNA Extraction System (Equivalent to Promega Maxwell RSC 48 AS8500) with computer, software, and peripherals Qty 1, EA.
• CLIN 0002 Installation, reagents, and consumables for startup Qty 1, LOT.
• CLIN 0003 User Training for minimum of 6 personnel Qty 1, LOT.
• CLIN 0004 One-year warranty (parts, labor, and software updates) Qty 1, LOT.
• Option CLINs 0005 0008 Maintenance Agreement for Years 2 5, including one preventative maintenance visit annually Qty 1, LOT each year.

(vi) Description of Requirement:

The U.S. Food and Drug Administration (FDA), Center for Veterinary Medicine (CVM), Office of Applied Science (OAS), requires an automated nucleic acid purification system capable of extracting high-quality, high molecular weight DNA from genomes, metagenomes, and enriched microbiomes. The system shall meet the salient characteristics described in the attached Statement of Work (Attachment 1).

(vii) Delivery/Acceptance:

• Delivery/Installation: Within 60 days after award.
• FOB Point: Destination.
• Delivery Location:
  U.S. FDA CVM OAS
  Bldg MOD2, 8401 Muirkirk Road
  Laurel, MD 20708
• Delivery Hours: 10:00 a.m. 4:00 p.m., Monday Friday, excluding Federal Holidays.

(viii) FAR 52.212-1, Instructions to Offerors Commercial Items (NOV 2021) applies. Offerors shall submit:

1. Volume I - Technical proposal addressing salient characteristics, installation, training, warranty and maintenance.

Volume I shall include the following:

• Cover page that includes a point of contact (name, telephone number and email address)
• Limited to 30 pages with 1-inch margins (Technical Appendix are not included in the page count.)
• Font size: greater than 12 point font.
• Tables of contents and works cited

Volume I shall not contain any pricing; however, Volume I must address at a minimum all the sections that is listed in Attachment I Statement of Work

Volume I must include clear objectives and outcomes, and provide a detailed narrative that clearly and completely demonstrates its technical approach to provide a comprehensive automated nucleic acid purification system capable of extracting high-quality, high molecular weight DNA from genomes, metagenomes, and enriched microbiomes adhering to all the requirements in Attachment I Statement of Work .

At a minimum, Volume I must include the following:

• Narrative discussion in sufficient detail addressing a sound, feasible, and achievable technical approach to accomplish all technical requirements.

Technical Appendices:

The Contractor/Company shall include a Technical Appendix that will include all attachments, such as transcripts, resumes, letters of commitment.

2. Volume II - Price proposal with breakdown by CLIN. (Attachment 2)

Volume II must include all pricing and all information necessary to allow for a comprehensive evaluation of the prices proposed in Attachment II Pricing Spreadsheet. The price quote shall be a firm fixed price and include all pricing.

The Contractor/Company 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.

Attachment II Pricing Spreadsheet shall be used to identify all the pricing associated with providing the equipment, installation and maintenance for an automated nucleic acid purification system to the FDA. Attachment III can be modified to include additional services that are being provided.

1. Documentation of training/certification for service engineers within Volume I
2. Volume III - Past performance references for similar systems.

Include the following in Volume III - Past Performance Information references:

• Contract Number
• UEI Number is applicable
• Name of Contractor and POC Information
• Type of Contract (e.g., BPA/IDIQ/Delivery Order/FFP/T&M/LH)
• Period of Performance
• Description of the scope of the requirement, size and complexity of training provided

Scope: Identifies the aspects of the scope that are the same or similar to the work requirements as listed in the SOW.

Complexity: Describes the specialized nature of the engagement.

Size: Identifies the total dollar value of the contract and the total number of personnel engaged in the effort.

Proposals must be prepared in accordance with and in compliance with the instructions given in this RFQ and address all of the requirements set forth in the Statement of Work (SOW). Merely reinstating the statement of work is not acceptable or not providing adequate information that clearly demonstrates the ability to provide and install that is being requested in the SOW will be considered unacceptable and the contractor will not be eligible for an award. The Government does not anticipate requesting revisions to quotes, so contractors should provide their best solution and price in its response to the RFQ.

The agency will assess the evaluation factors in accordance with FAR Subpart 12 or 13 and in accordance with the evaluation criteria stated within this solicitation. After this assessment, the Contracting Officer may award a contract to the Contractor/Company representing the best value or may contact the contractor (or multiple contractors) and request quote revisions that seek additional price discounts, provide revisions to the technical approach or explain aspects of the quote to improve the terms of the maintenance that are reflected in the quotel. In the event quote revisions are requested, the Government will not necessarily be seeking revisions from all contractors and will not be conducting "discussions".

(ix) FAR 52.212-2, Evaluation Commercial Items (NOV 2021) applies. Evaluation will be based on:

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. Technical Approach, Delivery schedule and Past performance, when combined, are significantly more important than price.

(a) The following factors shall be used to evaluate Quotes:

• FACTOR 1 Technical Capability (meeting salient characteristics, training, warranty, and maintenance).
• FACTOR 2 Delivery Schedule.
• FACTOR 3 Past Performance
• FACTOR 4 Price

(b) 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 a Proposal, whether or not there are negotiations after its receipt, unless a written notice of withdrawal is received before award.

(End of provision)

Award will be made to the responsible contractor whose quote represents the best value to the Government.

(x) Offerors shall complete FAR 52.212-3, Offeror Representations and Certifications Commercial Items (DEC 2022), via SAM.gov. (Include a copy with your technical proposal)

(xi) FAR 52.212-4, Contract Terms and Conditions Commercial Items (DEC 2022) applies.

(xii) FAR 52.212-5, Contract Terms and Conditions Required To Implement Statutes or Executive Orders Commercial Items (JUN 2023) applies, including:

• 52.204-10 Reporting Executive Compensation and First-Tier Subcontract Awards
• 52.209-6 Protecting the Government's Interest When Subcontracting with Debarred or Suspended Contractors
• 52.219-28 Post Award Small Business Program Rerepresentation
• 52.222-3 Convict Labor
• 52.222-19 Child Labor Cooperation with Authorities and Remedies
• 52.222-21 Prohibition of Segregated Facilities
• 52.222-26 Equal Opportunity
• 52.222-36 Equal Opportunity for Workers with Disabilities
• 52.222-50 Combating Trafficking in Persons
• 52.223-18 Encouraging Contractor Policies to Ban Text Messaging While Driving
• 52.225-1 Buy American Supplies
• 52.232-33 Payment by Electronic Funds Transfer System for Award Management

(xiii) Additional Contract Clauses (Incorporated by Reference) :

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):

https://www.acquisition.gov/far/part-52

https://www.acquisition.gov/hhsar/part-352-solicitation-provisions-and-contract-clauses

All applicable terms and conditions from the Contractor's MAS under SIN [334516] flows down to the associated and awarded order.

• 52.211-5 Material Requirements (DEVIATION) (RFO JUN 2025)
• 52.243-1 Changes-Fixed-Price (DEVIATION) (RFO JUN 2025)
• 52.211-6 Brand Name or Equal (AUG 1999)
• HHSAR 352.211-3 Paperwork Reduction Act (Dec 2015)
• HHSAR 352.222-70 Reserved (Deviation)
• HHSAR 352.232-71 Electronic Submission of Payment Requests.

Clauses by Full Text

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.

1. 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,
2. Other Direct Costs - include a listing of all other direct charges to the contract, e.g., office supplies, telephone, duplication, postage; and
3. Fee - amount as allowable in accordance with the Schedule and FAR 52.216-8 if applicable.
4. Indirect Costs (i.e., Fringe Benefits, Overhead, General and Administrative, Other Indirects)- show rate, base and total amount;
5. Consultants (if applicable) - include the name, number of days or hours worked, daily or hourly rate, and a total amount per consultant;
6. 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;
7. Subcontractors (if applicable) - include, for each subcontractor, the same data as required for the prime Contractor.

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:

(i.) invoice number, amount, & date submitted
(ii.) 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 Delivery 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.

(xiv) Additional Contract Requirements:

• Must meet 508 Compliance requirements (WCAG 2.0A & AA).
• Instrument must be new, not refurbished.
• Option year maintenance agreement (up to 4 years) required.
• Site visit required after award before installation.

(xv) Quotes are due no later than September 12, 2025@ 10am by email to:

Contract Specialist: Michele Jackson
Email: Michele.Jackson@fda.hhs.gov

(xvi) Points of Contact:

• Contracting Officer (CO): Michele Jackson Michele.Jackson@fda.hhs.gov
• Contracting Officer's Representative (COR): To Be determined at award
• Technical Point of Contact (TPOC): To Be determined at award

Attachments:

• Attachment 1: Statement of Work (SOW)
• Attachment 2: Pricing Spreadsheet