FDA-SOL-FY21-1238693.pdf

FDA-SOL-FY21-1238693

High-Throughput Automatic Sample Preparation System with Delivery, Installation, Training plus four (4) one (1) year optional Preventive Maintenance Services

This is a combined synopsis/solicitation for commercial services prepared in accordance with the format in FAR 12.6 as supplemented with FAR Part 13 and additional information included in this notice. The incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) 2021-05 dated March 10, 2021.

THIS ANNOUNCEMENT CONSTITUTES THE ONLY SOLICITATION AND A SEPARATE SOLICITATION

WILL NOT BE ISSUED. The solicitation number for this acquisition is FDA-SOL-FY21-1238693 and is being issued as a Request for Quote (RFQ). The NAICS Code for this solicitation is 334516 - Analytical Laboratory Instrument Manufacturing. This will be awarded as Firm-Fixed Price. The Government reserves the right to award an order without discussions if the Contracting Officer determines that the initial offer is providing the Best Value and discussions are not necessary.

The Government intends to issue a Purchase Order.

The U. S. Food and Drug Administration (FDA) has a need to procure a high throughput automatic sample preparation system with delivery, installation and training plus four (4) one

(1) year optional preventive maintenance services.

Minimum Required Salient Characteristics This requirement is for the purchase of a high throughput automatic sample preparation system with delivery, installation and Training plus four (4) one (1) year optional preventive maintenance services.

Detailed Technical Requirements

The high throughput automatic sample preparation system shall “meet or exceed” the following salient characteristics/specifications. Offerors shall include a technical brochure or otherwise reference the specific equipment, capabilities and characteristics referenced below. All of the following are minimum requirements. Equivalent requirements that differ from the below requirements must be justified by the proposing vendor and evaluated prior to award. The system must be a newly manufactured unit, not used and refurbished or previously used for demonstration:

1) Sample preparation workstation capable of processing at least 100 samples.

2) Automatically and accurately weighs samples for preparation method at ± 0.1 mg precision.

3) Extraction methods capable of extraction of tablets including tamper-resistant products, osmotic pump, modified/extended and delayed release formulations.

API’s, pastes, creams and solid delivery forms

4) Automatic cleaning between samples to eliminate sample carry-over.

5) An automatic filtration system.

6) An automatic centrifuge for processing samples like pastes, creams and polymer-heavy tablet formulations.

7) Ability to handle multiple solvents including acidic solvents and reagents.

8) Ability to do high precision dilutions of at least 1:1000000 for UPLC-HRMS analysis

9) Ability to collect samples into sealed HPLC vials

A. A Computer or Controller with operating system shall be included. Software for controlling the system and sample handling must be included. The Computer/Controller must be able to network and export sample lists and prep. information in a common format (e.g. CSV, Text, Excel).

B. The Automatic sample preparation system and all items included with purchase order, shall further be installed and verified as functionally operational. Installation and operational qualification (IQ/OQ) certification shall be provided.

C. Training on the operation, maintenance and application of the acquired system shall be provided.

Option Year Service Requirements

♦ Contractor shall provide annual service agreement of purchased systems for up to four (4) years following end of warranty consisting of:

o preventative maintenance per original equipment manufacture’s recommended schedule for service and replacement of parts.

o Corrective maintenance during the service period of performance.

o Updates and patches to instrument software and firmware shall be made available.

o Technical support shall be available by at least phone and email Monday through Friday 9-5PM EST excluding holidays o All parts, labor and travel shall be included as part of service agreement

♦ The government is not obligated to purchase this service agreement and exercise option unilaterally if in government’s best interest.

Trade and Service Specifications

1. The instrument shall be a newly manufactured unit, not used and refurbished or previously used for demonstration. The life cycle of this instrument is intended to be greater than ten years at full performance. FDA shall be able to reasonable expect service and technical support from the vendor during its lifecycle.

2. The entire system shall be warranted for parts and labor for 12 months from the date of installation. The vendor shall provide a copy and pricing for any available extended warranties and service contracts. The vendor shall also be capable of servicing the instrument through the extended warranty or service contract. This information shall not obligate FDA to purchase an extended warranty.

3. The vendor shall demonstrate the ability to manufacture the instrument system with a high degree of quality control as evidenced by units in use by other customers performing applications with similar technical demands.

Tasks Performed by Vendor

1. Delivery of system meeting technical requirements above (30 Days After Award)

2. Installation of system, followed by Installation and Operation Qualifications and Training (90 Days After Award)

Technical Evaluation Criteria

Bids should explain why and how their instrument meets or exceeds each detailed technical requirement and include supportive data and descriptions wherever possible.

1. Technical specifications: Award will be related to the degree to which the vendor meets or exceeds the detailed technical specifications.

2. Service capability: Award will be related to the ability of the vendor to provide technical support and service for the instrument over the next 10 years. This factor can be met by demonstrating that the vendor’s service department has been adequately staffed in previous years or by customer endorsements or by other methods.

3. Suitable for intended purpose: Award will be related to the ability of the vendor to demonstrate that their instrument has been used successfully by the pharmaceutical industry for applications with similar technical demands.

4. User friendliness: Award will be related to the ease of use of the instrument and software. This will include factors related to the ability of the user to export data and images to other programs including Microsoft Office products.

5. Lowest Price: Award will be related to the system satisfying the criteria above and for the lowest price.

Place of Performance

Division of Pharmaceutical Analysis

FDA/OPQ/OTR

645 S. Newstead Ave.

Saint Louis, MO 63110

Period of Performance

Deliver and perform IQ/OQ within 90 days after the contract award. Warranty period starts at the date of IQ/OQ completion. Up to four (4) Option Year Periods may be exercised unilaterally by government if it is in the government’s best interest.

Base Period: 08/31/2021 – 08/30/2022 Option Year 1: 08/31/2022 – 08/30/2023 Option Year 2: 08/31/2023 – 08/30/2024 Option Year 3: 08/31/2024 – 08/30/2025 Option Year 4: 08/31/2025 – 08/30/2026

Security

Contractors must either be escorted or be badged to HSPD 12 standard during instrument installation and IQ/OQ. Software required to control instrument shall be COTS must be approved on FDA MAT List prior to award.

A. IT PURCHASING REQUIREMENTS:

NOTE to Contractor: Before the task order is awarded, FDA is required to get pre-approval of all the IT hardware and/or software-firmware-freeware from the FDA Chief Information Officer (CIO). For IT hardware, this includes any device that processes or stores data, or is controlled by data (computers/data switches, etc.), but does not include passive hardware (rack, network cables, power supplies/cords, etc.). This will require the applicable Vendor to provide a complete list of hardware and/or software-firmware-freeware that the Vendor will use in fulfilling this task order.

This list will need to include:

1. IT hardware: manufacture, nomenclature and model number

2. Software (all types): manufacture, nomenclature and version number

Item(s) rejected by the CIO will need to be changed and the replacement item(s) would need to go through the same approval process.

INSTRUCTIONS TO OFFEROR FOR PROPOSAL SUBMISSION

FAR 52.212-1 Instructions to Offerors—Commercial Items (OCT 2018)

PROPOSAL SUBMISSION FORMAT:

***Proposal shall be in 2 volumes: 1 Technical and 2 Price. The volumes shall be separate and complete. The volumes shall be separate and complete, so that evaluation of one may be accomplished independently of, and concurrently with, the evaluation of the other. No pricing information shall be provided in volume 1***.

Quotes should explain why and how their instrument meets or exceeds each detailed technical requirement and include supportive data and descriptions wherever possible.

The total number of pages for the technical quote shall not exceed ten (10) pages, using 1” margins, single spaced, font type Time New Roman, and a font size of 12.

***The solicitation does not commit the Government to pay any cost for the preparation and submission of a quote or proposal. It is also advised that the Contracting Officer (CO) is the only individual who can legally commit and obligate the Government to the expenditure of public funds in connection with the proposed acquisition**.

QUESTIONS DEADLINE: Interested offerors shall submit questions electronically to Linda.Troutman@fda.hhs.gov no later than April 29, 2021 at 10:00 a.m. Eastern Standard Time. Please include the company name, FDA solicitation number, and “Question(s)” in the subject line.

No Phone Calls Please.

QUOTES DUE: All quotes are due, electronically via email to Linda.Troutman@fda.hhs.gov, no later than May 17, 2021, 10:00 a.m. Eastern Standard Time. Please list the solicitation number in the subject line.

PROVISIONS and CLAUSES:

The Full text of the Federal Acquisition Regulation (FAR) can be accessed on the internet at https://www.acquisition.gov/far/

The following provisions and clauses apply: FAR 52.212-1, Instructions to Offerors Commercial Items; FAR 52.212-2, Evaluation-Commercial Items; FAR 52.212-3 Offeror Representations and Certifications-Commercial Items; FAR 52.212-4, Contract Terms and Conditions Commercial Item; FAR 52.212-5, Contract Terms and Conditions Required to Implement Statutes Or Executive Orders--Commercial Items; 52.211-6 Brand Name or Equal; FAR 52.217-5, Evaluation of Options; FAR 52.217-8, Option to Extend Services; 52.217-9, Option to Extend the Term of the Contract; FAR 52.219-6, Notice of Total Small Business Set-Aside; FAR 52.219-8, Utilization of Small Business Concerns; FAR 52.219-13 Notice of Set-Aside of Orders; FAR 52.222-3, Convict Labor; FAR 52.222-19, Child Labor--Cooperation with Authorities and Remedies; FAR 52.222-21, Prohibition of Segregated Facilities; FAR 52.222-26, Equal Opportunity; FAR 52.222-36, Affirmative Action for Workers with Disabilities; FAR 52.232-18 Availability of Funds; FAR 52.232-33 Payment by Electronic Funds Transfer—System for Award Management; FAR 52.232- 40 Providing Accelerated Payments to Small Business Subcontractors.

Parties responding to this solicitation may submit their offer in accordance with their standard commercial practices (e.g. on company letterhead, formal quote form, etc.) but shall include the following information: 1) company’s complete mailing and remittance addresses 2) discounts for mailto:to%20Linda.Troutman@fda.hhs.gov mailto:to%20Linda.Troutman@fda.hhs.gov mailto:Linda.Troutman@fda.hhs.gov https://www.acquisition.gov/far/ prompt payment if applicable; 3) Dun & Bradstreet number; 4) Taxpayer ID number; 5) Catalog or Published Price Listing applicable to the service; 6) Offerors shall meet specifications as noted in the synopsis. Offerors shall include a completed copy of the provision at 52.212-3, Offeror Representations and Certifications/Commercial Items with their offer. Note: Contractor shall be registered and active in the System for Award Management (SAM) prior to the award of a contract. You may register by going to www.beta.sam.gov.

http://www.beta.sam.gov/