Combined Synopsis Solicitation_75A50121R00037.pdf

COMBINED SYNOPSIS / SOLICITATION

75A50121R00037

TITLE: COVID-19 Laboratory IVD (Diagnostics, Molecular)

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

(ii) The solicitation number is 75A50121R00037 and the solicitation is issued as a request for proposal

(RFP). This acquisition is for a commercial services and is conducted under the authority of the Federal Acquisition Regulation (FAR) Part 13—Simplified Acquisition Procedures, FAR Subpart 13.5—Simplified Procedures for Certain Commercial Items, and FAR Part 12—Acquisition of Commercial Items, FAR Subpart 18.202(d), and is expected to exceed the simplified acquisition threshold.

(iii) This is a competitive combined synopsis/solicitation. Award(s) will be made to the offerors whose proposal(s) successfully address each of the identified requirements, and for which the proposed price is determined to be fair, reasonable, and realistic.

(iv) The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 2021-03, dated February 16, 2021.

(v) The associated NAICS code is 325413 and the Small Business size standard is 1,250 employees. This requirement is competitive and is set aside exclusively for small businesses.

DESCRIPTION

(vi) The Biomedical Advanced Research and Development Authority (BARDA), Department of Health and Human Services (HHS) seeks to fund the necessary activities and clinical evaluations so an organization can transition their over the counter COVID-19 diagnostic tests from EUA to 510(k) and CLIA waiver. Among other things, the diagnostic test should be easy to use and not require external readers.

See attached Statement of Objectives for complete requirement details.

EVALUATION AND AWARD

(vii) The Government anticipates including a 14 – 20-month period of performance.

(viii) The Government plans to award a contract resulting from this solicitation. The resulting award will be made to the responsible Offeror whose offer will be most advantageous to the Government, price and other factors considered. The factors listed below shall be used to evaluate proposals. Comparative evaluations will be conducted if multiple proposals are received.

(a) Technical Capability

(b) Price

(c) Past Performance

SUBMISSION INSTRUCTIONS

(ix) All responses to this RFP must be received by 3:00pm Eastern Time on Thursday, May 13, 2021 and must reference the solicitation number cited above. Responses must be submitted via email to Jeffrey Schmidt at Jeffrey.Schmid2@hhs.gov

(x) This is an RFP. This request does not commit the Government to pay any costs incurred in the preparation of the submission of this proposal or to contract for supplies or service. Supplies are of domestic origin unless otherwise indicated by Offeror. Any representations and/or certifications attached to this RFP must be completed by the Offeror.

(xi) Responses to this RFP must include sufficient information to establish the interested parties’ bona-fide capabilities of providing the product or service. Responses must also include the Dun & Bradstreet Number (DUNS), the Taxpayer Identification Number (TIN), and the certification of business size.

(xii) Responses to this RFP must include separate technical and business volumes.

(xiii) The Technical Volume must include a detailed work plan indicating how each aspect of the objectives are to be accomplished. The technical volume should be in as much detail as you considered necessary to fully explain your proposed technical approach or method. In addition, the technical volume must include:

(a) Technical rationale, technical approach, and plan for accomplishment of goals and objectives within the timeframe allotted and in support of requirements and proposed deliverables.

Include in this section all proprietary claims to the results, property, intellectual property, or systems supporting and/or necessary for the effort in question. If there are no proprietary claims, this should be stated.

(b) A clearly defined organization chart for the program team which includes, as applicable: (1) the programmatic relationship of team member; (2) the unique capabilities of team members; (3) the task of responsibilities of team members; (4) the teaming strategy among the team members; and (5) the key personnel to be involved in the effort.

(c) Discussion concerning any potential likelihood to leverage the effort for use among other

Government organizations of interest if/as may be appropriate, along with any details concerning current use by other non-federal parties.

(d) Statement of Work (SOW) - In plain English, clearly define:

(1) The objective of the proposed contract.

(2) A detailed description of the proposed approach to accomplish the stated objective.

(3) The measurable milestones involved & associated completion criteria for each involved.

(4) All deliverables (reporting, data, reports, etc.) to be provided to the Government in support of the proposed tasks/activities.

(5) Description of the facilities to be used for the contracted effort, availability of the facility, and competition from other USG-funded activities.

(6) Capital and Commercial equipment to be purchased to achieve the contract objective.

(7) Estimated direct labor hours (including labor categories) to be performed to achieve the proposed objective.

(e) Past Performance Information – A list of the last three contracts completed during the past five years and all contracts currently being performed that are similar in nature to the solicitation work scope. Contracts listed may include those entered into by the Federal Government, agencies of state and local governments and commercial concerns. Include the following information for each contract listed: (1) Name of Contracting Organization; (2) Contract Number (for subcontracts, provide the prime contract number and the subcontract number); (3) Contract Type; (4) Total Contract Value; (5) Description of Requirement; (6) Contracting Officer's Name and Telephone Number; (7) Program Manager's Name and Telephone Number; and (8) North American Industry Classification System (NAICS) Code.

(xiv) The business volume shall contain enough information to allow the Government to perform a basic analysis of the propose cost or price of the work. The Government anticipates issuing a firm fixed price contract with payable milestones based on explicit milestone achievement criteria. The Cost Volume shall provide other than cost or pricing data in sufficient detail to substantiate the price proposed (e.g., realism and reasonableness). It is CRITICAL that the offeror’s cost proposal contain ALL prices and costs associated with each milestone. The proposal elements for each milestone must be supported by 3rd party vendor quotes, labor categories, labor hours, rates, applied fringe, overhead, G&A and profit. The breakdown shall include total proposed price, inclusive of all major cost items, as follows:

(a) Direct Labor – including individual labor categories with associated labor categories, labor hours and direct labor rates.

(b) Indirect Costs – Including Fringe Benefits, Overhead, General and Administrative (G&A) Expense, Cost of Money, Fee, etc. (must show base amount and rate).

(c) Subcontractors – List all subcontractors. For reach subcontractor, include total subcontract cost and build-out for all direct labor, indirect costs, travel, materials, and other direct costs.

(d) Travel – Provide the purpose of the trip, number of trips, number of days per trip, departure and arrival destinations, number of people, etc.

(e) Other Direct Costs (ODCs) – Itemized by cost category, with sufficient backup documentation to support proposed costs.

(f) Equipment Purchases – Itemized list with associated costs, including quantities, unit prices, proposed vendors (if known), and the basis of estimate (e.g., quotes, prior purchases, catalog price lists, etc.); any item that exceeds $10,000 must be supported with back-up documentation such as a copy of catalog price lists or quotes prior to purchase.

(g) Materials – Itemized list with associated costs, including quantities, unit prices, proposed vendors (if known), and the basis of estimate (e.g., quotes, prior purchases, catalog price lists, etc.); any item that exceeds $10,000 must be supported with back-up documentation such as a copy of catalog price lists or quotes prior to purchase.

(h) The source, nature, and amount of proposed costs to be billed to the Government.

(i) Any Forward Pricing Rate Agreement (FPRA), other rate agreements, other documentation concerning approved rates, or any other such documentation that may assist in expediting negotiations (if available).

(j) Proposers with a DCAA-approved cost accounting system must submit appropriate DCAA documentation that provides evidence of government approval of the cost accounting system.

COST INFORMATION SHALL BE PROVIDED IN MS EXCEL FORMAT WITH ACCESS TO ALL

CALULATIONS AND FORMULAS.

(xv) The Government anticipates requesting clarifying information after receipt and evaluation of your proposal.

(xvi) The Government reserves the right to enter into discussions.

(xvii) For information about this RFP, contact Jeffrey Schmidt, Contracting Officer, at 202- 205-0260 or Jeffrey.Schmidt2@hhs.gov.

TERMS AND CONDITIONS, PROVISIONS, AND REPRESENTATIONS

(xviii) The provision at 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 www.acquisition.gov.

The following provisions apply to this acquisition and are incorporated by reference:

(a) The provision at FAR 52.204-7, System for Award Management (Oct 2018).

(b) The provision at FAR 52.204-16, Commercial and Government Entity Code Reporting (Jul

2016).

(c) The provision at 52.204-26, Covered Telecommunications Equipment or Services-

Representation (Oct 2020).

(d) The provision at FAR 52.212-1, Instructions to Offerors – Commercial Items (Oct 2018).

(e) The provision at FAR 52.212-2 Evaluation—Commercial Items (Oct 2014).

(f) The provision at 52.212-3, Offeror Representations and Certifications—Commercial Items

(Dec 2019).

(xix) The clause at FAR 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 www.acquisition.gov.

In addition to the clauses checked in FAR 52.212-5 (attached), the following clauses also apply to this acquisition and are incorporated by reference:

(a) The clause at FAR 52.204-13, System for Award Management Maintenance (Oct 2018).

(b) The clause at FAR 52.204-18, Commercial and Government Entity Code Maintenance (Jul

2016).

(c) The clause at FAR 52.204-23, Prohibition on Contracting for Hardware, Software, and

Services Developed or Provided by Kaspersky Lab and Other Covered Entities (Jul 2018).

(d) The clause at FAR 52.204-24, Representation Regarding Certain Telecommunications and http://www.acquisition.gov/ http://www.acquisition.gov/

Video Surveillance Services or Equipment (Oct 2020).

(e) The clause at FAR 52.204-25, Prohibition on Contracting for Certain Telecommunications and

Video Surveillance Services or Equipment (Aug 2020).

(f) The clause at FAR 52.212-4, Contract Terms and Conditions – Commercial Items (Oct 2018).

(g) The clause at HHSAR 352.222-70, Contractor Cooperation in Equal Employment Opportunity

Investigations (December 18, 2015).

(xx) The following documents are attached:

(a) Statement of Objectives.

(b) The clause at FAR 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders–Commercial Items (Mar 2020).

(c) Special Contracting Requirements.

(d) Security Requirements.

(xxi) HHS reserves the right to exercise priorities and allocations authority with respect to this contract, to include rating this order in accordance with 45 CFR Part 101, Subpart A—Health Resources Priorities and Allocations System.”