D 75N95020Q00145_RFQ_Revised.pdf

COMBINED SYNOPSIS / SOLICITATION

Competitive

75N95020Q00145

TITLE: Regulatory Support for FDA Pre-IND Meeting: QGRFT for the Prevention of SARS-CoV-2 Infection

(i) This is a combined synopsis/solicitation for commercial items 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; quotations are being requested and a written solicitation will not be issued.

(ii) The solicitation number is 75N95020Q00145 and the solicitation is issued as a request for quotation (RFQ). This acquisition is for a commercial item and is conducted under the authority of the Federal Acquisition Regulation (FAR) Part 13—Simplified Acquisition Procedures and FAR Part 12—Acquisition of Commercial Items, and is not expected to exceed the simplified acquisition threshold.

(iii) The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 2020-06, dated May 6, 2020.

(iv) The associated NAICS code is 541990 and the Small Business size standard is $16.5M.

This requirement is set aside exclusively for Small Business.

DESCRIPTION

(v) The National Center for Advancing Translational Sciences (NCATS) at the National

Institutes of Health (NIH) requires regulatory and operational support for a pre- Investigational New Drug (IND) application meeting with the US Food and Drug Administration (FDA). This pre-IND application meeting is for the preclinical development of Q-Griffithsin (QGRFT), which may have therapeutic value as a preventative against SARS- CoV-2, the causative agent of the current COVID-19 pandemic. QGRFT data is proprietary to NCATS’ collaborators at the University of Louisville Research Foundation (ULRF) and the contractor must work collaboratively with ULRF and NCATS throughout the entire period of performance.

Due to the urgency of supporting the development of treatment for COVID-19, the awardee must be capable of beginning work with QGRFT immediately upon contract execution

See attached Revised Statement of Work for complete requirement details.

EVALUATION AND AWARD

(vi) The period of performance is 12 months from the date of award. The anticipated award date is June 19, 2020.

(vii) The Government plans to award a purchase order 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 quotations. Comparative evaluations will be conducted if multiple quotations are received.

1. Technical Capability. This includes a vendor’s ability to begin work on the requirements immediately upon contract execution. To demonstrate this capability, respondents may provide:

A. Evidence of experience working with Q-Griffithsin (QGRFT), or B. Any other information or documentation that demonstrates this capability

2. Past Performance. This includes past experience in preparing for, engaging in, and following-up after pre-IND meetings with the FDA in support of pre-clinical therapeutic development campaigns.

3. Price

SUBMISSION INSTRUCTIONS

(viii) All responses to this RFQ must be received by 11:59am Eastern Time on Wednesday, June 17, 2020 and must reference the solicitation number cited above. Responses must be submitted via email to Kimberly Espinosa at kimberly.espinosa@nih.gov.

(ix) The Government contemplates award of a Labor-Hour type of contract resulting from this solicitation. The offeror must specify fixed hourly rates in its offer that include wages, overhead, general and administrative expenses, and profit. The offeror must specify whether the fixed hourly rate for each labor category applies to labor performed by the offeror; subcontractors; and/or divisions, subsidiaries, or affiliates of the offeror under a common control. (FAR Provision 52.216-31) The total contract price must also be clearly indicated.

(x) Below is a suggested format that respondents may, but are not required to, use in its quotation.

Labor Category Fully Burdened Hourly Rate

Number of Hours (totaling 380) Total

Example Labor Category 1 $XXXX XX $XXX Example Labor Category 2 $XXXX XX $XXX

TOTAL $XXX

mailto:kimberly.espinosa@nih.gov

(xi) Responses to this RFQ must include sufficient information to establish the interested parties’ bona-fide capabilities of providing the product or service. Responses may also include any other information or factors that the respondents feel may be important to consider in the award decision. Responses must also include the Dun & Bradstreet Number (DUNS), the Taxpayer Identification Number (TIN), the certification of business size, and the completed representation in FAR Provision 52.204-24 (attached).

(xii) This is an RFQ. This request does not commit the Government to pay any costs incurred in the preparation of the submission of this quotation or to contract for supplies or service. Any representations and/or certifications attached to this RFQ must be completed by the quoter.

(xiii) For information about this RFQ, contact Kimberly Espinosa, Contracting Officer, at 301-

827-3546 or kimberly.espinosa@nih.gov.

TERMS AND CONDITIONS, PROVISIONS, AND REPRESENTATIONS

(xiv) 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:

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

2. The provision at FAR 52.204-16, Commercial and Government Entity Code Reporting

(Jul 2016)

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

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

6. The provision at 52.212-3, Offeror Representations and Certifications—Commercial

Items (Dec 2019)

(xv) 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:

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

2. The clause at FAR 52.204-18, Commercial and Government Entity Code Maintenance

(Jul 2016)

3. The clause at FAR 52.212-4, Contract Terms and Conditions – Commercial Items, Alternate I (Jan 2017)

4. The clause at HHSAR 352.222-70, Contractor Cooperation in Equal Employment

Opportunity Investigations (December 18, 2015)

5. The clause at HHSAR 352.224-71, Confidential Information (December 18, 2015)

6. The clause at HHSAR 352.231-70, Salary Rate Limitation (December 18, 2015)

(xvi) The following provisions and clauses apply to this acquisition and are attached in full text:

1. Statement of Work

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

3. FAR Provision 52.204-24, Representation Regarding Certain Telecommunications and

Video Surveillance Services or Equipment (Dec 2019)

4. NIH Invoice and Payment Provisions (2/2014)

5. NIH Electronic Invoice Submission Instructions (4/2020)

(xvii) There are no additional contract requirement(s) or terms and conditions applicable to this acquisition.

(xviii) The Defense Priorities and Allocations System (DPAS) are not applicable to this requirement.