Sources Sought Notice.pdf

SMALL BUSINESS SOURCES SOUGHT

1. Agency/Office Department of Health and Human Services, National Institutes of Health, NIAID

2. Contracting Office Location Office of Acquisitions Division of Extramural Activities, NIAID 5601 Fishers Lane Bethesda, MD 20892

3. Type Sources Sought

4. Solicitation Number:

75N93020Q00001

5. Title:

“In Vitro Assessment for Antimicrobial Activity Against SARS-CoV-2”

6. Classification Code B -- Special Studies and Analysis -- not R&D

7. NAICS Code 541380 – Testing Laboratories

8. Response Date:

July 13, 2020 – 3:00PM Eastern

9. Primary Point of Contact Alexandra Buck Contracting Officer alexandra.buck@nih.gov

10. Secondary Point of Contact Brian Madgey Contracting Officer Brian.madgey@nih.gov

11. Description

INTRODUCTION

This is a Small Business Sources Sought notice. This is NOT a solicitation for proposals, proposal abstracts, or quotations. The purpose of this notice is to obtain information regarding:

(1) the availability and capability of qualified small business sources; (2) whether they are small businesses; HUBZone small businesses; service-disabled, veteran-owned small businesses; 8(a) small businesses; veteran-owned small businesses; woman-owned small businesses; or small disadvantaged businesses; and (3) their size classification relative to the North American Industry Classification System (NAICS) code for the proposed acquisition. Your responses to the information requested will assist the Government in determining the appropriate acquisition mailto:alexandra.buck@nih.gov mailto:Brian.madgey@nih.gov method, including whether a set-aside is possible. An organization that is not considered a small business under the applicable NAICS code should not submit a response to this notice.

BACKGROUND

The National Institute of Allergy and Infectious Diseases (NIAID) supports a variety of preclinical research resources and services to promote drug discovery and development of new test molecules for prevention and treatment of infectious diseases, including AIDS. The NIAID has an immediate need for in vitro antiviral screening services conducted in human cell lines against SARS-CoV-2, the new coronavirus responsible for the COVID-19 pandemic.

Coronaviruses are a diverse family of viruses that cause a range of diseases in humans and animals, and there are currently no approved coronavirus vaccines or therapeutics. The World Health Organization (WHO) has declared COVID-19 disease a pandemic, with over 3 million reported cases worldwide. Tragically there have now been over 100,000 deaths in the United States alone. To advance development of effective medical countermeasures, there is an urgent public health need to establish and perform in vitro assays for testing antimicrobial activity against SARS-CoV-2. Test molecules submitted for analysis include a broad range of small molecules and biologics, including polyclonal antisera, monoclonal antibodies, recombinant proteins, and peptides, that may target various steps in the virus life cycle or cellular components involved in these processes. In each assay the contractor shall evaluate and verify viral inhibitory activity of test molecules against authentic SARS-CoV-2 in human cells as well as provide an assessment of cytotoxicity.

PURPOSE AND OBJECTIVES

The purpose of this Small Business Sources Sought Notice (SBSS) is to identify qualified small or small disadvantaged businesses, capable of and interested in performing the work described herein. The NIAID does not intend to award a contract on the basis of responses received nor otherwise pay for the preparation of any information submitted.

The objective of this acquisition is to perform in vitro testing of test molecules provided by the NIAID (or a designee) to evaluate the potential of the molecules to treat COVID-19. The NIAID seeks to acquire the capability to perform in vitro testing in human cell lines infected with authentic SARS-CoV-2. In addition to testing viral inhibition of the test molecules an assessment of the cytotoxicity is required.

PROJECT REQUIREMENTS

The NIAID intends to solicit proposals for the performance of approximately four hundred (400) assessments of test molecules. Each assessment shall evaluate and verify viral inhibitory activity of test molecules against authentic SARS-CoV-2 in human cells as well as provide an assessment of cytotoxicity. Each assessment shall be completed within fourteen (14) calendar days of receipt of the test molecule. For each test molecule at least 8 concentrations shall be evaluated to allow for the generation of a dose-response curve to generate EC50 and EC90 values (as possible). In addition, the contractor shall determine the in vitro cytotoxicity and use this to calculate the CC50. Finally, the contractor shall calculate a selectivity index (SI) based on the EC50 and CC50 values. Each evaluation shall include a positive control to validate and measure assay performance and accuracy. The duration of the firm fixed price purchase order is twelve months.

CAPABILITY STATEMENT/INFORMATION SOUGHT

Sources are expected to have the expertise, personnel, and facilities to meet the requirements of this project. Tailored Capability Statements submitted in response to this announcement should describe the company's experience and ability to perform this effort which includes the following:

(1) a summary list of similar work previously performed or being performed; (2) demonstrated scientific and technical ability to carry out the work; (3) the professional qualifications and specific experience of staff who may be assigned to the requirement; (4) a general description of the facilities and other resources needed to perform the work. Additionally, capability statements should demonstrate the offerors' qualifications and experience, specifically providing evidence as to their capability to perform this requirement, with particular attention to the following areas:

• Documented evidence of experience in the design, conduct, and analysis of standardized in vitro assays to measure the ability of test molecules to inhibit the replication authentic SARS-CoV-2 in human cell lines.

• Such experience shall include the ability to validate and measure assay performance and accuracy with positive antiviral drug controls for SARS-CoV-2, including giving a minimum Selectivity Index (SI) value of ≥ five (5).

• Experience testing at least 100 compounds for anti-viral activity against authentic SARS- CoV-2 in human cell lines.

• Documented availability and appropriate facilities and equipment to perform and timely meet the specified delivery schedule.

• Documented continued access to facilities at the appropriate level of biocontainment as required to perform in vitro SARS-CoV-2 testing.

HOW TO SUBMIT A RESPONSE / PAGE LIMITATIONS

Interested qualified small business organizations should submit a tailored capability statement not to exceed five pages, excluding resumes. Capability Statements must not include links to internet web site addresses (URLs) or otherwise direct readers to alternate sources of information. Font size must be 10 to 12 points. Spacing must be no more than 15 characters per inch. Within a vertical inch, there must be no more than six lines of text. Print margins must be at least one-inch on each edge of the paper. Print setup should be single-sided on standard letter size paper (8.5 x 11” in the U.S., A4 in Europe). All proprietary information should be marked as such.

REQUIRED BUSINESS INFORMATION

- DUNS;

- Company Name;

- Company Address;

- Company Point of Contact, Phone and Email address;

- Current GSA Schedules and/or Government-wide Acquisition Contracts (GWACs) appropriate to this Sources Sought;

- Do you have a Government approved accounting system? If so, please identify the agency that approved the system.

- Type of Company (i.e. small business, 8(a), woman owned, veteran owned, etc.) as validated via the System for Award Management (SAM) located https://www.sam.gov/index.html/#1.

This indication should be clearly marked on the first page of your Capability Statement (preferably placed under the eligible small business concern’s name and address).

NUMBER OF COPIES:

Please submit one (1) electronic copy of your response as follows:

All Capability Statements sent in response to this Small Business Sources Sought notice must be submitted electronic (via e-mail) to Alexandra Buck, Contracting Officer, at alexandra.buck@nih.gov in MS Word or Adobe Portable Document Format (PDF). The e-mail subject line must specify Sources Sought Reference Number. Facsimile responses will not be accepted.

COMMON CUT-OFF DATE:

Electronically submitted tailored capability statements are due no later than 3:00PM EST on July

13, 2020. CAPABILITY STATEMENTS RECEIVED AFTER THIS DATE AND TIME

WILL NOT BE CONSIDERED.

DISCLAIMER AND IMPORTANT NOTES

This notice does not obligate the Government to award a contract or otherwise pay for the information provided in response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization's qualifications to perform the work.

Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. After a review of the responses received, a combined synopsis/solicitation for commercial items may be published in the System for Award Management (SAM) at. However, responses to this notice will not be considered adequate responses to a solicitation.

CONFIDENTIALITY

No proprietary, classified, confidential, or sensitive information should be included in your response. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation(s).

12. Place of Contract Performance N/A

13. Set-Aside N/A

14. Archiving Policy Manual Archive

15. Allow Vendors to Add/Remove From Interested Vendors Yes https://www.sam.gov/index.html/#1 mailto:alexandra.buck@nih.gov

16. Allow Vendors to View Interested Vendors List No