B.3 - LSJ (PR# 54091) - Signed.pdf

Applicability of HHS Class J&A for 2019 Novel Coronavirus (COVID-19) to Current Requirement (HHS Acquisition Alert 2020-08)

ERR/PR#: 00HCBCD9-2021-53699

Applicability of HHS Class J&A for 2019 Novel Coronavirus (COVID-19) to Current Requirement The Department of Health and Human Services (HHS) has established a Class J&A for COVID-19 contract actions. Actions taken under the authority of this class J&A shall include (1) documentation of market research performed and prospective sources of supply and services, (2) evidence of the urgent and compelling nature of the particular action, reviewed and approved at a level above the Contracting Officer, (3) documentation of the contractor's qualifications and ability to perform the work as part of the Contracting Officer's responsibility determination,

(4) Documentation of the extent of competition undertaken, and (5) documentation of the price/cost analysis conducted and that the proposed price is fair and reasonable. The Class J&A shall be included with this document in the file folder.

When this document is printed, the blue italic instructions are automatically deleted on the printed version.

Please enter ERR number and, if applicable, PR number. If not associated with an ERR, please enter PR number

ERR/PR #: 00HCBCD9-2021-53699

Name of Proposed Contractor(s): The Broad Institute, Inc.

A. Contractor's Unique Qualifications:

The Broad Institute, Inc. has a large scale COVID diagnostic platform and several clinical and public health partnerships which provide them access to large numbers of positive SARS-CoV-2 specimens and the capacity to provide large numbers (up to 10,000/week if needed) of SARS-CoV-2 next generation sequencing covering New England, the Northeast US, CA ,CO,DC, FL, GA, MD, VA and WA . In addition, Broad has access to unique collections of specimens paired with detailed metadata, including passive vs active case detection, vaccine and immune status, symptoms and disease severity, duration of infection, and outcome. The Broad currently reports results electronically to associated state health departments and has a pipeline for depositing data in NCBI, SRA, and GISAID.

B. Identification of Services or Supplies:

Short description of the services or supplies required to meet the agency's needs. (e.g., "Q Stations PPE" / "Web Development")

For the base period of 26 weeks The Broad will sequence up to 5000 SARS-CoV-2 samples per week from across their catchment area and submit the sequencing data to a public repositories such as NCBI, Genbank, and GISAID. Option 1 and 2 continue the deliverables of 5,000 sequences and data per week for 13 weeks each.

C. Documentation of Market Research Performed & Prospective Sources of Supplies & Services (Class J&A Section 8):

Describe the extent of the market research conducted to identify all qualified sources and the results thereof. “Market Research” is defined as those attempts you made to ascertain whether other qualified sources exist, and can include contact with knowledgeable experts regarding similar or duplicate requirements, contact with industry, results of a sources sought synopsis, or draft solicitations. Research of the marketplace may consist of written, electronic (i.e. email) telephonic, or world wide web inquiries. Lack of advanced planning is not an acceptable reason for the lack of market research, but true urgency may necessitate abbreviated market research that is limited to readily available historical and commercial information. If action is a contract extension or bridge contract, describe the market research efforts underway or completed for the follow-on. See FAR 10.002(b)(2).

The Office of Advanced Molecular Detection (OAMD) used estimated market share of COVID-10 testing capacity provided by the Joint Coordination Cell/HHS/Lab testing and Diagnostic Work Group and CDC/Laboratory task force to conduct market research of commercial and academic laboratories within the US. Potential sources need to have access to a large number of SARS-CoV-2 positive samples and have the capacity to perform large scale genomic sequencing. OAMD sent out SARS-CoV-2 Next Generation Sequencing Capabilities Information Request letters to 14 laboratories making up 52% of the market share to identify interested sources. Interested sources are being evaluated on:

Number of complete sequences delivered per week Geographic area coverage Ramp up timeline Ability to perform genomic sequencing under CLIA certification at start of contract Ability to do bioinformatics (genome assembly, variant calling) Ability to submit data to public repositories (NCBI/SRA, NCBI/GenBank, and GISAID) Current status on reporting SARS-CoV-2 results electronically to state health departments Ability to transmit sample related data information electronically to state health departments

Applicability of HHS Class J&A for 2019 Novel Coronavirus (COVID-19) to Current Requirement (HHS Acquisition Alert 2020-08)

ERR/PR#: 00HCBCD9-2021-53699

Cost per specimen of doing the sequencing

Selection of Broad Institute was based on the above evaluation criteria and they were found to have access to a very large set of SARS- CoV-2 positive samples across the Northeastern section of the US with additional state coverage. Broad's testing platform provides ability to select positive specimens based on geography, population and incidence, targeting zip code level resolution. They are able to provide approximately 736 samples per week starting 2/2/21 and ramping up to 5,000 sequences per week starting 4/1/21 with additional capacity to ramp up to approximately 10,000 sequences/week if needed. They have bioinformatics pipelines in place and have ability and experience in reporting data electronically to state health departments. The price estimate included in their letter of interest was within the range of current contracts CDC has with other vendors for similar deliverables.

Other offerors had access to a smaller set of specimens or did not have access to both the positive specimens and necessary sequencing capabilities. Some offerors did not have capabilities to do the bioinformatic analysis of data.One offeror did not have sequencing capabilities within the US.

D. Basis and Rationale for Unusual & Compelling Nature (Class J&A Section 5.a):

Explain the chronological events leading up to the requirement and explain why time constraints cannot permit even a limited competition. Describe the detrimental effects/serious injury to the mission of the requiring activity or to the government, financial or otherwise, that will result if this justification is not approved and the product or service cannot be provided by the intended sole source contractor. May not exceed one year, including all options, unless the head of the agency determines that exceptional circumstances apply.

Emergence of novel variants of SARS-CoV-2 in the UK, SA, and US underscore the urgency of large scale genomic surveillance of the virus in the US. CDC needs to obtain genomic data on the virus circulating within the US to detect additional variants and monitor for known variants. So far some variants seem to spread more easily and quickly than other variants, which may lead to more cases of COVID-19.

An increase in the number of cases will put more strain on health care resources, lead to more hospitalizations, and potentially more deaths. Changes in the virus genome may change the effectiveness of COVID-19 vaccines and monoclonal antibody treatment as well as increase the reinfection rate. It is of critical importance that CDC monitor for vaccine escape variants so we can rapidly take action to reduce the potential for increased illness and death.

This contractor has the ability to provide genomic data rapidly upon contract award.

Reviewed and Approved by:

Official Name & Title Signature

Program Representative Melissa Olsen-Rasmussen

Contracting Officer H. Dale Bish

Approver at a Level Above the Contracting Officer Christine Godfrey

The File Includes the Following Documentation:

1. Contractor's Qualifications and Ability to Perform the Work As Part Of The Contracting Officer's Responsibility

Determination per FAR 9.103(b) (Class J&A Section 5.a). See Document(s) Identified Below:

Contracting Officer to Identify Specific Documents

A RFI was issued on 2/5/2021 directly to the contractor. The contractor provided a positive response to their ability to perform the requested tasks. OAS conducted a SAM Registration and SAM Reps and Certs check. Positive CPARS ratings were confirmed - Exceptional (16.67%); Very Good (58.33%) and Not Rated (25%).

2. Extent of competition undertaken (Class J&A Section 6). See Document(s) Identified Below:

Contracting Officer to Identify Specific Documents

This requirement will not be competed. A class J& A for COVID-19 is being utilized.

3. Price/cost analysis conducted and that the proposed price is fair and reasonable (Class J&A Section 7). See Document(s) Identified Below:

Contracting Officer to Identify Specific Documents

Applicability of HHS Class J&A for 2019 Novel Coronavirus (COVID-19) to Current Requirement (HHS Acquisition Alert 2020-08)

ERR/PR#: 00HCBCD9-2021-53699

A fair and reasonable price will be negotiated with the contractor. Historical pricing is one technique that will be used to determine the price to be fair and reasonable. In additional standard commercial pricing will be confirmed with additional discounts requested.

Previous contract(s): 75D30121P10310, awarded on 1/12/2021 for a similar product, had a Unit Price of $195.00.

75D30121P10261, awarded on 12/27/2020 for a similar product, had a Unit Price of $175.00. Both contracts were determined to be fair and reasonable. The current proposed Unit Price estimates average between $75 - $100.

Contracting Officer's Confirmation of Required Documentation:

Official Name Initials

Contracting Officer H. Dale Bish HDB

Applicability of HHS Class J&A for 2019 Novel Coronavirus (COVID-19) to Current Requirement (HHS Acquisition Alert 2020-08) Page of \\cdc.gov\private\L331\kpy2\Contracting Documents\SSJs & JOFOCs\COVID-19 Class J&A\CDC Letterhead.tiff Applicability of HHS Class J&A for 2019 Novel Coronavirus (COVID-19) to Current Requirement The Department of Health and Human Services (HHS) has established a Class J&A for COVID-19 contract actions. Actions taken under the authority of this class J&A shall include (1) documentation of market research performed and prospective sources of supply and services, (2) evidence of the urgent and compelling nature of the particular action, reviewed and approved at a level above the Contracting Officer, (3) documentation of the contractor's qualifications and ability to perform the work as part of the Contracting Officer's responsibility determination, (4) Documentation of the extent of competition undertaken, and (5) documentation of the price/cost analysis conducted and that the proposed price is fair and reasonable. The Class J&A shall be included with this document in the file folder.

When this document is printed, the blue italic instructions are automatically deleted on the printed version.

Please enter ERR number and, if applicable, PR number. If not associated with an ERR, please enter PR number A. Contractor's Unique Qualifications:

B. Identification of Services or Supplies:

Short description of the services or supplies required to meet the agency's needs. (e.g., "Q Stations PPE" / "Web Development") C. Documentation of Market Research Performed & Prospective Sources of Supplies & Services (Class J&A Section 8):

Describe the extent of the market research conducted to identify all qualified sources and the results thereof. “Market Research” is defined as those attempts you made to ascertain whether other qualified sources exist, and can include contact with knowledgeable experts regarding similar or duplicate requirements, contact with industry, results of a sources sought synopsis, or draft solicitations. Research of the marketplace may consist of written, electronic (i.e. email) telephonic, or world wide web inquiries. Lack of advanced planning is not an acceptable reason for the lack of market research, but true urgency may necessitate abbreviated market research that is limited to readily available historical and commercial information. If action is a contract extension or bridge contract, describe the market research efforts underway or completed for the follow-on. See FAR 10.002(b)(2).

D. Basis and Rationale for Unusual & Compelling Nature (Class J&A Section 5.a):

Explain the chronological events leading up to the requirement and explain why time constraints cannot permit even a limited competition. Describe the detrimental effects/serious injury to the mission of the requiring activity or to the government, financial or otherwise, that will result if this justification is not approved and the product or service cannot be provided by the intended sole source contractor. May not exceed one year, including all options, unless the head of the agency determines that exceptional circumstances apply.

Reviewed and Approved by:

Official Name & Title Signature Program Representative Contracting Officer Approver at a Level Above the Contracting Officer The File Includes the Following Documentation:

Contractor's Qualifications and Ability to Perform the Work As Part Of The Contracting Officer's Responsibility Determination per FAR 9.103(b) (Class J&A Section 5.a). See Document(s) Identified Below:

Contracting Officer to Identify Specific Documents Extent of competition undertaken (Class J&A Section 6). See Document(s) Identified Below:

Contracting Officer to Identify Specific Documents Price/cost analysis conducted and that the proposed price is fair and reasonable (Class J&A Section 7). See Document(s) Identified Below:

Contracting Officer to Identify Specific Documents Contracting Officer's Confirmation of Required Documentation:

Official Name Initials Contracting Officer 11.0.0.20130303.1.892433.887364 Justification & Approval - Other Than Full and Open Competition Health and Human Services Justification & Approval - Other Than Full and Open Competition Christine Godfrey

HDB

Number of complete sequences delivered per week Geographic area coverage Ramp up timeline Ability to perform genomic sequencing under CLIA certification at start of contract Ability to do bioinformatics (genome assembly, variant calling) Ability to submit data to public repositories (NCBI/SRA, NCBI/GenBank, and GISAID) Current status on reporting SARS-CoV-2 results electronically to state health departments Ability to transmit sample related data information electronically to state health departments Cost per specimen of doing the sequencing

Selection of Broad Institute was based on the above evaluation criteria and they were found to have access to a very large set of SARS-CoV-2 positive samples across the Northeastern section of the US with additional state coverage. Broad's testing platform provides ability to select positive specimens based on geography, population and incidence, targeting zip code level resolution. They are able to provide approximately 736 samples per week starting 2/2/21 and ramping up to 5,000 sequences per week starting 4/1/21 with additional capacity to ramp up to approximately 10,000 sequences/week if needed. They have bioinformatics pipelines in place and have ability and experience in reporting data electronically to state health departments. The price estimate included in their letter of interest was within the range of current contracts CDC has with other vendors for similar deliverables.

Other offerors had access to a smaller set of specimens or did not have access to both the positive specimens and necessary sequencing capabilities. Some offerors did not have capabilities to do the bioinformatic analysis of data.One offeror did not have sequencing capabilities within the US.

Explain the chronological events leading up to the requirement and explain why time constraints cannot permit even a limited competition. Describe the detrimental effects/serious injury to the mission of the requiring activity or to the government, financial or otherwise, that will result if this justification is not approved and the product or service cannot be provided by the intended sole source contractor. May not exceed one year, including all options, unless the head of the agency determines that exceptional circumstances apply. : Emergence of novel variants of SARS-CoV-2 in the UK, SA, and US underscore the urgency of large scale genomic surveillance of the virus in the US. CDC needs to obtain genomic data on the virus circulating within the US to detect additional variants and monitor for known variants. So far some variants seem to spread more easily and quickly than other variants, which may lead to more cases of COVID-19. An increase in the number of cases will put more strain on health care resources, lead to more hospitalizations, and potentially more deaths. Changes in the virus genome may change the effectiveness of COVID-19 vaccines and monoclonal antibody treatment as well as increase the reinfection rate. It is of critical importance that CDC monitor for vaccine escape variants so we can rapidly take action to reduce the potential for increased illness and death.

This contractor has the ability to provide genomic data rapidly upon contract award.

Previous contract(s): 75D30121P10310, awarded on 1/12/2021 for a similar product, had a Unit Price of $195.00.

75D30121P10261, awarded on 12/27/2020 for a similar product, had a Unit Price of $175.00. Both contracts were determined to be fair and reasonable. The current proposed Unit Price estimates average between $75 - $100.