JA_02212020_HHSF223201510104C_V.2TMsgnd_Redacted.pdf

Justification for Other than Full and Open Competition

41 U.S.C. 3304(a) (2)

Pursuant to the requirements of U.S. Code 41 U.S.C. 3304(a) (2) the Competition in Contracting Act (CICA) as implemented by Federal Acquisition Regulation (FAR), Subpart 6.302-2 and in accordance with the requirements of FAR, Subpart 6.303-1, the justification for the use of the statutory authority under FAR Subpart 6.3 is justified by the following facts and rationale required under FAR Subpart 6.303-2 as follows:

1. Identification of the agency and contracting activity:

a. Federal agency and contracting activity.

The Department of Health and Human Services (HHS), Food and Drug Administration (FDA), Office of Acquisition and Grants Services (OAGS).

b. Sponsoring organization.

Office of the Commissioner (OC), Office of the Chief Scientist (OCS), Office of Counterterrorism and Emerging Threats (OCET)

c. Contracting Officer’s Representative (COR)/Requiring Activity Point of Contact (POC) information.

Todd Myers FDA White Oak, Building 1, Room 4314 10903 New Hampshire Avenue, White Oak, MD 20903 todd.myers@fda.hhs.gov 301-796-4913

2. Nature and/or description of the action being approved.

FDA/OC/OCS/OCET has an urgent requirement to modify existing FDA Ebola research contract number HHSF223201510104C with Public Health England (PHE) to include a near-term analysis of 2019 Novel Coronavirus (2019-nCoV).

On January 31, 2020, the Secretary of Health and Human Services (HHS) issued a Public Health Emergency Declaration pursuant to section 319 of the Public Health Service (PHS) Act “as a result of confirmed cases of 2019 Novel Coronavirus (2019-nCoV)”. Following a section 319 declaration, the Secretary is authorized to take appropriate actions in response to the emergency including providing grants, entering into contracts; and conducting and supporting investigations into the cause, treatment, or prevention of the disease or disorder. An urgent requirement now exists for additional research in order to aid in the development of effective medical countermeasures (MCMs) to combat this emerging threat.

PHE has a demonstrated and unique expertise in performing research with similar viruses and is the only known source that can undertake OCET’s required research in a timely, safe and effective manner. This Contractor is known to have sufficient facilities to safely experiment and develop synthetic viruses, and the capability to document and deliver all research objectives within a compressed timeline. Due to this unusual and compelling urgency, it is not possible to evaluate alternate sources or award through full and open competition as this would create an unacceptable delay and seriously jeopardize the agency’s ability to identify timely and effective MCMs under the current public health emergency.

a. Acquisition purpose and objectives.

The purpose of this acquisition is to rapidly leverage current expertise, facilities, agreements, and other resources currently under contract for Ebola study, in order to execute urgent research to address near term knowledge gaps for the emerging 2019 novel coronavirus as authorized by the Public Health Emergency Declaration of January 31, 2020. The Contractor, PHE, is the only known source that can conduct the required research in a timely and effective manner, and also possesses unique expertise (including but not limited to 20 years of experience with this virus type and an appointment as a subject matter expert by the World Health Organization for this type of public health threat). This modification will enable FDA to urgently leverage this expertise as rapidly as possible to study 2019-nCoV and develop critical deliverables that FDA requires for assay development.

Presently, there are limited medical countermeasures (MCMs) due to several factors including a paucity of information on infection in humans, the absence of diverse animal models to ensure licencing, the difficulty in accessing samples from human patients with disease and the frequency of outbreaks.

By leveraging the current contract to execute the proposed research, FDA will be able to rapidly augment current activities underway in the characterization of Ebola infection, and use a similar technical approach to address key gaps of coronavirus. This would facilitate a modified approach to nCoV that is not only likely to provide timely delivery of urgently needed information on the novel virus but will also leverage expertise that is not currently available elsewhere in the scientific community.

Additionally, the modification will also facilitate adjustment of the technical approach for Ebola research, namely via enabling a comparative analysis of the World Health Organization (WHO) international standard using the WHO ELISA and the United States Ebola test (i.e., the Filovirus Animal Non-Clinical Group Enzyme-linked immunosorbent Assay [FANG ELISA]). Presently, both assays have been developed and standardized for Ebola research and response, by completing this cross validation, PHE shall provide a comparative analysis for both assays.

b. Project background.

Public Health England (PHE) was awarded contract number HHSF223201510104C in 2015 for the total amount of $3.2M via FDA’s broad agency announcement (BAA) for the study of Ebola virus.

The FDA BAA encourages participation by science and technology based firms and educational institutions in meeting FDA goals for innovative ideas and approaches for regulatory science.

PHE’s three (3) year project was selected for funding based in part on the expertise of the principle investigator, and the unique capabilities of the performer’s facilities (which include international outreach and the capabilities to obtain samples from austere and otherwise inaccessible environments). The project has been executed to date without significant incurred risks or challenges. Over the course of the contract, PHE has demonstrated not only their ability to successfully execute their technical approach, but also to respond in an effective and timely manner to the Ebola outbreak at that time. In 2016, the contract was extended through September 13, 2020 at no additional cost to the Government.

The current outbreak of novel coronavirus constitutes a public health emergency in part due to the heretofore unknown aspects of the virus. Presently, the US Government is engaged in a multilateral effort to source and characterize viral isolates, however, it is unclear when (or if) these efforts will be successful. As a result of FDA’s ongoing efforts with PHE, a unique opportunity exists based on PHE’s existing relationships, subcontracts, research facilities, and most notably expertise in coronavirus. Specifically, by modification of the current contract to include response activities for the coronavirus, FDA will enable PHE to utilize their unique capabilities to synthesize the virus, developing components and reagents that can then be used by FDA’s assay developers in CDRH for the creation of critically-needed assays for this coronavirus.

Additionally, in coordination with the National Institute for Biological Standards and Control (NIBSC), PHE shall construct, deliver, and make available standardized pseudoviruses for the investigation of MCMs and assays for 2019-nCoV. This comparative study of the WHO-standard based Ebola assay and the United States FANG assay will enhance overall project deliverables, and ultimately provide for a more standardized approach to Ebola and coronavirus research efforts across the global scientific community.

3. Description of the supplies or services required to meet the agency’s needs (including the estimated value).

Under this modification, PHE will leverage existing capabilities under the contract to complete several urgent objectives to support the public health response to the 2019 novel Coronavirus (2019-nCoV).

These objectives were identified in coordination with FDA scientists to support FDA’s public health mission:

Construct pseudoviruses for 2019-nCoV:

In coordination with the National Institute for Biological Standards and Control (NIBSC) PHE shall construct, deliver, and make available standardized pseudoviruses for the investigation of MCMs and assays for 2019-nCoV. Deliverable completion date: June 30, 2020.

Produce standardized characterized strains, prepare stocks of for further distribution, and provide standardized full-length clone technology for 2019-nCoV:

PHE shall utilize a rapid yeast-based reverse genetics system to generate a standardized preparation of 2019-nCoV that can be widely distributed to facilitate US/global response strategies. Deliverable completion date: no later than March 13, 2021.

Develop rapid and validated methods for sequencing 2019-nCoV:

PHE shall develop and document a rapid amplicon-based MinION sequencing protocol for amplifying all variants of 2019-nCoV. This will be validated on cell culture grown virus and samples from patients. Primer sequences and primers and internal controls shall be shared with the research community.

Concurrently, PHE shall conduct research on a metagenomic approach to identify 2019-nCoV for applications in the respiratory microbiome. The methodology for this approach shall also be documented and made available to the scientific community. Deliverables (manuscripts) for this objective will be completed no later than September 13, 2020.

Conduct comparative Ebola analysis utilizing the FANG assay:

As part of the ongoing Ebola research conducted in the existing contract, PHE will cross validate the WHO international standard using the WHO ELISA and the FANG ELISA. Presently, both assays have been developed and standardized for Ebola research and response, by completing this cross validation, PHE shall provide a comparative analysis for both assays. Deliverables (manuscript) from comparative analysis shall be provided no later than the end of contract date (March 13, 2021).

The estimated value of the work proposed under this modification is $250,000.00. A six (6) month extension is also sought through this modification from September 13, 2020 through March 13, 2021 to suitably facilitate distribution of synthetic virus (an essential reagent for assay development) and continued standardized testing (for FANG assay testing of Ebola samples).

a. Project title.

Profiling coronavirus infection for the rapid characterization of these viruses in humans and systems for medical countermeasure development and evaluation.

Requirement type.

Research & Development (R&D)

Type of action.

Follow-on

Proposed contract/order type.

Cost-plus-fixed-fee

Acquisition identification number.

Modification P0004 to contract HHSF223201510104C

b. Total estimated dollar value and performance/delivery period.

Base contract: $3.2M Modification: $250,000 Total (Base and Modification): $3.45M

Total Period of Performance: September 14, 2015 through March 13, 2021. This modification also seeks to extend the period of performance through March 13, 2021.

4. Identification of the statutory authority permitting other than full and open competition. Check the applicable block below based on the acquisition circumstance.

Federal Acquisition Regulation (FAR):

6.302-2 Unusual and compelling urgency. This acquisition is conducted under the authority of United States Code (U.S.C.) 10 U.S.C. 2304(c)(2) or 41 U.S.C. 3304(a)(2).

5. Demonstration that the proposed contractor(s) unique qualifications or the nature of the acquisition requires use of the authority cited.

FDA is seeking to leverage PHE’s unique and readily available expertise in Coronavirus to rapidly develop a synthetic version of the 2019-nCoV, along with validated strains, stocks, and formal methods for sequencing. PHE is the only known source that can readily and urgently initiate this research. These deliverables are crucial in the development of validation FDA assays, and for subsequent development, testing, and potential licensure of medical countermeasures. FDA is seeking to leverage the existing contract because this performer has unique qualifications to execute this work, including all of the following:

20 years of experience (supported by publications) with coronavirus, and a technical approach for nCoV that is likely to succeed, based on similar (successful) methodology used in SARS virus.

Access to high security (BSL3) facilities that are currently approved to work on nCoV. Other agencies/entities are processing approval for this capability, but PHE is the only facility currently with confirmed approval for this effort Existing regulatory institutional knowledge: PHE is a government agency for the UK, which provides extensive expertise in government-wide responses for public health threats; this is crucial for understanding and adjusting technical approach during a public health emergency and was demonstrated in the response effort for the Ebola virus.

International outreach and the capabilities to obtain samples from austere and otherwise inaccessible environments.

a. Name and address of the proposed contractor(s).

Public Health England Porton Down Salisbury, UK 620975

b. Nature of the acquisition and proposed unique qualifications of the contractor(s).

This is an urgent research requirement, to address knowledge gaps related to a previously unknown virus. In order to rapidly address this requirement, the Contractor must have extensive expertise in working with similar viruses, sufficient facilities to safely experiment and develop synthetic virus, and the capability to document and deliver all research objectives within a compressed timeline (as indicated in the deliverables table for the amended SOW). The contractor has an existing contract with FDA to complete similar characterization of another high-risk viral pathogen (Ebola Virus), and have demonstrated their ability to complete these activities over the course of the existing contract. In order for the technical approach to succeed, the use of the existing performer leverages the following unique research assets:

PHE’s subcontractor at the University of Liverpool hosts one of the major nodes for sequencing in the UK with both Illumina (MiSeq, HiSeq and NovaSeq), PacBIO and MInION sequencing. This equipment and facility will streamline sequencing of the 2019-nCoV to ensure the most expedient delivery to FDA.

The Hiscox laboratory has both UK Home Office approval and National Counter Terrorism Security Office (NaCTSO) to research and store nucleic acid from Category A agents as well as permission to use Schedule 1 toxic agents. This is a unique capability which is needed given the biosafety considerations of working with this virus.

PHE furthermore has access and approval to immediately begin work on the FDA’s Coronavirus research. This has been an ongoing process across other research entities and the impacts to delivery schedule from these other entities would present an unacceptable risk to timely completion. For these reasons, leveraging PHE’s unique capabilities is crucial in the timely completion of the additional work. Presently, no other research performer has been identified/available with the qualifications, expertise, and facilities to complete this work.

Concurrent efforts are primarily focused on obtaining virus isolates, which are encountering challenges that preclude a confirmed delivery timeline. As such, this is a unique capability and can only be conducted by PHE.

6. Description of efforts made to ensure that offers are solicited from as many potential sources as is practicable, including whether a notice was or will be publicized as required by subpart 5.2 and, if not, which exception under 5.202 applies.

The response to the 2019-nCoV has been international in scope, including public health agencies from countries around the globe. However, international coordination for a response is still in initial stages, given the recent emergence of the virus. Furthermore, while information sharing has been successful to the extent that response efforts are coordinated, challenges (specifically for obtaining virus isolates) are being experienced by all responding parties. To that end, a critical gap was identified in the ability to obtain either actual virus isolates or synthetic “pseudovirus” for the development and testing of assays. Although there are a number of approaches being implemented to address this gap, PHE’s capabilities are the only method identified that has sufficient likelihood to result in effective deliverables within the compressed urgent timelines demanded in such a response. The FDA program office has been in contact with intra and interagency partners to confirm that PHE is the only performer that can carry out this work in the time required.

PHE’s contract number HHSF223201510104C was awarded under the FDA’s Broad Agency Announcement (BAA) program. The FDA BAA encourages participation by science and technology based firms and educational institutions in meeting FDA goals for innovative ideas and approaches for regulatory science. Organizations with interest in providing similar research are invited to submit White Papers for evaluation within the framework of the BAA and this process promotes innovation and competition amongst the scientific community. Any organizations submitting White Papers through the BAA program will have their concepts evaluated for further consideration and possible future awards. Additionally, OCET continually conducts market research to develop additional sources for support of program objectives.

This proposed action is made under the authority of FAR 6.302-2 and due to the unusual and compelling urgency of this requirement, the Government cannot comply with the 15-day positing requirement for this solicitation. The positing exemption at FAR 5.202(a)(2) applies.

7. Determination by the Contracting Officer that the anticipated cost/price to the Government will be fair and reasonable.

The total value of this modification does not meet the threshold for requiring certified cost or pricing data at FAR 15.403-4(a)(1). The Contractor provided other than certified cost and pricing data to support their proposed price of $250,000.00 to complete this additional coronavirus research, including “ ” ( ) and fringe rates established at “ ” ( ). This is consistent with the methodology used at contract award. PHE has also provided their current rate agreement with HHS, and their proposed indirect cost rate of was audited and approved by HHS in August 2019.

The proposed level of effort for this modification aligns with the required subject matter expertise and objectives. The proposed methodologies are logical, and timelines are sufficient and realistic to complete the work in an accelerated manner to meet FDA requirements. The program office’s total IGCE for this modification is $250,000.00. While there are some deviations in the individual cost elements in the PHE modification proposal as compared to the IGCEs (i.e., higher and lower), the overall total costs for both modifications is equal to the IGCE amounts of $250,000.00 and is therefore determined to be fair and reasonable in accordance with FAR 15.405(b).

8. Description of the market research conducted (see FAR Part 10) and the results, or a statement of the reasons market research was not conducted.

With the international scope of the current 2019-nCoV response, the program office has completed an analysis of existing research assets (including the subject contract for modification), in conjunction with critical research needs. Based on this analysis, modification of the current contract is the only way to ensure that objectives will be met with sufficient timing for FDA to develop assays in response to this outbreak. Given PHE’s unique qualifications and facilities to complete this work, market research is relatively limited as no other performers were identified with the combination of expertise and facilities to reasonably complete the objectives.

9. Any other facts supporting the use of other than full and open competition.

Pursuant to the Secretary of HHS’s January 31, 2020 public health emergency declaration, FDA urgently requires a Contractor to rapidly develop a synthetic version of the 2019-nCoV, along with validated strains, stocks, and formal methods for sequencing. Through ongoing engagement with the scientific community, FDA has determined that there is only one source with the required expertise in Coronavirus, with the existing partnerships, facilities and overall capability to perform this research.

If FDA were to pursue this requirement with unknown alternate sources, unacceptable delays would be incurred, as the performer would be compelled to establish research partnerships to obtain viral data and sequence nCoV, identify facilities with sufficient biosecurity to complete the work, obtain permission to utilize that facility, and develop logistics to sufficiently deliver objectives to the FDA.

The Contractor would also need extensive expertise in working with similar viruses and the capability to document and deliver all research objectives within a compressed timeline. PHE is the only source known to have these capabilities readily available through its existing contract with FDA to complete similar characterization of another high-risk viral pathogen (Ebola Virus). PHE has demonstrated their ability to complete these activities over the course of the existing contract and shall provide all deliverables for the additional Coronavirus work no later than March 13, 2021.

Any attempts to solicit and evaluate alternate sources for this research would seriously injure the FDA’s ability to rapidly address the emergent public health threat of the coronavirus which has become a crisis in other parts of the world. Part of FDA’s mission is to foster the development and research of medical products, including countermeasures, to respond to deliberate and naturally emerging public health threats. The FDA’s ability to rapidly engage known research partners with documented research expertise is vital in accomplishing that mission. The delays which would be incurred in the solicitation and evaluation of new and untested alternate sources in a field of research of this type would create damaging and unacceptable delays in the FDA’s ability to respond to the current public health emergency declaration of January 31, 2020. Furthermore, if a contract were to be awarded to alternate sources, the delays of evaluating the acceptability of any research deliverables from new sources would seriously injure the FDA’s ability to advance this research as there is no guarantee that another source can provide acceptable research deliverables post award.

This would be a worst-case scenario and would put the FDA’s ability to respond to this emergent health threat in jeopardy. The costs associated with any delays under this scenario cannot be accurately estimated but would create an unacceptable risk to the FDA’s ability to accomplish its mission.

At the conclusion of the proposed additional Coronavirus research under this effort, the FDA will then make a determination on the next steps, including any continuation. During this time, the FDA will continue to conduct market research for research partners in this field while also encouraging organizations to submit White Paper research proposals for the FDA’s evaluation through the agency’s BAA which is available to all interested organizations.

10. Listing of sources, if any, that expressed, in writing, an interest in the acquisition.

No other sources have expressed an interest, in writing, in the proposed acquisition.

11. Statement of the actions, if any, the agency may take to remove or overcome any barriers to competition before any subsequent acquisition for the required supplies or services.

Under the current circumstances (i.e. a public health emergency requiring urgent development of deliverables and targeted knowledge products), it is unclear if any further actions could be done to expand potential sources in the future. However, the FDA BAA remains a viable means for alternate offerors to provide submissions and technical concepts to address numerous medical countermeasure needs, including the possibility of conducting rapid research for emerging threats.

12. Program office certification.

This is to certify that the portions of this justification that have been developed by the undersigned program office personnel, including supporting information and/or data verifying the Government’s minimum needs, schedule requirements and other rationale for other than full and open competition, are accurate and complete.

Signature:____________________________________

Robert Orr Requiring Activity POC

Tracy MacGill COR/POC Immediate Supervisor

Estella Jones Head of the Sponsoring Program Office

13. Contracting Officer Certification.

This is to certify that the justification for the proposed acquisition has been reviewed and that to the best of my knowledge and belief the information and/or data provided to support the rationale and recommendation for approval is accurate and complete.

Signature:____________________________________

Richard Robinson Contracting Officer

Robert P. Orr -S Digitally signed by Robert P. Orr -S Date: 2020.02.27 12:54:23 -05'00'

Tracy C. Macgill - S3

Digitally signed by Tracy C.

Macgill -S3 Date: 2020.02.27 13:41:23 -05'00'

Digitally signed by Estella Z.

Jones -S Date: 2020.02.27 14:24:12 -05'00'

Richard W. Robinson -S Digitally signed by Richard W. Robinson -S Date: 2020.02.27 16:56:24 -05'00'