LSJ_Redacted.pdf

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Justification and Approval

General Services Administration Federal Supply Schedule Limited Source Justification

Authority: FAR 8.405-6 (a)(l)(i)(B), Only One Source

1. Identification of the agency and contracting activity:

a. Federal agency and contracting activity.

U.S. Food and Drug Administration (FDA)

Office of Acquisition and Grants Services (OAGS)

b. Sponsoring organization.

Center for Devices and Radiological Health (CDRH)

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

i. Name: Crystal Reed- Tweedy

ii. Mailing address: 10903 New Hampshire Avenue, Silver Spring, MD 20993

iii. E-mail address: Crystal.Reed-Tweedy@fda.hhs.gov

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

a. Acquisition purpose and objectives.

The primary objective is to provide the CDRH with advanced scientific consultants to assist CDRH’s Offices with project/program and portfolio management in conjunction with CDRH’s mission, FDA COVID-19 Pandemic Recovery and Preparedness Plan (PREPP), The White House National Strategy for the COVID-19 Response, Pandemic Preparedness, and American Rescue Plan Distribution. The services provided will be critical scientific expertise in support of the President’s pandemic preparedness strategy, to be used for the evaluation of the continued performance, safety, and effectiveness, including with respect to both COVID–19 (including current and future variants) and other emerging threats, of vaccines, therapeutics, and diagnostics approved, cleared, licensed, or authorized for use for

Last Modified: May 18, 2016 Page 2 of 14 the treatment, prevention, or diagnosis of COVID–19; facilitation of advanced continuous manufacturing activities related to production of vaccines and related materials; facilitation and conduct of inspections related to the manufacturing of vaccines, therapeutics, and devices delayed or cancelled for reasons related to COVID–19; review of devices authorized for use for the treatment, prevention, or diagnosis of COVID–19; and, oversight of the supply chain and mitigation of shortages of vaccines, therapeutics, and devices approved, cleared, licensed, or authorized for use for the treatment, prevention, or diagnosis of COVID–19 by the FDA.

The FDA is responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation. The FDA is also responsible for advancing the public health by helping to speed innovations that make medicines and foods more effective, safer, and more affordable, and helping the public get the accurate, science-based information they need to use medicines and foods to improve their health.

Additionally, the FDA plays a critical role in protecting the United States from chemical, biological, radiological, nuclear, and emerging infectious disease threats. FDA ensures that medical countermeasures (MCMs)—including drugs, vaccines and diagnostic tests—to counter these threats are safe, effective, and secure.

The mission of the Center for Devices and Radiological Health (CDRH) is to protect and promote the public health. CDRH assure that patients and providers have timely and continued access to safe, effective, and high-quality medical devices and safe radiation-emitting products. We provide consumers, patients, their caregivers, and providers with understandable and accessible science-based information about the products we oversee. We facilitate medical device innovation by advancing regulatory science, providing industry with predictable, consistent, transparent, and efficient regulatory pathways, and assuring consumer confidence in devices marketed in the U.S.

In 2020, the FDA/CDRH, along with several other agencies, was truly put to the test in addressing one the largest health crises in recent memory. With the emergence of the novel coronavirus in China in late 2019, there was an urgent need to prepare for the potential pandemic with immediate concerns focused on diagnostic testing. As cases began appearing in the US, the need for diagnostic tests grew exponentially. As the pandemic grew in the US early in spring 2020, medical professionals and the public quickly encountered difficulties obtaining necessary medical products, including basic personal protective equipment, needed to combat the COVID19 pandemic.

Additionally, therapies to affect COVID19 and its symptoms were not readily available, and medical professionals were just learning of the effects and how to manage patients. To help combat the pandemic, hundreds of manufacturers from around the globe requested emergency use of thousands of medical devices ranging from advanced diagnostics tests and personal protective equipment (PPE) to ventilators and renal replacement therapies.

As the pandemic carried on, much was learned about COVID19, how better to treat patients, and what types of products and therapies were more effective in managing patients with COVID19. Furthermore, demand also expanded the types of tests needed and the speed at which results would be needed. As the course of the pandemic continued, FDA had to adjust to the changing pandemic as supply and

Last Modified: May 18, 2016 Page 3 of 14 demand for different medical devices changed due to increased manufacturing as well as both new and increasing demands from the field as more was learned about COVID19 and its effects.

The FDA launched the COVID-19 Pandemic Recovery and Preparedness Plan (PREPP) initiative in 2020 to strengthen the response to the COVID-19 pandemic and resiliency for future public health emergencies.

On January 21, 2021, The White House released the National Strategy for the COVID-19 Response and Pandemic Preparedness. According to the executive summary, “the United States is initiating a coordinated pandemic response that not only improves the effectiveness of our fight against COVID-19, but also helps restore trust, accountability and a sense of common purpose in our response to the pandemic.” This directive includes not only the current COVID-19 pandemic, but also tasks several agencies with analyzing the response to COVID-19, plan for the future, and build better preparedness for future threats.

The CDRH seeks expert consultants to assist CDRH’s Offices with project/program and portfolio management in conjunction with the CDRH’s mission, the FDA’s PREPP Initiative, The White House National Strategy for the COVID-19 Response and Pandemic Preparedness, and the American Rescue Plan Distribution. The CDRH requires consultants that have sufficient skilled capacity that includes general microbiology, microbiology with expertise in virology, toxicology, chemistry as it relates to material compatibility, ultraviolet sterilization, and in reprocessing of medical devices in real world settings. Additionally, the CDRH is interested in personnel with expertise in diagnostics testing, such as molecular testing, serology testing, antigen testing, infectious disease testing, clinical laboratory testing.

Other specialties and studies CDRH require includes Biology, Chemistry, Epidemiology, General Engineering, Physics, Statistics, Computer Science, Virology, Toxicology, Pulmonology, Anesthesiology, and Infectious Diseases. Additionally, the expert consultants shall have demonstrated experience, in depth knowledge, and a clear understanding of the policies, practices, and procedures of the federal government's, specially, the FDA's programs and initiatives related to the response to the COVID-19 pandemic, as well as the agency's response to past national and global medical emergencies.

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

a. Project title.

Center for Devices and Radiological Health (CDRH) Professional & Scientific Support BPA

b. Project Description.

The primary objective is to provide CDRH with advanced scientific consultants to assist CDRH’s Offices with project/program and portfolio management in conjunction with CDRH’s mission, The White House National Strategy for the COVID-19 Response, Pandemic Preparedness, and American Rescue Plan Distribution. The services provided will be critical scientific expertise in support of the President’s

Last Modified: May 18, 2016 Page 4 of 14 pandemic preparedness strategy, to be used for the evaluation of the continued performance, safety, and effectiveness, including with respect to both COVID–19 (including current and future variants) and other emerging threats, of vaccines, therapeutics, and diagnostics approved, cleared, licensed, or authorized for use for the treatment, prevention, or diagnosis of COVID–19; facilitation of advanced continuous manufacturing activities related to production of vaccines and related materials; facilitation and conduct of inspections related to the manufacturing of vaccines, therapeutics, and devices delayed or cancelled for reasons related to COVID–19; review of devices authorized for use for the treatment, prevention, or diagnosis of COVID–19; and oversight of the supply chain and mitigation of shortages of vaccines, therapeutics, and devices approved, cleared, licensed, or authorized for use for the treatment, prevention, or diagnosis of COVID–19 by the FDA.

Requirement type.

Support services (non-R&D)

Supplies/equipment

Information Technology (IT)

Other:

Type of action.

New requirement

Follow-on

Other:

Proposed contract/order type.

Firm-fixed-price

Time and materials

Indefinite delivery:

Other: Labor-Hour

Completion Form

Term Form

Acquisition identification number.

CDRH CIN: CDRH-21-C-0269

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

The total amount with base and options is $75M; approximately will be funded for the first BPA Order.

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The term of the BPA will be 5 years with 5 distinct ordering periods to allow, as follows:

Ordering Period 1: July 30, 2021 through July 29, 2022

Ordering Period 2: July 30, 2022 through July 29, 2023

Ordering Period 3: July 30, 2023 through July 29, 2024

Ordering Period 4: July 30, 2024 through July 29, 2025

Ordering Period 5: July 30, 2025 through July 29, 2026

4. The authority and supporting rationale (see FAR 8.405-6(a)(1)(i); (b)(1)) and, if applicable, a demonstration of the proposed contractor’s unique qualifications to provide the required supply or service.

a. Acquisition authority.

This acquisition is conducted under the authority of the Multiple Award Schedule Program. In accordance with Federal Acquisition Regulation (FAR) 8.405-6(a), consideration of schedule contractors will be restricted to fewer than the number required at FAR 8.405-1, FAR 8.405-2, FAR 8.405-3 (i.e., fewer than three FSS contractors). FAR 8.405-6 (a)(1)(i), for a proposed order or BPA with an estimated value exceeding the micro-purchase threshold not placed or established in accordance with the procedures in FAR 8.405-1, FAR 8.405-2, or FAR 8.405-3, the only circumstances that may justify the actions are-

(A) An urgent and compelling need exists, and following the procedures would result in unacceptable delays;

(B) Only one source is capable of providing the supplies or services required at the level of quality required because the supplies or services are unique or highly specialized;

Tunnell is the only source capable of providing services at the level of quality required because of their unique capabilities that can be leveraged immediately.

The DHHS and the DoD are the primary U.S. Government agencies responsible for the development of MCMs required to protect our homeland and our deployed military forces from both naturally occurring and weaponized threat agents. Within HHS, the NIH conducts early research to identify candidate MCMs, while BARDA serves as the “advanced developer” responsible for taking the most promising candidate MCMs and partnering with industry to develop them, obtain FDA clearance/approval/licensure, and make then commercially available and/or add the MCMs to the Strategic National Stockpile. Within the DoD, the WRAIR and USAMRIID conduct the early research while USAMMDA and JPEO CBRND serve as the advanced developers. The FDA has ultimate responsibility for reviewing applications (e.g., EUA, 510(k), PMA, NDA or BLA) submitted by product sponsors (e.g., BARDA, USAMMDA or JPEO CBRND or the commercial companies that they support) for approval of candidate MCMs. In this area, the focus will be on Tunnell’s support to the U.S. Government’s MCM advanced developers (BARDA, USAMMDA, JPEO CBRND) as well as to the regulatory agency responsible for the review and approval of MCMs.

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BARDA:

USAMMDA:

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JPEO CBRND:

FDA: Since 2020, Tunnell SMEs have supported the FDA Center for Devices and Radiological Health (CDRH) response to the ongoing COVID-19 Outbreak. Tunnell ventilator, medical device decontamination, medical device biocompatibility, and in vitro diagnostic SMEs have supported the review of an unprecedented number of Emergency Use Authorization (EUA) applications for a broad array of medical devices. The technical qualifications and deep and broad industry experience provided by Tunnell have greatly enhanced the FDAs ability to review and approved urgently required medical devices.

Tunnell is the incumbent and has the institutional knowledge to provide critical scientific expertise in support of CDRH's mission to conduct and coordinate Center actions regarding approval, denial, and there will be no break in the current support during the pandemic.

Tunnell's vast pandemic preparedness experience laid out above is unparalleled within HHS when taken as a whole and Tunnell's ability to continue services with the breadth and depth of experience that affords no delays is critical to continuing the WH initiative and tackling the COVID-19 pandemic.

(C) In the interest of economy and efficiency, the new work is a logical follow-on to an original Federal Supply Schedule order provided that the original order was placed in accordance with the applicable Federal Supply Schedule ordering procedures. The original order or BPA must not have been previously issued under sole-source or limited-sources procedures.

This acquisition is conducted under the authority of the Multiple Award Schedule Program.

In accordance with FAR 8.405-6(b), consideration of schedule contractors will be restricted only to the item peculiar to one manufacturer. An item peculiar to one manufacturer can be a particular brand name, product, or a feature of a product, peculiar to one manufacturer. A brand name item, whether available on one or more schedule contracts, is an item peculiar to one manufacturer.

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b. Demonstration of the proposed contractor(s) unique qualifications to provide the required supply or service.

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

Tunnell Consulting, Inc.

6701 Democracy Boulevard, Suite 405

Bethesda, MD 20817

GSA Contract Number: 47QRAA18D0004

Phone: (240) 383-3033

Fax: (240) 383-3024 www.tunnellconsulting.com

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

Distinctive breadth and depth of real-time insight on the evolving crisis, pandemic preparedness and Presidential strategy

The nature of this acquisition requires that the FDA, at a minimum, continues with its current pace of responding to the COVID-19 pandemic while concurrently establishing programs necessary to meet the WH directives of providing a viable and effective means for the United States to rapidly respond to future pandemics. This multifold capability requires that the FDA obtain support that has demonstrated and proven capability, experience, expertise, and knowledge in all aspects of the government’s challenges, policies, processes, and procedures, when responding to global or national medical emergencies. This support must allow the FDA to continue pandemic response operations without any delays.

Due to its current and prior work with federal agencies during national emergencies, Tunnell personnel have obtained a unique level of expertise, experience, knowledge and understanding that no other contractor currently possesses. Tunnell’s work with HHS agencies such as BARDA, FDA, and DOD during emergency medical response operations has allowed its personnel to develop a depth of experience and understanding of how the government executes in the areas of scientific research, analysis, testing, experimentation, emergency use authorization approvals, risk management, interactions with industry, oversight of the vaccine manufacturing process, and supply chain management. Due to Tunnell’s current work with supporting the government in responding to the COVID-19 pandemic, it is the only company capable of providing immediate and uninterrupted capability to the government in its continued need to rapidly respond to the ever-changing challenges posed by the ongoing pandemic. Although other companies may have highly educated personnel, there are none that can meet the government’s current need for support that is uninterrupted, rapid, and performs at a high level of expertise with an understanding of all processes and procedures necessary to prevent delays in the government’s response to the WH directives. Tunnell’s unique qualifications will allow the FDA to continue ongoing initiatives and build upon recent successes in responding to the COVID-19 pandemic.

The following are some selected examples of Tunnell's unique capabilities that specifically relate to the requirement as it relates to vast pandemic preparedness experience with HHS:

H1N1 Pandemic (2009): Since 2006, Tunnell SMEs have supported BARDA’s multi-tiered approach to preparing for a potential influenza pandemic, to include support to influenza vaccine, diagnostics and therapeutics development programs, the pandemic influenza vaccine stockpile program, influenza

Last Modified: May 18, 2016 Page 9 of 14 vaccine manufacturing infrastructure through the Centers for Innovation in Advanced Development and Manufacturing (CIADM), and the international influenza vaccine manufacturing capacity building program. Tunnell SMEs were instrumental in the systematic production and oversight of five multi-national manufactured influenza vaccines in the 2009 H1N1 pandemic.

Peramivir, , Peramivir

Peramivir . Peramivir is now commercially available under brand name Rapivab® and is currently included in the Strategic National Stockpile (SNS) for immediate deployment in response to future influenza public health emergencies.

Since first beginning their partnership as BARDA’s prime contractor in 2006, Tunnell SMEs have supported the development of a total of 26 BARDA-funded influenza (pandemic and seasonal) medical countermeasures

MERS Outbreak (2012): During and after the 2012 MERS outbreak, Tunnell SMEs at BARDA supported all of BARDA’s MERS MCM development efforts, to include vaccines, therapeutics, and diagnostics.

West Africa Ebola Virus Epidemic (2013-2016): During the West Africa Ebola outbreak, Tunnell SMEs supported BARDA efforts to accelerate the development of candidate vaccines, therapeutics, and diagnostics.

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Zika Virus Epidemic (2015-2016): Tunnell SMEs played a critical role in all of BARDA’s Zika virus response efforts. Tunnell SMEs were there at the beginning of the Zika epidemic and continue to support the development of MCMs to prevent, diagnose and treat Zika virus infections to this day.

COVID-19 Pandemic (2019-Present): Tunnell SMEs at BARDA, FDA, and the IRF have played a critical role in the ongoing COVID-19 pandemic. Within the context of the COVID-19 pandemic, Tunnell’s support to the BARDA mission has never been more important. For example, Tunnell’s senior personnel supported BARDA’s rapid evaluation and validation of various specimen collection devices. This includes alternative materials for upper respiratory swabs and additional types of swabs (e.g., to allow for the use of nasal swabs vs. nasopharyngeal swabs), which allowed for significant increases in the level of COVID-19 sample collection necessary to scale up the level of testing in the United States. Tunnell SMEs worked with BARDA to facilitate a rapid regulatory pathway leading to EUAs for a range of diagnostic tests for this novel pathogen. Tunnell SMEs also supported proactive measures that include conducting recurring virtual town halls, and helped issue policy documents and templates to guide developers’ preparation and submission of EUAs for COVID-19 diagnostic tests.

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Tunnell senior SMEs are deeply involved in the USGs COVID-19 pandemic response goal of delivering millions of doses of safe, effective vaccine for COVID-19 beginning January 2021. Tunnell has helped to accelerate and continues to support development of vaccines for this novel viral pathogen by carrying out developmental steps simultaneously (versus what traditionally occurs in series) while ensuring appropriate standards of safety and efficacy are maintained. This effort is being realized through a partnership among organizational components of the DHHS, including BARDA, FDA, NIH, the Centers for Disease Control and Prevention (CDC), and the DoD. Tunnell is deeply familiar with the types of services required to support medical readiness, having provided similar capabilities to multiple federal clients operating within the Public Health Emergency Medical Countermeasures Enterprise (PHEMCE) over the past 15 years.

Tunnell SMEs working in the BARDA Pharmaceutical Countermeasures Infrastructure (PCI) and Influenza and Emerging Infectious Disease (IEID) Divisions were selected as part of the U.S. Government’s COVID- 19 Manufacturing Leads to support each of the six (6) COVID-19 vaccine programs. In these roles, Tunnell SMEs oversaw and advised on all manufacturing, EUA, and delivery activities with the vaccine sponsors and their sub-contractor contract manufacturing organizations (CMOs). The SMEs also fulfilled key advisor roles in the BARDA CoronaWatch program that provided for over 600 CoronaWatch meetings with industry partners.

Tunnell SMEs at the FDA have supported the review of an extensive array of Emergency Use Authorization applications and a limited number of 510(k) applications for In Vitro Diagnostic devices, ventilators and medical device decontamination processes and procedures that were submitted in response to the DHHS declaration of a nationwide Public Health Emergency in response to the COVID-19 outbreak. To this day, Tunnell SMEs continue to provide this support.

5. Determination by the ordering activity Contracting Officer that the order represents the best value consistent with FAR 8.404(d).

The Contracting Officer will compare the contractor's pricing with the contractor's Federal Supply Schedule contract pricing (which was previously determined to be fair and reasonable by the General Services Administration cognizant Contracting Officer), and ensure that respective pricing does not exceed those ceiling figures. Furthermore, the FDA will be requesting a discount from the contractor's Federal Supply Schedule pricing at time of solicitation. Negotiations may or may not be required to ensure pricing is most advantageous to the Government prior to award. Either way, due to the contractor's unique qualifications and pre-screened pricing, it is reasonably foreseeable that the prospective Blanket Purchase Agreement final pricing agreement will represent the best value to the government.

6. Description of the market research conducted among schedule holders and the results, or a statement of the reasons market research was not conducted.

the incumbent is the only entity uniquely situated and able to immediately begin work at a high level and provide rapid results to assist FDA in responding to the White House mandates without undue risk of delay or performance.

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7. Any other facts supporting the justification.

Based on the above information it would be in the government’s best interest to utilize a sole source to the vendor Tunnell Consulting. Due to the mandate by the White House, Congress has appropriated a very large supplemental funding stream to address the issue making it a huge initiative, and that while the implementation of this is urgent, it is ongoing and will take years to implement initially but need to keep going in line with pandemic preparedness, in general, from the COVID-19 global pandemic and national public health emergency declared by the President of the United States.

FDA/ CDRH must act immediately to effectively respond to the direct and urgent operational challenges for CDRH in the face of the evolving global COVID-19 pandemic and the FDA is not aware of any other businesses, small or large, that can meet the FDA's critical needs.

Competing requirements would result in unacceptable time delays in addressing a global pandemic and national public health emergency. It would jeopardize HHS' public health mission in a way that would result in unacceptable risks to the health of the general public in the United States. Delays in award of critical contracts would result in serious injury, financial or other, to the Government due to the unacceptable jeopardy that would be posed to the health of the general public. This greatly impacts the center's ability to meet its mission to protect and promote public health. Because of their in-house experience in FDA and other agencies they are exclusively positioned to see the big picture and act urgently. Another contractor would not have the depth of understanding of the needs of OPEQ/FDA/HHS like Tunnell because of Tunnell's unprecedented relationship with several HHS agencies providing SM Es in different disciplines for pandemic preparedness. The learning curve, cost and speed to build up another contractor in the face of a WH mandate and ongoing pandemic could prove to be a threat to national security and cause unnecessary loss of life.

8. Statement of the actions, if any, the agency may take to remove or overcome any barriers that led to the restricted consideration before any subsequent acquisition for the supplies or services is made.

a) Removal of barriers to competition.

Ongoing market research will continue to assess whether other sources become available. Any subsequent acquisitions will undergo thorough market research before any decision is made about available sources.

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

None.

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9. Program office certification.

Evidence that any supporting data that is the responsibility of technical or requirements personnel (e.g., verifying the Government’s minimum needs or requirements or other rationale for limited sources) and which form a basis for the justification have been certified as complete and accurate by the technical or requirements personnel.

Signature:____________________________________

Crystal Reed-Tweedy COR/Requiring Activity POC

Christopher Scott COR/POC Immediate Supervisor

Daniel Montgomery Head of the Sponsoring Program Office

10. Contracting Officer Certification.

This is to certify that the justification is accurate and complete to the best of the contracting officer’s knowledge and belief.

Terry L. Frederick Contracting Officer

Crystal R. Reed-tweedy -S

Digitally signed by Crystal R.

Reed-tweedy -S Date: 2021.06.16 10:06:11 -04'00'

Christopher T.

Scott -S

Digitally signed by Christopher T. Scott -S Date: 2021.06.16 10:09:17 -04'00'

Daniel R.

Montgomery -S

Digitally signed by Daniel R.

Montgomery -S Date: 2021.06.16 13:35:06 -04'00'

Terry L. Frederick -S Digitally signed by Terry L. Frederick -S Date: 2021.06.16 15:50:12 -04'00'

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11. Division Director and Head of the Contracting Activity signatures.

Vidya Vish Division Director

Leonard D. Grant Head of the Contracting Activity

12. Competition Advocate signature.

Jim Sigg Competition Advocate

Vidya Vish -S Digitally signed by Vidya Vish - S Date: 2021.06.16 16:23:42 -04'00'

Digitally signed by Leonard Grant -S Date: 2021.06.21 20:01:30 -04'00'

James M. Sigg -S

Digitally signed by James M. Sigg -S Date: 2021.06.22 10:07:37 -04'00'