Justification and Approval Anavasi updated 10-15-21 djf 10-22-21.pdf

Justification and Approval for Sole Source

“Source Selection Information – see FAR 2.101 and 3.104”

1. Identification of the agency and contracting activity.

a. Federal agency and contracting activity.

HHS / National Institutes of Health (NIH) / National Heart, Lung, and Blood

Institute (NHLBI) Office of Acquisitions

b. Sponsoring organization.

National Institute of Biomedical Imaging and Bioengineering (NIBIB)

c. Project Officer information.

• Project Officer’s name: Melissa Porter, Director of Operations, Center for Cancer Genomics, National Cancer Institute

• Mailing address. 31 Center Drive, Bethesda Md 20892

• E-mail address. porterm@mail.nih.gov Telephone number.

240-7813284

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

a. Acquisition purpose and objectives.

The Government intends to negotiate and award a contract for RADx Tech

Project #2180 for ADL Diagnostics, Inc trading as Anavasi Diagnostics without providing for full and open competition as part of NIH’s response to the nationwide public health emergency, first declared by the Secretary of

Health and Human Services on January 31, 2020.

ADL Diagnostics, Inc t/a Anavasi Diagnostics. has developed a Highly

Scalable, Affordable, At-Home Rapid Molecular Diagnostic Test. This contract is structured to deliver these innovative testing strategies to the public and is an accelerated and comprehensive multi-pronged effort by NIH to make SARS-CoV-2 testing readily available to every American. The scope of work executed under this contract includes completing the validation, approval, and production processes in order to deliver a viable product in a scaled-up capacity to the U.S. public.

b. Project background.

The nationwide public health emergency, first declared by the Secretary of

Health and Human Services on January 31, 2020, remains in effect, as does the National Emergency Concerning the Coronavirus Disease 2019 (COVID-

19) declared pursuant to the National Emergencies Act in Proclamation 9994 of March 13, 2020.

In April 2020, the NIH launched the RADx program to complete the validation, emergency use authorization, and production processes to deliver COVID-19 tests to the U.S. public.

In recent months there has been a crisis with the unvaccinated public and a contagious new delta variant has substantially increased the demand for testing. On July 20, 2021, the U.S. Department of Health and Human Services Secretary Xavier Becerra extended the COVID-19 Public Health Emergency (PHE) for an additional 90 days.

https://www.phe.gov/emergency/news/healthactions/phe/Pages/COVID- 19July2021.aspx

As physical distancing and masking mandates have been relaxed and social activities and travel are on the rise, the 7-day moving average remains high at 155,882 cases.

https://covid.cdc.gov/covid-data-tracker/#trends_dailycases

Children younger than age 12 are still not approved to receive the vaccine and the risk of increased spread of the virus is a concern as schools are physically reopening for the 2021-2022 school year.

On September 9, 2021 President Biden introduced a Path Out of the Pandemic COVID-19 Acton Plan. The action plan contains a six-pronged, comprehensive national strategy to combat COVID-19 and save lives in the months ahead, while also keeping schools open and safe, and protecting our economy from lockdowns and damage.

https://www.whitehouse.gov/covidplan/

The action plan states that it will mobilize industry to expand easy-to-use testing production and that “the Administration will ensure a broad, sustained industrial capacity for COVID-19 test manufacturing.”

The desired industry capacity will assist in satisfying the following action plan objectives, all of which require reliable COVID-19 tests: (1) requiring all employers with 100+ employees to ensure their workers are vaccinated or tested weekly; (2) calling on large entertainment venues to require proof of vaccination or testing for entry; (3) getting students and school staff tested regularly; (4) sending free rapid, at-home tests to food banks and community health centers; and (5) expanding free, pharmacy testing.

These factors indicate significant demand for diagnostic tests in the coming months. Maintaining a sufficient supply of testing kits is essential to keep the nation open and help outpace the delta and other emerging coronavirus variants.

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

a. Project title. RADx Tech Project # 2180 RADx 2 “Low-cost Moderate-throughput Covid-19 test to support massive test scaleup at small clinics and community sites.”

b. Project description. This contract will be with ADL Diagnostics, Inc t/a

Anavasi Diagnostics to develop AscencioDX, a rapid point-of-care molecular

COVID-19 test using lower nasal swabs. This point-of-care molecular test supports NIH’s RADx Tech program to mobilize industry and ensure vital suppliers are available in response to the March 13, 2020, national emergency proclamation and more recently the September 9, 2021, “Path out of the Pandemic”. The plan specifically orders a mobilization of industry to due to the urgent and compelling need to accelerate the production of rapid

COVID-19 tests, including at-home tests, and continue to ensure that manufacturers prioritize creating these products to prevent the spread of

COVID-19 and its variants.

i. Requirement type.

❑ Research & development (R&D) ❑ R & D support services

◼ Support services (non-R&D)

❑ Supplies/equipment

❑ Information technology (IT)

❑ Construction

❑ Architect-engineer (A & E) services

❑ Design-build

❑ Other (specify):

ii. Type of action.

◼ New requirement

❑ Follow-on

iii. Proposed contract/order type.:

◼ Firm-fixed-price ❑ Other fixed-price (specify, e.g., fixed-price award-fee, fixed-price incentive-fee):

❑ Cost-plus-fixed-fee

❑ Other cost reimbursement (specify, e.g., cost-plus-award-fee, cost-plus-incentive-fee):

❑ Time and materials ❑ Indefinite delivery (specify whether indefinite quantity, definite quantity, or requirements):

❑ Completion Form ❑ Term form

Acquisition identification number.

RADx Tech Project #2180; Purchase Requisition/POTS Number: TBD

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

Total Estimated Value: $14,900,000.00 Period of Performance: October 25, 2021 to October 24, 2022

4. Identification of the statutory authority permitting other than full and open competition.

◼ This acquisition is conducted under the authority of 41 United States Code (U.S.C.) 3304(a)(3) as set forth in Federal Acquisition Regulation (FAR) 6.302-3 (a)(2)(i).

❑ This acquisition is conducted under the authority of section 4202 of the Clinger-Cohen Act of 1996.

❑ This acquisition is conducted under the authority of the Services Acquisition Reform Act of 2003 (41 U.S.C. 428a).

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

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

ADL Diagnostics t/a Anavasi Diagnostics.

17926 NE 196th St Woodinville, Washington 98077-8243

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

As noted in FAR 6.302-3, full and open competition need not be provided for when it is necessary to award the contract to a particular source or sources in order to maintain a facility, producer, manufacturer, or other supplier available for furnishing supplies or services in case of a national emergency or to achieve industrial mobilization.

ADL Diagnostics, Inc t/a Anavasi Diagnostics, has unique qualifications to provide the services and product design for this requirement and is the only organization that can complete validation, seek and obtain Emergency Use Authorization (EUA) approval from the FDA, scale up manufacturing capabilities, and maintain production capacity at this time

ADL Diagnostics, Inc t/a Anavasi Diagnostics is an independent small in vitro diagnostic company incorporated in the United States. Their device called AscencioDX is a rapid (~25 min) point-of-care molecular COVID-19 test using lower nasal swabs

ADL Diagnostics, Inc t/a Anavasi Diagnostics has a proprietary ownership of its designs and data from the testing of its device. This device is unique and only ADL Diagnostics, Inc t/a Anavasi Diagnostics is uniquely qualified to adapt its manufacturing processes to produce testing kits capable of tests.

Allowing the current, uniquely qualified and responsible contractor to complete validation, seek and obtain Emergency Use Authorization (EUA) approval from the FDA, scale up manufacturing capabilities and maintain this production is appropriate in that it is an efficient and effective implementation strategy to satisfy the President’s September 9, 2021 Executive Order.

In light of the aforementioned factors, it benefits the Government to issue a contract to ADL Diagnostics, Inc t/a Anavasi Diagnostics in order to ensure that they receive their EUA approval from the FDA, which allows ADL Diagnostics, Inc t/a Anavasi Diagnostics to launch their product and achieve the production capacity metrics as negotiated in the contract.

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

In accordance with FAR Subpart 5.202, a pre-solicitation notice will not be published electronically to beta.sam.gov. The Contracting Officer has determined that an advance notice is not appropriate or reasonable in accordance with FAR 5.202(a)(10).

Advance notice is not appropriate or reasonable in this case because the Government cannot delay issuance of this award. Advance notice may result in a significant number of submissions from interested parties, which may or may not have technical merit, and necessitate in-depth technical reviews.

As of September 16, 2021, according to https://covid.cdc.gov/covid-data-tracker/#county-view , 97% of the counties in the U.S. have “High” or “Substantial” community transmission. With 97% of the counties in the U.S.

having “High” or “Substantial” community transmission levels, and the pandemic among the unvaccinated worsening, the Government has a responsibility and mandate from the President to mobilize industry and ensure a broad, sustained industrial capacity for COVID-19 test manufacturing.

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

A fixed-price contract is contemplated. Pursuing the services under this contract on a fixed-price basis does not subject the Government to a significantly higher price for these services. The contractor is not required to build unpredictable work flows or accept extensive risk during contract performance.

The IGCE amount of $14,900,000 is above the truth in negotiations $2 million threshold for prime contracts awarded on or after July 1, 2018 specified in FAR 15.403-4(a); however, a Certificate of Current Cost and Pricing Data will not be required because of the commercial exception stated in FAR 15.403-1(C)(3).

The contract will be awarded only if, during discussions, it is demonstrated that the anticipated cost to the Government for the work to be performed is determined to be fair and reasonable in accordance with FAR 15.4.

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.

Tactical market research such as a sources sought announcement, notice of intent posting, or request for information has not been conducted for this action because of the circumstances noted in Section 6; however, the Government has continuously conducted strategic market research in the form of surveying industry market capabilities and reviewing literature published by qualified organizations since the beginning of the pandemic.

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

The period of performance of twelve (12) months provides the vendor the opportunity to complete validation, seek and obtain Emergency Use Authorization (EUA) approval from the FDA, scale up manufacturing capabilities, and maintain production capacity. These are key deliverables for the Rapid Acceleration of Diagnostics (RADx) program to be a success.

The period of performance is consistent with observed (RADx) milestone completion timelines and inclusive of known supply chain risks.

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.

The Government continually attempts to overcome barriers to competition by analyzing different sources that might be qualified for similar future acquisitions.

However, access to the data listed in Section 5.b.from any other known source does not currently lend itself to full and open competition. The Government is using the authority provided by (U.S.C.) 3304(a)(3) to facilitate industrial mobilization without providing for full and open competition. If the requirement changes, or another source develops a comparable set of data, the Government will begin surveying the market for new sources.

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.

Official Name & Title Signature Date

Contracting Officer Representative

(COR)

Melissa Porter, National Cancer Institute

Head of the Sponsoring Program Office

Jason Ford, Executive Officer, NIBIB

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.

Rashida Ferebee

Contracting Contracting Officer, Officer NHLBI Office of

Acquisitions

14. Chief of the Contracting Office and Head of the Contracting Activity signature(s).

Chief of the Contracting Office

Ann Gawalt, Director, Office of Acquisitions, NHLBI

Head of the Contracting Activity

Diane J. Frasier, Director, OALM

15. Competition Advocate signature Official Name & Title Signature Date

Competition Advocate

Dr. Richard G. Wyatt, Deputy Director, Office of Intramural Research