F4FDAY0182A101_JA_FINAL.pdf

JUSTIFICATION FOR OTHER THAN

FULL AND OPEN COMPETITION

I. Agency and Contracting Activity.

This Justification and Approval is to request authority for Other Than Full and Open Competition supporting requirements generated for the Department of Health and Human Services (DHHS). The contracting activity for this requirement is the Air Force Material Command (AFMC) Air Force Life Cycle Management Center (AFLCMC) / WNKF. The purchase request number supporting this contract action is F4FDAY0182A101.

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

Due to circumstances described herein, the activity requests authority to acquire industrial base capacity expansion of ventilator components and consumables using Other Than Full and Open Competition as prescribed by FAR 6.302-2, Unusual and Compelling Urgency. Firm Fixed Price (FFP) letter contract FA8576-20-P-0003 was awarded 21 Jul 2020. The period of performance (PoP) is 21 Jul 2020 through 21 Nov 2021.

This sole source requirement will be purchased from the following company:

Pall Biomedical, Inc.

DBA: Pall Medical 25 Harbor Park Dr.

Port Washington, NY 11050-4605 Cage: 6Y8J7 Size: Large

III. Description of the supplies/services required to meet agency needs (including the estimated value).

This requirement is for a domestic industrial base capacity expansion by Pall Medical to increase production of ventilator components and consumables in the US. This will be done by acquiring tooling equipment and setting up a new production line in Fajardo, Puerto Rico or Putnam, CT, one of Pall Medicals existing facilities. As a result, Pall will create domestic production from 0 to 650,000 filters per month after 16 months or completion of the production line, whichever is sooner.

The purpose of this requirement is to build a manufacturing line in the United States to address the breathing line and ventilator filter shortage due to the COVID-19 Pandemic. The increase in domestic capacity is necessary to streamline ventilator components and consumables to meet the increasing demand created by the COVID-19 pandemic.

Compared to pre-crisis levels, Pall Medical was dependent on their UK facility for ventilator components and consumables. This effort however will create domestic production of ventilator components and consumables to 650,000 filters per month after 16 months or production line set up, whichever is sooner.

PERIOD FISCAL YEAR ESTIMATED TOTAL

Basic FY20 Not To Exceed (NTE) $4,910,000.00

The nominal Contract Line Item Numbers (CLINs) anticipated for each period are as follows:

Unit of CLIN DESCRIPTION COST QTY/Min/Max/BEQ Measure 0001 Capacity Expansion FFP 12 EA

Total estimated contract value is a NTE of $4,910,000.00. The basis of this estimated cost was derived from Pall Medical’s spend plan/timeline dated 26 Jun 2020. The PoP of the contract is 21 Jul 2020 through 21 Nov 2021.

IV. Statutory authority permitting other than full and open competition.

10 U.S.C. 2304(c) (2), as implemented by FAR 6.302-2, Unusual and Compelling Urgency.

V. Demonstration that the contractor’s unique qualifications or the nature of the acquisition requires use of the authority cited above (applicability of authority).

On 13 Mar 2020, the President declared a national emergency, under section 501(b) of the Stafford Disaster Relief and Emergency Assistance Act 42 USC 5121-5207 (the “Stafford Act”), recognizing the threat that the novel (new) coronavirus known as SARS-CoV-2 poses to national security. On 25 Mar 2020, Under Secretary of Defense for Acquisition and Sustainment Ms.

Ellen Lord established the COVID-19 Joint Acquisition Task Force (JATF). Led by the Principal Deputy Assistant Secretary of Defense, Acquisition Enablers, Ms. Stacy Cummings, the JATF team includes acquisition professionals from all Military Departments and DoD Agencies, and is synchronizing and supporting the acquisition execution of DoD’s COVID-19 response to the interagency (Federal Emergency Management Agency (FEMA) and DHHS) for medical resources. On 27 Apr 2020, the Head of the Contracting Agency for DHHS, Assistant Secretary for Preparedness Response (ASPR), signed a Determination and Findings in accordance with the authority of the Economy Act (31 U.S.C. 1535), as implemented in subpart

17.5 of the Federal Acquisition Regulation (FAR), on behalf of the requesting agency, DHHS, to enter into an inter-agency agreement for acquisition assistance with the servicing agency, the Department of Defense (DoD), United States Air Force (USAF). In accordance with the Economy Act, DHHS is in need of urgent acquisition assistance from USAF that only USAF can provide within the time-frame required. The global pandemic drives the need for DHHS to rapidly support, maintain, and expand critical United States (US) industrial capacity for medical supplies and services. The DoD, through the JATF, has significant expertise, robust capability, and extensive processes in place to acquire supplies and services necessary to expand US industrial production in response to the COVID-19 pandemic.

Pall Medical currently is reliant on their UK facility for production of filters and ventilator components and with the current crisis is already unable to meet demand. Pall Medical with the funding from this requirement, will match the UK output in the United States. Increasing the domestic capabilities for production is necessary in order to support DHHS.

Accordingly, Pall Medical, is the only firm capable of providing the requirements described in Section III above without the DHHS experiencing unacceptable delays in fulfilling its requirements.

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

In accordance with FAR 5.202 (a) (2), the contracting officer did not submit the notice required by FAR 5.201 because the contracting officer determined that the proposed contract action is made under the conditions described in FAR 6.302-2 and the Government’s support of the COVID-19 pandemic response would have been seriously injured if the agency complies with the time periods specified in FAR 5.203.

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

The overall cost of this acquisition will be negotiated in accordance with procedures in FAR Part 12 and FAR 15.404-1 (b), and include a statement of price reasonableness confirming the ultimate price to the Government is fair and reasonable.

VIII. Description of the market research conducted and the results, or a statement of the reasons market research was not conducted.

Market Research was performed and conducted by Health and Human Services (HHS) for this effort before we received the requirement. We are currently working to receive and file this Market Research after requesting it.

IX. Any other facts supporting the use of Other Than Full and Open Competition.

None.

X. List of any sources that expressed, in writing, an interest in the acquisition.

None. See Section VI above.

XI. A statement of the actions, if any, the agency may take to remove or overcome any barriers to competition before making subsequent acquisitions for the supplies or services required.

No actions are planned to remove or overcome any barriers to competition for future acquisitions as this is a one-time buy to cover all known present requirements.

There was not a prior J&A, therefore higher level approval in accordance with DFARS PGI 206.304(a) (S-70) (ii) does not apply.

XII. Certification by the Contracting Officer.

As evidenced by my signature above, I have determined this document to be both accurate and complete to the best of my knowledge and belief.

XIII. Certification by the technical/requirements personnel.

As evidenced by my (our) signature(s) above, I (we) certify that any supporting data contained herein, which is my (our) responsibility, is both accurate and complete.