Redacted_JA.pdf

CONTROLLED UNCLASSIFIED INFORMATION

Justification and Approval (J&A) for Other Than Full and Open Competition

Was a J&A approved for the preceding acquisition? ~ Yes D No

! ! Attach the preceding J&A in the staff package for this J&A. The preceding J&A will be used as a reference document.

Is this a new or amended J&A Document? ~ New D Amended ( Prior to Award Only! )

Is this a Bridge Action as defined at AFFARS 5302.101 ? D Yes ~ No

Dollar Value of this Acquisition: D ~ $750K ~ > $750K and ~ $1 SM D > $1 SM and ~ $1 00M D > $1 00M

Contracting Activity: Air Force Life Cycle Management Center Agile Combat Support Directorate (AFLCMC/WN)

Purchase Request (if available): FA8638-20-C-0046

Program / Project (and PE, if applicable): Capacity Expansion for U.S. Respiratory Protection

Program Type (PEO, Enterprise, of Operational):

Authority: 6.302·3 - 10 USC 2304(c)(3), Industrial Mobilization; Engineering, Developmental, or Research Capability; or Expert Services

Estimated Contract Cost (including opt ions): $ 4.02M J&A Type: D Class ~ Individual

COORDINATION ( AFFARS 5306.304(a ))

APPROVAL ( AFFARS 5306.304(al )

April 2021 CONTROLLED UNCLASSIFIED INFORMATION Page 1 of 5

I. Agency and Contracting Activity.

Department of the Air Force Air Force Materiel Command Air Force Life Cycle Management Center Agile Combat Support Directorate (AFLCMC/WN) Bldg 16, Area B 2275 D Street Wright-Patterson AFB, OH 45433-7239 This is an Individual J&A for Other t han Full and Open Competition.

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

This individual Justification and Approval (J&A) is for the award of a contract modificat ion to The 3M Company (hereafter referred to as 3M) on contract FA8638-20-C-0046. 3M was awarded contract FA8638-20-C-0046 on 1 May 2020 for the acquisition to expedite and expand the domestic production of National Institute for Occupational Safety and Health (NIOSH)-approved N95 respirators to resolve urgent supply needs in response to the COVID-19 Pandemic. The contract was awarded in accordance with (IAW) FAR 6.302-2 - 10 USC 2304(c)(2), Unusual and Compelling Urgency. See attached. IAW FAR 6.302-2 -10 USC 2304(c)(2), the performance of the contract may not exceed 12 months, which would be 30 Apri l 2021 on the subject contract. 3M has requested a no cost five (5) month PoP extension due to a scope adjustment, extending the performance end date from 30 April 2021 to 30 September 2021. 3M has already met the performance requirements of the contract, achieving an increased production capacity of■■■■■■-per month, but has requested an extended PoP and payment schedule to reflect the invoicing to be incurred w ith the in-scope adjustment. The in-scope adjustment will add an additional automated packaging equipment and pallet izing equipment upgrade in l ieu of t he exhale valve equipment upgrades. The adjustment is largely attributed to the Occupational Safety and Health Administration (OSHA) recommended caution against the use of exhalation vents to help control the exposure of COVID-19. This in-scope adjustment will further the recovery of the U.S. depleted stockpile of personal protective equipment, particularly respira tors, and to further increase the availabili ty of respirators to the general U.S. population. The adjustment will provide 3M with greater manufacturing flexibilities allowing its N95 respirators to be packaged in bulk casing of-units to as few as • units. The flexibility in packaged units will allow 3M to be prepared to adequately respond to the current pandemic and national emergency, as well as provide long-term support to aid in the preventative measures to stop the spread of COVl~ation. The automated packaging equipment and palletizing upgrade w ill be accomplished in 3M's lllllllllllllllllllllllllm the 2nd high speed converting Aura respirator manufacturing line.

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

The Agile Combat Support (ACS) directorate plans to award the contract modification to 3M to design, procure and integrate the automated packaging equipment and palletizing upgrade onto its 2nd high speed converting Aura respirator manufacturing l ine. As a result, this w ill enable 3M to adj ust its automated packaging from~ 95 respirator units to as few asla-,!95 respirator units. 3M shall be responsible for securing NIOSH approval on the expanded production capabil ity and shall ensure planning, execution, and follow-through regarding all necessary certification of t he proposed faci lity and equipment upgrades to comply with appropriate certifications and local, state, and federal regulations.

3M has already met the original contractual requirements of increasing the product ion capacity by per month or per annum. The requested $4.02M J&A ceil ing is based on 3M's 16 April 2021 scope adjustment (debit/credit) and PoP extension request on Contract FA8638-20-C-0046.

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

The contracting actions covered by this individual J&A falls w ithin the authority found under 1 O U.S.C. 2304(c)(3), as implemented by Federal Acquisition Regulation (FAR) 6.302-3(a)(2) - Industrial Mobilization; engineering, developmental, or

April 2021 CONTROLLED UNCLASSIFIED INFORMATION Page 2 of 5 research capability; or expert services.

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

IAW with FAR 6.302-3(a)(2)(i), it is necessary to award this contract modification to 3M to maintain the domestic production of N95 respirators due to the declared national emergency. This contract modification enables 3M to package the highly demanded N95 respirators in various packaging sizes. By enabling 3M's manufacturing l ines to adjust its packaging sizes fromllllll.mits to as few as. units will allow 3M to reach a larger group of consumers, not just very large groups, to further support preventing the spread of COVID-19. On 13 March 2020, the President declared a national emergency, under section 501 (b) of the Stafford Disaster Rel ief 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 March 2020,Under Secretary of Defense for Acquisition and Sustainment ■■■■•stablished the COVID-19 Joint Acquisition Task Force (JATF). Led by the Principal Deputy Assistant Secretary of Defense, Acquisition Enablers, ■■■■■■■lthe JATF team includes acquisition professionals from the Mil itary 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 April 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 interagency agreement for acquisition assistance with the servicing agency, the Department of Defense (DoD), United States Air Force (USAF). IAW 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 U.S. industrial capacity for medical supplies and services. The DoD, through the Joint Acquisition Task Force, has significant expertise, robust capability, and extensive processes in place to acquire suppl ies and services necessary to expand U.S. industrial production in response to the COVID-19 pandemic.

IAW FAR 6.302-3(b)(1 )(i), it is necessary to award this contract modification to 3M to provide the short-term N95 respirator supply requirements in response to the national emergency, as well as long-term requirements. The automated packaging and palletizing will enable 3M with flexibil ity to protect mass groups with bulk packaging as well as smaller groups and individual consumers. This additional capability will further assist 3M to maintain its business and supply of N95 respirators following the national emergency in the event of a future national emergency. Publ ic health requires the increase of production capability to address critical inventory and production gaps for N95 respirators, to ensure the U.S. is prepared for both short-term and long-term events that requi re the need for N95 respirat ors. Failure to increase production capability will deplete N95 respirator inventories, leaving the government and the nation critically unprepared for this and the next pandemic emergency. The U.S. Government is pursuing contracts with several domestic manufacturers of N95 respirators, but does not have time to formerly compete the requirement due to the emergency circumstances. In the case of the National Response to the Spread of COVID-1 9, the contracting officer has determined that the 3M Company,_

- is a responsible domestic source for producing the required health and medical resources, specifically N95 respirators, suitable to provide the needed response to the spread of COVID-19. Furthermore, the contractor has demonstrated its responsibil ity through its ongoing contracts with the Government.

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.

IAW FAR 5.202(a)(10), the contracting officer did not submit the notice required by 5.201 because the contract ing officer has determined t hat the proposed contract act ion is made under the conditions described in FAR 6.302-3.

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

3M has estimated the effort to add the upgraded packaging equipment and pallet izing upgrade can be accomplished under $4.02M based on a contractor provided spend plan comprised largely of machinery and equipment purchases. This same piece of equipment and upgrade was included for one (1) line under t he attached J&A. This addit ion of work will be incorporated on the 2nd line. Although the commercial exemption to requesting certi fied cost or pricing data applies for

April 2021 CONTROLLED UNCLASSIFIED INFORMATION Page 3 of 5 this effort, the contracti ng officer w ill utilize various price analysis techniques to determine the contract price is fai r and reasonable. Since t he same equipment was originally proposed for the initial requirement on respirator line 1, the contracting officer can use actuals, quotes, and estimates provided t hen, in addition to updated quotes provided.

Additionally, the Government w ill conduct a technical evaluation and analysis of the proposal to assess the materials and labor proposed. If more information is necessary to make a a reasonable determination, the contracting officer will request other than certified cost or pricing data from the contractor in accordance with FAR 15.403-3.

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

The Air Force Research Laboratory (AFRL) issued a Hybrid Open Funding Opportunity Announcement (FOA) to allow industry to self- identify to the Government a short-fall in various critical industrial bases, to include N95 respirator production.-

In addition, through employment of the Economy Act, DHHS requested USAF award a second contract to 3M (Phase 11) to further expand its N95 respirator production capacity.

DHHS has awarded a number of supply contracts for N95 respirators, but has concluded that the domestic supply of these respirators is insufficient to meet the needs of the nation to combat COVID 19. Through the Economy Act, DHHS seeks to accelerate N95 respirator production to meet current and future demands through "contracting services and support for N95 respirator production capital and manufacturing expansion to 3M ... " Acting on DHHS's behalf, the Air Force has awarded a FAR Part 12 commercial contract to 3M for equipment purchases and equipment conversions to further expand the domestic N95 respirator manufacturing capacity. DHHS will continue to purchase N95 respirators through existing contracts; the Economy Act transactions are intended to accelerate respirator del iveries under these existing DHHS contracts, not replace them.

No further market research has been conducted since the initial contract award and the contracting officer determined that the market research initially conducted is still current, accurate, and relevant IAW FAR 10.002(b)(1) for this contract modification. Additionally, this new work is an identical requirement to what was approved in the preceding J&A, which included automated packaging and palletizing requirements on the 1st Respirator Aura Line. Therefore the contracting officer reviewed the market research undertaken to the identical requirement, IAW FAR 10.002(b)(2)(ii). Lastly, as mentioned in the 1st paragraph of this section, AFRL conducted a market survey via FOA where industry self- identified the Government's short-fa ll in various critical industrial bases, to include N95 respirator production.

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.

See Section VIII 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.

In the absence of an emergency situation, such as the COVID-19 pandemic, the USAF will publicize similar contract actions to increase competition, broaden industry participations, and assist small business concerns.

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

April 2021 CONTROLLED UNCLASSIFIED INFORMATION Page 4 of 5 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.

April 2021 CONTROLLED UNCLASSIFIED INFORMATION Page 5 of 5