JUSTIFICATION DETAILS for COVIfinal--D-19 Class JandA signed para 5a - OWS Kitting Operations Contract- 9.19 1500 eSigned.pdf

JUSTIFICATION DETAILS FOR COVID-19

EMERGENCY RESPONSE ACTIVITIES

The Department of Health and Human Services (HHS) issued a class Justification & Approval (J&A) in accordance with FAR § 6.303- 1(d) and 6.302-2, Unusual and Compelling Urgency, FAR § 8.405- 6(a)(1)(A), Limiting Sources, and FAR § 16.505(b)(2)(i)(A), Exceptions to the Fair Opportunity Process for all contract actions to facilitate the recovery efforts necessary to address the 2019 Novel Coronavirus (COVID-19). The J & A is essential to respond to urgent requests for immediate support to respond to the expanding outbreak of the COVID-19 global pandemic.

This form must be completed for all actions to meet the requirement set forth in 5(a) of the Department of Health and Human Services (HHS) class J&A for the COVID-19 pandemic response issued via HHS Acquisition Alert 2020-08.

Actions taken under this authority shall include documentation of market research performed and prospective sources of supply and services.

Additionally, shall include evidence of the urgent and compelling nature of the particular action, reviewed and approved at a level above the Contracting Officer.

Identification of Program Office, Contracting Activity, and Proposed Requirement, Justification and Program Office Certification:

A. Program Office:

Division of Strategic National Stockpile 2945 Flowers Rd. South Atlanta, GA 30341

B. Contracting Activity:

Health & Human Services Assistant Secretary for Preparedness and Response Office of Resource Management Contracts & Grants Division Strategic National Stockpile (SNS) Contracts Branch

C. Identification of Requirement:

a. Nature of Action to be Approved:

Sole source acquisition of:

In response to COVID-19, ASPR has a requirement to assemble, package, label, and ship

COVID-19 vaccine ancillary kits containing items both to be provided by the vendor as well as by the United States Government (USG). Items composing of the kits include hypodermic needle and syringes of various makes and sizes, mixing syringes, sterile alcohol prep pads, Personal Protective Equipment (PPE), vaccination cards, and other medical products. These

DEPARTMENT OF HEALTH & HUMAN SERVICES Office of the Secretary

Office of the Assistant Secretary for Preparedness & Response Washington, DC 20201

Rev. 3/25/2020 items will be placed into packages or kits suitable for healthcare providers to administer a vaccine as part of a national vaccination campaign.

D. Demonstration that the proposed contractor(s) unique qualifications or the nature of the acquisition requires use of the authority cited in the class J&A for the COVID-19 pandemic response

a. Describe market research performed and prospective sources of supply and services:

This acquisition is limited to offerors who have established distributor/wholesaler relationships with FDA registered medical device manufacturers. Among these, the predominate relationship is to ensure the uninterrupted access to sterile, individually wrapped isopropyl alcohol prep pads, disposable face shields and surgical masks for kitting. The acquisition objective is to acquire for kitting services for up to 760 million vaccine administrations.

The Assistant Secretary for Preparedness and Response has had extensive interaction and experience with ancillary manufacturers and maintains an awareness of market trends and capabilities. Market research draws heavily from the 2009 H1N1 Influenza pandemic where it contracted for kitting services and periodically reviewed requirements when events dictated enhanced readiness; most recently in 2017 through the sixth wave of H7N9 outbreaks in Asia and in Pandemic Influenza and National Level exercises. Research was also performed using other Government and commercial data bases for relevant information regarding this procurement.

b. Proposed Vendor: McKesson

c. Estimated Procurement Amount:

Total Base CLINs: $283,734,338.50 Total Option CLINs: $285,209,338.50 Total Contract Value: $568,943,677.00

E. Provide evidence of the urgent and compelling nature of the particular action:

a. Explain:

After performing Market Research, we request that we perform a Sole Source procurement to McKesson MedSurge. McKesson is one of the Nation’s largest distributor of pharmaceuticals and medical supplies. As an established distributor, manufacturer, and kitting vendor, they have close relationships with multiple USG Agencies including the FDA, CDC, and ASPR. As one of the largest distributors/wholesalers, they have a unique ability to quickly source and kit the items. They have the ability to perform kitting operations co-located their distribution facilities to ensure rapid distribution of such.

The Centers for Disease Control and Prevention (CDC) has an existing contract (200-2017- 92968) with McKesson to support centralized vaccine distribution for the Vaccines for Children Program (VFC) and 317 programs. This contract includes an option to distribute vaccine for a pandemic which was exercised on Friday August 14th, 2020. This contract will be used for the distribution of the COVID19 vaccine nationwide.

It would be in the Government’s best interest to award the Kitting Operations and Distribution Contract to McKesson to allow for a continuity of operations, efficiencies in the coordination and distribution of the vaccine, ability to ramp kitting production, current on-hand availability of a significant amount of ancillary supplies, and their current involvement in the USG OWS. Given the importance and need to expedite this requirement due to the pandemic and a revised vaccine delivery schedule, identifying a vendor with these capabilities, ability to immediately ramp-up, and the immense coordination with the USG, vaccine manufacturers, and the vaccine distributor, another vendor could not reasonably meet the governments requirement for ancillary kits positioned with the vaccine for distribution by October 1. With one single vendor, communications will be streamlined and more efficient, decreasing the administration burden and risk to the Government. Additionally, SNS works closely with CDC for the distribution of the ancillary kits and vaccine and it would be advantageous to use the end-to-end IT

Rev. 3/25/2020 architecture VTrckS system already in place and used by both CDC and McKesson. The VTrckS system is used for the overall order distribution of the vaccine and ancillary kits to their destination.

Optional CLINs are included due to the uncertainties related to vaccine development and the administration associated with this requirement. As the U.S. and World expeditiously proceed towards a COVID-19 Vaccine, there are numerous variables that ultimately determine the Government’s final need for ancillary/mixing kits and distribution. The Vaccines are currently undergoing trials and the final vaccine(s) that will be approved and rapidly administered are currently unknown. The USG cannot wait until approval of vaccine is obtained before developing kits to administer such. Given the unknowns and variables, the Government is including these Optional CLINs to account for such.

b. Other facts supporting sole source procurement if any:

F. Program Office Certification:

Technical / Requirements Certification: By my signature below, I certify that the supporting data being used under the class J & A and certify the justification is true and accurate to the best of my knowledge.

Contracting Officer Representative’s Name: Brian Hall

Position Title: Logistics COR

COR Signature:

Date: 8/13/2020

G. Contracting Officer’s Certification

I hereby certify that this justification is accurate and complete to the best of my knowledge. I approve this justification subject to availability of funds, and provided that the services and supplies herein describe have otherwise been authorized for acquisition.

Contracting Officer’s Name: Annette Wright

Position Title: Team Lead

Contracting Officer’s Signature:

Date: 09/15/2020.

H. Approval One Level Above the Contracting Officer

I have reviewed this justification and ! approve or " do not approve the action.

Name: Vivian S. Hubbs.

Position Title: Chief Contracting Officer

Signature:

Date: 09/15/2020

David M.

Kelley -S

Digitally signed by

David M. Kelley -S

Date: 2020.09.14

14:54:39 -04'00'

Annette Wright -S Digitally signed by Annette

Wright -S

Date: 2020.09.15 19:41:22 -04'00'