JUSTIFICATION DETAILS for COVID-19 Class JandA para 5a - Three Ply Surgical Face Masks.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. 1. Identification of Requirement:

a. Nature of Action to be Approved:

Sole source acquisition of: Surgical Three Ply Face Masks

D. 2. 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:

Market research has been conducted including surveying several commercial manufacturers of these products and their supply chain partners as well as discussions with government agencies

DEPARTMENT OF HEALTH & HUMAN SERVICES Office of the Secretary

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

Rev. 3/25/2020 such as the Air Force, VA, FEMA, and Army. GSA e-buy, schedules, commercial pricing sheets, and internet research were conducted and there are no existing Government contract mechanisms with the ability to satisfy the stated requirement. These items were specifically identified as they have characteristics and abilities to fit the mission set in which they will be used.

For example, surgical face masks are one part of an infection control strategy and are examples of personal protective equipment (PPE) that is a disposable device intended for medical purposes that is worn over the face to prevent contamination between patient and health care personnel.

The appropriate use of PPE is an important component of the overall strategy of certain infection control guidelines. Also for their ability to operate in an austere environment, uniformity/interoperability with other equipment and supplies that are also supporting this mission set and the vendor’s ability to meet the needed quantities and timeline.

b. Proposed Vendor: Accent Import Inc. DBA Viral Protection Labs

c. Estimated Procurement Amount: $14,500,000.00

E. 3. Provide evidence of the urgent and compelling nature of the particular action:

a. Explain:

On January 30, 2020, the International Health Regulations Emergency Committee of the World Health Organization declared the outbreak a “Public Health Emergency of International Concern” (PHEIC). On January 31, 2020 Health and Human Services Secretary Alex M. Azar II declared a Public Health Emergency (PHE) for the United States to aid the nation’s healthcare community in responding to 2019-nCoV. On March 11, 2020, the World Health Organization (WHO) declared the COVID-19 outbreak a global pandemic, and on March 13, 2020, the United States issued a Presidential Proclamation declaring the COVID-19 outbreak to be a national emergency.

Additionally, all fifty states and the District of Columbia have declared emergencies due to COVID-19. This requirement is to purchase critically needed supplies and services to respond to the COVID-19 global outbreak. There is currently a global market shortage of nearly all Personal Protective Equipment and medical supplies, including surgical face masks. The ultimate spread, length of time, and severity of the COVID-19 outbreak is unknown as this time, but it is anticipated that it will continue to spread exponentially across the globe. This is a serious public health threat. The fact that this virus has caused severe illness and sustained person-to-person spread not only across the world but within the United States has created a health care emergency. The risk to individuals is dependent on exposure. At this time, some people will have an increased risk of infection, for example healthcare workers caring for COVID-19 patients and other close contacts. The goal of the ongoing U.S. public health response is to prevent sustained spread and mitigate the risk of transmission to healthcare providers in this country.

b. Other facts supporting sole source procurement if any: Click here to enter text

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: David Kelley

Position Title: Lead Resource Management Specialist

COR Signature:

Date: 4/8/2020

Rev. 3/25/2020

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: Click here to enter text.

Position Title: Click here to enter text.

Contracting Officer’s Signature:

Date: Click or tap to enter a date.

H. Approval One Level Above the Contracting Officer

I have reviewed this justification and ☒ approve or ☐ do not approve the action.

Name: Click here to enter text.

Position Title: Click here to enter text.

Signature:

Date: Click or tap to enter a date.