Class J and A Final 3.21.20.pdf

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“Source Selection Information- see FAR 2.101 and 3.104”

1. Identification of the agency and contracting activity.

a. Federal agency and contracting activity.

Health & Human Services/ Office of the Secretary/Assistant Secretary for Financial

Resources/Office of Acquisition. This class justification covers all HHS acquisition offices.

b. Sponsoring organization.

HHS/OS/ASFR/OA

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

This is 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). Because COVID-19 is an emerging disease, and there are no vaccines or approved treatments, it is prudent to have adequate flexibility to address this public health emergency. This class J&A is essential to respond to urgent requests for immediate support to respond to the expanding outbreak of COVID-19 which was just declared a pandemic on March 11, 2020 and a national emergency via Presidential Proclamation on

March 13, 2020. This class J&A supersedes all other class J&A’s executed and issued by HHS and negates the need for individual J&As for contract actions to facilitate the recovery efforts necessary to address COVID-19.

Requirements that arise and are executed by HHS contracts offices can be processed under the authority of the class

J&A. A copy of the class J&A must go in the award file for all requirements processed under the authority of this class J&A and each contracting activity must maintain a log of all contract actions awarded under the authority of this class J&A.

a. Acquisition purposes and objectives.

The requirement is to purchase critically needed supplies and services to respond to the COVID-19 global outbreak. 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.

Class Justification for Other Than Full and Open Competition

COVID-19 Response

The mission to respond to the community spread of COVID-19 throughout the United States and the mission to repatriate individuals who have been exposed to the virus are both ongoing and growing. The COVID-19 outbreak has evolved at a fast pace, resulting in an urgent and compelling need to rapidly procure supplies and services to support the containment and recovery of the outbreak throughout the country and world. This constitutes an unusual and compelling urgency that demands immediate attention. Immediate acquisition of services and supplies will help ensure that the United States of America remains prepared for and capable of responding to a public health emergency in the necessary and immediate manner that is required.

b. Project background.

This justification for unusual and compelling urgency is due to the public health emergency caused by COVID-19, which was declared a global pandemic by the WHO. The first confirmed case of COVID-19 in the United States was announced on January 21, 2020 and a national emergency was declared via Presidential Proclamation on March 13, 2020. The ultimate spread, length of time, and severity of the COVID-19 outbreak is unknown as this time and current data indicate that COVID-19 has begun to spread exponentially, in the typical pattern for an epidemic.. The goal of the ongoing U.S. public health response is to respond to and mitigate sustained spread of COVID-19 in this country.

The HHS has a requirement to provide medical and pharmaceutical related material and services to various locations across the US during this public health emergency and response effort. The Department anticipates receiving Mission

Assignments generated from within and outside HHS to purchase and distribute required services, products and equipment. Any delay in providing critical medical supplies, services and equipment could cause irreparable harm and put American citizens at an increased risk of transmission and exposure. Every effort must be made to provide needed products and services in the most expedient manner.

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

a. Project Title:

COVID-19 Response: Supplies and Services to support response and recovery to the national emergency created by the COVID-19 pandemic. Specific requirements and costs will be defined at the contract level and shall be documented as a part of the contract file.

Contract Performance for COVID-19 Supplies and Services

The exact length and breadth of this response cannot be determined at this time and therefore, the period of performance for COVID-19 supplies and services will vary from immediate to longer term support but is not to exceed 12 months.

b. Project Description:

The HHS is working in tandem with other Federal Agencies which, among others, are providing disaster medical assistance teams to provide medical relief and assistance to areas impacted by COVID-19. In support of these efforts, the HHS has an urgent need to obtain supplies and services to ensure the delivery of potentially lifesaving and preventative medical supplies and services in support of the response to the COVID-19 pandemic.

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): Additional requirements as needed to support recovery efforts related to this national emergency

Type of action.

New requirement

Follow-on

Other (specify):

Proposed contract/order type.

Contract type will be defined at the contract or task/delivery order level. All contract types available under FAR part 16 are authorized under this J&A and shall be documented as part of the contract file.

Acquisition identification number.

To be identified at the individual contract and task/delivery order level. All contract actions made under this class J&A shall include a copy of this in the contract file.

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

The estimated value of these supplies and services is $30,000,000,000.00 based upon the supplemental funding provided by Congress and historical information from the first 6 weeks of the emergency COVID-19 response, and previous federal presidentially declared responses for similar public health emergencies such as Zika and H1N1. Supplemental appropriations were recently approved for immediate purchases to mitigate the further spread of COVID-19. The needs and extent of supplies and services will continue to evolve as the virus spreads across the nation. In the face of a potential public health disaster, the exact needs and locations can change rapidly and therefore the planned emergency acquisitions under this class J&A takes this into account in estimating the value. This class J &A is for all supplies and other related services described under

Section 2- Nature and/or description of the actions. The exact length and breadth of this response cannot be determined at this time and therefore, the period of performance for COVID-19 supplies and services will vary from immediate to longer term support but is not to exceed 12 months. This is consistent with FAR

6.302-2(d)(ii).

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.) 253(c)(1) as set forth in Federal Acquisition Regulation (FAR) 6.302- 2 Unusual and compelling urgency, FAR 8.405-

6(a)(1)(A); and FAR 18.104. An urgent and compelling need exists, and following the procedures would result in unacceptable delays, and FAR 16.505(b)(2)(i)(A) The agency need for the supplies or services is so urgent that providing a fair opportunity would result in unacceptable delays.

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).

Actions taken under the authority of this class J&A shall include documentation of market research performed and prospective sources of supply and services. Additionally, actions taken under the authority of this class J&A shall include evidence of the urgent and compelling nature of the particular action, reviewed and approved at a level above the Contracting Officer.

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

Actions taken under the authority of this J&A shall include documentation of the contractor’s qualifications and ability to perform the work as part of the Contracting Officer’s responsibility determination.

6. Actions taken under the authority of this class J&A shall include documentation that the proposed contractor is found to be responsible to perform the work. Description of the efforts made to ensure that offers are solicited from as many potential sources as practicable. Indicate whether a Contract

Opportunities notice was or will be publicized in beta.SAM.gov as required by FAR Subpart 5.2 and, if not, which exception under FAR 5.202 applies.

Due to the unusual and compelling urgency of this requirement, expedited procedures may be utilized.

For commercial items, therefore in accordance with FAR Part 12 and 13, simplified procedures may be utilized for some actions, including informally requesting quotes via telephone or email, or other electronic means.

When the agency’s need for the supplies or services is of such an unusual and compelling urgency that the

Government would be seriously injured unless the agency is permitted to limit the number of sources from which it solicits bids or proposals, full and open competition need not be provided for.

Actions taken under the authority of this class justification shall include documentation of the extent of competition undertaken.

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

The Contracting Officer will use appropriate and available information to review proposed prices and determine that they are fair and reasonable, and such documentation shall be included in the contract file.

The contracting officer will review the offerors’ published commercial price, including prices list on various government-wide acquisition vehicles and other sites, such as pricing data contained in the GSA Acquisition

Gateway Pricing Portal. The Contracting Officer will also request other cost data, and explanations regarding market conditions, from the offeror, in the event that offerors submit prices that exceed published commercial prices. Other information that may be used includes Independent Government Cost Estimates

(IGCE), historical information, contractor’s invoice payments and commercial pricing that have been determined to be fair and reasonable.

Actions taken under the authority of this class justification shall include a documentation of the price/cost analysis conducted and that the proposed price is fair and reasonable.

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.

Actions taken under the authority of this class J&A shall include documentation of market research performed and prospective sources of supply and services.

https://beta.sam.gov/

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

Competing requirements taken under the authority of this class J&A would result in unacceptable time delays in fulfilling the agency's urgent needs in addressing a global pandemic and national public health emergency. It would jeopardize HHS’ public health mission in a way that would result in unacceptable risks to the health of the general public in the United States. Delays in award of critical contracts would result in serious injury, financial or other, to the Government due to the unacceptable jeopardy that would be posed to the health of the general public.

9. Listing of sources, if any, that expressed, in writing, an interest in the acquisition.

Non

None, sources and market research shall be defined at the contract or task/delivery order level, and shall be documented in the contract file.

10. 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.

None, this is an immediate, urgent requirement. This class J&A shall remain in place for the duration of the national emergency as declared by Presidential Proclamation on March 13, 2020 as described under Section 2 or until revoked by the HHS SPE.

David R. Dasher //s//

Deputy Assistant Secretary for Office of Acquisitions, ASFR

Senior Procurement Executive, Department of Health and Human Services