ID03200010_Limited Source Justification_MOD 17_Final Posting_11 September 2021.pdf

Limited-Sources Justification

For The Joint Program Executive Office for Chemical, Biological, Radiological, and Nuclear

Defense

(JPEO-CBRND)

Specialized Support Services (S3)

GSA ASSIST ID Number: ID03200010; ASSIST Acquisition ID Number:

47QFMA20K0013

Note: This document is prepared in accordance with the requirements of FAR 8.405-6(c)(2).

This acquisition will be conducted under the authority of the Multiple Award Schedule Program.

This documentation is required due to a Time and Materials (T&M) ceiling increase which will be executed via modification 17 of the subject task order.

(c)(2)(i) Identification of the agency and the contracting activity, and specific identification of the document as a “Limited-Sources Justification.”

The requiring activity is for The Joint Program Executive Office for Chemical, Biological, Radiological, and Nuclear Defense (JPEO-CBRND), Gunpowder, MD 21010

The contracting activity is GSA/FAS, Mid-Atlantic Region, Philadelphia, PA 19106.

This document is hereby identified as a Limited-Sources Justification.

(c)(2)(ii) Nature and/or description of the action being approved.

The action being approved is a ceiling increase to the subject task order.

The Contracting Officer determined that this action was within scope of the current PWS and was critical in order to provide increased support for COVID-19 vaccination efforts. The ceiling increase will be applied to Option Year 1. The following details the current conditions that led to the critical need for additional vaccination support for the U.S.:

The Department of Defense (DoD), through JPEO CBRND, has been tasked with establishing a dedicated team to expand the U.S. domestic vaccine capacity. Over the past year the DoD, in support of the Department of Health and Human Services (HHS), spent approximately to acquire the necessary vaccines, therapeutics, diagnostics, consumables, personal protective equipment (PPE), and other enablers required to address the pandemic. As of February 5, 2021, the U.S. had over 26 million cumulative reported cases of COVID-19 and about 449,020 reported deaths.

The primary purpose of this this additional expertise is to execute the President’s and the Department of Health and Human Services’ (HHS) plan to expand U.S. domestic vaccine capacity and build/maintain infrastructure to increase long-term pandemic preparedness. Their goal in partnership with JPEO CBRND is to booster capacity to ensure surge production capabilities to support production of a booster or annual vaccine shot for the U.S. population.

The DoD and HHS partnership, herein referred to as Operation Warp Speed’s (OWS) production goals, have been met with the following manufacturing challenges:

• A shortage of facilities with capacity to handle the vaccine manufacturing needs can lead to production bottlenecks.

• Vaccine manufacturing supply chains have been strained by the global demand for certain goods and workforce disruptions caused by the global pandemic.

• Gaps in the available workforce (hiring and training personnel with the specialized skills needed to run vaccine-manufacturing processes)

To mitigate these challenges, the White House is investing in the development of U.S.

Government dedicated manufacturing capacity for both Drug Substance and Fill-Finish Operations. The Chemistry, Manufacturing, and Controls (CMC) Regulatory Affairs (RA) will be instrumental to this investment as it is crucial to the success of expanding the U.S. domestic vaccine capacity.

Anser will support the White House U.S. Vaccination efforts by serving as the JPEO-CBRND Deputy Medical representative at JPEO, the DoD, and HHS meetings in the context of Public Health Emergency Medical Countermeasures Enterprise / Operation Warp Speed (PHEMCE / OWS) development of medical countermeasures and related efforts. Anser will also be tasked with the management of a subset of regulatory strategy and regulatory operations. They will be providing expertise as regulatory Subject Matter Expert (SME) for CMC and Manufacturing across all multiple programs, in addition to providing expertise across the product and facilities portfolio.

Anser will also be tasked with compiling and documenting relevant research and clinical findings for regulators and maintaining knowledge and familiarity of acquisition advanced development programs with activities of other agencies that can be effectively and economically applied to the requirements of PEO/PM programs. The following sections detail and support Anser’s ability to address this critical U.S. Vaccination work.

(c)(2)(iii) A description of the supplies or services required to meet the agency’s needs (including the estimated value)

The subject task order is currently performed by Analytic Services Inc. (ANSER), utilizing the Professional Services Schedule (PSS), SIN 874 1 (Integrated Consulting Services), Contract Number.: GS-00F-095CA.

This task order provides the necessary subject matter expertise to the JPEO CBRND in the areas of National Security Strategies, Compliance, Advisement, Analysis; Strategic Planning; Strategic Communications; Acquisition Planning; Program Management and Integration; Engineering Management; and Acquisition Milestone Decision Preparation.

The ceiling increase will be executed via modification 17. As a result of the modification, the task order ceiling is anticipated to increase in the estimated amount of for Option Year 1.

(c)(2)(iv) The authority and supporting rationale (see 8.405(a)(1)(i) and (b)(1)) and, if applicable, a demonstration of the proposed contractor’s unique qualifications to provide the required supply or service.

This acquisition was originally conducted under the authority of the Multiple Award Schedule program. The statutory authority permitting other than full and open competition is Section 201 of the Federal Property and Administrative Services Act of 1949 (40 U.S.C. 501), as implemented by FAR 8.405-6.

In accordance with FAR 8.405-6 (a)(1)(i)(A) - An urgent and compelling need exists, and following the procedures would result in unacceptable delays.

ANSER is the only capable source that can provide the current critical services required for U.S.

Vaccination support, at the level of quality and in the timeframe required. It would be impossible for another contractor to perform this requirement at such a short notice. This is especially true since the personnel required to perform the required tasks must possess executive level experience within the CBRN community. ANSER has acquired the personnel who possess both the CBRN expertise and experience and are currently performing the requirement.

(c)(2)(v) A determination by the ordering activity Contracting Officer that the order represents the best value consistent with 8.404(d).

The assigned GSA Program Manager and the Client Representative completed a technical evaluation on the contractor’s quote submission to ensure the labor mix and hours are appropriate for the work to be performed under Modification 17. A price analysis verified the quoted rates against the FSS Schedule rates and a fair and reasonable price determination was made.

(c)(2)(vi) A description of the market research conducted among schedule holders and the results or a statement of the reason market research was not conducted.

Market Research was conducted in accordance with FAR Part 10, prior to award of this modification for vaccination support. The client representative (JPEO CBRND) conducted their own independent research, which included coordination with six (6) other Government agencies to determine if there were contracts already in place that had the capacity to accommodate this requirement. In addition, GSA conducted a separate review of GSA Advantage and other sources of information for the subject services. The results showed that a limited number of other firms could possibly provide similar type of service; however, as stated above, the expertise of this contractor will ensure that this critical work is addressed without delay. The section directly below provides further detail supporting market research and the decision to incorporate vaccination work under this task order.

(c)(2)(vii) Any other facts supporting the justification.

ANSER has successfully fulfilled the Specialized Support Service requirement since 30 December 2015 via task order HHSP23337001T against HHS’s Indefinite Delivery/Indefinite Quantity (IDIQ) contract HHSP233201500154I. The original task order was competed amongst more than 100 IDIQ awardees. However, through several competitive acquisitions, Anser has been the only contractor to respond to the Specialized Support Services (S3) solicitation.

(c)(2)(viii) A statement of the actions, if any, the agency may take to remove or overcome any barrier that led to the restricted consideration before any subsequent acquisition for the supplies or services is made.

If future expenditures and allowances are granted for continued support during the period of performance of this task order, all efforts will be made by the Government to seek alternate sources of service for the support.

However, it is important to note that many variables will play into this alternative source potential, such as changes in Government priorities within the current operations, and shifting needs.

Written determination by the Approving Official identifying the Circumstances that Apply:

The Contracting Officer hereby determines that only one awardee is capable of providing the services required due to an urgent and compelling need that would result in unacceptable delays.

CERTIFICATIONS AND APPROVALS

Requirements Personnel Certification:

I certify that the supporting data under my cognizance, which are included in the Exception to Fair Opportunity, are accurate and complete to the best of my knowledge and belief.

Roger Willis GSA, Information Technology Manager

Contracting Personnel Certification:

I certify that this Exception to Fair Opportunity is accurate and complete to the best of my knowledge and belief.

William Houseman Contract Specialist

Contracting Officer Certification:

Michael Levy Contracting Officer

Branch Chief Federal Acquisition Service Mid-Atlantic Region

Director, Acquisition Operations Division Federal Acquisition Service Mid-Atlantic Region

Legal Counsel Certification:

Assistant Regional Counsel GSA FAS, Mid-Atlantic Region

Special Advocate for Competition Certification:

Deputy Regional Commissioner / Competition Advocate GSA FAS, Mid-Atlantic Region