A02 JA FAR PART 6 ICON Extension 18-C-0178 for REDACTiON_Redacted.pdf

Control Number: JA-21-04-00284 CUI

CUI

(Source Selection information - See FAR 2.101 and 3.104-4)

Mar 2021

Justification Review Document for Other than Full and Open Competition - FAR Part 6

Program/Equipment: United States Army Medical Research and Development Command (USAMRDC) Office of Regulated Activities (ORA) Regulatory, Clinical, and Technical Support

Authority: 10 U.S.C. 2304(c)(1) as implemented by FAR Part 6.302-1(a)(2)(iii)(B) -- Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements

Amount: $3,841,029.00 (with all options)

Prepared by:

Typed Name: Herbert Caj Keen

Title: Contract Specialist Date: 20 April 2021

Contracting Officer:

Typed Name: Samantha L. Connors

Date Reviewed: 20 April 2021

Technical Representative:

Typed Name: Jami M. Clevenger

Title: Acquisition Management Liaison Officer Date Reviewed: 20 April 2021

Requirements Representative:

Typed Name: MAJ Victor Zottig

Title: Branch Chief Date Reviewed: 20 April 2021

ORA Regulatory Clinical and Technical Support, Fort Detrick, MD

CUI

(Source Selection Information - See FAR 2.101 and 3.104-4)

APR 2021

Reviews

I have reviewed this justification and find it adequate to support other than full and open competition.

Legal Counsel

Typed Name: R. Seth Higgs DSN:

Signature: _______________ __ _ Date:______________________

(Source Selection Information - See FAR 2.101 and 3.104-4)

APR 2021

Justification and Approval for Other than Full and Open Competition – FAR Part 6

1. Contracting Activity: United States Army Medical Research Acquisition Activity (USAMRAA) 820 Chandler Street, Fort Detrick, MD 21702-5014

2. Description of Action: The United States Army Medical Research and Development Command (USAMRDC) Office of Regulated Activities (ORA) requests a Cost Plus Fixed Fee (CPFF) contract modification to extend W81XWH18C0178 with ICON Government and Public Health Solutions (ICON) located at 1265 Ridge Road Suite A, Hinckley, OH 44233. FY21/22 Army Research, Development, Test and Evaluation funds will be used. This extension will allow the mission critical services procured under W81XWH-18-C-0178 for regulatory, clinical, and technical support services to continue.

3. Description of Supplies/Services: The Government requires continued performance of services under W81XWH18C0178 with ICON to provide regulatory, clinical, and technical services necessary to facilitate full program coordination, management, policy development, execution, and oversight across all ORA clinical, technical, and regulatory areas.

Period of Performance (PoP):

Base Period: 1 May 2021 to 31 Aug 2021 Option Period 1: 1 Sep 2021 to 30 Sep 2021 Option Period 2: 1 Oct 2021 to 31 Oct 2021 Option Period 3: 1 Nov 2021 to 30 Nov 2021

Estimated total value, including options: $3,841,029.00

4. Authority Cited: 10 United States Code 2304(c)(1) as implemented by Federal Acquisition Regulation 6.302-1(a)(2)(iii)(B), Only one responsible source and no other supplies or services will satisfy agency requirements. Services may be deemed to be available only from the original source in the case of follow-on contracts for the continued provision of services when it is likely that award to any other source would result in unacceptable delays in fulfilling the agency's requirements.

5. Reason for Authority Cited:

(a) As described at FAR 6.302-1(a)(2)(iii)(B), services may be deemed to be available only from the original source in the case of follow-on contracts for the continued provision of services when it is likely that award to any other source would result in unacceptable delays in fulfilling the agency's requirements.

USAMRAA initially awarded W81XWH18C0178 to ICON with a Period of Performance of 1 October 2018 to 30 April 2020.

USAMRAA awarded a competitive follow-on contract (W81XWH21D0003) and an initial task order (W81XWH21F0158) on 31 March 2021 and 1 April 2021, respectively.

A post-award protest was filed and, as a result, stop work orders were issued for

W81XWH21D0003 and W81XWH21F0158 on 14 April 2021.

USAMRAA intends to extend W81XWH18C0178 to ensure continuity of mission.

Any break in these critical services would lead to unacceptable degradation or failure of USAMRDC’s mission. If a bridge action is not approved, support for DoD drug, biologic, device, and combination products from product concept to products in the advanced development pipeline (Phase 1-3) will essentially stop. The ORA support services, which include regulatory strategy and advice, data management, pharmacovigilance, biostatistics, product technical services and support, clinical monitoring, regulatory, publishing, and submissions to the Food and Drug Administration (FDA) would be halted as well. Without the extension ORA will be without contractor support for 115 projects within USAMRDC and to outside customers such as the Joint Program Executive Office for Chemical and Biological Defense. ORA will no longer be able to support submissions to the FDA to include top priority submissions as outlined by Department of Health Affairs and Office of the Secretary of Defense.

The extension will allow for continuation of these mission critical services while the protest is resolved. Award to any other source would result in unacceptable delays in fulfilling the agency's requirements, as the contract under which these mission critical services are currently provided will expire on 30 April 2021. The four-month extension period and three one-month option periods are expected to allow sufficient time for protest resolution, and any necessary corrective action or potential supplemental protest(s). The option periods will be exercised if, and only if, the protest is not yet resolved.

6. Efforts to Obtain Competition: No effort will be made to solicit offers from other sources. To do so is not practicable as this is a short-term interim requirement to provide adequate time for protest resolution. Competitive efforts would not be effective for the required performance period and would result in unacceptable delays.

In accordance with FAR 5.201, a notice of intent to sole source was posted on beta.sam.gov on 19 April 2021. Any responses received will be taken into consideration before proceeding with the proposed extension.

a. Effective competition. Because this is a sole source action, effective competition is not applicable.

b. Subcontracting competition. There are no new subcontracting opportunities under this action. ICON will continue subcontracting to the same small business concerns.

7. Actions to Increase Competition: Follow-on contract W81XWH21D0003 was awarded using full and open competition and is currently pending protest resolution.

8. Market Research: Sufficient market research was conducted and addressed under W81XWH21D0003. For the proposed extension, a request for information / sources sought notice was posted as described in Paragraph 9.

9. Interested Sources: In accordance with DFARS 206.302-1(d), and DFARS PGI 206.302-1(d), a request for information / sources sought notice was posted to beta.sam.gov on 15 April 2021 with responses due on 19 April 2021. The only response received was from ICON. To date, no other sources have written to express an interest.

10. Other Facts:

a. Procurement history

(1) Contract numbers and dates of all awarded contracts for these same requirements.

W81XWH-18-C-0178 PoP 1 Oct 2018 - 30 Apr 2020 Awarded 24 Sept 2018 W81XWH-13-C-0003 PoP 1 Nov 2012 - 31 Oct 2018 Awarded 31 Oct 2012

(2) The competitive status of these actions.

W81XWH-18-C-0178 Solicited Full and Open competition W81XWH-13-C-0003 Solicited Full and Open competition

(3) Authority previously cited if less than full and open competition was used. Not Applicable.

(4) If a justification was prepared to support the procurement made before this one, a summary of the contents of paragraph 7 of the justification for that procurement and an explanation of the results. Not Applicable.

(5) If any prior contract for this requirement was accomplished using full and open competition, include a detailed explanation of the changed circumstances causing this action to now limit the sources. See Paragraph 5. This J&A is to execute a sole source contract modification for continued services as a result of a protest.

(6) An explanation of any unusual patterns that may be revealed by the history, e.g., several consecutive, urgent buys. Not Applicable.

(7) If a justification was prepared to support the procurement made before this one, briefly describe the circumstances justifying the procurement and whether there have been any significant changes. Not Applicable.

b. Other facts. Not Applicable.

11. Technical Certification:

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

Signature: _ _ Date: 20 April 2021

Typed Name: Jami M. Clevenger Title: Acquisition Management Liaison Officer

12. Requirements Certification:

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

Signature: ___ Date: 20 April 2021

Typed Name: MAJ Victor Zottig Title: Branch Chief

13. Fair and Reasonable Cost Determination:

I hereby determine that the anticipated cost to the Government for this contract action will be fair and reasonable.

Basis for determination: Contract costs will be determined fair and reasonable based upon cost analysis techniques described at FAR 15.404-1(c), including verification of cost data and evaluation of cost elements; comparison of costs proposed by the offeror for individual cost elements with actual costs previously incurred by the same offeror;

previous cost estimates from the offeror for the same services; and independent government cost estimates by technical personnel. Certified cost or pricing data will be required in accordance with FAR 15.403-4.

Signature:

Typed Name: Samantha L. Connors Title: Contracting Officer

14. Contracting Officer Certification

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

Signature:

Typed Name: Samantha L. Connors Title: Contracting Officer

Approval

Based on the foregoing justification, I hereby approve the procurement of continued performance of the services to provide regulatory, clinical, and technical services necessary to facilitate full program coordination, management, policy development, execution, and oversight across all of ORA clinical, technical and regulatory areas for the estimated total amount of $3,841,029.00 on an other than full and open competition basis pursuant to the authority of 10 United States Code 2304(c)(1) as implemented by Federal Acquisition Regulation 6.302-1(a)(2)(iii)(B), subject to availability of funds, and provided that the services or property herein described have otherwise been authorized for acquisition.

Signature: Date: ____________________________

Typed Name: Christopher E. Sherman Title: Command Advocate for Competition