Regulated_Activities_Support_Services_Exception_to_Fair_Opportunity_(JEFO)_final.pdf

Justification for an Exception to Fair Opportunity

1. Contracting Activity/Customer: The Contracting Activity responsible for this Justification for an Exception to Fair Opportunity (JEFO) is the U.S. Medical Research Acquisition Activity (USAMRAA), Fort Detrick, MD on behalf of the U.S Army Medical Research Institute of Infectious Diseases (USAMRIID), Fort Detrick, MD. The USAMRAA Contracting Officer is and the USAMRAA Contract Specialist is

2. Description of the Action: This JEFO is being requested to initiate a modification to the firm-fixed priced task order contract no. with under the U.S. Small Business Administration’s Competitive 8(a) Program. Approval is requested to award a bridge contract that will allow the Regulated Activities contract continuing the existing support provided under

Task Order on a sole source basis for eight (8) months (6-month base period, with two (2) 1-month option periods). This Bridge contract is necessary in order to allow proper time for the issuances of the competitive follow-on contract/task order. The follow-on contract/task order is being competitively issued among the six Multiple Award- Indefinite Delivery Contract (MA-IDC) 8(a) awardees, with said base contracts awarded however, the contractor support must continue while the follow-on competitive task order action is ongoing. In order to allow work to continue and to avoid a break in service, approval is requested for this Bridge contract, which has an estimated value of This contract type will be Firm-Fixed-Price and the resultant modification will obligate R&D funds.

3. Description of Supplies/Services: Regulated Activities Support Services extension will allow USAMRIID’s Office of Human Use and Ethics (OHU&E), Quality Assurance and Regulatory Compliance Office (QARCO), Non-Clinical Development (NCD) Division, Institutional Animal Care and Use Committee (IACUC) Office, Safety, Radiation, and Environmental Division, Regulatory Validation, Biosecurity, and Biostatistical Section support to meet the needs of the Institute.

The extension will also allow the Regulated Activities Support Services to accomplish the following critical objectives:

i. Provide professional level administrative support to the OHU&E associated with developing and administering the USAMRIID Human Research Protection Program [HRPP] (DOD and DHHS Assurances respectively) assuring that all studies aimed at development and testing medical countermeasures and diagnostics associated with biological warfare defense in order to accomplish the mission of the Institute in compliance with DOD, Federal and State regulations.

ii. Provide technical support to the QARCO in the areas of FDA and ISO-Regulated quality assurance and document control to support the USAMRIID.

iii. Provide management, scientific and technical support to the NCD Division for the conduct of non-clinical studies in accordance with the Food and Drug Administration (FDA) Good Laboratory Practices (GLP) Regulation 21 CFR Part 58 and other applicable FDA guidance documents.

iv. Provide support for the USAMRIID animal care and use program, the IACUC, and the scientific research staff.

v. Provide technical support in the areas of Biological and Occupational Safety to the Safety, Radiation, and Environmental Division.

vi. Provide research technical support to the Biostatistical Section in the areas of clinical and non-clinical development including but not limited to disease models, countermeasure efficiency, GCP studies, GLP studies, and technology development and integration.

vii. Provide equipment qualification and software validation in support of USAMRIID FDA GLP (FDA GLP Regulation 21 CFR Part 58 and other relevant DoD Regulations) and non- GLP research studies.

viii. Provide research support to biological safety, physical security, personnel security, personnel reliability, and biological select agent and toxin (BSAT) management to ensure the USAMRIID is compliant with all governing regulations.

The services provided by under the current Multi-Award Indefinite Delivery Contract augment the USAMRIID’s mission, and were issued via task orders on a requirement basis. The current task orders are issued on a Firm-Fixed-Price and/or Cost- Plus-Fixed-Fee basis; however, the Bridge Contract CLINs will allow for Firm-Fixed-Price support.

The discussed earlier contains a hybrid contract type, allowing for the resultant task orders to be issued either on a Firm-Fixed-Price or Cost-Plus-Fixed-Fee basis, based on the whether the services to be provided are deemed commercial or non-commercial. Strategic sourcing techniques will be employed on the re-compete action to improve the ordering efficiency for the Government. The estimated price to execute the extension of contract is The current contract’s period of performance ends as of with no further options available. A Bridge contract is required to allow for continued, uninterrupted services while the competitively-issued follow-on task order is being processed.

4. Authority Cited: Pursuant to 10 U.S.C. 2304(c) as implemented by FAR 16.505(b) (2) and substantiated by the following:

10 U.S.C. 2304c (b) (1) as implemented by FAR Part 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.

10 U.S.C. 2304c(b)(2) as implemented by FAR Part 16.505(b)(2)(i)(B) – Only one awardee is capable of providing the supplies or services required at the level of quality required because the supplies or services ordered are unique or highly specialized.

10 U.S.C. 2304c (b) (3) as implemented by FAR Part 16.505(b) (2) (i) (C) – The order must be issued on a sole-source basis in the interest of economy and efficiency because it is a logical follow-on to an order already issued under the contract, provided that all awardees were given a fair opportunity to be considered for the original order.

10 U.S.C. 2304c (b) (4) as implemented by FAR Part 16.505(b) (2) (i) (D) – It is necessary to place an order to satisfy a minimum guarantee.

10 U.S.C. 2304c(b)(5) as implemented by FAR 16.505(b) (2) (i) (E) – For orders exceeding the simplified acquisition threshold, a statute expressly authorizes or requires that the purchase be made from a specified source.

10 U.S.C. 2304c(b)(5) as implemented by FAR 16.505(a) (4) – Restricting consideration to an item peculiar to one manufacturer (e.g., a particular brand-name, product, or a feature of a product that is peculiar to one manufacturer).

5. Reason for Authority Cited: All awardees were given a fair opportunity to be considered under the original order. The original Task Order was award on This is the first time an exception to the fair opportunity process is being used.

The current contract is and the performance period end date is

A Bridge contract is required to allow the necessary time to issue and award a competitively issued follow-on task order under the competitive 8(a) MA-IDC contracts. In order to promote competition and to provide the offerors with ample time to prepare and submit quality proposals, and to allow the Government time to conduct its necessary package reviews and the critical SSEB evaluations, a Bridge Contract is necessary.

What follows is the estimated milestone schedule for the competitively-issued follow-on task order:

In order to avoid a break in service due to the length of time it will take to process a competitively-issued follow-on task order, a Bridge contract must be issued. In accordance with AFARS 5106.303-1, JA-18-30 is hereby issued citing FAR 16.505(b) (2) (i) (C) – The order must be issued on a sole-source basis in the interest of economy and efficiency because it is a logical follow-on to an order already issued under the contract. All awardees were given a fair opportunity to be considered for the original order. Failure to approve the Regulated Activities Bridge Contract would jeopardize the USAMRIID mission and result in a breach of contract by USAMRIID with several industry, academic, and Federal Government partnerships. Contractors aligned with the Task Order support laboratory studies for the Institute performed under defined laboratory quality management systems requiring good documentation practices, to include the FDA Good Laboratory Practices (GLP) regulation (21 CFR Part 58). Contractors provide an expertise within the Institute for overall regulatory compliance and are responsible for maintaining coordination with Sponsors of candidate medical products. The medical products include medical countermeasures for several biodefense agents to protect the warfighter and the nation. As such the Task Order is a key component of the Institute’s objective to become the

The , a component of the President's Medical Countermeasures Initiative and a strategic national investment in the Department of Defense's MCM development for biological defense, is highly dependent upon the regulatory support services provided by the contractors. The economic impact is which is based upon all studies conduct at the Institute. In addition, the break in service will cause the Government to lose the research performed under this contract. The break in service will also create delay in research. The possibility of recreating the research and the delay in all FY18 research scheduled will have an economic impact on the Government.

A break in services would also lead to catastrophic mission failure for the of the existing , the mission of would experience significant degradation if the current contract did not continue. This JEFO is required so that mission degradation is avoided and there is no break or disruption in service.

6. Actions to Increase Competition: Not applicable for this action. No competition is sought for this Bridge award as any break in service would be unacceptable. As part of the follow-on procurement replacing the requirement was competitively awarded among six MA-IDC 8(a) awardees, with said base contracts awarded via Contract Numbers . Competition among these six awardees is now in progress for the final Regulated Activities Support Services task and a definitive task order will be the result of the competition. However, in order to process this competitive follow-on task order in the appropriate manner, there is insufficient time;

therefore, the existing contractor support must continue while the follow-on competitive action is being processed. While there is no effective competition for this Bridge Contract; the follow-on replacement contract will be awarded in a competitive nature maximizing competition among the MA-IDC holders. USAMRAA is requesting approval to issue a Bridge contract extension to allow time to process the follow-on competitively-issued task order.

7. Market Research: Based on the available market research in , the present contract was synopsized and competed via the SBA’s Competitive 8(a) Program. There were a sufficient number of qualified 8(a) vendors under the NAICS code available to submit competitive proposals. The proposals were reviewed, discussions conducted, and a best value award determination was made with an award to

No further market research is necessary at this time for the Indefinite Delivery Contract (IDC) award for an additional eight (8) months bridge contract. With the follow-on procurement, the same acquisition strategy of a Competitive 8(a) set-aside was utilized, as there were two or more eligible, qualified 8(a) concerns in the current marketplace that were capable of submitting competitive proposals under the code. In order to process competitively-issued follow-on task orders and with the potential for protest(s) while competing task order(s) among the , the Government requires continued, uninterrupted performance under this Bridge award. A Bridge is required because the existing contract . The Government will ensure the follow-on contract/task order to the Bridge award will be successfully competed and awarded among the six MA-IDC contract holders while this Bridge Contract is ongoing.

8. Other Facts:

a. Procurement History:

The FAR clause 52.217-8 “Option to Extend Services,” as contained in the task order’s ADM [award determination memorandum] document, was cited as the authority for extending the existing task order to allow continued support while the competitive follow-on task order could be processed.

(1) Contract numbers and dates of last several awards.

(2) Competitive status of these actions.

(3) Authority previously used for less than full and open competition.

The existing task order was competitively issued and cited a base period of

), with an option to extend services (FAR 52.217-8) period of . However, the revisions by the Requiring Activity to the Performance

Work Statement (PWS) resulted in additional delay and an incomplete package.

The base contract was competitively awarded; however, there was a J&A issued citing 10 U.S.C. 2304(c) (1) and FAR 6.302-1 to extend the base IDC contract for a one year period.

9. Technical Certification:

As the Technical Representative, I hereby certify the basis for the Justification for an Exception to Fair Opportunity and the supporting data under my cognizance which are included in the justification are complete and accurate to the best of my knowledge and belief.

Typed Name:

Requirements Certification:

As the Requirements Representative, I hereby certify the basis for the Justification for an Exception to Fair Opportunity and the supporting data under my cognizance which are included in the justification are complete and accurate to the best of my knowledge and belief.

Date: 2017.12.11 12:33:48 -05'00'

11. Fair and Reasonable Cost/Price Determination:

As the Contracting Officer, I hereby determine that the anticipated cost/price to the Government for this order will be fair and reasonable. The price established for the required services will be determined to be fair and reasonable based upon the price analysis techniques of comparison of the proposed price with prices found reasonable on previous purchases and current price lists. Certified cost or pricing data will not be required in accordance with the exception at FAR 15.403-1(b)(3).

12. Contracting Officer Certification:

As the Contracting Officer, I certify the basis for the Justification for an Exception to Fair Opportunity is accurate and complete to the best of my knowledge and belief.

13. Legal Sufficiency Review:

Based on the foregoing, I hereby find this Justification for an Exception to Fair Opportunity to be legally sufficient.

14. Special Advocate for Competition:

Based on the foregoing justification, I hereby find this Justification for an Exception to Fair Opportunity to be compliant with statute and regulation and approve the procurement of Regulated Activities Support Services on pursuant to the authority of 10 U.S.C. 2304C as implemented by FAR 16.505(b)(2)(i)(C), subject to availability of funds, and provided that the services and property herein described have otherwise been authorized for acquisition.