J-and-A-Exception to Fair Opportunity_ACTIV 2.pdf

JUSTIFICATION FOR AN EXCEPTION TO FAIR

OPPORTUNITY

Completion Instructions: HHS has established a standard template for the preparation of a Justification for an Exception to Fair Opportunity pursuant to FAR Subpart 16.5 for orders valued at greater than the simplified acquisition threshold, including all options. This template is only applicable when requesting an acquisition as an exception to the fair opportunity process for task and delivery-order contracts awarded against multiple-award contracts, such as indefinite delivery, indefinite quantity contracts.

This template is not for use (i) with small business set asides in accordance with FAR 16.505(b)(2)(i)(F), nor (ii) for Federal Supply Schedule contracts awarded pursuant to FAR 8.4. See FAR Subpart 16.5 for additional guidance.

Tailor all aspects of this template to the individual acquisition. Consult FAR 16.505 for guidance. An addendum may be added in case additional space is needed.

When this document is printed, the blue italic instructions are automatically deleted on the printed version.

Acquisition Title:

Agency:

Acquisition Year (FY): 2022

Author and Title:

2. Description of Action:

Nature: New Requirement ✔ Follow-on Order This proposed action is a follow-on to Task Order No.

75N93022F00001, which expires on 11/05/2022.

Modification to Existing Delivery/Task Order/Contract Number:

Order Against: Multiple Award ID/IQ Contract Number: 75N93021D00035

Pricing: Firm-Fixed Price Time & Materials ✔ Cost Type

Funds: OMA ✔ Other Funds: This proposed action will be funded with COVID supplemental appropriation funds provided by the

Name of Proposed Contractor(s): PPD Development, LP CARES Act (PL 116-136) and the Coronavirus Preparedness and Response Supplemental Appropriations Act (PL 116-123), which expire on

Street Address:

City, State, Zip:

929 North Front Street

Wilmington, NC 28401-3331

September 30, 2024. Since this proposed action will result in a non-severable, completion type Task Order award, we will fully fund the Task Order at the time of award.

Rosemary Gomes, Contracting Officer, NIAID, OA, AIDS RCB

NIH

Completion of ACTIV 2 Study https://www.acquisition.gov/far/part-16#FAR_Subpart_16_5 https://www.acquisition.gov/far/part-16#FAR_16_505 https://www.acquisition.gov/far/part-8#FAR_Subpart_8_4 https://www.acquisition.gov/far/part-16#FAR_Subpart_16_5 https://www.acquisition.gov/far/part-16#FAR_16_505

3. Description of Applicable Contract Provisions:

Summarize all contract provisions relevant to this determination.

This justification for an exception to fair opportunity is being conducted under the authority of FAR Subpart 16.505(b)(2)(i)(C), which states that 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.

This action is a follow-on to Task Order No. 75N93022F00001, which was previously issued under Contract No. 75N93021D00035. All awardees under Task Area A of the Comprehensive and Rapid Response for NIAID Research Programs (CARRRP) IDIQ contracts were given a fair opportunity to be considered for the original order, and the Contractor, PPD Development LP, was the only offeror to submit a proposal in response to the original order. Since the proposed action exceeds the simplified acquisition threshold, the justification will be prepared in accordance with FAR Subpart 16.505(b)(2)(ii)(B) and submitted to the HCA for approval, in accordance with FAR Subpart 16.505(b)(2)(ii)(C)(3). Finally, the Contracting Officer will adhere to the posting requirements under FAR Subpart 16.505(b)(2)(ii)(D).

4. Description of Supplies and Services: I

The estimated value of the proposed action, including all options is $ 74,927,653.

Briefly describe the supplies or services to be provided, including make & model number where appropriate.

• Indicate whether the item to be procured is peculiar to one manufacturer (e.g., a particular brand name, product, or a feature of a product, peculiar to one manufacturer).

• If applicable, include quantities of supplies or period of performance for services. Provide information for any options included in the order.

• If the action is a modification to an existing order, distinguish clearly between the work covered by the basic order and the work to be obtained by the proposed modification; provided that if the action is to extend an existing order utilizing the FAR 52.217-8 extension of services clause, this must be discussed.

This proposed action is a logical follow-on to Task Order No. 75N93022F00001, which was previously issued under Task Area A of Contract No. 75N93021D00035 with PPD Development, and will result in a non-severable, cost-reimbursement, completion type task order. The purpose of this proposed action is to provide a full suite of clinical trial management services for the follow-on and completion of the DAIDS-sponsored ACTIV-2 study, and will culminate in the completion and submission of the final clinical study report for each agent used during the course of the trial. The previous order that this action is a logical follow-on to (Task Order No. 75N93022F00001) will expire on November 5, 2022, and this proposed action will be effective on November 6, 2022 (there will be no overlap of services between the two task orders).

Specifically, the Contractor will be responsible for providing the following services, for the completion of ACTIV-2:

• Project Management

• Platform Design and Study Document Development

• Regulatory Affairs

• Medical Writing and Publishing

• Protocol Registration

• Clinical Site Contracting

• Clinical Site Training

• Clinical Site Management

• Clinical Site Monitoring

• Call Center

• Data Management

• Medical Monitoring and Safety Oversight

• Statistical Design and Analysis

• Interactive Response Technology

• Electronic Trial Master File

• Quality Assurance and Quality Control

• Central Laboratory Services

• Investigational Product (IP), Pharmacy, and Ancillary Supplies Coordination

• Subcontracting with vendors

• Coordinating/collaborating with a variety of grantees/contractors and stakeholders https://www.acquisition.gov/far/part-52#FAR_52_217_8

The Statement of Work for the Task Order is attached to this document as a reference (see Attachment A).

5. Authority and Rationale:

The Contracting Officer shall give every awardee a fair opportunity to be considered for a delivery/task order exceeding the micro purchase threshold unless one of the following statutory exceptions applies. FAR 16.505(b)(2). Mark the applicable exception:

The agency need for the supplies or services is so urgent that providing a fair opportunity would result in unacceptable delays [FAR 16.505(b)(2)(i)(A)];

Factually establish the urgent need, provide the required performance/delivery schedule, address the lead-time involved, address why other contractors cannot fulfill the government’s needs, and explain the harm/serious injury that will come to the government if the justification is not approved.

Only one awardee is capable of providing the supplies or services required at the level or quality required because the supplies or services are unique or highly specialized (FAR 16.505(b)(2)(i)(B));

Explain what is unique or highly specialized about the supply or service, what level of quality is required and why only the specified contractor can meet the requirement. If the requirement is an item peculiar to one manufacturer, justify the restriction to the item peculiar to one manufacturer.

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 [FAR 16.505(b)(2)(i)(C)];

Provide the original order number and explain why it is a logical follow-on to an order already issued under the contract, for example, in terms of scope, period of performance or value. Describe the process by which all awardees were given a fair opportunity to be considered for the original order. Specify how recent the previous competitive order was and the number of times this exception has been used; discuss why the specific requirement continues and why it is to the benefit of the Government for the particular contractor to continue this work.

This is a logical follow-on to PPD Development, LP (PPD), Contract No. 75N93021D00035, Task Order No. 75N93022F00001, and the authority provided by Subpart 16.505(b)(2)(i)(C) has not been used previously under this contract.

Regarding the aforementioned original order, a full and open competition was conducted among all four of the awardees under Task Area A of the Comprehensive and Rapid Response for NIAID Research Programs (CARRRP) IDIQ contract, in order to continue the activities of ACTIV 2 support services, which could no longer be supported under the Clinical Research Support Services (CRSS) contract with PPD (Contract No. HHSN272201700078C). Only PPD submitted a proposal in response to the solicitation under Task Area A of the CARRRP IDIQ contract (i.e., NIAID did not receive proposals from the other three awardees under Task Area A of the CARRRP IDIQ contract). As a result of negotiations, PPD, Contract No. 75N93021D00035, Task Order No. 75N93022F00001 was awarded as a severable Task Order for support services of the ACTIV 2 clinical trial, with a period of performance of May 6, 2022 through November 5, 2022 [all prior ACTIV 2 work was transferred from the CRSS contract (PPD, Contract No.

HHSN272201700078C) to the CARRRP IDIQ contract (PPD, Contract No. 75N93021D0003, Task Order No. 75N93022F00001)].

The ACTIV-2 study is in the active follow up phase with 1,085 Phase II follow-up enrollees, and over 600 Phase III follow-up enrollees, for a total of over 1,700 total enrollees and over 250 sites worldwide. The last visit for the last patient (LPLV) is scheduled for June 2023. The NIAID Division of AIDS (DAIDS), being the Investigational New Drug (IND) Application Sponsor, is required to ensure compliance with applicable regulations, including Title 21 Code of Federal Regulations (CFR) Part 312, Human Subjects Protection Title 45 CFR Part 46, and ICH E6(R2) International Conference on Harmonisation-Good Clinical Practices (ICH-GCP), for the duration of the ACTIV-2 study.

NIAID is seeking to issue a logical follow-on to the CARRRP Task order with PPD (Contract No. 75N93021D00035, Task Order No.

75N93022F00001). The Government has determined that a completion type Task Order is needed at this time, in order to receive the full benefit of the ACTIV 2 trial. The purpose of this proposed action is to provide a full suite of clinical trial management services for the follow-on and completion of the DAIDS-sponsored ACTIV-2 study, and will culminate in the completion and submission of the final clinical study report for each agent used during the course of the trial. The previous order that this action is a logical follow-on to (Task Order No. 75N93022F00001) will expire on November 5, 2022, and this proposed action will be effective on November 6, 2022 (there will be no overlap of services between the two task orders).

Under Contract No. 75N93021D00035, Task Order No. 75N93022F00001, PPD is currently providing clinical trial management support services to the ACTIV-2 study; most of these services have been formally transferred to PPD via a transfer of regulatory https://www.acquisition.gov/far/part-16#FAR_16_505 https://www.acquisition.gov/far/part-16#FAR_16_505 obligations (TORO) document. To date, for ACTIV-2, PPD has tailored, implemented and integrated its full clinical trial suite of services under DAIDS’s authority as the funder and sponsor of this trial, in order to ensure that DAIDS meets all regulatory requirements, while also ensuring the safe monitoring and follow-up of the enrolled patients. Specifically, PPD has customized/integrated over 20 critical clinical trial support systems to meet the specialized requirements, highly unique complexities, and operational challenges of an adaptive platform trial such as ACTIV-2. PPD has fully implemented safety and database systems, which include PPD’s Interactive Response Technology (IRT), Electronic Data Capture (EDC), as well the PPD ACTIV-2 Safety Databases. These systems are unique to PPD, and meet the distinct platform design of the ACTIV-2 clinical trial. Further, of the 20 clinical trial systems utilized/integrated, 8 of these are proprietary systems developed by PPD and further customized for ACTIV-2.

Specific milestones/achievements by the PPD ACTIV-2 team, to date, have included the following:

• Evaluated over 400,000 sites for ACTIV-2B. Additionally, for ACTIV-2, PPD has provided 247 activated sites in 22 countries, 1,130 Investigational Product-specific re-activations (product arm additions and protocol schedule of events updates).

• Executed >1,950 clinical trial agreements with ACTIV-2 sites.

• Enrolled 4,044 participants across all ACTIV-2 product arms, phase II and phase III.

• Enrolled 10 phase II arms within 1 year for ACTIV-2.

• ACTIV-2 Lilly arm, phase III enrolled >1,000 participants in 8 weeks.

• Supported a successful Aug 2021 DSMB for the ACTIV-2 Brii arm (under ongoing US FDA EUA review).

• Completed more than 450 country level regulatory authority and ethics committee submissions and more than 1,100 site level submissions for ACTIV-2, in 2021.

• Implemented 8 protocol versions, 9 letters of amendments, and 8 clarification memos for ACTIV-2.

• Conducted over 3,000 ACTIV-2 site monitoring visits (on-site and remote).

• Conducted 13 routine ACTIV-2 site audits, 18 pre-inspection visits, and hosted DAIDS Quality Management Services for 5

ACTIV-2 process audits and 4 site audits.

• Uploaded over 180,000+ documents into the ACTIV-2 electronic trial master file (ETMF) with another 57,000+ documents expected to be uploaded by PPD. Additionally, PPD has filed 10,000–15,000 documents on average per month.

• Collected >275,000 laboratory samples received, >483,000 tests run, >330,000 lab kits shipped, and 44 lab database updates.

• Implemented 20 ACTIV-2 clinical database modifications to date, and NIAID/DAIDS and ACTG approved prioritized data delivery queue.

• Delivered >160 biostatistics and programming ACTIV-2 deliveries to date (typical trial has 1-3 per quarter).

• Performed 20 database modifications; delivered 9 data pulls and 2 database locks; and completed 1 final data upload.

• Entered 484,273+ Case Report Forms (CRFs)

The ACTIV-2 study is in the active study follow-on phase with uniquely tailored and specialized PPD ACTIV-2 clinical trial management systems supporting the execution of the study (i.e., data management system, site monitoring, site oversight, trial master file, trial safety database, etc.). The ongoing and active support of the ACTIV-2 study by PPD has resulted in a dynamic, highly unique/integrated, specialized suite of clinical trial services, fully implemented within the DAIDS clinical trial environment. Any operational interruption or change to the ACTIV-2 environment or delay to trial completion would have catastrophic implications, including significant regulatory violations (e.g., ICH-GCP and ethical standards of clinical research), thereby making it imperative that PPD complete the services required for the ACTIV-2 trial. Introducing a different contractor could violate the rights and safety of participants’ rights, compromise data integrity (rendering most of the trial data as unusable), waste significant government resources, and ultimately delay the availability of therapeutic modalities for COVID-19. This in turn could result in further loss of life by depriving the nation of a therapeutic during this unprecedented pandemic and public health emergency.

Transitioning this ongoing clinical trial effort to another vendor would result in at least 6 months to a year’s delay to bring another vendor up to speed. During this delay, the new contractor would be required to develop, design and implement multiple data, safety and related regulatory systems, resulting in a major duplication of already existing clinical trial management support systems, along with their attendant costs. It has been estimated that the cost burden of these transition activities to the government would be approximately 30 percent of the total task order amount to complete the ACTIV-2 study.

In summary, transferring to a different vendor (rather than continuing with the current vendor) would be catastrophic to the ACTIV-2 study and its thousand plus enrolled participants, for the myriad reasons described above. In addition, such a disruption would be economically inefficient, resulting in significant waste and unnecessary duplication of government resources. Whereas, by continuing with the same contractor, PPD, it would promote the standard of “economy and efficiency” and mitigate the risks described above.

Therefore, NIAID has determined that PPD, as the current vendor, should receive the follow-on Task Order for the successful and safe completion of the ACTIV-2 trial. Based on the foregoing, NIAID intends to negotiate on a sole source basis with PPD, under the authority of FAR Subpart 16.505(b)(2)(i)(C).

It is necessary to place the order to satisfy a minimum guarantee [FAR 16.505(b)(2)(i)(D)]; or When citing exception to the fair opportunity process under FAR 16.505(b)(2)(iv), identify the contract clause and language that specifies the minimum guaranteed amount.

A statute expressly authorizes or requires that the purchase be made from a specified source. [FAR 16.505(b)(2)(i)(E)].

Provide a citation to the statutory authorization and a brief description of its content, or identify the specified source or other agency.

6. Agency Actions to take or Remove Barriers That Led to Fair Opportunity Exception (If applicable):

Describe the actions, if any, the agency may take to remove or overcome any business that led to the restriction consideration prior to any subsequent acquisition for the supplies of services is made. If no such actions have been taken, explain why.

Due to this need being a follow-on exception, there are no actions that can be taken to remove barriers that led to this sole source. As stated above, under item 5. Authority and Rationale, regarding the original order, a full and open competition was conducted among all four of the awardees under Task Area A of the Comprehensive and Rapid Response for NIAID Research Programs (CARRRP) IDIQ contract, in order to continue the activities of ACTIV 2 support services, which could no longer be supported under the Clinical Research Support Services (CRSS) contract with PPD (Contract No. HHSN272201700078C). Only PPD submitted a proposal in response to the solicitation under Task Area A of the CARRRP IDIQ contract (i.e., NIAID did not receive proposals from the other three awardees under Task Area A of the CARRRP IDIQ contract). As a result of negotiations, PPD, Contract No. 75N93021D00035, Task Order No.

75N93022F00001 was awarded as a severable Task Order for support services of the ACTIV 2 clinical trial, with a period of performance of May 6, 2022 through November 5, 2022 [all prior ACTIV 2 work was transferred from the CRSS contract (PPD, Contract No.

HHSN272201700078C) to the CARRRP IDIQ contract (PPD, Contract No. 75N93021D0003, Task Order No. 75N93022F00001)].

Further, PPD has been an active participant in the ACTIV 2 clinical trial since the beginning of the COVID pandemic outbreak in the US.

Due to the unpredictable nature of clinical trials in general, the ACTIV-2 study has both changed and evolved through the pandemic, which has shaped the Government’s understanding of this study and led to the need for an all-inclusive report (showing the finalization of study activities and study results from all ACTIV 2 agents), in order to receive the full benefit of the ACTIV 2 trial. Based on the foregoing, PPD is the only offeror that is able to complete this work, as it is a logical follow-on to the original order placed with PPD. By continuing with the same contractor, PPD, it would promote the standard of “economy and efficiency” and mitigate the risks associated with placing this requirement with another contractor.

7. Fair and Reasonable Price/Cost Determination: As Contracting Officer, by my signature below, I hereby determine that the anticipated price/cost to the Government for this contract action will be fair and reasonable.

Insert a description of the techniques and applicable FAR provisions (e.g. FAR 15.404-1(b)) used to ensure award will be at fair and reasonable cost. For example, did the Contracting Officer use a comparison of industry cost for similar work? The Independent Government Cost Estimate (IGCE) will primarily be an analysis of the contractor’s proposed cost. Additionally, the techniques identified at (e.g. FAR 15.404-1(c)(2)(iii)) will be used to further ensure award will be at fair and reasonable prices.

In addition, specify whether or not Certified Cost and Pricing Data will be obtained.

The Independent Government Cost Estimate (IGCE) [Attachment B] was developed using knowledge of this type of work, as well as the historical costs. In addition, the Contracting Officer will obtain certified cost and pricing data, to establish a fair and reasonable price for the services being acquired, as required by FAR 15.403-4. Finally, the Contracting Officer will conduct a cost analysis and cost realism analysis, as part of the proposal analysis. Negotiations will be conducted, if needed, to ensure that the proposed costs are fair and reasonable for performance of the proposed work. A field audit will not be performed, as it is not considered necessary because NIAID has historical cost data to assist in the analysis of the proposed costs.

Signature :

Digitally signed by Rosemary

Rosemary Gomes -S Gomes -S Date: 2022.07.19 13:57:16 -04'00'

Date: 07/12/2022

Name: Rosemary Gomes Phone:

240-669-5374

Title: Contracting Officer

8. Any other facts supporting the justification:

In addition to the above, the COR and Contracting Officer believe that there would be a duplication of cost by awarding this work to another organization. The estimated duplication is $22 million and was derived from a review of the costs billed to date for study start up.

9. Technical / Requirements Certification: By my signature below, I certify that the supporting data included in this Justification for an Exception to Fair Opportunity is accurate and complete.

Program Manager

Name: Carole Andres

Position Title: Chief, Clinical Research Resources Branch https://www.acquisition.gov/far/part-15#FAR_15_404_1 https://www.acquisition.gov/far/part-15#FAR_15_404_1

Email address:

andresca@niaid.nih.gov

Phone: 301-496-0701

Program Manager Supervisor (or one level above Program Manager)

Name: Carol Worrell

Position Title: Program Director, Office for Policy in Clinical Research Operations

Email address:

worrellc@mail.nih.gov

Signature: Carol J. Worrell -S Digitally signed by Carol J. Worrell -S Date: 2022.07.19 15:07:04 -04'00'

Date: 07/19/2022 mailto:andresca@niaid.nih.gov mailto:worrellc@mail.nih.gov

10. Contracting Officer's Approval (Required for proposed contract not to exceed $700,000 (value calculated including all options)): 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 described have otherwise been authorized for acquisition.

Name: Rosemary Gomes Phone: 240-669-5374

Signature: Rosemary Gomes -S Digitally signed by Rosemary Go Date: 2022.07.19 14:00:08 -04'00' es -S Date:

11. Legal Review:

All J&As greater than $75 million must have a legal review from the General Law Division of the Office of the General Counsel prior to sending it to the Department.

12. OPDIV Competition Advocate Approval (Required for proposed contract over $700,000 but not exceeding $75 million (value calculated including all options)):

I have reviewed this justification and find that it adequately supports other than full and open competition.

Name: Sheryl K. Brining, Ph.D Phone:

Signature: Brining, Sheryl (NIH/ Digitally signed by Brining, Sheryl

(NIH/OD) [E]

OD) [E] Date: 2022.07.22 15:54:46 -04'00' Date:

All J&As greater than $75 million must have a review from the Office of Small & Disadvantaged Business Utilization (OSDBU) prior to sending it to the Department. The OSDBU at their discretion may review any J&A.

13. Office of Small and Disadvantaged Business Utilization Review: (Required for contracts exceeding $75 million (value calculated including all options)):

Concur:

Non-Concur:

Name:

Phone:

Signature:

14. OPDIV HCA Approval (Required for proposed contract over $13.5 million but not exceeding $75 million (value calculated including all options)):

Name: for Diane J. Frasier Phone:

Digitally signed by Nancy M.

Nancy M. Norton -S Norton -S Date: 2022.07.22 11:20:25 -04'00'

15. Department Competition Advocate

Concur:

Non-Concur:

(The below approval paragraph is required if the cumulative contract value, including all options, exceeds $75 million.)

16. HHS Senior Procurement Executive (SPE) Approval:

Based on the foregoing justification, I hereby approve other than full and open competition for the above stated procurement, subject to the availability of funds, and provided that the services herein described have otherwise been authorized for acquisition.

State supplies/services being procured:

State the full statutory authority and FAR cite and title, consistent with paragraph 4, e.g. 41 U.S.C. 3304: