Approved JA_Health Decisions Inc_Contract 75N94019D00004.pdf

JUSTIFICATION AND APPROVAL

FOR OTHER THAN FULL AND OPEN COMPETITION

Completion Instructions: The Department of Health and Human Services (HHS) has established a standard template for the preparation of a J&A for Other Than Full and Open Competition. If this is an 8(a) set-aside, please note this form is not required unless the acquisition is valued (including all options) at greater than $22 million. This template is NOT applicable for actions using simplified acquisition procedures (FAR Part 13), Federal Supply Schedule orders (FAR 8.4) or task or delivery orders subject to fair opportunity (FAR 16.505).

Tailor all aspects of this template to the individual acquisition. Consult FAR Subpart 6.3 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):

Author and Title:

2. Description of Action:

Nature: New Requirement Follow-on Requirement

Modification to Existing Purchase Order/Contract Number:

Pricing: Firm-Fixed Price Time & Materials Cost

Other:

Funds: OMA Other Funds:

Name of Proposed Contractor(s):

Street Address:

City, State, Zip:

3. Description of Services or Supplies:

Basis for Approval (FAR 6.303-1(d)): Individual Basis Class Basis

The total estimated value of the proposed action, including all options is $

As applicable, briefly describe the services or supplies required to meet the agency's needs, including make & model number where appropriate. Include quantities of supplies or period of performance for services. Provide information for any options included. If the action is a modification to an existing contract, distinguish clearly between the work covered by the original contract and the work to be obtained by the proposed modification.

https://www.acquisition.gov/far/part-8#FAR_Subpart_8_4 https://www.acquisition.gov/far/part-13 https://www.acquisition.gov/far/part-16#FAR_16_505 https://www.acquisition.gov/far/part-6#FAR_Subpart_6_3 https://www.acquisition.gov/far/part-6#FAR_6_303_1

4. Authority and Rationale: Identify the statutory authority, FAR title and FAR citation permitting other than full and open competition. It may be one of the following most commonly used citations by the operating divisions of the Department of Health and Human Services (HHS), but other exceptions may apply per FAR Subpart 6.3.

Actions other than simplified acquisition procedures (select only one and provide an explanation):

FAR 6.302-1: Only one responsible source and no other supplies or services will satisfy agency requirements, 41 U.S.C.

3304(a)(1)

Explain why the intended contractor is the only responsible source who can provide the required supplies or s ervices.

Discuss the unique capabilities, expertise, etc. that support the lack of competition/why no other type of supplies or servic es will satisfy agency requirements. Explain factors/unique qualifications such as proprietary data or exclusive licensing rights, if applicable. When competition is limited to items particular to one manufacturer, this justification must explain why the particular brand name, product, or feature is essential to the Government's requirements, and that market research indicates other companies' similar products, or products lacking the particular feature, do not meet, or cannot be modified to meet the agency's needs in accordance with FAR 11.105. If in connection with a follow-on contract for continued development or production of highly specialized equipment, detail the substantial duplication of cost or unacceptable delays.

FAR 6.302-2: Unusual and compelling urgency, 41 U.S.C. 3304(a)(2)

If unusual and compelling urgency is the basis for the justification, explain the chronological events leading up to the requirement and explain why time constraints cannot permit even a limited competition. Describe the detrimental effects/ serious injury to the mission of the requiring activity or to the government, financial or otherwise, that will result if this justification is not approved. Describe impact of required delivery/performance date. Describe the detrimental effects/ serious injury to the mission of the requiring activity or to the government, financial or otherwise, that will result if this justification is not approved and the product or service cannot be provided by the intended sole source contractor. Failure to plan for expiring funds is not a valid reason for citing this exception. May not exceed one year, including all options, unless the head of the agency determines that exceptional circumstances apply.

FAR 6.302-5: Authorized or Required by Statute, 41 U.S.C. 3304(a)(5)

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

Other (See FAR Subpart 6.3 for additional authority)

Provide the authority and citation to the applicable section of FAR 6.3.

Provide a full explanation to justify use of the exception.

5. Agency Actions to Take or Remove Barriers That Led to Other Than Full and Open Competition (If applicable):

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

https://www.acquisition.gov/far/part-6#FAR_6_302_1 https://www.acquisition.gov/far/part-6#FAR_Subpart_6_3 https://www.acquisition.gov/far/part-11#FAR_11_105 https://www.acquisition.gov/far/part-6#FAR_6_302_2 https://www.acquisition.gov/far/part-6#FAR_6_302_5

6. Bridge Contracts:

For contract extensions or bridge contracts when a competitive follow-on is in the process of being developed, summarize history of current contract and explain the reasons for any delays in the acquisition. Include discussion of the milestones f or the follow-on action; the milestones should be as efficient as possible. Discuss why it would be neither cost effective nor realistic to expect another contractor to perform during the brief interim period; include issues such as start -up costs, phase-in, transfer of GFP, recruitment and staffing, etc. If the action is because of a protest, provide a brief discussion of the protest including the date the protest was filed and the basis of the protest. Explain that the action will provide the minimum quant ity or performance period.

7. Actions to Increase Competition:

Describe efforts made to compete the action, including whether a notice was or will be publicized as required by FAR Subpart

5.2 or which exception under FAR 5.202 applies. If a notice was publicized, discuss the number of written responses to the synopsis and the results of the assessment of the written responses. List sources, if any, that expressed, in writing, an interest in the acquisition. Provide rationale if interested sources were rejected. If applicable, state that no other sources have expressed interest, but all offers received shall be considered. Describe what actions will be taken to increase competition before subsequent acquisition of the supplies or services is required. You may state that an action is a one-time requirement, but if a similar requirement arises, every effort will be made to compete it to the maximum extent possible. If action is sole source because of proprietary data or licensing rights and there will be a continuing need for the requirement, there must be evidence that advanced planning has been initiated to overcome the barriers to competition, or there should be documentation to support an analysis that replacement costs/licensing purchase costs outweigh the benefits of competition. If the action is a contract extension or bridge, explain actions to compete the follow-on. If action is an urgent new requirement and a competitive follow-on is anticipated, explain that efforts are underway to facilitate a full and open competition.

8. Market Research:

Describe the extent of the market research conducted to identify all qualified sources and the results thereof. “Market Research” is defined as those attempts you made to ascertain whether other qualified sources exist, and can include contact with knowledgeable experts regarding similar or duplicate requirements, contact with industry, results of a sources sought synopsis, or draft solicitations. Research of the marketplace may consist of written, electronic (i.e. email) telephonic, or world wide web inquiries. Lack of advanced planning is not an acceptable reason for the lack of market research, but true urgency may necessitate abbreviated market research that is limited to readily available historical and commercial information. If ac tion is a contract extension or bridge contract, describe the market research efforts underway or completed for the follow-on. See FAR 10.002(b)(2).

9. Procurement History:

Purchase order or contract number:

Was action competed? Yes No

If action was not competed, state the cited authority, summarize rationale, and describe the actions that were supposed to be taken to increase competition and the results thereof:

https://www.acquisition.gov/far/part-5#FAR_Subpart_5_2 https://www.acquisition.gov/far/part-5#FAR_Subpart_5_2 https://www.acquisition.gov/far/part-5#FAR_5_202 https://www.acquisition.gov/far/part-10#FAR_10_002

10. Additional Information to support the justification:

If applicable, explain why technical packages or specifications to facilitate competition were not developed or available;

describe actions taken to remedy the situation.

All information has been provided in previous sections above.

11. Technical / Requirements Certification: By my signature below, I certify that the supporting data included in this J&A is accurate and complete.

Contracting Officer’s Representative

Name: Jeffrey Kroopnick, MD

Position Title: Chief Medical Officer, DiPHR, NICHD

Email address:

jeffrey.kroopnick@nih.gov

Signature:

Program Manager Supervisor (or one level above Program Manager)

Name: Diana Blithe, PhD

Position Title: Chief, Contraceptive Development Program, DiPHR, NICHD

Email address:

diana.blithe@nih.gov

Signature:

Division Director

Name Jagteshwar Grewal, PhD, MPH

Position Title Director, DiPHR

Email address: grewalja@mail.nih.gov

Signature:

12. 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.

Provide the basis for this determination, e.g., describe techniques to be used to determine fair and reasonable price (FAR Subpart 15.402), such as price analysis, cost analysis, cost realism. Per FAR Subpart 15.403-4(a)(1), the threshold for obtaining cost or pricing data is $750,000.

Name: Theresa Ranjit Phone: 301-435-6957

Signature: Date:

Jeffrey M. Kroopnick -S Digitally signed by Jeffrey M. Kroopnick -S Date: 2024.05.10 13:52:08 -04'00'

Diana L. Blithe -S Digitally signed by Diana L. Blithe -S Date: 2024.05.10 13:59:52 -04'00'

Grewal, Jagteshwar (NIH/NICHD) [E]

Digitally signed by Grewal, Jagteshwar (NIH/NICHD) [E] Date: 2024.05.13 09:38:03 -04'00'

Theresa A. Ranjit -S Digitally signed by Theresa A.

Ranjit -S Date: 2024.05.13 11:24:39 -04'00'

Please see the attached "Continuation" document, for the Contracting Officer's basis for fair and reasonable price/cost determination.

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13. 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: Theresa Ranjit Phone: 301-435-6957

Signature: Date:

NICHD OA Concurrences:

This is to certify that the justification for the proposed acquisition has been reviewed and that to the best of my knowledge and belief the information and/or data provided to support the rationale and recommendation for approval is accurate and complete.

Chief, Section A, Contracts Management Branch, NICHD Office of Acquisitions

Name: Noor Shakeel Phone: 301-496-3211

Chief, Contracts Management Branch, NICHD Office of Acquisitions

Name: Alice Pagan Pereira Phone: 301-435-6959

Director, NICHD Office of Acquisitions

Name: Marlene Mireles Phone: 301-443-7795

Theresa A. Ranjit -S Digitally signed by Theresa A.

Ranjit -S Date: 2024.05.13 11:25:29 -04'00'

Noor F.

Shakeel -S

Digitally signed by Noor F.

Shakeel -S Date: 2024.05.13 12:54:38 -04'00'

Alice M. Pagan Pereira -S

Digitally signed by Alice M.

Pagan Pereira -S Date: 2024.05.13 14:37:36 -04'00'

Marlene T. Mireles -S

Digitally signed by Marlene T.

Mireles -S Date: 2024.05.16 15:10:54 -04'00'

14. Legal Review:

All J&As greater than $68 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.

15. OPDIV Competition Advocate Approval (Required for proposed contract over $700,000 but not exceeding $13.5 million (value calculated including all options)):

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

Name: Phone:

Signature: Date:

All J&As greater than $68 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.

16. Office of Small and Disadvantaged Business Utilization Review: (Required for contracts exceeding $68 million (value calculated including all options)):

Concur: Non-Concur:

Name: Phone:

Signature: Date:

17. OPDIV HCA Approval (Required for proposed contract over $13.5 million but not exceeding $68 million (value calculated including all options)):

Name: Phone:

Signature: Date:

18. Department Competition Advocate (Required for contracts exceeding $68 million (value calculated including all options)):

Concur: Non-Concur:

Name: Phone:

Signature: Date:

(The below approval paragraph is required if the cumulative contract value, including all options, exceeds $68 million.)

19. 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:

Name: Phone:

Attachment 1: Justification and Approval of Other Than Full and Open Competition (Continuation)

12. Fair and Reasonable Price/Cost Determination:

(a) In accordance with FAR 15.403-4, the Contracting Officer will require submission of certified cost or pricing data, as defined in 2.101, from the contractor to the extent necessary to determine fairness and reasonableness of the costs.

(b) The COR and Contractor Officer will evaluate all proposed costs and then complete and sign the Project Officer Technical Questionnaire form. A cost analysis of the contractor's business proposal will be conducted by the Contracting Officer in accordance with FAR Subpart 15.404-1(c) and the principles established in the 0MB Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards. The cost analysis will include a review and analysis of separate cost elements to determine fairness and reasonableness. In addition, an evaluation of the separate cost estimates of the HD proposal will be compared against the Independent Government Cost Estimate. The Contracting Officer will also consider historical costs. Furthermore, a cost realism analysis will be conducted in accordance with FAR 15.404-1(d) and documented in the file which will reflect the process of independently reviewing and evaluating specific elements of the contractor's proposed cost estimate to determine whether the estimated proposed cost elements are realistic for the work to be performed, reflect a clear understanding of the requirements, and are consistent with the unique methods of performance and materials described in the contractor's technical proposal.

(c) An audit will not be necessary.

Office of Extramural Research, NIH

The Contraceptive Development Program (CDP)’s mission is to develop new methods of contraception for men and women. CDP is situated within the Division of Population Health Research (DiPHR) at NICHD. The CDP focuses on conducting translational and clinical research to develop novel methods of contraception for women and men. Through the SCCC, new female and male contraceptive drugs and devices, as well as potential treatments of selected gynecological conditions, are evaluated for their safety and efficacy in Phase I, II, III, and IV clinical trials. The results of these clinical trials on new entities would be the basis for advancing candidate drugs and devices through clinical development with the ultimate goal of submission to the Food and Drug Administration (FDA) in support of an Investigational New Drug (IND) application and initiation of New Drug Application (NDA) for a new drug for male or female contraception; and for a device, Premarket notification 510K, Premarket Approval (PMA), and Investigation Device Exemption (IDE). The SCCC is the critical CCTN contract that covers the organization, coordination, monitoring, data collection, data analysis, and preparation of a Clinical Study Report for each clinical trial.

The success of the CCTN studies has exceeded prior predictions such that its contraceptive drugs and products have advanced to later phases of clinical development (i.e. Phase II and III trials). Consequently, to conduct these large and complex clinical trials will require funding to surpass the current contract maximum ceiling of $18,900,000. Doing so will allow for the continuation of the subsequent phase of the clinical trials while ensuring continuity and consistency in data management operations.

The work contained in this Justification and Approval (J&A) request is within the scope of the existing SCCC contract, and it is still critical that the work continues to accomplish the vital research. The Statement of Work (SOW) is attached to this J&A. Successful completion of a clinical trial requires the SCCC to perform activities including, but not limited to the following:

• Assist in protocol development and composition

• Manage data collection, analysis, and storage

• Provide statistical leadership and guidance

• Monitor protocol compliance for each clinical site, including source document review and verification

• Monitor for safety and adverse events monitoring, particularly tracking and analyzing safety data and supporting the Data Safety & Monitoring Board

• Compose clinical study reports (CSR)

• Maintain, review, reconcile, and archive the trial master file

• Track all regulatory documents and regulatory submissions

• Provide all clinical support and coordination with the provision of ancillary services

List of clinical trials to be completed under the proposed modification:

This J&A requests an increase to the IDIQ ceiling contract by $13,140,946 in order to complete the following ongoing trials:

1. The Levonorgestrel Butanoate (LB) Phase II-III clinical trial projected to begin on 01/01/2025-12/31/2027 for a total estimated cost of $3,782,219.

2. The Nestorone®/Testosterone (Nes-T) Phase III trial anticipated to begin on 09/01/2024-08/31/2026 for a total estimated cost of $7,626,536.

3. Transition Phase (in the event the incumbent contractor does not receive the award) anticipated to begin on 04/01/2025 until 09/28/2026 for a total estimated cost of $1,732,191.

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The purpose of this Justification and Approval (J&A) is to modify the Indefinite-Delivery Indefinite-Quantity (IDIQ) Contract No. 75N94019D00004 to increase the ceiling by $13,140,946. The increase in the ceiling will ensure the ongoing statistical and clinical coordinating support to the CCTN for the expansion of ongoing clinical trials of novel methods of male and female contraceptive products under Good Clinical Practices (GCP) guidelines. The approval of this ceiling increase will ensure Program’s ability to fulfill the objectives of the contract, and maintain continuity of operations, thereby preventing any unacceptable delays in the progress of these research initiatives.

Throughout the life of this IDIQ contract, unforeseen events accelerated the depletion of the IDIQ contract's ceiling, bringing it closer to exhaustion sooner than anticipated. Therefore, it is crucial to address this to ensure sufficient ceiling remains to accommodate the continuation of the next phase of some of the ongoing CCTN trials. One of the significant factors contributing to this depletion is the cost of conducting early phase clinical trials that has had unexpected increases due to extenuating circumstances caused by the COVID-19 global pandemic. Throughout the period of performance of the current contract, there have been as many as eight (8) clinical trials active within a given year. These are multi-year trials. Some of these trials began under the previous IDIQ contract with Health Decisions, Inc. (HD) and were contracted for under fully funded non-severable task orders. As those clinical trials came to an end, residual work regarding data analysis was conducted under a new task order under the current IDIQ contract with HD. However, as the COVID-19 pandemic occurred during this current IDIQ contract, it caused a catastrophic impact for two years (2020 and 2021), and many of the effects remain at present. In February 2020, when COVID-19 began, it impacted several of our international sites and affected all sites beginning in March 2020 when the situation escalated to a worldwide pandemic. At that time, eight (8) CCTN clinical trials were active. The performance of contractors and associated subcontracts at thirty domestic sites and six (6) international sites was severely impacted, with different site-specific regulatory or governmental (state, country) restrictions dependent on the severity of the conditions at a given time and location. All active trials in 2020 suffered major impacts due to the COVID-19 pandemic. These impacts included loss of personnel, extended illness of key personnel, restrictions or shutting down of all non-COVID-related activities at clinical sites, inability to conduct monitoring visits in person, delays in new enrollments, extraordinary efforts to follow up on active participants in the ongoing trials, to name a few. This disruption was unanticipated and caused timelines for all active trials to be extended by a minimum of one year and even longer in some cases. There were extenuating activities that required additional staff time. Creative workarounds were implemented to allow continued follow-up of active participants and product re-supply, employing conditions limiting in-person visits while maximizing safety assurance. These events led to higher costs for the active clinical trials.

Moreover, the pandemic led to a flood of funding for clinical research organizations for research on COVID-related projects. This resulted in increased salaries for employees and major staff turnover as organizations competed for a limited pool of qualified staff. Supply chain shortages led to higher costs for most materials, and the cost of licensing and maintaining software necessary for electronic data capture rose dramatically. Overall, costs have doubled since 2020. As such, the current ceiling of $18,900,000 will be reached prior to the originally scheduled timeline. The services need to continue, and this ceiling increase is necessary to avoid harmful interruption of proceeding with the subsequent phases of the ongoing trials as well as the support activities, data analysis, and other duties of the SCCC.

Furthermore, the costs of the current SCCC soared during and following COVID due to government requirements for information management as costs for obtaining and maintaining an electronic data capture system that is the Federal Information Security Modernization Act (FISMA) compliant have risen substantially as well as costs for maintaining coding licenses for data entry, and transport services for shipping and storage of investigational products. This ceiling increase will allow the critical clinical trials to continue the performance of the next phase of clinical development through the current IDIQ contract, ensuring consistency within this multi-center trials program.

The CCTN has utilized the same SCCC contractor for over 27 years and has successfully completed or is currently conducting 30 clinical trials, including small first-in-human through large Phase III and Phase IV studies. There is no other entity that could complete the current work without major disruption and at a much higher cost to the government. No other sources are similarly qualified, trained and positioned to be able to perform this work right now. Given the complexity of the coordination, management, and uniqueness that this requirement presents, this program requires the same contractor to ensure consistency within the overall CCTN execution of clinical research, which includes the clinical trials ecosystem of standard operating procedures (SOPs), study protocols, and data collection and management. Consistency in trial management is crucial.

As the incumbent contractor, Health Decision, Inc. (HD) is currently providing statistical and clinical coordinating services in support of ongoing CCTN Phase I-III contraceptive clinical trial activities. HD has developed and is currently implementing the clinical coordination and monitoring of CCTN sites, ensuring protocol compliance, and instituting data entry protocols that allow for review of data quality and data analyses for inclusion in clinical study reports that will be submitted to the FDA. HD has also been tasked with data storage. Transitioning to a new contractor during such critical junctures such as monitoring data, safety monitoring, tracking study progress, and submitting study data to FDA, require a high level of coordination, effort, and time; therefore, any delays or potential work stoppage would cause considerable harm to the program and subjects participating in ongoing studies due to interruption of multiple active clinical studies. Specifically, interruption in these activities would result in unacceptable scientific risk and duplication of costs invested in the ongoing studies as well as unrecoverable losses in vital areas such as subject recruitment, data analyses, data quality review, and the submission of finalized data to the FDA for product review. If we transition to a new contractor at this point, NICHD estimates that it would cost the government an additional estimated amount of $3,000,000. In view of that, it is critical that the SCCC services remain intact and uninterrupted, as this operation is essential to the success of the subsequent CCTN studies.

In addition, due to the magnitude and complexity of the ongoing work being performed under the current SCCC contract, if the incumbent contractor does not receive the new award, additional time and expense will be necessary to complete successful transfer of the SCCC data and clinical services. It is estimated that the transition period will require at least 12 months to completely transfer the portfolio of CCTN studies to a new contractor while maintaining full operational capability of the CCTN SCCC. Ultimately, the transition timeline will depend upon the status of actively enrolling studies as these studies require the longest transition period. Furthermore, it is anticipated that the use of any other source during these phases of the trials would result in substantial duplication of costs as well as additional time to develop the necessary capability within another contractor’s staff that is not expected to be recovered through competition. Extensive government resources have been used to create an infrastructure to support these studies, including also training staff at HD on SOPs, study protocols, and data collection and analysis, and management. Accordingly, conducting the follow-up phases with a different SCCC contractor would result in duplication of almost all the previous work and unacceptable delays that would increase costs to the Government. Additionally, HD has longstanding relationships with the CCTN clinical sites currently conducting the ongoing trials. This will facilitate the coordination among current sites that will be very critical to the success of the CCTN program.

In summary, the limitation of the current contract’s ceiling calls for an immediate action to preserve the stability of the CCTN ongoing clinical trials. Although the recompetition of this acquisition is under way, an increase in existing IDIQ contract ceiling is imperative. This modification is key in upholding the dedicated resources to the advancement of these contraceptive development research initiatives by ensuring the required constancy and reliability within CCTN studies, mitigating the risks of interruptions in clinical services, and preventing the duplication of effort and cost, which will ultimately lead to the continued progress and success of these research initiatives.

The period of performance, funds obligated to date, and the IDIQ ceiling of the incumbent contract with HD are listed below:

(i) Name of Current Contractor: Health Decisions, Inc.

(ii) Period of Performance: 09/20/2019-09/19/2026 (Ordering Period)

(iii) IDIQ Ceiling: $18,900,000

Total amount obligated under contract: $11,237,105

Current remaining ceiling: $7,662,895*

Total proposed IDIQ ceiling increase: $13,140,946

*It is projected that the remaining ceiling of the IDIQ contract will cover specific required tasks anticipated for FY24 and some for FY25. The increase in the maximum ceiling will allow NICHD Program to cover follow-on studies the incumbent contractor must perform. Any new requirements beyond the requested current ceiling will be performed under the new IDIQ contract.