D2. d. Exception to Fair Opportunity Justification_LRN-IDES_Signed.pdf

Template for a 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.

JUSTIFICATION FOR AN EXCEPTION TO FAIR OPPORTUNITY

Acquisition Title: Laboratory Response Network (LRN) Informatics and Data Exchange Services (IDES)

Agency: CDC

Acquisition Year (FY): 2024

Author: Beth Schweitzer

2. Description of Action:

Nature: New Requirement Follow-on Order

Modification to Existing Delivery/Task Order/Contract Number: HHSN316201200028W

Order Against: Multiple Award ID/IQ Contract Number:

Pricing: Firm-Fixed Price Time & Materials Cost Type

Funds: OMA Other Funds: Project and Task Support

3. Description of Applicable Contract Provisions:

Summarize all contract provisions relevant to this determination.

A modification is being issued to one (1)-NIH Information Technology Acquisition and Assessment Center (NITAAC) contract-holder under task Order- 75D30122F14646 pursuant to 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.

4. Description of Supplies or Services:

The estimated value of the proposed action, including all options, is: $ 695,983.59

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 -8 extension of services clause, this must be discussed.

This requirement for Laboratory Response Network (LRN) Task Order- 75D30122F14646 was originally competed on NITAAC among large and small businesses. The original contract was awarded to ICF Incorporated, L.L.C. in support and modernization of the data reporting systems used by the Laboratory Response Network (LRN) members to send their laboratory data to CDC.

In May 2023 the National Center for Injury Prevention and Control, Division of Overdose Prevention released the Notice of Funding Opportunity (NOFO): Overdose Data to Action in States (OD2A). The OD2A Biosurveillance Strategy requires awardees to submit laboratory test results utilizing LRN data reporting systems. The LRN Data Exchange (LRNDE) will expand the current data reporting capabilities for LRN thus allowing the OD2A data to be sent to CDC. This reuse of data systems is in alignment of the CDC Data Modernization Initiative. OD2A Labs will report using current LRN methods and the data would be ingested into the existing databases.

Data will be provided to stakeholders through a new database view.

Due to the above changes in activities, Modification 00002 will add new Task 7 to support the OD2A Biosurveillance data collection. The contractor, ICF shall provide the support services listed under the new Task 7 as part of the current contract . Furthermore, the support services and technical assistance under Task 7 will continue in Options 2-4 (years 2024-2027).

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 of 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 action is a logical follow-on to an existing task order 75D30122F14646. The requirement is to add new Task 7 to support the OD2A Biosurveillance data collection. The contractor, ICF shall provide the support services listed under the new Task 7 as part of the current contract . Furthermore, the support services and technical assistance under Task 7 will continue in Options 2-4 (years 2024-2027).

The current task order was awarded on 07/28/2022 via competition on NITAAC among large and small businesses. All awardees of the original order were provided a fair opportunity to submit a proposal in 2022, which was evaluated by a review panel prior to award. This is the first time the exception to fair opportunity has been used for this task order. Re-competing this work and having multiple vendors working on same projects and tasks concurrently would be highly inefficient and detrimental to the successful outcome of the project.

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 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.

This action is a logical follow-on to an existing task order 75D30122F14646. It will allow the incumbent to support the OD2A Bio-surveillance project under new Task 7. All future LRN IDES work will be competed.

7. Fair and Reasonable Price/Cost Determination: I hereby determine that the anticipated price/cost 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 original rates were determined to be fair and reasonable at the time of award. The rates, hours, and labor categories for additional services will be reviewed by the Contracting Officer (CO) to ensure the rates are acceptable, fair and reasonable.

Signature: Date: Apr 30, 2024

Name: Liubov Kriel

Title: Contracting Officer

8. Any other facts supporting the justification:

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

Program Manager

Name: Rebecca McNall

Position Title: Informatics Team Lead

Email address: dqo2@cdc.gov

Phone: 404-639-4541

Program Manager Supervisor (or one level above Program Manager)

Name: Jasmine Chaitram

Position Title: NLRSB- Branch Chief

Email address: zoa6@cdc.gov

Signature:

Date:

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 sole source justification subject to availability of funds, and provided that the services and supplies herein described have otherwise been authorized for acquisition.

Name: Liubov Kriel Phone: 770.488.2856

Signature: Date: Apr 30, 2024

11. 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.

12. 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 an exception to fair opportunity.

Name: Phone:

Signature: Date:

13. Office of Small and Disadvantaged Business Utilization:

I have reviewed this justification and find that it adequately supports an exception to fair opportunity.

Name: Phone:

Signature: Date:

14. 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:

15. Department Competition Advocate:

Concur: Non-Concur:

Name: Phone:

Signature: Date:

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

16. HHS Senior Procurement Executive (SPE) Approval:

Based on the foregoing justification, I hereby approve the procurement of stated supplies/services being procured on the exception to the fair opportunity basis pursuant to the authority of paragraph 5, 41 U.S.C. 4101, as implemented by FAR 16.501-2.

State supplies/services being procured:

This requirement for Laboratory Response Network (LRN) Task Order- 75D30122F14646 was originally competed on NITAAC among large and small businesses. The original contract was awarded to ICF Incorporated, L.L.C. in support and modernization of the data reporting systems used by the Laboratory Response Network (LRN) members to send their laboratory data to CDC.

In May 2023 the National Center for Injury Prevention and Control, Division of Overdose Prevention released the Notice of Funding Opportunity (NOFO): Overdose Data to Action in States (OD2A). The OD2A Biosurveillance Strategy requires awardees to submit laboratory test results utilizing LRN data reporting systems. The LRN Data Exchange (LRNDE) will expand the current data reporting capabilities for LRN thus allowing the OD2A data to be sent to CDC. This reuse of data systems is in alignment of the CDC Data Modernization Initiative. OD2A Labs will report using current LRN methods and the data would be ingested into the existing databases.

Data will be provided to stakeholders through a new database view.

Due to the above changes in activities, Modification 00002 will add new Task 7 to support the OD2A Biosurveillance data collection. The contractor, ICF shall provide the support services listed under the new Task 7 as part of the current contract . Furthermore, the support services and technical assistance under Task 7 will continue in Options 2-4 (years 2024-2027).

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

Name: Phone:

Signature: Date:

Template for a 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.

JUSTIFICATION FOR AN EXCEPTION TO FAIR OPPORTUNITY

2. Description of Action:

Nature:

Order Against:

Multiple Award ID/IQ Contract Number:

Pricing:

Funds:

3. Description of Applicable Contract Provisions:

Summarize all contract provisions relevant to this determination.

4. Description of Supplies or Services:

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 -8 extension of services clause, this must be discussed.

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:

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.

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.

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.

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.

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 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.

7. Fair and Reasonable Price/Cost Determination: I hereby determine that the anticipated price/cost 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.

Signature:

Date:

Name:

Title:

Contracting Officer

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

Program Manager Name:

Position Title:

Email address:

Phone:

Program Manager Supervisor (or one level above Program Manager) Name:

Position Title:

Email address:

Signature:

Date:

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 sole source justification subject to availability of funds, and provided that the services and supplies herein described have otherwise been authorized for acquisition.

Name:

Phone:

Signature:

Date:

11. 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.

12. 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 an exception to fair opportunity.

Name:

Phone:

Signature:

Date:

13. Office of Small and Disadvantaged Business Utilization:

I have reviewed this justification and find that it adequately supports an exception to fair opportunity.

Name:

Phone:

Signature:

Date:

14. 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:

15. Department Competition Advocate:

Concur:

Non-Concur:

Name:

Phone:

Signature:

Date:

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

16. HHS Senior Procurement Executive (SPE) Approval:

Based on the foregoing justification, I hereby approve the procurement of stated supplies/services being procured on the exception to the fair opportunity basis pursuant to the authority of paragraph 5, 41 U.S.C. 4101, as implemented by FAR 16.501-2.

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:

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

Phone:

Signature:

Date:

11.0.0.20130303.1.892433.887364 Justification & Approval - Exemption to Fair Opportunity Health and Human Services Justification & Approval - Exemption to Fair Opportunity

The current task order was awarded on 07/28/2022 via competition on NITAAC among large and small businesses. All awardees of the original order were provided a fair opportunity to submit a proposal in 2022, which was evaluated by a review panel prior to award. This is the first time the exception to fair opportunity has been used for this task order. Re-competing this work and having multiple vendors working on same projects and tasks concurrently would be highly inefficient and detrimental to the successful outcome of the project.

In May 2023 the National Center for Injury Prevention and Control, Division of Overdose Prevention released the Notice of Funding Opportunity (NOFO): Overdose Data to Action in States (OD2A). The OD2A Biosurveillance Strategy requires awardees to submit laboratory test results utilizing LRN data reporting systems. The LRN Data Exchange (LRNDE) will expand the current data reporting capabilities for LRN thus allowing the OD2A data to be sent to CDC. This reuse of data systems is in alignment of the CDC Data Modernization Initiative. OD2A Labs will report using current LRN methods and the data would be ingested into the existing databases. Data will be provided to stakeholders through a new database view.

Due to the above changes in activities, Modification 00002 will add new Task 7 to support the OD2A Biosurveillance data collection. The contractor, ICF shall provide the support services listed under the new Task 7 as part of the current contract . Furthermore, the support services and technical assistance under Task 7 will continue in Options 2-4 (years 2024-2027).

In May 2023 the National Center for Injury Prevention and Control, Division of Overdose Prevention released the Notice of Funding Opportunity (NOFO): Overdose Data to Action in States (OD2A). The OD2A Biosurveillance Strategy requires awardees to submit laboratory test results utilizing LRN data reporting systems. The LRN Data Exchange (LRNDE) will expand the current data reporting capabilities for LRN thus allowing the OD2A data to be sent to CDC. This reuse of data systems is in alignment of the CDC Data Modernization Initiative. OD2A Labs will report using current LRN methods and the data would be ingested into the existing databases. Data will be provided to stakeholders through a new database view.

Due to the above changes in activities, Modification 00002 will add new Task 7 to support the OD2A Biosurveillance data collection. The contractor, ICF shall provide the support services listed under the new Task 7 as part of the current contract . Furthermore, the support services and technical assistance under Task 7 will continue in Options 2-4 (years 2024-2027).