Amendment to JOFOC-CP-JL_Fully Executed.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.

11. Technical / Requirements Certification: By my signature below, I certify that the supporting data included in this

J&A 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:

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: Phone:

Signature: Date:

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: Phone:

Signature: Date:

https://www.acquisition.gov/far/part-15#FAR_15_402 https://www.acquisition.gov/far/part-15#FAR_15_402 https://www.acquisition.gov/far/part-15#FAR_15_403_4

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:

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

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

Concur:

Non-Concur:

(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:

• For point of care use

• Handheld

• Lateral flow, rapid antigen test for Ebola virus

• Either emergency use authorized or Section 510(k) cleared by the U.S. Food and Drug Administration (FDA)

• Sample oral fluid from cadavers

• For use on individuals or suspected to have recently died from the Ebola virus disease Alternative tests will not work because the Government will be unable to assess infection with the Ebola Virus in individuals and cadavers.

Because there are currently no other FDA cleared tests for use in cadavers, it would take significantly longer for another company to obtain FDA clearance on a new test than it would to improve OraSure’s already cleared test and obtain new FDA clearance.

Developing a new test would significantly delay the Government’s ability to assess infections, therefore jeopardizing HHS’ public health mission in a way that would result in unacceptable risks to the health of the public.

The only FDA 510(k) cleared test is the OraQuick Ebola Rapid Antigen Test by OraSure Technologies, and the test can be used on whole blood from living patients suspected of exposure to the virus and on oral fluid from the recently deceased. 510(k) clearance was announced by the FDA on 10OCT2019. Two non-FDA 510(k) cleared rapid tests were found. In addition to not being FDA cleared, neither of these tests can use samples from cadavers.

BARDA completed an Internal Process Review (IPR) on 07 August 2023. The result of the IPR was to have OraSure revise the Scope of Work to include the completion of analytical and clinical validation studies and regulatory activities for 510(k) clearance of the second-generation OraQuick® Ebola Rapid Antigen Test. The proposed modification was determined to be in-scope.