A13- JA for Other Than Full and Open Competition_CO signed 18Mar24_redacted.pdf
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- Attached to
- Evolva AG tick repellent Federal contract opportunity
- Solicitation number
- PR-83839
About this file
This document is a Justification and Approval (J&A) for Other Than Full and Open Competition for the development and testing of a nootkatone-based body lotion with tick repellent and toxicant properties. The proposed work is a follow-on contract resulting from a previous competitively awarded contract to develop and test experimental product formulations using nootkatone, a naturally derived compound with both repellent and toxic effects on ticks.
The main purpose of the proposed follow-on work is to refine and optimize body lotion formulations with both repellent and toxicant activity against ticks. The intended period of performance is 1 September 2024 to 28 February 2026 (18 months). The J&A cites the statutory authority under 41 U.S.C. 3304 and states that a price and cost analysis, historical data, and comparison of rates with other large businesses were used to determine a fair and reasonable price. No actions can be taken to remove the barriers to lead to other than open competition, as this is a follow-on contract for continuity of services.
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| File | Type | Posted |
|---|---|---|
| A11- Notice of Intent to Sole Source_CO reviewed.pdf |
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Template for 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.
JUSTIFICATION AND APPROVAL FOR OTHER THAN FULL AND OPEN COMPETITION
2. Description of Action:
Nature:
Pricing:
Funds:
3. Description of Services or Supplies:
Basis for Approval (FAR 6.303-1(d)):
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.
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):
Explain why the intended contractor is the only responsible source who can provide the required supplies or services. Discuss the unique capabilities, expertise, etc. that support the lack of competition/why no other type of supplies or services 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. May not Exceed one year, including all options, unless the head of the agency (Secretary of HHS) determines that exceptional circumstances apply.
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.
Provide a citation to the statutory authorization and a brief description of its content, or identify the specified source or other agency.
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.
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 for 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 quantity 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 action 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:
Was action competed?
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:
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 herin describe have otherwise been authorized for acquisition.
Name:
Phone:
Signature:
Date:
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:
16. Office of Small and Disadvantaged Business Utilization:
I have reviewed this justification and find that it adequately supports other than full and open competition.
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:
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:
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 - Other Than Full and Open Competition Health and Human Services Justification & Approval - Other Than Full and Open Competition
| AcquisitionTitle: Development and testing of nootkatone-based body lotion with tick repellent and toxicant properties |
| Agency: CDC |
| NIHDrop: |
| PSCDrop: |
| PSCOther: |
| AcqusitionYear: 24 |
| Author: Lars Eisen, Research Entomologist; Cindy Summerhawk, Business Services Support Specialist |
| CheckBox4: 0 |
| CheckBox5: 1 |
| CheckBox1: 0 |
| Purchase order/contract number: 75D30122C15711 |
| CheckBox8: 1 |
| CheckBox7: 0 |
| CheckBox6: 0 |
| CheckBox9: 0 |
| Agency Actions to Take or Remove Barriers That Led to Fair Opportunity Exception (If applicable): There arent any actions that can take place to remove the barriers to lead to other than open competition. This is a follow-on contract for continuity of services. |
| CheckBox10: 0 |
| CheckBox11: 1 |
| Other funds: |
| TextField5: Evolva AG |
| TextField5: Duggingerstrasse 23 |
| TextField5: CH-4153 Reinach, Switzerland |
| CheckBox2: 1 |
| CheckBox3: 0 |
| TextField7: |
| 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 basic order and the work to be obtained by the proposed modification.: Human-biting ticks are an increasing threat to public health in the United States. Use of personal protection measures is the primary defense against tick bites and infection with tick-borne disease agents. Effective synthetic chemical tick repellents are available on the market to prevent a tick encounter from resulting in a bite but their uptake by the public remains limited. Moreover, products (such as lotions) with potential to impact attached ticks that escape notice while biting and therefore are not removed in time to prevent transmission of the pathogens they carry are lacking from the market. In the last decade, naturally derived compounds have been shown to have both repellent and toxic effects on ticks. Such natural compounds also tend to be more acceptable by the public for use as tick repellents compared to synthetic chemicals. Nootkatone, registered by the Environmental Protection Agency as a biopesticide, is one emerging compound with potential for use both as a tick repellent (to prevent a tick encounter from resulting in a bite) and as a tick toxicant (to kill a tick that goes undetected while biting). The currently proposed work represents a follow on contract resulting from the successful completion of a previous competitively awarded contract to develop and test experimental product fomulations using nootkatone to repel and kill ticks. The main purpose of the proposed follow on work is to refine and optimize body lotion formulations with both repellent and toxicant activity against ticks. The intended period of performance is 1 September 2024 to 28 February 2026 (18 months). |
| CheckBox12: 1 |
| State the full statutory authority and FAR cite and title, consistent with paragraph 4, e.g. 41 U.S.C. 3304: Full and open competition is not contemplated. The purpose of the contract is to develop and test nootkatone-based products to repel and kill ticks. Only one responsible source and no other supplies or services will satisfy agency requirements, as Evolva AG is a joint owner with CDC on patents for the use of Nootkatone to repel and kill arthropod pathogen vectors. We therefore conclude that the only vendor option for the service/contract is Evolva AG. |
| State the full statutory authority and FAR cite and title, consistent with paragraph 4, e.g. 41 U.S.C. 3304: Not applicable - this is not a bridge contract. |
| State the full statutory authority and FAR cite and title, consistent with paragraph 4, e.g. 41 U.S.C. 3304: No such action is possible. The purpose of the contract is to develop and test nootkatone-based products to repel and kill ticks. Evolva AG is a joint owner with CDC on patents for the use of Nootkatone to repel and kill arthropod pathogen vectors. |
| State the full statutory authority and FAR cite and title, consistent with paragraph 4, e.g. 41 U.S.C. 3304: The purpose of the contract is to develop and test nootkatone-based products to repel and kill ticks. Evolva AG is a joint owner with CDC on patents for the use of Nootkatone to repel and kill arthropod pathogen vectors. Market research therefore cannot identify other qualified sources. |
| State the full statutory authority and FAR cite and title, consistent with paragraph 4, e.g. 41 U.S.C. 3304: The techniques that were used to determine fair and reasonable price is a price and cost analysis, historical data, comparing rates with other large businesses. |
| CheckBox13: 0 |
| CheckBox14: 0 |
| CheckBox15: 0 |
| TextField9: Follow on work based on a previously secured and completed competitive contract, funded via the CDC Broad Agency Announcement mechanism (contract 75D30122C15711). |
| CheckBox16: 1 |
| CheckBox17: 0 |
| Program Manager name: Cindy Summerhawk, COR |
| Program Manager position title: Business Services Support Specialist |
| Program Manager email address: hrf8@cdc.gov |
| Program Manager phone: 970-225-4240 |
| Program Manager Supervisor name: Ed Cotton, PMO |
| Program Manager Supervisor position title: Program Management Officer |
| Program Manager Supervisor email address: euq8@cdc.gov |
| HHS Senior Procurement Executive (SPE) signature: |
| Program Manager Supervisor date: 2024-01-25 |
| Contract Officer's Approval name: Sheena Delaine |
| HHS Senior Procurement Executive (SPE) phone: 770.488.2974 |
| Contract Officer's Approval date: 2024-03-18 |
| HHS Senior Procurement Executive (SPE) name: |
| DateField6: |
| Office of Small Business date: |
| OPDIV HCA date: |
| Concur with Acquisition: 0 |
| Non-Concur with Acquisition: 0 |
| HHS Senior Procurement Executive (SPE) date: |
| State supplies/services being procured: Human-biting ticks are an increasing threat to public health in the United States. Use of personal protection measures is the primary defense against tick bites and infection with tick-borne disease agents. Effective synthetic chemical tick repellents are available on the market to prevent a tick encounter from resulting in a bite but their uptake by the public remains limited. Moreover, products (such as lotions) with potential to impact attached ticks that escape notice while biting and therefore are not removed in time to prevent transmission of the pathogens they carry are lacking from the market. In the last decade, naturally derived compounds have been shown to have both repellent and toxic effects on ticks. Such natural compounds also tend to be more acceptable by the public for use as tick repellents compared to synthetic chemicals. Nootkatone, registered by the Environmental Protection Agency as a biopesticide, is one emerging compound with potential for use both as a tick repellent (to prevent a tick encounter from resulting in a bite) and as a tick toxicant (to kill a tick that goes undetected while biting). The currently proposed work represents a follow on contract resulting from the successful completion of a previous competitively awarded contract to develop and test experimental product fomulations using nootkatone to repel and kill ticks. The main purpose of the proposed follow on work is to refine and optimize body lotion formulations with both repellent and toxicant activity against ticks. The intended period of performance is 1 September 2024 to 28 February 2026 (18 months). |
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