JA 3.13.24 (002).pdf signed.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

The Influenza Division (ID) of the National Center for Immunization and Respiratory Diseases (NCIRD), CDC, owns a significant number of Qiagen laboratory equipment, which are used to perform critical virology and genomics analyses related to influenza viruses in support of its public health mission. These instruments are used in analyses performed for high-throughput influenza surveillance, emergency response, and research and development in preventing the spread of influenza viruses, reducing the severity of the disease, and protecting vulnerable populations from serious complications. These instruments are highly complex, and maintenance/repair requires a high degree of technical proficiency and training. In order to ensure readiness to respond to the event of an emergency response it is crucial that these instruments are able to run 95% of the time. The period of performance will be for five (5) years between April 1, 2024 - March 31, 2029.

Period of Performance:

Base Period: Apr 1, 2024 – Mar 31, 2025 Option Period One: Apr 1, 2025 – Mar 31, 2026 Option Period Two: Apr 1, 2026 – Mar 31, 2027 Option Period Three: Apr 1, 2027 – Mar 31, 2028 Option Period Four: Apr 1, 2028 – Mar 31, 2029

As per Policy's guidance due to the lack of a formal FAR PART 13.5 template, this template is being used for this sole source justification to comply with the requirements as listed FAR PART 13.501.

Qiagen is the manufacturer of the equipment, who can provide certified trained personnel and original manufacturer parts. Also, Qiagen is the only vendor who can continue the exact protocols required to service the equipment in the laboratory.

Future requirements will be re-evaluated to determine if additional sources can meet the requirement.

State the full statutory authority and FAR cite and title, consistent with paragraph 4, e.g. 41 U.S.C. 3304: NCIRD-ID conducted comprehensive market research that began in October 2023 and concluded in November 2023. The research included internet searches of businesses with the same NAICS code and searches specifically for Qiagen instruments repair and service. Also reviews of GovCB site, SAM.gov site, and GSA schedule site.

Using NAICS Code 811210 (Electronic and Precision Equipment Repair and Maintenance) identified the Multiple Award Schedule (MAS) category 532490ESA- Equipment Service Agreements with a total of six (6) contractors identified. Advanced Testing Technologies specializes in avionics equipment, Dragoon Technologies, Inc specializes in Engineering services, Franklin Young Int’l, Inc provides services for various scientific items such as microscopes, laboratory freezers, environmental instruments, and other items of this type. Surfacide specializes in heating equipment, TacMed Simulation, Inc is supplier of various medical items such as blood filling systems silicone molds and trauma trainers. Lastly, Technical Communities, Inc. d/b/a TestMart also provides services for laboratory refrigerators, diagnostic and testing equipment. A second search utilizing NAICS Code 334516 (Analytical Laboratory Instrument Manufacturing) to identify contractors having the capabilities to support the required level of service was conducted. The intent was to review potential sources related to laboratory instrument manufacturers. GSA e-library revealed 71 potential small and 27 large business (98 total) contractors using NAICS code 334516. Among the laboratory vendors who populated the search who are known instrument distributors and could potentially provide maintenance to laboratory instruments included: AB Sciex, Inc., Abbott Laboratories, Inc., Agilent Technologies, Inc., Luminex Corp., Roche Diagnostics Corporation, Shimadzu Scientific Instruments, Inc. Siemens Healthcare Diagnostics, Inc., Thermo Electron North America LLC, and Waters Technologies Corporation. To narrow the search, NAICS code 541380 was combined with the key word ‘Qiagen’ which generated 1 small business named Government Scientific Source, Inc. which was a medical equipment and supply company, but they did not offer on-site preventative maintenance of Qiagen laboratory equipment. Both Qiagen, Inc. and The REMI Group, LLC were not produced in the GSA search, but they are included in the list below as they both are known to be able to service Qiagen laboratory equipment, which are large businesses.

REMI is capable of providing equipment and maintenance for some Qiagen, Inc. products and has access to some Qiagen, Inc. new or refurbished equipment, but not the full level of service and support required by NCIRD-ID.

The most recent market research conducted confirmed details identified earlier in regards that Qiagen, Inc. is the best option for meeting the needs of NCIRD/ID.

A review of potential contractors on GSA Schedule 66, SIN 502; SIN 615 5000 was conducted and yielded that no other GSA contract holders were capable of the technical requirements. Qiagen, Inc. has performed this current work under contract 200-2021-M-10504 was awarded in FY 2021 with a 5-year period of performance (7/1/2021 – 6/30/2024). Contract 200-2018-M-01749 was awarded in FY 2018 with a 5-year period of performance (8/29/2018 – 08/28/2023). Contract 200-2017-M-92822 was awarded in FY 2017 with a 3-year period of performance (12/29/2016 – 12/28/2019). Contract 200-2017-94686 was awarded in FY 2017 with a 1-year period of performance (7/30/2017 – 7/29/2018). Most contracts were awarded using a Justification and Approval for Other than Full and Open Competition document.(J&A) The J&As were posted in accordance with FAR procedures.

The Influenza Division (ID) of the National Center for Immunization and Respiratory Diseases (NCIRD), CDC, owns a significant number of Qiagen laboratory equipment, which are used to perform critical virology and genomics analyses related to influenza viruses in support of its public health mission. These instruments are used in analyses performed for high-throughput influenza surveillance, emergency response, and research and development in preventing the spread of influenza viruses, reducing the severity of the disease, and protecting vulnerable populations from serious complications. These instruments are highly complex, and maintenance/repair requires a high degree of technical proficiency and training. In order to ensure readiness to respond to the event of an emergency response it is crucial that these instruments are able to run 95% of the time. The period of performance will be for five (5) years between April 1, 2024 - March 31, 2029.

Period of Performance:

Base Period: Apr 1, 2024 – Mar 31, 2025 Option Period One: Apr 1, 2025 – Mar 31, 2026 Option Period Two: Apr 1, 2026 – Mar 31, 2027 Option Period Three: Apr 1, 2027 – Mar 31, 2028 Option Period Four: Apr 1, 2028 – Mar 31, 2029

As per Policy's guidance due to the lack of a formal FAR PART 13.5 template, this template is being used for this sole source justification to comply with the requirements as listed FAR PART 13.501.