A16 - Intent to Sole Source (LSJ).pdf

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Template for a Federal Supply Schedule (FSS) Limited-Sources Justification

Completion Instructions: HHS has established a standard template for the preparation of a Limited-Sources Justification (LSJ) pursuant to FAR Subpart 8.4. This template is for use with orders issued under the Federal Supply Schedule (FSS) program where the value exceeds simplified acquisition threshold and competition is restricted: (1) to fewer schedule contractors than required in FAR 8.405-1, 8.405-2, or 8.405-3, or (2) to an item peculiar to one manufacturer. See FAR Subpart 8.4 for additional guidance. This template is not for use with acquisitions other than those under FAR Subpart 8.4.

Tailor all aspects of this template to the individual acquisition. Consult FAR 8.405-6 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.

FEDERAL SUPPLY SCHEDULE

LIMITED-SOURCES JUSTIFICATION

2. Description of Action:

Nature:

Pricing:

Funds:

<For each proposed contractor if more than one (e.g., brand name):>

3. Description of Supplies and Services to Include Contract Vehicle/Number Utilized:

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.

4. Authority:

When competition is limited to items peculiar 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.

5. Market Research:

Describe the extent of the market research conducted among the schedule holders and the results, or a statement of the reason that market research was not conducted. Brand name specifications shall not be used unless the particular brand name, product, or feature is essential to the Government’s requirements, and 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 need.

6. Actions to Increase Competition:

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 or services is made. If no such actions have been taken, explain why.

7. Any other facts supporting the justification:

8. Technical / Requirements Certification: By my signature below, I certify that the supporting data under my review which is included in this Limited-Sources Justification 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:

9. Best Value Determination: By my signature below, after review of the relevant documents, I have determined that the order subject to this Limited-Sources Justification represents the best value for the Government as set forth in FAR 8.404(d), and constitutes a fair and reasonable price. The basis for my determination is as follows:

Describe in detail the basis for the determination that this order provides the best value, and that the price is fair and reasonable. Attach and/or summarize applicable market research, commercial prices lists, comparable GSA schedule pricing or other markers that were used in this determination.

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 justification subject to the availability of funds, and provided that the services and supplies herein described have otherwise been approved 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 limiting sources.

Name:

Phone:

Signature:

Date:

13. Office of Small and Disadvantaged Business Utilization:

I have reviewed this justification and find that it adequately supports limiting sources.

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 limiting sources 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 - Federal Supply Schedule Health and Human Services Justification & Approval - Federal Supply Schedule

4 - Agilent 7010B GC QQQ MS 2 - Agilent 6470 LC-QQQ MS 2 - Agilent 6495 LC-QQQ MS 2 - Agilent 7000D GC/TQ 1 - Agilent 6546 LC-QTOF 1 - Agilent 1290 LC 1 - Agilent LC MS Prep System State the full statutory authority and FAR cite and title, consistent with paragraph 4, e.g. 41 U.S.C. 3304: Agilent 8890 GC 7010B QQQ MS/MS:

Trans Fatty Project within the Protein Biomarker Laboratory of the Clinical Chemistry Branch is currently performing CLIA certified biomonitoring studies to assess human exposure to trans-fatty acids in the U.S. population. GC/MS analysis for the trans fatty acid method must be highly sensitive, specific, and reproducible. In order to perform this work in a reliable manner, specific instrumentation and supplies are necessary for sample processing, as well as high throughput and prevention of any delays in the continuity of project activities. Additionally, the Tobacco Products Laboratory at the CDC has been analyzing harmful and potentially harmful constituents in cigarettes and related products for over 20 years. The rapidly changing market of vaping products in recent years has brought a huge number of new products to the market, including products with cannabinoids. These new products bring new challenges in their analysis. Vaping products, including those with cannabinoids, typically are a mixture of many natural products. The matrices of these natural products tend to cause the ion source of the mass spectrometer to quickly become dirty. Agilent distributes the Agilent 8890 GC System equipped with 7693A Autoinjector, coupled to a 7010B Triple Quadrupole MS/MS system. The Agilent System is equipped with multiple integrated features that address Protein Biomarker Laboratory’s need for continued high sample throughput, productivity, and reliable results, and the Tobacco Products Laboratory's need for robustness. It provides precise gas and temperature control. Its chromatographic peak retention time reproducibility is less than 0.0008 minutes, and its area reproducibility has less than a 0.5% relative standard deviation. This is very critical for one method because we are monitoring over 30 fatty acid analytes in one chromatographic run and retention time of each analyte peak needs to be well controlled. Moreover, the microchannel-based electron pneumatics control structure on the GC provides protection against gas contaminants, and thus, extends the lives of consumable parts. This is very beneficial because our GC column are customized and require long production time. Therefore, it is crucial to maintain the quality and lifespan of the columns and other replaceable parts. Contamination and neutral noise can be eliminated by the heated monolithic quartz gold quadrupole and triple axis detector, respectively. Also, the system is compatible with three different electron ionization (EI) sources and has multiple sample introduction methods. This versatility will optimize method efficiency for both ongoing methods and future method development. In addition, the High Efficiency Source (HES) for this GC/MS system produces at least 20 times on average as many ions as the previous generation and can increase the MS signal by ten-fold, down to attogram-level detection, which reduces the sample injection volume typically required by one-tenth. This consequently reduces the amount of biological sample we need per sample analysis and the amount of sample and chemical waste produced. The system also comes with an updated software which increases the efficiency of method editing but full training of the software is not necessary since our lab analysts have been previously trained on the basic functionalities of the software. Additionally, Agilent's patented JetClean self-cleaning ion source greatly reduces or even eliminates the need for manual source cleaning, greatly reducing the maintenance required for upkeep and enabling higher throughput by extending the time between source cleanings, which is a critical need for our analyses. This will enable more reproducible measurements, less downtime, and less analyst time, saving money by these improvements. Moreover, it has a large capacity auto sampler for higher throughput, built in controls to ensure security of data, as well as advanced GC technologies like inert flow path which helps enable lower detection limits, backflush option which reverses the flow in the column so that any remaining components are forced out through the sample inlet, and early maintenance feedback to minimize downtime and support planned maintenance. The Agilent 8890 GC System includes the 6th Gen microchannel-based Electronic Pneumatics Control (EPC) that improves system longevity and reliability with the removal of gas contaminants, a Capillary Flow Technology (CFT) that provide multi-dimensional GC gas flows for GCxGC and Dean’s Switch integration, a Purged Ultimate Union for the incorporation of deactivated column delivered to the MS and allows GC column exchange without breaking vacuum (significantly reduces system downtime), and is certified for hardware/software/firmware compatibility with the Agilent 7000D Triple Quadupole GC/MS.

Agilent 6470 LC-QQQ MS:

The Agilent 6470 Triple Quadrupole LC/MS includes a 20 kV High-Energy Conversion Dynode for increased sensitivity (lower LOD), VacShield Technology for replacing Ion Transfer Capillaries without system venting (reduces system downtime), a curved hexapole collision cell (reduces detector background noise and takes up a smaller laboratory footprint), and is certified for hardware/software/firmware compatibility with the Agilent 1290 Infinity II LC System.

Agilent 6495 LC-QQQ MS:

The Agilent 6495 Triple Quadupole LC/MS includes the 3rd Gen, All-metal iFunnel (increases sensitivity 8-10x and reduces matrix contribution to baseline), 20 kV High-Energy Conversion Dynode for increased sensitivity (lower LOD), VacShield Technology for replacing Ion Transfer Capillaries without system venting (reduces system downtime), and is certified for hardware/software/firmware compatibility with the Agilent 1290 Infinity II LC System.

Agilent 7000D GC/TQ:

The Agilent 7000D Triple Quadrupole GC/MS includes the InertPlus Electron Ionization (EI) Source with JetClean self-cleaning (significant reduction in background noise and reduces frequency of system venting and manual hardware cleaning), heated gold quadrupole, triple-axis HED-EM detector (increased sensitivity), dynamically-ramped Iris, fast venting for quick system downtime when performing repairs or maintenance, and is certified for hardware/software/firmware compatibility with the Agilent 8890 GC System.

Agilent 6546 LC-QTOF:

The 6546 LC/Q-TOF includes 5 orders of magnitude in-spectra dynamic range, maintains 30K (low mass) and 60K (high mass) resolutions independent of acquisition rate or ion abundances, contains the Quadrupole Resolved All Ions (Q-RAI) capability that allows for compound fragment identification in MS mode, acquisition rates of 3 – 30 Hz in targeted MS/MS and data independent Q-RAI modes, consistent <1 ppm mass accuracies for extended periods of time to increase data stability, and is certified for hardware/software/firmware compatibility with the Agilent 1290 Infinity II LC System.

Agilent 1290 LC:

The Agilent 1290 Infinity II LC System includes a High-Speed Binary Pump (rated for two mobile phases up to 5 mL/min, <0.5% ripple, and 1300 bar backpressure), a Multisampler that contains a refrigerated (4 ̊C) sample storage “hotel” for 14 x 96-well PCR plates (1344 samples) and a three solvent multiwash (eliminates sample carryover from injection), and a Multicolumn Thermostat that can store and heat up to 8 LC columns (temperature range of 20 ̊C below ambient to 110 ̊C), and is certified for hardware/software/firmware compatibility with the Agilent 6470, 6495, or 6546 systems.

Agilent LC MS Prep System: (GSA Contracts GS-07F-0564X334516 and GS-07F-0564X532490L) The Emergency Response Branch (ERB) requires a liquid chromatography mass spectrometry preparative (LCMS prep) system for all synthesis projects, such as, extraction of target analytes from biological matrices, the synthesis of metabolic standards for toxin detection, and purifications from solid phase synthesis of peptide standards. Many of the targets for the ERB lack commercial availability, so the Agilent prep LC system will give the branch the ability to isolate synthesized and natural products to the highest purity to ensure that standards used for mass spec purpose will have minimized interferences. The Agilent system is equipped with multi-level analysis with a variable wave detector, diode array detector, and a mass spec unit for the highest level of analyte detection for purification. The column compartment can fit up 10 columns for analyte/column compatibility development. The dual pump system ranges from a 0.1-200 mL/min flowrate and sample injects can range from 5-15700 uL, which gives the branch the ability to isolate on the sub milligram level to the gram scale for ultimate versatility. The fraction collector can collect up 5.9L of analyte solution for 432 fractions. This system will give the branch the ability to use this system for any project with purification needs.

This requirement is on Agilent's GSA contract #GS-07F-0564X334516.