SSJ pdf.pdf

JUSTIFICATION FOR SOLE SOURCE PROCUREMENT (OPEN MARKET OR GSA)

UNDER $250,000

Sole source acquisitions may be used on a limited basis and only when the Contracting Officer’s Representative (COR)/Program Official has provided sufficient justification and the Contracting Officer has determined that the circumstances warrant such action. The content for a justification must contain detailed facts and rationale to justify the sole source acquisition. Soliciting from a single source must be done in accordance with FAR 13.106-1(b) or 8.405-6. At a minimum, the following information must be included:

Identification of Program Office, Contracting Activity, and Proposed Requirement, Justification and Program Office Certification:

A. Program Office:

National Center for Environmental Health Chamblee Campus Building 110, Room 5202, MS-F50 Centers for Disease Control and Prevention Atlanta, GA 30341

B. Contracting Activity:

Centers for Disease Control and Prevention Office of Financial Resources Acquisition Branch 4, C. Identification of Requirement:

1. Nature of Action to be Approved by Contracting Officer:

a. Sole source acquisition of: Fifty (50) HALO BioClass Peptide ES-C18, 160 Å, 2.7 um, 4.6 x 5 mm, Fuse-Core Guard Column 3/pk, item # 92124102 from Mac-Mod Analytical

b. Procurement Request (PR) Number (if available):

2. Proposed Vendor and Estimated Procurement Amount (if available):

a. Proposed Vendor: Mac-Mod Analytical, Inc. 103 Commons Court, Chadds Ford, PA 19317

b. Estimated Procurement Amount: $

3. Is the requirement on GSA Schedule? ☐ Yes ☒ No

If yes, provide schedule number:

Rev. 5/14/19

D. Justification:

1. The justification for this non-competitive action is:

☒ In accordance with FAR 13.106-1(b)(1), “only one source [is] reasonably available” which states that, “For purchases not exceeding the simplified acquisition threshold. (i) Contracting officers may solicit from one source if the contracting officer determines that the circumstances of the contract action deem only one source reasonably available (e.g., urgency, exclusive licensing agreements, brand-name or industrial mobilization). (ii) Where a single source is identified to provide a portion of a purchase because that portion of the purchase specifies a particular brand-name item, the documentation in paragraph (b)(1)(i) of this section only applies to the portion of the purchase requiring brand-name item. The documentation should state it is covering only the portion of the acquisition which is brand- name.”

☐ Urgency ☐ Exclusive licensing agreements/Proprietary data ☐ Brand name required ☐ Industrial mobilization ☒ Other (e.g., compatibility, space issues, continuity, compatibility, etc.)

☐ In accordance with FAR 8.405-6 “Limiting Sources” which states that, “the only circumstances that may justify the action are – (A) An urgent and compelling need exists, and following the procedures would result in unacceptable delays; (B) Only one source 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; or (C) In the interest of economy and efficiency, the new work is a logical follow-up to an original Federal Supply Schedule order provided that the original order was placed in accordance with the applicable Federal Supply Schedule ordering procedures. The original BPA must not have been previously issued under sole-source or limited-sources procedures.”

☐ Urgency ☐ Only One Source ☐ Logical Follow Up ☐ Brand name required

2. Other facts supporting sole source procurement:

a. What can this product/service do that other products/services cannot do?

The Mac-Mod guard columns have been characterized and optimized on six Perfinity systems for high throughput of lipid samples in our Apolipoprotein quantitation method. The Mac-Mod guard columns are specifically designed to work on-line with our analytical column to provide a rapid and a continuous sample analysis. Also, the Mac-Mod guard columns are optimized and validated to work with our on-line trypsin columns and analytical columns in our Perfinity systems to provide a highly efficient digestion while providing higher peptide recovery. Other products cannot provide the integrated and continuous sample analysis and high throughput that our lipids method requires to accomplish our organized workflow of sample analysis. The Mac- Mod guard columns assist in sample clean-up, pre-concentration, desalting and detergent removal at 50 C and while functioning optimally during analytical analysis of an average of 2000 injections per week. To assure the continuity of our lipids program and to continue with our sample analysis and throughput, it is essential to acquire the same Mac-Mod guard columns.

b. What other products/services were considered and why did they not meet the need?

Rev. 5/14/19

The Mac-Mode guard columns are the only columns that we must continue using in our clinical studies to accomplish our project’s objectives and to fulfill the CDC’s mission. The use of a different guard column will invalidate our analyses and it will completely halt the project since a new method validation will be required

3. Program Office efforts to seek potential offerors:

An extensive review of online vendor literature was conducted to identify alternate vendors for this product. Our current working oven temperature for our methods are 50 degrees at 7-8 pH range which eliminated most vendors. Based on the temperature and the pore size specifications no other vendor met the specifications of our validated methods.

E. Program Office Certification:

I have reviewed this sole source justification and certify the justification is true and accurate to the best of my knowledge and adequate to support other than full and open competition.

Center/Institute/Office COR/Program Official Name/Title: CDC/DDNID/NCEH/DLS/

Certification Date:

F. Contracting Office Certification:

I have fully relied on the information provided herein and hereby certify that this justification is accurate and complete to the best of my knowledge and belief:

Contracting Officer Name:

Certification Date:

Howard D. Bish -S

Digitally signed by Howard D.

Bish -S Date: 2022.03.14 13:52:30 -04'00'