SSJ - PE Redacted.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:

CDC/NCIRD/DVD

Roybal Campus, Bldg. 24, Room 5136, MS H24-5 Centers for Disease Control and Prevention Atlanta, GA Click here to enter text.

B. Contracting Activity:

Centers for Disease Control and Prevention Office of Financial Resources Acquisition Branch Click here to enter text.

C. Identification of Requirement:

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

a. Sole source acquisition of:

The contractor shall conduct genetic testing of DNA samples at the contractor’s facility.

The contractor is in the possession of the DNA samples which are stored at contractor's facility as per contract 75D30119C05084. Results of the testing shall be shared with CDC after completion of the testing.

b. Procurement Request (PR) Number (if available): 000HCVGED-2020-45121

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

b. Proposed Vendor: Marshfield Clinic Research Institute, a division of Marshfield Clinic, Inc.

i. Estimated Procurement Amount:

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

If yes, provide schedule number: Click here to enter text.

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:

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

The current project will built on previous work done by the contractor. The contractor has access to a cohort of 665 subjects who received their third dose of MMR vaccine as part of the “MMR3 Study” in 2009-2010 and which is well characterized; subjects' sera results are available from immediately prior to the third MMR vaccine dose, as well as one month, one, and five years following the administration of the third dose.

During 2019-2021, the contractor is enrolling participants for evaluating antibody response to MMR 9 years after administration of the vaccine. At the same study visit, participants were invited to participate into a genetic evaluation study and those who agreed provided a blood specimen from which the contractor extracted DNA for subsequent genetic testing. Combined with previous serology results from immediately prior to the third MMR vaccine dose, one month, one, five, and nine years following the administration of the third dose, we aim to examine HLA associations with immune response (neutralizing antibody titer) to measles, mumps, and rubella and safety following receipt of a third dose of MMR vaccine among young adults to study the role of genetics in vaccine-response to measles, mumps, and rubella in this cohort. This will allow to better understand characteristics of persons who do not respond or generate low antibody response to (repeat) vaccination and are thus potentially susceptible to disease.

Rev. 5/14/19

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

No other products and services were considered because these samples were collected during the previous study and are the only ones in existence from this cohort of study participants.

3. Program Office efforts to seek potential offerors:

Market research was not conducted. No other agency has long-term serologic data on a cohort of participants that received 3 doses of the MMR vaccine. Additionally, when participants provide samples for the genetic evaluation the consent form at enrollment indicates that the samples they provided will be shared with researchers at CDC only and not another laboratory. CDC does not have the capability to do the genetic testing on the samples. Therefore, only this agency can be used to do the genetic testing on the samples collected to examine HLA associations with immune response (neutralizing antibody titer) to measles, mumps, and rubella and safety following receipt of a third dose of MMR vaccine among young adults.

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: Mona Marin, MD, Medical epidemiologist

Center/Institute/Office COR/Program Official Signature:

Certification Date: April 28, 2020

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: Click here to enter text.

Contracting Officer Signature:

Certification Date: Click here to enter a date.

5/28/2020