JOFOC_1229150.pdf

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Justification for Other than Full and Open Competition

1. Identification of the agency and contracting activity:

a. Federal agency and contracting activity.

U.S. Food and Drug Administration

b. Sponsoring organization.

Division of Microbiology, Office of Regulatory Science, Center for Food Safety and Applied Nutrition, U.S. Food and Drug Administration

c. Contracting Officer’s Representative (Requiring Activity Point of Contact (POC) information.

i. Name: Dumitru Macarisin

i. Mailing address: Room 4E-007, 5001 Campus Drive, College Park, MD 20740

ii. E-mail address: dumitru.macarisn@fda.hhs.gov

iii. Telephone number: 240-402-1860

2. Nature and/or description of the action being approved.

Justification for Other than Full and Open Competition

a. Acquisition purpose and objectives.

The purpose of this requirement is to monitor total bacterial and fungal communities in three commercial tree fruit packing facilities’ environments that might be associated with the persistence of L. monocytogenes by supporting the establishment and biofilm growth. To achieve this goal the study proposes following specific objectives:

Objective 1: Evaluate the effectiveness of different cleaning and sanitizing procedures in reduction of environmental microbiota and Listeria monocytogenes.

Objective 2: Compare the microbial communities’ composition and ability to detect L.

monocytogenes using shotgun and amplicon sequencing

b. Project background.

FDA-CFSAN and The Pennsylvania State University research teams have been working with three tree fruit packers in Pennsylvania for the past three years to establish a baseline prevalence of L.

monocytogenes under the contract # HHSF223201610124C. While L. monocytogenes was discovered in all facilities sampled, some facilities had alarmingly high occurrence and

Last Modified: April 5, 2017 Page 2 of 7 concentrations of the pathogen in the packing house environment (~105 CFU/sponge swab), particularly directly underneath the roller brush conveyors that transport the apples through the washing, drying, and waxing process. Furthermore, a preliminary monitoring of total bacterial and fungal communities in these facilities’ environments indicated that environments with high occurrence of L. monocytogenes also have distinct microbiomes, which possibly support biofilm growth due to high relative abundance of Pseudomonadaceae species. In cases when microbiota in the environment forms biofilms, L. monocytogenes can be protected from cleaning and sanitizing activities and persist in the environment over longer periods. This leads to food safety concerns and presents a serious threat to the viability of tree fruit packing businesses as well as public health.

3. Description of the supplies or services required to meet the agency’s needs (including the estimated value).

Contractor must continue to deliver:

1. Surveillance data on the aerobic plate count (APC) and quantitative data (using MPN method with media recommended by the FDA BAM) on L. monocytogenes concentrations for 120 samples collected as specified under the objective 1.

2. Results characterizing the microbiota using 16S rRNA V4 and ITS2 sequencing for 120 samples collected as specified under the objective 1

3. Results characterizing the microbiota using a shotgun metagenomics approach with Nanopore MinION for 30 samples collected as specified under the objective 1.

4. Results on the comparison of the microbial communities’ composition and ability to detect L.

monocytogenes using shotgun and amplicon sequencing, as specified under the objective 2.

• Contractor must provide the deliverables (1 to 4) specified above by the end of the performance period, August 5, 2021.

a. Project title.

Characterization of the environmental microbiota composition and the presence of Listeria monocytogenes in commercial tree fruit packinghouses

b. Project Description.

This is a follow-on requirement to continue to monitor total bacterial and fungal communities in three (3) commercial tree fruit packing facilities’ environments that might be associated with the persistence of L. monocytogenes by supporting the establishment and biofilm growth.

Requirement type.

☒ Research & Development (R&D)

☐ R&D support services

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☐ Support services (non-R&D)

☐ Supplies/equipment

☐ Information Technology (IT)

☐ Construction

☐ Architect-Engineer (A&E) services

☐ Design-build

☐ Other:

Type of action.

☐ New requirement

☒ Follow-on

☐ Other:

Proposed contract/order type.

☒ Firm-fixed-price

☐ Other fixed-price:

☐ Cost-plus-fixed-fee

☐ Other cost reimbursement:

☐ Time and materials

☐ Indefinite delivery:

☐ Other:

☐ Completion Form

☐ Term Form

Acquisition identification number.

FDA Purchase Order number 75F40120P00425

c. Total estimated dollar value and performance/delivery period.

$75,000.00

4. Identification of the statutory authority permitting other than full and open competition. Check the applicable block below based on the acquisition circumstance.

Federal Acquisition Regulation (FAR):

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☐ 6.302-1 Only one responsible source and no other supplies or services will satisfy agency requirements. This acquisition is conducted under the authority of United States Code (U.S.C.) 10 U.S.C. 2304(c)(1) or 41 U.S.C. 3304(a)(1).

☐ 6.302-2 Unusual and compelling urgency. This acquisition is conducted under the authority of United States Code (U.S.C.) 10 U.S.C. 2304(c)(2) or 41 U.S.C. 3304(a)(2).

☒ 6.302-3 Industrial mobilization; engineering, developmental, or research capability; or expert services. This acquisition is conducted under the authority of United States Code (U.S.C.) 10 U.S.C. 2304(c)(3) or 41 U.S.C. 3304(a)(3).

☐ 6.302-4 International agreement. This acquisition is conducted under the authority of United States Code (U.S.C.) 10 U.S.C. 2304(c)(4) or 41 U.S.C. 3304(a)(4).

☐ 6.302-5 Authorized or required by statute. This acquisition is conducted under the authority of United States Code (U.S.C.) 10 U.S.C. 2304(c)(5) or 41 U.S.C. 3304(a)(5).

☐ 6.302-6 National security. This acquisition is conducted under the authority of United States Code (U.S.C.) 10 U.S.C. 2304(c)(6) or 41 U.S.C. 3304(a)(6).

☐ 6.302-7 Public interest. This acquisition is conducted under the authority of United States Code (U.S.C.) 10 U.S.C. 2304(c)(7) or 41 U.S.C. 3304(a)(7).

☐ 13.501(a)(1)(ii) Sole source, including brand name, under Simplified Procedures for Certain Commercial Items. This acquisition is using this justification format, modified to reflect that the procedures in FAR subpart 13.5 were used in accordance with 41 U.S.C. 1901 or the authority of 41 U.S.C. 1903.

5. Demonstration that the proposed contractor(s) unique qualifications or the nature of the acquisition requires use of the authority cited.

a. Name and address of the proposed contractor(s).

Jasna Kovac, Ph.D.

Assistant Professor Department of Food Science Microbiome Center The Pennsylvania State University 437 Rodney A. Erickson Food Science Building University Park, PA 16802 Phone: (814) 865-2883 Email: jzk303@psu.edu

Luke LaBorde, Ph.D.

Professor of Food Science 442 Rodney A. Erickson Food Science Building University Park, PA 16802 Email: lfl5@psu.edu Work Phone: 814-863-2298 https://www.acquisition.gov/far/html/Subpart%206_3.html http://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title10-section2304c&num=0&edition=prelim http://uscode.house.gov/view.xhtml?req=granuleid%3AUSC-prelim-title41-chapter33&edition=prelim https://www.acquisition.gov/far/html/Subpart%206_3.html http://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title10-section2304c&num=0&edition=prelim http://uscode.house.gov/view.xhtml?req=granuleid%3AUSC-prelim-title41-chapter33&edition=prelim https://www.acquisition.gov/far/html/Subpart%206_3.html http://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title10-section2304c&num=0&edition=prelim http://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title10-section2304c&num=0&edition=prelim http://uscode.house.gov/view.xhtml?req=granuleid%3AUSC-prelim-title41-chapter33&edition=prelim https://www.acquisition.gov/far/html/Subpart%206_3.html http://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title10-section2304c&num=0&edition=prelim http://uscode.house.gov/view.xhtml?req=granuleid%3AUSC-prelim-title41-chapter33&edition=prelim https://www.acquisition.gov/far/html/Subpart%206_3.html http://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title10-section2304c&num=0&edition=prelim http://uscode.house.gov/view.xhtml?req=granuleid%3AUSC-prelim-title41-chapter33&edition=prelim https://www.acquisition.gov/far/html/Subpart%206_3.html http://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title10-section2304c&num=0&edition=prelim http://uscode.house.gov/view.xhtml?req=granuleid%3AUSC-prelim-title41-chapter33&edition=prelim https://www.acquisition.gov/far/html/Subpart%206_3.html http://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title10-section2304c&num=0&edition=prelim http://uscode.house.gov/view.xhtml?req=granuleid%3AUSC-prelim-title41-chapter33&edition=prelim https://www.acquisition.gov/far/html/Subpart%2013_5.html https://www.acquisition.gov/far/html/Subpart%2013_5.html http://uscode.house.gov/view.xhtml?req=(title:41%20section:1901%20edition:prelim) http://uscode.house.gov/view.xhtml?req=(title:41%20section:1903%20edition:prelim) mailto:jzk303@psu.edu

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FDA-CFSAN recently had a three-year contract (#HHSF223201610124C) with The Pennsylvania State University focused on surveillance of three tree fruit packers in Pennsylvania to establish a baseline prevalence of L. monocytogenes. While this surveillance research discovered L.

monocytogenes occurrence in all three packinghouses, some facilities had alarmingly high occurrence and concentrations of the pathogen in specific fruit washing and processing areas (hot areas). This is quite a surprising observation s all three packing houses have similar cleaning and sanitizing protocols in place, suggesting that some other facility-specific environmental factors influence L. monocytogenes survival and persistence in tree fruit packing plans. The need for a new contract is to conduct focused surveillance for L. monocytogenes, in the hot areas identified within the facilities under the previous contract, with high-resolution microbiome characterization in the problematic areas of this tree fruit packing facilities. No other party other than the Pennsylvania State University would possess the required knowledge about hot areas and be authorized by industry to conduct sampling on those specific three tree fruit packing facilities.

b. Nature of the acquisition and proposed unique qualifications of the contractor(s)..

1. The Pennsylvania State University research faculties and technical personal possess comprehensive and unique expertise and qualifications in the area of tree fruit production and food safety. Principal investigators performing the contract project have a distinguishable scientific leadership and decades of experience in conducting microbial environmental sampling in the orchards, fruit packing and processing environments, fruit storage facilities. No other known party possesses the comparable level of expertise and reputation in characterizing environmental microbiome, managing fruit quality and microbial safety in the apple and stone fruit production chain in this area.

2. The Pennsylvania State University has over 100 years working relationship with the Pennsylvania apple fruit growers. The Penn State University has been involved in addressing the fruit quality and microbial safety issues with apple and stone fruit growers, that developed an unprecedented degree of trust and mutual respect between commercial fruit production and Penn State University faculties. Finding another Contractor with the requisite experience and qualifications to study these facilities would be challenging but moreover, would also require a duplication of efforts on research previously conducted.

3. The Pennsylvania State University is ideally located in proximity of Adams County, PA, which is the heart of tree fruit production in Pennsylvania, producing 75% of the tree fruit in the state. The nearby large commercial fruit orchards and packing/storage facilities are representative of fruit production in the United States. Consequently, due to the close geographical proximity of the Pennsylvania State University to the representative commercial fruit packing facilities, the Penn State University has unique ability to accomplish the project under the proposed budget. Considering the amount of type of samples to be collected and processed required by the contract, no other party can perform this contract at the more advantageous cost to the government.

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4. As this is a follow-on requirement to research already conducted, no other sources currently have the ability to meet the FDA’s needs.

6. Description of efforts made to ensure that offers are solicited from as many potential sources as is practicable, including whether a notice was or will be publicized as required by subpart 5.2 and, if not, which exception under 5.202 applies. .

A Presolicitation Notice (Notice of Intent to Sole Source) for this requirement was posted on betaSAM.gov on June 10, 2020 and no responses were received from interested parties in relation to this posting.

7. Determination by the Contracting Officer that the anticipated cost/price to the Government will be fair and reasonable.

The FDA scientists, Dr. Dumitru Macarisin and Dr. Narjol Gonzalez-Escalona, developed the statement of work for the current requirement and are FDA subject matter experts in isolation, identification, and genomics of foodborne pathogens. This statement of work aligns with the level of effort proposed on a firm-fixed price basis. The Pennsylvania State University is a non-profit educational institution and the proposed price includes no fee or profit. The rates for the principal investigators follow previously negotiated rates under the previous contract for which this work is to continue. The proposed firm-fixed price has been determined to be fair and reasonable after an analysis of the labor elements required to complete the studies required under the statement of work.

8. Description of the market research conducted (see FAR Part 10) and the results, or a statement of the reasons market research was not conducted.

A Presolicitation Notice (Notice of Intent to Sole Source) for this requirement was posted on betaSAM.gov on June 10, 2020 and no responses were received from interested parties in relation to this posting. Additionally, there are no other known sources that have the capability to continue this research without a substantial duplication of previous efforts. The only known source with the ability to continue this research requirement is the Pennsylvania State University through a follow-on contract.

9. Any other facts supporting the use of other than full and open competition.

Through is previous research efforts at these commercial fruit packing facilities, Pennsylvania State University has an established relationship with the facility operators which provides for an efficient follow-on of these research services. No other service provider has the established relationships to efficiently conduct these studies without a substantial duplication of previous efforts.

10. Listing of sources, if any, that expressed, in writing, an interest in the acquisition.

N/A

11. Statement of the actions, if any, the agency may take to remove or overcome any barriers to competition before any subsequent acquisition for the required supplies or services.

The FDA continually conducts market research to develop new sources. Additionally, industry responses to the FDA’s Broad Agency Announcement (BAA) are carefully reviewed for relevance to all https://www.acquisition.gov/far/html/Subpart%205_2.html https://www.acquisition.gov/far/html/Subpart%205_2.html https://www.acquisition.gov/?q=browse/far/10

Last Modified: April 5, 2017 Page 7 of 7 of the FDA’s ongoing areas of study interest. If an interested party has expertise in research areas relevant to this ongoing effort, this will be taken into consideration for future acquisitions.

12. Program office certification.

This is to certify that the portions of this justification that have been developed by the undersigned program office personnel, including supporting information and/or data verifying the Government’s minimum needs, schedule requirements and other rationale for other than full and open competition, are accurate and complete.

Signature:____________________________________

Dumitru Macarisin COR/Requiring Activity POC

August 4, 2020

13. Contracting Officer Certification.

This is to certify that the justification for the proposed acquisition has been reviewed and that to the best of my knowledge and belief the information and/or data provided to support the rationale and recommendation for approval is accurate and complete.

Signature:____________________________________

Benjamin Golway Contracting Officer

August 4, 2020