REDACTED JOFOC.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.

Department of Health and Human Services Food and Drug Administration, Office of Acquisitions and Grant Services (OAGS)

b. Sponsoring organization.

Center for Food Safety and Applied Nutrition (CFSAN), Office of Applied Research and Safety Assessment (OARSA)

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

i. Name: REDACTED

ii. E-mail address: REDACTED

iii. Telephone number: REDACTED

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

The Food and Drug Administration (FDA), Center for Food Safety and Applied Nutrition (CFSAN), Office of Applied Research and Safety Assessment (OARSA) requires systematic reviews and meta-analysis training from Dr. Annette O’Connor. The focus of the required training workshop is the application of research synthesis technologies for plant science.

a. Acquisition purpose and objectives.

FDA has a mission to protect and promote public health. OARSA provides Center and Agency leadership in toxicology: reproductive toxicology, neurotoxicology, immunotoxicology, molecular toxicology, and in vitro toxicology with special emphasis on developing higher throughput methods in hepatotoxicity, neurotoxicity, renal toxicity, cardiotoxicity, dermal and nanoparticle toxicity; microbiology, which includes foodborne parasites and viruses, and molecular biology:

genetic and biomarkers, microbial genetics, including molecular epidemiology and molecular virology, and foodborne allergens and glutens. OARSA supports the program offices, Office of Food and Veterinary Medicine (OFVM) and the field laboratories of Office of Regulatory Affairs (ORA) in achieving goals established through the research prioritization process. The required systematic review and meta-analysis training provides Food and Drug Administration (FDA) staff hands on/interactive sessions to enable participants to practice evidence synthesis concepts. This new requirement is for a plant science workshop that will focus on discussing different types of questions: prevalence, risk factors for exposure, and interventions to reduce contamination. The required system review and meta-analysis training differs from the prior workshops on systematic reviews in toxicology, which were directed at understanding the different layers of Population (including animal species), Exposure, Comparator, and Outcomes (PECO) questions about the toxicity of exposure: human, animal, and mechanistic evidence. The required plant science

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b. Project background.

FDA has received systematic review and meta-analysis training for the past four (4) years from Dr.

Annette O’Connor, an international and national expert in the use of systematic reviews and data synthesis. Last year’s training under Contract 75F40122P00221 was for systematic reviews, methodology and scoping exercises. The required system review and meta-analysis training differs from the prior workshops on systematic reviews in toxicology, which were directed at understanding the different layers of Population (including animal species), Exposure, Comparator, and Outcomes (PECO) questions about the toxicity of exposure: human, animal, and mechanistic evidence. The subject plant science workshop will focus on prevalence, risk factors for exposure, and interventions to reduce contamination.

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

The Contractor shall present all didactic and practical material to FDA staff at the FDA facility in Laurel, MD. Each of the four (4) daily session shall be a mixture of interactive lectures with practical/software sessions that will enable roughly 20 to 25 participants to practice the evidence synthesis concepts. The practical sessions shall be group exercises, with two (2) instructors moving between groups and guiding discussion. Software sessions shall show participants how the results are generated by the software. The Contractor shall furnish the necessary personnel, materials, services, and facilities and otherwise do all the things necessary for, or incident to, the performance of the work as described below. The contractor shall work closely with CFSAN’s Contracting Officer Representative (COR) throughout the contract.

Base Period: 7/11/23 to 7/14/23. Value: REDACTED Option Period 1: Value: REDACTED

a. Project title.

SCOPING REVIEWS AND SYSTEMATIC REVIEWS IN PLANT SCIENCE

b. Project Description.

See attached Statement of Work

Requirement type.

☐ Research & Development (R&D)

☐ R&D support services

☐ Support services (non-R&D)

☐ Supplies/equipment

☐ Information Technology (IT)

☐ Construction

☐ Architect-Engineer (A&E) services

☐ Design-build

☒ Other: Training

Type of action.

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☐ 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.

Requisition 1266951.

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

Estimated cost is REDACTED (base plus option period 1)

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):

☒ 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).

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

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☐ 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).

Annette O’Connor

EVIDENCE AND EPIDEMIOLOGY CONSULTING

2019 Pawnee Trail Okemos, 48864.

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

The Government requires unique training that is of high importance to CFSAN, specifically for developmental neurotoxicology. The proposed sole source vendor, Dr. Annette O’Connor is the only known source that that is an international and national expert in the use of systematic reviews and data synthesis. The proposed vendor has the expertise and has previously supported CFSAN’s ability to train scientists in both microbiology and toxicology. There was no other vendor found that could offer to teach both topics at the same time. Furthermore, the desired vendor has trained the entire European Food Safety Agency on these methods and analysis that OARSA is requesting. FDA’s training by the same vendor provides a common framework for international and national research and helps bring uniformity to guidance development. The purpose of this course is to acquire training on the application of research synthesis technologies to plant science, which will help CFSAN OARSA strategically plan and guide research direction. The required workshop also builds off the previous four (4) years of training, but with updates to the technologies and techniques. The proposed vendor provides FDA with the training that is described above and is the only known source that can do so.

Therefore, only the proposed vendor: Annette O’Connor of Evidence and Epidemiology Consulting is able to meet the Government’s minimum requirements.

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

Effective competition is not applicable based upon the market research conducted by the Contracting Officer’s Representative Kristen McLaughlin and Technical Point of Contract Elizabeth Dennard during the months of April to June 2023. Market research consisted of searching the internet, researching previous market research performed on similar acquisition, and talking to knowledgeable colleagues in FDA and industry to obtain information on other experts with the ability to provide the required training. Only Dr. Annette O Connor of Evidence and Epidemiology Consulting was found with the ability to provide OARSA with the required plant science workshop on the application of research synthesis technologies. Dr. O’Connor is the only known source who is an international and national expert in the use of systematic reviews and data synthesis. Furthermore, Dr. O’Connor has trained the entire European Food Safety Agency on these methods and analysis that OARSA is requesting.

Having FDA’s training by the same source provides a common framework for international and national research and helps bring uniformity to guidance development. The proposed vendor provides FDA with the required training that meets the Government minimum requirements and is the only known source with the qualifications, expertise, training, and background required to provide the required plant science workshop that that builds off the previous four (4) years of training in systematic review and meta-analysis that was also taught by Dr. O’Connor 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) https://www.acquisition.gov/?q=browse/far/10

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

The Contracting Officer will conduct price analysis to determine the reasonableness of the proposed price. The Contracting Officer will request a published price list or two (2) previous invoices from for similar or same supplies and services to determine fair and reasonable pricing. The Contracting Officer will also request a most favorable customer statement. The Contracting Officer will not obtain the certificate of current cost or pricing as the acquisition is under the required $2 million threshold and is commercial.

8. 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: REDACTED

REDACTED

COR/Requiring Activity POC

06/13/2023

9. 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:____ 6/28/2023

X Jennifer Mun

Signed by: Jennifer M. Mun -S Jennifer Mun

Contracting Officer

06/13/2023