Updated_JOFOC_SOT.pdf

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TMPLT 2016.06-011

Justification for Other than Full and Open Competition

Completion Instructions:

1. Identification of the agency and contracting activity:

a. Federal agency and contracting activity.

FDA/CFSAN

b. Sponsoring organization.

OFAS/Society of Toxicology

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

i. Name: M. Thomas Keels

ii. Mailing address: FDA/CFSAN 4300 River Road, HFS-107, College Park, MD 20740

iii. E-mail address: E-mail address: M.Thomas.Keels@fda.hhs.gov

iv. Telephone number: 240-402-1035

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

Delivery of Colloquia containing four workshops on Emerging Toxicological Science Challenges in Food and Ingredient Safety Training.

a. Acquisition purpose and objectives.

To bring the most current and challenging information to Toxicologist and other Scientist within the Center for Food Safety and Applied Nutrition community. We have been able to reach our scientist in Dauphin Island and Moffett with these seminars. The information has been very beneficial to the scientific community of CFSAN.

b. Project background.

The FDA and the Society of Toxicology (SOT) have entered a partnership via Memorandum of Understanding 225-16-02 in which both organizations agreed to work collaboratively to promote best practices associated with regulatory science and toxicology. The agreement dates back to 2016 and the FDA has been purchasing an Colloquia from the SOT once per year since the start of the agreement.

Template mailto:M.Thomas.Keels@fda.hhs.gov

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

a. Project title.

Society of Toxicology Delivery of four one-half day workshops.

b. Project Description.

Refer to Statement of Work (SOW).

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:

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

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☐ Term Form

Acquisition identification number.

OFAS-19-C-2708

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

The total dollar value of this acquisition is $168,266.00 with $82,566.00 obligated at the time of award.

The contract includes one option period valued at $85,700.00 expiring on 05/31/2020.

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).

☐ 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).

Society of Toxicology

11190 Sunrise Valley Drive, Suite 300 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)

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Reston, Virginia 20191

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

The FDA and the SOT share interest in scientific progress in areas that directly and indirectly affect medicine and human and animal health. In fulfilling its responsibilities under the Federal Food, Drug and Cosmetic Act, the FDA must stay abreast of the latest developments in the field of toxicology to ensure the safety of foods, drugs and cosmetics. The FDA and SOT entered a partnership through MOU 225-16-027 to foster a well-grounded foundation in interdisciplinary fields in which professional societies and government share mutual interest. The SOT has unique capabilities and is the sole source provider for FDA/SOT Colloquia on Emerging Toxicological Sciences. As a nonpartisan body, the SOT possesses unique experiences and is an expert at conducting open sessions presenting balanced information about emerging toxicological sciences. Additionally, the workshops are taught without discussing regulatory issues under review at the FDA. With input from FDA scientists, speakers who are preeminent in the areas of special interest to CFSAN are brought on to present at the workshop sessions. The SOT draws on the broad experience of the SOT membership of over 8,100 members, encompassing those practicing toxicology in academia, government, industry, and consulting from around the world. A review of qualifications is required for membership status into the SOT and all members participate in one of twenty-nine different disciplinary sections, including the Food Safety Specialty Section, which is of unique interest to CFSAN. The SOT is unique in its extensive reach to toxicologists around the world. The personnel that the SOT provides including content specialists and program and logistics staff allow to provide for efficient and effective performance of the Colloquia;

The membership and service that the SOT provides extend significantly beyond the day of the actual colloquium and beyond what any other organization can provide. The SOTs capabilities and its long-standing partnerships with federal agencies on various projects establishes the SOT as a unique organization to satisfy the requirements.

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 Notice of Intent to award to a Sole Source vendor was announced in Federal Business Opportunities under Notice No. 1214807 on May 22nd, 2019. No interested vendors responded to the solicitation.

7. 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 Notice of Intent to Sole Source was posted to Federal Business Opportunities, requesting capability statements from interested vendors to open the requirement for competition. No vendors submitted a capability The Society of Toxicology (SOT) has been providing instructor-led training for CFSAN employees since 2016. These workshops are designed to accommodate 50-250 FDA personnel. The price per workshop proposed for 2019 courses is consistent with the fixed rate of $20,641.50, which has been in effect since 2016. According to the historical invoices provided dating back to 2016 deliveries of courses, it has been confirmed SOT has provided these courses for the same fixed price in 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

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2016, 2017, and 2018 without any increase in price to the Government. As such, when compared to the historical price, the 2019 proposed price is considered fair and reasonable.

In addition to comparing pricing to historical rates paid, the CS reviewed pricing for instructor-led training from the GSA vendor Management Concepts, Inc. (47QREA18D000Y) and considered the lowest price per student offering, which was $599.00. SOT’s proposed price per student is $412.83 ($20,641.50/50 students). As such, when compared to approved GSA pricing for instructor-led training, SOT’s proposed price per student is considered fair and reasonable.

Lastly, the CS considered the GSA pricing for Management Concepts instructor-led offerings for courses of 26-30 students. Those prices ranged from $9,884.00 to $26,054.00. While SOT’s proposed price is on the higher end of this scale, it is considered fair and reasonable given that the workshop is intended to support up to 250 students, which far exceeds the student capacity for the Management Concepts prices.

In view of the analysis above, SOT’s proposed pricing is considered fair and reasonable when compared to historical pricing, GSA approved pricing per student, and discounted GSA pricing for course offerings of 26-30 students.

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

The FDA would risk a Colloquia of unacceptable quality if awarding to another vendor and would unjustifiably bring uncertainty to a critical area that directly supports the FDA’s mission to public health. Additionally, as described above, as a nonpartisan body, the SOT possesses unique experiences and is an expert at conducting open sessions presenting balanced information about emerging toxicological sciences.

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

A Notice of Intent to Sole Source was posted to Federal Business Opportunities, requesting capability statements from interested vendors to open the requirement for competition. No vendors submitted a capability statement.

10. 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 MOU between the FDA and the SOT expires in 2021 and a reevaluation will be performed to determine if the partnership and subsequent Colloquium will continue or if commercial vendors will be capable of providing the services.

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11. 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:____________________________________

M. Thomas Keels COR/Requiring Activity POC

Mable T. Dixon COR/POC Immediate Supervisor

Dennis M. Keefe Head of the Sponsoring Program Office

12. 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.

Richard Robinson Contracting Officer