LSJ.pdf

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TMPLT 2016.06-012

Limited Source Justification

Completion Instructions:

1. Identification of the agency and contracting activity:

a. Federal agency and contracting activity.

Department of Health and Human Services (HHS) U.S. Food and Drug Administration (FDA) Office of Acquisition and Grants Services (OAGS)

b. Sponsoring organization.

Center for Devices and Radiological Health (CDRH) Office of The Center Director Quality (OCD) Quality Management and Organizational Excellence (QMOE)

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

i. COR/POC: Karina Kuhn

ii. Mailing address: karina.kuhn@hhs.fda.gov

iii. E-mail address: karina.kuhn@hhs.fda.gov

iv. Telephone number: 301-796-4059

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

a. Acquisition purpose and objectives.

New; AnyLogic Software Acquisition

CDRH Office of the Center Directory (OCD) is required to determine resources and schedules for meeting congressional requirements related to public health. Using Discrete Event Simulations will allow OCD to understand processes and determine the resources and staff needed to meet schedule requirements. This approach is needed for a high visibility project being championed by the CDRH Center Director and will be advanced with the AnyLogic Software.

b. Project background.

Template

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This is a new requirement for CDRH/QMOE to purchase this software. There is an existing contract in another center (CDER) for the same software but a different requirement. That contract is sole source.

ANYLOGIC NORTH AMERICA, LLC

1 TOWER LN STE 2655

OAKBROOK, IL 60181-4666

There is an existing contract, 47QTCA18D007Q/75F40121F80119 in CDER for the same software.

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

a. Project title.

AnyLogic Software Acquisition

b. Project Description.

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.

Req # 1255499

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

Period of performance is for 12 months base period and four (4) Option Years

Total Cost: $71,736.28

4. Identification of the exception to fair opportunity (see 6.302) and the supporting rationale, including a demonstration that the proposed contractor’s unique qualifications or the nature of the acquisition requires use of the exception cited. If the contracting officer uses the logical follow-on exception, the rationale shall describe why the relationship between the initial order and the follow-on is logical (e.g., in terms of scope, period of performance, or value).

(A) The agency need for the supplies or services is so urgent that providing a fair opportunity would result in unacceptable delays.

(B) Only one awardee is capable of providing the supplies or services required at the level of quality required because the supplies or services ordered are unique or highly specialized.

IAW 13.501(a)(1)(ii) suggests placing brand-name justifications under this exception.

(C) The order must be issued on a sole-source basis in the interest of economy and efficiency because it is a logical follow-on to an order already issued under the contract, provided that all awardees were given a fair opportunity to be considered for the original order.

(D) It is necessary to place an order to satisfy a minimum guarantee.

(E) For orders exceeding the simplified acquisition threshold, a statute expressly authorizes or requires that the purchase be made from a specified source.

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

"Prior to the award of the proposed contract/order, cost or pricing information will be obtained from the proposed contractor and price and/or cost analysis will be performed and documented to sufficiently determine that the cost to the Government of the proposed acquisition will be fair and reasonable."

The Cost/Price for is based on AnyLogic’s GSA Pricing found here:

0WEJQG.3S4WP7_47QTCA18D007Q_ANYLOGICTEXTFILE20210729.PDF (gsaadvantage.gov)

6. Any other facts supporting the justification.

The AnyLogic acquisition is proprietary COTS software with GSA advantage pricing.

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AnyLogic supports three modeling approaches: system dynamics, discrete event simulation, and Agent-based modeling. Although AnyLogic will first be used for discrete event simulation, the other capabilities may be needed for future simulation projections. AnyLogic uses a graphical modeling language, but also allows users to tailor or add to simulation models using custom code written in either the Java or Python programming languages. The ability to add functions beyond those provided with the application is key to being able to create models of the unique processes used by CDRH.

7. Statement of the actions, if any, the agency may take to remove or overcome any barriers that led to the exception to fair opportunity before any subsequent acquisition for the supplies or services is made.

Requirements will be re-evaluated before each option year. However, as long as the requirement can only be met by AnyLogic.

8. Program office certification.

Evidence that any supporting data that is the responsibility of technical or requirements personnel (e.g., verifying the Government’s minimum needs or requirements or other rationale for an exception to fair opportunity) and which form a basis for the justification have been certified as complete and accurate by the technical or requirements personnel.

Signature:____________________________________

Karina Kuhn COR/Requiring Activity POC

Signature:____________________________________

Christopher Scott COR/POC Immediate Supervisor

Signature:____________________________________

Cathy Oliveri Head of the Sponsoring Program

9. Contracting Officer Certification.

The CO shall complete the information required below and sign the certification in the block provided.

This is to certify that the justification is accurate and complete to the best of the contracting officer’s knowledge and belief.

Signature:____________________________________

Contracting Officer

Cathy M. Oliveri -S Digitally signed by Cathy M. Oliveri -S Date: 2022.06.20 19:26:35 -04'00'

Karina Kuhn -S Digitally signed by Karina Kuhn -S Date: 2022.06.28 14:15:39 -04'00'

Christopher T. Scott -S Digitally signed by Christopher T.

Scott -S Date: 2022.06.29 01:23:17 -04'00'

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