JA.pdf

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TMPLT 2016.06-012

Justification for an Exception to Fair Opportunity

1. Identification of the agency and contracting activity:

a. Federal agency and contracting activity.

Center for Biologics Evaluation and Research (CBER)

b. Sponsoring organization.

N/A

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

i. COR/POC: Sherrie High

ii. Mailing address: U.S. Food & Drug Administration

10903 New Hampshire Avenue

WO71-G103

Silver Spring, MD 20993-0002

iii. E-mail address: Sherrie.High@fda.hhs.gov

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

Scientific Data Abstraction and Information Management

a. Project background.

The Mission of the CBER is to protect and enhance the public health through the regulation of biological and related products. This includes blood, vaccines, and cellular and gene therapy products, human and cell tissues for implantation or transplantation, and medical devices involved in the collection and processing of blood and blood components according to statutory authorities. The regulation of these products is founded on science and law to ensure their purity, potency, safety, efficacy and availability. The vision of CBER is that it advances the public health and merits the public trust through innovative regulation to ensure that safe and effective products reach the public as rapidly as possible.

CBER demonstrates international leadership in science-based regulation through a managed regulatory process, coordinated research, and the use of partnerships. Included in CBER’s goals is a managed and integrated regulatory process from discovery of a product to post marketing, and participation in interactive information systems, which is integral to all CBER activities.

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The Records Management Staff (RMS) supports CBER in its public health mission by providing life cycle records management, information management and information governance. The

RMS focuses on critical program areas related to records management, scientific support, bioinformatics, regulatory data quality and process, document management functions and business operations support for the CBER community in their efforts to ensure the purity, potency, safety and efficacy of biologics.

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

Scientific Data Abstraction and Information Management

a. Project title.

Center for Biologics Evaluation and Research (CBER) Scientific Data Abstraction and Information Management

b. Project Description.

See 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:

Type of action.

☐ New requirement ☒ Follow-on 75F40120D00022/75F40121F19014 ☐ Other:

Proposed contract/order type.

☒ Firm-fixed-price ☐ Other fixed-price:

☐ Cost-plus-fixed-fee ☐ Other cost reimbursement:

☐ Time and materials

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☐ Indefinite delivery:

☐ Other:

☐ Completion Form ☐ Term Form

Acquisition identification number.

CBER-2026-133050

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

$2,001,241.20

4. Identification of the exception to fair opportunity (see 16.505(b)(2)) 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 16.505(a)(4)(ii) suggests placing brand-name justifications under this exception.

Only MPF -ZAI is capable of performing data abstraction due to their exclusive access to the proprietary database system and specialized methodologies and training. No other vendor possesses technical expertise and validated processes and several years of working with the systems being used which makes them uniquely qualified to meet the project requirements. A pre-solicitation notice was posted on SAM.gov and no responses were received.

☐ (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.

The Contracting Officer has determined that the anticipated cost to the Government is fair and reasonable. This determination was made in accordance with applicable federal acquisition regulations and is based on a thorough review and analysis of the proposed costs, pricing data, and other relevant factors. The Contracting Officer is satisfied that the agreed-upon cost reflects a reasonable price for the supplies, services, or solutions to be provided, and that the Government's interests are adequately protected under the terms of this agreement.

https://www.acquisition.gov/far/html/Subpart%2016_5.html https://www.acquisition.gov/far/html/Subpart%2016_5.html

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6. Any other facts supporting the justification.

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.

The agency acknowledges that the current acquisition was awarded under an exception to the fair opportunity process as required under FAR 16.505(b)(2). In recognition of its commitment to promoting competition and ensuring the best value to the Government, the agency intends to take the following actions prior to any subsequent acquisition for the same or similar supplies or services:

Market Research: The Contracting Officer (CO) and requiring activity will conduct comprehensive market research to identify all contractors within the applicable pool who are capable of fulfilling the requirement. This research will be documented and used to inform future acquisition planning.

Advance Planning: The requiring activity will provide sufficient lead time to the contracting office to allow for a competitive fair opportunity process. This includes early identification of requirements, timely submission of acquisition packages, and avoidance of artificial urgency that may otherwise necessitate a sole-source or limited-competition approach.

Requirements Review: The requiring activity will review and, where feasible, revise the scope of work or performance requirements to eliminate any unnecessarily restrictive specifications that may have limited competition. Requirements will be written in a manner that is technology- and vendor-neutral to the greatest extent practicable.

Contractor Development: Where applicable, the agency will engage in outreach efforts, such as industry days or requests for information (RFIs), to inform potential offerors of upcoming requirements and encourage participation in future competitions.

Coordination with Program Office: The CO will work closely with the program office to ensure that future requirements are not structured in a manner that creates dependency on a single contractor or otherwise forecloses competition.

Documentation and Oversight: The agency will maintain appropriate documentation of all steps taken to promote fair opportunity for subsequent acquisitions and will ensure that any future exceptions are properly justified, approved, and documented in accordance with applicable regulations.

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:____________________________________

Sherrie High COR/Requiring Activity POC

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Signature:____________________________________

COR/POC Immediate Supervisor

9. Contracting Officer Certification.

The CO shall complete the information required below and sign the certification in the block provided. (NOTE: The CO’s signed certification may serve as approval of a JEFO over $150,000 but not exceeding $700,000, FAR 16.505(b)(2)(ii)(C)(1) depending on OPDIV procedures.)

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

Signature:____________________________________

Ian Weiss Contracting Officer

10. Competition Advocate signature.

The designated OPDIV Competition Advocate (CA), upon acceptance of the rationale provided in the JEFO, shall complete the information required below and sign in the block provided as the approving official for any JEFO over $700,000 but not exceeding $13.5 million (FAR 16.505(b)(2)(ii)(C)(2)).

Competition Advocate

11. Head of the Procuring Activity signature(s).

The HPA, if applicable, and the HCA shall indicate review of, and concurrence with, any JEFO over $13.5M, but not exceeding $68M (FAR 16.505(b)(2)(ii)(C)(3)) by providing the information required below and signing in the applicable block.

Head of the Contracting Activity

12. HHS Senior Procurement Executive signature.

The HHS SPE, upon acceptance of the rationale provided in the JEFO, shall complete the information required below and sign in the block provided as the approving official for any JEFO over $68 million (FAR 16.505(b)(2)(ii)(C)(4)).

HHS Senior Procurement Executive https://www.acquisition.gov/?q=/browse/far/16

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