ORA BNJ.pdf

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Brand Name Justification

1. Identification of the agency and contracting activity:

a. Federal agency and contracting activity.

U.S. Food and Drug Administration (FDA) and Office of Acquisition and Grants Services (OAGS)" federal agency and contracting activity.

b. Sponsoring organization.

Office of Regulatory Affairs/Office of Regulatory Management Operations

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

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

The nature and purpose of this document is to delineate in writing the justification and approval (J&A) of a Brand Name acquisition for the Budget Trucker subscription in accordance with the Federal Acquisition Regulation (FAR 16.505(a)(4) & (b)(2)(B).

In accordance with FAR 16.505(b)(2)(B), the action being proposed for approval is a justification for an exception to fair opportunity under a contract. This is a brand name justification for the subscriptions of federal and state legislative tracking tools which expands beyond policy and budget news, and Services, currently FDA utilizes this information to meet its mission.

Procurement of brand subscription is critical for the Agency to meet its regulatory mission. FDA is responsible for protecting and promoting public health by ensuring the safety, effectiveness, and security of human and animal drugs, biologic products, medical devices, food, and cosmetics and regulating tobacco products. In support of this mission, FDA requires subscriptions to support the management FDA’s extensive budget data sets. FDA requires the continuation of this subscription because ORA’s budget and formulation teams develop and monitor the financial plan, prepares budget estimates and budget justifications, keeps abreast of congressional hearings, and respond to formal questions from appropriation subcommittees. The nature of ORA’s mission necessitates 24/7 access to customized detailed alerts, which enables ORA to effectively manage, track, and communicate comprehensive and timely information easily and quickly. No other subscription service provides this level of breadth and scale.

a. acquisition purpose and objectives.

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The objective of the contract is to purchase subscriptions to news, schedules, federal budget and appropriations.

b. Project background.

In the Food and Drug Administration, Office of Regulatory Affairs, Budget Formulation and Execution Senior Managers need to be kept abreast of Budget & Appropriations activities in the House and Senate to know the status of bills such as continuing resolutions and budget votes in real-time updates. We have been using the contractors and the information is below:

Current Previous Contract/Order 75F40119P10244 HHSF223201820058A Incumbent CQ Roll Call Inc. CQ Roll Call Inc.

Period of Performance 8/21/2019 to 8/09/2024 8/21/2018 to 8/20/2019 Amount Awarded Initial award CQ Roll Call with BNJ CQ Roll Call with BNJ

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

FDA needs subscriptions for six (6) individuals, the purchase of subscriptions for an estimated dollar value of the base year is and option year 1 to 4 is .

FDA is in need of news and schedules which includes daily legislative news and insight, schedules, defense, magazine, a newsletter which focuses on the politics, people and personalities of Capitol Hill and carries a legacy of objective and non-partisan news and a document or method to track the federal budget and appropriations.

Without this critical information, budget estimation would be jeopardized. Consequently, using an alternative solution would not allow the FDA to have this information. This would not be an acceptable solution and would prevent the FDA from meeting the mission of protecting public health.

a. Project title.

Subscription to news, schedules, federal budget and appropriations.

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

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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.

ALP No. ORA-2024-123692

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

for Base and 4 Option Years

4. An identification of the statutory authority permitting other than full and open competition.

The statutory authority permitting items peculiar to one manufacturer is in accordance with 16.505(a)(4).

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

This acquisition will be competed on SAM.gov. The FDA will accept quotes from all vendors who can provide subscriptions for daily legislative news and insight, schedules, defense, magazine, a PDF formatted newsletter and a PDF form of the federal budget and appropriations. An Independent Government Cost Estimate (IGCE) developed by the program office and previous contracts will be used to compare at a high level to the submitted quotes to aid in the price reasonableness determination.

6. Any other facts supporting the justification.

No additional input.

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.

ORA reviews its strategic technology investments and works with OAGS to develop long-term goals for improved competition.

8. Program office certification.

Evidence of any supporting data 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

Last Modified: May 18, 2016 Page 4 of 4 opportunity) and which form a basis for the justification have been certified as complete and accurate by the technical or requirements personnel.

Signature: ____________________________________

Soma Bhattacharyya COR/Requiring Activity POC

COR/POC Immediate Supervisor

Head of the Sponsoring Program Office

Melanie L. Bailey -S Digitally signed by Melanie L.

Bailey -S Date: 2024.08.13 06:58:44 -04'00'

Michelle Hawley -S Digitally signed by Michelle Hawley -S Date: 2024.08.13 07:35:41 -04'00'