Site_Visit_Presentation.pdf

Solicitation No.: FDA-Off-Site-RIM-000141 Fully Integrated Records Facility

(Offsite Document Control Center)

Site Visit June 2, 2014

10:00 AM – 12:00 PM

White Oak Campus

Building 66, G514 Conference Room

Tania Gates, Contract Specialist, Office of Acquisitions and Grants Services (OAGS)

Jennifer Fagan, Contracting Officer, Office of Acquisitions and Grants Services (OAGS) - not in attendance

Robin Jeffries, Center for Devices and Radiological Health

(CDRH)

Barbara Zimmerman, Center for Devices and Radiological Health (CDRH)

Introductions

We will not be answering questions TODAY! All Questions must be submitted in writing to Tania Gates at Tania.Gates@fda.hhs.gov by the question deadline or 12:00pm ET Tuesday June 3, 2014 and shall be in the format indicated in Attachment 9. Refer to Section 48 of the solicitation.

This Presentation will be uploaded to FedBizOpps NLT tomorrow morning. Paper copies will not be provided today.

The site visit will occur at the conclusion of this presentation.

Rules of Engagement and Other Information

The FDA is establishing an Indefinite Delivery/Indefinite Quantity (IDIQ) contract for an off-site Fully Integrated Records Facility

All work shall be performed at the Contractor’s facility.

Give a walk through of the current on-site document control center

Purpose

Solicitation Issuance: May 23, 2014

Site Visit: June 2, 2014; 10:00 AM – 12:00 PM

Questions Deadline: June 3, 2014, 12:00 PM ET

Proposal Due Date: June 23, 2014, 2:00 PM ET – Hard copies, duplicate CDs, and Past Performance Questionnaires must all be in by this due date to Tania Gates at:

Food and Drug Administration Office of Acquisitions & Grants Services 5630 Fishers Lane, HFA-500 Rm 2116 Rockville, MD 20857

Key Dates

Set-Aside: 100% Small Business Set-Aside. Award will be made to a small business. Only small businesses are eligible to make offers.

NAICS code: 541611 with a Small Business Size Standard of $14.0 million

52.219-14 Limitations on Subcontracting applies to the resultant IDIQ contract and respective task orders. The prime contractor MUST perform 51% of the service with their own in-house labor.

Resultant Contract Overview

Number of Awards: One (1) Contract Award will be made.

Contract Type: Hybrid, Firm Fixed Price, Labor Hour or Time and Materials Task Orders

Minimum: Task Order 1 fulfills the minimum order guarantee

Ceiling Price: $103,000,000.00; aggregate dollar value of all task orders awarded over a 60 month ordering period.

Period of Performance: 60 month ordering period which consists of a 12 month base period with four 12 month optional periods

Task Orders Period of Performance: Each Task Order performance work statement will specify the task order period of performance

Task Order #1: Premarket Tracking Services

Please pay close attention to the following items in the solicitation:

– Go/No Go Facility Criteria

– Proposal Instructions; There are two pricing spreadsheets (Attachments 5 and 6) that shall be submitted with your proposal.

– Evaluation Criteria

Solicitation Requirements

The Government will make a Best Value Determination using a Tradeoff Process.

The weighted technical evaluation factors combined, are significantly more important than cost or price.

As technical merit of offeror’s proposals become equal, the evaluated price may become the determining factor.

How the Government will Evaluate Quotations

Past Performance will be evaluated as a risk assessment, not as a weighted technical evaluation factor.

Helpful Hint: Make your initial submission your best offer! The Government reserves the right to make award without discussions.

How the Government will Evaluate Quotations

Proposal must demonstrate that offeror’s facility meets ALL criteria for the Go/No Go Factor

If a proposal does not meet all criteria, offeror will no longer be considered for award.

Go/No Go Factor

This is the initial task order that will be awarded in conjunction with the IDIQ contract

Refer to Attachment #2 to the solicitation

Barbara Zimmerman will provide a brief overview of the services at the conclusion of this presentation

Task Order #1: Premarket Tracking Services

I can submit questions after the deadline and the Government has to answer them. Not true - Submit all of your Questions by the Question Deadline – June 3, 2014 12PM ET. Questions submitted after the deadline may not be answered.

If I make it into the Competitive Range, I will have an opportunity to submit a BAFO – this is Urban Legend and not Real. Make your initial offer your BAFO.

This opportunity is wired. No, No, No – this opportunity is wide-open. Teaming Arrangements are encouraged and we are looking for healthy competition.

Tania talks entirely too much – 100% true!

Closing Remarks – De-Bunking Myths