Notice of Intent NICHD-21-014.pdf

INTRODUCTION

THIS IS A PRE-SOLICITATION NON-COMPETITIVE (NOTICE OF INTENT) SYNOPSIS TO AWARD A

CONTRACT OR PURCHASE ORDER WITHOUT PROVIDING FOR FULL OR OPEN COMPETITION.

The National Institutes of Health, National Institute of Child Health and Development (NICHD), in support of the work of the National Institute of Diabetes, Digestive, and Kidney Disease (NIDDK), intends to award a purchase order without providing for full and open competition to Information Management Services (IMS), 3901 Calverton Blvd, Calverton, MD 20705 to acquire data repository transition services.

NORTH AMERICAN INDUSTRY CLASSIFICATION SYSTEM (NAICS) CODE

The intended procurement is classified under NAICS code 541990 with a Size Standard $16.5M.

REGULATORY AUTHORITY

The resultant contract will include all applicable provisions and clauses in effect through the Federal Acquisition Regulation (FAR) Circular (FAC) 2020-09 effective 10-26-2020. This acquisition is conducted under the procedures as prescribed in FAR subpart 13.5-Simplified Procedures for Certain Commercial Items exceeding $250,000 and FAR Subpart 12- Acquisition of Commercial Items.

STATUTORY AUTHORITY

This acquisition is conducted under the authority of the Federal Acquisition Regulation (FAR) Part 13 & 13.5, Subpart 13.106-1 (b) (1), Soliciting from a single source. Contracts awarded using FAR Part 13—Simplified Acquisition Procedures are exempt from the requirements of FAR Part 6— Competition Requirements.

Place of Performance National Institutes of Health 9000 Rockville Pike Bethesda MD 20892 United States

DESCRIPTION OF REQUIREMENT

The NIDDK Central Repository program seeks to establish a contract to ensure the successful transition of the NIDDK Data Repository beyond the current period of performance for task order number 75N92019D00019-75N92020F0001, allowing time for a seamless transition to a new Data Repository contractor with minimal disruptions to routine Central Repository operations and

PRE-SOLICITATION NON-COMPETITIVE (NOTICE OF INTENT) SYNOPSIS

support to NIDDK-funded research projects.

Storing and allowing subsequent use of biological materials and associated data collected in clinical studies is one way for the NIDDK to meet its responsibility to maximize the value of these studies. The NIDDK Central Repository collection of the biosamples and associated clinical, diagnostic, genotypic, pedigree structure and/or other data is a resource that advances the development of diagnostic and treatment tools for many diseases. The NIDDK Biorepository houses biological materials collected in large clinical studies. The project described in this Statement of Work, which will be referred to herein as the "Data Repository," stores the data from these large studies, including data associated with the stored biosamples and acts as the Data Coordinating Center for the NIDDK Central Repository. A full and open competitive requirement was awarded to Information Management Services (IMS) to perform as the NIDDK Data Repository on July 1, 2013. Contract No. HHSN276201300007C was awarded to IMS as a 1-year base period with 4 option years. The contract was extended on June 29, 2018 through November 30th, 2018 via Modification 0014. The Contract was extended again in 2019 (Contract Number:

75N92019D00019, Task Order: 75N92020F00001) with a PoP end date of November 29th, 2020 to allow time to complete contract re-competition.

The Data Repository, acting as a central coordinating entity for the Central Repository operation, facilitates efficient distribution of data and samples. As an archive and distributor of highly usable legacy datasets, the Data Repository also allows re-analysis of these data and, where relevant, of specific biosamples, thus encouraging work by junior investigators, investigators with novel approaches, and others not included in the original funded studies.

SCOPE OF WORK

The Scope of Work consists of all services necessary for the vendor to provide transition out support for the successful transition of Data Repository to a new vendor. Support shall ensure the continued operation of the Data Repository during transition as well providing support and services necessary for the incoming vendor to seamlessly continue current Data Repository operations after the expiration of this contract.

PERIOD OF PERFORMANCE

Base Period: December 1, 2020 – March 1, 2021 Option Period 1: March 2, 2021 – April 1, 2021

CONTRACTING WITHOUT PROVIDING FOR FULL OR OPEN COMPETITION (INCLUDING BRAND-

NAME) DETERMINATION

The determination by the Government to award a contract without providing for full and open competition is based upon the market research conducted as prescribed in FAR Part 10—Market Research. Only one source is available: Per FAR 13.106-1(b)(1) the Contracting Officer has determined that Information Management Services (IMS) is the only Contractor capable of providing the required data transition services.

The transition period is required to allow the new vendor sufficient time to develop systems and procedures, transfer existing NIDDK Central Repository held data resources and biosample data and associated metadata from the incumbent contractor, and to get up to speed on the requirements for the day to day operations and maintenance of the Central Repository, and provide a seamless hand-off to the new vendor at the end of this period of performance.

The current contractor, IMS, has the necessary personnel in place with the unique knowledge of platforms and software used, regulatory requirements, procedures, protocols and skills to continue the mission requirement for the proposed period.

IMS holds the NIDDK Central Repository clinical research data, associated sample data, and all systems and processes related to Central Repository operations. No other contractor could fulfill all the requirements necessary to compete for a transition contract as they don’t hold these DK supported resources. Attempting to have another vendor perform this short, 3-month option period will create an unnecessary duplication of cost, and worse, the inability to perform the activities required. Additionally, choosing a new vendor creates technical risks such as loss of data, unexpected system crashes, unauthorized data access, needless rework of artifacts during development, decrease in customer support and satisfaction, and data loss in transferring data from one vendor to another. The amount of time it would take a new vendor to ramp up to perform at a level that eliminates these risks would take most, if not all, of the extension period.

Competing the award would pose unnecessary delays and additional down time for all Central Repository operations which would be detrimental to the active studies and the ability to fulfill data and sample requests from outside researchers.

CLOSING STATEMENT

This synopsis is not a request for competitive proposals. However, interested parties may identify their interest and capability to respond to this notice. Responses to this notice shall contain sufficient information to establish the interested parties’ bona-fide capabilities for fulfilling the requirement, unit price, list price, shipping and handling costs, the delivery period after contract award, the prompt payment discount terms, the F.O.B. Point (Destination or Origin), the Dun & Bradstreet Number (DUNS), the Taxpayer Identification Number (TIN), and the certification of business size. All offerors must have an active registration in the System for Award Management (SAM) www.sam.gov.”

A determination by the Government not to compete this proposed contract based upon responses to this notice is solely within the discretion of the Government. The information received will normally be considered solely for the purposes of determining whether to proceed on a non-competitive basis or to conduct a competitive procurement.

All responses to this notice shall be submitted electronically by 12:00 PM Eastern Standard Time, on November 23, 2020.

Assessment of Capability The contractor will be evaluated on their capability to provide the product to the specifications as stated on the solicitation. Responses to this notice shall contain sufficient information to established the interested parties bona-fide capabilities for fulfilling the requirement and include:

certification by the OEM that you are authorized to provide services, unit price, list price, shipping http://www.sam.gov/ and handling costs, the delivery period after contract award, the prompt payment discount terms, the F.O.B. Point ( Destination or Origin), the Duns & Bradstreet Number (DUNS), the Taxpayer Identification Number (TIN), and certification of business size. All offerors must have an active registration in the System for Award Management (SAM) www.sam.gov.