Notice of Intent.pdf

Notice of Intent to Sole Source

Solicitation Number: 75N92022Q0473 Solicitation Type: Sole Source (Non-Competitive) Title: Williams Syndrome Clinic Support NAICS / Size Standard: 541990/ $17 M

Introduction

THIS IS A PRE-SOLICITATION NON-COMPETITIVE (NOTICE OF INTENT) SYNOPSIS TO AWARD A PURCHASE ORDER WITHOUT PROVIDING FOR FULL AND OPEN COMPETITION. The National Heart, Lung, and Blood Institute (NHLBI), Office of Acquisitions (OA), intends to negotiate and award a purchase order on a noncompetitive sole source basis to Washington University to provide Williams Syndrome Clinic Support to the NHLBI Division of Intramural Research (DIR) in accordance with the following information.

Background Information

Dr. Beth Kozel of the Division of Intramural Research of the National Heart Lung and Blood Institute (NHLBI) is engaged in translational research of Williams Syndrome. Williams Syndrome is a gene deletion disorder that leads to severe adverse cardiovascular, musculoskeletal and cognitive abnormalities. Much of the severe abnormalities are a direct result of variants in the elastin (ELN) gene. Elastin is the protein that is responsible for recoil in tissues that undergo repeated deformation such as the skin, lungs and blood vessels. Individuals possessing mutations in the elastin gene that cause haploinsufficiency for elastin exhibit the rare stenotic vascular disease supravalvular aortic stenosis (SVAS). Similarly, when the entire elastin gene is deleted as part of the contiguous gene deletion syndrome, Williams Syndrome, patients display SVAS in addition to other syndromic features, such as characteristic faces and a gregarious personality. Vascular features in individuals with either of these conditions include areas of narrowing in large conducting vessels such as the aorta and pulmonary artery, increased vascular stiffness and hypertension, but vary greatly from individual to individual even though most of the WS population shares the same deletion.

During her tenure at Washington University of St. Louis, Dr. Kozel developed a world-renowned clinic for Williams Syndrome patients called the St. Louis Children’s Hospital Williams Syndrome Clinic (WSC). The WSC is a highly coordinated multi-disciplinary clinic directed that sees patients with Williams Syndrome and isolated SVAS for clinical care related to their disease. As such, the WSC has rare access to a unique pool of patients that will be a source of various NHLBI-sponsored protocols.

In order to establish a close, working relationship with WSC and maintain access to a unique pool of patients for future NHLBI protocols, the NHLBI will fund part of one Nurse Practitioner, one Genetic Counselor and one Nurse Coordinator at WSC. It will also fund provide funds to cover research expenses incurred at WUSM such as phlebotomy fees and patient facing surveys/questionnaires. It is expected that these additional resources will not only contribute directly to NHLBI protocols but also augment NHLBI’s presence within the Williams Syndrome community which extends beyond national boundaries.

Purpose and Objectives

The NHLBI Division of Intramural Research aims to help fund translational research of Williams Syndrome by funding a Nurse Practitioner, Genetic Counselor, and Nurse Coordinator at Williams Syndrome Clinic, and research related expenses. This effort’s aim is to enhance the health of Williams Syndrome patients both domestically and internationally.

Period of Performance

The Period of Performance will be September 1, 2022 through August 31, 2023 with the potential of four option periods as follows:

Option Period 1: September 1, 2023 through August 31, 2024.

Option Period 2: September 1, 2024 through August 31, 2025.

Option Period 3: September 1, 2025 through August 31, 2026.

Option Period 4: September 1, 2026 through August 31, 2027.

Contractor Requirements

Independently, and not as an agent of the Government, the contractor shall provide one licensed Nurse Practitioner, one nurse coordinator and one Genetic Counselor on a part-time basis to perform the following tasks in collaboration with Dr. Beth Kozel:

• Set up and maintain a website that aims to bring patients with Williams Syndrome to the St. Louis Children’s Hospital Williams Syndrome Clinic (WSC): http://www.stlouischildrens.org/our-services/williams-syndrome-center.

• Coordinate visits for patients coming to the WSC, including answering questions from potential patients and their families, obtaining outside records for medical review, and coordination of the patient visit.

• Participate in the consent and sample acquisition process for IRB approved protocols. Maintain appropriate study files.

• Send research related samples (saliva, blood, skin samples) and paperwork to the NIH using appropriate shipping methods.

• Support the clinic operations (answering patient questions, responding to urgent medical needs) when Dr. Kozel is not available.

• Return results to patients of clinical tests and research results when release has been approved by the study IRB.

• Maintain communication with the study's Principal Investigator.

Sole Source Justification

The Washington University’s William Syndrome Clinic of St. Louis Children’s Hospital is a unique organization with unique access to a large pool of patients needed for the NHLBI to conduct large, longitudinal studies of Genetic Modifies of Elastic Fiber Disease. As such, the WSC has rare access to a unique pool of patients that will be a source of various NHLBI-sponsored protocols. The William Syndrome Clinic’s pool of patients is the only one large enough to effectively carry-out NHLBI protocols.

Without the support of the William Syndrome Clinic, the NHLBI cannot conduct its research into the Genetic Modifiers of Elastic Fiber Disease.

Regulatory Authority

This acquisition is conducted under the authority of the Federal Acquisition Regulations (FAR) Subpart 13.106-1(b) Soliciting from a single source. (1) For purchases not exceeding the simplified acquisition threshold, contracting officers may solicit from one source if the contracting officer determines that the circumstances of the contract action deem only one source reasonably available (e.g., urgency, exclusive licensing agreements, or industrial mobilization).

FAR Clauses

The provision at FAR clause 52.212-1, Instructions to Offerors – Commercial Items, applies to this acquisition.

The provision at FAR clause 52.212-2, Evaluation – Commercial Items, is applicable. The Government will award a contract resulting from this notice to the offeror listed above. The following factors shall be used to evaluate the offer: The contractor shall demonstrate its ability to provide the services listed that meets the specifications provided above.

FAR clause 52.212-3, Offeror Representations and Certifications – Commercial Items, is applicable. An offeror shall complete only paragraphs (b) of this provision if the offeror has completed the annual representations and certificates electronically via http://www.acquisition.gov. If an offeror has not completed the annual representations and certifications electronically at the System for Award Management (SAM) website, the offeror shall complete only paragraphs (c) through (p) of this provision.

FAR clause at 52.212-4, Contract Terms and Conditions – Commercial Items, applies to this acquisition.

FAR clause at 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders – Commercial Items, applies to this acquisition.

FAR clause 52.217-9, Option to Extend the Term of the Contract applies to this acquisition.

(a) The Government may extend the term of this contract by written notice to the Contractor within thirty

(30) calendar days; provided that the Government gives the Contractor a preliminary written notice of its intent to extend prior to contract expiration. The preliminary notice does not commit the Government to an extension.

(b) If the Government exercises this option, the extended contract shall be considered to include this option clause.

(c) The total duration of this contract, including the exercise of any options under this clause, shall not exceed five years.

Additional Information http://www.acquisition.gov/

The North American Industry Classification System (NAICS) Code is 541990 and the Small Business Size Standard is 17 Million. This acquisition is being conducted under FAR Part 13, Simplified Acquisition Procedures, therefore the requirements of FAR Part 6, Competitive Requirements, are not applicable and the resultant award will include all applicable provisions and clauses in effect through the Federal Acquisition Circular 2022-07 effective August 10, 2022.

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 and include: 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 Unique Entity Identifier (UEI), 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 must be received by August 29, 2022 at 5:00PM EST and must reference synopsis number 75N92022Q0473. Responses shall be submitted electronically to nicole.freid@nih.gov. Responses will only be accepted if dated and signed by an authorized company representative. All responsible sources may submit a bid, proposal, or quotation which shall be considered by the agency.

http://www.sam.gov/ mailto:nicole.freid@nih.gov