presol_intent_final.pdf

11/16

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

INTRODUCTION

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

SYNOPSIS TO AWARD A PURCHASE ORDER WITHOUT PROVIDING FOR FULL

OR OPEN COMPETITION.

The National Heart, Lung, and Blood Institute (NHLBI), Office of Acquisitions (OA) on behalf of the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) intends to negotiate and award a purchase order without providing for full and open competition to the University of California San Francisco to serve as a second clinical trial site for the Pustular Psoriasis Study.

NORTH AMERICAN INDUSTRY CLASSIFICATION SYSTEM (NAICS) CODE

The intended procurement is classified under NAICS code 541715 with a Size Standard of 1,000 employees.

REGULATORY AUTHORITY

The resultant contract will include all applicable provisions and clauses in effect through the Federal Acquisition Circular (FAC) 2005-95.

This acquisition is conducted under the procedures as prescribed in FAR subpart 13— Simplified Acquisition Procedures at an amount not exceeding the simplified acquisition threshold ($150,000).

STATUTORY AUTHORITY

This acquisition is conducted under the authority of the Federal Acquisition Regulation (FAR) Part 13—Simplified Acquisition Procedures, Subpart 13.106-1 (b) (1), Soliciting from a single source and is not expected to exceed the simplified acquisition threshold.

Contracts awarded using FAR Part 13—Simplified Acquisition Procedures are exempt from the requirements of FAR Part 6—Competition Requirements.

BACKGROUND

The National Institute of Arthritis and Musculoskeletal and Skin Disease (NIAMS) is seeking small businesses to serve as a second Clinical Center (CC) for the ongoing clinical trial under the Protocol 13-C-0071, “A Phase 2 Study of Anakinra in Inflammatory Pustular Dermatoses: Evaluation of Therapeutic Efficacy and Validation of Pathogenic Mechanisms”. Protocol 13-C-0071 has been actively recruiting for over four

(4) years. The NIAMS Dermatology Consultation Service and Clinical Research Unit (DCSCR) is the initial site for the ongoing protocol and during the past four years, the DCSCR has recruited 15 out of the 25 evaluable patients needed under the approved study.

Inflammatory pustular skin diseases are a type of autoinflammatory disease in which the immune system attacks the body tissues. These diseases cause painful and itchy skin rashes, eye and mouth irritation, join pain and fever. Several drugs for treating these diseases suppress the immune system. However, they can cause severe side effects when taken over a long period of time. IL-1 is a small protein that may be important in causing the inflammation seen in pustular skin diseases. Anakinra is a drug that works by blocking IL-1. It has been effective in treating some inflammatory conditions such as rheumatoid arthritis. However, anakinra has not be studied for use in patients with pustular skin diseases. This objective of this study is to characterize the clinical efficacy, optimal dosing and safety of anakinra in patients with pustular skin disease.

This acquisition is for a purchase order for one clinical trial site with subcontracts and/or other mechanisms as needed to accomplish all necessary work described in this Statement of Work.

DESCRIPTION OF REQUIREMENT

During the estimated time period from July 13, 2018 to July 12, 2020, the clinical trial site is expected to provide the necessary technical expertise and facilities to effectively perform the tasks and meet the requirements identified below.

Throughout the period of performance, the clinical trial site is expected to provide appropriate senior personnel with expertise in clinical trial management and extensive knowledge on pustular dermatoses to:

1) Enroll three (3) patients per year who have inflammatory pustular skin disease.

Oversee and obtain informed consent and collect and transmit screening and enrollment data to the NIAMS DCSCR.

2) Screen study participants with physical examinations and medical history. Evaluate patients with pustular skin disease through blood tests, urine tests, and imaging studies. Skin biopsies may be collected as well.

3) Administer study drug, Anakinra, to study participants and show how to properly administer daily injections of anakinra at participant’s home.

4) Conduct participant study visits at weeks 0, 4, 8, 12, and 16. Study participants will be required to record any side effects in a daily diary.

5) Work cooperatively with the NIAMS DCSCR in all relevant aspects of the study execution.

6) Implement a transition plan for data flow to the NIAMS DCSCR for further analysis.

7) Perform activities related to study closeout or study transition activities as directed by the NIAMS Project Office. Ensure all participant data has been transferred to the

NIAMS DCSCR.

PERIOD OF PERFORMANCE

The anticipated period of performance of any resultant purchase order from this potential requirement shall begin on or around July 13, 2018 through July 12, 2019, and include an option to exervise one (1) additional one year option period.

If the Government decides to exercise the option period, the ultimate purchase order period of performance will be July 13, 2018 to July 12, 2020.

Periods Anticipated Dates

Base July 13, 2018 – July 12, 2019

Option 1 July 13, 2019 – July 12, 2020

OTHER IMPORTANT CONSIDERATIONS

N/A

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, specifically the review and evaluation of the responses to the sources sought notice published in the FedBizOpps on April 27, 2018 (HHS-NIH- NHLBI-SBSS-75N92018Q0136, Pustular Psoriasis Study).

The University of California San Fransisco (UCSF) is capable of performining the project requirements and has extensive experience in the dermatology and is a top 10 dermatology department in the Univted States. UCSF currently has a large cohort of existing psoriasis patients that could be potential candiadates for the trial. Based on historical evidence for the past four (4) years, it has been determined that traveling from great distances to montly clinical visits is difficult for patients with severe pustular skin disease. Thus, the establishment of a second clinical trial site at UCSF will expedite recruitment, enrollment, and completion of the clinical trial and will likely draw patients from the West Coast. The key personnel that will be overseeing this trial has extensive history in the field of psoriasis and has been assisting in the conduct of this research at the NIH for the past four (4) years, where the initial site is located. Now working at the UCSF, the key personnel will manage the second site and provide the services as specified above.

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 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 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 must be received by 12:00 PM on May 29, 2018. Responses must be submitted via the FedConnect webportal (www.fedconnect.net). Potential Offerors do not need to register to view a notice; however, in order to submit questions and/or response to this Notice, an account will need to be established. Should you require a waiver not to use FedConnect, please contact the Contracting Officer listed in this notice.

“All responsible sources may submit a bid, proposal, or quotation which shall be considered by the agency.”